WO2010067463A1 - Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery - Google Patents
Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery Download PDFInfo
- Publication number
- WO2010067463A1 WO2010067463A1 PCT/JP2008/072898 JP2008072898W WO2010067463A1 WO 2010067463 A1 WO2010067463 A1 WO 2010067463A1 JP 2008072898 W JP2008072898 W JP 2008072898W WO 2010067463 A1 WO2010067463 A1 WO 2010067463A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- aortic valve
- tissue piece
- tool
- tissue
- capturing
- Prior art date
Links
- 0 *OCCC1CCCCC1 Chemical compound *OCCC1CCCCC1 0.000 description 2
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
Definitions
- the present invention relates to a tissue piece capturing tool for aortic valve replacement surgery for suppressing the invasion of a tissue piece remnant that may be generated by aortic valve resection in an aortic valve replacement operation, and a tissue piece for aortic valve replacement surgery.
- the present invention relates to a capturing device set and a tissue fragment capturing method in aortic valve replacement surgery.
- aortic valve replacement surgery is widely performed as a treatment for aortic stenosis or aortic regurgitation caused by aortic valvular disease.
- the aortic valve replacement operation refers to an operation in which the aortic valve is removed and replaced with a mechanical valve or a biological valve introduced from the outside in order to treat aortic stenosis or aortic regurgitation caused by aortic valvular disease.
- Aortic valvular disease refers to a state in which the aortic valvular membrane hinders opening and closing movements, and when it develops, the blood transfusion efficiency of the heart decreases. In principle, it is considered a serious disease requiring surgical treatment.
- Aortic stenosis refers to a condition where the opening of the aortic valve is not successful
- aortic valve insufficiency refers to a condition where the closure is not successful.
- the aortic valve is resected from an incision made by previously incising the ascending aortic wall near the leaflet of the aortic valve.
- aortic valve replacement surgery when aortic valve is excised, a minute tissue fragment residue may be generated, and the tissue fragment residue generated by the excision may enter the ventricle. If the tissue piece has entered the ventricle, if the operation is completed as it is, the tissue piece will remain in the ventricle or other organs.
- the capture device such as gauze
- the size of the capture device such as gauze needs to be sufficient to block the aortic valve.
- the maximum inner diameter on the annulus side of the aortic valve is approximately 15 to 25 mm for adults. That is, it is necessary to use a capturing tool having a size of 15 to 25 mm.
- the gap between the leaflets of the aortic valve is generally 3 to 7 mm when the maximum length is an adult. Therefore, the capturing device such as gauze cannot pass through the gap between the leaflets as it is.
- the present invention provides a tissue piece capturing device for aortic valve replacement surgery that can close the aortic valve before excising the leaflets, a tissue piece capturing device set for aortic valve replacement surgery, and aortic valve replacement.
- An object of the present invention is to provide a method for capturing a tissue piece in an operation.
- a tissue fragment capturing tool for aortic valve replacement surgery comprises: A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; An expanded state having a size, and prior to the replacement operation of the aortic valve, the aortic valve leaflet is passed from the aorta side toward the left ventricle side in the contracted state, and after the introduction of the left ventricle In the expanded state, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue piece residue is prevented from entering the left ventricle.
- it is composed of a film-like material and inflates like a so-called balloon by injecting air.
- the whole is made of an inflatable material that expands by absorbing liquid, and can be changed from a contracted state to an expanded state by absorbing liquid.
- the structure includes an inflatable material that expands by absorbing liquid, and a sheet-like capturing portion that wraps the inflatable material, and the inflatable material absorbs the liquid.
- the contracted state can be changed to the expanded state.
- a sheet-like capture unit that captures the tissue piece and a movable support unit that supports and deforms the capture unit, and by deforming the capture unit through operation of the support unit, There is means for switching from the contracted state to the expanded state.
- the support portion is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capture portion is a cloth material covering the periphery of the brush.
- the support portion is a plurality of disc-shaped brushes provided with hair material radially from the center toward the outer periphery, and the capturing portion is a disc-shaped brush inserted between the brushes. It is a cloth material.
- the contraction state of the brush of the support part is a state where the disk-like brush is closed in an umbrella shape, and the expansion state is the disk-like brush.
- the expansion state is the disk-like brush.
- the technique using the tissue piece capturing device of the present invention is a new concept tissue piece capturing method that has never been known before, and there is no example that discloses such a capturing device.
- the aortic valve gap of 3 to 7 mm can be inserted, and in the expanded state, the inner diameter of the 15 to 25 mm aortic valve on the annulus side can be closed.
- a structure having a thread-like, tubular or rod-like recovery tool is provided, and one end of the recovery tool is left on the aorta side before and after the aortic valve replacement surgery.
- one end of the recovery tool is pulled to pass through the aortic valve to enable recovery from the aortic side.
- tissue piece capturing tool set for aortic valve replacement surgery of the present invention A tubular member introducer having an outer diameter capable of passing through the gap of the aortic valve leaflet; A tissue piece capturing device comprising a contracted state having a shape and size capable of passing through the inside of the introducer, and an expanded state having a shape and size that fits in the vicinity of the aortic valve annulus in the left ventricle and closes the aortic valve
- An opening tool that pushes out the tissue piece capturing tool housed inside the introduction tool and releases it from the tubular member;
- the introducer that houses the tissue piece capturing device in the contracted state is introduced into the gap of the aortic valve leaflet so that the left ventricle side from the aorta side.
- the aorta is secured by allowing the tissue piece capturing device to be pushed out by the opening device and passing through the inside of the introducing device, and after the tissue piece capturing device is introduced into the left ventricle, the expanded state is established.
- the aortic valve is closed in the vicinity of the annulus to prevent the tissue fragment residue from entering the left ventricle.
- the tissue fragment capturing method in the aortic valve replacement surgery of the present invention A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve;
- a tissue piece capture device with an expanded state that becomes a size Prior to the replacement operation of the aortic valve, the tissue piece capturing device is passed through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side in the contracted state, and the expanded state after the introduction of the left ventricle
- the aortic valve is closed in the vicinity of the aortic annulus, and the tissue fragment residue is prevented from entering the left ventricle.
- FIG. 1 is a diagram showing an expanded state of a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a.
- FIG. 2 is a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a.
- FIG. 3 is a diagram showing another contracted state of the tissue piece capturing device 10a.
- FIG. 4 is a diagram showing an expanded state of a configuration example of the spherical three-dimensional tissue piece capturing device 10b.
- FIG. 5 is a diagram showing a contracted state of the configuration example of the spherical solid-shaped tissue piece capturing tool 10b.
- FIG. 6 shows an expanded state of the configuration example of the substantially bowl-shaped three-dimensional tissue piece capturing tool 10c.
- FIG. 7 is a diagram showing a contracted state of a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing device 10c.
- FIG. 8 is a configuration example of a conical substantially scissor-shaped tissue piece capturing device 10d.
- FIG. 9 is a diagram showing a contracted state of a configuration example of the cone-shaped substantially scissor-shaped tissue piece capturing tool 10d.
- FIG. 10 is a diagram showing an expanded state of a configuration example of a substantially donut-shaped capturing tool 10e whose central portion is closed with a membrane.
- FIG. 11 is a diagram where the central portion is closed with a membrane.
- FIG. 12 is a diagram showing a contracted state of a configuration example of a substantially donut-shaped three-dimensional capturing device 10e.
- FIG. 12 is a diagram showing a contracted state of a tissue piece capturing device 10c by applying air pressure.
- FIG. 14 is a diagram showing a configuration example in which the tissue piece capturing tool 10c is switched from the contracted state to the expanded state.
- FIG. 14 is a diagram showing the contracted state of the tissue piece capturing tool 10e shown in FIG.
- FIG. 16 is a diagram showing a configuration example of switching from the contracted state of the tissue piece capturing tool 10e shown in FIG. 11 to the expanded state of the tissue piece capturing tool 10e shown in FIG. 11.
- FIG. 16 shows the contraction of the tissue piece capturing tool 10a shown in FIG.
- FIG. 17 Shown in Figure 2 from the state
- FIG. 17 is a diagram showing a configuration example of switching to the expanded state of the tissue piece capturing tool 10a.
- FIG. 17 switches from the contracted state of the tissue piece capturing tool 10a shown in FIG. 3 to the expanded state of the tissue piece capturing tool 10a shown in FIG.
- Fig. 18 is a diagram showing a configuration example.
- Fig. 18 is a diagram showing a configuration example for switching from the contracted state of the tissue piece capturing device 10d shown in Fig. 9 to the expanded state of the tissue piece capturing device 10d shown in Fig. 8.
- FIG. 20 is a diagram showing a configuration example in which the tissue piece capturing section 10 is deformed through operation of the support section.
- FIG. 20 is a diagram showing a configuration example in which the tissue piece capturing section 10 is deformed through operation of the support section.
- FIG. 20 shows a state in which the entire tissue piece capturing tool 10f is contracted by contracting the support ring 15 to the left and right.
- FIG. 21 is a diagram showing another configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit.
- FIG. 22 shows a state in which the support balloon 17 is deflated by removing air. It is a figure showing typically
- FIG. 24 is a diagram showing an expanded state of a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h.
- FIG. 24 is a diagram showing a contracted state of a configuration example of the brush-shaped three-dimensional tissue piece capturing tool 10h.
- FIG. 25 is a diagram showing an expanded state of the configuration example of the brush-shaped three-dimensional tissue piece capturing tool 10h ′ in which the hair material is covered with the cloth material.
- FIG. 26 is a brush-like shape in which the hair material is covered with the cloth material.
- FIG. 27 is a diagram showing a contracted state of a configuration example of a three-dimensional tissue piece capturing device 10h ′.
- FIG. 27 is a diagram showing an expanded state of a configuration example of a tissue piece capturing device 10h ′′ in which a cloth material is sandwiched between bristle materials.
- FIG. 28 is a diagram schematically showing an exploded view of two bristle materials of the tissue piece capturing tool 10h ′′ and a cloth material sandwiched between them.
- FIG. 29 is a diagram of FIG. It is a figure which shows the structure provided with the collection
- FIG. 30 is a view showing a configuration in which the recovery tool 30 is provided for the tissue piece capturing tool 10f with the support ring 15 shown in FIG. 19 of the first embodiment.
- FIG. 31 shows the tissue piece capturing tool 10f as the introduction tool 40.
- FIG. 32 is a view showing a state in which the tissue piece capturing tool 10f is released by pushing it from the inside of the introduction tool 40 to the outside through the release side opening 41.
- FIG. FIG. 34 is a view showing a state in which the tissue piece capturing tool 10f is accommodated in the introduction tool 40.
- FIG. 30 is a view showing a configuration in which the recovery tool 30 is provided for the tissue piece capturing tool 10f with the support ring 15 shown in FIG. 19 of the first embodiment.
- FIG. 31 shows the tissue piece capturing tool 10f as the
- FIG. 34 is a diagram showing that the tissue piece capturing tool 10f is pushed out from the introduction tool 40 to the outside through the release side opening 41.
- FIG. 35 is a view showing a released state.
- FIG. 35 is a view showing a state in which the tissue piece capturing tool 10g is accommodated in the introduction tool 40.
- FIG. 36 is a view showing the tissue piece capturing tool 10g from the inside of the introduction tool 40. Outside through the opening 41
- FIG. 37 is a view showing a state where the tissue piece capturing device 10 is pushed out by the push-out rod 50 as the opening device 50.
- FIG. 38 is a view showing the leaflet of the aortic valve.
- FIG. 39 is a diagram showing a procedure for dissecting the ascending aortic wall in the vicinity and providing an incision.
- FIG. 39 passes the space 4 of the leaflet of the aortic valve 3 and introduces the introducer 40 up to the annulus 6 of the aortic valve 3.
- FIG. 40 is a diagram showing a procedure for closing the aortic valve 3 by placing the tissue piece capturing device 10 in an expanded state and placing it in the vicinity of the aortic valve annulus.
- FIG. 41 is a diagram showing the introducing device 40. It is a figure which shows the procedure which takes out from the incision to the exterior of the ascending aorta
- tissue piece capturing device for aortic valve replacement surgery the tissue piece capturing device set for aortic valve replacement surgery, and the tissue piece capturing method in aortic valve replacement surgery according to the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings.
- the present invention is not limited to these examples.
- the tissue piece capturing device for aortic valve replacement surgery of the present invention suppresses invasion of a tissue piece residue into the left ventricle that may be caused by excision of the aortic valve in aortic valve replacement surgery.
- Example 1 various structure examples of the tissue piece capturing tool 10 for aortic valve replacement surgery and a structure for switching between an expanded state and a contracted state of the tissue piece capturing tool will be described.
- Example 2 a configuration example of the tissue piece capturing tool 10 with the recovery tool 30 is shown.
- Example 3 an operation procedure for placing and removing the tissue piece capturing device 10 at a predetermined position of the ventricle using the introducing device 40 and the opening device 50 will be described.
- FIG. 1 and FIG. 2 are diagrams showing a configuration example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a.
- FIG. 1 shows an expanded state of the tissue piece capturing tool 10a
- FIG. 2 shows a contracted state of the tissue piece capturing tool 10a. 1 and 2, (a) is a front view, (b) is a side view, and (c) is a perspective view.
- the shape and size of the tissue piece capturing device 10a in the expanded state are not particularly limited as long as the shape and size are close to the aortic valve annulus in the left ventricle of the patient and close the aortic valve, but the size is not limited.
- the capturing device 10 will be located in the vicinity of the aortic valve, and the operation such as excision of the valve leaflet will be performed. When working, the work space is compressed and obstacles occur. Therefore, about 1 to 30 mm is preferable.
- the shape is a wide, substantially cylindrical three-dimensional shape, and the edge portion is a smooth curved surface.
- This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
- the shape and size of the tissue piece capturing device 10a in the contracted state are not limited as long as the shape and size can pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side.
- the shape is a thin cylindrical solid shape, and the edge portion is a smooth curved surface.
- the size is 3 to 7 mm in diameter and 3 to 7 mm in height.
- the tissue piece capturing device 10a of the present invention Prior to the aortic valve replacement operation, the tissue piece capturing device 10a of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG.
- the gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10a of the present invention can pass through in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10a cannot pass, the leaflets may be cut to increase the gap.
- the length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
- the tissue piece capturing device 10a of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed and the tissue piece residue is captured in a substantially cylindrical internal void. In this way, prior to the aortic valve replacement operation, the tissue piece capture device 10a can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
- FIG. 3 is an example of another contracted state of the tissue piece capturing tool 10a.
- a part of the expanded state of FIG. 1 is contracted and the other part is expanded to be contracted. That is, although the outer diameter of the substantially cylindrical shape is reduced from the expanded state of FIG. 1, the height is increased and the whole is contracted into a compact shape.
- the shape of the tissue piece capturing tool 10 of the present invention is not limited to that shown in FIGS. 1 and 2 or those shown in FIGS. 1 and 3, and various other shapes and sizes are possible.
- FIGS. 1 and 2 an example of a spherical three-dimensional tissue piece capturing tool 10b is shown.
- 4 and 5 are diagrams showing a configuration example of a spherical solid-shaped tissue piece capturing tool 10b.
- FIG. 4 shows an expanded state of the tissue piece capturing tool 10b
- FIG. 5 shows a contracted state of the tissue piece capturing tool 10b. 4 and 5, (a) is a front view, and (b) is a side view.
- the capturing tool 10b has a spherical three-dimensional shape in the expanded state, has a shape and a size that fits in the vicinity of the aortic valve annulus, and closes the aortic valve.
- the shape of the capturing device 10b does not necessarily have an accurate spherical shape, and even the non-spherical capturing device 10b may have a shape and size that can be accommodated in the vicinity of the aortic valve annulus.
- the diameter of the sphere is 10 to 30 mm.
- the capturing tool 10b has a thin cylindrical solid shape in a contracted state, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape.
- the size is 3 to 7 mm in diameter and 10 to 30 mm in height.
- the tissue piece capturing device 10b of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG.
- the gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10b of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10b cannot pass, the leaflets may be cut to increase the gap.
- the length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
- the tissue fragment capturing device 10b of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. Capture tissue debris.
- FIG. 6 shows the expanded state of the tissue piece capturing tool 10c
- FIG. 7 shows the contracted state of the tissue piece capturing tool 10c.
- the capturing tool 10c has a substantially bowl-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus, and has a substantially bowl-like shape.
- the mouth closes the aortic valve.
- the diameter of the ridge is 10 to 30 mm.
- the edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
- FIG. 6 is a front view
- FIG. 6 is a side view
- the capturing tool 10c has a substantially bowl-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus, and has a substantially bowl-like shape.
- the mouth closes the aortic valve.
- the diameter of the ridge is 10 to 30 mm.
- the edge portion is disclosed as a smooth curved surface
- the tissue piece capturing tool 10c has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl shape inside.
- the edge portion is disclosed as a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape.
- the size is 3 to 7 mm in diameter and 10 to 30 mm in length.
- the tissue piece capturing device 10c of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG.
- the gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10c of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10c cannot pass, the leaflets may be cut to increase the gap.
- the length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
- the tissue piece capturing device 10c of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG.
- FIG. 8 and FIG. 9 are diagrams showing a configuration example of a cone-shaped substantially scissor-shaped tissue piece capturing tool 10d.
- FIG. 8 shows an expanded state of the tissue piece capturing tool 10d
- FIG. 9 shows an expanded state of the tissue piece capturing tool 10d
- the tissue piece capturing tool 10d has a conical substantially saddle-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus.
- the aortic valve is closed by a shaped mouth.
- the diameter of the ridge is 10 to 30 mm.
- the edge portion is disclosed as a smooth curved surface.
- the trapping tool 10 d has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl-like shape inside. In this example, the shape is almost the same as that in FIG. 7, and the edge portion has a smooth curved surface.
- This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape.
- the size is 3 to 7 mm in diameter and 10 to 30 mm in length.
- the tissue piece capturing tool 10d of the present invention Prior to the aortic valve replacement operation, the tissue piece capturing tool 10d of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG.
- the gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10d of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10d cannot pass, the leaflets may be cut to increase the gap.
- the length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
- the tissue piece capturing device 10d of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG.
- the valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
- the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10d.
- FIG. 11 are diagrams showing a configuration example of a substantially donut-shaped three-dimensional capturing tool 10e whose central portion is closed with a membrane.
- FIG. 10 shows an expanded state of the tissue piece capturing tool 10e
- FIG. 11 shows a contracted state of the tissue piece capturing tool 10e.
- 10 and 11 (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
- the tissue piece capturing device 10e has a substantially donut-shaped three-dimensional shape in which the central portion is closed with a membrane in the expanded state, and has a shape and size that fits in the vicinity of the aortic valve annulus. The aortic valve is blocked.
- the outer diameter of the donut is 10 to 30 mm.
- the edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
- the contracted state of the capturing tool 10e has a three-dimensional shape that is entirely contracted from the expanded state of FIG.
- the outer diameter of the donut is 3 to 7 mm.
- contact with a tissue is eased at the time of introduction into the body.
- the tissue piece capturing tool 10e of the present invention Prior to the aortic valve replacement operation, the tissue piece capturing tool 10e of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG.
- the gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10e of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10e cannot pass, the leaflets may be cut to increase the gap.
- the length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
- the tissue piece capturing device 10e of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. 10 so that the aortic valve is surrounded by the portion corresponding to the mouth of the donut.
- the valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
- the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10e.
- the structure of the tissue piece capturing tool 10 is not limited, the volume can be reduced by a simple operation, and the volume can be increased to the original by a simple operation, for example, by shape recovery by shape memory ability.
- a structure capable of forming is preferable. As such a structure, for example, a porous structure having shape memory ability or a fiber is preferable.
- 12 and 13 are diagrams illustrating a configuration example in which the tissue piece capturing tool 10 is switched from the contracted state to the expanded state by applying air pressure.
- FIG. 6 is a diagram illustrating a configuration example in which the tissue piece capturing device 10a illustrated in FIG.
- FIG. 12 shows a contracted state before air pressure is applied to the tissue piece capturing tool 10a.
- FIG. 13 shows a state in which the tissue piece capturing tool 10a is switched to the expanded state by applying air pressure. Both FIG. 12 and FIG. 13 are shown by side sectional views.
- the tissue piece capturing tool 10 a includes a balloon 11 and an inlet 12 provided in the balloon 11.
- a pressure supply tube 20 that can apply air pressure to the balloon 11 can be attached to the balloon 11 via the suction port 12.
- the air pressure is decreased as shown in FIG. 12 to such an extent that it can pass through the gap between the leaflets of the aortic valve.
- the tissue piece capturing device 10a in the state of FIG. 12 is passed through the gap between the leaflets in the horizontal direction in the drawing from the lower side, the tissue piece capturing device 10a is in a contracted state in the traveling direction.
- the tissue piece capturing device 10a is passed as it is from the aortic valve leaflet side to the annulus side, and introduced into the vicinity of the aortic valve annulus in the left ventricle. Thereafter, as shown in FIG.
- FIG. 14 shows a state before air pressure is applied to the tissue piece capturing tool 10e.
- FIG. 15 shows a state in which the tissue piece capturing tool 10e is switched to the expanded state by applying air pressure.
- 14A is a side sectional view
- FIG. 14B is a perspective view with a part omitted.
- FIG. 15 shows a side sectional view.
- the tissue piece capturing device 10 e includes a balloon 11 and an inlet 12 provided in the balloon 11.
- a pressure supply tube 20 that can apply air pressure to the balloon 11 can be attached to the balloon 11 via the suction port 12.
- the left side of the tissue piece capturing tool 10 e is referred to as “lower part”, and the right side of the tissue piece capturing tool 10 e is referred to as “upper part”.
- the tissue piece capturing device 10 e has a substantially donut shape with the center closed by a membrane. At the time of introduction, the air pressure is reduced to a contracted state and passed through the gap of the aortic valve leaflet.
- the tissue piece capturing tool 10e is passed through the gap of the aortic valve leaflet and introduced to the vicinity of the aortic valve annulus in the left ventricle. Thereafter, the lower part is directed to the aortic valve inflow part side and the upper part is directed to the aortic valve outflow part side, and then the air pressure is applied from the suction port 12 to the balloon 11 through the pressure feeding tube 20 as shown in FIG. To close the aortic valve by inflating to an expanded state. Although the maximum diameter of the balloon 11 in the expanded state in which air pressure is applied is not limited, it is preferable not to apply excessive pressure in the vicinity of the aortic valve annulus.
- the maximum diameter of the cross section of the balloon 11 is, for example, about 10 to 30 mm.
- the length from the upper part to the lower part is not limited, since the ventricle is closed during operation and the tissue piece capturing device 10e cannot enter, if the length is too long, the tissue piece capturing device is located in the vicinity of the aortic valve. 10e is located, and the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of the aortic valve leaflet. Therefore, for example, about 1 to 30 mm is preferable.
- the material of the balloon 11 is not limited, and examples thereof include silicon resin, fluorine resin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, and various blend materials.
- the tissue piece capturing tool 10 may further include a capturing sheet that covers the outer layer of the balloon 11 in order to capture the tissue pieces more efficiently.
- the structure of such a capture sheet is not limited, but a structure having high affinity with a tissue piece is preferable. As such a structure, for example, a rough surface, a fiber, a nonwoven fabric, or a porous material is preferable.
- the material of the capture sheet is not limited, and examples thereof include silicon resin, fluororesin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, cellulose, chitosan, and various blend materials.
- FIG. 16 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 1 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. The upper part of FIG.
- FIG. 16 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid.
- the lower part of FIG. 16 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid.
- Both the upper view and the lower view of FIG. 16 are shown by side sectional views.
- swelling raw material 13 will not be limited if it absorbs a liquid and expand
- the compressed fiber lump is mentioned.
- a raw material is not limited, For example, a cellulosic fiber is mentioned.
- tissue piece capturing device 10a is maintained.
- the volume can be expanded. If the size of the tissue piece capturing device 10a is large enough to pass through the gap between the leaflets of the aortic valve in the contracted state in which the expansion material 13 is dried, the side of the aortic valve leaflet is set to the advancing direction side. The gap can be passed. Thereafter, by exposing the tissue piece capturing tool 10a to a liquid such as physiological saline to increase the volume, the vicinity of the aortic valve annulus can be closed. FIG.
- FIG. 17 is a diagram illustrating a configuration example of switching from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 3 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. 1 by absorbing physiological saline.
- the upper part of FIG. 17 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid.
- the lower part of FIG. 17 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid.
- Both the upper view and the lower view of FIG. FIG. 17 shows a tissue piece capturing device by forming a substantially cylindrical bag with a water-permeable sheet 14 that can be reduced, expanded, or folded, and filling the bag with a plurality of inflatable materials 13 that expand by absorbing liquid.
- FIG. 17 It is a figure which shows the example which comprised 10a.
- the upper part of FIG. 17 is a perspective view showing the tissue piece capturing tool 10a which has been dried to reduce the expanded material 13 and brought into a contracted state.
- the lower view of FIG. 17 is a perspective view showing the tissue piece capturing tool 10a in an expanded state by absorbing the liquid and expanding the expansion material 13.
- the water-permeable sheet 14 having a substantially cylindrical shape in the upper part of FIG. 17 is deformed by reducing a part thereof and expanding the other part, and has a substantially cylindrical outer diameter as shown in the lower part of FIG. The height is reduced by expanding.
- FIG. 18 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10d illustrated in FIG. 9 to the expanded state of the tissue piece capturing device 10d illustrated in FIG. 18 shows a contracted state before the tissue piece capturing tool 10d absorbs the liquid.
- the lower part of FIG. 18 shows an expanded state after the tissue piece capturing tool 10d has absorbed the liquid.
- Both the upper and lower views of FIG. 18 are shown by side sectional views. In the contracted state shown in the upper diagram of FIG.
- the aortic valve can be blocked by passing through the gap between the leaflets of the aortic valve, and then exposing the tissue piece capturing device 10 d to a liquid such as physiological saline and expanding it by absorbing water. it can.
- swelling raw material 13 is not limited,
- the compressed fiber lump is mentioned.
- the raw material of the compressed fiber lump is not limited,
- a cellulose fiber lump is mentioned.
- the size of the compressed fiber lump when dried is preferably about 1 mm to 7 mm.
- the size when the liquid is absorbed and expanded is not limited, for example, in the case of a cellulosic fiber lump, the volume increases about three times as compared with the time of drying.
- the structure of the water-permeable sheet 14 is not limited, For example, a nonwoven fabric, the nonwoven fabric by which many holes were carried out, and a porous membrane are mentioned.
- the raw material of the water-permeable sheet 14 is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned.
- the material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
- FIG. 19 is a diagram illustrating a configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit.
- FIG. 19A is a front view
- FIG. 19B is a side view.
- the tissue piece capturing tool 10 f for aortic valve replacement surgery includes a ring-shaped support portion 15 and a capture sheet 16 attached to the support portion 15.
- the lower side of the tissue piece capturing tool 10 f is referred to as “lower part”
- the upper side of the tissue piece capturing tool 10 f is referred to as “upper part”.
- FIG. 19 the tissue piece capturing tool 10 f for aortic valve replacement surgery includes a ring-shaped support portion 15 and a capture sheet 16 attached to the support portion 15.
- the lower side of the tissue piece capturing tool 10 f is referred to as “lower part”
- the upper side of the tissue piece capturing tool 10 f is referred to as “upper part”.
- FIG. 19 is a diagram illustrating a configuration example
- the tissue piece capturing device 10f of the present invention has a substantially disk shape, and has a shape that fits in the vicinity of the aortic valve annulus when the tissue sheet is captured by the capturing sheet 16, for example. is doing.
- the shape of the tissue piece capturing tool 10f is not necessarily a substantially disk shape, and may be any shape that can block the aortic valve. For example, it may be substantially cylindrical.
- the tissue piece capturing device 10f is contracted to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, as shown in FIG.
- the support ring 15 is contracted left and right to bring the entire tissue piece capturing device 10f into a contracted state, and the tissue piece capturing device 10f is passed through the gap between the aortic valve leaflets in the contracted state. Introduce up to the valve annulus. Thereafter, the aortic valve can be closed by adjusting the direction in which the tissue piece is captured by the capture sheet 16 and then in the expanded state shown in the upper diagram of FIG.
- the maximum diameter of the support portion 15 is not limited, but is preferably about 10 to 30 mm, for example, because it needs to fit in the aortic valve. Also, the height of the ring-shaped support portion 15 is not limited.
- the structure of the support ring 15 is not limited, but a structure that can be transformed into a contracted state by a simple operation and can be returned to an expanded state by a simple operation, for example, by shape recovery by shape memory ability, is preferable. .
- a ring structure and a spring structure having shape memory ability are preferable.
- the raw material of the support ring 15 is not limited, For example, stainless steel, titanium (Ti), tantalum (Ta), nitinol (Ni-Ti alloy), etc. are mentioned.
- the structure of the capture sheet 16 is not limited, but a structure that can follow the deformation of the support ring 15 and can capture a tissue piece is preferable. As such a structure, a fiber, a nonwoven fabric, a porous structure, etc. are preferable, for example.
- the material of the capture sheet 16 is not limited, and examples thereof include silicon resin, fluorine resin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, and various blend materials. FIG.
- FIG. 21 is a diagram illustrating another configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit 15.
- FIG. 21A is a front view
- FIG. 21B is a side view
- FIG. 22 is a diagram schematically showing a contracted state.
- the tissue piece capturing tool 10 g includes a support balloon 17 and a capture sheet 16 attached to the support balloon 17.
- FIG. 21 shows a state in which air pressure is applied to the support balloon 17.
- the tissue piece capturing tool 10g has a substantially disk shape in a state where air pressure is applied to the support balloon 17, and for example, when the tissue piece is captured by the capturing sheet 16, the aortic valve It has a shape that fits in the vicinity of the annulus.
- the shape of the tissue piece capturing tool 10g is not necessarily a substantially disc shape when air pressure is applied, and may be any shape that can block the aortic valve inflow portion when air pressure is applied. For example, it may be substantially cylindrical.
- the tissue piece capturing device 10g When introduced into the ventricle, the tissue piece capturing device 10g is reduced to such an extent that it can pass through the gap between the aortic valve leaflets. For example, as shown in FIG. 22, when the air is extracted from the support balloon 17, the entire tissue piece capturing tool 10g is in a contracted state. The tissue piece capturing tool 10g is set in a contracted state, is passed through the gap of the aortic valve leaflet, and is introduced to the vicinity of the aortic valve annulus.
- the aortic valve can then be closed by adjusting the direction so that the tissue piece is captured by the capture sheet 16 and then returning the expanded state by applying air pressure to the support balloon 17.
- the maximum diameter of the support balloon 17 in a state where air pressure is applied is not limited, it is preferable not to apply excessive pressure to the aortic valve, so that the support that closes the aortic valve in a state where it is in the vicinity of the aortic valve annulus is supported.
- the maximum diameter of the cross section of the balloon 17 is preferably about 10 to 30 mm, for example.
- the ventricle is closed at the time of surgery, and the tissue piece capturing device 10g cannot enter.
- the material of the support balloon 17 may be a polymer material that can be stretched and is not limited.
- polyethylene, polypropylene, polyester, polyurethane, polyamide, polyethylene terephthalate, polystyrene, polyvinyl alcohol, polyvinyl chloride, polyvinylidene chloride, Polymer materials such as polyimide, polyacetylene and polysulfone, and copolymers and mixtures thereof are applicable.
- the structure of the capture sheet 16 is not limited, but a structure that can follow the deformation of the support balloon 17 and can capture a tissue piece is preferable. As such a structure, a fiber, a nonwoven fabric, a porous structure, etc. are preferable, for example.
- the material of the capture sheet 16 is not limited, and examples thereof include silicon resin, fluororesin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, cellulose, chitosan, and various blend materials.
- FIG. 23 and FIG. 24 are diagrams showing a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h.
- FIG. 23 and FIG. 24 are diagrams showing a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h.
- FIG. 23 shows an expanded state of the tissue piece capturing tool 10h
- FIG. 24 shows a contracted state of the tissue piece capturing tool 10h.
- 23 and 24 (a) shows a side view and (b) shows a front view.
- the tissue piece capturing tool 10 h sandwiches a large number of hair materials 191 along the longitudinal direction between the two core materials 18, and integrates these core materials 18 together.
- the hair material 191 is radially provided around the core material 18 by twisting.
- the tissue piece capturing tool 10h is not limited to such a configuration, and the hair material 191 is provided radially around the core material 18. Any configuration may be used as long as it is provided. In this example, as shown in FIGS.
- the bristle material 191 is radially provided around the core material 18 in a direction perpendicular to the core material 18 in the expanded state, and the aortic valve annulus. It has a shape and size that fit in the vicinity and closes the aortic valve.
- the outer diameter of the radial circle formed by the bristle material 191 around the core material 18 is 15 to 25 mm.
- the contraction state of the tissue piece capturing tool 10h is reduced from the expanded state of FIG. 23 in the outer diameter of the radial circle formed by the bristle material 191 around the core material 18. It has a three-dimensional shape.
- the outer diameter is 3 to 7 mm.
- the contracted state is such that the disc-shaped bristle material 191 is closed like an umbrella
- the expanded state is such that the disc-like bristle material 191 is opened like an umbrella, so that the umbrella can be opened and closed. It is supposed to be deformed.
- the outer diameter of the radial circle formed by the bristle material 191 of the tissue piece capturing tool 10 h around the core material 18 can pass through the gap between the leaflets of the aortic valve. Shrink to the extent.
- the tissue piece capturing tool 10h is passed through the gap of the aortic valve leaflet in the contracted state and introduced to the vicinity of the aortic valve annulus. Thereafter, the aortic valve can be closed by the expanded state shown in FIG.
- the material of the hair material 191 is not limited, but a material having elasticity is preferable so that the tissue piece capturing tool 10h can be switched naturally from the contracted state to the expanded state without requiring external force.
- a flexible material is preferable so as not to damage tissue such as a blood vessel wall.
- polyamide, polyester, alkene polymer, diene polymer and the like can be mentioned.
- the raw material of the core material 18 is not limited, the raw material which has the intensity
- a material that is plastically deformed by applying an external force is preferable.
- a metal, a synthetic resin monofilament, etc. are mentioned.
- a tissue piece capturing tool 10h ′ which is a first configuration by combining cloth materials, is shown.
- the support portion 15 is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capturing portion 16 is a cloth material covering the periphery of the brush. is there.
- the tissue piece capturing tool 10 h ′ has a configuration in which the periphery of the hair material 191 provided radially around the core material 18 is further covered with a cloth material 192. With such a configuration, the aortic valve can be closed more densely, so that more tissue fragment residue generated when the aortic valve is excised can be captured.
- FIG. 25 shows an expanded state of the tissue piece capturing tool 10h ′
- 26 shows a contracted state of the tissue piece capturing tool 10h ′.
- 25 and 26 (a) shows a side view and (b) shows a front view.
- the structure of the cloth material 192 is not limited, it is more preferable in performing the operation that the tissue piece capturing tool 10h ′ closes the aortic valve to the extent that the liquid such as blood is not completely blocked. Is preferred.
- a nonwoven fabric, a nonwoven fabric with many holes, and a porous membrane are mentioned.
- the raw material of the fabric material 192 which has water permeability is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned.
- the material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
- a tissue piece capturing tool 10h ′′ which is a second configuration by combining cloth materials is shown.
- a plurality of disc-shaped support members 15 are provided with hair materials radially from the center toward the outer periphery.
- the tissue piece capturing tool 10 h ′′ has a configuration in which a cloth material 192 is sandwiched between brush-shaped three-dimensional hair materials 191 disposed along the longitudinal direction of the core material 18.
- Fig. 28 is a schematic exploded view of two bristle materials 191 and a cloth material 192 sandwiched between them. It is a figure.
- the material of the core material 18 is made of, for example, a general resin (ABS, PP, PE, PC, acrylic, PET), and in this configuration example, has a cylindrical shape.
- the material of the bristle material 191 may also be made of a general resin, and is a ring shape in which resin hairs are planted in a circle. For example, the diameter of the ring is about 2 to 3 cm in diameter, and the thickness of the hair is 0.1 mm or less.
- the bristle material 191 may have any configuration as long as the bridging material 191 is provided radially around the core material 18.
- the material of the cloth material 192 is a fibrous material such as a non-woven fabric or gauze, and is preferably a fiber material that has water permeability and is not easily bent or twisted.
- the raw material of the fabric material 192 which has water permeability is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned. Examples thereof include polyester, polypropylene, and polyethylene terephthalate.
- a non-woven cloth material 192 having substantially the same diameter is sandwiched between two circular brush-like bristle materials 191.
- Adhesion between the bristle material 191 and the cloth material 192 is not performed, etc.
- the structure is such that the cloth material 192 is inserted between the bristle material 191 as a so-called filter.
- the cloth material 192 may have a diameter slightly larger than the diameter of the bristle material 191 in order to improve the adhesion between the blood vessel wall.
- the bristle material 191 and the cloth material 192 may be bonded, it is necessary to consider so as not to disturb the blood flow.
- a size of about 3 cm in the longitudinal direction is easy to use at the time of surgery, but in order to improve the operability at the time of insertion, a removable extension rod may be attached.
- tissue piece capturing tool for aortic valve replacement surgery it is possible to start capturing the tissue fragment residue from the time of starting resection of the valve leaflet by attaching it to the surgical affected area. Compared to the capture tool, the tissue fragment residue can be captured more reliably and without leakage.
- tissue piece capturing tool for aortic valve replacement surgery As a tissue piece capturing tool for aortic valve replacement surgery according to the second embodiment, a configuration example including a collection tool 30 joined to the tissue piece capturing tool 10 will be described.
- the tissue piece capturing device of the present invention according to Example 2 is In addition to the tissue piece capturing tool 10 shown in the first embodiment, a thread-like, tubular or rod-like collecting tool 30 is provided, and one end of the collecting tool 30 is left on the aorta side before and after the aortic valve replacement operation.
- the tissue piece capturing tool 10 can be recovered from the aorta side by pulling one end of the recovery tool 30 after the replacement operation.
- FIG. 29 is a diagram illustrating a configuration in which a recovery tool 30 is provided to the tissue piece capturing tool 10a having a substantially cylindrical solid shape illustrated in FIG.
- FIG. 29 shows a perspective view.
- the recovery tool 30 is attached to the upper part of the tissue piece capturing tool 10a.
- the attachment position is not limited to the upper part, and the recovery tool 30 is pulled in the blood flow direction after aortic valve replacement surgery. If the tissue piece capturing tool 10a can be recovered outside the body through the aortic valve gap, the recovery tool 30 may be joined to any position of the tissue piece capturing tool 10a.
- FIG. 29 shows a diagram illustrating a configuration in which a recovery tool 30 is provided to the tissue piece capturing tool 10a having a substantially cylindrical solid shape illustrated in FIG.
- FIG. 29 shows a perspective view.
- the recovery tool 30 is attached to the upper part of the tissue piece capturing tool 10a.
- the attachment position is not limited to the upper part, and the recovery tool 30 is pulled in the blood flow direction after
- FIG. 30 is another configuration example of the tissue piece capturing device for aortic valve replacement surgery according to the second embodiment of the present invention, and the tissue piece capturing device 10f with the support ring 15 shown in FIG. 19 of the first embodiment. It is a figure which shows the structure provided with the collection
- FIG. 30 shows a perspective view. As shown in FIG. 30, the recovery tool 30 is attached to the support ring 15 of the tissue piece capturing tool 10f, but the attachment position is not limited, and the recovery tool 30 is pulled in the direction of blood flow after aortic valve replacement surgery. As long as the tissue piece capturing device 10f can be recovered from the aortic valve gap to the outside of the body, any position of the support ring 15 may be used. In the example of FIG.
- the recovery tool 30 is extended from the joint point with the support ring 15 to the vicinity of the center of the capture sheet 16 and further extended in a linear direction perpendicular to the capture sheet 16.
- This is a device for positioning the end of the collection tool 30 located on the opposite side of the joint point with the support ring 15 in the vicinity of the center of the capture sheet 16 when viewed in a linear direction perpendicular to the capture sheet 16. .
- the end of the recovery device 30 is grasped with a finger or the like.
- the collection tool 30 may be stretched as it is in a linear direction perpendicular to the capture sheet 16 from the joint point with the support ring 15.
- recovery tool 30 is not limited, For example, thread shape, tubular shape, or rod shape etc. are mentioned.
- the length of the recovery tool 30 is not limited, and may be a length that allows the tissue piece capturing tool 10f to be recovered from the aortic valve gap outside the body by pulling the recovery tool 30 in the blood flow direction after the aortic valve replacement operation. That's fine. Therefore, for example, about 20 to 200 mm is preferable.
- the structural example with the introduction tool 40 and the opening tool 50 is shown as a tissue piece capture tool set for aortic valve replacement operation concerning Example 3.
- the introducer 40 is a tubular member having an outer diameter that can pass through the gap between the aortic valve leaflets.
- the release tool 50 is a jig that pushes out the tissue piece capturing tool 10 housed inside the tubular member introduction tool 40 and releases it from the introduction tool.
- the tissue piece capturing device 10 is in a contracted state and has a shape and size that can pass through the inside of the introduction device 40.
- the introduction device 40 Prior to the replacement operation of the aortic valve, the introduction device 40 that houses the tissue piece capturing device is inserted into the aortic valve leaflet.
- FIG. 31 and 32 are diagrams showing a configuration example of a tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention.
- the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissue piece capturing tool 10.
- FIG. 31 and 32 show perspective views.
- FIG. 31 shows a state in which the tissue piece capturing tool 10f is accommodated in the introduction tool 40.
- FIG. 32 shows a state in which the tissue piece capturing tool 10f is released by pushing it out from the inside of the introduction tool 40 through the release side opening 41.
- FIGS. 33 and 34 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention.
- the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissue piece capturing tool 10.
- the collection tool 30 is attached at the end portion of the collection sheet 30 near the center of the capture sheet 16.
- 33 and 34 show perspective views.
- FIG. 33 shows a state in which the tissue piece capturing tool 10f is housed in the introduction tool 40.
- FIG. 34 shows a state in which the tissue piece capturing tool 10f is released by being pushed out from the inside of the introduction tool 40 through the release side opening 41.
- the tissue piece capture tool 10f is pushed out from the inside of the introduction tool 40.
- FIGS. 35 and 36 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention.
- the tissue piece capturing tool 10g deformed by the support balloon 17 shown in the first embodiment is used as an example of the tissue piece capturing tool 10.
- 35 and 36 show perspective views.
- FIG. 35 shows a state in which the tissue piece capturing tool 10g is housed in the introduction tool 40.
- FIG. 36 shows a state in which the tissue piece capturing tool 10g is released by being pushed out from the inside of the introducing tool 40 through the release side opening 41.
- the introduction tool 40 is substantially tubular and includes a release side opening 41 at one end in the long axis direction.
- the introduction tool 40 includes an accommodation-side opening 42 at the other end. This is a device that enables the tissue piece capturing tool 10 to be accommodated in the introduction tool 40 through an opening different from the opening 41 on the release side. In addition, it is not limited so that the introduction tool 40 may be provided with such an accommodation side opening 42.
- the introducer 40 is passed through the gap of the aortic valve leaflet, and the release side opening 41 is introduced to the vicinity of the aortic valve annulus. Thereafter, the tissue piece capturing tool 10g is released to the outside from the release side opening 41, and the aortic valve can be closed by adjusting the direction so that the tissue piece is captured by the capturing sheet 16.
- the diameter of the diameter of the cylindrical cross section of the introducer 40 is not limited, but is preferably about 3 to 10 mm, for example, because it is necessary to pass through the gap of the aortic valve leaflet.
- the length in the major axis direction of the introduction tool 40 is not limited as long as it is a length that can accommodate the tissue piece capturing tool 10g.
- the raw material of the introduction tool 40 is not limited, For example, various polymers, such as a polypropylene, an acrylonitrile butadiene styrene copolymer (ABS), polymethylpentene, etc. are mentioned.
- FIG. 37 is a view showing a state in which the tissue piece capturing tool 10 is pushed out by the push-out rod 50 as the opening tool 50.
- the tissue piece capturing tool 10 housed therein is pushed out, and the tissue piece capturing tool 10 is opened to the outside from the release side opening 41. . If the release side opening 41 is positioned near the aortic valve annulus in the ventricle, the tissue piece capturing tool 10 is opened near the aortic valve annulus.
- FIGS. 38 to 41 are views for explaining the placement procedure of the tissue piece capturing tool 10 for aortic valve replacement surgery in the vicinity of the aortic valve annulus according to the present invention.
- this procedure it is a structural example with the collection
- the tissue piece capturing device 10 is first introduced into the ascending aorta 2 in the heart 1 by being introduced through the incision in a state of being accommodated in the introduction device 40 as a contracted state.
- the valve is passed through the leaflet gap 4 and introduced to the vicinity 6 of the annulus of the aortic valve 3 (see FIG. 39).
- a notch may be provided in advance in the leaflet of the aortic valve 3, and this notch may be used as an introduction path for the tissue piece capturing tool 10.
- the length of the cut is not limited, but a cut having a maximum length of about 10 mm or less is preferable because there is no risk of a tissue piece being formed when the cut is made, and the tissue piece does not enter the ventricle.
- tissue piece capturing device for aortic valve replacement surgery can be applied to a patient requiring aortic valve replacement surgery as an instrument for assisting the surgery. While preferred embodiments of the invention have been illustrated and described, it will be appreciated that various changes can be made without departing from the scope of the invention. Therefore, the technical scope of the present invention is limited only by the description of the appended claims.
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Disclosed is an instrument for capturing a tissue piece to be used in aortic valve replacement surgery which can close the aortic valve before removing the valve cusps. An instrument for capturing a tissue piece to be used in aortic valve replacement surgery which can prevent the invasion of the residue of a tissue piece, which is formed in association with the removal of the aortic valve in a surgery for replacing the heart aortic valve, into the left ventricle. This instrument for capturing a tissue piece can be in a contracted state with a shape and size allowing the passage of the same through the space among the aortic valve cusps from the aortic side to the left ventricle side as well as in a dilated state with a shape and size allowing the placement of the same in the vicinity of the aortic valve rings in the left ventricle so as to close the aortic valve. Prior to the surgery for replacing the heart aortic valve, the instrument in the contracted state is passed through the space among the aortic valve cusps from the aortic side to the left ventricle side. After introducing into the left ventricle, the instrument is made into the dilated state so as to close the aortic valve in the vicinity of the aortic valve rings in the left ventricle. Thus, it becomes possible to prevent the invasion of the residue of a tissue piece into the left ventricle.
Description
本発明は、大動脈弁置換手術において、大動脈弁切除により生じうる組織片残滓が心室内へ侵入することを抑止するための大動脈弁置換手術用の組織片捕捉具、大動脈弁置換手術用の組織片捕捉具セットおよび大動脈弁置換手術における組織片捕捉方法に関するものである。
The present invention relates to a tissue piece capturing tool for aortic valve replacement surgery for suppressing the invasion of a tissue piece remnant that may be generated by aortic valve resection in an aortic valve replacement operation, and a tissue piece for aortic valve replacement surgery. The present invention relates to a capturing device set and a tissue fragment capturing method in aortic valve replacement surgery.
従来技術において、大動脈弁膜症により引き起こされる大動脈弁狭窄または大動脈弁閉鎖不全の治療として、大動脈弁置換手術が広く行われている。
大動脈弁置換手術とは、大動脈弁膜症により引き起こされる大動脈弁狭窄または大動脈弁閉鎖不全を治療するために、大動脈弁を切除し、外部から導入した機械弁または生体弁に置き換える手術をいう。
大動脈弁膜症とは、大動脈弁膜が開閉運動に支障をきたした状態をいい、発症すると心臓の送血効率が低下する。原則として外科的治療を必要とする重篤な疾病とされている。
大動脈弁狭窄とは、大動脈弁膜の開放がうまくいかない状態をいい、大動脈弁閉鎖不全とは、閉鎖がうまくいかない状態をいう。
大動脈弁置換手術に際しては、あらかじめ大動脈弁の弁尖付近の上行大動脈壁を切開してできた切開口から大動脈弁の切除を行う。大動脈弁置換手術において、大動脈弁を切除した際に微小な組織片残滓が生じることがあり、その切除に伴い生じた組織片残滓が心室内側へ入り込んでしまうおそれがある。組織片が心室内へ入り込んでしまった場合、そのまま手術を完了してしまうと組織片が心室内またはその他の器官内に留まることとなり好ましくない。特に、手術後に組織片が血流に乗って他の器官内に移動すれば脳梗塞などの危険な合併症を引き起こすおそれがある。したがって、組織片残滓の心室内への侵入を阻止する処置や、心室内へ入り込んでしまった組織片を体外へ排出する処置を施すことが必要となる。例えば、組織片残滓の捕捉するガーゼなどを心室内の大動脈弁弁輪付近に詰めることによって阻止していた。
特表2002−527157号公報
特表2005−503197号公報 In the prior art, aortic valve replacement surgery is widely performed as a treatment for aortic stenosis or aortic regurgitation caused by aortic valvular disease.
The aortic valve replacement operation refers to an operation in which the aortic valve is removed and replaced with a mechanical valve or a biological valve introduced from the outside in order to treat aortic stenosis or aortic regurgitation caused by aortic valvular disease.
Aortic valvular disease refers to a state in which the aortic valvular membrane hinders opening and closing movements, and when it develops, the blood transfusion efficiency of the heart decreases. In principle, it is considered a serious disease requiring surgical treatment.
Aortic stenosis refers to a condition where the opening of the aortic valve is not successful, and aortic valve insufficiency refers to a condition where the closure is not successful.
At the time of aortic valve replacement surgery, the aortic valve is resected from an incision made by previously incising the ascending aortic wall near the leaflet of the aortic valve. In aortic valve replacement surgery, when aortic valve is excised, a minute tissue fragment residue may be generated, and the tissue fragment residue generated by the excision may enter the ventricle. If the tissue piece has entered the ventricle, if the operation is completed as it is, the tissue piece will remain in the ventricle or other organs. In particular, if a tissue piece moves on the bloodstream and moves into other organs after surgery, it may cause dangerous complications such as cerebral infarction. Therefore, it is necessary to perform a treatment for preventing the tissue piece residue from entering the ventricle and a treatment for discharging the tissue piece that has entered the ventricle. For example, gauze or the like captured by a tissue fragment residue is blocked by packing it near the aortic valve annulus in the ventricle.
JP-T-2002-527157 Publication JP-T-2005-503197 Publication
大動脈弁置換手術とは、大動脈弁膜症により引き起こされる大動脈弁狭窄または大動脈弁閉鎖不全を治療するために、大動脈弁を切除し、外部から導入した機械弁または生体弁に置き換える手術をいう。
大動脈弁膜症とは、大動脈弁膜が開閉運動に支障をきたした状態をいい、発症すると心臓の送血効率が低下する。原則として外科的治療を必要とする重篤な疾病とされている。
大動脈弁狭窄とは、大動脈弁膜の開放がうまくいかない状態をいい、大動脈弁閉鎖不全とは、閉鎖がうまくいかない状態をいう。
大動脈弁置換手術に際しては、あらかじめ大動脈弁の弁尖付近の上行大動脈壁を切開してできた切開口から大動脈弁の切除を行う。大動脈弁置換手術において、大動脈弁を切除した際に微小な組織片残滓が生じることがあり、その切除に伴い生じた組織片残滓が心室内側へ入り込んでしまうおそれがある。組織片が心室内へ入り込んでしまった場合、そのまま手術を完了してしまうと組織片が心室内またはその他の器官内に留まることとなり好ましくない。特に、手術後に組織片が血流に乗って他の器官内に移動すれば脳梗塞などの危険な合併症を引き起こすおそれがある。したがって、組織片残滓の心室内への侵入を阻止する処置や、心室内へ入り込んでしまった組織片を体外へ排出する処置を施すことが必要となる。例えば、組織片残滓の捕捉するガーゼなどを心室内の大動脈弁弁輪付近に詰めることによって阻止していた。
特表2002−527157号公報
特表2005−503197号公報 In the prior art, aortic valve replacement surgery is widely performed as a treatment for aortic stenosis or aortic regurgitation caused by aortic valvular disease.
The aortic valve replacement operation refers to an operation in which the aortic valve is removed and replaced with a mechanical valve or a biological valve introduced from the outside in order to treat aortic stenosis or aortic regurgitation caused by aortic valvular disease.
Aortic valvular disease refers to a state in which the aortic valvular membrane hinders opening and closing movements, and when it develops, the blood transfusion efficiency of the heart decreases. In principle, it is considered a serious disease requiring surgical treatment.
Aortic stenosis refers to a condition where the opening of the aortic valve is not successful, and aortic valve insufficiency refers to a condition where the closure is not successful.
At the time of aortic valve replacement surgery, the aortic valve is resected from an incision made by previously incising the ascending aortic wall near the leaflet of the aortic valve. In aortic valve replacement surgery, when aortic valve is excised, a minute tissue fragment residue may be generated, and the tissue fragment residue generated by the excision may enter the ventricle. If the tissue piece has entered the ventricle, if the operation is completed as it is, the tissue piece will remain in the ventricle or other organs. In particular, if a tissue piece moves on the bloodstream and moves into other organs after surgery, it may cause dangerous complications such as cerebral infarction. Therefore, it is necessary to perform a treatment for preventing the tissue piece residue from entering the ventricle and a treatment for discharging the tissue piece that has entered the ventricle. For example, gauze or the like captured by a tissue fragment residue is blocked by packing it near the aortic valve annulus in the ventricle.
JP-T-2002-527157 Publication JP-T-2005-503197 Publication
上記の従来技術における捕捉具による処置では、ガーゼなどの捕捉具を大動脈弁の弁尖側から大動脈弁の弁輪側に導入する必要がある。ガーゼなどの捕捉具の大きさは大動脈弁を塞ぐのに十分なものである必要がある。大動脈弁の弁輪側の最大内径は成人の場合は概ね15~25mmである。つまり15~25mmの大きさの捕捉具を用いる必要がある。ところが、大動脈弁の弁尖の間隙は最大長さが成人の場合おおむね3~7mmである。したがってそのままではガーゼなどの捕捉具は弁尖の間隙を通過することができない。そこで、ガーゼなどの捕捉具を大動脈弁の弁尖側から大動脈弁の弁輪側に導入するためには、一または二以上の弁尖を切除することで導入経路をあらかじめ設ける必要があった。しかし、導入経路を確保するための弁尖切除の際にも組織片残滓が生じうるため、ガーゼなどの捕捉具の導入が完了する前に組織片残滓が心室内に侵入してしまうおそれがあるという問題があった。
上記問題点に鑑み、本発明は、弁尖を切除する前に大動脈弁を塞ぐことができる大動脈弁置換手術用の組織片捕捉具、大動脈弁置換手術用の組織片捕捉具セット、大動脈弁置換手術における組織片捕捉方法を提供することを目的とする。 In the above-described treatment using the capture device, it is necessary to introduce a capture device such as gauze from the leaflet side of the aortic valve to the annulus side of the aortic valve. The size of the capture device such as gauze needs to be sufficient to block the aortic valve. The maximum inner diameter on the annulus side of the aortic valve is approximately 15 to 25 mm for adults. That is, it is necessary to use a capturing tool having a size of 15 to 25 mm. However, the gap between the leaflets of the aortic valve is generally 3 to 7 mm when the maximum length is an adult. Therefore, the capturing device such as gauze cannot pass through the gap between the leaflets as it is. Therefore, in order to introduce a capture device such as gauze from the leaflet side of the aortic valve to the annulus side of the aortic valve, it is necessary to provide an introduction path in advance by excising one or more leaflets. However, tissue fragment residue may also occur during valve leaflet excision to secure the introduction route, so that the tissue fragment residue may enter the ventricle before the introduction of the capture device such as gauze is completed. There was a problem.
In view of the above problems, the present invention provides a tissue piece capturing device for aortic valve replacement surgery that can close the aortic valve before excising the leaflets, a tissue piece capturing device set for aortic valve replacement surgery, and aortic valve replacement. An object of the present invention is to provide a method for capturing a tissue piece in an operation.
上記問題点に鑑み、本発明は、弁尖を切除する前に大動脈弁を塞ぐことができる大動脈弁置換手術用の組織片捕捉具、大動脈弁置換手術用の組織片捕捉具セット、大動脈弁置換手術における組織片捕捉方法を提供することを目的とする。 In the above-described treatment using the capture device, it is necessary to introduce a capture device such as gauze from the leaflet side of the aortic valve to the annulus side of the aortic valve. The size of the capture device such as gauze needs to be sufficient to block the aortic valve. The maximum inner diameter on the annulus side of the aortic valve is approximately 15 to 25 mm for adults. That is, it is necessary to use a capturing tool having a size of 15 to 25 mm. However, the gap between the leaflets of the aortic valve is generally 3 to 7 mm when the maximum length is an adult. Therefore, the capturing device such as gauze cannot pass through the gap between the leaflets as it is. Therefore, in order to introduce a capture device such as gauze from the leaflet side of the aortic valve to the annulus side of the aortic valve, it is necessary to provide an introduction path in advance by excising one or more leaflets. However, tissue fragment residue may also occur during valve leaflet excision to secure the introduction route, so that the tissue fragment residue may enter the ventricle before the introduction of the capture device such as gauze is completed. There was a problem.
In view of the above problems, the present invention provides a tissue piece capturing device for aortic valve replacement surgery that can close the aortic valve before excising the leaflets, a tissue piece capturing device set for aortic valve replacement surgery, and aortic valve replacement. An object of the present invention is to provide a method for capturing a tissue piece in an operation.
上記目的を達成するため、本発明の大動脈弁置換手術用の組織片捕捉具は、
大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まって前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備え、前記大動脈弁の置換手術に先立ち、前記収縮状態にて前記大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過させ、前記左心室導入後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめるものである。
なお、収縮状態から拡張状態へ切り替え手段としては様々な手段があり得る。
例えば、空気圧を利用して前記収縮状態から前記拡張状態へ切り替える手段がある。例えば、膜状の素材で構成し、空気を注入していわゆるバルーンのように膨らませる構成がある。
また、例えば、液体を吸収して膨張することにより前記収縮状態から前記拡張状態へ切り替える手段がある。膨張させる手段としては、全体が液体を吸収することによって膨張する可膨性素材からなり、液体を吸収することによって収縮状態から拡張状態となるようにすることができる。他の膨張させる手段としては、液体を吸収することによって膨張する可膨性素材と、可膨性素材を包むシート状の捕捉部を備えた構成とし、可膨性素材が液体を吸収することによって、収縮状態から拡張状態となるようにすることができる。
また、例えば、前記組織片を捕捉するシート状の捕捉部と前記捕捉部を支持・変形させる可動式の支持部を備え、前記支持部の操作を介して前記捕捉部を変形させることにより、前記収縮状態から前記拡張状態へ切り替える手段がある。一構成例としては、支持部は中心から外周に向けて放射状に毛材を設けた少なくとも1枚の円板状のブラシであり、捕捉部がブラシの周囲を覆った布材である。他の構成例としては、支持部が中心から外周に向けて放射状に毛材を設けた複数枚の円板状のブラシであり、捕捉部がブラシ同士の間に間挿せしめた円板状の布材である。支持部の操作による前記捕捉部の変形手段としては、前記支持部の前記ブラシの前記収縮状態が前記円板状のブラシが傘状に閉じた状態、前記拡張状態が前記円板状のブラシが傘状に開いた状態とする手段がある。
上記構成により、従来のように組織片の捕捉具を留置する前にあらかじめ一または二以上の弁尖を切除する必要はなく、大動脈弁弁尖の間隙を通して捕捉具を左心室の大動脈弁弁輪側に導入することができ、捕捉具の導入前に組織片を生じさせることはないため、弁尖切除に伴う組織片をより確実に漏れなく捕捉することができる。
本発明の組織片捕捉具を用いた術式は、従来にはまったくない新しい概念の組織片捕捉式であり、このような捕捉具を開示した例はない。収縮状態において3~7mmの大動脈弁の間隙を通し入れ、拡張状態において15~25mmの大動脈弁の弁輪側の内径を塞ぐことが可能となる。
また、大動脈弁置換手術用の組織片捕捉具において、糸状、管状または棒状の回収具を備えた構造とし、前記大動脈弁の置換手術の前後にわたり前記回収具の一端を前記大動脈側に残しておき、前記大動脈弁の置換手術後に前記回収具の一端を引っ張ることにより前記大動脈弁を通過させ、前記大動脈側からの回収を可能とすることが好ましい。
上記構成により、大動脈弁置換手術が終了すれば患者の心臓から外部へ容易かつ確実に回収することができる。
次に、本発明の大動脈弁置換手術用の組織片捕捉具セットは、
前記大動脈弁弁尖の間隙を通過できる外径を備えた管状部材の導入具と、
前記導入具の内側を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まり前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備えた組織片捕捉具と、
前記導入具の内側に収容されている前記組織片捕捉具を押し出して前記管状部材から開放する開放具とを備え、
前記大動脈弁の置換手術に先立ち、前記組織片捕捉具を前記収縮状態にて内側に収容している前記導入具を前記大動脈弁弁尖の間隙に導入することにより前記大動脈側から前記左心室側への通路を確保せしめ、前記開放具により前記組織片捕捉具を押し出して前記導入具の内側を通過させ、前記組織片捕捉具を前記左心室に導入した後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめるものである。
上記構成により、本発明の組織片捕捉具を所定位置にすみやかに収め、手術時間を短縮することができる。
次に、本発明の大動脈弁置換手術における組織片捕捉方法は、
大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まって前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備えた組織片捕捉具を用い、
前記大動脈弁の置換手術に先立ち、前記組織片捕捉具を前記収縮状態にて前記大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過させ、前記左心室導入後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめる方法である。 In order to achieve the above object, a tissue fragment capturing tool for aortic valve replacement surgery according to the present invention comprises:
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; An expanded state having a size, and prior to the replacement operation of the aortic valve, the aortic valve leaflet is passed from the aorta side toward the left ventricle side in the contracted state, and after the introduction of the left ventricle In the expanded state, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue piece residue is prevented from entering the left ventricle.
There may be various means for switching from the contracted state to the expanded state.
For example, there is means for switching from the contracted state to the expanded state using air pressure. For example, it is composed of a film-like material and inflates like a so-called balloon by injecting air.
Further, for example, there is means for switching from the contracted state to the expanded state by absorbing liquid and expanding. As a means for inflating, the whole is made of an inflatable material that expands by absorbing liquid, and can be changed from a contracted state to an expanded state by absorbing liquid. As another means for inflating, the structure includes an inflatable material that expands by absorbing liquid, and a sheet-like capturing portion that wraps the inflatable material, and the inflatable material absorbs the liquid. The contracted state can be changed to the expanded state.
In addition, for example, a sheet-like capture unit that captures the tissue piece and a movable support unit that supports and deforms the capture unit, and by deforming the capture unit through operation of the support unit, There is means for switching from the contracted state to the expanded state. As one configuration example, the support portion is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capture portion is a cloth material covering the periphery of the brush. As another configuration example, the support portion is a plurality of disc-shaped brushes provided with hair material radially from the center toward the outer periphery, and the capturing portion is a disc-shaped brush inserted between the brushes. It is a cloth material. As the means for deforming the capturing part by operating the support part, the contraction state of the brush of the support part is a state where the disk-like brush is closed in an umbrella shape, and the expansion state is the disk-like brush. There is a means to make it open like an umbrella.
With the above configuration, it is not necessary to resect one or more leaflets before placing the tissue piece capturing device in the conventional manner, and the capturing device is inserted through the gap between the aortic valve leaflets and the aortic valve annulus in the left ventricle. Since the tissue piece can be introduced to the side and the tissue piece is not generated before the capture tool is introduced, the tissue piece associated with the leaflet resection can be more reliably captured without leakage.
The technique using the tissue piece capturing device of the present invention is a new concept tissue piece capturing method that has never been known before, and there is no example that discloses such a capturing device. In the contracted state, the aortic valve gap of 3 to 7 mm can be inserted, and in the expanded state, the inner diameter of the 15 to 25 mm aortic valve on the annulus side can be closed.
Further, in the tissue piece capturing tool for aortic valve replacement surgery, a structure having a thread-like, tubular or rod-like recovery tool is provided, and one end of the recovery tool is left on the aorta side before and after the aortic valve replacement surgery. It is preferable that after the aortic valve replacement operation, one end of the recovery tool is pulled to pass through the aortic valve to enable recovery from the aortic side.
With the above configuration, when the aortic valve replacement operation is completed, it can be easily and reliably collected from the patient's heart to the outside.
Next, the tissue piece capturing tool set for aortic valve replacement surgery of the present invention,
A tubular member introducer having an outer diameter capable of passing through the gap of the aortic valve leaflet;
A tissue piece capturing device comprising a contracted state having a shape and size capable of passing through the inside of the introducer, and an expanded state having a shape and size that fits in the vicinity of the aortic valve annulus in the left ventricle and closes the aortic valve When,
An opening tool that pushes out the tissue piece capturing tool housed inside the introduction tool and releases it from the tubular member;
Prior to the replacement operation of the aortic valve, the introducer that houses the tissue piece capturing device in the contracted state is introduced into the gap of the aortic valve leaflet so that the left ventricle side from the aorta side. The aorta is secured by allowing the tissue piece capturing device to be pushed out by the opening device and passing through the inside of the introducing device, and after the tissue piece capturing device is introduced into the left ventricle, the expanded state is established. The aortic valve is closed in the vicinity of the annulus to prevent the tissue fragment residue from entering the left ventricle.
With the above configuration, the tissue piece capturing tool of the present invention can be quickly placed in a predetermined position, and the operation time can be shortened.
Next, the tissue fragment capturing method in the aortic valve replacement surgery of the present invention,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; Using a tissue piece capture device with an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the tissue piece capturing device is passed through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side in the contracted state, and the expanded state after the introduction of the left ventricle Thus, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue fragment residue is prevented from entering the left ventricle.
大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まって前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備え、前記大動脈弁の置換手術に先立ち、前記収縮状態にて前記大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過させ、前記左心室導入後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめるものである。
なお、収縮状態から拡張状態へ切り替え手段としては様々な手段があり得る。
例えば、空気圧を利用して前記収縮状態から前記拡張状態へ切り替える手段がある。例えば、膜状の素材で構成し、空気を注入していわゆるバルーンのように膨らませる構成がある。
また、例えば、液体を吸収して膨張することにより前記収縮状態から前記拡張状態へ切り替える手段がある。膨張させる手段としては、全体が液体を吸収することによって膨張する可膨性素材からなり、液体を吸収することによって収縮状態から拡張状態となるようにすることができる。他の膨張させる手段としては、液体を吸収することによって膨張する可膨性素材と、可膨性素材を包むシート状の捕捉部を備えた構成とし、可膨性素材が液体を吸収することによって、収縮状態から拡張状態となるようにすることができる。
また、例えば、前記組織片を捕捉するシート状の捕捉部と前記捕捉部を支持・変形させる可動式の支持部を備え、前記支持部の操作を介して前記捕捉部を変形させることにより、前記収縮状態から前記拡張状態へ切り替える手段がある。一構成例としては、支持部は中心から外周に向けて放射状に毛材を設けた少なくとも1枚の円板状のブラシであり、捕捉部がブラシの周囲を覆った布材である。他の構成例としては、支持部が中心から外周に向けて放射状に毛材を設けた複数枚の円板状のブラシであり、捕捉部がブラシ同士の間に間挿せしめた円板状の布材である。支持部の操作による前記捕捉部の変形手段としては、前記支持部の前記ブラシの前記収縮状態が前記円板状のブラシが傘状に閉じた状態、前記拡張状態が前記円板状のブラシが傘状に開いた状態とする手段がある。
上記構成により、従来のように組織片の捕捉具を留置する前にあらかじめ一または二以上の弁尖を切除する必要はなく、大動脈弁弁尖の間隙を通して捕捉具を左心室の大動脈弁弁輪側に導入することができ、捕捉具の導入前に組織片を生じさせることはないため、弁尖切除に伴う組織片をより確実に漏れなく捕捉することができる。
本発明の組織片捕捉具を用いた術式は、従来にはまったくない新しい概念の組織片捕捉式であり、このような捕捉具を開示した例はない。収縮状態において3~7mmの大動脈弁の間隙を通し入れ、拡張状態において15~25mmの大動脈弁の弁輪側の内径を塞ぐことが可能となる。
また、大動脈弁置換手術用の組織片捕捉具において、糸状、管状または棒状の回収具を備えた構造とし、前記大動脈弁の置換手術の前後にわたり前記回収具の一端を前記大動脈側に残しておき、前記大動脈弁の置換手術後に前記回収具の一端を引っ張ることにより前記大動脈弁を通過させ、前記大動脈側からの回収を可能とすることが好ましい。
上記構成により、大動脈弁置換手術が終了すれば患者の心臓から外部へ容易かつ確実に回収することができる。
次に、本発明の大動脈弁置換手術用の組織片捕捉具セットは、
前記大動脈弁弁尖の間隙を通過できる外径を備えた管状部材の導入具と、
前記導入具の内側を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まり前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備えた組織片捕捉具と、
前記導入具の内側に収容されている前記組織片捕捉具を押し出して前記管状部材から開放する開放具とを備え、
前記大動脈弁の置換手術に先立ち、前記組織片捕捉具を前記収縮状態にて内側に収容している前記導入具を前記大動脈弁弁尖の間隙に導入することにより前記大動脈側から前記左心室側への通路を確保せしめ、前記開放具により前記組織片捕捉具を押し出して前記導入具の内側を通過させ、前記組織片捕捉具を前記左心室に導入した後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめるものである。
上記構成により、本発明の組織片捕捉具を所定位置にすみやかに収め、手術時間を短縮することができる。
次に、本発明の大動脈弁置換手術における組織片捕捉方法は、
大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まって前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備えた組織片捕捉具を用い、
前記大動脈弁の置換手術に先立ち、前記組織片捕捉具を前記収縮状態にて前記大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過させ、前記左心室導入後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめる方法である。 In order to achieve the above object, a tissue fragment capturing tool for aortic valve replacement surgery according to the present invention comprises:
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; An expanded state having a size, and prior to the replacement operation of the aortic valve, the aortic valve leaflet is passed from the aorta side toward the left ventricle side in the contracted state, and after the introduction of the left ventricle In the expanded state, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue piece residue is prevented from entering the left ventricle.
There may be various means for switching from the contracted state to the expanded state.
For example, there is means for switching from the contracted state to the expanded state using air pressure. For example, it is composed of a film-like material and inflates like a so-called balloon by injecting air.
Further, for example, there is means for switching from the contracted state to the expanded state by absorbing liquid and expanding. As a means for inflating, the whole is made of an inflatable material that expands by absorbing liquid, and can be changed from a contracted state to an expanded state by absorbing liquid. As another means for inflating, the structure includes an inflatable material that expands by absorbing liquid, and a sheet-like capturing portion that wraps the inflatable material, and the inflatable material absorbs the liquid. The contracted state can be changed to the expanded state.
In addition, for example, a sheet-like capture unit that captures the tissue piece and a movable support unit that supports and deforms the capture unit, and by deforming the capture unit through operation of the support unit, There is means for switching from the contracted state to the expanded state. As one configuration example, the support portion is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capture portion is a cloth material covering the periphery of the brush. As another configuration example, the support portion is a plurality of disc-shaped brushes provided with hair material radially from the center toward the outer periphery, and the capturing portion is a disc-shaped brush inserted between the brushes. It is a cloth material. As the means for deforming the capturing part by operating the support part, the contraction state of the brush of the support part is a state where the disk-like brush is closed in an umbrella shape, and the expansion state is the disk-like brush. There is a means to make it open like an umbrella.
With the above configuration, it is not necessary to resect one or more leaflets before placing the tissue piece capturing device in the conventional manner, and the capturing device is inserted through the gap between the aortic valve leaflets and the aortic valve annulus in the left ventricle. Since the tissue piece can be introduced to the side and the tissue piece is not generated before the capture tool is introduced, the tissue piece associated with the leaflet resection can be more reliably captured without leakage.
The technique using the tissue piece capturing device of the present invention is a new concept tissue piece capturing method that has never been known before, and there is no example that discloses such a capturing device. In the contracted state, the aortic valve gap of 3 to 7 mm can be inserted, and in the expanded state, the inner diameter of the 15 to 25 mm aortic valve on the annulus side can be closed.
Further, in the tissue piece capturing tool for aortic valve replacement surgery, a structure having a thread-like, tubular or rod-like recovery tool is provided, and one end of the recovery tool is left on the aorta side before and after the aortic valve replacement surgery. It is preferable that after the aortic valve replacement operation, one end of the recovery tool is pulled to pass through the aortic valve to enable recovery from the aortic side.
With the above configuration, when the aortic valve replacement operation is completed, it can be easily and reliably collected from the patient's heart to the outside.
Next, the tissue piece capturing tool set for aortic valve replacement surgery of the present invention,
A tubular member introducer having an outer diameter capable of passing through the gap of the aortic valve leaflet;
A tissue piece capturing device comprising a contracted state having a shape and size capable of passing through the inside of the introducer, and an expanded state having a shape and size that fits in the vicinity of the aortic valve annulus in the left ventricle and closes the aortic valve When,
An opening tool that pushes out the tissue piece capturing tool housed inside the introduction tool and releases it from the tubular member;
Prior to the replacement operation of the aortic valve, the introducer that houses the tissue piece capturing device in the contracted state is introduced into the gap of the aortic valve leaflet so that the left ventricle side from the aorta side. The aorta is secured by allowing the tissue piece capturing device to be pushed out by the opening device and passing through the inside of the introducing device, and after the tissue piece capturing device is introduced into the left ventricle, the expanded state is established. The aortic valve is closed in the vicinity of the annulus to prevent the tissue fragment residue from entering the left ventricle.
With the above configuration, the tissue piece capturing tool of the present invention can be quickly placed in a predetermined position, and the operation time can be shortened.
Next, the tissue fragment capturing method in the aortic valve replacement surgery of the present invention,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; Using a tissue piece capture device with an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the tissue piece capturing device is passed through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side in the contracted state, and the expanded state after the introduction of the left ventricle Thus, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue fragment residue is prevented from entering the left ventricle.
第1図は幅広の略円筒状の立体形状の組織片捕捉具10aの構成例の拡張状態を示す図である
第2図は幅広の略円筒状の立体形状の組織片捕捉具10aの構成例の収縮状態を示す図である
第3図は組織片捕捉具10aの別の収縮状態を示す図である
第4図は球状の立体形状の組織片捕捉具10bの構成例の拡張状態を示す図である
第5図は球状の立体形状の組織片捕捉具10bの構成例の収縮状態を示す図である
第6図は略椀状の立体形状の組織片捕捉具10cの構成例の拡張状態を示す図である
第7図は略椀状の立体形状の組織片捕捉具10cの構成例の収縮状態を示す図である
第8図は円錐状の略椀状の組織片捕捉具10dの構成例の拡張状態を示す図である
第9図は円錐状の略椀状の組織片捕捉具10dの構成例の収縮状態を示す図である
第10図は中央部が膜で閉鎖されている略ドーナツ状の立体形状の捕捉具10eの構成例の拡張状態を示す図である
第11図は中央部が膜で閉鎖されている略ドーナツ状の立体形状の捕捉具10eの構成例の収縮状態を示す図である
第12図は空気圧を加えることにより組織片捕捉具10cの収縮状態を示す図である
第13図は空気圧を加えることにより組織片捕捉具10cの収縮状態から拡張状態に切り替える構成例を示す図である
第14図は図10に示した組織片捕捉具10eの収縮状態を示す図である
第15図は図10に示した組織片捕捉具10eの収縮状態から図11に示した組織片捕捉具10eの拡張状態に切り替える構成例を示す図である
第16図は図1に示した組織片捕捉具10aの収縮状態から図2に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である
第17図は図3に示した組織片捕捉具10aの収縮状態から図1に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である
第18図は図9に示した組織片捕捉具10dの収縮状態から図8に示した組織片捕捉具10dの拡張状態に切り替える構成例を示す図である
第19図は支持部の操作を介して組織片捕捉部10を変形させる構成例を示す図である
第20図は支持リング15を左右に収縮させることにより組織片捕捉具10f全体を収縮状態とした様子を示す図である
第21図は支持部の操作を介して組織片捕捉部10を変形させる別の構成例を示す図である
第22図は支持バルーン17の空気を抜いて収縮状態とした様子を模式的示す図である
第23図はブラシ状の立体形状の組織片捕捉具10hの構成例の拡張状態を示す図である
第24図はブラシ状の立体形状の組織片捕捉具10hの構成例の収縮状態を示す図である
第25図は布材で毛材を覆ったブラシ状の立体形状の組織片捕捉具10h’の構成例の拡張状態を示す図である
第26図は布材で毛材を覆ったブラシ状の立体形状の組織片捕捉具10h’の構成例の収縮状態を示す図である
第27図は毛材の間に布材を挟み込んだ組織片捕捉具10h”の構成例の拡張状態を示す図である
第28図は組織片捕捉具10h”の2つの毛材とそれらの間に挟まれた布材とを分解して模式的に示した図である
第29図は実施例1の図1で示した略円筒状の立体形状である組織片捕捉具10aに対して回収具30を備えた構成を示す図である
第30図は実施例1の図19で示した支持リング15を伴う組織片捕捉具10fに対して回収具30を備えた構成を示す図である
第31図は組織片捕捉具10fを導入具40の内部に収容した状態を示した図である
第32図は組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示した図である
第33図は組織片捕捉具10fを導入具40の内部に収容した状態を示した図である
第34図は組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示した図である
第35図は組織片捕捉具10gを導入具40の内部に収容した状態を示した図である
第36図は組織片捕捉具10gを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示した図である
第37図は開放具50としての押し出し棒50により組織片捕捉具10を押し出してゆく様子を示す図である
第38図は大動脈弁の弁尖付近の上行大動脈壁を切開し、切開口を設ける手順を示す図である
第39図は大動脈弁3の弁尖の間隙4を通過させ、導入具40を大動脈弁3の弁輪近傍6まで導入する手順を示す図である
第40図は組織片捕捉具10を拡張状態とすることにより大動脈弁3を塞ぎ、大動脈弁弁輪近傍に留置せしめる手順を示す図である
第41図は導入具40を切開口から上行大動脈の外部へと取り出す手順を示す図である FIG. 1 is a diagram showing an expanded state of a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a. FIG. 2 is a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a. FIG. 3 is a diagram showing another contracted state of the tissue piece capturing device 10a. FIG. 4 is a diagram showing an expanded state of a configuration example of the spherical three-dimensional tissue piece capturing device 10b. FIG. 5 is a diagram showing a contracted state of the configuration example of the spherical solid-shaped tissue piece capturing tool 10b. FIG. 6 shows an expanded state of the configuration example of the substantially bowl-shaped three-dimensional tissue piece capturing tool 10c. FIG. 7 is a diagram showing a contracted state of a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing device 10c. FIG. 8 is a configuration example of a conical substantially scissor-shaped tissue piece capturing device 10d. FIG. 9 is a diagram showing a contracted state of a configuration example of the cone-shaped substantially scissor-shaped tissue piece capturing tool 10d. FIG. 10 is a diagram showing an expanded state of a configuration example of a substantially donut-shaped capturing tool 10e whose central portion is closed with a membrane. FIG. 11 is a diagram where the central portion is closed with a membrane. FIG. 12 is a diagram showing a contracted state of a configuration example of a substantially donut-shaped three-dimensional capturing device 10e. FIG. 12 is a diagram showing a contracted state of a tissue piece capturing device 10c by applying air pressure. FIG. 14 is a diagram showing a configuration example in which the tissue piece capturing tool 10c is switched from the contracted state to the expanded state. FIG. 14 is a diagram showing the contracted state of the tissue piece capturing tool 10e shown in FIG. FIG. 16 is a diagram showing a configuration example of switching from the contracted state of the tissue piece capturing tool 10e shown in FIG. 11 to the expanded state of the tissue piece capturing tool 10e shown in FIG. 11. FIG. 16 shows the contraction of the tissue piece capturing tool 10a shown in FIG. Shown in Figure 2 from the state FIG. 17 is a diagram showing a configuration example of switching to the expanded state of the tissue piece capturing tool 10a. FIG. 17 switches from the contracted state of the tissue piece capturing tool 10a shown in FIG. 3 to the expanded state of the tissue piece capturing tool 10a shown in FIG. Fig. 18 is a diagram showing a configuration example. Fig. 18 is a diagram showing a configuration example for switching from the contracted state of the tissue piece capturing device 10d shown in Fig. 9 to the expanded state of the tissue piece capturing device 10d shown in Fig. 8. FIG. 20 is a diagram showing a configuration example in which the tissuepiece capturing section 10 is deformed through operation of the support section. FIG. 20 shows a state in which the entire tissue piece capturing tool 10f is contracted by contracting the support ring 15 to the left and right. FIG. 21 is a diagram showing another configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit. FIG. 22 shows a state in which the support balloon 17 is deflated by removing air. It is a figure showing typically FIG. 24 is a diagram showing an expanded state of a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h. FIG. 24 is a diagram showing a contracted state of a configuration example of the brush-shaped three-dimensional tissue piece capturing tool 10h. FIG. 25 is a diagram showing an expanded state of the configuration example of the brush-shaped three-dimensional tissue piece capturing tool 10h ′ in which the hair material is covered with the cloth material. FIG. 26 is a brush-like shape in which the hair material is covered with the cloth material. FIG. 27 is a diagram showing a contracted state of a configuration example of a three-dimensional tissue piece capturing device 10h ′. FIG. 27 is a diagram showing an expanded state of a configuration example of a tissue piece capturing device 10h ″ in which a cloth material is sandwiched between bristle materials. FIG. 28 is a diagram schematically showing an exploded view of two bristle materials of the tissue piece capturing tool 10h ″ and a cloth material sandwiched between them. FIG. 29 is a diagram of FIG. It is a figure which shows the structure provided with the collection | recovery tool 30 with respect to the tissue piece capturing tool 10a which is the substantially cylindrical solid shape shown FIG. 30 is a view showing a configuration in which the recovery tool 30 is provided for the tissue piece capturing tool 10f with the support ring 15 shown in FIG. 19 of the first embodiment. FIG. 31 shows the tissue piece capturing tool 10f as the introduction tool 40. FIG. 32 is a view showing a state in which the tissue piece capturing tool 10f is released by pushing it from the inside of the introduction tool 40 to the outside through the release side opening 41. FIG. FIG. 34 is a view showing a state in which the tissue piece capturing tool 10f is accommodated in the introduction tool 40. FIG. 34 is a diagram showing that the tissue piece capturing tool 10f is pushed out from the introduction tool 40 to the outside through the release side opening 41. FIG. 35 is a view showing a released state. FIG. 35 is a view showing a state in which the tissue piece capturing tool 10g is accommodated in the introduction tool 40. FIG. 36 is a view showing the tissue piece capturing tool 10g from the inside of the introduction tool 40. Outside through the opening 41 FIG. 37 is a view showing a state where the tissue piece capturing device 10 is pushed out by the push-out rod 50 as the opening device 50. FIG. 38 is a view showing the leaflet of the aortic valve. FIG. 39 is a diagram showing a procedure for dissecting the ascending aortic wall in the vicinity and providing an incision. FIG. 39 passes the space 4 of the leaflet of the aortic valve 3 and introduces the introducer 40 up to the annulus 6 of the aortic valve 3. FIG. 40 is a diagram showing a procedure for closing the aortic valve 3 by placing the tissue piece capturing device 10 in an expanded state and placing it in the vicinity of the aortic valve annulus. FIG. 41 is a diagram showing the introducing device 40. It is a figure which shows the procedure which takes out from the incision to the exterior of the ascending aorta
第2図は幅広の略円筒状の立体形状の組織片捕捉具10aの構成例の収縮状態を示す図である
第3図は組織片捕捉具10aの別の収縮状態を示す図である
第4図は球状の立体形状の組織片捕捉具10bの構成例の拡張状態を示す図である
第5図は球状の立体形状の組織片捕捉具10bの構成例の収縮状態を示す図である
第6図は略椀状の立体形状の組織片捕捉具10cの構成例の拡張状態を示す図である
第7図は略椀状の立体形状の組織片捕捉具10cの構成例の収縮状態を示す図である
第8図は円錐状の略椀状の組織片捕捉具10dの構成例の拡張状態を示す図である
第9図は円錐状の略椀状の組織片捕捉具10dの構成例の収縮状態を示す図である
第10図は中央部が膜で閉鎖されている略ドーナツ状の立体形状の捕捉具10eの構成例の拡張状態を示す図である
第11図は中央部が膜で閉鎖されている略ドーナツ状の立体形状の捕捉具10eの構成例の収縮状態を示す図である
第12図は空気圧を加えることにより組織片捕捉具10cの収縮状態を示す図である
第13図は空気圧を加えることにより組織片捕捉具10cの収縮状態から拡張状態に切り替える構成例を示す図である
第14図は図10に示した組織片捕捉具10eの収縮状態を示す図である
第15図は図10に示した組織片捕捉具10eの収縮状態から図11に示した組織片捕捉具10eの拡張状態に切り替える構成例を示す図である
第16図は図1に示した組織片捕捉具10aの収縮状態から図2に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である
第17図は図3に示した組織片捕捉具10aの収縮状態から図1に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である
第18図は図9に示した組織片捕捉具10dの収縮状態から図8に示した組織片捕捉具10dの拡張状態に切り替える構成例を示す図である
第19図は支持部の操作を介して組織片捕捉部10を変形させる構成例を示す図である
第20図は支持リング15を左右に収縮させることにより組織片捕捉具10f全体を収縮状態とした様子を示す図である
第21図は支持部の操作を介して組織片捕捉部10を変形させる別の構成例を示す図である
第22図は支持バルーン17の空気を抜いて収縮状態とした様子を模式的示す図である
第23図はブラシ状の立体形状の組織片捕捉具10hの構成例の拡張状態を示す図である
第24図はブラシ状の立体形状の組織片捕捉具10hの構成例の収縮状態を示す図である
第25図は布材で毛材を覆ったブラシ状の立体形状の組織片捕捉具10h’の構成例の拡張状態を示す図である
第26図は布材で毛材を覆ったブラシ状の立体形状の組織片捕捉具10h’の構成例の収縮状態を示す図である
第27図は毛材の間に布材を挟み込んだ組織片捕捉具10h”の構成例の拡張状態を示す図である
第28図は組織片捕捉具10h”の2つの毛材とそれらの間に挟まれた布材とを分解して模式的に示した図である
第29図は実施例1の図1で示した略円筒状の立体形状である組織片捕捉具10aに対して回収具30を備えた構成を示す図である
第30図は実施例1の図19で示した支持リング15を伴う組織片捕捉具10fに対して回収具30を備えた構成を示す図である
第31図は組織片捕捉具10fを導入具40の内部に収容した状態を示した図である
第32図は組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示した図である
第33図は組織片捕捉具10fを導入具40の内部に収容した状態を示した図である
第34図は組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示した図である
第35図は組織片捕捉具10gを導入具40の内部に収容した状態を示した図である
第36図は組織片捕捉具10gを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示した図である
第37図は開放具50としての押し出し棒50により組織片捕捉具10を押し出してゆく様子を示す図である
第38図は大動脈弁の弁尖付近の上行大動脈壁を切開し、切開口を設ける手順を示す図である
第39図は大動脈弁3の弁尖の間隙4を通過させ、導入具40を大動脈弁3の弁輪近傍6まで導入する手順を示す図である
第40図は組織片捕捉具10を拡張状態とすることにより大動脈弁3を塞ぎ、大動脈弁弁輪近傍に留置せしめる手順を示す図である
第41図は導入具40を切開口から上行大動脈の外部へと取り出す手順を示す図である FIG. 1 is a diagram showing an expanded state of a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a. FIG. 2 is a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a. FIG. 3 is a diagram showing another contracted state of the tissue piece capturing device 10a. FIG. 4 is a diagram showing an expanded state of a configuration example of the spherical three-dimensional tissue piece capturing device 10b. FIG. 5 is a diagram showing a contracted state of the configuration example of the spherical solid-shaped tissue piece capturing tool 10b. FIG. 6 shows an expanded state of the configuration example of the substantially bowl-shaped three-dimensional tissue piece capturing tool 10c. FIG. 7 is a diagram showing a contracted state of a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing device 10c. FIG. 8 is a configuration example of a conical substantially scissor-shaped tissue piece capturing device 10d. FIG. 9 is a diagram showing a contracted state of a configuration example of the cone-shaped substantially scissor-shaped tissue piece capturing tool 10d. FIG. 10 is a diagram showing an expanded state of a configuration example of a substantially donut-shaped capturing tool 10e whose central portion is closed with a membrane. FIG. 11 is a diagram where the central portion is closed with a membrane. FIG. 12 is a diagram showing a contracted state of a configuration example of a substantially donut-shaped three-dimensional capturing device 10e. FIG. 12 is a diagram showing a contracted state of a tissue piece capturing device 10c by applying air pressure. FIG. 14 is a diagram showing a configuration example in which the tissue piece capturing tool 10c is switched from the contracted state to the expanded state. FIG. 14 is a diagram showing the contracted state of the tissue piece capturing tool 10e shown in FIG. FIG. 16 is a diagram showing a configuration example of switching from the contracted state of the tissue piece capturing tool 10e shown in FIG. 11 to the expanded state of the tissue piece capturing tool 10e shown in FIG. 11. FIG. 16 shows the contraction of the tissue piece capturing tool 10a shown in FIG. Shown in Figure 2 from the state FIG. 17 is a diagram showing a configuration example of switching to the expanded state of the tissue piece capturing tool 10a. FIG. 17 switches from the contracted state of the tissue piece capturing tool 10a shown in FIG. 3 to the expanded state of the tissue piece capturing tool 10a shown in FIG. Fig. 18 is a diagram showing a configuration example. Fig. 18 is a diagram showing a configuration example for switching from the contracted state of the tissue piece capturing device 10d shown in Fig. 9 to the expanded state of the tissue piece capturing device 10d shown in Fig. 8. FIG. 20 is a diagram showing a configuration example in which the tissue
以下、本発明を実施するための最良の形態について実施例により具体的に説明する。なお本発明はこれらの実施例に限定されるものではない。
以下、本発明の大動脈弁置換手術用の組織片捕捉具、大動脈弁置換手術用の組織片捕捉具セット、および大動脈弁置換手術における組織片捕捉方法を添付図面に示す好適実施例に基づいて詳細に説明する。なお、本発明はこれらの実施例に限定されるものではない。
本発明の大動脈弁置換手術用の組織片捕捉具は、心臓の大動脈弁の置換手術において大動脈弁の切除に伴い生じうる組織片残渣の左心室内への侵入を抑止するものである。
以下、まず、実施例1として、大動脈弁置換手術用の組織片捕捉具10の様々な形状例および組織片捕捉具の拡張状態と収縮状態を切り替える構造について示す。
実施例2として回収具30を伴った組織片捕捉具10の構成例を示す。
実施例3として、導入具40と開放具50を用いた心室所定位置への組織片捕捉具10の留置と取り出しの術式手順を示す。 Hereinafter, the best mode for carrying out the present invention will be described specifically by way of examples. The present invention is not limited to these examples.
Hereinafter, the tissue piece capturing device for aortic valve replacement surgery, the tissue piece capturing device set for aortic valve replacement surgery, and the tissue piece capturing method in aortic valve replacement surgery according to the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings. Explained. The present invention is not limited to these examples.
The tissue piece capturing device for aortic valve replacement surgery of the present invention suppresses invasion of a tissue piece residue into the left ventricle that may be caused by excision of the aortic valve in aortic valve replacement surgery.
Hereinafter, first, as Example 1, various structure examples of the tissuepiece capturing tool 10 for aortic valve replacement surgery and a structure for switching between an expanded state and a contracted state of the tissue piece capturing tool will be described.
As a second embodiment, a configuration example of the tissuepiece capturing tool 10 with the recovery tool 30 is shown.
As Example 3, an operation procedure for placing and removing the tissuepiece capturing device 10 at a predetermined position of the ventricle using the introducing device 40 and the opening device 50 will be described.
以下、本発明の大動脈弁置換手術用の組織片捕捉具、大動脈弁置換手術用の組織片捕捉具セット、および大動脈弁置換手術における組織片捕捉方法を添付図面に示す好適実施例に基づいて詳細に説明する。なお、本発明はこれらの実施例に限定されるものではない。
本発明の大動脈弁置換手術用の組織片捕捉具は、心臓の大動脈弁の置換手術において大動脈弁の切除に伴い生じうる組織片残渣の左心室内への侵入を抑止するものである。
以下、まず、実施例1として、大動脈弁置換手術用の組織片捕捉具10の様々な形状例および組織片捕捉具の拡張状態と収縮状態を切り替える構造について示す。
実施例2として回収具30を伴った組織片捕捉具10の構成例を示す。
実施例3として、導入具40と開放具50を用いた心室所定位置への組織片捕捉具10の留置と取り出しの術式手順を示す。 Hereinafter, the best mode for carrying out the present invention will be described specifically by way of examples. The present invention is not limited to these examples.
Hereinafter, the tissue piece capturing device for aortic valve replacement surgery, the tissue piece capturing device set for aortic valve replacement surgery, and the tissue piece capturing method in aortic valve replacement surgery according to the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings. Explained. The present invention is not limited to these examples.
The tissue piece capturing device for aortic valve replacement surgery of the present invention suppresses invasion of a tissue piece residue into the left ventricle that may be caused by excision of the aortic valve in aortic valve replacement surgery.
Hereinafter, first, as Example 1, various structure examples of the tissue
As a second embodiment, a configuration example of the tissue
As Example 3, an operation procedure for placing and removing the tissue
実施例1にかかる大動脈弁置換手術用の組織片捕捉具10の様々な形状例を添付の図面を参照しながら具体的に説明する。
まず、幅広の略円筒状の立体形状の組織片捕捉具10aの例を示す。図1および図2は、幅広の略円筒状の立体形状の組織片捕捉具10aの構成例を示す図である。図1は組織片捕捉具10aの拡張状態を示しており、図2は組織片捕捉具10aの収縮状態を示している。図1、図2とも(a)は正面図、(b)は側面図、(c)は斜視図を示している。
拡張状態における組織片捕捉具10aの形状および大きさは、患者の左心室内の大動脈弁弁輪近傍に収まって大動脈弁を塞ぐ形状および大きさであれば良く限定されないが、その大きさは円筒の径は10~30mm、高さが1~30mmとなっている。なお、手術時においては心室内が閉鎖しており捕捉具10aが侵入できないため、高さが高すぎると大動脈弁の近傍に捕捉具10が位置することになり、弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、1~30mm程度が好ましい。
実施例1にかかる組織片捕捉具10aの例では、図1に見るようにその形状は幅広の略円筒状の立体形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
次に、収縮状態における組織片捕捉具10aの形状および大きさは、大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過できる形状および大きさであれば良く限定されないが、実施例1にかかる組織片捕捉具10aの例では、図2に見るようにその形状は細い円柱形の立体形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで高さは3~7mmとなっている。
本発明の組織片捕捉具10aは、大動脈弁の置換手術に先立ち、図2の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10aは図2の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10aが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10aは、大動脈弁弁尖の間隙を通過して左心室導入後、図1の拡張状態となり、略円筒状の口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略円筒状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10aで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
図3は組織片捕捉具10aの別の収縮状態の例である。図1の拡張状態から一部を縮小しかつ他の部分を拡張させることにより収縮させた状態となっている。つまり、図1の拡張状態から略円筒形の外径は小さく縮小するものの高さが高くなり全体がコンパクトな形に収縮した状態となっている。
本発明の組織片捕捉具10の形状は、図1および図2のもの、または、図1および図3のものに限定されず、他にも様々な形状および大きさが可能である。
次に、球状の立体形状の組織片捕捉具10bの例を示す。図4および図5は、球状の立体形状の組織片捕捉具10bの構成例を示した図である。図4は組織片捕捉具10bの拡張状態を示しており、図5は組織片捕捉具10bの収縮状態を示している。図4および図5とも(a)は正面図、(b)は側面図を示している。
この例では図4に示すように、捕捉具10bは拡張状態において球状の立体形状であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており、大動脈弁を塞ぐものとなっている。なお、捕捉具10bの形状はかならずしも正確な球状である必要はなく、非球状の捕捉具10bであっても大動脈弁弁輪近傍に収まる形状および大きさであれば良い。例えば球の直径が10~30mmとなっている。
また、この例では図5に示すように、捕捉具10bは収縮状態において細い円柱形の立体形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで高さは10~30mmとなっている。
本発明の組織片捕捉具10bは、大動脈弁の置換手術に先立ち、図5の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10bは図5の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10bが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10bは、大動脈弁弁尖の間隙を通過して左心室導入後、図3の拡張状態となり、球状表面にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10bで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
次に、略椀状の立体形状の組織片捕捉具10cの例を示す。図6及び図7は、略椀状の立体形状の組織片捕捉具10cの構成例を示した図である。図6は組織片捕捉具10cの拡張状態を示しており、図7は組織片捕捉具10cの収縮状態を示している。図6、図7とも(a)は正面図、(b)は側面図、(c)は側面断面図、(d)は斜視図を示している。
この例では図6に示すように、捕捉具10cは拡張状態において略椀状の立体形状であり、であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており、略椀状の口により大動脈弁を塞ぐものとなっている。例えば椀の径が10~30mmとなっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
また、この例では図7に示すように、組織片捕捉具10cは収縮状態において外形は細い円柱形、内部は椀状形の立体形状となっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで長さは10~30mmとなっている。
本発明の組織片捕捉具10cは、大動脈弁の置換手術に先立ち、図7の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10cは図7の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10cが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10cは、大動脈弁弁尖の間隙を通過して左心室導入後、図6の拡張状態となり、略椀状の口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略椀状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10cで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
なお、組織片捕捉具10の形状はかならずしも半球の略椀状である必要はなく、たとえば円錐状の略椀状でもよい。図8および図9は、円錐状の略椀状の組織片捕捉具10dの構成例を示した図である。図8は組織片捕捉具10dの拡張状態を示しており、図9は組織片捕捉具10dの収縮状態を示している。図8および図9とも(a)は正面図、(b)は側面図、(c)は側面断面図、(d)は斜視図を示している。
この例では図8に示すように、組織片捕捉具10dは拡張状態において円錐状の略椀状の立体形状であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており、略椀状の口により大動脈弁を塞ぐものとなっている。例えば椀の径が10~30mmとなっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
また、この例では図9に示すように、捕捉具10dは収縮状態において外形は細い円柱形、内部は椀状形の立体形状となっている。この例では図7とほぼ同様の形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで長さは10~30mmとなっている。
本発明の組織片捕捉具10dは、大動脈弁の置換手術に先立ち、図9の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10dは図9の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10dが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10dは、大動脈弁弁尖の間隙を通過して左心室導入後、図8の拡張状態となり、略ドーナツの口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略椀状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10dで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
次に、中央部が膜で閉鎖されている略ドーナツ状の立体形状の組織片捕捉具10eの例を示す。図10および図11は、中央部が膜で閉鎖されている略ドーナツ状の立体形状の捕捉具10eの構成例を示した図である。図10は組織片捕捉具10eの拡張状態を示しており、図11は組織片捕捉具10eの収縮状態を示している。図10および図11とも(a)は正面図、(b)は側面図、(c)は側面断面図、(d)は斜視図を示している。
この例では図10に示すように、組織片捕捉具10eは拡張状態において中央部が膜で閉鎖されている略ドーナツ状の立体形状であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており大動脈弁を塞ぐものとなっている。例えばドーナツの外径が10~30mmとなっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
また、この例では図11に示すように、捕捉具10eの収縮状態は図10の拡張状態から全体が収縮した立体形状となっている。大きさはドーナツの外径が3~7mmとなっている。なお、全体が曲面であるため体内への導入時に組織との接触が和らげられる。
本発明の組織片捕捉具10eは、大動脈弁の置換手術に先立ち、図11の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10eは図11の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10eが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10eは、大動脈弁弁尖の間隙を通過して左心室導入後、図10の拡張状態となり、略ドーナツの口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略椀状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10eで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
次に、上記の様々な形状の組織片捕捉具10の拡張状態と収縮状態とを切り替える構造について説明する。
組織片捕捉具10の構造は限定されないが、簡易な操作で体積を減少させることができ、かつ、簡易な操作で、例えば形状記憶能による形状回復などにより、体積を元のものまで増加させることができる構造が好ましい。そのような構造としては、例えば形状記憶能を有する多孔質構造、または繊維などが好ましい。
まず、空気圧を加えることによって組織片捕捉具10を収縮状態から拡張状態へ切り替える構造について説明する。
図12および図13は、空気圧を加えることにより組織片捕捉具10の収縮状態から拡張状態に切り替える構成例を示す図である。一例として図4に示した組織片捕捉具10aの収縮状態から図5に示した球状の組織片捕捉具10aの拡張状態に切り替える構成例を示す図である。図12は組織片捕捉具10aに空気圧を加える前の収縮状態を示している。いっぽう図13は組織片捕捉具10aに空気圧を加えることによって、拡張状態に切り替える様子を示している。図12および図13とも側面断面図により示している。
図12および図13の構成例では、組織片捕捉具10aは、バルーン11と、バルーン11に設けられた吸入口12を備えている。バルーン11には、吸入口12を介して、バルーン11に空気圧を加えることのできる送圧チューブ20を取り付けることができる。
大動脈弁の弁尖側から弁輪側へ導入する際には、図12のように空気圧を減少させて大動脈弁の弁尖の間隙を通過できる程度にまで減少させる。たとえば、図12の状態にある組織片捕捉具10aを下部側より図の水平方向に弁尖の間隙を通過させる場合において、進行方向に組織片捕捉具10aを収縮状態とした例である。続いて、組織片捕捉具10aをそのままの状態で、大動脈弁弁尖側から弁輪側へ通過させ、左心室の大動脈弁弁輪近傍に導入する。その後に図13に示すように送圧チューブ20を通して吸入口12よりバルーン11に空気圧を加えて拡張状態となるまで膨張させることにより大動脈弁を塞ぐ。
他の構成例も示しておく。図14および図15は、図10に示した組織片捕捉具10eの収縮状態から図11に示した球状の組織片捕捉具10eの拡張状態に切り替える構成例を示す図である。図14は組織片捕捉具10eに空気圧を加える前の状態を示している。いっぽう図15は組織片捕捉具10eに空気圧を加えることによって、拡張状態に切り替える様子を示している。図14(a)は側面断面図、図14(b)は一部を省略した斜視図となっている。図15は側面断面図を示している。
図14および図15に示すように、組織片捕捉具10eは、バルーン11と、バルーン11に設けられた吸入口12を備えている。バルーン11には、吸入口12を介して、バルーン11に空気圧を加えることのできる送圧チューブ20を取り付けることができる。以下、図14(a)および図15において組織片捕捉具10eの左側を「下部」、組織片捕捉具10eの右側を「上部」と呼ぶ。図14および図15に示すように、組織片捕捉具10eは、中央が膜で閉鎖された略ドーナツ形状である。
導入の際には、空気圧を減少させて収縮状態とし、大動脈弁弁尖の間隙を通過させる。その後、組織片捕捉具10eをそのままの状態で、大動脈弁弁尖の間隙を通過させ、左心室の大動脈弁弁輪近傍まで導入する。その後に、下部を大動脈弁流入部側へ向け、かつ、上部を大動脈弁流出部側へ向けるように配置したうえで、図11に示すように送圧チューブ20を通して吸入口12よりバルーン11に空気圧を加え、拡張状態まで膨張させることにより、大動脈弁を塞ぐ。
空気圧が加えられた拡張状態におけるバルーン11の最大径は限定されないが、大動脈弁弁輪近傍に過度の圧力を与えないことが好ましいので、大動脈弁弁輪近傍に収まった状態において、大動脈弁を塞いでいるバルーン11の断面の最大径が例えば10~30mm程度であることが好ましい。また、上部から下部までの長さも限定されないが、手術時においては心室内が閉鎖しており組織片捕捉具10eが侵入できないため、この長さが長すぎると大動脈弁の近傍に組織片捕捉具10eが位置することになり、大動脈弁弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、例えば、1~30mm程度が好ましい。
バルーン11の素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、または各種ブレンド材等が挙げられる。
組織片捕捉具10は、組織片をより効率よく捕捉するため、バルーン11の外層を覆う捕捉シートをさらに備えていてもよい。かかる捕捉シートの構造は限定されないが、組織片との親和性が高い構造が好ましい。そのような構造としては、例えば粗面、繊維、不織布または多孔質などが好ましい。捕捉シートの素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、セルロース、キトサン、または各種ブレンド材等が挙げられる。
次に、生理食塩水などの液体を吸収することによって収縮状態から拡張状態へ切り替える構造について説明する。
この構成例では、液体を吸収することにより膨張する膨張素材13を複数含み、かつ、該素材の集合が透水性シート14によって被覆されている組織片捕捉具10の構成例を説明する。組織片捕捉具10の収縮状態では膨張素材13が乾燥状態であり体積が減少しており、拡張状態では膨張素材13が吸水状態であり体積が膨張している。
図16は、生理食塩水を吸収することにより図1に示した組織片捕捉具10aの収縮状態から図2に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である。図16の上図は組織片捕捉具10aが液体を吸収する前の収縮状態を示している。いっぽう図16の下図は組織片捕捉具10aが液体を吸収した後の拡張状態を示している。図16の上図、下図とも側面断面図により示している。
膨張素材13は液体を吸収して膨張するものであれば限定されないが、例えば、圧縮された繊維塊が挙げられる。素材は限定されないが、例えば、セルロース系繊維が挙げられる。
図16に示した組織片捕捉具10aを生理食塩水などの液体に曝し、透水性シート14を通して液体を膨張素材13に吸収させることによって、三次元比率をほぼ保ったまま組織片捕捉具10aの体積を膨張させることができる。
膨張素材13が乾燥した収縮状態において、組織片捕捉具10aの大きさが、大動脈弁の弁尖の間隙を通過できる程度の大きさであれば、側部を進行方向側として大動脈弁弁尖の間隙を通過させることができる。その後に組織片捕捉具10aを生理食塩水などの液体に曝し体積を増加させることにより、大動脈弁弁輪近傍を塞ぐことができる。
図17は、生理食塩水を吸収することにより図3に示した組織片捕捉具10aの収縮状態から図1に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である。図17の上図は組織片捕捉具10aが液体を吸収する前の収縮状態を示している。いっぽう図17の下図は組織片捕捉具10aが液体を吸収した後の拡張状態を示している。図17の上図、下図とも側面断面図により示している。図17は、縮小、拡張または折り畳みが可能な透水性シート14で略円筒状の袋を構成し、液体を吸収することにより膨張する複数の膨張素材13を該袋に詰めることで組織片捕捉具10aを構成した例を示す図である。図17上図は、乾燥させて膨張素材13を縮小させ、収縮状態となった組織片捕捉具10aを示す斜視図である。図17の下図は、液体を吸収させて膨張素材13を膨張させ、拡張状態となった組織片捕捉具10aを示す斜視図である。図17の上図において略円筒状となっていた透水性シート14を、その一部を縮小しかつ他の部分を拡張させることにより変形させ、図17の下図のように略円筒形の外径を拡張させ高さを減少させている。
図18は、生理食塩水を吸収することにより図9に示した組織片捕捉具10dの収縮状態から図8に示した組織片捕捉具10dの拡張状態に切り替える構成例を示す図である。図18の上図は組織片捕捉具10dが液体を吸収する前の収縮状態を示している。いっぽう図18の下図は組織片捕捉具10dが液体を吸収した後の拡張状態を示している。図18の上図、下図とも側面断面図により示している。
図18の上図の収縮状態において、大動脈弁の弁尖の間隙を通過させ、その後に組織片捕捉具10dを生理食塩水などの液体に曝し吸水により膨張させることにより、大動脈弁を塞ぐことができる。
膨張素材13の構造は限定されないが、例えば、圧縮された繊維塊が挙げられる。
圧縮された繊維塊の素材は限定されないが、例えば、セルロース系繊維塊が挙げられる。圧縮された繊維塊の乾燥時の大きさは1mm~7mm程度が好ましい。液体を吸収し膨張したときの大きさは限定されないが、例えばセルロース系繊維塊の場合は乾燥時に比べて3倍程度体積が増加する。
透水性シート14の構造は限定されないが、例えば、不織布、多数開孔された不織布および多孔質膜が挙げられる。
透水性シート14の素材は限定されないが、例えば、疎水性繊維が親水処理されたものが挙げられる。
疎水性繊維の素材は限定されないが、例えば、ポリエステル、ポリプロピレンおよびポリエチレンテレフタレートが挙げられる。
次に、組織片捕捉部を支持・変形させる可動式の支持部を備え、支持部の操作を介して組織片捕捉部を変形させ、収縮状態から拡張状態へ切り替えられる構成例を説明する。
図19は、支持部の操作を介して組織片捕捉部10を変形させる構成例を示す図である。図19(a)は正面図となっており、図19(b)は側面図となっている。
図19に示すように、大動脈弁置換手術用の組織片捕捉具10fは、リング状の支持部15と、支持部15に取り付けられた捕捉シート16を備えている。以下、図19において組織片捕捉具10fの下側を「下部」、組織片捕捉具10fの上側を「上部」と呼ぶ。図19に示すように、本発明の組織片捕捉具10fは、略円板状であり、例えば、捕捉シート16で組織片を捕捉せしめるように配置すると、大動脈弁弁輪近傍に収まる形状を有している。なお、組織片捕捉具10fの形状はかならずしも略円板状である必要はなく、大動脈弁を塞ぐことができる形状であればよい。たとえば略円筒状でもよい。
心室への導入の際には、組織片捕捉具10fを大動脈弁の弁尖の間隙を通過できる程度にまで収縮させる。たとえば、図20に示すように支持リング15を左右に収縮させることにより組織片捕捉具10f全体を収縮状態とし、組織片捕捉具10fを収縮状態にて大動脈弁弁尖の間隙を通過させ、大動脈弁弁輪近傍まで導入する。その後に捕捉シート16で組織片を捕捉せしめるよう方向を整えたうえで図19の上図の拡張状態とすることにより大動脈弁を塞ぐことができる。
支持部15の最大径は限定されないが、大動脈弁に収まる必要があるので、例えば10~30mm程度が好ましい。また、リング状の支持部15の高さも限定されないが、手術時においては心室内が閉鎖しており組織片捕捉具10fが侵入できないため、この高さが高すぎると大動脈弁の近傍に組織片捕捉具10fが位置することになり、弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、例えば、1~30mm程度が好ましい。
支持リング15の構造は限定されないが、簡易な操作で収縮状態に変形することができ、かつ、簡易な操作で、例えば形状記憶能による形状回復などにより、拡張状態まで戻すことができる構造が好ましい。そのような構造としては、例えば形状記憶能を有するリング構造およびスプリング構造などが好ましい。支持リング15の素材は限定されないが、例えば、ステンレス鋼、チタン(Ti)、タンタル(Ta)およびニチノール(Ni−Ti合金)等が挙げられる。
捕捉シート16の構造は限定されないが、支持リング15の変形に追従することができ、かつ、組織片を捕捉することができる構造が好ましい。そのような構造としては、例えば繊維、不織布および多孔質構造などが好ましい。捕捉シート16の素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、または各種ブレンド材等が挙げられる。
図21は、支持部15の操作を介して組織片捕捉部10を変形させる別の構成例を示す図である。図21(a)は正面図、図21(b)は側面図、図22は収縮状態の様子を模式的示す図となっている。
図21に示すように、組織片捕捉具10gは、支持バルーン17と、支持バルーン17に取り付けられた捕捉シート16を備えている。図21は、支持バルーン17に空気圧が加えられた状態を示している。図21に示すように、組織片捕捉具10gは、支持バルーン17に空気圧が加えられた状態において略円板状であり、例えば、捕捉シート16で組織片を捕捉せしめるように配置すると、大動脈弁弁輪近傍に収まる形状を有している。なお、組織片捕捉具10gの形状は空気圧が加えられた状態においてかならずしも略円板状である必要はなく、空気圧が加えられた状態において大動脈弁流入部を塞ぐことができる形状であればよい。たとえば略円筒状でもよい。
心室内に導入する際には、組織片捕捉具10gを大動脈弁弁尖の間隙を通過できる程度にまで減少させる。たとえば、図22に示すように支持バルーン17から空気を抜くことにより、組織片捕捉具10g全体が収縮状態となっている。組織片捕捉具10gを収縮状態として、大動脈弁弁尖の間隙を通過させ、大動脈弁弁輪近傍まで導入する。その後捕捉シート16で組織片を捕捉せしめるよう方向を整えたうえで支持バルーン17に空気圧を加えて拡張状態に戻すことにより、大動脈弁を塞ぐことができる。
空気圧が加えられた状態における支持バルーン17の最大径は限定されないが、大動脈弁に過度の圧力を与えないことが好ましいので、大動脈弁弁輪近傍に収まった状態において、大動脈弁を塞いでいる支持バルーン17の断面の最大径が例えば10~30mm程度であることが好ましい。また、高さも限定されないが、手術時においては心室内が閉鎖しており組織片捕捉具10gが侵入できないため、この高さが高すぎると大動脈弁の近傍に組織片捕捉具10gが位置することになり、弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、例えば、1~30mm程度が好ましい。
支持バルーン17の素材は延伸加工が可能な高分子材料であればよく、限定されないが、例えばポリエチレン、ポリプロピレン、ポリエステル、ポリウレタン、ポリアミド、ポリエチレンテレフタレート、ポリスチレン、ポリビニルアルコール、ポリ塩化ビニル、ポリ塩化ビニリデン、ポリイミド、ポリアセチレン、ポリサルフォン等の高分子材料とその共重合体、混合体が適用可能である。
捕捉シート16の構造は限定されないが、支持バルーン17の変形に追従することができ、かつ、組織片を捕捉することができる構造が好ましい。そのような構造としては、例えば繊維、不織布および多孔質構造などが好ましい。捕捉シート16の素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、セルロース、キトサンまたは各種ブレンド材等が挙げられる。
次に、ブラシ状の立体形状の組織片捕捉具10hの例を示す。図23および図24は、ブラシ状の立体形状の組織片捕捉具10hの構成例を示した図である。図23は組織片捕捉具10hの拡張状態を示しており、図24は組織片捕捉具10hの収縮状態を示している。図23および図24とも(a)は側面図、(b)は正面図を示している。
この例では図23および図24に示すように、組織片捕捉具10hは、2本の芯材18の間に長手方向に沿って多数の毛材191を挟み込むとともに、これら芯材18を一体に捻り合わせ、毛材191を芯材18の周囲に放射状に設けたものであるが、組織片捕捉具10hは、このような構成に限定されず、毛材191を芯材18の周囲に放射状に設けた構成であればどのような構成でもよい。
この例では、図23及び図24に示すように、組織片捕捉具10hは拡張状態において毛材191が芯材18の周囲に芯材18と直交する方向に放射状に設けられ、大動脈弁弁輪近傍に収まる形状と大きさを有しており大動脈弁を塞ぐものとなっている。例えば毛材191が芯材18を中心として形成する放射円の外径が15~25mmとなっている。
また、この例では図23および図24に示すように、組織片捕捉具10hの収縮状態は図23の拡張状態から毛材191が芯材18を中心として形成する放射円の外径が収縮した立体形状となっている。例えば、外径が3~7mmとなっている。
この構成例では変形手段として、収縮状態は円板状の毛材191が傘状に閉じた状態、拡張状態が円板状の毛材191が傘状に開いた状態のように傘の開閉のように変形するものとなっている。
心室への導入の際には、図24に示すように、組織片捕捉具10hの毛材191が芯材18を中心として形成する放射円の外径を大動脈弁の弁尖の間隙を通過できる程度にまで収縮させる。組織片捕捉具10hを収縮状態にて大動脈弁弁尖の間隙を通過させ、大動脈弁弁輪近傍まで導入する。その後図23の拡張状態とすることにより大動脈弁を塞ぐことができる。
毛材191の素材は限定されないが、組織片捕捉具10hの縮小状態から拡張状態への切り替えが外力を要さず自然に行われるよう、弾性を有する素材が好ましい。また、血管壁等の組織を傷めないよう、柔軟性を有する素材が好ましい。例えば、ポリアミド、ポリエステル、アルケンポリマー、ジエンポリマー等が挙げられる。
芯材18の素材は限定されないが、毛材191を支持することができる程度の強度を有する素材が好ましい。また、図23および図24に示すように組織片捕捉具10hを芯材18を一体に捻り合わせる構成とする場合は、外力を加えることにより塑性変形する素材が好ましい。例えば、金属、合成樹脂モノフィラメント等が挙げられる。
また、組織片捕捉具10hの構成として、支持部15となる毛材に捕捉部16となる布材を組み合わせて組織片残渣の捕捉能力を高める工夫を施す構成も可能である。
布材を組み合わせ第1の構成である組織片捕捉具10h’を示す。この例では、支持部15が中心から外周に向けて放射状に毛材を設けた少なくとも1枚の円板状のブラシであり、捕捉部16がブラシの周囲を覆った布材である構成例である。
組織片捕捉具10h’は、図25及び図26に示すように、芯材18の周囲に放射状に設けた毛材191の周りをさらに布材192で覆うようにした構成である。このような構成とすることで大動脈弁をより密に塞ぐことができるため、大動脈弁を切除した際に生じる組織片残滓をより多く捕捉することができる。図25は組織片捕捉具10h’の拡張状態を示しており、図26は組織片捕捉具10h’の収縮状態を示している。図25及び図26とも(a)は側面図、(b)は正面図を示している。
布材192の構造は限定されないが、血液などの液体を完全に遮断しない程度に組織片捕捉具10h’が大動脈弁を塞ぐようにしたほうが手術を行う上でより好ましいので、透水性を有する構造が好ましい。例えば、不織布、多数開孔された不織布および多孔質膜が挙げられる。
透水性を有する布材192の素材は限定されないが、例えば、疎水性繊維が親水処理されたものが挙げられる。
疎水性繊維の素材は限定されないが、例えば、ポリエステル、ポリプロピレンおよびポリエチレンテレフタレートが挙げられる。
次に、布材を組み合わせ第2の構成である組織片捕捉具10h”を示す。この例では、支持部15が中心から外周に向けて放射状に毛材を設けた複数枚の円板状のブラシであり、捕捉部16がブラシ同士の間に間挿せしめた円板状の布材である構成例である。
組織片捕捉具10h”は、図27および図28に示すように、芯材18の長手方向に沿って配されているブラシ状の立体形状の毛材191の間に布材192を挟み込んだ構成である。図27は拡張状態の組織片捕捉具10h”を示した図であり、図28は2つの毛材191とそれらの間に挟まれた布材192とを分解して模式的に示した図である。
芯材18の素材は、たとえば一般的な樹脂製(ABS、PP、PE、PC、アクリル、PET)により形成され、この構成例では円柱状のものとなっている。
毛材191の素材も一般的な樹脂製で良く、円形に樹脂製の毛を植毛したリング状のものである。例えばリングの径は直径2~3cm程度、毛の太さは、0.1mm以下であり、大動脈弁弁輪近傍に収まる形状及び大きさを有しており大動脈弁を塞ぐものとなっている。毛材191は芯材18の周囲に放射状に設けた構成であればどのような構成でもよい。
布材192の素材は不織布やガーゼなどの繊維状のものであり、透水性を持ち、折れ曲がりにくく、よれにくい繊維素材が望ましい。透水性を有する布材192の素材は限定されないが、例えば、疎水性繊維が親水処理されたものが挙げられる。例えば、ポリエステル、ポリプロピレンおよびポリエチレンテレフタレートなどが挙げられる。
図27および図28に示した組織片捕捉具10h”の構成例では、二枚の円形のブラシ状の毛材191の間に略同径の不織布の布材192を挟み込む構造となっており、毛材191と布材192の間の接着などは行っていない。布材192をいわゆるフィルターのように毛材191の間に間挿した構造となっている。なお、組織片捕捉具10h”と血管壁との間の密着性を高めるため、布材192の直径を毛材191の直径よりも若干大きいものとしても良い。また、毛材191と布材192の間の接着を行っても良いが血流を阻害しないように配慮する必要がある。
なお、サイズは、長手方向も3cm程度のものが手術時に使いやすいが、別途挿入時の操作性を高めるために、取り外しできるエクステンションの棒を装着してもよい。また、末端に穴を開けて、糸を通すことで取り出しやすくすることも好ましい。
以上、本発明にかかる大動脈弁置換手術用の組織片捕捉具によれば、手術患部に取り付けることにより、弁尖の切除を始める時点から組織片残滓の捕捉を開始することができるので、従来の捕捉具に比べ、より確実に漏れなく組織片残滓を捕捉できる。 Various shape examples of the tissuepiece capturing tool 10 for aortic valve replacement surgery according to the first embodiment will be specifically described with reference to the accompanying drawings.
First, an example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a is shown. FIG. 1 and FIG. 2 are diagrams showing a configuration example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a. FIG. 1 shows an expanded state of the tissue piece capturing tool 10a, and FIG. 2 shows a contracted state of the tissue piece capturing tool 10a. 1 and 2, (a) is a front view, (b) is a side view, and (c) is a perspective view.
The shape and size of the tissue piece capturing device 10a in the expanded state are not particularly limited as long as the shape and size are close to the aortic valve annulus in the left ventricle of the patient and close the aortic valve, but the size is not limited. Has a diameter of 10 to 30 mm and a height of 1 to 30 mm. During the operation, since the ventricle is closed and the capturing device 10a cannot enter, if the height is too high, the capturingdevice 10 will be located in the vicinity of the aortic valve, and the operation such as excision of the valve leaflet will be performed. When working, the work space is compressed and obstacles occur. Therefore, about 1 to 30 mm is preferable.
In the example of the tissue piece capturing tool 10a according to the first embodiment, as shown in FIG. 1, the shape is a wide, substantially cylindrical three-dimensional shape, and the edge portion is a smooth curved surface. Has been. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
Next, the shape and size of the tissue piece capturing device 10a in the contracted state are not limited as long as the shape and size can pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side. In the example of the tissue piece capturing tool 10a according to No. 1, as shown in FIG. 2, the shape is a thin cylindrical solid shape, and the edge portion is a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 3 to 7 mm in height.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10a of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10a of the present invention can pass through in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10a cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10a of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed and the tissue piece residue is captured in a substantially cylindrical internal void.
In this way, prior to the aortic valve replacement operation, the tissue piece capture device 10a can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
FIG. 3 is an example of another contracted state of the tissue piece capturing tool 10a. A part of the expanded state of FIG. 1 is contracted and the other part is expanded to be contracted. That is, although the outer diameter of the substantially cylindrical shape is reduced from the expanded state of FIG. 1, the height is increased and the whole is contracted into a compact shape.
The shape of the tissuepiece capturing tool 10 of the present invention is not limited to that shown in FIGS. 1 and 2 or those shown in FIGS. 1 and 3, and various other shapes and sizes are possible.
Next, an example of a spherical three-dimensional tissue piece capturing tool 10b is shown. 4 and 5 are diagrams showing a configuration example of a spherical solid-shaped tissue piece capturing tool 10b. 4 shows an expanded state of the tissue piece capturing tool 10b, and FIG. 5 shows a contracted state of the tissue piece capturing tool 10b. 4 and 5, (a) is a front view, and (b) is a side view.
In this example, as shown in FIG. 4, the capturing tool 10b has a spherical three-dimensional shape in the expanded state, has a shape and a size that fits in the vicinity of the aortic valve annulus, and closes the aortic valve. . Note that the shape of the capturing device 10b does not necessarily have an accurate spherical shape, and even the non-spherical capturing device 10b may have a shape and size that can be accommodated in the vicinity of the aortic valve annulus. For example, the diameter of the sphere is 10 to 30 mm.
Further, in this example, as shown in FIG. 5, the capturing tool 10b has a thin cylindrical solid shape in a contracted state, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in height.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10b of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10b of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10b cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue fragment capturing device 10b of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. Capture tissue debris.
As described above, prior to the replacement operation of the aortic valve, the tissue piece capturing tool 10b can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
Next, an example of a substantially scissor-shaped three-dimensional tissue piece capturing tool 10c will be described. 6 and 7 are diagrams showing a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing tool 10c. FIG. 6 shows the expanded state of the tissue piece capturing tool 10c, and FIG. 7 shows the contracted state of the tissue piece capturing tool 10c. 6 and 7, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 6, the capturing tool 10c has a substantially bowl-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus, and has a substantially bowl-like shape. The mouth closes the aortic valve. For example, the diameter of the ridge is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
In this example, as shown in FIG. 7, the tissue piece capturing tool 10c has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl shape inside. The edge portion is disclosed as a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in length.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10c of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10c of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10c cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10c of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed, and the tissue debris is captured in the internal cavity of a generally saddle shape.
In this way, prior to the aortic valve replacement operation, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10c.
Note that the shape of the tissuepiece capturing tool 10 is not necessarily a substantially hemispherical bowl shape, and may be, for example, a conical substantially bowl shape. FIG. 8 and FIG. 9 are diagrams showing a configuration example of a cone-shaped substantially scissor-shaped tissue piece capturing tool 10d. FIG. 8 shows an expanded state of the tissue piece capturing tool 10d, and FIG. 9 shows a contracted state of the tissue piece capturing tool 10d. 8 and 9, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 8, the tissue piece capturing tool 10d has a conical substantially saddle-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus. The aortic valve is closed by a shaped mouth. For example, the diameter of the ridge is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
In this example, as shown in FIG. 9, the trapping tool 10 d has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl-like shape inside. In this example, the shape is almost the same as that in FIG. 7, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in length.
Prior to the aortic valve replacement operation, the tissue piece capturing tool 10d of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10d of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10d cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10d of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
In this way, prior to the aortic valve replacement surgery, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10d.
Next, an example of a substantially doughnut-shaped three-dimensional tissue piece capturing tool 10e having a central portion closed with a membrane will be described. FIG. 10 and FIG. 11 are diagrams showing a configuration example of a substantially donut-shaped three-dimensional capturing tool 10e whose central portion is closed with a membrane. FIG. 10 shows an expanded state of the tissue piece capturing tool 10e, and FIG. 11 shows a contracted state of the tissue piece capturing tool 10e. 10 and 11, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 10, the tissue piece capturing device 10e has a substantially donut-shaped three-dimensional shape in which the central portion is closed with a membrane in the expanded state, and has a shape and size that fits in the vicinity of the aortic valve annulus. The aortic valve is blocked. For example, the outer diameter of the donut is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
Moreover, in this example, as shown in FIG. 11, the contracted state of the capturing tool 10e has a three-dimensional shape that is entirely contracted from the expanded state of FIG. The outer diameter of the donut is 3 to 7 mm. In addition, since the whole is a curved surface, contact with a tissue is eased at the time of introduction into the body.
Prior to the aortic valve replacement operation, the tissue piece capturing tool 10e of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10e of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10e cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10e of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. 10 so that the aortic valve is surrounded by the portion corresponding to the mouth of the donut. The valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
As described above, prior to the replacement operation of the aortic valve, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10e.
Next, a structure for switching between the expanded state and the contracted state of the tissuepiece capturing device 10 having various shapes will be described.
Although the structure of the tissuepiece capturing tool 10 is not limited, the volume can be reduced by a simple operation, and the volume can be increased to the original by a simple operation, for example, by shape recovery by shape memory ability. A structure capable of forming is preferable. As such a structure, for example, a porous structure having shape memory ability or a fiber is preferable.
First, a structure for switching the tissuepiece capturing tool 10 from the contracted state to the expanded state by applying air pressure will be described.
12 and 13 are diagrams illustrating a configuration example in which the tissuepiece capturing tool 10 is switched from the contracted state to the expanded state by applying air pressure. FIG. 6 is a diagram illustrating a configuration example in which the tissue piece capturing device 10a illustrated in FIG. 4 is switched from the contracted state to the expanded state of the spherical tissue piece capturing device 10a illustrated in FIG. 5 as an example. FIG. 12 shows a contracted state before air pressure is applied to the tissue piece capturing tool 10a. On the other hand, FIG. 13 shows a state in which the tissue piece capturing tool 10a is switched to the expanded state by applying air pressure. Both FIG. 12 and FIG. 13 are shown by side sectional views.
In the configuration example of FIGS. 12 and 13, the tissue piece capturing tool 10 a includes aballoon 11 and an inlet 12 provided in the balloon 11. A pressure supply tube 20 that can apply air pressure to the balloon 11 can be attached to the balloon 11 via the suction port 12.
When introducing from the leaflet side of the aortic valve to the annulus side, the air pressure is decreased as shown in FIG. 12 to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, in the case where the tissue piece capturing device 10a in the state of FIG. 12 is passed through the gap between the leaflets in the horizontal direction in the drawing from the lower side, the tissue piece capturing device 10a is in a contracted state in the traveling direction. Subsequently, the tissue piece capturing device 10a is passed as it is from the aortic valve leaflet side to the annulus side, and introduced into the vicinity of the aortic valve annulus in the left ventricle. Thereafter, as shown in FIG. 13, the aortic valve is closed by inflating theballoon 11 through the pressure feeding tube 20 until the balloon 11 is expanded by applying air pressure to the balloon 11.
Other configuration examples are also shown. 14 and 15 are diagrams showing a configuration example in which the contraction state of the tissue piece capturing device 10e shown in FIG. 10 is switched to the expanded state of the spherical tissue piece capturing device 10e shown in FIG. FIG. 14 shows a state before air pressure is applied to the tissue piece capturing tool 10e. On the other hand, FIG. 15 shows a state in which the tissue piece capturing tool 10e is switched to the expanded state by applying air pressure. 14A is a side sectional view, and FIG. 14B is a perspective view with a part omitted. FIG. 15 shows a side sectional view.
As shown in FIGS. 14 and 15, the tissue piece capturing device 10 e includes aballoon 11 and an inlet 12 provided in the balloon 11. A pressure supply tube 20 that can apply air pressure to the balloon 11 can be attached to the balloon 11 via the suction port 12. Hereinafter, in FIGS. 14A and 15, the left side of the tissue piece capturing tool 10 e is referred to as “lower part”, and the right side of the tissue piece capturing tool 10 e is referred to as “upper part”. As shown in FIGS. 14 and 15, the tissue piece capturing device 10 e has a substantially donut shape with the center closed by a membrane.
At the time of introduction, the air pressure is reduced to a contracted state and passed through the gap of the aortic valve leaflet. Thereafter, the tissue piece capturing tool 10e is passed through the gap of the aortic valve leaflet and introduced to the vicinity of the aortic valve annulus in the left ventricle. Thereafter, the lower part is directed to the aortic valve inflow part side and the upper part is directed to the aortic valve outflow part side, and then the air pressure is applied from thesuction port 12 to the balloon 11 through the pressure feeding tube 20 as shown in FIG. To close the aortic valve by inflating to an expanded state.
Although the maximum diameter of theballoon 11 in the expanded state in which air pressure is applied is not limited, it is preferable not to apply excessive pressure in the vicinity of the aortic valve annulus. It is preferable that the maximum diameter of the cross section of the balloon 11 is, for example, about 10 to 30 mm. Although the length from the upper part to the lower part is not limited, since the ventricle is closed during operation and the tissue piece capturing device 10e cannot enter, if the length is too long, the tissue piece capturing device is located in the vicinity of the aortic valve. 10e is located, and the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of the aortic valve leaflet. Therefore, for example, about 1 to 30 mm is preferable.
The material of theballoon 11 is not limited, and examples thereof include silicon resin, fluorine resin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, and various blend materials.
The tissuepiece capturing tool 10 may further include a capturing sheet that covers the outer layer of the balloon 11 in order to capture the tissue pieces more efficiently. The structure of such a capture sheet is not limited, but a structure having high affinity with a tissue piece is preferable. As such a structure, for example, a rough surface, a fiber, a nonwoven fabric, or a porous material is preferable. The material of the capture sheet is not limited, and examples thereof include silicon resin, fluororesin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, cellulose, chitosan, and various blend materials.
Next, a structure for switching from a contracted state to an expanded state by absorbing a liquid such as physiological saline will be described.
In this configuration example, a configuration example of the tissuepiece capturing tool 10 that includes a plurality of inflatable materials 13 that expand by absorbing a liquid and in which a set of the materials is covered with a water-permeable sheet 14 will be described. In the contracted state of the tissue piece capturing tool 10, the expansion material 13 is in a dry state and the volume is reduced. In the expanded state, the expansion material 13 is in a water-absorbing state and the volume is expanded.
FIG. 16 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 1 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. The upper part of FIG. 16 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid. On the other hand, the lower part of FIG. 16 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid. Both the upper view and the lower view of FIG. 16 are shown by side sectional views.
Although the expansion | swellingraw material 13 will not be limited if it absorbs a liquid and expand | swells, For example, the compressed fiber lump is mentioned. Although a raw material is not limited, For example, a cellulosic fiber is mentioned.
The tissue piece capturing device 10a shown in FIG. 16 is exposed to a liquid such as physiological saline, and the liquid is absorbed by theexpansion material 13 through the water permeable sheet 14, so that the three-dimensional ratio is substantially maintained and the tissue piece capturing device 10a is maintained. The volume can be expanded.
If the size of the tissue piece capturing device 10a is large enough to pass through the gap between the leaflets of the aortic valve in the contracted state in which theexpansion material 13 is dried, the side of the aortic valve leaflet is set to the advancing direction side. The gap can be passed. Thereafter, by exposing the tissue piece capturing tool 10a to a liquid such as physiological saline to increase the volume, the vicinity of the aortic valve annulus can be closed.
FIG. 17 is a diagram illustrating a configuration example of switching from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 3 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. 1 by absorbing physiological saline. The upper part of FIG. 17 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid. On the other hand, the lower part of FIG. 17 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid. Both the upper view and the lower view of FIG. FIG. 17 shows a tissue piece capturing device by forming a substantially cylindrical bag with a water-permeable sheet 14 that can be reduced, expanded, or folded, and filling the bag with a plurality of inflatable materials 13 that expand by absorbing liquid. It is a figure which shows the example which comprised 10a. The upper part of FIG. 17 is a perspective view showing the tissue piece capturing tool 10a which has been dried to reduce the expanded material 13 and brought into a contracted state. The lower view of FIG. 17 is a perspective view showing the tissue piece capturing tool 10a in an expanded state by absorbing the liquid and expanding the expansion material 13. The water-permeable sheet 14 having a substantially cylindrical shape in the upper part of FIG. 17 is deformed by reducing a part thereof and expanding the other part, and has a substantially cylindrical outer diameter as shown in the lower part of FIG. The height is reduced by expanding.
FIG. 18 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10d illustrated in FIG. 9 to the expanded state of the tissue piece capturing device 10d illustrated in FIG. 18 shows a contracted state before the tissue piece capturing tool 10d absorbs the liquid. On the other hand, the lower part of FIG. 18 shows an expanded state after the tissue piece capturing tool 10d has absorbed the liquid. Both the upper and lower views of FIG. 18 are shown by side sectional views.
In the contracted state shown in the upper diagram of FIG. 18, the aortic valve can be blocked by passing through the gap between the leaflets of the aortic valve, and then exposing the tissue piece capturing device 10 d to a liquid such as physiological saline and expanding it by absorbing water. it can.
Although the structure of the expansion | swellingraw material 13 is not limited, For example, the compressed fiber lump is mentioned.
Although the raw material of the compressed fiber lump is not limited, For example, a cellulose fiber lump is mentioned. The size of the compressed fiber lump when dried is preferably about 1 mm to 7 mm. Although the size when the liquid is absorbed and expanded is not limited, for example, in the case of a cellulosic fiber lump, the volume increases about three times as compared with the time of drying.
Although the structure of the water-permeable sheet 14 is not limited, For example, a nonwoven fabric, the nonwoven fabric by which many holes were carried out, and a porous membrane are mentioned.
Although the raw material of the water-permeable sheet 14 is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned.
The material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
Next, a description will be given of a configuration example in which a movable support unit that supports and deforms the tissue piece capturing unit is provided, and the tissue piece capturing unit is deformed through the operation of the support unit and switched from the contracted state to the expanded state.
FIG. 19 is a diagram illustrating a configuration example in which the tissuepiece capturing unit 10 is deformed through the operation of the support unit. FIG. 19A is a front view, and FIG. 19B is a side view.
As illustrated in FIG. 19, the tissue piece capturing tool 10 f for aortic valve replacement surgery includes a ring-shapedsupport portion 15 and a capture sheet 16 attached to the support portion 15. Hereinafter, in FIG. 19, the lower side of the tissue piece capturing tool 10 f is referred to as “lower part”, and the upper side of the tissue piece capturing tool 10 f is referred to as “upper part”. As shown in FIG. 19, the tissue piece capturing device 10f of the present invention has a substantially disk shape, and has a shape that fits in the vicinity of the aortic valve annulus when the tissue sheet is captured by the capturing sheet 16, for example. is doing. Note that the shape of the tissue piece capturing tool 10f is not necessarily a substantially disk shape, and may be any shape that can block the aortic valve. For example, it may be substantially cylindrical.
At the time of introduction into the ventricle, the tissue piece capturing device 10f is contracted to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, as shown in FIG. 20, thesupport ring 15 is contracted left and right to bring the entire tissue piece capturing device 10f into a contracted state, and the tissue piece capturing device 10f is passed through the gap between the aortic valve leaflets in the contracted state. Introduce up to the valve annulus. Thereafter, the aortic valve can be closed by adjusting the direction in which the tissue piece is captured by the capture sheet 16 and then in the expanded state shown in the upper diagram of FIG.
The maximum diameter of thesupport portion 15 is not limited, but is preferably about 10 to 30 mm, for example, because it needs to fit in the aortic valve. Also, the height of the ring-shaped support portion 15 is not limited. However, since the ventricle is closed at the time of surgery and the tissue piece capturing device 10f cannot enter, if the height is too high, the tissue piece is located near the aortic valve. The capturing tool 10f is positioned, and the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of the valve leaflet. Therefore, for example, about 1 to 30 mm is preferable.
The structure of thesupport ring 15 is not limited, but a structure that can be transformed into a contracted state by a simple operation and can be returned to an expanded state by a simple operation, for example, by shape recovery by shape memory ability, is preferable. . As such a structure, for example, a ring structure and a spring structure having shape memory ability are preferable. Although the raw material of the support ring 15 is not limited, For example, stainless steel, titanium (Ti), tantalum (Ta), nitinol (Ni-Ti alloy), etc. are mentioned.
The structure of thecapture sheet 16 is not limited, but a structure that can follow the deformation of the support ring 15 and can capture a tissue piece is preferable. As such a structure, a fiber, a nonwoven fabric, a porous structure, etc. are preferable, for example. The material of the capture sheet 16 is not limited, and examples thereof include silicon resin, fluorine resin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, and various blend materials.
FIG. 21 is a diagram illustrating another configuration example in which the tissuepiece capturing unit 10 is deformed through the operation of the support unit 15. FIG. 21A is a front view, FIG. 21B is a side view, and FIG. 22 is a diagram schematically showing a contracted state.
As shown in FIG. 21, the tissue piece capturing tool 10 g includes asupport balloon 17 and a capture sheet 16 attached to the support balloon 17. FIG. 21 shows a state in which air pressure is applied to the support balloon 17. As shown in FIG. 21, the tissue piece capturing tool 10g has a substantially disk shape in a state where air pressure is applied to the support balloon 17, and for example, when the tissue piece is captured by the capturing sheet 16, the aortic valve It has a shape that fits in the vicinity of the annulus. Note that the shape of the tissue piece capturing tool 10g is not necessarily a substantially disc shape when air pressure is applied, and may be any shape that can block the aortic valve inflow portion when air pressure is applied. For example, it may be substantially cylindrical.
When introduced into the ventricle, the tissue piece capturing device 10g is reduced to such an extent that it can pass through the gap between the aortic valve leaflets. For example, as shown in FIG. 22, when the air is extracted from thesupport balloon 17, the entire tissue piece capturing tool 10g is in a contracted state. The tissue piece capturing tool 10g is set in a contracted state, is passed through the gap of the aortic valve leaflet, and is introduced to the vicinity of the aortic valve annulus. The aortic valve can then be closed by adjusting the direction so that the tissue piece is captured by the capture sheet 16 and then returning the expanded state by applying air pressure to the support balloon 17.
Although the maximum diameter of thesupport balloon 17 in a state where air pressure is applied is not limited, it is preferable not to apply excessive pressure to the aortic valve, so that the support that closes the aortic valve in a state where it is in the vicinity of the aortic valve annulus is supported. The maximum diameter of the cross section of the balloon 17 is preferably about 10 to 30 mm, for example. Although the height is not limited, the ventricle is closed at the time of surgery, and the tissue piece capturing device 10g cannot enter. Therefore, if the height is too high, the tissue piece capturing device 10g is located in the vicinity of the aortic valve. Therefore, the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of a leaflet. Therefore, for example, about 1 to 30 mm is preferable.
The material of thesupport balloon 17 may be a polymer material that can be stretched and is not limited. For example, polyethylene, polypropylene, polyester, polyurethane, polyamide, polyethylene terephthalate, polystyrene, polyvinyl alcohol, polyvinyl chloride, polyvinylidene chloride, Polymer materials such as polyimide, polyacetylene and polysulfone, and copolymers and mixtures thereof are applicable.
The structure of thecapture sheet 16 is not limited, but a structure that can follow the deformation of the support balloon 17 and can capture a tissue piece is preferable. As such a structure, a fiber, a nonwoven fabric, a porous structure, etc. are preferable, for example. The material of the capture sheet 16 is not limited, and examples thereof include silicon resin, fluororesin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, cellulose, chitosan, and various blend materials.
Next, an example of a brush-shaped three-dimensional tissuepiece capturing tool 10h is shown. FIG. 23 and FIG. 24 are diagrams showing a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h. FIG. 23 shows an expanded state of the tissue piece capturing tool 10h, and FIG. 24 shows a contracted state of the tissue piece capturing tool 10h. 23 and 24, (a) shows a side view and (b) shows a front view.
In this example, as shown in FIGS. 23 and 24, the tissuepiece capturing tool 10 h sandwiches a large number of hair materials 191 along the longitudinal direction between the two core materials 18, and integrates these core materials 18 together. The hair material 191 is radially provided around the core material 18 by twisting. However, the tissue piece capturing tool 10h is not limited to such a configuration, and the hair material 191 is provided radially around the core material 18. Any configuration may be used as long as it is provided.
In this example, as shown in FIGS. 23 and 24, in the tissuepiece capturing device 10h, the bristle material 191 is radially provided around the core material 18 in a direction perpendicular to the core material 18 in the expanded state, and the aortic valve annulus. It has a shape and size that fit in the vicinity and closes the aortic valve. For example, the outer diameter of the radial circle formed by the bristle material 191 around the core material 18 is 15 to 25 mm.
In this example, as shown in FIGS. 23 and 24, the contraction state of the tissuepiece capturing tool 10h is reduced from the expanded state of FIG. 23 in the outer diameter of the radial circle formed by the bristle material 191 around the core material 18. It has a three-dimensional shape. For example, the outer diameter is 3 to 7 mm.
In this configuration example, as a deforming means, the contracted state is such that the disc-shaped bristlematerial 191 is closed like an umbrella, and the expanded state is such that the disc-like bristle material 191 is opened like an umbrella, so that the umbrella can be opened and closed. It is supposed to be deformed.
At the time of introduction into the ventricle, as shown in FIG. 24, the outer diameter of the radial circle formed by thebristle material 191 of the tissue piece capturing tool 10 h around the core material 18 can pass through the gap between the leaflets of the aortic valve. Shrink to the extent. The tissue piece capturing tool 10h is passed through the gap of the aortic valve leaflet in the contracted state and introduced to the vicinity of the aortic valve annulus. Thereafter, the aortic valve can be closed by the expanded state shown in FIG.
The material of thehair material 191 is not limited, but a material having elasticity is preferable so that the tissue piece capturing tool 10h can be switched naturally from the contracted state to the expanded state without requiring external force. In addition, a flexible material is preferable so as not to damage tissue such as a blood vessel wall. For example, polyamide, polyester, alkene polymer, diene polymer and the like can be mentioned.
Although the raw material of thecore material 18 is not limited, the raw material which has the intensity | strength of the grade which can support the bristle material 191 is preferable. 23 and 24, when the tissue piece capturing tool 10h is configured to twist the core material 18 integrally, a material that is plastically deformed by applying an external force is preferable. For example, a metal, a synthetic resin monofilament, etc. are mentioned.
In addition, as a configuration of the tissuepiece capturing tool 10h, a configuration in which a hair material that becomes the support portion 15 is combined with a cloth material that becomes the capture portion 16 to increase the ability to capture tissue piece residue is possible.
A tissuepiece capturing tool 10h ′, which is a first configuration by combining cloth materials, is shown. In this example, the support portion 15 is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capturing portion 16 is a cloth material covering the periphery of the brush. is there.
As shown in FIGS. 25 and 26, the tissuepiece capturing tool 10 h ′ has a configuration in which the periphery of the hair material 191 provided radially around the core material 18 is further covered with a cloth material 192. With such a configuration, the aortic valve can be closed more densely, so that more tissue fragment residue generated when the aortic valve is excised can be captured. FIG. 25 shows an expanded state of the tissue piece capturing tool 10h ′, and FIG. 26 shows a contracted state of the tissue piece capturing tool 10h ′. 25 and 26, (a) shows a side view and (b) shows a front view.
Although the structure of thecloth material 192 is not limited, it is more preferable in performing the operation that the tissue piece capturing tool 10h ′ closes the aortic valve to the extent that the liquid such as blood is not completely blocked. Is preferred. For example, a nonwoven fabric, a nonwoven fabric with many holes, and a porous membrane are mentioned.
Although the raw material of thefabric material 192 which has water permeability is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned.
The material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
Next, a tissuepiece capturing tool 10h ″ which is a second configuration by combining cloth materials is shown. In this example, a plurality of disc-shaped support members 15 are provided with hair materials radially from the center toward the outer periphery. It is a structural example which is a brush and the capture part 16 is a disk-shaped cloth material inserted between the brushes.
As shown in FIGS. 27 and 28, the tissuepiece capturing tool 10 h ″ has a configuration in which a cloth material 192 is sandwiched between brush-shaped three-dimensional hair materials 191 disposed along the longitudinal direction of the core material 18. Fig. 27 is a diagram showing the expanded tissue piece capturing tool 10h ", and Fig. 28 is a schematic exploded view of two bristle materials 191 and a cloth material 192 sandwiched between them. It is a figure.
The material of thecore material 18 is made of, for example, a general resin (ABS, PP, PE, PC, acrylic, PET), and in this configuration example, has a cylindrical shape.
The material of thebristle material 191 may also be made of a general resin, and is a ring shape in which resin hairs are planted in a circle. For example, the diameter of the ring is about 2 to 3 cm in diameter, and the thickness of the hair is 0.1 mm or less. The bristle material 191 may have any configuration as long as the bridging material 191 is provided radially around the core material 18.
The material of thecloth material 192 is a fibrous material such as a non-woven fabric or gauze, and is preferably a fiber material that has water permeability and is not easily bent or twisted. Although the raw material of the fabric material 192 which has water permeability is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned. Examples thereof include polyester, polypropylene, and polyethylene terephthalate.
In the configuration example of the tissuepiece capturing tool 10h ″ shown in FIGS. 27 and 28, a non-woven cloth material 192 having substantially the same diameter is sandwiched between two circular brush-like bristle materials 191. Adhesion between the bristle material 191 and the cloth material 192 is not performed, etc. The structure is such that the cloth material 192 is inserted between the bristle material 191 as a so-called filter. The cloth material 192 may have a diameter slightly larger than the diameter of the bristle material 191 in order to improve the adhesion between the blood vessel wall. Moreover, although the bristle material 191 and the cloth material 192 may be bonded, it is necessary to consider so as not to disturb the blood flow.
A size of about 3 cm in the longitudinal direction is easy to use at the time of surgery, but in order to improve the operability at the time of insertion, a removable extension rod may be attached. Moreover, it is also preferable to make it easy to take out by making a hole at the end and passing the thread.
As described above, according to the tissue piece capturing tool for aortic valve replacement surgery according to the present invention, it is possible to start capturing the tissue fragment residue from the time of starting resection of the valve leaflet by attaching it to the surgical affected area. Compared to the capture tool, the tissue fragment residue can be captured more reliably and without leakage.
まず、幅広の略円筒状の立体形状の組織片捕捉具10aの例を示す。図1および図2は、幅広の略円筒状の立体形状の組織片捕捉具10aの構成例を示す図である。図1は組織片捕捉具10aの拡張状態を示しており、図2は組織片捕捉具10aの収縮状態を示している。図1、図2とも(a)は正面図、(b)は側面図、(c)は斜視図を示している。
拡張状態における組織片捕捉具10aの形状および大きさは、患者の左心室内の大動脈弁弁輪近傍に収まって大動脈弁を塞ぐ形状および大きさであれば良く限定されないが、その大きさは円筒の径は10~30mm、高さが1~30mmとなっている。なお、手術時においては心室内が閉鎖しており捕捉具10aが侵入できないため、高さが高すぎると大動脈弁の近傍に捕捉具10が位置することになり、弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、1~30mm程度が好ましい。
実施例1にかかる組織片捕捉具10aの例では、図1に見るようにその形状は幅広の略円筒状の立体形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
次に、収縮状態における組織片捕捉具10aの形状および大きさは、大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過できる形状および大きさであれば良く限定されないが、実施例1にかかる組織片捕捉具10aの例では、図2に見るようにその形状は細い円柱形の立体形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで高さは3~7mmとなっている。
本発明の組織片捕捉具10aは、大動脈弁の置換手術に先立ち、図2の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10aは図2の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10aが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10aは、大動脈弁弁尖の間隙を通過して左心室導入後、図1の拡張状態となり、略円筒状の口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略円筒状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10aで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
図3は組織片捕捉具10aの別の収縮状態の例である。図1の拡張状態から一部を縮小しかつ他の部分を拡張させることにより収縮させた状態となっている。つまり、図1の拡張状態から略円筒形の外径は小さく縮小するものの高さが高くなり全体がコンパクトな形に収縮した状態となっている。
本発明の組織片捕捉具10の形状は、図1および図2のもの、または、図1および図3のものに限定されず、他にも様々な形状および大きさが可能である。
次に、球状の立体形状の組織片捕捉具10bの例を示す。図4および図5は、球状の立体形状の組織片捕捉具10bの構成例を示した図である。図4は組織片捕捉具10bの拡張状態を示しており、図5は組織片捕捉具10bの収縮状態を示している。図4および図5とも(a)は正面図、(b)は側面図を示している。
この例では図4に示すように、捕捉具10bは拡張状態において球状の立体形状であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており、大動脈弁を塞ぐものとなっている。なお、捕捉具10bの形状はかならずしも正確な球状である必要はなく、非球状の捕捉具10bであっても大動脈弁弁輪近傍に収まる形状および大きさであれば良い。例えば球の直径が10~30mmとなっている。
また、この例では図5に示すように、捕捉具10bは収縮状態において細い円柱形の立体形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで高さは10~30mmとなっている。
本発明の組織片捕捉具10bは、大動脈弁の置換手術に先立ち、図5の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10bは図5の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10bが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10bは、大動脈弁弁尖の間隙を通過して左心室導入後、図3の拡張状態となり、球状表面にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10bで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
次に、略椀状の立体形状の組織片捕捉具10cの例を示す。図6及び図7は、略椀状の立体形状の組織片捕捉具10cの構成例を示した図である。図6は組織片捕捉具10cの拡張状態を示しており、図7は組織片捕捉具10cの収縮状態を示している。図6、図7とも(a)は正面図、(b)は側面図、(c)は側面断面図、(d)は斜視図を示している。
この例では図6に示すように、捕捉具10cは拡張状態において略椀状の立体形状であり、であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており、略椀状の口により大動脈弁を塞ぐものとなっている。例えば椀の径が10~30mmとなっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
また、この例では図7に示すように、組織片捕捉具10cは収縮状態において外形は細い円柱形、内部は椀状形の立体形状となっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで長さは10~30mmとなっている。
本発明の組織片捕捉具10cは、大動脈弁の置換手術に先立ち、図7の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10cは図7の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10cが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10cは、大動脈弁弁尖の間隙を通過して左心室導入後、図6の拡張状態となり、略椀状の口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略椀状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10cで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
なお、組織片捕捉具10の形状はかならずしも半球の略椀状である必要はなく、たとえば円錐状の略椀状でもよい。図8および図9は、円錐状の略椀状の組織片捕捉具10dの構成例を示した図である。図8は組織片捕捉具10dの拡張状態を示しており、図9は組織片捕捉具10dの収縮状態を示している。図8および図9とも(a)は正面図、(b)は側面図、(c)は側面断面図、(d)は斜視図を示している。
この例では図8に示すように、組織片捕捉具10dは拡張状態において円錐状の略椀状の立体形状であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており、略椀状の口により大動脈弁を塞ぐものとなっている。例えば椀の径が10~30mmとなっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
また、この例では図9に示すように、捕捉具10dは収縮状態において外形は細い円柱形、内部は椀状形の立体形状となっている。この例では図7とほぼ同様の形状となっており、エッジの部分は滑らかな曲面となっているものが開示されている。これは、体内への導入時に組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。またその大きさは径が3~7mmで長さは10~30mmとなっている。
本発明の組織片捕捉具10dは、大動脈弁の置換手術に先立ち、図9の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10dは図9の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10dが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10dは、大動脈弁弁尖の間隙を通過して左心室導入後、図8の拡張状態となり、略ドーナツの口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略椀状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10dで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
次に、中央部が膜で閉鎖されている略ドーナツ状の立体形状の組織片捕捉具10eの例を示す。図10および図11は、中央部が膜で閉鎖されている略ドーナツ状の立体形状の捕捉具10eの構成例を示した図である。図10は組織片捕捉具10eの拡張状態を示しており、図11は組織片捕捉具10eの収縮状態を示している。図10および図11とも(a)は正面図、(b)は側面図、(c)は側面断面図、(d)は斜視図を示している。
この例では図10に示すように、組織片捕捉具10eは拡張状態において中央部が膜で閉鎖されている略ドーナツ状の立体形状であり、大動脈弁弁輪近傍に収まる形状および大きさを有しており大動脈弁を塞ぐものとなっている。例えばドーナツの外径が10~30mmとなっている。エッジの部分は滑らかな曲面となっているものが開示されている。これは、大動脈弁を塞ぐ際に人体組織との接触を和らげるための工夫であるが、そのような形状を採ることは必須ではない。
また、この例では図11に示すように、捕捉具10eの収縮状態は図10の拡張状態から全体が収縮した立体形状となっている。大きさはドーナツの外径が3~7mmとなっている。なお、全体が曲面であるため体内への導入時に組織との接触が和らげられる。
本発明の組織片捕捉具10eは、大動脈弁の置換手術に先立ち、図11の収縮状態にて大動脈側から左心室側に向けて大動脈弁弁尖の間隙を通過させる。大動脈弁弁尖の間隙は3~7mm程度であり、本発明の組織片捕捉具10eは図11の収縮状態であれば通過することができる。もし、大動脈弁弁尖の間隙が小さく組織片捕捉具10eが通過できない場合、弁尖に切れ込みを入れて間隙を大きくしても良い。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはない。
本発明の組織片捕捉具10eは、大動脈弁弁尖の間隙を通過して左心室導入後、図10の拡張状態となり、略ドーナツの口にあたる部分にて大動脈弁の弁輪を取り囲むように大動脈弁を塞ぎ、略椀状の内部の空隙において組織片残渣を捕捉する。
このように、大動脈弁の置換手術に先立ち、組織片捕捉具10eで大動脈弁の弁輪を取り囲むように大動脈弁を塞ぐことにより組織片残渣の左心室内への侵入を抑止することができる。
次に、上記の様々な形状の組織片捕捉具10の拡張状態と収縮状態とを切り替える構造について説明する。
組織片捕捉具10の構造は限定されないが、簡易な操作で体積を減少させることができ、かつ、簡易な操作で、例えば形状記憶能による形状回復などにより、体積を元のものまで増加させることができる構造が好ましい。そのような構造としては、例えば形状記憶能を有する多孔質構造、または繊維などが好ましい。
まず、空気圧を加えることによって組織片捕捉具10を収縮状態から拡張状態へ切り替える構造について説明する。
図12および図13は、空気圧を加えることにより組織片捕捉具10の収縮状態から拡張状態に切り替える構成例を示す図である。一例として図4に示した組織片捕捉具10aの収縮状態から図5に示した球状の組織片捕捉具10aの拡張状態に切り替える構成例を示す図である。図12は組織片捕捉具10aに空気圧を加える前の収縮状態を示している。いっぽう図13は組織片捕捉具10aに空気圧を加えることによって、拡張状態に切り替える様子を示している。図12および図13とも側面断面図により示している。
図12および図13の構成例では、組織片捕捉具10aは、バルーン11と、バルーン11に設けられた吸入口12を備えている。バルーン11には、吸入口12を介して、バルーン11に空気圧を加えることのできる送圧チューブ20を取り付けることができる。
大動脈弁の弁尖側から弁輪側へ導入する際には、図12のように空気圧を減少させて大動脈弁の弁尖の間隙を通過できる程度にまで減少させる。たとえば、図12の状態にある組織片捕捉具10aを下部側より図の水平方向に弁尖の間隙を通過させる場合において、進行方向に組織片捕捉具10aを収縮状態とした例である。続いて、組織片捕捉具10aをそのままの状態で、大動脈弁弁尖側から弁輪側へ通過させ、左心室の大動脈弁弁輪近傍に導入する。その後に図13に示すように送圧チューブ20を通して吸入口12よりバルーン11に空気圧を加えて拡張状態となるまで膨張させることにより大動脈弁を塞ぐ。
他の構成例も示しておく。図14および図15は、図10に示した組織片捕捉具10eの収縮状態から図11に示した球状の組織片捕捉具10eの拡張状態に切り替える構成例を示す図である。図14は組織片捕捉具10eに空気圧を加える前の状態を示している。いっぽう図15は組織片捕捉具10eに空気圧を加えることによって、拡張状態に切り替える様子を示している。図14(a)は側面断面図、図14(b)は一部を省略した斜視図となっている。図15は側面断面図を示している。
図14および図15に示すように、組織片捕捉具10eは、バルーン11と、バルーン11に設けられた吸入口12を備えている。バルーン11には、吸入口12を介して、バルーン11に空気圧を加えることのできる送圧チューブ20を取り付けることができる。以下、図14(a)および図15において組織片捕捉具10eの左側を「下部」、組織片捕捉具10eの右側を「上部」と呼ぶ。図14および図15に示すように、組織片捕捉具10eは、中央が膜で閉鎖された略ドーナツ形状である。
導入の際には、空気圧を減少させて収縮状態とし、大動脈弁弁尖の間隙を通過させる。その後、組織片捕捉具10eをそのままの状態で、大動脈弁弁尖の間隙を通過させ、左心室の大動脈弁弁輪近傍まで導入する。その後に、下部を大動脈弁流入部側へ向け、かつ、上部を大動脈弁流出部側へ向けるように配置したうえで、図11に示すように送圧チューブ20を通して吸入口12よりバルーン11に空気圧を加え、拡張状態まで膨張させることにより、大動脈弁を塞ぐ。
空気圧が加えられた拡張状態におけるバルーン11の最大径は限定されないが、大動脈弁弁輪近傍に過度の圧力を与えないことが好ましいので、大動脈弁弁輪近傍に収まった状態において、大動脈弁を塞いでいるバルーン11の断面の最大径が例えば10~30mm程度であることが好ましい。また、上部から下部までの長さも限定されないが、手術時においては心室内が閉鎖しており組織片捕捉具10eが侵入できないため、この長さが長すぎると大動脈弁の近傍に組織片捕捉具10eが位置することになり、大動脈弁弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、例えば、1~30mm程度が好ましい。
バルーン11の素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、または各種ブレンド材等が挙げられる。
組織片捕捉具10は、組織片をより効率よく捕捉するため、バルーン11の外層を覆う捕捉シートをさらに備えていてもよい。かかる捕捉シートの構造は限定されないが、組織片との親和性が高い構造が好ましい。そのような構造としては、例えば粗面、繊維、不織布または多孔質などが好ましい。捕捉シートの素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、セルロース、キトサン、または各種ブレンド材等が挙げられる。
次に、生理食塩水などの液体を吸収することによって収縮状態から拡張状態へ切り替える構造について説明する。
この構成例では、液体を吸収することにより膨張する膨張素材13を複数含み、かつ、該素材の集合が透水性シート14によって被覆されている組織片捕捉具10の構成例を説明する。組織片捕捉具10の収縮状態では膨張素材13が乾燥状態であり体積が減少しており、拡張状態では膨張素材13が吸水状態であり体積が膨張している。
図16は、生理食塩水を吸収することにより図1に示した組織片捕捉具10aの収縮状態から図2に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である。図16の上図は組織片捕捉具10aが液体を吸収する前の収縮状態を示している。いっぽう図16の下図は組織片捕捉具10aが液体を吸収した後の拡張状態を示している。図16の上図、下図とも側面断面図により示している。
膨張素材13は液体を吸収して膨張するものであれば限定されないが、例えば、圧縮された繊維塊が挙げられる。素材は限定されないが、例えば、セルロース系繊維が挙げられる。
図16に示した組織片捕捉具10aを生理食塩水などの液体に曝し、透水性シート14を通して液体を膨張素材13に吸収させることによって、三次元比率をほぼ保ったまま組織片捕捉具10aの体積を膨張させることができる。
膨張素材13が乾燥した収縮状態において、組織片捕捉具10aの大きさが、大動脈弁の弁尖の間隙を通過できる程度の大きさであれば、側部を進行方向側として大動脈弁弁尖の間隙を通過させることができる。その後に組織片捕捉具10aを生理食塩水などの液体に曝し体積を増加させることにより、大動脈弁弁輪近傍を塞ぐことができる。
図17は、生理食塩水を吸収することにより図3に示した組織片捕捉具10aの収縮状態から図1に示した組織片捕捉具10aの拡張状態に切り替える構成例を示す図である。図17の上図は組織片捕捉具10aが液体を吸収する前の収縮状態を示している。いっぽう図17の下図は組織片捕捉具10aが液体を吸収した後の拡張状態を示している。図17の上図、下図とも側面断面図により示している。図17は、縮小、拡張または折り畳みが可能な透水性シート14で略円筒状の袋を構成し、液体を吸収することにより膨張する複数の膨張素材13を該袋に詰めることで組織片捕捉具10aを構成した例を示す図である。図17上図は、乾燥させて膨張素材13を縮小させ、収縮状態となった組織片捕捉具10aを示す斜視図である。図17の下図は、液体を吸収させて膨張素材13を膨張させ、拡張状態となった組織片捕捉具10aを示す斜視図である。図17の上図において略円筒状となっていた透水性シート14を、その一部を縮小しかつ他の部分を拡張させることにより変形させ、図17の下図のように略円筒形の外径を拡張させ高さを減少させている。
図18は、生理食塩水を吸収することにより図9に示した組織片捕捉具10dの収縮状態から図8に示した組織片捕捉具10dの拡張状態に切り替える構成例を示す図である。図18の上図は組織片捕捉具10dが液体を吸収する前の収縮状態を示している。いっぽう図18の下図は組織片捕捉具10dが液体を吸収した後の拡張状態を示している。図18の上図、下図とも側面断面図により示している。
図18の上図の収縮状態において、大動脈弁の弁尖の間隙を通過させ、その後に組織片捕捉具10dを生理食塩水などの液体に曝し吸水により膨張させることにより、大動脈弁を塞ぐことができる。
膨張素材13の構造は限定されないが、例えば、圧縮された繊維塊が挙げられる。
圧縮された繊維塊の素材は限定されないが、例えば、セルロース系繊維塊が挙げられる。圧縮された繊維塊の乾燥時の大きさは1mm~7mm程度が好ましい。液体を吸収し膨張したときの大きさは限定されないが、例えばセルロース系繊維塊の場合は乾燥時に比べて3倍程度体積が増加する。
透水性シート14の構造は限定されないが、例えば、不織布、多数開孔された不織布および多孔質膜が挙げられる。
透水性シート14の素材は限定されないが、例えば、疎水性繊維が親水処理されたものが挙げられる。
疎水性繊維の素材は限定されないが、例えば、ポリエステル、ポリプロピレンおよびポリエチレンテレフタレートが挙げられる。
次に、組織片捕捉部を支持・変形させる可動式の支持部を備え、支持部の操作を介して組織片捕捉部を変形させ、収縮状態から拡張状態へ切り替えられる構成例を説明する。
図19は、支持部の操作を介して組織片捕捉部10を変形させる構成例を示す図である。図19(a)は正面図となっており、図19(b)は側面図となっている。
図19に示すように、大動脈弁置換手術用の組織片捕捉具10fは、リング状の支持部15と、支持部15に取り付けられた捕捉シート16を備えている。以下、図19において組織片捕捉具10fの下側を「下部」、組織片捕捉具10fの上側を「上部」と呼ぶ。図19に示すように、本発明の組織片捕捉具10fは、略円板状であり、例えば、捕捉シート16で組織片を捕捉せしめるように配置すると、大動脈弁弁輪近傍に収まる形状を有している。なお、組織片捕捉具10fの形状はかならずしも略円板状である必要はなく、大動脈弁を塞ぐことができる形状であればよい。たとえば略円筒状でもよい。
心室への導入の際には、組織片捕捉具10fを大動脈弁の弁尖の間隙を通過できる程度にまで収縮させる。たとえば、図20に示すように支持リング15を左右に収縮させることにより組織片捕捉具10f全体を収縮状態とし、組織片捕捉具10fを収縮状態にて大動脈弁弁尖の間隙を通過させ、大動脈弁弁輪近傍まで導入する。その後に捕捉シート16で組織片を捕捉せしめるよう方向を整えたうえで図19の上図の拡張状態とすることにより大動脈弁を塞ぐことができる。
支持部15の最大径は限定されないが、大動脈弁に収まる必要があるので、例えば10~30mm程度が好ましい。また、リング状の支持部15の高さも限定されないが、手術時においては心室内が閉鎖しており組織片捕捉具10fが侵入できないため、この高さが高すぎると大動脈弁の近傍に組織片捕捉具10fが位置することになり、弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、例えば、1~30mm程度が好ましい。
支持リング15の構造は限定されないが、簡易な操作で収縮状態に変形することができ、かつ、簡易な操作で、例えば形状記憶能による形状回復などにより、拡張状態まで戻すことができる構造が好ましい。そのような構造としては、例えば形状記憶能を有するリング構造およびスプリング構造などが好ましい。支持リング15の素材は限定されないが、例えば、ステンレス鋼、チタン(Ti)、タンタル(Ta)およびニチノール(Ni−Ti合金)等が挙げられる。
捕捉シート16の構造は限定されないが、支持リング15の変形に追従することができ、かつ、組織片を捕捉することができる構造が好ましい。そのような構造としては、例えば繊維、不織布および多孔質構造などが好ましい。捕捉シート16の素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、または各種ブレンド材等が挙げられる。
図21は、支持部15の操作を介して組織片捕捉部10を変形させる別の構成例を示す図である。図21(a)は正面図、図21(b)は側面図、図22は収縮状態の様子を模式的示す図となっている。
図21に示すように、組織片捕捉具10gは、支持バルーン17と、支持バルーン17に取り付けられた捕捉シート16を備えている。図21は、支持バルーン17に空気圧が加えられた状態を示している。図21に示すように、組織片捕捉具10gは、支持バルーン17に空気圧が加えられた状態において略円板状であり、例えば、捕捉シート16で組織片を捕捉せしめるように配置すると、大動脈弁弁輪近傍に収まる形状を有している。なお、組織片捕捉具10gの形状は空気圧が加えられた状態においてかならずしも略円板状である必要はなく、空気圧が加えられた状態において大動脈弁流入部を塞ぐことができる形状であればよい。たとえば略円筒状でもよい。
心室内に導入する際には、組織片捕捉具10gを大動脈弁弁尖の間隙を通過できる程度にまで減少させる。たとえば、図22に示すように支持バルーン17から空気を抜くことにより、組織片捕捉具10g全体が収縮状態となっている。組織片捕捉具10gを収縮状態として、大動脈弁弁尖の間隙を通過させ、大動脈弁弁輪近傍まで導入する。その後捕捉シート16で組織片を捕捉せしめるよう方向を整えたうえで支持バルーン17に空気圧を加えて拡張状態に戻すことにより、大動脈弁を塞ぐことができる。
空気圧が加えられた状態における支持バルーン17の最大径は限定されないが、大動脈弁に過度の圧力を与えないことが好ましいので、大動脈弁弁輪近傍に収まった状態において、大動脈弁を塞いでいる支持バルーン17の断面の最大径が例えば10~30mm程度であることが好ましい。また、高さも限定されないが、手術時においては心室内が閉鎖しており組織片捕捉具10gが侵入できないため、この高さが高すぎると大動脈弁の近傍に組織片捕捉具10gが位置することになり、弁尖を切除するなどの手術作業をするうえで作業空間が圧迫され障害が生じる。したがって、例えば、1~30mm程度が好ましい。
支持バルーン17の素材は延伸加工が可能な高分子材料であればよく、限定されないが、例えばポリエチレン、ポリプロピレン、ポリエステル、ポリウレタン、ポリアミド、ポリエチレンテレフタレート、ポリスチレン、ポリビニルアルコール、ポリ塩化ビニル、ポリ塩化ビニリデン、ポリイミド、ポリアセチレン、ポリサルフォン等の高分子材料とその共重合体、混合体が適用可能である。
捕捉シート16の構造は限定されないが、支持バルーン17の変形に追従することができ、かつ、組織片を捕捉することができる構造が好ましい。そのような構造としては、例えば繊維、不織布および多孔質構造などが好ましい。捕捉シート16の素材は限定されないが、例えば、シリコン樹脂、フッ素樹脂、ナイロン樹脂、ポリウレタン樹脂、ポリエチレン樹脂、各種のエラストマ、セルロース、キトサンまたは各種ブレンド材等が挙げられる。
次に、ブラシ状の立体形状の組織片捕捉具10hの例を示す。図23および図24は、ブラシ状の立体形状の組織片捕捉具10hの構成例を示した図である。図23は組織片捕捉具10hの拡張状態を示しており、図24は組織片捕捉具10hの収縮状態を示している。図23および図24とも(a)は側面図、(b)は正面図を示している。
この例では図23および図24に示すように、組織片捕捉具10hは、2本の芯材18の間に長手方向に沿って多数の毛材191を挟み込むとともに、これら芯材18を一体に捻り合わせ、毛材191を芯材18の周囲に放射状に設けたものであるが、組織片捕捉具10hは、このような構成に限定されず、毛材191を芯材18の周囲に放射状に設けた構成であればどのような構成でもよい。
この例では、図23及び図24に示すように、組織片捕捉具10hは拡張状態において毛材191が芯材18の周囲に芯材18と直交する方向に放射状に設けられ、大動脈弁弁輪近傍に収まる形状と大きさを有しており大動脈弁を塞ぐものとなっている。例えば毛材191が芯材18を中心として形成する放射円の外径が15~25mmとなっている。
また、この例では図23および図24に示すように、組織片捕捉具10hの収縮状態は図23の拡張状態から毛材191が芯材18を中心として形成する放射円の外径が収縮した立体形状となっている。例えば、外径が3~7mmとなっている。
この構成例では変形手段として、収縮状態は円板状の毛材191が傘状に閉じた状態、拡張状態が円板状の毛材191が傘状に開いた状態のように傘の開閉のように変形するものとなっている。
心室への導入の際には、図24に示すように、組織片捕捉具10hの毛材191が芯材18を中心として形成する放射円の外径を大動脈弁の弁尖の間隙を通過できる程度にまで収縮させる。組織片捕捉具10hを収縮状態にて大動脈弁弁尖の間隙を通過させ、大動脈弁弁輪近傍まで導入する。その後図23の拡張状態とすることにより大動脈弁を塞ぐことができる。
毛材191の素材は限定されないが、組織片捕捉具10hの縮小状態から拡張状態への切り替えが外力を要さず自然に行われるよう、弾性を有する素材が好ましい。また、血管壁等の組織を傷めないよう、柔軟性を有する素材が好ましい。例えば、ポリアミド、ポリエステル、アルケンポリマー、ジエンポリマー等が挙げられる。
芯材18の素材は限定されないが、毛材191を支持することができる程度の強度を有する素材が好ましい。また、図23および図24に示すように組織片捕捉具10hを芯材18を一体に捻り合わせる構成とする場合は、外力を加えることにより塑性変形する素材が好ましい。例えば、金属、合成樹脂モノフィラメント等が挙げられる。
また、組織片捕捉具10hの構成として、支持部15となる毛材に捕捉部16となる布材を組み合わせて組織片残渣の捕捉能力を高める工夫を施す構成も可能である。
布材を組み合わせ第1の構成である組織片捕捉具10h’を示す。この例では、支持部15が中心から外周に向けて放射状に毛材を設けた少なくとも1枚の円板状のブラシであり、捕捉部16がブラシの周囲を覆った布材である構成例である。
組織片捕捉具10h’は、図25及び図26に示すように、芯材18の周囲に放射状に設けた毛材191の周りをさらに布材192で覆うようにした構成である。このような構成とすることで大動脈弁をより密に塞ぐことができるため、大動脈弁を切除した際に生じる組織片残滓をより多く捕捉することができる。図25は組織片捕捉具10h’の拡張状態を示しており、図26は組織片捕捉具10h’の収縮状態を示している。図25及び図26とも(a)は側面図、(b)は正面図を示している。
布材192の構造は限定されないが、血液などの液体を完全に遮断しない程度に組織片捕捉具10h’が大動脈弁を塞ぐようにしたほうが手術を行う上でより好ましいので、透水性を有する構造が好ましい。例えば、不織布、多数開孔された不織布および多孔質膜が挙げられる。
透水性を有する布材192の素材は限定されないが、例えば、疎水性繊維が親水処理されたものが挙げられる。
疎水性繊維の素材は限定されないが、例えば、ポリエステル、ポリプロピレンおよびポリエチレンテレフタレートが挙げられる。
次に、布材を組み合わせ第2の構成である組織片捕捉具10h”を示す。この例では、支持部15が中心から外周に向けて放射状に毛材を設けた複数枚の円板状のブラシであり、捕捉部16がブラシ同士の間に間挿せしめた円板状の布材である構成例である。
組織片捕捉具10h”は、図27および図28に示すように、芯材18の長手方向に沿って配されているブラシ状の立体形状の毛材191の間に布材192を挟み込んだ構成である。図27は拡張状態の組織片捕捉具10h”を示した図であり、図28は2つの毛材191とそれらの間に挟まれた布材192とを分解して模式的に示した図である。
芯材18の素材は、たとえば一般的な樹脂製(ABS、PP、PE、PC、アクリル、PET)により形成され、この構成例では円柱状のものとなっている。
毛材191の素材も一般的な樹脂製で良く、円形に樹脂製の毛を植毛したリング状のものである。例えばリングの径は直径2~3cm程度、毛の太さは、0.1mm以下であり、大動脈弁弁輪近傍に収まる形状及び大きさを有しており大動脈弁を塞ぐものとなっている。毛材191は芯材18の周囲に放射状に設けた構成であればどのような構成でもよい。
布材192の素材は不織布やガーゼなどの繊維状のものであり、透水性を持ち、折れ曲がりにくく、よれにくい繊維素材が望ましい。透水性を有する布材192の素材は限定されないが、例えば、疎水性繊維が親水処理されたものが挙げられる。例えば、ポリエステル、ポリプロピレンおよびポリエチレンテレフタレートなどが挙げられる。
図27および図28に示した組織片捕捉具10h”の構成例では、二枚の円形のブラシ状の毛材191の間に略同径の不織布の布材192を挟み込む構造となっており、毛材191と布材192の間の接着などは行っていない。布材192をいわゆるフィルターのように毛材191の間に間挿した構造となっている。なお、組織片捕捉具10h”と血管壁との間の密着性を高めるため、布材192の直径を毛材191の直径よりも若干大きいものとしても良い。また、毛材191と布材192の間の接着を行っても良いが血流を阻害しないように配慮する必要がある。
なお、サイズは、長手方向も3cm程度のものが手術時に使いやすいが、別途挿入時の操作性を高めるために、取り外しできるエクステンションの棒を装着してもよい。また、末端に穴を開けて、糸を通すことで取り出しやすくすることも好ましい。
以上、本発明にかかる大動脈弁置換手術用の組織片捕捉具によれば、手術患部に取り付けることにより、弁尖の切除を始める時点から組織片残滓の捕捉を開始することができるので、従来の捕捉具に比べ、より確実に漏れなく組織片残滓を捕捉できる。 Various shape examples of the tissue
First, an example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a is shown. FIG. 1 and FIG. 2 are diagrams showing a configuration example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a. FIG. 1 shows an expanded state of the tissue piece capturing tool 10a, and FIG. 2 shows a contracted state of the tissue piece capturing tool 10a. 1 and 2, (a) is a front view, (b) is a side view, and (c) is a perspective view.
The shape and size of the tissue piece capturing device 10a in the expanded state are not particularly limited as long as the shape and size are close to the aortic valve annulus in the left ventricle of the patient and close the aortic valve, but the size is not limited. Has a diameter of 10 to 30 mm and a height of 1 to 30 mm. During the operation, since the ventricle is closed and the capturing device 10a cannot enter, if the height is too high, the capturing
In the example of the tissue piece capturing tool 10a according to the first embodiment, as shown in FIG. 1, the shape is a wide, substantially cylindrical three-dimensional shape, and the edge portion is a smooth curved surface. Has been. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
Next, the shape and size of the tissue piece capturing device 10a in the contracted state are not limited as long as the shape and size can pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side. In the example of the tissue piece capturing tool 10a according to No. 1, as shown in FIG. 2, the shape is a thin cylindrical solid shape, and the edge portion is a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 3 to 7 mm in height.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10a of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10a of the present invention can pass through in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10a cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10a of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed and the tissue piece residue is captured in a substantially cylindrical internal void.
In this way, prior to the aortic valve replacement operation, the tissue piece capture device 10a can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
FIG. 3 is an example of another contracted state of the tissue piece capturing tool 10a. A part of the expanded state of FIG. 1 is contracted and the other part is expanded to be contracted. That is, although the outer diameter of the substantially cylindrical shape is reduced from the expanded state of FIG. 1, the height is increased and the whole is contracted into a compact shape.
The shape of the tissue
Next, an example of a spherical three-dimensional tissue piece capturing tool 10b is shown. 4 and 5 are diagrams showing a configuration example of a spherical solid-shaped tissue piece capturing tool 10b. 4 shows an expanded state of the tissue piece capturing tool 10b, and FIG. 5 shows a contracted state of the tissue piece capturing tool 10b. 4 and 5, (a) is a front view, and (b) is a side view.
In this example, as shown in FIG. 4, the capturing tool 10b has a spherical three-dimensional shape in the expanded state, has a shape and a size that fits in the vicinity of the aortic valve annulus, and closes the aortic valve. . Note that the shape of the capturing device 10b does not necessarily have an accurate spherical shape, and even the non-spherical capturing device 10b may have a shape and size that can be accommodated in the vicinity of the aortic valve annulus. For example, the diameter of the sphere is 10 to 30 mm.
Further, in this example, as shown in FIG. 5, the capturing tool 10b has a thin cylindrical solid shape in a contracted state, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in height.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10b of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10b of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10b cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue fragment capturing device 10b of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. Capture tissue debris.
As described above, prior to the replacement operation of the aortic valve, the tissue piece capturing tool 10b can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
Next, an example of a substantially scissor-shaped three-dimensional tissue piece capturing tool 10c will be described. 6 and 7 are diagrams showing a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing tool 10c. FIG. 6 shows the expanded state of the tissue piece capturing tool 10c, and FIG. 7 shows the contracted state of the tissue piece capturing tool 10c. 6 and 7, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 6, the capturing tool 10c has a substantially bowl-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus, and has a substantially bowl-like shape. The mouth closes the aortic valve. For example, the diameter of the ridge is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
In this example, as shown in FIG. 7, the tissue piece capturing tool 10c has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl shape inside. The edge portion is disclosed as a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in length.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10c of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10c of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10c cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10c of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed, and the tissue debris is captured in the internal cavity of a generally saddle shape.
In this way, prior to the aortic valve replacement operation, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10c.
Note that the shape of the tissue
In this example, as shown in FIG. 8, the tissue piece capturing tool 10d has a conical substantially saddle-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus. The aortic valve is closed by a shaped mouth. For example, the diameter of the ridge is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
In this example, as shown in FIG. 9, the trapping tool 10 d has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl-like shape inside. In this example, the shape is almost the same as that in FIG. 7, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in length.
Prior to the aortic valve replacement operation, the tissue piece capturing tool 10d of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10d of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10d cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10d of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
In this way, prior to the aortic valve replacement surgery, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10d.
Next, an example of a substantially doughnut-shaped three-dimensional tissue piece capturing tool 10e having a central portion closed with a membrane will be described. FIG. 10 and FIG. 11 are diagrams showing a configuration example of a substantially donut-shaped three-dimensional capturing tool 10e whose central portion is closed with a membrane. FIG. 10 shows an expanded state of the tissue piece capturing tool 10e, and FIG. 11 shows a contracted state of the tissue piece capturing tool 10e. 10 and 11, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 10, the tissue piece capturing device 10e has a substantially donut-shaped three-dimensional shape in which the central portion is closed with a membrane in the expanded state, and has a shape and size that fits in the vicinity of the aortic valve annulus. The aortic valve is blocked. For example, the outer diameter of the donut is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
Moreover, in this example, as shown in FIG. 11, the contracted state of the capturing tool 10e has a three-dimensional shape that is entirely contracted from the expanded state of FIG. The outer diameter of the donut is 3 to 7 mm. In addition, since the whole is a curved surface, contact with a tissue is eased at the time of introduction into the body.
Prior to the aortic valve replacement operation, the tissue piece capturing tool 10e of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10e of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10e cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10e of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. 10 so that the aortic valve is surrounded by the portion corresponding to the mouth of the donut. The valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
As described above, prior to the replacement operation of the aortic valve, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10e.
Next, a structure for switching between the expanded state and the contracted state of the tissue
Although the structure of the tissue
First, a structure for switching the tissue
12 and 13 are diagrams illustrating a configuration example in which the tissue
In the configuration example of FIGS. 12 and 13, the tissue piece capturing tool 10 a includes a
When introducing from the leaflet side of the aortic valve to the annulus side, the air pressure is decreased as shown in FIG. 12 to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, in the case where the tissue piece capturing device 10a in the state of FIG. 12 is passed through the gap between the leaflets in the horizontal direction in the drawing from the lower side, the tissue piece capturing device 10a is in a contracted state in the traveling direction. Subsequently, the tissue piece capturing device 10a is passed as it is from the aortic valve leaflet side to the annulus side, and introduced into the vicinity of the aortic valve annulus in the left ventricle. Thereafter, as shown in FIG. 13, the aortic valve is closed by inflating the
Other configuration examples are also shown. 14 and 15 are diagrams showing a configuration example in which the contraction state of the tissue piece capturing device 10e shown in FIG. 10 is switched to the expanded state of the spherical tissue piece capturing device 10e shown in FIG. FIG. 14 shows a state before air pressure is applied to the tissue piece capturing tool 10e. On the other hand, FIG. 15 shows a state in which the tissue piece capturing tool 10e is switched to the expanded state by applying air pressure. 14A is a side sectional view, and FIG. 14B is a perspective view with a part omitted. FIG. 15 shows a side sectional view.
As shown in FIGS. 14 and 15, the tissue piece capturing device 10 e includes a
At the time of introduction, the air pressure is reduced to a contracted state and passed through the gap of the aortic valve leaflet. Thereafter, the tissue piece capturing tool 10e is passed through the gap of the aortic valve leaflet and introduced to the vicinity of the aortic valve annulus in the left ventricle. Thereafter, the lower part is directed to the aortic valve inflow part side and the upper part is directed to the aortic valve outflow part side, and then the air pressure is applied from the
Although the maximum diameter of the
The material of the
The tissue
Next, a structure for switching from a contracted state to an expanded state by absorbing a liquid such as physiological saline will be described.
In this configuration example, a configuration example of the tissue
FIG. 16 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 1 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. The upper part of FIG. 16 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid. On the other hand, the lower part of FIG. 16 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid. Both the upper view and the lower view of FIG. 16 are shown by side sectional views.
Although the expansion | swelling
The tissue piece capturing device 10a shown in FIG. 16 is exposed to a liquid such as physiological saline, and the liquid is absorbed by the
If the size of the tissue piece capturing device 10a is large enough to pass through the gap between the leaflets of the aortic valve in the contracted state in which the
FIG. 17 is a diagram illustrating a configuration example of switching from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 3 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. 1 by absorbing physiological saline. The upper part of FIG. 17 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid. On the other hand, the lower part of FIG. 17 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid. Both the upper view and the lower view of FIG. FIG. 17 shows a tissue piece capturing device by forming a substantially cylindrical bag with a water-
FIG. 18 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10d illustrated in FIG. 9 to the expanded state of the tissue piece capturing device 10d illustrated in FIG. 18 shows a contracted state before the tissue piece capturing tool 10d absorbs the liquid. On the other hand, the lower part of FIG. 18 shows an expanded state after the tissue piece capturing tool 10d has absorbed the liquid. Both the upper and lower views of FIG. 18 are shown by side sectional views.
In the contracted state shown in the upper diagram of FIG. 18, the aortic valve can be blocked by passing through the gap between the leaflets of the aortic valve, and then exposing the tissue piece capturing device 10 d to a liquid such as physiological saline and expanding it by absorbing water. it can.
Although the structure of the expansion | swelling
Although the raw material of the compressed fiber lump is not limited, For example, a cellulose fiber lump is mentioned. The size of the compressed fiber lump when dried is preferably about 1 mm to 7 mm. Although the size when the liquid is absorbed and expanded is not limited, for example, in the case of a cellulosic fiber lump, the volume increases about three times as compared with the time of drying.
Although the structure of the water-
Although the raw material of the water-
The material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
Next, a description will be given of a configuration example in which a movable support unit that supports and deforms the tissue piece capturing unit is provided, and the tissue piece capturing unit is deformed through the operation of the support unit and switched from the contracted state to the expanded state.
FIG. 19 is a diagram illustrating a configuration example in which the tissue
As illustrated in FIG. 19, the tissue piece capturing tool 10 f for aortic valve replacement surgery includes a ring-shaped
At the time of introduction into the ventricle, the tissue piece capturing device 10f is contracted to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, as shown in FIG. 20, the
The maximum diameter of the
The structure of the
The structure of the
FIG. 21 is a diagram illustrating another configuration example in which the tissue
As shown in FIG. 21, the tissue piece capturing tool 10 g includes a
When introduced into the ventricle, the tissue piece capturing device 10g is reduced to such an extent that it can pass through the gap between the aortic valve leaflets. For example, as shown in FIG. 22, when the air is extracted from the
Although the maximum diameter of the
The material of the
The structure of the
Next, an example of a brush-shaped three-dimensional tissue
In this example, as shown in FIGS. 23 and 24, the tissue
In this example, as shown in FIGS. 23 and 24, in the tissue
In this example, as shown in FIGS. 23 and 24, the contraction state of the tissue
In this configuration example, as a deforming means, the contracted state is such that the disc-shaped bristle
At the time of introduction into the ventricle, as shown in FIG. 24, the outer diameter of the radial circle formed by the
The material of the
Although the raw material of the
In addition, as a configuration of the tissue
A tissue
As shown in FIGS. 25 and 26, the tissue
Although the structure of the
Although the raw material of the
The material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
Next, a tissue
As shown in FIGS. 27 and 28, the tissue
The material of the
The material of the
The material of the
In the configuration example of the tissue
A size of about 3 cm in the longitudinal direction is easy to use at the time of surgery, but in order to improve the operability at the time of insertion, a removable extension rod may be attached. Moreover, it is also preferable to make it easy to take out by making a hole at the end and passing the thread.
As described above, according to the tissue piece capturing tool for aortic valve replacement surgery according to the present invention, it is possible to start capturing the tissue fragment residue from the time of starting resection of the valve leaflet by attaching it to the surgical affected area. Compared to the capture tool, the tissue fragment residue can be captured more reliably and without leakage.
実施例2にかかる大動脈弁置換手術用の組織片捕捉具として、組織片捕捉具10と接合された回収具30を備えた構成例を説明する。実施例2にかかる本発明の組織片捕捉具は、
実施例1に示した組織片捕捉具10に加え、糸状、管状または棒状の回収具30を備え、大動脈弁の置換手術の前後にわたり回収具30の一端を大動脈側に残しておき、大動脈弁の置換手術後に回収具30の一端を引っ張ることにより組織片捕捉具10を大動脈側から回収可能としたものである。
図29は、実施例1の図1で示した略円筒状の立体形状である組織片捕捉具10aに対して回収具30を備えた構成を示す図である。なお、図29は斜視図を示している。
図29に示すように、回収具30は組織片捕捉具10aの上部に取り付けられているが、取り付けられる位置は上部に限定されず、大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10aを大動脈弁間隙を通過させて体外へ回収せしめることができれば、回収具30は組織片捕捉具10aのどの位置に接合してもよい。
図30は、本発明の実施例2にかかる大動脈弁置換手術用の組織片捕捉具の別の構成例であって、実施例1の図19で示した支持リング15を伴う組織片捕捉具10fに対して回収具30を備えた構成を示す図である。なお、図30は斜視図を示している。
図30に示すように、回収具30は組織片捕捉具10fの支持リング15に取り付けられているが、取り付けられる位置は限定されず、大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10fを大動脈弁間隙から体外へ回収せしめることができれば、支持リング15のどの位置であってもよい。なお、図30の例では、回収具30は支持リング15との接合点から捕捉シート16の中心付近まで延伸されたうえで捕捉シート16と直行する直線方向にさらに延伸されている。これは、支持リング15との接合点側の反対側に位置する回収具30の端部を、捕捉シート16と直行する直線方向に見て捕捉シート16の中心付近に位置せしめるための工夫である。
大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10fを大動脈弁間隙から体外へ回収しようとする際には、回収具30の端部を指などで把持したうえで血流方向に引っ張ることになるため、端部をこのように位置せしめることによって、端部が体内の壁部に接近しにくくなり、指などで把持する操作が容易になる。ただし、回収具30がこのような構成を採ることは必須ではなく、例えば、支持リング15との接合点から回収具30が捕捉シート16と直行する直線方向にそのまま延伸されていてもよい。
回収具30の構造は限定されないが、例えば、糸状、管状または棒状などが挙げられる。
また、回収具30の長さは限定されず、大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10fを大動脈弁間隙から体外へ回収せしめることができる長さであればよい。したがって、例えば、20~200mm程度が好ましい。 As a tissue piece capturing tool for aortic valve replacement surgery according to the second embodiment, a configuration example including acollection tool 30 joined to the tissue piece capturing tool 10 will be described. The tissue piece capturing device of the present invention according to Example 2 is
In addition to the tissuepiece capturing tool 10 shown in the first embodiment, a thread-like, tubular or rod-like collecting tool 30 is provided, and one end of the collecting tool 30 is left on the aorta side before and after the aortic valve replacement operation. The tissue piece capturing tool 10 can be recovered from the aorta side by pulling one end of the recovery tool 30 after the replacement operation.
FIG. 29 is a diagram illustrating a configuration in which arecovery tool 30 is provided to the tissue piece capturing tool 10a having a substantially cylindrical solid shape illustrated in FIG. FIG. 29 shows a perspective view.
As shown in FIG. 29, therecovery tool 30 is attached to the upper part of the tissue piece capturing tool 10a. However, the attachment position is not limited to the upper part, and the recovery tool 30 is pulled in the blood flow direction after aortic valve replacement surgery. If the tissue piece capturing tool 10a can be recovered outside the body through the aortic valve gap, the recovery tool 30 may be joined to any position of the tissue piece capturing tool 10a.
FIG. 30 is another configuration example of the tissue piece capturing device for aortic valve replacement surgery according to the second embodiment of the present invention, and the tissue piece capturing device 10f with thesupport ring 15 shown in FIG. 19 of the first embodiment. It is a figure which shows the structure provided with the collection | recovery tool 30 with respect to. FIG. 30 shows a perspective view.
As shown in FIG. 30, therecovery tool 30 is attached to the support ring 15 of the tissue piece capturing tool 10f, but the attachment position is not limited, and the recovery tool 30 is pulled in the direction of blood flow after aortic valve replacement surgery. As long as the tissue piece capturing device 10f can be recovered from the aortic valve gap to the outside of the body, any position of the support ring 15 may be used. In the example of FIG. 30, the recovery tool 30 is extended from the joint point with the support ring 15 to the vicinity of the center of the capture sheet 16 and further extended in a linear direction perpendicular to the capture sheet 16. This is a device for positioning the end of the collection tool 30 located on the opposite side of the joint point with the support ring 15 in the vicinity of the center of the capture sheet 16 when viewed in a linear direction perpendicular to the capture sheet 16. .
When attempting to recover the tissue piece capturing device 10f from the aortic valve gap to the outside of the body by pulling therecovery device 30 in the direction of blood flow after the aortic valve replacement surgery, the end of the recovery device 30 is grasped with a finger or the like. Since the end portion is pulled in the direction of blood flow, positioning the end portion in this way makes it difficult for the end portion to approach the wall portion in the body and facilitates an operation of grasping with a finger or the like. However, it is not essential for the collection tool 30 to take such a configuration. For example, the collection tool 30 may be stretched as it is in a linear direction perpendicular to the capture sheet 16 from the joint point with the support ring 15.
Although the structure of the collection |recovery tool 30 is not limited, For example, thread shape, tubular shape, or rod shape etc. are mentioned.
Further, the length of therecovery tool 30 is not limited, and may be a length that allows the tissue piece capturing tool 10f to be recovered from the aortic valve gap outside the body by pulling the recovery tool 30 in the blood flow direction after the aortic valve replacement operation. That's fine. Therefore, for example, about 20 to 200 mm is preferable.
実施例1に示した組織片捕捉具10に加え、糸状、管状または棒状の回収具30を備え、大動脈弁の置換手術の前後にわたり回収具30の一端を大動脈側に残しておき、大動脈弁の置換手術後に回収具30の一端を引っ張ることにより組織片捕捉具10を大動脈側から回収可能としたものである。
図29は、実施例1の図1で示した略円筒状の立体形状である組織片捕捉具10aに対して回収具30を備えた構成を示す図である。なお、図29は斜視図を示している。
図29に示すように、回収具30は組織片捕捉具10aの上部に取り付けられているが、取り付けられる位置は上部に限定されず、大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10aを大動脈弁間隙を通過させて体外へ回収せしめることができれば、回収具30は組織片捕捉具10aのどの位置に接合してもよい。
図30は、本発明の実施例2にかかる大動脈弁置換手術用の組織片捕捉具の別の構成例であって、実施例1の図19で示した支持リング15を伴う組織片捕捉具10fに対して回収具30を備えた構成を示す図である。なお、図30は斜視図を示している。
図30に示すように、回収具30は組織片捕捉具10fの支持リング15に取り付けられているが、取り付けられる位置は限定されず、大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10fを大動脈弁間隙から体外へ回収せしめることができれば、支持リング15のどの位置であってもよい。なお、図30の例では、回収具30は支持リング15との接合点から捕捉シート16の中心付近まで延伸されたうえで捕捉シート16と直行する直線方向にさらに延伸されている。これは、支持リング15との接合点側の反対側に位置する回収具30の端部を、捕捉シート16と直行する直線方向に見て捕捉シート16の中心付近に位置せしめるための工夫である。
大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10fを大動脈弁間隙から体外へ回収しようとする際には、回収具30の端部を指などで把持したうえで血流方向に引っ張ることになるため、端部をこのように位置せしめることによって、端部が体内の壁部に接近しにくくなり、指などで把持する操作が容易になる。ただし、回収具30がこのような構成を採ることは必須ではなく、例えば、支持リング15との接合点から回収具30が捕捉シート16と直行する直線方向にそのまま延伸されていてもよい。
回収具30の構造は限定されないが、例えば、糸状、管状または棒状などが挙げられる。
また、回収具30の長さは限定されず、大動脈弁置換手術後に回収具30を血流方向に引っ張ることにより組織片捕捉具10fを大動脈弁間隙から体外へ回収せしめることができる長さであればよい。したがって、例えば、20~200mm程度が好ましい。 As a tissue piece capturing tool for aortic valve replacement surgery according to the second embodiment, a configuration example including a
In addition to the tissue
FIG. 29 is a diagram illustrating a configuration in which a
As shown in FIG. 29, the
FIG. 30 is another configuration example of the tissue piece capturing device for aortic valve replacement surgery according to the second embodiment of the present invention, and the tissue piece capturing device 10f with the
As shown in FIG. 30, the
When attempting to recover the tissue piece capturing device 10f from the aortic valve gap to the outside of the body by pulling the
Although the structure of the collection |
Further, the length of the
実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットとして、導入具40と開放具50を伴った構成例を示す。
導入具40とは、大動脈弁弁尖の間隙を通過できる外径を備えた管状部材である。
開放具50とは、管状部材の導入具40の内側に収容されている組織片捕捉具10を押し出して導入具から開放する治具である。
組織片捕捉具10を収縮状態として導入具40の内側を通過できる形状および大きさとし、大動脈弁の置換手術に先立ち、組織片捕捉具を内側に収容している導入具40を大動脈弁弁尖の間隙に導入することにより大動脈側から左心室側への通路を確保せしめ、開放具50により組織片捕捉具10を押し出し、組織片捕捉具10を左心室に導入した後に拡張状態とすることにより大動脈弁輪近傍で大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめるものである。
図31および図32は、本発明の実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットの構成例を示す図である。この構成例では組織片捕捉具10の例としては実施例1で示した組織片捕捉具10fを用いた。なお、回収具30の取り付け位置としては支持リング15に取り付けられた例となっている。図31および図32は斜視図を示している。
図31は組織片捕捉具10fを導入具40の内部に収容した状態を示している。一方図32は、組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示している。この例では回収具30の取り付け位置としては支持リング15に取り付けられているので導入具40の内部から組織片捕捉具10fが押し出された結果、図32に示すように組織片捕捉具10fが展開される。
図33および図34は、本発明の実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットの別の構成例を示す図である。この構成例では組織片捕捉具10の例としては実施例1で示した組織片捕捉具10fを用いた。なお、回収具30の取り付け位置としては実施例2の図30に示したように回収具30の端部を捕捉シート16の中心付近に位置せしめたものである。図33および図34は斜視図を示している。
図33は組織片捕捉具10fを導入具40の内部に収容した状態を示している。いっぽう図34は、組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示している。この例では回収具30の取り付け位置としては捕捉シート16の中心付近に取り付けられているので、導入具40の内部から組織片捕捉具10fが押し出された結果、図34に示すように組織片捕捉具10fが展開される。
図35および図36は、本発明の実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットの別の構成例を示す図である。この構成例では組織片捕捉具10の例としては実施例1で示した支持バルーン17により変形する組織片捕捉具10gを用いた。図35および図36は斜視図を示している。図35は組織片捕捉具10gを導入具40の内部に収容した状態を示している。いっぽう図36は、組織片捕捉具10gを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示している。
図31ないし図36に示すように、導入具40は、略管状であり、長軸方向の一方端に解放側開口部41を備えている。図31ないし図36の例では、導入具40は他方端に収容側開口部42を備えている。これは組織片捕捉具10を解放側開口部41とは別の開口部を通して導入具40の内部に収容することを可能とする工夫である。なお、導入具40がこのような収容側開口部42を備えるように限定はされない。
心室内へ導入する際には、まず組織片捕捉具10を収縮状態で、導入具40の内部に収容側開口部42または解放側開口部41を通して収容しておき、組織片捕捉具10を収容したままの状態で導入具40を大動脈弁尖の間隙に通し入れ、解放側開口部41を大動脈弁弁輪近傍まで導入する。その後に解放側開口部41から組織片捕捉具10gを外部に解放し、捕捉シート16で組織片を捕捉せしめるよう方向を整えることにより、大動脈弁を塞ぐことができる。
導入具40の円筒断面の直径の大きさは限定されないが、大動脈弁尖の間隙に通し入れる必要があるので、例えば3~10mm程度が好ましい。導入具40の長軸方向長さは、組織片捕捉具10gを収容できる長さであればよく、限定されない。ただし、導入具40の長軸方向長さが長すぎる場合には、大動脈弁流入部に解放側開口部41を位置せしめたときに収容側開口部42が上行大動脈の内壁に接触しやすくなり、導入具40の位置取りが困難になることもあるため、できれば20~100mm程度が好ましい。
導入具40の素材は限定されないが、例えば、ポリプロピレン、アクリロニトリル・ブタジエン・スチレン・コポリマー(ABS)、ポリメチルペンテン等の各種高分子等が挙げられる。
開放具50の例としては、導入具40に収容された組織片捕捉具10を解放側開口部41から押し出して解放するための押し出し棒がある。
図37は開放具50としての押し出し棒50により組織片捕捉具10を押し出してゆく様子を示す図である。押し出し棒50を導入具40の内側に挿入してゆくことにより内部に収められていた組織片捕捉具10が押し出されてゆき、組織片捕捉具10が解放側開口部41から外部に開放される。解放側開口部41が心室内の大動脈弁弁輪近傍に位置しておれば、組織片捕捉具10が大動脈弁弁輪近傍にて開放される。 The structural example with theintroduction tool 40 and the opening tool 50 is shown as a tissue piece capture tool set for aortic valve replacement operation concerning Example 3. FIG.
Theintroducer 40 is a tubular member having an outer diameter that can pass through the gap between the aortic valve leaflets.
Therelease tool 50 is a jig that pushes out the tissue piece capturing tool 10 housed inside the tubular member introduction tool 40 and releases it from the introduction tool.
The tissuepiece capturing device 10 is in a contracted state and has a shape and size that can pass through the inside of the introduction device 40. Prior to the replacement operation of the aortic valve, the introduction device 40 that houses the tissue piece capturing device is inserted into the aortic valve leaflet. By introducing it into the gap, a passage from the aorta side to the left ventricle side is ensured, the tissue piece capturing device 10 is pushed out by the opening device 50, and after the tissue piece capturing device 10 is introduced into the left ventricle, the expanded state is obtained. The aortic valve is closed in the vicinity of the annulus and the entry of the tissue fragment residue into the left ventricle is suppressed.
31 and 32 are diagrams showing a configuration example of a tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissuepiece capturing tool 10. In addition, as an attachment position of the collection | recovery tool 30, it is the example attached to the support ring 15. FIG. 31 and 32 show perspective views.
FIG. 31 shows a state in which the tissue piece capturing tool 10f is accommodated in theintroduction tool 40. On the other hand, FIG. 32 shows a state in which the tissue piece capturing tool 10f is released by pushing it out from the inside of the introduction tool 40 through the release side opening 41. In this example, since the collection tool 30 is attached to the support ring 15 as a mounting position, the tissue piece capturing tool 10f is deployed as shown in FIG. Is done.
FIGS. 33 and 34 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissuepiece capturing tool 10. Note that, as shown in FIG. 30 of the second embodiment, the collection tool 30 is attached at the end portion of the collection sheet 30 near the center of the capture sheet 16. 33 and 34 show perspective views.
FIG. 33 shows a state in which the tissue piece capturing tool 10f is housed in theintroduction tool 40. On the other hand, FIG. 34 shows a state in which the tissue piece capturing tool 10f is released by being pushed out from the inside of the introduction tool 40 through the release side opening 41. In this example, since the collection tool 30 is attached near the center of the capture sheet 16, the tissue piece capture tool 10f is pushed out from the inside of the introduction tool 40. As a result, the tissue piece capture is shown in FIG. The tool 10f is deployed.
FIGS. 35 and 36 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10g deformed by thesupport balloon 17 shown in the first embodiment is used as an example of the tissue piece capturing tool 10. 35 and 36 show perspective views. FIG. 35 shows a state in which the tissue piece capturing tool 10g is housed in the introduction tool 40. FIG. On the other hand, FIG. 36 shows a state in which the tissue piece capturing tool 10g is released by being pushed out from the inside of the introducing tool 40 through the release side opening 41.
As shown in FIGS. 31 to 36, theintroduction tool 40 is substantially tubular and includes a release side opening 41 at one end in the long axis direction. In the example of FIGS. 31 to 36, the introduction tool 40 includes an accommodation-side opening 42 at the other end. This is a device that enables the tissue piece capturing tool 10 to be accommodated in the introduction tool 40 through an opening different from the opening 41 on the release side. In addition, it is not limited so that the introduction tool 40 may be provided with such an accommodation side opening 42.
When introducing into the ventricle, the tissuepiece capturing device 10 is first housed in the introduction device 40 through the storage side opening 42 or the release side opening 41 in the contracted state, and the tissue piece capturing device 10 is stored. In this state, the introducer 40 is passed through the gap of the aortic valve leaflet, and the release side opening 41 is introduced to the vicinity of the aortic valve annulus. Thereafter, the tissue piece capturing tool 10g is released to the outside from the release side opening 41, and the aortic valve can be closed by adjusting the direction so that the tissue piece is captured by the capturing sheet 16.
The diameter of the diameter of the cylindrical cross section of theintroducer 40 is not limited, but is preferably about 3 to 10 mm, for example, because it is necessary to pass through the gap of the aortic valve leaflet. The length in the major axis direction of the introduction tool 40 is not limited as long as it is a length that can accommodate the tissue piece capturing tool 10g. However, if the length in the major axis direction of the introducer 40 is too long, the accommodation side opening 42 is likely to come into contact with the inner wall of the ascending aorta when the release side opening 41 is positioned in the aortic valve inflow part, Since positioning of the introducer 40 may be difficult, it is preferably about 20 to 100 mm if possible.
Although the raw material of theintroduction tool 40 is not limited, For example, various polymers, such as a polypropylene, an acrylonitrile butadiene styrene copolymer (ABS), polymethylpentene, etc. are mentioned.
As an example of therelease tool 50, there is a push bar for pushing out and releasing the tissue piece capturing tool 10 accommodated in the introduction tool 40 from the release side opening 41.
FIG. 37 is a view showing a state in which the tissuepiece capturing tool 10 is pushed out by the push-out rod 50 as the opening tool 50. By inserting the push rod 50 into the introduction tool 40, the tissue piece capturing tool 10 housed therein is pushed out, and the tissue piece capturing tool 10 is opened to the outside from the release side opening 41. . If the release side opening 41 is positioned near the aortic valve annulus in the ventricle, the tissue piece capturing tool 10 is opened near the aortic valve annulus.
導入具40とは、大動脈弁弁尖の間隙を通過できる外径を備えた管状部材である。
開放具50とは、管状部材の導入具40の内側に収容されている組織片捕捉具10を押し出して導入具から開放する治具である。
組織片捕捉具10を収縮状態として導入具40の内側を通過できる形状および大きさとし、大動脈弁の置換手術に先立ち、組織片捕捉具を内側に収容している導入具40を大動脈弁弁尖の間隙に導入することにより大動脈側から左心室側への通路を確保せしめ、開放具50により組織片捕捉具10を押し出し、組織片捕捉具10を左心室に導入した後に拡張状態とすることにより大動脈弁輪近傍で大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめるものである。
図31および図32は、本発明の実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットの構成例を示す図である。この構成例では組織片捕捉具10の例としては実施例1で示した組織片捕捉具10fを用いた。なお、回収具30の取り付け位置としては支持リング15に取り付けられた例となっている。図31および図32は斜視図を示している。
図31は組織片捕捉具10fを導入具40の内部に収容した状態を示している。一方図32は、組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示している。この例では回収具30の取り付け位置としては支持リング15に取り付けられているので導入具40の内部から組織片捕捉具10fが押し出された結果、図32に示すように組織片捕捉具10fが展開される。
図33および図34は、本発明の実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットの別の構成例を示す図である。この構成例では組織片捕捉具10の例としては実施例1で示した組織片捕捉具10fを用いた。なお、回収具30の取り付け位置としては実施例2の図30に示したように回収具30の端部を捕捉シート16の中心付近に位置せしめたものである。図33および図34は斜視図を示している。
図33は組織片捕捉具10fを導入具40の内部に収容した状態を示している。いっぽう図34は、組織片捕捉具10fを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示している。この例では回収具30の取り付け位置としては捕捉シート16の中心付近に取り付けられているので、導入具40の内部から組織片捕捉具10fが押し出された結果、図34に示すように組織片捕捉具10fが展開される。
図35および図36は、本発明の実施例3にかかる大動脈弁置換手術用の組織片捕捉具セットの別の構成例を示す図である。この構成例では組織片捕捉具10の例としては実施例1で示した支持バルーン17により変形する組織片捕捉具10gを用いた。図35および図36は斜視図を示している。図35は組織片捕捉具10gを導入具40の内部に収容した状態を示している。いっぽう図36は、組織片捕捉具10gを導入具40の内部から解放側開口部41を通して外部へ押し出すことで解放した状態を示している。
図31ないし図36に示すように、導入具40は、略管状であり、長軸方向の一方端に解放側開口部41を備えている。図31ないし図36の例では、導入具40は他方端に収容側開口部42を備えている。これは組織片捕捉具10を解放側開口部41とは別の開口部を通して導入具40の内部に収容することを可能とする工夫である。なお、導入具40がこのような収容側開口部42を備えるように限定はされない。
心室内へ導入する際には、まず組織片捕捉具10を収縮状態で、導入具40の内部に収容側開口部42または解放側開口部41を通して収容しておき、組織片捕捉具10を収容したままの状態で導入具40を大動脈弁尖の間隙に通し入れ、解放側開口部41を大動脈弁弁輪近傍まで導入する。その後に解放側開口部41から組織片捕捉具10gを外部に解放し、捕捉シート16で組織片を捕捉せしめるよう方向を整えることにより、大動脈弁を塞ぐことができる。
導入具40の円筒断面の直径の大きさは限定されないが、大動脈弁尖の間隙に通し入れる必要があるので、例えば3~10mm程度が好ましい。導入具40の長軸方向長さは、組織片捕捉具10gを収容できる長さであればよく、限定されない。ただし、導入具40の長軸方向長さが長すぎる場合には、大動脈弁流入部に解放側開口部41を位置せしめたときに収容側開口部42が上行大動脈の内壁に接触しやすくなり、導入具40の位置取りが困難になることもあるため、できれば20~100mm程度が好ましい。
導入具40の素材は限定されないが、例えば、ポリプロピレン、アクリロニトリル・ブタジエン・スチレン・コポリマー(ABS)、ポリメチルペンテン等の各種高分子等が挙げられる。
開放具50の例としては、導入具40に収容された組織片捕捉具10を解放側開口部41から押し出して解放するための押し出し棒がある。
図37は開放具50としての押し出し棒50により組織片捕捉具10を押し出してゆく様子を示す図である。押し出し棒50を導入具40の内側に挿入してゆくことにより内部に収められていた組織片捕捉具10が押し出されてゆき、組織片捕捉具10が解放側開口部41から外部に開放される。解放側開口部41が心室内の大動脈弁弁輪近傍に位置しておれば、組織片捕捉具10が大動脈弁弁輪近傍にて開放される。 The structural example with the
The
The
The tissue
31 and 32 are diagrams showing a configuration example of a tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissue
FIG. 31 shows a state in which the tissue piece capturing tool 10f is accommodated in the
FIGS. 33 and 34 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissue
FIG. 33 shows a state in which the tissue piece capturing tool 10f is housed in the
FIGS. 35 and 36 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10g deformed by the
As shown in FIGS. 31 to 36, the
When introducing into the ventricle, the tissue
The diameter of the diameter of the cylindrical cross section of the
Although the raw material of the
As an example of the
FIG. 37 is a view showing a state in which the tissue
次に、本発明に係る大動脈弁置換手術用の組織片捕捉具10の留置の手順について詳細に説明する。
本発明に係る大動脈弁置換手術用の組織片捕捉具の留置手順を段階を追って図を参照しつつ詳しく説明する。
図38~図41は、それぞれ、本発明に係る大動脈弁置換手術用の組織片捕捉具10の大動脈弁弁輪近傍への留置手順を説明するための図である。この手順の例では回収具30を伴う構成例であり、また、導入にあたり導入具40を用いた例となっている。
なお、大動脈弁置換手術用の組織片捕捉具10の留置手順については、実施例1~実施例3の種々の構成例を適用することができることは理解されるであろう。また、説明を分かりやすくするために、図に示す種々の要素は、一定の縮尺では描かれていない。
(手順1)
大動脈弁3の弁尖付近の上行大動脈壁を切開し、切開口を設ける(図38参照)。この手順により、術者の手および捕捉具セットを上行大動脈の外から大動脈弁へアクセスするための経路が確保される。
(手順2)
組織片捕捉具10を、まず、収縮状態として導入具40の内部に収容した状態で、切開口より導入することで、心臓1にある上行大動脈2内に導入し、続いて、大動脈弁3の弁尖の間隙4を通過させ、さらに、大動脈弁3の弁輪近傍6まで導入する(図39参照)。
なお、大動脈弁3の弁尖にあらかじめ切れ込み設けておき、この切れ込みを、組織片捕捉具10の導入経路として利用してもよい。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはなく、心室内へと組織片が侵入しないため、好ましい。
(手順3)
大動脈弁弁尖を通過させた後、組織片捕捉具10を拡張状態とすることにより大動脈弁3を塞ぎ、大動脈弁弁輪近傍に留置せしめる(図40参照)。
(手順4)
導入具40を切開口から上行大動脈の外部へと取り出す(図41参照)。
(手順5)
大動脈弁置換手術が終了した後、回収具30を引っ張ることにより、切開口から組織片捕捉具10を上行大動脈の外部へと取り出し回収する。
以上、本発明の大動脈弁置換手術用の組織片捕捉具の構成例ならびに使用方法における好ましい実施例を図示して説明してきたが、本発明の技術的範囲を逸脱することなく種々の変更が可能であることは理解されるであろう。 Next, a procedure for placing the tissuepiece capturing tool 10 for aortic valve replacement surgery according to the present invention will be described in detail.
The indwelling procedure of the tissue piece capturing tool for aortic valve replacement surgery according to the present invention will be described in detail step by step with reference to the drawings.
FIGS. 38 to 41 are views for explaining the placement procedure of the tissuepiece capturing tool 10 for aortic valve replacement surgery in the vicinity of the aortic valve annulus according to the present invention. In the example of this procedure, it is a structural example with the collection | recovery tool 30, and is an example using the introduction tool 40 in the case of introduction | transduction.
It should be understood that various configuration examples of the first to third embodiments can be applied to the indwelling procedure of the tissuepiece capturing tool 10 for aortic valve replacement surgery. Also, for ease of explanation, the various elements shown in the figures are not drawn to scale.
(Procedure 1)
An incision is made in the ascending aorta wall near the leaflet of the aortic valve 3 (see FIG. 38). This procedure ensures a path for the operator's hand and capture tool set to access the aortic valve from outside the ascending aorta.
(Procedure 2)
The tissuepiece capturing device 10 is first introduced into the ascending aorta 2 in the heart 1 by being introduced through the incision in a state of being accommodated in the introduction device 40 as a contracted state. The valve is passed through the leaflet gap 4 and introduced to the vicinity 6 of the annulus of the aortic valve 3 (see FIG. 39).
A notch may be provided in advance in the leaflet of theaortic valve 3, and this notch may be used as an introduction path for the tissue piece capturing tool 10. The length of the cut is not limited, but a cut having a maximum length of about 10 mm or less is preferable because there is no risk of a tissue piece being formed when the cut is made, and the tissue piece does not enter the ventricle.
(Procedure 3)
After passing through the aortic valve leaflet, theaortic valve 3 is closed by placing the tissue piece capturing device 10 in an expanded state and is placed in the vicinity of the aortic valve annulus (see FIG. 40).
(Procedure 4)
Theintroducer 40 is taken out from the incision to the outside of the ascending aorta (see FIG. 41).
(Procedure 5)
After completion of the aortic valve replacement surgery, thetissue collection device 10 is taken out of the ascending aorta and collected by pulling the collection device 30.
As described above, the configuration example and the preferred embodiment of the method for using the tissue piece capturing device for aortic valve replacement surgery according to the present invention have been illustrated and described, but various modifications can be made without departing from the technical scope of the present invention. It will be understood that.
本発明に係る大動脈弁置換手術用の組織片捕捉具の留置手順を段階を追って図を参照しつつ詳しく説明する。
図38~図41は、それぞれ、本発明に係る大動脈弁置換手術用の組織片捕捉具10の大動脈弁弁輪近傍への留置手順を説明するための図である。この手順の例では回収具30を伴う構成例であり、また、導入にあたり導入具40を用いた例となっている。
なお、大動脈弁置換手術用の組織片捕捉具10の留置手順については、実施例1~実施例3の種々の構成例を適用することができることは理解されるであろう。また、説明を分かりやすくするために、図に示す種々の要素は、一定の縮尺では描かれていない。
(手順1)
大動脈弁3の弁尖付近の上行大動脈壁を切開し、切開口を設ける(図38参照)。この手順により、術者の手および捕捉具セットを上行大動脈の外から大動脈弁へアクセスするための経路が確保される。
(手順2)
組織片捕捉具10を、まず、収縮状態として導入具40の内部に収容した状態で、切開口より導入することで、心臓1にある上行大動脈2内に導入し、続いて、大動脈弁3の弁尖の間隙4を通過させ、さらに、大動脈弁3の弁輪近傍6まで導入する(図39参照)。
なお、大動脈弁3の弁尖にあらかじめ切れ込み設けておき、この切れ込みを、組織片捕捉具10の導入経路として利用してもよい。切れ込みの長さは限定されないが、最大長さが約10mm以下の切れ込みであれば、切れ込みを入れる際に組織片が生じるおそれはなく、心室内へと組織片が侵入しないため、好ましい。
(手順3)
大動脈弁弁尖を通過させた後、組織片捕捉具10を拡張状態とすることにより大動脈弁3を塞ぎ、大動脈弁弁輪近傍に留置せしめる(図40参照)。
(手順4)
導入具40を切開口から上行大動脈の外部へと取り出す(図41参照)。
(手順5)
大動脈弁置換手術が終了した後、回収具30を引っ張ることにより、切開口から組織片捕捉具10を上行大動脈の外部へと取り出し回収する。
以上、本発明の大動脈弁置換手術用の組織片捕捉具の構成例ならびに使用方法における好ましい実施例を図示して説明してきたが、本発明の技術的範囲を逸脱することなく種々の変更が可能であることは理解されるであろう。 Next, a procedure for placing the tissue
The indwelling procedure of the tissue piece capturing tool for aortic valve replacement surgery according to the present invention will be described in detail step by step with reference to the drawings.
FIGS. 38 to 41 are views for explaining the placement procedure of the tissue
It should be understood that various configuration examples of the first to third embodiments can be applied to the indwelling procedure of the tissue
(Procedure 1)
An incision is made in the ascending aorta wall near the leaflet of the aortic valve 3 (see FIG. 38). This procedure ensures a path for the operator's hand and capture tool set to access the aortic valve from outside the ascending aorta.
(Procedure 2)
The tissue
A notch may be provided in advance in the leaflet of the
(Procedure 3)
After passing through the aortic valve leaflet, the
(Procedure 4)
The
(Procedure 5)
After completion of the aortic valve replacement surgery, the
As described above, the configuration example and the preferred embodiment of the method for using the tissue piece capturing device for aortic valve replacement surgery according to the present invention have been illustrated and described, but various modifications can be made without departing from the technical scope of the present invention. It will be understood that.
本発明の大動脈弁置換手術用の組織片捕捉具は、大動脈弁置換手術を要する患者に対して、その手術を補助する器具として適用することができる。
以上、本発明の好ましい実施形態を図示して説明してきたが、本発明の技術的範囲を逸脱することなく種々の変更が可能であることは理解されるであろう。従って本発明の技術的範囲は添付された特許請求の範囲の記載によってのみ限定されるものである。 The tissue piece capturing device for aortic valve replacement surgery according to the present invention can be applied to a patient requiring aortic valve replacement surgery as an instrument for assisting the surgery.
While preferred embodiments of the invention have been illustrated and described, it will be appreciated that various changes can be made without departing from the scope of the invention. Therefore, the technical scope of the present invention is limited only by the description of the appended claims.
以上、本発明の好ましい実施形態を図示して説明してきたが、本発明の技術的範囲を逸脱することなく種々の変更が可能であることは理解されるであろう。従って本発明の技術的範囲は添付された特許請求の範囲の記載によってのみ限定されるものである。 The tissue piece capturing device for aortic valve replacement surgery according to the present invention can be applied to a patient requiring aortic valve replacement surgery as an instrument for assisting the surgery.
While preferred embodiments of the invention have been illustrated and described, it will be appreciated that various changes can be made without departing from the scope of the invention. Therefore, the technical scope of the present invention is limited only by the description of the appended claims.
Claims (12)
- 心臓の大動脈弁の置換手術において前記大動脈弁の切除に伴い生じうる組織片残渣の左心室内への侵入を抑止する大動脈弁置換手術用の組織片捕捉具であって、
大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まって前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備え、
前記大動脈弁の置換手術に先立ち、前記収縮状態にて前記大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過させ、前記左心室導入後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめることを特徴とする大動脈弁置換手術用の組織片捕捉具。 A tissue fragment capturing device for aortic valve replacement surgery that suppresses the invasion of tissue fragment residue that may occur with resection of the aortic valve in the replacement of the aortic valve of the heart into the left ventricle,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; It has an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the aorta is passed through the gap of the aortic valve leaflet from the aorta side to the left ventricle side in the contracted state, and is in the expanded state after the introduction of the left ventricle. A tissue fragment capturing tool for aortic valve replacement surgery, which closes the aortic valve in the vicinity of an annulus and prevents the tissue fragment residue from entering the left ventricle. - 空気圧を加えることによって前記収縮状態から前記拡張状態へ切り替えられることを特徴とする請求項1に記載の大動脈弁置換手術用の組織片捕捉具。 The tissue piece capturing tool for aortic valve replacement surgery according to claim 1, wherein the contracted state is switched to the expanded state by applying air pressure.
- 液体を吸収することによって前記収縮状態から前記拡張状態となることを特徴とする請求項1に記載の大動脈弁置換手術用の組織片捕捉具。 The tissue fragment capturing tool for aortic valve replacement surgery according to claim 1, wherein the contracted state is changed to the expanded state by absorbing liquid.
- 全体が液体を吸収することによって膨張する可膨性素材からなり、液体を吸収することによって、前記収縮状態から前記拡張状態となることを特徴とする請求項3に記載の大動脈弁置換手術用の組織片捕捉具。 The aortic valve replacement surgery according to claim 3, wherein the whole is made of an inflatable material that expands by absorbing liquid, and the liquid is absorbed to change from the contracted state to the expanded state. Tissue piece trap.
- 液体を吸収することによって膨張する可膨性素材と、前記可膨性素材を包むシート状の捕捉部を備え、前記可膨性素材が液体を吸収することによって、前記収縮状態から前記拡張状態となることを特徴とする請求項3に記載の大動脈弁置換手術用の組織片捕捉具。 An inflatable material that expands by absorbing liquid; and a sheet-like capturing portion that wraps the expandable material, and the inflatable material absorbs liquid to change the expanded state from the contracted state to the expanded state. The tissue piece capturing tool for aortic valve replacement surgery according to claim 3, wherein
- 前記組織片を捕捉するシート状の捕捉部と、前記捕捉部を支持・変形させる可動式の支持部を備え、
前記支持部の操作を介して前記捕捉部を変形させることにより、前記収縮状態から前記拡張状態へ切り替えられることを特徴とする請求項1に記載の大動脈弁置換手術用の組織片捕捉具。 A sheet-like capture unit that captures the tissue piece, and a movable support unit that supports and deforms the capture unit,
2. The tissue piece capturing tool for aortic valve replacement surgery according to claim 1, wherein the capturing section is changed from the contracted state to the expanded state by deforming the capturing section through operation of the support section. - 前記支持部が中心から外周に向けて放射状に毛材を設けた少なくとも1枚の円板状のブラシであり、前記捕捉部が前記ブラシの周囲を覆った布材である請求項6に記載の大動脈弁置換手術用の組織片捕捉具。 The said support part is at least 1 disk-shaped brush which provided the hair material radially toward the outer periphery from the center, The said capture | acquisition part is the cloth material which covered the circumference | surroundings of the said brush. A tissue piece capture device for aortic valve replacement surgery.
- 前記支持部が中心から外周に向けて放射状に毛材を設けた複数枚の円板状のブラシであり、前記捕捉部が前記ブラシ間に間挿せしめた円板状の布材である請求項6に記載の大動脈弁置換手術用の組織片捕捉具。 The support part is a plurality of disk-shaped brushes provided with hairs radially from the center toward the outer periphery, and the capturing part is a disk-shaped cloth material interposed between the brushes. 6. A tissue piece capturing tool for aortic valve replacement surgery according to 6.
- 前記支持部の操作による前記捕捉部の変形が、前記支持部の前記ブラシの前記収縮状態が前記円板状のブラシが傘状に閉じた状態、前記拡張状態が前記円板状のブラシが傘状に開いた状態であることを特徴とする請求項6から8のいずれか1項に記載の大動脈弁置換手術用の組織片捕捉具。 The deformation of the capturing part by the operation of the support part is such that the contraction state of the brush of the support part is a state in which the disk-shaped brush is closed in an umbrella shape, and the expanded state is the umbrella in which the disk-shaped brush is an umbrella. The tissue piece capturing tool for aortic valve replacement surgery according to any one of claims 6 to 8, wherein the tissue piece capturing tool is in an open state.
- 前記支持部につながった糸状、管状または棒状の回収具を備え、
前記大動脈弁の置換手術の前後にわたり前記回収具の一端を前記大動脈側に残しておき、
前記大動脈弁の置換手術後に前記回収具の一端を引っ張ることにより前記大動脈弁を通過させ、前記大動脈側からの回収を可能とした請求項1から9のいずれか1項に記載の大動脈弁置換手術用の組織片捕捉具。 A thread-like, tubular or rod-like recovery tool connected to the support part,
Leave one end of the recovery tool on the aorta side before and after the aortic valve replacement surgery,
The aortic valve replacement operation according to any one of claims 1 to 9, wherein the aortic valve is allowed to pass through by pulling one end of the recovery tool after the aortic valve replacement operation, thereby enabling recovery from the aortic side. Tissue piece capture tool. - 心臓の大動脈弁の置換手術において前記大動脈弁の切除に伴い生じうる組織片残渣の左心室内への侵入を抑止する大動脈弁置換手術用の組織片捕捉具セットであって、
前記大動脈弁弁尖の間隙を通過する外径を備えた管状部材の導入具と、
前記導入具の内側を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まり前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備えた組織片捕捉具と、
前記導入具の内側に収容されている前記組織片捕捉具を押し出して前記管状部材から開放する開放具とを備え、
前記大動脈弁の置換手術に先立ち、前記組織片捕捉具を前記収縮状態にて内側に収容している前記導入具を前記大動脈弁弁尖の間隙に導入することにより前記大動脈側から前記左心室側への通路を確保せしめ、前記開放具により前記組織片捕捉具を押し出して前記導入具の内側を通過させ、前記組織片捕捉具を前記左心室に導入した後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめることを特徴とする大動脈弁置換手術用の組織片捕捉具セット。 A tissue fragment capturing device set for aortic valve replacement surgery that suppresses invasion of tissue fragment residue that may occur with resection of the aortic valve in the replacement of the aortic valve of the heart into the left ventricle,
A tubular member introducer having an outer diameter passing through the gap of the aortic valve leaflet;
A tissue piece capturing device comprising a contracted state having a shape and size capable of passing through the inside of the introducer, and an expanded state having a shape and size that fits in the vicinity of the aortic valve annulus in the left ventricle and closes the aortic valve When,
An opening tool that pushes out the tissue piece capturing tool housed inside the introduction tool and releases it from the tubular member;
Prior to the replacement operation of the aortic valve, the introducer that houses the tissue piece capturing device in the contracted state is introduced into the gap of the aortic valve leaflet so that the left ventricle side from the aorta side. The aorta is secured by allowing the tissue piece capturing device to be pushed out by the opening device and passing through the inside of the introducing device, and after the tissue piece capturing device is introduced into the left ventricle, the expanded state is established. A tissue piece capturing tool set for aortic valve replacement surgery, which closes the aortic valve in the vicinity of the annulus and prevents the tissue piece residue from entering the left ventricle. - 心臓の大動脈弁の置換手術において前記大動脈弁の切除に伴い生じうる組織片残渣の左心室内への侵入を抑止する大動脈弁置換手術における組織片捕捉方法であって、
大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過できる形状および大きさとなる収縮状態と、前記左心室内で前記大動脈弁弁輪近傍に収まって前記大動脈弁を塞ぐ形状および大きさとなる拡張状態とを備えた組織片捕捉具を用い、
前記大動脈弁の置換手術に先立ち、前記組織片捕捉具を前記収縮状態にて前記大動脈側から前記左心室側に向けて前記大動脈弁弁尖の間隙を通過させ、前記左心室導入後に前記拡張状態とすることにより前記大動脈弁輪近傍で前記大動脈弁を塞ぎ、前記組織片残渣の前記左心室内への侵入を抑止せしめることを特徴とする大動脈弁置換手術における組織片捕捉方法。 A method for capturing a tissue fragment in an aortic valve replacement operation that suppresses invasion of a tissue fragment residue into the left ventricle, which may be caused by excision of the aortic valve in the replacement operation of the aortic valve of the heart,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; Using a tissue piece capture device with an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the tissue piece capturing device is passed through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side in the contracted state, and the expanded state after the introduction of the left ventricle Thus, the aortic valve is closed in the vicinity of the aortic annulus and the tissue fragment residue is prevented from invading into the left ventricle.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/JP2008/072898 WO2010067463A1 (en) | 2008-12-10 | 2008-12-10 | Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/JP2008/072898 WO2010067463A1 (en) | 2008-12-10 | 2008-12-10 | Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2010067463A1 true WO2010067463A1 (en) | 2010-06-17 |
Family
ID=42242472
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2008/072898 WO2010067463A1 (en) | 2008-12-10 | 2008-12-10 | Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2010067463A1 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2011101782A (en) * | 2009-10-15 | 2011-05-26 | Jms Co Ltd | Aid for heart valve surgery |
WO2020211943A1 (en) * | 2019-04-18 | 2020-10-22 | Clearstream Technologies Limited | Embolization devices and methods of manufacturing the same |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH10500587A (en) * | 1994-03-16 | 1998-01-20 | ハートポート インコーポレイテッド | Equipment for performing cardiac surgery |
JP2002536115A (en) * | 1999-02-10 | 2002-10-29 | ハートポート インコーポレイテッド | Method and apparatus for implanting a heart valve |
JP2003508107A (en) * | 1999-08-31 | 2003-03-04 | マイクロ・セラピューティクス・インコーポレーテッド | Liquid embolic composition injection control device |
JP2003513751A (en) * | 1999-11-17 | 2003-04-15 | セガン,ジャック | Device for replacing heart valves by percutaneous route |
JP2005230427A (en) * | 2004-02-23 | 2005-09-02 | Terumo Corp | Biological tissue closing device |
-
2008
- 2008-12-10 WO PCT/JP2008/072898 patent/WO2010067463A1/en active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH10500587A (en) * | 1994-03-16 | 1998-01-20 | ハートポート インコーポレイテッド | Equipment for performing cardiac surgery |
JP2002536115A (en) * | 1999-02-10 | 2002-10-29 | ハートポート インコーポレイテッド | Method and apparatus for implanting a heart valve |
JP2003508107A (en) * | 1999-08-31 | 2003-03-04 | マイクロ・セラピューティクス・インコーポレーテッド | Liquid embolic composition injection control device |
JP2003513751A (en) * | 1999-11-17 | 2003-04-15 | セガン,ジャック | Device for replacing heart valves by percutaneous route |
JP2005230427A (en) * | 2004-02-23 | 2005-09-02 | Terumo Corp | Biological tissue closing device |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2011101782A (en) * | 2009-10-15 | 2011-05-26 | Jms Co Ltd | Aid for heart valve surgery |
WO2020211943A1 (en) * | 2019-04-18 | 2020-10-22 | Clearstream Technologies Limited | Embolization devices and methods of manufacturing the same |
US11439402B2 (en) | 2019-04-18 | 2022-09-13 | Clearstream Technologies Limited | Embolization devices and methods of manufacturing the same |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP6957441B2 (en) | Embolic protection device and usage | |
US11382733B2 (en) | Intra-aortic emboli protection filter device | |
EP2337521B3 (en) | Temporary embolic protection device | |
US7255706B2 (en) | Apparatus and method for cutting a heart valve | |
US20040073253A1 (en) | Arterial embolic filter deployed from catheter | |
JP2001524008A (en) | Percutaneous catheter and guidewire with filter and medical device deployment capabilities | |
WO2014133667A1 (en) | Embolic protection device | |
JP2015510820A (en) | Device for filtering emboli with a filter system connected to the distal end of the sheath during percutaneous aortic valve replacement and repair | |
WO1998046297A1 (en) | Cannula with associated filter and methods of use during cardiac surgery | |
JP2003529410A (en) | Filter device for left atrial appendage ostium | |
JP2012501682A (en) | Articulating extraction device | |
KR20150132120A (en) | Vascular filtration device | |
WO2010067463A1 (en) | Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery | |
JP7345198B2 (en) | Intra-aortic embolism protection filter device | |
CN218979097U (en) | Bolt taking device and bolt taking system |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 08878762 Country of ref document: EP Kind code of ref document: A1 |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
122 | Ep: pct application non-entry in european phase |
Ref document number: 08878762 Country of ref document: EP Kind code of ref document: A1 |
|
NENP | Non-entry into the national phase |
Ref country code: JP |