CN110314016B - Valve conveying device and conveying system thereof - Google Patents
Valve conveying device and conveying system thereof Download PDFInfo
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- CN110314016B CN110314016B CN201810295492.XA CN201810295492A CN110314016B CN 110314016 B CN110314016 B CN 110314016B CN 201810295492 A CN201810295492 A CN 201810295492A CN 110314016 B CN110314016 B CN 110314016B
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- valve
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- 210000003709 heart valve Anatomy 0.000 claims abstract description 69
- 229910052751 metal Inorganic materials 0.000 claims description 10
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- 230000008859 change Effects 0.000 claims description 6
- 230000004323 axial length Effects 0.000 claims description 5
- 230000000694 effects Effects 0.000 abstract description 6
- 230000003902 lesion Effects 0.000 description 9
- 229920000642 polymer Polymers 0.000 description 7
- 210000003205 muscle Anatomy 0.000 description 5
- 238000000034 method Methods 0.000 description 4
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 3
- 208000018578 heart valve disease Diseases 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 229910001000 nickel titanium Inorganic materials 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 229930040373 Paraformaldehyde Natural products 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 2
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 2
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- -1 polyethylene Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920006324 polyoxymethylene Polymers 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
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- 239000007769 metal material Substances 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
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- 229920001296 polysiloxane Polymers 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
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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
- A61F2/02—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
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- 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
The present invention provides a valve delivery device and delivery system thereof, the valve delivery device comprising: the catheter part is provided with a distal end used for being conveyed into a human body and a proximal end used for remote operation, and comprises a middle sheath tube, an outer sheath tube sleeved outside the middle sheath tube and an inner sheath tube sleeved in the middle sheath tube; an expansion member for positioning the prosthetic heart valve, the expansion member being secured to the distal end of the intermediate sheath, the expansion member having a morphologically distinct expanded state and a non-expanded state, and the expansion member being coupled to the inner sheath; a first control structure disposed at a proximal end of the catheter section; and a second control structure disposed at a proximal end of the catheter section. The valve conveying device provided by the invention can be used for positioning and limiting the artificial heart valve, and can ensure good adherence of the artificial heart valve, so that the generation of paravalvular leakage is prevented, and a good treatment effect is achieved.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a valve conveying device and a conveying system thereof.
Background
Valvular heart disease is a common cardiovascular disease with incidence inferior to coronary heart disease and hypertension, and its incidence increases significantly with age, whereas valvular heart disease has become an important public health problem with aging of the social population.
Currently, valve delivery devices are commonly used for valve surgery to treat patients suffering from valvular heart disease. However, in the process of using the existing valve conveying device for valve operation, as the release process of the valve is not controlled by an operator and the radial supporting force of the valve is insufficient, the valve is easy to be incompletely released, so that the valve function is limited, and then the valve peripheral leakage is easy to occur at a lesion position, so that the curative effect of the valve operation is influenced.
It can be seen that the existing valve delivery devices have the problem of poor therapeutic effect.
Disclosure of Invention
The embodiment of the invention provides a valve conveying device and a conveying system thereof, which are used for solving the problem that the existing valve conveying device has poor treatment effect.
An embodiment of the present invention provides a valve delivery device for implanting a prosthetic heart valve into a human body, the valve delivery device comprising:
a catheter portion having a distal end for delivery into a human body and a proximal end for remote operation, the catheter portion including an intermediate sheath, an outer sheath sleeved outside the intermediate sheath, and an inner sheath sleeved inside the intermediate sheath, both the outer sheath and the inner sheath being slidable relative to the intermediate sheath, the prosthetic heart valve being disposed at the distal end and sandwiched between the intermediate sheath and the outer sheath such that the prosthetic heart valve is released when the intermediate sheath and the outer sheath are slid relative to each other;
an expansion member for positioning the prosthetic heart valve, the expansion member being secured to the distal end of the intermediate sheath, the expansion member having an expanded state and a non-expanded state of different morphology, the expansion member being coupled to the inner sheath, the inner sheath being capable of controlling the expansion member to change between the expanded state and the non-expanded state upon relative sliding movement of the inner sheath and the intermediate sheath;
a first control structure provided at a proximal end of the catheter section for controlling relative sliding of the intermediate sheath and the outer sheath;
and a second control structure provided at a proximal end of the catheter section for controlling relative sliding of the inner sheath and the intermediate sheath.
Optionally, the first control structure includes:
a control rod fixedly connected with the proximal end of the intermediate sheath;
the handle sleeve is sleeved outside the control rod and fixedly connected with the outer sheath tube;
the handle sleeve can move relative to the control rod along the axial direction of the control rod so as to drive the middle sheath tube and the outer sheath tube to slide relatively.
Optionally, the control rod is a threaded rod with external threads;
the handle sleeve is provided with an internal thread matched with the external thread, and when the handle sleeve is rotated, the handle sleeve axially moves on the threaded rod.
Optionally, the second control structure includes:
the multifunctional sheath tube comprises a control rod, a functional handle fixedly connected to the proximal end of the control rod, and a push button and three gears for switching the position of the push button in the axial direction of the inner sheath tube are arranged on the functional handle, wherein the proximal end of the inner sheath tube penetrates through the control rod and the interior of the functional handle and is fixedly connected with the push button, so that the push button drives the inner sheath tube to slide relative to the middle sheath tube when different gears are changed.
Optionally, the expansion state includes a first expansion state and a second expansion state, and the expansion member has a first outer diameter in the first expansion state, a second outer diameter in the second expansion state, and a third outer diameter in the non-expansion state, wherein the first outer diameter is greater than the second outer diameter, the second outer diameter is greater than the third outer diameter, and the third outer diameter is less than the inner diameter of the outer sheath so that the expansion member in the non-expansion state can be accommodated within the outer sheath.
Optionally, the inner sheath tube is arranged inside the expansion member in a penetrating manner and is fixedly connected with the distal end of the expansion member, and the proximal end of the expansion member is fixedly connected with the distal end of the intermediate sheath tube, so that when the inner sheath tube slides relative to the intermediate sheath tube, the distal end of the expansion member can be pulled to move relative to the proximal end of the expansion member, and the axial length of the expansion member is changed, so that the expansion member is controlled to switch between the first expansion state, the second expansion state and the non-expansion state.
Optionally, the expansion member is cylindric structure, just the expansion member include N piece flexible muscle and connect respectively in two stiff ends at the opposite ends of N piece flexible muscle, N piece flexible muscle is followed the circumference interval setting of stiff end, the both ends of every flexible muscle all are equipped with first trompil, and the middle part of every flexible muscle is equipped with the second trompil, wherein, the area of first trompil is greater than the area of second trompil, N is more than or equal to 3 and less than or equal to 20 integer.
Optionally, the width of each deformable rib end portion of the expansion member is smaller than the width of the middle portion, the first opening and the second opening are oblong holes, and the width of the first opening is larger than the width of the second opening.
Optionally, the outer sheath tube comprises a metal tube and a polymer braided tube, the outer sheath tube is fixedly connected with the handle jacket through the polymer braided tube, and when the outer sheath tube slides to the distal end of the catheter part, the expansion part is covered by the metal tube.
In the embodiment of the invention, the valve conveying device comprises the expansion part for positioning the artificial heart valve, and the expansion part has the expansion state and the non-expansion state with different forms, so that when the artificial heart valve is conveyed by the valve conveying device, the artificial heart valve can be positioned and limited by the expansion part, so that the artificial heart valve can be released to a precise lesion part, and after the artificial heart valve is released, radial force can be applied to the artificial heart valve by the expansion part, so that the artificial heart valve can be well adhered, the generation of perivalvular leakage can be effectively prevented, and a better treatment effect is achieved.
Drawings
FIG. 1 is a schematic view of a valve delivery device according to an embodiment of the present invention;
FIG. 2 is a schematic structural diagram of a first control mechanism and a second control mechanism according to an embodiment of the present invention;
FIG. 3 is a schematic illustration of an expansion device according to an embodiment of the present invention in a non-expanded state;
FIG. 4 is a schematic illustration of an expansion device according to an embodiment of the present invention in a first expanded state;
FIG. 5 is a schematic illustration of an expansion device according to an embodiment of the present invention in a second expanded state;
FIG. 6 is a schematic view of the structure of an expansion device according to an embodiment of the present invention;
FIG. 7 is a schematic deployment view of an expansion device according to an embodiment of the present invention;
FIG. 8 is a schematic illustration of a valve delivery device reaching a target lesion site provided by an embodiment of the present invention;
FIG. 9 is a schematic illustration of an embodiment of the present invention providing a control expansion device in a first expanded state for positioning;
FIG. 10 is a schematic illustration of a prosthetic heart valve according to an embodiment of the present invention released from a valve delivery device;
FIG. 11 is a schematic illustration of an expansion member according to an embodiment of the present invention being moved into a prosthetic heart valve lumen for apposition;
fig. 12 is a schematic illustration of a prosthetic heart valve separated from a valve delivery device provided in an embodiment of the present invention.
Detailed Description
In order to make the technical problems, technical solutions and advantages to be solved more apparent, the following detailed description will be given with reference to the accompanying drawings and specific embodiments.
As shown in fig. 1, an embodiment of the present invention provides a valve delivery device 100 for implanting a prosthetic heart valve into a human body, the valve delivery device 100 comprising:
a catheter portion 101 having a distal end for delivery into a human body and a proximal end for remote operation, the catheter portion 101 including an intermediate sheath 1011, an outer sheath 1012 sleeved outside the intermediate sheath 1011, and an inner sheath sleeved inside the intermediate sheath 1011, the outer sheath 1012 and the inner sheath each being slidable with respect to the intermediate sheath 1011, the prosthetic heart valve being disposed at the distal end and sandwiched between the intermediate sheath 1011 and the outer sheath 1012 such that the prosthetic heart valve is released when the intermediate sheath 1011 and the outer sheath 1012 are slid relatively;
an expansion member 102 for positioning the prosthetic heart valve, the expansion member 102 being fixed to the distal end of the intermediate sheath 1011, the expansion member 102 having an expanded state and a non-expanded state of different configurations, the expansion member 102 being connected to the inner sheath, the inner sheath being capable of controlling the expansion member 102 to change between the expanded state and the non-expanded state when the inner sheath and the intermediate sheath 1011 are slid relative to each other;
a first control structure 103 provided at a proximal end of the catheter 101 for controlling relative sliding between the intermediate sheath 1011 and the outer sheath 1012;
and a second control structure 104 provided at a proximal end of the catheter section 101 for controlling relative sliding of the inner sheath and the intermediate sheath 1011.
In this embodiment, as shown in fig. 1, the valve delivery device 100 includes a catheter portion 101, the catheter portion 101 has a distal end for delivering into a human body and a proximal end for remote operation, i.e. a prosthetic heart valve can be loaded on the distal end of the catheter portion 101, and enters a valve lesion site of the human body along with the distal end of the catheter portion 101, and the proximal end of the catheter portion 101 can be used for setting a control mechanism for remote operation.
The catheter part 101 comprises an intermediate sheath 1011, an outer sheath 1012 which is sleeved outside the intermediate sheath 1011, and an inner sheath which is sleeved inside the intermediate sheath 1011, wherein the outer sheath 1012 and the inner sheath can both slide relative to the intermediate sheath 1011, and the artificial heart valve can be mounted on the intermediate sheath 1011 and can be clamped between the intermediate sheath 1011 and the outer sheath 1012, so that when the outer sheath 1012 slides to the proximal end of the catheter part 101 relative to the intermediate sheath 1011, the artificial heart valve can be exposed from the outer sheath 1012, and the artificial heart valve can be separated from the valve delivery device 100 by self-expansion and released to the diseased site of the human valve.
The valve delivery device 100 further comprises an expansion member 102, the expansion member 102 is fixed at the distal end of the middle sheath 1011, the expansion member 102 has an expanded state and a non-expanded state with different shapes, the expansion member 102 is connected with the inner sheath, when the inner sheath slides relative to the middle sheath 1011, the expansion member 102 can be controlled to change between the expanded state and the non-expanded state, and the artificial heart valve is mounted at the proximal end of the expansion member 102, so that the valve delivery device 100 can enter a human body when the expansion member 102 is in the non-expanded state, and can position and limit the artificial heart valve when the expansion member 102 is in a larger expanded state, thereby preventing the release position of the artificial heart valve from being inaccurate and being thrown out distally, and can well adhere to the artificial heart valve when the expansion member 102 is in a smaller expanded state, thereby effectively preventing the occurrence of paravalvular leakage.
The valve delivery device 100 further includes a first control structure 103 provided at the proximal end of the catheter 101 for controlling the relative sliding of the intermediate sheath 1011 and the outer sheath 1012, so that the intermediate sheath 1011 and the outer sheath 1012 can be slid relatively by the first control structure 103 to expose the prosthetic heart valve from the outer sheath 1012 and release it to the diseased region of the valve of the human body.
The valve delivery device 100 further includes a second control structure 104 disposed at the proximal end of the catheter 101 for controlling the relative sliding of the inner sheath and the intermediate sheath 1011, so that the inner sheath and the intermediate sheath 1011 can be slid relatively by the second control structure 104, and the expansion member 102 can be switched between the expanded state and the unexpanded state, thereby achieving the functions of positioning and attaching the prosthetic heart valve.
Optionally, as shown in fig. 2, the first control structure 103 includes:
a control lever 1031 fixedly connected to a proximal end of the intermediate sheath 1011;
and a handle outer sleeve 1032 sleeved outside the control rod 1031, wherein the handle outer sleeve 1032 is fixedly connected with the outer sheath 1012;
the handle outer sleeve 1032 is capable of moving along the axial direction of the control rod 1031 relative to the control rod 1031, so as to drive the middle sheath 1011 and the outer sheath 1012 to slide relatively.
In this embodiment, as shown in fig. 2, the first control structure 103 includes a control rod 1031 and a handle outer sleeve 1032, where the control rod 1031 is fixedly connected to the proximal end of the middle sheath 1011 so as to form an integral structure with the middle sheath 1011, the handle outer sleeve 1032 is sleeved outside the control rod 1031 and is fixedly connected to the outer sheath 1012 so as to form an integral structure with the outer sheath 1012, and the handle outer sleeve 1032 is capable of moving relative to the control rod 1031 along the axial direction of the control rod 1031.
In this way, by controlling the relative movement of the handle sleeve 1032 and the control rod 1031, the intermediate sheath 1011 and the outer sheath 1012 can be driven to slide relatively, thereby completing the release of the prosthetic heart valve.
Alternatively, as shown in fig. 2, the control lever 1031 is a threaded rod with external threads;
the handle sleeve 1032 has internal threads that mate with the external threads, and when the handle sleeve 1032 is rotated, the handle sleeve 1032 moves axially on the threaded rod.
In this embodiment, as shown in fig. 2, the control rod 1031 is a threaded rod with an external thread, the handle outer sleeve 1032 has an internal thread matching with the external thread, so that by rotating the handle outer sleeve 1032, the handle outer sleeve 1032 can move axially on the threaded rod, so as to drive the middle sheath 1011 to slide relatively to the outer sheath 1012, and the manner of controlling the relative movement of the handle outer sleeve 1032 and the threaded rod by using the thread can control the handle outer sleeve 1032 to move relatively precisely and slowly on the threaded rod, so as to reduce or avoid damage to the human vascular inner membrane caused when the outer sheath 1012 slides relatively to the middle sheath 1011.
Optionally, as shown in fig. 2, the second control structure 104 includes:
the function handle 1041 fixedly connected to the proximal end of the control rod 1031, the function handle 1041 is provided with a push button 10411 and three gears for switching the position of the push button 10411 in the axial direction of the inner sheath, and the proximal end of the inner sheath passes through the control rod 1031 and the inside of the function handle 1041 and is fixedly connected with the push button 10411, so that the push button 10411 drives the inner sheath to slide relative to the middle sheath 1011 when the push button 10411 changes in different gears.
In this embodiment, as shown in fig. 2, the second control structure 104 includes a functional handle 1041 fixedly connected to a proximal end of the control rod 1031, where the proximal end of the control rod 1031 is an end of the control rod 1031 far away from the outer sheath 1012, a push button 10411 is disposed on the functional handle 1041, and a proximal end of the inner sheath passes through the control rod 1031 and an inside of the functional handle 1041 and is fixedly connected to the push button 10411.
The functional handle 1041 is further provided with three gears for switching the position of the push button 10411 in the axial direction of the inner sheath, namely, a gear 0, a gear 1 and a gear 2, so that by sliding the push button 10411 to different gears, the inner sheath can be driven to slide relative to the middle sheath 1011, thereby controlling the expansion member 102 to switch between the non-expanded state and the expanded state. Specifically, when the push button 10411 is in gear 0, the expansion member 102 is in the non-expanded state, when the push button 10411 is in gear 1, the expansion member 102 is in a smaller expanded state, and when the push button 10411 is in gear 2, the expansion member 102 is in a larger expanded state.
In this way, the second control structure 104 may control the expansion member 102 to have three different expansion states, such that the three different expansion states of the expansion member 102 may be utilized to achieve the positioning and apposition functions of the expansion member 102.
Alternatively, as shown in fig. 3, 4 and 5, the expanded states include a first expanded state and a second expanded state, and the expansion member 102 has a first outer diameter in the first expanded state, a second outer diameter in the second expanded state, and a third outer diameter in the unexpanded state, wherein the first outer diameter is greater than the second outer diameter, the second outer diameter is greater than the third outer diameter, and the third outer diameter is less than the inner diameter of the outer sheath 1012, such that the expansion member 102 in the unexpanded state is receivable within the outer sheath 1012.
In this embodiment, the expanded state includes a first expanded state, as shown in fig. 3, in which the expansion member 102 has a first outer diameter R1, as shown in fig. 4, and a second expanded state, as shown in fig. 4, in which the expansion member 102 has a second outer diameter R2, as shown in fig. 5, in which the expansion member 102 has a third outer diameter R3, and R1> R2> R3. The non-expanded state is an initial state of the expansion member 102, specifically, when the push button 10411 is in gear 0, the expansion member 102 is in the non-expanded state, when the push button 10411 is in gear 1, the expansion member 102 is in the second expanded state, and when the push button 10411 is in gear 2, the expansion member 102 is in the first expanded state.
The third outer diameter is smaller than the inner diameter of the outer sheath 1012 such that the expansion member 102 is receivable within the outer sheath 1012 when in the unexpanded state. It should be noted that, the first outer diameter may be greater than the inner diameter of the prosthetic heart valve in the release state, so after the valve delivery device 100 enters the human body and the valve lesion site is determined, the expansion member 102 may be controlled to be in the first expansion state, so that the expansion member 102 is attached to the annulus, the release position of the prosthetic heart valve is positioned, and then the prosthetic heart valve is exposed from the sheath 1012, and since the outer diameter of the expansion member 102 is greater than the inner diameter of the prosthetic heart valve, the expansion member 102 may limit the prosthetic heart valve to prevent the prosthetic heart valve from sliding out of the valve delivery device 100 to other sites.
It should be noted that the second outer diameter may be close to the inner diameter of the prosthetic heart valve in the released state, so that after the prosthetic heart valve is released to the lesion of the human body, the expansion member 102 may be positioned in the inner cavity of the prosthetic heart valve, and the expansion member 102 may be controlled to alternate between the second expanded state and the unexpanded state, so as to complete the attachment operation of the prosthetic heart valve.
Optionally, as shown in fig. 3, the inner sheath is disposed through the inside of the expansion member 102 and is fixedly connected to the distal end of the expansion member 102, and the proximal end of the expansion member 102 is fixedly connected to the distal end of the intermediate sheath 1011, so that when the inner sheath slides relative to the intermediate sheath 1011, the distal end of the expansion member 102 can be pulled to move relative to the proximal end of the expansion member 102, so that the axial length of the expansion member 102 is changed, thereby controlling the expansion member 102 to switch among the first expansion state, the second expansion state and the non-expansion state.
In this embodiment, as shown in fig. 3, the inner sheath is disposed inside the expansion member 102 and is fixedly connected to the distal end of the expansion member 102, and the proximal end of the expansion member 102 is fixedly connected to the distal end of the intermediate sheath 1011, wherein the distal end of the expansion member 102 is the end of the expansion member 102 away from the intermediate sheath 1011, and the proximal end of the expansion member 102 is the end of the expansion member 102 near the intermediate sheath 1011. The distal end of the inner sheath tube is fixedly connected with the push button 10411 on the functional handle 1041, and the functional handle 1041 is sequentially provided with a gear 0, a gear 1 and a gear 2 from the distal end to the proximal end, wherein the distal end of the functional handle 1041 is one end of the functional handle 1041 close to the control rod 1031, and the proximal end of the functional handle 1041 is one end of the functional handle 1041 far away from the control rod 1031.
Thus, when the push button 10411 is in the gear 0, the expansion member 102 is in the non-expansion state, and when the push button 10411 is gradually switched from the gear 0 to the gear 1 and the gear 2, the inner sheath will be driven to move towards the proximal end of the catheter portion 101 relative to the middle sheath 1011, and the distal end of the expansion member 102 can be pulled to move towards the proximal end of the expansion member 102, so that the axial length of the expansion member 102 is changed, and the expansion member 102 can be controlled to gradually change from the non-expansion state to the second expansion state and the first expansion state; conversely, when the push button 10411 is in the gear 2, the expansion member 102 is in the first expansion state, and when the push button 10411 is gradually switched from the gear 2 to the gear 1 and the gear 0, the inner sheath will be driven to move towards the distal end of the catheter portion 101 relative to the intermediate sheath 1011, and can pull the distal end of the expansion member 102 to move away from the proximal end of the expansion member 102, so that the axial length of the expansion member 102 is changed, and the expansion member 102 can be controlled to be gradually changed from the first expansion state to the second expansion state and the non-expansion state.
Optionally, as shown in fig. 6, the expansion member 102 is of a cylindrical structure, and the expansion member 102 includes N deformable ribs 1021 and two fixing ends 1022 respectively connected to opposite ends of the N deformable ribs, the N deformable ribs 1021 are disposed at intervals along a circumferential direction of the fixing ends 1022, two ends of each deformable rib 1021 are respectively provided with a first opening 10211, and a second opening 10212 is provided in a middle portion of each deformable rib 1021, where an area of the first opening 10211 is greater than an area of the second opening 10212, and N is an integer greater than or equal to 3 and less than or equal to 20.
In this embodiment, as shown in fig. 6, the expansion member 102 is of a cylindrical structure, and the expansion member 102 includes N deformable ribs 1021 and two fixing ends 1022 respectively connected to opposite ends of the N deformable ribs, where the N deformable ribs 1021 are disposed at intervals along a circumferential direction of the fixing ends 1022, specifically, the number of the N deformable ribs 1021 may be between 3 and 20, preferably, the expansion member 102 in fig. 6 includes 6 deformable ribs 1021, so that it is ensured that the adhesion operation of the expansion member 102 on the prosthetic heart valve can be well completed, and the difficulty in manufacturing the expansion member 102 can be reduced to a certain extent.
As shown in fig. 6, the two ends of each deformable rib 1021 are provided with a first opening 10211, the middle part of each deformable rib 1021 is provided with a second opening 10212, that is, three openings are arranged on each deformable rib 1021, wherein the area of the first opening 10211 is larger than that of the second opening 10212, so that the strength of the two ends of each deformable rib 1021 is lower than that of the middle part, and when the distal end of the expansion part 102 approaches to the proximal end of the expansion part 102, the two ends of each deformable rib 1021 are bent first, and the middle part of each deformable rib 1021 is not bent, so that the expansion part 102 is in a second expansion state as shown in fig. 4; as the distal end of the expansion member 102 continues to approach the proximal end of the expansion member 102, the middle portion of each of the deformable ribs 1021 will also deform and buckle, thereby placing the expansion member 102 in the first expanded state as shown in fig. 3.
Optionally, as shown in fig. 7, the width of the end portion 10213 of each deformable rib 1021 of the expansion member 102 is smaller than the width of the middle portion, the first opening 10211 and the second opening 10212 are oblong holes, and the width of the first opening 10211 is larger than the width of the second opening 10212.
In this embodiment, as shown in fig. 7, the width of the end 10213 of each deformable rib 1021 of the expansion member 102 is smaller than the width of the middle portion, so as to ensure that the strength of the end 10213 of the expansion member 102 is lower than that of the middle portion, and further ensure that the expansion member 102 is easier to change to a desired expansion state. The first opening 10211 and the second opening 10212 are oblong holes, the width of the first opening 10211 is greater than the width of the second opening 10212, and the length of the first opening 10211 may be equal to or smaller than the width of the second opening 10212, so that the strength of both ends of each deformable rib 1021 is lower than the strength of the middle part, and the expansion member 102 is ensured to have good deformation performance.
Optionally, as shown in fig. 1, the outer sheath 1012 includes a metal tube 10121 and a polymer braided tube 10122, the outer sheath 1012 is fixedly connected to the handle outer sleeve 1032 by the polymer braided tube 10122, and the expansion member 102 is covered by the metal tube 10121 when the outer sheath 1012 slides to the distal end of the catheter portion 101.
In this embodiment, as shown in fig. 1, the outer sheath 1012 includes a metal tube 10121 and a polymer braided tube 10122, and the outer sheath 1012 is fixedly connected to the handle housing 1032 through the polymer braided tube 10122. That is, the metal tube 10121 may be made of a metal material, for example: thin-walled tubing of nitinol, cobalt-chromium alloy, etc. to ensure that the wall thickness of the metal tube 10121 can be between 50 microns and 500 microns, the polymeric braided tube 10122 can be made of polymeric materials such as: polyethylene (PE) or nylon, etc., to ensure good softness of the polymer braided tube 10122. Thus, the outer sheath 1012 can be ensured to cover the expansion member 102 and the artificial heart valve through the metal tube 10121, and damage to the human vascular intima caused by too strong hardness of the outer sheath 1012 can be avoided.
Preferably, in the embodiment of the present invention, the expansion member 102 may be made of a nickel-titanium alloy, and the phase transition temperature of the expansion member 102 may be between 0 and 25 degrees, and the wall thickness of the expansion member 102 may be between 100 micrometers and 500 micrometers.
The material of the intermediate sheath 1011 may be stainless steel, for example: the nickel-titanium alloy is adopted to form grains cut by laser; the control bar 1031 and the handle housing may be made of medical Polycarbonate (PC) plastic, acrylonitrile butadiene styrene (Acrylonitrile Butadiene Styrene ABS) plastic, or Polyoxymethylene (POM) plastic.
As shown in fig. 1, the distal end of the expansion member 102 may further be secured with a tapered tip 105, the tapered tip 105 may be made of soft silicone, and the tapered tip 105 may facilitate the entry of the valve delivery device 100 into the human body.
The method of operation of the valve delivery device 100 is described below with reference to fig. 8-10:
the prosthetic heart valve may be loaded onto the distal end of the intermediate sheath 1011 and the outer sheath 1012 is allowed to encase the prosthetic heart valve and the expansion member 102 prior to implantation of the prosthetic heart valve into the human body. As shown in fig. 8, the distal end of the valve delivery device 100 with the prosthetic heart valve attached thereto may be pushed into a target lesion of the human body by guidance from the contrast image.
As shown in fig. 9, the handle sleeve 1032 may be rotated outwardly to move the outer sheath 1012 proximally to expose the expansion member 102 from the outer sheath 1012, and then the push button 10411 may be shifted to gear 2 to place the expansion member 102 in a first expanded state and against the annulus to position the prosthetic heart valve in a released position.
As shown in fig. 10, the handle sleeve 1032 may be rotated outwardly again to drive the outer sheath 1012 to continue moving proximally, such that the prosthetic heart valve 1000 is exposed from the outer sheath 1012, and the expansion member 102, which is currently in the first expanded state, may position the prosthetic heart valve 1000 such that the prosthetic heart valve 1000 may self-expand and conform to a target lesion.
As shown in fig. 11, the push button 10411 may be first switched to the gear 0 to make the expansion member 102 in a non-expanded state, then the valve delivery device 100 is slightly retracted by guiding of a contrast image to make the expansion member 102 located in the inner cavity of the prosthetic heart valve 1000, and finally the push button 10411 is directly and alternately switched between the gear 1 and the gear 0 to make the expansion member 102 be in a second expanded state and the non-expanded state, so as to perform an adherence operation on the prosthetic heart valve 1000, and confirm through the contrast image to ensure that the prosthetic heart valve 1000 has a good adherence effect.
As shown in fig. 12, after the attachment is completed, the push button 10411 may be switched to the gear 0, and the handle sleeve 1032 may be rotated inwards to drive the outer sheath 1012 to continue moving distally until the outer sheath 1012 covers the expansion member 102, and finally the valve delivery device 100 is withdrawn from the human body, so that the release process of the prosthetic heart valve 1000 is completed.
In the embodiment of the invention, the valve conveying device comprises the expansion part for positioning the artificial heart valve, and the expansion part has the expansion state and the non-expansion state with different forms, so that when the artificial heart valve is conveyed by the valve conveying device, the artificial heart valve can be positioned and limited by the expansion part, so that the artificial heart valve can be released to a precise lesion part, and after the artificial heart valve is released, radial force can be applied to the artificial heart valve by the expansion part, so that the artificial heart valve can be well adhered, the generation of perivalvular leakage can be effectively prevented, and a better treatment effect is achieved.
Embodiments of the present invention also provide a valve delivery system comprising a valve delivery device and a prosthetic heart valve as described in the embodiments shown in fig. 1-7. In this embodiment, the valve delivery system achieves the same advantages as the embodiments shown in fig. 1 to 7, and in order to avoid repetition, the description thereof is omitted.
While the foregoing is directed to the preferred embodiments of the present invention, it will be appreciated by those skilled in the art that various modifications and adaptations can be made without departing from the principles of the present invention, and such modifications and adaptations are intended to be comprehended within the scope of the present invention.
Claims (8)
1. A valve delivery device for implanting a prosthetic heart valve into a human body, the valve delivery device comprising:
a catheter portion having a distal end for delivery into a human body and a proximal end for remote operation, the catheter portion including an intermediate sheath, an outer sheath sleeved outside the intermediate sheath, and an inner sheath sleeved inside the intermediate sheath, both the outer sheath and the inner sheath being slidable relative to the intermediate sheath, the prosthetic heart valve being disposed at the distal end and sandwiched between the intermediate sheath and the outer sheath such that the prosthetic heart valve is released when the intermediate sheath and the outer sheath are slid relative to each other;
an expansion member for positioning the prosthetic heart valve, the expansion member being secured to the distal end of the intermediate sheath, the expansion member having an expanded state and a non-expanded state of different configurations, the expansion member being coupled to the inner sheath, the inner sheath being capable of controlling the expansion member to change between the expanded state and the non-expanded state upon relative sliding movement of the inner sheath and the intermediate sheath;
a first control structure provided at a proximal end of the catheter section for controlling relative sliding of the intermediate sheath and the outer sheath;
and a second control structure provided at a proximal end of the catheter section for controlling relative sliding of the inner sheath and the intermediate sheath;
the expanded state comprises a first expanded state and a second expanded state, and the expansion member has a first outer diameter in the first expanded state, a second outer diameter in the second expanded state, and a third outer diameter in the unexpanded state, wherein the first outer diameter is greater than the second outer diameter, the second outer diameter is greater than the third outer diameter, and the third outer diameter is less than the inner diameter of the outer sheath so that the expansion member in the unexpanded state can be received within the outer sheath;
the inner sheath tube penetrates through the expansion part and is fixedly connected with the distal end of the expansion part, the proximal end of the expansion part is fixedly connected with the distal end of the middle sheath tube, so that when the inner sheath tube slides relative to the middle sheath tube, the distal end of the expansion part can be pulled to move relative to the proximal end of the expansion part, the axial length of the expansion part is changed, and the expansion part is controlled to switch between a first expansion state, a second expansion state and a non-expansion state.
2. The valve delivery device of claim 1, wherein the first control structure comprises:
a control rod fixedly connected with the proximal end of the intermediate sheath;
the handle sleeve is sleeved outside the control rod and fixedly connected with the outer sheath tube;
the handle sleeve can move relative to the control rod along the axial direction of the control rod so as to drive the middle sheath tube and the outer sheath tube to slide relatively.
3. The valve delivery device of claim 2, wherein the control rod is a threaded rod having external threads;
the handle sleeve is provided with an internal thread matched with the external thread, and when the handle sleeve is rotated, the handle sleeve axially moves on the threaded rod.
4. The valve delivery device of claim 3, wherein the second control structure comprises:
the multifunctional sheath tube comprises a control rod, a functional handle fixedly connected to the proximal end of the control rod, and a push button and three gears for switching the position of the push button in the axial direction of the inner sheath tube are arranged on the functional handle, wherein the proximal end of the inner sheath tube penetrates through the control rod and the interior of the functional handle and is fixedly connected with the push button, so that the push button drives the inner sheath tube to slide relative to the middle sheath tube when different gears are changed.
5. The valve delivery device of claim 1, wherein the expansion member is a cylindrical structure, and the expansion member comprises N deformable ribs and two fixed ends respectively connected to opposite ends of the N deformable ribs, the N deformable ribs are arranged at intervals along a circumferential direction of the fixed ends, two ends of each deformable rib are provided with first openings, and a second opening is arranged in a middle portion of each deformable rib, wherein an area of the first opening is larger than an area of the second opening, and N is an integer greater than or equal to 3 and less than or equal to 20.
6. The valve delivery device of claim 5, wherein the width of each deformable rib end of the expansion member is less than the width of the middle portion, the first aperture and the second aperture are oblong holes, and the width of the first aperture is greater than the width of the second aperture.
7. The valve delivery device of any one of claims 2 to 4, wherein the outer sheath comprises a metal tube and a polymeric braided tube, the outer sheath being fixedly connected to the handle casing by the polymeric braided tube, the expansion member being covered by the metal tube when the outer sheath is slid to the distal end of the catheter section.
8. A valve delivery system comprising the valve delivery device of any one of claims 1 to 7 and a prosthetic heart valve.
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| CN201810295492.XA CN110314016B (en) | 2018-03-30 | 2018-03-30 | Valve conveying device and conveying system thereof |
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| CN201810295492.XA CN110314016B (en) | 2018-03-30 | 2018-03-30 | Valve conveying device and conveying system thereof |
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| WO2021227856A1 (en) * | 2020-05-09 | 2021-11-18 | 杭州德诺睿华医疗科技有限公司 | Cutting device and cutting system |
| CN113367774B (en) * | 2020-07-06 | 2022-07-19 | 杭州启明医疗器械股份有限公司 | Interventional instrument delivery system |
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| CN102573703A (en) * | 2009-08-27 | 2012-07-11 | 麦德托尼克公司 | Transcatheter valve delivery systems and methods |
| CN103118630A (en) * | 2010-09-24 | 2013-05-22 | 西美蒂斯股份公司 | Stent valve, delivery apparatus and method therefor |
| CN104968300A (en) * | 2013-02-06 | 2015-10-07 | 西美蒂斯股份公司 | Prosthetic valve, delivery apparatus and delivery method |
| CN209032745U (en) * | 2018-03-30 | 2019-06-28 | 康迪泰科(北京)医疗科技有限公司 | A kind of valve delivery device and its transportation system |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US11116630B2 (en) * | 2016-05-16 | 2021-09-14 | Boston Scientific Scimed, Inc. | Sheathing aid |
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| CN102573703A (en) * | 2009-08-27 | 2012-07-11 | 麦德托尼克公司 | Transcatheter valve delivery systems and methods |
| CN103118630A (en) * | 2010-09-24 | 2013-05-22 | 西美蒂斯股份公司 | Stent valve, delivery apparatus and method therefor |
| CN104968300A (en) * | 2013-02-06 | 2015-10-07 | 西美蒂斯股份公司 | Prosthetic valve, delivery apparatus and delivery method |
| CN209032745U (en) * | 2018-03-30 | 2019-06-28 | 康迪泰科(北京)医疗科技有限公司 | A kind of valve delivery device and its transportation system |
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