JP7502214B2 - Catheter System - Google Patents

Description

The present invention relates to a catheter system.

The catheter system includes, for example, a balloon catheter for treating diseased parts (stenosis or obstruction) of the fallopian tubes, and an endoscope. The balloon catheter includes a flexible outer tube, an inner tube disposed in the lumen of the outer tube so as to be movable in the axial direction of the outer tube relative to the outer tube, and a tubular balloon that connects the tip of the outer tube with the tip of the inner tube and expands radially inward of the outer tube.

In fallopianoscopic salpingoplasty, the balloon is supported in an inflated state by the linear insertion portion of the fallopianoscope, and a pushing force toward the tip is transmitted from the inner tube to the balloon, causing the tip of the balloon to turn over and protrude from the tip opening of the outer tube, and then inserted into the fallopian tube orifice.

For example, Patent Document 1 discloses the structure of a medical endoscope. The insertion section of this type of endoscope includes a lens unit (objective lens) provided at the tip of the insertion section, and an image guide that extends along the axial direction of the insertion section and transmits the image obtained by the lens unit to the base end of the insertion section.

JP 2003-190077 A

In the above-mentioned fallopianoscopic salpingoplasty, in cases where the diseased part of the fallopian tube is completely blocked, a relatively large pushing force may be required to push open the diseased part with the balloon. In such cases, a relatively large axial compressive force acts on the balloon, which may cause the insertion part to bend excessively together with the balloon. This may cause the image guide of the insertion part to break.

The present invention was made in consideration of these problems, and aims to provide a catheter system that can prevent the image guide from breaking when an axial compressive force acts on the balloon, and, even if the image guide does break, can prevent the broken part from being exposed from the outer surface of the insertion part.

One aspect of the present invention is a catheter system comprising: a balloon catheter having a flexible outer tube; an inner tube disposed in the inner cavity of the outer tube so as to be movable in the axial direction of the outer tube relative to the outer tube; a tubular balloon that connects the distal end of the outer tube to the distal end of the inner tube and expands radially inwardly of the outer tube; and an endoscope having a linear insertion part inserted into the inner cavity of the balloon, the balloon being supported by the insertion part when a pushing force in the distal direction is applied from the inner tube to the balloon. When the image is transmitted to the catheter, the tip of the balloon is rolled up and protrudes from the tip opening of the outer tube in the tip direction, and the insertion section has a lens unit located at the tip of the insertion section, an image guide that extends along the axial direction of the insertion section and transmits the image obtained by the lens unit to the base end side of the insertion section, and a reinforcing structure that is provided to cover the entire outer periphery of the image guide, and the reinforcing structure is provided on the portion of the insertion section that comes into contact with the balloon in an inflated state.

According to the present invention, the reinforcement structure can improve the rigidity of the insertion section (the portion of the insertion section that comes into contact with the inflated balloon), thereby preventing the insertion section from bending excessively when an axial compressive force acts on the balloon. This can prevent the image guide from breaking. Even if the image guide breaks, the broken portion can be prevented from being exposed from the outer surface of the insertion section.

1 is a schematic configuration diagram of a catheter system according to an embodiment of the present invention. FIG. 2 is a longitudinal sectional view of the catheter system of FIG. 1 with a portion thereof omitted. FIG. 3 is an enlarged longitudinal sectional view of the distal end portion of the endoscope of FIG. 2 with a portion omitted. FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. FIG. 2 is a first explanatory diagram of salpingoscopic salpingoplasty using the catheter system of FIG. 1. FIG. 2 is a second explanatory diagram of the salpingoscopic salpingoplasty. FIG. 3 is a third explanatory diagram of the fallopianoscopic salpingoplasty. FIG. 4 is a fourth explanatory diagram of the fallopianoscopic salpingoplasty. FIG. 5 is a fifth explanatory diagram of the fallopianoscopic salpingoplasty. FIG. 6 is an explanatory diagram of the fallopianoscopic salpingoplasty. 13 is a longitudinal sectional explanatory view, with a portion omitted, of a tip side of an insertion portion of an endoscope according to a first modified example. FIG. 13 is a longitudinal sectional explanatory view, with a portion omitted, of the tip side of an insertion portion of an endoscope according to a second modified example. FIG. 13A is a longitudinal sectional explanatory view, with some parts omitted, of the tip side of an insertion portion of an endoscope according to a third modified example, and FIG. 13B is a transverse sectional explanatory view taken along line XIIIB-XIIIB in FIG. 13A. 14A is a partially omitted longitudinal cross-sectional explanatory view of the tip side of an insertion portion of an endoscope according to a fourth modified example, and FIG. 14B is a transverse cross-sectional explanatory view taken along line XIVB-XIVB in FIG. 14A.

Below, a preferred embodiment of the catheter system according to the present invention will be described with reference to the attached drawings.

As shown in FIG. 1, a catheter system 10 according to an embodiment of the present invention includes a balloon catheter 12 and an endoscope 14 (falling tube scope), which is a medical device. As shown in FIGS. 5 to 10, the catheter system 10 is used, for example, in fallopian tube endoscopic salpingoplasty for treating a lesion 204 (such as a stenosis or obstruction) in a fallopian tube 202. However, the catheter system 10 may also be used to treat lesions in biological tubes other than the fallopian tube 202, such as blood vessels, bile ducts, tracheas, esophagus, urethra, large intestine, and other organs.

In the following description of the catheter system 10, the left side in FIG. 1 (the direction of the arrow X1) is referred to as the "distal end," and the right side in FIG. 1 (the direction of the arrow X2) is referred to as the "base end."

As shown in Figures 1 and 2, the balloon catheter 12 includes an outer catheter 16, a slider 18 provided on the outer catheter 16, an inner catheter 20 inserted into the outer catheter 16, and a balloon 22.

The outer catheter 16 has a long, flexible outer tube 24, an outer tube hub 26 (outer tube operating section) provided at the base end of the outer tube 24, and a fixing screw 28 provided on the outer tube hub 26. The total length of the outer tube 24 is preferably set to 100 mm or more and 1500 mm or less, and more preferably set to 200 mm or more and 1000 mm or less.

2, the outer tube 24 includes an outer tube body 30 and a tip member 32 (tip) provided at the tip of the outer tube body 30. Examples of materials constituting the outer tube body 30 and the tip member 32 include polyolefins (polyethylene, polypropylene, polybutene, etc.), polyesters (polyethylene terephthalate, etc.), elastomer resins (polyolefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, etc.), flexible polymeric materials (polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymers, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, fluororesins, etc.

The outer tube body 30 has a first lumen 34 that penetrates from the tip to the base end. The tip of the outer tube body 30 is shaped so as to be curved in an arc in the axial direction. The outer tube body 30 has a generally constant outer diameter over its entire length.

The outer peripheral surface of the tip member 32 is curved to prevent damage to the balloon catheter 12 or biological tissue. The tip member 32 is formed with a balloon outlet hole 52 for leading the balloon 22 in the distal direction (arrow X1 direction) from the tip member 32. The balloon outlet hole 52 is connected to the tip opening 54 of the outer tube 24.

As shown in Figures 1 and 2, the outer tube hub 26 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.). Examples of hard resin include polycarbonate, acrylic resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, etc.

In FIG. 2, the outer tube hub 26 is formed hollow and has a size that makes it easy to operate by hand. The outer tube hub 26 is provided with a first space 53 that communicates with the first lumen 34 of the outer tube 24, a first insertion hole 55 located on the base end side of the first space 53 and through which the inner catheter 20 is inserted, and a first introduction port portion 56 for introducing a balloon expansion fluid into the first space 53. The balloon expansion fluid is for inflating the balloon 22 shown in FIG. 2 radially inward of the outer tube 24. The balloon expansion fluid is, for example, physiological saline. The outer tube hub 26 is provided with a first seal member 57 that prevents the balloon expansion fluid in the first space 53 from leaking to the outside through the first insertion hole 55.

The fixing screw 28 is for fixing the inner catheter 20 to the outer tube hub 26. The fixing screw 28 may be made of the same material as the outer tube hub 26.

The slider 18 is provided in a state in which it can move (slide) in the axial direction of the outer tube 24 relative to the outer peripheral surface of the outer tube body 30. The overall length of the slider 18 is shorter than the overall length of the outer tube 24. The slider 18 has a long tubular slider body 58 and a slider hub 60 (slider operation part) provided at the base end of the slider body 58. The slider body 58 and the slider hub 60 are each made of the same material as the outer tube hub 26 described above. The slider hub 60 is formed in an annular shape with a size that makes it easy to operate by hand.

When the slider 18 is moved to the most proximal side (arrow X2 direction) relative to the outer tube body 30 (when the proximal end of the slider 18 is positioned at the tip of the outer tube hub 26), the tip side of the outer tube body 30 is exposed further to the tip side than the slider 18 and curves in an arc. When the slider 18 is moved to the most distal side (arrow X1 direction) relative to the outer tube body 30, the tip side of the outer tube body 30 extends in a straight line along the shape of the slider body 58.

As shown in Figures 1 and 2, the inner catheter 20 comprises a long inner tube 62 and an inner tube hub 64 (inner tube operating section) provided at the base end of the inner tube 62. The total length of the inner tube 62 is preferably set to 100 mm or more and 1500 mm or less, and more preferably set to 200 mm or more and 1000 mm or less.

In FIG. 2, the material of the inner tube 62 may be a relatively hard resin (e.g., fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or a metal (e.g., stainless steel, titanium, titanium alloy, etc.). The inner tube 62 has a second lumen 66 that runs through it from the tip to the base end.

The inner tube 62 is inserted through the outer tube hub 26 and disposed in the first lumen 34 of the outer tube body 30. The tip of the inner tube 62 is located in the proximal direction (the direction of the arrow X2) from the tip of the outer tube body 30. Between the outer peripheral surface of the inner tube 62 and the inner peripheral surface of the outer tube body 30, an outer lumen Sa (expansion lumen) through which the balloon expansion fluid flows is provided.

The long insertion section 80 of the endoscope 14, which also functions as a balloon support device, is inserted into the second lumen 66 of the inner tube 62. With the insertion section 80 inserted into the second lumen 66 of the inner tube 62, an inner lumen Sb (irrigation lumen) through which perfusion fluid flows is formed between the inner tube 62 and the insertion section 80. The perfusion fluid is, for example, physiological saline. Note that FIG. 2 shows a simplified configuration of the insertion section 80. The same applies to FIGS. 5 to 10.

The inner tube hub 64 is made of the same material as the outer tube hub 26. The inner tube hub 64 is formed to be hollow. The inner tube hub 64 is provided with a second space 68 that communicates with the second lumen 66 of the inner tube 62, a second insertion hole 70 located on the base end side of the second space 68 and through which the insertion part 80 is inserted, and a second introduction port part 72 for introducing irrigation fluid into the second space 68. The inner tube hub 64 is provided with a second seal member 73 that prevents the irrigation fluid in the second space 68 from leaking to the outside through the second insertion hole 70.

The balloon 22 is a tubular member that connects the tip of the outer tube 24 and the tip of the inner tube 62. The balloon 22 is inflated radially inward of the outer tube 24 by the balloon expansion fluid. In other words, the balloon 22 is formed to be elastically deformable in the radial direction.

The balloon 22 is preferably made of polyolefin (polyethylene, polypropylene, polybutene, etc.), polyester (polyethylene terephthalate, etc.), elastomer resin (polyolefin elastomer, polyester elastomer, polyamide elastomer, polyurethane elastomer, polystyrene elastomer, etc.), flexible polymeric material (natural rubber, ethylene-propylene copolymer, polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, polyisoprene, polyester, fluororesin, etc.

One end of the balloon 22 is adhered or fused to the tip of the outer tube 24 (the base end of the tip member 32). In other words, one end of the balloon 22 is adhered or fused to the outer tube 24 near the base end side of the balloon outlet hole 52. Specifically, one end of the balloon 22 is sandwiched between the tip of the outer tube body 30 and the tip member 32.

The other end of the balloon 22 is fixed to the outer circumferential surface of the tip of the inner tube 62 by a balloon fixing member 74. The other end of the balloon 22 may be glued or fused to the tip of the inner circumferential surface of the inner tube 62. The balloon 22 has an inner cavity 76 into which the insertion section 80 of the endoscope 14 can be inserted. A bag-shaped outer space Sc with a closed tip is formed between the outer circumferential surface of the balloon 22 and the inner circumferential surface of the outer tube body 30. The balloon fixing member 74 is formed in an annular shape. The balloon fixing member 74 is disposed in the first inner cavity 34 of the outer tube body 30.

As shown in FIG. 7, when a pushing force (pushing force in the tip direction) is transmitted from the inner tube 62 to the balloon 22, the tip portion 22a of the balloon 22 is rolled back and protrudes in the tip direction from the tip opening 54 of the outer tube 24. At this time, a radially double-folded portion is formed in the protruding portion 22b of the balloon 22 that protrudes in the direction of the arrow X1 beyond the tip opening 54 of the outer tube 24.

In FIG. 2, the endoscope 14 is a fallopian tube scope for observing the fallopian tube 202 (see FIG. 5). The endoscope 14 has a long, flexible insertion section 80 inserted into the second lumen 66 of the inner tube 62 of the balloon catheter 12 and the lumen 76 of the balloon 22. Although not shown, the endoscope 14 also has a display section such as a display, and an imaging control device for displaying the captured image (endoscopic image) on the display section. An operation section (not shown) for operating the insertion section 80 is provided at the base end of the insertion section 80. The overall length of the insertion section 80 is set to, for example, about 2000 mm. However, the overall length of the insertion section 80 can be set as appropriate.

As shown in Figs. 3 and 4, the insertion section 80 includes a tube member 82, a lens unit 84, a plurality of light guides 86, an image guide 88, and a reinforcing structure 90. The tube member 82 is flexible. The tube member 82 is made of a resin material such as, but not limited to, polyimide, polyurethane, polyethylene, polytetrafluoroethylene, etc.

The lens unit 84 is provided at the tip of the tube member 82. The lens unit 84 has a circular outer peripheral surface. The lens unit 84 includes an objective lens. The lens unit 84 may include multiple lenses. The axis Ax1 of the lens unit 84 is offset from the axis Ax2 of the tube member 82 (see FIG. 4). One surface 92a of the lens unit 84 is located at the tip of the insertion portion 80.

The light guide 86 is a light-guiding member that guides light from a light source (e.g., an LED) (not shown) provided on the base end side of the insertion section 80 to the tip of the insertion section 80. In this embodiment, five light guides 86 are provided. However, the number of light guides 86 is not particularly limited, and may be one or multiple (other than five).

The light guide 86 extends along the axis Ax2 of the tube member 82. The light guide 86 extends over the entire length of the tube member 82. The tip of each light guide 86 is arranged along the outer circumferential surface of the lens unit 84 (see FIG. 4). The light guide 86 is formed, for example, by bundling a plurality of optical fibers. However, the light guide 86 may be formed from a single optical fiber. As the optical fiber, for example, a plastic optical fiber whose core and clad are made of plastic is used. However, the optical fiber may be a glass optical fiber whose core and clad are made of glass (for example, quartz glass).

The image guide 88 is a transmission member that guides the image obtained by the lens unit 84 to the base end side of the insertion section 80. The image guide 88 is arranged coaxially with the lens unit 84. That is, the axis Ax3 of the image guide 88 is offset from the axis Ax2 of the tube member 82. The tip surface 94 of the image guide 88 is in contact with or close to the other surface 92b of the lens unit 84. The outer diameter of the image guide 88 is equal to or smaller than the outer diameter of the lens unit 84. The image guide 88 is formed of an optical fiber similar to the light guide 86 described above.

The reinforcement structure 90 is provided so as to cover the entire outer peripheral surface of the image guide 88. The reinforcement structure 90 is provided on the tip side of the image guide 88, but is not provided on the base end side of the image guide 88. The reinforcement structure 90 is provided on the portion of the insertion section 80 that comes into contact with the balloon 22 in an inflated state. The total length L1 of the reinforcement structure 90 is longer than the total length L2 of the balloon 22 in the initial state of the balloon catheter 12 (see FIG. 1). Specifically, the reinforcement structure 90 is provided only within a range of 25 cm from the tip of the insertion section 80.

The reinforcing structure 90 includes a flexible adhesive 96 filled in the inner cavity of the tube member 82. The adhesive 96 is in contact (bonded) with the entire outer circumferential surface of the image guide 88. The adhesive 96 is in contact (bonded) with the inner circumferential surface of the tube member 82, the outer circumferential surfaces of each light guide 86, and the outer circumferential surface of the lens unit 84. The adhesive 96 does not have to be filled on the distal side of the tip of the image guide 88 (the outer circumferential side of the lens unit 84). In this case, the distal side of the tip of the image guide 88 is filled with another type of adhesive (e.g., a hard adhesive) different from the adhesive 96, and the lens unit 84 is fixed to the tube member 82 by the adhesive.

In general, minute irregularities are formed on the tip surface 94 of the image guide 88 and the other surface 92b of the lens unit 84. Therefore, when the tip surface 94 of the image guide 88 and the other surface 92b of the lens unit 84 are close to each other, it is preferable to interpose an adhesive 96 between the tip surface 94 of the image guide 88 and the other surface 92b of the lens unit 84. This fills the recesses of the tip surface 94 of the image guide 88 and the recesses of the other surface 92b of the lens unit 84 with adhesive 96, reducing image distortion caused by the unevenness of the interface, making it possible to capture endoscopic images more clearly. Note that an adhesive with different properties from the adhesive 96 may be interposed between the tip surface 94 of the image guide 88 and the other surface 92b of the lens unit 84.

The adhesive 96 may be made of, for example, a silicone-, epoxy-, or urethane-based resin material having elasticity. The adhesive 96 preferably has a hardness of 30 or more as measured with a durometer type A according to the JIS K 6253 standard, and a hardness of 65 or less as measured with a durometer type D according to the JIS K 6253 standard. In this case, the tip side of the insertion portion 80 can be given an appropriate degree of flexibility.

Next, we will explain how to perform salpingoscopic salpingoplasty using the catheter system 10 configured in this manner.

In fallopianoscopic tuboplasty, the above-mentioned catheter system 10 is prepared in a preparation process. In the preparation process, the user fixes the inner tube 62 by using the fixing screw 28 in a state where it is fully pulled toward the base end (in the direction of the arrow X2). Furthermore, the slider 18 is set to the initial state. This causes the tip side of the outer tube body 30 to extend straight by the slider body 58.

Next, in the insertion step, the user inserts the balloon catheter 12 transcervically to the uterine fundus 200. Then, as shown in FIG. 5, in the sliding step, the slider 18 is pulled back relative to the outer tube 24 toward the base end of the outer tube 24. As a result, the tip side of the outer tube main body 30 is exposed from the slider 18 and assumes a curved shape. At this time, the user positions the tip of the insertion section 80 of the endoscope 14 at the tip opening 54 of the outer tube 24 and positions the tip opening 54 of the outer tube 24 near the fallopian tube opening 202a while checking the endoscopic image.

Then, the balloon extraction process is performed. Specifically, in the balloon extraction process, as shown in FIG. 6, a balloon expansion fluid is supplied to the first introduction port 56 (pressurization process). Then, the balloon expansion fluid is supplied from the first introduction port 56 through the outer lumen Sa to the outer space Sc of the balloon 22. Therefore, the balloon 22 is pressed radially inward by the balloon expansion fluid supplied to the outer space Sc and elastically deforms. In other words, the portion of the balloon 22 located on the outer periphery side of the insertion portion 80 is in close contact with the outer periphery of the insertion portion 80. The inner surfaces of the portions of the balloon 22 located further forward than the tip of the insertion portion 80 are in contact with each other.

Then, with the fixing screw 28 loosened, the user operates the inner tube hub 64 to advance the inner tube 62 relative to the outer tube 24 (advancement process). Then, as shown in FIG. 7, the balloon 22, which is pushed toward the distal end by the inner tube 62, advances together with the insertion portion 80 relative to the outer tube 24. In other words, the pushing force is transmitted from the inner tube 62 to the balloon 22, and the balloon 22 protrudes together with the insertion portion 80 from the distal end opening 54 of the outer tube 24 in the distal direction (the direction of the arrow X1).

In the forward movement process, one end of the balloon 22 is fixed to the tip of the outer tube 24, so the balloon 22 moves forward while its tip 22a (protruding end) is rolled back. That is, the balloon 22 is rolled back at its tip 22a (protruding end) so that the inner surface faces outward. Therefore, the balloon 22 moves forward a distance equivalent to half the forward movement distance of the insertion section 80.

Then, the user determines whether the balloon 22 has reached the lesion 204 based on the endoscopic image. If the balloon 22 is located in front of the lesion 204, the balloon expansion fluid is depressurized and perfusion fluid (perfusion fluid) is supplied to the second introduction port portion 72 (depressurization process). This allows perfusion fluid to flow between the balloon 22 and the insertion portion 80 of the endoscope 14 via the inner lumen Sb. Next, the user moves the endoscope 14 backward a predetermined distance as shown in FIG. 8 (retraction process). Thereafter, the pressurization process and advancement process described above are performed again.

As shown in FIG. 9, when the tip 22a of the balloon 22 comes into contact with the lesion 204 during the forward movement process, a relatively large axial compressive force acts on the balloon 22 when the user pushes the inner tube 62 in the distal direction. Such compressive force tends to be large when the lesion 204 is completely blocked.

However, because the reinforcing structure 90 (adhesive 96) is provided to cover the entire outer peripheral surface of the image guide 88, the rigidity of the tip side of the insertion section 80 is improved compared to a case in which the reinforcing structure 90 is not provided. Therefore, when axial compressive stress acts on the balloon 22, excessive bending of the tip side of the insertion section 80 is suppressed. Therefore, breakage of the image guide 88 is suppressed.

After that, as shown in FIG. 10, when the balloon 22 completely passes through the lesion 204, the balloon 22 pushes open the lesion 204. In other words, the stenosis or blockage of the fallopian tube 202 is improved.

After expanding the lesion 204, the user reduces the pressure of the balloon expansion fluid and then removes the balloon catheter 12 and the endoscope 14 (removal process). Note that before removing the balloon catheter 12, the user may inject irrigation fluid through the second introduction port 72 while pulling the inner tube 62 to retract the balloon 22, and at the same time, operate the endoscope 14 to position it at the tip 22a of the balloon 22, thereby removing the balloon catheter 12 while observing the inside of the fallopian tube 202 during the removal process. This completes the fallopianoscopic salpingoplasty.

This embodiment provides the following advantages:

According to this embodiment, the reinforcing structure 90 can improve the rigidity of the insertion section 80 (the portion of the insertion section 80 that contacts the balloon 22 in an inflated state), and therefore excessive bending of the insertion section 80 can be suppressed when an axial compressive force acts on the balloon 22. This can suppress breakage of the image guide 88. Even if the image guide 88 breaks, it can suppress the broken portion from damaging the tube member 82 and becoming exposed from the outer surface of the insertion section 80.

The reinforcing structure 90 is provided on the distal end side of the image guide 88 and is not provided on the proximal end side of the image guide 88.

This configuration makes it easier to manufacture the insertion section 80 than if the reinforcing structure 90 was provided over the entire length of the image guide 88. This reduces the manufacturing costs of the endoscope 14 (catheter system 10).

The overall length of the reinforcing structure 90 is longer than the overall length of the balloon 22 in the initial state of the balloon catheter 12.

This configuration effectively improves the rigidity of the portion of the insertion section 80 that comes into contact with the inflated balloon 22 (the portion that is pressurized by the balloon 22).

The insertion section 80 has a tube member 82 that covers the lens unit 84 and the image guide 88. The reinforcing structure 90 includes an adhesive 96 that is filled on the outer periphery of the image guide 88 in the inner cavity of the tube member 82.

This configuration makes it easy to manufacture the insertion section 80 having the reinforcing structure 90.

The adhesive 96 is in contact with the outer peripheral surface of the image guide 88 and the inner peripheral surface of the tube member 82.

With this configuration, the rigidity of the tip side of the insertion section 80 can be effectively improved by the adhesive 96. In addition, the image guide 88 can be fixed to the tube member 82 by the adhesive 96.

The insertion section 80 has a light guide 86 for guiding light from the base end side of the insertion section 80 to the tip of the insertion section 80.

With this configuration, the light guide 86 can improve the rigidity of the insertion section 80.

(First Modification)
Next, an endoscope 14A according to a first modified example will be described with reference to Fig. 11. In the endoscope 14A according to this modified example, the same components as those in the endoscope 14 described above are given the same reference numerals, and the description thereof will be omitted. The same applies to the endoscopes 14B to 14D according to the second to fourth modified examples described later.

As shown in FIG. 11, the insertion section 80a of the endoscope 14A includes a tube member 82, a lens unit 84, a plurality of light guides 86, an image guide 88, and a reinforcing structure 90a. The reinforcing structure 90a is provided so as to cover the entire outer peripheral surface of the image guide 88. The reinforcing structure 90a is provided on the tip side of the image guide 88, but is not provided on the base end side of the image guide 88. The reinforcing structure 90a is provided on a portion of the insertion section 80a that comes into contact with the balloon 22 in an inflated state. The total length of the reinforcing structure 90a is longer than the total length L2 (see FIG. 1) of the balloon 22 in the initial state of the balloon catheter 12. Specifically, the reinforcing structure 90a is provided only in a range of 25 cm from the tip of the insertion section 80a.

The reinforcing structure 90a includes a reinforcing tube 98 that covers the outer peripheral surface of the image guide 88. The reinforcing tube 98 is made of a flexible polymeric material. Specifically, the reinforcing tube 98 is preferably made of, for example, polycarbonate, acrylic resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, or the like. The reinforcing tube 98 may also be made of fluorine-based resin (PFA, PTFE, FEP, ETFE, PVDF, PCTFE, ECTFE, or the like), PEEK resin, polycarbonate, PMMA, elastomer resin (polyolefin elastomer, polyester elastomer, polyamide elastomer, fluorine resin elastomer, polyurethane elastomer, or the like), or flexible resin (natural rubber, ethylene-propylene copolymer, polytetrafluoroethylene, ethylene-vinyl acetate copolymer, silicone rubber, soft polyvinyl chloride, polyurethane, polyisoprene, polyimide, polyamide, or the like).

The inner circumferential surface of the reinforcing tube 98 is in contact with the outer circumferential surface of the image guide 88. A space exists on the outer circumferential side of the reinforcing tube 98. In other words, the reinforcing tube 98 is spaced apart from the inner circumferential surface of the tube member 82 and from each light guide 86. The tip of the reinforcing tube 98 extends to the position of the tip of the image guide 88.

In this type of endoscope 14A, the same configuration as the endoscope 14 described above provides the same effects. In addition, this modified example provides the following effects.

The reinforcing structure 90a includes a reinforcing tube 98 that covers the outer peripheral surface of the image guide 88.

With this configuration, the reinforcing tube 98 can effectively prevent the image guide 88 from bending excessively.

The reinforcing tube 98 is made of a flexible resin material.

This configuration allows the tip side of the insertion section 80a to bend appropriately. This allows the insertion section 80 and the balloon 22 to be smoothly pushed forward along the shape of the fallopian tube 202.

This modified example is not limited to the above-mentioned configuration. The reinforcing structure 90a may be formed to include a reinforcing tube 98 and the above-mentioned adhesive 96. In this case, the adhesive 96 is filled on the outer circumferential side of the reinforcing tube 98 in the inner cavity of the tube member 82.

(Second Modification)
Next, an endoscope 14B according to a second modification will be described with reference to FIG. 12. As shown in FIG. 12, the insertion section 80b of the endoscope 14B includes a tube member 82, a lens unit 84, a plurality of light guides 86, an image guide 88, and a reinforcing structure 90b. The reinforcing structure 90b is provided so as to cover the entire outer peripheral surface of the image guide 88. The reinforcing structure 90b is provided on the tip side of the image guide 88, and is not provided on the base end side of the image guide 88. The reinforcing structure 90b is provided on a portion of the insertion section 80b that comes into contact with the balloon 22 in an inflated state. The total length of the reinforcing structure 90b is longer than the total length L2 (see FIG. 1) of the balloon 22 in the initial state of the balloon catheter 12. Specifically, the reinforcing structure 90b is provided only in a range of 25 cm from the tip of the insertion section 80b.

The reinforcing structure 90b includes a linear member 100 that is arranged to be wound in a spiral shape around the outer peripheral surface of the image guide 88. That is, the reinforcing structure 90b is formed in a coil shape. The linear member 100 is formed as a solid body. However, the linear member 100 may be formed as a hollow body.

The linear member 100 is made of a metal material. Specifically, the linear member 100 is preferably made of various metal materials such as stainless steel and superelastic alloys (Ni-Ti alloys, Ni-Al alloys, Cu-Zn alloys, etc.), or the metal materials whose outer surfaces are coated with a resin material. However, the linear member 100 may also be made of a relatively high-rigidity resin material.

The linear member 100 is in contact with the outer peripheral surface of the image guide 88. A space exists between the linear member 100 and the inner peripheral surface of the tube member 82. A space is also formed between the linear member 100 and the light guide 86. The linear member 100 extends to the tip of the image guide 88. The coil pitch of the reinforcing structure 90b can be set appropriately. The reinforcing structure 90b may be formed by winding one linear member 100 in a spiral shape, or may be formed by winding two or more linear members 100 in a spiral shape.

In this type of endoscope 14B, the same configuration as the endoscope 14 described above provides the same effects. In addition, this modified example provides the following effects.

The reinforcing structure 90b includes a linear member 100 that is wound in a spiral shape around the outer circumferential surface of the image guide 88.

This configuration effectively prevents the tip side of the insertion section 80b from being excessively bent by the linear member 100. In addition, the tip side of the insertion section 80b can be bent appropriately.

The linear member 100 is made of a metal material.

This configuration allows the tip side of the insertion section 80b to bend appropriately and more effectively prevents excessive bending of the image guide 88.

This modified example is not limited to the above-mentioned configuration. The reinforcing structure 90b may be formed to include a linear member 100 and the above-mentioned adhesive 96. The reinforcing structure 90b may also be formed to include a linear member 100, adhesive 96, and a reinforcing tube 98. In this case, the linear member 100 is arranged to be wound helically around the outer circumferential surface of the reinforcing tube 98.

(Third Modification)
Next, an endoscope 14C according to a third modified example will be described with reference to Figures 13A and 13B. As shown in Figures 13A and 13B, an insertion section 80c of the endoscope 14C includes a tube member 82, a lens unit 84, a plurality of light guides 86 (six in this modified example), an image guide 88, and a reinforcing structure 90c. The image guide 88 and the lens unit 84 are provided coaxially with the tube member 82.

The reinforcement structure 90c is provided so as to cover the entire outer peripheral surface of the image guide 88. The reinforcement structure 90c is provided on the tip side of the image guide 88, but is not provided on the base end side of the image guide 88. The reinforcement structure 90c is provided on the portion of the insertion section 80c that comes into contact with the inflated balloon 22. The total length of the reinforcement structure 90c is longer than the total length L2 (see FIG. 1) of the balloon 22 in the initial state of the balloon catheter 12. Specifically, the reinforcement structure 90c is provided only within a range of 25 cm from the tip of the insertion section 80c.

The reinforcement structure 90c is formed by winding the tip side of multiple light guides 86 around the outer circumferential surface of the image guide 88. That is, the reinforcement structure 90c is formed in a coil shape. In other words, the reinforcement structure 90c is formed like a multi-strand coil (six-strand coil). The base end side of each light guide 86 extends along the axial direction of the image guide 88 and does not form the reinforcement structure 90c. In other words, the light guide 86 is not wound around the base end side of the image guide 88. This makes it easier to manufacture the insertion section 80c compared to the case where the light guide 86 is wound over the entire length of the image guide 88.

In the reinforcement structure 90c, each light guide 86 is in contact with the inner peripheral surface of the tube member 82 while being spaced apart from the outer peripheral surface of the image guide 88. However, in the reinforcement structure 90c, each light guide 86 may be in contact with the outer peripheral surface of the image guide 88 or may be spaced apart from the inner peripheral surface of the tube member 82. The tip of each light guide 86 is located on the outer peripheral side of the lens unit 84. The tip of the multiple light guides 86 is provided at equal intervals in the circumferential direction of the lens unit 84.

In this type of endoscope 14C, the same configuration as the endoscope 14 described above provides the same effects. In addition, this modified example provides the following effects.

The reinforcing structure 90c is formed by winding the light guide 86 around the outer peripheral surface of the image guide 88.

With this configuration, the reinforcing structure 90c can be formed from the light guide 86, which reduces the number of parts compared to when the reinforcing structure 90c is formed from a separate member from the light guide 86.

The light guide 86 is a plastic optical fiber.

This configuration allows the light guide 86 to be easily wrapped around the outer peripheral surface of the image guide 88.

This modified example is not limited to the above-mentioned configuration. The reinforcing structure 90c may be formed to further include the adhesive 96 described above. The reinforcing structure 90c may also be formed to further include the adhesive 96 and the reinforcing tube 98. In this case, the multiple light guides 86 are arranged to spirally wind around the outer circumferential surface of the reinforcing tube 98. In this modified example, the number of light guides 86 may be one or more (other than six).

(Fourth Modification)
Next, an endoscope 14D according to a fourth modified example will be described with reference to Figures 14A and 14B. As shown in Figures 14A and 14B, an insertion section 80d of the endoscope 14D includes a tube member 82, a lens unit 84, a plurality of (ten in this modified example) light guides 86, an image guide 88, and a reinforcing structure 90d. The image guides 88 and the lens unit 84 are provided coaxially with respect to the tube member 82. Each light guide 86 extends along an axis Ax3 of the image guide 88. The reinforcing structure 90d is provided over the entire length of the image guide 88. The entire length of the reinforcing structure 90d is longer than the entire length L2 (see Figure 1) of the balloon 22 in the initial state of the balloon catheter 12.

The reinforcing structure 90d is formed by arranging a plurality of light guides 86 in a circumferential direction around the image guide 88. In other words, the plurality of light guides 86 cover the entire outer peripheral surface of the image guide 88.

In this type of endoscope 14D, the same configuration as the endoscopes 14, 14A to 14C described above provides the same effects. In addition, this modified example provides the following effects.

The light guides 86 are provided in a plurality of positions extending along the axial direction of the image guide 88. The reinforcing structure 90d is formed by arranging the plurality of light guides 86 in a circumferential direction around the image guide 88.

With this configuration, the reinforcing structure 90d can be formed from the light guide 86, which reduces the number of parts compared to when the reinforcing structure 90d is formed from a separate member from the light guide 86.

This modified example is not limited to the above-mentioned configuration. The reinforcing structure 90d may be formed to further include the adhesive 96 described above. The reinforcing structure 90d may also be formed to further include the adhesive 96 and the reinforcing tube 98. The reinforcing structure 90d may also be formed to further include the adhesive 96, the linear member 100, and the reinforcing tube 98. In this modified example, the number of light guides 86 is not limited to 10.

The present invention is not limited to the above-described embodiment, and various modifications are possible without departing from the spirit of the present invention.

The above embodiments can be summarized as follows:

The above embodiment is a catheter system (10) including a balloon catheter (12) having a flexible outer tube (24), an inner tube (62) arranged in the inner cavity (34) of the outer tube so as to be movable in the axial direction of the outer tube relative to the outer tube, a tubular balloon (22) that connects the tip end of the outer tube and the tip end of the inner tube to each other and expands radially inwardly of the outer tube, and an endoscope (14, 14A-14D) having a linear insertion portion (80, 80a-80d) inserted into the inner cavity (76) of the balloon, in which the balloon is supported by the insertion portion when a pushing force in the tip direction is applied to the inner tube. The catheter system discloses a catheter system in which the distal end (22a) of the balloon is rolled up and protrudes from the distal end opening (54) of the outer tube toward the distal end as the light is transmitted from the distal end to the balloon, and the insertion section has a lens unit (84) located at the distal end of the insertion section, an image guide (88) that extends along the axial direction of the insertion section and transmits an image obtained by the lens unit to the base end side of the insertion section, and a reinforcing structure (90, 90a to 90d) that is provided to cover the outer peripheral surface of the image guide over the entire circumference, and the reinforcing structure is provided on the portion of the insertion section that comes into contact with the balloon in an inflated state.

In the above catheter system, the reinforcing structure may be provided on the distal end side of the image guide and may not be provided on the proximal end side of the image guide.

In the above catheter system, the overall length (L1) of the reinforcing structure may be longer than the overall length (L2) of the balloon in the initial state of the balloon catheter.

In the above catheter system, the insertion section has a tube member (82) that covers the lens unit and the image guide, and the reinforcing structure may include an adhesive (96) filled on the outer periphery of the image guide in the inner cavity of the tube member.

In the above catheter system, the adhesive may be in contact with the outer circumferential surface of the image guide and the inner circumferential surface of the tube member.

In the above catheter system, the reinforcing structure may include a reinforcing tube (98) that covers the outer peripheral surface of the image guide.

In the above catheter system, the reinforcing tube may be made of a flexible polymeric material.

In the above catheter system, the reinforcing structure may include a linear member (100) arranged to spirally wind around the outer circumferential surface of the image guide.

In the above catheter system, the linear member may be made of a metal material.

In the above catheter system, the insertion section may have a light guide (86) for guiding light from the base end side of the insertion section to the tip of the insertion section.

In the above catheter system, the reinforcing structure may be formed by winding the light guide around the outer peripheral surface of the image guide.

In the above catheter system, the light guide may be a plastic optical fiber.

In the above catheter system, the light guide may be provided in a plurality of locations extending along the axial direction of the image guide, and the reinforcing structure may be formed by arranging the plurality of light guides in a circumferential direction around the image guide.

10... Catheter system 12... Balloon catheter 14, 14A to 14D... Endoscope 22... Balloon 24... Outer tube 54... Tip opening 62... Inner tube 80, 80a to 80d... Insertion section 82... Tube member 84... Lens unit 86... Light guide 88... Image guide 90, 90a to 90d... Reinforcing structure 96... Adhesive 98... Reinforcing tube 100... Linear member

Claims (13)

a balloon catheter including a flexible outer tube, an inner tube disposed in the inner cavity of the outer tube so as to be movable in the axial direction of the outer tube relative to the outer tube, and a tubular balloon connecting a distal end of the outer tube with a distal end of the inner tube and expanding radially inwardly of the outer tube;
An endoscope having a linear insertion portion inserted into an inner cavity of the balloon,
When the balloon is in an inflated state and supported by the insertion portion, a pushing force in a distal direction is transmitted from the inner tube to the balloon, causing the distal end of the balloon to turn back and protrude in the distal direction from the distal end opening of the outer tube,
The insertion portion is
a lens unit located at a tip of the insertion portion;
an image guide extending along an axial direction of the insertion portion and transmitting an image obtained by the lens unit to a base end side of the insertion portion;
a reinforcing structure provided to cover an outer peripheral surface of the image guide over an entire periphery,
A catheter system in which the reinforcing structure is provided in a portion of the insertion section that comes into contact with the balloon in an inflated state. 2. The catheter system of claim 1,
A catheter system, wherein the reinforcing structure is provided on the distal end side of the image guide and is not provided on the proximal end side of the image guide. The catheter system according to claim 1 or 2,
A catheter system, wherein the overall length of the reinforcing structure is longer than the overall length of the balloon in an initial state of the balloon catheter. The catheter system according to any one of claims 1 to 3,
the insertion section has a tube member that covers the lens unit and the image guide,
A catheter system, wherein the reinforcing structure includes an adhesive filled on an outer circumferential side of the image guide in the inner cavity of the tubular member. 5. The catheter system of claim 4,
The adhesive is in contact with an outer circumferential surface of the image guide and an inner circumferential surface of the tubular member. The catheter system according to any one of claims 1 to 3,
The catheter system, wherein the reinforcing structure includes a reinforcing tube covering an outer peripheral surface of the image guide. 7. The catheter system of claim 6,
A catheter system, wherein the reinforcing tube is made of a flexible polymeric material. The catheter system according to any one of claims 1 to 3,
A catheter system, wherein the reinforcing structure includes a linear member arranged to spirally wind around the outer circumferential surface of the image guide. 9. The catheter system of claim 8,
A catheter system, wherein the linear member is constructed to include a metallic material. The catheter system according to any one of claims 1 to 3,
A catheter system, wherein the insertion portion has a light guide for guiding light from a base end side of the insertion portion to a tip end of the insertion portion. 11. The catheter system of claim 10,
A catheter system, wherein the reinforcing structure is formed by winding the light guide around the outer peripheral surface of the image guide. 12. The catheter system of claim 11,
The catheter system, wherein the light guide is a plastic optical fiber. 11. The catheter system of claim 10,
The light guide is provided in a plurality of states extending along the axial direction of the image guide,
A catheter system, wherein the reinforcing structure is formed by arranging a plurality of the light guides around the image guide in a circumferential direction.

Images