CN114176500A - Balloon catheter - Google Patents

Abstract

The invention provides a balloon catheter capable of efficiently inserting a balloon into a living body orifice. The balloon catheter (10) has a tubular balloon (26) that connects the distal end of the outer tube (32) and the distal end of the inner tube (52) to each other and bulges radially inward of the outer tube (32), and the balloon (26) transmits a pushing force from the inner tube (52) to the balloon (26) so that the distal end (26a) of the balloon (26) protrudes from the distal end opening (66) of the outer tube (32) while being rewound, and an endoscope (14) is inserted into the balloon (26) through the lumen (56) of the inner tube (52). A linear member (28) is fixed to the distal end (33) of the outer tube (32) so as to project from the distal end surface (33) of the outer tube (32) in the projecting direction of the balloon (26).

Description

Balloon catheter

Technical Field

The present invention relates to balloon catheters.

Background

For example, patent document 1 discloses a catheter system having a balloon catheter for treating a diseased portion (a stenosed portion or a blocked portion) of a fallopian tube and a salpingoscope (endoscope). A balloon catheter is provided with: an outer tube having flexibility; an inner tube disposed in an inner cavity of the outer tube so as to be movable in an axial direction relative to the outer tube; and a tubular balloon connecting a top end portion of the outer tube and a top end portion of the inner tube to each other. The balloon is inserted into the ostium by transmitting a pushing force from the inner tube to the balloon, and protruding from the distal opening of the outer tube while the distal end portion of the balloon is rewound. The oviduct lens is inserted into the inner side of the balloon through the inner cavity of the inner tube.

Documents of the prior art

Patent document

Patent document 1: japanese patent No. 3921108

Disclosure of Invention

However, the scope inserted inside the balloon has a narrower visual field and a shorter focal length than the scope used for observation of the uterus. The image captured by the oviduct scope is darker and has a lower image quality than the image captured by the hysteroscope. Therefore, it is not easy for the user to find the oval orifice based on the captured image of the oviductlens, and the balloon may not be efficiently inserted into the oval orifice (biological orifice).

The present invention has been made in view of such problems, and an object thereof is to provide a balloon catheter that can insert a balloon into a living body orifice efficiently.

A balloon catheter according to one embodiment of the present invention includes: an outer tube having flexibility; an inner tube disposed in an inner cavity of the outer tube so as to be movable in an axial direction with respect to the outer tube; and a tubular balloon that connects a distal end portion of the outer tube and a distal end portion of the inner tube to each other and bulges out radially inward of the outer tube, the balloon projecting from a distal end opening of the outer tube while being rewound by transmission of a pushing force from the inner tube to the balloon, and an endoscope being inserted into the balloon through an inner lumen of the inner tube, wherein a linear member is fixed to the distal end portion of the outer tube so as to project from a distal end surface of the outer tube in a projecting direction of the balloon.

A balloon catheter according to another aspect of the present invention includes: an outer tube having flexibility; an inner tube disposed in an inner cavity of the outer tube so as to be movable in an axial direction with respect to the outer tube; and a tubular balloon that connects a distal end portion of the outer tube and a distal end portion of the inner tube to each other and bulges out radially inward of the outer tube, the balloon projecting from a distal end opening of the outer tube while being rewound by transmitting a pushing force from the inner tube to the balloon, wherein a lumen through which a linear member is inserted is formed in at least the distal end portion of the outer tube so that the linear member can project from the distal end surface of the outer tube in a projecting direction of the balloon.

Effects of the invention

According to the present invention, by inserting a linear member into a balloon insertion target site and confirming the visual representation of the linear member from an image taken by an endoscope (endoscope image), it is possible to easily distinguish whether the insertion target site is in a living body orifice or simply in a concave portion. Thereby, the user can easily find the living body orifice (for example, oval orifice) based on the endoscope image. This enables efficient insertion of the balloon into the living body orifice.

Drawings

Fig. 1 is a schematic configuration diagram of a catheter system including a balloon catheter according to embodiment 1 of the present invention.

Fig. 2 is a longitudinal sectional view of the distal end side of the balloon catheter of fig. 1.

Fig. 3 is a partially omitted perspective view of the distal end side of the balloon catheter of fig. 1.

Fig. 4 is a flowchart for explaining a oviduct forming operation using the catheter system of fig. 1 under a salpingoscope.

FIG. 5 is a 1 st illustration of the oviduct forming procedure under the salpingoscope.

FIG. 6 is a 2 nd illustration of the oviduct forming procedure under the salpingoscope.

FIG. 7 is a 3 rd illustration of the oviduct forming procedure under the salpingoscope.

FIG. 8 is a 4 th illustrative view of the oviduct forming operation under the oviduct mirror.

FIG. 9 is a 5 th illustrative view of the oviduct forming operation under the oviduct scope.

Fig. 10 is a schematic configuration diagram of a catheter system including a balloon catheter according to embodiment 2 of the present invention.

Fig. 11 is a flowchart for explaining a oviduct forming operation under a salpingoscope using the balloon catheter of fig. 10.

Fig. 12 is a schematic configuration diagram of a catheter system including a balloon catheter according to embodiment 3 of the present invention.

Fig. 13 is a cross-sectional view taken along line XIII-XIII of fig. 12.

Fig. 14 is a schematic configuration diagram of a catheter system including a balloon catheter according to embodiment 4 of the present invention.

Fig. 15 is an explanatory diagram of the operation of the balloon catheter of fig. 14.

Description of the reference numerals

10. 10A-10C … balloon catheter

12. 12A-12C … catheter system

14 … endoscope

26 … balloon

28. 28 a-28 c … Linear Member

32. 32 a-32 c … outer tube

33 … tip end face

52 … inner tube

66 … open at the top end

82. 84, 86 … lumen

83a, 85a, 87a … opening No. 1

83b, 85b, 87b … opening 2

Detailed Description

Hereinafter, a balloon catheter according to the present invention will be described by referring to the drawings, taking preferred embodiments as examples of the relationship with the catheter system.

(embodiment 1)

As shown in fig. 1, a catheter system 12 according to embodiment 1 of the present invention includes a balloon catheter 10 and an endoscope 14. As shown in fig. 5 to 9, the balloon catheter 10 is used in, for example, a fallopian tube subtopic fallopian tube formation operation for treating a lesion 204 (a stenosed portion, an occluded portion, or the like) of a fallopian tube 202. However, the balloon catheter 10 may be used for treatment of a lesion other than the fallopian tube 202, for example, for treatment of a lesion in a living body vessel such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra, or other organs.

In the following description of the catheter system 12, the left side (direction of arrow a) in fig. 1 is referred to as the "tip end", and the right side (direction of arrow B) in fig. 1 is referred to as the "base end".

As shown in fig. 1 and 2, the balloon catheter 10 includes an outer catheter 20, a slider 22 provided on the outer catheter 20, an inner catheter 24 inserted into the outer catheter 20, a balloon 26, and a linear member 28.

In fig. 1, the outer catheter 20 includes a long flexible outer tube 32, an outer tube holder 34 (outer tube operating portion) provided at a proximal end portion of the outer tube 32, and a fixing screw 36 provided on the outer tube holder 34. The overall length of the outer tube 32 is preferably set to 100mm to 1500mm, and more preferably 200mm to 1000 mm.

In fig. 2, the outer tube 32 includes an outer tube main body 38, and a tip member 40 (tip piece) provided at a tip end portion of the outer tube main body 38. Examples of the constituent material of each of the outer tube main body 38 and the distal end member 40 include a polymer material having flexibility, such as polyolefin (e.g., polyethylene, polypropylene, polybutylene, etc.), olefin elastomer, polyester (e.g., polyethylene terephthalate, etc.), polyester elastomer, soft polyvinyl chloride, polyurethane, ammonia elastomer, polyamide, amide elastomer, polytetrafluoroethylene, fluororesin elastomer, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, and the like.

The outer tube main body 38 is formed with a 1 st lumen 42 penetrating from the distal end to the proximal end. The outer tube body 38 has a substantially constant outer diameter throughout its entire length. The distal end side of the outer tube main body 38 is given a shape curved in an arc shape in the axial direction.

The outer surface of the distal end member 40 is curved to prevent damage to the balloon catheter 10 and the living tissue. The distal end member 40 is formed with a balloon outlet hole 44 for leading out the balloon 26 in the distal direction (direction of arrow a) with respect to the distal end member 40. The balloon outlet port 44 communicates with the top end opening 66 of the outer tube 32.

In fig. 1, the outer tube base 34 is made of hard resin or metal (stainless steel, titanium alloy, or the like). Examples of the hard resin include polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, and polyetherimide.

The outer tube holder 34 is formed in a hollow shape in a size that is easy to handle with a human hand. The outer tube holder 34 is provided with a 1 st introduction port 46 for introducing a balloon inflation fluid. The balloon inflation fluid is used to inflate the balloon 26 shown in fig. 2 radially inward of the outer tube 32. The balloon inflation fluid is, for example, saline.

The set screw 36 is used to fix the inner catheter 24 relative to the outer catheter hub 34. The same material as that of the outer tube holder 34 can be used as the material of the fixing screw 36.

The slider 22 is provided in a state of being movable (slidable) in the axial direction of the outer tube 32 with respect to the outer peripheral surface of the outer tube 32. The overall length of the slider 22 is shorter than the overall length of the outer tube 32. The slider 22 includes a long tubular slider body 48 and a slider seat 50 (slider operating portion) provided at a proximal end portion of the slider body 48. The slider body 48 and the slider seat 50 are each made of the same material as the outer tube base 34. The slider seat 50 is formed in a ring shape in a size that is easily operated by a human hand.

In a state where the slider 22 is moved toward the base end side (arrow B direction) with respect to the outer tube main body 38 (in a state where the base end of the slider 22 is positioned at the tip end of the outer tube base 34), the tip end side of the outer tube main body 38 is exposed toward the tip end side than the slider 22 and is curved in an arc shape (see fig. 1). In a state where the slider 22 is moved to the most distal side (arrow a direction) with respect to the outer tube main body 38, the distal end side of the outer tube main body 38 linearly extends along the shape of the slider main body 48 (see fig. 5).

As shown in fig. 1 and 2, the inner catheter 24 includes an elongated inner tube 52 and an inner tube holder 54 (inner tube operating section) provided at a proximal end portion of the inner tube 52. The entire length of the inner tube 52 is preferably set to 100mm to 1500mm, and more preferably set to 200mm to 1000 mm.

In fig. 2, the inner tube 52 is made of a relatively hard resin (for example, fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or metal (for example, stainless steel, titanium alloy, etc.). The inner tube 52 has a 2 nd lumen 56 formed therethrough from the distal end to the proximal end.

The inner tube 52 is inserted into the outer tube base 34 and is disposed in the 1 st lumen 42 of the outer tube body 38. The distal end of the inner tube 52 is located in the proximal direction (arrow B direction) with respect to the distal end of the outer tube main body 38. An outer lumen 58 (an inflation lumen) through which a balloon inflation fluid flows is provided between the inner tube 52 and the outer tube body 38.

An insertion portion 80 having a long size of the endoscope 14 functioning as a balloon support device is inserted into the No. 2 lumen 56 of the inner tube 52. In a state where the insertion portion 80 is inserted into the No. 2 lumen 56 of the inner tube 52, an inner lumen 60 (perfusion lumen) through which perfusion fluid flows is formed between the inner tube 52 and the insertion portion 80. The perfusion fluid is, for example, physiological saline.

In fig. 1, the inner tube base 54 is made of the same material as the outer tube base 34. The inner tube holder 54 is formed in a hollow shape. The inner tube holder 54 is provided with a 2 nd inlet port 62 for introducing a perfusion liquid.

As shown in fig. 2, the balloon 26 is a tubular member that connects the tip end portion of the outer tube 32 and the tip end portion of the inner tube 52 to each other. The balloon 26 bulges out radially inward of the outer tube 32. In other words, the balloon 26 is elastically deformable in the radial direction.

Examples of the material of the balloon 26 include natural rubber, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, soft polyvinyl chloride, polyurethane elastomer, polyisoprene, polyamide elastomer, polyester elastomer, polyimide, polytetrafluoroethylene, and silicone rubber. The balloon 26 is preferably made of polyamide elastomer, polyurethane elastomer, or polyester elastomer.

One end of the balloon 26 is bonded or welded to the distal end portion of the outer tube 32 (the proximal end portion of the distal end member 40). In other words, one end portion of the balloon 26 is bonded or welded to the outer tube 32 in the vicinity of the base end side of the balloon lead-out hole 44. The other end of the balloon 26 is bonded or welded to the distal end portion of the outer surface of the inner tube 52. However, the other end portion of the balloon 26 may be bonded or welded to the distal end portion of the inner surface of the inner tube 52. The balloon 26 has an inner lumen 64 into which an insertion portion 80 of the endoscope 14 can be inserted. A bag-shaped outer space S having a closed top end is formed between the balloon 26 and the outer tube main body 38.

As shown in fig. 7 and 9, when a pushing force (pushing force in the distal direction) is transmitted from the inner tube 52 to the balloon 26, the distal end portion 26a of the balloon 26 protrudes in the distal direction from the distal end opening 66 of the outer tube 32 while being rewound. At this time, the balloon 26 is formed with a portion folded into a double layer in the radial direction in the protruding portion 26b protruding in the arrow a direction from the distal end opening 66 of the outer tube 32.

As shown in fig. 2 and 3, the linear member 28 is fixed to the distal end portion of the outer tube 32 so as to protrude from the distal end surface 33 of the outer tube 32 in the protruding direction (arrow a direction) of the balloon 26. The linear member 28 is fixed to the distal end face 33 of the outer tube 32 at a position adjacent to the distal end opening 66. The linear member 28 is a columnar member having appropriate rigidity and appropriate flexibility.

The protruding length L of the outer tube 32 of the linear member 28 from the distal end surface 33 is set to 0.5cm to 6 cm. The projection length L is preferably set to 1cm or more and 4cm or less, and more preferably set to about 2.5 cm. It is preferable to apply a spray coating (hydrophilic lubrication coating, PTFE coating, or the like) that reduces the frictional force with the balloon 26 to the outer circumferential surface of the linear member 28.

The linear member 28 includes a light guide portion 70 (hard portion) extending in a linear shape, and a covering portion 72 covering the outer peripheral surface of the light guide portion 70. Examples of the material of the light guide part 70 include acrylic resin (PMMA) and quartz. The proximal end surface of the light guide part 70 is not covered with the covering part 72 in order to introduce light from a light source not shown. The distal end portion of the light guide unit 70 is a portion for emitting light from the light source, and is exposed to the outside without being covered by the covering portion 72.

The cover 72 is made of, for example, a resin material which does not transmit light. In this case, the light introduced from the proximal end surface of the light guide part 70 is reflected by the covering part 72 and guided to the distal end part of the light guide part 70. Therefore, the distal end portion of the light guide portion 70 can be efficiently illuminated (the distal end portion of the linear member 28 can be illuminated relatively brightly).

The light source for supplying light to the light guide portion 70 is provided separately from the balloon catheter 10, for example. In this case, the balloon catheter 10 is provided with a light guide (such as an optical fiber) for guiding light of an external light source to the linear member 28. The light guide members are disposed in the wall of the outer tube 32 and the wall of the outer tube holder 34 so as to extend from the linear member 28 to the base end of the outer tube holder 34, for example. As the light source, for example, a discharge lamp such as an LED or a xenon lamp, a bulb, or the like can be used. However, the light guide part 70 may be extended to the base end of the outer stem 34 without providing a light guide member, thereby guiding the light from the light source to the light guide part 70. Further, the light source may be disposed in a wall portion of the distal end portion (distal end member 40) of the outer tube 32.

The covering portion 72 has an outer diameter smaller than the inner diameter (bore diameter) of the balloon outlet hole 44. The distal end portion of the linear member 28 (light guide portion 70) is formed into an R-shape (for example, a semicircular shape) in order to prevent damage to living tissues (the fallopian tube 202 and uterus).

The linear member 28 may not have the covering portion 72. In this case, the linear member 28 emits light as a whole of the portion of the linear member 28 protruding from the distal end surface 33 of the outer tube 32. The linear member 28 is not limited to a configuration that emits light. That is, the linear member 28 may be made of various metal materials such as a superelastic alloy such as stainless steel, a nickel-titanium alloy, a nickel-aluminum alloy, or a copper-zinc alloy, or a resin material having relatively high rigidity. The linear member 28 is not limited to an example of a cylindrical structure, and may have an appropriate shape such as a prismatic shape, a cylindrical shape, or a prismatic shape.

As shown in fig. 7, the endoscope 14 is, for example, a fallopian tube lens for photographing the inside of a fallopian tube 202. The endoscope 14 includes a flexible long insertion portion 80. The insertion portion 80 supports the balloon 26 that bulges radially inward in a state where the No. 2 inner cavity 56 of the inner tube 52 is inserted into the inner cavity 64 of the balloon 26. The endoscope 14 can photograph the balloon catheter 10 from the inside of the balloon 26 in the direction of arrow a. The image (endoscope image) captured by the endoscope 14 is displayed on a display unit (not shown).

Next, a description will be given of a fallopian tube forming operation using the catheter system 12 thus configured, in accordance with the flowchart of fig. 4.

In the oviduct forming operation under the salpingoscope, first, as shown in fig. 4, in the preparatory step (step S1), the endoscope 14 (salpingoscope) is inserted from the proximal end side of the inner catheter 24 to the 2 nd lumen 56 of the inner tube 52. The inner tube 52 is fixed by the fixing screw 36 in a state of being completely pulled to the base end side (arrow B direction). Then, the slider 22 is slid in the distal end direction of the outer tube 32 with respect to the outer tube 32, whereby the distal end side of the outer tube main body 38 is made straight (see fig. 5).

Next, in the insertion step (step S2), the user inserts the balloon catheter 10 into the uterine fundus 200 through the cervical canal (see fig. 5). Then, in the sliding step (step S3), the slider 22 is pulled back in the proximal direction of the outer tube 32 with respect to the outer tube 32. Thereby, the distal end side of the outer tube main body 38 is exposed from the slider 22 and is bent (see fig. 6). At this time, the user operates the inner tube holder 54 in a state where the fixing screw 36 (see fig. 1) is loosened, thereby positioning the distal end of the endoscope 14 at the distal end opening 66 of the outer tube 32. Therefore, the endoscope 14 can photograph the distal end direction (the arrow a direction) of the balloon catheter 10 through the distal end opening 66 of the outer tube 32. An image (endoscope image) captured by the endoscope 14 is displayed on a display unit (not shown).

In the specifying step (step S4), the user specifies the intended insertion target site 203 of the balloon 26 based on the endoscope image. Then, in the confirmation step (step S5), the user operates the balloon catheter 10 to insert the linear member 28 into the insertion target site 203 (see fig. 6), and confirms the visual appearance of the linear member 28 from the endoscope image. At this time, light from a light source, not shown, is guided to the linear member 28, and the light guide portion 70 of the linear member 28 emits light. At this time, when the user confirms, for example, from the endoscopic image that the linear member 28 is being inserted into the insertion target site 203, the user determines that the insertion target site 203 is the ostium 202 a.

On the other hand, when it is confirmed from the endoscope image that the linear member 28 is not inserted into the insertion target region 203, the user determines that the insertion target region 203 is not the oval port 202a (e.g., is a simple concave portion). When the user determines that the insertion target site 203 is not the oval port 202a, the above-described specific step and confirmation step are repeated until the oval port 202a is found.

After the confirmation step of identifying the ostium 202a, the user moves the endoscope 14 to the proximal end side by a predetermined length with respect to the outer tube 32, and then performs a balloon derivation step (step S6). Specifically, the balloon inflation fluid is supplied to the 1 st introduction port portion 46 (see fig. 1) (pressurization step). Then, the balloon inflation fluid is supplied from the 1 st introduction port 46 to the outer space S of the balloon 26 through the outer lumen 58 (see fig. 1 and 2). The balloon 26 is pressed radially inward by the balloon-expanding fluid supplied to the outer space S and is elastically deformed. That is, a portion of the balloon 26 located on the outer peripheral side of the insertion portion 80 is in close contact with the outer peripheral surface of the insertion portion 80. The portions of the balloon 26 located on the distal end side of the distal end of the insertion portion 80 have inner surfaces in contact with each other.

Then, as shown in fig. 7, the user advances the inner tube 52 relative to the outer tube 32 (advancing process). Then, the balloon 26 pushed in the distal direction by the inner tube 52 advances with respect to the outer tube 32 together with the insertion portion 80. That is, the balloon 26 is projected in the distal direction (the direction of arrow a) from the distal end opening 66 of the outer tube 32 together with the insertion portion 80 by transmitting the pushing force from the inner tube 52 to the balloon 26.

In the advancing step, one end portion of the balloon 26 is fixed to the distal end portion of the outer tube 32, and the distal end portion 26a of the balloon 26 advances while being rewound. That is, the balloon 26 is turned back at the distal end portion 26a thereof such that the inner surface faces outward. Therefore, the balloon 26 advances by a distance corresponding to half of the advancing distance of the insertion portion 80. The advancing process is performed until the distal end of the endoscope 14 reaches the distal end portion 26a (projecting end) of the balloon 26. At this time, the balloon 26 protrudes while being in contact with the linear member 28. The balloon 26 is thus inserted into the ostium 202a with high probability.

Next, the user determines whether the balloon 26 has reached the lesion 204 based on the endoscope image. The user may determine that the balloon 26 has reached the lesion 204 by guiding out all of the balloons 26 forward. When the balloon 26 is positioned in front of the lesion 204, as shown in fig. 8, the balloon-expanding fluid is depressurized, and a perfusion fluid (perfusion fluid) is supplied to the 2 nd introduction port portion 62 (see fig. 1) (depressurization step). Thereby, a perfusion fluid is circulated between the balloon 26 and the insertion portion 80 of the endoscope 14 through the inner lumen 60. Next, the user retracts the endoscope 14 by a predetermined distance (retraction step).

Then, the above-described pressing step and advancing step are performed again. As shown in fig. 9, when the balloon 26 completely passes through the lesion 204, the lesion 204 is expanded by the balloon 26. That is, the narrowing or obstruction of the fallopian tubes 202 is improved.

After the lesion 204 is expanded, in the removal step (step S7 in fig. 4), the user removes the balloon catheter 10 and the endoscope 14 after depressurizing the balloon inflation fluid. Before the balloon catheter 10 is extracted, the balloon catheter 10 may be extracted while observing the inside of the fallopian tube 202 in the extraction step by injecting a perfusion liquid through the 2 nd introduction port 62 (see fig. 1), pulling the inner tube 52 to retract the balloon 26, and operating so that the endoscope 14 is positioned at the distal end portion of the balloon 26. Thereby, the oviduct forming operation under the oviduct mirror is ended.

The balloon catheter 10 of the present embodiment achieves the following effects.

The wire member 28 is fixed to the distal end portion of the outer tube 32 so as to protrude from the distal end surface 33 of the outer tube 32 in the protruding direction of the balloon 26.

According to such a configuration, the linear member 28 is inserted into the insertion target site 203 of the balloon 26, and the visual representation of the linear member 28 is confirmed by the endoscope image, whereby it is possible to easily distinguish whether the insertion target site 203 is the oval port 202a or a simple concave portion. Thus, the user can easily find the oval port 202a based on the endoscope image. This enables the balloon 26 to be efficiently inserted into the ostium 202 a.

The balloon 26, when protruding from the top end opening 66 of the outer tube 32, contacts the linear member 28 in a manner along the linear member 28.

With such a configuration, the balloon 26 can be guided (guided) to the oval port 202a by the linear member 28.

The linear member 28 is fixed to the distal end face 33 of the outer tube 32 at a position adjacent to the distal end opening 66.

With such a configuration, the balloon 26 can be brought into contact with the linear member 28 along the linear member 28 with a simple configuration.

The protruding length L of the outer tube 32 of the linear member 28 from the distal end surface 33 is set to 0.5cm to 6 cm.

With this configuration, the linear member 28 can be efficiently inserted into the ostium 202 a. Further, when the distal end portion of the balloon catheter 10 is guided to the uterine fundus 200, the linear member 28 can be prevented from getting in the way.

The linear member 28 has light guiding properties so that at least the protruding end portion of the linear member 28 can emit light.

With this configuration, since the linear member 28 can emit light, it is easy to recognize a change in visual appearance of the linear member 28 in the endoscope image.

(embodiment 2)

Next, a catheter system 12A according to embodiment 2 will be described with reference to fig. 10 and 11. In the catheter system 12A of the present embodiment, the same components as those of the catheter system 12 are denoted by the same reference numerals, and the description thereof is omitted. The same applies to the catheter system 12B according to embodiment 3 and the catheter system 12C according to embodiment 4, which will be described later.

As shown in fig. 10, the catheter system 12A has a balloon catheter 10A, an endoscope 14, and a linear member 28 a. The balloon catheter 10A has an outer catheter 20A, a slider 22, and an inner catheter 24. The outer catheter 20a has an outer tube 32a, an outer tube seat 34 and a set screw 36. Outer tube 32a includes an outer tube body 38 and a tip member 40 a. At the distal end portion (distal end member 40a) of the outer tube 32a, a lumen 82 is formed through which the linear member 28a is inserted so that the linear member 28a can protrude from the distal end surface 33 of the outer tube 32a in the protruding direction of the balloon 26.

The lumen 82 is formed so as to allow the linear member 28a to be pulled out. The 1 st opening 83a at the tip of the lumen 82 opens at the tip end face 33 of the outer tube 32a (tip member 40 a). The 2 nd opening 83b located at the base end of the lumen 82 opens on the outer peripheral surface of the outer tube 32a (the outer peripheral surface of the tip member 40 a). The 1 st opening 83a is provided in the top end face 33 of the outer tube 32a at a position adjacent to the top end opening 66. The 2 nd opening 83b is located in the tip end direction of the outer tube 32a than the slider 22.

The linear member 28a is formed to be longer than the outer catheter 20 a. The linear member 28a is a member extending the linear member 28. Therefore, the description of the structure of the linear member 28a is omitted. Further, the outer diameter of the linear member 28a (covering portion 72) is slightly smaller than the inner diameter of the lumen 82.

Next, a description will be given of a fallopian tube-forming operation using the catheter system 12A thus constructed.

As shown in fig. 11, in the preparation step (step S11) of the present embodiment, the linear member 28a is inserted into the lumen 82 of the balloon catheter 10A. At this time, the linear member 28a protrudes a predetermined length in the protruding direction (arrow a direction) of the balloon 26 from the distal end surface 33 of the outer tube 32 a.

In the insertion step (step S12), the user inserts the balloon catheter 10A and the linear member 28a together into the fundus 200 through the cervical canal. The sliding process (step S13) and the specifying process (step S14) are the same as the sliding process (step S3) and the specifying process (step S4). Therefore, the description of the sliding process (step S13) and the specific process (step S14) is omitted.

In the confirmation step (step S15), the user operates the linear member 28a to insert the linear member 28a into the insertion target site 203, and confirms the visual expression of the linear member 28a from the endoscope image. The confirmation step is similar to the confirmation step (step S5) described above except for the point at which the user operates the linear member 28 a.

In the balloon derivation step (step S16), the linear member 28a is pulled out after the first pressurization step, the forward movement step, the depressurization step, and the backward movement step are performed. Thus, in the second and subsequent pressurizing steps and advancing steps, the linear member 28a is not pressed against the inner surface of the fallopian tube 202 by the balloon 26. The time for pulling out the linear member 28a may be between the first decompression step and the retraction step, or between the confirmation step and the balloon derivation step.

The extracting step (step S17) is the same as the extracting step (step S7) described above. Therefore, the explanation of the drawing step (step S17) is omitted.

The operation for forming a fallopian tube under a salpingoscope used for the balloon catheter 10A of the present embodiment is not limited to the above-described method. For example, the linear member 28a may not be inserted into the lumen 82 during the preparation process. In this case, in the insertion step, for example, the linear member 28a is inserted into the uterus together with a hysteroscope, not shown, and the distal end portion of the linear member 28a is inserted into the uterine fundus 200 while observing an image captured by the hysteroscope. Then, the user operates the balloon catheter 10A so as to insert the linear member 28a from the base end side of the linear member 28a into the lumen 82 of the balloon catheter 10A. Then, the balloon catheter 10A is advanced along the linear member 28a, and the distal end portion of the balloon catheter 10A is positioned at the uterine fundus 200. That is, in this case, the linear member 28a functions as a so-called guide wire for guiding the distal end portion of the balloon catheter 10A to the uterine fundus 200.

The balloon catheter 10A of the present embodiment has the same operational effects as the above-described balloon catheter 10.

In the present embodiment, at least the distal end portion of the outer tube 32a is formed with a lumen 82 through which the linear member 28a is inserted so that the linear member 28a can protrude from the distal end surface 33 of the outer tube 32a in the protruding direction of the balloon 26.

With such a configuration, the linear member 28a is inserted into the insertion site 203 of the balloon 26, and the visual appearance of the insertion portion 80 is confirmed by the endoscopic image, whereby it is possible to easily distinguish whether the insertion site 203 is the oval port 202a or a simple concave portion. Thus, the user can easily find the oval port 202a based on the endoscope image. This enables the balloon 26 to be efficiently inserted into the oval port 202 a.

The lumen 82 is formed so as to allow the linear member 28a to be pulled out.

With such a configuration, for example, in the balloon derivation step, the linear member 28a can be pulled out from the fallopian tube 202 (biological vessel) after the first pressurization step, advancing step, depressurization step, and retraction step. This prevents the linear member 28a from being pressed against the inner surface of the fallopian tube 202 (biological vessel) by the balloon 26 in the second and subsequent pressurizing steps and advancing steps. For example, the linear member 28a can be pulled out from the fallopian tube 202 (biological vessel) between the confirmation step and the balloon derivation step. In this case, the linear member 28a can be prevented from being pressed against the inner surface of the fallopian tube 202 (biological vessel) by the balloon 26 from the first pressurizing step and the advancing step.

The 1 st opening 83a at the distal end of the lumen 82 opens to the distal end surface 33 of the outer tube 32a, and the 2 nd opening 83b at the proximal end of the lumen 82 opens to the outer peripheral surface of the outer tube 32 a.

With such a configuration, the frictional resistance during the operation of the linear member 28a can be reduced as compared with the case where the lumen 82 is formed over the entire length of the outer catheter 20A of the balloon catheter 10A.

(embodiment 3)

Next, a catheter system 12B according to embodiment 3 will be described with reference to fig. 12 and 13.

As shown in fig. 12, the catheter system 12B has a balloon catheter 10B, an endoscope 14, and a linear member 28B. The balloon catheter 10B has an outer catheter 20B, a slider 22, and an inner catheter 24. The outer catheter 20b has an outer tube 32b, an outer tube seat 34a, and a set screw 36. Outer tube 32b includes an outer tube body 38a and a tip member 40 b. In fig. 12 and 13, the outer catheter 20b is formed with a lumen 84 through which the linear member 28b is inserted so that the linear member 28b can protrude from the distal end surface 33 of the outer tube 32b in the protruding direction of the balloon 26.

The lumen 84 is formed to allow the linear member 28b to be pulled out. In fig. 12, the 1 st opening 85a at the tip of the lumen tube 84 opens at the tip end surface of the outer tube 32b (tip member 40 b). The 1 st opening 85a is provided in the top end face 33 of the outer tube 32b at a position adjacent to the top end opening 66. The 2 nd opening 85b located at the base end of the lumen tube 84 opens on the base end surface of the outer tube seat 34 a.

The linear member 28b is configured similarly to the linear member 28 a. The outer diameter of the linear member 28b is slightly smaller than the inner diameter of the lumen 84.

The oviduct forming operation using the catheter system 12B of the present embodiment is performed in the same manner as the oviduct forming operation using the catheter system 12A of embodiment 2 except for the point where the linear member 28B is inserted into the lumen 84. Therefore, a description of the oviduct forming operation under a salpingoscope in which the catheter system 12B is used is omitted.

The balloon catheter 10B of the present embodiment has the same operational advantages and configurations as those of the balloon catheters 10 and 10A.

In the present embodiment, the balloon catheter 10B has an outer tube holder 34a provided at the proximal end of the outer tube 32B. The 1 st opening 85a at the distal end of the lumen tube 84 opens to the distal end surface 33 of the outer tube 32b, and the 2 nd opening 85b at the proximal end of the lumen tube 84 opens to the proximal end surface of the outer tube base 34 a.

With such a configuration, the linear member 28b can be suppressed from being bent when the linear member 28b is manipulated.

(embodiment 4)

Next, a catheter system 12C according to embodiment 4 of the present invention will be described with reference to fig. 14 and 15.

As shown in fig. 14, the catheter system 12C has a balloon catheter 10C and an endoscope 14. The balloon catheter 10C has an outer catheter 20C, a slider 22, an inner catheter 24, and a linear member 28C. The outer catheter 20c has an outer tube 32c, an outer tube seat 34, and a set screw 36. Outer tube 32c includes an outer tube body 38 and a tip member 40 c. At the distal end portion (distal end member 40c) of the outer tube 32c, a lumen 86 is formed through which the linear member 28c is inserted so that the linear member 28c can protrude from the distal end surface 33 of the outer tube 32c in the protruding direction of the balloon 26.

The lumen 86 is formed to enable the linear member 28c to be pulled out. The 1 st opening 87a at the tip of the lumen tube 86 opens at the tip end face 33 of the outer tube 32c (tip member 40 c). The 2 nd opening 87b located at the base end of the lumen tube 86 opens on the outer peripheral surface of the outer tube 32c (the outer peripheral surface of the tip member 40 c). The 1 st opening 87a is provided in the top end face 33 of the outer tube 32c at a position adjacent to the top end opening 66. The 2 nd opening 87b is located in the tip end direction of the outer tube 32c than the slider 22.

The linear member 28c is formed by extending the linear member 28. The linear member 28c is inserted into the lumen 86 formed in the tip member 40 c. The proximal end portion of the linear member 28c is fixed to the wall portion of the distal end portion of the slider body 48. However, the proximal end portion of the linear member 28c may be fixed to the outer peripheral surface of the distal end portion of the slider body 48.

In the balloon catheter 10C configured as described above, as shown in fig. 15, the distal end portion of the linear member 28C can be positioned within the lumen 86 by moving the slider 22 relative to the outer tube 32C in the proximal direction of the outer tube 32C. In addition, in the operation of forming the fallopian tube under the salpingoscope, if the operation of repeating the specific step and the confirmation step until the oval port 202a is found is repeated, the linear member 28c is unlikely to be accidentally detached. Therefore, there is an advantage that an operation of removing the catheter system 12C and reattaching the linear member 28C when it is detached is not required.

In a fallopian tube-forming operation to which the catheter system 12C of the present embodiment is applied, the operation is performed substantially in accordance with the flowchart shown in fig. 4 described above. In the present embodiment, however, after the first pressurizing step, advancing step, depressurizing step, and retreating step are performed in the balloon drawing-out step (step S6), the slider 22 is moved in the proximal direction of the outer tube 32c with respect to the outer tube 32c, and the linear member 28c is pulled out from the fallopian tube 202. At this time, the distal end portion of the linear member 28c is positioned in the lumen 86. Thus, in the second and subsequent pressurizing steps and advancing steps, the linear member 28c is not pressed against the inner surface of the fallopian tube 202 by the balloon 26. The time for pulling out the linear member 28c may be between the first decompression step and the retraction step, or between the confirmation step and the balloon derivation step.

The balloon catheter 10C of the present embodiment has the same operational effects as those of the balloon catheters 10, 10A, and 10B described above.

In the present embodiment, the balloon catheter 10C includes the slider 22 disposed on the outer peripheral surface of the outer tube 32C so as to be movable in the axial direction with respect to the outer tube 32C, and the linear member 28C fixed to the slider 22. The 1 st opening 87a located at the distal end of the lumen tube 86 opens on the distal end surface 33 of the outer tube 32c, and the 2 nd opening 87b located at the proximal end of the lumen tube 86 opens on the outer peripheral surface of the outer tube 32c closer to the distal end of the outer tube 32c than the slider 22. The distal end portion of the linear member 28c is positioned in the lumen 86 by moving the slider 22 in the proximal direction of the outer tube 32 c.

With this configuration, it is not necessary to separately operate the linear member 28C and the balloon catheter 10C. That is, the linear member 28C can be easily pulled out from the fallopian tube 202 (biological vessel) by operating the slider 22 of the balloon catheter 10C.

The present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention.

To summarize the above embodiment, the following is made.

The above embodiment discloses a balloon catheter 10 having: an outer tube 32 having flexibility; an inner tube 52 disposed in the inner cavity 42 of the outer tube so as to be movable in the axial direction relative to the outer tube; and a tubular balloon 26 that connects the distal end portion of the outer tube and the distal end portion of the inner tube to each other and bulges radially inward of the outer tube, the balloon projecting the distal end portion 26a of the balloon from the distal end opening 66 of the outer tube while being rewound by transmitting a pushing force from the inner tube to the balloon, and inserting the endoscope 14 into the balloon through the lumen 56 of the inner tube, wherein a linear member 28 is fixed to the distal end portion of the outer tube so as to project from the distal end surface 33 of the outer tube in the projecting direction of the balloon.

In the balloon catheter described above, the balloon may be configured to contact the linear member so as to follow the linear member when protruding from the distal end opening of the outer tube.

In the balloon catheter described above, the linear member may be fixed to the distal end surface of the outer tube at a position adjacent to the distal end opening.

In the balloon catheter described above, the length L of the linear member protruding from the distal end surface of the outer tube may be set to 0.5cm or more and 6cm or less.

In the balloon catheter described above, the linear member may have a light guiding property so that at least a protruding end portion of the linear member can emit light.

The above embodiment discloses a balloon catheter 10A to 10C having: flexible outer tubes 32a to 32 c; an inner tube disposed in an inner cavity of the outer tube so as to be movable in an axial direction with respect to the outer tube; and a tubular balloon that connects a distal end portion of the outer tube and a distal end portion of the inner tube to each other and bulges out radially inward of the outer tube, the balloon projecting the distal end portion of the balloon from a distal end opening of the outer tube while being rewound by transmitting a pushing force from the inner tube to the balloon, wherein at least the distal end portion of the outer tube is formed with lumens 82, 84, 86 through which the linear members 28a to 28c are inserted so as to be able to project from the distal end surface of the outer tube in a projecting direction of the balloon.

In the balloon catheter described above, the lumen may be formed so as to allow the linear member to be pulled out.

In the balloon catheter described above, the 1 st opening 83a located at the distal end of the lumen may be open at the distal end surface of the outer tube, and the 2 nd opening 83b located at the proximal end of the lumen may be open at the outer peripheral surface of the outer tube.

The balloon catheter may include an outer tube seat provided at a proximal end portion of the outer tube, wherein the 1 st opening 85a located at a distal end of the lumen tube opens at the distal end surface of the outer tube, and the 2 nd opening 85b located at a proximal end of the lumen tube opens at a proximal end surface of the outer tube seat.

In the balloon catheter described above, the balloon catheter may include: a slider 22 disposed on an outer peripheral surface of the outer tube so as to be movable in an axial direction relative to the outer tube; and the linear member 28c fixed to the slider, wherein a 1 st opening 87a located at a distal end of the lumen opens in the distal end surface of the outer tube, a 2 nd opening 87b located at a proximal end of the lumen opens in an outer peripheral surface of the outer tube at a distal end side of the outer tube compared to the slider, and the distal end portion of the linear member is located in the lumen by moving the slider in a proximal end direction of the outer tube.

Claims (10)

1. A balloon catheter having:

an outer tube having flexibility;

an inner tube disposed in an inner cavity of the outer tube so as to be movable in an axial direction with respect to the outer tube; and

a tubular balloon that connects a tip end portion of the outer tube and a tip end portion of the inner tube to each other and bulges out radially inward of the outer tube,

the balloon transmits a pushing force from the inner tube to the balloon, whereby a distal end portion of the balloon protrudes from a distal end opening of the outer tube while being rewound,

inserting an endoscope through the lumen of the inner tube to the inside of the balloon, the balloon catheter being characterized in that,

a linear member is fixed to a distal end portion of the outer tube so as to protrude from the distal end surface of the outer tube in a protruding direction of the balloon.

2. The balloon catheter of claim 1,

the balloon contacts the linear member along the linear member when protruding from the tip opening of the outer tube.

3. A balloon catheter according to claim 1 or 2,

the linear member is fixed at a position adjacent to the tip opening in the tip end surface of the outer tube.

4. The balloon catheter according to any one of claims 1 to 3,

the length of the linear member protruding from the distal end surface of the outer tube is set to 0.5cm to 6 cm.

5. The balloon catheter according to any one of claims 1 to 4,

the linear member has a light guiding property so that at least a protruding end portion of the linear member can emit light.

6. A balloon catheter having:

an outer tube having flexibility;

an inner tube disposed in an inner cavity of the outer tube so as to be movable in an axial direction with respect to the outer tube; and

a tubular balloon that connects a tip end portion of the outer tube and a tip end portion of the inner tube to each other and bulges out radially inward of the outer tube,

the balloon is configured to protrude from the distal end opening of the outer tube while the distal end portion of the balloon is being rewound by transmitting an insertion force from the inner tube to the balloon,

at least the distal end portion of the outer tube is formed with a lumen through which the linear member is inserted so as to be able to protrude from the distal end surface of the outer tube in the protruding direction of the balloon.

7. The balloon catheter of claim 6,

the lumen is formed in such a manner that the linear member can be pulled out.

8. The balloon catheter of claim 7,

the 1 st opening at the top end of the lumen opens at the top end face of the outer tube,

the 2 nd opening at the base end of the lumen opens on the outer peripheral surface of the outer tube.

9. The balloon catheter of claim 7,

an outer tube holder provided at a base end portion of the outer tube,

the 1 st opening at the top end of the lumen opens at the top end face of the outer tube,

the 2 nd opening located at the base end of the lumen opens at the base end surface of the outer tube base.

10. A balloon catheter according to claim 6, having:

a slider disposed on an outer peripheral surface of the outer tube so as to be movable in an axial direction with respect to the outer tube; and

the linear member fixed to the slider,

the 1 st opening at the top end of the lumen opens at the top end face of the outer tube,

the 2 nd opening at the base end of the lumen is opened at the tip end side of the outer tube than the slider in the outer peripheral surface of the outer tube,

the distal end portion of the linear member is positioned in the lumen by moving the slider in the proximal direction of the outer tube.

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