Conduit system

By incorporating a reinforced structure into the balloon catheter insertion section, the problem of easy breakage of the image guide in the insertion section during tuboendoscopic surgery was solved, the rigidity of the insertion section was improved, and the smooth progress of the surgery and the integrity of the equipment were ensured.

CN114931692BActive Publication Date: 2026-02-17TERUMO KK
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Patent Information

Application Number
CN202111196979.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2021-02-12
Filing Date
2021-10-14
Publication Date
2026-02-17
Estimated Expiration
2041-10-14

AI Technical Summary

Technical Problem

During tubal reconstruction under salpingoscopy, the balloon requires a large pushing force to push the lesion, which makes the image guide of the insertion part easy to break, and the broken part may be exposed from the outer surface of the insertion part.

Method used

A reinforcing structure is provided in the insertion part of the balloon catheter to cover the outer peripheral surface of the imaging guide. The rigidity of the insertion part is improved by adhesive or reinforcing tube to prevent excessive bending.

Benefits of technology

It effectively suppresses excessive bending of the insertion section and damage to the image guide, ensuring the smooth progress of the surgery and the integrity of the equipment.

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Abstract

The present invention provides a catheter system that can suppress the breakage of the image guide when a compressive force in the axial direction is applied to the balloon, and can also suppress the breakage portion from protruding from the outer surface of the insertion portion even if the image guide is broken. The insertion portion (80) of the endoscope (14) of the catheter system (10) has: a lens unit (84) located at the top end of the insertion portion (80); an image guide (88) that transmits the image obtained by the lens unit (84) to the base end side of the insertion portion (80); and a reinforcement structure (90) provided in such a way that it covers the outer peripheral surface of the image guide (88) in the entire circumference. The reinforcement structure (90) is provided in the portion that is in contact with the balloon (22) in the inflated state in the insertion portion (80).
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Description

TECHNICAL FIELD

[0001] The present application relates to a catheter system. BACKGROUND

[0002] A catheter system has, for example, a balloon catheter for treating a lesion (a stenosis or an occlusion) of a fallopian tube, and a scope. The balloon catheter has an outer tube that is flexible, an inner tube that is disposed in a lumen of the outer tube in a manner so as to be movable in an axial direction of the outer tube 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 expands to an inside in a radial direction of the outer tube.

[0003] In a fallopian tube forming surgery under a falloposcope, the balloon is caused to protrude from a tip end opening of the outer tube and to be inserted into a fallopian tube ostium while the tip end portion of the balloon is caused to roll back while protruding from the tip end of the outer tube in a state where the balloon in an expanded state is supported by a linear insertion portion of the falloposcope by transmitting a pushing force in a tip end direction from the inner tube to the balloon.

[0004] A configuration of a medical scope is disclosed in, for example, Patent Literature 1. The insertion portion of the scope has a lens unit (an objective lens) provided at a tip end portion of the insertion portion, and an image guide that extends along an axial direction of the insertion portion and transmits an image obtained by the lens unit to a base end side of the insertion portion.

[0005] PRIOR ART DOCUMENTS

[0006] PATENT LITERATURE

[0007] Patent Literature 1: Japanese Patent Application Laid-Open No. 2003-190077 SUMMARY

[0008] However, in the above-described fallopian tube forming surgery under a falloposcope, for a case where a lesion of a fallopian tube is completely occluded, a relatively large pushing force is sometimes required when the lesion is pushed by the balloon. In such a case, since a relatively large compression force in the axial direction is applied to the balloon, the insertion portion is sometimes excessively bent together with the balloon. As a result, there is a risk that the image guide of the insertion portion is damaged.

[0009] The present application has been made in view of such a problem, and an object thereof is to provide a catheter system that can suppress damage of an image guide when a compression force in an axial direction is applied to a balloon, and can suppress exposure of a damaged portion from an outer surface of an insertion portion even if it is assumed that the image guide is damaged.

[0010] One embodiment of the present application is a catheter system including: a balloon catheter including an outer tube that is flexible; an inner tube that is disposed in an inner lumen of the outer tube in a manner that is movable in the axial direction of the outer tube with respect to the outer tube; a balloon that is tubular and that connects a tip end portion of the outer tube and a tip end portion of the inner tube to each other and that expands to the inside in the radial direction of the outer tube; and a scope including a linear insertion portion that is inserted into an inner lumen of the balloon, wherein the tip end portion of the balloon is caused to project in the tip end direction from a tip end opening of the outer tube while being rolled back by transmitting a pushing force in the tip end direction from the inner tube to the balloon in a state in which the balloon in the expanded state is supported by the insertion portion, the insertion portion includes: a lens unit that is located at a tip end portion of the insertion portion; an image guide that extends in the axial direction of the insertion portion and that transmits an image obtained by the lens unit to the base end side of the insertion portion; and a reinforcing structure that is provided in a portion of the insertion portion that is contacted by the balloon in the expanded state, the reinforcing structure being provided in a manner that covers the outer peripheral surface of the image guide in the entire circumferential range.

[0011] Effects of the Invention

[0012] According to the present application, since the rigidity of the insertion portion (the portion of the insertion portion that is contacted by the balloon in the expanded state) can be increased by the reinforcing structure, the excessive bending of the insertion portion when a compressive force in the axial direction is applied to the balloon can be suppressed. Thus, the image guide can be prevented from being damaged. In addition, even if the image guide is damaged, the damaged portion can be prevented from being exposed from the outer surface of the insertion portion. BRIEF DESCRIPTION OF DRAWINGS

[0013] Figure 1 is a schematic configuration view of a catheter system according to one embodiment of the present application.

[0014] Figure 2 is a partial and omitted longitudinal sectional view of the catheter system of Figure 1

[0015] Figure 3 is a partial and omitted enlarged longitudinal sectional view of a tip end portion of the scope of Figure 2

[0016] Figure 4 is a cross-sectional view along the IV-IV line of Figure 3

[0017] Figure 5 is a first explanatory view of a falloposcopy fallopian tube forming surgery using the catheter system of Figure 1

[0018] Figure 6 is a second explanatory view of the falloposcopy fallopian tube forming surgery. ​​​​

[0019] Figure 7 This is the third explanatory diagram of the endoscopic fallopian tube formation procedure.

[0020] Figure 8 This is the fourth illustration of the endoscopic fallopian tube formation procedure.

[0021] Figure 9 This is the fifth illustration of the endoscopic fallopian tube formation procedure.

[0022] Figure 10 This is the sixth explanatory diagram of the endoscopic fallopian tube formation procedure.

[0023] Figure 11 This is a partial, omitted longitudinal sectional view of the tip of the insertion portion of the endoscope in the first modified example.

[0024] Figure 12 This is a partial, omitted longitudinal sectional view of the tip of the insertion portion of the endoscope in the second modified example.

[0025] Figure 13A This is a partially omitted longitudinal sectional view of the tip side of the insertion portion of the endoscope in the third modified example. Figure 13B It is along Figure 13A Explanatory diagram of the cross section view of line XIIIB-XIIIB.

[0026] Figure 14A This is a partially omitted longitudinal sectional view of the tip side of the insertion part of the endoscope in the fourth modified example. Figure 14B It is along Figure 14A Explanatory diagram of the cross section view of the XIVB-XIVB line.

[0027] Explanation of reference numerals in the attached figures

[0028] 10…catheter system

[0029] 12…balloon catheter

[0030] 14, 14A~14D… Endoscopes

[0031] 22…balloon

[0032] 24…outer tube

[0033] 54…top opening

[0034] 62…inner tube

[0035] 80, 80a~80d… Insertion section

[0036] 82…pipe components

[0037] 84…lens unit

[0038] 86…Light guide

[0039] 88 image guide

[0040] 90, 90a to 90d reinforcing structure

[0041] 96 adhesive

[0042] 98 reinforcing tube

[0043] 100 linear member DETAILED DESCRIPTION

[0044] Hereinafter, a catheter system of the present application will be described with reference to the accompanying drawings, taking a preferred embodiment.

[0045] As shown in Figure 1 , a catheter system 10 of one embodiment of the present application has a balloon catheter 12 and an endoscope 14 (salpingoscope) as a medical instrument. As shown in Figures 5 to 10 , the catheter system 10 is used, for example, in a salpingoscopy-based fallopian tube forming surgery for treating a lesion portion 204 (a stenosis portion or an occlusion portion, etc.) of a fallopian tube 202. However, the catheter system 10 can also be used in surgeries for treating lesions in biological tubes other than the fallopian tube 202, for example, surgeries for treating lesions in blood vessels, bile ducts, tracheas, esophagi, urethras, large intestines, other organs, etc.

[0046] In the following description of the catheter system 10, the left side (arrow X1 direction) in Figure 1 will be referred to as "the tip end", and the right side (arrow X2 direction) in Figure 1 will be referred to as "the base end".

[0047] As shown in Figure 1 and Figure 2 , the balloon catheter 12 has an outer catheter 16, a sliding member 18 provided to the outer catheter 16, an inner catheter 20 inserted into the outer catheter 16, and a balloon 22.

[0048] The outer catheter 16 has an outer tube 24 having a long dimension with flexibility, an outer tube hub 26 (an outer tube operation portion) provided to a base end portion of the outer tube 24, and a fixing screw 28 provided to the outer tube hub 26. The entire 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.

[0049] Figure 2In this process, the outer tube 24 includes an outer tube body 30 and a top part 32 (top piece) disposed at the top end of the outer tube body 30. Examples of materials constituting the outer tube body 30 and the top part 32 include polyolefins (polyethylene, polypropylene, polybutene, etc.), polyesters (polyethylene terephthalate, etc.), elastomer resins (polyolefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, etc.), flexible polymer materials (polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, fluoropolymers, etc.

[0050] A first inner cavity 34 is formed in the outer tube body 30, extending from the top end to the base end. The top end of the outer tube body 30 is shaped by bending into an arc shape in the axial direction. The outer tube body 30 has a substantially fixed outer diameter along its entire length.

[0051] To prevent damage to the balloon catheter 12 and biological tissues, the outer peripheral surface of the tip member 32 is curved. A balloon exit hole 52 is formed in the tip member 32 for allowing the balloon 22 to exit in the tip direction (arrow X1 direction) relative to the tip member 32. The balloon exit hole 52 communicates with the tip opening 54 of the outer tube 24.

[0052] like Figure 1 as well as Figure 2 As shown, the outer tube seat 26 is made of rigid resin or metal (stainless steel, titanium, titanium alloy, etc.). Examples of rigid resins include polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, polyetherimide, etc.

[0053] exist Figure 2 In this design, the outer tube seat 26 is hollow and sized for easy manual operation. The outer tube seat 26 includes: a first space 53 communicating with the first inner cavity 34 of the outer tube 24; a first insertion hole 55 located at the base of the first space 53 for the inner catheter 20 to pass through; and a first inlet port 56 for introducing balloon dilation fluid into the first space 53. The balloon dilation fluid is used to... Figure 2 The balloon 22 shown expands radially inward toward the outer tube 24. The balloon dilation fluid is, for example, physiological saline. A first sealing member 57 is provided at the outer tube seat 26 to prevent the balloon dilation fluid in the first space 53 from leaking to the outside through the first insertion hole 55.

[0054] The fixing screw 28 is used to fix the inner conduit 20 relative to the outer tube seat 26. The fixing screw 28 can be made of the same material as the outer tube seat 26.

[0055] The slide 18 is provided in a state in which it is movable (slidable) in the axial direction of the outer tube 24 with respect to the outer peripheral surface of the outer tube body 30. The overall length of the slide 18 is shorter than the overall length of the outer tube 24. The slide 18 has a tubular slide body 58 of a long dimension, and a slide tube seat 60 (slide operation portion) provided at the base end portion of the slide body 58. The slide body 58 and the slide tube seat 60 are each formed of the same material as the outer tube seat 26 described above. The slide tube seat 60 is formed in a ring shape to a size that is easy to be handled by a human hand.

[0056] In a state in which the slide 18 is moved to the most base end side (arrow X2 direction) with respect to the outer tube body 30 (a state in which the base end of the slide 18 is positioned at the top end of the outer tube seat 26), the top end side of the outer tube body 30 is exposed on the top end side compared with the slide 18, and is curved in a circular arc shape. In a state in which the slide 18 is moved to the most top end side (arrow X1 direction) with respect to the outer tube body 30, the top end side of the outer tube body 30 extends in a straight line in accordance with the shape of the slide body 58.

[0057] As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. Figure 1 As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. Figure 2 As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30.

[0058] As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. Figure 2 As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30.

[0059] As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30.

[0060] As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. Figure 2 As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30. Figures 5 to 10 As shown in Figs. 1 and 2, the inner tube 62 is inserted into the first inner cavity 34 of the outer tube body 30 with the slide tube seat 60 of the slide 18 interposed therebetween. The top end of the inner tube 62 is positioned on the base end side compared with the top end of the outer tube body 30.

[0061] The inner tube base 64 is made of the same material as the outer tube base 26. The inner tube base 64 is formed in a hollow shape. The inner tube base 64 is provided with a second space 68 that communicates with the second inner lumen 66 of the inner tube 62, a second insertion hole 70 that is located on the proximal end side of the second space 68 and through which the insertion portion 80 is inserted, and a second introduction port portion 72 for introducing the perfusion fluid to the second space 68. The inner tube base 64 is provided with a second sealing member 73 that prevents the perfusion fluid in the second space 68 from leaking to the outside through the second insertion hole 70.

[0062] The balloon 22 is a tubular member that connects the tip end portion of the outer tube 24 and the tip end portion of the inner tube 62 to each other. The balloon 22 is inflated to the radially inner side of the outer tube 24 by a balloon expansion fluid. In other words, the balloon 22 is formed in a manner that is elastically deformable in the radial direction.

[0063] 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.), a high molecular material having flexibility (natural rubber, ethylene-propylene-diene copolymer, polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, polyisoprene, polyester, fluororesin, or the like.

[0064] One end portion of the balloon 22 is bonded or fused to the tip end portion of the outer tube 24 (the proximal end portion of the tip end member 32). In other words, the one end portion of the balloon 22 is bonded or fused in the vicinity of the proximal end side of the balloon lead-out hole 52 in the outer tube 24. Specifically, the one end portion of the balloon 22 is sandwiched between the tip end of the outer tube main body 30 and the tip end member 32.

[0065] In addition, the other end portion of the balloon 22 is fixed to the outer peripheral surface of the tip end portion of the inner tube 62 by a balloon fixing member 74. Further, the other end portion of the balloon 22 can also be bonded or fused to the tip end portion of the inner peripheral surface of the inner tube 62. The balloon 22 has an inner lumen 76 into which the insertion portion 80 of the endoscope 14 is inserted. An outer side space Sc that is a bag-like space closed at the tip end is formed between the outer peripheral surface of the balloon 22 and the inner peripheral surface of the outer tube main body 30. The balloon fixing member 74 is formed in a circular ring shape. The balloon fixing member 74 is disposed in the first inner lumen 34 of the outer tube main body 30.

[0066] As Figure 7As shown, the balloon 22 is pushed inward by the inner tube 62, causing the tip portion 22a of the balloon 22 to roll back while protruding from the tip opening 54 of the outer tube 24 in the tip direction. At this time, the balloon 22 has a radially double-folded portion in the protruding portion 22b that protrudes in the direction of arrow X1 compared to the tip opening 54 of the outer tube 24.

[0067] Figure 2 In the middle, endoscope 14 is used to observe fallopian tube 202 (refer to...). Figure 5 The endoscope 14 is a tubal endoscope. It has a flexible, elongated insertion section 80 that is 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 in the figure, the endoscope 14 has a display unit such as a monitor and a camera control device for displaying captured images (endoscopic images) on the display unit. At the base of the insertion section 80, there is an operating section (not shown) for operating the insertion section 80. The total length of the insertion section 80 is, for example, set to approximately 2000 mm. However, the total length of the insertion section 80 can be appropriately set.

[0068] like Figure 3 as well as Figure 4 As shown, the insertion part 80 includes a tube component 82, a lens unit 84, multiple light guides 86, an image guide 88, and a reinforcing structure 90. The tube component 82 is flexible. The tube component 82 is not particularly limited, but may be made of resin materials such as polyimide, polyurethane, polyethylene, or polytetrafluoroethylene.

[0069] Lens unit 84 is disposed at the top end of tube component 82. Lens unit 84 has a circular outer peripheral surface. Lens unit 84 includes an object lens. Alternatively, lens unit 84 may include multiple lenses. The axis Ax1 of lens unit 84 is offset relative to the axis Ax2 of tube component 82 (see reference). Figure 4 One surface 92a of the lens unit 84 is located at the top of the insertion part 80.

[0070] The light guide 86 is a light guiding member that guides light from a light source (e.g., an LED) provided at the base end of the insertion portion 80 toward the top end of the insertion portion 80. In this embodiment, five light guides 86 are provided. However, the number of light guides 86 is not particularly limited, and there may be one or more (five or more).

[0071] The light guide 86 extends along the axis Ax2 of the tube component 82. The light guide 86 extends along the entire length of the tube component 82. The tip portions of each light guide 86 are arranged along the outer peripheral surface of the lens unit 84 (see reference). Figure 4The light ray guide 86 is formed, for example, by bundling a plurality of optical fibers. However, the light ray guide 86 can also be formed by one optical fiber. As the optical fiber, a plastic optical fiber composed of a core material and a cladding material made of plastic is used, for example. However, the optical fiber can also be a glass optical fiber composed of a core material and a cladding material made of glass (e.g., quartz glass).

[0072] The image guide 88 is a transmission member that guides the image obtained by the lens unit 84 toward the base end side of the insertion portion 80. The image guide 88 is coaxially arranged with the lens unit 84. That is, the axis Ax3 of the image guide 88 is offset with respect to the axis Ax2 of the tube member 82. The tip end face 94 of the image guide 88 is in contact with or close to the other face 92b of the lens unit 84. The outer diameter of the image guide 88 is smaller than the outer diameter of the lens unit 84. The image guide 88 is formed of the same optical fiber as the light ray guide 86 described above.

[0073] The reinforcing structure 90 is provided so as to cover the outer peripheral surface of the image guide 88 in the entire circumferential range. The reinforcing structure 90 is provided at the tip end side of the image guide 88, and is not provided at the base end side of the image guide 88. The reinforcing structure 90 is provided at a portion in the insertion portion 80 that is contacted by the balloon 22 in the inflated state. The entire length LI of the reinforcing structure 90 is larger than the entire length L2 of the balloon 22 in the preliminary state of the balloon catheter 12 (refer to FIG. 1). Specifically, the reinforcing structure 90 is provided only in a range of 25 cm from the tip end of the insertion portion 80. Figure 1

[0074] The reinforcing structure 90 includes a soft adhesive 96 that is filled in the inner lumen of the tube member 82. The adhesive 96 is in contact (adhered) in the entire circumferential range of the outer peripheral surface of the image guide 88. The adhesive 96 is in contact (adhered) with the inner peripheral surface of the tube member 82, the outer peripheral surface of each light ray guide 86, and the outer peripheral surface of the lens unit 84. Further, the adhesive 96 can also be such that it is not filled to the tip end side (the outer peripheral side of the lens unit 84) compared to the tip end of the image guide 88. In this case, a different type of adhesive (e.g., a hard adhesive) from the adhesive 96 is filled on the tip end side compared to the tip end of the image guide 88, and the lens unit 84 is fixed with respect to the tube member 82 by the adhesive.

[0075] ​Typically, minute irregularities are formed on the top surface 94 of the image guide 88 and the other surface 92b of the lens unit 84. Therefore, when the top surface 94 of the image guide 88 and the other surface 92b of the lens unit 84 are close together, it is preferable to sandwich an adhesive 96 between them. This fills the recesses of the top 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 interface irregularities, thereby enabling clearer endoscopic images. Alternatively, an adhesive with properties different from adhesive 96 can be sandwiched between the top surface 94 of the image guide 88 and the other surface 92b of the lens unit 84.

[0076] Examples of elastic resin materials, such as silicone, epoxy, and amide esters, can be used as constituent materials of the adhesive 96. The adhesive 96 is preferably characterized by a hardness of 30 or higher as measured by a type A hardness tester according to JIS K 6253 specifications, and a hardness of 65 or lower as measured by a type D hardness tester according to JIS K 6253 specifications. In this case, appropriate flexibility can be maintained at the tip of the insertion portion 80.

[0077] Next, the endoscopic tubal formation procedure using the catheter system 10 constructed in this manner will be described.

[0078] In the salpingoscopic tubal reconstruction procedure, the aforementioned catheter system 10 is prepared during the preparation phase. During this preparation phase, the user secures the inner tube 62 with the fixing screw 28 while it is fully pulled to the base side (arrow X2 direction). Furthermore, the sliding member 18 is set to the initial position. Thus, the tip of the outer tube body 30 extends straight through the sliding member body 58.

[0079] Next, during the insertion procedure, the user inserts the balloon catheter 12 through the cervical canal to the fundus of the uterus 200. And, as... Figure 5 As shown, during the sliding process, the sliding member 18 is pulled back relative to the outer tube 24 towards the base end of the outer tube 24. As a result, the top end of the outer tube body 30 protrudes from the sliding member 18 and becomes curved. At this time, the user confirms the endoscopic image by positioning the top end of the insertion part 80 of the endoscope 14 at the top opening 54 of the outer tube 24, while simultaneously positioning the top opening 54 of the outer tube 24 near the oviduct orifice 202a.

[0080] Then, the balloon extraction procedure is performed. Specifically, in the balloon extraction procedure, such as... Figure 6As shown, the balloon expansion fluid is supplied to the first introduction port portion 56 (pressurization process). Then, the balloon expansion fluid is supplied from the first introduction port portion 56 to the outer space Sc of the balloon 22 via the outer chamber Sa. Thus, the balloon 22 is elastically deformed by the balloon expansion fluid supplied to the outer space Sc to be pushed to the radially inner side. That is, the portion of the balloon 22 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 22 located on the tip side of the tip end of the insertion portion 80 are in contact with each other at the inner surfaces.

[0081] Then, the user advances the inner tube 62 relative to the outer tube 24 while loosening the fixing screw 28 (advancement process). Then, as shown in FIG. 6, the balloon 22 pushed by the inner tube 62 to the tip end direction advances relative to the outer tube 24 together with the insertion portion 80. That is, the balloon 22 is protruded from the tip end opening 54 of the outer tube 24 to the tip end direction (arrow X1 direction) by the transmission of the pushing force from the inner tube 62 to the balloon 22. Figure 7

[0082] In the advancement process, the one end portion of the balloon 22 is fixed to the tip end portion of the outer tube 24, whereby the balloon 22 advances while winding back the tip end portion 22a (protruding end portion). That is, the balloon 22 is wound back in such a manner that the inner surfaces face the outer side at the tip end portion 22a (protruding end portion). Thus, the balloon 22 advances a distance equivalent to half the advancement distance of the insertion portion 80.

[0083] Next, the user determines whether the balloon 22 has reached the lesion portion 204 based on the endoscope image. In the case where the balloon 22 is located near the lesion portion 204, the balloon expansion fluid is depressurized, and the perfusion fluid is supplied to the second introduction port portion 72 (depressurization process). Thus, the perfusion fluid flows to between the balloon 22 and the insertion portion 80 of the endoscope 14 via the inner chamber Sb. Next, as shown in FIG. 8, the user retreats the endoscope 14 by a predetermined distance (retreat process). Then, the above-mentioned pressurization process and advancement process are performed again. Figure 8

[0084] As shown in FIG. 7, in the advancement process, if the tip end portion 22a of the balloon 22 contacts the lesion portion 204, the user applies a relatively large compression force in the axial direction to the balloon 22 when pushing the inner tube 62 to the tip end direction. Such a compression force easily becomes large in the case where the lesion portion 204 is completely blocked. Figure 9

[0085] ​​​However, since the reinforcing structure 90 (the adhesive 96) is provided so as to cover the outer peripheral surface of the image guide 88 over the entire circumference, the rigidity of the tip end side of the insertion portion 80 is improved compared to a case where the reinforcing structure 90 is not provided. Therefore, when a compressive stress in the axial direction is applied to the balloon 22, excessive bending of the tip end side of the insertion portion 80 is suppressed. Thus, the image guide 88 can be prevented from being damaged.

[0086] Then, as shown in FIG. 8, if the balloon 22 has passed through the lesion portion 204, the lesion portion 204 is expanded by the balloon 22. That is, the narrowing or obstruction of the oviduct 202 is improved. Figure 10

[0087] After the lesion portion 204 is expanded, the user pulls out the balloon catheter 12 and the endoscope 14 after reducing the pressure of the balloon expansion fluid (pull-out process). In addition, before the balloon catheter 12 is pulled out, the perfusion fluid can be injected through the second introduction port portion 72, and the balloon 22 can be retracted by pulling the inner tube 62 while the endoscope 14 is operated so as to be positioned at the tip end portion 22a of the balloon 22. Thus, the balloon catheter 12 can be pulled out while the inside of the oviduct 202 is observed at the pull-out process. Thus, the oviduct formation under the endoscope is completed.

[0088] The present embodiment has the following effects.

[0089] According to the present embodiment, the rigidity of the insertion portion 80 (the portion of the insertion portion 80 that is contacted by the balloon 22 in the expanded state) can be improved by the reinforcing structure 90, and thus excessive bending of the insertion portion 80 when a compressive force in the axial direction is applied to the balloon 22 can be suppressed. Thus, the image guide 88 can be prevented from being damaged. In addition, even if the image guide 88 is damaged, the damaged portion can be prevented from damaging the tube member 82 and being exposed from the outer surface of the insertion portion 80.

[0090] The reinforcing structure 90 is provided at the tip end side of the image guide 88, and is not provided at the base end side of the image guide 88.

[0091] According to such a configuration, the insertion portion 80 can be easily manufactured compared to a case where the reinforcing structure 90 is provided over the entire length of the image guide 88. Thus, the manufacturing cost of the endoscope 14 (the catheter system 10) can be suppressed.

[0092] The entire length of the reinforcing structure 90 is greater than the entire length of the balloon 22 in the preliminary state of the balloon catheter 12.

[0093] According to such a configuration, the rigidity of the portion of the insertion portion 80 that is contacted by the balloon 22 in the expanded state (the portion that is pressurized by the balloon 22) can be effectively improved.

[0094] ​The insertion portion 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 fills the outer periphery of the image guide 88 into the cavity of the tube member 82.

[0095] Based on this configuration, the insertion part 80 with the reinforcing structure 90 can be easily manufactured.

[0096] Adhesive 96 contacts the outer peripheral surface of image guide 88 and the inner peripheral surface of tube component 82.

[0097] With this configuration, the rigidity of the tip side of the insertion portion 80 can be effectively improved by the adhesive 96. Furthermore, the image guide 88 can be fixed relative to the tube component 82 by the adhesive 96.

[0098] The insertion part 80 has a light guide 86 for guiding light from the base end side of the insertion part 80 to the tip end of the insertion part 80.

[0099] With this configuration, the rigidity of the insertion part 80 can be improved by the light guide 86.

[0100] (First variation)

[0101] Next, while referring to Figure 11 The endoscope 14A of the first modified example will be described. Furthermore, in the endoscope 14A of this modified example, the same reference numerals are used for components identical to those of the endoscope 14 described above, and their descriptions are omitted. The same applies to the endoscopes 14B to 14D of the second to fourth modified examples described later.

[0102] like Figure 11 As shown, the insertion portion 80a of the endoscope 14A includes a tube component 82, a lens unit 84, multiple light guides 86, an image guide 88, and a reinforcing structure 90a. The reinforcing structure 90a is provided such that it covers the entire circumference of the outer peripheral surface of the image guide 88. The reinforcing structure 90a is provided on the top end side of the image guide 88, but not on the base end side. The reinforcing structure 90a is provided in the portion of the insertion portion 80a that contacts the balloon 22 in its inflated state. The total length of the reinforcing structure 90a is greater than the total length L2 of the balloon 22 in its early state (see reference). Figure 1 Specifically, the reinforcing structure 90a is only provided within a range of 25cm from the top of the insertion part 80a.

[0103] 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 composed of a high molecular material having flexibility. Specifically, the reinforcing tube 98 is, for example, preferably polycarbonate, propylene resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, or the like. In addition, the reinforcing tube 98 can also be composed 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 a resin having flexibility (natural rubber, ethylene-propylene copolymer, polytetrafluoroethylene, ethylene-vinyl acetate copolymer, silicone rubber, soft polyvinyl chloride, polyurethane, polyisoprene, polyimide, polyamide, or the like).

[0104] The inner peripheral surface of the reinforcing tube 98 is in contact with the outer peripheral surface of the image guide 88. There is a space on the outer peripheral side of the reinforcing tube 98. That is, the reinforcing tube 98 is separated from the inner peripheral surface of the tube member 82 and is also separated from each light guide 86. The tip end of the reinforcing tube 98 extends to the position of the tip end of the image guide 88.

[0105] In such a scope 14A, the same effects as the scope 14 described above are exerted with respect to the same configuration. In addition, the present modification example exerts the following effects.

[0106] The reinforcing structure 90a includes a reinforcing tube 98 that covers the outer peripheral surface of the image guide 88.

[0107] According to such a configuration, the excessive bending of the image guide 88 can be effectively suppressed by the reinforcing tube 98.

[0108] The reinforcing tube 98 is composed of a resin material having flexibility.

[0109] According to such a configuration, the tip end side of the insertion portion 80a can be moderately flexed. Thus, the insertion portion 80 and the balloon 22 can be smoothly advanced along the shape of the oviduct 202.

[0110] The present modification example is not limited to the above-described configuration. The configuration of the reinforcing structure 90a can also include the reinforcing tube 98 and the above-described adhesive 96. In this case, the adhesive 96 is filled into the outer peripheral side of the reinforcing tube 98 in the inner cavity of the tube member 82.

[0111] (2nd Modification Example)

[0112] Next, the scope 14B of the 2nd modification example will be described with reference to Figure 12 Figure 12 ​As shown, the insertion portion 80b of the endoscope 14B has 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 in a manner to cover the outer peripheral surface of the image guide 88 over the entire circumference. The reinforcing structure 90b is provided at the tip end side of the image guide 88, and is not provided at the base end side of the image guide 88. The reinforcing structure 90b is provided at a portion of the insertion portion 80b that is contacted by the balloon 22 in the inflated state. The entire length of the reinforcing structure 90b is greater than the entire length L2 of the balloon 22 in the preliminary state of the balloon catheter 12 (refer to FIG. 2). Figure 1 Specifically, the reinforcing structure 90b is provided only in a range of 25 cm from the tip end of the insertion portion 80b.

[0113] The reinforcing structure 90b includes a wire member 100 provided in a manner to wrap the outer peripheral surface of the image guide 88 in a spiral shape. That is, the reinforcing structure 90b is formed in a coil shape. The wire member 100 is formed in a solid shape. However, the wire member 100 can also be formed in a hollow shape.

[0114] The wire member 100 is constituted of a metal material. Specifically, it is preferable that the wire member 100 is constituted of, for example, various metal materials such as stainless steel, super-elastic alloy (nickel-titanium alloy, nickel-aluminum alloy, copper-zinc alloy, etc.), and a material in which a resin material is coated on the outer surface of the metal material. However, the wire member 100 can also be constituted of a resin material having relatively high rigidity or the like.

[0115] The wire member 100 is in contact with the outer peripheral surface of the image guide 88. There is a space between the wire member 100 and the inner peripheral surface of the tube member 82. Further, a space is formed between the wire member 100 and the light guides 86. The wire member 100 extends up to the position of the tip end of the image guide 88. The pitch of the coil of the reinforcing structure 90b can be appropriately set. The reinforcing structure 90b can be formed by spirally winding one wire member 100, or can be formed by spirally winding two or more wire members 100.

[0116] In such an endoscope 14B, as for the same constitution as the above-described endoscope 14, the same effects are exerted. Further, the present modification example exerts the following effects.

[0117] The reinforcing structure 90b includes a wire member 100 provided in a manner to wrap the outer peripheral surface of the image guide 88 in a spiral shape.

[0118] According to such a constitution, it is possible to effectively suppress excessive bending of the tip end side of the insertion portion 80b by the wire member 100. Further, it is possible to moderately flex the tip end side of the insertion portion 80b.

[0119] The wire member 100 is constituted of a metal material.

[0120] According to such a configuration, the tip end side of the insertion portion 80b can be moderately flexed, and excessive bending of the image guide 88 can be further effectively suppressed.

[0121] The present modification is not limited to the above-described configuration. The reinforcing structure 90b can be formed of the linear member 100 and the above-described adhesive 96. Alternatively, the reinforcing structure 90b can be formed of the linear member 100, the adhesive 96, and the reinforcing tube 98. In this case, the linear member 100 is provided so as to wrap the outer peripheral surface of the reinforcing tube 98 in a spiral shape.

[0122] (Third Modification)

[0123] Next, the endoscope 14C of the third modification will be described with reference to Figure 13A and Figure 13B As shown in Figure 13A and Figure 13B , the insertion portion 80c of the endoscope 14C has a tube member 82, a lens unit 84, a plurality of (six in the present modification) light guides 86, an image guide 88, and a reinforcing structure 90c. The image guide 88 and the lens unit 84 are coaxially provided with respect to the tube member 82.

[0124] The reinforcing structure 90c is provided so as to cover the outer peripheral surface of the image guide 88 over the entire circumference. The reinforcing structure 90c is provided at the tip end side of the image guide 88, and is not provided at the base end side of the image guide 88. The reinforcing structure 90c is provided at a portion of the insertion portion 80c that is contacted by the balloon 22 in the inflated state. The entire length of the reinforcing structure 90c is greater than the entire length L2 of the balloon 22 in the preliminary state of the balloon catheter 12 (refer to Figure 1 ). Specifically, the reinforcing structure 90c is provided only in a range of 25 cm from the tip end of the insertion portion 80c.

[0125] The reinforcing structure 90c is formed by winding the tip end side of the plurality of light guides 86 around the outer peripheral surface of the image guide 88. That is, the reinforcing structure 90c is formed in a coil shape. In other words, the reinforcing structure 90c is formed like a plurality of winding coils (six winding coils). The base end side of each light guide 86 extends along the axial direction of the image guide 88, and the reinforcing structure 90c is not formed. That is, the light guides 86 are not wound at the base end side of the image guide 88. Thus, compared to a case where the light guides 86 are wound over the entire length of the image guide 88, the insertion portion 80c is easily manufactured.

[0126] In the reinforcement structure 90c, each light ray guide 86 is in contact with the inner peripheral surface of the tube member 82 in a state of being separated from the outer peripheral surface of the image guide 88. However, in the reinforcement structure 90c, each light ray guide 86 can also be in contact with the outer peripheral surface of the image guide 88 and can also be separated from the inner peripheral surface of the tube member 82. The tip end portion of each light ray guide 86 is located on the outer peripheral side of the lens unit 84. The tip end portions of the plurality of light ray guides 86 are provided at equal intervals in the circumferential direction of the lens unit 84.

[0127] In such a borescope 14C, the same effects as the above-described borescope 14 are exerted with respect to the same configuration. In addition, the present modification example exerts the following effects.

[0128] The reinforcement structure 90c is formed by winding the light ray guides 86 around the outer peripheral surface of the image guide 88.

[0129] According to such a configuration, the reinforcement structure 90c can be formed by the light ray guides 86, and thus, compared to a case where the reinforcement structure 90c is formed by components different from the light ray guides 86, it is possible to reduce the number of components.

[0130] The light ray guide 86 is an optical fiber made of plastic.

[0131] According to such a configuration, it is possible to easily wind the light ray guides 86 around the outer peripheral surface of the image guide 88.

[0132] The present modification example is not limited to the above-described configuration. The reinforcement structure 90c can also be formed further including the above-described adhesive 96. In addition, the reinforcement structure 90c can also be formed further including the adhesive 96 and the reinforcing tube 98. In this case, the plurality of light ray guides 86 are provided in a manner of being wound in a spiral shape around the outer peripheral surface of the reinforcing tube 98. In the present modification example, the number of light ray guides 86 can be one or more (six or more).

[0133] (4th Modification Example)

[0134] Next, the borescope 14D of the 4th modification example will be described with reference to Figure 14A and Figure 14B As shown in Figure 14A and Figure 14B The insertion portion 80d of the borescope 14D has a tube member 82, a lens unit 84, a plurality of (ten in the present modification example) light ray guides 86, an image guide 88, and a reinforcement structure 90d. The image guide 88 and the lens unit 84 are coaxially provided with respect to the tube member 82. Each light ray guide 86 extends along the axis Ax3 of the image guide 88. The reinforcement structure 90d is provided over the entire length of the image guide 88. The entire length of the reinforcement structure 90d is greater than the entire length L2 of the balloon 22 in the preliminary state of the balloon catheter 12 (refer to FIG. 1).Figure 1 ).

[0135] The reinforcing structure 90d is formed by the plurality of light guiding members 86 being arranged one round in the circumferential direction of the image guiding member 88. In other words, the plurality of light guiding members 86 cover the outer circumferential surface of the image guiding member 88 in the full circumferential range.

[0136] In such a borescope 14D, the same effects as the above-described borescope 14, 14A to 14C are exerted with respect to the same configuration. In addition, the present modification example exerts the following effects.

[0137] The light guiding members 86 are provided in a plurality in a state of extending in the axial direction of the image guiding member 88. The reinforcing structure 90d is formed by the plurality of light guiding members 86 being arranged one round in the circumferential direction of the image guiding member 88.

[0138] According to such a configuration, since the reinforcing structure 90d can be formed by the light guiding members 86, compared with a case where the reinforcing structure 90d is formed by members different from the light guiding members 86, reduction in the number of parts can be sought.

[0139] The present modification example is not limited to the above-described configuration. The reinforcing structure 90d can also be formed further including the above-described adhesive 96. In addition, the reinforcing structure 90d can also be formed further including the adhesive 96 and the reinforcing tube 98. Furthermore, the reinforcing structure 90d can also be formed further including the adhesive 96, the linear member 100, and the reinforcing tube 98. In the present modification example, the number of the light guiding members 86 is not limited to ten.

[0140] The present application is not limited to the above-described embodiments, and various changes can be made within the scope of the gist of the present application.

[0141] If the above-described embodiments are summarized, the following is obtained.

[0142] The above-described embodiment discloses a catheter system 10 having: a balloon catheter 12 having: a flexible outer tube 24; an inner tube 62 disposed in a lumen 34 of the outer tube in a manner movable in the axial direction of the outer tube with respect to the outer tube; a tubular balloon 22 connecting the tip end portions of the outer tube and the inner tube to each other and expanding to the radially inner side of the outer tube; and a scope 14, 14A to 14D having a linear insertion portion 80, 80a to 80d inserted into a lumen 76 of the balloon, wherein the balloon is caused to project the tip end portion 22a thereof from a tip end opening 54 of the outer tube in the tip end direction while being rolled back by transmitting a pushing force in the tip end direction from the inner tube to the balloon in a state where the balloon in the expanded state is supported by the insertion portion, the insertion portion has: a lens unit 84 at the tip end portion of the insertion portion; an image guide 88 extending in the axial direction of the insertion portion and transmitting an image obtained by the lens unit to the base end side of the insertion portion; and a reinforcing structure 90, 90a to 90d provided in a manner covering the outer peripheral surface of the image guide in the entire circumferential range, the reinforcing structure being provided at a portion of the insertion portion contacted by the balloon in the expanded state.

[0143] In the above-described catheter system, the reinforcing structure can be provided at the tip end side of the image guide and not provided at the base end side of the image guide.

[0144] In the above-described catheter system, the entire length LI of the reinforcing structure can be greater than the entire length L2 of the balloon in the preliminary state of the balloon catheter.

[0145] In the above-described catheter system, the insertion portion can have a tube member 82 covering the lens unit and the image guide, and the reinforcing structure can include an adhesive 96 filling the outer peripheral side of the image guide in the lumen of the tube member.

[0146] In the above-described catheter system, the adhesive can be in contact with the outer peripheral surface of the image guide and the inner peripheral surface of the tube member.

[0147] In the above-described catheter system, the reinforcing structure can include a reinforcing tube 98 covering the outer peripheral surface of the image guide.

[0148] In the above-described catheter system, the reinforcing tube can be composed of a high molecular material having flexibility.

[0149] In the above-described catheter system, the reinforcing structure can include a linear member 100 provided in a manner winding the outer peripheral surface of the image guide in a spiral shape.

[0150] In the catheter system described above, the linear member can be configured of a metal material.

[0151] In the catheter system described above, the insertion portion can have a light guide 86 for guiding light from the proximal end side of the insertion portion toward the distal end of the insertion portion.

[0152] In the catheter system described above, the reinforcing structure can be formed by winding the light guide around the outer peripheral surface of the image guide.

[0153] In the catheter system described above, the light guide can be an optical fiber made of plastic.

[0154] In the catheter system described above, a plurality of light guides can be provided in a state of extending along the axial direction of the image guide, and the reinforcing structure can be formed by arranging the plurality of light guides in a manner of winding around the image guide in the circumferential direction.

Claims

1. A catheter system having: a balloon catheter having a flexible outer tube, an inner tube disposed in an inner lumen of the outer tube in a manner capable of moving in the axial direction of the outer tube, a tubular balloon connecting a tip portion of the outer tube and a tip portion of the inner tube to each other and expanding to the radially inner side of the outer tube, and an endoscope having a linear insertion portion inserted into an inner lumen of the balloon, the catheter system being characterized in that: the balloon is caused to project from the tip opening of the outer tube in the tip direction while rolling back the tip portion thereof by transmitting a pushing force in the tip direction from the inner tube to the balloon in a state in which the balloon in the expanded state is supported by the insertion portion, the insertion portion has: a lens unit at a tip portion thereof, an image guide extending in the axial direction of the insertion portion and transmitting an image obtained by the lens unit to the base end side of the insertion portion, and a reinforcing structure provided in a manner covering the outer peripheral surface of the image guide in the entire circumferential range, and the reinforcing structure is provided at a portion of the insertion portion contacted by the balloon in the expanded state.

2. The catheter system according to claim 1, characterized in that: the reinforcing structure is provided at the tip side of the image guide and is not provided at the base end side of the image guide.

3. The catheter system according to claim 1 or 2, characterized in that: the entire length of the reinforcing structure is greater than the entire length of the balloon in the preliminary state of the balloon catheter.

4. The catheter system according to claim 1 or 2, characterized in that: the insertion portion has a tube member covering the lens unit and the image guide, and the reinforcing structure includes an adhesive filled into the outer peripheral side of the image guide in the inner lumen of the tube member.

5. The catheter system according to claim 4, characterized in that: the adhesive is in contact with the outer peripheral surface of the image guide and the inner peripheral surface of the tube member.

6. The catheter system according to claim 1 or 2, characterized in that: the reinforcing structure includes a reinforcing tube covering the outer peripheral surface of the image guide.

7. The catheter system according to claim 6, characterized in that: the reinforcing tube is composed of a high molecular material having flexibility.

8. The catheter system according to claim 1 or 2, characterized in that: the reinforcing structure includes a linear member provided in a manner winding the outer peripheral surface of the image guide in a spiral shape.

9. The catheter system according to claim 8, characterized in that: the linear member is composed of a metal material.

10. The catheter system according to claim 1 or 2, characterized in that: the insertion portion has a light ray guide for guiding light from the base end side of the insertion portion to the tip thereof.

11. The catheter system according to claim 10, characterized in that: the reinforcing structure is formed by winding the light ray guide around the outer peripheral surface of the image guide.

12. The catheter system according to claim 11, characterized in that: the light ray guide is an optical fiber made of plastic. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 13. The catheter system according to claim 10, wherein the light guide is provided with a plurality of, the light guides are provided in a state of extending in the axial direction of the image guide, the reinforcing structure is formed by being configured in such a manner that the plurality of light guides are disposed so as to make one round in the circumferential direction of the image guide.

Citation Information

Patent Citations

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