Catheter System
The catheter system addresses the challenge of inefficient balloon insertion in fallopian tubes by using a protrusion and slider mechanism for precise positioning, enhancing visibility and safety during insertion.
Patent Information
- Application Number
- JP2021026186
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-02-22
- Publication Date
- 2025-02-05
- Estimated Expiration
- 2041-02-22
AI Technical Summary
The existing catheter systems face challenges in efficiently inserting balloons into fallopian tubes due to the narrower and shorter focal length of fallopian tube mirrors, resulting in darker imaging and difficulty in locating the fallopian tube entrance, which can lead to inefficient balloon insertion.
A catheter system with a balloon catheter and endoscope that includes a protrusion on the outer tube tip, allowing for easy identification of the fallopian tube entrance through endoscopic imaging, and a slider mechanism to maintain the outer tube in a linear shape for precise insertion.
The system enables efficient and accurate insertion of balloons into fallopian tubes by clearly distinguishing the tube entrance from concavities in endoscopic images, reducing the risk of damage to uterine tissue and improving the visibility of the protrusion during insertion.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present invention relates to a catheter system. [Background technology]
[0002] For example, Patent Document 1 discloses a catheter system including a balloon catheter for treating diseased parts (stenosis or obstruction) of fallopian tubes and a fallopian tube scope (endoscope). The balloon catheter includes a flexible outer tube, an inner tube disposed in the lumen of the outer tube so as to be movable in the axial direction of the outer tube relative to the outer tube, and a tubular balloon that connects the tip end of the outer tube with the tip end of the inner tube and expands radially inward of the outer tube.
[0003] In fallopianoscope fallopian tube plastic surgery, the balloon is supported in an inflated state by the linear insertion portion of the fallopianoscope, and a pushing force toward the tip is transmitted from the inner tube to the balloon, causing the tip of the balloon to roll back and protrude from the tip opening of the outer tube and be inserted into the fallopian tube orifice. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Patent No. 3921108 Summary of the Invention [Problem to be solved by the invention]
[0005] However, the fallopian tube scope inserted inside the balloon has a narrower field of view and a shorter focal length than the hysteroscope for observing the inside of the uterus. Also, the image captured by the fallopian tube scope is darker and of lower quality than the image captured by the hysteroscope. Therefore, it is difficult for the user to find the fallopian tube opening based on the image captured by the fallopian tube scope, and the user may not be able to efficiently insert the balloon into the fallopian tube opening (biological tube opening).
[0006] The present invention has been made in consideration of the above problems, and an object of the present invention is to provide a catheter system that can efficiently insert a balloon into the opening of a biological vessel. [Means for solving the problem]
[0007] One aspect of the present invention is , possible a balloon catheter having a tubular balloon that connects a distal end of the outer tube with a distal end of the inner tube and expands radially inward of the outer tube; and an endoscope having a linear insertion portion that is inserted into the inner cavity of the balloon, wherein a pushing force in the distal direction is transmitted from the inner tube to the balloon, causing the distal end of the balloon to turn over and protrude in the distal direction from a distal opening of the outer tube, and the outer tube comprises a tubular outer tube main body, an outer tube distal end portion provided at the distal end of the outer tube main body and having the distal opening formed therein, and a protrusion protruding in the distal direction from the outer tube distal end portion. the protrusion portion is integrally molded with a tip portion of the outer tube and is provided with a slider that is movable along the axial direction of the outer tube relative to the outer peripheral surface of the outer tube and that holds the outer tube in a straight shape, the tip portion of the outer tube body is exposed from the slider when the slider is moved in a base end direction relative to the outer tube and is curved in an arc shape in the axial direction, the slider has a tubular slider body and a cover portion that protrudes from the tip portion of the slider body toward the tip direction, and the cover portion is located on the opposite side of the protrusion portion with respect to the tip opening and faces the protrusion portion in an initial state of the slider when the slider is moved furthest in the tip direction relative to the outer tube. Effect of the Invention
[0008] According to the present invention, by inserting the protrusion into the insertion target portion of the balloon and checking the appearance of the protrusion in an image captured by an endoscope (endoscopic image), it is possible to easily distinguish whether the insertion target portion is a biological canal orifice or a simple recess. This allows the user to easily find the biological canal orifice (e.g., the fallopian tube orifice) based on the endoscopic image. Furthermore, by inserting the protrusion into the biological canal orifice, the distal end opening of the outer tube can be positioned relative to the biological canal orifice. Therefore, the balloon can be efficiently inserted into the biological canal orifice. [Brief description of the drawings]
[0009] [Figure 1] 1 is a schematic configuration diagram of a catheter system according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a longitudinal sectional view of the catheter system of FIG. 1, with a portion thereof omitted. [Diagram 3] 3 is an enlarged longitudinal sectional view of the outer tube of FIG. 2, with a portion omitted. [Figure 4] 4 is a front view of the tip opening of the outer tube of FIG. 3. FIG. [Diagram 5] 5A is a perspective view of the tip end side of the balloon catheter in FIG. 2, and FIG. 5B is a plan view of the tip end side of the balloon catheter in FIG. 5A as viewed from the cover portion side. [Figure 6] 10 is an explanatory diagram showing the angle formed between the tip surface of the endoscope and a protrusion portion. FIG. [Figure 7] FIG. 2 is a first explanatory diagram of salpingoscopic salpingoplasty using the balloon catheter of FIG. 1. [Figure 8] FIG. 2 is a second explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 9] FIG. 3 is a third explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 10] FIG. 4 is a fourth explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 11] FIG. 5 is a fifth explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 12] FIG. 6 is a sixth explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 13] FIG. 7 is a seventh explanatory diagram of the fallopianoscopic salpingoplasty. [Figure 14] FIG. 14A is a perspective view of the tip end of a balloon catheter according to a first modified example, and FIG. 14B is a plan view of the tip end of the balloon catheter in FIG. 14A as viewed from the cover portion side. [Figure 15] FIG. 15A is a perspective view of the tip end of a balloon catheter according to a second modified example, and FIG. 15B is a plan view of the tip end of the balloon catheter in FIG. 15A as viewed from the cover portion side. [Figure 16] FIG. 13 is a perspective view of the distal end side of a balloon catheter according to a third modified example. [Figure 17] FIG. 17A is an explanatory oblique view showing the state in which the protruding end of the protrusion is inserted into the tip opening of the balloon catheter of FIG. 16, and FIG. 17B is an explanatory cross-sectional view showing the operation of exposing the protruding end of the protrusion from the tip opening toward the tip. [Figure 18] FIG. 18A is a perspective view of the tip end of a balloon catheter according to a fourth modified example, and FIG. 18B is an explanatory diagram showing the angle formed between the tip face of an endoscope and a protrusion in the balloon catheter of FIG. 18A. [Figure 19] FIG. 13 is a perspective view of the distal end side of a balloon catheter according to a fifth modified example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0010] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A catheter system according to a preferred embodiment of the present invention will be described below with reference to the accompanying drawings.
[0011] As shown in Fig. 1, a catheter system 10 according to an embodiment of the present invention includes a balloon catheter 12 and an endoscope 14 (falling tube scope) which is a medical device. As shown in Figs. 7 to 13, the catheter system 10 is used, for example, in fallopian tube endoscopic salpingoplasty for treating a lesion 204 (such as a stenosis or obstruction) in a fallopian tube 202. However, the catheter system 10 may also be used to treat a lesion in a biological tube other than the fallopian tube 202, such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra, a large intestine, or another organ.
[0012] In the following description of the catheter system 10, the left side in FIG. 1 (the direction of the arrow X1) is referred to as the "distal end," and the right side in FIG. 1 (the direction of the arrow X2) is referred to as the "proximal end."
[0013] As shown in FIGS. 1 and 2, the balloon catheter 12 includes an outer catheter 16, a slider 18 provided on the outer catheter 16, an inner catheter 20 inserted into the outer catheter 16, and a balloon 22.
[0014] The outer catheter 16 has a long, flexible outer tube 24, an outer tube hub 26 (outer tube operating portion) provided at the base end of the outer tube 24, and a fixing screw 28 provided on the outer tube hub 26. The overall length of the outer tube 24 is preferably set to be 100 mm or more and 1500 mm or less, and more preferably set to be 200 mm or more and 1000 mm or less.
[0015] 2, the outer tube 24 includes an outer tube main body 30 and a tip member 32 (tip tip) provided at the tip of the outer tube main body 30. Examples of materials constituting the outer tube main body 30 and the tip member 32 include polyolefin (e.g., polyethylene, polypropylene, polybutene, etc.), polyester (e.g., polyethylene terephthalate, etc.), elastomer resin (e.g., polyolefin elastomer, polyester elastomer, polyamide elastomer, fluororesin elastomer, polyurethane elastomer, etc.), flexible polymeric material (polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, etc. The outer tube main body 30 and the tip member 32 may be integrally molded.
[0016] A first lumen 34 is formed in the outer tube body 30, penetrating from the tip to the base end. The tip of the outer tube body 30 is shaped so as to be curved in an arc in the axial direction. The outer tube body 30 has a generally constant outer diameter over its entire length.
[0017] 2 to 4, the tip member 32 has an outer pipe tip portion 38 provided at the tip of the outer pipe main body 30 and having a tip opening 36 formed therein, and a protrusion 40 protruding in the tip direction from the outer pipe tip portion 38. The tip member 32 is an integrally molded product. In other words, the protrusion 40 is integrally molded with the outer pipe tip portion 38.
[0018] The outer peripheral surface of the outer tube tip portion 38 is curved to prevent damage to living tissue. A balloon lead-out hole 42 is formed in the outer tube tip portion 38 to lead out the balloon 22 in the distal direction (arrow X1 direction) from the outer tube tip portion 38.
[0019] The balloon outlet hole 42 includes a first hole 44 that is connected to the first lumen 34 (a lumen 94 described later) and extends linearly, and a second hole 46 that is connected to the first hole 44 and extends linearly. Each of the first hole 44 and the second hole 46 has a circular cross section. The diameter of the first hole 44 is the same as the diameter of the second hole 46. The extension direction of the second hole 46 is inclined with respect to the extension direction of the first hole 44. The second hole 46 is connected to the tip opening 36 of the outer tube 24. The wall portion located on the outer periphery of the tip opening 36 has a semicircular cross section. That is, the tip surface 48 of the outer tube tip portion 38 has a cross section curved in an arc shape. The tip opening 36 faces in a direction intersecting with the first center line La of the first hole 44.
[0020] A circular opening communication portion 50 is provided at the boundary between the distal opening 36 and the second hole 46. As shown in Fig. 4, the outer tube distal end portion 38 includes a first region 52 located distally of a tangent line Lc passing through a point (base end point P1) located most proximally (in the direction of arrow X2) on the outer periphery of the opening communication portion 50, and a second region 54 located proximally of the tangent line Lc, when viewed from the extension direction of the second center line Lb of the distal opening 36 (when viewed from the front of the distal opening 36). The thickness of the first region 52 is thicker than the thickness of the second region 54 (see Figs. 2 and 3).
[0021] In Figs. 2 to 4, the protrusion 40 protrudes from the first region 52 of the outer tube distal end 38 in the distal direction. Specifically, the protrusion 40 is located on the opposite side of the base end point P1 with respect to the second center line Lb. In Fig. 3, the protrusion length L1 of the protrusion 40 (the distance from the distal end surface 48 of the outer tube distal end 38 to the protruding end of the protrusion 40) is set to 1.5 mm or more and 60 mm or less. The protrusion length L1 of the protrusion 40 is preferably set in the range of 2 mm or more and 7 mm or less. The protrusion 40 has flexibility. That is, the protrusion 40 is formed so as to bend when it comes into contact with the inner surface of the fallopian tube 202 or the uterus. The protrusion 40 may be made of the same material as the material of the outer tube main body 30 described above.
[0022] The protrusion 40 is formed to be narrow and thin in the protruding direction of the protrusion 40. The protrusion 40 includes a flat protrusion inner surface 56 on the side where the tip opening 36 is located, and a curved protrusion outer surface 60 located on the opposite side to the protrusion inner surface 56.
[0023] The base end of the protrusion outer surface 56 is connected to the tip surface 48 of the outer tube tip portion 38. The base end of the protrusion outer surface 60 is connected to the outer peripheral surface of the outer tube tip portion 38. The base end of the protrusion outer surface 60 is located in the base end direction (in the direction of arrow X2) from the base end of the protrusion inner surface 56. The width of the base end of the protrusion outer surface 60 (the widest part of the protrusion 40) is greater than the diameter of the tip opening 36. The tip of the protrusion outer surface 60 is the protruding end of the protrusion 40 and is located in the tip direction from the tip of the protrusion inner surface 56.
[0024] 1 and 2, the outer tube hub 26 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.). Examples of hard resin include polycarbonate, acrylic resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, etc.
[0025] In FIG. 2, the outer tube hub 26 is formed hollow and has a size that is easy to operate by hand. The outer tube hub 26 is provided with a first space 64 communicating with the first lumen 34 of the outer tube 24, a first insertion hole 66 located on the base end side of the first space 64 and through which the inner catheter 20 is inserted, and a first introduction port portion 68 for introducing a balloon expansion fluid into the first space 64. The balloon expansion fluid is for inflating the balloon 22 shown in FIG. 2 radially inward of the outer tube 24. The balloon expansion fluid is, for example, physiological saline. The outer tube hub 26 is provided with a first seal member 70 for preventing the balloon expansion fluid in the first space 64 from leaking to the outside through the first insertion hole 66.
[0026] The fixing screw 28 is for fixing the inner catheter 20 to the outer tube hub 26. The fixing screw 28 may be made of the same material as the outer tube hub 26.
[0027] 1 and 2, the slider 18 is provided in a state in which it can move (slide) in the axial direction of the outer tube 24 relative to the outer peripheral surface of the outer tube main body 30. The overall length of the slider 18 is shorter than the overall length of the outer tube 24. The slider 18 has a long tubular slider main body 72, a cover portion 74 protruding from the tip end of the slider main body 72 toward the tip direction, and a slider hub 76 (slider operation portion) provided at the base end of the slider main body 72. The slider main body 72, the cover portion 74, and the slider hub 76 may each be made of the same material as the above-mentioned outer tube hub 26.
[0028] 1, 2, 5A, and 5B, when the slider 18 is moved to the most distal side (arrow X1 direction) with respect to the outer tube main body 30 (initial state of the slider 18), the distal side of the outer tube main body 30 extends linearly along the shape of the slider main body 72. As shown in Figures 6 and 8, when the slider 18 is moved to the most proximal side (arrow X2 direction) with respect to the outer tube main body 30 (state where the proximal end of the slider 18 is positioned at the distal end of the outer tube hub 26), the distal side of the outer tube main body 30 is exposed further distal than the slider main body 72 and curves in an arc shape.
[0029] 1, 2, 5A, and 5B, the cover portion 74 covers the protrusion portion 40 in the initial state of the slider 18. In other words, the inner surface of the cover portion 74 faces the protrusion inner surface 56 of the protrusion portion 40 in the initial state of the slider 18. The cover portion 74 covers the outer tube tip portion 38 (tip opening 36) in the initial state of the slider 18. The protruding end of the cover portion 74 is in the same position as the protruding end of the protrusion portion 40 in the axial direction of the slider body 72 in the initial state of the slider 18 (see FIG. 5B). However, the protruding end of the cover portion 74 may be located on the tip side of the protruding end of the protrusion portion 40 in the initial state of the slider 18.
[0030] The cover portion 74 has a longitudinal section and a transverse section each formed in an arc shape. In FIG. 5B, the cover portion 74 is formed so that the center portion in the protruding direction of the cover portion 74 is the widest. In other words, the width of the center portion in the protruding direction of the cover portion 74 is wider than the widths of both ends of the cover portion 74. The cover portion 74 is formed so that the width gradually increases from the slider body 72 toward the center portion in the protruding direction of the cover portion 74, and gradually decreases from the center portion toward the protruding end of the cover portion 74. The width of the center portion in the protruding direction of the cover portion 74 is wider than the outer diameter of the slider body 72. The size of the cover portion 74 can be set appropriately.
[0031] 1 and 2, the slider hub 76 is formed in an annular shape with a size that makes it easy to operate by hand. The inner catheter 20 includes a long inner tube 78 and an inner tube hub 80 (inner tube operation portion) provided at the base end of the inner tube 78. The total length of the inner tube 78 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.
[0032] 2, the material of the inner tube 78 may be a relatively hard resin (e.g., fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or a metal (e.g., stainless steel, titanium, titanium alloy, etc.). A second lumen 82 is formed in the inner tube 78, penetrating from the tip to the base end.
[0033] The inner tube 78 is inserted through the outer tube hub 26 and disposed in the first lumen 34 of the outer tube main body 30. The tip of the inner tube 78 is located in the proximal direction (the direction of arrow X2) from the tip of the outer tube main body 30. Between the outer peripheral surface of the inner tube 78 and the inner peripheral surface of the outer tube main body 30, an outer lumen Sa (expansion lumen) through which a balloon expansion fluid flows is provided.
[0034] A long insertion portion 100 of the endoscope 14, which also functions as a balloon support device, is inserted into the second lumen 82 of the inner tube 78. With the insertion portion 100 inserted into the second lumen 82 of the inner tube 78, an inner lumen Sb (irrigation lumen) through which an irrigation fluid flows is formed between the inner tube 78 and the insertion portion 100. The irrigation fluid is, for example, physiological saline.
[0035] The inner tube hub 80 is made of the same material as the outer tube hub 26. The inner tube hub 80 is formed to be hollow. The inner tube hub 80 is provided with a second space 84 communicating with the second lumen 82 of the inner tube 78, a second insertion hole 86 located on the proximal end side of the second space 84 and through which the insertion section 100 is inserted, and a second introduction port section 88 for introducing the perfusion fluid into the second space 84. The inner tube hub 80 is provided with a second seal member 90 for preventing the perfusion fluid in the second space 84 from leaking to the outside through the second insertion hole 86.
[0036] The balloon 22 is a tubular member that connects the tip of the outer tube 24 and the tip of the inner tube 78. The balloon 22 is inflated radially inward of the outer tube 24 by a balloon expansion fluid. In other words, the balloon 22 is formed to be elastically deformable in the radial direction.
[0037] The balloon 22 is preferably made of a material such as polyolefin (e.g., polyethylene, polypropylene, polybutene, etc.), polyester (polyethylene terephthalate, etc.), elastomer resin (polyolefin elastomer, polyester elastomer, polyamide elastomer, fluororesin elastomer, polyurethane elastomer, etc.), flexible polymeric material (natural rubber, ethylene-propylene copolymer, polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber, etc.), soft polyvinyl chloride, polyurethane, polyamide, polyisoprene, polyester, etc.
[0038] One end of the balloon 22 is adhered or fused to the tip of the outer tube 24 (the base end of the outer tube tip 38). In other words, one end of the balloon 22 is adhered or fused to the vicinity of the base end side of the balloon lead-out hole 42 of the outer tube 24. Specifically, one end of the balloon 22 is sandwiched between the tip of the outer tube main body 30 and the tip member 32. The other end of the balloon 22 is fixed to the outer peripheral surface of the tip of the inner tube 78 by a balloon fixing member 92. The other end of the balloon 22 may be adhered or fused to the tip of the inner peripheral surface of the inner tube 78. The balloon 22 has an inner cavity 94 into which the insertion section 100 of the endoscope 14 can be inserted. Between the outer peripheral surface of the balloon 22 and the inner peripheral surface of the outer tube main body 30, a bag-shaped outer space Sc with a closed tip is formed.
[0039] 11, when a pushing force (pushing force in the distal direction) is transmitted from the inner tube 78 to the balloon 22, the distal end 22a of the balloon 22 is turned back and protrudes in the distal direction from the distal end opening 36 of the outer tube 24. At this time, a radially double-folded portion is formed in the protruding portion 22b of the balloon 22 that protrudes in the direction of the arrow X1 beyond the distal end opening 36 of the outer tube 24.
[0040] 2 and 6, the endoscope 14 is an fallopian tube scope for observing the fallopian tube 202 (see FIG. 8). The endoscope 14 includes a flexible insertion section 100 inserted into the second lumen 82 of the inner tube 78 of the balloon catheter 12 and the lumen 94 of the balloon 22. In FIG. 6, an imaging section 102 for imaging the distal end direction of the insertion section 100 is provided on a flat distal end surface 104 of the insertion section 100.
[0041] When the distal end surface 104 of the endoscope 14 is positioned at or near the distal end opening 36, the angle (hereinafter referred to as "first angle θ1") between the protrusion 40 (protrusion inner surface 56) and the distal end surface 104 is set to 40° or more and 150° or less. If the first angle θ1 is smaller than 40°, the protrusion 40 may hinder the progress of the balloon 22 when the balloon 22 is projected from the distal end opening 36 in the distal direction, and the balloon 22 may be damaged by the protrusion 40. If the first angle θ1 is larger than 150°, the protrusion 40 displayed in the captured image (endoscopic image) of the endoscope 14 becomes difficult to visually recognize, and the protrusion 40 becomes likely to hit the inner surface of the fallopian tube 202 (the protrusion 40 becomes likely to damage the inner surface of the fallopian tube 202). It is more preferable that the first angle θ1 is 55° or more and 105° or less. In this case, the progress of the balloon 22 and the visibility of the protrusion 40 displayed in the endoscopic image are further improved.
[0042] Next, a salpingoscopic salpingoplasty using the catheter system 10 thus configured will be described.
[0043] In fallopianoscopic salpingoplasty, the above-mentioned catheter system 10 is prepared in a preparation step. Then, the user fixes the inner tube 78 with the fixing screw 28 in a state where it is fully pulled toward the base end side (in the direction of the arrow X2). Furthermore, the slider 18 is set to the initial state. As a result, the tip side of the outer tube main body 30 extends straight by the slider main body 72, and the protrusion portion 40 is covered by the cover portion 74.
[0044] Next, in the insertion step, the user inserts the balloon catheter 12 transcervically to the uterine fundus 200. At this time, since the cover part 74 covers the protrusion part 40, the protruding end of the protrusion part 40 is prevented from hitting the inner wall of the uterus (the inner surface of the uterus is prevented from being damaged by the protrusion part 40).
[0045] Then, in the sliding process, the slider 18 is pulled back toward the base end of the outer tube 24 relative to the outer tube 24. As a result, the tip side of the outer tube main body 30 is exposed from the slider 18 and becomes curved. Also, the protruding end of the cover part 74 is located on the base end side of the outer tube tip part 38. In other words, the protrusion part 40 is completely exposed. At this time, the user positions the tip surface 104 of the insertion part 100 of the endoscope 14 at the tip opening 36 of the outer tube tip part 38 or in the vicinity of the tip opening 36. As a result, the endoscope 14 captures an image from the tip opening 36 of the outer tube 24 to the tip direction of the balloon catheter 12. The endoscopic image captured by the endoscope 14 is displayed on a display part (display) not shown. The endoscopic image displays the protrusion part 40.
[0046] Thereafter, in a specification step, the user specifies the insertion target site 203 into which the balloon 22 is to be inserted based on the endoscopic image. Next, in a confirmation step, the user operates the balloon catheter 12 to insert the protrusion 40 into the insertion target site 203 (see FIG. 8) and checks the appearance of the protrusion 40 in the endoscopic image. At this time, for example, when the user checks in the endoscopic image how the protrusion 40 is being inserted toward the insertion target site 203, the user determines that the insertion target site 203 is the fallopian tube orifice 202a.
[0047] On the other hand, for example, when the user confirms from the endoscopic image that the protrusion 40 is not inserted into the insertion target site 203, the user determines that the insertion target site 203 is not the fallopian tube opening 202a (for example, it is simply a recess, etc.). When the user determines that the insertion target site 203 is not the fallopian tube opening 202a, the user repeats the above-mentioned identification process and confirmation process until the fallopian tube opening 202a is found.
[0048] When the fallopian tube opening 202a is confirmed in the confirmation step, the user performs the balloon extraction step after retracting the insertion section 100 of the endoscope 14 by a predetermined distance relative to the outer tube 24 (after bringing it into the state shown in FIG. 9). Specifically, in the balloon extraction step, as shown in FIG. 10, a balloon expansion fluid is supplied to the first introduction port section 68 (pressurization step). Then, the balloon expansion fluid is supplied from the first introduction port section 68 through the outer lumen Sa to the outer space Sc of the balloon 22. Therefore, the balloon 22 is pressed radially inward by the balloon expansion fluid supplied to the outer space Sc and elastically deforms. That is, the portion of the balloon 22 located on the outer periphery side of the insertion section 100 is in close contact with the outer periphery surface of the insertion section 100. The inner surfaces of the portions of the balloon 22 located on the tip side of the tip of the insertion section 100 are in contact with each other.
[0049] Thereafter, with the fixing screw 28 loosened, the user operates the inner tube hub 80 to advance the inner tube 78 relative to the outer tube 24 (advancing step). Then, as shown in Fig. 11, the balloon 22, pushed in the distal direction by the inner tube 78, advances together with the insertion portion 100 relative to the outer tube 24. That is, the balloon 22 protrudes together with the insertion portion 100 from the distal opening 36 of the outer tube 24 in the distal direction (arrow X1 direction) as a result of the pushing force being transmitted from the inner tube 78 to the balloon 22.
[0050] In the forward movement step, since one end of the balloon 22 is fixed to the tip of the outer tube 24, the balloon 22 advances while its tip 22a (protruding end) is turned up. That is, the balloon 22 is turned up at its tip 22a (protruding end) so that the inner surface faces outward. Therefore, the balloon 22 advances a distance equivalent to half the advancement distance of the insertion section 100.
[0051] Next, the user determines whether or not the balloon 22 has reached the lesion 204 based on the endoscopic image. If the balloon 22 is located in front of the lesion 204, the balloon inflation fluid is depressurized and perfusion fluid (perfusion fluid) is supplied to the second introduction port portion 88 (depressurization step). This allows the perfusion fluid to flow between the balloon 22 and the insertion portion 100 of the endoscope 14 via the inner lumen Sb. Next, the user moves the endoscope 14 backward a predetermined distance as shown in FIG. 12 (retraction step). Thereafter, the pressurization step and advancement step described above are performed again.
[0052] 13, when the balloon 22 completely passes through the lesion 204, the lesion 204 is expanded by the balloon 22. That is, the stenosis or blockage of the fallopian tube 202 is improved.
[0053] After expanding the lesion 204, the user reduces the pressure of the balloon inflation fluid and then removes the balloon catheter 12 and the endoscope 14 (removal step). Note that before removing the balloon catheter 12, the user may inject irrigation fluid through the second introduction port portion 88 while pulling the inner tube 78 to retract the balloon 22, and at the same time operate the endoscope 14 to be positioned at the tip portion 22a of the balloon 22, thereby removing the balloon catheter 12 while observing the inside of the fallopian tube 202 during the removal step. This completes the fallopianoscopic salpingoplasty.
[0054] This embodiment provides the following advantages.
[0055] According to this embodiment, by inserting the protrusion 40 into the insertion target site 203 of the balloon 22 and checking the appearance of the protrusion 40 in an endoscopic image, it is possible to easily distinguish whether the insertion target site 203 is the fallopian tube opening 202a (biological tube opening) or a simple recess. This allows the user to easily find the fallopian tube opening 202a based on the endoscopic image. In addition, by inserting the protrusion 40 into the fallopian tube opening 202a, the distal end opening 36 of the outer tube 24 can be positioned relative to the fallopian tube opening 202a. Therefore, the balloon 22 can be efficiently inserted into the fallopian tube opening 202a.
[0056] An imaging unit 102 for imaging the tip direction of the insertion portion 100 is provided on the tip surface 48 of the insertion portion 100, and when the insertion portion 100 is positioned at or near the tip opening 36, the angle (first angle θ1) between the tip surface 48 of the insertion portion 100 and the protrusion portion 40 is greater than or equal to 40° and less than 150°.
[0057] According to this configuration, the protrusion 40 can be efficiently displayed on the endoscopic image while preventing the protrusion 40 from interfering with the advancement of the balloon 22.
[0058] In a front view of the distal opening 36, when the outer tube distal end 38 is divided into a first region 52 located distally of a tangent Lc passing through a base end point P1 that is located furthest toward the base end of the outer tube 24 on the outer periphery of the distal opening 36, and a second region 54 located proximally of the tangent Lc, the protrusion 40 is located in the first region 52. The first angle θ1 is equal to or greater than 55° and equal to or less than 105°.
[0059] According to such a configuration, the visibility of the protrusion 40 displayed on the endoscopic image can be improved.
[0060] The thickness of the first region 52 is greater than the thickness of the second region 54 .
[0061] According to this configuration, the protrusion 40 can be supported by the first region 52, which has a relatively large thickness.
[0062] The protruding length of the protrusion 40 is not less than 1.5 mm and not more than 60 mm.
[0063] According to this configuration, since the protrusion length of the protrusion 40 is 1.5 mm or more, by inserting the protrusion 40 into the insertion target site 203 of the balloon 22, it is possible to more easily distinguish whether the insertion target site 203 is the fallopian tube orifice 202a or a simple recess. In addition, since the protrusion length of the protrusion 40 is 60 mm or less, it is possible to prevent the protrusion 40 from getting in the way when inserting the balloon catheter 12 to the uterine fundus 200.
[0064] The balloon catheter 12 has a slider 18 that is provided movably along the axial direction of the outer tube 24 relative to the outer peripheral surface of the outer tube 24 and that maintains the outer tube 24 in a straight shape. When the slider 18 is moved in the proximal direction relative to the outer tube 24, the tip of the outer tube body 30 is exposed from the slider 18 and curves in an arc in the axial direction.
[0065] According to this configuration, the outer tube 24 can be held in a straight shape by the slider 18, so that the outer tube 24 can be easily inserted up to the uterine fundus 200. Moreover, after the outer tube 24 is inserted up to the uterine fundus 200, the slider 18 is moved in the proximal direction to curve the tip of the outer tube main body 30 in an arc shape in the axial direction, so that the tip opening 36 can be easily positioned near the tubal orifice 202a.
[0066] The slider 18 has a tubular slider body 72 and a cover portion 74 protruding from the tip of the slider body 72 in the tip direction, and the cover portion 74 is located further in the tip direction than the tip of the outer tube tip portion 38 in the initial state of the slider 18 when the slider 18 has been moved the furthest in the tip direction relative to the outer tube 24.
[0067] According to this configuration, when the outer tube 24 is inserted into the fundus 200 of the uterus, the cover portion 74 can prevent the protruding end of the projection 40 from hitting the inner surface of the uterus.
[0068] The cover portion 74 faces the protrusion portion 40 in the initial state of the slider 18 .
[0069] According to this configuration, the cover portion 74 can effectively prevent the protruding end of the projection portion 40 from contacting the inner surface of the uterus.
[0070] (First Modification) Next, a balloon catheter 12A according to a first modified example will be described with reference to Figures 14A and 14B. In the balloon catheter 12A according to this modified example, the same components as those in the balloon catheter 12 described above are given the same reference numerals, and the description thereof will be omitted.
[0071] 14A and 14B, the balloon catheter 12A includes an outer catheter 16a and a slider 18a. Note that the configuration of the balloon catheter 12A other than the outer catheter 16a and the slider 18a is the same as that of the balloon catheter 12A described above.
[0072] The outer tube 24a of the outer catheter 16a includes an outer tube main body 30 and a tip member 32a. The tip member 32a has an outer tube tip portion 38a provided at the tip of the outer tube main body 30 and having a tip opening 36 formed therein, and a protrusion 40 protruding in the tip direction from the outer tube tip portion 38a. The outer tube tip portion 38a has a shape obtained by removing a portion of the outer circumferential surface of the outer tube tip portion 38 described above.
[0073] Specifically, the outer peripheral surface of the outer tube tip portion 38a includes a first curved surface 110 having a semicircular cross section, a pair of flat side surfaces 112 located on both sides of the first curved surface 110, and a second curved surface 114 (see FIG. 14A) to which the base end of the protrusion portion 40 is connected. The first curved surface 110 extends from the second region 54 to the first region 52 of the outer tube tip portion 38a. In other words, the first curved surface 110 extends over the entire second region 54 and a part of the first region 52. The first curved surface 110 is located radially inward from the outer peripheral surface of the outer tube main body 30. Each side surface 112 extends along the axial direction (arrow X direction) of the outer tube 24a.
[0074] The slider 18a has a slider body 72a, a cover portion 74a, and a slider hub 76 (see Figs. 1 and 2). The tip of the slider body 72a is cut out obliquely with respect to the axial direction of the slider body 72a. As a result, the tip of the slider body 72a is formed in an arc shape (an arc of less than 180°). The cover portion 74a protrudes from the tip of the slider body 72a in the tip direction.
[0075] The cover portion 74a is formed to be wider in the protruding direction of the cover portion 74a. The tip of the cover portion 74a has an arc shape that is convex toward the tip. The cover portion 74a covers the protrusion portion 40 in the initial state of the slider 18a. In other words, the inner surface of the cover portion 74a faces the protrusion inner surface 56 of the protrusion portion 40 in the initial state of the slider 18a. The protruding end of the cover portion 74a is in the same position as the protruding end of the protrusion portion 40 in the axial direction of the slider main body 72a in the initial state of the slider 18a. However, the protruding end of the cover portion 74a may be located on the tip side of the protruding end of the protrusion portion 40 in the initial state of the slider 18a.
[0076] In such a balloon catheter 12A, the same configuration as the balloon catheter 12 described above provides the same effects.
[0077] (Second Modification) Next, a balloon catheter 12B according to a second modification will be described with reference to Figures 15A and 15B. In the balloon catheter 12B according to this modification, the same components as those of the balloon catheters 12 and 12A described above are denoted by the same reference numerals, and the description thereof will be omitted.
[0078] 15A and 15B, the balloon catheter 12B includes a slider 18b. Note that the configuration of the balloon catheter 12B other than the slider 18b is the same as that of the balloon catheter 12A according to the first modified example.
[0079] The slider 18b has a slider body 72, a cover portion 74b, and a slider hub 76 (see Figures 1 and 2). The cover portion 74b protrudes from the tip of the slider body 72 in the tip direction. The cover portion 74b is molded integrally with the slider body 72. The cover portion 74b has a shape in which a cylindrical portion is cut out obliquely with respect to its axis. As a result, the tip of the cover portion 74b is formed in an arc shape (an arc of less than 180°). The cover portion 74b is formed to be narrower in the protruding direction of the cover portion 74b.
[0080] The cover portion 74b covers the protrusion portion 40 in the initial state of the slider 18b. In other words, the inner surface of the cover portion 74b faces the protrusion inner surface 56 of the protrusion portion 40 in the initial state of the slider 18b. The protruding end of the cover portion 74b is in the same position as the protruding end of the protrusion portion 40 in the axial direction of the slider body 72 in the initial state of the slider 18b. However, the protruding end of the cover portion 74b may be located further forward than the protruding end of the protrusion portion 40 in the initial state of the slider 18b.
[0081] In such a balloon catheter 12B, the same configuration as the above-mentioned balloon catheters 12, 12A provides the same effects.
[0082] (Third Modification) Next, a balloon catheter 12C according to a third modified example will be described with reference to Figures 16 to 17B. In the balloon catheter 12C according to this modified example, the same components as those in the balloon catheter 12 described above are given the same reference numerals, and the description thereof will be omitted.
[0083] 16, the balloon catheter 12C includes an outer catheter 16b and a slider 18c. Note that the configuration of the balloon catheter 12C is the same as that of the balloon catheter 12 described above, except for the outer catheter 16b and the slider 18c.
[0084] The outer tube 24b of the outer catheter 16b includes an outer tube main body 30 and a tip member 32b. The tip member 32b has an outer tube tip section 38 provided at the tip of the outer tube main body 30 and having a tip opening 36 formed therein, and a protrusion 40a protruding in the tip direction from the outer tube tip section 38. The protrusion 40a protrudes in the tip direction from a first region 52 of the outer tube tip section 38. The protrusion 40a is provided on a tip surface 48 of the outer tube tip section 38 at a position shifted 180° from the base end point P1 in the circumferential direction of the tip opening 36.
[0085] The protruding length of the protruding portion 40a is set to be the same as the protruding length L1 of the protruding portion 40a described above. The protruding portion 40a has flexibility. In other words, the protruding portion 40a is formed to be elastically deformable. The constituent material of the protruding portion 40a may be the same as the constituent material of the outer tube main body 30 described above. The protruding portion 40a is formed in a cylindrical shape. The protruding end surface of the protruding portion 40a has an arc-shaped cross section. When the distal end surface 48 of the endoscope 14 is positioned at or near the distal end opening 36, the angle between the protruding portion 40a and the distal end surface 48 is set to be the same as the first angle θ1 described above.
[0086] The slider 18c has a slider body 72 and a slider hub 76 (see FIGS. 1 and 2). That is, the slider 18c does not have the cover portion 74 described above.
[0087] 17A and 17B, in the initial state of the catheter system 10, the protrusion 40a is engaged with the inner surface of the outer tube distal end 38 in a state in which the protruding end of the protrusion 40a is elastically deformed so as to be inserted into the distal end opening 36. That is, in this state, the protruding end of the protrusion 40a is pressed against the wall surface forming the second hole 46 by the restoring force of the protrusion 40a. Therefore, the protrusion 40a is maintained in a curved shape with its protruding end inserted into the distal end opening 36.
[0088] In such a catheter system 10, in the insertion step, the balloon catheter 12C can be inserted up to the uterine fundus 200 with the protruding end of the protrusion 40a inserted into the distal end opening 36, so that the protruding end of the protrusion 40a is prevented from hitting the inner surface of the uterus (the inner surface of the uterus is prevented from being damaged by the protrusion 40a). After the insertion step, the insertion section 100 of the endoscope 14 is advanced relative to the outer tube 24b, so that the protrusion 40a is pressed toward the distal end by the insertion section 100. This releases the engagement of the protrusion 40a with the inner surface of the outer tube distal end 38a, and the protrusion 40a assumes a straight shape over its entire length (see FIG. 17B). Therefore, the identification step and the confirmation step can be performed reliably.
[0089] In such a balloon catheter 12C, the same configuration as the balloon catheter 12 described above provides the same effects.
[0090] The protrusion 40a can be engaged with the inner surface of the outer tube tip portion 38a in a state in which the protrusion 40a is elastically deformed so that the protrusion 40a can be inserted into the tip opening 36, and when the protrusion 40a is pushed toward the tip by the insertion portion 100, the engagement of the protrusion 40a with the inner surface of the outer tube tip portion 38a is released.
[0091] With this configuration, the outer tube 24b can be inserted up to the uterine fundus 200 with the protrusion 40a inserted into the distal opening 36, so that the protruding end of the protrusion 40a is prevented from hitting the inner surface of the uterus. After the outer tube 24b is inserted up to the uterine fundus 200, the protrusion 40a can be pressed in the distal direction by the insertion section 100 of the endoscope 14, so that the protruding end of the protrusion 40a can be exposed in the distal direction beyond the outer tube distal end 38a. This allows the protrusion 40a to be inserted into the fallopian tube orifice 202a.
[0092] The balloon catheter 12C may include the above-mentioned sliders 18, 18a, 18b instead of the slider 18c. In this case, the protrusion 40a is covered by the covers 74, 74a, 74b of the sliders 18, 18a, 18b, so that the outer tube 24b can be inserted up to the uterine fundus 200 with the protruding end of the protrusion 40a exposed from the distal opening 36 in the distal direction.
[0093] (Fourth Modification) Next, a balloon catheter 12D according to a fourth modified example will be described with reference to Figures 18A and 18B. In the balloon catheter 12D according to this modified example, the same components as those in the balloon catheter 12 described above are denoted by the same reference symbols, and the description thereof will be omitted.
[0094] 18A and 18B, the balloon catheter 12D includes an outer catheter 16c and a slider 18d. Note that the configuration of the balloon catheter 12D is the same as that of the balloon catheter 12 described above, except for the outer catheter 16c and the slider 18d.
[0095] The outer tube 24c of the outer catheter 16c includes an outer tube main body 30 and a tip member 32c. The tip member 32c has an outer tube tip section 38 provided at the tip of the outer tube main body 30 and having a tip opening 36 formed therein, and a protrusion 40b protruding in the tip direction from the outer tube tip section 38. The protrusion 40b protrudes in the tip direction from a second region 54 of the outer tube tip section 38. The protrusion 40b is provided on a tip surface 48 of the outer tube tip section 38.
[0096] The protruding length of the protruding portion 40b is set to be the same as the protruding length L1 of the protruding portion 40 described above. The protruding portion 40b has flexibility. The constituent material of the protruding portion 40b may be the same as the constituent material of the outer tube main body 30 described above. The protruding portion 40b extends along the circumferential direction of the tip opening 36. The protruding portion 40b is formed narrower in the protruding direction. The protruding inner surface 120 of the protruding portion 40b (the surface on the side where the tip opening 36 is located) is curved in an arc shape along the circumferential direction of the tip opening 36 and also curved in an arc shape in the protruding direction of the protruding portion 40b.
[0097] 18B, with the distal end surface 48 of the endoscope 14 positioned at or near the distal end opening 36, the angle (hereinafter referred to as the "second angle θ2") between the distal end surface 48 of the insertion section 100 and the protrusion 40b (the tip of the protrusion inner surface 120 of the protrusion 40b) is set to be 40° or more and 150° or less. The second angle θ2 is more preferably 100° or more and 130° or less. In this case, the progress of the balloon 22 and the visibility of the protrusion 40b in the endoscopic image are further improved.
[0098] 18A and 18B, the slider 18d has a slider body 72, a cover portion 74c, and a slider hub 76 (see FIGS. 1 and 2). The cover portion 74c has a shape obtained by rotating the cover portion 74 of the balloon catheter 12 described above by 180° in the circumferential direction of the slider body 72.
[0099] The cover portion 74c covers the protrusion portion 40b in the initial state of the slider 18d. In other words, the inner surface of the cover portion 74c faces the protrusion inner surface 120 of the protrusion portion 40b in the initial state of the slider 18d. The protruding end of the cover portion 74c is in the same position as the protruding end of the protrusion portion 40b in the axial direction of the slider body 72 in the initial state of the slider 18d. However, the protruding end of the cover portion 74c may be located further forward than the protruding end of the protrusion portion 40b in the initial state of the slider 18d.
[0100] In such a balloon catheter 12D, the same configuration as the balloon catheter 12 described above provides the same effects.
[0101] The protrusion 40b is located in the second region 54, and the second angle θ2 is not less than 40° and not more than 150°.
[0102] According to such a configuration, it is possible to improve the visibility of the protrusion 40b displayed on the endoscopic image.
[0103] (Fifth Modification) Next, a balloon catheter 12E according to a fifth modified example will be described with reference to Fig. 19. In the balloon catheter 12E according to this modified example, the same components as those in the balloon catheter 12 described above are given the same reference numerals, and the description thereof will be omitted.
[0104] 19, the balloon catheter 12E includes an outer catheter 16d and a slider 18c. Note that the configuration of the balloon catheter 12E is the same as that of the balloon catheter 12 described above, except for the outer catheter 16d and the slider 18c.
[0105] The outer tube 24d of the outer catheter 16d includes an outer tube main body 30 and a tip member 32d. The tip member 32d has an outer tube tip portion 38 provided at the tip of the outer tube main body 30 and having a tip opening 36, and a plurality of protrusions 40c protruding in the tip direction from the outer tube tip portion 38. Examples of materials constituting the protrusions 40c include the same materials as those constituting the outer tube main body 30 described above.
[0106] The multiple protrusions 40c are formed in the same shape. The protrusions 40c extend along the circumferential direction of the tip opening 36. The protrusions 40c are formed to be thin toward the protruding direction of the protrusions 40c. The protrusion length of the protrusions 40c is set to be the same as the protruding length L1 of the protrusions 40 described above. The protrusion inner surface 122 of the protrusions 40c (the surface on the side where the tip opening 36 is located) is curved in an arc shape along the circumferential direction of the tip opening 36 and is also curved in an arc shape in the protruding direction of the protrusions 40c.
[0107] In this embodiment, the tip member 32d has three protrusions 40c1, 40c2, and 40c3 as the multiple protrusions 40c. The three protrusions 40c1, 40c2, and 40c3 are provided on the tip surface 48 of the outer tube tip portion 38. The three protrusions 40c1, 40c2, and 40c3 are provided at equal intervals in the circumferential direction of the tip opening 36. The two protrusions 40c1 and 40c2 protrude from the first region 52 of the outer tube tip portion 38 in the tip direction. The one protrusion 40c3 protrudes from the second region 54 of the outer tube tip portion 38 in the tip direction.
[0108] With the distal end surface 48 of the endoscope 14 positioned at or near the distal end opening 36, the angle formed by the protrusions 40c1, 40c2 (tips of the protrusion inner surfaces 122 of the protrusions 40c1, 40c2) protruding from the first region 52 of the outer tube distal end portion 38 and the distal end surface 48 of the endoscope 14 is set similar to the first angle θ1 described above. With the distal end surface 48 of the endoscope 14 positioned at or near the distal end opening 36, the angle formed by the protrusion 40c3 (tips of the protrusion inner surfaces 122 of the protrusion 40c3) protruding from the second region 54 of the outer tube distal end portion 38 and the distal end surface 48 of the endoscope 14 is set similar to the second angle θ2 described above.
[0109] In such a balloon catheter 12E, the same configuration as the balloon catheter 12 described above provides the same effects.
[0110] A plurality of protrusions 40c are provided.
[0111] This configuration can improve the visibility of the protrusions 40c displayed on the endoscopic image. It can also prevent only one protruding end of the protrusion 40c from hitting the inner surface of the uterus. In other words, even if the protrusion 40c hits the inner surface of the uterus, the force acting from the protrusion 40c on the inner surface of the uterus can be reduced by the multiple protrusions 40c.
[0112] The protrusions 40c are provided at equal intervals in the circumferential direction of the outer tube tip portion .
[0113] According to such a configuration, the visibility of the protrusion 40c displayed on the endoscopic image can be further improved.
[0114] The present invention is not limited to the above-described embodiment, and various modifications are possible without departing from the gist of the present invention.
[0115] The above embodiments can be summarized as follows.
[0116] The above embodiment relates to a catheter system (10) including a flexible outer tube (24, 24a to 24d), an inner tube (78) disposed in an inner cavity (34) of the outer tube so as to be movable in an axial direction of the outer tube relative to the outer tube, a balloon catheter (12, 12A to 12E) having a tubular balloon (22) connecting a distal end of the outer tube and a distal end of the inner tube to each other and expanding radially inwardly of the outer tube, and an endoscope (14) including a linear insertion portion (100) to be inserted into an inner cavity (94) of the balloon, The balloon protrudes in the distal direction from a distal opening (36) of the outer tube while being rolled back as a pushing force in the distal direction is transmitted from the inner tube to the balloon, and the outer tube has a tubular outer tube body (30), an outer tube tip portion (38, 38a) provided at the tip portion of the outer tube body and in which the tip opening is formed, and protrusions (40, 40a-40c) protruding in the distal direction from the outer tube tip portion, and the protrusions are integrally molded with the outer tube tip portion.
[0117] In the above catheter system, an imaging unit (102) for imaging the tip direction of the insertion portion is provided on the tip surface (104) of the insertion portion, and when the insertion portion is positioned at or near the tip opening, an angle (θ1, θ2) between the tip surface of the insertion portion and the protrusion portion may be greater than or equal to 40° and less than 150°.
[0118] In the above catheter system, when the outer tube tip is divided into a first region (52) located further toward the distal end than a tangent (Lc) passing through a point (P1) on the outer circumference of the tip opening that is located furthest toward the proximal end of the outer tube, and a second region (54) located further toward the proximal end than the tangent, in a front view of the tip opening, the protrusion is located in the first region, and the angle (θ1) may be greater than or equal to 55° and less than 105°.
[0119] In the above catheter system, when the outer tube tip is divided into a first region located further toward the tip than a tangent line passing through a point on the outer circumference of the tip opening that is located furthest toward the base end of the outer tube, and a second region located further toward the base end than the tangent line, in a front view of the tip opening, the protrusion is located in the second region, and the angle (θ2) may be greater than or equal to 100° and less than 130°.
[0120] In the above catheter system, the first region may have a greater wall thickness than the second region.
[0121] In the above catheter system, the protrusion portion may have a protruding length (L1) of 1.5 mm or more and 60 mm or less.
[0122] In the above catheter system, the balloon catheter may have a slider (18, 18a to 18d) that is movably provided along the axial direction of the outer tube relative to the outer peripheral surface of the outer tube and that holds the outer tube in a straight shape, and the tip portion of the outer tube body may be exposed from the slider when the slider is moved in the base end direction relative to the outer tube and may be curved in an arc shape in the axial direction.
[0123] In the above catheter system, the slider has a tubular slider body (72) and a cover portion (74, 74a to 74c) protruding from a tip portion of the slider body toward the tip direction, and the cover portion may be located in the tip direction further than the tip of the outer tube tip portion in an initial state of the slider where the slider is moved furthest in the tip direction relative to the outer tube.
[0124] In the above catheter system, the cover portion may face the protrusion portion in the initial state of the slider.
[0125] In the above catheter system, a plurality of the protrusions may be provided.
[0126] In the above catheter system, the protrusions may be provided at equal intervals in a circumferential direction of the outer tube tip portion.
[0127] In the above catheter system, the protrusion can be engaged with the inner surface of the outer tube tip portion in a state in which the protrusion is elastically deformed so that the protrusion can be inserted into the tip opening, and the engagement of the protrusion with the inner surface of the outer tube tip portion can be released by the protrusion being pushed toward the tip by the insertion portion. [Explanation of symbols]
[0128] 10... Catheter system 12, 12A to 12E... Balloon catheter 14... Endoscope 18, 18a to 18d... Slider 22... balloon 24, 24a to 24d... outer tube 30...Outer tube body 34...First lumen 36...Tip opening 38, 38a...Outer tube body 40, 40a~40c...Protrusion 52...First area 54: second region 72, 72a: slider body 74, 74a to 74c... Cover portion 78... Inner tube 100: Insertion section 102: Imaging section 104…Tip surface L1…Protrusion length Lc...tangent P1...base point θ1…First angle θ2…Second angle
Claims
1. a balloon catheter including a flexible outer tube, an inner tube disposed in the inner cavity of the outer tube so as to be movable in the axial direction of the outer tube relative to the outer tube, and a tubular balloon connecting a distal end of the outer tube with a distal end of the inner tube and expanding radially inwardly of the outer tube; An endoscope having a linear insertion portion that is inserted into the inner cavity of the balloon, a distal end of the balloon is turned up and protrudes from the distal end opening of the outer tube in the distal direction by a pushing force transmitted from the inner tube to the balloon in the distal direction; The outer tube is A tubular outer tube body; an outer tube tip portion provided at a tip portion of the outer tube main body and having the tip opening; a protrusion protruding from the outer tube tip in the tip direction, The protrusion is integrally formed with the tip end of the outer tube, a slider that is provided to be movable along the axial direction of the outer tube relative to an outer peripheral surface of the outer tube and that maintains the outer tube in a straight shape; a distal end portion of the outer tube main body is exposed from the slider when the slider is moved in a proximal direction relative to the outer tube and is curved in an arc shape in the axial direction; The slider includes: A tubular slider body; a cover portion protruding from a tip end portion of the slider body toward the tip end direction, A catheter system, wherein the cover portion is positioned on the opposite side of the tip opening from the protrusion portion and faces the protrusion portion in an initial state of the slider in which the slider is moved most toward the tip direction relative to the outer tube.
2. A catheter system according to claim 1, An imaging unit for imaging a tip direction of the insertion portion is provided on a tip surface of the insertion portion, A catheter system, wherein when the insertion portion is positioned at or near the tip opening, an angle between the tip surface of the insertion portion and the protrusion is greater than or equal to 40° and less than 150°.
3. A catheter system according to claim 2, When the distal end portion of the outer tube is divided into a first region located in the distal direction of a tangent line passing through a point on an outer periphery of the distal opening that is located closest to the proximal end of the outer tube, and a second region located in the proximal direction of the tangent line, the protrusion is located in the first region, A catheter system, wherein the angle is greater than or equal to 55° and less than or equal to 105°.
4. A catheter system according to claim 2, When the distal end portion of the outer tube is divided into a first region located in the distal direction of a tangent line passing through a point on an outer periphery of the distal opening that is located closest to the proximal end of the outer tube, and a second region located in the proximal direction of the tangent line, the protrusion is located in the second region, A catheter system, wherein the angle is greater than or equal to 100° and less than or equal to 130°.
5. A catheter system according to claim 3 or 4, A catheter system, wherein the wall thickness of the first region is greater than the wall thickness of the second region.
6. A catheter system according to any one of claims 1 to 5, A catheter system, wherein the protrusion length of the protrusion is 1.5 mm or more and 60 mm or less.
7. A catheter system according to any one of claims 1 to 6, A catheter system, wherein the cover portion is located in the distal direction further than the tip of the outer tube tip portion in the initial state of the slider.
8. A catheter system according to any one of claims 1 to 7, the protrusion is capable of being engaged with an inner surface of the outer tube tip end portion in a state in which the protrusion is elastically deformed so as to be inserted into the tip opening, A catheter system, wherein the protrusion is pushed in the distal direction by the insertion section, thereby releasing the engagement of the protrusion with the inner surface of the outer tube distal section.
Citation Information
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