Catheter system
By designing a catheter system with a flexible outer tube, a movable inner tube, a tubular balloon and a collection part, the problem in the existing technology that it is difficult to efficiently collect diseased tissue in the body's lumen is solved, and an efficient and simplified method is achieved. tissue collection effect.
Patent Information
- Application Number
- CN202410972488.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-07-19
- Filing Date
- 2024-07-19
- Publication Date
- 2025-01-21
AI Technical Summary
It is difficult for existing catheter systems to efficiently collect lesion tissue in the lumen of the organism, especially in the narrow or occlusive areas of the fallopian tube.
A catheter system is designed, which includes a flexible outer tube, a movable inner tube, a tubular balloon and a collection part. The balloon is inflated by the expansion fluid, and the collection part is formed on the outer periphery of the balloon, which can effectively collect the tissue in the lumen while the balloon is traveling.
When the catheter system travels along the lumen of a living body, it is possible to efficiently collect diseased tissue in the lumen, simplifying the structure and reducing manufacturing costs.
Smart Images
Figure CN119327012A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to catheter systems. Background Art
[0002] Patent document 1 discloses a balloon catheter for treating a diseased part (stenotic part or occluded part) of a fallopian tube. The balloon catheter comprises: an outer tube having flexibility; an inner tube disposed in the inner cavity of the outer tube so as to be movable in the axial direction relative to the outer tube; a tubular balloon connecting the front end of the outer tube and the front end of the inner tube; and an operating part disposed in the middle of the outer tube. An endoscope is inserted into the inner side of the balloon. When the user operates the operating part, the endoscope moves along the outer tube toward the front end.
[0003] Patent Document 1: Japanese Patent No. 3921112
[0004] It is desirable to efficiently collect tissue from a lesion (such as fallopian tube cancer, a stenotic part, or an occluded part) in the lumen of a living body. Summary of the invention
[0005] (1) An embodiment of the present invention is a catheter system that is inserted into a lumen of a living body and is capable of traveling along the lumen, the catheter system comprising: an outer tube that is flexible; an inner tube that is disposed in the lumen of the outer tube so as to be movable along the axial direction of the outer tube; a tubular balloon that connects the front end portion of the outer tube and the front end portion of the inner tube to each other and expands radially inwardly of the outer tube so as to allow a rod-shaped member to be inserted through the inner tube; and a collecting portion that protrudes from the front end of the outer tube in a front direction and is inserted into the lumen of the living body to collect tissue in the lumen, wherein after the balloon protrudes from the front end of the outer tube in a front direction, the balloon has an outer peripheral portion that contacts the inner peripheral surface of the lumen, and the collecting portion is a convex portion formed on the outer peripheral portion of the balloon, a concave portion formed on the outer peripheral portion, or a part of the rod-shaped member inserted into the balloon.
[0006] According to this catheter system, when the balloon is moved along the lumen of a living body, tissue in the lumen can be effectively collected by the collecting portion which is a convex portion formed on the outer periphery of the balloon, a concave portion formed on the outer periphery, or a part of a rod-shaped member inserted into the balloon.
[0007] (2) In the catheter system according to (1) above, the collecting portion may be the convex portion or the concave portion formed on the outer peripheral portion of the balloon.
[0008] According to this structure, by providing the collecting part as a convex part or a concave part on the balloon, the balloon can be used to collect tissue, and compared with the structure in which the collecting part is provided on other components, the structure can be simplified and the manufacturing cost can be reduced. By providing the convex part or the concave part on the balloon, the collecting part can be easily realized.
[0009] (3) In the catheter system according to (2) above, the base end of the inner tube may include an inner tube hub having a port for supplying and discharging perfusion fluid, and the port may be connected to the interior of the inner tube and the balloon.
[0010] According to this configuration, after the tissue is collected by the collecting portion of the balloon while the perfusion fluid is supplied into the balloon through the port, the perfusion fluid is discharged from the port, thereby enabling the tissue to be efficiently recovered from the port together with the perfusion fluid.
[0011] (4) In the catheter system according to (1) above, the collecting portion may be provided at a distal end portion of the rod-shaped member.
[0012] According to this configuration, by providing the collecting portion at the distal end portion of the rod-shaped member, a larger amount of tissue in the lumen can be collected reliably.
[0013] (5) In the catheter system described in (1) or (4) above, the inner tube may include a first scale portion arranged at a constant interval in the axial direction, and the rod-shaped member may include a second scale portion, wherein the second scale portion is arranged at a constant interval in the axial direction from the front end toward the base end and is half the interval of the first scale portion in the axial direction.
[0014] According to this structure, when the front end of the balloon is inserted into the lumen of a biological body, after the rod-shaped component is relatively moved toward the base end direction using the second scale portion, the inner tube is moved toward the front end direction based on the first scale portion, thereby preventing the rod-shaped component from protruding from the balloon toward the front end direction before the front end of the balloon reaches the target position in the lumen.
[0015] (6) In the catheter system according to any one of (1) to (3) above, the rod-shaped member may be an endoscope.
[0016] According to this configuration, for example, the balloon can be inserted into the lumen of a living body using an endoscopic image without operating the balloon while checking the scale (in addition, by marking the lesion using a cell surface marker or the like, it is possible to check the lesion using an endoscopic image).
[0017] According to the present invention, the catheter system is provided with a collection part, which protrudes from the front end of the outer tube toward the front end and is inserted into the lumen of the living body to collect tissue in the lumen, and the collection part is a convex part or a concave part formed on the outer circumference of the balloon, or a part of a rod-shaped member inserted into the balloon. Thus, when the balloon is moved in the lumen of the living body, the tissue in the lumen can be effectively collected by the collection part. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Figure 1 This is a schematic configuration diagram of a catheter system according to a first embodiment of the present invention.
[0019] Figure 2 yes Figure 1 A partially omitted cross-sectional view of a catheter system.
[0020] Figure 3 It is used Figure 1 Figure 1 of the illustration of endoscopic fallopian tube surgery with a catheter system.
[0021] Figure 4 yes Figure 3 The second illustration of endoscopic salpingoplasty is shown.
[0022] Figure 5 yes Figure 4 The third illustration of endoscopic salpingoplasty is shown.
[0023] Figure 6 yes Figure 5 The fourth illustration of endoscopic salpingoplasty is shown.
[0024] Figure 7 yes Figure 6 The fifth illustration of endoscopic salpingoplasty is shown.
[0025] Figure 8 yes Figure 7 FIG6 is an illustration of endoscopic salpingoplasty.
[0026] Fig. 9 yes Figure 8 FIG7 is an illustration of endoscopic salpingoplasty.
[0027] Fig.10 It is an explanatory diagram of the endoscopic fallopian tube plasty according to the first modified example.
[0028] Fig.11 It is an explanatory diagram of the endoscopic fallopian tube plasty according to the second modified example.
[0029] Fig.12 This is a schematic configuration diagram of a catheter system according to a second embodiment of the present invention.
[0030] Fig.13 yes Fig.12 The first explanatory diagram of endoscopic fallopian tube tissue collection is shown.
[0031] Fig.14 yes Fig.13 The second explanatory diagram of endoscopic fallopian tube tissue collection is shown.
[0032] Fig.15A It is an enlarged cross-sectional view showing a rod-shaped member according to a first modification. Fig. 15B It is an enlarged cross-sectional view showing a rod-shaped member according to a second modification.
[0033] Description of Reference Numerals
[0034] 10, 10A...catheter system; 14...outer tube; 18...inner tube; 20...balloon; 21, 21A, 21B, 21C...collection part; 22...endoscope; 23, 210A, 210B, 210C...rod-shaped member; 211...convex part; 202...fallopian tube; 203...peripheral part. DETAILED DESCRIPTION
[0035] like Figure 1 As shown in FIG. 1 , the catheter system 10 according to the first embodiment is inserted into a lumen of a living body and can move along the lumen. The catheter system 10 is used, for example, in endoscopic tuboplasty for treating a lesion 204 (lesion such as fallopian tube cancer, a stenosis, or an occlusion) of a fallopian tube 202 as a lumen (see FIG. 1 ). Figure 3 In addition, the catheter system 10 can also be used to treat lesions in parts other than the fallopian tube 202, such as blood vessels, bile ducts, trachea, esophagus, urethra, other organs, and other biological organs. Figure 1 The left side of the catheter system 10 (the direction of arrow X1) is referred to as the "front end direction". Figure 1 The right direction of the catheter system 10 in FIG. 1 (the direction of arrow X2) is referred to as the "proximal direction".
[0036] The catheter system 10 includes a catheter 12. The catheter 12 includes an outer tube 14, a slider 16, an inner tube 18, a balloon 20, an operation unit 24 for operating an endoscope 22 inserted into the inner tube 18, and a handheld unit 26. Therefore, the catheter 12 is a balloon catheter. The endoscope 22 is a rod-shaped member 23 that can be inserted into the tubular balloon 20 through the inner tube 18.
[0037] like Figure 2As shown in the figure, the outer tube 14 has: a flexible outer tube main body 28, an outer tube hub 30, and a fixing screw 32. The outer tube main body 28 includes a tube body 34 and a front end component 36 (front end contact). As the constituent materials of the tube body 34 and the front end component 36, for example, polyolefin, polyester, elastomer resin, flexible polymer material, soft polyvinyl chloride, polyurethane, polyamide, fluororesin, etc. can be cited. The outer tube 14 is an outer conduit.
[0038] The tube body 34 has a first lumen 341. The first lumen 341 penetrates the entire length of the tube body 34 in the axial direction. The front end of the tube body 34 is shaped so as to be curved in an arc shape in the axial direction of the tube body 34. The tube body 34 has a substantially constant outer diameter over the entire length in the axial direction.
[0039] The front end member 36 is provided at the front end portion of the tube body 34. The outer peripheral surface of the front end member 36 is in contact with the fallopian tube opening 202a (see Figure 3 ) is bent in accordance with the shape of the front end member 36. The front end member 36 has a balloon outlet hole 38. The balloon outlet hole 38 includes the front end opening 281 of the outer tube body 28. The balloon 20 is introduced through the balloon outlet hole 38 toward the front end direction (arrow X1 direction) of the front end member 36.
[0040] The outer tube hub 30 is fixed to the base end of the outer tube body 28. For example, a hard resin or a metal material is used as a constituent material of the outer tube hub 30. Examples of the hard resin constituting the outer tube hub 30 include polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, polyetherimide, etc. Examples of the metal material constituting the outer tube hub 30 include stainless steel, titanium, titanium alloy, etc.
[0041] The outer tube hub 30 is formed in a hollow shape. The outer tube hub 30 is formed in a size that is easy for the user to operate. The outer tube hub 30 has a first space 301, a first insertion hole 302, and a first introduction port 303. The first space 301 is connected to the first inner cavity 341 of the outer tube body 28. The first insertion hole 302 is located in the arrow X2 direction of the first space 301. The inner tube 18 is inserted into the first insertion hole 302. The first introduction port 303 introduces an expansion fluid into the first space 301.
[0042] The expansion fluid expands the balloon 20 radially inwardly of the outer tube body 28. The expansion fluid is, for example, physiological saline. Alternatively, the expansion fluid may be sterile water. A first sealing member 40 is provided in the first space 301 of the outer tube hub 30. The first sealing member 40 prevents the expansion fluid in the first space 301 from leaking out from the first insertion hole 302 to the outside.
[0043] The fixing screw 32 is screwed to the outer tube hub 30. When the user tightens the fixing screw 32, the inner tube 18 is fixed to the outer tube hub 30. When the user loosens the fixing screw 32, the inner tube 18 can move relative to the outer tube hub 30.
[0044] The slider 16 is mounted on the outer tube 14. The slider 16 slides on the outer peripheral surface of the tube body 34 along the axial direction of the outer tube main body 28. The overall length of the slider 16 in the axial direction is shorter than the overall length of the outer tube main body 28 in the axial direction. The slider 16 includes a slider main body 161 and a slider hub 162. The slider main body 161 is a tubular member. The slider hub 162 is fixed to the base end of the slider main body 161. The slider hub 162 is formed in a cylindrical shape.
[0045] In a state where the slider 16 is moved to the maximum extent in the direction of the arrow X1 relative to the tube body 34 (initial state of the slider 16), the front end portion of the tube body 34 extends linearly along the shape of the slider main body 161. When the slider 16 is moved in the direction of the arrow X2 relative to the tube body 34 in the opposite direction, the front end portion of the tube body 34 is exposed in the direction of the arrow X1 from the slider 16. At this time, the front end portion of the tube body 34 is bent in an arc shape. Before the catheter system 10 is used, the catheter system 10 is stored in a state where the front end portion of the tube body 34 is bent.
[0046] The inner tube 18 includes an inner tube body 42 and an inner tube hub 44. As the constituent material of the inner tube body 42, relatively hard resin materials or metal materials can be cited. As the hard resin constituting the inner tube body 42, for example, polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, polyetherimide, etc. can be cited. As the metal material constituting the inner tube body 42, for example, stainless steel, titanium, titanium alloy, etc. can be cited. The inner tube body 42 has a second inner cavity 421 that passes through the entire length of the inner tube body 42 in the axial direction. The inner tube 18 is an inner conduit.
[0047] The inner tube body 42 is disposed in the first lumen 341 of the outer tube body 28 so as to be movable along the axial direction of the outer tube body 28. The inner tube body 42 is inserted through the outer tube hub 30. The front end of the inner tube body 42 is disposed closer to the arrow X2 direction than the front end of the tube body 34. An outer lumen Sa for the flow of an expansion fluid is provided between the outer circumferential surface of the inner tube body 42 and the inner circumferential surface of the tube body 34.
[0048] The insertion portion 221 of the endoscope 22 is inserted into the second lumen 421 of the inner tube body 42. When the insertion portion 221 is inserted into the second lumen 421 of the inner tube body 42, an inner lumen Sb is provided between the inner tube body 42 and the insertion portion 221 for flowing perfusion fluid.
[0049] The inner tube hub 44 is fixed to the base end of the inner tube body 42. The inner tube hub 44 is formed in a hollow shape. The inner tube hub 44 has a second space 441, a second insertion hole 442, and a second introduction port 443. The second space 441 is connected to the second inner cavity 421 of the inner tube body 42. The second insertion hole 442 is located in the arrow X2 direction of the second space 441. The insertion portion 221 of the endoscope 22 is inserted into the second insertion hole 442. The second introduction port 443 introduces perfusion fluid into the second space 441.
[0050] The perfusion liquid is, for example, physiological saline. A second sealing member 46 is provided in the second space 441 of the inner tube hub 44. The second sealing member 46 prevents the perfusion liquid in the second space 441 from leaking out from the second insertion hole 442 to the outside.
[0051] The balloon 20 is a tubular member that connects the front end of the outer tube body 28 and the front end of the inner tube body 42. The balloon 20 is expanded radially inward of the outer tube body 28 by the expansion fluid. In other words, the balloon 20 is formed to be elastically deformable in the radial direction. The balloon 20 is preferably composed of polyolefin, polyester, elastomer resin, flexible polymer material, soft polyvinyl chloride, polyurethane, polyamide, polyisobutylene, polyester, fluororesin, etc.
[0052] One end of the balloon 20 is bonded to the front end of the outer tube body 28 by an adhesive (not shown). Alternatively, one end of the balloon 20 may be welded to the front end of the outer tube body 28. One end of the balloon 20 is clamped between the front end of the tube body 34 and the front end member 36.
[0053] The other end of the balloon 20 is fixed to the outer peripheral surface of the front end of the inner tube body 42 by the balloon fixing member 48. In addition, the other end of the balloon 20 may also be bonded to the front end of the inner peripheral surface of the inner tube body 42 by an adhesive. The other end of the balloon 20 may also be welded to the front end of the inner peripheral surface of the inner tube body 42.
[0054] The balloon 20 has an inner cavity 201 into which the insertion portion 221 of the endoscope 22 can be inserted. Between the outer peripheral surface of the balloon 20 and the inner peripheral surface of the tube body 34, a bag-shaped outer space Sc with a closed front end is provided.
[0055] When the balloon 20 is expanded radially inward, a pressing force (a pressing force in the distal direction) is transmitted from the inner tube body 42 to the balloon 20, whereby the balloon 20 protrudes in the distal direction from the distal end opening 281 of the outer tube body 28 (see Figure 5 At this time, the front end of the balloon 20 is rolled back in a manner that the inner surface of the balloon 20 faces outward. That is, the protruding portion of the balloon 20 that protrudes in the direction of arrow X1 from the front end opening 281 of the outer tube body 28 includes a portion of the wall of the balloon 20 that is double-folded in the radial direction.
[0056] like Figure 7 As shown, the balloon 20 has an outer peripheral portion 203 disposed on the outer peripheral side of the balloon 20 after the balloon 20 protrudes from the front end of the outer tube 14 to the front end direction. The outer peripheral portion 203 contacts the inner peripheral surface 2021 of the oviduct 202 of the organism. When the balloon 20 is accommodated in the outer tube 14, the outer peripheral portion 203 is disposed on the inner peripheral side.
[0057] The outer circumference 203 of the balloon 20 is provided with a collection portion 21 capable of collecting tissue in a living body. After the balloon 20 protrudes from the front end of the outer tube 14 toward the front end direction and the outer circumference 203 of the balloon 20 is inserted into the fallopian tube 202 of the living body and contacts the inner circumference 2021 of the fallopian tube 202, the collection portion 21 contacts the inner circumference 2021 of the fallopian tube 202. The collection portion 21 is a convex portion 211 formed on the outer circumference 203 of the balloon 20. The convex portion 211 protrudes radially outward from the outer circumference 203. The convex portion 211 is formed in a ring shape along the circumference of the balloon 20. Figure 2 As shown, the convex portion 211 protrudes radially inward and faces the inner cavity 201 when the balloon 20 is accommodated in the outer tube 14 .
[0058] In addition, the convex part 211 is not limited to the case where it is formed in an annular shape along the circumferential direction of the balloon 20. For example, a plurality of convex parts 211 separated from each other may be provided in the circumferential direction of the balloon 20.
[0059] The convex portion 211 includes a first convex piece 211A and a second convex piece 211B. The first convex piece 211A and the second convex piece 211B are separately arranged in the axial direction (arrow X direction) of the balloon 20. When the balloon 20 is accommodated in the outer tube 14, the first convex piece 211A is arranged closer to the front end direction (arrow X1 direction) than the second convex piece 211B. In addition, the first convex piece 211A and the second convex piece 211B are not limited to the case of a single setting. For example, the first convex piece 211A and the second convex piece 211B can each be provided with more than two. The first convex piece 211A and the second convex piece 211B can be the same shape, and the first convex piece 211A and the second convex piece 211B can also be different shapes.
[0060] The first convex piece 211A is provided to collect tissue between the lesion 204 of the fallopian tube 202 and the fallopian tube opening 202a (see Figure 7 The second protruding piece 211B is provided to collect tissue of the lesion 204 of the fallopian tube 202 (see Figure 8 ). In addition, the convex portion 211 is not limited to the case where it includes the first convex piece 211A and the second convex piece 211B. The convex portion 211 only needs to include at least the second convex piece 211B that can collect the tissue of the lesion 204.
[0061] The collecting portion 21 is not limited to the convex portion 211 protruding radially outward from the outer peripheral portion 203 of the balloon 20. For example, it may be a concave portion recessed radially inward from the outer peripheral portion 203 of the balloon 20.
[0062] like Figure 2 As shown, the endoscope 22 is an endoscope for observing the fallopian tube 202. The endoscope 22 includes a flexible insertion portion 221. The insertion portion 221 is inserted into the second lumen 421 of the inner tube body 42 and the lumen 201 of the balloon 20.
[0063] The insertion portion 221 includes a light guide, a lens unit, an image guide, and a covering portion, not shown in the figure. The light guide guides light from a light source, not shown, connected to the base end of the insertion portion 221 toward the front end of the insertion portion 221. The lens unit is an objective lens located at the front end of the insertion portion 221. The image guide guides the image obtained by the lens unit toward the base end of the insertion portion 221. The covering portion is a tube component that protects the light guide, the lens unit, and the image guide. The endoscope 22 is used together with a display portion such as a monitor and a shooting control device for displaying a captured image (endoscopic image) on the display portion. In addition, in Figure 2 In FIG. 1 , the structure of the insertion portion 221 is simplified.
[0064] like Figure 1 As shown in FIG. 1 , the operation part 24 is provided outside the base end of the inner tube body 42. The operation part 24 moves the insertion part 221 of the endoscope 22 relative to the inner tube 18 in the axial direction (arrow X direction) of the catheter 12. That is, the operation part 24 moves the endoscope 22 inserted into the inner cavity 201 of the balloon 20 through the inner tube body 42 forward and backward along the inner tube body 42.
[0065] The operation part 24 has a housing 50 and a delivery member 52. The housing 50 has a housing body 56, a first connection part 58, and a second connection part 60. The first connection part 58 protrudes from the housing body 56 toward the front end direction (arrow X1 direction). The base end of the inner tube hub 44 is connected to the first connection part 58. The second connection part 60 protrudes from the housing 50 toward the base end direction (arrow X2 direction). The handle part 26 is fixed to the second connection part 60.
[0066] The delivery member 52 is provided inside the housing 50. The delivery member 52 includes a first rotating body 861 and a second rotating body 862. The first rotating body 861 and the second rotating body 862 are arranged side by side in the up-down direction of the housing body 56. The first rotating body 861 and the second rotating body 862 are supported to be rotatable relative to the housing 50. The insertion portion 221 of the endoscope 22 is sandwiched between the first rotating body 861 and the second rotating body 862. By rotating the first rotating body 861 and the second rotating body 862, the endoscope 22 can be delivered toward the inner tube body 42.
[0067] The grip part 26 includes a tubular member 102 and a protective tube part 104. The tubular member 102 is formed in a tubular shape. The distal end of the tubular member 102 is connected to the proximal end of the second connection part 60 of the operation part 24. The protective tube part 104 is fixed to the proximal end of the tubular member 102.
[0068] Next, endoscopic fallopian tube angioplasty using the catheter system 10 will be described.
[0069] Endoscopic fallopian tube plasty includes a preparation step of preparing the catheter system 10. In the preparation step, the fixing screw 32 is tightened in a state where the inner tube body 42 is completely pulled in the direction of the arrow X2 relative to the outer tube body 28. Thus, the inner tube body 42 is fixed to the outer tube body 28. By bringing the slider 16 to the initial state, the front end portion of the tube body 34 extends straight through the slider body 161.
[0070] Next, in the insertion process, the catheter 12 is inserted into the uterine fundus 200 through the cervical canal. Figure 3 As shown, the slider 16 is pulled back relative to the outer tube body 28 toward the base end direction (arrow X2 direction) of the outer tube body 28. As a result, the front end of the tube body 34 is exposed from the slider 16 and bent. At this time, the front end opening 281 of the outer tube body 28 is located near the fallopian tube opening 202a.
[0071] In the insertion process, the endoscope 22 is inserted into the second lumen 421 of the inner tube body 42 through the protective tube portion 104 of the handheld portion 26. After the front end portion of the endoscope 22 is inserted into the tubular member 102 of the handheld portion 26, the user moves the endoscope 22 in the front end direction (arrow X1 direction). The front end portion 22A of the endoscope 22 is inserted into the operation portion 24 from the second connection portion 60.
[0072] like Figure 1 As shown, by rotating the first rotating body 861 of the operating part 24 in a clockwise direction, the second rotating body 862 rotates in a counterclockwise direction opposite to the first rotating body 861. Along with the rotation of the first rotating body 861 and the second rotating body 862, the endoscope 22 is sent out in the front end direction (travel direction, arrow X1 direction).
[0073] like Figure 3 As shown, during the insertion process, the distal end portion 22A of the endoscope 22 passes through the operation portion 24 (see Figure 1) toward the second lumen 421 of the inner tube body 42. The first rotating body 861 of the operating unit 24 is further operated to advance the endoscope 22 along the second lumen 421 of the inner tube body 42, so that the front end portion 22A of the endoscope 22 advances to the front end portion of the balloon 20. At this time, the convex portion 211 of the collecting unit 21 is arranged on the inner side of the balloon 20 and is arranged to face the lumen 201.
[0074] Then, in the confirmation step, the user advances the endoscope 22 so that the front end of the endoscope 22 is located at the front end of the outer tube body 28 (the front end opening of the balloon outlet hole 38), thereby confirming the fallopian tube opening 202a using the image of the endoscope 22. Next, the fixing screw 32 is loosened to release the fixation of the inner tube body 42 relative to the outer tube 14.
[0075] Next, the balloon is led out. Figure 4 As shown, in the pressurization process of the balloon lead-out process, the expansion fluid is supplied to the first introduction port 303 and pressurized. The expansion fluid is supplied from the first introduction port 303 to the outer space Sc of the balloon 20 between the outer tube body 28 and the inner tube body 42 in the inner cavity of the outer tube body 28 via the outer lumen Sa. In the pressurization process, the outer space Sc is pressurized in the range of 5 to 9 atmospheres by the expansion fluid. In addition, it is also possible that after the endoscope 22 is temporarily retracted relative to the outer tube 14, the outer space Sc is pressurized in the range of 5 to 9 atmospheres by the expansion fluid. It is further preferred that the outer space Sc is pressurized to 6 atmospheres.
[0076] The balloon 20 is pressed radially inward and elastically deformed by the expansion fluid supplied to the outer space Sc. That is, the portion of the balloon 20 located radially outward of the insertion portion 221 is in close contact with the outer peripheral surface of the insertion portion 221. The inner surfaces of the portion of the balloon 20 located closer to the arrow X1 direction than the front end of the insertion portion 221 are in contact with each other.
[0077] After that, the user operates the inner tube hub 44 to advance the inner tube body 42 relative to the outer tube body 28 while loosening the fixing screw 32 and pressurizing the outer space Sc with the expansion fluid (advancing step). In this advancing step, the outer space Sc is continuously pressurized by the expansion fluid within the range of 5 to 9 atmospheres. Figure 5 As shown, the balloon 20 pressed toward the front end direction (arrow X1 direction) by the inner tube body 42 moves forward relative to the outer tube body 28. In other words, the pressing force is transmitted from the inner tube body 42 to the balloon 20, so that the balloon 20 and the insertion portion 221 protrude from the front end opening 281 of the outer tube body 28 in the arrow X1 direction. As the balloon 20 moves forward, the collecting portion 21 (convex portion 211) moves toward the front end direction along the inner cavity 201.
[0078] In the advancing process, one end of the balloon 20 is fixed to the front end of the outer tube body 28. Therefore, when the balloon 20 is advanced, the balloon 20 is rolled back at the front end (protruding end) of the balloon 20. That is, the inner surface of the balloon 20 faces outward at the front end of the balloon 20. The portion of the balloon 20 facing outward is the outer peripheral portion 203.
[0079] Next, the user determines whether the endoscope 22 has reached the front end of the balloon 20 based on the endoscopic image. Figure 6 As shown in FIG. 4 , the perfusion liquid is supplied to the second introduction port 443 (supplying process). As a result, the perfusion liquid flows between the balloon 20 and the insertion portion 221 of the endoscope 22 via the inner lumen Sb. The balloon 20 is separated radially outward relative to the insertion portion 221 by the perfusion liquid. In the perfusion liquid supplying process, the perfusion liquid is supplied while the outer space Sc of the balloon 20 is continuously pressurized in the range of 1 to 7 atmospheres.
[0080] Next, the user retreats the endoscope 22 a predetermined distance (retreat process). In the retreat process, if the user rotates the first rotating body 861 of the operating portion 24 in the counterclockwise direction, the second rotating body 862 rotates in the clockwise direction. The insertion portion 221 of the endoscope 22 retreats toward the base end direction (arrow X2 direction) through the first rotating body 861 and the second rotating body 862. In the retreat process, the endoscope 22 is retreated while the outer space Sc of the balloon 20 continues to be pressurized in the range of 1 to 7 atmospheres. Afterwards, the above-mentioned pressurization process and forward process are performed again.
[0081] That is, in endoscopic fallopian tube plasty using the catheter system 10, the movement of the balloon 20 toward the front end direction (forward movement) in the balloon delivery process, the supply of the perfusion fluid between the inner tube body 42 and the endoscope 22 in the supply process, and the retreat movement of the endoscope 22 relative to the inner tube body 42 and the balloon 20 in the retreat process are respectively performed in a state where the space is pressurized in the range of 1 to 7 atmospheres by the expansion fluid (perfusion fluid).
[0082] like Figure 7As shown, in the advancing step, the front end of the balloon 20 advances and contacts the lesion 204. The outer peripheral portion 203 of the balloon 20 contacts the inner peripheral surface 2021 of the fallopian tube 202. At this time, the first protrusion 211A of the collecting portion 21 contacts the inner peripheral surface 2021 of the fallopian tube 202. The inner peripheral surface 2021 of the fallopian tube 202 is slightly pressed radially outward by the protrusion 211. Thereafter, by continuing the advancing step, the outer peripheral portion 203 of the balloon 20 advances in a state of contacting the inner peripheral surface 2021 of the fallopian tube 202. The balloon 20 advances in a state of contacting the inner peripheral surface 2021 of the fallopian tube 202 by the first protrusion 211A of the collecting portion 21. At this time, the tissue of the inner peripheral surface 2021 of the fallopian tube 202 contacts the first protrusion 211A.
[0083] like Figure 8 As shown, if the balloon 20 completely passes through the lesion 204, the lesion 204 is expanded by the outer peripheral portion 203 of the balloon 20. That is, the stenosis or occlusion of the fallopian tube 202 is improved. As the balloon 20 advances, the second protrusion 211B of the collection part 21 is arranged at a position facing the lesion 204, and contacts the inner peripheral surface of the lesion 204 (fallopian tube 202). As the balloon 20 advances, the second protrusion 211B advances in contact with the inner peripheral surface 2021, and the tissue of the inner peripheral surface of the lesion 204 contacts the second protrusion 211B. In a state where the balloon 20 protrudes from the front end of the outer tube 14 to the front end direction, the second protrusion 211B is arranged in the front end direction (arrow X1 direction) relative to the first protrusion 211A.
[0084] After the lesion 204 is expanded radially outward by the balloon 20, the catheter 12 and the endoscope 22 are removed from the uterus (removal step). Fig. 9 As shown, in the removal process, the perfusion fluid may be injected through the second introduction port 443, and the inner tube body 42 may be pulled to retract the balloon 20, while the endoscope 22 is positioned at the front end of the balloon 20. Thus, the catheter 12 and the endoscope 22 can be removed from the uterus while observing the inside of the fallopian tube 202 with the endoscope 22.
[0085] In the removal process, as the balloon 20 moves backward, the outer peripheral portion 203 and the convex portion 211 of the balloon 20 move while sliding in contact with the inner peripheral surface 2021 of the fallopian tube 202, and the tissue of the inner peripheral surface of the lesion 204 is scraped and collected by the second convex piece 211B of the convex portion 211. The tissue of the inner peripheral surface 2021 of the fallopian tube 202 that is closer to the base end direction (arrow X2 direction) than the lesion 204 is scraped and collected by the first convex piece 211A of the convex portion 211. At this time, the tissue of the lesion 204 is hooked on the second convex piece 211B protruding from the outer peripheral portion 203 and collected. The tissue in the base end direction of the lesion 204 is hooked on the first convex piece 211A protruding from the outer peripheral portion 203 and collected. The collected tissue remains around the first convex piece 211A and the second convex piece 211B in the outer peripheral portion 203 of the balloon 20. After the removal process, the endoscopic fallopian tube plasty is completed. After the catheter system 10 is removed from the living body, the balloon 20 is removed from the outer tube 14 and expanded to recover the tissue of the living body collected by the collection portion 21. In addition, when the collection portion 21 is a recessed portion provided in the outer peripheral portion 203 of the balloon 20, the tissue of the inner peripheral surface 2021 of the fallopian tube 202 can be hooked near the boundary between the recessed portion and the outer peripheral portion 203 and collected.
[0086] In addition, in the removal process, the balloon 20 is not limited to being retracted relative to the outer tube 14 and being removed from the uterine fundus 200 after being accommodated in the outer tube 14. Fig.10 As shown, the balloon 20 may not be housed in the outer tube 14. When the balloon 20 protrudes from the front end of the outer tube 14 toward the front end direction (direction of arrow X1), the collecting part 21 is in a state where the peripheral part 203 is exposed, and the catheter system 10 including the balloon 20 is removed from the uterine fundus 200.
[0087] In addition, it is also possible to collect only tissue near the lesion 204 before treating the lesion 204 of the fallopian tube 202. In this case, Figure 7 As shown, in the advancing step of the catheter system 10, after the outer peripheral portion 203 of the balloon 20 contacts the inner peripheral surface 2021 of the fallopian tube 202 and the first protruding piece 211A of the collecting portion 21 contacts the inner peripheral surface 2021, the balloon 20 is retracted to scrape the tissue of the inner peripheral surface 2021 of the fallopian tube 202 near the lesion 204 (the part in the proximal direction of the lesion 204) through the first protruding piece 211A. Then, in the removing step, the catheter system 10 is removed from the uterine fundus 200.
[0088] The tissue of the living body collected by the catheter system 10 is not limited to being recovered after the removal process. Fig.11In the endoscopic fallopian tube plasty according to the second modified example shown, after the lesion 204 is expanded radially outward by the balloon 20 in the advancing step, the supply of the perfusion fluid from the second introduction port 443 to the inner lumen Sb is stopped. A suction device (syringe, etc.) not shown is connected to the second introduction port 443, and the perfusion fluid in the inner lumen Sb and the second space 441 is sucked by the suction device, so that the tissue of the living body is taken out from the second introduction port 443 through the second space 441 of the inner tube hub 44 together with the perfusion fluid supplied to the front end side of the balloon 20.
[0089] The first embodiment has the following effects.
[0090] like Figure 2 As shown, the catheter system 10 comprises: an outer tube 14; an inner tube 18, which is movably disposed in the first lumen 341 of the outer tube 14; a tubular balloon 20, which connects the front end of the outer tube 14 and the front end of the inner tube 18; and a collecting part 21, which protrudes from the front end of the outer tube 14 in the front end direction (arrow X1 direction) and is inserted into the fallopian tube 202 (lumen) of the living body to collect tissue in the fallopian tube 202. Figure 8 As shown, the collecting portion 21 is formed on the outer peripheral portion 203 of the balloon 20 that contacts the inner peripheral surface 2021 of the fallopian tube 202 .
[0091] Thus, when the balloon 20 is advanced into the fallopian tube 202 along the inside of the fallopian tube 202 of the living body, the tissue inside the fallopian tube 202 can be efficiently collected by the collecting section 21 .
[0092] The collecting portion 21 is a convex portion 211 (or concave portion) formed on the outer peripheral portion 203 of the balloon 20. Thus, by providing the collecting portion 21 as the convex portion 211 (or concave portion) on the balloon 20, the balloon 20 can be used to collect tissue in the fallopian tube 202, and compared with a structure in which the collecting portion 21 is provided on other components, the structure of the catheter system 10 can be simplified and the manufacturing cost can be reduced. By providing the convex portion 211 (or concave portion) on the balloon 20, the collecting portion 21 can be easily implemented.
[0093] The base end of the inner tube 18 includes an inner tube hub 44 having a second introduction port 443 capable of supplying and discharging perfusion fluid, and the second introduction port 443 is connected to the second lumen 421 of the inner tube 18 and the lumen 201 of the balloon 20. Fig.11 As shown, after the tissue is collected by the collecting portion 21 of the balloon 20 while the perfusion fluid is supplied into the balloon 20 through the second introduction port 443, the perfusion fluid is discharged from the second introduction port 443, so that the tissue and the perfusion fluid can be taken out from the second introduction port 443 and effectively recovered.
[0094] like Fig.12 As shown, the catheter system 10A according to the second embodiment includes a collection portion 21A that protrudes from the front end of the outer tube 14 toward the front end and is inserted into the fallopian tube 202 of the living body to collect tissue in the fallopian tube 202. Fig.13 As shown, the collecting part 21A is a part of a rod-shaped member 210A inserted into the balloon 20. The rod-shaped member 210A is composed of, for example, a cotton swab 212A. The rod-shaped member 210A has a main body 214A, and the collecting part 21A is provided at the front end of the main body 214A. The maximum diameter of the rod-shaped member 210A viewed in the extension direction is less than the minimum diameter of the inner cavity 201 of the balloon 20.
[0095] like Fig.13 As shown in FIG. 1 , the catheter system 10A includes a first scale portion 216 provided on the inner tube 18 and a second scale portion 218 provided on the main body 214A of the rod-shaped member 210A. The first scale portion 216 is provided on the outer peripheral surface of the inner tube main body 42. The first scale portion 216 is arranged at a constant interval along the axial direction (arrow X direction) of the inner tube main body 42. The second scale portion 218 is formed on the outer peripheral surface of the main body 214A of the rod-shaped member 210A. In the axial direction of the rod-shaped member 210A, the interval D2 of the second scale portion 218 is half of the interval D1 of the first scale portion 216.
[0096] First, in the insertion process, the endoscope 22 is advanced into the fallopian tube 202 of the living body, the fallopian tube ostium 202a is confirmed using the image of the endoscope 22, and the lesion 204 is expanded by the outer peripheral portion 203 of the balloon 20.
[0097] In addition, instead of using the endoscope 22 to check the fallopian tube opening 202a, for example, a method of checking the fallopian tube opening 202a by a hysteroscope without using the endoscope 22 may be adopted. In addition, a method of observing from the outside of the fallopian tube 202 by a laparoscope or a method of observing by X-rays may also be adopted.
[0098] Next, after the endoscope 22 is removed from the balloon 20 and the inner tube 18 in the proximal direction (arrow X2 direction), the rod-shaped member 210A is inserted into the inner cavity 201 of the balloon 20 through the second inner cavity 421 of the inner tube 18, and the rod-shaped member 210A is moved relative to the balloon 20 in the distal direction. Fig.13As shown, in the axial direction of the catheter system 10A, the front end of the outer tube 14 (the front end of the front end member 36), the front end of the balloon 20, and the front end of the rod-shaped member 210A are aligned. The front end of the balloon 20 is inserted into the fallopian tube 202 of the living body. After the rod-shaped member 210A is relatively moved in the proximal direction (arrow X2 direction) with respect to the balloon 20 and the inner tube 18 by an amount corresponding to one scale of the second scale portion 218, the inner tube 18 is relatively moved in the front end direction (arrow X1 direction) by an amount corresponding to one scale of the first scale portion 216. The balloon 20 is folded back, so the moving distance of the balloon 20 in the front end direction is twice the moving distance of the rod-shaped member 210A in the axial direction. Therefore, the distance the balloon 20 moves toward the distal end after the inner tube 18 moves toward the distal end by an amount corresponding to one scale mark of the second scale portion 218 is the same as the distance the rod-shaped member 210A moves toward the proximal end by an amount corresponding to one scale mark of the first scale portion 216 .
[0099] By moving the rod-shaped member 210A in advance toward the proximal direction relative to the inner tube 18 and the balloon 20, the front end of the rod-shaped member 210A does not protrude from the front end of the balloon 20 toward the front end direction (arrow X1 direction). That is, the front end of the rod-shaped member 210A does not protrude from the front end of the balloon 20, and the rod-shaped member 210A moves toward the front end direction while being covered by the balloon 20. That is, the rod-shaped member 210A is prevented from protruding from the balloon 20 toward the front end direction before the front end of the balloon 20 reaches the lesion 204 as the target position.
[0100] like Fig.14 As shown, after the front end of the balloon 20 reaches a position facing the lesion 204, the rod-shaped member 210A is relatively moved in the front direction relative to the inner tube 18. The collecting portion 21A provided at the front end of the rod-shaped member 210A protrudes from the front end of the balloon 20 in the front direction. By tilting the front end of the rod-shaped member 210A toward the inner peripheral surface 2021 of the fallopian tube 202 and bringing the collecting portion 21A into contact with the inner peripheral surface 2021 near the lesion 204, the tissue of the lesion 204 is attached to the surface of the collecting portion 21A. The tissue of the inner peripheral surface 2021 of the fallopian tube 202 is collected by the collecting portion 21A. In addition, the moving distance (insertion length) of the inner tube 18 in the front direction during the insertion process is substantially equal to the moving distance (insertion length) of the endoscope 22 when the fallopian tube orifice 202a is confirmed by the endoscope 22 before the insertion process.
[0101] After the tissue of the living body is collected by the collecting portion 21A, the rod-shaped member 210A is moved in the proximal direction (in the direction of arrow X2) relative to the balloon 20 and removed from the proximal end of the inner tube 18. In addition, it is not limited to the case where the rod-shaped member 210A is first removed relative to the balloon 20. For example, the rod-shaped member 210A and the balloon 20 may be moved together in the proximal direction and removed from the uterine fundus 200 of the living body.
[0102] The second embodiment has the following effects.
[0103] like Fig.13 As shown, the catheter system 10A comprises: an outer tube 14; an inner tube 18 movably disposed in the first lumen 341 of the outer tube 14; a tubular balloon 20 connecting the front end of the outer tube 14 and the front end of the inner tube 18; and a collecting portion 21A protruding from the front end of the outer tube 14 to the front end direction and inserted into the fallopian tube 202 (lumen) of the living body to collect tissue in the fallopian tube 202. The collecting portion 21A is a part of a rod-shaped member 210A inserted into the lumen 201 of the balloon 20.
[0104] Thus, when the balloon 20 is advanced in the fallopian tube 202 of the living body, the tissue in the fallopian tube 202 can be collected by the collecting portion 21A.
[0105] The collecting section 21A is provided at the front end of the rod-shaped member 210A. Thus, by providing the collecting section 21A at the front end of the rod-shaped member 210A, more tissues in the fallopian tube 202 can be collected reliably.
[0106] The inner tube 18 has a first scale portion 216 arranged at a constant interval in the axial direction, and the rod-shaped member 210A has a second scale portion 218 arranged at a constant interval in the axial direction from the front end toward the base end, and the second scale portion 218 is half the interval of the first scale portion 216 in the axial direction. Thus, when the front end of the balloon 20 is inserted into the fallopian tube 202 of the living body, after the rod-shaped member 210A is relatively moved in the base end direction by the second scale portion 218, the inner tube 18 is moved in the front end direction based on the first scale portion 216, thereby preventing the rod-shaped member 210A from protruding from the balloon 20 in the front end direction before the front end of the balloon 20 reaches the target position such as the lesion 204 in the fallopian tube 202.
[0107] In addition, the rod-shaped member 210A is not limited to the cotton swab 212A having the collecting portion 21A at the front end. Fig.15A As shown, the rod-shaped member 210B may be a brush member 212B having a collection portion 21B at the front end. The front end of the brush member 212B includes a brush portion 214B. The brush portion 214B is the collection portion 21B. The tissue in the fallopian tube 202 of the living body can be collected by the brush portion 214B. Fig. 15B As shown, the rod-shaped member 210C may be a forceps member 212C having a collecting portion 21C at the front end. A forceps portion 214C is provided at the front end of the forceps member 212C. The forceps portion 214C can be opened and closed, and tissue in the fallopian tube 202 of the living body can be collected by closing the open forceps portion 214C.
[0108] In addition, the present invention is not limited to the above disclosure, and various structures can be adopted without departing from the gist of the present invention.
Claims
1. A catheter system that is inserted into a lumen of a living body and is capable of traveling along the lumen, The catheter system is characterized by comprising: An outer tube, wherein the outer tube is flexible; an inner tube, the inner tube being disposed in the inner cavity of the outer tube in a manner movable along the axial direction of the outer tube; a tubular balloon that connects the front end of the outer tube and the front end of the inner tube to each other and expands radially inwardly of the outer tube to allow a rod-shaped member to be inserted through the inner tube; and a collecting part, the collecting part protruding from the front end of the outer tube toward the front end and inserted into the lumen of the biological body to collect tissue in the lumen, After the balloon protrudes from the front end of the outer tube toward the front end direction, the balloon has an outer peripheral portion in contact with the inner peripheral surface of the lumen. The collecting portion is a convex portion formed on the outer peripheral portion of the balloon, a concave portion formed on the outer peripheral portion, or a part of the rod-shaped member inserted into the balloon.
2. The catheter system according to claim 1, characterized in that The collecting portion is the convex portion or the concave portion formed on the outer peripheral portion of the balloon.
3. The catheter system according to claim 2, characterized in that The inner tube has an inner tube hub at its proximal end, and the inner tube hub has a port capable of supplying and discharging a perfusion fluid. The port is in communication with the inner tube and the interior of the balloon.
4. The catheter system according to claim 1, characterized in that The collecting portion is provided at the front end portion of the rod-shaped member.
5. The catheter system according to claim 4, characterized in that The inner tube has first scale portions arranged at constant intervals in the axial direction. The rod-shaped member has a second scale portion which is arranged at a constant interval in the axial direction from the distal end toward the proximal end and is half the interval of the first scale portion in the axial direction.
6. The catheter system according to claim 1, characterized in that The rod-shaped member is an endoscope.