Catheter system
The catheter system addresses inefficiencies in fallopian tube tissue collection by integrating convex or concave portions on the balloon for direct tissue retrieval, enhancing collection efficiency and reducing complexity and cost.
Patent Information
- Application Number
- JP2023117510
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-07-19
- Publication Date
- 2025-01-30
AI Technical Summary
Existing catheter systems are inefficient in collecting tissue from lesions in the fallopian tubes, such as cancerous lesions or blockages, and often require separate collection members, increasing complexity and cost.
A catheter system with a balloon that has convex or concave portions on its outer periphery, allowing for direct collection of tissue, integrated with a perfusion system for effective tissue retrieval, and optionally featuring a rod-shaped member for enhanced collection.
The system effectively collects tissue from fallopian tubes by using the balloon's convex or concave portions, simplifies structure, reduces manufacturing costs, and ensures reliable collection with integrated perfusion, while allowing for endoscopic imaging.
Smart Images
Figure 2025014726000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a catheter system. [Background technology]
[0002] Patent Document 1 discloses a balloon catheter for treating a diseased portion (a narrowed portion or an obstructed portion) of the fallopian tube. This 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 relative to the outer tube, a tubular balloon connecting the distal end of the outer tube to the distal end of the inner tube, and an operating unit provided midway through the outer tube. An endoscope is inserted inside the balloon. When a user operates the operating unit, the endoscope advances along the outer tube toward the distal end. [Prior art documents] [Patent documents]
[0003] [Patent Document 1] Patent No. 3921112 Summary of the Invention [Problem to be solved by the invention]
[0004] It is desirable to efficiently collect tissue from lesions in the lumen of a living body (lesions such as fallopian tube cancer, stenosis, or obstruction). [Means for solving the problem]
[0005] (1) An aspect of the present invention is a catheter system capable of being inserted into a lumen of a living body and advancing along the lumen, comprising: a flexible outer tube; an inner tube provided within an inner lumen of the outer tube so as to be movable in an axial direction of the outer tube; a tubular balloon connecting a tip end of the outer tube to a tip end of the inner tube and expanding radially inward of the outer tube, into which a rod-shaped member can be inserted through the inner tube; and a collection portion that protrudes distally from the tip of the outer tube and is inserted into the lumen of the living body to collect tissue within the lumen, wherein when the balloon protrudes distally from the tip of the outer tube, the balloon has an outer periphery that contacts an inner periphery of the lumen, and the collection portion is a convex portion formed on the outer periphery of the balloon, a concave portion formed on the outer periphery, or a part of the rod-shaped member inserted into the balloon.
[0006] With this catheter system, when the balloon is advanced along the inside of the lumen of the living body, tissue within the lumen can be effectively sampled using a convex portion formed on the outer periphery of the balloon, a concave portion formed on the outer periphery, or a sampling portion which is part of a rod-shaped member inserted into the balloon.
[0007] (2) In the catheter system described in (1) above, the collection portion may be the convex portion or the concave portion formed on the outer periphery of the balloon.
[0008] With this configuration, by providing the collection portion, which is a convex or concave portion, on the balloon, tissue can be collected using the balloon, and the structure can be simplified and manufacturing costs can be reduced compared to a configuration in which the collection portion is provided on a separate member. By providing the balloon with a convex or concave portion, the collection portion can be easily realized.
[0009] (3) In the catheter system described in (2) above, the base end of the inner tube may be provided with an inner tube hub having a port capable of supplying and discharging perfusion fluid, and the port may be connected to the inside of the inner tube and the balloon.
[0010] With this configuration, when perfusion fluid is supplied into the balloon through the port and tissue is harvested using the harvesting portion of the balloon, the tissue can be effectively recovered from the port together with the perfusion fluid by discharging the perfusion fluid from the port.
[0011] (4) In the catheter system described in (1) above, the collection portion may be provided at the tip of the rod-shaped member.
[0012] With this configuration, by providing a sampling portion at the tip of the rod-shaped member, it is possible to sample a larger amount of tissue from within the lumen more reliably.
[0013] (5) In the catheter system described in (1) or (4) above, the inner tube may have first graduation portions arranged at regular intervals in the axial direction, and the rod-shaped member may have second graduation portions arranged at regular intervals in the axial direction from the tip to the base end and having intervals that are half the intervals of the first graduation portions in the axial direction.
[0014] With this configuration, when the tip of the balloon is inserted into a lumen of a living body, the rod-shaped member is moved relatively in the base end direction by the second scale portion, and then the inner tube is moved in the tip direction based on the first scale portion, thereby preventing the rod-shaped member from protruding in the tip direction from the balloon before the tip of the balloon reaches the target position within the lumen.
[0015] (6) In the catheter system described in any one of (1) to (3) above, the rod-shaped member may be an endoscope.
[0016] With this configuration, for example, it is possible to advance the balloon into the body's lumen without having to operate it while checking the scale using endoscopic images (and it may also be possible to identify the lesion using endoscopic images by labeling it with a cell surface marker or the like). Effect of the Invention
[0017] According to the present invention, the catheter system includes a collection section that protrudes from the tip of the outer tube in the tip direction and is inserted into a lumen of a living body to collect tissue from the lumen, the collection section being a convex or concave section formed on the outer periphery of the balloon, or a part of a rod-shaped member inserted into the balloon, whereby when the balloon is advanced into the lumen of the living body, tissue from the lumen can be effectively collected by the collection section. [Brief description of the drawings]
[0018] [Figure 1] FIG. 1 is a schematic configuration diagram of a catheter system according to a first embodiment of the present invention. [Diagram 2] FIG. 2 is a cross-sectional view of the catheter system of FIG. 1 with some parts omitted. [Diagram 3] FIG. 3 is a first explanatory diagram of endoscopic salpingoplasty using the catheter system of FIG. [Figure 4] FIG. 4 is a second explanatory diagram of the endoscopic salpingoplasty shown in FIG. [Diagram 5] FIG. 5 is a third explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 6] FIG. 6 is a fourth explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 7] FIG. 7 is a fifth explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 8] FIG. 8 is a sixth explanatory diagram of the endoscopic salpingoplasty shown in FIG. [Figure 9] FIG. 9 is a seventh explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 10] FIG. 10 is an explanatory diagram of endoscopic salpingoplasty according to the first modified example. [Figure 11] FIG. 11 is an explanatory diagram of endoscopic salpingoplasty according to the second modified example. [Figure 12] FIG. 12 is a schematic configuration diagram of a catheter system according to the second embodiment of the present invention. [Figure 13] FIG. 13 is a first explanatory view of the endoscopic fallopian tube tissue sampling procedure shown in FIG. [Figure 14]FIG. 14 is a second explanatory view of the endoscopic fallopian tube tissue sampling procedure shown in FIG. [Figure 15] Fig. 15A is an enlarged cross-sectional view showing a rod-shaped member according to a first modified example, and Fig. 15B is an enlarged cross-sectional view showing a rod-shaped member according to a second modified example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] As shown in Fig. 1, the catheter system 10 according to the first embodiment can be inserted into a lumen of a living body and advanced along the lumen. The catheter system 10 is used, for example, in endoscopic salpingoplasty for treating a lesion 204 (lesion such as fallopian tube cancer, stenosis, or obstruction) in a lumen of a fallopian tube 202 (see Fig. 3). The catheter system 10 may be used to treat a lesion in a living organ other than the fallopian tube 202, for example, a blood vessel, a bile duct, a trachea, an esophagus, a urethra, or another organ. In the following description, the leftward direction (arrow X1 direction) of the catheter system 10 in Fig. 1 is referred to as the "distal direction," and the rightward direction (arrow X2 direction) of the catheter system 10 in Fig. 1 is referred to as the "base direction."
[0020] 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 section 24 for operating an endoscope 22 inserted into the inner tube 18, and a handle section 26. Thus, 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.
[0021] 2, the outer tube 14 has a flexible outer tube body 28, an outer tube hub 30, and a fixing screw 32. The outer tube body 28 includes a tubular body 34 and a distal end member 36 (distal tip). Examples of materials constituting the tubular body 34 and the distal end member 36 include polyolefin, polyester, elastomer resin, flexible polymeric material, soft polyvinyl chloride, polyurethane, polyamide, fluororesin, etc. The outer tube 14 is an outer catheter.
[0022] The tube 34 has a first lumen 341. The first lumen 341 penetrates the entire length of the tube 34 in the axial direction. The tip of the tube 34 is shaped to be curved in an arc in the axial direction of the tube 34. The tube 34 has a substantially constant outer diameter over the entire length in the axial direction.
[0023] The tip member 36 is provided at the tip of the tubular body 34. The outer circumferential surface of the tip member 36 is curved corresponding to the shape of the fallopian tube orifice 202a (see FIG. 3), which is curved with respect to the advancing direction of the catheter 12. The tip member 36 has a balloon outlet hole 38. The balloon outlet hole 38 includes a tip opening 281 of the outer tube main body 28. The balloon 20 passes through the balloon outlet hole 38 and is led out in the tip direction (arrow X1 direction) from the tip member 36.
[0024] The outer tube hub 30 is fixed to the base end of the outer tube body 28. The material constituting the outer tube hub 30 may be, for example, a hard resin or a metal material. Examples of the hard resin constituting the outer tube hub 30 include polycarbonate, acrylic resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, etc. Examples of the metal material constituting the outer tube hub 30 include stainless steel, titanium, titanium alloy, etc.
[0025] The outer tube hub 30 is formed to be hollow. The outer tube hub 30 is formed to have a size that is easy for a user to operate. The outer tube hub 30 has a first space 301, a first insertion hole 302, and a first introduction port portion 303. The first space 301 communicates with a first lumen 341 of the outer tube main body 28. The first insertion hole 302 is located in the direction of the arrow X2 of the first space 301. The inner tube 18 is inserted into the first insertion hole 302. The first introduction port portion 303 introduces an expansion fluid into the first space 301.
[0026] The expansion fluid inflates the balloon 20 radially inward of the outer tube main body 28. The expansion fluid is, for example, physiological saline. The expansion fluid may be sterile water. The first space 301 of the outer tube hub 30 is provided with a first seal member 40. The first seal member 40 prevents the expansion fluid in the first space 301 from leaking out through the first insertion hole 302 to the outside.
[0027] The fixing screw 32 is screwed into the outer tube hub 30. When a user tightens the fixing screw 32, the inner tube 18 is fixed to the outer tube hub 30. When a user loosens the fixing screw 32, the inner tube 18 becomes movable relative to the outer tube hub 30.
[0028] The slider 16 is attached to the outer tube 14. The slider 16 slides on the outer peripheral surface of the tube body 34 in 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 has 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.
[0029] When the slider 16 is moved to the furthest position in the direction of arrow X1 relative to the tube 34 (initial position of the slider 16), the tip of the tube 34 extends linearly along the shape of the slider body 161. Conversely, when the slider 16 is moved in the direction of arrow X2 relative to the tube 34, the tip of the tube 34 becomes more exposed in the direction of arrow X1 than the slider 16. At this time, the tip of the tube 34 is curved in an arc. Before use, the catheter system 10 is stored with the tip of the tube 34 curved.
[0030] The inner pipe 18 includes an inner pipe body 42 and an inner pipe hub 44. Examples of the material constituting the inner pipe body 42 include a relatively hard resin material or a metal material. Examples of the hard resin constituting the inner pipe body 42 include polycarbonate, acrylic resin, polyester, polyolefin, styrene-based resin, polyamide, polysulfone, polyarylate, polyetherimide, etc. Examples of the metal material constituting the inner pipe body 42 include stainless steel, titanium, titanium alloy, etc. The inner tube body 42 has a second lumen 421 penetrating through the entire axial length of the inner tube body 42. The inner tube 18 is an inner catheter.
[0031] The inner tube body 42 is provided in the first lumen 341 of the outer tube body 28 so as to be movable in the axial direction of the outer tube body 28. The inner tube body 42 passes through the outer tube hub 30. The tip of the inner tube body 42 is positioned in the direction of arrow X2 further than the tip of the tube 34. An outer lumen Sa is provided between the outer peripheral surface of the inner tube body 42 and the inner peripheral surface of the tube 34, through which the expansion fluid flows.
[0032] The insertion section 221 of the endoscope 22 is inserted into the second lumen 421 of the inner tube body 42. With the insertion section 221 inserted into the second lumen 421 of the inner tube body 42, an inner lumen Sb through which a perfusion fluid flows is provided between the inner tube body 42 and the insertion section 221.
[0033] The inner tube hub 44 is fixed to the base end of the inner tube main 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 portion 443. The second space 441 communicates with the second lumen 421 of the inner tube main body 42. The second insertion hole 442 is located in the direction of the arrow X2 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 portion 443 introduces the perfusion fluid into the second space 441.
[0034] The perfusion fluid is, for example, physiological saline. A second seal member 46 is provided in the second space 441 of the inner tube hub 44. The second seal member 46 prevents the perfusion fluid in the second space 441 from leaking out through the second insertion hole 442 to the outside.
[0035] The balloon 20 is a tubular member that connects the tip of the outer tube body 28 and the tip of the inner tube body 42. The balloon 20 is inflated radially inward of the outer tube body 28 by the expansion fluid. In other words, the balloon 20 is formed so as to be elastically deformable in the radial direction. The balloon 20 is preferably made of polyolefin, polyester, elastomer resin, flexible polymer material, soft polyvinyl chloride, polyurethane, polyamide, polyisoprene, polyester, fluororesin, or the like.
[0036] One end of the balloon 20 is adhered to the tip of the outer tube body 28 by an adhesive (not shown). Note that, for example, one end of the balloon 20 may be welded to the tip of the outer tube body 28. One end of the balloon 20 is sandwiched between the tip of the tube 34 and the tip member 36.
[0037] The other end of the balloon 20 is fixed to the outer circumferential surface of the tip portion of the inner tube body 42 by a balloon fixing member 48. The other end of the balloon 20 may be bonded to the tip portion of the inner circumferential surface of the inner tube body 42 by an adhesive. The other end of the balloon 20 may be welded to the tip portion of the inner circumferential surface of the inner tube body 42.
[0038] 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 tubular body 34, a bag-shaped outer space Sc having a closed tip is provided.
[0039] With the balloon 20 inflated radially inward, a pushing force (pushing force in the distal direction) is transmitted from the inner tube main body 42 to the balloon 20, causing the balloon 20 to protrude in the distal direction from the distal opening 281 of the outer tube main body 28 (see FIG. 5). At this time, the distal end of the balloon 20 is turned back so that the inner surface of the balloon 20 faces outward. In other words, the protruding portion of the balloon 20 that protrudes in the direction of arrow X1 beyond the distal opening 281 of the outer tube main body 28 includes a portion where the wall of the balloon 20 is folded twice in the radial direction.
[0040] 7, the balloon 20 has an outer peripheral portion 203 that is disposed on the outer peripheral side of the balloon 20 when the balloon 20 protrudes in the distal direction from the distal end of the outer tube 14. The outer peripheral portion 203 comes into contact with an inner peripheral surface 2021 of the fallopian tube 202 of a living organism. When the balloon 20 is housed inside the outer tube 14, the outer peripheral portion 203 is disposed on the inner peripheral side.
[0041] The outer circumferential portion 203 of the balloon 20 is provided with a collection portion 21 capable of collecting tissue from within a living body. The balloon 20 protrudes from the tip of the outer tube 14 in the tip direction, and when the outer circumferential portion 203 of the balloon 20 is inserted into the fallopian tube 202 of a living body and contacts the inner circumferential surface 2021 of the fallopian tube 202, the collection portion 21 contacts the inner circumferential surface 2021 of the fallopian tube 202. The collection portion 21 is a convex portion 211 formed on the outer circumferential portion 203 of the balloon 20. The convex portion 211 protrudes radially outward from the outer circumferential portion 203. The convex portion 211 is formed in a ring shape along the circumferential direction of the balloon 20. As shown in FIG. 2, the convex portion 211 protrudes radially inward and faces the lumen 201 when the balloon 20 is housed in the outer tube 14.
[0042] The protrusion 211 is not limited to being formed in an annular shape along the circumferential direction of the balloon 20. For example, a plurality of protrusions 211 spaced apart from each other in the circumferential direction of the balloon 20 may be provided.
[0043] The protruding portion 211 includes a first protruding piece 211A and a second protruding piece 211B. The first protruding piece 211A and the second protruding piece 211B are arranged apart from each other in the axial direction (arrow X direction) of the balloon 20. When the balloon 20 is accommodated in the outer tube 14, the first protruding piece 211A is arranged further forward (arrow X1 direction) than the second protruding piece 211B. Note that the first protruding piece 211A and the second protruding piece 211B are not limited to being provided singly. For example, two or more of the first protruding piece 211A and the second protruding piece 211B may be provided. The first protruding piece 211A and the second protruding piece 211B may have the same shape, or the first protruding piece 211A and the second protruding piece 211B may have different shapes.
[0044] The first convex piece 211A is provided so that tissue between the lesion 204 in the fallopian tube 202 and the tubal orifice 202a can be collected (see FIG. 7). The second convex piece 211B is provided so that tissue of the lesion 204 in the fallopian tube 202 can be collected (see FIG. 8). Note that the convex portion 211 is not limited to having the first and second convex pieces 211A and 211B. It is sufficient that the convex portion 211 is provided with at least the second convex piece 211B that can collect tissue of the lesion 204.
[0045] The collection portion 21 is not limited to the convex portion 211 protruding radially outward from the outer circumferential portion 203 of the balloon 20. For example, it may be a concave portion recessed radially inward from the outer circumferential portion 203 of the balloon 20.
[0046] 2, 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 main body 42 and the lumen 201 of the balloon 20.
[0047] The insertion section 221 includes a light guide (not shown), a lens unit, an image guide, and a covering section. The light guide guides light from a light source (not shown) connected to the base end of the insertion section 221 to the tip of the insertion section 221. The lens unit is an objective lens located at the tip of the insertion section 221. The image guide guides an image obtained by the lens unit toward the base end of the insertion section 221. The covering section is a tube member that protects the light guide, the lens unit, and the image guide. The endoscope 22 is used together with a display section such as a display, and an imaging control device for displaying a captured image (endoscopic image) on the display section. Note that FIG. 2 shows a simplified configuration of the insertion section 221.
[0048] 1, the operation unit 24 is provided on the outside of the base end of the inner tube main body 42. The operation unit 24 moves the insertion portion 221 of the endoscope 22 in the axial direction of the catheter 12 (the direction of the arrow X) relative to the inner tube 18. In other words, the operation unit 24 moves the endoscope 22, which is inserted into the lumen 201 of the balloon 20 through the inner tube main body 42, back and forth along the inner tube main body 42.
[0049] The operating unit 24 has a case 50 and a delivery member 52. The case 50 has a case main body 56, a first connection portion 58, and a second connection portion 60. The first connection portion 58 protrudes from the case main body 56 in the distal direction (the direction of the arrow X1). The base end of the inner tube hub 44 is connected to the first connection portion 58. The second connection portion 60 protrudes from the case 50 in the proximal direction (the direction of the arrow X2). The handle portion 26 is fixed to the second connection portion 60.
[0050] The delivery member 52 is provided inside the case 50. The delivery member 52 includes first and second rotating bodies 861, 862. The first rotating body 861 and the second rotating body 862 are arranged next to each other in the up-down direction of the case main body 56. The first and second rotating bodies 861, 862 are rotatably supported with respect to the case 50. The insertion portion 221 of the endoscope 22 is clamped between the first rotating body 861 and the second rotating body 862. The endoscope 22 can be delivered toward the inner tube main body 42 by rotating the first and second rotating bodies 861, 862.
[0051] The handle portion 26 includes a tubular member 102 and a protective tube portion 104. The tubular member 102 is formed in a tubular shape. The tip of the tubular member 102 is connected to the base end of the second connection portion 60 in the operation portion 24. The protective tube portion 104 is fixed to the base end of the tubular member 102.
[0052] Next, endoscopic salpingoplasty using the catheter system 10 will be described.
[0053] Endoscopic salpingoplasty includes a preparation step of preparing the catheter system 10. In the preparation step, the fixing screw 32 is tightened while the inner tube body 42 is fully pulled in the direction of the arrow X2 relative to the outer tube body 28. This fixes the inner tube body 42 to the outer tube body 28. By setting the slider 16 to the initial state, the tip of the tube body 34 is made to extend straight by the slider body 161.
[0054] Next, in the insertion step, the catheter 12 is inserted transcervically to the uterine fundus 200. As shown in Fig. 3, the slider 16 is pulled back relative to the outer tube main body 28 in the direction of the base end of the outer tube main body 28 (the direction of arrow X2). As a result, the tip of the tubal body 34 is exposed from the slider 16 and curved. At this time, the tip opening 281 of the outer tube main body 28 is positioned near the fallopian tube orifice 202a.
[0055] In the insertion step, the endoscope 22 is inserted into the second lumen 421 of the inner tube main body 42 through the protective tube portion 104 of the handle portion 26. After inserting the tip portion of the endoscope 22 into the inside of the tubular member 102 of the handle portion 26, the user advances the endoscope 22 toward the tip direction (the direction of the arrow X1). The tip portion 22A of the endoscope 22 is inserted into the operation portion 24 from the second connection portion 60.
[0056] As shown in FIG. 1, by rotating the first rotating body 861 of the operating unit 24 clockwise, the second rotating body 862 rotates counterclockwise, which is the opposite direction to the first rotating body 861, and as the first and second rotating bodies 861, 862 rotate, the endoscope 22 is sent out toward the tip (travel direction, direction of arrow X1).
[0057] 3, in the insertion step, the tip portion 22A of the endoscope 22 advances through the operation unit 24 (see FIG. 1) into the second lumen 421 of the inner tube main body 42. Furthermore, by operating the first rotating body 861 of the operation unit 24, the endoscope 22 advances along the second lumen 421 of the inner tube main body 42, and the tip portion 22A of the endoscope 22 advances to the tip of the balloon 20. At this time, the convex portion 211 of the collection portion 21 is disposed inside the balloon 20 so as to face the lumen 201.
[0058] Thereafter, in the confirmation step, the user advances the endoscope 22 so that the tip of the endoscope 22 is positioned at the tip of the outer tube body 28 (the tip opening of the balloon outlet hole 38), thereby confirming the tubal orifice 202a on the image of the endoscope 22. Next, the fastening screw 32 is loosened to release the fixation of the inner tube body 42 to the outer tube 14.
[0059] Next, a balloon extraction step is performed. As shown in FIG. 4, in the pressurizing step of the balloon extraction step, pressurization is performed by supplying an expansion fluid to the first introduction port portion 303. The expansion fluid is supplied from the first introduction port portion 303 through the outer lumen Sa to the outer space Sc of the balloon 20, which is between the outer tube main body 28 and the inner tube main body 42 in the lumen of the outer tube main body 28. In the pressurizing step, the outer space Sc is pressurized to a pressure range of 5 to 9 atmospheres with the expansion fluid. Note that the outer space Sc may be pressurized to a pressure range of 5 to 9 atmospheres with the expansion fluid after the endoscope 22 is once retracted relative to the outer tube 14. It is more preferable that the outer space Sc is pressurized to 6 atmospheres.
[0060] The balloon 20 is pressed radially inward by the expansion fluid supplied to the outer space Sc and elastically deforms. That is, the portion of the balloon 20 located radially outward of the insertion part 221 is in close contact with the outer circumferential surface of the insertion part 221. The portions of the balloon 20 located in the direction of the arrow X1 beyond the tip of the insertion part 221 are in contact with each other at their inner surfaces.
[0061] Thereafter, the user loosens the fixing screw 32, and operates the inner tube hub 44 while the outer space Sc is pressurized by the expansion fluid to advance the inner tube main body 42 toward the outer tube main body 28 (advancement step). In this advancement step, the outer space Sc is continuously pressurized by the expansion fluid at a pressure in the range of 5 to 9 atm. Then, as shown in FIG. 5, the balloon 20 pushed toward the distal end (arrow X1 direction) by the inner tube main body 42 advances toward the outer tube main body 28. That is, the balloon 20 protrudes from the distal end opening 281 of the outer tube main body 28 together with the insertion part 221 in the arrow X1 direction by the pushing force being transmitted from the inner tube main body 42 to the balloon 20. As the balloon 20 advances, the collection part 21 (protrusion 211) moves toward the distal end along the lumen 201.
[0062] In the forward movement step, one end of the balloon 20 is fixed to the tip of the outer tube main body 28. Therefore, when the balloon 20 moves forward, the balloon 20 is rolled up at the tip (protruding end) of the balloon 20. That is, the inner surface of the balloon 20 faces outward at the tip of the balloon 20. The part of the balloon 20 facing outward becomes the outer circumferential portion 203.
[0063] Next, the user determines whether or not the endoscope 22 has reached the tip of the balloon 20 based on the endoscopic image. When the balloon 20 is located in front of the lesion 204, as shown in FIG. 6, the perfusion fluid is supplied to the second introduction port portion 443 (supply step). This allows the perfusion fluid to flow between the balloon 20 and the insertion portion 221 of the endoscope 22 via the inner lumen Sb. The perfusion fluid moves the balloon 20 away from the insertion portion 221 radially outward. In the perfusion fluid supply step, the perfusion fluid is supplied in a state in which the outer space Sc of the balloon 20 is continuously pressurized within a range of 1 to 7 atm.
[0064] Next, the user retreats the endoscope 22 a predetermined distance (retreating step). In the retracting step, when the user rotates the first rotating body 861 of the operation unit 24 counterclockwise, the second rotating body 862 rotates clockwise. The first and second rotating bodies 861, 862 cause the insertion portion 221 of the endoscope 22 to retreat toward the base end (the direction of the arrow X2). In the retracting step, the endoscope 22 is retreated in a state in which the outer space Sc of the balloon 20 is continuously pressurized within a range of 1 to 7 atm. Thereafter, the pressurizing step and the advancing step described above are performed again.
[0065] That is, in endoscopic salpingoplasty using the catheter system 10, the advancement (forward movement) of the balloon 20 toward the tip in the balloon extraction process, the supply of perfusion fluid between the inner tube body 42 and the endoscope 22 in the supply process, and the retraction of the endoscope 22 relative to the inner tube body 42 and the balloon 20 in the retraction process are all performed with the space pressurized in the range of 1 to 7 atmospheres by the expansion fluid (perfusion fluid).
[0066] As shown in FIG. 7, in the forward movement step, the tip of the balloon 20 moves forward and contacts the diseased area 204. The outer circumferential portion 203 of the balloon 20 comes into contact with the inner circumferential surface 2021 of the fallopian tube 202. At this time, the first convex piece 211A of the collection portion 21 comes into contact with the inner circumferential surface 2021 of the fallopian tube 202. The inner circumferential surface 2021 of the fallopian tube 202 is slightly pressed radially outward by the convex portion 211. Thereafter, by continuing the forward movement step, the outer circumferential portion 203 of the balloon 20 moves forward in a state of contacting the inner circumferential surface 2021 of the fallopian tube 202. The first convex piece 211A of the collection portion 21 moves forward in a state of contacting the inner circumferential surface 2021 of the fallopian tube 202. At this time, the tissue on the inner circumferential surface 2021 of the fallopian tube 202 comes into contact with the first convex piece 211A.
[0067] As shown in FIG. 8, when the balloon 20 completely passes through the lesion 204, the lesion 204 is pushed open by the outer circumferential portion 203 of the balloon 20. That is, the stenosis or blockage of the fallopian tube 202 is improved. As the balloon 20 advances, the second convex piece 211B of the collection portion 21 is disposed at a position facing the lesion 204 and contacts the inner circumferential surface of the lesion 204 (fallopian tube 202). As the balloon 20 advances, the second convex piece 211B advances in contact with the inner circumferential surface 2021, and the tissue on the inner circumferential surface of the lesion 204 comes into contact with the second convex piece 211B. With the balloon 20 protruding from the tip of the outer tube 14 in the distal direction, the second convex piece 211B is disposed in the distal direction (arrow X1 direction) relative to the first convex piece 211A.
[0068] After the lesion 204 is spread radially outward by the balloon 20, the catheter 12 and the endoscope 22 are removed from the uterus (removal step). As shown in Fig. 9, in the removal step, the balloon 20 may be retracted by pulling the inner tube main body 42 while injecting perfusion fluid through the second introduction port portion 443, and at the same time, the endoscope 22 may be operated to be positioned at the tip of the balloon 20. This allows the catheter 12 and the endoscope 22 to be removed from the uterus while observing the inside of the fallopian tube 202 with the endoscope 22.
[0069] In the removal step, as the balloon 20 retreats, the outer circumferential portion 203 and the convex portion 211 of the balloon 20 move while sliding against the inner circumferential surface 2021 of the fallopian tube 202, and the second convex piece 211B of the convex portion 211 scrapes off and collects tissue on the inner circumferential surface of the diseased portion 204. The first convex piece 211A of the convex portion 211 scrapes off and collects tissue on the inner circumferential surface 2021 of the fallopian tube 202 that is in the proximal direction (arrow X2 direction) from the diseased portion 204. At this time, the tissue of the diseased portion 204 is caught by the second convex piece 211B protruding from the outer circumferential portion 203 and collected. The tissue in the proximal direction of the diseased portion 204 is caught by the first convex piece 211A protruding from the outer circumferential portion 203 and collected. The collected tissue remains around the first convex piece 211A and the second convex piece 211B in the outer circumferential portion 203 of the balloon 20. After the removal step, the endoscopic salpingoplasty is completed. After the catheter system 10 is removed from the living body, the balloon 20 is removed from the outer tube 14, and the balloon 20 is expanded to retrieve the living body tissue collected by the collection part 21. When the collection part 21 is a recessed part provided on the outer periphery 203 of the balloon 20, the tissue on the inner periphery 2021 of the fallopian tube 202 can be hooked and collected near the boundary between the recessed part and the outer periphery 203.
[0070] The removal step is not limited to the case where the balloon 20 is retracted relative to the outer tube 14, and then the balloon 20 is housed within the outer tube 14 and then removed from the uterine fundus 200. For example, as shown in Fig. 10, the balloon 20 may not be housed in the outer tube 14, but rather the catheter system 10 including the balloon 20 may be removed from the uterine fundus 200 in a state where the balloon 20 protrudes from the tip of the outer tube 14 in the tip direction (the direction of the arrow X1) and the collection portion 21 is exposed to the outer circumferential portion 203.
[0071] Also, before treating the lesion 204 of the fallopian tube 202, it is possible to collect only tissue in the vicinity of the lesion 204 in advance. In this case, as shown in Fig. 7, in the advancement step of the catheter system 10, the outer circumferential portion 203 of the balloon 20 comes into contact with the inner circumferential surface 2021 of the fallopian tube 202, and after the first convex piece 211A of the collection part 21 comes into contact with the inner circumferential surface 2021, the balloon 20 is retracted, whereby the first convex piece 211A scrapes off tissue on the inner circumferential surface 2021 of the fallopian tube 202 in the vicinity of the lesion 204 (the portion in the proximal direction of the lesion 204). Thereafter, in the removal step, the catheter system 10 is removed from the uterine fundus 200.
[0072] The living tissue collected by the catheter system 10 is not limited to being collected after the removal step. In the endoscopic salpingoplasty according to the second modified example shown in Fig. 11, after the balloon 20 spreads the lesion 204 radially outward in the advancing step, the supply of the perfusion fluid from the second introduction port 443 to the inner lumen Sb is stopped. By connecting a suction device (such as a syringe) (not shown) to the second introduction port 443 and suctioning the perfusion fluid from the inner lumen Sb and the second space 441 with the suction device, the living tissue together with the perfusion fluid supplied to the tip side of the balloon 20 is taken out from the second introduction port 443 through the second space 441 of the inner tube hub 44.
[0073] The first embodiment provides the following advantages.
[0074] 2, the catheter system 10 includes an outer tube 14, an inner tube 18 movably provided in a first lumen 341 of the outer tube 14, a tubular balloon 20 connecting a distal end of the outer tube 14 and a distal end of the inner tube 18, and a collection portion 21 that protrudes from the distal end of the outer tube 14 in a distal direction (arrow X1 direction) and is inserted into an fallopian tube 202 (lumen) of a living body to collect tissue from the fallopian tube 202. As shown in FIG. 8, the collection portion 21 is formed on an outer circumferential portion 203 of the balloon 20 that contacts an inner circumferential surface 2021 of the fallopian tube 202.
[0075] This allows tissue within the fallopian tube 202 to be effectively collected by the collection portion 21 when the balloon 20 is advanced along the fallopian tube 202 of the living body.
[0076] The collection portion 21 is a convex portion 211 (or a concave portion) formed on the outer circumferential portion 203 of the balloon 20. Thus, by providing the collection portion 21, which is the convex portion 211 (or a concave portion), on the balloon 20, it is possible to use the balloon 20 to collect tissue inside the fallopian tube 202, and it is possible to simplify the structure of the catheter system 10 and reduce manufacturing costs compared to a configuration in which the collection portion 21 is provided on a separate member. By providing the balloon 20 with the convex portion 211 (or a concave portion), the collection portion 21 can be easily realized.
[0077] The base end of the inner tube 18 is equipped with an inner tube hub 44 having a second introduction port portion 443 capable of supplying and discharging perfusion fluid, and the second introduction port portion 443 communicates with the second lumen 421 of the inner tube 18 and the lumen 201 of the balloon 20. As a result, as shown in Fig. 11, when tissue is collected by the collection portion 21 of the balloon 20 while perfusion fluid is supplied into the balloon 20 through the second introduction port portion 443, the tissue can be effectively collected by removing it from the second introduction port portion 443 together with the perfusion fluid by discharging the perfusion fluid from the second introduction port portion 443.
[0078] As shown in Fig. 12, the catheter system 10A according to the second embodiment includes a collection unit 21A that protrudes from the tip of the outer tube 14 in the tip direction and is inserted into the fallopian tube 202 of a living body to collect tissue from within the fallopian tube 202. As shown in Fig. 13, the collection unit 21A is a part of a rod-shaped member 210A that is inserted into the balloon 20. The rod-shaped member 210A is formed of, for example, a cotton swab 212A. The rod-shaped member 210A has a main body 214A, and the collection unit 21A is provided at the tip of the main body 214A. The maximum diameter of the rod-shaped member 210A as viewed in the extension direction is equal to or smaller than the minimum diameter of the lumen 201 of the balloon 20.
[0079] As shown in Fig. 13, the catheter system 10A includes a first graduation portion 216 provided on the inner tube 18 and a second graduation portion 218 provided on the main body portion 214A of the rod-shaped member 210A. The first graduation portion 216 is provided on the outer circumferential surface of the inner tube main body 42. The first graduation portion 216 is arranged at regular intervals in the axial direction (direction of arrow X) of the inner tube main body 42. The second graduation portion 218 is formed on the outer circumferential surface of the main body portion 214A of the rod-shaped member 210A. In the axial direction of the rod-shaped member 210A, the interval D2 of the second graduation portion 218 is half the interval D1 of the first graduation portion 216.
[0080] Next, a case where tissue is collected from a living body using the catheter system 10A will be described. First, in an insertion step, the endoscope 22 is advanced inside the fallopian tube 202 of the living body to confirm the fallopian tube opening 202a on the image of the endoscope 22, and the outer periphery 203 of the balloon 20 pushes and spreads the affected area 204.
[0081] Instead of checking the fallopian tube opening 202a using the endoscope 22, for example, a method of checking the fallopian tube opening 202a using a hysteroscope may be adopted without using the endoscope 22. Furthermore, a method of observing the fallopian tube 202 from the outside using a laparoscope, a method of observing using X-rays, etc. may also be adopted.
[0082] Next, the endoscope 22 is removed from the balloon 20 and the inner tube 18 in the proximal direction (arrow X2 direction), and then 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. As shown in FIG. 13, the distal end of the outer tube 14 (the distal end of the distal end member 36), the distal end of the balloon 20, and the distal end of the rod-shaped member 210A are aligned in the axial direction of the catheter system 10A. The distal end of the balloon 20 is inserted into the fallopian tube 202 of the living organism. The rod-shaped member 210A is moved relative to the balloon 20 and the inner tube 18 in the proximal direction (arrow X2 direction) by one second graduation 218, and then the inner tube 18 is moved relative to the balloon 20 and the inner tube 18 in the distal direction (arrow X1 direction) by one first graduation 216. Because the balloon 20 is folded back, the distance traveled by the balloon 20 in the distal direction is twice as long as the distance traveled by the rod-shaped member 210A in the axial direction. Therefore, the distance traveled by the balloon 20 in the distal direction when the inner tube 18 is moved in the distal direction by one second graduation 218 is the same as the distance traveled by the rod-shaped member 210A in the proximal direction by one first graduation 216.
[0083] By moving the rod-shaped member 210A in the proximal direction ahead of the inner tube 18 and the balloon 20, the tip of the rod-shaped member 210A does not protrude in the tip direction (arrow X1 direction) from the tip of the balloon 20. That is, the tip of the rod-shaped member 210A moves in the tip direction while being covered by the balloon 20, without protruding from the tip of the balloon 20. That is, the rod-shaped member 210A is prevented from protruding in the tip direction from the balloon 20 before the tip of the balloon 20 reaches the lesion site 204, which is the target position.
[0084] As shown in FIG. 14, after the tip of the balloon 20 reaches a position facing the lesion 204, the rod-shaped member 210A is moved toward the tip relative to the inner tube 18. The collection part 21A provided at the tip of the rod-shaped member 210A protrudes from the tip of the balloon 20 toward the tip. The tip of the rod-shaped member 210A is tilted toward the inner circumferential surface 2021 of the fallopian tube 202, and the collection part 21A is brought into contact with the inner circumferential surface 2021 near the lesion 204, so that the tissue of the lesion 204 adheres to the surface of the collection part 21A. The tissue on the inner circumferential surface 2021 of the fallopian tube 202 is collected by the collection part 21A. The movement distance (insertion length) of the inner tube 18 toward the tip in the insertion process is approximately equal to the movement distance (insertion length) of the endoscope 22 when the endoscope 22 checks the fallopian tube opening 202a before the insertion process.
[0085] After the tissue of the living body is collected by the collection part 21A, the rod-shaped member 210A is moved in the proximal direction (the direction of the arrow X2) relative to the balloon 20 and removed from the proximal end of the inner tube 18. Note that the rod-shaped member 210A is not limited to being removed prior 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.
[0086] The second embodiment provides the following advantages.
[0087] 13, the catheter system 10A includes an outer tube 14, an inner tube 18 movably provided in a first lumen 341 of the outer tube 14, a tubular balloon 20 connecting the tip end of the outer tube 14 and the tip end of the inner tube 18, and a collection unit 21A that protrudes in the tip direction from the tip of the outer tube 14 and is inserted into the fallopian tube 202 (lumen) of a living body to collect tissue from within the fallopian tube 202. The collection unit 21A is a part of a rod-shaped member 210A that is inserted into the lumen 201 of the balloon 20.
[0088] As a result, when the balloon 20 is advanced into the fallopian tube 202 of a living body, tissue within the fallopian tube 202 can be collected by the collection portion 21A.
[0089] The collection portion 21A is provided at the tip of the rod-shaped member 210A. Thus, by providing the collection portion 21A at the tip of the rod-shaped member 210A, it is possible to collect a larger amount of tissue from within the fallopian tube 202 reliably.
[0090] The inner tube 18 has first graduations 216 arranged at regular intervals in the axial direction, and the rod-shaped member 210A has second graduations 218 arranged at regular intervals in the axial direction from the tip to the base end and having intervals that are half the intervals of the first graduations 216 in the axial direction. As a result, when the tip of the balloon 20 is inserted into the fallopian tube 202 of a living organism, the rod-shaped member 210A is moved relatively in the base end direction by the second graduations 218, and then the inner tube 18 is moved in the tip direction based on the first graduations 216, thereby preventing the rod-shaped member 210A from protruding in the tip direction from the balloon 20 before the tip of the balloon 20 reaches a target position such as a lesion 204 in the fallopian tube 202.
[0091] The rod-shaped member 210A is not limited to the swab 212A having the collection portion 21A at the tip. As shown in FIG. 15A, the rod-shaped member 210B may be a brush member 212B having the collection portion 21B at the tip. The tip of the brush member 212B is provided with a brush portion 214B. The brush portion 214B is the collection portion 21B. The brush portion 214B can be used to collect tissue from within the fallopian tube 202 of a living organism. As shown in FIG. 15B, the rod-shaped member 210C may be a forceps member 212C having a collection portion 21C at the tip. The forceps portion 214C is provided at the tip of the forceps member 212C. The forceps portion 214C can be opened and closed, and the tissue from within the fallopian tube 202 of a living organism can be collected by closing the forceps portion 214C in the open state.
[0092] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention. [Explanation of symbols]
[0093] 10, 10A…Catheter system 14...Outer tube 18…Inner tube 20…Balloon 21, 21A, 21B, 21C...Collection section 22...Endoscope 23, 210A, 210B, 210C... Rod-shaped members 211…Convex part 202...Fallen tube 203…Outer periphery
Claims
1. 1. A catheter system capable of being inserted into a lumen of a living body and advanced along the lumen, comprising: a flexible outer tube; an inner tube provided in an inner cavity of the outer tube so as to be movable in an axial direction of the outer tube; a tubular balloon that connects a distal end of the outer tube and a distal end of the inner tube and expands radially inward of the outer tube, allowing a rod-shaped member to be inserted through the inner tube; a sampling section that protrudes from a distal end of the outer tube in a distal direction and is inserted into a lumen of the living body to sample tissue within the lumen; Equipped with When the balloon protrudes from the distal end of the outer tube in a distal direction, the balloon has an outer circumferential portion that contacts an inner circumferential surface of the lumen, A catheter system, wherein the collection portion is a convex portion formed on the outer periphery of the balloon, a concave portion formed on the outer periphery, or a part of the rod-shaped member inserted into the balloon.
2. The catheter system of claim 1, A catheter system, wherein the collection portion is the convex portion or the concave portion formed on the outer periphery of the balloon.
3. The catheter system according to claim 2, The proximal end of the inner tube is provided with an inner tube hub having a port capable of supplying and discharging irrigation fluid; The port communicates with the interior of the inner tube and the balloon.
4. The catheter system of claim 1, A catheter system, wherein the collection portion is provided at the tip of the rod-shaped member.
5. The catheter system according to claim 4, the inner tube has first scale portions arranged at regular intervals in the axial direction, The catheter system has second graduations arranged at regular intervals in the axial direction from the tip to the base end and having second graduations that are half the intervals of the first graduations in the axial direction.
6. The catheter system of claim 1, A catheter system, wherein the rod-shaped member is an endoscope.
Citation Information
Patent Citations
balloon catheter
JP3921112B2