Catheter system and method for operating catheter system

Abstract

A catheter system (10) is provided with: a flexible outer tube (14); an inner tube (18) movably provided in the first lumen (341) of the outer tube (14) in the axial direction; and a tubular balloon (20) that connects the tip of the outer tube (14) and the tip of the inner tube (18) to each other. In a catheter system (10), an endoscope (22) is inserted through an inner tube (18) into a lumen (201) of a balloon (20), and the endoscope (22) is capable of advancing and retracting along the inner tube (18). The outer tube (14) is provided with a first visible part (39) through which the balloon (20) in the outer tube (14) can be visible from the outside of the outer tube (14).

Description

Technical Field

[0001] The present invention relates to a catheter system and a method of operating a catheter system. Background Art

[0002] Patent Document 1 discloses a balloon catheter for treating a lesion (stenotic or occluded portion) 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; and a tubular balloon connecting the front end of the outer tube and the front end of the inner tube. A fallopian tube scope (endoscope) is inserted into the inner side of the balloon.

[0003] Patent Document 1: Japanese Patent No. 3921112

[0004] The balloon arranged in the inner cavity of the outer tube is protruded from the front end opening of the outer tube to the front end direction together with the endoscope and inserted into the fallopian tube orifice of the organism. At this time, there is the following problem: the balloon is sometimes bent and overlapped axially in the outer tube, so that the endoscope moves toward the overlapping part of the balloon, and thus the endoscope cannot move toward the front end direction, which leads to an increased risk of damage to the endoscope and the balloon. In addition, in the state before the catheter system is used, in order to protect the balloon, the balloon is sometimes pre-bent axially in the outer tube to accommodate the balloon. In this case, it is necessary to stretch the balloon axially before use and then insert the endoscope into the inner cavity of the balloon, but it is possible that the endoscope is mistakenly inserted into the balloon that remains bent, so that the endoscope contacts the balloon and is damaged. Summary of the invention

[0005] An object of the present invention is to solve the above-mentioned problems.

[0006] (1) A first aspect of the present invention is a catheter system that is inserted into a lumen of a biological body and can move along the lumen, wherein the catheter system comprises: an outer tube that is flexible; an inner tube that is movably disposed in the inner lumen of the outer tube along the axial direction of the outer tube; and 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, an endoscope is inserted into the inner lumen of the balloon through the inner tube, and the endoscope is enabled to move forward and backward along the inner tube, and the outer tube is provided with a visual identification portion that can visually identify the balloon in the outer tube from the outside of the outer tube, and the visual identification portion has a transparent portion or a translucent portion.

[0007] According to the catheter system, in a state before the catheter system is used, when the balloon is axially bent and accommodated in the outer tube, the balloon in the outer tube can be visually identified by a visual identification portion having a transparent portion or a translucent portion during use, thereby being able to confirm the bent state of the balloon. Thus, before inserting an endoscope into the catheter system, the user can easily recognize that an operation to eliminate the bend of the balloon (an operation to stretch the balloon) should be performed. Therefore, the risk of damage to the endoscope or the balloon caused by the movement of the endoscope in a state where the balloon is bent can be effectively reduced.

[0008] In addition, when the balloons in the outer tube overlap in the axial direction and cluster, the user can visually identify the cluster of balloons through the visual recognition unit. Thus, the user can easily recognize the situation where the operation of eliminating the cluster of balloons should be performed. Therefore, the risk of damage to the endoscope or balloons caused by the endoscope moving toward the overlapping part of the balloons can be effectively reduced.

[0009] (2) In the catheter system described in (1) above, the balloon may be formed of a translucent member.

[0010] According to this configuration, when the balloons are clustered and overlapped in the axial direction in the outer tube, the user can efficiently check the overlapping portion of the balloons from the outside of the outer tube by checking the change in color of the overlapping portion of the overlapping balloons.

[0011] (3) In the catheter system described in (1) or (2) above, the visual confirmation portion may be provided in a range at least from the distal end of the outer tube to the proximal end of the balloon in the axial direction of the outer tube.

[0012] According to this configuration, the state of the balloon in the outer tube can be effectively checked over the entire axial direction of the balloon.

[0013] (4) In the catheter system described in any one of (1) to (3) above, it may also be provided with a sliding member, which is arranged on the outside of the outer tube and moves axially along the outer tube and can accommodate the front end of the outer tube, and the sliding member has a second visual identification portion that can visually identify the balloon through the outer tube, and the second visual identification portion has a transparent portion or a translucent portion.

[0014] According to this configuration, the second visual confirmation portion allows the state of the balloon to be effectively visually confirmed from the outside of the slider through the outer tube.

[0015] (5) In the catheter system described in (4) above, the second visual confirmation portion may be provided in a range from the distal end to the proximal end of the slider in the axial direction.

[0016] According to this configuration, even when the slider is moved along the outer tube, the balloon can be visually recognized from the outside of the slider through the second visual recognition portion and the outer tube throughout the entire movement range of the slider.

[0017] (6) In the catheter system described in any one of (1) to (5) above, the catheter system may supply an expansion fluid to the space between the outer tube and the inner tube in the inner cavity of the outer tube, expand the balloon with the help of the expansion fluid and move it along the inner cavity toward the front end, supply perfusion fluid between the inner tube and the endoscope, and cause the endoscope to retreat relative to the inner tube and the balloon. The movement of the balloon moving toward the front end, the supply of the perfusion fluid between the inner tube and the endoscope, and the movement of the endoscope retreating relative to the inner tube and the balloon are performed in a state where the space is pressurized in the range of 5 to 7 atmospheres with the help of the expansion fluid.

[0018] According to this structure, since a pressure of 5 to 7 atmospheres is continuously applied to the balloon in the space, the balloon to which the pressure is applied is brought close to the endoscope, and when the balloon is repeatedly moved forward or backward, the balloon and the endoscope are likely to move together. Since the balloon and the endoscope move together, balloon clustering is likely to occur. However, since the state of the balloon in the outer tube can be visually recognized through the visual recognition unit, balloon clustering can be effectively eliminated.

[0019] (7) A second aspect of the present invention is a method for operating a catheter system, wherein the catheter system is inserted into a lumen of a biological body and can move along the lumen, wherein the catheter system comprises: an outer tube, which is flexible; an inner tube, which is movably arranged in the inner lumen of the outer tube along the axial direction of the outer tube; and a tubular balloon, which 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, and an endoscope is inserted into the inner lumen of the balloon through the inner tube, and the endoscope is enabled to move forward and backward along the inner tube, and the outer tube is provided with a visual recognition portion that can visually recognize the balloon in the outer tube from the outside of the outer tube, and the visual recognition portion has a transparent portion or a semi-transparent portion, and the operating method comprises the following steps: an insertion step, wherein the inner tube is inserted into the inner lumen of the balloon. The front end of the outer tube is inserted into the lumen and moves toward the front end direction, and the front end of the endoscope moves to the front end of the balloon; a pressurizing step, supplying an expansion fluid to the space between the outer tube and the inner tube in the inner lumen of the outer tube, and pressurizing the space in the range of 5 to 7 atmospheres, thereby expanding the front end of the balloon; an advancing step, in a state where the space is pressurized in the range of 5 to 7 atmospheres, the front end of the balloon moves in the lumen toward the front end direction; a supplying step, in a state where the space is further pressurized in the range of 5 to 7 atmospheres, a perfusion fluid is supplied between the balloon and the endoscope; and a retracting step, in a state where the perfusion fluid is supplied, the endoscope is retracted relative to the inner tube.

[0020] According to the operating method of the catheter system, the balloon to which pressure is applied is continuously applied by 5 to 7 atmospheres from the pressurization process to the forward process and the backward process, so that the balloon to which pressure is applied is brought close to the endoscope, and accordingly, the balloon and the endoscope are easily advanced or retreated as a whole. Since the balloon and the endoscope move as a whole, balloon clustering is likely to occur. However, since the user can confirm the state of the balloon in the outer tube through the visual recognition unit, the user can easily recognize the situation in which the operation of eliminating balloon clustering should be performed. Therefore, the risk of damage to the endoscope or balloon caused by the endoscope moving toward the overlapping part of the balloon can be effectively reduced.

[0021] According to the present invention, in the state before using the catheter system, when the balloon is axially bent and accommodated in the outer tube, the user can visually identify the balloon in the outer tube through the visual recognition part with a transparent part or a translucent part, so that the deflected state of the balloon can be confirmed. Thus, the user can easily identify the situation in which the operation of eliminating the deflection of the balloon should be performed before inserting the endoscope into the catheter system. Therefore, the risk of damage to the endoscope or the balloon caused by the advancement of the endoscope under the state of the balloon deflection can be effectively reduced. In addition, in the process of using the catheter system, when the balloon in the outer tube overlaps axially and clusters, the user can visually identify the clustering of the balloon through the visual recognition part. Thus, the user can easily identify the situation in which the operation of eliminating the clustering of the balloon should be performed. Therefore, the risk of damage to the endoscope or the balloon caused by the advancement of the endoscope to the overlapping part of the balloon can be effectively reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic structural diagram of a catheter system according to an embodiment of the present invention.

[0023] Figure 2 yes Figure 1 A cross-sectional view of a portion of the catheter system is omitted.

[0024] Figure 3 1 is a schematic structural diagram showing a catheter package housing a catheter system before use.

[0025] Figure 4 It is used Figure 1 First illustration of the catheter system for endoscopic tuboplasty.

[0026] Figure 5 yes Figure 4 A second illustration of endoscopic tuboplasty is shown.

[0027] Figure 6 yes Figure 5 A third illustrative diagram of endoscopic fallopian tube surgery is shown.

[0028] Fig. 7A This is an enlarged schematic diagram showing a state in which balloons are clustered during the insertion process of the catheter system. Figure 7B Observed from the thickness direction Fig. 7A Schematic diagram of the overlapping areas of the balloon.

[0029] Fig. 8A This is an enlarged schematic diagram showing a state in which other clustering occurs in the balloon during the insertion process of the catheter system. Figure 8B Observed from the thickness direction Fig. 8A Schematic diagram of the overlapping areas of the balloon.

[0030] Fig. 9 This is a schematic diagram showing a state in which the balloon is bent during the insertion process of the catheter system.

[0031] Fig.10 yes Figure 6 A fourth illustrative diagram of endoscopic fallopian tube surgery is shown.

[0032] Fig.11 yes Fig.10 A fifth illustrative diagram of endoscopic fallopian tube surgery is shown.

[0033] Fig.12 yes Fig.11 A sixth illustrative diagram of endoscopic fallopian tube surgery is shown.

[0034] Fig.13 yes Fig.12 A seventh illustrative diagram of endoscopic fallopian tube surgery is shown.

[0035] Explanation of reference numerals: 10 ... catheter system; 12 ... catheter; 14 ... outer tube; 18 ... inner tube; 20 ... balloon; 22 ... endoscope; 39 ... first visual identification part; 163 ... second visual identification part. DETAILED DESCRIPTION

[0036] like Figure 1 As shown in FIG. 1 , the catheter system 10 of this embodiment is inserted into a lumen of a living body and can move along the lumen. The catheter system 10 is used, for example, for endoscopic tuboplasty to treat a lesion 404 (a stenotic portion or an occluded portion, etc.) of a fallopian tube 402 as a lumen (see FIG. 1 ). Figure 4 In addition, the catheter system 10 can also be used to treat lesions in organs other than fallopian tubes, such as blood vessels, bile ducts, trachea, esophagus, urethra, and other 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 side of the catheter system 10 (the direction of arrow X2) is referred to as the "base end direction".

[0037] 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 handle 26. Therefore, the catheter 12 is a balloon catheter.

[0038] like Figure 2As shown in FIG. 1 , the outer tube 14 includes: a flexible outer tube body 28, an outer tube seat 30, and a fixing screw 32. The outer tube body 28 includes a tube body 34 and a front end component 36 (front end tip). 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 catheter.

[0039] The tube body 34 has a first lumen 341. The first lumen 341 penetrates the entire axial length of the tube body 34. The front end of the tube body 34 is formed into a shape curved in an arc in the axial direction of the tube body 34. The tube body 34 has a substantially constant outer diameter throughout the entire axial length.

[0040] 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 curved corresponding to the shape of the fallopian tube opening 402a that is curved relative to the advancing direction of the catheter 12. 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 passes through the balloon outlet hole 38 and is introduced in a direction closer to the front end than the front end member 36 (in the direction of the arrow X1).

[0041] The first visual identification portion (visual identification portion) 39 is provided in the outer tube 14. The first visual identification portion 39 can visually identify the balloon 20 in the outer tube 14 from the outside of the outer tube 14. The first visual identification portion 39 is provided in the tube body 34 of the outer tube main body 28. The first visual identification portion 39 has a first transparent portion 39A. The first visual identification portion 39 is provided in the range from at least the front end of the tube body 34 to the base end of the balloon 20 accommodated in the outer tube 14 in the axial direction of the outer tube 14 (arrow X direction). The first visual identification portion 39 is provided throughout the entire area of ​​the tube body 34 from the front end to the base end. That is, the entire tube body 34 in the outer tube 14 is the first transparent portion 39A.

[0042] The first transparent portion 39A may be colorless and transparent or colored and transparent. The first visual identification portion 39 is not limited to the case of having the first transparent portion 39A. The first visual identification portion 39 may also have a translucent portion. The first visual identification portion 39 may be a structure that allows the entire area in the length direction of the balloon 20 to be visually identified from the outside of the tube body 34 of the outer tube 14.

[0043] The outer tube base 30 is fixed to the base end of the outer tube body 28. For example, a hard resin or a metal material can be used as a constituent material of the outer tube base 30. Examples of the hard resin constituting the outer tube base 30 include polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, and polyetherimide. Examples of the metal material constituting the outer tube base 30 include stainless steel, titanium, and titanium alloys.

[0044] The outer tube seat 30 is formed in a hollow shape. The outer tube seat 30 is formed in a size that is easy for the user to operate. The outer tube seat 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 the expansion fluid into the first space 301.

[0045] 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 seat 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.

[0046] The fixing screw 32 is threadedly engaged with the outer tube seat 30. The user fixes the inner tube 18 to the outer tube seat 30 by tightening the fixing screw 32. The user loosens the fixing screw 32 to allow the inner tube 18 to move relative to the outer tube seat 30.

[0047] 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 (arrow X direction) of the outer tube main body 28. The total axial length of the slider 16 is shorter than the total axial length of the outer tube main body 28. The slider 16 has a slider main body 161 and a slider seat 162. The slider main body 161 is a tubular member. The slider seat 162 is fixed to the base end of the slider main body 161. The slider seat 162 is formed in a cylindrical shape.

[0048] The second visual identification portion 163 can visually identify the balloon 20 in the outer tube 14 through the first visual identification portion 39 of the outer tube 14. The second visual identification portion 163 is provided on the slider body 161. The second visual identification portion 163 is provided in the range from the front end to the base end in the axial direction (arrow X direction) of the slider 16. In addition, the second visual identification portion 163 is not limited to being provided only on the slider body 161. The entire axial direction of the slider 16 from the slider body 161 to the slider seat 162 may also be provided with the second visual identification portion 163.

[0049] The second visual identification portion 163 has a second transparent portion 163A. The balloon 20 in the outer tube 14 can be visually identified from the outside of the slider 16 via the second transparent portion 163A. The second transparent portion 163A can be colorless and transparent, or can be colored and transparent. The second visual identification portion 163 is not limited to the case of having the second transparent portion 163A. The second visual identification portion 163 can also have a translucent portion. The second visual identification portion 163 only needs to have a structure that allows the entire area in the length direction of the balloon 20 in the outer tube 14 to be visually identified from the outside of the slider 16 from the front end to the base end of the slider 16. That is, when the slider 16 and the outer tube 14 overlap in the radial direction, the user can visually identify the balloon 20 in the outer tube 14 through the first visual identification portion 39 and the second visual identification portion 163.

[0050] In a state where the slider 16 is moved to the maximum in the direction of the arrow X1 relative to the tube body 34 (initial state of the slider 16), the front end of the tube body 34 extends linearly along the shape of the slider main body 161. Conversely to the above, if the slider 16 is moved in the direction of the arrow X2 relative to the tube body 34, the front end of the tube body 34 is exposed in the direction of the arrow X1 more than the slider 16. At this time, the front end 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 of the tube body 34 is bent.

[0051] The inner tube 18 includes an inner tube body 42 and an inner tube seat 44. The inner tube body 42 is made of relatively hard resin or metal. The inner tube body 42 has a second lumen 421 extending throughout the entire length of the inner tube body 42 in the axial direction.

[0052] The inner tube body 42 is movably disposed in the first inner cavity 341 of the outer tube body 28 along the axial direction of the outer tube body 28. The inner tube body 42 is inserted through the outer tube seat 30. The front end of the inner tube body 42 is arranged closer to the arrow X2 direction than the front end of the tube body 34. An outer lumen Sa for the expansion fluid to flow is provided between the outer peripheral surface of the inner tube body 42 and the inner peripheral surface of the tube body 34.

[0053] The insertion portion 221 of the endoscope 22 is inserted into the second lumen 421 of the inner tube body 42 so as to be retractable along the axial direction. An inner lumen Sb is provided for allowing perfusion fluid to flow between the inner tube body 42 and the insertion portion 221 when the insertion portion 221 is inserted into the second lumen 421 of the inner tube body 42.

[0054] The inner tube seat 44 is fixed to the base end of the inner tube body 42. The inner tube seat 44 is formed in a hollow shape. The inner tube seat 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 the perfusate into the second space 441.

[0055] The perfusion liquid is, for example, physiological saline. A second sealing member 46 is provided in the second space 441 of the inner tube seat 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.

[0056] 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. The balloon 20 is formed of a translucent member so as to be elastically deformable in the radial direction. The balloon 20 is preferably composed of polyolefin, polyester, elastomer resin, a flexible polymer material, soft polyvinyl chloride, polyurethane, polyamide, polyisoprene, polyester, fluororesin, etc.

[0057] In addition, the balloon 20 is not limited to the case where it is formed by a translucent component. For example, the balloon 20 may also be formed by a transparent component. In the case where the balloon 20 is formed by a transparent component, it is preferred that the first visual identification portion 39 of the outer tube 14 has a transparent first transparent portion 39A, and the second visual identification portion 163 of the slider 16 has a transparent second transparent portion 163A. The balloon 20 formed by the transparent component can be visually identified from the outside of the slider 16 through the first transparent portion 39A and the second transparent portion 163A.

[0058] The front end of the balloon 20 is bonded to the front end of the outer tube body 28 by an adhesive (not shown). Alternatively, the front end of the balloon 20 may be welded to the front end of the outer tube body 28. The front end of the balloon 20 is sandwiched between the front end of the tube 34 and the front end member 36.

[0059] The base 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 base end of the balloon 20 can also be bonded to the front end of the inner peripheral surface of the inner tube body 42 by an adhesive. The base end of the balloon 20 can also be welded to the front end of the inner peripheral surface of the inner tube body 42.

[0060] The balloon 20 has a lumen 201 into which the insertion portion 221 of the endoscope 22 can be inserted. A bag-shaped outer space Sc with a closed front end is provided between the outer circumference of the balloon 20 and the inner circumference of the tube body 34. The insertion portion 221 of the endoscope 22 is inserted into the lumen 201 of the balloon 20 through the inner tube 18.

[0061] When the balloon 20 is expanded radially inward, a pushing force (pushing 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 6 At this time, the front end of the balloon 20 is rolled up in a manner that the inner surface of the balloon 20 faces outward. That is, the protruding portion of the balloon 20 that protrudes further in the direction of the arrow X1 than 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.

[0062] like Figure 2 As shown, the endoscope 22 is an endoscope for observing the fallopian tube 402. 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 cover portion, which are not shown in the figure. The light guide guides light from a light source, which is not shown in the figure, connected to the base end of the insertion portion 221 to 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 cover 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 display, and a shooting control device for causing the display portion to display the captured image (endoscopic image). In addition, in Figure 2 The structure of the insertion portion 221 is simplified and shown in FIG.

[0064] like Figure 1 As shown in FIG. 1 , the operation part 24 is provided on the outside of 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 along 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 forward and backward along the inner tube body 42 through the inner tube body 42.

[0065] like Figure 3 As shown, the operation unit 24 includes a housing 50 and a delivery member 52 .

[0066] The housing 50 is formed of a resin material into a hollow shape. The housing 50 includes a housing body 56, a first connection portion 58, and a second connection portion 60. The upper portion of the housing body 56 includes an open portion 70. The first connection portion 58 is provided in the front end direction of the housing body 56. The first connection portion 58 is connected to the base end of the inner tube seat 44 via a first fitting 72. The second connection portion 60 is provided in the base end direction of the housing body 56. The second connection portion 60 is connected to the front end of the handle portion 26 via a second fitting 79.

[0067] The housing body 56 includes an insertion portion 62 through which the endoscope 22 can be inserted. The endoscope 22 is movable along the insertion portion 62 in the axial direction (the direction of arrow X).

[0068] 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 opposite to each other across the insertion portion 62. The first rotating body 861 and the second rotating body 862 are rotatably supported by the housing body 56 via the shaft 90.

[0069] The first rotating body 861 is exposed above the housing 50 via the opening 70. The first rotating body 861 can be rotated by moving the upper portion of the first rotating body 861 in the circumferential direction. The first rotating body 861 has a plurality of first teeth 921 on its outer peripheral portion.

[0070] The second rotating body 862 is arranged below the first rotating body 861. A plurality of second teeth 922 are provided on the outer periphery of the second rotating body 862. The second teeth 922 mesh with the first teeth 921 of the first rotating body 861. The user can rotate the second rotating body 862 in the opposite direction to the first rotating body 861 by rotating the first rotating body 861. The outer peripheral surface of the endoscope 22 is clamped and held between the outer periphery of the first rotating body 861 and the outer periphery of the second rotating body 862 in the insertion portion 62. The endoscope 22 can be sent toward the inner tube body 42 by rotating the first rotating body 861 and the second rotating body 862. In addition, as Figure 3 As shown, the first rotating body 861 of the operating part 24 is not limited to the case where it is arranged above the second rotating body 862. For example, when the catheter system 10 is used, the first rotating body 861 and the second rotating body 862 may be arranged in the left-right direction intersecting the up-down direction by rotating the operating part 24 relative to the central axis of the first fitting 72. In the following description, the case where the first rotating body 861 is arranged above and the second rotating body 862 is arranged below is described.

[0071] like Figure 1As shown, the handle 26 includes a tubular member 102 and a protective tube 104. The tubular member 102 is formed in a tubular shape. The front end 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 104 is fixed to the base end of the tubular member 102.

[0072] Next, endoscopic fallopian tube surgery using the catheter system 10 will be described.

[0073] Endoscopic fallopian tube formation has a preparation process of preparing the catheter system 10. Figure 3 As shown, before the catheter system 10 is used, the catheter system 10 is contained in a packaging body 11 and is constituted as a catheter package P. In the catheter package P, the balloon 20 is sometimes contained in a relaxed state relative to the natural state of the balloon 20 (a state in which the balloon 20 is bent in the longitudinal direction) for the purpose of preventing the balloon 20 from being permanently deformed by stretching.

[0074] In this preparation process, after the user removes the catheter system 10 from the catheter package P, an operation is performed to stretch the balloon 20 in the length direction to eliminate the deflection of the balloon 20. Specifically, the user visually identifies the state of the balloon 20 in the outer tube 14 from the outside of the outer tube 14 through the second visual identification portion 163 of the slider 16 and the first visual identification portion 39 of the outer tube 14, while moving the handle portion 26 in the proximal direction (in the direction of arrow X2) relative to the outer tube 14. The inner tube 18 moves in the proximal direction together with the handle portion 26, and the proximal end of the balloon 20 is pulled in the proximal direction. At this time, since the front end portion of the balloon 20 is fixed to the front end portion of the outer tube 14, the balloon 20 stretches in the proximal direction, becomes straight in the length direction, and eliminates the deflection (refer to Figure 1 After the operation of eliminating the deflection is completed, the user confirms through the first visual recognition unit 39 and the second visual recognition unit 163 that the deflection of the balloon 20 is eliminated and the balloon 20 becomes straight in the longitudinal direction.

[0075] Furthermore, in the preparation process, 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.

[0076] Next, in the insertion process, the catheter 12 is inserted into the uterine fundus 400 through the cervical canal. Figure 4As 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 orifice 402a.

[0077] In the insertion process, the endoscope 22 is inserted into the inner cavity of the inner tube body 42 through the protective tube portion 104 of the handle portion 26. After the front end portion 22A of the endoscope 22 is inserted into the tubular member 102 of the handle portion 26, the user moves the endoscope 22 toward the front end direction (the direction of the arrow X1). The front end portion 22A of the endoscope 22 is inserted into the housing body 56 of the operation portion 24 through the second connection portion 60 (see FIG. Figure 1 ).

[0078] like Figure 1 As shown, by rotating the first rotating body 861 of the operation portion 24 clockwise and rotating the second rotating body 862 counterclockwise in the opposite direction to the first rotating body 861, the endoscope 22 is inserted and clamped between the first rotating body 861 and the second rotating body 862 in the insertion portion 62 in the housing 50. By further rotating the first rotating body 861, the endoscope 22 is sent out in the front end direction (travel direction, arrow X1 direction) by the first rotating body 861 and the second rotating body 862.

[0079] exist Figure 4 In the insertion process shown, the endoscope 22 is advanced from the operation portion 24 along the second lumen 421 of the inner tube body 42 in accordance with the operation of the operation portion 24, so that the front end portion 22A of the endoscope 22 moves to the front end portion of the balloon 20. At this time, the user can perform the operation while visually recognizing the state of the balloon 20 through the first visual recognition portion 39 and the second visual recognition portion 163.

[0080] Then, in the confirmation step, the user moves the endoscope 22 forward 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 orifice 402a 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.

[0081] Next, the balloon is led out. Figure 5As shown, in the pressurizing process of the balloon lead-out process, the first introduction port 303 is supplied with an expansion fluid for pressurization. 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 pressurizing process, the outer space Sc is pressurized in the range of 5 to 7 atmospheres by the expansion fluid. More preferably, the outer space Sc is pressurized to 6 atmospheres.

[0082] 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 front end portion 202 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.

[0083] After that, the user loosens the fixing screw 32 and, while the outer space Sc is pressurized by the expansion fluid, operates the inner tube seat 44 to advance the inner tube body 42 relative to the outer tube body 28 (advancing step). In this advancing step, the outer space Sc is continuously pressurized by the expansion fluid in the range of 5 to 7 atmospheres. Figure 6 As shown, the balloon 20 pushed in the distal direction (arrow X1 direction) by the inner tube body 42 advances relative to the outer tube body 28. That is, the pushing 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 distal end opening 281 of the outer tube body 28 in the arrow X1 direction.

[0084] In the forward process, Figure 5 As shown in FIG. 1 , in the first lumen 341 of the outer tube body 28, the balloon 20 moves toward the front end direction while being pressurized radially inward by the expansion fluid. Therefore, the front end portion 202 of the balloon 20 protrudes in the axial direction, and the balloon 20 and the endoscope 22 move as a whole while being in contact. As the balloon 20 and the endoscope 22 move as a whole, Fig. 7A As shown, sometimes clustering occurs. Clustering is, for example, a state where a portion of the balloon 20 is folded in multiple places mainly in the axial direction to form a bellows shape. When clustering occurs, a portion of the balloon 20 is folded in the axial and radial directions to form multiple overlapping portions 203. For example, when the outer tube 14 is continuously pressurized within a range of 5 to 7 atmospheres, the balloon 20 is more likely to always be in contact with the endoscope 22, compared to a case where the balloon is advanced in a state where the outer tube is not pressurized. As a result, clustering of the balloon 20 is more likely to occur.

[0085] In the case of clustering, the balloon 20 forms an overlapping portion 203 where a portion of the peripheral wall 204 of the balloon 20 overlaps along the axial direction, such as Figure 7B As shown, when the first visual recognition unit 39 and the second visual recognition unit 163 are observed from the overlapping direction, the translucent parts overlap in the radial direction to form a plurality of overlapping parts 203. The plurality of overlapping parts 203 appear darker in color than the parts other than the overlapping parts 203. The plurality of overlapping parts 203 are arranged to be continuous along the axial direction of the balloon 20. When the user visually recognizes the balloon 20 through the first visual recognition unit 39 and the second visual recognition unit 163, the user can confirm the clustered overlapping parts 203 by confirming the darkened parts.

[0086] In the balloon lead-out process, when the clustering of the balloons 20 is confirmed, an operation for eliminating the clustering is performed. The supply of the expansion fluid to the first introduction port 303 is stopped, the pressure of the outer space Sc in the outer tube 14 is reduced, and the radially inner pressurization of the balloon 20 is eliminated. At the same time, the perfusion fluid is injected into the second inner cavity 421 of the inner tube body 42 from the second introduction port 443 in the supply process described later. As a result, the perfusion fluid is supplied to the inner cavity 201 of the balloon 20, and the balloon 20 is expanded radially outward by the perfusion fluid, so that the overlapping part 203 is stretched, and the balloon 20 is separated from the endoscope 22 in the radial direction and the axial direction. The user moves the handle part 26 in the proximal direction (arrow X2 direction) relative to the outer tube 14. The inner tube 18 and the handle part 26 move together in the proximal direction, and the proximal end of the balloon 20 is pulled in the proximal direction. Thus, along with the movement of the base end portion of the balloon 20 , the overlap of the balloon 20 at the overlap portion 203 is eliminated, and the balloon 20 is restored to a normal state in which it is substantially straight along the longitudinal direction.

[0087] In addition, the method of eliminating the clustering is not limited to the method of moving the handle 26 in the proximal direction in addition to supplying the perfusate to the inner cavity 201 of the balloon 20. For example, the clustering may be eliminated by supplying the perfusate to the inner cavity 201 of the balloon 20 so that the overlapping portion 203 is pushed in the distal direction and moves in the distal direction, and the overlapping portion 203 is stretched in the axial direction. In this case, the operation of moving the handle 26 in the proximal direction relative to the outer tube 14 is unnecessary.

[0088] In addition, if Fig. 7A As shown, clustering is not limited to the case where the overlapping parts 203 are formed in multiple folds in the axial direction of the balloon 20. For example, Fig. 8A As shown, in the cluster, there is also a case where the peripheral wall 204 of the balloon 20 overlaps in the radial direction and is folded in a predetermined range in the axial direction, thereby forming a single overlapping portion 203A. Figure 8BAs shown, when the user visually recognizes the balloon 20 through the first visual recognition unit 39 and the second visual recognition unit 163, he can recognize the overlapping portion 203A of the cluster by confirming the darker portion where the peripheral wall 204 overlaps in the radial direction. Since the overlapping portion 203A is single and has a predetermined range in the axial direction, it is easier to recognize the cluster.

[0089] In addition, if Fig. 9 As shown, sometimes, at the front end side of the endoscope 22, a part (front end portion) of the balloon 20 is bent in a radial direction (thickness direction) and overlapped in the axial direction to form an overlapping portion 203B. In this case, when the balloon 20 is visually recognized by the first visual recognition portion 39 and the second visual recognition portion 163, by confirming the overlapping portion 203B that overlaps in the radial direction and the axial direction and has a darker color, it is possible to confirm the portion where the peripheral wall 204 is bent and clustered.

[0090] In the advancement process, the front 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 up 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.

[0091] Next, the user determines whether the endoscope 22 has reached the front end of the balloon 20 based on the endoscopic image. Fig.10 As shown, 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 in a state where the outer space Sc of the balloon 20 is continuously pressurized in the range of 5 to 7 atmospheres.

[0092] Next, the user Fig.11 As shown, the endoscope 22 is retracted a predetermined distance (retraction process). In the retraction process, the user rotates the first rotating body 861 of the operating part 24 counterclockwise. Along with the rotation of the first rotating body 861, the second rotating body 862 rotates clockwise, and the insertion portion 221 of the endoscope 22 clamped by the first rotating body 861 and the second rotating body 862 is retracted toward the base end direction (arrow X2 direction). In the retraction process, the endoscope 22 is retracted in a state where the outer space Sc of the balloon 20 is continuously pressurized in the range of 5 to 7 atmospheres. Afterwards, the above-mentioned pressurization process and forward process are performed again.

[0093] That is, in endoscopic fallopian tube formation surgery using the catheter system 10, while the space is pressurized in the range of 5 to 7 atmospheres by means of an expansion fluid, the balloon 20 moves in the front end direction (forward motion) in the balloon extraction process, the perfusion fluid is supplied between the inner tube body 42 and the endoscope 22 in the supply process, and the endoscope 22 retreats relative to the inner tube body 42 and the balloon 20 in the retreat process.

[0094] like Fig.12 As shown, in the advancing step, the front end of the balloon 20 advances and contacts the lesion 404. Then, if the advancing step is continued, as shown in FIG. Fig.13 The balloon 20 shown completely passes through the lesion 404, and the lesion 404 is expanded by the balloon 20. That is, the stenosis or occlusion of the fallopian tube 402 is improved.

[0095] After the lesion 404 is expanded radially outward by the balloon 20, the catheter 12 and the endoscope 22 are pulled out from the uterus (pulling process). In the pulling process, the balloon 20 may be pulled back by pulling the inner tube body 42 while injecting the perfusion fluid through the second introduction port 443, and the endoscope 22 may be operated to be located at the front end of the balloon 20. In this way, the catheter 12 and the endoscope 22 can be pulled out from the uterus while observing the inside of the fallopian tube 402 by the endoscope 22. After the pulling process, the endoscopic fallopian tube formation is completed.

[0096] This embodiment has the following effects.

[0097] like Figure 1 As shown, the catheter system 10 comprises: an outer tube 14, an inner tube 18, and a tubular balloon 20 that connects the front end portion of the outer tube 14 and the front end portion of the inner tube 18 and expands radially inwardly of the outer tube 14, and the outer tube 14 is provided with a first visual identification portion 39 that can visually identify the balloon 20 in the outer tube 14 from the outside of the outer tube 14, and the first visual identification portion 39 has a first transparent portion 39A (semi-transparent portion).

[0098] Therefore, if Figure 3 As shown, in the state before using the catheter system 10, when the balloon 20 is axially bent and accommodated in the outer tube 14, the balloon 20 in the outer tube 14 can be visually identified by the first visual identification portion 39 having the first transparent portion 39A during use, so that the bent state of the balloon 20 can be confirmed. As a result, the user can easily recognize that the operation of eliminating the bend of the balloon 20 (the operation of moving the inner tube 18 toward the base end direction to stretch the balloon 20 in the length direction) should be performed before inserting the endoscope 22 into the catheter system 10. Therefore, the risk of damage to the endoscope 22 or the balloon 20 caused by the movement of the endoscope 22 in the state where the balloon 20 is bent can be effectively reduced.

[0099] In addition, if Fig. 7A As shown, during the use of the catheter system 10, when the balloons 20 overlap in the axial direction and cluster in the outer tube 14, the user can visually recognize the clustering of the balloons 20 through the first visual recognition portion 39. Thus, the user can easily recognize that an operation should be performed to eliminate the clustering of the balloons 20. Therefore, the risk of damage to the endoscope 22 or the balloon 20 caused by the endoscope 22 moving toward the overlapping portion 203 of the balloons 20 can be effectively reduced.

[0100] Since the balloon 20 is formed of a translucent member, Figure 7B As shown, when using the catheter system 10 , when the balloons 20 are clustered and overlapped in the axial direction within the outer tube 14 , the user can effectively confirm the overlapping portion 203 of the balloons 20 from the outside of the outer tube 14 by confirming the change in color of the overlapping portion 203 where the balloons 20 overlap.

[0101] like Figure 1 As shown, the first visual confirmation part 39 is provided in the range from at least the distal end of the outer tube 14 to the proximal end of the balloon 20 in the axial direction of the outer tube 14. Thus, the state of the balloon 20 in the outer tube 14 can be effectively confirmed in the entire axial region of the balloon 20.

[0102] The sliding member 16 is provided with a sliding member 16, which is arranged on the outside of the outer tube 14 and moves axially along the outer tube 14 to accommodate the front end of the outer tube 14. The sliding member 16 has a second visual identification portion 163 that can visually identify the balloon 20 through the outer tube 14. The second visual identification portion 163 has a second transparent portion 163A (semi-transparent portion).

[0103] Thus, the state of the balloon 20 can be effectively visually recognized from the outside of the slider 16 through the outer tube 14 by the second visual recognition portion 163 .

[0104] The second visual recognition portion 163 is provided in the axial range from the front end to the base end of the slider 16. Thus, even when the slider 16 is moved axially along the outer tube 14, the balloon 20 can be visually recognized from the outside of the slider 16 through the outer tube 14 in the entire range of movement of the slider 16.

[0105] The catheter system 10 performs the actions of moving the balloon 20 toward the distal end, supplying perfusion fluid between the inner tube 18 and the endoscope 22, and retracting the endoscope 22 relative to the inner tube 18 and the balloon 20 while the outer space Sc is pressurized in the range of 5 to 7 atmospheres by the expansion fluid.

[0106] Thus, since a pressure of 5 to 7 atmospheres is continuously applied to the balloon 20 in the outer space Sc, the balloon 20 and the endoscope 22 are brought close to each other, and when the balloon 20 is repeatedly moved forward or backward, the balloon 20 and the endoscope 22 move integrally, and thus the balloon 20 is easily clustered. However, since the state of the balloon 20 in the outer tube 14 can be visually recognized through the first visual recognition unit 39 and the second visual recognition unit 163, the clustering of the balloon 20 can be effectively eliminated.

[0107] In the operation method of the catheter system 10, the balloon leading-out process includes: a pressurizing process of supplying a dilating fluid to the outer space Sc between the outer tube body 28 and the balloon 20 in the first lumen 341 of the outer tube body 28 and pressurizing the outer space Sc in the range of 5 to 7 atmospheres, thereby dilating the front end of the balloon 20; and an advancing process of advancing the front end of the balloon 20 in the fallopian tube 402 toward the front end direction (arrow X1 direction) in the state where the outer space Sc is pressurized in the range of 5 to 7 atmospheres. The operation method of the catheter system 10 also includes: a supplying process of supplying a perfusion fluid between the balloon 20 and the endoscope 22 in the state where the outer space Sc is pressurized in the range of 5 to 7 atmospheres; and a retracting process of retracting the endoscope 22 relative to the inner tube body 42 in the state where the perfusion fluid is supplied.

[0108] When operating the catheter system 10, a pressure of 5 to 7 atmospheres is continuously applied to the balloon 20 from the pressurization step to the forward step and the backward step of the balloon lead-out step, so that the balloon 20 to which the pressure is applied is close to the endoscope 22, and the balloon 20 and the endoscope 22 are easy to move forward or backward as a whole, and with this, the balloon 20 is easy to cluster. However, since the user can confirm the state of the balloon 20 in the outer tube 14 through the first visual recognition unit 39 and the second visual recognition unit 163, the user can easily recognize the situation where the operation of eliminating the clustering of the balloon 20 should be performed. Therefore, the risk of damage to the endoscope 22 or the balloon 20 caused by the endoscope 22 moving toward the overlapping portion 203 of the balloon 20 can be effectively reduced.

[0109] 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, inserted into a lumen of a biological body and capable of traveling along the lumen, characterized in that: have: an outer tube, which is flexible; an inner tube movably disposed in the inner cavity of the outer tube along the axial direction of the outer tube; and 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, The endoscope is inserted into the inner cavity of the balloon through the inner tube, and the endoscope is enabled to move forward and backward along the inner tube. The outer tube is provided with a visual confirmation portion that allows the balloon in the outer tube to be visually confirmed from the outside of the outer tube, and the visual confirmation portion has a transparent portion or a semi-transparent portion.

2. The catheter system according to claim 1, characterized in that The balloon is formed of a translucent member.

3. The catheter system according to claim 1 or 2, characterized in that: The visual confirmation portion is provided in a range at least from the front end of the outer tube to the base end of the balloon in the axial direction of the outer tube.

4. The catheter system according to claim 1 or 2, characterized in that: A sliding member is provided, which is arranged outside the outer tube and moves axially along the outer tube and can accommodate the front end of the outer tube. The slider includes a second visual recognition portion that allows visual recognition of the balloon through the outer tube. The second visual confirmation portion has a transparent portion or a semi-transparent portion.

5. The catheter system according to claim 4, characterized in that The second visual confirmation portion is provided in a range from a front end to a base end in an axial direction of the slider.

6. The catheter system according to claim 1, characterized in that The catheter system supplies an expansion fluid to the space between the outer tube and the inner tube in the inner cavity of the outer tube, expands the balloon with the expansion fluid and moves along the inner cavity toward the front end, supplies a perfusion fluid between the inner tube and the endoscope, and causes the endoscope to retreat relative to the inner tube and the balloon. The movement of the balloon moving toward the distal end, the supply of the perfusion fluid between the inner tube and the endoscope, and the retreat of the endoscope relative to the inner tube and the balloon are performed while the space is pressurized in the range of 5 to 7 atmospheres by the expansion fluid.

7. A method for operating a catheter system, wherein the catheter system is inserted into a lumen of a biological body and can move along the lumen, characterized in that: The catheter system comprises: an outer tube, which is flexible; an inner tube movably disposed in the inner cavity of the outer tube along the axial direction of the outer tube; and 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, The endoscope is inserted into the inner cavity of the balloon through the inner tube, and the endoscope is enabled to move forward and backward along the inner tube. The outer tube is provided with a visual recognition portion that allows the balloon in the outer tube to be visually recognized from the outside of the outer tube, and the visual recognition portion has a transparent portion or a semi-transparent portion. The operation method has the following steps: an inserting step of inserting the front end portion of the outer tube into the lumen and advancing it toward the front end direction, and advancing the front end portion of the endoscope to the front end portion of the balloon; A pressurizing step of supplying an expansion fluid to a space between the outer tube and the inner tube in the inner cavity of the outer tube and pressurizing the space in a range of 5 to 7 atmospheres, thereby expanding the front end of the balloon; A forwarding step of moving the front end of the balloon toward the front end direction in the lumen while the space is pressurized in a range of 5 to 7 atmospheres; a supplying step of supplying a perfusion fluid between the balloon and the endoscope while the space is further pressurized in a range of 5 to 7 atmospheres; as well as The retreat step is to retreat the endoscope relative to the inner tube in a state where the perfusion fluid is supplied.

Images