Catheter system and operation method of catheter system

Abstract

To solve the problem that when a balloon provided in a lumen of an outer tube is caused to protrude in a tip direction from a tip opening of the outer tube together with an endoscope and be inserted into a fallopian tube opening of a living body, there is a case where the balloon is bent and folded in an axial direction in the outer tube, which prevents the endoscope from advancing in a tip direction when the endoscope is advanced to a portion where the balloon is folded, thereby increasing a risk of damaging the endoscope and the balloon.SOLUTION: A catheter system 10 includes a flexible outer tube 14, an inner tube 18 provided so as to be axially movable to a first lumen of the outer tube 14, and a tubular balloon 20 for connecting the tip of the outer tube 14 and the tip of the inner tube 18 together. In the catheter system 10, an endoscope 22 is inserted into a lumen of the balloon 20 through the inner tube 18, and the endoscope 22 can be advanced and retreated along the inner tube 18. The outer tube 14 is provided with a first visual recognition part 39 that allows the balloon 20 in the outer tube 14 to be visually recognized from outside the outer tube 14.SELECTED DRAWING: Figure 1

Description

[Technical field]

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

[0002] Patent Document 1 discloses a balloon catheter for treating diseased parts (stenosis or obstruction) of fallopian tubes. 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, and a tubular balloon connecting the tip of the outer tube with the tip of the inner tube. An fallopian tube scope (endoscope) is inserted inside the balloon. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 3921112 Summary of the Invention [Problem to be solved by the invention]

[0004] The balloon provided in the lumen of the outer tube is inserted into the oviductal opening of the living body by projecting the balloon from the distal end opening of the outer tube together with the endoscope in the distal direction. At this time, the balloon may bend and overlap in the axial direction in the outer tube, and when the endoscope is advanced to the overlapping portion of the balloon, the endoscope cannot be advanced in the distal direction, and the risk of damage to the endoscope and the balloon increases. In addition, before the catheter system is used, the balloon may be pre-bent in the axial direction and stored in the outer tube to protect the balloon. In this case, the balloon needs to be stretched in the axial direction before use, and then the endoscope needs to be inserted into the lumen of the balloon. However, if the endoscope is mistakenly inserted into the balloon in the bent state, there is a concern that the endoscope may come into contact with the balloon and be damaged.

[0005] The present invention aims to solve the above-mentioned problems. [Means for solving the problem]

[0006] (1) A first 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 disposed within the lumen of the outer tube so as to be movable in the axial direction of the outer tube; and 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, wherein an endoscope is inserted into the lumen of the balloon through the inner tube and can be advanced and retreated along the inner tube, and the outer tube is provided with a viewing portion that makes the balloon within the outer tube visible from outside the outer tube, the viewing portion having a transparent or semi-transparent portion.

[0007] According to this catheter system, when the balloon is accommodated in the outer tube in an axially bent state before the catheter system is used, the balloon in the outer tube can be visually confirmed through a visual confirmation section having a transparent or semi-transparent section during use to confirm the state of the balloon's bend. This allows the user to easily recognize that an operation to eliminate the balloon's bend (operation to stretch the balloon) should be performed before inserting the endoscope into the catheter system. This effectively reduces the risk of damage to the endoscope or the balloon caused by the endoscope proceeding with the balloon bent.

[0008] Furthermore, if the balloons overlap in the axial direction inside the outer tube during use of the catheter system, causing bunching, the user can visually confirm the bunching of the balloons through the visual confirmation section. This allows the user to easily recognize that an operation should be performed to resolve the bunching of the balloons. This effectively reduces the risk of damage to the endoscope or the balloons due to the endoscope moving into the overlapped portion of the balloons.

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

[0010] With this configuration, when the balloons bunch and overlap axially inside the outer tube, the user can effectively check the overlapping portions of the balloons from outside the outer tube by checking the color change at the overlapping portions of the balloons.

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

[0012] With this configuration, the condition of the balloon inside 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, a slider is provided outside the outer tube, moves axially along the outer tube, and is capable of accommodating the tip of the outer tube, and the slider has a second viewing portion that allows the balloon to be viewed through the outer tube, and the second viewing portion may have a transparent portion or a translucent portion.

[0014] With this configuration, the state of the balloon can be effectively visually observed from outside the slider through the outer tube using the second visual observation portion.

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

[0016] With this configuration, even when the slider is moved along the outer tube, the balloon can be visually observed from outside the slider through the second visual observation portion and the outer tube over the entire range of movement 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 a space between the outer tube and the inner tube in the lumen of the outer tube, expand the balloon with the expansion fluid and move it along the lumen toward the distal end, supply perfusion fluid between the inner tube and the endoscope, and move the endoscope backward relative to the inner tube and the balloon, while the movement of the balloon toward the distal end, the supply of the perfusion fluid between the inner tube and the endoscope, and the movement of the endoscope backward relative to the inner tube and the balloon are performed while the space is pressurized by the expansion fluid to a pressure in the range of 5 to 7 atmospheres.

[0018] With this configuration, a pressure of 5 to 7 atmospheres is continuously applied to the balloon in the space, bringing the pressurized balloon and the endoscope closer together, and when the balloon is repeatedly advanced or retreated, the balloon and the endoscope tend to move together. The balloon bunching is likely to occur when the balloon and the endoscope move together. However, because the state of the balloon inside the outer tube can be visually confirmed through the visual confirmation section, the balloon bunching can be effectively eliminated.

[0019] (7) A second aspect of the present invention is a method for operating a catheter system capable of being inserted into a lumen of a living body and advancing along the lumen, the catheter system comprising: an outer tube having flexibility; an inner tube provided in an inner lumen of the outer tube so as to be movable in an axial direction of the outer tube; and a tubular balloon connecting a tip end of the outer tube with a tip end of the inner tube and expanding radially inward of the outer tube, an endoscope being inserted into the inner lumen of the balloon through the inner tube and capable of advancing and retreating along the inner tube, the outer tube being provided with a viewing portion that allows the balloon in the outer tube to be viewed from outside the outer tube, the viewing portion having a transparent portion or a semi-transparent portion, and the operating method comprising the steps of: inserting a tip end of the outer tube into the lumen; a pressurizing step of supplying an expansion fluid to a space between the outer tube and the inner tube in the lumen of the outer tube and pressurizing the space to a range of 5 to 7 atmospheres to expand the tip of the balloon; an advancing step of advancing the tip of the balloon within the lumen toward the tip while the space is pressurized to a range of 5 to 7 atmospheres; a supplying step of supplying perfusion fluid between the balloon and the endoscope while the space is pressurized to a range of 5 to 7 atmospheres; and a retracting step of retracting the endoscope relative to the inner tube while the perfusion fluid is supplied.

[0020] According to this method of operating the catheter system, a pressure of 5 to 7 atmospheres is continuously applied to the balloon from the pressurizing step to the forward movement step and the backward movement step, so that the balloon and the endoscope approach each other, and as a result, the balloon and the endoscope tend to move forward or backward together. The balloon bunching tends to occur when the balloon and the endoscope move together. However, since the user can check the state of the balloon inside the outer tube through the visual confirmation unit, the user can easily recognize that an operation to eliminate the bunching of the balloon should be performed. Therefore, the risk of damage to the endoscope or the balloon caused by the endoscope proceeding into the overlapping portion of the balloon can be effectively reduced. Effect of the Invention

[0021] According to the present invention, when the balloon is accommodated in the outer tube in an axially bent state before the catheter system is used, the user can visually check the balloon in the outer tube through the visual confirmation section having a transparent or semi-transparent section to confirm the bent state of the balloon. This allows the user to easily recognize that an operation to eliminate the balloon's bend 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 endoscope proceeding in a bent state of the balloon can be effectively reduced. Furthermore, when the balloons overlap in the axial direction in the outer tube during use of the catheter system, causing bunching, the user can visually confirm the bunching of the balloons through the visual confirmation section. This allows the user to easily recognize that an operation to eliminate the bunching of the balloons should be performed. Therefore, the risk of damage to the endoscope or the balloon caused by the endoscope proceeding into the overlapping portion of the balloon can be effectively reduced. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a schematic configuration diagram of a catheter system according to an 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 schematic diagram showing a catheter package containing a catheter system before use. [Figure 4] FIG. 4 is a first explanatory diagram of endoscopic salpingoplasty using the catheter system of FIG. [Diagram 5] FIG. 5 is a second explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 6] FIG. 6 is a third explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 7]Fig. 7A is an enlarged schematic diagram showing a state in which bunching occurs in a balloon during an insertion process of a catheter system, and Fig. 7B is a schematic diagram showing a polymerization portion of the balloon in Fig. 7A as viewed from the thickness direction. [Figure 8] Fig. 8A is an enlarged schematic view showing a state in which another bunching occurs in the balloon during the insertion process of the catheter system, and Fig. 8B is a schematic view showing the overlapping portion of the balloon in Fig. 8A as viewed from the thickness direction. [Figure 9] FIG. 9 is a schematic diagram showing a state in which a balloon is deflected during the insertion process of the catheter system. [Figure 10] FIG. 10 is a fourth explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 11] FIG. 11 is a fifth explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 12] FIG. 12 is a sixth explanatory view of the endoscopic salpingoplasty shown in FIG. [Figure 13] FIG. 13 is a seventh explanatory view of the endoscopic salpingoplasty shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] As shown in Fig. 1, the catheter system 10 according to this 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 404 (such as a stenosis or obstruction) in a lumen of an fallopian tube 402 (see Fig. 4). The catheter system 10 may be used to treat a lesion in a living organ other than a fallopian tube, such as 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 "proximal direction."

[0024] 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.

[0025] 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, and fluororesin. The outer tube 14 is an outer catheter.

[0026] The tube 34 has a first lumen 341. The first lumen 341 penetrates the entire axial length of the tube 34. 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 axial length.

[0027] The tip member 36 is provided at the tip of the tubular body 34. The outer peripheral surface of the tip member 36 is curved corresponding to the shape of the fallopian tube orifice 402a, 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.

[0028] The first visual confirmation portion (visual confirmation portion) 39 is provided in the outer tube 14. The first visual confirmation portion 39 allows the balloon 20 in the outer tube 14 to be visually confirmed from outside the outer tube 14. The first visual confirmation portion 39 is provided in the tube body 34 of the outer tube main body 28. The first visual confirmation portion 39 includes a first transparent portion 39A. The first visual confirmation portion 39 is provided in the range from at least the tip of the tube body 34 to the base end of the balloon 20 contained in the outer tube 14 in the axial direction (arrow X direction) of the outer tube 14. The first visual confirmation portion 39 is provided over the entire area from the tip to the base end of the tube body 34. That is, the entire tube body 34 in the outer tube 14 is the first transparent portion 39A.

[0029] The first transparent portion 39A may be colorless and transparent or colored and transparent. The first visual portion 39 is not limited to having the first transparent portion 39A. The first visual portion 39 may have a semi-transparent portion. The first visual portion 39 may be configured to be able to visually confirm the entire area of ​​the balloon 20 in the longitudinal direction from the outside of the tubular body 34 of the outer tube 14.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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 direction of the arrow X). The overall axial length of the slider 16 is shorter than the overall axial length of the outer tube main body 28. 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.

[0035] The second visual confirmation portion 163 makes it possible to view the balloon 20 inside the outer tube 14 through the first visual confirmation portion 39 of the outer tube 14. The second visual confirmation portion 163 is provided on the slider body 161. The second visual confirmation portion 163 is provided in a range from the tip to the base end in the axial direction (arrow X direction) of the slider 16. Note that the second visual confirmation portion 163 is not limited to being provided only on the slider body 161. The second visual confirmation portion 163 may be provided over the entire axial direction of the slider 16, from the slider body 161 to the slider hub 162.

[0036] The second viewing portion 163 has a second transparent portion 163A. The balloon 20 in the outer tube 14 can be viewed from the outside of the slider 16 through the second transparent portion 163A. The second transparent portion 163A may be colorless and transparent or colored and transparent. The second viewing portion 163 is not limited to having the second transparent portion 163A. The second viewing portion 163 may have a semi-transparent portion. The second viewing portion 163 may be configured to be able to view the entire area in the longitudinal direction of the balloon 20 in the outer tube 14 from the outside of the slider 16, from the tip 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 view the balloon 20 in the outer tube 14 through the first viewing portion 39 and the second viewing portion 163.

[0037] 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.

[0038] The inner pipe 18 includes an inner pipe body 42 and an inner pipe hub 44. The inner pipe body 42 may be made of a relatively hard resin material or metal material. The inner pipe body 42 has a second lumen 421 that penetrates the inner pipe body 42 over the entire length in the axial direction.

[0039] 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.

[0040] The insertion section 221 of the endoscope 22 is inserted into the second lumen 421 of the inner tube main body 42 so as to be able to advance and retreat along the axial direction. With the insertion section 221 inserted into the second lumen 421 of the inner tube main body 42, an inner lumen Sb through which a perfusion fluid flows is provided between the inner tube main body 42 and the insertion section 221.

[0041] 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.

[0042] 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.

[0043] 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 to each other. The balloon 20 is inflated radially inward of the outer tube body 28 by an expansion fluid. The balloon 20 is formed from a translucent member 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.

[0044] The balloon 20 is not limited to being made of a translucent material. For example, the balloon 20 may be made of a transparent material. When the balloon 20 is made of a transparent material, it is preferable that the first visible portion 39 of the outer tube 14 has a transparent first transparent portion 39A, and the second visible portion 163 of the slider 16 has a transparent second transparent portion 163A. The balloon 20 made of a transparent material can be seen from the outside of the slider 16 through the first and second transparent portions 39A and 163A.

[0045] The tip of the balloon 20 is adhered to the tip of the outer tube body 28 by an adhesive (not shown). The tip of the balloon 20 may be welded to the tip of the outer tube body 28, for example. The tip of the balloon 20 is sandwiched between the tip of the tube 34 and the tip member 36.

[0046] The base 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 base 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 base end of the balloon 20 may be welded to the tip portion of the inner circumferential surface of the inner tube body 42.

[0047] The balloon 20 has an inner cavity 201 into which the insertion portion 221 of the endoscope 22 can be inserted. A bag-shaped outer space Sc with a closed tip is provided between the outer peripheral surface of the balloon 20 and the inner peripheral surface of the tubular body 34. The insertion portion 221 of the endoscope 22 is inserted into the inner cavity 201 of the balloon 20 through the inner tube 18.

[0048] 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. 6). At this time, the distal end of the balloon 20 is rolled 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.

[0049] 2, 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 main body 42 and the lumen 201 of the balloon 20.

[0050] 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.

[0051] 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 (the direction of the arrow X) of the catheter 12 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.

[0052] As shown in FIG. 3, the operating unit 24 has a case 50 and a delivery member 52.

[0053] The case 50 is formed of a resin material and has a hollow shape. The case 50 has a case body 56, a first connection part 58, and a second connection part 60. The upper part of the case body 56 has an open part 70. The first connection part 58 is provided in the distal direction of the case body 56. The first connection part 58 is connected to the proximal end of the inner tube hub 44 via a first attachment 72. The second connection part 60 is provided in the proximal direction of the case body 56. The second connection part 60 is connected to the distal end of the handle part 26 via a second attachment 79.

[0054] An insertion portion 62 through which the endoscope 22 can be inserted is provided inside the case body 56. The endoscope 22 can move along the insertion portion 62 in the axial direction (the direction of the arrow X).

[0055] The feed member 52 is provided inside the case 50. The feed member 52 includes first and second rotating bodies 861, 862. The first rotating body 861 and the second rotating body 862 are arranged side by side in the up-down direction of the case main body 56. The first rotating body 861 and the second rotating body 862 face each other with the insertion portion 62 in between. The first and second rotating bodies 861, 862 are rotatably supported by the case main body 56 by the shaft 90.

[0056] The first rotating body 861 is exposed above the case 50 through the opening 70. The first rotating body 861 can be rotated by moving an upper part of the first rotating body 861 in the circumferential direction. The outer periphery of the first rotating body 861 has a plurality of first teeth 921.

[0057] The second rotor 862 is disposed below the first rotor 861. The second rotor 862 has a plurality of second teeth 922 on its outer periphery. The second teeth 922 mesh with the first teeth 921 of the first rotor 861. When the user rotates the first rotor 861, the second rotor 862 can rotate in the opposite direction to the first rotor 861. In the insertion section 62, the outer periphery of the endoscope 22 is clamped and held between the outer periphery of the first rotor 861 and the outer periphery of the second rotor 862. The endoscope 22 can be sent toward the inner tube main body 42 by rotating the first and second rotors 861 and 862. Note that the present invention is not limited to the case where the first rotor 861 of the operation section 24 is disposed above the second rotor 862 as shown in FIG. 3. For example, when using the catheter system 10, it is also possible to use the catheter system 10 by arranging the first rotating body 861 and the second rotating body 862 in a left-right direction intersecting with the up-down direction by rotating the operation unit 24 about the central axis of the first attachment 72. In the following description, a case will be described in which the first rotating body 861 is arranged on the upper side and the second rotating body 862 is arranged on the lower side.

[0058] 1, 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.

[0059] Next, endoscopic salpingoplasty using the catheter system 10 will be described.

[0060] Endoscopic salpingoplasty includes a preparation step of preparing a catheter system 10. As shown in Fig. 3, before the catheter system 10 is used, the catheter system 10 is contained in a packaging body 11 to form a catheter package P. In this catheter package P, the balloon 20 may be contained in a relaxed state (a state in which the balloon 20 is bent in the longitudinal direction) with respect to its natural state in order to prevent permanent tensile deformation of the balloon 20.

[0061] In this preparation step, after the user removes the catheter system 10 from the catheter package P, the user performs an operation to straighten the balloon 20 in the longitudinal direction to eliminate the deflection of the balloon 20. Specifically, the user moves the handle portion 26 in the proximal direction (the direction of the arrow X2) relative to the outer tube 14 while visually checking the state of the balloon 20 in the outer tube 14 from the outside of the outer tube 14 through the second visual confirmation portion 163 of the slider 16 and the first visual confirmation portion 39 of 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 tip end of the balloon 20 is fixed to the tip end of the outer tube 14, the balloon 20 stretches in the proximal direction and becomes straight along the longitudinal direction, eliminating the deflection (see FIG. 1). After the operation to eliminate the deflection is completed, the user confirms through the first and second visual confirmation portions 39, 163 that the deflection of the balloon 20 has been eliminated and the balloon 20 has become straight in the longitudinal direction.

[0062] Furthermore, in a 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 34 is made to extend straight by the slider body 161.

[0063] Next, in the insertion step, the catheter 12 is inserted transcervically to the uterine fundus 400. As shown in Fig. 4, 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 402a.

[0064] In the insertion step, the endoscope 22 is inserted into the lumen of the inner tube main body 42 through the protective tube portion 104 of the handle portion 26. After inserting the tip portion 22A 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 case main body 56 of the operation unit 24 (see FIG. 1) through the second connection portion 60.

[0065] 1, by rotating the first rotating body 861 of the operation unit 24 clockwise, the second rotating body 862 rotates counterclockwise which is the opposite direction to the first rotating body 861, and the endoscope 22 is inserted and clamped between the first rotating body 861 and the second rotating body 862 in the insertion portion 62 inside the case 50. By further rotating the first rotating body 861, the endoscope 22 is sent out in the distal direction (traveling direction, arrow X1 direction) by the first and second rotating bodies 861, 862.

[0066] 4, in accordance with the operation of the operation unit 24, the endoscope 22 is advanced from the operation unit 24 along the second lumen 421 of the inner tube main body 42, and the tip portion 22A of the endoscope 22 is advanced to the tip portion of the balloon 20. At this time, the user can perform the operation while visually checking the state of the balloon 20 through the first and second visual check units 39, 163.

[0067] 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 402a 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.

[0068] Next, the balloon extraction process is performed. As shown in Fig. 5, in the pressurizing process of the balloon extraction process, 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 body 28 and the inner tube body 42 in the lumen of the outer tube body 28. In the pressurizing process, the outer space Sc is pressurized to a pressure in the range of 5 to 7 atmospheres with the expansion fluid. It is more preferable that the outer space Sc is pressurized to 6 atmospheres.

[0069] 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 portion 221 is in close contact with the outer circumferential surface of the insertion portion 221. The inner surfaces of the distal end portion 202 of the balloon 20 located in the direction of the arrow X1 from the distal end of the insertion portion 221 are in contact with each other.

[0070] Thereafter, the user loosens the fixing screw 32, and in a state in which the outer space Sc is pressurized by the expansion fluid, operates the inner tube hub 44 to advance the inner tube main body 42 relative to the outer tube main body 28 (advancing step). In this advancing step, the outer space Sc is continuously pressurized by the expansion fluid at a pressure in the range of 5 to 7 atm. Then, as shown in Fig. 6, the balloon 20, which is pushed in the distal direction (arrow X1 direction) by the inner tube main body 42, advances relative to the outer tube main body 28. In other words, the balloon 20 protrudes from the distal opening 281 of the outer tube main body 28 together with the insertion part 221 in the arrow X1 direction as a result of the pushing force being transmitted from the inner tube main body 42 to the balloon 20.

[0071] In the forward movement step, as shown in FIG. 5, the balloon 20 advances toward the distal end in a state where it is pressurized radially inward by the inflation fluid in the first lumen 341 of the outer tube main body 28. Therefore, the distal end portion 202 of the balloon 20 is in a state of being stretched in the axial direction, and the balloon 20 and the endoscope 22 advance together in a state of contact. When the balloon 20 and the endoscope 22 move together, bunching may occur as shown in FIG. 7A. Bunching is, for example, a state in which a part of the balloon 20 is folded over at multiple points mainly in the axial direction to form a bellows shape. When bunching occurs, a part of the balloon 20 is folded over in the axial and radial directions to form multiple overlapping portions 203. For example, compared to a case in which the balloon advances with the inside of the outer tube not pressurized, when the inside of the outer tube 14 is continuously pressurized within a range of 5 to 7 atm, the balloon 20 is likely to be in a state of always being in contact with the endoscope 22, and as a result, bunching of the balloon 20 is relatively likely to occur.

[0072] When bunching occurs, the balloon 20 is formed with overlapping portions 203 in the axial direction of the peripheral wall 204 of the balloon 20, and as shown in FIG. 7B, when viewed from the overlapping direction through the first and second visualizing units 39, 163, the translucent members overlap in the radial direction to form the multiple overlapping portions 203. The multiple overlapping portions 203 appear darker in color than the portions other than the overlapping portions 203. The multiple overlapping portions 203 are arranged so as to be continuous in the axial direction of the balloon 20. When the user visually checks the balloon 20 through the first and second visualizing units 39, 163, the user can check the bunched overlapping portions 203 by checking the portions with darker colors.

[0073] In the balloon extraction step, when bunching of the balloon 20 is confirmed, an operation is performed to eliminate the bunching. The supply of the expansion fluid to the first introduction port portion 303 is stopped to reduce the pressure of the outer space Sc in the outer tube 14, and the radially inward pressurization of the balloon 20 is eliminated. At the same time, perfusion fluid is injected into the second lumen 421 of the inner tube main body 42 from the second introduction port portion 443, which is performed in a supply step described later. As a result, perfusion fluid is supplied to the lumen 201 of the balloon 20, and the perfusion fluid spreads the balloon 20 radially outward, thereby spreading the polymerization site 203, and the balloon 20 is separated radially and axially from the endoscope 22. The user moves the handle portion 26 in the proximal direction (arrow X2 direction) 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. As a result, as the base end of the balloon 20 moves, the overlapping of the balloon 20 at the overlapping portion 203 is eliminated, and the balloon 20 returns to its normal state in which it is substantially straight along the longitudinal direction.

[0074] The method of eliminating bunching is not limited to the method of moving the handle portion 26 in the proximal direction in addition to supplying perfusion fluid to the lumen 201 of the balloon 20. For example, bunching may be eliminated by supplying perfusion fluid to the lumen 201 of the balloon 20, pushing the polymerization site 203 in the distal direction and moving it in the distal direction, and spreading the polymerization site 203 in the axial direction. In this case, it is not necessary to move the handle portion 26 in the proximal direction relative to the outer tube 14.

[0075] As shown in FIG. 7A, bunching is not limited to the case where the overlapping ...

[0076] 9, a part (tip) of the balloon 20 may bend in the radial direction (thickness direction) and bend so as to overlap in the axial direction at the tip side of the endoscope 22, forming an overlapping area 203B. In this case, when the balloon 20 is visually observed through the first and second visualizing parts 39, 163, the overlapping areas 203B, which are dark in color and overlap in the radial and axial directions, can be confirmed, thereby making it possible to confirm the area where the peripheral wall 204 has been bent and bunched.

[0077] In the forward movement step, the tip 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 turned 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.

[0078] 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 404, as shown in FIG. 10, 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 5 to 7 atm.

[0079] Next, as shown in FIG. 11, the user moves the endoscope 22 backward by a predetermined distance (retraction process). In the retraction process, the user rotates the first rotating body 861 of the operation unit 24 counterclockwise. 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 between the first and second rotating bodies 861, 862 moves backward toward the base end (arrow X2 direction). In the retraction process, the endoscope 22 is retracted in a state in which the outer space Sc of the balloon 20 is continuously pressurized within a range of 5 to 7 atm. Thereafter, the pressurization process and the advancement process described above are performed again.

[0080] 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 to a pressure range of 5 to 7 atmospheres by the expansion fluid.

[0081] As shown in Fig. 12, in the advancing step, the tip of the balloon 20 advances and comes into contact with the lesion 404. Thereafter, by continuing the advancing step, as shown in Fig. 13, when the balloon 20 completely passes through the lesion 404, the lesion 404 is pushed open by the balloon 20. In other words, the stenosis or blockage of the fallopian tube 402 is improved.

[0082] After the lesion 404 has been spread radially outward by the balloon 20, the catheter 12 and the endoscope 22 are removed from the uterus (removal step). In the removal step, the inner tube main body 42 may be pulled to retract the balloon 20 while injecting irrigation 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 makes it possible to remove the catheter 12 and the endoscope 22 from the uterus while observing the inside of the fallopian tube 402 with the endoscope 22. After the removal step, the endoscopic salpingoplasty is completed.

[0083] This embodiment provides the following advantages.

[0084] As shown in FIG. 1, in a catheter system 10 including an outer tube 14, an inner tube 18, and a tubular balloon 20 that connects the tip of the outer tube 14 to the tip of the inner tube 18 and expands radially inward of the outer tube 14, the outer tube 14 is provided with a first viewing portion 39 that allows the balloon 20 within the outer tube 14 to be viewed from outside the outer tube 14, and the first viewing portion 39 has a first transparent portion 39A (semi-transparent portion).

[0085] 3, when the balloon 20 is accommodated in the outer tube 14 in a bent state in the axial direction before the catheter system 10 is used, the bent state of the balloon 20 can be confirmed by visually checking the balloon 20 in the outer tube 14 through the first visual check section 39 having the first transparent section 39A during use. This allows the user to easily recognize that an operation to eliminate the bend of the balloon 20 (an operation to move the inner tube 18 in the proximal direction to stretch the balloon 20 in the longitudinal direction) should be performed before inserting the endoscope 22 into the catheter system 10. This effectively reduces the risk of damage to the endoscope 22 or the balloon 20 caused by the endoscope 22 proceeding in a bent state.

[0086] 7A, when the balloons 20 overlap in the axial direction inside the outer tube 14 during use of the catheter system 10, causing bunching, the user can visually confirm the bunching of the balloons 20 through the first visual confirmation unit 39. This allows the user to easily recognize that an operation should be performed to eliminate the bunching of the balloons 20. Therefore, the risk of damage to the endoscope 22 or the balloon 20 due to the endoscope 22 proceeding into the overlapping portion 203 of the balloon 20 can be effectively reduced.

[0087] Since the balloon 20 is formed from a translucent material, as shown in FIG. 7B, when the balloon 20 bunches and overlaps in the axial direction inside the outer tube 14 during use of the catheter system 10, the user can effectively check the overlapping portion 203 of the balloon 20 from outside the outer tube 14 by checking the color change of the overlapping portion 203 of the balloon 20.

[0088] 1, the first visual confirmation portion 39 is provided at least in the range from the tip of the outer tube 14 to the base end of the balloon 20 in the axial direction of the outer tube 14. This makes it possible to effectively check the state of the balloon 20 inside the outer tube 14 over the entire axial direction of the balloon 20.

[0089] The slider 16 is provided on the outside of the outer tube 14, moves axially along the outer tube 14, and is capable of accommodating the tip of the outer tube 14. The slider 16 has a second viewing portion 163 that allows the balloon 20 to be viewed through the outer tube 14, and the second viewing portion 163 has a second transparent portion 163A (semi-transparent portion).

[0090] This allows the state of the balloon 20 to be effectively visually confirmed from outside the slider 16 through the outer tube 14 by using the second visual confirmation portion 163.

[0091] The second visual confirmation portion 163 is provided in a range from the tip to the base end in the axial direction of the slider 16. As a result, even when the slider 16 is moved in the axial direction along the outer tube 14, the balloon 20 can be visually confirmed from outside the slider 16 through the outer tube 14 throughout the entire range of movement of the slider 16.

[0092] In the catheter system 10, the advancement of the balloon 20 toward the tip, the supply of perfusion fluid between the inner tube 18 and the endoscope 22, and the retraction of the endoscope 22 relative to the inner tube 18 and the balloon 20 are performed while the outer space Sc is pressurized to a pressure in the range of 5 to 7 atmospheres by the expansion fluid.

[0093] As a result, a pressure of 5 to 7 atmospheres is continuously applied to the balloon 20 in the outer space Sc, bringing the balloon 20 and the endoscope 22 closer together, and when the balloon 20 is repeatedly moved forward or backward, the balloon 20 and the endoscope 22 move together, which is likely to cause bunching of the balloon 20. However, because the state of the balloon 20 inside the outer tube 14 can be visually confirmed via the first and second visual confirmation parts 39, 163, bunching of the balloon 20 can be effectively eliminated.

[0094] In the method for operating the catheter system 10, the balloon leading-out step includes a pressurizing step of supplying an expansion 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 to a range of 5 to 7 atmospheres to expand the tip of the balloon 20, and an advancing step of advancing the tip of the balloon 20 toward the tip direction (arrow X1 direction) within the fallopian tube 402 while the outer space Sc is pressurized to a range of 5 to 7 atmospheres. The method for operating the catheter system 10 further includes a supplying step of supplying perfusion fluid between the balloon 20 and the endoscope 22 while the outer space Sc is pressurized to a range of 5 to 7 atmospheres, and a retracting step of retracting the endoscope 22 relative to the inner tube body 42 while the perfusion fluid is supplied.

[0095] When operating the catheter system 10, a pressure of 5 to 7 atmospheres is continuously applied to the balloon 20 from the pressurizing step to the forward movement step and the backward movement step of the balloon leading-out step, so that the balloon 20 to which pressure is applied approaches the endoscope 22, and the balloon 20 and the endoscope 22 tend to move forward or backward together, which makes it easier for bunching of the balloon 20 to occur. However, since the user can check the state of the balloon 20 in the outer tube 14 through the first and second visual confirmation parts 39 and 163, the user can easily recognize that an operation to eliminate bunching of the balloon 20 should be performed. Therefore, the risk of damage to the endoscope 22 or the balloon 20 due to the endoscope 22 proceeding to the overlapping portion 203 of the balloon 20 can be effectively reduced.

[0096] 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]

[0097] 10. Catheter system 12...Catheter 14...Outer tube 18…Inner tube 20…Balloon 22...Endoscope 39…First viewing area 163…Second Vision Section

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; Equipped with An endoscope is inserted into the inner cavity of the balloon through the inner tube, and the endoscope can be advanced and retreated along the inner tube, A catheter system, wherein the outer tube is provided with a viewing portion that enables the balloon within the outer tube to be viewed from outside the outer tube, the viewing portion having a transparent portion or a translucent portion.

2. The catheter system of claim 1, A catheter system, wherein the balloon is formed from a translucent material.

3. The catheter system according to claim 1 or 2, A catheter system, wherein the visualization portion is provided in the axial direction of the outer tube at least in the range from the tip of the outer tube to the base end of the balloon.

4. The catheter system according to claim 1 or 2, a slider that is provided outside the outer tube, moves along the outer tube in the axial direction, and is capable of receiving a tip of the outer tube; The slider includes a second viewing portion that allows the balloon to be viewed through the outer tube, A catheter system, wherein the second viewing portion has a transparent portion or a translucent portion.

5. The catheter system according to claim 4, A catheter system, wherein the second viewing portion is provided in the range from the tip to the base end in the axial direction of the slider.

6. The catheter system of claim 1, The catheter system supplies an expansion fluid to a space between the outer tube and the inner tube in the lumen of the outer tube, expands the balloon with the expansion fluid and advances the balloon toward a distal end along the lumen, supplies an irrigation fluid between the inner tube and the endoscope, and retracts the endoscope relative to the inner tube and the balloon. A catheter system in which the advancement of the balloon toward the tip, the supply of the perfusion fluid between the inner tube and the endoscope, and the retraction of the endoscope relative to the inner tube and the balloon are performed while the space is pressurized to a pressure in the range of 5 to 7 atmospheres by the expansion fluid.

7. 1. A method for operating a catheter system capable of being inserted into and advancing along a lumen of a living body, comprising: The catheter system includes a flexible outer tube and 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; Equipped with An endoscope is inserted into the inner cavity of the balloon through the inner tube, and the endoscope can be advanced and retreated along the inner tube, The outer tube is provided with a visual confirmation portion through which the balloon inside the outer tube can be visually confirmed from the outside of the outer tube, the visual confirmation portion having a transparent portion or a semi-transparent portion, The operation method includes an insertion step of inserting a distal end portion of the outer tube into the lumen and advancing the outer tube in a distal direction, and advancing a distal end portion of the endoscope to a distal 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 lumen of the outer tube, and pressurizing the space to a pressure in the range of 5 to 7 atmospheres, thereby expanding the tip portion of the balloon; an advancing step of advancing a distal end of the balloon in the lumen toward the distal end while the space is pressurized to a pressure in the range of 5 to 7 atmospheres; a supply step of supplying a perfusion fluid between the balloon and the endoscope while the space is pressurized to a pressure in the range of 5 to 7 atmospheres; a retracting step of retracting the endoscope relative to the inner tube while the perfusion fluid is being supplied; A method of operating a catheter system comprising:

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