Incision device

Abstract

This incision device comprises a tube, an incision member, and an operation member. The tube has a first lumen and a second lumen. The incision member is received in the first lumen. The operation member is received in the second lumen. The tube has, between the distal and proximal ends thereof, an opening that communicates with the first lumen and exposes a portion of the incision member to the outside. The distal end of the operation member is fixed to the tube at a position closer to the distal end side than the proximal end of the opening.

Description

Cutting device

[0001] The technology disclosed in this specification relates to a cutting device.

[0002] As a treatment method for choledocholithiasis, endoscopic sphincterotomy (EST: Endoscopic Sphincterotomy) is known. In endoscopic sphincterotomy, the operator inserts a cutting device into the papilla corresponding to the outlets of the bile duct and pancreatic duct, and cuts the living body with the cutting device.

[0003] Known cutting devices have a tube, a cutting tool, and an operating tool (see, for example, Patent Document 1). A part of the cutting tool is exposed outside the tube. The operator operates the operating tool to adjust the orientation of the exposed part of the cutting tool, and passes a high-frequency current from a high-frequency power source to the cutting tool, thereby cutting the living body with the exposed part of the cutting tool.

[0004] Japanese Patent No. 6856759

[0005] Known cutting devices have a simple structure and cannot improve both the cutting performance of the cutting tool and the smoothness of the operation by the operating tool. Such problems are not limited to the cutting device used in endoscopic sphincterotomy for cutting the papilla, but are common problems for all cutting devices inserted into various organs in the human body, such as the vascular system, lymphatic system, biliary system, urinary system, airway system, digestive organ system, secretory glands, and reproductive organs, to cut the living body.

[0006] This specification discloses a technology capable of solving the above-described problems.

[0007] The cutting device disclosed in this specification includes a tube, a cutting tool, and an operating tool. The tube has a first lumen and a second lumen. The cutting tool is accommodated in the first lumen. The operating tool is accommodated in the second lumen. The tube has a hole that communicates with the first lumen and exposes a part of the cutting tool between the distal end and the proximal end of the tube. The distal end of the operating tool is fixed to the tube at a position on the distal end side of the proximal end of the hole.

[0008] An explanatory diagram showing the external configuration of the cutting device of this embodiment. An explanatory diagram showing a cross-section of the cutting device at position II-II in Figure 1. An explanatory diagram showing a longitudinal section of the tip of the cutting device. An explanatory diagram showing another longitudinal section of the tip of the cutting device. An explanatory diagram showing a cross-section of the operating tool fixing member at position V-V in Figure 4. An explanatory diagram showing an example of how to operate the cutting device. An explanatory diagram showing an example of how to operate the cutting device. A cross-section of the operating tool fixing member in a modified example. A cross-section of the operating tool fixing member in another modified example. An explanatory diagram showing a longitudinal section of the tip of the cutting device

[0009] (Configuration of the incision device) Figure 1 is an explanatory diagram showing the external configuration of the incision device 100 of this embodiment. Figure 2 is an explanatory diagram showing a cross-section of the incision device 100 at position II-II in Figure 1. Figure 3 is an explanatory diagram showing a longitudinal section of the tip of the incision device 100. Figure 4 is an explanatory diagram showing another longitudinal section of the tip of the incision device 100. In Figure 1, the positive Z-axis side is the tip side (distal side) that is inserted into the body, and the negative Z-axis side is the proximal end side (proximal side) that is operated by the surgeon. In this specification, with respect to the incision device 100 and its components (hereinafter simply referred to as "incision device 100" in this paragraph), the tip end is referred to as the "tip," the tip and its vicinity as the "tip portion," the proximal end is referred to as the "proximal end," and the proximal end and its vicinity as the "proximal end portion." The cross-section of the incision device 100 means a cross-section perpendicular to the longitudinal direction. The longitudinal section of the cutting device 100 refers to a section parallel to the longitudinal direction. For the cutting device 100, the direction perpendicular to the central axis in the longitudinal direction is called the radial direction.

[0010] The incision device 100 is a device for incising living tissue. The incision device 100 is used, for example, in endoscopic sphincterotomy (EST) for the treatment of common bile duct stones. The incision device 100 is not limited to endoscopic sphincterotomy, but may also be inserted into various organs within the human body, such as the vascular system, lymphatic system, biliary system, urinary tract system, respiratory system, digestive system, secretory glands, and reproductive organs, to incise living tissue. The incision device 100 is a medical incision device.

[0011] The cutting device 100 includes a tube 10, a cutting tool 102, an operating tool 106, a connector 30, a sliding operating section 40, and a rotating operating section 50.

[0012] The tube 10 is a long, elongated member extending along the central axis Ax1. The cross-sectional shape of the tube 10 is, for example, approximately circular. The outer diameter of the tube 10 may be constant along its entire length or may vary along its longitudinal direction. The tube 10 is composed of a tip-side tube 10d on the tip end side and a base-side tube 10p on the base end side, with reference to the hole base end position P2, which will be described later. The base-side tube 10p is composed of a single continuous member. In this embodiment, the tube 10 is composed of a single continuous member along its entire length.

[0013] As shown in Figure 2, the tube 10 has a device lumen 16L, a cutting instrument lumen 17L, and a manipulating instrument lumen 18L. The device lumen 16L is a lumen into which a combined device, such as a guidewire, is inserted. The cutting instrument lumen 17L is a lumen into which a cutting instrument 102 is housed. The manipulating instrument lumen 18L is a lumen into which a manipulating instrument 106 is housed. Each lumen extends longitudinally from the tip to the proximal end of the tube 10. At least one of the three lumens (for example, the device lumen 16L) may also be used as a fluid delivery lumen for flowing liquids such as contrast agents or saline solution. The cross-sectional shape of each lumen is, for example, approximately circular. The proximal end tube 10p has only the three lumens described above. In this embodiment, the entire tube 10 has only the three lumens described above. Lumen 16L for devices is an example of a third lumen, lumen 17L for cutting instruments is an example of a first lumen, and lumen 18L for operating instruments is an example of a second lumen.

[0014] As shown in Figure 1, a branch section 33 is connected to the base end of the tube 10. The branch section 33 is a substantially cylindrical member extending in a direction intersecting the central axis Ax1. The branch section 33 is provided with a first port 34, which is an insertion point for a combined device such as a guide wire, and a second port 35, to which a syringe is connected for flowing liquids such as contrast agents or saline solution. The first port 34 and the second port 35 are connected to the device lumen 16L of the tube 10 via the lumen of the branch section 33.

[0015] The tube 10 is formed from, for example, a resin material or a metal material. Examples of resin materials for forming the tube 10 include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of fluororesins include polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), and chlorotrifluoroethylene-ethylene copolymer (ECTFE). Examples of metal materials for forming the tube 10 include stainless steel such as SUS304, Ni-Ti alloy, and cobalt-chromium alloy.

[0016] The incision tool 102 is a component for incising living tissue. As shown in Figure 3, the incision tool 102 includes an incision tool body 20 and an incision tool fixing member 82.

[0017] The cutting instrument body 20 is a linear member. The cutting instrument body 20 is formed, for example, from wire or rope. The outer diameter of the tip of the cutting instrument body 20 is smaller than the outer diameter of the base of the cutting instrument body 20. In this embodiment, the cutting instrument body 20 has a first portion 21, a second portion 22, and a third portion 23 arranged in order from the tip side to the base side. The first portion 21 is the portion that includes the tip of the cutting instrument body 20. The first portion 21 and the third portion 23 are cylindrical with an outer diameter of approximately constant. The outer diameter of the first portion 21 is, for example, 0.10 mm or more and 0.30 mm or less. The outer diameter of the first portion 21 may also be, for example, 0.15 mm or more and 0.25 mm or less. The outer diameter of the third portion 23 is larger than the outer diameter of the first portion 21. The second portion 22 is tapered, with an outer diameter that gradually increases from the tip side to the base side. The outer diameter of the tip of the second section 22 is approximately the same as the outer diameter of the base end of the first section 21, and the outer diameter of the base end of the second section 22 is approximately the same as the outer diameter of the tip of the third section 23. As shown in Figure 1, the base end of the cutting instrument body 20 extends beyond the base end of the tube 10 towards the base end, reaches the slide operating section 40 via the lumen of the connector 30 (described later), and is fixed to the support section 45 of the slide operating section 40.

[0018] The cutting instrument body 20 is formed from, for example, a metal material. Examples of metal materials that can be used to form the cutting instrument body 20 include stainless steel alloys such as SUS302, SUS304, and SUS316, Ni-Ti alloys, nickel-chromium alloys, cobalt alloys, gold, platinum, tungsten, and alloys containing these elements.

[0019] The cutting instrument fixing member 82 is a member for fixing the cutting instrument 102 to the tube 10. The cutting instrument fixing member 82 is connected to the tip of the cutting instrument body 20. The cutting instrument fixing member 82 is fixed to the tube 10 by the outer surface of the cutting instrument fixing member 82 contacting the inner surface of the cutting instrument lumen 17L of the tube 10. The cutting instrument fixing member 82 is formed of, for example, a metal material. As the metal material for forming the cutting instrument fixing member 82, for example, a stainless steel alloy can be used.

[0020] As shown in Figure 3, the tube 10 has a tip side hole 12d and a base side hole 12p that connect the lumen 17L for the cutting instrument to the outside. Hereinafter, the tip side hole 12d and the base side hole 12p will be collectively referred to as holes 12d and 12p. The tip of holes 12d and 12p, that is, the position of the tip of tip side hole 12d, will be called the hole tip position P1, and the base of holes 12d and 12p, that is, the position of the base of base side hole 12p, will be called the hole base position P2.

[0021] A portion of the cutting instrument body 20 (hereinafter referred to as the "exposed portion 20E") is exposed to the outside of the tube 10 between the tip and base of the tube 10. More specifically, in the cutting instrument body 20, the portion closer to the base of the portion fixed by the cutting instrument fixing member 82 is exposed to the outside of the tube 10 through the tip side hole 12d, and the portion closer to the base is again housed in the cutting instrument lumen 17L through the base side hole 12p. The exposed portion 20E is the portion of the cutting instrument body 20 from the position passing through the tip side hole 12d to the position passing through the base side hole 12p. In this embodiment, the exposed portion 20E is composed of the first portion 21 of the cutting instrument body 20. In this embodiment, the exposed portion 20E is always exposed to the outside of the tube 10.

[0022] A portion of the proximal end of the exposed portion 20E of the incision instrument body 20 is covered by an insulating tube 70. The insulating tube 70 is made of an insulating material such as PTFE or polyamide resin. The portion of the exposed portion 20E that is not covered by the insulating tube 70 functions as an incision portion 20S for cutting living tissue.

[0023] The tip of the cutting instrument 102, that is, the tip of the cutting instrument fixing member 82, is located on the tip side of the hole base end position P2. The tip of the cutting instrument fixing member 82 is located on the tip side of the hole tip end position P1. In this specification, when a particular part of a particular member is located on the tip side of a particular position, it includes the embodiment in which the particular part is located at the particular position. In this specification, when a particular part of a particular member is located on the base end side of a particular position, it does not include the embodiment in which the particular part is located at the particular position.

[0024] The operating tool 106 is a component for changing the orientation of the exposed portion 20E of the cutting tool 102. The operating tool 106 is housed in the operating tool lumen 18L and is electrically insulated from the cutting tool 102 housed in the cutting tool lumen 17L. As shown in Figure 4, the operating tool 106 includes an operating tool body 60 and an operating tool fixing member 86.

[0025] The operating tool body 60 is a linear member. The operating tool body 60 is formed, for example, from a wire or rope. The outer diameter of the tip of the operating tool body 60 is smaller than the outer diameter of the base end of the operating tool body 60. In this embodiment, the operating tool body 60 has a first portion 61, a second portion 62, and a third portion 63 arranged in order from the tip side to the base end side. The first portion 61 is the portion that includes the tip of the operating tool body 60. The first portion 61 and the third portion 63 are cylindrical with an outer diameter of approximately constant. The outer diameter of the first portion 61 is, for example, 0.15 mm or more and 0.50 mm or less. The outer diameter of the first portion 61 may also be, for example, 0.20 mm or more and 0.45 mm or less. The outer diameter of the third portion 63 is larger than the outer diameter of the first portion 61. The second portion 62 is tapered, with an outer diameter that gradually increases from the tip side to the base end side. The outer diameter of the tip of the second section 62 is approximately the same as the outer diameter of the base end of the first section 61, and the outer diameter of the base end of the second section 62 is approximately the same as the outer diameter of the tip of the third section 63. As shown in Figure 1, the base end of the operating tool body 60 extends beyond the base end of the tube 10 towards the base end, reaches the rotary operating section 50 via the lumen of the connector 30 (described later), and is fixed to the dial section 52 of the rotary operating section 50.

[0026] The operating tool body 60 is formed from, for example, a metal material. As the metal material for forming the operating tool body 60, for example, stainless steel alloys such as SUS302, SUS304, and SUS316, Ni-Ti alloys, nickel-chromium alloys, cobalt alloys, gold, platinum, tungsten, and alloys containing these elements can be used.

[0027] The operating tool fixing member 86 is a member for fixing the operating tool 106 to the tube 10. Figure 5 is a cross-sectional view of the operating tool fixing member 86 at the position V-V in Figure 4. The operating tool fixing member 86 includes a base-side fixing portion 86p and a tip-side fixing portion 86d connected to the tip side of the base-side fixing portion 86p. The base-side fixing portion 86p is cylindrical and extends in the longitudinal direction of the tube 10. The tip of the operating tool body 60 is inserted into the hollow portion of the base-side fixing portion 86p and fixed, for example, by crimping. The tip-side fixing portion 86d is columnar and extends in the longitudinal direction of the tube 10. As shown in Figure 5, the shape of the outer peripheral edge of the cross-section of the tip-side fixing portion 86d is non-circular. More specifically, the shape of the outer peripheral edge of the cross-section of the tip-side fixing portion 86d is approximately rectangular. The outer circumferential surface of the tip-side fixing portion 86d is in contact with the inner circumferential surface of the lumen 18L for the operating tool of the tube 10. This fixes the tip-side fixing portion 86d to the tube 10. The operating tool fixing member 86 is formed from, for example, a metal material. For example, a stainless steel alloy can be used as the metal material for forming the operating tool fixing member 86.

[0028] The tip of the operating tool 106, that is, the tip of the operating tool fixing member 86, is located on the tip side of the hole base end position P2. The tip of the operating tool fixing member 86 is located on the tip side of the hole tip position P1. As shown in Figures 3 and 4, in the longitudinal direction of the tube 10, the position of the tip of the operating tool fixing member 86 is approximately the same as the position of the tip of the cutting tool fixing member 82 of the cutting tool 102. The outer diameter of the exposed portion 20E of the cutting tool body 20 is smaller than the outer diameter of the portion of the operating tool body 60 that is aligned with the exposed portion 20E in the radial direction. The tensile strength of the operating tool body 60 may be higher than the tensile strength of the cutting tool body 20. The torque transmission performance of the operating tool body 60 may be higher than the torque transmission performance of the cutting tool body 20.

[0029] As shown in Figure 1, the connector 30 is a component connected to the base end of the tube 10. The connector 30 has a base portion 31 and a branch portion 32. The base portion 31 is a substantially cylindrical portion that extends along the central axis Ax1 of the tube 10.

[0030] The branch portion 32 of the connector 30 is a substantially cylindrical portion that extends from the middle of the base portion 31 in a direction intersecting the central axis Ax1. The angle θ1 between the central axis Ax1 of the tube 10 and the central axis Ax2 of the branch portion 32 is, for example, 10 degrees or more and 80 degrees or less. The angle θ1 may also be 15 degrees or more and 70 degrees or less, 20 degrees or more and 60 degrees or less, or 25 degrees or more and 50 degrees or less. The lumen of the branch portion 32 is connected to the lumen 17L for the cutting tool of the tube 10 via the lumen of the base portion 31. The cutting tool body 20 that constitutes the cutting tool 102 extends from the base end to the base end of the lumen 17L for the cutting tool of the tube 10, reaches the lumen of the branch portion 32 via the lumen of the base portion 31 of the connector 30, and penetrates the lumen of the branch portion 32. In other words, the cutting instrument 102 has a portion that extends along a direction that intersects the longitudinal direction of the cutting instrument lumen 17L (i.e., the direction of the central axis Ax1) (i.e., the direction of the central axis Ax2).

[0031] The slide operating section 40 is located on the base end side of the branch section 32 of the connector 30. The slide operating section 40 has a shaft portion 41 and a slide portion 42. The shaft portion 41 is a substantially cylindrical member that extends along the central axis A x 2 of the branch section 32 of the connector 30. The shaft portion 41 is connected to the base end of the branch section 32 of the connector 30. The lumen of the shaft portion 41 is connected to the lumen of the branch section 32 of the connector 30. A ring-shaped first finger receiving portion 43 is provided at the base end of the shaft portion 41.

[0032] The sliding portion 42 is a substantially cylindrical member. The sliding portion 42 is mounted on the shaft portion 41 so as to be slidable along the central axis Ax2. The sliding portion 42 is provided with a support portion 45 that protrudes into the lumen of the shaft portion 41. The base end of the cutting instrument body 20 of the cutting instrument 102 is fixed to the support portion 45. Therefore, the base end of the cutting instrument body 20 slides along the central axis Ax2 as the sliding portion 42 slides. The support portion 45 is made of a conductive material such as metal. A high-frequency power supply (not shown) is connected to the support portion 45. The high-frequency current from the high-frequency power supply flows through the cutting instrument body 20 via the support portion 45. A pair of ring-shaped second finger receiving portions 44 are provided on the side surface of the sliding portion 42.

[0033] The rotary operating section 50 is located on the base end side of the base portion 31 of the connector 30. The rotary operating section 50 has a shaft portion 51 and a dial portion 52. The shaft portion 51 is a substantially cylindrical member that extends along the central axis Ax1 of the base portion 31 of the connector 30. The shaft portion 51 is connected to the base end of the base portion 31 of the connector 30. The lumen of the shaft portion 51 is connected to the lumen of the base portion 31 of the connector 30.

[0034] The dial portion 52 is a substantially cylindrical member. The dial portion 52 is rotatably mounted on the shaft portion 51 around a central axis Ax1. The rotation angle of the dial portion 52 relative to the shaft portion 51 may be fixed. For example, a male thread formed on the outer circumferential surface of the tip of the dial portion 52 may engage with a female thread formed on the inner circumferential surface of the base end of the shaft portion 51. The base end of the operating tool body 60 of the operating tool 106 is fixed to the dial portion 52. Therefore, the base end of the operating tool body 60 rotates around the central axis Ax1 as the dial portion 52 rotates.

[0035] The connector 30, the slide operating section 40, and the rotation operating section 50 are formed from, for example, a resin material. Examples of resin materials that can be used to form these components include polyurethane, polypropylene, rigid polyvinyl chloride, polycarbonate resin, acrylic resin, and the like.

[0036] (Operation Method of the Cutting Device 100) Figures 6 and 7 are explanatory diagrams showing an example of how to operate the cutting device 100. As shown in Figure 6, the operator grasps the dial portion 52 of the rotary operation unit 50 and rotates the dial portion 52 relative to the shaft portion 51 (arrow AR2). This generates rotational torque at the base end of the operating tool body 60 fixed to the dial portion 52. This rotational torque is transmitted to the tip of the tube 10 to which the operating tool fixing member 86 is fixed, via the operating tool body 60 and the operating tool fixing member 86. As a result, the tube 10 rotates around the central axis Ax1, and the orientation (circumferential position) of the exposed portion 20E of the cutting tool body 20 changes. In this way, the operator can set the orientation of the exposed portion 20E of the cutting tool body 20 to a desired orientation by operating the operating tool 106 via the rotary operation unit 50.

[0037] As shown in Figure 7, when a surgeon inserts their thumb into the first finger receiving portion 43 of the slide operating portion 40 and their index and middle fingers into the pair of second finger receiving portions 44, and then pulls their index and middle fingers towards the proximal end (arrow AR1), the slide portion 42 slides towards the proximal end using the shaft portion 41 as a guide. This pulls the incision instrument body 20, which is fixed to the support portion 45 of the slide portion 42, towards the proximal end, and tension is applied to the incision instrument body 20. This tension is transmitted to the tip of the tube 10 to which the incision instrument fixing member 82 is fixed, via the incision instrument body 20 and the incision instrument fixing member 82. As a result, the tip of the tube 10 curves into an arc shape. When the slide portion 42 is returned to the tip side from this state, the tension on the incision instrument body 20 is relieved, and the tip of the tube 10 returns to a nearly straight shape. In this way, the operator can set the degree of curvature of the tip of the tube 10 to a desired degree by manipulating the cutting instrument 102 via the slide operation unit 40.

[0038] For example, in endoscopic papillotomy, the surgeon inserts an endoscope into the duodenum and delivers a guidewire, inserted under endoscopic guidance, from the opening of the papilla to the common bile duct. Next, the surgeon delivers the cutting device 100 along the guidewire to the opening of the papilla. Specifically, with the guidewire inserted into the device lumen 16L of the cutting device 100, the surgeon advances the cutting device 100 toward the tip until the tip of the cutting device 100 reaches the opening of the papilla. At this time, the surgeon positions the sliding part 42 toward the tip (Figure 1). This makes the tip of the tube 10 straight, preventing the tip of the tube 10 from getting caught on the papilla or common bile duct when the cutting device 100 is delivered.

[0039] The operator rotates the dial portion 52 of the rotating control unit 50 relative to the tube 10 (arrow AR2 in Figure 6), thereby rotating the tip of the tube 10 and setting the orientation of the exposed portion 20E of the incision instrument body 20 to an appropriate orientation for incising the nipple.

[0040] The operator applies tension to the cutting instrument body 20 by sliding the sliding part 42 of the sliding operation part 40 toward the base end using the shaft part 41 as a guide (arrow AR1 in Figure 7). This causes the tip of the tube 10 to curve into an arc shape, and the exposed part 20E of the cutting instrument body 20 is pressed against the cutting site. In this state, the operator applies a high-frequency current to the cutting instrument body 20 using a high-frequency power supply. As a result, a predetermined area of ​​the nipple is cut into a predetermined shape by the exposed part 20E of the cutting instrument body 20.

[0041] (Effects of this embodiment) As described above, the cutting device 100 of this embodiment comprises a tube 10, a cutting tool 102, and an operating tool 106. The tube 10 has a lumen 17L for the cutting tool and a lumen 18L for the operating tool. The cutting tool 102 is housed in the lumen 17L for the cutting tool. The operating tool 106 is housed in the lumen 18L for the operating tool. The tube 10 has holes 12d and 12p between its tip and base. The holes 12d and 12p are connected to the lumen 17L for the cutting tool and expose an exposed portion 20E, which is part of the cutting tool 102, to the outside. The tip of the operating tool 106 is fixed to the tube 10 at a position closer to the tip than the base end position P2 of the holes 12d and 12p. Thus, since the cutting device 100 of this embodiment has an operating tool 106, the cutting tool 102 is not used to adjust the orientation of the exposed portion 20E of the cutting tool 102. Therefore, the functions of the cutting tool 102 and the operating tool 106 can be separated into cutting the living body and adjusting the orientation of the exposed portion 20E, respectively, thereby improving the performance of both the cutting tool 102 and the operating tool 106. The tip of the operating tool 106 is fixed to the tube 10 at a position closer to the tip than the base end position P2 of the hole. Therefore, the rotational torque due to the rotation of the operating tool 106 is transmitted to a part of the tube 10 closer to the tip, improving the smoothness of adjusting the orientation of the exposed portion 20E of the cutting tool 102. Accordingly, the cutting device 100 of this embodiment improves both the cutting performance of the cutting tool 102 and the smoothness of operation by the operating tool 106 with a relatively simple configuration.

[0042] In the incision device 100 of the present embodiment, the tip of the operating tool 106 is fixed to the tube 10 at a position on the tip side of the tip position P1 of the hole portions 12d and 12p, which is the tip of the hole portions. Therefore, the rotational torque caused by the rotation of the operating tool 106 is transmitted to a portion closer to the tip of the tube 10, and the smoothness of adjusting the orientation of the exposed portion 20E of the incision tool 102 is further improved.

[0043] In the incision device 100 of the present embodiment, the tip of the operating tool 106 is fixed to the tube 10 inside the lumen 18L for the operating tool. Therefore, the occurrence of kinks and habits in the operating tool 106 is suppressed.

[0044] In the incision device 100 of the present embodiment, the tip of the incision tool 102 is fixed to the tube 10 at a position on the tip side of the tip position P1 of the hole portion. Therefore, the exposed portion 20E of the incision tool 102 can be arranged closer to the tip of the tube 10, and the incision performance of the incision tool 102 is further improved.

[0045] In the incision device 100 of the present embodiment, the tip of the incision tool 102 is fixed to the tube 10 inside the lumen 17L for the incision tool. Therefore, the occurrence of kinks and habits in the incision tool 102 is suppressed.

[0046] In the incision device 100 of the present embodiment, on the base end side of the base end of the tube 10, the operating tool 106 extends along the longitudinal direction of the lumen 18L for the operating tool, and the incision tool 102 has a portion extending along a direction intersecting the longitudinal direction of the lumen 17L for the incision tool. Therefore, the arrangement of the base ends of the operating tool 106 and the incision tool 102 is prevented from being complicated, and the occurrence of habits accompanying the rotation of the operating tool 106 is suppressed.

[0047] The incision device 100 of the present embodiment further includes a rotation operation unit 50 that is connected to the base end portion of the operating tool 106 and rotates the base end portion of the operating tool 106. Therefore, the operability of the operating tool 106 is further improved.

[0048] The incision device 100 of the present embodiment further includes a slide operation unit 40 that is connected to the proximal end portion of the incision tool 102 and slides the proximal end portion of the incision tool 102 at least in one of the distal end side and the proximal end side. Therefore, the operability of the incision tool 102 is further improved.

[0049] In the incision device 100 of the present embodiment, the incision tool 102 and the operation tool 106 are electrically insulated from each other. Therefore, the durability of the incision tool 102 and the operation tool 106 is improved.

[0050] In the incision device 100 of the present embodiment, the proximal end tube 10p has, as a lumen, only the incision tool lumen 17L, the operation tool lumen 18L, and the device lumen 16L into which a combined device is inserted. Therefore, an increase in the outer diameter of the tube 10 is suppressed, and the durability of the tube 10 is improved.

[0051] In the incision device 100 of the present embodiment, the operation tool 106 has a linear operation tool body 60 and an operation tool fixing member 86 that is connected to the distal end portion of the operation tool body 60 and fixed to the tube 10. Therefore, an increase in the outer diameter of the operation tool body 60 is suppressed, the operation tool 106 is securely fixed to the tube 10, the rotational torque due to the rotation of the operation tool 106 is reliably transmitted to the distal end of the tube 10, and the operability of the operation tool 106 is further improved.

[0052] In the incision device 100 of the present embodiment, the outer diameter of the distal end of the operation tool body 60 is smaller than the outer diameter of the proximal end of the operation tool body 60. Therefore, the transmission property of the rotational torque via the operation tool 106 is improved, and the operability of the operation tool 106 is further improved.

[0053] In the incision device 100 of the present embodiment, the shape of the outer peripheral edge of the cross section of the operation tool fixing member 86 orthogonal to the longitudinal direction of the tube 10 is non-circular. Therefore, the operation tool fixing member 86 of the operation tool 106 is more securely fixed to the tube 10, the rotational torque due to the rotation of the operation tool 106 is more reliably transmitted to the distal end of the tube 10, and the operability of the operation tool 106 is further improved.

[0054] In the cutting device 100 of this embodiment, the cutting tool 102 is linear and includes a cutting tool body 20 having an exposed portion 20E, and a cutting tool fixing member 82 connected to the tip of the cutting tool body 20 and fixed to the tube 10. Therefore, while suppressing an increase in the outer diameter of the cutting tool body 20, the cutting tool 102 is securely fixed to the tube 10, the tension of the cutting tool 102 is reliably transmitted to the tip of the tube 10, and the operability of the cutting tool 102 is further improved.

[0055] In the cutting device 100 of this embodiment, the outer diameter of the exposed portion 20E of the cutting instrument body 20 is smaller than the outer diameter of the portion of the operating instrument body 60 that is aligned with the exposed portion 20E in a direction perpendicular to the longitudinal direction of the tube 10. As a result, both the cutting performance of the cutting instrument 102 and the operability of the operating instrument 106 are further improved.

[0056] In the cutting device 100 of this embodiment, the proximal tube 10p is made from a single continuous member. Therefore, complexity in the structure of the tube 10 is avoided, and the durability of the tube 10 is improved.

[0057] In the cutting device 100 of this embodiment, at least a portion of the operating tool fixing member 86 and at least a portion of the cutting tool fixing member 82 may be arranged at the same position in the longitudinal direction of the tube 10. With this configuration, the operating tool fixing member 86 and the cutting tool fixing member 82 not only perform the function of fixing, but also perform the function of significantly improving the visibility of the two fixing members in the field of view where the operating tool fixing member 86 and the cutting tool fixing member 82 overlap, for example under X-ray fluoroscopy.

[0058] (Modifications) The technologies disclosed herein are not limited to the embodiments described above and can be modified in various forms without departing from the spirit thereof, for example, the following modifications are possible.

[0059] Figure 8 is a cross-sectional view of the operating tool fixing member 86 in a modified example. In the modified example shown in Figure 8, the shape of the outer peripheral edge of the cross-section of the tip-side fixing portion 86d is non-circular. More specifically, the shape of the outer peripheral edge of the cross-section of the tip-side fixing portion 86d is approximately triangular. According to this modified example, similar to the above embodiment, the operating tool fixing member 86 of the operating tool 106 is more securely fixed to the tube 10, the rotational torque due to the rotation of the operating tool 106 is more reliably transmitted to the tip of the tube 10, and the operability of the operating tool 106 is further improved.

[0060] Figure 9 is a cross-sectional view of the operating tool fixing member 86 in another modified example. In the modified example shown in Figure 9, the shape of the outer peripheral edge of the cross-section of the tip-side fixing portion 86d is non-circular. More specifically, the shape of the outer peripheral edge of the cross-section of the tip-side fixing portion 86d is such that a projection 87 protrudes from a predetermined position on a substantially circular circumference. In this modified example, the projection 87 is located at four positions that divide the circumference into approximately four equal parts. According to this modified example, similar to the above embodiment, the operating tool fixing member 86 of the operating tool 106 is more securely fixed to the tube 10, the rotational torque due to the rotation of the operating tool 106 is more reliably transmitted to the tip of the tube 10, and the operability of the operating tool 106 is further improved.

[0061] Figure 10 is an explanatory diagram showing a longitudinal cross-section of the tip of the cutting device 100 in another modified example. In the modified example shown in Figure 10, the tip of the operating tool 106, that is, the tip of the operating tool fixing member 86, is located towards the tip side of the hole tip position P1. In the longitudinal direction of the tube 10, the position of the tip of the operating tool fixing member 86 is towards the base end side of the position of the tip of the cutting tool fixing member 82 of the cutting tool 102 (see Figure 3). According to this modified example, both the cutting performance of the cutting tool 102 and the smoothness of operation by the operating tool 106 are improved, similar to the above embodiment. Furthermore, according to this modified example, it is possible to improve the cutting performance of the cutting tool 102 while suppressing an increase in the outer diameter of the tube 10.

[0062] Figure 11 is an explanatory diagram showing a longitudinal cross-section of the tip of the cutting device 100 in another modified example. In the modified example shown in Figure 11, the tip of the operating tool 106, that is, the tip of the operating tool fixing member 86, is located on the base side of the hole tip position P1 and on the tip side of the hole base position P2. In the longitudinal direction of the tube 10, the position of the tip of the operating tool fixing member 86 is on the base side of the position of the tip of the cutting tool fixing member 82 of the cutting tool 102 (see Figure 3). According to this modified example, both the cutting performance of the cutting tool 102 and the smoothness of operation by the operating tool 106 are improved, similar to the above embodiment. Furthermore, according to this modified example, it is possible to improve the cutting performance of the cutting tool 102 while suppressing an increase in the outer diameter of the tube 10.

[0063] Figure 12 is an explanatory diagram showing a longitudinal cross-section of the tip of the cutting device 100 in another modified example. In the modified example shown in Figure 12, the tip of the operating tool 106, that is, the tip of the operating tool fixing member 86, is located on the base side of the hole tip position P1 and on the tip side of the hole base position P2. In the longitudinal direction of the tube 10, the position of the tip of the operating tool fixing member 86 is on the base side of the position of the tip of the cutting tool fixing member 82 of the cutting tool 102 (see Figure 3). According to this modified example, both the cutting performance of the cutting tool 102 and the smoothness of operation by the operating tool 106 are improved, similar to the above embodiment. Furthermore, according to this modified example, it is possible to improve the cutting performance of the cutting tool 102 while suppressing an increase in the outer diameter of the tube 10.

[0064] In the above embodiment, lumens other than the device lumen 16L, the cutting instrument lumen 17L, and the manipulating instrument lumen 18L may be formed in the tube 10. At least one of the three lumens may be omitted in a portion of the tube 10.

[0065] In the above embodiment, the tip of the tube 10 may be shaped so that the tip end has a smaller diameter. This makes it easier to insert the incision device into the nipple. This reduces the risk of tissue damage when inserting the incision device into the nipple, thus improving safety. To shape the tip of the tube 10 so that the tip end has a smaller diameter, for example, the periphery of the tip of the tube 10 can be chamfered, a portion of the tip of the tube 10 can be shaved off, or the tip of the tube 10 can be shaped into a tapered shape so that the tip end has a smaller diameter. Examples of processing methods to make the tip of the tube 10 have a smaller diameter include polishing, shaving, notching, and melting deformation.

[0066] If the tip of the tube 10 is shaped so that the tip portion has a smaller diameter, the diameter of the cutting instrument lumen 17L, which is an example of the first lumen, at the tip of the tube 10 can be set to be smaller than the diameter of the cutting instrument lumen 17L on the proximal end side of the tip. If the tip of the tube 10 is shaped so that the tip portion has a smaller diameter, the opening area of ​​the cutting instrument lumen 17L, which is an example of the first lumen, at the tip of the tube 10 may be set to be smaller than the opening area of ​​the cutting instrument lumen 17L on the proximal end side of the tip. If the tip of the tube 10 is shaped so that the tip portion has a smaller diameter, the cutting instrument lumen 17L, which is an example of the first lumen, at the tip of the tube 10 may be closed, while the cutting instrument lumen 17L on the proximal end side of the tip may not be closed. This makes it easier to set the tip of the tube 10 to be shaped so that the tip portion has a smaller diameter.

[0067] If the tip of the tube 10 is shaped so that the tip portion has a smaller diameter, the diameter of the operating tool lumen 18L, which is an example of a second lumen, at the tip of the tube 10 can be set to be smaller than the diameter of the operating tool lumen 18L on the base end side of the tip. If the tip of the tube 10 is shaped so that the tip portion has a smaller diameter, the opening area of ​​the operating tool lumen 18L, which is an example of a second lumen, at the tip of the tube 10 may be set to be smaller than the opening area of ​​the operating tool lumen 18L on the base end side of the tip. If the tip of the tube 10 is shaped so that the tip portion has a smaller diameter, the operating tool lumen 18L, which is an example of a second lumen, at the tip of the tube 10 may be closed, while the operating tool lumen 18L on the base end side of the tip may not be closed. This makes it easier to set the tip of the tube 10 to be shaped so that the tip portion has a smaller diameter.

[0068] In the above embodiment, the cutting instrument 102 may be made of an integral member, and the operating tool 106 may be made of an integral member. The cutting instrument 102 may be fixed to the tube 10 outside the lumen 17L for the cutting instrument. The operating tool 106 may be fixed to the tube 10 outside the lumen 18L for the operating tool.

[0069] In the above embodiment, the hole portion may consist of a single hole. Alternatively, the hole portion may consist of three or more holes.

[0070] In the above embodiment, the rotary operating part 50 may be located on the base end side of the branch portion 32 of the connector 30, and the slide operating part 40 may be located on the base end side of the base portion 31. At least one of the rotary operating part 50 and the slide operating part 40 may be omitted.

[0071] In the above embodiment, the position of the tip of the cutting instrument 102, that is, the position of the tip of the cutting instrument fixing member 82, may be closer to the base end than the position of the tip of the operating tool 106, that is, the position of the tip of the operating tool fixing member 86.

[0072] In the above embodiment, the outer diameters of the cutting instrument body 20 and the operating instrument body 60 at each position along the longitudinal direction can be arbitrarily changed. The relative sizes of the outer diameters of the cutting instrument body 20 and the operating instrument body 60 can also be arbitrarily changed.

[0073] In the above embodiment, the exposed portion 20E of the cutting instrument body 20 does not need to be constantly exposed to the outside. The exposed portion 20E may be exposed to the outside of the tube 10 at least when the tube 10 is in a predetermined position (for example, when the tube 10 is greatly curved).

[0074] In the above embodiment, the insulating tube 70 may be omitted. Instead of the insulating tube 70, the outer surface of the cutting instrument body 20 may be coated with an insulating material.

Claims

1. A cutting device (100) comprising: a tube (10) having a first lumen (17L) and a second lumen (18L); a cutting instrument (102) housed in the first lumen (17L); and an operating tool (106) housed in the second lumen (18L), wherein the tube (10) has holes (12d, 12p) between its tip and base end that pass through the first lumen (17L) and expose a portion of the cutting instrument (102) to the outside; and the tip of the operating tool (106) is fixed to the tube (10) at a position closer to the tip than the base end of the holes (12d, 12p).

2. The incision device (100) according to claim 1, wherein the tip of the operating tool (106) is fixed to the tube (10) at a position closer to the tip of the hole portion (12d, 12p).

3. An incision device (100) according to claim 1 or claim 2, wherein the tip of the operating tool (106) is fixed to the tube (10) inside the second lumen (18L).

4. An incision device (100) according to any one of claims 1 to 3, wherein the tip of the incision tool (102) is fixed to the tube (10) at a position closer to the tip of the hole portion (12d, 12p).

5. An incision device (100) according to any one of claims 1 to 4, wherein the tip of the incision tool (102) is fixed to the tube (10) inside the first lumen (17L).

6. An incision device (100) according to any one of claims 1 to 5, wherein, at a proximal end to the tube (10), the operating tool (106) extends along the longitudinal direction of the second lumen (18L), and the incision tool (102) has a portion that extends along a direction intersecting the longitudinal direction of the first lumen (17L).

7. An incision device (100) according to any one of claims 1 to 6, further comprising a rotating operating part (50) connected to the base end of the operating tool (106) for rotating the base end of the operating tool (106).

8. An incision device (100) according to any one of claims 1 to 7, further comprising a slide operating unit (40) connected to the base end of the incision tool (102) for sliding the base end of the incision tool (102) toward at least one of the tip end and the base end.

9. An incision device (100) according to any one of claims 1 to 8, wherein the incision tool (102) and the operating tool (106) are electrically insulated from each other.

10. An incision device (100) according to any one of claims 1 to 9, wherein the portion of the tube (10) closer to the proximal end of the hole (12d, 12p) has as lumens only the first lumen (17L), the second lumen (18L), and the third lumen (16L) into which a combined device is inserted.

11. An incision device (100) according to any one of claims 1 to 10, wherein, in the longitudinal direction of the tube (10), the position of the tip of the incision tool (102) is different from the position of the tip of the operating tool (106).

12. The cutting device (100) according to claim 11, wherein, in the longitudinal direction of the tube (10), the position of the tip of the operating tool (106) is closer to the proximal end than the position of the tip of the cutting instrument (102).

13. An incision device (100) according to any one of claims 1 to 12, wherein the operating tool (106) comprises a linear operating tool body (60) and an operating tool fixing member (86) connected to the tip of the operating tool body (60) and fixed to the tube (10).

14. The incision device (100) according to claim 13, wherein the outer diameter of the tip of the operating tool body (60) is smaller than the outer diameter of the base of the operating tool body (60).

15. An incision device (100) according to claim 13 or claim 14, wherein the shape of the outer peripheral edge of the cross-section of the operating tool fixing member (86) perpendicular to the longitudinal direction of the tube (10) is non-circular.

16. An incision device (100) according to any one of claims 13 to 15, wherein the incision tool (102) comprises: an incision tool body (20) which is linear and has a portion exposed to the outside of the tube (10); and an incision tool fixing member (82) which is connected to the tip of the incision tool body (20) and fixed to the tube (10).

17. The cutting device (100) according to claim 16, wherein the outer diameter of the portion of the cutting instrument body (20) that is exposed from the tube (10) is smaller than the outer diameter of the portion of the operating instrument body (60) that is aligned radially with the exposed portion.

18. An incision device (100) according to any one of claims 1 to 17, wherein the portion of the tube (10) that is closer to the proximal end than the proximal end of the holes (12d, 12p) is made of a single continuous member.

19. The cutting device (100) according to claim 16 or claim 17, wherein at least a portion of the operating tool fixing member (86) and at least a portion of the cutting tool fixing member (82) are arranged at the same position in the longitudinal direction of the tube (10).

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