Incision device

Abstract

Provided is an incision device that has excellent operability when an incision is being made. This incision device comprises: a shaft that has a first interior cavity extending in a longitudinal direction and, in an outer side surface of a distal section, a first opening that communicates with the first interior cavity; a conducting wire that has a first region disposed in the first interior cavity and a second region located closer to the tip side than the first region and exposed via the first opening; and a handle to which a base-end section of the conducting wire is fixed. In a first perspective, which is side view of the shaft and in which at least part of the second region of the conducting wire is located in front of the shaft and appears to overlap with the shaft, the second region of the conducting wire can be bent by operation of the handle so as to form a first mountain-shaped section that protrudes in a first direction that separates from a central axis of the shaft, and an apex of the first mountain-shaped section is located closer to the proximal side than the center of a line segment connecting the proximal end and the distal end of the second region of the conducting wire.

Description

cutting device

[0001] The present invention relates to a lancing device.

[0002] Conventionally, in the field of medical care, an incision device having a cutting wire has been used to incise biological tissue. For example, Patent Document 1 discloses such an incision device, which is for use in a treatment including a dilation procedure performed inside a patient, and includes a catheter directed through an internal passage of the patient, the catheter including a proximal end, a distal end, a proximal portion adjacent to the proximal end, a distal portion adjacent to the distal end, a first lumen, and at least one second lumen substantially parallel to the first lumen, the first lumen and the second lumen extending between the proximal portion and the distal portion, and the cutting wire for performing the dilation procedure extending through the second lumen to operate the distal portion in response to manipulation at the proximal end, the cutting wire being connected to the catheter at the distal end of the second lumen. a cutting wire having a distal end attached to a catheter, a portion of the cutting wire being on an exterior surface of the catheter along a length coextensive with a portion of the distal portion of the catheter, the cutting wire further including a handle for manipulating the cutting wire from a location proximal to the catheter, a rotatable coupling coupling the handle to the catheter to allow the handle to rotate relative to the proximal end of the catheter, a rotatable coupling engaging the proximal end of the cutting wire to rotate the distal portion of the catheter by rotating the proximal end of the cutting wire, and a locking mechanism for locking the orientation of the distal portion of the cutting wire.

[0003] Special Publication No. 2005-511195

[0004] In conventional devices such as that described in Patent Document 1, rotating the handle allows the distal portion of the catheter to be bent and changed in direction via the cutting wire. This configuration eliminates the need to rotate the entire catheter when aligning the cutting wire with biological tissue and moving the cutting wire circumferentially outside the catheter. However, in recent years, there has been a demand for improved operability. The present invention has been made in response to the above-mentioned problems, and its purpose is to provide an incision device that is easy to operate during incision.

[0005] The incision device according to the embodiment of the present invention that can solve the above problems is as follows. [1] An incision device comprising: a shaft extending in a longitudinal direction, the shaft having a first lumen extending in the longitudinal direction, and a first opening on an outer surface of a distal portion thereof, the first opening communicating with the first lumen; a conductive wire having a base end and a tip end fixed to a portion of the shaft distal to the first opening, the conductive wire having a first region located distal to the base end and disposed in the first lumen, and a second region located distal to the first region and exposed from the first opening; and a handle to which the base end of the conductive wire is fixed, wherein in a first field of view in a side view of the shaft, in which at least a portion of the second region of the conductive wire is located closer to the user than the shaft and appears to overlap with the shaft, the second region of the conductive wire can be bent by operating the handle to form a first mountain-shaped portion protruding in a first direction away from a central axis of the shaft, and an apex of the first mountain-shaped portion is located proximal to the center of a line segment connecting the proximal end and the distal end of the second region of the conductive wire.

[0006] As described above, by operating the handle, the conductive wire is bent outside the distal portion of the shaft to form the first peak in the first field of view, thereby enabling the conductive wire to contact a portion that could not be contacted in the past without rotating the distal portion of the shaft or rotating the entire shaft. In other words, the incision device according to the embodiment allows the conductive wire to contact a portion that could not be contacted in the past without rotating the shaft. In this way, the incision device according to the embodiment has excellent operability during incision.

[0007] The dissection device according to the embodiment is preferably any one of the following [2] to

[13] . [2] The dissection device according to [1], wherein only the first mountain-shaped portion can be formed as the mountain-shaped portion of the second region in the first field of view. [3] The dissection device according to [1] or [2], wherein the first field of view is a field in which the length of the second region appears to be the longest. [4] The dissection device according to any one of [1] to [3], wherein the conductive wire includes a conductive wire and an insulating film coating the conductive wire, and wherein, in the first field of view, the distal end of the insulating film is located distal to the apex of the first mountain-shaped portion. [5] The dissection device according to any one of [1] to [4], wherein, in the first field of view, the length from the apex of the first mountain-shaped portion to the distal end of the second region is longer than the length from the proximal end of the second region to the apex of the first mountain-shaped portion. [6] The dissection device according to any one of [1] to [5], wherein the conductive wire has a fixture fixed to the surface of the tip. [7] The incision device according to any one of [1] to [6], wherein, in the first field of view, the second region of the conductive wire can be further bent by operating the handle to form the first mountain-shaped portion and a second mountain-shaped portion located distal to the first mountain-shaped portion and protruding in a second direction away from the central axis of the shaft opposite to the first direction. [8] The incision device according to [7], wherein, in the first field of view, the apex of the first mountain-shaped portion is located on one side of a virtual line passing through the proximal and distal ends of the second region, and the apex of the second mountain-shaped portion is located on the other side. [9] The incision device according to [7] or [8], wherein the conductive wire includes a conductive wire and an insulating film covering the conductive wire, and wherein, in the first field of view, the distal end of the insulating film is located proximal to the apex of the second mountain-shaped portion.

[10] An incision device described in any of [7] to [9], in a second field of view in which the apex of the first mountain-shaped portion of the second region is located on the front side and the apex of the second mountain-shaped portion is located on the back side when viewed from the side of the shaft, the second region forms only one mountain-shaped portion that protrudes in a direction away from the central axis of the shaft.

[11] The incision device according to any one of [1] to

[10] , wherein the handle includes: a first member having an extending portion extending in the longitudinal direction; and a second member having an inner cavity extending in the longitudinal direction and capable of moving in the longitudinal direction without rotating circumferentially relative to the shaft, wherein a portion of the extending portion is disposed in the inner cavity of the second member.

[12] The incision device according to

[11] , wherein the first member has a first fitting portion extending in the longitudinal direction, and the second member has a second fitting portion that slidably fits into the first fitting portion in the longitudinal direction.

[13] The incision device according to

[11] or

[12] , wherein the base end of the conductive wire is fixed to the second member.

[0008] With the above configuration, it is possible to provide an incision device that is easy to operate during incision.

[0009] FIG. 1 is a plan view of an incision device according to a first embodiment. FIG. 2 is a plan view of the distal portion of the shaft when the conductive wire of FIG. 1 is pushed and bent. FIG. 3 is a longitudinal cross-sectional view of the distal portion of the shaft of FIG. 2. FIG. 4 is a plan view of the distal portion of the shaft when the conductive wire of FIG. 2 is further pushed to form a first peak. FIG. 5 is a side view of the distal portion of the shaft in a direction from one side A to the other side B of FIG. 4. FIG. 6 is a plan view of the distal portion of the shaft when the conductive wire of FIG. 4 is further pushed to form a first peak and a second peak. FIG. 7 is a side view of the distal portion of the shaft in a direction from one side A to the other side B of FIG. 6. FIG. 8 is a cross-sectional view of the distal portion of the shaft when the conductive wire of FIG. 3 is pulled and bent. FIG. 9 is a plan view of a modified example of the distal portion of the shaft of FIG. 1. FIG. 10 is a cross-sectional view taken along the line A-A of FIG. 1. FIG. 11 is a plan view of an incision device according to a second embodiment. Fig. 12 is a plan view of the distal portion of the shaft when the distal portion of the shaft in Fig. 11 is bent and changed in direction. Fig. 13 is a longitudinal cross-sectional view of the connecting member and its vicinity in Fig. 11. Fig. 14 is a cross-sectional view taken along line B-B in Fig. 11.

[0010] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. Note that, for convenience, component reference numerals may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0011] The incision device of one embodiment comprises: a shaft extending in the longitudinal direction, the shaft having a first lumen extending in the longitudinal direction and a first opening on the outer surface of the distal portion that communicates with the first lumen; a conductive wire having a base end and a tip end fixed to a portion of the shaft distal to the first opening, the conductive wire having a first region located distal to the base end and disposed in the first lumen, and a second region located distal to the first region and exposed from the first opening; and a handle to which the base end of the conductive wire is fixed. In a first field of view from the side of the shaft, in which at least a portion of the second region of the conductive wire is located closer to the user than the shaft and appears to overlap with the shaft, the second region of the conductive wire can be bent by operating the handle to form a first mountain-shaped portion that protrudes in a first direction away from the central axis of the shaft, and the apex of the first mountain-shaped portion is located proximal to the center of the line segment connecting the proximal end and distal end of the second region of the conductive wire.

[0012] As described above, by operating the handle, the conductive wire is bent outside the distal portion of the shaft to form a first mountain-shaped portion in the first field of view, allowing the conductive wire to contact a portion that previously could not be contacted without rotating the distal portion of the shaft or the entire shaft. In other words, the incision device according to the embodiment allows the conductive wire to contact a portion that previously could not be contacted without rotating the shaft, even without a rotation operation. As described above, the incision device according to the embodiment has excellent operability during incision. Furthermore, since the incision device is configured so that the apex of the first mountain-shaped portion can be positioned proximal to the center of the line segment connecting the proximal and distal ends of the second region of the conductive wire by operating the handle, further pushing the conductive wire easily forms a second mountain-shaped portion in a different direction from the first mountain-shaped portion at a position distal to the first mountain-shaped portion in the second region. This facilitates incising tissue in multiple directions.

[0013] A dissection device according to a first embodiment will be described below with reference to FIGS. 1 to 10 . FIG. 1 is a plan view of the dissection device according to the first embodiment. FIG. 2 is a plan view of the distal portion of the shaft when the conductive wire of FIG. 1 is pushed and bent. FIG. 3 is a longitudinal cross-sectional view of the distal portion of the shaft of FIG. 2. FIG. 4 is a plan view of the distal portion of the shaft when the conductive wire of FIG. 2 is further pushed to form a first peak. FIG. 5 is a side view of the distal portion of the shaft in a direction from one side A to the other side B of FIG. 4. FIG. 6 is a plan view of the distal portion of the shaft when the conductive wire of FIG. 4 is further pushed to form a first peak and a second peak. FIG. 7 is a side view of the distal portion of the shaft in a direction from one side A to the other side B of FIG. 6. FIG. 8 is a cross-sectional view of the distal portion of the shaft when the conductive wire of FIG. 3 is pulled and bent. FIG. 9 is a plan view of a modified example of the distal portion of the shaft of FIG. 1. FIG. 10 is a cross-sectional view taken along line AA in FIG.

[0014] As shown in FIG. 1, the incision device 91 according to the first embodiment includes a shaft 1 , a conductive wire 2 , and a handle 3 .

[0015] As shown in FIGS. 1 , 2 , and 3 , the shaft 1 extends in the longitudinal direction 1X. The shaft 1 has a first lumen 11L extending in the longitudinal direction 1X, and a first opening 11O communicating with the first lumen 11L is provided on the outer surface 1s of the distal portion 1b. The conductive wire 2 is exposed to the outside of the shaft 1 through the first opening 11O, and electrical current is passed through the conductive wire 2 to incise biological tissue. Specifically, the conductive wire 2 is preferably one that can incise biological tissue by passing a high-frequency current through it. The frequency of the high-frequency current is preferably 100 kHz or more and 20 MHz or less, more preferably 200 kHz or more and 5 MHz or less, and even more preferably 300 kHz or more and 1 MHz or less.

[0016] 1 and 2, the conductive wire 2 has a base end 2a, a tip end 2b, a first region 21, and a second region 22. It is preferable that the conductive wire 2 has the base end 2a, the first region 21, the second region 22, and the tip end 2b in this order from the proximal side to the distal side.

[0017] The tip portion 2b of the conductive wire 2 is fixed to a portion of the shaft 1 distal to the first opening 11O. By pushing the conductive wire 2 fixed in this manner distally, the conductive wire 2 can be bent in a direction D away from the shaft 1, as shown in Figures 2 and 3. By pushing the conductive wire 2 further distally, the conductive wire 2 can be bent outside the shaft 1, as shown in Figure 4 of the first field of view described below. On the other hand, as shown in Figure 8, the conductive wire 2 fixed as described above can be pulled proximally to bend the distal portion 1b of the shaft 1, and the conductive wire 2 can be turned into a knife portion like a bowstring.

[0018] The first region 21 of the conductive wire 2 is located closer to the distal end than the proximal end 2 a and is disposed in the first lumen 11 L. This allows the first region 21 to be protected by the shaft 1.

[0019] The second region 22 of the conductive wire 2 is located closer to the tip than the first region 21 and is exposed from the first opening 11O. Examples of the exposed state include a state in which at least a portion of the second region 22 is located outside the shaft 1 relative to the first opening 11O as shown in Figure 3, and a state in which the second region 22 inside the shaft 1 can be seen from outside the shaft 1 through the first opening 11O.

[0020] As shown in Figure 1, the base end 2a of the conductive wire 2 is fixed to the handle 3. The conductive wire 2 can be manipulated by operating this handle 3. The base end 2a is preferably directly fixed to the handle 3, but may also be indirectly fixed to the handle 3 via another member. The rigidity of the distal portion 1b of the shaft 1 may be increased so that only the conductive wire 2 can be bent by operating the handle 3, without bending the distal portion 1b of the shaft 1.

[0021] As shown in Fig. 4 , the incision device 91 can bend the second region 22 of the conductive wire 2 by operating the handle 3 in a first field of view, in which at least a portion of the second region 22 of the conductive wire 2 is located closer to the user than the shaft 1 and appears overlapped with the shaft 1 as viewed from the side of the shaft 1, to form a first mountain-shaped portion M1 protruding in a first direction D1 away from the central axis C of the shaft 1. In this case, in the first field of view, the apex P1 of the first mountain-shaped portion M1 is located proximal to the center 22C of the line segment 22L connecting the proximal end 22a and the distal end 22b of the second region 22 of the conductive wire 2. By bending the conductive wire 2 in this way in the first field of view, it is possible to bring the conductive wire 2 into contact with areas that are difficult to reach with an unbent conductive wire 2 in the first field of view, as shown in Fig. 2 .

[0022] Furthermore, because the incision device 91 is configured so that the apex P1 of the first mountain-shaped portion M1 can be positioned proximal to the center 22C of the line segment 22L by operating the handle 3, when, for example, the conductive wire 2 is further pushed in, the second mountain-shaped portion M2 is likely to be formed in a position distal to the first mountain-shaped portion M1 in the second region 22, with a different orientation from the first mountain-shaped portion M1, as shown in FIG. 6 . Note that the incision device 91 may be configured so that, by operating the handle 3, only the first mountain-shaped portion M1 is formed as the mountain-shaped portion of the second region 22 in the first field of view. In other words, it may be possible to form only the first mountain-shaped portion M1 as the mountain-shaped portion of the second region 22 in the first field of view. Modes in which only the first mountain-shaped portion M1 can be formed as the mountain-shaped portion of the second region 22 in the first field of view include a mode in which only the first mountain-shaped portion M1 can be formed and then the first mountain-shaped portion M1 and the second mountain-shaped portion M2 can be formed, and a mode in which only the first mountain-shaped portion M1 can be formed but no other mountain-shaped portions can be formed thereafter. Modes in which only the first mountain-shaped portion M1 can be formed but no other mountain-shaped portions can be formed thereafter include, for example, a mode in which the handle 3 is configured so that the conductive wire 2 cannot be further pushed distally after the handle 3 is operated to push the conductive wire 2 distally to form only the first mountain-shaped portion M1, and a mode in which the conductive wire 2 is configured so that no other mountain-shaped portions can be formed even if the conductive wire 2 is further pushed distally after the handle 3 is operated to push the conductive wire 2 distally to form only the first mountain-shaped portion M1. When only the first mountain-shaped portion M1 is formed, it is easy to confirm the incision portion 2i of the second region 22 of the conductive wire 2, which will be described later, from the proximal side inside the body using an endoscope.

[0023] 4, in the first field of view, it is preferable that the apex P1 of the first mountain-shaped portion M1 is located at a position that does not overlap with the shaft 1. By having the apex P1 of the first mountain-shaped portion M1 spaced apart from the shaft 1 in this manner, the reachable range of the conductive wire 2 is increased.

[0024] As shown in Fig. 4, the first field of view is preferably a field of view in which the length of the second region 22 appears to be the longest. The field of view in which the length of the second region 22 appears to be the longest means a field of view in which the length of the second region 22 appears to be the longest in a stationary state. In the field of view in which the length of the second region 22 appears to be the longest, the first mountain-shaped portion M1 protrudes, which makes it easier for the first mountain-shaped portion M1 to exert the above-mentioned effect. The first field of view preferably coincides with a field of view in which the area of ​​the first opening 11O appears to be the largest.

[0025] The first field of view may be a field of view in which the length of the second region 22 appears to be the longest when the second region 22 is bent so that the length of the second region 22 is at its longest. This makes it easier to achieve the effect of the mountain-shaped portion of the second region 22. To maximize the length of the second region 22, for example, the conductive wire 2 can be bent by pushing it distally to its limit by operating the handle 3. Hereinafter, the conductive wire 2 when the second region 22 is bent so that the length of the second region 22 is at its longest will be referred to as the conductive wire 2 in its maximum bend state.

[0026] As shown in Fig. 6 , in the incision device 91, it is preferable that, in the first field of view, the second region 22 of the conductive wire 2 can be further curved by operating the handle 3 to form a first mountain-shaped portion M1 and a second mountain-shaped portion M2 that is located distal to the first mountain-shaped portion M1 and protrudes in a second direction D2 opposite to the first direction D1, away from the central axis C of the shaft 1. This makes it easier to incise tissue in the first direction D1 in a mode in which the first mountain-shaped portion M1 is formed as shown in Fig. 4 , while it makes it easier to incise tissue in the second direction D2 opposite to the first direction D1 in a mode in which the second mountain-shaped portion M2 is formed as shown in Fig. 6 . Therefore, tissue can be incised in multiple directions by adjusting the amount of depression of the conductive wire 2.

[0027] 6, in the first field of view, the apex P1 of the first mountain-shaped portion M1 is preferably located on one side A of the two sides A and B defined by an imaginary line L passing through the proximal end 22a and the distal end 22b of the second region 22, and the apex P2 of the second mountain-shaped portion M2 is preferably located on the other side B. In this arrangement, the second mountain-shaped portion M2 on the other side B can make it easier to incise biological tissue. It is more preferable that the apex P1 and the apex P2 have the above-mentioned positional relationship in the first field of view of the conductive wire 2 when maximally bent.

[0028] 2 to 8, the conductive wire 2 preferably includes a conductive wire 2c and an insulating film 2d covering the conductive wire 2c. The insulating film 2d protects the conductive wire 2c and makes it easier to avoid incising areas other than the planned incision site. The conductive wire 2 preferably includes an incision portion 2i located in a region distal to the distal end 2db of the insulating film 2d, where the conductive wire 2c is not covered by the insulating film 2d. By passing electricity through the incision portion 2i, biological tissue can be incised.

[0029] As shown in Figures 4 and 6, in the first field of view, the distal end 2db of the insulating film 2d is preferably located distal to the apex P1 of the first mountain-shaped portion M1. This makes it easier to avoid incising areas other than the planned incision site. On the other hand, the distal end 2db of the insulating film 2d is preferably located proximal to the distal end 22b of the second region 22. This makes it easier to incise the biological tissue. Note that the distal end 2db of the insulating film 2d may be located at the apex P1 of the first mountain-shaped portion M1 or may be located proximal to the apex P1. This makes it easier to incise the biological tissue using the first mountain-shaped portion M1. In this case, the distal end 2db of the insulating film 2d is preferably located distal to the proximal end 22a of the second region 22. Furthermore, in the first field of view of the conductive wire 2 when it is maximally bent, it is more preferable that the distal end 2db and the apex P1, the distal end 2db and the distal end 22b, and the distal end 2db and the proximal end 22a have the above-mentioned positional relationships, respectively.

[0030] 6, in the first field of view, the distal end 2db of the insulating film 2d is preferably located closer to the proximal side than the apex P2 of the second mountain-shaped portion M2. This allows the second mountain-shaped portion M2 to have an exposed portion of the conductive wire 2c that is not covered by the insulating film 2d, making it easier to incise biological tissue using the second mountain-shaped portion M2. In the first field of view of the conductive wire 2 at its maximum bending, it is more preferable that the distal end 2db and the apex P2 have the above-mentioned positional relationship.

[0031] Although not shown, the proximal end of the insulating film 2d is preferably located in the first region 21. This makes it easier to avoid incising portions other than the intended incision site. Furthermore, when the conductive wire 2 is at its maximum bending position, it is more preferable that the proximal end of the insulating film 2d is located in the first region 21.

[0032] 4 and 6, in the first field of view, the length from the apex P1 of the first mountain-shaped portion M1 to the distal end 22b of the second region 22 is preferably longer than the length from the proximal end 22a of the second region 22 to the apex P1 of the first mountain-shaped portion M1. This makes it easier to incise biological tissue distal to the apex P1 of the first mountain-shaped portion M1. It is more preferable that the above length relationship be satisfied in the first field of view of the conductive wire 2 when it is maximally bent.

[0033] 6, in the conductive wire 2 in the first field of view, the radius of curvature of the second mountain-shaped portion M2 at the apex P2 is preferably smaller than the radius of curvature of the first mountain-shaped portion M1 at the apex P1. This improves the rigidity of the second mountain-shaped portion M2, making it easier to incise biological tissue with the second mountain-shaped portion M2. It is more preferable that the above-mentioned relationship be satisfied in the first field of view of the conductive wire 2 when it is maximally bent.

[0034] As shown in Figure 5, in a side view of the shaft 1, in a second field of view in which the apex P1 of the first mountain-shaped portion M1 of the second region 22 is located on the near side, the second region 22 preferably forms only one mountain-shaped portion M protruding in a direction D away from the central axis C of the shaft 1. This makes it easier to bring the conductive wire 2 into contact with biological tissue. Furthermore, in the second field of view, the apex P of the mountain-shaped portion M is preferably located distal to the apex P1 of the first mountain-shaped portion M1. This makes it easier for the portion of the second region 22 distal to the apex P1 of the first mountain-shaped portion M1 to come into contact with biological tissue. The direction of the near side in the second field of view is preferably perpendicular to the direction of the near side in the first field of view.

[0035] 7 , in a side view of the shaft 1, in a second field of view in which the apex P1 of the first mountain-shaped portion M1 of the second region 22 is located on the near side and the apex P2 of the second mountain-shaped portion M2 is located on the far side, the second region 22 preferably has only one mountain-shaped portion M protruding in a direction D away from the central axis C of the shaft 1. This makes it easier to bring the conductive wire 2 into contact with biological tissue. The direction from the near side to the far side in the second field of view is preferably perpendicular to the direction from the near side to the far side in the first field of view.

[0036] Furthermore, as shown in Fig. 7, it is more preferable that, in the second field of view, the conductive wire 2 at its maximum bending time has only one mountain-shaped portion M protruding in the direction D. Furthermore, as shown in Figs. 3 and 5, it is even more preferable that, in the second field of view, the conductive wire 2 at its bending time before its maximum bending time has only one mountain-shaped portion M protruding in the direction D away from the central axis C of the shaft 1. This makes it easier to incise a portion that can be contacted when the conductive wire 2 is not meandering. It is preferable that the apex P of the mountain-shaped portion M is located distal to the apex P1 of the first mountain-shaped portion M1 and proximal to the apex P2 of the second mountain-shaped portion M2. This makes it easier for the apex P2 of the second mountain-shaped portion M2 to come into contact with biological tissue.

[0037] In the second field of view of the conductive wire 2 at its maximum bending time, the shortest radial distance from the apex P of the mountain-shaped portion M to the outer surface 1s of the shaft 1 may be, for example, at least two, at least three, or at least four times the outer diameter of the shaft 1, or may be at most 16, at most 14, or at most 12 times the outer diameter of the shaft 1. The outer diameter of the shaft 1 is preferably the outer diameter of the shaft 1 at the portion closest to the apex P.

[0038] The conductive wire 2 may be formed by, for example, plastically or elastically deforming a straight wire so that it curves or meanders. Alternatively, the conductive wire 2 may be formed by fixing a twisted straight wire to the shaft 1 and the handle 3. This facilitates the formation of one or more mountain-shaped portions in the first field of view when the conductive wire 2 is pushed. Alternatively, the conductive wire 2 may be configured so that only a first mountain-shaped portion M1 is formed as a mountain-shaped portion in the first field of view by adjusting the pushing amount of the conductive wire 2 using the handle 3. Alternatively, the conductive wire 2 may be configured so that a second mountain-shaped portion M2 is formed after the first mountain-shaped portion M1 is formed. The pushing amount of the conductive wire 2 may be adjusted, for example, by configuring the handle 3 so that, when the conductive wire 2 is pushed distally by a predetermined amount by operating the handle 3, the conductive wire 2 cannot be pushed further distally. For example, the pushing amount may be adjusted by adjusting the position of an enlarged diameter portion 31H of the first member 31, which will be described later.

[0039] The conductive wire 2c included in the conductive wire 2 preferably contains a metal, and more preferably is made of a metal. This makes it easier for high-frequency current to pass through the conductive wire 2c. Examples of metals that can be used include nickel-titanium alloys, stainless steel, gold, silver, copper, platinum, nickel, iron, titanium, aluminum, tin, zinc, tungsten, and alloys thereof, with nickel-titanium alloys and stainless steel being more preferred. Examples of stainless steel include SUS303, SUS304, and SUS316.

[0040] The conductive wire 2c may be a single wire or a twisted wire formed by twisting together multiple single wires. The diameter of the single wire is preferably 0.1 mm or more and 1.5 mm or less. This allows the conductive wire 2c to be easily bent while maintaining its strength. The conductive wire 2c may have a structure in which multiple wires are spliced ​​together in the longitudinal direction 1X.

[0041] The cross-sectional shape of the conductive wire 2c in the radial direction is preferably elliptical or circular, and more preferably circular, which makes it easier to cauterize biological tissue and to manipulate the conductive wire 2.

[0042] The insulating film 2d preferably includes an extrusion molding. An example of the extrusion molding is an insulating tube. The extrusion molding can improve the durability of the insulating film 2d and enhance safety. For example, the conductive wire 2c can be covered with the insulating film 2d by inserting the conductive wire 2c into the lumen of an insulating tube of a desired length produced by extrusion molding. The insulating tube and the conductive wire 2c may also be bonded with an adhesive or the like. Alternatively, the insulating film 2d may be formed by adhering an insulating resin to the surface of the conductive wire 2c.

[0043] The insulating film 2d preferably contains a resin, and more preferably is made of a resin, which facilitates insulation. The resin is preferably a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a fluorine resin, a vinyl chloride resin, a silicone resin, natural rubber, or a mixture thereof, and more preferably a polyamide resin, a fluorine resin, or a mixture thereof.

[0044] The conductive wire 2 preferably further includes a third region 23 located distal to the second region 22 and disposed in the first lumen 11L. The third region 23 is not exposed from the first opening 11O. At least a portion of the third region 23 is preferably fixed to the inner surface of the shaft 1. Specifically, it is more preferable that the distal end of the third region 23 is fixed to the inner surface that constitutes the first lumen 11L of the shaft 1. This makes it easier to bend or meander the conductive wire 2 by operating the handle 3. The fixation may be direct or indirect. An example of direct fixation is when at least a portion of the third region 23 is fixed to the inner surface of the shaft 1 by welding, adhesion, brazing, or the like.

[0045] The conductive wire 2 preferably has a fixture 2f fixed to the surface of the tip portion 2b. At least a portion of the third region 23 can be indirectly fixed to the inner surface of the shaft 1 via the fixture 2f. This firmly fixes the tip portion 2b of the conductive wire 2, making it easier to push the conductive wire 2 into a meandering shape. Specifically, it is preferable that the tip portion 2b of the conductive wire 2 is fixed inside the fixture 2f, and that the fixture 2f is fixed to the inner surface of the shaft 1. The number of fixtures 2f is preferably two or more, more preferably three or more, and preferably eight or less, and more preferably six or less.

[0046] The fastener 2f may be fixed to the inner surface of the shaft 1 by welding, adhesion, brazing, or the like. The fastener 2f may also be fixed so as to bite into the inner surface of the shaft 1. In this case, the fastener 2f preferably includes a polygonal prism, a truncated pyramid, a truncated cone, or any of these connected in the axial direction. By including one or more such blocks, the fastener 2f can form one or more protrusions, making it easier to bite into the inner surface of the shaft 1. The fastener 2f may also include a cylindrical column. The fastener 2f preferably includes a resin and / or a metal, and more preferably includes a metal. Examples of metals include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloys, and Co—Cr alloys. These may be used alone or in combination.

[0047] 2, the shaft 1 preferably has a second opening 12O on the outer surface 1s distal to the first opening 11O. The second region 22 is preferably exposed between the first opening 11O and the second opening 12O. This makes it easier to bring the second region 22 of the conductive wire 2 into contact with biological tissue.

[0048] Before the formation of the peaks, the second region 22 of the conductive wire 2 preferably has a portion that extends linearly in the longitudinal direction 1X on the outside of the shaft 1. This makes it easier to insert the shaft 1 into the body.

[0049] Before the formation of the mountain-shaped portion, at least a portion of the second region 22 of the conductive wire 2 is preferably in contact with the outer surface 1s between the first opening 11O and the second opening 12O. In other words, by arranging at least a portion of the second region 22 of the conductive wire 2 so as to follow the outer surface 1s between the two openings, it becomes easier to insert the shaft 1 into the body.

[0050] The shapes of the first opening 11O and the second opening 12O on the outer surface 1s of the shaft 1 are preferably circular, elliptical, polygonal, or rounded polygonal, more preferably elliptical, square, or rounded square, and even more preferably elliptical, rectangular, or rounded rectangular. This makes it easier to bend the conductive wire 2 on the outside of the shaft 1. Furthermore, the first opening 11O and the second opening 12O on the outer surface 1s of the shaft 1 preferably extend in the longitudinal direction 1X.

[0051] As shown in Fig. 9, the shaft 1 may have only the first opening 11O, without the second opening 12O, as an opening for exposing the conductive wire 2 to the outside of the shaft 1. Even in this embodiment, the conductive wire 2 can be bent in the direction D away from the shaft 1 by operating the handle 3. Furthermore, as shown in Fig. 8, the distal portion 1b of the shaft 1 can be bent so that the conductive wire 2 resembles a bowstring, forming a knife portion.

[0052] As shown in FIG. 2 and other figures, the shaft 1 preferably has a proximal colored portion 10C in a portion adjacent to the proximal end 11Oa of the first opening 11O. Furthermore, the shaft 1 preferably has a plurality of colored portions 14C distal to the proximal end 11Oa of the first opening 11O. The proximal colored portion 10C can be used as a marker for the portion where the conductive wire 2 begins to be exposed to the outside of the shaft 1. Therefore, the proximal colored portion 10C is preferably located proximal to the proximal end 11Oa of the first opening 11O. The plurality of colored portions 14C can be used as markers for the start point, center point, end point, etc. of the incision portion 2i of the conductive wire 2. Each of the plurality of colored portions 14C preferably extends in the circumferential direction 1Y, and more preferably extends over the entire circumference in the circumferential direction 1Y.

[0053] The plurality of colored portions 14C preferably include a first colored portion 11C, a second colored portion 12C, and a third colored portion 13C, which can be used as markers for each point in the cut portion 2i of the conductive wire 2.

[0054] 3, 5, 7, etc., the first colored portion 11C is preferably located distal to the proximal end 11Oa of the first opening 11O and proximal to the distal end 22b of the second region 22. Furthermore, the first colored portion 11C is more preferably located distal to the distal end of the first opening 11O and proximal to the proximal end of the second opening 12O. This makes it easier for the first colored portion 11C to function as a marker for the start point of the incision portion 2i of the conductive wire 2.

[0055] 3, 5, 7, etc., the second colored portion 12C is preferably located distal to the distal end 11Cb of the first colored portion 11C and proximal to the distal end 22b of the second region 22. Furthermore, the second colored portion 12C is more preferably located proximal to the proximal end of the second opening 12O. This makes it easier for the second colored portion 12C to function as a marker for the midpoint of the incision portion 2i of the conductive wire 2.

[0056] 3, 5, 7, etc., the third colored portion 13C is preferably located distal to the distal end 22b of the second region 22. Furthermore, the third colored portion 13C is more preferably located adjacent to the distal end of the second opening 12O. This makes it easier for the third colored portion 13C to function as a marker for the end point of the incision portion 2i of the conductive wire 2.

[0057] The insulating film 2d, the proximal colored portion 10C, and the plurality of colored portions 14C each preferably contain a colorant. The colorant is preferably a pigment, a dye, or a mixture thereof, and more preferably a pigment. The pigment is preferably an organic pigment, an inorganic pigment, or a mixture thereof.

[0058] The insulating film 2d and the proximal side colored portion 10C preferably contain a brown colorant, a purple colorant, a black colorant, or a mixture thereof, and more preferably contain a black colorant, which makes it easier to prevent halation caused by illumination from the endoscope when the endoscope is used.

[0059] Each of the plurality of colored portions 14C preferably contains a green colorant, a yellow colorant, a blue colorant, a brown colorant, a purple colorant, a black colorant, or a mixture thereof, and more preferably contains a green colorant, a blue colorant, or a mixture thereof, which makes the plurality of colored portions 14C easier to view in vivo.

[0060] The insulating film 2d, the proximal colored portion 10C, and the plurality of colored portions 14C may each contain a brown colorant, a purple colorant, a black colorant, or a mixture thereof, or may contain a black colorant, which can make it easier to prevent halation in each portion when, for example, an endoscope with high illumination intensity is used.

[0061] Examples of the green colorant, yellow colorant, blue colorant, brown colorant, purple colorant, and black colorant include colorants whose hues are green, yellow, blue, brown, violet, and black in the Color Index names.

[0062] These colorants may be attached to the outer surface 1s of the shaft 1, or may be mixed into a tube that constitutes the shaft 1. Furthermore, these colorants may be mixed with a binder resin and attached to the outer surface 1s of the shaft 1.

[0063] 3, the shaft 1 preferably further has a second lumen 12L extending in the longitudinal direction 1X. The distal end of the second lumen 12L is preferably located at the distal end of the shaft 1. This allows a guidewire to be inserted into the second lumen 12L, making it easier to insert the shaft 1 into the body. Liquids such as contrast agents and drugs may also be supplied into the body via the second lumen 12L.

[0064] The diameter of the first lumen 11L is preferably smaller than the diameter of the second lumen 12L. This makes it less likely for the conductive wire 2 disposed in the first lumen 11L to shake during each operation, making it easier to perform operations such as bending. In particular, the diameter of the first lumen 11L is preferably smaller than the diameter of the second lumen 12L at the proximal end of the second region 22 of the conductive wire 2, the distal end of the second region 22, or both ends thereof.

[0065] Although not shown, the outer surface 1s of the shaft 1 preferably has a proximal opening that communicates with the second lumen 12L and is located proximal to the center of the shaft 1 in the longitudinal direction 1X. A guidewire or the like can be inserted through the proximal opening. The proximal opening may be located at the proximal end of the shaft 1, or may be located distal to the proximal end of the shaft 1.

[0066] The shaft 1 preferably contains a resin and / or a metal. Examples of resins include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine-based resins, vinyl chloride resins, silicone resins, and natural rubber. These may be used alone or in combination of two or more. Examples of metals include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, and Co-Cr alloys. These may be used alone or in combination of two or more. The shaft 1 preferably includes a tube containing a resin. The shaft 1 may also have a laminated structure made of different materials or the same material. The shaft 1 may include, for example, a metal tube whose surface is coated with a resin. The shaft 1 may also have a structure in which multiple tubes are joined together in the longitudinal direction 1X. In this case, the multiple tubes may have different outer diameters, and the end of one tube may be disposed within the lumen of another tube. The shaft 1 may also have a structure in which multiple tubes are joined in the radial direction. The shaft 1 may also have a branched structure, for example, at the proximal end. One of the openings communicating with the lumen of the branched structure may be a proximal opening through which the above-mentioned guide wire or the like can be inserted.

[0067] As shown in Fig. 1, the handle 3 preferably has a first member 31 and a second member 32. The first member 31 preferably has an extending portion 31E extending in the longitudinal direction 1X. Furthermore, as shown in Fig. 10, the second member 32 preferably has an inner cavity 32L extending in the longitudinal direction 1X. A portion of the extending portion 31E is preferably disposed in the inner cavity 32L of the second member 32. By disposing the extending portion 31E of the first member 31 in the inner cavity 32L of the second member 32 in this manner, the second member 32 can easily move in the longitudinal direction 1X along the extending portion 31E of the first member 31, thereby improving operability.

[0068] It is preferable that the extension portion 31E of the first member 31 has a first fitting portion 31F described later, more preferably has the first fitting portion 31F and an expanded diameter portion 31H described later, and even more preferably has the first fitting portion 31F, an expanded diameter portion 31H and a columnar portion 31G described later.

[0069] It is preferable that the second member 32 be able to move in the longitudinal direction 1X without rotating in the circumferential direction 1Y relative to the shaft 1. As a result, for example, when the base end 2a of the conductive wire 2 is fixed to the second member 32, the conductive wire 2 can be manipulated by moving the second member 32 in the longitudinal direction 1X.

[0070] It is preferable that the second member 32 be able to move from the proximal side to the distal side without rotating in the circumferential direction 1Y relative to the shaft 1. This allows, for example, when the base end portion 2a of the conductive wire 2 is fixed to the second member 32, the conductive wire 2 to be bent as shown in Figures 3 to 7, etc.

[0071] Furthermore, it is preferable that the second member 32 be movable from the distal side to the proximal side without rotating in the circumferential direction 1Y relative to the shaft 1. As a result, for example, when the base end 2a of the conductive wire 2 is fixed to the second member 32, the distal portion 1b of the shaft 1 can be bent as shown in Figure 8, making the conductive wire 2 like a bowstring and serving as a knife portion. This makes it possible to incise parts that are difficult to incise with the peak-shaped portion of the conductive wire 2.

[0072] The base end 2a of the conductive wire 2 is preferably fixed to the second member 32. This allows the conductive wire 2 to be manipulated by moving the second member 32 in the longitudinal direction 1X as described above.

[0073] 1 , when the base end 2a of the conductive wire 2 is fixed to the second member 32, the second member 32 preferably has a connection terminal 3c connected to the base end 2a of the conductive wire 2. By exposing at least a portion of the connection terminal 3c from the second member 32, the high frequency power source and the conductive wire 2 can be connected via the connection terminal 3c. The connection terminal 3c preferably contains a metal, and more preferably is made of a metal. The connection terminal 3c is preferably rod-shaped.

[0074] 1 and 10, the first member 31 preferably has a first fitting portion 31F extending in the longitudinal direction 1X. The second member 32 preferably has a second fitting portion 32F that slidably fits into the first fitting portion 31F in the longitudinal direction 1X. This makes it possible to easily move the second member 32 in the longitudinal direction 1X without rotating in the circumferential direction 1Y.

[0075] The second fitting portion 32F preferably has an inner cavity 32L extending in the longitudinal direction 1X, and a portion of the first fitting portion 31F is preferably disposed within the inner cavity 32L. This allows the second fitting portion 32F to slide easily along the first fitting portion 31F. The radial length of the gap between the inner surface of the second fitting portion 32F and the outer surface of the first fitting portion 31F is preferably 0.1 mm or more and 2.0 mm or less, and more preferably 0.2 mm or more and 1.0 mm or less. This allows the second fitting portion 32F to slide even more easily along the first fitting portion 31F.

[0076] At least in a radial cross section at the distal end, the proximal end, or both ends of the first fitting portion 31F, the shape of the outer edge of the first fitting portion 31F and the shape of the outer edge of the lumen 32L of the second fitting portion 32F are preferably similar to each other, so that the second fitting portion 32F can easily slide along the first fitting portion 31F.

[0077] The first fitting portion 31F and the second fitting portion 32F may each include a rail, a bolt, a nut, a roller, a bearing, a rack, a pinion, or a combination thereof. These may form a sliding mechanism that allows the second fitting portion 32F to slide in the longitudinal direction 1X relative to the first fitting portion 31F. The first fitting portion 31F may also be disposed outside the second fitting portion 32F.

[0078] The first fitting portion 31F preferably has a through hole 31Fh. The through hole 31Fh preferably penetrates the side wall constituting the first fitting portion 31F in the radial direction. This allows the conductive wire 2 to be fixed to the second member 32 via the through hole 31Fh. Furthermore, the through hole 31Fh preferably extends in the longitudinal direction 1X. In this case, the through hole 31Fh is preferably located in a region distal to the proximal end of the first fitting portion 31F, but proximal to the distal end.

[0079] The first fitting portion 31F preferably has a polygonal prism extending in the longitudinal direction 1X. The polygonal prism is preferably a quadrangular prism, a pentagonal prism, a hexagonal prism, a heptagonal prism, or an octagonal prism, and more preferably a hexagonal prism or an octagonal prism. This makes it easier for the extending portion 31E to fit with the second member 32. The polygonal prism also includes a polygonal prism with rounded corners. The polygonal prism preferably has an inner cavity 31L extending in the longitudinal direction 1X. The conductive wire 2 can be placed in the inner cavity 31L. The polygonal prism may also have through-holes 31Fh that radially penetrate the side walls that make up the polygonal prism.

[0080] The second fitting portion 32F preferably has a lumen 32L extending in the longitudinal direction 1X. The radial cross-sectional shape of the lumen 32L is preferably a square, pentagon, hexagon, heptagon, or octagon, and more preferably a hexagon or octagon. This makes it easier for the second member 32 to fit with the first member 31. Note that polygons also include polygons with rounded corners.

[0081] As shown in FIG. 1 , the first member 31 preferably has an expanded diameter portion 31H, located distal to and adjacent to the distal end of the first fitting portion 31F, that has a diameter larger than the diameter of the first fitting portion 31F. Such expanded diameter portion 31H can function as a stopper at the distal end when the second member 32 slides from the proximal side to the distal side. For example, in FIG. 10 , the expanded diameter portion 31H is located further back than the second member 32. When the second member 32 moves from the front to the rear, the second member 32 comes into contact with the expanded diameter portion 31H and cannot move further back than the expanded diameter portion 31H. The expanded diameter portion 31H may have a tapered portion inclined in the longitudinal direction 1X. The expanded diameter portion 31H may also have a step portion perpendicular to the longitudinal direction 1X.

[0082] 1, the first member 31 preferably has a columnar portion 31G located distal to the first fitting portion 31F and extending in the longitudinal direction 1X. The columnar portion 31G is preferably a circular cylinder, an elliptical cylinder, or a combination thereof, and more preferably a circular cylinder. The columnar portion 31G preferably has an inner cavity 31L extending in the longitudinal direction 1X. The conductive wire 2 can be disposed in the inner cavity 31L.

[0083] The second member 32 preferably has a locking portion 32s that stops sliding in the longitudinal direction 1X relative to the first member 31. The locking portion 32s preferably has a screw. By screwing a screw into a screw hole provided in the thickness direction of the second member 32 and bringing the screw into contact with the first member 31, movement of the second member 32 in the longitudinal direction 1X relative to the first member 31 can be stopped.

[0084] The first member 31 preferably has a finger-through portion 31D. The finger-through portion 31D preferably has a ring-shaped portion. For example, a thumb can be passed through a through-hole in the center of the ring. The second member 32 preferably has a finger-through portion 32D. The finger-through portion 32D preferably has two or more through-holes that pass through in the thickness direction. For example, an index finger and a middle finger can be passed through two through-holes. By passing the fingers through the second member 32 and moving the fingers in this manner, the second member 32 can be easily slid in the longitudinal direction 1X relative to the first member 31.

[0085] The proximal end of the shaft 1 is preferably fixed directly or indirectly to the extension 31E. The lumen 31L of the extension 31E is preferably in communication with the first lumen 11L of the shaft 1. This allows the conductive wire 2 to be disposed from the extension 31E through the shaft 1.

[0086] As described above, with the incision device 91, when aligning the conductive wire 2 with biological tissue, it is possible to bring the conductive wire 2 into contact with parts that previously required rotating the distal portion 1b of the shaft 1 or rotating the entire shaft 1, without performing any rotational operation.

[0087] The incision device 91 can be suitably used for endoscopic sphincterotomy (EST), endoscopic surgery for incising cancer, polyps, and the like.

[0088] The following describes an incision device according to the second embodiment with reference to Figures 11 to 14, etc. Figure 11 is a plan view of the incision device according to the second embodiment. Figure 12 is a plan view of the distal portion of the shaft of Figure 11 when the distal portion of the shaft is bent and changed in direction. Figure 13 is a longitudinal cross-sectional view of the connecting member of Figure 11 and its vicinity. Figure 14 is a B-B cross-sectional view of Figure 11. Note that the A-A cross-sectional view of Figure 11 has the same shape as Figure 10. A detailed description of parts of the incision device according to the second embodiment that overlap with those of the incision device according to the first embodiment will be omitted.

[0089] 11 , an incision device 92 according to the second embodiment includes a shaft 1, a conductive wire 2, and a handle 3. As shown in FIG. 11 , the handle 3 preferably includes a first member 31 and a second member 32.

[0090] The first member 31 is preferably rotatable in the circumferential direction 1Y relative to the shaft 1. By rotating the first member 31 in the circumferential direction 1Y, a torsional force can be directly or indirectly applied to the conductive wire 2. As a result, for example, as shown in FIG. 12 , the distal portion 1b of the shaft 1 can be bent in direction D3 by the tip end 2b of the conductive wire 2, thereby changing the orientation of the distal portion 1b. Furthermore, by reversing the rotation direction, the distal portion 1b can be bent in direction D4 opposite to direction D3, thereby changing the orientation of the distal portion 1b. With the orientation of the distal portion 1b changed in this way, pushing the conductive wire 2 distally to form the first mountain-shaped portion M1 widens the reachable range of the conductive wire 2.

[0091] It is preferable that the first member 31 is capable of moving in the longitudinal direction 1X while rotating in the circumferential direction 1Y relative to the shaft 1. This allows the first member 31 to move in the longitudinal direction 1X while rotating in the circumferential direction 1Y, for example, like a screw. By moving the first member 31 in the longitudinal direction 1X while rotating in the circumferential direction 1Y, when the second member 32 is interlocked with the first member 31, the amount of movement of the second member 32 in the longitudinal direction 1X when bending or meandering the conductive wire 2 outside the shaft 1 can be reduced, thereby improving operability.

[0092] It is preferable that the first member 31 can move from the proximal side toward the distal side while rotating in the circumferential direction 1Y relative to the shaft 1, and can also move from the distal side toward the proximal side while rotating in the circumferential direction 1Y relative to the shaft 1. In this way, by moving the first member 31 as if turning a screw in both clockwise and counterclockwise directions, the distal portion 1b of the shaft 1 can be curved in both directions D2 and D3 in Figure 12, for example, and the orientation of the distal portion 1b of the shaft 1 can be changed in both directions.

[0093] The first member 31 preferably has a threaded portion or a threaded hole portion extending in the longitudinal direction 1X. This allows the threaded hole portion 31h of the first member 31 to be fitted into a threaded portion 4i of the connecting member 4, which will be described later, as shown in Fig. 13, for example, and as a result, the first member 31 can be moved in the longitudinal direction 1X while being rotated in the circumferential direction 1Y. The first member 31 preferably has the threaded portion or the threaded hole portion in a distal portion, and more preferably in a distal end portion.

[0094] The first member 31 preferably has a first fitting portion 31F extending in the longitudinal direction 1X. The second member 32 preferably has a second fitting portion 32F that slidably fits into the first fitting portion 31F in the longitudinal direction 1X. This makes it possible to easily move the second member 32 in the longitudinal direction 1X without rotating in the circumferential direction 1Y. For details of these, please refer to the description of FIG. 10, which shows the A-A cross-sectional view of the incision device 91 according to the first embodiment.

[0095] As shown in FIG. 10 , the second fitting portion 32F is preferably fitted into the first fitting portion 31F so that the first member 31 can rotate in the circumferential direction 1Y in conjunction with the rotation of the second member 32 in the circumferential direction 1Y. In this manner, the first member 31 rotates in the circumferential direction 1Y in conjunction with the second member 32, so that the first member 31 can be rotated in the circumferential direction 1Y by operating the second member 32. In FIG. 10 , when the second member 32 is rotated in the circumferential direction 1Y, the inner surface of the second fitting portion 32F comes into contact with the outer surface of the first fitting portion 31F, causing the first fitting portion 31F to rotate, and as a result, causing the first member 31 to rotate in the circumferential direction 1Y. Alternatively, the first member 31 may be rotated in the circumferential direction 1Y by directly applying a force to the first member 31 in the circumferential direction 1Y.

[0096] In a radial cross section of the first fitting portion 31F, it is preferable that at least two or more locations on the inner surface of the second fitting portion 32F are located within the circumscribed circle of the first fitting portion 31F. As a result, as the second member 32 rotates in the circumferential direction 1Y, two or more locations on the inner surface of the second member 32 come into contact with the outer surface of the first member 31, making it easier for the first member 31 to rotate in the circumferential direction 1Y.

[0097] As shown in FIGS. 11 and 13 , the incision device 92 preferably further includes a connecting member 4 connecting the shaft 1 and the handle 3. The connecting member 4 preferably has an inner cavity 4L extending in the longitudinal direction 1X. As shown in FIG. 13 , the connecting member 4 preferably has a threaded portion 4i on its inner surface 4s that engages with a threaded hole portion 31h of the first member 31. This allows the connecting member 4 to connect the shaft 1 and the first member 31 so that the first member 31 can move in the longitudinal direction 1X while rotating in the circumferential direction 1Y relative to the shaft 1. Although not shown, the connecting member 4 may also have a threaded hole portion on the inner cavity 4L that engages with the threaded portion of the first member 31.

[0098] The connecting member 4 preferably has a groove or protrusion extending in the longitudinal direction 1X. The first member 31 preferably has a protrusion or a groove extending in the longitudinal direction 1X on the outer surface 31Es of the distal end 31Eb of the extending portion 31E that fits into the groove or protrusion. Such a protrusion on the connecting member 4 or the first member 31 can function as a temporary stop when the first member 31 is rotated in the circumferential direction 1Y. For example, as shown in FIG. 14 , if the first member 31 has a protrusion 31p on the distal end 31Eb of the extending portion 31E and the connecting member 4 has two grooves 4g that face each other and extend in the longitudinal direction 1X, the protrusion 31p of the first member 31 fits into the groove 4g of the connecting member 4 every half rotation of the first member 31, temporarily stopping rotation. This makes it easier for the operator to grasp the amount of rotation. When a force is applied to the first member 31 in the circumferential direction 1Y from this fitted state, the protrusion 31p comes off the groove 4g, and the first member 31 can further rotate.

[0099] The number of grooves 4g is not limited to two and may be one or more, three or more, ten or less, or six or less. When the number of grooves 4g is two or more, the grooves 4g are preferably arranged at equal intervals in the circumferential direction 1Y. The grooves 4g are preferably U-shaped grooves. Furthermore, the protrusions 31p are preferably hemispherical or semi-elliptical protrusions. This makes it easier to restart rotation after temporarily stopping it. Although not shown, rotation can also be temporarily stopped when the first member 31 has a groove extending in the longitudinal direction 1X and the connecting member 4 has a protrusion.

[0100] It is preferable that the first member 31, the second member 32, and the connecting member 4 each include a molded body. The molded body preferably includes a resin, and is preferably made of a resin. This makes it easier to prevent electric leakage.

[0101] Although not shown, the first member 31 may be capable of rotating in the circumferential direction 1Y relative to the shaft 1 but not moving in the longitudinal direction 1X relative to the shaft 1. An example of such a configuration is one in which the connecting member 4 has a groove or protrusion extending in the circumferential direction 1Y, and the extending portion 31E of the first member 31 has a protrusion or a groove extending in the circumferential direction 1Y that fits into the groove or protrusion. In this case, it is preferable that the second member 32 be capable of moving in the longitudinal direction 1X without rotating in the circumferential direction 1Y relative to the shaft 1.

[0102] This application claims the benefit of priority based on Japanese Patent Application No. 2023-172993, filed on October 4, 2023. The entire contents of the specification of Japanese Patent Application No. 2023-172993, filed on October 4, 2023, are incorporated herein by reference.

[0103] A, B One side, other side C Central axis D Direction away from shaft D1, D2 First direction, second direction L Virtual line M, M1, M2 Mountain-shaped portion, first mountain-shaped portion, second mountain-shaped portion P, P1, P2 Apex 1 Shaft 1b Distal portion 1s Outer surface 1X Longitudinal direction 1Y Circumferential direction 2 Conductive wire 2a Base end portion 2b Tip portion 2c Conductive wire 2d Insulating film 2db Distal end 2f Fixing device 2i Incision portion 3 Handle 3c Connection terminal 4 Connecting member 4L Inner cavity 4i Threaded portion 4s Inner surface 4g Groove 10C Proximal colored portion 11C, 12C, 13C, 14C First colored portion, second colored portion, third colored portion, multiple colored portions 11Cb Distal end 11L, 12L First inner cavity, second inner cavity 11O, 12O First opening, second opening 11Oa Proximal end of first opening 21, 22, 23 First region, second region, third region 22a Proximal end of second region 22b Distal end of second region 22C Center of line segment 22L Line segment 31, 32 First member, second member 31D Finger passage portion 31E Extension portion 31Eb Distal end portion 31Es Outer surface 31F First fitting portion 31Fh Through hole 31h Threaded hole portion 31p Protrusion 31G Pillar portion 31H Enlarged diameter portion 32D Finger passage portion 32L Inner cavity 32F Second fitting portion 32s Lock portion 91, 92 Incising device

Claims

1. An incision device comprising: a shaft extending in a longitudinal direction, the shaft having a first lumen extending in the longitudinal direction, and a first opening on an outer surface of a distal portion which communicates with the first lumen; a conductive wire having a base end and a tip end fixed to a portion of the shaft distal to the first opening, the conductive wire having a first region located distal to the base end and disposed in the first lumen, and a second region located distal to the first region and exposed from the first opening; and a handle to which the base end of the conductive wire is fixed, wherein in a first field of view in a side view of the shaft, at least a portion of the second region of the conductive wire is located in front of the shaft and appears to overlap with the shaft, the second region of the conductive wire can be curved by operating the handle to form a first peak protruding in a first direction away from a central axis of the shaft, and an apex of the first peak is located proximal to the center of a line segment connecting the proximal end and the distal end of the second region of the conductive wire.

2. The incision device according to claim 1, wherein only the first mountain-shaped portion is formed as the mountain-shaped portion of the second region in the first field of view.

3. An incision device according to claim 1 or 2, wherein the first field of view is a field of view in which the length of the second region appears the longest.

4. The incision device according to claim 1 or 2, wherein the conductive wire has a conductive wire and an insulating film covering the conductive wire, and in the first field of view, the distal end of the insulating film is located distal to the apex of the first mountain-shaped portion.

5. An incision device as described in claim 1 or 2, wherein in the first field of view, the length from the apex of the first peak to the distal end of the second region is longer than the length from the proximal end of the second region to the apex of the first peak.

6. The incision device according to claim 1 or 2, wherein the conductive wire has a fixture fixed to the surface of the tip.

7. An incision device as described in claim 1 or 2, wherein, in the first field of view, the second region of the conductive wire can be further curved by operating the handle to form the first ridge and a second ridge located distal to the first ridge and protruding in a second direction away from the central axis of the shaft and opposite to the first direction.

8. The incision device described in claim 7, wherein, in the first field of view, the apex of the first mountain-shaped portion is located on one side of the other side defined by an imaginary line passing through the proximal end and distal end of the second region, and the apex of the second mountain-shaped portion is located on the other side.

9. The incision device according to claim 7, wherein the conductive wire comprises a conductive wire and an insulating film covering the conductive wire, and in the first field of view, the distal end of the insulating film is located proximal to the apex of the second mountain-shaped portion.

10. An incision device as described in claim 7, wherein in a second field of view, viewed from the side of the shaft, the apex of the first peak of the second region is located on the front side and the apex of the second peak is located on the back side, the second region forms only one peak protruding in a direction away from the central axis of the shaft.

11. The incision device of claim 1 or 2, wherein the handle comprises: a first member having an extension portion extending in the longitudinal direction; and a second member having an inner cavity extending in the longitudinal direction and capable of moving in the longitudinal direction without rotating circumferentially relative to the shaft, and a portion of the extension portion is disposed in the inner cavity of the second member.

12. The incision device according to claim 11, wherein the first member has a first fitting portion extending in the longitudinal direction, and the second member has a second fitting portion that slidably fits into the first fitting portion in the longitudinal direction.

13. The lancing device of claim 12, wherein said proximal end of said conductive wire is fixed to said second member.

Images