JP2025001111A - Cutting instruments - Google Patents

Abstract

The orientation of an exposed portion of a knife wire can be smoothly changed to a desired orientation by rotating a support member while maintaining the inner and outer diameters of a tube and the outer diameter of a knife wire.
[Solution] The incision instrument comprises a tube having at least one lumen including a first lumen, a knife wire housed in the first lumen, and a support member rotatably supporting the base end of the knife wire. Between the tip and base ends of the tube, the knife wire has an exposed portion that is exposed to the outside of the tube through a hole that communicates with the first lumen at least when the tube is in a predetermined position. A slit is formed in the tube that reaches at least one of the outer surface and the inner surface of the tube. When no external force is applied to the tube, a pair of surfaces of the tube that face each other via the slit are in contact with each other.
[Selected figure] Figure 3

Description

The technology disclosed in this specification relates to an incision instrument.

Endoscopic sphincterotomy (EST) is known as a treatment for common bile duct stones. In endoscopic sphincterotomy, a cutting instrument is inserted into the papilla, which corresponds to the outlet of the bile duct and pancreatic duct, and the biological tissue is incised with the cutting instrument.

The incision instrument used in endoscopic papillotomy comprises a tube with a lumen, a knife wire (cutting wire) housed in the lumen, and a support member that rotatably supports the base end of the knife wire (see, for example, Patent Document 1). A portion of the knife wire (hereinafter referred to as the "exposed portion") is exposed to the outside of the tube at all times or when the tube is in a specified position. By applying a high-frequency current from a high-frequency power source to the knife wire, biological tissue can be incised by the exposed portion of the knife wire.

The operator rotates the support member to incise a specified area of biological tissue in the papilla in a specified shape. This generates a rotational torque at the base end of the knife wire supported by the support member, and the rotational torque is transmitted to the tube via the knife wire. As a result, the tube rotates around its central axis, and the orientation of the exposed part of the knife wire changes to the desired orientation.

Patent No. 4896351

In conventional incision instruments, the torsional rigidity of the tube is high, so even if the operator applies rotational torque to the base end of the knife wire by rotating the support member, the tube does not rotate smoothly, and the orientation of the exposed part of the knife wire cannot be smoothly changed to the desired orientation. It is possible to reduce the torsional rigidity of a portion of the tube by making that portion thinner, but in that case, the inner and outer diameters of that portion will be thinner and it will be impossible to form a lumen of the required size. It is also possible to increase the outer diameter of the knife wire to improve rotational torque transmission, but increasing the outer diameter of the knife wire may reduce the incision ability of the knife wire.

As such, conventional incision instruments have the problem that it is not possible to smoothly change the orientation of the exposed part of the knife wire to a desired orientation by rotating the support member while maintaining the inner and outer diameters of the tube and the outer diameter of the knife wire.

These issues are not limited to cutting instruments used in endoscopic nipple resection to cut the nipple, but are common to all cutting instruments that are inserted into various organs in the human body to cut biological tissue, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs.

This specification discloses a technology that can solve the above-mentioned problems.

The technology disclosed in this specification can be realized, for example, in the following forms:

(1) The incision instrument disclosed in this specification comprises a tube having at least one lumen including a first lumen, a knife wire housed in the first lumen, and a support member that rotatably supports the base end of the knife wire. The knife wire has an exposed portion between the tip and base ends of the tube that is exposed to the outside of the tube through a hole that communicates with the first lumen at least when the tube is in a predetermined position. The tube has a slit that reaches at least one of the outer surface and the inner surface of the tube. When no external force is applied to the tube, the pair of surfaces of the tube that face each other through the slit are in contact with each other.

In this way, in this incision instrument, since a slit is formed in the tube, the torsional rigidity of the tube can be reduced. Therefore, while maintaining the inner and outer diameters of the tube and the outer diameter of the knife wire, the orientation of the exposed portion of the knife wire can be smoothly changed to the desired orientation by rotating the support member. Furthermore, in this incision instrument, when no external force is applied to the tube, a pair of surfaces of the tube facing each other via the slit are in contact with each other. Therefore, it is possible to prevent the slit from widening significantly when an external force is applied to the tube. This makes it possible to prevent, for example, interference between the incision instrument and other devices.

(2) In the above incision instrument, at least a portion of the slit may be formed in a first portion of the tube that exposes the exposed portion of the knife wire. By adopting this configuration, the torsional rigidity of the first portion of the tube that exposes the exposed portion of the knife wire can be effectively reduced, and the orientation of the exposed portion of the knife wire can be changed more smoothly by rotating the support member. In addition, the bending rigidity of the first portion of the tube can be effectively reduced, and operability can be improved when bending the tube and making an incision with the exposed portion of the knife wire.

(3) In the above-mentioned incision instrument, the slits may be configured to extend along the axial direction of the tube. By adopting this configuration, the torsional rigidity of the portion of the tube where the slits are formed can be evenly reduced, and the orientation of the exposed portion of the knife wire can be changed more smoothly by rotating the support member.

(4) In the above-mentioned incision instrument, the tube may be configured to have a plurality of the slits. By adopting this configuration, the torsional rigidity of the tube can be effectively reduced, and the orientation of the exposed portion of the knife wire can be smoothly changed to a desired orientation by rotating the handle body.

(5) In the above-mentioned incision instrument, the slit may be configured to extend from the outer surface of the tube to the inner surface of the lumen, which serves as the inner surface. By adopting this configuration, the torsional rigidity of the tube can be effectively reduced by the slit, and the orientation of the exposed portion of the knife wire can be changed more smoothly by rotating the support member.

(6) In the incision instrument, the at least one lumen may include a second lumen that houses a combination device and a third lumen for liquid delivery, and the slit may extend from the inner surface of one of the lumens as the inner surface to the inner surface of the other lumen as the inner surface. By adopting this configuration, it is possible to effectively prevent the slit from widening significantly or the outer shape of the tube from changing when an external force is applied to the tube.

(7) In the above-mentioned incision instrument, the slit may be formed in a portion of the tube along the axial direction. By adopting this configuration, it is possible to reduce the torsional rigidity of a portion of the tube while ensuring the rigidity of the tube as a whole, and the orientation of the exposed portion of the knife wire can be smoothly changed by rotating the support member.

(8) In the above-mentioned incision instrument, the minimum diameter of the exposed portion of the knife wire may be 0.15 mm or more and 0.30 mm or less. By adopting this configuration, it is possible to achieve both an improvement in the rotational torque transmission of the knife wire and an improvement in the incision ability of the knife wire.

The technology disclosed in this specification can be realized in various forms, such as an incision instrument, a system including an incision instrument, and a method for manufacturing such an instrument and system.

FIG. 1 is an explanatory diagram illustrating a schematic configuration of an incision instrument 100 according to a first embodiment. FIG. 2 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100 taken along the line II-II in FIG. FIG. 2 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100 at the position of III-III in FIG. FIG. 1 is an explanatory diagram showing the configuration of a vertical cross section of the tip of the incision instrument 100. FIG. 1 is a perspective view showing the external configuration of a tip portion of an incision instrument 100. FIG. 1 is an explanatory diagram showing an example of a method for operating the incision instrument 100. FIG. 1 is an explanatory diagram showing an example of a method for operating the incision instrument 100. FIG. 11 is an explanatory diagram showing a cross-sectional configuration of an incision instrument 100a according to a second embodiment. FIG. 13 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100b according to the third embodiment. FIG. 13 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100c according to the fourth embodiment. FIG. 13 is an explanatory diagram showing a cross-sectional configuration of an incision instrument 100d according to a fifth embodiment. FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100 according to a modified example. FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100 according to another modified example.

A. First embodiment:
(Configuration of incision instrument 100)
1 is an explanatory diagram showing a schematic configuration of an incision instrument 100 according to a first embodiment. The incision instrument 100 is an instrument for incising biological tissue, and is used, for example, in endoscopic sphincterotomy (EST) for treating choledocholithiasis. Note that the incision instrument 100 may be used not only for endoscopic sphincterotomy, but also for insertion into various organs in the human body, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs, to incise biological tissue.

1, some of the components of the incision instrument 100 are omitted. Also, in FIG. 1, XYZ axes perpendicular to each other are shown. The positive side of the Z axis is the tip side (distal side) that is inserted into the body, and the negative side of the Z axis is the base side (proximal side) that is operated by a surgeon such as a doctor. In FIG. 1, each part of the incision instrument 100 is shown in a state in which it is approximately linear parallel to the Z axis, but at least a part of the incision instrument 100 has flexibility to the extent that it can be curved. These points are the same in the subsequent figures. In this specification, the tip side end of the incision instrument 100 and its components are referred to as the "tip", the tip and its vicinity are referred to as the "tip portion", the base side end is referred to as the "base end", and the base end and its vicinity are referred to as the "base end portion".

The incision instrument 100 comprises a tube 10, a knife wire 20, a connector 30, and a handle portion 40. FIG. 1 shows the central axis Ax of the tube 10. In this embodiment, the central axes of the connector 30 and the handle portion 40 are approximately aligned with the central axis Ax of the tube 10. However, these central axes may differ from the central axis Ax of the tube 10.

Figure 2 is an explanatory diagram showing the cross-sectional configuration (XY cross-section) of the incision instrument 100 at the position II-II in Figure 1, Figure 3 is an explanatory diagram showing the cross-sectional configuration of the incision instrument 100 at the position III-III in Figure 1, Figure 4 is an explanatory diagram showing the longitudinal cross-sectional configuration (YZ cross-section) of the tip of the incision instrument 100, and Figure 5 is a perspective view showing the external configuration of the tip of the incision instrument 100. Note that the knife wire 20 (see Figure 1) is omitted from Figure 3 (and Figures 8-11 described below).

The tube 10 is an elongated member extending along a central axis Ax. As shown in Figs. 2 and 3, the outer shape of the cross section of the tube 10 is, for example, substantially circular or substantially elliptical. The outer diameter of the tube 10 may be constant over its entire length or may vary along the longitudinal direction.

The tube 10 is formed with a device lumen 16L, a knife wire lumen 17L, and a liquid supply lumen 18L. The device lumen 16L is an inner cavity through which a combined device such as a guide wire is housed (inserted), and extends longitudinally from the tip of the tube 10 to a branching portion 19 provided at the base end of the tube 10. The knife wire lumen 17L is an inner cavity through which a knife wire 20 is housed (inserted), and extends longitudinally from the tip to the base end of the tube 10. The liquid supply lumen 18L is an inner cavity for passing a liquid such as a contrast agent or saline, and extends longitudinally from the tip to the base end of the tube 10. The cross-sectional shape of each lumen is, for example, approximately circular or approximately elliptical. In this embodiment, as shown in Figures 2 and 3, the diameter W16 of the device lumen 16L is larger than the diameter W17 of the knife wire lumen 17L, which is larger than the diameter W18 of the liquid supply lumen 18L. The relationship between the diameters of the lumens can be changed as desired. The knife wire lumen 17L is an example of a first lumen, the device lumen 16L is an example of a second lumen, and the liquid supply lumen 18L is an example of a third lumen.

The tube 10 is preferably antithrombotic, flexible, and biocompatible, and can be made of, for example, a resin material or a metal material. Examples of resin materials that can be used to form the tube 10 include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of metal materials that can be used to form the tube 10 include stainless steel such as SUS304, Ni-Ti alloys, and cobalt chrome alloys.

The knife wire 20 is a long member for incising biological tissue. The knife wire 20 is housed in a knife wire lumen 17L formed in the tube 10. The tip of the knife wire 20 is fixed to the tip of the tube 10. More specifically, as shown in FIG. 4, a fixing member 80 is filled in the tip of the knife wire lumen 17L, and the tip 21 of the knife wire 20 is fixed to the tip of the tube 10 by being fixed to the fixing member 80. Also, as shown in FIG. 1, the base end 22 of the knife wire 20 extends from the base end of the knife wire lumen 17L through the inner cavity of the connector 30 to the position of the handle portion 40, and is supported by a wire support portion 45 of the handle portion 40, which will be described later.

A portion of the knife wire 20 (hereinafter referred to as the "exposed portion 20E") is exposed to the outside of the tube 10 between the tip and base ends of the tube 10. More specifically, as shown in FIG. 4, the tube 10 is formed with a tip side hole 12 and a base side hole 13 that communicate between the knife wire lumen 17L and the outside. In the knife wire 20, the portion on the base side of the tip 21 fixed to the fixing member 80 in the knife wire lumen 17L is exposed to the outside of the tube 10 through the tip side hole 12, and the further base side portion is housed again in the knife wire lumen 17L through the base side hole 13. The exposed portion 20E of the knife wire 20 is a portion from the position passing through the tip side hole 12 to the position passing through the base side hole 13. The minimum diameter of the exposed portion 20E of the knife wire 20 is, for example, 0.15 mm or more and 0.30 mm or less. The minimum diameter of the exposed portion 20E of the knife wire 20 may be, for example, 0.18 mm or more and 0.25 mm or less. In this embodiment, the distal end hole 12 and the proximal end hole 13 are formed on the outer circumferential surface of the tube 10. In the following description, the portion of the tube 10 where the exposed portion 20E of the knife wire 20 is exposed is referred to as the first portion P1. The first portion P1 of the tube 10 is a portion in the longitudinal direction of the tube 10, and is the portion from the position of the distal end hole 12 to the position of the proximal end hole 13.

A high-frequency current is applied to the knife wire 20 from a high-frequency power source (not shown). The high-frequency power source is connected to the wire support portion 45. When the high-frequency power source is connected to the wire support portion 45, the wire support portion 45 can be made of a conductive material such as a metal. This allows the exposed portion 20E of the knife wire 20 to incise biological tissue.

The knife wire 20 is preferably conductive, anti-thrombogenic, and biocompatible, and can be made from metal materials such as 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.

The configuration of the tube 10 will now be described in detail. As shown in Figures 3 and 5, a slit 56 is formed in the tip portion P2, which encompasses the first portion P1 of the tube 10, and reaches at least one of the outer surface 10P and the inner surface 10I of the tube 10. The slit 56 is a cut. In other words, when no external force is applied to the tube 10, the pair of surfaces of the tube 10 that face each other via the slit 56 are in contact with each other.

In this embodiment, the slit 56 extends from the outer surface 10P of the tube 10 to the inner surface of the device lumen 16L as the inner surface 10I. That is, in this embodiment, the slit 56 reaches both the outer surface 10P and the inner surface 10I of the tube 10. In addition, in this embodiment, the slit 56 of the same shape is formed so as to extend along the axial direction of the tube 10 over the entire length of the distal end P2 of the tube 10. As described above, since the first portion P1 of the tube 10 is included in the distal end P2, it can be said that a part of the slit 56 is formed in the first portion P1 of the tube 10. In addition, in this embodiment, the slit 56 is not formed in the base end P3 located on the proximal side of the distal end P2 of the tube 10. That is, the slit 56 is formed in a part along the axial direction of the tube 10.

The manufacturing method of the tube 10 having the slit 56 may be, for example, a method of producing a tube 10 without the slit 56, and then cutting the tip surface or the outer surface 10P of the tube 10 to form the slit 56. Alternatively, the manufacturing method may be a method of directly forming the tube 10 into a shape having the slit 56 using a mold or the like. In other words, the slit 56 is not limited to being formed by some cutting process, but may be a cut that is formed directly without going through a cutting process.

As shown in FIG. 5, markers 14 are formed on the outer surface of the tube 10 near the exposed portion 20E of the knife wire 20 to indicate the position of the exposed portion 20E. In this embodiment, one marker 14 is disposed distal to the tip of the exposed portion 20E, one marker 14 is disposed proximal to the base end of the exposed portion 20E, and two markers 14 are disposed between the tip and base ends of the exposed portion 20E. The number and positions of the markers 14 can be changed as desired. Markers 14 do not necessarily have to be formed. In other figures, the markers 14 are omitted from illustration as appropriate.

As shown in FIG. 1, the connector 30 is a tubular member connected to the base end of the tube 10. The connector 30 has a thin diameter section 31, a tapered section 32, and a thick diameter section 33. The thin diameter section 31 is a section that forms the tip end of the connector 30 and has a substantially constant outer diameter. The thick diameter section 33 is a section that forms the base end of the connector 30 and has a substantially constant outer diameter that is larger than the outer diameter of the thin diameter section 31. The tapered section 32 is provided between the thin diameter section 31 and the thick diameter section 33, and is a section whose outer diameter gradually increases from the boundary with the thin diameter section 31 to the boundary with the thick diameter section 33.

A branch section 39 is formed in the small diameter section 31 of the connector 30, extending in a direction intersecting the central axis Ax. The inner cavity of the branch section 39 is connected to the liquid supply lumen 18L formed in the tube 10. Therefore, liquids such as contrast medium and saline can be supplied to the liquid supply lumen 18L via the branch section 39.

The handle portion 40 is disposed on the base end side of the connector 30. The handle portion 40 has a shaft portion 41 and a handle body portion 42. The shaft portion 41 is a substantially cylindrical member and is connected to the base end of the connector 30. The inner cavity of the shaft portion 41 communicates with the inner cavity of the connector 30. A ring-shaped first finger receiving portion 43 is provided at the base end of the shaft portion 41.

The handle body 42 is a substantially cylindrical member and is attached to the shaft 41 so as to be slidable along the central axis Ax. The handle body 42 is provided with a wire support 45 that protrudes into the inner cavity of the shaft 41, and the base end 22 of the knife wire 20 is supported (fixed) to the wire support 45. In addition, a pair of ring-shaped second finger receiving portions 44 are provided on the side of the handle body 42. The handle body 42 is an example of a support member.

The connector 30 and the handle portion 40 can be formed, for example, from a resin material. Examples of resin materials that can be used to form the connector 30 and the handle portion 40 include polyurethane, polypropylene, rigid polyvinyl chloride, polycarbonate resin, acrylic resin, etc.

(Method of Operating the Cutting Instrument 100)
6 and 7 are explanatory diagrams showing an example of a method of operating the incision instrument 100. As shown in FIG. 6, the surgeon, for example, inserts the thumb through the first finger receiving portion 43 and the index finger and middle finger through the second finger receiving portion 44, and rotates the handle body portion 42 relative to the tube 10 (arrow AR2). Then, a rotational torque is generated at the base end portion 22 of the knife wire 20 supported by the wire support portion 45 of the handle body portion 42, and the rotational torque is transmitted to the tip portion of the tube 10 fixed to the tip portion of the knife wire 20 via the knife wire 20. This causes the tube 10 to rotate around the central axis Ax, and as a result, the orientation of the exposed portion 20E of the knife wire 20 changes. The incision instrument 100 may have a locking mechanism that fixes the rotation angle of the handle body portion 42 (i.e., the orientation of the exposed portion 20E of the knife wire 20).

As shown in FIG. 7, when the surgeon inserts the thumb through the first finger receiving portion 43 and the index and middle fingers through the second finger receiving portion 44 and then pulls the index and middle fingers toward the base end (arrow AR1), the handle body 42 moves toward the base end along the outer circumferential surface of the shaft 41. Then, the base end 22 of the knife wire 20 supported by the wire support portion 45 of the handle body 42 is pulled toward the base end, applying tension to the knife wire 20. This tension causes the tip of the tube 10 fixed to the tip of the knife wire 20 to bend in an arch shape. When the handle body 42 is returned to the tip side, the tension of the knife wire 20 is relieved and the tip of the tube 10 returns to a substantially straight shape.

Next, the procedure of incising the papilla using the incision instrument 100 in endoscopic papilla incision will be described. First, the surgeon inserts the endoscope into the duodenum and delivers the guidewire (combined device) inserted under the endoscope from the opening of the papilla to the common bile duct. Next, the surgeon delivers the incision instrument 100 along the guidewire to the opening of the papilla. Specifically, after inserting the base end of the guidewire into the distal opening of the device lumen 16L of the incision instrument 100, the incision instrument 100 is advanced toward the distal end (distal side) until the tip of the incision instrument 100 reaches the opening of the papilla. At this time, the surgeon positions the handle main body 42 toward the distal end (Figure 1). This makes the distal end of the tube 10 straight, and the distal end of the tube 10 does not get caught on the papilla or the common bile duct when the incision instrument 100 is delivered.

Next, the surgeon rotates the handle body 42 of the handle portion 40 relative to the tube 10 (Figure 6, arrow AR2), thereby rotating the tip of the tube 10 and setting the orientation of the exposed portion 20E of the knife wire 20 to an appropriate orientation for incising the nipple.

Then, the surgeon applies tension to the knife wire 20 by sliding the handle main body 42 along the outer circumferential surface of the shaft 41 toward the base end (arrow AR1 in Figure 7). This causes the tip of the tube 10 to bend into a bow shape, with the exposed portion 20E of the knife wire 20 pressed against the incision site. In this state, the surgeon applies a high-frequency current to the knife wire 20 from the high-frequency power source. This causes the exposed portion 20E of the knife wire 20 to incise a predetermined area of the nipple into a predetermined shape.

(Effects of this embodiment)
As described above, the incision instrument 100 of this embodiment includes the tube 10 having at least one lumen including the knife wire lumen 17L, the knife wire 20 housed in the knife wire lumen 17L, and the handle body 42 that rotatably supports the base end of the knife wire 20. Between the tip and base ends of the tube 10, the knife wire 20 has an exposed portion 20E that is exposed to the outside of the tube 10 through the tip side hole 12 and the base side hole 13 that communicate with the knife wire lumen 17L. The tube 10 is formed with a slit 56 that reaches at least one of the outer surface 10P and the inner surface 10I of the tube 10. When no external force is applied to the tube 10, a pair of surfaces of the tube 10 that face each other through the slit 56 are in contact with each other.

In this way, in the incision instrument 100 of this embodiment, the slit 56 is formed in the tube 10, so that the torsional rigidity of the tube 10 can be reduced. Therefore, while maintaining the inner and outer diameters of the tube 10 and the outer diameter of the knife wire 20, the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed to a desired orientation by rotating the handle main body 42. In addition, in the incision instrument 100 of this embodiment, when no external force is applied to the tube 10, a pair of surfaces of the tube 10 facing each other through the slit 56 are in contact with each other. Therefore, when an external force is applied to the tube 10, the slit 56 can be prevented from widening significantly. This can prevent, for example, interference between the incision instrument 100 and other devices.

In addition, in the incision instrument 100 of this embodiment, at least a portion of the slit 56 is formed in the first portion P1, which is the portion in the tube 10 where the exposed portion 20E of the knife wire 20 is exposed. Therefore, according to the incision instrument 100 of this embodiment, the torsional rigidity of the first portion P1 in the tube 10 where the exposed portion 20E of the knife wire 20 is exposed can be effectively reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be changed more smoothly by rotating the handle main body 42. In addition, the bending rigidity of the first portion P1 of the tube 10 can be effectively reduced, and the operability can be improved when bending the tube 10 and performing an incision with the exposed portion 20E of the knife wire 20.

In addition, in the incision instrument 100 of this embodiment, the slits 56 extend along the axial direction of the tube 10. Therefore, with the incision instrument 100 of this embodiment, the torsional rigidity of the portion of the tube 10 where the slits 56 are formed can be evenly reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be changed more smoothly by rotating the handle main body 42.

In addition, in the incision instrument 100 of this embodiment, the slit 56 extends from the outer surface 10P of the tube 10 to the inner surface of the lumen, which is the inner surface 10I. Therefore, according to the incision instrument 100 of this embodiment, the slit 56 can effectively reduce the torsional rigidity of the tube 10, and the orientation of the exposed portion 20E of the knife wire 20 can be changed more smoothly by rotating the handle main body 42.

In addition, in the incision instrument 100 of this embodiment, the slit 56 is formed in a portion of the tube 10 along the axial direction. Therefore, with the incision instrument 100 of this embodiment, the torsional rigidity of a portion of the tube 10 can be reduced while maintaining the rigidity of the tube 10 as a whole, and the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed by rotating the handle main body 42.

In addition, in the incision instrument 100 of this embodiment, the minimum diameter of the exposed portion 20E of the knife wire 20 is 0.15 mm or more and 0.30 mm or less. Therefore, according to the incision instrument 100 of this embodiment, it is possible to achieve both an improvement in the rotational torque transmission of the knife wire 20 and an improvement in the incision ability of the knife wire 20.

B. Second embodiment:
Fig. 8 is an explanatory diagram showing the cross-sectional configuration (XY cross section) of the incision instrument 100a of the second embodiment. Fig. 8 shows the cross-sectional configuration of the incision instrument 100a at the position of the tip P2 (see Fig. 1) of the tube 10. In the following, among the configurations of the incision instrument 100a of the second embodiment, the same configurations as those of the incision instrument 100 of the first embodiment described above are appropriately omitted by assigning the same reference numerals.

The incision instrument 100a of the second embodiment differs from the incision instrument 100 of the first embodiment in the configuration of the slit 56 formed in the tip portion P2 of the tube 10. Specifically, in the incision instrument 100a of the second embodiment, the slit 56 formed in the tube 10 reaches the outer surface 10P of the tube 10, but does not reach the inner surface 10I.

In the second embodiment of the incision instrument 100a, as in the first embodiment of the incision instrument 100, a slit 56 is formed in the tube 10, so that the torsional rigidity of the tube 10 can be reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed to a desired orientation by rotating the handle main body 42 while maintaining the inner and outer diameters of the tube 10 and the outer diameter of the knife wire 20.

In addition, in the incision instrument 100a of the second embodiment, the slit 56 formed in the tube 10 reaches the outer surface 10P of the tube 10, but does not reach the inner surface 10I. Therefore, the incision instrument 100a of the second embodiment can effectively prevent the slit 56 from widening significantly when an external force is applied to the tube 10.

C. Third embodiment:
Fig. 9 is an explanatory diagram showing the cross-sectional configuration (XY cross section) of the incision instrument 100b of the third embodiment. Fig. 9 shows the cross-sectional configuration of the incision instrument 100b at the position of the tip part P2 (see Fig. 1) of the tube 10. In the following, among the configurations of the incision instrument 100b of the third embodiment, the same configurations as those of the incision instrument 100 of the first embodiment described above are appropriately omitted by assigning the same reference numerals.

The incision instrument 100b of the third embodiment differs from the incision instrument 100 of the first embodiment in the configuration of the slit 56 formed in the tip portion P2 of the tube 10. Specifically, in the incision instrument 100b of the third embodiment, the slit 56 formed in the tube 10 reaches the inner surface of the device lumen 16L as the inner surface 10I of the tube 10, but does not reach the outer surface 10P.

In the third embodiment of the incision instrument 100b, as in the first embodiment of the incision instrument 100, a slit 56 is formed in the tube 10, so that the torsional rigidity of the tube 10 can be reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed to a desired orientation by rotating the handle main body 42 while maintaining the inner and outer diameters of the tube 10 and the outer diameter of the knife wire 20.

In addition, in the third embodiment of the incision instrument 100b, the slit 56 formed in the tube 10 reaches the inner surface 10I of the tube 10, but does not reach the outer surface 10P. Therefore, the third embodiment of the incision instrument 100b can effectively prevent the slit 56 from widening significantly or the outer shape of the tube 10 from changing when an external force is applied to the tube 10.

D. Fourth embodiment:
Fig. 10 is an explanatory diagram showing the cross-sectional configuration (XY cross section) of the incision instrument 100c of the fourth embodiment. Fig. 10 shows the cross-sectional configuration of the incision instrument 100c at the position of the tip part P2 (see Fig. 1) of the tube 10. In the following, among the configurations of the incision instrument 100c of the fourth embodiment, the same configurations as those of the incision instrument 100 of the first embodiment described above are appropriately omitted by assigning the same reference numerals.

The incision instrument 100c of the fourth embodiment differs from the incision instrument 100 of the first embodiment in the configuration of the slit 56 formed in the tip portion P2 of the tube 10. Specifically, in the incision instrument 100c of the fourth embodiment, the slit 56 formed in the tube 10 extends from the inner surface of one lumen (device lumen 16L) as the inner surface 10I to the inner surface of the other lumen (fluid delivery lumen 18L) as the inner surface 10I. In the incision instrument 100c of the fourth embodiment, the slit 56 does not reach the outer surface 10P of the tube 10.

In the incision instrument 100c of the fourth embodiment, as in the incision instrument 100 of the first embodiment, a slit 56 is formed in the tube 10, so that the torsional rigidity of the tube 10 can be reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed to a desired orientation by rotating the handle main body 42 while maintaining the inner and outer diameters of the tube 10 and the outer diameter of the knife wire 20.

In addition, in the incision instrument 100c of the fourth embodiment, the slit 56 formed in the tube 10 extends from the inner surface of one lumen as the inner surface 10I of the tube 10 to the inner surface of the other lumen as the inner surface 10I. Therefore, the incision instrument 100c of the fourth embodiment can effectively prevent the slit 56 from widening significantly or the outer shape of the tube 10 from changing when an external force is applied to the tube 10.

E. Fifth embodiment:
Fig. 11 is an explanatory diagram showing the cross-sectional configuration (XY cross section) of the incision instrument 100d of the fifth embodiment. Fig. 11 shows the cross-sectional configuration of the incision instrument 100d at the position of the tip P2 (see Fig. 1) of the tube 10. In the following, among the configurations of the incision instrument 100d of the fifth embodiment, the same configurations as those of the incision instrument 100 of the first embodiment described above are appropriately omitted by assigning the same reference numerals.

The incision instrument 100d of the fifth embodiment differs from the incision instrument 100 of the first embodiment in the configuration of the slit 56 formed in the tip portion P2 of the tube 10. Specifically, in the incision instrument 100d of the fifth embodiment, a plurality of (two) slits 56 are formed in the tube 10. One of the slits 56 formed in the tube 10 extends from the outer surface 10P of the tube 10 to the inner surface of the device lumen 16L as the inner surface 10I, as in the first embodiment. The other slit 56 formed in the tube 10 extends from the inner surface of one lumen (device lumen 16L) as the inner surface 10I of the tube 10 to the inner surface of the other lumen (fluid supply lumen 18L) as the inner surface 10I, as in the fourth embodiment.

In the incision instrument 100d of the fifth embodiment, as in the incision instrument 100 of the first embodiment, a slit 56 is formed in the tube 10, so that the torsional rigidity of the tube 10 can be reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed to a desired orientation by rotating the handle main body 42 while maintaining the inner and outer diameters of the tube 10 and the outer diameter of the knife wire 20.

In addition, in the incision instrument 100d of the fifth embodiment, multiple slits 56 are formed in the tube 10. Therefore, according to the incision instrument 100d of the fifth embodiment, the torsional rigidity of the tube 10 can be effectively reduced, and the orientation of the exposed portion 20E of the knife wire 20 can be smoothly changed to a desired orientation by rotating the handle main body 42.

F. Variations:
The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified in various forms without departing from the spirit of the invention. For example, the following modifications are also possible.

The configuration of the incision instrument 100 in the above embodiment is merely an example and can be modified in various ways. For example, in the above embodiment, the slit 56 is formed over the entire length of the tip P2 of the tube 10 (see FIG. 1), but the position of the slit 56 in the axial direction can be modified in various ways. For example, as in the modified example shown in FIG. 12, the slit 56 may be formed over the entire length of the base end P5 of the tube 10 including the first portion P1, and not formed in the tip P4 on the tip side of the base end P5. Alternatively, as in the modified example shown in FIG. 13, the slit 56 may be formed over the entire length of the intermediate portion P7 of the tube 10 including the first portion P1, and not formed in the tip P6 on the tip side of the intermediate portion P7 and the base end P8 on the base side of the intermediate portion P7. Even in these modified examples, it can be said that at least a portion of the slit 56 is formed in the first portion P1 of the tube 10. The entire slit 56 may be formed in the first portion P1 of the tube 10, or conversely, the entire slit 56 may be formed in a portion of the tube 10 other than the first portion P1. The slits 56 may be formed in a plurality of portions of the tube 10 that are spaced apart from each other in the axial direction. For example, in the modified example shown in FIG. 13, the slits 56 may be formed in the distal end portion P6 and the proximal end portion P8, and the slits 56 may not be formed in the intermediate portion P7. It is preferable that the tube 10 has a portion on the proximal side of the portion where the slits 56 are formed, where the slits 56 are not formed.

In the above embodiment, the number of slits 56 formed in the tube 10 can be changed as desired. For example, three or more slits 56 may be formed in the tube 10.

In the above embodiment, the slits 56 formed in the tube 10 extend along the axial direction of the tube 10, but the slits 56 may extend at an angle to the axial direction of the tube 10 (non-parallel to the axial direction of the tube 10). Also, in the above embodiment, the slits 56 extend linearly in the cross section of the tube 10, but the slits 56 may extend in a curved manner or may extend in a bent manner.

In the first and third embodiments, the slits 56 formed in the tube 10 reach the inner surface of the device lumen 16L, but the slits 56 may reach the inner surface of another lumen. In the fourth embodiment, the slits 56 extend from the inner surface of the device lumen 16L to the inner surface of the liquid supply lumen 18L, but the slits 56 may extend between the inner surfaces of other combinations of lumens. The slits 56 may not reach the inner surface of the lumen, but may reach the inner surface of the tube 10 other than the inner surface of the lumen.

In the above embodiment, the tube 10 is formed with a lumen 17L for the knife wire, a lumen 16L for the device, and a lumen 18L for the fluid supply, but the lumen 16L for the device and/or the lumen 18L for the fluid supply may not be formed.

In the above embodiment, the exposed portion 20E of the knife wire 20 is always exposed to the outside of the tube 10, but it is sufficient that the exposed portion 20E of the knife wire 20 is exposed to the outside of the tube 10 at least when the tube 10 is in a predetermined position (e.g., a position in which the tube 10 is greatly curved), and it is not necessary for the exposed portion 20E to be always exposed to the outside.

The technology disclosed in this specification has been described above based on embodiments and modifications, but the above-mentioned embodiments and modifications are intended to facilitate understanding of the technology disclosed in this specification and do not limit the technology disclosed in this specification. The technology disclosed in this specification may be modified or improved without departing from the spirit thereof, and the technology disclosed in this specification includes equivalents thereof. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate.

10: Tube 10I: Inner surface 10P: Outer surface 12: Distal hole 13: Base hole 14: Marker 16L: Device lumen 17L: Knife wire lumen 18L: Fluid delivery lumen 19: Branch 20: Knife wire 20E: Exposed portion 21: Distal portion 22: Base end 30: Connector 31: Thin portion 32: Tapered portion 33: Thick portion 39: Branch 40: Handle portion 41: Shaft portion 42: Handle body 43: First finger receiving portion 44: Second finger receiving portion 45: Wire support portion 56: Slit 80: Fixing member 100: Cutting instrument Ax: Central axis P1: First portion

Claims (8)

1. An incision instrument comprising:
a tube having at least one lumen including a first lumen;
a knife wire housed in the first lumen;
a support member that rotatably supports a base end of the knife wire;
Equipped with
the knife wire has an exposed portion between the distal end and the proximal end of the tube, the exposed portion being exposed to the outside of the tube through a hole communicating with the first lumen at least when the tube is in a predetermined position;
The tube has a slit formed therein, the slit reaching at least one of an outer surface and an inner surface of the tube;
A cutting instrument, wherein a pair of surfaces of the tube opposing each other across the slit are in contact with each other when no external force is applied to the tube. 2. The incision instrument of claim 1,
At least a portion of the slit is formed in a first portion of the tube that exposes the exposed portion of the knife wire. The incision instrument according to claim 1 or 2,
The slit extends along the axial direction of the tube. The incision instrument according to any one of claims 1 to 3,
The tube has a plurality of the slits formed therein. The incision instrument according to any one of claims 1 to 4,
The slit extends from the outer surface of the tube to the inner surface of the lumen as the inner surface. The incision instrument according to any one of claims 1 to 5,
The at least one lumen includes a second lumen for accommodating a combination device and a third lumen for liquid delivery;
The slit extends from the inner surface of one of the lumens as the inner surface to the inner surface of the other of the lumens as the inner surface. A dissection instrument according to any one of claims 1 to 6,
The slit is formed in a portion of the tube along the axial direction. A dissection instrument according to any one of claims 1 to 7,
An incision instrument, wherein the minimum diameter of the exposed portion of the knife wire is 0.15 mm or more and 0.30 mm or less.

Images