Incision instrument

Abstract

To smoothly change an orientation of an exposed part of a knife wire to a desired orientation by rotating a support member while maintaining inner and outer diameters of a tube and an outer diameter of the knife wire.SOLUTION: An incision instrument includes: a tube having at least one lumen including a first lumen; a knife wire housed in the first lumen; and a support member for rotatably supporting a base end of the knife wire. The knife wire has an exposed portion exposed to the outside of the tube through a hole communicating with the first lumen at least when the tube is in a predetermined posture, between a tip and a base end of the tube. The tube has a shape with a notch, groove, or hole that does not reach an outer surface of the tube inside between the tip and the base end of the tube.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The technology disclosed herein relates to dissection instruments. [Background technology]

[0002] Endoscopic sphincterotomy (EST) is known as a treatment for common bile duct stones. In EST, an incision 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 incision instrument.

[0003] An 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 to the knife wire from a high-frequency power source, biological tissue can be incised by the exposed portion of the knife wire.

[0004] The operator rotates the support member to incise a predetermined shape in a predetermined area of ​​the biological tissue of the papilla. 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. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 4896351 Summary of the Invention [Problem to be solved by the invention]

[0006] In conventional incision instruments, the torsional rigidity of the tube is high, so that even if the operator applies a 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 part of the tube by making the diameter of the part thinner, but in that case, the inner and outer diameters of the part become thinner and it is not possible to form a lumen of a required size. It is also possible to increase the outer diameter of the knife wire to improve the rotational torque transmission, but increasing the outer diameter of the knife wire may reduce the incision ability of the knife wire.

[0007] Thus, conventional cutting instruments have the problem that it is not possible to smoothly change the orientation of the exposed portion 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.

[0008] Furthermore, 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 within the human body, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs, to cut biological tissue.

[0009] This specification discloses a technique that can solve the above-mentioned problems. [Means for solving the problem]

[0010] The technology disclosed in this specification can be realized, for example, in the following forms.

[0011] (1) The incision instrument disclosed in the present 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 for rotatably supporting a 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 shape having a notch, groove, or hole that does not reach the outer surface of the tube, inside the tube between the tip and base ends of the tube.

[0012] In this manner, in the present incision instrument, the tube has a shape with a notch, groove, or hole that does not reach the outer surface of the tube, and the presence of the notch, groove, or hole can reduce the torsional rigidity of the tube. Therefore, with this incision instrument, the orientation of the exposed portion of the knife wire can be smoothly changed 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.

[0013] (2) In the above incision instrument, at least a portion of the notch, groove or hole 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.

[0014] (3) In the above incision instrument, the notch, groove, or hole may extend along the axial direction of the tube. By adopting this configuration, the torsional rigidity of the portion of the tube where the notch, groove, or hole is formed can be uniformly reduced, and the orientation of the exposed portion of the knife wire can be changed more smoothly by rotating the support member.

[0015] (4) In the above incision instrument, the tube may be configured to have a shape having a plurality of the notches, grooves, or holes. By adopting this configuration, it is possible to effectively reduce the torsional rigidity of the tube by providing the tube with a plurality of notches, grooves, or holes while suppressing the increase in the outer diameter of the tube.

[0016] (5) In the above incision instrument, the tube may have a shape having the notches, and the notches may enlarge the cross-sectional area of ​​the lumen. By adopting this configuration, it is possible to suppress the enlargement of the outer diameter of the tube compared to a configuration in which notches are formed independently of each lumen, while providing the notches in the tube and uniformly reducing the torsional rigidity of the tube.

[0017] (6) In the incision instrument, the at least one lumen may include a second lumen for accommodating a combination device and a third lumen for liquid delivery, and the tube may have a shape having the notch, and the second lumen and the third lumen may be connected to each other through the notch. By adopting this configuration, it is possible to effectively reduce the torsional rigidity of the tube by providing the notch in the tube while suppressing the increase in the outer diameter of the tube compared to a configuration in which the notch is formed independently of each lumen.

[0018] (7) 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 transmissibility of the knife wire and an improvement in the incision ability of the knife wire.

[0019] The technology disclosed in this specification can be realized in various forms, such as a cutting instrument, a system including a cutting instrument, and methods of manufacturing these devices and systems. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is an explanatory diagram illustrating a schematic configuration of an incision instrument 100 according to a first embodiment. [Diagram 2] FIG. 2 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100 taken along the line II-II in FIG. [Diagram 3] FIG. 3 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100 taken along the line III-III in FIG. [Figure 4] FIG. 1 is an explanatory diagram showing the configuration of a vertical cross section of the tip of the incision instrument 100. [Diagram 5] FIG. 1 is a perspective view showing the external configuration of the tip of an incision instrument 100. [Figure 6] FIG. 1 is an explanatory diagram showing an example of a method for operating the incision instrument 100. [Figure 7] FIG. 1 is an explanatory diagram showing an example of a method for operating the incision instrument 100. [Figure 8] FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100a according to the second embodiment. [Figure 9] FIG. 13 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100a of the second embodiment. [Figure 10] FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100b according to the third embodiment. [Figure 11] FIG. 13 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100b according to the third embodiment. [Figure 12] FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100c according to the fourth embodiment. [Figure 13] FIG. 13 is an explanatory diagram showing a cross-sectional configuration of the incision instrument 100c according to the fourth embodiment. [Figure 14] FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100 according to a modified example. [Figure 15] FIG. 13 is a perspective view showing the external configuration of the tip of the incision instrument 100 according to another modified example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] A. First embodiment: (Configuration of incision instrument 100) 1 is an explanatory diagram showing a schematic configuration of an incision instrument 100 of 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 is not limited to endoscopic sphincterotomy, and may be inserted 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.

[0022] In FIG. 1, some of the components of the incision instrument 100 are omitted as appropriate. FIG. 1 also shows X, Y, and Z axes that are orthogonal to each other. 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 technician such as a doctor. In FIG. 1, each part of the incision instrument 100 is shown in a state in which it is approximately linearly 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".

[0023] The incision instrument 100 includes a tube 10, a knife wire 20, a connector 30, and a handle portion 40. Fig. 1 shows a central axis Ax of the tube 10. In this embodiment, the central axes of the connector 30 and the handle portion 40 approximately coincide with the central axis Ax of the tube 10. However, these central axes may differ from the central axis Ax of the tube 10.

[0024] Fig. 2 is an explanatory diagram showing the configuration of a cross section (XY cross section) of the incision instrument 100 taken at the position II-II in Fig. 1, Fig. 3 is an explanatory diagram showing the configuration of a cross section of the incision instrument 100 taken at the position III-III in Fig. 1, Fig. 4 is an explanatory diagram showing the configuration of a vertical section (YZ cross section) of the tip of the incision instrument 100, and Fig. 5 is a perspective view showing the external configuration of the tip of the incision instrument 100. Note that the knife wire 20 (see Fig. 1) is omitted in Fig. 3 (and Figs. 9, 11, and 13 described below).

[0025] The tube 10 is an elongated member extending along a central axis Ax. As shown in Figures 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.

[0026] 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 in the longitudinal direction from the tip of the tube 10 to a branched 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 in the longitudinal direction 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 in the longitudinal direction from the tip to the base end of the tube 10. The outer shape of the cross section of each lumen is, for example, approximately circular or approximately elliptical. In this embodiment, as shown in Fig. 2, in the base end portion of the tube 10 (base end portion P3 shown in Fig. 1), 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 fluid supply lumen 18L. The relationship in size 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 fluid supply lumen 18L is an example of a third lumen.

[0027] The tube 10 is preferably antithrombotic, flexible, and biocompatible, and may 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 alloy, and cobalt chrome alloy.

[0028] 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.

[0029] 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, a portion on the base side of the tip portion 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 a 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 side hole 12 and the proximal side 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 a first portion P1. The first portion P1 of the tube 10 is a portion in the longitudinal direction of the tube 10, and is a portion from the position of the distal side hole 12 to the position of the proximal side hole 13.

[0030] 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 supporting portion 45. When the high-frequency power source is connected to the wire supporting portion 45, a conductive material such as a metal can be used as a material for forming the wire supporting portion 45. This allows the exposed portion 20E of the knife wire 20 to incise the biological tissue.

[0031] The knife wire 20 preferably has electrical conductivity, anti-thrombogenicity, and biocompatibility, and can be formed from a metallic material such as a stainless steel alloy such as SUS302, SUS304, SUS316, Ni-Ti alloy, nickel-chromium alloy, cobalt alloy, gold, platinum, tungsten, or an alloy containing these elements.

[0032] Here, the configuration of the tube 10 will be described in detail. As shown in FIG. 3, in the distal end P2 (see FIG. 1) including the first portion P1 of the tube 10, a notch 51 that does not reach the outer surface 10P of the tube 10 is formed around the liquid supply lumen 18L. As a result, the cross-sectional area of ​​the liquid supply lumen 18L is enlarged compared to the base end P3 (see FIG. 1) of the tube 10. In addition, in FIG. 3, the contour line L18p (see FIG. 2) of the liquid supply lumen 18L at the base end P3 of the tube 10 is shown by a broken line. The notch 51 is a cross-sectional defect portion of the tube 10. That is, in the cross-section at the distal end P2 of the tube 10 (see FIG. 3), a part of the cross-section (the area outside the contour line L18p in FIG. 3) is defective compared to the cross-section at the base end P3 of the tube 10 (see FIG. 2). In this embodiment, the notch 51 is provided to enlarge the cross-sectional area of ​​the lumen, and therefore, in a configuration in which the lumen has a constant cross-sectional shape from the distal end to the proximal end, the notch 51 would not be present.

[0033] In this embodiment, a notch 51 of the same size is formed over the entire length of the tip portion P2 of the tube 10 so as to extend along the axial direction of the tube 10. As described above, since the first portion P1 of the tube 10 is included in the tip portion P2, it can be said that a part of the notch 51 is formed in the first portion P1 of the tube 10.

[0034] The method for manufacturing tube 10 having notch 51 may be, for example, a method in which tube 10 without notch 51 is manufactured, and then notch 51 is formed by removing a portion of tube 10. Alternatively, it may be a method in which tube 10 having a shape having notch 51 is directly formed using a mold or the like. In other words, notch 51 is not limited to being formed by some kind of removal process, and may be a cross-sectional defect portion that is directly formed without going through a removal process.

[0035] As shown in FIG. 5, markers 14 indicating the position of exposed portion 20E are formed on the outer surface of tube 10 near exposed portion 20E of knife wire 20. In this embodiment, one marker 14 is arranged on the distal side of exposed portion 20E, one marker 14 is arranged on the proximal side of proximal end of exposed portion 20E, and two markers 14 are arranged between the distal end and proximal end of exposed portion 20E. The number and positions of markers 14 can be changed as desired. Markers 14 do not necessarily have to be formed. In other figures, illustration of markers 14 is omitted as appropriate.

[0036] 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 constitutes the tip end of the connector 30 and has a substantially constant outer diameter. The thick diameter section 33 is a section that constitutes 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.

[0037] A branched portion 39 extending in a direction intersecting the central axis Ax is formed in the small diameter portion 31 of the connector 30. The inner cavity of the branched portion 39 communicates with the liquid supply lumen 18L formed in the tube 10. Therefore, liquid such as a contrast agent or saline can be supplied to the liquid supply lumen 18L via the branched portion 39.

[0038] 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 main 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.

[0039] The handle main 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 main body 42 is provided with a wire support portion 45 that protrudes into the inner cavity of the shaft 41, and the base end 22 of the knife wire 20 is supported (fixed) by the wire support portion 45. In addition, a pair of ring-shaped second finger receiving portions 44 are provided on the side surface of the handle main body 42. The handle main body 42 is an example of a support member.

[0040] The connector 30 and the handle portion 40 can be made of, for example, a resin material. Examples of resin materials that can be used to make the connector 30 and the handle portion 40 include polyurethane, polypropylene, hard polyvinyl chloride, polycarbonate resin, and acrylic resin.

[0041] (Method of operating the incision 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 his thumb into the first finger receiving portion 43 and his index finger and middle finger into the second finger receiving portion 44, and rotates the handle main body 42 relative to the tube 10 (arrow AR2). Then, a rotational torque is generated in the base end 22 of the knife wire 20 supported by the wire support portion 45 of the handle main body 42, and the rotational torque is transmitted to the tip of the tube 10 fixed to the tip 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 main body 42 (i.e., the orientation of the exposed portion 20E of the knife wire 20).

[0042] 7, when the operator 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 then pulls the index finger and middle finger toward the base end (arrow AR1), the handle main body 42 moves toward the base end along the outer circumferential surface of the shaft portion 41. Then, the base end 22 of the knife wire 20 supported by the wire support portion 45 of the handle main body 42 is pulled toward the base end, and tension is applied 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 main 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.

[0043] Next, a procedure for incising the papilla using the incision instrument 100 in endoscopic papilla incision will be described. First, the surgeon inserts an endoscope into the duodenum, and delivers a guidewire (combination 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 tip opening of the device lumen 16L of the incision instrument 100, the incision instrument 100 is advanced toward the tip side (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 on the tip side (FIG. 1). This makes the tip of the tube 10 straight, and the tip of the tube 10 does not get caught on the papilla or the common bile duct when the incision instrument 100 is delivered.

[0044] Next, the surgeon rotates the handle main 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.

[0045] Thereafter, 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 FIG. 7). This causes the tip of the tube 10 to bend into an arch 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 papilla into a predetermined shape.

[0046] (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 main 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 via the tip side hole 12 and the base side hole 13 that communicate with the knife wire lumen 17L. The tube 10 has a shape that has a notch 51 inside between the tip and base ends of the tube 10 that does not reach the outer surface 10P of the tube 10.

[0047] In this manner, in the incision instrument 100 of this embodiment, the tube 10 has the notch 51 that does not reach the outer surface 10P of the tube 10, thereby reducing the torsional rigidity of the tube 10. Therefore, according to the incision instrument 100 of this embodiment, the inner and outer diameters of the tube 10 and the outer diameter of the knife wire 20 can be maintained, 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.

[0048] Moreover, in the incision instrument 100 of this embodiment, at least a portion of the notch 51 is formed in the first portion P1, which is a portion where the exposed portion 20E of the knife wire 20 in the tube 10 is exposed. Therefore, according to the incision instrument 100 of this embodiment, the torsional rigidity of the first portion P1 where the exposed portion 20E of the knife wire 20 in the tube 10 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 when bending the tube 10 and performing an incision with the exposed portion 20E of the knife wire 20 can be improved.

[0049] Furthermore, in the incision instrument 100 of this embodiment, the notch 51 extends along the axial direction of the tube 10. Therefore, according to the incision instrument 100 of this embodiment, the torsional rigidity of the portion of the tube 10 where the notch 51 is formed can be uniformly 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.

[0050] Furthermore, in the incision instrument 100 of this embodiment, the cross-sectional area of ​​a lumen (e.g., liquid supply lumen 18L) formed in the tube 10 is enlarged by the notch 51. Therefore, according to the incision instrument 100 of this embodiment, the torsional rigidity of the tube 10 can be uniformly reduced by providing the notch 51 in the tube 10 while suppressing the enlargement of the outer diameter of the tube 10 compared to a configuration in which notches are formed independently of each lumen.

[0051] 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 transmissibility of the knife wire 20 and an improvement in the incision ability of the knife wire 20.

[0052] B. Second embodiment: Fig. 8 is a perspective view showing the external configuration of the tip of the incision instrument 100a of the second embodiment, and Fig. 9 is an explanatory diagram showing the configuration of the cross section (XY cross section) of the incision instrument 100a of the second embodiment. Fig. 9 shows the cross section configuration of the incision instrument 100a at the position of the tip P2 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.

[0053] The incision instrument 100a of the second embodiment differs from the incision instrument 100 of the first embodiment in the configuration of the notch 51 formed in the tip P2 of the tube 10. Specifically, in the incision instrument 100a of the second embodiment, a notch 51 that communicates the liquid supply lumen 18L and the device lumen 16L is formed in the tip P2 of the tube 10. In the second embodiment, the notch 51 of the same size is formed so as to extend along the axial direction of the tube 10 over the entire length of the tip P2 of the tube 10. As described above, since the first portion P1 of the tube 10 is included in the tip P2, it can be said that a part of the notch 51 is formed in the first portion P1 of the tube 10. Note that, in the second embodiment, the notch 51 also expands the cross-sectional area of ​​the liquid supply lumen 18L and / or the device lumen 16L.

[0054] Thus, in the incision instrument 100a of the second embodiment, similar to the incision instrument 100 of the first embodiment, the tube 10 has a shape having a notch 51 inside between the tip and base ends of the tube 10 that does not reach the outer surface 10P of the tube 10. Therefore, according to the incision instrument 100a of the second embodiment, similar to the incision instrument 100 of the first embodiment, the presence of the notch 51 can reduce the torsional rigidity of the tube 10, 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.

[0055] Moreover, in the incision instrument 100a of the second embodiment, a notch 51 that communicates the liquid supply lumen 18L and the device lumen 16L is formed in the tube 10. Therefore, according to the incision instrument 100a of the second embodiment, the torsional rigidity of the tube 10 can be effectively reduced by providing the notch 51 in the tube 10 while suppressing the expansion of the outer diameter of the tube 10 compared to a configuration in which notches are formed independently of each lumen.

[0056] C. Third embodiment: Fig. 10 is a perspective view showing the external configuration of the tip of the incision instrument 100b of the third embodiment, and Fig. 11 is an explanatory diagram showing the configuration of the cross section (XY cross section) of the incision instrument 100b of the third embodiment. Fig. 11 shows the cross section configuration of the incision instrument 100b at the position of the tip P2 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.

[0057] The incision instrument 100b of the third embodiment differs from the incision instrument 100 of the first embodiment in the configuration for reducing the torsional rigidity of the tip P2 of the tube 10. Specifically, in the incision instrument 100b of the third embodiment, two grooves 53 communicating with the liquid supply lumen 18L are formed in the tip P2 of the tube 10. The grooves 53 are cross-sectional defects in the tube 10. That is, in the cross section of the tube 10 where the grooves 53 are formed (cross section shown in FIG. 11), a portion corresponding to the grooves 53 is missing compared to the cross sections of the other portions. In this specification, the groove 53 means a cross-sectional defect having a pair of side surfaces 53S and a bottom surface 53B, and the notch 51 means a cross-sectional defect not having either of them, and the two are used interchangeably, but there is no essential difference between the two, and the groove may be called a notch, and the notch may be called a groove.

[0058] In the third embodiment, two grooves 53 of the same size are formed to extend along the axial direction of the tube 10 over the entire length of the tip portion P2 of the tube 10. As described above, the first portion P1 of the tube 10 is included in the tip portion P2, and therefore it can be said that a part of the grooves 53 is formed in the first portion P1 of the tube 10. Note that, in the third embodiment as well, the grooves 53 increase the cross-sectional area of ​​the liquid supply lumen 18L.

[0059] Thus, in the incision instrument 100b of the third embodiment, the tube 10 has a shape having a groove 53 that does not reach the outer surface 10P of the tube 10 inside between the tip and base ends of the tube 10. Therefore, according to the incision instrument 100b of the third embodiment, as with the incision instrument 100 of the first embodiment, the presence of the groove 53 can reduce the torsional rigidity of the tube 10, 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.

[0060] Moreover, in the incision instrument 100b of the third embodiment, a plurality of grooves 53 are formed in the tube 10. Therefore, according to the incision instrument 100b of the third embodiment, it is possible to effectively reduce the torsional rigidity of the tube 10 by providing the plurality of grooves 53 in the tube 10 while suppressing the increase in the outer diameter of the tube 10.

[0061] D. Fourth embodiment: Fig. 12 is a perspective view showing the external configuration of the tip of the incision instrument 100c of the fourth embodiment, and Fig. 13 is an explanatory diagram showing the configuration of the cross section (XY cross section) of the incision instrument 100c of the fourth embodiment. Fig. 13 shows the cross section configuration of the incision instrument 100c at the position of the tip P2 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.

[0062] The incision instrument 100c of the fourth embodiment differs from the incision instrument 100 of the first embodiment in the configuration for reducing the torsional rigidity of the tip portion P2 of the tube 10. Specifically, in the incision instrument 100c of the fourth embodiment, two holes 54 having a substantially circular cross section are formed in the tip portion P2 of the tube 10. The holes 54 are cross-sectional defects in the tube 10. That is, in the cross section of the tube 10 at the portion where the holes 54 are formed (the cross section shown in FIG. 13), a portion corresponding to the holes 54 is missing compared to the cross sections of the other portions. The holes 54 are formed independently of each lumen.

[0063] In the fourth embodiment, two holes 54 of the same size are formed to extend along the axial direction of the tube 10 over the entire length of the tip portion P2 of the tube 10. As described above, the first portion P1 of the tube 10 is included in the tip portion P2, so it can be said that a part of the holes 54 is formed in the first portion P1 of the tube 10.

[0064] Thus, in the incision instrument 100c of the fourth embodiment, the tube 10 has a shape having a hole 54 inside the tube 10 between the tip and base ends thereof, the hole 54 not reaching the outer surface 10P of the tube 10. Therefore, according to the incision instrument 100c of the fourth embodiment, similar to the incision instrument 100 of the first embodiment, the presence of the hole 54 can reduce the torsional rigidity of the tube 10, 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.

[0065] Moreover, in the incision instrument 100c of the fourth embodiment, a plurality of holes 54 are formed in the tube 10. Therefore, according to the incision instrument 100c of the fourth embodiment, it is possible to effectively reduce the torsional rigidity of the tube 10 by providing a plurality of holes 54 in the tube 10 while suppressing the increase in the outer diameter of the tube 10.

[0066] E. 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.

[0067] The configuration of the incision instrument 100 in the above embodiment is merely an example, and various modifications are possible. For example, in the above first embodiment, the notch 51 is formed over the entire length of the tip end P2 (see FIG. 1) of the tube 10, but the position of the notch 51 in the axial direction can be variously modified. For example, as in the modified example shown in FIG. 14, the notch 51 may be formed over the entire length of the base end P5 of the tube 10 including the base end of the first portion P1, and not formed in the tip end P4 on the tip side of the base end P5. Alternatively, as in the modified example shown in FIG. 15, the notch 51 may be formed over the entire length of the intermediate portion P7 of the tube 10 including the base end of the first portion P1, and not formed in the tip end P6 on the tip side of the intermediate portion P7 and the base end P8 on the base side of the intermediate portion P7. In these modified examples, it can be said that at least a portion of the notch 51 is formed in the first portion P1 of the tube 10. The entire notch 51 may be formed in the first portion P1 of the tube 10, or the entire notch 51 may be formed in a portion of the tube 10 other than the first portion P1. The notch 51 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. 15, the notch 51 may be formed in the distal end portion P6 and the proximal end portion P8, and the notch 51 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 notch 51 is formed where the notch 51 is not formed. The above points are the same for the notch 51, the groove 53, and the hole 54 in the other embodiments.

[0068] In the above embodiment, the number of notches 51, grooves 53, or holes 54 formed in the tube 10 can be changed as desired. Also, in the above embodiment, two or three of the notches 51, grooves 53, and holes 54 may be formed in the tube 10.

[0069] In the above embodiment, the notch 51, groove 53 or hole 54 formed in the tube 10 extends along the axial direction of the tube 10, but the notch 51, groove 53 or hole 54 may also extend so as to be inclined with respect to the axial direction of the tube 10 (non-parallel to the axial direction of the tube 10).

[0070] In the above third embodiment, the notch 51 formed in the tube 10 connects the fluid supply lumen 18L and the device lumen 16L, but the notch 51 may also connect other combinations of lumens (for example, the combination of the fluid supply lumen 18L and the knife wire lumen 17L).

[0071] In the above embodiment, the shape of the notch 51, the groove 53, or the hole 54 can be changed arbitrarily. For example, the groove 53 may be a spiral stripe, an oblique cross stripe, or a wavy stripe. Also, the cross section of the hole 54 may be an ellipse or a polygon.

[0072] In the above embodiment, the knife wire lumen 17L, the device lumen 16L, and the liquid supply lumen 18L are formed in the tube 10, but the device lumen 16L and / or the liquid supply lumen 18L may not be formed.

[0073] 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 exposed to the outside at all times.

[0074] The technology disclosed in this specification has been described above based on the 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 its equivalents. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate. [Explanation of symbols]

[0075] 10: Tube 10P: Outer surface 12: Distal hole 13: Base hole 14: Marker 16L: Device lumen 17L: Knife wire lumen 18L: Fluid delivery lumen 19: Branching section 20: Knife wire 20E: Exposed section 21: Distal section 22: Base end section 30: Connector 31: Thin section 32: Tapered section 33: Thick section 39: Branching section 40: Handle section 41: Shaft section 42: Handle body section 43: First finger receiving section 44: Second finger receiving section 45: Wire support section 51: Notch 53: Groove 53B: Bottom surface 53S: Side surface 54: Hole 80: Fixing member 100: Cutting instrument Ax: Central axis P1: First section

Claims

1. It is an incision instrument, A tube having at least one lumen, including a first lumen, The knife wire housed in the first lumen, A support member that rotatably supports the base end of the knife wire, Equipped with, The knife wire has an exposed portion between the tip and base end of the tube that is exposed to the outside of the tube through a hole that leads to the first lumen when the tube is in a predetermined position, The tube is shaped to have a notch, groove, or hole inside between the tip and base of the tube that does not reach the outer surface of the tube, as an incision instrument.

2. The cutting instrument according to claim 1, A cutting instrument wherein at least a portion of the notch, groove, or hole is formed in a first portion of the tube that exposes the exposed portion of the knife wire.

3. An incision instrument according to claim 1 or claim 2, An incision instrument wherein the notch, groove, or hole extends along the axial direction of the tube.

4. An incision instrument according to claim 1 or claim 2, The tube is a cutting instrument having a shape that includes multiple notches, grooves, or holes.

5. An incision instrument according to claim 1 or claim 2, The tube has the shape of having the notch, An incision instrument in which the area of ​​the cross-sectional surface of the lumen is enlarged by the aforementioned notch.

6. An incision instrument according to claim 1 or claim 2, The at least one lumen includes a second lumen in which a combined device is housed, and a third lumen for fluid delivery. The tube has the shape of having the notch, An incision instrument in which the second lumen and the third lumen are connected by the aforementioned notch.

7. An incision instrument according to claim 1 or claim 2, An incision instrument in which the minimum diameter of the exposed portion of the knife wire is 0.15 mm or more and 0.30 mm or less.

Images