Incision apparatus for endoscope

Abstract

An embodiment of the present specification provides an incision apparatus for an endoscope. The incision apparatus for an endoscope comprises: an operating portion; a sheath tube, comprising an injection lumen and a cutting wire lumen, a proximal end of the sheath tube being connected to the operating portion; and a cutting wire, at least partially disposed within the cutting wire lumen, a proximal end of the cutting wire being connected to the operating portion, and the cutting wire comprising a cutting section, the cutting section extending out of the sheath tube from a side wall of the sheath tube and being used to form a knife portion for performing surgical operations.

Description

Endoscopic incision device Cross-references

[0001] This application claims priority to Chinese patent application No. 202311738136.8 filed on December 15, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention relates to the field of medical technology, and in particular to an endoscopic incision device. Background Art

[0003] Endoscopic sphincterotomy (EST) is a clinical procedure performed under endoscopic retrograde cholangiopancreatography (ERCP) using a high-frequency electrosurgical unit to incise the duodenal sphincter and widen the bile duct opening. During the procedure, after the ERCP procedure is completed, the sheath is gently retracted to bend the distal end into an arch, exposing the incisor. A high-frequency current is then passed through the incisor to incise the sphincter. However, poor control of the pulling force on the incisor can easily lead to breakage or dislocation of the incisor, requiring a high level of operator experience.

[0004] Therefore, it is necessary to provide an endoscopic incision device to solve the above technical problems. Summary of the Invention

[0005] One or more embodiments of the present specification provide an endoscopic cutting device, comprising: a sheath tube, comprising an injection cavity and a wire cutting cavity, the proximal end of the sheath tube being connected to the operating part; a wire cutting device, at least partially arranged in the wire cutting cavity, the proximal end of the wire cutting device being connected to the operating part, the wire cutting device comprising a cutting section, a limiting section and a rotating action section, the cutting section, the limiting section and the rotating action section being respectively located at different positions of the wire cutting device, the cutting section extending from the side wall of the sheath tube outside the sheath tube, the limiting section being arranged in the wire cutting cavity and being configured to form an axial limit with the wire cutting cavity, the rotating action section being arranged in the injection cavity or in the wire cutting cavity and being configured to drive the sheath tube to rotate around the axis of the proximal end of the wire cutting device when the operating part rotates the wire cutting device.

[0006] In some embodiments, the wire cutting cavity includes a first cavity, the limiting portion includes a bending action segment, the bending action segment is arranged on the distal side of the cutting segment, and the bending action segment is partially arranged in the first cavity. The bending action segment is configured to drive the distal end of the sheath to bend when the operating portion pulls the wire cutting from the distal end to the proximal end.

[0007] In some embodiments, the limiting portion further includes a first limiting member, which is disposed in the first cavity, and the bending action segment is fixed to the first limiting member, and the first limiting member is used to limit the axial displacement of the bending action segment relative to the first cavity.

[0008] In some embodiments, an axially limiting snap-fit ​​structure is formed between the first limiting member and the inner wall of the first cavity, and the snap-fit ​​structure includes at least one limiting recess and at least one limiting protrusion extending in the circumferential direction, one of the limiting recess and the limiting protrusion is arranged on the outer wall of the first limiting member, and the other is arranged on the inner wall of the first cavity, and the limiting recess and the limiting protrusion are engaged with each other.

[0009] In some embodiments, the cross-sectional shape of the first limiting member is circular, and the engaging structure includes one or more combinations of a tower-shaped structure, a sawtooth-shaped structure, and a threaded structure.

[0010] In some embodiments, at least a portion of the cross-sectional shape of the first limiting member is non-circular, and the first limiting member and the first cavity form a circumferential limit.

[0011] In some embodiments, the first limiting member is configured as a cylinder with a constant cross-section along its axial direction, and the first limiting member is fixed in the first cavity by means of interference fit.

[0012] In some embodiments, the side wall of the first lumen is formed with a first perforation group and at least one second perforation group connected to the outer wall of the sheath, and the at least one second perforation group is arranged on the distal side of the first perforation group. The first perforation group includes a first hole and a second hole. The cutting wire passes through the first hole to the outside of the sheath to form the cutting section, the bending action section passes through the second hole to the first lumen, and the rotating action section passes through the second perforation group in sequence and is fixed to the first lumen.

[0013] In some embodiments, the endoscopic incision device also includes a second limiter, which is axially movably arranged in the first cavity, and at least a portion of the rotational action section is fixed to the second limiter, and the second limiter is used to limit the circumferential displacement of the rotational action section relative to the first cavity.

[0014] In some embodiments, a circumferentially limiting limiting structure is formed between the second limiting member and the inner wall of the first cavity, and the limiting structure includes at least one recess and at least one protrusion extending axially, one of the recess and the protrusion is provided on the outer wall of the second limiting member, and the other is provided on the inner wall of the first cavity, and the recess and the protrusion cooperate with each other.

[0015] In some embodiments, the shredding cavity further includes a second cavity connected to the first cavity, the second cavity is non-collinear with the first cavity, and the rotation action section is located in the second cavity.

[0016] In some embodiments, the second lumen is parallel to the first lumen, and the rotational action section enters the second lumen and extends toward the distal end of the sheath or toward the proximal end of the sheath.

[0017] In some embodiments, the inner diameter of the second lumen is equal to the outer diameter of the rotation section.

[0018] In some embodiments, a first connecting hole is formed between the injection cavity and the first cavity, and the first connecting hole is located at the distal end of the injection cavity. The rotation action section bends from the first connecting hole into the injection cavity and extends toward the distal end of the sheath tube or toward the proximal end of the sheath tube.

[0019] In some embodiments, the diameter of the rotational action section is greater than or equal to the inner diameter of the injection cavity.

[0020] In some embodiments, the sheath also includes a guidewire lumen, a second connecting hole is formed between the guidewire lumen and the injection lumen, the second connecting hole is between the middle of the sheath and the first connecting hole, and a sealing member is provided in the injection lumen, the sealing member is located between the first connecting hole and the second connecting hole, and is used to seal the injection lumen.

[0021] In some embodiments, the sheath includes a tip structure, which is fixed to the distal end of the sheath, the diameter of the proximal end of the tip structure is equal to the diameter of the distal end of the sheath, and the diameter of the tip structure gradually decreases from the proximal end to the distal end; the tip structure includes an outlet cavity, and the proximal end of the outlet cavity is connected to the distal end of the guidewire cavity.

[0022] In some embodiments, the rotating action section is provided with a developing structure.

[0023] In some embodiments, the operating part includes a pulling part and a rotating part, the pulling part is used to control the movement of the cutting wire from the distal end to the proximal end, and the bending action segment drives the distal end of the sheath to bend, and the rotating part is used to control the rotation of the cutting wire, and the rotating action segment drives the sheath to rotate; the rotating part is connected to the proximal end of the pulling part; or, the rotating part and the pulling part are arranged at intervals.

[0024] In some embodiments, the sheath further includes a guidewire lumen, a second connecting hole being formed between the guidewire lumen and the injection lumen, the second connecting hole being arranged between the sheath bending starting point and the middle of the sheath, for guiding the solution in the injection lumen to the guidewire lumen, wherein the bending starting point is the end point of the proximal end of the bending section of the sheath.

[0025] In some embodiments, the shredding cavity includes a first cavity for accommodating the shredded wire, a first connecting hole is formed between the injection cavity and the first cavity, the first connecting hole is located at the distal end of the injection cavity, and the rotating action section is fixed to the injection cavity through the first connecting hole.

[0026] In some embodiments, the diameter of the rotational action section is greater than or equal to the diameter of the injection cavity.

[0027] In some embodiments, a cross-sectional area of ​​the second communicating hole is larger than a cross-sectional area of ​​the injection cavity.

[0028] In some embodiments, a blocking member is provided in the injection cavity. The blocking member is located between the second communicating hole and the distal end of the injection cavity and is used to seal the injection cavity.

[0029] In some embodiments, the shredded material cavity includes a first cavity for accommodating the shredded material, a first connecting hole is formed between the injection cavity and the first cavity, and the rotating action section is fixed to the injection cavity through the first connecting hole.

[0030] In some embodiments, a second communicating hole is formed between the guidewire lumen and the injection lumen, and the second communicating hole is used to guide the solution in the injection lumen to the guidewire lumen.

[0031] In some embodiments, the first communicating hole is located at the distal end of the injection cavity, and the second communicating hole and the first communicating hole are staggered along the axial direction of the sheath tube.

[0032] According to the scheme in the above embodiment, the limiting part and the rotating action section of the wire cutting are set separately, so the force applied to the wire cutting control sheath when it is bent and the force applied to the wire cutting control sheath when it is rotated can be dispersed at different positions of the wire cutting, thereby avoiding excessive stress concentration on the wire cutting when the control sheath is bent and rotated, and preventing the wire cutting from breaking or falling off. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] This specification will be further described in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting, and in these embodiments, like numbers represent like structures, wherein:

[0034] FIG1 is a schematic diagram of an exemplary structure of an endoscopic incision device according to some embodiments of this specification;

[0035] FIG2 is a schematic structural diagram of the distal end of an endoscopic incision device according to some embodiments of the present specification;

[0036] FIG3 is a cross-sectional view of the distal end of an endoscopic incision device according to some embodiments of the present specification;

[0037] FIG4 is a schematic diagram of the distal end of an endoscopic incision device in a bent state according to some embodiments of the present specification;

[0038] FIG5 is a schematic structural diagram of a first position-limiting member according to some embodiments of this specification;

[0039] FIG6 is a schematic structural diagram of a first position-limiting member according to other embodiments of this specification;

[0040] FIG7 is a cross-sectional view of the distal end of an endoscopic incision device according to other embodiments of the present specification;

[0041] FIG8 is a schematic cross-sectional view of the endoscopic incision device taken along line AA according to some embodiments of FIG7 ;

[0042] FIG9 is a cross-sectional view of the distal end of an endoscopic incision device according to yet other embodiments of the present specification;

[0043] FIG10 is a cross-sectional view of the distal end of an endoscopic incision device according to yet other embodiments of the present specification;

[0044] FIG11A is a partial enlarged view of region B of the endoscopic incision device according to some embodiments of FIG10 ;

[0045] FIG11B is a schematic cross-sectional view of the endoscopic incision device taken along CC according to some embodiments of FIG10 ;

[0046] FIG12 is a cross-sectional view of the distal end of an endoscopic incision device according to some other variant embodiments of the present specification;

[0047] FIG13 is a cross-sectional view of the distal end of an endoscopic incision device according to other variant embodiments of the present specification;

[0048] FIG14 is a schematic cross-sectional view of the endoscopic incision device taken along DD according to some embodiments of FIG12 ;

[0049] FIG15 is a schematic structural diagram of the distal end of an endoscopic incision device according to other embodiments of this specification;

[0050] FIG16 is a partial cross-sectional view of the distal end of the endoscopic incision device shown in FIG15;

[0051] FIG17 is a side view of the distal end of the endoscopic incision device shown in FIG15;

[0052] FIG18A is a schematic cross-sectional view of the endoscopic incision device shown in FIG17 taken along line EE;

[0053] FIG18B is a schematic cross-sectional view of the endoscopic incision device shown in FIG17 taken along line FF;

[0054] FIG18C is a schematic cross-sectional view of the endoscopic incision device shown in FIG17 taken along line GG;

[0055] FIG18D is a schematic cross-sectional view of the endoscopic incision device shown in FIG17 taken along line HH;

[0056] FIG19 is a schematic diagram of a shredding structure according to other embodiments of the present disclosure;

[0057] FIG20A is a partial enlarged view of the region R at the distal end of the endoscopic incision device shown in FIG15 ;

[0058] FIG20B is a partially enlarged view of a region R according to a modified embodiment of the distal end of the endoscopic incision device shown in FIG15.

[0059] The accompanying drawings are:

[0060] 100, operating part; 110, liner assembly frame; 120, metal electrode; 130, guide hose; 140, pulling part; 150, rotating part; 200, sheath; 210, first cavity; 220, first perforation group; 221, first hole; 222, second hole; 230, second perforation group; 231, exit hole; 232, entry hole; 240, second cavity; 250, through hole; 260, Injection cavity; 261, first connecting hole; 270, guide wire cavity; 271, second connecting hole; 272, blocking member; 280, tip structure; 281, outlet cavity; 300, wire cutting; 310, cutting section; 320, bending section; 330, rotating section; 400, insulating sleeve; 500, first limiting member; 510, locking structure; 600, second limiting member; 610, limiting structure. DETAILED DESCRIPTION

[0061] To more clearly illustrate the technical solutions of the embodiments of this specification, the following briefly describes the drawings required for describing the embodiments. Obviously, the drawings described below are merely examples or embodiments of this specification. Those skilled in the art can apply this specification to other similar scenarios based on these drawings without inventive effort. Unless otherwise apparent from the context or otherwise noted, the same reference numerals in the figures represent the same structure or operation.

[0062] It should be understood that the terms "device," "structure," and / or "module" used herein are a method for distinguishing different components, elements, parts, portions, or assemblies at different levels. However, other terms may be used to replace the terms if they achieve the same purpose.

[0063] As used in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" do not refer to the singular but also include the plural. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements.

[0064] The endoscopic cutting device can be the main medical device used for endoscopic surgery such as endoscopic sphincterotomy (EST). The endoscopic cutting device includes an operating part, a sheath, and a cutting wire. The operating part is connected to the proximal end of the sheath. The cutting wire passes through the inside of the sheath to the distal end of the sheath and forms a cutting segment on the outside of the distal end of the sheath. By passing a high-frequency current into the cutting segment, the papillary sphincter and other objects can be cut. During the operation, the operator gently pulls the cutting wire through the operating part to bend the front end of the sheath, or rotates the cutting wire to rotate the sheath. Due to reasons such as concentrated force on the cutting wire or unstable connection, accidents such as cutting wire breakage or falling off may occur, increasing the risk of surgery.

[0065] In view of this, some embodiments of the present specification provide an endoscopic cutting device, which solves the problem of the cut wire being broken due to stress concentration by dispersing the force acting on the cut wire at different positions of the cut wire, for example, separating the rotation action section of the cut wire from the bending action section, and solves the problem of the cut wire falling off due to the large pulling force by improving the fixing method of the cut wire, for example, reinforcing the cut wire through a first limit member and / or a second limit member.

[0066] The first embodiment of the present specification provides an endoscopic incision device, which is designed to disperse the force exerted on the cut wire at different locations on the cut wire, thereby improving the cutting stability. The exemplary implementation of the endoscopic incision device of the first embodiment of the present specification will be described in detail below with reference to Figures 1 to 14.

[0067] Figure 1 is a schematic diagram of an exemplary structure of an endoscopic incision device according to some embodiments of the present specification. Figure 2 is a schematic diagram of the structure of the distal end of an endoscopic incision device according to some embodiments of the present specification.

[0068] As shown in FIG. 1 and FIG. 2 , the endoscopic incision device includes an operating portion 100 , a sheath tube 200 , and a cutting wire 300 .

[0069] In some embodiments, the sheath 200 includes at least one internal lumen, for example, the sheath 200 includes an injection lumen 260 for injecting solutions such as developer (as shown in FIG16 ), a guidewire lumen 270 for accommodating a guidewire (as shown in FIG16 ), at least one cutting wire lumen for accommodating a cutting wire 300 (hereinafter referred to as the first lumen 210 and the second lumen 240 ), etc. (as shown in FIG3 ).

[0070] In some embodiments, the operating part 100 is arranged at the proximal end of the sheath 200, and the operating part 100 includes a handle (bracelet, hand wheel, etc.) for operating the cutting wire 300, a liner assembly frame 110 connected to the distal end of the handle, a metal electrode 120 arranged on the liner assembly frame 110, and a guide hose 130 arranged between the liner assembly frame 110 and the sheath 200 and other components.

[0071] In some embodiments, at least a portion of the cutting wire 300 is housed within the sheath tube 200, and the proximal end of the cutting wire 300 is connected to the operating portion 100. The operating portion 100 allows an operator to hold and control the cutting wire 300. For example, the operating portion 100 can control the cutting wire 300 to move axially along the sheath tube 200 or rotate about its own axis. The axial direction of the sheath tube 200 refers to the length direction of the sheath tube 200.

[0072] In some embodiments, the cut wire 300 includes a limiting portion, which is disposed in the cut wire cavity and is configured to form an axial limit with the cut wire cavity. For example, the limiting portion includes a bending action segment and a first limiting member 500 (see description below). The limiting portion can be fixed in the cut wire cavity by the first limiting member 500, or the limiting portion can be disposed in the cut wire cavity by an interference fit, for limiting the axial displacement of the cut wire 300, so that when the operating portion 100 pulls the cut wire 300, the cut wire 300 can drive the sheath tube 200 to bend.

[0073] In some embodiments, the shredder 300 includes a rotational action section 330, which is disposed in the injection lumen 260 or within the shredder lumen and is configured to drive the sheath 200 to rotate about the axis of the proximal end of the shredder 300 when the operating unit 100 rotates the shredder 300. For example, the rotational action section 330 can be disposed within the injection lumen 260. For example, the shredder lumen includes a first lumen 210 and a second lumen 240 (described below), and the rotational action section 330 is disposed within the first lumen 210 or the second lumen 240. By independently disposing the rotational action section 330, the torque of the shredder 300 driving the sheath 200 to rotate is dispersed to different locations, avoiding stress concentration.

[0074] Figure 3 is a cross-sectional view of the distal end of an endoscopic incision device according to some embodiments of the present specification. Figure 4 is a schematic view of the distal end of an endoscopic incision device in a bent state according to some embodiments of the present specification.

[0075] As shown in FIG. 3 and FIG. 4 , in some embodiments, the sheath tube 200 includes a first lumen 210 for accommodating the cutting wire 300 . The first lumen 210 extends axially from the proximal end of the sheath tube 200 to the distal end of the sheath tube 200 .

[0076] In some embodiments, at least a portion of the cutting wire 300 is movably disposed in the first lumen 210 , and at least another portion of the cutting wire 300 extends from the sidewall of the sheath tube 200 outside the sheath tube 200 and is connected to the distal end of the sheath tube 200 .

[0077] In some embodiments, the distal end of the cutting wire 300 includes a cutting segment 310, a bending segment 320, and a rotating segment 330. In some embodiments, the cutting segment 310, the bending segment 320, and the rotating segment 330 are adjacently disposed on the cutting wire 300. In some embodiments, the cutting segment 310, the bending segment 320, and the rotating segment 330 are spaced apart on the cutting wire 300. It should be noted that the cutting segment 310, the bending segment 320, and the rotating segment 330 may refer to sections of the cutting wire 300 that have corresponding functions, and their edge ends do not have clear boundaries. For example, the bending segment 320 may refer to the section of the cutting wire 300 that drives the sheath 200 to bend, and the rotating segment 330 may refer to the section of the cutting wire 300 that drives the sheath 200 to rotate. Small sections at both ends of these sections that do not have corresponding functions may also be classified as corresponding sections.

[0078] In some embodiments, the cutting section 310 includes a section of the cutting wire 300 located outside the sheath 200, which is used to form a knife portion for cutting human tissue. For example, a high-frequency current is supplied to the cutting section 310 through the metal electrode 120 on the liner assembly frame 110, so that the cutting section 310 can cut the target cutting object (such as the papillary sphincter, etc.). In some embodiments, the endoscopic cutting device also includes an insulating sleeve 400, at least a portion of the insulating sleeve 400 is arranged outside the sheath 200, a portion of the cutting section 310 is sleeved inside the insulating sleeve 400, and the other portion is exposed outside the insulating sleeve 400, serving as a cutting tool. The insulating layer can shorten the actual cutting distance of the cutting section 310 to reduce the wound. In some embodiments, a portion of the insulating sleeve 400 is arranged in the first lumen 210 of the sheath 200, and the other portion is arranged outside the sheath 200. In other embodiments, the entire insulating sleeve is arranged outside the sheath 200. In some embodiments, the insulating sleeve 400 is wrapped around the cut wire 300 and can move with the cut wire 300. When the operating part 100 controls the cut wire 300 to move axially relative to the first lumen 210, the insulating sleeve 400 located outside the sheath tube 200 will retract into the first lumen 210.

[0079] In some embodiments, the limiting portion includes a bending section 320. The bending section 320 may refer to the portion of the cutting wire 300 that contacts the sheath tube 200 and applies a pulling force to the sheath tube 200 when the distal end of the sheath tube 200 is pulled and bent. In some embodiments, the bending section 320 is disposed distally to the cutting section 310. The bending section 320 is configured to cause the distal end of the sheath tube 200 to bend when the operating unit 100 pulls the cutting wire 300 from the distal end to the proximal end. In some embodiments, at least a portion of the bending section 320 is disposed within the first lumen 210, with another portion of the bending section 320 exposed from the sidewall of the sheath tube 200. In some embodiments, the bending section 320 is disposed at the location where the distal end of the cutting section 310 enters the sheath tube 200.

[0080] In some embodiments, the cutting wire 300 includes a rotational section 330. The rotational section 330 may refer to the portion of the cutting wire 300 that contacts the sheath tube 200 and applies torque to the sheath tube 200 when the cutting wire 300 rotates about its own axis. In some embodiments, the rotational section 330 may be disposed proximal to the cutting section 310 and / or the bending section 320, or distal to the cutting section 310 and / or the bending section 320. The rotational section 330 is configured to drive the sheath tube 200 to rotate about the axis proximal to the cutting wire 300 when the operating unit 100 rotates the cutting wire 300.

[0081] In some embodiments, the cutting section 310, the limiting portion and the rotating action section 330 are respectively located at different positions of the wire cutting, which can disperse the force exerted on the wire cutting at different positions of the wire cutting, facilitate the optimization of the force transmission of each section, and improve the reliability of the wire cutting 300.

[0082] According to the scheme in the above embodiment, the bending section 320 and the rotation section 330 of the cutting wire 300 are set separately, so the force applied to the cutting wire 300 when controlling the sheath tube 200 to bend and the force applied to the cutting wire 300 when controlling the sheath tube 200 to rotate can be dispersed at different positions of the cutting wire 300, thereby avoiding excessive stress concentration on the cutting wire 300 when controlling the sheath tube 200 to bend and rotate, and preventing the cutting wire 300 from breaking or falling off.

[0083] Hereinafter, some exemplary embodiments of the bending section 320 and its related components (such as the first limiting member 500 ) will be described in detail with reference to the accompanying drawings.

[0084] In some embodiments, the bending section 320 forms an axial limit with the first lumen 210, so that the distal end of the sheath 200 is bent under the pulling force from the distal end to the proximal end of the operating portion 100. In some embodiments, the bending section 320 and the first lumen 210 are axially limited by, but not limited to, providing a first limiter 500, interference fit, and other methods.

[0085] In some embodiments, the limiting portion further includes a first limiting member 500, which is disposed within the first lumen 210. The bending section 320 is fixed to the first limiting member 500, and the first limiting member 500 is used to limit the axial displacement of the bending section 320 relative to the first lumen 210. After the axial displacement of the bending section 320 relative to the first lumen 210 is limited, the operating portion 100 pulls the cutting wire 300 from the distal end to the proximal end, causing the proximal portion of the cutting section 310 located outside the sheath tube 200 to enter the first lumen 210. The bending section 320 then causes the distal end of the sheath tube 200 to bend into an arch shape. At this point, the cutting section 310 changes from a state of contact with the side wall of the sheath tube 200 to a state of separation from the side wall of the sheath tube 200, facilitating its use as a blade to cut human tissue.

[0086] In some embodiments, the bending section 320 is fixedly connected to the first position-limiting member 500. In some embodiments, the bending section 320 and the first position-limiting member 500 are integrally formed.

[0087] As shown in FIG3 , in some embodiments, an axially limiting engaging structure 510 is formed between the first stopper 500 and the inner wall of the first lumen 210. The engaging structure 510 includes at least one circumferentially extending concave and at least one circumferentially extending convex portion. One of the concave and convex portion is located on the outer wall of the first stopper 500, and the other is located on the inner wall of the first lumen 210. The concave and convex portion engage with each other. When the concave and convex portion engage, the first stopper 500 is axially positioned relative to the first lumen 210, thereby enabling the bending section 320 to drive the distal end of the sheath 200 to bend.

[0088] In some embodiments, the snap-fit ​​structure 510 includes a plurality of limiting protrusions and a plurality of limiting recesses, wherein the plurality of limiting protrusions are arranged axially at intervals on the inner wall of the first cavity 210 (or the outer wall of the first limiting member 500), and the plurality of limiting recesses are arranged axially at intervals on the outer wall of the first limiting member 500 (or the inner wall of the first cavity 210), and the limiting protrusions and the limiting recesses correspond to each other one by one and cooperate with each other.

[0089] In some embodiments, the engaging structure 510 includes a plurality of limiting protrusions and a plurality of limiting recesses. At least one of the limiting protrusions is located on the inner wall of the first cavity 210, and the remaining limiting protrusions are located on the outer wall of the first limiting member 500; at least one of the limiting recesses is located on the outer wall of the first limiting member 500, and the remaining limiting recesses are located on the inner wall of the first cavity 210. In other embodiments, the limiting protrusions and limiting recesses of the engaging structure 510 can also have other configurations.

[0090] Fig. 5 is a schematic diagram of the structure of a first position-limiting member 500 according to some embodiments of the present disclosure. Fig. 6 is a schematic diagram of the structure of a first position-limiting member 500 according to other embodiments of the present disclosure.

[0091] As shown in Figures 5 and 6, in some embodiments, the first stopper 500 only limits the axial displacement of the bending segment 320 relative to the first lumen 210, but does not limit the circumferential displacement of the bending segment 320 relative to the first lumen 210. In some embodiments, the first stopper 500 has a circular cross-sectional shape and is rotatable relative to the first lumen 210. In some embodiments, the bending segment 320 includes the portion from the distal end of the cutting segment 310 entering the sheath 200 to the distal end of the first stopper 500. Due to the circumferential freedom of movement of the first stopper 500 relative to the first lumen 210, the rotation segment 330 can be driven to rotate by the first stopper 500. For example, during surgical operation, when the rotating action section 330 is set at the distal end of the bending action section 320, the operating part 100 drives the cutting wire 300 to rotate, the cutting wire 300 drives the first limiting member 500 to rotate, and the first limiting member 500 drives the rotating action section 330 to rotate, so that the rotating action section 330 drives the sheath tube 200 to rotate.

[0092] In some embodiments, the first limiting member 500 is axially limited by a snap-fit ​​structure 510 , and the snap-fit ​​structure 510 includes one or more combinations of a tower-like structure, a sawtooth-like structure, and a threaded structure.

[0093] As shown in FIG. 5 , in some embodiments, the engaging structure 510 includes a tower-shaped structure formed by overlapping multiple frustums with one end larger than the other, and the end with the larger diameter of the tower-shaped structure engages with the inner wall of the first cavity 210 .

[0094] As shown in Figure 6, in some embodiments, the engaging structure 510 includes a sawtooth structure, which is formed by a plurality of circular rings arranged on the first limiting member 500. In some embodiments, the cross-section of the circular ring includes but is not limited to a triangle, an arc, a quadrilateral, etc.

[0095] In some other embodiments, the engaging structure 510 includes other structures such as a threaded structure.

[0096] According to the solution in the above embodiment, the first limiter 500 limits the axial displacement of the bending section 320, but does not limit the circumferential displacement of the bending section 320, so that the axial displacement and the circumferential displacement are dispersed to prevent the cut wire 300 from breaking and falling off.

[0097] Figure 7 is a cross-sectional view of the distal end of an endoscopic incision device according to some other embodiments of the present disclosure. Figure 8 is a cross-sectional schematic view of the endoscopic incision device according to some embodiments of Figure 7 taken along line AA.

[0098] In some embodiments, the first limiting member 500 can limit both the axial displacement of the bending section 320 relative to the first cavity 210 and the circumferential displacement of the bending section 320 relative to the first cavity 210 .

[0099] As shown in Figures 7 and 8, in some embodiments, at least a portion of the cross-sectional shape of the first stopper 500 is non-circular, so that the first stopper 500 forms a circumferential limit with the first cavity 210. In some embodiments, the cross-sectional shape of the first stopper 500 includes, but is not limited to, a triangle, a rectangle, a pentagon, a gear, etc.

[0100] In some embodiments, the first stopper 500 includes an axially limiting snap-fit ​​structure 510 and a circumferentially limiting non-circular cross-sectional portion. Thus, the first stopper 500 limits both the axial displacement of the cut wire 300 relative to the first lumen 210 and the circumferential displacement of the cut wire 300 relative to the first lumen 210. For example, the first stopper 500 can be configured as a square tower structure, etc.

[0101] In some embodiments, the first stopper 500 is fixed to the first lumen 210 both axially and circumferentially, the distal end of the cutting wire 300 is fixed to the first stopper 500, the bending section 320 includes a portion extending from the position where the distal end of the cutting section 310 enters the sheath 200 to the proximal end of the first stopper 500, and the rotation section 330 includes a portion fixed within the first stopper 500. During surgical operation, when the operating unit 100 pulls the cutting wire 300 from the distal end to the proximal end, the cutting wire 300 causes the distal end of the sheath 200 to bend via the bending section 320; when the operating unit 100 causes the cutting wire 300 to rotate, the cutting wire 300 transmits torque to the first stopper 500, which in turn transmits the torque to the sheath 200, causing the sheath 200 to rotate.

[0102] In some embodiments, the first stopper 500 is configured as a cylinder with a constant cross-section along its axial direction. The first stopper 500 is secured within the first cavity 210 via an interference fit. This interference fit enables the first stopper 500 to simultaneously limit the axial and circumferential displacement of the cut wire 300 within the first cavity 210. A cylinder with a constant cross-section refers to a cylinder whose shape and dimensions remain constant at any cross-section along the axial direction of the first stopper 500. In some embodiments, the first stopper 500 includes, but is not limited to, cylindrical, triangular, quadrangular, and pentagonal prisms. Columnar structures are simple to manufacture and cost-effective.

[0103] According to the above technical solution, the first limiting member 500 limits the axial and circumferential displacements of the cut wire 300 relative to the first cavity 210 , so that the bending section 320 and the rotating section 330 are arranged adjacent to each other, simplifying the overall structure.

[0104] Hereinafter, some exemplary embodiments of the rotation section 330 and its related components (such as the second limiting member 600 and the second cavity 240 ) will be described in detail with reference to the accompanying drawings.

[0105] In some embodiments, the rotational action section 330 forms a circumferential stop with the first lumen 210, so that under the action of the torsional force transmitted from the proximal end to the distal end of the operating portion 100, the sheath 200 is driven to rotate about the axis of the proximal end of the filament 300. The proximal axis of the filament 300 refers to the axis of the portion of the filament 300 located proximal to the cutting section 310. In some embodiments, the rotational action section 330 forms a circumferential stop with the first lumen 210 by repeatedly penetrating the second perforation group 230 (as described in FIG. 9 and related description below). In some embodiments, the rotational action section 330 forms a circumferential stop with the first lumen 210 via a second stopper 600 disposed in the first lumen 210 (as described in FIG. 10 and FIG. 11A and FIG. 11B and related description below). In some embodiments, the rotational action section 330 forms a circumferential stop with the first lumen 210 by being disposed within the second lumen 240 (as described in FIG. 12 to FIG. 14 and related description below).

[0106] FIG9 is a cross-sectional view of the distal end of an endoscopic incision device according to yet other embodiments of the present specification.

[0107] In some embodiments, the sidewall of the first lumen 210 is formed with a first perforation group 220 and at least one second perforation group 230 that communicate with the outer wall of the sheath 200. The at least one second perforation group 230 is disposed distally to the first perforation group 220. The perforation group includes holes that allow the cut wire 300 to pass from the first lumen 210 out of the sheath 200 and holes that allow the cut wire 300 to pass from the outside of the sheath 200 into the first lumen 210.

[0108] In some embodiments, the first perforation group 220 includes a first hole 221 and a second hole 222. The cut wire 300 passes through the first hole 221 to the outside of the sheath 200 to form a cutting segment 310. The cutting segment 310 includes the section between the position of the cut wire 300 at the first hole 221 and the position of the cut wire 300 at the second hole 222.

[0109] In some embodiments, the bending section 320 penetrates from the second hole 222 to the first lumen 210 , wherein the bending section 320 includes a section between the position where the cutting wire 300 is located at the second hole 222 and the position where the cutting wire 300 first penetrates the second perforating assembly 230 .

[0110] In some embodiments, the rotation section 330 sequentially passes through the second perforation set 230 and is fixed to the first lumen 210. The rotation section 330 includes a section from the position where the cut wire 300 first passes through the second perforation set 230 to the position where the cut wire 300 last passes through the second perforation set 230.

[0111] In some embodiments, the sidewall of the first lumen 210 is formed with one or more second perforation groups 230, each of which includes an exit hole 231 and an entry hole 232. The rotational action segment 330 passes through the exit hole 231 within the first lumen 210 to the outside of the sheath 200, and then passes through the entry hole 232 outside the sheath 200 into the first lumen 210, and continues to pass through the other perforation groups in sequence. The rotational action segment 330 forms a circumferential limit with the first lumen 210 through the second perforation group 230. When the operating unit 100 rotates the shredder 300, the rotational action segment 330 drives the sheath 200 to rotate.

[0112] In some embodiments, the plurality of second perforation groups 230 are sequentially arranged along the axial direction of the sheath tube 200. In some embodiments, the plurality of second perforation groups 230 are randomly arranged in the axial and circumferential directions of the sheath tube 200. This specification does not limit the arrangement of the second perforation groups 230.

[0113] According to the solution in the above embodiment, by providing the second perforation group 230 to cooperate with the rotating operation section, the structure is simple, and the rotation stress and bending stress can be dispersed, thereby reducing the risk of the cut wire 300 falling off.

[0114] Figure 10 is a cross-sectional view of the distal end of an endoscopic incision device according to some further embodiments of the present specification. Figure 11A is a partial enlarged view of region B of the endoscopic incision device according to some embodiments of Figure 10. Figure 11B is a schematic cross-sectional view taken along line CC of the endoscopic incision device according to some embodiments of Figure 10.

[0115] 10 and 11A , in some embodiments, the rotation segment 330 is disposed in the first lumen 210 . In some embodiments, the rotation segment 330 is disposed proximal to the cutting segment 310 , or between the bending segment 320 and the first stopper 500 .

[0116] In some embodiments, the endoscopic cutting device also includes a second limit member 600, which is axially movably arranged in the first cavity 210, and at least a portion of the rotating action section 330 is fixed to the second limit member 600. The second limit member 600 is used to limit the circumferential displacement of the rotating action section 330 relative to the first cavity 210.

[0117] In some embodiments, the portion of the shredded wire 300 that penetrates the second stopper 600 constitutes the rotational section 330. When the operating unit 100 controls the shredded wire 300 to rotate, the rotational section 330 drives the second stopper 600 to rotate, and the second stopper 600 drives the sheath 200 to rotate. In some embodiments, the rotational section 330 and the second stopper 600 are integrally formed or fixed by means of a snap connection, adhesive bonding, or the like.

[0118] As shown in Figure 11B, in some embodiments, a circumferentially limiting limiting structure 610 is formed between the second limiting member 600 and the inner wall of the first cavity 210. The limiting structure 610 includes at least one recess and at least one protrusion extending axially. One of the recess and the protrusion is provided on the outer wall of the second limiting member 600, and the other is provided on the inner wall of the first cavity 210. The recess and the protrusion cooperate with each other to limit the circumferential displacement of the limiting structure 610 and the inner wall of the first cavity 210.

[0119] In some embodiments, the cross-section of the second limiter 600 constitutes a cross-shaped symmetrical structure, and the inner wall of the first cavity 210 includes a protrusion that cooperates with the second limiter 600. When the wire cutter 300 drives the second limiter 600 to rotate, the force applied by the second limiter 600 to the side wall of the first cavity 210 is relatively uniform in the circumferential direction, thereby avoiding the failure of the torque applied by the second limiter 600 to the sheath tube 200.

[0120] In some embodiments, the axial length of the concave and / or convex portion of the inner wall of the first lumen 210 is greater than the axial length of the second stopper 600, ensuring that the second stopper 600 always maintains a mating state with the concave and / or convex portion of the inner wall of the first lumen 210 during axial movement. In some embodiments, the axial length of the concave and / or convex portion of the inner wall of the first lumen 210 is 5 to 20 times the axial length of the second stopper 600. In some embodiments, the entire inner wall of the first lumen 210 is provided with concave and / or convex portions along the axial direction to simplify the processing of the first lumen 210.

[0121] FIG12 is a cross-sectional view of the distal end of an endoscopic incision device according to some other variant embodiments of the present specification. FIG13 is a cross-sectional view of the distal end of an endoscopic incision device according to some other variant embodiments of the present specification. FIG14 is a schematic cross-sectional view of the endoscopic incision device according to some embodiments of FIG12 taken along line DD.

[0122] As shown in Figures 3 and 12 to 14, in some embodiments, the cutting lumen further includes a second lumen 240 connected to the first lumen 210. The second lumen 240 is arranged non-collinearly with the first lumen 210, and the rotational action section 330 is located in the second lumen 240. The "non-collinear arrangement" means that the first lumen 210 and the second lumen 240 are not on the same axis. For example, the first lumen 210 and the second lumen 240 can be parallel or intersect at an angle. When the operating unit 100 rotates the cutting lumen 300, the rotational action section 330 located in the second lumen 240 can generate torque on the sheath tube 200, causing the sheath tube 200 to rotate. Because the second lumen 240 is arranged non-collinearly with the first lumen 210, the force arm of the rotational action section 330 exerting force on the sheath tube 200 increases, increasing the torque and making the sheath tube 200 easier to rotate.

[0123] In some embodiments, the second lumen 240 is parallel to or intersects the first lumen 210 at an angle. For example, the second lumen 240 is perpendicular to the first lumen 210, or the angle between the second lumen 240 and the first lumen 210 is 30°, 45°, 60°, etc.

[0124] In some embodiments, the length of the second lumen 240 can be set according to actual needs. For example, the length of the second lumen 240 can be equal to the length of the rotational section 330. For another example, the length of the second lumen 240 can be greater than the length of the rotational section 330 and less than the axial length of the sheath 200. For another example, the length of the second lumen 240 can be equal to the axial length of the sheath 200.

[0125] In some embodiments, the second lumen 240 is parallel to the first lumen 210 , and the rotational action section 330 enters the second lumen 240 and extends toward the distal end of the sheath 200 (as shown in FIG. 13 ) or toward the proximal end of the sheath 200 (as shown in FIG. 12 ).

[0126] In some embodiments, a through hole 250 is formed on the sidewall of the second cavity 240 and communicates with the first cavity 210. The shredded wire 300 passes through the through hole 250 in the first cavity 210 and enters the second cavity 240. In some embodiments, the through hole 250 is disposed at an end of the second cavity 240. In some embodiments, the through hole 250 is disposed between two ends of the second cavity 240.

[0127] In some embodiments, the inner diameter of the second lumen 240 is equal to the outer diameter of the rotating section 330, so that the rotating section 330 fits closely to the inner wall of the second lumen 240, making it easier to apply the rotational force of the rotating section 330 to the sheath 200 and improve the torque transmission efficiency.

[0128] In some embodiments, the second lumen 240 is a straight lumen. In some embodiments, the second lumen 240 is a curved lumen.

[0129] In some embodiments, the second lumen 240 in the sheath 200 can be replaced by an injection lumen 260 to reduce the number of channels in the sheath 200 and reduce the cross-sectional size of the sheath 200. An exemplary embodiment of an endoscopic incision device provided in Example 2 of this specification will be described in detail below with reference to Figures 15 to 20B. The endoscopic incision device in Example 2 is intended to utilize the injection lumen 260 to accommodate the distal end of the cutting wire to reduce the number of lumens in the sheath 200. It should be understood that, unless there is a conflict, the endoscopic incision device in Example 2 can be appropriately combined, improved, or referenced with the endoscopic incision device in Example 1.

[0130] Figure 15 is a schematic structural diagram of the distal end of an endoscopic incision device according to other embodiments of the present disclosure; Figure 16 is a partial cross-sectional view of the distal end of the endoscopic incision device shown in Figure 15; Figure 17 is a side view of the distal end of the endoscopic incision device shown in Figure 15; and Figures 18A and 18B are schematic cross-sectional views of the endoscopic incision device shown in Figure 17 at different positions.

[0131] As shown in Figures 15 to 18D, the endoscopic incision device provided in the second embodiment of the present specification includes a sheath tube 200 and a cutting wire 300 disposed in the sheath tube 200.

[0132] In some embodiments, the sheath 200 includes an injection lumen 260 and a first lumen 210 for accommodating the shredded wire 300. A first communicating hole 261 is formed between the injection lumen 260 and the first lumen 210. At least a portion of the shredded wire 300 passes through the first communicating hole 261 and is fixed to the injection lumen 260. For example, the rotational action section 330 bends from the first communicating hole 261 and enters the injection lumen 260. By utilizing the injection lumen 260 to accommodate the shredded wire 300, it is avoided that too many lumens are provided (for example, no second lumen is required) to reduce the strength of the distal end of the sheath 200, thereby preventing the sheath 200 from unexpected bending deformation.

[0133] In some embodiments, the first connecting hole 261 is located at the distal end of the injection lumen 260. For example, the distal end of the shredded wire 300 forms a rotating section 330. The rotating section 330 bends at the distal end of the first lumen 210 and enters the injection lumen 260 through the first connecting hole 261. When the operating unit 100 rotates the shredded wire 300, the rotating section 330 located between the first lumen 210 and the injection lumen 260 can generate torque on the sheath 200, causing the sheath 200 to rotate. Because at least a portion of the rotating section 330 is disposed within the injection lumen 260, there is no need to increase the number of lumens, which reduces the processing difficulty and facilitates reducing the cross-sectional dimensions of the sheath 200. Furthermore, the rotating section 330 is disposed separately from the bending section 320 to avoid stress concentration and prevent the shredded wire 300 from breaking.

[0134] In some embodiments, the rotational action section 330 extends toward the distal end of the sheath tube 200 to facilitate assembly. As shown in FIG18A , in some embodiments, the rotational action section 330 extends toward the proximal end of the sheath tube 200. That is, the rotational action section 330 extends distally within the first lumen 210 to the first connecting hole 261, then bends back into the injection lumen 260. The overall hook-shaped structure enables it to hook onto the first connecting hole 261 to form an axial limit, thereby improving the connection stability of the cut wire 300.

[0135] FIG19 is a schematic structural diagram of a shredder 300 according to other embodiments of the present disclosure.

[0136] As shown in Figures 16-19 , in some embodiments, the diameter of the rotating segment 330 is greater than or equal to the inner diameter of the injection lumen 260. This creates an interference fit between the rotating segment 330 and the injection lumen 260, limiting axial displacement of the rotating segment 330 relative to the injection lumen 260 and improving the connection stability of the cut wire 300. For example, the diameter of the rotating segment 330 ranges from 0.2 mm to 0.6 mm, and preferably, the diameter of the rotating segment 330 is 0.45 mm.

[0137] In some embodiments, the length of the rotational section 330 within the injection channel 260 ranges from 1 mm to 15 mm. For example, the distal end of the shredded wire 300 is approximately 5 mm long, and the length of the shredded wire that bends into the injection channel 260 is approximately 2 mm. This length range facilitates assembly while ensuring stable fit between the shredded wire 300 and the injection channel 260.

[0138] In some embodiments, the diameter of the cutting segment 310 of the shredder 300 is smaller than the diameter of the other parts, making the cutting segment 310 sharper and having higher cutting accuracy. For example, the shredder 300 can be a shredder 300 with a diameter of 0.45 mm, and the diameter of the cutting segment 310 is about 0.24 mm. The processing method includes: packaging the shredder 300 with a diameter of 0.45 mm, exposing only the cutting segment 310, immersing the shredder 300 after packaging in a dissolving liquid, so that the diameter of the cutting segment 310 becomes thinner, for example, dissolving it to 0.24 mm, and finally, assembling the processed shredder to the sheath. Because the cutting segment 310 is thinner than the bending action segment 320, the rotation action segment 330, and the proximal portion, better cutting performance is guaranteed.

[0139] In some embodiments, the rotating action segment 330 is provided with a display structure (not shown in the figure), which can display the position of the rotating action segment 330 to facilitate guiding the operator to bend the rotating action segment 330 from the first cavity 210 into the injection cavity 260.

[0140] As shown in FIG16 , Example 2 of the present specification also provides another embodiment of an endoscopic incision device. In some embodiments, the sheath 200 includes a guidewire lumen 270 and an injection lumen 260. A second communication hole 271 is formed between the guidewire lumen 270 and the injection lumen 260. The second communication hole 271 is located between the bending start point of the sheath 200 and the middle of the sheath 200, and is used to guide the solution in the injection lumen 260 to the guidewire lumen 270. The bending start point is the proximal end point of the bending section of the sheath 200. The bending section refers to the portion of the sheath 200 between the two ends of the cut section after the sheath 200 is bent by pulling the sheath 200. The "middle of the sheath 200" is based on the entire length of the sheath 200. In the axial direction of the sheath 200, the section that is a certain distance to the left or right of the midpoint of the sheath 200 can be referred to as the middle of the sheath 200. By setting a second connecting hole 271 to connect the guidewire cavity 270 and the injection cavity 260, the solution in the injection cavity is guided to the guidewire cavity 270, and a setting position can be reserved at the distal end of the sheath 200, and setting space can be reserved for other distal structures, so that the product structure is reasonable and stable; in one embodiment, the distal part of the injection cavity 260 located at the second connecting hole 271 can be used as a cavity for installing the cutting wire 300, so as to reduce the number of cavities, avoid opening too many cavities, and improve the structural strength of the distal end of the sheath; and the second connecting hole 271 is set between the starting point of the bow and the middle of the sheath, which can avoid the bow section and ensure the structural strength of the distal end of the sheath.

[0141] In some embodiments, the second connecting hole 271 can be provided at the starting point of the bow, that is, the position where the cutting section extends from the proximal end to the distal end of the side wall of the sheath tube 200, for ease of processing. In some embodiments, after the cutting section 310 forms the blade portion, the corresponding portion of the sheath tube 200 will bend to form a bow segment. To prevent the second connecting hole 271 from affecting the bow shape or strength of the sheath tube 200, preferably, the second connecting hole 271 is provided at a position that avoids the curved portion of the sheath tube 200 and is provided at a position closer to the middle of the sheath tube 200 on the proximal side of the curved portion of the sheath tube 200. In other words, the second connecting hole is provided between the middle of the sheath tube 200 and the position where the cutting section 310 extends from the sheath tube 200 to ensure the structural strength of the curved portion of the sheath tube 200.

[0142] In some embodiments, the second communicating hole 271 and the first communicating hole 261 are staggered along the axial direction of the sheath tube 200. For example, the second communicating hole 271 is between the middle portion of the sheath tube 200 and the first communicating hole 261, that is, the second communicating hole 271 can be provided in the curved section of the sheath tube 200, or can be provided on other sections proximal to the curved section.

[0143] In some embodiments, the cross-sectional area of ​​the second communication hole 271 is larger than the cross-sectional area of ​​the injection lumen 260 , so as to avoid excessive pressure or blockage when the solution enters the guidewire lumen 270 from the injection lumen 260 .

[0144] In some embodiments, a blocking member 272 is disposed in the injection cavity 260 . The blocking member 272 is located between the first communicating hole 261 and the second communicating hole 271 and is used to seal the injection cavity 260 .

[0145] As shown in FIG18B , on the proximal side of the second connecting hole 271, the guidewire lumen 270 and the injection lumen 260 are independent of each other. As shown in FIG18C , at the second connecting hole 271, the guidewire lumen 270 and the injection lumen 260 are connected to each other. For example, after the guidewire lumen 270 and the injection lumen 260 are connected, the injection lumen 260 is blocked by the blocking member 272. When in use, the solution (such as the developer) enters from the proximal end of the injection lumen 260, flows to the guidewire lumen 270 through the second connecting hole 271, and flows along the guidewire lumen 270 to the distal end of the sheath 200. In this way, after the distal portion of the injection lumen 260 is used to accommodate the rotating action segment 330, the distal portion of the guidewire lumen 270 is used to guide the flow of the solution, providing a layout position for the rotating action segment 330 without increasing the number of original lumens of the sheath 200, and without affecting the various functions of the sheath 200.

[0146] In some embodiments, the blocking member 272 includes but is not limited to sealing glue and rubber elastic blocks. In other embodiments, the injection cavity 260 can also be blocked by melting or other methods.

[0147] Fig. 20A is a partial enlarged view of the region R of the distal end of the endoscopic incision device shown in Fig. 15. Fig. 20B is a partial enlarged view of the region R of a modified embodiment of the distal end of the endoscopic incision device shown in Fig. 15.

[0148] In certain embodiments, sheath tube 200 includes a tip structure 280, which is fixed to sheath tube 200 distal ends. The diameter of the proximal end of the tip structure 280 is equal to the diameter of the distal end of the sheath tube 200, and the diameter of the tip structure 280 gradually decreases from the proximal end to the distal end. For example, the tip structure 280 is configured as a truncated cone (as shown in Figure 20 A) or a hemispherical (as shown in Figure 20 B) with a large proximal cross section and a small distal cross section. By arranging the tip structure 280, the size of the distal end of the sheath tube 200 can be reduced, and there is a guiding effect during the advancement of the sheath tube 200.

[0149] As shown in conjunction with FIG16 and FIG18D , in some embodiments, the tip structure 280 includes an outlet cavity 281, the proximal end of which interfaces with the distal end of the guidewire lumen 270, allowing both the guidewire and the solution to be drawn out of the outlet cavity 281. In some embodiments, the diameter of the outlet cavity 281 gradually decreases from the proximal end to the distal end, facilitating further reduction in the size of the tip structure 280. In some embodiments, the diameter of the outlet cavity 281 remains constant to facilitate processing.

[0150] In some embodiments, the axial length of the tip structure 280 ranges from 1 mm to 10 mm. Within this length range, the tip structure 280 will not damage tissue during guidance.

[0151] Hereinafter, some exemplary embodiments of the operating unit 100 will be described in detail with reference to FIG. 1 .

[0152] As shown in Figure 1, in some embodiments, the operating part 100 includes a pulling part 140 and a rotating part 150. For example, the pulling part 140 is used to control the movement of the cutting wire 300 from the distal end to the proximal end, so that the bending action section 320 of the cutting wire 300 drives the distal end of the sheath tube 200 to bend. When the distal end of the sheath tube 200 is bent, the part of the cutting wire 300 located outside the sheath tube 200 constitutes a knife part, which is convenient for cutting human tissue (such as the nipple sphincter). For example, the rotating part 150 is used to control the rotation of the cutting wire 300, so that the rotating action section 330 of the cutting wire 300 drives the sheath tube 200 to rotate, making it convenient for the operator to point the aforementioned knife part toward the direction to be cut (such as the 11 o'clock direction toward the nipple sphincter). By separately providing the pulling part 140 and the rotating part 150, the rotation operation and axial movement operation of the cutting wire 300 are controlled separately to avoid misoperation.

[0153] In some embodiments, the rotating portion 150 and the pulling portion 140 are disposed adjacent to each other on the operating portion 100. For example, the rotating portion 150 is connected to the proximal end of the pulling portion 140 to facilitate operator control. In some embodiments, the rotating portion 150 and the pulling portion 140 are spaced apart. For example, the pulling portion 140 is disposed at the proximal end of the operating portion 100, and the rotating portion 150 is disposed on the liner assembly frame 110.

[0154] In some embodiments, the pulling portion 140 includes at least one slider slidably mounted on the operating portion 100 , and the proximal end of the cutting wire 300 is fixed to the slider. When the operator pulls the slider, the slider drives the cutting wire 300 to move axially within the sheath 200 .

[0155] In some embodiments, the rotating portion 150 includes a rotating wristband that is rotatably mounted on the proximal end of the operating portion 100 and fixedly connected to the pulling portion 140. When the operator controls the rotating wristband to rotate, the rotating wristband drives the pulling portion 140 to rotate together, and the pulling portion 140 drives the shredded wire 300 to rotate. In some embodiments, the rotating portion 150 includes a handwheel (not shown) that is mounted on the liner assembly frame 110. The proximal end of the shredded wire 300 passes through the handwheel and cooperates with the handwheel. When the operator controls the handwheel to rotate, the handwheel can drive the shredded wire 300 to rotate about its own axis.

[0156] Some embodiments of the present specification also provide an endoscope, which includes an endoscopic incision device as described in any of the above embodiments.

[0157] The beneficial effects that may be brought about by the embodiments of the present application include but are not limited to:

[0158] (1) The bending action section and the rotation action section of the cutting wire are set separately, so that the force applied to the cutting wire control sheath when it is bent and the force applied to the cutting wire control sheath when it is rotated can be dispersed at different positions of the cutting wire, thereby avoiding excessive stress concentration on the cutting wire when the control sheath is bent and rotated, and preventing the cutting wire from breaking or falling off.

[0159] (2) The first limiter limits the axial displacement of the bending action section, but does not limit the circumferential displacement of the bending action section, so that the axial displacement and the circumferential displacement are dispersed to prevent the cut wire from breaking and falling off.

[0160] (3) The first limiting member limits the axial displacement and circumferential displacement of the cut wire relative to the first cavity, so that the bending action section and the rotation action section are arranged adjacent to each other, simplifying the overall structure.

[0161] (4) By setting up a second perforation group to cooperate with the rotating operation section, the structure is simple and the rotation stress and bending stress can be dispersed, thereby reducing the risk of the cut wire falling off.

[0162] (5) By providing a second lumen and arranging the second lumen non-collinearly with the first lumen, the force arm of the rotating action section exerting force on the sheath tube is increased, thereby increasing the torque and making it easier to drive the sheath tube to rotate.

[0163] (6) At least part of the rotating action section is arranged in the injection cavity, without increasing the number of cavities, which reduces the processing difficulty and is conducive to reducing the cross-sectional size of the sheath.

[0164] (7) By setting a first connecting hole to connect the injection cavity and the shredding cavity, the shredding rotation section is set in the injection cavity, avoiding the opening of too many cavities (for example, no need to configure a second cavity) to reduce the strength of the distal end of the sheath, thereby preventing the sheath from unexpected bending deformation.

[0165] (8) By setting a second connecting hole to connect the guidewire cavity and the injection cavity, a setting position can be reserved at the distal end of the sheath tube, and setting space can be reserved for other distal structures, so that the product structure is reasonable and stable; and the second connecting hole is set between the starting point of the bow and the middle of the sheath tube, which can avoid the bow section and ensure the structural strength of the distal end of the sheath tube.

[0166] It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced may be any one or a combination of the above, or any other possible beneficial effects.

[0167] While the basic concepts have been described above, it will be apparent to those skilled in the art that the detailed disclosure is merely illustrative and does not limit this specification. Although not explicitly stated herein, various modifications, improvements, and revisions to this specification may be made by those skilled in the art. Such modifications, improvements, and revisions are suggested in this specification and remain within the spirit and scope of the exemplary embodiments of this specification.

[0168] This specification also uses specific terms to describe the embodiments of this specification. For example, "one embodiment," "an embodiment," and / or "some embodiments" refer to a feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "one embodiment," "an embodiment," or "an alternative embodiment" two or more times in different locations in this specification do not necessarily refer to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of this specification may be appropriately combined.

[0169] Similarly, it should be noted that, in order to simplify the description of this specification and facilitate understanding of one or more embodiments, the foregoing description of the embodiments of this specification sometimes combines multiple features into a single embodiment, figure, or description thereof. However, this disclosure method does not mean that the subject matter of this specification requires more features than those recited in the claims. In fact, the features of an embodiment may be fewer than all the features of the individual embodiments disclosed above.

[0170] In some embodiments, numbers are used to describe the quantity of components and attributes. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise stated, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the description and claims are approximate values, which may change according to the required characteristics of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the settings of such numerical values ​​are as accurate as possible within the feasible range.

[0171] Finally, it should be understood that the embodiments described in this specification are intended only to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, by way of example and not limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly described and illustrated in this specification.

Claims

1. An endoscopic incision device, characterized in that: include: Operations Department; A sheath tube, comprising an injection channel and a shredding channel, wherein the proximal end of the sheath tube is connected to the operating part; The wire cutting device is at least partially arranged in the wire cutting cavity, and the proximal end of the wire cutting device is connected to the operating part. The wire cutting device includes a cutting section, a limiting section and a rotating action section. The cutting section, the limiting section and the rotating action section are respectively located at different positions of the wire cutting device. The cutting section extends from the side wall of the sheath tube outside the sheath tube. The limiting section is arranged in the wire cutting cavity and is configured to form an axial limit with the wire cutting cavity. The rotating action section is arranged in the injection cavity or in the wire cutting cavity, and is configured to drive the sheath tube to rotate around the axis of the proximal end of the wire cutting device when the operating part rotates the wire cutting device.

2. The endoscopic incision device according to claim 1, characterized in that: The wire cutting cavity includes a first cavity, and the limiting portion includes a bending action segment, which is arranged on the distal side of the cutting segment, and at least a portion of the bending action segment is arranged in the first cavity. The bending action segment is configured to drive the distal end of the sheath tube to bend when the operating portion pulls the wire cutting from the distal end to the proximal end.

3. The endoscopic incision device according to claim 2, characterized in that: The limiting portion further includes a first limiting member, which is disposed in the first cavity, the bending action section is fixed to the first limiting member, and the first limiting member is used to limit the axial displacement of the bending action section relative to the first cavity.

4. The endoscopic incision device according to claim 3, characterized in that: An axially limiting snap-fit ​​structure is formed between the first limiting member and the inner wall of the first cavity, and the snap-fit ​​structure includes at least one limiting recess and at least one limiting protrusion extending in the circumferential direction, one of the limiting recess and the limiting protrusion is arranged on the outer wall of the first limiting member, and the other is arranged on the inner wall of the first cavity, and the limiting recess and the limiting protrusion are engaged with each other.

5. The endoscopic incision device according to claim 4, characterized in that: The cross-sectional shape of the first limiting member is circular, and the engaging structure includes one or more combinations of a tower-shaped structure, a sawtooth-shaped structure, and a threaded structure.

6. The endoscopic incision device according to claim 3, characterized in that: At least a portion of the cross-sectional shape of the first limiting member is non-circular, and the first limiting member and the first cavity form a circumferential limit.

7. The endoscopic incision device according to claim 3, characterized in that: The first limiting member is configured as a cylinder with a uniform cross section along its axial direction, and the first limiting member is fixed in the first cavity in a manner of interference fit.

8. The endoscopic incision device according to claim 2, characterized in that: The side wall of the first cavity is formed with a first perforation group and at least one second perforation group connected to the outer wall of the sheath tube. The at least one second perforation group is arranged on the distal side of the first perforation group. The first perforation group includes a first hole and a second hole. The cut wire passes through the first hole to the outside of the sheath tube to form the cutting section. The bending action section passes through the second hole to the first cavity. The rotating action section passes through the second perforation group in sequence and is fixed to the first cavity.

9. The endoscopic incision device according to claim 2, characterized in that: The endoscopic incision device also includes a second limiter, which is axially movably arranged in the first cavity, and at least part of the rotating action section is fixed to the second limiter, and the second limiter is used to limit the circumferential displacement of the rotating action section relative to the first cavity.

10. The endoscopic incision device according to claim 9, characterized in that: A circumferentially limiting limiting structure is formed between the second limiting member and the inner wall of the first cavity, and the limiting structure includes at least one recess and at least one protrusion extending along the axial direction, one of the recess and the protrusion is arranged on the outer wall of the second limiting member, and the other is arranged on the inner wall of the first cavity, and the recess and the protrusion cooperate with each other.

11. The endoscopic incision device according to claim 2, characterized in that: The wire cutting cavity further comprises a second cavity communicated with the first cavity, the second cavity is arranged non-collinearly with the first cavity, and the rotating action section is located in the second cavity.

12. The endoscopic incision device according to claim 11, characterized in that: The second lumen is parallel to the first lumen, and the rotation action section enters the second lumen and extends toward the distal end of the sheath tube or toward the proximal end of the sheath tube.

13. The endoscopic incision device according to claim 11, characterized in that: The inner diameter of the second cavity is equal to the outer diameter of the rotating action section.

14. The endoscopic incision device according to claim 2, characterized in that: A first connecting hole is formed between the injection cavity and the first cavity, and the first connecting hole is located at the distal end of the injection cavity. The rotation action section bends from the first connecting hole into the injection cavity and extends toward the distal end of the sheath tube or toward the proximal end of the sheath tube.

15. The endoscopic incision device according to claim 14, characterized in that: The diameter of the rotating action section is greater than or equal to the inner diameter of the injection cavity.

16. The endoscopic incision device according to claim 14, characterized in that: The sheath also includes a guidewire lumen, a second connecting hole is formed between the guidewire lumen and the injection lumen, the second connecting hole is between the middle of the sheath and the first connecting hole, a sealing member is arranged in the injection lumen, the sealing member is located between the first connecting hole and the second connecting hole, and is used to seal the injection lumen.

17. The endoscopic incision device according to claim 16, characterized in that: The sheath tube comprises a tip structure, the tip structure is fixed to the distal end of the sheath tube, the diameter of the proximal end of the tip structure is equal to the diameter of the distal end of the sheath tube, and the diameter of the tip structure gradually decreases from the proximal end to the distal end; The tip structure includes an outlet cavity, and the proximal end of the outlet cavity is connected to the distal end of the guide wire cavity.

18. The endoscopic incision device according to claim 14, characterized in that: The rotating action section is provided with a developing structure.

19. The endoscopic incision device according to claim 2, characterized in that: The operating part includes a pulling part and a rotating part, the pulling part is used to control the cutting wire to move from the distal end to the proximal end, the bending action section drives the distal end of the sheath tube to bend, the rotating part is used to control the cutting wire to rotate, and the rotating action section drives the sheath tube to rotate; The rotating portion is connected to the proximal end of the pulling portion; or, the rotating portion and the pulling portion are spaced apart.

20. The endoscopic incision device according to claim 1, characterized in that: The sheath also includes a guidewire lumen, a second connecting hole is formed between the guidewire lumen and the injection lumen, the second connecting hole is arranged between the sheath bending starting point and the middle part of the sheath, and is used to guide the solution in the injection lumen to the guidewire lumen, wherein the bending starting point is the endpoint of the proximal end of the bending section of the sheath.

21. The endoscopic incision device according to claim 20, characterized in that: The shredding cavity includes a first cavity for accommodating the shredded wire, a first connecting hole is formed between the injection cavity and the first cavity, the first connecting hole is located at the distal end of the injection cavity, and the rotating action section passes through the first connecting hole and is fixed to the injection cavity.

22. The endoscopic incision device according to claim 21, characterized in that: The diameter of the rotating action section is greater than or equal to the diameter of the injection cavity.

23. The endoscopic incision device according to claim 20, characterized in that: The cross-sectional area of ​​the second communicating hole is larger than the cross-sectional area of ​​the injection cavity.

24. The endoscopic incision device according to claim 20, characterized in that: A blocking piece is arranged in the injection cavity, and the blocking piece is located between the second communicating hole and the distal end of the injection cavity, and is used for sealing the injection cavity.

25. The endoscopic incision device according to claim 1, characterized in that: The shredded material cavity comprises a first cavity for accommodating the shredded material, a first connecting hole is formed between the injection cavity and the first cavity, and the rotating action section passes through the first connecting hole and is fixed to the injection cavity.

26. The endoscopic incision device according to claim 25, characterized in that: The sheath tube further comprises a guidewire lumen, a second communicating hole is formed between the guidewire lumen and the injection lumen, and the second communicating hole is used to guide the solution in the injection lumen to the guidewire lumen.

27. The endoscopic incision device according to claim 26, characterized in that: The first communicating hole is located at the distal end of the injection cavity, and the second communicating hole and the first communicating hole are staggered along the axial direction of the sheath tube.

28. The endoscopic incision device according to claim 26, characterized in that: The cross-sectional area of ​​the second communicating hole is larger than the cross-sectional area of ​​the injection cavity.

29. The endoscopic incision device according to claim 25, characterized in that: The diameter of the rotating action section is greater than or equal to the diameter of the injection cavity.

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