Novel multifunctional digestive endoscope needle holder

Abstract

The needle holder comprises a forceps clip assembly arranged at the far end of a digestive endoscopy sheath tube, the forceps clip assembly comprises a fixed forceps arm and a movable forceps arm, the two forceps arms are closed to form a needle holding cavity, a sliding groove extending axially is formed in the fixed forceps arm, a traction piece is assembled in the sliding groove in a sliding mode, and a needle holding cavity is formed in the movable forceps arm. The traction piece can be driven by the driving piece to move along the sliding groove so as to be switched among the wiring position, the cutting position and the built-in position. When the traction piece moves from the far end to the near end, the traction piece firstly passes through the thread connection position where the needle holding cavity is located, and the traction piece is used for hooking and driving the operation thread in the needle holding cavity to move towards a preset slit in the far end of the sheath tube. At the cutting position, the cutting edge on the inner side of the traction piece and the slit jointly define a cutting area, and in the process that the traction piece continues to retract and slides through the slit area to enter the concealed position in the sheath tube, the traction piece is matched with the edge of the slit to cut off the operation line.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a novel multifunctional needle holder for digestive endoscopes. BACKGROUND

[0002] With the development of endoscopic technology from diagnosis to treatment, its application in minimally invasive surgery is increasingly widespread. However, the endoscopic operating space (single channel) is extremely narrow and limited (usually 2.8-3.2 mm in diameter for a gastroscope biopsy channel, 3.2-3.8 mm for a colonoscope, and 3.8-4.2 mm for a duodenoscope), which requires surgical instruments to be small in size so that the operator can achieve precise single-person operation. In various types of digestive endoscopic minimally invasive operations, suturing is a key technology with relatively high difficulty, especially in wound suturing after endoscopic full-thickness resection (EFTR).

[0003] Endoscopic suturing technology can achieve precise alignment suturing of the digestive tract wall, which is essential for tissue healing and preventing postoperative leakage. It is the most basic and reliable endoscopic technology, and is the last choice when other technologies (conventional metal clip closure, large-diameter hemostatic clip closure, nylon loop combined with hemostatic clip purse-string suture method, OTSC, etc.) cannot guarantee effective closure or cannot be implemented. Endoscopic suturing usually requires the cooperation of endoscopes, suturing needles, barbed wires, and needle holders.

[0004] As the core instrument for holding suturing needles, the design rationality, manufacturing process, and quality of the needle holder directly affect the efficiency and convenience of surgical operations. However, the closure of the wound under the endoscope is relatively difficult to operate, and there are very limited surgical instruments that can be placed through the biopsy channel. In addition, double-channel endoscopes have low popularity and are not frequently used. Conventional suturing instruments are limited by the narrow space of the endoscopic channel, making it difficult to meet the needs of precise suturing of deep and large wounds under the endoscope. Therefore, there is an urgent need to develop new instruments specifically for digestive endoscopic minimally invasive surgery.

[0005] CN208388670U discloses a needle holder for digestive endoscopic minimally invasive surgery, in which the jaw is designed as a double-degree-of-freedom movable structure. However, this design has deficiencies in actual application. First, the jaw is difficult to form a stable clamping force when clamping the suturing needle, as both jaw arms are movable, which can easily slip or loosen. Second, the function of the needle holder is single, as it can only clamp the suturing needle, without integrating the important functions such as cutting the suturing line during endoscopic suturing.

[0006] In addition, on the one hand, due to the difference in understanding of those skilled in the art; on the other hand, because the applicant made the invention when he studied a large number of literatures and patents, but limited by the size and did not list all the details and contents in detail, but this does not mean that the invention does not have these characteristics of prior art, on the contrary, the invention has all the characteristics of prior art, and the applicant reserves the right to add relevant prior art in the background art. SUMMARY

[0007] In view of the deficiencies of the prior art, the present application provides a new multifunctional needle holder for digestive endoscope, which comprises a clamp assembly arranged at the distal end of the sheath of the digestive endoscope, the clamp assembly comprising a fixed jaw and a movable jaw, the two jaws being closed to form a needle holding cavity, the fixed jaw being provided with an axially extending sliding groove, and a traction member being slidingly arranged in the sliding groove and being movable along the sliding groove under the driving of a driving member, so as to switch between a connecting position, a cutting position and a hidden position; the proximal end of the sliding groove is in communication with the inner cavity of the sheath, forming a continuous channel for the movement of the traction member; wherein when the traction member moves from the distal end to the proximal end, it first passes through the connecting position where the needle holding cavity is located, and the traction member is used to hook and drive the surgical thread in the needle holding cavity to move towards the pre-set slit at the distal end of the sheath; in the cutting position, the inner side of the traction member and the slit jointly define a cutting area, and in the process of the traction member continuing to retract and sliding through the slit area into the hidden position inside the sheath, the traction member cooperates with the edge of the slit to cut off the surgical thread. At this time, the surgical thread is limited in the cutting area, and the blade of the traction member overcomes the edge of the slit to realize shearing.

[0008] This technical solution achieves integrated "suture, traction, and cutting" within the extremely limited single-channel space of a digestive endoscope by constructing a sophisticated cutting mechanism inside the fixed clamp arm that engages with the sheath slit. This completely solves the inefficiency of traditional surgery, which requires repeated withdrawal of the needle holder to replace scissors after suturing, significantly shortening surgical time and reducing potential damage to the digestive tract and endoscope caused by instrument entry and exit. The solution utilizes the traction device to hook the surgical suture and guide it into the slit at the distal end of the sheath. The suture is cut by the relative shearing motion between the traction device and the slit edge as the traction device retracts. This "moving blade" combined with a "fixed blade" shearing principle is more reliable than simple compression cutting, especially suitable for soft sutures in slippery environments. To prevent the surgical suture from getting stuck between the traction device and the inner wall of the sheath before cutting, the traction device or the inner wall of the sheath has a clearance structure (such as a receiving groove) to ensure that when the traction device retracts through the slit, only shearing force, not compression force, is applied to the suture. Meanwhile, the concealed design of the traction component ensures that the sharp parts are completely housed inside the instrument when not cutting, effectively preventing accidental damage to the endoscopic channel or surrounding tissues during entry / exit of the forceps or suturing operations, thus ensuring the efficiency and safety of the surgery. This invention, through its structure of "fixed groove + moving traction component + distal sheath cutting position," resolves the contradiction between instrument multifunctionality and structural strength in a single-forceps environment. This solution utilizes the axial reciprocating motion of the moving traction component to achieve radial cutting. Whether using a traction component with its own cutting edge (moving edge), utilizing the slit edge or main cutting section to form a fixed edge, or a flip-top blade structure, all are based on the same concept: using the moving component to forcibly introduce the surgical suture into the confined space of the slit, and using the geometric interference of the retraction stroke to complete the cut.

[0009] This invention is specifically designed for the unique operating conditions of single-channel endoscopic surgical instruments. First, considering that endoscopes are often in a state of large-angle bending within the body, the traction component or its driving mechanism adopts a flexible or segmented hinged design. This ensures that the traction component can still move smoothly within the groove when the sheath is bent, avoiding jamming, wear, or transmission failure caused by rigid interference. Second, addressing the structural strength challenges brought about by multifunctional integration, the fixing clamp arm is manufactured using a high-strength medical alloy through a one-piece molding process, ensuring sufficient safety factor and fatigue life under the expected loads of suturing and cutting.

[0010] According to a preferred embodiment, the traction device is constructed as a hook with a cutting edge on its inner side, and the slit forms a fixed blade that engages with the cutting edge. This design utilizes the inner cutting edge of the hook as a "moving blade" to form a shearing engagement with the slit as a "fixed blade," cutting the suture using the shearing force generated when the hook retracts rather than simply squeezing. This shearing principle significantly improves the reliability of cutting slippery or highly resilient surgical sutures. Simultaneously, this integrated design ensures that suture hooking, traction, and cutting operations can be continuously performed using the same instrument within the confined space of a single clamp channel, eliminating the need for repeated instrument changes and effectively shortening the operation time.

[0011] According to a preferred embodiment, the traction member is configured as a bladeless hook, and the shear-fit structure comprises a main cutting portion disposed at or adjacent to the slit, the main cutting portion having a cutting edge facing the surgical thread. The bladeless hook design eliminates the risk of accidental injury to surrounding tissues during the process of searching and hooking the suture, significantly improving the safety of operation. In combination with the high-strength material of the main cutting portion, the process difficulty of integrating a high-strength cutting edge into a slender hook is solved, enabling the instrument to withstand greater cutting resistance, especially suitable for handling thicker or high-toughness barbed threads, ensuring the success rate of cutting and the flatness of the incision under complex working conditions.

[0012] According to a preferred embodiment, the traction member comprises a reversible knife head, which is configured to stand up to form a cutting edge during extension and cut off the surgical thread in cooperation with the slit during retraction. This scheme realizes the state switching of "flat storage and vertical work" through the reversible knife head, effectively overcoming the physical limitation of the single-pincer pore diameter on the width of the cutting edge. Compared with the traditional structure, the wide blade after standing up greatly increases the cutting contact area, avoiding the phenomenon of surgical thread slipping or incomplete cutting caused by too narrow blade, especially suitable for cutting off high-strength suture threads, while ensuring the passability and safety of the instrument in the non-working state.

[0013] According to a preferred embodiment, the distal end of the movable pincer arm is configured as a single-tooth structure, and the distal end of the fixed pincer arm is configured as a double-tooth structure, when the pincer assembly is closed, the single-tooth structure of the movable pincer arm is embedded between the double-tooth structure of the fixed pincer arm, wherein the inner wall of the needle holding cavity is provided with an anti-skid structure for enhancing the frictional clamping force on the suture needle. The asymmetric structure of single-tooth embedded in double-tooth provides strong lateral limiting, effectively preventing the pincer arm from being misaligned under stress, significantly improving the clamping rigidity. In combination with the anti-skid structure of the inner wall of the needle holding cavity, the gripping force on the suture needle is greatly enhanced through the physical friction principle, fundamentally preventing the suture needle from rotating, sliding or falling in a wet and slippery environment, ensuring the stability of the fine suture operation and the precise control of the needle insertion angle under endoscopy.

[0014] According to a preferred embodiment, an axially extending sliding groove is opened at the end of the movable pincer arm, the sliding groove is configured to accommodate the distal end of the traction member when the movable pincer arm is in the closed state, and the sliding groove is separated from the traction member when the movable pincer arm is in the open state. The sliding groove design at the end of the movable pincer arm realizes the mechanical decoupling of the pincer arm opening and closing and the traction member movement, ensuring that the traction member can still smoothly pass through the pincer head area to perform cutting in the closed clamping state, avoiding the motion interference between components.

[0015] According to a preferred embodiment, a resilient reset member is further provided inside the sheath, the resilient reset member assists the movable pincer arm to complete the opening and closing action through the elastic force acting on the opening and closing member at the end of the movable pincer arm.

[0016] According to a preferred embodiment, a locking member is further included, which is arranged on the operating part and linked with the first driving member, and is used for locking the position of the first driving member to maintain the closed state of the movable jaw and the fixed jaw. By mechanically maintaining the clamping state through the locking member, the fatigue problem caused by long-time hand force maintaining is solved. In the key links such as puncture or knotting, it can lock the position of the driving member to ensure the constant clamping force and prevent the needle dropping accident caused by finger fatigue, thereby significantly improving the stability and safety of the operation.

[0017] According to a preferred embodiment, the inner wall of the slit has a hierarchical structure arranged along the sheath tube in sequence, which includes a first hierarchical structure for preliminarily maintaining the surgical thread and a second hierarchical structure for making the surgical thread in a taut state, and the traction member cooperates with the second hierarchical structure to realize the cutting of the surgical thread in the taut state. According to the scheme, the hierarchical structure of the inner wall of the slit is utilized to preliminarily limit the swing of the surgical thread, and then forcibly introduce it into a narrow area and make it in an extremely taut state. Cooperating with the cutting of the traction member, the principle of "taut object easy to cut" is utilized to greatly reduce the cutting resistance and ensure the neat and smooth incision, and even the high-toughness barbed thread can be precisely and one-time cut. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is the overall structure schematic diagram of the needle holder for digestive endoscope provided by the present application; Figure 2 is the local structure schematic diagram of the jaw assembly in the closed state; Figure 3 is the local structure schematic diagram of the jaw assembly in the open state; Figure 4 is the internal transmission structure sectional view of the jaw assembly in the closed state in the embodiment 1 of the present application; Figure 5 is the internal structure stereoscopic sectional view of the jaw assembly in the open state in the embodiment 1 of the present application; Figure 6 is the structure schematic diagram of the jaw assembly in the open state and the traction member in the extension state in the embodiment 1 of the present application, which shows the cooperation between the traction member and the movable jaw sliding groove; Figure 7 is the structure schematic diagram of the traction member in the retraction state and the cooperation with the slit for the cutting action in the embodiment 1 of the present application; Figure 8 is the structure schematic diagram of the jaw assembly containing the main cutting part (fixed blade) and the bladeless traction member in the embodiment 2 of the present application; Figure 9 is the relative position relationship structure schematic diagram of the surgical thread and the bladeless traction member in the embodiment 2 of the present application; Figure 10is the schematic diagram of the action of the bladeless traction member in the embodiment 2 of the present application to traction the surgical thread to the main cutting part; Figure 11 is the schematic diagram of the local structure of the sheath tube distal end provided with the hierarchical structure (the first hierarchical structure and the second hierarchical structure) in the embodiment 3 of the present application; Figure 12 is the local enlarged schematic diagram of the hierarchical structure in the embodiment 3 of the present application, showing the stepped structure of the slit; Figure 13 is the schematic diagram of the side structure of the hierarchical structure and the traction member in the embodiment 3 of the present application; Figure 14 is the schematic diagram of the three-dimensional structure of the surgical thread when being preliminarily held by the first hierarchical structure in the embodiment 3 of the present application; Figure 15 is the schematic diagram of the top view principle of the surgical thread when being held by the second hierarchical structure in the embodiment 3 of the present application; Figure 16 is the schematic diagram of the working principle of the bladeless traction member cooperating with the hierarchical structure and the main cutting part in the embodiment 4 of the present application; Figure 17 is the schematic diagram of the local details of the hierarchical structure and the main cutting part in the embodiment 4 of the present application; Figure 18 is the schematic diagram of the three-dimensional structure of the surgical thread in the hierarchical structure in the embodiment 4 of the present application in the taut state; Figure 19 is the schematic diagram of the top view principle of the surgical thread in the hierarchical structure in the embodiment 4 of the present application in the taut state; Figure 20 is the schematic diagram of the three-dimensional sectional view of the internal structure of the clamp assembly adopting the wide-blade cutter head assembly (the reversible cutter head) in the embodiment 5 of the present application; Figure 21 is the local enlarged schematic diagram of the cutter head in the embodiment 5 of the present application in the flat-lying state (non-cutting state) in the sliding groove; Figure 22 is the local structure schematic diagram of the cutter head in the embodiment 5 of the present application under the action of the arc-shaped guide groove to stand (cutting state); Figure 23 is the local enlarged schematic diagram of the anti-skid structure of the clamp arm in the embodiment 6 of the present application.

[0019] List of reference signs 100: digestive endoscope; 101: endoscope lens; 102: endoscope forceps channel; 110: sheath tube; 120: operation part; 121: forceps arm handle; 122: blade handle; 123: forceps arm locking piece; 200: forceps assembly; 201: movable forceps arm; 202: fixed forceps arm; 203: forceps head; 204: needle holding cavity; 205: operation inner cavity; 206: traction piece; 207a, 207b: sliding groove; 208: second driving piece; 209: cutting operation inner tube; 209.1: slit; 210: main cutting part; 211: cutting edge; 220: hierarchical structure; 221: first hierarchical structure; 222: second hierarchical structure; 230: blade head; 231: stepped shaft; 232: blade rod; 233: arc-shaped guide groove; 240: anti-skid structure; 300: elastic reset piece; 310: first driving piece; 320: opening and closing piece; 330: shaft. DETAILED DESCRIPTION

[0020] The present application will be described in detail below with reference to the accompanying drawings.

[0021] In the description of the present application, the "shearing cooperation structure" refers to the structure combination at the distal end of the sheath tube and the relative movement of the traction piece to achieve the cutting of the surgical thread. The shearing cooperation structure under the concept of the present application includes but is not limited to the following preferred forms: Form one: as shown in Figures 1-7 The traction piece 206 itself is provided with a cutting edge (moving blade), and the edge of the slit 209.1 serves as a fixed blade. When the traction piece 206 retracts and slides through the slit 209.1, a "moving blade shearing fixed blade" cooperation is formed; Form two: as shown in Figures 8-10 The traction piece 206 is a bladeless hook, and a fixed main cutting part 210 (fixed blade) is provided at the slit 209.1. The traction piece 206 pulls the surgical thread to the fixed blade, and the retraction force makes the surgical thread cut on the fixed blade; Form three: as shown in Figures 20-22 The traction piece 206 contains a deformable or reversible blade head assembly, which stands up to form a blade in the working position, and cooperates with the slit 209.1 to complete the cutting.

[0022] The above forms are based on the unified inventive concept of "axial movement traction + radial limiting shearing".

[0023] Example 1 This embodiment relates to a new type of multifunctional digestive endoscope needle holder, which is a core instrument suitable for clinical operation of digestive endoscope, has integrated functions of clamping, pulling and cutting, and realizes efficient operation under single forceps channel endoscope. As shown in Figures 1-4As shown, the needle holder is integrally assembled on the sheath tube 110 of the digestive endoscope 100, the sheath tube 110 serves as a support and guide structure of the instrument, the distal end directly interfaces with the clamp assembly 200, and the proximal end is connected with the operation part 120 to form a support channel connecting the control end and the execution end, ensuring accurate transmission of operation instructions during the operation. The sheath tube 110 is adapted to the endoscope clamp channel 102 of the digestive endoscope 100, meeting the single-clamp channel operation requirement. Among them, the endoscope lens 101 is located at the front end of the digestive endoscope 100.

[0024] As shown in Figures 2-4 , the clamp assembly 200 is fixedly assembled at the distal end of the sheath tube 110 as the core component directly executing the clamping and auxiliary cutting functions, which is mainly composed of a fixed clamp arm 202 and a movable clamp arm 201. The two clamp arms are rotatably connected through a rotating shaft 330, and the rotating shaft 330 is arranged near the proximal end region of the clamp arm, so that the movable clamp arm 201 can be flexibly opened and closed relative to the fixed clamp arm 202 with the rotating shaft 330 as the center, meeting the operation requirement of clamping and releasing the suture needle. When the movable clamp arm 201 approaches and closes to the fixed clamp arm 202, the clamping surfaces of the two clamp arms jointly enclose to form a needle holding cavity 204. The profile of the needle holding cavity 204 is adapted to the shape of the suture needle, and can form a wrapping clamping on the suture needle to avoid the suture needle from deviating or falling off during the operation.

[0025] The fixed clamp arm 202 is the fixed support of the clamp assembly 200 and the core carrier of the cutting function, which is preferably integrally formed by precise machining with high-strength and high-toughness medical-grade materials. An axial sliding groove 207a (see Figure 7 ) is formed in the inside of the fixed clamp arm 202. The wall thickness of the sliding groove 207a is optimized by finite element analysis (FEA) to ensure that the stress distribution is uniform and far below the yield limit of the material when bearing the maximum clamping reaction force of the suture needle and the fatigue load of the reciprocating movement of the traction member 206, and has sufficient safety margin. The sliding groove 207a penetrates the length direction of the fixed clamp arm 202, and the proximal end opening directly communicates with the inner cavity of the sheath tube 110 to allow the traction member 206 to be completely retracted into the sheath tube 110. The inner wall of the sliding groove 207a is smoothly processed to provide a smooth movement path for the subsequent sliding of the traction member 206. The cross-sectional shape of the sliding groove 207a matches the cross-sectional shape of the rod part of the traction member 206. When the traction member 206 is designed to be flexible, the inner wall of the sliding groove 207a is smooth and has sufficient radial clearance to accommodate the morphological changes of the traction member 206 in the curved state, while limiting its excessive radial swing through shape matching to ensure the movement accuracy and the alignment of the cutting edge.

[0026] The traction member 206, as a key component with the dual functions of pulling the surgical thread and cutting the surgical thread, is slidingly assembled in the sliding groove 207a of the fixed forceps arm 202. To adapt to the bending of the endoscope in the body, the rod part of the traction member 206 is designed to be flexible. For example, it is composed of a series of micro hinges in series, or made of a super-elastic nickel-titanium alloy wire. Such a design enables the traction member 206 to bend with the sheath 110 when the sheath 110 bends, while still being able to stably transmit the axial pushing and pulling force. The distal end is provided with a hook structure to facilitate hooking and pulling the surgical thread, and the proximal end is connected with the transmission component to receive the control instructions of the operation part 120. As shown in Figure 4 、 Figure 5 The traction member 206 can freely move along the axial direction of the sliding groove 207a and realize the switching of three key positions, namely the wiring position, the cutting position and the hidden position, during the movement process. The three positions are distributed in sequence along the axial direction of the sliding groove 207a, covering the complete movement trajectory of the traction member 206 from the working state to the storage state.

[0027] When the surgical thread needs to be pulled during the operation, first, the first driving member 310 is operated to drive the movable forceps arm 201 to open, so as to release the suture needle clamped in the needle holding cavity 204, and make the needle holding cavity 204 in an empty state. Subsequently, as shown in Figure 7 The traction member 206 moves to the wiring position along the sliding groove 207a to the distal end, which corresponds to the area where the needle holding cavity 204 is located, and the hook-shaped part of the traction member 206 can exactly extend into the empty needle holding cavity 204 to accurately hook the surgical thread near the needle holding cavity 204. After the hooking is completed, the traction member 206 moves from the distal end to the proximal end under the traction of the transmission component, in the process of which the surgical thread is simultaneously moved to the sheath 110 direction under the traction of the traction member 206, and the surgical thread gradually approaches the slit 209.1 opened at the distal end of the sheath 110 under the pulling action of the traction member 206. The slit 209.1 is opened on the side wall of the distal end of the sheath 110 in the axial direction, and is in a long strip shape, the extension direction of which is perpendicular to the axial direction of the sheath 110 or at a certain angle, which can provide positioning and supporting action for the surgical thread.

[0028] As shown in Figure 7As shown, when the traction member 206 moves to the cutting position, the traction member 206 as a whole is still located in the sliding groove 207a of the fixed jaw arm 202, but the cutting edge 211 (not shown in the figure) on the inner side of the traction member 206 is just moved to a position opposite to the slit 209.1 on the side wall of the sheath 110. As seen from the cross-sectional view, the edge plane of the traction member 206 is in close proximity to the plane where the slit 209.1 is located, and the two planes together define a narrow cutting area in space. The proximal edge of the slit 209.1 serves as a "fixed blade", forming a pair of precisely matched shearing pairs with the cutting edge 211 on the traction member 206 as a "moving blade". The size of the cutting area is adapted to the diameter of the surgical thread, which can ensure that the surgical thread is accurately limited in the cutting area. In order to solve the physical interference that the traction member 206 with the surgical thread enters the narrow space, the back or side of the traction member 206 can be provided with a micro-avoidance slot (not shown in the figure), or the shearing gap between the traction member 206 and the edge of the slit 209.1 is less than the diameter of the surgical thread. As the traction member 206 continues to retract proximally, a relative shearing force is formed between the inner cutting edge 211 and the slit 209.1, and the shearing force continuously acts on the surgical thread during the process of the traction member 206 sliding through the slit 209.1 and gradually entering the hidden position inside the sheath 110, finally achieving precise and rapid cutting of the surgical thread. The cut end falls into the avoidance slot to prevent jamming. The hidden position is located in the proximal region inside the sheath 110 away from the slit 209.1, when the traction member 206 is in this position, its whole is received in the sheath 110 and the sliding groove 207a of the fixed jaw arm 202, and is not exposed outside the instrument, which can not only avoid the interference of the traction member 206 on other surgical operations such as clamping and suturing, but also protect the cutting edge 211 of the traction member 206 from being accidentally damaged or worn.

[0029] During the whole process, the sliding cooperation of the traction member 206 and the sliding groove 207a, the shearing cooperation of the traction member 206 and the slit 209.1, and the opening and closing cooperation of the movable jaw arm 201 and the fixed jaw arm 202 form a coordinated linkage, ensuring seamless connection of the three functions of clamping, pulling and cutting, effectively solving the technical pain points of unstable clamping of double movable jaw arms and incompatible clamping and cutting functions in single jaw channel endoscopy, and significantly improving the operation efficiency and safety of digestive endoscopy.

[0030] As shown in Figure 2 , Figure 6 , the movable jaw arm 201 adopts a single-tooth structure design, which is in the shape of a long strip, and has an independent clamping tooth at the distal end. The end face of the clamping tooth is arc-shaped, and the arc profile is adapted to the outer peripheral arc of the suturing needle, so that it can form a close fit with the suturing needle when clamping. The thickness of the clamping tooth matches the clamping area of the fixed jaw arm 202, ensuring that it can smoothly embed into the clamping space of the fixed jaw arm 202 when closed, forming a stable clamping cooperation.

[0031] As Figure 2 , Figure 6 shown, the fixed jaw arm 202 corresponds to the adoption of a double-tooth structure, and its distal end is provided with two symmetrically distributed clamping teeth, and a certain gap is formed between the two clamping teeth. The width of the gap is matched with the thickness of the single tooth of the movable jaw arm 201, so that when the movable jaw arm 201 is closed, the single tooth can be exactly clamped into the gap between the double teeth, realizing the precise butt joint of the two jaw arms. The fixed jaw arm 202 with a double-tooth structure cooperates with the movable jaw arm 201 with a single-tooth structure to form a clamping mode of "one tooth embedded in double teeth". This asymmetric jaw arm structure simulates the classic design of the laparoscope needle holder, which can effectively avoid the problem of unstable clamping caused by force dispersion of the double movable jaw arms, and significantly improve the concentration of clamping force.

[0032] As Figure 2 , Figure 4 shown, the needle holding cavity 204 is formed by the movable jaw arm 201 with a single-tooth structure and the fixed jaw arm 202 with a double-tooth structure when they are closed. The overall shape of the needle holding cavity 204 is an arc cross section matching the contour of the suture needle. This contour design fully considers the shape characteristics of common suture needles. The main part of the suture needle is usually a cylindrical straight needle or an arc-shaped curved needle structure. The needle holding cavity 204 can form full-range contact with the outer surface of the suture needle, increasing the clamping area while making the clamping force evenly distributed on the surface of the suture needle. This not only avoids local excessive pressure leading to deformation or damage of the suture needle, but also effectively prevents the suture needle from rotating, sliding or slipping in the needle holding cavity 204, ensuring the stability of the position of the suture needle during the operation and providing reliable guarantee for precise suturing.

[0033] The formation of the needle holding cavity 204 not only depends on the shape matching of the clamping teeth of the two jaw arms, but also is further optimized through the arc design of the clamping surface of the jaw arm. The inner clamping surface of the single tooth of the movable jaw arm 201 and the inner clamping surface of the double tooth of the fixed jaw arm 202 are both arc-shaped structures matching the contour of the suture needle. When closed, each clamping surface is in contact with the suture needle at the same time, forming a wrapped clamping effect, which further enhances the stability and reliability of clamping.

[0034] As Figure 4 and Figure 7As shown, the overall shape of the traction member 206 is long strip, the distal end is a hook structure, which is convenient to hook and pull the surgical thread, the proximal end is a rod structure, which is used to connect with the transmission component and slide along the sliding groove. The inner side of the traction member 206 is provided with a cutting edge 211 (in this embodiment, it is a continuous edge) along the length direction, which extends from the hook-shaped part to the middle area of the rod-shaped part, and the edge is finely polished to have good sharpness, which can ensure effective cutting of the surgical thread. The design of the cutting edge 211 can form effective shearing action at different contact points of the traction member 206 at the cutting position, avoiding the problem of cutting failure or incomplete breaking of the surgical thread caused by discontinuous cutting edge 211.

[0035] The cross section of the rod part of the traction member 206 is completely matched with the inner wall shape of the sliding groove 207a of the fixed forceps arm 202, and the two adopt a clearance fit mode, which can not only ensure smooth axial sliding of the traction member 206 along the sliding groove 207a without jamming or blocking phenomenon, but also can limit the radial shaking or circumferential rotation of the traction member 206 during sliding, so as to ensure that the cutting edge 211 of the traction member 206 always keeps consistent with the extension direction of the sliding groove 207a, laying a foundation for the subsequent precise cooperation with the slit 209.1. The contact surfaces of the inner wall of the sliding groove 207a and the rod part of the traction member 206 are both subjected to smooth treatment, which reduces the friction in the sliding process and improves the convenience and flexibility of operation.

[0036] The structural strength of the traction member 206 is specially designed to withstand the reverse force generated when the surgical thread is pulled off. To achieve this strength requirement, the traction member 206 adopts an integrated forming structure without splicing or welding nodes, avoiding the occurrence of stress concentration phenomenon; at the same time, the key stress parts of the traction member 206, such as the connection between the hook-shaped part and the rod-shaped part and the area where the cutting edge 211 is located, are all subjected to thickening design or special structural strengthening treatment, so as to ensure that the traction member 206 will not bend, deform or break when the surgical thread is pulled to a tight state and cut, ensuring the safety and reliability of the surgical operation. This design of structural strength not only meets the functional requirements of pulling and cutting, but also will not cause the weight of the traction member 206 to increase or the flexibility to decrease due to excessive strengthening, achieving the balance between strength and flexibility.

[0037] To ensure that the traction member 206 does not interfere with the movable forceps arm 201 during sliding, Figure 6As shown, the end of the movable jaw 201 is provided with an axially extending sliding groove 207b, which is configured as a clearance groove to provide accommodation space for the traction member 206 when the jaw assembly 200 is closed. The sliding groove 207b of the movable jaw 201 is provided at the end of the movable jaw 201 close to the jaw head 203, and extends through the thickness direction of the movable jaw 201, so that the traction member 206 can pass out of the sliding groove 207a of the fixed jaw 202 and be accommodated in the sliding groove 207b of the movable jaw 201 without obstruction in the closed state. The sliding groove 207b and the sliding groove 207a of the fixed jaw 202 maintain the same axial direction, and when the movable jaw 201 is opened, the sliding groove 207b moves away from the traction member 206, and the traction member 206 is guided by the sliding groove 207a of the fixed jaw 202, thereby avoiding the movement interference between the components. Preferably, in order to prevent the traction member 206 from being interfered when it is stretched out due to the deviation of the sliding groove 207b from the axial direction when the movable jaw 201 is opened at a large angle, a flared guide structure (not shown in the figure) can be provided at the proximal end of the sliding groove 207b to guide the traction member 206 to enter; or, in the operation logic, the traction member 206 is driven to stretch out only when the movable jaw 201 is in the closed state or a small-angle slightly open state (i.e., the sliding groove 207b is basically aligned with the sliding groove 207a).

[0038] The width of the sliding groove 207b is matched with the thickness of the traction member 206, and a small gap is adopted to ensure that the traction member 206 is not pressed when the jaw is closed, and to provide lateral limiting. The length of the sliding groove 207b of the movable jaw 201 is matched with the movement stroke of the traction member 206, and covers the key movement area of the traction member 206 from the wiring position to the cutting position, so as to ensure that the traction member 206 is always guided by the sliding groove 207a of the fixed jaw 202 when performing the traction and cutting actions, and is protected by the sliding groove 207b of the movable jaw 201 in the closed state, and does not contact or collide with other parts of the movable jaw 201.

[0039] The design of the sliding groove 207b not only realizes the anti-interference function, but also ensures that the traction member 206 can still move freely inside to perform the hooking operation while the jaw is closed to clamp the suture needle, and ensures the accurate implementation of the traction and cutting actions. At the same time, the inner wall of the sliding groove 207b is also treated to be smooth to reduce the friction between the traction member 206 and the sliding groove 207b, thereby avoiding the problems of increased operation resistance or aggravated component wear caused by friction.

[0040] The needle holder of the present application also comprises a first driving member 310 for driving the movable jaw 201 to open and close, which is a key transmission component and bears the function of transmitting the control force of the operation part 120 to the movable jaw 201. As shown in the figure, Figure 4 and Figure 5As shown, the first driving component 310 passes through the operating cavity 205 of the sheath 110. The operating cavity 205 is a hollow channel opened inside the sheath 110, and its axis coincides with the axis of the sheath 110. This channel not only provides installation space for the first driving component 310, but also guides and protects the movement of the first driving component 310, preventing it from getting entangled or rubbing against other components inside the sheath 110 during movement. The inner wall of the operating cavity 205 is smooth, which can reduce the friction force when the first driving component 310 slides, ensuring smooth transmission.

[0041] One end of the first driving component 310 is fixedly connected to the clamp arm handle 121 of the operating part 120. The connection method adopts a reliable mechanical fixing structure to ensure that the two are firmly connected and will not fall off or loosen during repeated push and pull operations. As a component directly controlled by the operator, the clamp arm handle 121 is ergonomically designed for easy hand gripping and force application. By swinging or pushing and pulling the clamp arm handle 121, the first driving component 310 can be driven to move axially along the operating inner cavity 205.

[0042] The other end of the first driving member 310 is fixedly connected to the proximal end of the opening / closing member 320, and the distal end of the opening / closing member 320 is fixedly connected to the movable clamp arm 201, such as... Figure 4 As shown, when the first driving member 310 drives the opening / closing member 320 to rotate axially along the rotating shaft 330, the opening / closing member 320 drives the movable clamp arm 201 to rotate around the rotating shaft 330, thereby realizing the opening and closing of the clamp arm. When the operator pulls the clamp arm handle 121 towards the proximal end, the first driving member 310 is pulled and moves towards the proximal end, causing the opening / closing member 320 to rotate in the opposite direction (manifested as downward pressure), thereby pulling the proximal end of the movable clamp arm 201 closer to the fixed clamp arm 202, realizing the closing action of the movable clamp arm 201; when the operator pushes the clamp arm handle 121 towards the distal end, the first driving member 310 is pushed and moves towards the distal end, causing the proximal end of the movable clamp arm 201 to move away from the fixed clamp arm 202, realizing the opening action of the movable clamp arm 201.

[0043] To further enhance the stability and reliability of the transmission, a protective sleeve can be fitted over the first driving component 310. This protective sleeve slides against the inner wall of the operating cavity 205, preventing wear caused by direct friction between the first driving component 310 and the operating cavity 205, and also preventing excessive deformation of the first driving component 310 under bending conditions, thus ensuring long-term stability of its transmission performance. Through this transmission structure design, the operator can precisely control the opening and closing angle and force of the movable clamp arm 201 via the clamp arm handle 121 of the operating part 120, meeting the clamping needs of different surgical scenarios.

[0044] The needle holder further comprises a second driving member 208 for driving the traction member 206 to move and a cutting operation inner tube 209, both of which form a coordinated transmission structure to realize precise control of the traction member 206, ensuring that the traction member 206 can be stably switched to the wiring position, the cutting position and the hidden position.

[0045] The cutting operation inner tube 209 is a hollow tubular structure, and the material thereof has excellent flexibility and axial stiffness. Preferably, a woven mesh reinforced polymer tube or a nickel-titanium alloy spiral tube structure is adopted to ensure that the axial push-pull force can be efficiently and low-resistance transmitted when the sheath tube 110 is bent at a large angle. The second driving member 208 is also designed to be flexible (such as a push-pull steel wire rope), and cooperates with the cutting operation inner tube 209 to ensure that the traction member 206 can be precisely driven in any bending state. Figure 4 and Figure 5 As shown in the drawings, the second driving member 208 is arranged inside the cutting operation inner tube 209, and the two are coaxially assembled, with the axes completely coinciding. This assembly mode forms a mutual supporting and guiding relationship between the second driving member 208 and the cutting operation inner tube 209, and the second driving member 208 can smoothly slide along the axial direction of the cutting operation inner tube 209, while the cutting operation inner tube 209 can also protect the second driving member 208 from bending or damage.

[0046] The second driving member 208 and the cutting operation inner tube 209 are jointly assembled in the operation inner cavity 205 of the sheath tube 110, and the operation inner cavity 205 provides sufficient installation space for the two, and the axes of the three are kept consistent to ensure that there is no deviation or interference during transmission. The outer wall of the cutting operation inner tube 209 and the inner wall of the operation inner cavity 205 are in clearance fit, with small sliding resistance, which can ensure smooth movement of the overall transmission structure.

[0047] One end of the second driving member 208 is fixedly connected with the blade handle 122 of the operation part 120, and the connection mode adopts firm mechanical fixation to ensure reliable connection without loosening or falling off during repeated operation. The structure design of the blade handle 122 is coordinated with the arm handle 121, which facilitates the operator to quickly switch the control object when holding the operation part 120, and improves the operation efficiency. One end of the cutting operation inner tube 209 is fixedly connected with the main body of the operation part 120, and the other end of the second driving member 208 is fixedly connected with the blade handle 122, ensuring that the control force of the blade handle 122 can be synchronously transmitted to the second driving member 208 and the cutting operation inner tube 209.

[0048] This ensures that only the second driving member 208 moves with the blade handle 122, while the cutting operation inner tube 209 remains stationary to provide support.

[0049] The other end of the second driving member 208 is fixedly connected to the end of the traction member 206 away from the cutting edge 211, and the other end of the cutting operation inner tube 209 is fixedly connected to the proximal end of the sheath tube 110 or the fixed clamp arm 202 (that is, the cutting operation inner tube 209 serves as a fixed guide that does not move with the traction member 206). This combination means that the traction member 206 is subjected to the pushing and pulling force of the second driving member 208 during the movement, while the support of the cutting operation inner tube 209 prevents the second driving member 208 from buckling and deforming under pressure, making the transmission more stable and reliable. When the operator moves the blade handle 122 to the proximal end, the second drive unit 208, guided and restricted by the inner tube 209 of the cutting operation, pulls the traction unit 206 to the proximal end, causing the traction unit 206 to switch sequentially from the wiring position to the cutting position and the concealed position; when the operator moves the blade handle 122 to the distal end, the second drive unit 208, guided and restricted by the inner tube 209 of the cutting operation, pushes the traction unit 206 to the distal end, causing the traction unit 206 to switch from the concealed position to the cutting position and the wiring position.

[0050] This guide drive structure design ensures the accuracy and stability of the movement of the traction component 206, while also improving the reliability and durability of the transmission. It can meet the needs of rapid and precise control of the traction component 206 during surgery, ensuring the effective realization of traction and cutting actions.

[0051] like Figure 4 As shown, the needle holder also includes an elastic element 300 disposed inside the sheath 110. The elastic element 300 is configured as an auxiliary stabilizing component for the opening / closing member 320. The elastic element 300 is located radially outward of the opening / closing member 320, with one end fixedly connected to the inner wall of the sheath 110 or the proximal end of the fixing clamp arm 202, and the other end being a free end that elastically abuts against the surface of the opening / closing member 320.

[0052] The elastic element 300 is preferably made of a sheet-like elastic medical alloy material, and has an overall arc-shaped or zigzag structure. During the process of the first driving element 310 driving the opening / closing element 320 to move axially to open / close the movable clamp arm 201, the elastic element 300 consistently applies a radial preload (biasing force) to the opening / closing element 320. This preload serves two purposes: firstly, it eliminates the transmission gap at the connection between the opening / closing element 320 and the first driving element 310 or the movable clamp arm 201, preventing mechanical play or component vibration during surgical operations and improving the surgeon's tactile feedback; secondly, this elastic force provides a certain degree of damping or auxiliary reset tendency for the movement of the movable clamp arm 201, ensuring that the clamp arm's position is controllable when not under stress.

[0053] The material of the elastic member 300 is subjected to anti-fatigue treatment, so that the elastic member 300 can maintain stable elastic pressing force for a long time under the repeated reciprocating movement of the opening and closing member 320 and will not fail due to wear. This design significantly improves the stability and precision of the opening and closing action of the clamp assembly 200 by introducing an elastic pre-tightening link in the transmission chain.

[0054] The clamp arm locking member 123 of the operation part 120 adopts a ring structure design, which can well adapt to the holding area of the operation part 120, facilitating the operator to perform locking and unlocking operations while holding the operation part 120, improving the convenience and continuity of the operation.

[0055] The clamp arm locking member 123 is sleeved outside the holding area of the operation part 120, which is the cylindrical body part of the operation part 120 and is provided with anti-slip texture on the surface to facilitate the operator to hold and exert force. The clamp arm locking member 123 can slide axially or rotate circumferentially along the holding area, and the specific movement mode is determined according to the design of the linkage structure. Regardless of the movement mode, the operator can realize the locking and unlocking functions through simple pressing, sliding or rotating actions.

[0056] The linkage between the clamp arm locking member 123 and the first driving member 310 is realized through a linkage structure, which can be a gear transmission structure, a connecting rod transmission structure or a buckle transmission structure, etc. The specific structure design needs to ensure that the movement of the locking member can be accurately transmitted to the first driving member 310 to realize the locking of the position of the first driving member 310. The linkage structure is hidden inside the operation part 120 and is not exposed on the surface, which not only ensures the neat appearance of the operation part 120, but also avoids the linkage structure from being contaminated or damaged by the outside world.

[0057] When the movable clamp arm 201 and the fixed clamp arm 202 are closed and hold the suture needle, the operator needs to maintain the clamping state to perform the suturing operation. At this time, the clamp arm locking member 123 is pressed, slid or rotated to drive the linkage structure to act, so that the linkage structure clamps the first driving member 310 to lock the axial position of the first driving member 310. Since the first driving member 310 is fixedly connected with the movable clamp arm 201, when the position of the first driving member 310 is locked, the position of the movable clamp arm 201 is also fixed and cannot be opened and closed relative to the fixed clamp arm 202, so as to maintain a stable clamping state and ensure that the suture needle will not slip or displace due to loosening of the clamping force during the suturing process.

[0058] When the suturing operation is completed and the suture needle needs to be released, the operator reverses the operation of the jaw locking piece 123, the linkage structure releases the first driving piece 310, and the locking of the first driving piece 310 is released. At this time, the operator can control the movable jaw 201 to open through the jaw handle 121 to release the suture needle. The locking state of the jaw locking piece 123 has good stability and can continuously lock the position of the first driving piece 310 during the operation, and will not be accidentally unlocked due to vibration or slight touch. At the same time, the unlocking operation is simple and labor-saving, and will not increase the work burden of the operator.

[0059] The design of such a locking structure effectively solves the problem of needing to maintain the clamping state for a long time during the operation, improves the stability and accuracy of the suturing operation, reduces the risk of changes in clamping force caused by hand fatigue of the operator, and further ensures the safety of the operation.

[0060] The structure design of the needle holding cavity 204 fully considers the actual needs of the operation, and the long axis direction is consistent with the axial direction of the sheath 110, and the short axis direction is consistent with the opening and closing direction of the jaw. The design of the shaft direction can maximize the stability of the clamping and the adaptability of the operation. The long axis direction is consistent with the axial direction of the sheath 110, which means that the needle holding cavity 204 extends along the operation direction of the digestive endoscope 100. This design makes the axis of the suture needle coincide with the axis of the sheath 110 after being clamped, which is convenient for the operator to observe the position of the suture needle through the field of view of the digestive endoscope 100, and to push or pull the needle holder along the axial direction of the sheath 110 to realize the accurate positioning of the suture needle in the operation site and the suturing operation. At the same time, this axial consistent design also avoids the interference between the suture needle and the sheath 110 or the endoscope forceps channel 102, and ensures that the needle holder can move smoothly in the narrow endoscope forceps channel 102. The short axis direction is consistent with the opening and closing direction of the jaw, so that the expansion and contraction of the needle holding cavity 204 is completely along the opening and closing direction of the jaw. When the movable jaw 201 is opened, the needle holding cavity 204 expands along the short axis direction, which is convenient for the suture needle to be put in. When the movable jaw 201 is closed, the needle holding cavity 204 contracts along the short axis direction to form a clamping force on the suture needle. This design can concentrate the clamping force in the radial direction of the suture needle, ensure firm clamping, and at the same time avoid the axial sliding of the suture needle caused by improper clamping force direction.

[0061] The inner wall of the needle holding cavity 204 is matched with the outer peripheral surface of the suture needle. The inner wall has a smooth arc-shaped structure without sharp protrusions or corners, which can avoid damaging the surface coating or structure of the suture needle and increase the contact area between the inner wall and the suture needle, so that the clamping force is uniformly distributed on the outer peripheral surface of the suture needle. The matched design enables the suture needle to be in full contact with the inner wall after being placed in the needle holding cavity 204, forming a wrapping clamping effect, effectively preventing the suture needle from rotating, shaking or slipping in the needle holding cavity 204. Even if the needle holder slightly vibrates or deflects during the operation, the suture needle can maintain a stable position, providing reliable protection for precise suturing.

[0062] To further improve the matching effect, the inner wall of the needle holding cavity 204 can be made of a slightly elastic material or provided with slightly elastic protrusions. These elastic structures can slightly deform during clamping, better match the outer peripheral surface of suture needles of different specifications, and enhance the adaptability and stability of clamping. At the same time, the smooth treatment of the inner wall can also reduce the friction when the suture needle is placed and taken out, avoiding unnecessary damage to the suture needle.

[0063] The connection position of the traction member 206 corresponds to the distal end region of the needle holding cavity 204. The setting of this position enables the hook-shaped part of the traction member 206 to extend into the needle holding cavity 204 and accurately hook the surgical thread on the suture needle after the movable jaw arm 201 and the fixed jaw arm 202 close to clamp the suture needle. The specific height of the connection position is matched with the height of the needle holding cavity 204, ensuring that the hook-shaped part of the traction member 206 can smoothly contact and hook the surgical thread, without colliding with or interfering with the inner wall of the needle holding cavity 204 or the suture needle. When the traction member 206 is at the connection position, the rod part is still partially located in the sliding groove 207a of the fixed jaw arm 202, ensuring the stability of the traction member 206 and avoiding shaking when hooking the surgical thread.

[0064] The cutting position is located on the proximal side of the slit 209.1 and is correspondingly arranged with the slit 209.1. This positional relationship enables the inner cutting edge 211 of the traction member 206 to be accurately aligned with the slit 209.1 when the traction member 206 moves to the cutting position, forming an effective shearing cooperation. The distance between the cutting position and the slit 209.1 is optimized to ensure that the surgical thread is naturally taut when it is pulled to this position and is exactly located in the cutting region between the cutting edge 211 and the slit 209.1. The length of the cutting position is matched with the length of the cutting edge 211 of the traction member 206, ensuring that the surgical thread is always within the shearing range of the cutting edge 211 during cutting, achieving complete cutting.

[0065] The inner hiding position is located inside the sheath 110, away from the proximal end area of the slit 209.1, which can completely accommodate the traction member 206 in the sheath 110 and the sliding groove 207a of the fixed forceps arm 202, avoiding the exposure of the traction member 206. When the traction member 206 is in the inner hiding position, neither the hook-shaped part nor the cutting edge 211 of the traction member 206 exceeds the distal end face of the sheath 110, neither interfering with the opening and closing action of the movable forceps arm 201 and the fixed forceps arm 202, nor rubbing or colliding with the surgical site or the endoscopic forceps channel 102 during the movement of the needle holder, while also protecting the cutting edge 211 from being contaminated or damaged.

[0066] The moving stroke of the traction member 206 covers the whole process from the wiring position to the inner hiding position, and the stroke length matches the length of the sliding groove 207a, ensuring that the traction member 206 can be completely switched between the three positions without dead stroke. The moving track of the traction member 206 is a straight line, extending axially along the sliding groove 207a of the fixed forceps arm 202, ensuring the accuracy and smoothness of the switching of each position. When in the cutting position, the cutting edge 211 of the traction member 206 is coplanar with the center line of the slit 209.1, which makes the shearing force concentrated along the radial direction of the surgical line, avoiding the incomplete cutting or deviation of the surgical line caused by the misalignment of the cutting edge 211 and the slit 209.1, and ensuring the accuracy and efficiency of the cutting action.

[0067] In summary, the embodiment provides a dynamic shearing mechanism under the internal constraint of the fixed forceps arm, which solves the objective defects of the prior art (such as CN103961146A) that simply rely on the retraction of the flexible inner core for shearing, leading to the easy escape of the suture, low shearing force transmission efficiency and easy damage to the instrument channel, and the deficiency of CN107440753A that lacks the integrated function of suture cutting.

[0068] Specifically, the clamp assembly 200 of the present application has a fixed jaw 202, a traction member 206 and a slit 209.1 formed in the distal end of the sheath tube, wherein the traction member 206 and the fixed jaw 202 can establish a radial limiting relationship when the traction member 206 is in a force state of axial retraction, so that the traction member 206 is fixed to the straight line trajectory defined by the fixed jaw 202. More specifically, the traction member 206 is in a constrained position of the sliding groove 207a inside the fixed jaw 202 when moving from the distal terminal position to the proximal cutting position, so that the outer wall of the rod portion of the traction member 206 is in a circumferential anti-rotation relationship with the inner wall of the sliding groove 207a; and the traction member 206 is in a concealed position inside the sheath tube 110 when continuing to retract and passing through the slit 209.1, so that the cutting edge 211 of the traction member 206 is in a zero-gap or extremely small gap shearing relationship with the proximal edge of the slit 209.1. This design uses the high-rigidity body of the fixed jaw 202 as a support base for the shearing counterforce, effectively solving the cutting failure problem caused by deformation of the soft shearing structure in the prior art when dealing with high-toughness barbed wires.

[0069] Embodiment 2 This embodiment is a further improvement of the foregoing embodiments, and repeated contents will not be described again.

[0070] As shown in Figure 8 , the traction member 206 in this embodiment is designed as a bladeless structure (hereinafter referred to as a bladeless pull hook), and the inner side of the bladeless pull hook is not provided with a continuous blade, but is provided with an arc-shaped groove structure for stably holding the surgical suture and avoiding the suture from slipping; the structural strength thereof can also withstand the reverse force when pulling the surgical suture, and the cross section of the rod portion is matched with the shape of the inner wall of the sliding groove 207a of the fixed jaw 202, so as to ensure smooth sliding along the sliding groove 207a.

[0071] The main cutting portion 210 is arranged on the side wall of the distal end of the sheath tube 110 in a sickle form adjacent to the slit 209.1, and is made of a high-strength medical alloy with a mechanical strength higher than that of the bladeless pull hook. The blade of the main cutting portion 210 is directed to the side of the slit 209.1 and is coplanar with the center line of the slit 209.1. The sliding groove 207b is formed at the end of the movable jaw 201 and maintains the same axial direction as the sliding groove 207a of the fixed jaw 202, so as to avoid interference with the forward and backward movement of the bladeless pull hook.

[0072] When it is necessary to pull and cut the surgical suture, as shown in Figure 9 , Figure 10As shown, the bladeless hook moves distally along the groove 207a to the connection position under the drive of the second drive member 208 and the inner tube of the cutting operation 209. Its arc-shaped groove structure hooks the surgical suture connected to the suture needle in the needle holding cavity 204. Then the bladeless hook moves proximally, driving the surgical suture towards the slit 209.1 of the sheath tube 110. When it reaches the cutting position, it pulls the surgical suture to the blade edge of the main cutting part 210. With continued pulling of the bladeless hook, the surgical suture is taut between the blade edge of the main cutting part 210 and the slit 209.1. As the bladeless hook retracts to the concealed position, the blade edge of the main cutting part 210 and the slit 209.1 work together to complete the precise cutting of the surgical suture.

[0073] The main cutting section 210 avoids the problem of insufficient cutting ability caused by the lack of a cutting edge in the bladeless hook. At the same time, the high-strength material ensures the stability and reliability of the cutting process, making it suitable for surgical scenarios that require high cutting force.

[0074] In this embodiment, the movable clamp arm 201 has a single-tooth structure, a distal slide groove 207b, and / or a flared guide portion. The distal slide groove 207b and the traction member 206 can establish a coaxial connection when the movable clamp arm 201 is closed or slightly open, allowing the traction member 206 to extend unobstructed to the distal end of the needle-holding cavity 204. Specifically, the second driving member 208 drives the traction member 206 to reciprocate axially, and the first driving member 310 drives the movable clamp arm 201 to open and close. When the movable clamp arm 201 is fully closed, the traction member 206 passes through the needle-holding cavity 204 under the constraint of the continuous channel formed by the slide grooves 207a and 207b. When the movable clamp arm 201 is in a large-angle opening, the traction member 206 is locked inside the fixed clamp arm 202 under the control logic or mechanical limit conditions, and / or when the traction member 206 retracts to complete the cutting, the movable clamp arm 201 releases the closing locking relationship with the fixed clamp arm 202 according to a preset program.

[0075] Example 3 This embodiment is a further improvement on the foregoing embodiment, and repeated content will not be described again.

[0076] like Figure 11 As shown, in this embodiment, the slit 209.1 at the distal end of the sheath 110 is optimized by adding a graded structure 220, so that the graded structure 220 can be used in conjunction with the bladed traction member 206 to improve cutting efficiency.

[0077] like Figures 12-15As shown, the hierarchical structure 220 is integrally formed in the slit 209.1 region at the distal end of the sheath tube 110, including a first hierarchical structure 221 and a second hierarchical structure 222 arranged sequentially along the axial direction of the sheath tube 110. Both are arc-shaped structures that bulge inward from the inner wall of the slit 209.1, and the bulge height of the first hierarchical structure 221 is lower than that of the second hierarchical structure 222, forming a hierarchical limiting.

[0078] like Figures 12-15 As shown, the arc-shaped protrusion of the first graded structure 221 is adapted to the inner cutting edge 211 of the bladed traction member 206. When the bladed traction member 206 moves the surgical suture to the first graded structure 221, the two work together to initially maintain the surgical suture, preventing it from deviating during traction. Figures 13-15 As shown, as the bladed traction member 206 continues to retract proximally, the surgical suture is further pulled to the second grade structure 222. Due to the higher protrusion of the second grade structure 222, the surgical suture is taut under the limiting effect of the second grade structure 222. At this time, the cutting edge 211 of the bladed traction member 206, together with the second grade structure 222 and the slit 209.1, defines a precise cutting area. As the bladed hook continues to retract, the cutting edge 211 applies shearing force to the taut surgical suture, completing the cutting action.

[0079] The graded structure 220 design enables the surgical suture to form a stable tension before cutting, avoiding incomplete cutting or cutting position deviation caused by suture loosening, further improving the accuracy and reliability of cutting, and is especially suitable for surgical sutures with thicker diameter or stronger toughness.

[0080] The traction member 206 is coaxially sleeved with a second driving member 208, which has a cutting operation inner tube 209 and is in a clearance fit with the cutting operation inner tube 209. This allows the second driving member 208 to transmit axial push-pull force to the proximal end of the traction member 206. Here, the cutting operation inner tube 209 may have a compression-resistant braided layer, a flexible substrate, and an inner lubricating layer. The compression-resistant braided layer, the flexible substrate, and the inner lubricating layer, together with the second driving member 208, constitute a buckling-resistant support structure. This buckling-resistant support structure has the characteristics of efficiently transmitting axial thrust in a bending path and preventing wire buckling.

[0081] Example 4 This embodiment is a further improvement on the foregoing embodiment, and repeated content will not be described again.

[0082] like Figures 16-19 As shown, the first hierarchical structure 221 and the second hierarchical structure 222 of the hierarchical structure 220 can be disposed in the slit 209.1 region at the distal end of the sheath 110, such as... Figure 16As shown, the first hierarchical structure 221 is used to cooperate with the arc-shaped groove of the bladeless traction member 206 to achieve the preliminary retention of the surgical thread; as Figure 17 、 Figure 18 As shown, after the bladeless traction member 206 pulls the surgical thread to the main cutting part 210, the bladeless traction hook is continuously pulled, and the surgical thread moves to the second hierarchical structure 222 under the guidance of the first hierarchical structure 221 and is tightened, the blade edge of the main cutting part 210 and the second hierarchical structure 222, the slit 209.1 collectively define a cutting area, and the cutting of the surgical thread is completed.

[0083] In addition, in the preferred embodiment of the present embodiment, the blade edge of the main cutting part 210 can also be manually operated to push forward to the surgical thread through additional transmission structure, further enhancing the cutting strength of the tightened surgical thread, suitable for the cutting requirements of super-high toughness surgical suture.

[0084] In summary, the hierarchical structure 220 is used to pre-position and tension the surgical thread in a wet and slippery environment before cutting, the first hierarchical structure 221 is used to provide preliminary lateral limiting to prevent the suture from slipping, and the second hierarchical structure 222 is used to lift the suture height to force the suture to be tightened. Among them, in the case that the traction member 206 drives the surgical thread to contact the first hierarchical structure 221, the surgical thread is centered with the central axis of the slit 209.1 under the arc-shaped guidance of the first hierarchical structure 221, and in the case that the traction member 206 continues to retract to the second hierarchical structure 222, the surgical thread is in an extreme tension accumulation relationship with the hook groove of the traction member 206 under the high position step blocking condition of the second hierarchical structure 222, according to the instantaneous release principle, and the surgical thread in the tightened state occurs a blasting type cutting relationship.

[0085] Embodiment 5 The present embodiment is a further improvement of the foregoing embodiments, and the repeated contents will not be described again.

[0086] As shown, the first hierarchical structure 221 is used to cooperate with the arc-shaped groove of the bladeless traction member 206 to achieve the preliminary retention of the surgical thread; as Figure 20As shown, the embodiment is aimed at the problem of narrow blade of the traction member 206 and limited cutting effect, and the traction member 206 is specifically configured as a wide-blade bit head assembly. The wide-blade bit head assembly includes a bit head 230, a bit rod 232, and a stepped rotating shaft 231. The blade width of the bit head 230 is greater than the blade width of the conventional blade traction member 206, which improves the cutting contact area and ensures complete cutting. The bit rod 232 is a main rod part of the traction member 206 and has a strip-shaped structure. The cross section of the bit rod 232 matches the shape of the inner wall of the sliding groove 207a of the fixed forceps arm 202, ensuring smooth sliding. The bit head 230 is rotationally connected to the bit rod 232 through the stepped rotating shaft 231. The stepped rotating shaft 231 has two stable clamping positions corresponding to the flat-lying state and the vertical state of the bit head 230. In order to ensure that the bit head 230 can be reliably reset under stress, a micro torsional spring or an elastic sheet (not shown in the figure) is arranged at the stepped rotating shaft 231. The elastic member always applies a biasing force to the bit head 230 to restore the flat-lying state.

[0087] In addition to the axially extending sliding groove 207a, the fixed forceps arm 202 is also provided with an arc-shaped guide groove 233 (see Figure 21 ) at the front end region thereof. This region is a key part with the highest structural integration. Through 3D printing or special micro-machining process, smooth transition of the arc-shaped guide groove 233 and the sliding groove 207a is realized in a very small space, and the structural integrity of this region is ensured. Material selection and heat treatment process ensure that this place has sufficient wear resistance and fatigue resistance to withstand the cyclic stress caused by repeated turning of the bit head 230.

[0088] As shown in Figures 20-22 , in the non-cutting state, the bit head 230 lies flat in the sliding groove 207a to avoid external interference with clamping or suturing operations; as shown in Figure 21 , when cutting the surgical thread is needed, the bit rod 232 (i.e. the traction member 206) is driven to move distally by the second driving member 208 and the cutting operation inner tube 209. The bit head 230 is pushed out to the front end of the fixed forceps arm 202 and is rotated around the stepped rotating shaft 231 to stand up against the biasing force of the elastic member under the guidance of the arc-shaped guide groove 233. The stepped rotating shaft 231 is clamped and fixed in the vertical state, so that the blade edge of the bit head 230 faces the cutting direction. Then the bit rod 232 is retracted proximally, and the blade edge of the bit head 230 cooperates with the slit 209.1 of the sheath tube 110 to complete the cutting of the surgical thread. After cutting is completed, the bit rod 232 continues to retract, and the bit head 230 is reset to lie flat in the sliding groove 207a under the restoring force of the elastic member, and finally retracts to the hidden position with the bit rod 232.

[0089] The traction member 206 has a blade bar 232, a reversible blade head 230, and an elastic biasing element, wherein the blade head 230 and the blade bar 232 can be in a vertically upright cutting relationship under radial extrusion at the arc-shaped guide groove 233 at the front end of the fixed jaw arm 202, so that the blade head 230 is fixed to a vertical working posture in the cutting stroke. Specifically, the blade head 230 is in a horizontal storage position in the sliding groove 207a in the non-working state, so that the back of the blade head 230 is in a fitting relationship with the bottom surface of the sliding groove 207a; and the blade head 230 is in an upright working position under the condition of extending to the distal end and being guided by the arc-shaped guide groove 233, so that the wide blade of the blade head 230 is in a vertical and opposite relationship with the slit 209.1.

[0090] The design of the wide-blade blade head 230 assembly solves the problem of incomplete cutting by a narrow blade, and is especially suitable for thick-diameter and high-toughness surgical sutures. The cooperation of the stepped shaft 231 and the arc-shaped guide groove 233 ensures the stability and accuracy of the state switching of the blade head 230.

[0091] Embodiment 6 This embodiment is a further improvement of the foregoing embodiments, and repeated contents will not be described again.

[0092] As shown in Figure 23 , this embodiment particularly adds anti-slip structures 240 on the opposite surfaces of the movable jaw arm 201 and the fixed jaw arm 202. The anti-slip structures 240 are concave-convex interlaced strip textures or point-shaped protruding structures arranged along the length direction of the jaw arm, which are integrally formed on the single-tooth clamping surface of the movable jaw arm 201 and the double-tooth clamping surface of the fixed jaw arm 202 by using a medical anti-slip material. The texture depth and protrusion height are optimized and designed, which can increase the friction force with the outer peripheral surface of the suture needle without damaging the surface of the suture needle.

[0093] When the movable jaw arm 201 and the fixed jaw arm 202 are closed and clamp the suture needle, the anti-slip structures 240 are in close contact with the outer peripheral surface of the suture needle, which effectively prevents the suture needle from rotating, sliding or slipping out in the needle holding cavity 204 by increasing the friction force. It is especially suitable for scenes where the needle holder needs to be frequently moved or adjusted in angle during the operation, and further improves the stability of clamping and the safety of operation.

[0094] In summary, the novel multifunctional digestive endoscope needle holder provided by the present invention includes a clamping assembly 200 disposed at the distal end of the sheath 110 of the digestive endoscope 100. The clamping assembly 200 has a movable clamping arm 201, a fixed clamping arm 202, and an opening / closing member 320. The opening / closing member 320 is axially connected to the movable clamping arm 201, which has a first driving member 310 and is in a proximal fixed connection relationship with the first driving member 310, such that the movable clamping arm 201 can rotate around a pivot 330 to engage with the fixed clamping arm 202. The clamping arms 202 open and close to form a needle-holding cavity 204 when closed. The needle-holding cavity 204 has an enveloping space whose long axis is aligned with the axial direction of the sheath 110 and whose short axis is aligned with the opening and closing direction of the clamping arms. The inner wall of the needle-holding cavity 204 is provided with an anti-slip structure 240 integrally formed from medical anti-slip material and has alternating concave and convex strip textures. This allows the anti-slip structure 240 to form a physically friction-enhancing enveloping clamping relationship with the outer peripheral surface of the suture needle when the needle-holding cavity 204 is closed.

[0095] In response to the objective defects of the simple suture-pulling structure disclosed in CN104981211A, which cannot achieve in-situ cutting, resulting in surgical suture residue and the need for repeated instrument replacement, this application proposes an integrated cutting and fitting structure, which includes: a traction member for hooking and guiding the surgical suture located in the needle holding cavity 204 to the distal end of the sheath for cutting; a slit 209.1 opened on the distal side wall of the sheath 110 and communicating with its inner cavity; and a groove 207a extending axially along the fixed clamp arm 202 and communicating with the inner cavity of the sheath 110 at its proximal end. Specifically, when the traction member 206 extends along the groove 207a to the distal region of the needle-holding cavity 204, the traction member 206 hooks with the surgical suture at the connection position using its distal hook-like structure; when the traction member 206 pulls the surgical suture back from the distal end to the proximal end to the cutting position, the rod of the traction member 206 slides linearly within the groove 207a in a cross-sectional matching manner with the inner wall of the groove, resulting in circumferential rotational restriction; and / or when the traction member 206 slides through the slit 209.1 and retracts to the proximal recessed position, the traction member 206 at the slit 209.1 has a geometric interference relationship of moving blade shearing fixed blade with the edge of the slit or the main cutting part 210 located at the slit, so that the surgical suture is cut in one go under extreme tension.

[0096] The movable jaw 201 has a sliding groove 207b axially extending through its thickness at the end position, wherein the sliding groove 207b, the sliding groove 207a and the traction member 206 form an axial alignment structure, so that the axial alignment structure has a continuous guiding characteristic of full-range unobstructed sliding when the movable jaw 201 is in the closed state. The sliding groove 207b has a flared guiding structure at the proximal end entrance, so that the traction member 206 can smoothly enter the movable jaw from the fixed jaw when the movable jaw 201 is at a slight opening angle and there is an angle compensation between the sliding groove 207b and the sliding groove 207a. This effectively solves the technical contradiction of broken movement path caused by the opening of the jaw, and ensures that the hooking operation can be performed while the suture needle is clamped and stitched.

[0097] The slit 209.1 has a hierarchical structure 220, which includes a first hierarchical structure 221 and a second hierarchical structure 222 arranged axially along the sheath 110 in sequence, wherein the first hierarchical structure 221 and the second hierarchical structure 222 are both configured as arc-shaped limiting steps protruding inwardly from the inner wall of the slit. The first hierarchical structure 221 and the second hierarchical structure 222 can establish a hierarchical tensioning relationship when the traction member 206 is switched from the self-cutting position to the inwardly concealed position, so that the surgical thread is forced to enter the cutting area defined by the cutting edge 211 of the traction member 206 and the edge of the slit 209.1.

[0098] The traction member 206 has a knife rod 232, a knife head 230 and a stepped rotating shaft 231, wherein the knife rod 232, the knife head 230 and the stepped rotating shaft 231 form a state switching structure with the arc-shaped guiding groove 233 at the front end of the fixed jaw 202, so that the state switching structure has the posture transformation characteristic of "lying down storage and standing work".

[0099] When the knife rod 232 moves distally, the knife head 230 is flipped from a horizontal position to a vertical position around the stepped rotating shaft 231 under the radial pushing action of the arc-shaped guiding groove 233. When the knife head 230 is in the vertical position, the stepped rotating shaft 231 is rotationally positioned with the knife head through the internal stable clamping, so that the cutting edge 211 with a wide blade structure has a vertical shearing relationship with the slit 209.1 in the cutting position. When the cutting is completed and the knife rod 232 continues to retract, the knife head 230 is reset to a lying state and completely enters the concealed position under the biasing force of the elastic member and the reverse guiding action of the arc-shaped guiding groove. The first drive member 310 and the second drive member 208 are both arranged in the operation inner cavity 205 of the sheath 110, wherein the second drive member 208 is coaxially sleeved in the internal part of the cutting operation inner tube 209, so that the second drive member 208 and the cutting operation inner tube 209 can be in a push-pull transmission relationship with the traction member 206 through the knife handle 122 of the operation part 120.

[0100] It should be noted that the above-mentioned embodiments illustrate rather than limit the application, and that those skilled in the art will be able to devise modifications which, though perhaps not explicitly described or shown herein, nonetheless fall within the scope of the application. Accordingly, the patent application includes all modifications encompassed within the scope of the claims and their equivalents. The patent application contains several inventive concepts, and the applicant reserves the right to file separate applications on each of these concepts, or on any combination or sub-combination of these concepts.

Claims

1. A novel multifunctional endoscope needle holder, comprising a clamping assembly (200) disposed at the distal end of the sheath (110) of an endoscope (100), the clamping assembly (200) comprising a fixed clamping arm (202) and a movable clamping arm (201), the two clamping arms forming a needle-holding cavity (204) when closed, characterized in that, The fixed clamp arm (202) is provided with an axially extending slide groove (207a), and a traction member (206) is slidably assembled in the slide groove (207a). The traction member (206) can move along the slide groove (207a) under the drive of the driving member, thereby switching between the wiring position, the cutting position and the concealed position. The distal sidewall of the sheath (110) is provided with a slit (209.1) that communicates with its inner cavity, and the slit (209.1) is located on the proximal side of the extension path of the groove (207a); When the traction member (206) is in the wiring position, the distal end of the traction member (206) extends into the needle holding cavity (204) to hook the surgical suture; when the traction member (206) retracts from the wiring position to the concealed position, the traction member (206) drives the surgical suture into the slit (209.1), and the area where the traction member (206) and the slit (209.1) are located forms a shearing fit structure, and the surgical suture is cut by the shearing motion when the traction member (206) retracts through the slit (209.1).

2. The novel multifunctional digestive endoscope needle holder according to claim 1, characterized in that, The traction member (206) is constructed as a hook with a cutting edge (211) on the inside, and the slit (209.1) forms a fixed edge that cooperates with the cutting edge (211).

3. The novel multifunctional digestive endoscope needle holder according to claim 1, characterized in that, The traction member (206) is constructed as a bladeless hook, and the shearing engagement structure includes a main cutting portion (210) disposed at or near the slit (209.1), the main cutting portion (210) having a cutting edge facing the surgical line.

4. The novel multifunctional digestive endoscope needle holder according to claim 1, characterized in that, The traction member (206) includes a reversible blade (230) configured to stand upright during extension to form a cutting edge and to cooperate with the slit (209.1) to cut the surgical suture during retraction.

5. The novel multifunctional digestive endoscope needle holder according to any one of claims 1 to 4, characterized in that, The distal end of the movable clamp arm (201) has a single-tooth structure, while the distal end of the fixed clamp arm (202) has a double-tooth structure. When the clamping assembly (200) is closed, the single-tooth structure of the movable clamping arm (201) is engaged between the double-tooth structure of the fixed clamping arm (202). The inner wall of the needle holding cavity (204) is provided with an anti-slip structure (240) to enhance the frictional clamping force on the suture needle.

6. The novel multifunctional digestive endoscope needle holder according to any one of claims 1 to 5, characterized in that, The movable clamp arm (201) has an axially extending groove (207b) at its end. The groove (207b) is configured such that when the movable clamp arm (201) is in the closed state, the groove (207b) accommodates the distal end of the traction member (206); when the movable clamp arm (201) is in the open state, the groove (207b) separates from the traction member (206).

7. The novel multifunctional digestive endoscope needle holder according to any one of claims 1 to 6, characterized in that, It also includes a first drive (310) and a second drive (208) that pass through the operating cavity (205) of the sheath (110). The first driving member (310) is used to drive the movable clamp arm (201) to open and close; the second driving member (208) is used to drive the traction member (206) to switch positions along the slide (207a).

8. The novel multifunctional digestive endoscope needle holder according to any one of claims 1 to 7, characterized in that, It also includes an elastic reset member (300), which is disposed inside the sheath (110). The elastic reset member (300) assists the movable clamp arm (201) in completing the opening and closing action by means of the elastic force acting on the opening and closing member (320) at the end of the movable clamp arm (201).

9. The novel multifunctional digestive endoscope needle holder according to any one of claims 1 to 8, characterized in that, It also includes a clamp arm locking member (123), which is disposed on the operation part (120) and linked with the first drive member (310) to lock the position of the first drive member (310) to maintain the closed state of the movable clamp arm (201) and the fixed clamp arm (202).

10. The novel multifunctional digestive endoscope needle holder according to any one of claims 1 to 9, characterized in that, The inner wall of the slit (209.1) has a hierarchical structure arranged sequentially along the axial direction of the sheath (110). The hierarchical structure includes a first hierarchical structure (221) for initially holding the surgical suture and a second hierarchical structure (222) for keeping the surgical suture taut. The traction member (206) cooperates with the second hierarchical structure (222) to cut the surgical suture in the taut state.

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