A cutting knife for an anastomat, a staple cartridge assembly and a surgical instrument

Abstract

The present application relates to the technical field of surgical medical instruments, and discloses a cutting knife for an anastomat, a staple cartridge assembly and a surgical instrument, the cutting knife comprising a blade surface part and a blade edge part, the blade edge part having a protruding part or a recessed part arranged along a cutting axis; the staple cartridge assembly comprising a mounting seat, a pusher and the aforementioned cutting knife, and the surgical instrument comprising a handle assembly, a barrel assembly, an executor assembly and the aforementioned cutting knife; by arranging the protruding or recessed structure along the cutting axis on the blade edge part, the protruding part can first pierce the tissue during cutting, apply a lateral pushing action to the tissue and tension the tissue; the recessed part can first cut into the fixed tissue through the blade edges at both ends, constrain the lateral movement of the tissue; both can reduce the probability of axial sliding of the tissue from the cutting end, ensure the regularity of the cutting path, avoid tearing of the tissue due to pulling, thereby effectively reducing the sliding of the tissue and improving the cutting accuracy.

Description

Technical Field

[0001] This invention relates to the field of surgical medical device technology, and in particular to a cutting blade for an anastomosis device, a stapler assembly, and a surgical instrument. Background Technology

[0002] Currently, minimally invasive surgery occupies an important position in surgical procedures, and the stapler is a commonly used surgical instrument in minimally invasive surgery. The working principle of the stapler is to clamp the jaws of the distal actuator at a specific position near the lesion, remove the tissue with the cutting blade of the distal actuator, and simultaneously suture it with the staple cartridge assembly of the distal actuator.

[0003] However, during the tissue cutting process, the tissue may slip under the force of the cutting blade, resulting in poor formation of some anastomotic staples. There may also be problems with insufficient blade sharpness, such as bleeding and damage to the tissue cut surface, which will affect the surgical outcome and the patient's postoperative recovery. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the prior art and provide a cutting blade, staple cartridge assembly, and surgical instrument for an anastomosis device. Based on the existing main structure of the anastomosis device, it effectively alleviates the problem of tissue slippage during the cutting process, while balancing the sharpness of the cutting edge and the durability of the blade body, improving the quality of the tissue cutting section and the stability of the anastomosis staple formation, and reducing the risk of surgical complications.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In a first aspect, a cutting blade for a stapler is proposed, comprising a cutting edge portion and a cutting edge portion, wherein the cutting edge portion is located at the distal end of the cutting edge portion, and the cutting edge portion has a protrusion or a recess portion disposed along the cutting axis; the cutting edge portion includes a first cutting edge portion and a second cutting edge portion disposed corresponding to the first cutting edge portion and the second cutting edge portion disposed corresponding to the second cutting edge portion; In a cross section perpendicular to the cutting axis, the thickness of the first cutting edge is greater than the thickness of the second cutting edge, and the cutting angle of the first cutting edge is greater than the cutting angle of the second cutting edge.

[0006] Optionally, both the first cutting edge and the second cutting edge are straight structures, and the slope of the cutting line of the first cutting edge is different from that of the second cutting edge, and the protrusion or the recess is formed at the connection between the two.

[0007] Optionally, the first cutting edge is a straight structure, the second cutting edge is an arc-shaped structure, and the first cutting edge and the second cutting edge are smoothly connected to form the protrusion or the recess.

[0008] Optionally, both the first cutting edge and the second cutting edge are arc-shaped structures, and the center of the arc of the first cutting edge and the center of the arc of the second cutting edge are located on opposite sides of the line connecting the two cutting edges. The first cutting edge and the second cutting edge are smoothly connected to form the protrusion or the recess.

[0009] Optionally, it also includes a support portion, which has a blade edge side and a blade back side disposed opposite to each other. The first blade face and the second blade face are both disposed on the blade edge side of the support portion, and the support portion, the blade face and the blade edge are integrally formed.

[0010] In a second aspect, a staple cartridge assembly is proposed, comprising a mounting base, a staple pusher, and a stapler cutter as described in the first aspect. The mounting base is provided with a plurality of mounting positions for mounting staples. The staple pusher is movably disposed on the mounting base. The staple cutter is movably connected to the mounting base, and the staple pusher and the staple cutter are movable along a cutting axis from the proximal end to the distal end of the mounting base.

[0011] Optionally, the cutting blade and the pusher are engaged and connected as a single unit, and the two can synchronously reciprocate linearly along the cutting axis.

[0012] Thirdly, a surgical instrument is proposed, comprising a handle assembly, a barrel assembly, an actuator assembly, and a cutting blade for a stapler as described in the first aspect, wherein the proximal end of the barrel assembly is connected to the handle assembly, and a transmission mechanism is provided within the barrel assembly. The distal end of the barrel assembly is connected to the actuator assembly, which includes a first jaw and a second jaw. The first jaw and the second jaw are movably connected and can be closed and opened relative to each other. The cutting blade is disposed on the transmission mechanism, which can drive the cutting blade to move along the cutting axis from the proximal end to the distal end of the actuator assembly.

[0013] Optionally, the actuator assembly is equipped with a staple cartridge assembly as described in the second aspect, the staple cartridge assembly being driven in conjunction with the transmission mechanism.

[0014] Optionally, the first jaw and the second jaw are hinged together, and when they are closed, an accommodating channel is formed inside for the cutting blade to pass through.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) In this invention, by setting protruding or recessed structures distributed along the cutting axis at the cutting edge, the protruding part can puncture the tissue first during the cutting process, apply lateral pushing action to the tissue and tighten the tissue; the recessed part can cut into and fix the tissue first through the two cutting edges, constraining the lateral movement of the tissue; both can reduce the probability of axial slippage of the tissue from the cutting end, ensure the cutting path is regular, avoid tissue tearing, thereby effectively reducing tissue slippage and improving cutting accuracy; (2) In this invention, an asymmetrical and differentiated blade design is adopted. The thick blade with a large blade angle can ensure the strength of the blade structure, improve the wear resistance and anti-fracture ability, and at the same time help push the tissue to move towards the thin blade side; the thin blade with a small blade angle can ensure the cutting sharpness of the blade edge, achieve smooth cutting of the tissue, effectively improve the flatness of the tissue cross section, and reduce intraoperative bleeding caused by rough cross section and damage. (3) In this invention, the blade structure and the cross-sectional structure work together to improve the quality of anastomosis simultaneously; the tissue tensioning and fixing effect of the concave and convex blades, together with the flat cutting effect of the differentiated blade surfaces, stabilizes the tissue before cutting, which can ensure the stability of the tissue relative to the anastomosis staples during the cutting process, significantly improve the consistency and pass rate of anastomosis staple formation, and reduce the risk of complications such as postoperative bleeding and poor healing. (4) In this invention, the improved cutting blade can be directly adapted to the transmission mechanism and staple cartridge guide groove of the existing mainstream stapler without the need for major modifications to the main hardware of the existing instrument; when integrated into the disposable staple cartridge assembly, it can be replaced synchronously with the staple cartridge, avoiding the blunting of the cutting edge caused by repeated use, continuously ensuring cutting performance, and reducing the learning threshold of operation, which helps to improve the overall efficiency of surgery. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of a surgical instrument structure according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the cutting blade structure according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the cutting edge structure of a cutting blade according to another embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of the cutting blade in an embodiment of the present invention along the direction perpendicular to the cutting axis; Figure 5 This is an exploded view of the staple cartridge assembly according to an embodiment of the present invention; Among them, 11. Handle assembly; 12. Barrel assembly; 121. Transmission mechanism; 13. Actuator assembly; 131. First jaws; 132. Second jaws; 20. Cutting blade; 21. First cutting edge; 22. Second cutting edge; 23. First cutting edge face; 24. Second cutting edge face; 251. Protrusion; 252. Recess; 26. Supporting part; 27. Blade side; 28. Back side; 31. Mounting base; 32. Push pin component; A. Cutting axis. Detailed Implementation

[0017] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. These drawings are simplified schematic diagrams, which are only used to illustrate the basic structure of the present invention and therefore only show the components relevant to the present invention.

[0018] In this manual, the proximal end refers to the end closer to the surgeon and the handle assembly 11, and the distal end refers to the end closer to the surgical site and the actuator assembly 13; the cutting axis A refers to the central axis of the cutting blade 20, which extends along the axial direction of the stapler.

[0019] The improvements of this invention focus on the structure of the cutting blade 20 of the stapler. By combining the optimization of the blade profile and the optimization of the blade cross section, the problems of soft tissue cutting slippage and blade performance imbalance are solved simultaneously. On this basis, the cutting blade 20 is applied to the independent staple cartridge assembly and the complete surgical instrument to form a multi-dimensional product solution. The structure and working process of each solution are described in detail below through several specific embodiments.

[0020] Example 1, as Figure 1 , Figure 3 Figure 4 As shown, this embodiment provides a surgical instrument with a zigzag blade protruding structure, wherein the surgical instrument includes a handle assembly 11, a barrel assembly 12, an actuator assembly 13, and a cutting blade 20.

[0021] The proximal end of the barrel assembly 12 is fixedly connected to the handle assembly 11. The barrel assembly 12 is equipped with a gear-driven transmission mechanism 121. The transmission mechanism 121 is rigidly connected to the cutting blade 20 through a locking structure, which can synchronously drive the cutting blade 20 to reciprocate linearly along the preset cutting axis A.

[0022] The distal end of the barrel assembly 12 is snapped and fixed to the actuator assembly 13. The actuator assembly 13 includes a first jaw 131 and a second jaw 132 that are hinged to each other. The two jaws can be opened and closed relative to each other by the drive of the linkage handle. When fully closed, a flat receiving channel is formed inside the jaws, which allows the staple cartridge assembly and the cutting blade 20 to pass through. The channel length is set to 60mm, which is suitable for the tissue cutting stroke of conventional minimally invasive surgery.

[0023] The cutting blade 20 is integrally stamped from medical-grade 304 stainless steel, including a support section 26, a cutting edge section, and a cutting mouth section. The support section 26 has a blade side 27 and a blade back side 28 that are arranged opposite to each other. The thickness of the blade back side 28 is set to 2mm to ensure the structural strength of the overall blade body.

[0024] The cutting edge is further divided into a first cutting edge 23 and a second cutting edge 24. Both the first cutting edge 23 and the second cutting edge 24 are located on the blade side 27 of the bearing portion 26. The cutting edge portion is correspondingly divided into a first cutting edge portion 21 and a second cutting edge portion 22. The first cutting edge portion 21 is located at the distal end of the first cutting edge portion 23, and the second cutting edge portion 22 is located at the distal end of the second cutting edge portion 24.

[0025] In this embodiment, both the first cutting edge 21 and the second cutting edge 22 are straight structures. The slope of the cutting line of the first cutting edge 21 relative to the cutting axis A is set to 15°, and the slope of the cutting line of the second cutting edge 22 relative to the cutting axis A is set to 30°. The two cutting edges meet at the connection point to form a triangular protrusion 251 extending outward along the cutting axis A. The top of the protrusion 251 extends 2 mm beyond the axial distance of the meeting point.

[0026] In a section perpendicular to the cutting axis A, the thickness of the first cutting edge 23 is set to 1.2 mm, and the thickness of the second cutting edge 24 is set to 0.6 mm; the cutting angle of the first cutting edge 21 is set to 45°, and the cutting angle of the second cutting edge 22 is set to 25°.

[0027] In this embodiment, during operation, the first cutting edge 21 of the protrusion 251 first penetrates and pierces the soft tissue to be cut, applying a lateral pushing force to the tissue during the initial cutting stage. This gradually tensions the tissue towards the second cutting edge 22, effectively preventing the tissue from slipping under the axial force of the cutting blade 20. Subsequently, the thinner second cutting edge 22 with a smaller cutting angle smoothly cuts along the already tensioned tissue end face, preventing tissue tearing during the cutting process. The smoothness of the tissue cross-section after cutting is greatly improved, and there is no problem of local damage. When the subsequent anastomotic staples are formed on the fixed tissue, the forming angle and depth of all staples are consistent, which can effectively reduce the probability of poor forming and reduce the risk of bleeding from the tissue cross-section.

[0028] Example 2, as Figure 1 and Figure 2 As shown, this embodiment provides a surgical instrument with a recessed zigzag cutting edge. The overall structure of the surgical instrument is basically the same as that of Embodiment 1, except for the structural design of the cutting edge.

[0029] In this embodiment, the slopes of the cutting lines of the first cutting edge portion 21 and the second cutting edge portion 22 relative to the cutting axis A are set to -15° and -30°, respectively. The two cutting edges meet at the connection point to form a triangular recess 252 that is recessed inward along the cutting axis A. The lowest point of the recess 252 is 2mm away from the axial distance of the line connecting the two ends of the cutting edge.

[0030] When the cutting blade 20 of this embodiment starts its cutting action, the two smaller-angled tips at both ends of the blade edge first cut into the tissue, fixing the tissue on both sides of the area to be cut and preventing the tissue from shifting to the left and right. As the cutting blade 20 moves forward, the central recessed portion 252 gradually follows, bringing the already fixed and tensioned tissue on both sides together to complete the cut. This also effectively reduces axial slippage of the tissue, achieving a smooth cut. This structure is particularly suitable for cutting soft tissue with high fat content, avoiding uneven cut surfaces caused by slippage of fat tissue and problems with insecure suture fixation.

[0031] Example 3, as Figure 1 and Figure 3 As shown, this embodiment provides a surgical instrument with a straight and curved cutting edge structure. The overall structure of the surgical instrument is basically the same as that of Embodiment 1, except for the combination structure of the cutting surface and the cutting edge.

[0032] In this embodiment, the first cutting edge 21 is a straight line structure with a slope of 20° relative to the cutting axis A. The second cutting edge 22 is an outwardly convex arc structure with a radius of curvature of 10mm. The straight first cutting edge 21 and the arc-shaped second cutting edge 22 are smoothly connected to form an arc-shaped triangular protrusion 251 extending outward along the cutting axis A.

[0033] Correspondingly, the thickness of the first cutting edge 23 is set to 1.3 mm, and the cutting angle is set to 40°; the thickness of the second cutting edge 24 is set to 0.5 mm, and the cutting angle is set to 20°.

[0034] The protruding part 251 of this embodiment has an arc-shaped cutting edge that can achieve a smoother tissue insertion effect. When cutting hard connective tissue, there will be no jamming of the cutting edge, and the cutting resistance will be smaller, further reducing the force burden on the surgeon. At the same time, it ensures that the edges of the connective tissue are neat after cutting, and there will be no problem of the fibrous tissue being pulled and loosened.

[0035] Example 4: This example provides a surgical instrument with a double-arc cutting edge combination structure. The overall structure of the surgical instrument is basically the same as that in Example 1, such as... Figure 1 As shown, its cutting edge adopts a double-arc configuration, which belongs to... Figure 3 In another embodiment shown, the cross-sectional structure can be referred to Figure 4 .

[0036] In this embodiment, both the first cutting edge 21 and the second cutting edge 22 are convex arc structures. The center of the arc of the first cutting edge 21 and the center of the arc of the second cutting edge 22 are located on opposite sides of the line connecting the two cutting edges. The two arcs are smoothly connected and form a smooth arc protrusion 251 extending outward along the cutting axis A. The top of the protrusion 251 extends 2.5mm beyond the axial distance of the two cutting edges.

[0037] Correspondingly, the thickness of the first cutting edge 23 is 1.1 mm and the cutting angle is 42°, while the thickness of the second cutting edge 24 is 0.7 mm and the cutting angle is 22°.

[0038] The cutting edge of this embodiment has no sharp intersection point, and there will be no problem of local chipping of the cutting edge after repeated cutting, which can improve the service life of the cutting blade 20, and at the same time avoid the risk of excessive puncture and damage to surrounding non-target tissues by the sharp cutting edge.

[0039] Example 5, as Figure 2 and Figure 5 As shown, this embodiment provides a staple cartridge assembly adapted to the aforementioned surgical instruments, which includes a mounting base 31, a cutting blade 20, and a staple pusher 32.

[0040] The mounting base 31 is made of medical polymer material by injection molding and has a length of 55mm. There are 36 mounting positions for installing sutures in three rows along the arrangement direction on the top surface of the mounting base 31. Each mounting position is pre-installed with a titanium alloy suture.

[0041] The pusher 32 is made of medical-grade stainless steel and is movably fitted into the internal groove of the mounting base 31. It can move linearly along the axis of the mounting base 31 under external force. The top of the pusher 32 is provided with a push protrusion that matches the bottom of the suture staple. When moving, it can push the suture staple out of the mounting position to complete the firing and forming.

[0042] The cutting blade 20 is movably fitted into the guide groove in the middle of the mounting base 31. The structure of the cutting blade 20 adopts the zigzag blade protrusion structure described in the first embodiment above. The cutting blade 20 and the pusher 32 are engaged as one unit through the side slot. The two can move synchronously along the cutting axis A from the near end to the far end of the mounting base 31.

[0043] The staple cartridge assembly of this embodiment can be used as an independent accessory with a conventional surgical stapler without modifying other structures of the original instrument. It effectively reduces tissue slippage and improves cutting and suturing quality, and is compatible with most minimally invasive stapler products of the same specifications on the market, demonstrating strong versatility. After surgery using this staple cartridge assembly, the stability of the staple formation on the tissue cross-section is effectively improved, helping to reduce the probability of postoperative complications.

[0044] In summary, this invention combines a non-straight concave-convex cutting edge profile with an asymmetrical differentiated cutting surface cross section. The two work synergistically in terms of cutting sequence and force transmission. Specifically, the concave-convex cutting edge is responsible for completing tissue puncture and positional constraint in the initial stage of cutting, while the asymmetrical cutting surface undertakes load support and precision cutting functions respectively in the cutting stage. Together, they achieve the technical effects of reducing tissue slippage, improving cross-sectional flatness, and ensuring the durability of the blade.

[0045] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many improvements and modifications under the guidance of the present invention without departing from the spirit and scope of the claims. These improvements and modifications should also be considered within the scope of protection of the present invention.

[0046] In the description of this invention, it should be understood that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0047] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0048] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

Claims

1. A cutting blade for an anastomosis device, characterized in that: It includes a cutting edge portion and a cutting edge portion, the cutting edge portion being located at the distal end of the cutting edge portion, the cutting edge portion having a protrusion or a recess portion arranged along the cutting axis; the cutting edge portion includes a first cutting edge portion and a second cutting edge portion, the cutting edge portion including a first cutting edge portion corresponding to the first cutting edge portion and a second cutting edge portion corresponding to the second cutting edge portion; In a cross section perpendicular to the cutting axis, the thickness of the first cutting edge is greater than the thickness of the second cutting edge, and the cutting angle of the first cutting edge is greater than the cutting angle of the second cutting edge.

2. The cutting blade for a stapler according to claim 1, characterized in that: Both the first cutting edge and the second cutting edge are straight structures, and the slope of the cutting line of the first cutting edge is different from that of the second cutting edge. The protrusion or the recess is formed at the connection between the two.

3. The cutting blade for a stapler according to claim 1, characterized in that: The first cutting edge is a straight line structure, and the second cutting edge is an arc structure. The first cutting edge and the second cutting edge are smoothly connected to form the protrusion or the recess.

4. The cutting blade for a stapler according to claim 1, characterized in that: Both the first cutting edge and the second cutting edge are arc-shaped structures, and the center of the arc of the first cutting edge and the center of the arc of the second cutting edge are located on opposite sides of the line connecting the two cutting edges. The first cutting edge and the second cutting edge are smoothly connected to form the protrusion or the recess.

5. The cutting blade for a stapler according to claim 1, characterized in that: It also includes a support portion, which has a blade side and a back side that are disposed opposite to each other. The first blade face and the second blade face are both disposed on the blade side of the support portion, and the support portion, the blade face and the blade edge are integrally formed.

6. A staple cartridge assembly, characterized in that: The device includes a mounting base, a pusher, and a cutting blade for a stapler as described in any one of claims 1-5. The mounting base is provided with a plurality of mounting positions for mounting staples. The pusher is movably disposed on the mounting base. The cutting blade is movably connected to the mounting base, and the cutting blade and the pusher are movable along a cutting axis from the proximal end to the distal end of the mounting base.

7. The staple cartridge assembly according to claim 6, characterized in that: The cutting blade and the pusher are engaged and connected as a whole, and the two can move back and forth in a straight line synchronously along the cutting axis.

8. A surgical instrument, characterized in that: It includes a handle assembly, a barrel assembly, an actuator assembly, and a cutting blade for a stapler as described in any one of claims 1-5, wherein the proximal end of the barrel assembly is connected to the handle assembly, and a transmission mechanism is provided within the barrel assembly; The distal end of the barrel assembly is connected to the actuator assembly, which includes a first jaw and a second jaw. The first jaw and the second jaw are movably connected and can be closed and opened relative to each other. The cutting blade is disposed on the transmission mechanism, which can drive the cutting blade to move along the cutting axis from the proximal end to the distal end of the actuator assembly.

9. The surgical instrument according to claim 8, characterized in that: The actuator assembly is equipped with a staple cartridge assembly as described in any one of claims 6-7, and the staple cartridge assembly is in driving cooperation with the transmission mechanism.

10. The surgical instrument according to claim 8, characterized in that: The first jaw and the second jaw are hinged together, and when they are closed, an accommodating channel is formed inside for the cutting blade to pass through.

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