Surgical stapler and staple cartridge for surgical stapler

JP2025511861A5Pending Publication Date: 2026-04-08CILAG GMBH INTERNATIONAL
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-04-05
Publication Date
2026-04-08

AI Technical Summary

Technical Problem

When existing medical fixtures apply, the fixture cannot effectively cover the area where the needle is retained, resulting in the gap between tissues being unable to be effectively clamped, which may lead to bleeding and tissue fluid leakage, affecting the healing process.

Method used

A new fixture is designed in which the position of the retaining needle is adjusted to ensure that the outermost fixture line can cover at least half of the retaining pinhole opening, thereby avoiding the formation of gaps and improving the stability of the retaining needle and the overall strength of the fixture by increasing the diameter of the retaining needle and using an eccentric design.

Benefits of technology

It effectively solves the problem that the fixture line cannot cover the retaining needle area, reduces the risk of bleeding and tissue fluid leakage, and improves the overall performance and stability of the tissue fixture.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure relates to a surgical stapler and a staple cartridge for use with the surgical stapler, the staple cartridge having a cartridge body including a tissue contacting platform, a plurality of staple cavities arranged in a row along a longitudinal direction of the staple cartridge, and a retaining pin assembly slidably disposed at an end of the cartridge body adjacent an exterior side and capable of extending distally from a retaining pin hole opened on the tissue contacting platform along a longitudinal direction of the surgical stapler when a closure drive mechanism is actuated, the pin rod of the retaining pin assembly having a circular cross-section.
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Description

[Technical field]

[0001] The present disclosure relates to the field of medical or cutting staplers, and more particularly to surgical staplers for stapling tissue in open surgical procedures, and staple cartridges for use with surgical staplers. [Background technology]

[0002] In the prior art, medical staplers or medical cutting staplers (hereinafter collectively referred to as surgical staplers) are typically used to apply rows of staples on either side of an incision made in tissue during a surgical procedure to close the incision, thus reducing or eliminating tissue bleeding and accelerating wound healing. A typical surgical stapler adapted for open surgery has an end effector disposed at a distal end of the surgical stapler, the end effector including a staple cartridge for receiving staples and an anvil for stapling deformation of the staples disposed opposite the staple cartridge, the anvil and staple cartridge collectively forming a jaw structure for clamping tissue.

[0003] A retaining pin is often provided on the cartridge body of the staple cartridge to maintain a stable relative positional relationship between the staple cartridge, the anvil, and the tissue to be stapled throughout the process of the surgical stapler clamping the tissue until stapling is completed. The retaining pin is used to align and secure the staple cartridge with the anvil when the end effector clamps the tissue to be stapled, so that the staple forming pockets in the anvil align with the openings of the staple cavities in the staple cartridge to prevent relative movement between the staple cartridge and the anvil resulting from external forces applied when the surgical stapler is fired. In this case, the staples cannot be accurately aligned with the staple forming pockets formed on the anvil, and as a result, the staples cannot be properly deformed and therefore cannot effectively staple the tissue.

[0004] In existing open surgical staplers, as shown in FIG. 1, the retaining pin is generally centered relative to the longitudinal centerline of the staple cartridge, and the openings of the staple cavities are located on either side of the centerline along the length of the staple cartridge. In such a configuration, the retaining pin chute opening is located further outward relative to the opening of the outermost staple cavity. Such a configuration has the disadvantage that the staple line formed by the outermost staple cannot cover the area where the retaining pin chute opening is located during stapling, so that a gap is formed therebetween. In particular, when the area of ​​tissue to be stapled has a large width, the width of the tissue to be stapled exceeds the respective lengths of the staple cartridge and anvil of the stapler. In this situation, the retaining pin may squeeze or even penetrate the tissue when the tissue is clamped, so that the staple cannot cover the tissue around the retaining pin, leaving a gap formed in the area not covered by the staple line. This potentially results in localized bleeding and leakage of tissue fluids, slowing healing of the incision, extending the time to hemostasis, and causing other undesirable symptoms such as localized inflammation. Sometimes the clinician even needs to perform extra local stapling and hemostatic actions, thus extending the actual surgery and recovery time. Summary of the Invention

[0005] To solve the above-mentioned problems, there is a need for a novel open surgical stapler that can enable the outermost staple line to cover at least half of the retention pinch opening to ensure tissue stapling effect and therefore reduce the risk of bleeding and tissue fluid leakage.

[0006] In accordance with one aspect of the present disclosure, there is provided a staple cartridge for use with a surgical stapler, the staple cartridge comprising: a plurality of staples; a cartridge body, the cartridge body comprising: a tissue contacting platform; a plurality of staple cavities, each of the staple cavities comprising an opening formed in the tissue contacting platform, a staple positioned within each of the staple cavities and extending through the opening when deployed, the plurality of staple cavities arranged in a row along a longitudinal length of the staple cartridge; and a retaining pin assembly slidably disposed at an end of the cartridge body adjacent an exterior thereof and operatively connected to a closure drive mechanism of the surgical stapler, whereby upon actuation of the closure drive mechanism: and a retaining pin assembly that can extend distally from a retaining pin hole opened on the tissue contacting platform along a longitudinal direction of the surgical stapler, the retaining pin assembly comprising a cylindrical pin rod extending along the longitudinal direction of the retaining pin assembly, wherein in the longitudinal direction of the staple cartridge, an outermost edge of an outermost staple cavity in at least one row of staple cavities is aligned with or extends beyond the longitudinal axis of the pin rod, the retaining pin assembly being offset relative to the longitudinal centerline of the staple cartridge, or the retaining pin assembly being centered relative to the longitudinal centerline of the staple cartridge, and the longitudinal centerlines of the multiple rows of staple cavities being offset relative to the longitudinal centerline of the staple cartridge.

[0007] According to the above-mentioned technical solution of the present disclosure, regardless of the number of rows of staples in the staple cartridge and regardless of the longitudinal centerline of the staple line being offset from the longitudinal centerline of the staple cartridge, the opening of at least one staple cavity, preferably the opening of at least one staple cavity in the opening of the plurality of staple cavities, can extend to or pass through the center of the pin rod (i.e., the center of the retaining pin hole for receiving the pin rod of the retaining pin assembly) to cover the area around the retaining pin hole, thus avoiding the situation where the staples are not applied around the retaining pin hole in the stapling procedure. In this way, the technical solution can reduce the possibility of local bleeding and tissue fluid leakage and enhance the stapling effect.

[0008] In addition, the staple cartridge according to the present disclosure includes a pin rod having a full circular cross section with a larger diameter, and compared with the semicircular pin rod according to the prior art, the pin rod according to the present invention can not only increase the strength but also greatly improve the stability of the retaining pin assembly during operation, thereby ensuring the quality of the formed staples.

[0009] In accordance with a preferred implementation of the present disclosure, the pin rod of the retaining pin assembly is offset relative to the longitudinal centerline of the staple cartridge, and the longitudinal centerlines of the multiple rows of staple cavities are aligned with the longitudinal centerline of the staple cartridge.

[0010] In accordance with another preferred implementation of the present disclosure, the pin rod of the retaining pin assembly is offset relative to the longitudinal centerline of the staple cartridge and the longitudinal centerlines of the multiple rows of staple cavities are offset relative to the longitudinal centerline of the staple cartridge.

[0011] According to a further preferred implementation of the present disclosure, the staple cavities are arranged in two rows, with the outermost edge of the outermost staple cavity in one of the two staple cavity rows extending beyond the longitudinal axis of the pin rod of the retaining pin assembly, and the other staple cavity row being positioned adjacent to the retaining pin hole.

[0012] According to yet another preferred implementation of the present disclosure, the pin rod comprises a free end that can extend from the retaining pin hole and another end opposite the free end, the retaining pin assembly further comprises a pin base fixedly connected to the other end of the pin rod, and the pin rod is offset with respect to the longitudinal central axis of the pin base. Such a configuration can be applied in cooperation with the solution of offsetting the retaining pin rod, which helps to make the pin rod of the retaining pin assembly pass through the structure of the staple driver plate so that the retaining pin assembly can be pushed through the staple driver plate to reach a more remote position. In this way, the present disclosure can save the internal space of the staple cartridge and reduce the height of the staple cartridge.

[0013] According to yet another preferred implementation of the present disclosure, the retaining pin assembly has an asymmetric structure on both sides of the offset pin rod. In this case, by adopting an asymmetric configuration on the side where the pin rod is offset, for example by increasing the volume of the offset side, the present disclosure can increase the supporting strength of the offset pin rod, and thus ensure the stability of the offset retaining pin assembly in the extension and retraction process.

[0014] In accordance with yet another preferred implementation of the present disclosure, the staple cartridge further comprises a staple driver plate extending along a length of the staple cartridge and having a plurality of teeth on a surface facing the distal end of the surgical stapler configured to extend toward the distal end of the surgical stapler and to push the staples out of the staple cavities, the staple driver plate being formed at a distal end portion proximate the retaining pin assembly having an avoidance feature that enables the retaining pin assembly to advance toward the distal end of the surgical stapler by overriding the staple driver plate.

[0015] According to yet another preferred implementation of the present disclosure, the avoidance feature is a notch formed on one side of the staple driver plate adjacent to the retaining pin assembly, the notch extending along the firing direction of the staple cartridge and configured to allow the retaining pin to pass through the notch. In this way, the present disclosure can not only achieve the objective of allowing the retaining pin assembly to pass through, but also ensure that at least one row of staple lines is formed around the retaining pin assembly, thereby reducing bleeding and leakage.

[0016] According to yet another preferred implementation of the present disclosure, the retaining pin assembly further comprises clips formed on both sides of the pin base, the clips being configured to extend from the cartridge body along slots formed on two sides of the cartridge body and extending along the firing direction of the staple cartridge, such that the retaining pin assembly is manipulated by a user to slide along the slots.

[0017] In accordance with yet another preferred implementation of the present disclosure, the clip has ear-like structures to facilitate a user's manual manipulation of the surgical stapling instrument.

[0018] According to yet another preferred implementation of the present disclosure, the ear-like clips located on both sides of the pin base are different in size, which is an optimized adjustment to the offset pin rod configuration of the retaining pin assembly, ensuring the stability of the offset retaining pin assembly in the retraction process, and therefore ensuring the staple formation quality.

[0019] According to yet a further preferred implementation of the present disclosure, the cartridge body further comprises a plurality of ridges extending from the tissue contacting platform, wherein at least a portion of each of the staple cavity openings is surrounded by a portion of the ridge or a portion of the ridge, This configuration allows the ridges to be the first to contact the tissue when the jaws are closed to prevent or at least limit relative movement between the tissue and the staple cartridge.

[0020] Additionally, in accordance with yet another preferred implementation of the present disclosure, at least a portion of the retaining pin hole is circumferentially formed with a bump, which can provide better guidance for the pin rod during actuation of the retaining pin assembly and can prevent tissue from being crushed when the end effector is closed.

[0021] According to yet another preferred implementation of the present disclosure, the free end of the retaining pin assembly is configured as a tip, which allows the retaining pin assembly to conveniently penetrate tissue and be smoothly inserted into the retaining pin receiving hole on the anvil side.

[0022] According to yet another preferred implementation of the present disclosure, the pin rod of the retaining pin assembly has a diameter greater than 1.7 mm. Therefore, the present disclosure can not only ensure sufficient strength of the pin rod, but also ensure that the pin rod is sufficiently stable when penetrating tissue.

[0023] According to another aspect of the present disclosure, there is provided a surgical stapler for stapling tissue in a surgical procedure comprising: a staple cartridge according to various preferred implementations of the present disclosure; an anvil for forming staples in the staple cartridge; and a firing drive mechanism operatively connected to the staple cartridge, the staple firing mechanism actuating a staple driver plate to drive a plurality of staple drivers to move distally from the surgical stapler to deploy staples from the staple cavities, the anvil comprising a tissue contacting surface and a plurality of staple forming pockets formed in the tissue contacting surface, the plurality of staple forming pockets being arranged in rows corresponding to the plurality of staple cavities of the staple cartridge; and a retaining pin receiving hole for receiving a free end of a retaining pin assembly of the staple cartridge, the retaining pin receiving hole being arranged at an end adjacent to an outer side of the anvil, and in a longitudinal direction of the anvil, an outermost edge of an outermost staple forming pocket in at least one row of staple forming pockets is aligned with or extends beyond a center of the retaining pin receiving hole on the anvil side.

[0024] According to the above-mentioned implementation solution of the present disclosure, the anvil adopts a configuration that matches the staple cartridge, and at least one row of staple lines can extend or pass through the center of the retaining pin hole for receiving the pin rod, thereby covering the area around the retaining pin and thus avoiding a situation where staples are not applied around the retaining pin hole.

[0025] In accordance with a preferred implementation of the present disclosure, the retaining pin receiving hole on the anvil is centered relative to the longitudinal centerline of the anvil, and the longitudinal centerlines of the multiple rows of staple forming pockets are offset relative to the longitudinal centerline of the anvil.

[0026] According to another preferred implementation of the present disclosure, the retaining pin receiving holes on the anvil are offset relative to the longitudinal centerline of the anvil, and the longitudinal centerlines of the multiple rows of staple forming pockets are offset relative to the longitudinal centerline of the anvil.

[0027] According to a further preferred implementation of the present disclosure, the retaining pin receiving holes on the anvil are offset relative to the longitudinal centerline of the anvil, and the longitudinal centerlines of the multiple rows of staple forming pockets coincide with the longitudinal centerline of the anvil.

[0028] According to yet another preferred implementation of the present disclosure, the retaining pin receiving hole on the anvil opens outwardly toward the side of the anvil along the lateral direction of the anvil. With such a design, the present disclosure can facilitate alignment of the retaining pin assembly when the surgical stapler is closed.

[0029] According to yet another preferred implementation of the present disclosure, the retaining pin receiving hole on the anvil side is connected to the outside via a notch formed on one side edge of the anvil adjacent to the retaining pin receiving hole.

[0030] According to yet another preferred implementation of the present disclosure, the anvil has a first portion and a second portion divided along a median plane of the surgical stapler, the retaining pin receiving hole on the anvil side is disposed in the first portion, and the width of the first portion is greater than the width of the second portion.

[0031] According to yet another preferred implementation of the present disclosure, the surgical stapler further comprises an anvil mounting portion to which the anvil is fixedly attached, and the anvil mounting portion is flanked by a thin inner shim such that the median surface of the anvil is offset relative to the median surface of the surgical stapler. With such a structure, the present disclosure can increase the strength of the distal end of the surgical stapler, thus absorbing the operating force applied to the distal end and preventing damage to the clamped tissue. This is particularly advantageous when the retaining pin assembly has a thick pin rod, which can not only ultimately ensure a good staple forming effect, but also reduce impact or damage to the tissue.

[0032] According to another preferred implementation of the present disclosure, the shape of the inner shim is the same as the shape of at least a portion of a side surface of the anvil mounting portion.

[0033] The staple cartridge and surgical stapler according to the present disclosure can solve the above-mentioned technical problems existing in the prior art, and can not only guarantee the tissue stapling effect, thereby reducing the risk of bleeding and tissue fluid leakage, but also optimize the internal space of the staple cartridge, thereby reducing the height of the staple cartridge. In addition, a thin inner shim is placed on the side of the anvil mounting portion, thereby reducing the impact and damage to the tissue. [Brief description of the drawings]

[0034] Hereinafter, the preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. The following description is provided merely as an example, and does not imply any limitation to the present disclosure, and other similar situations that can also achieve the objectives of the present disclosure are all included in the protection scope of the present disclosure. For ease of understanding, the same reference numerals are used for the same components throughout the description and drawings (either in the prior art or in various implementations of the present disclosure). Of the drawings: [Figure 1]1 is a schematic diagram of a prior art staple cartridge showing the relative positions of the retaining pin holes on the tissue contacting platform and the staple cavity openings. [Diagram 2] FIG. 1 is a side view of an end effector of a surgical stapler in accordance with the present disclosure; [Diagram 3] 1 is a perspective view of a staple cartridge in accordance with the present disclosure; FIG. [Figure 4] 1 is a principal view of a staple cartridge according to the present disclosure; FIG. [Diagram 5] 1 is a perspective view of a portion of an end effector of a surgical stapler according to the present disclosure; FIG. [Figure 6a] 1A-1C are schematic diagrams illustrating a portion of a staple cartridge according to different preferred implementations of the present disclosure; [Figure 6b] 1A-1C are schematic diagrams illustrating a portion of a staple cartridge according to different preferred implementations of the present disclosure; [Figure 7a] 1A-1C are schematic diagrams illustrating a portion of an anvil in different preferred implementations of a surgical stapler according to the present disclosure; [Figure 7b] 1A-1C are schematic diagrams illustrating a portion of an anvil in different preferred implementations of a surgical stapler according to the present disclosure; [Figure 8a] 1A-1C are perspective, side and bottom views, respectively, of a retaining pin hole according to the present disclosure; [Figure 8b] 1A-1C are perspective, side and bottom views, respectively, of a retaining pin hole according to the present disclosure; [Figure 8c] 1A-1C are perspective, side and bottom views, respectively, of a retaining pin hole according to the present disclosure; [Figure 9a] 9A and 9B are rear views of the end effector showing the structure of and relationship between the retaining pin assembly and staple drive panel, with FIG. 9a being according to the prior art and FIG. 9b being according to a preferred embodiment of the present disclosure. [Figure 9b]9A and 9B are rear views of the end effector showing the structure of and relationship between the retaining pin assembly and staple drive panel, with FIG. 9a being according to the prior art and FIG. 9b being according to a preferred embodiment of the present disclosure. [Figure 10] FIG. 9c illustrates the retaining pin assembly as shown in FIG. 9b being pushed distally past the staple driver plate to its end position. [Figure 11a] 1A-1C are schematic diagrams illustrating the closure trigger and firing trigger, respectively, of the closure and firing mechanisms of a surgical stapler in accordance with the present disclosure; [Figure 11b] 1A-1C are schematic diagrams illustrating the closure trigger and firing trigger, respectively, of the closure and firing mechanisms of a surgical stapler in accordance with the present disclosure; [Figure 11c] 1A-1C are schematic diagrams illustrating the closure trigger and firing trigger, respectively, of the closure and firing mechanisms of a surgical stapler in accordance with the present disclosure; [Figure 12] 1 is a schematic diagram illustrating an implementation of a closure and firing mechanism of a surgical stapler in accordance with the present disclosure in a fully fired state; [Figure 13] FIG. 13 is a partial enlarged view of the display mechanism shown in FIG. [Figure 14] 13 is a schematic diagram illustrating a closure trigger in a further implementation of a closure and trigger mechanism of a surgical stapler in accordance with the present disclosure; [Figure 15] FIG. 15 is a partial enlarged perspective view of the closure trigger shown in FIG. 14. [Figure 16] FIG. 16 is a schematic diagram of the closure and firing mechanism shown in FIGS. 14 and 15 in a fully fired state. [Figure 17] FIG. 1 is a partial perspective view of a distal end of a body frame of a surgical stapler according to the present disclosure showing an anvil mounted on a hook plate; [Figure 18] FIG. 18 is a schematic diagram of a cutting portion of the anvil shown in FIG. 17. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] With reference to the drawings, the technical solutions of the present disclosure are further described below through specific embodiments, but are not limited to these embodiments. It is understood that the embodiments described and illustrated herein are non-limiting examples, and the specific structural and functional details disclosed herein may be representative and exemplary. Modifications and changes thereto may be made without departing from the scope of the claims.

[0036] As used herein, "various embodiments," "some embodiments," "one embodiment," "embodiment," and the like refer to a particular feature, structure, or characteristic described with reference to an embodiment or embodiments being included in at least one embodiment, and thus do not necessarily refer to the same embodiment. In addition, particular features, structures, or characteristics may be combined in any suitable manner, in one or more embodiments. Thus, without limitation, a particular feature, structure, or characteristic illustrated or described with reference to one embodiment may be combined in whole or in part with a feature, structure, or characteristic included in one or more other embodiments.

[0037] The terms "proximal," "distal," "proximal end," and "distal end" are used herein with respect to a user or operator manipulating a surgical stapler, with "proximal" and "proximal end" referring to the side closest to the operator and "distal" and "distal end" referring to the side located away from the operator. For example, an end effector is located distal to a surgeon manipulating a surgical stapler handle.

[0038] As used herein, with respect to the terms "inner" and "outer," inner refers to the side proximate to the hook plate extending toward the distal end of the surgical stapler, and distal refers to the side located away from the hook plate, with respect to a longitudinal axis of the staple cartridge or anvil that is perpendicular to the longitudinal axis of the surgical stapler.

[0039] As used herein, the term "length" with respect to a staple cartridge refers to the dimension of the staple cartridge along the longitudinal extension of the staple cartridge, "width" refers to the dimension perpendicular to the length of the staple cartridge in a plane parallel to the tissue contacting platform of the staple cartridge, and "height" refers to the dimension along the longitudinal extension of the surgical stapler.

[0040] Additionally, the terms "lateral," "longitudinal," and "vertical" are used herein with respect to the staple cartridge or anvil structures being described, with longitudinal referring to the length of the staple cartridge or anvil, lateral referring to the width of the staple cartridge or anvil, and vertical referring to the height of the staple cartridge or anvil.

[0041] It will be appreciated that for convenience and clarity, spatial terms such as "vertical," "horizontal," "top," and "bottom" may be used herein with reference to the illustrated embodiments, however, these terms are used to aid the reader and are not intended to be limiting and absolute.

[0042] Furthermore, although the embodiment shown in the drawings relates only to a linear stapler adapted for open surgery, the scope of protection of the present disclosure should not be limited thereto and may further include a surgical stapler having an angled head. In addition, the scope of protection of the stapler according to the present disclosure should not be limited to a surgical stapler having only a stapling function as described herein, but should instead include a surgical cutting stapler having both a cutting and stapling function. That is, the surgical instrument is also provided with a cutting blade, which is a surgical stapler that can simultaneously implement the cutting and stapling functions.

[0043] For example, Chinese Patent No. 102835983(B) describes a surgical stapler adapted for open surgery, comprising a support base, a trigger located at a proximal end, a handle, and a retaining pin, the retaining pin being operatively connected to the support base and extending distally therefrom. The upper support base supports the retaining pin, which extends through a through hole at the upper end of the movable jaw, and the retaining pin can be advanced into the hole of the anvil to ensure accurate alignment between the anvil and the staple cartridge and to hold the tissue captured therebetween. If the retaining pin is not moved distally to the home position, the trigger of the surgical stapler cannot be fired. The trigger can only be triggered when the operator presses the retaining pin in the home position as required.

[0044] The present disclosure relates to a surgical stapler of similar construction and function adapted for open surgery.

[0045] Hereinafter, the basic structure of the surgical stapler according to the present disclosure will be described with reference to Fig. 2. Fig. 2 shows a part of the end effector 1 of the surgical stapler according to the present disclosure. For convenience, only the structure related to the technical solution claimed in this specification is shown, and the structure of components such as the grip, firing mechanism, and actuation mechanism are omitted. For the structure not shown here, reference can be made to the relevant description on the prior art.

[0046] As shown in Fig. 2, a surgical stapler according to the present disclosure is configured with an end effector 1 at a distal end for clamping tissue to be stapled and implementing a stapling operation. The end effector 1 mainly includes a substantially U-shaped fixed jaw and a movable jaw movable relative to the fixed jaw, the movable jaw includes a staple cartridge 10 for receiving staples, and an anvil 20 is fixedly attached to a surface of the fixed jaw facing the movable jaw, and the anvil 20 is disposed opposite the staple cartridge 10. The staple cartridge 10 and the anvil 20 collectively form a jaw structure for clamping tissue.

[0047] The staple cartridge 10 is a replaceable disposable product and can be replaced by a surgeon with a new one after each firing operation is completed. As shown in FIG. 3, the staple cartridge 10 mainly includes a plurality of staples and a cartridge body 101, the cartridge body 101 includes a tissue contacting platform 111 extending along a longitudinal direction L of the staple cartridge 10, and a plurality of staple cavities 112 each including an opening 117 located on the tissue contacting platform 111, and the plurality of staples are located within each staple cavity 112 and can extend from the opening 117 upon deployment. In addition, the plurality of staple cavities 112 are arranged in two or more rows along the longitudinal direction of the staple cartridge.

[0048] As shown in Figure 5, the anvil 20 has a plurality of staple forming pockets 202 formed thereon for stapling deformation of the staples, which are positioned to correspond to the plurality of staple cavities 112 located on the staple cartridge. In addition, as shown in Figure 2, the anvil 20 is integral with the body frame 30 of the surgical stapler and is fixedly connected to a pistol grip of the closure and firing mechanism of the stapler.

[0049] Staple cartridge 10 is received within body frame 30 and coupled to a firing drive mechanism also received within the body frame. The firing drive mechanism is configured to actuate staple driver plate 103 of staple cartridge 10 to drive staple drivers (i.e., tines on the staple push plate) toward a distal end of surgical stapler 1 to deploy staples from staple cavities 112.

[0050] To ensure that openings 117 of staple cavities 112 on staple cartridge 10 are aligned with staple forming pockets 202 on anvil 20 when the end effector clamps tissue to be stapled, staple cartridge 10 is further provided with a retaining pin assembly 102 thereon. Retaining pin assembly 102 is disposed at an end of cartridge body 101 of staple cartridge 10 adjacent its exterior and is operably connected to closure drive mechanism 40 of the surgical stapler so as to extend distally from retaining pin holes 114 of hollow cavities 113 opening onto tissue contacting platform 111. In a preferred embodiment, retaining pin assembly 102 is disposed perpendicular to tissue contacting platform 111 of staple cartridge 10.

[0051] However, in prior art open surgical staplers, as shown in FIG. 1, the retaining pin is typically centered relative to the longitudinal centerline of the staple cartridge, and the staple holes are symmetrically positioned on either side of the longitudinal centerline of the staple cartridge. In other words, the longitudinal centerline of the multiple rows of staple cavities 112 and the center of the retaining pin holes are located on the same straight line. In such a configuration, the staple line formed by the outermost staples cannot cover the area where the retaining pin holes are located, so a gap is formed between them where no staples are applied. Especially when the area of ​​tissue to be stapled has a large width, the width of the tissue to be stapled often exceeds the respective lengths of the staple cartridge and anvil of the stapler. In this situation, the retaining pin will likely squeeze or even penetrate the tissue when the tissue is clamped. At this time, the tissue around the retaining pin cannot be covered or stapled by the staples, and a notch is formed around the area where the retaining pin penetrates after stapling is completed, which may result in localized bleeding and leakage of tissue fluid.

[0052] 3 illustrates the surface configuration and structure of an improved staple cartridge for a surgical stapler according to the present disclosure. As shown therein, the tissue contacting platform 111 of the staple cartridge 10 facing the anvil 20 is provided with a plurality of rows of openings 117 of staple cavities 112 that allow staples to pass therethrough. The staple cavities 112 are arranged in two rows along the longitudinal direction L of the staple cartridge 10, but may be arranged in three or more rows. At an end proximate the exterior of the staple cartridge 10, the retaining pin assembly 102 is configured to be received within the hollow cavity 113 and extend from a retaining pin hole 114 formed on the tissue contacting platform 111, and ultimately inserted into a retaining pin receiving hole 203 formed on the anvil 20. As shown, the vertical direction L of the staple cartridge 10 and the vertical direction F of the stapler are generally perpendicular to one another.

[0053] 3, the retaining pin assembly 102 is disposed perpendicular to the tissue contacting platform 111 of the staple cartridge 10. The retaining pin assembly 102 is slidable within the hollow cavity 113 along the longitudinal direction F of the stapler 1 (i.e., the retaining pin assembly 102 can slide from a mounting position fully received within the hollow cavity 102 to an end position extending into the retaining pin receiving hole 203 on the anvil 20) and is operably coupled to the closure drive mechanism 40 of the surgical stapler 1. In this manner, when the closure drive mechanism 40 is actuated, the pin rod 121 of the retaining pin assembly 102 extends distally from the retaining pin hole 114 opened on the tissue contacting platform 111 along the longitudinal direction F of the surgical stapler 1.

[0054] According to a preferred embodiment of the present disclosure, the retaining pin assembly 102 includes a pin rod 121 extending along the longitudinal direction of the retaining pin assembly 102. The pin rod 121 has a completely circular cross-sectional shape and includes a free end 126 that can extend from the retaining pin hole 114 and the other end opposite to the free end. In this example, compared with the existing design, the pin rod 121 is offset to one side with respect to the centerline of the staple cartridge 10, so that the pin rod maintains a completely circular cross-sectional shape and allows the pin rod 102 to have a larger diameter. In one example, the pin rod of the retaining pin assembly has a diameter larger than 1.7 mm. Therefore, the solution of the present invention can provide greater strength to the pin rod, obviously improving the stability of the retaining pin assembly 102 during operation, and ensuring that the pin rod 121 smoothly enters the retaining pin receiving hole on the anvil side after penetrating the tissue, thereby ensuring a good staple forming effect.

[0055] 3 further illustrates a staple driver plate 103 disposed within the staple cartridge 10. The staple driver plate 103 extends along the longitudinal direction L of the staple cartridge 10, and is provided on a surface of a distal end facing the surgical stapler 1 with a plurality of teeth extending toward the distal end of the surgical stapler 1, the teeth being configured to push the staples out of the staple cavities 112. The staple driver plate 103 is operatively coupled to a firing drive mechanism (e.g., firing bar 401) of the surgical stapler 1. In this case, the staple driver plate 103 is driven by the firing drive mechanism to move toward the distal end of the surgical stapler 1 when a firing trigger is pulled to perform a firing operation, and the plurality of teeth disposed on the staple driver plate can push the staples to complete deployment accordingly.

[0056] Figure 4 is a principal view of a staple cartridge 10 according to the present disclosure. Figure 4 clearly shows a tissue contacting platform 111 on the cartridge body 101 of the staple cartridge 10. Provided on the tissue contacting platform 111 are two or more rows of staple cavities (the staple cavities 112 are arranged in two rows in the embodiment shown in Figure 4, but may be arranged in three or more rows in other embodiments) arranged in the longitudinal direction L of the staple cartridge 10, and retaining pin holes 114 that allow the pin rods 121 of the retaining pin assemblies 102 to extend therethrough. 4, two rows of staple cavities 112 are disposed along the longitudinal direction L of the staple cartridge 10 on either side of the longitudinal centerline of the staple cartridge, the longitudinal centerline of which coincides with the longitudinal centerline of the staple cartridge, and the retaining pin holes 114 for receiving the retaining pin assemblies 112 are offset relative to the centerline of the staple cartridge 10 such that the outermost edge of the outermost staple cavity in the row of staple cavities 112 is aligned with or extends from the center of the pin rod 121 of the retaining pin or the center of the retaining pin hole 114. With such a configuration, the present disclosure can achieve that the outermost staple line covers at least half of the retaining pin hole 114 after firing, thereby ensuring a tissue stapling effect and reducing the risk of bleeding and tissue fluid leakage.

[0057] In accordance with a preferred implementation of the present disclosure, the pin rod 121 of the retaining pin assembly 102 is offset relative to the longitudinal centerline of the staple cartridge 10 and the longitudinal centerlines of the rows of staple cavities 112 are offset relative to the longitudinal centerline of the staple cartridge 10. Alternatively, in accordance with a further solution, the pin rod 121 of the retaining pin assembly 102 is centered relative to the longitudinal centerline of the staple cartridge 10 and the longitudinal centerlines of the rows of staple cavities 112 are offset relative to the longitudinal centerline of the staple cartridge 10.

[0058] In an example according to the present disclosure, the staple cavities 112 are arranged in two rows, and the two rows of staple cavities 112 can have the same length or different lengths. When the two rows of staple cavities have different lengths, the outermost edge of the outermost staple cavity in the longer row of staple cavities extends beyond the longitudinal axis of the pin rod 121, and the shorter row of staple cavities is adjacent to the opening 114 of the chute 113. When the two rows of staple cavities have the same length, the two rows of staple cavities are arranged offset, and the outermost edge of the outermost staple cavity in one row of staple cavities extends beyond the longitudinal axis of the pin rod 121, while the outermost edge of the outermost staple cavity in another row of staple cavities is adjacent to the opening 114 of the chute 113. In this manner, blood or fluid leakage can be further reduced.

[0059] 4, cartridge body 101 further includes a plurality of ridges 116 extending from tissue contacting platform 111 toward the distal end of surgical stapler 1, such that two adjacent ends of openings 117 of two adjacent staple cavities are surrounded by respective ridges 116. Alternatively, at least a portion of opening 117 of each staple cavity is surrounded by a portion of a respective ridge 116 or a portion of a plurality of ridges. Thus, when the jaws are closed, ridges 116 contact tissue first to prevent, or at least limit, relative movement between the tissue and the staple cartridge.

[0060] Additionally, a ring-shaped bump 127 may be formed around the retaining pin hole 114. Alternatively, the bump 127 only partially surrounds the retaining pin hole 114. The bump can not only provide better guidance and additional support for the pin rod 121 when the retaining pin assembly is actuated, but can also prevent tissue from being squeezed out of the end effector when the end effector is closed.

[0061] 5 is a perspective view of a portion of an end effector 1 according to the present disclosure. The cross section shown in FIG. 5 is of the end effector having the jaw structure and located adjacent the exterior. It can be seen that the anvil 20 includes a tissue contacting surface 201, the tissue contacting surface of the anvil 20 configured having a plurality of staple forming pockets 202 thereon for stapling deformation of staples arranged in rows corresponding to the plurality of staple cavities 112 on the staple cartridge.

[0062] Additionally, the tissue contacting surface 201 of the anvil 20 is further provided with a retaining pin receiving hole 201 for receiving and positioning the pin rod of the retaining pin assembly 102. The retaining pin receiving hole 203 is aligned with the retaining pin chute opening 114 on the cartridge body 101 of the staple cartridge 10 such that the staple cavity openings 117 of the staple cavities 112 on the staple cartridge 10 are aligned with the staple forming pockets 202 on the anvil 20 when the end effector 1 is clamping tissue to be stapled. When the jaws of the end effector are closed to clamp tissue, the pin rod of the retaining pin assembly 102 of the staple cartridge 10 can extend from the retaining pin chute opening 114 as the retaining pin assembly 102 slides within the retaining pin chute 113 and the free end 126 of the pin rod 121 can be inserted into the retaining pin receiving hole 203.

[0063] As shown in Fig. 5, similar to the situation of the staple cavities 112 and the retaining pin chute openings 114 on the staple cartridge, the outermost edge of the outermost staple forming pocket in at least one row of the staple forming pockets 202 is aligned with or extends from the center of the retaining pin hole in the longitudinal direction L of the anvil 20, and the retaining pin receiving holes 203 and the staple forming pockets 202 on the anvil 20 are aligned with the retaining pin chute openings 114 and the staple cavities 112, respectively, in the embodiment shown in Fig. 4. In the embodiment shown in Fig. 5, the retaining pin receiving holes 203 are configured in a cylindrical shape, and each retaining pin chute opening 114 is correspondingly configured in a circular shape. Of course, as long as the retaining pin assembly 102 can be positioned, other shapes of the retaining receiving holes 203 and the retaining pin chute openings 114 that can be conceived by a person skilled in the art can be adopted, and all of these are within the scope of protection of the present disclosure.

[0064] Additionally, as can be seen in FIG. 5, the cartridge body 101 of the staple cartridge 10 on both sides is further configured with a slot 115 extending along the longitudinal direction F of the surgical stapler 1 such that the respective structures of the retaining pin assemblies 102 extend from the cartridge body 101 in a preferred embodiment.

[0065] As mentioned above, in the embodiment of the staple cartridge 10 shown in FIG. 4, the retaining pin assembly 102 is offset relative to the longitudinal centerline of the staple cartridge 10, and the longitudinal centerlines of the rows of staple cavities 112 are coincident with the longitudinal centerline of the staple cartridge 10. Thus, as observed from the main view of the staple cartridge 10, the staple cavity openings 117 are perfectly centered on the tissue contacting platform 111, while the retaining pin holes 114 are offset. In contrast, FIGS. 6a and 6b respectively show two other possible preferred embodiments of the staple cartridge 10. Here, in the embodiment as shown in FIG. 6a, the pin rods 121 of the retaining pin assembly 102 are centered relative to the longitudinal centerline of the staple cartridge 10, while the longitudinal centerlines of the rows of staple cavities 112 are offset relative to the longitudinal centerline of the staple cartridge 10. In this case, the staple cavity openings 117 are generally offset on the tissue contacting platform 111 while the retaining pin holes 114 are centered. In the embodiment as shown in FIGURE 6b, the retaining rods 1121 of the retaining pin assembly 102 are offset relative to the longitudinal centerline of the staple cartridge 10 and the longitudinal centerlines of the multiple rows of staple cavities 112 are offset relative to the longitudinal centerline of the staple cartridge. In this case, the retaining pin holes 114 and the staple cavity openings 117 are all offset on the tissue contacting platform 111.

[0066] 7a and 7b are schematic diagrams of a portion of an anvil according to different preferred implementations of the surgical stapler of the present disclosure. As shown in FIG. 7a, the retaining pin receiving hole 203 on the anvil 20 is configured to open toward the side of the anvil along the lateral direction of the anvil 20. As shown in FIG. 7b, the retaining pin receiving hole 203 on the anvil 20 connects to the outside through a notch formed on the edge of the anvil on one side adjacent to the retaining pin receiving hole. In the embodiment shown in FIG. 7a and 7b, the retaining pin receiving hole 203 has an incomplete circular shape, preferably an eccentric semicircular shape, for example. The retaining pin receiving hole 203 having such a shape can also receive the tip-like free end 126 of the retaining pin assembly 102, thereby performing the positioning function of the retaining pin assembly 102.

[0067] FIG. 8 shows a schematic view of the structure of a retaining pin assembly 102 of a staple cartridge 10 according to a preferred embodiment of the present disclosure from multiple perspectives, with FIGS. 8a to 8c being perspective, side, and bottom views of the retaining pin assembly 102, respectively.

[0068] As shown in Figures 8a to 8c, the retaining pin assembly 102 includes a pin rod 121 extending along its longitudinal direction, the pin rod having a tip-shaped free end 126 that can extend from the retaining pin hole 114 of the cartridge body 101 and the other end opposite the free end, a pin base 122 connected to the other end of the pin rod 122 and fixedly holding the pin rod 121, and a retaining pin tail 125, in this embodiment, fixed to the side of the pin base 122 away from the pin rod 121 and having two legs spaced apart from each other.

[0069] In addition, as shown in FIG. 8a, the retaining pin assembly 102 further includes a pair of clips 123, 124 disposed on both sides of the pin base 122. The pair of clips 123 and 124 are configured with a wrinkled or corrugated structure thereon for anti-slip purposes when they are held by a clinician. When the closure drive mechanism 40 is not actuated, the clinician can manually slide the retaining pin assembly 102 in the retaining pin chute 113 by manipulating the clips 123, 124 with his fingers. The clips 123, 124 are configured on two sides of the cartridge body 101 and extend from the cartridge body 101 along a slot 115 extending in the stapler's longitudinal direction, as shown in FIG. 5, so that the retaining pin assembly 102 is manipulated by the user to slide along the retaining pin chute 113. According to a preferred implementation, as shown in FIG. 8a and FIG. 8c, the clips 123, 124 have an ear-like structure.

[0070] 9A and 9B are rear views of the end effector showing the structure of and the relative relationship between the retaining pin assembly 102 and the staple driver plate 103 of the staple cartridge 10, with FIG. 9A being a view according to the prior art and FIG. 9B being a view according to a preferred embodiment of the present disclosure.

[0071] In the prior art, the pin rod 121 of the retaining pin assembly 102 is generally centrally located relative to the pin base 122. As shown in FIG 9a, a pair of clips 123, 124 are configured with mirror symmetry about the central axis of the retaining pin assembly, such that the retaining pin assembly 102 is positioned generally above the staple driver plate 103 and the pin base 122 can pass above an edge surface of the staple driver plate 103.

[0072] 8a-8c respectively show a retaining pin assembly according to a preferred embodiment of the present disclosure. In particular, the pin rod 121 of the retaining pin assembly 102 is offset with respect to the longitudinal central axis of the pin base 122. When the pin rod 121 is offset, in order to reinforce the overall strength of the retaining pin assembly 102, the pin rod 121 offset is designed to have an asymmetric structure on both sides. For example, according to a preferred implementation, on one side (i.e., the side where the pin rod 121 is offset) where the offset of the pin rod 121 has a short distance from the lateral edge of the pin base 122, the thickness of the pin base 122 is increased. Furthermore, to accommodate the offset design of the pin rod 121 and prevent the retaining pin assembly 102 from tilting or pivoting caused by uneven stress distribution when the clips 123, 124 are manually pressed, the pair of clamps 123, 124 are also designed to be asymmetrical around the central axis of the retaining pin assembly 102, i.e., the clip 124 located on the side where the pin rod 121 is offset is configured to be larger than the clip 123 on the side where the pin rod 121 is offset. In other words, the ear-like clips 123, 124 on both sides of the pin base are of different sizes.

[0073] However, a disadvantage of the retaining pin assembly shown in Figures 8a to 8c is that because the pin rod 121 is offset and the pin base 122 is thicker on the side where the pin rod 121 is offset, a part of the pin base 122 interferes with the staple driver plate 103 in the longitudinal direction L of the staple cartridge, and the retaining pin assembly 102 cannot be manually pushed onto the staple driver plate 103.

[0074] To solve the above problem, a possible solution is to increase the length of the pin rod 121 so that the free end 126 of the pin rod 121 reaches the retaining pin receiving hole 203 on the anvil 20 before the pin base 122 interferes with the staple driver plate 103. However, since the overall length of the retaining pin assembly 102 is increased, the cartridge body 101 becomes longer along the longitudinal direction F of the stapler, and therefore cannot be made into a compact structure. For this purpose, FIG. 9b shows an embodiment adapted to the retaining pin assembly 102 as shown in FIG. 8, which can avoid interference between the retaining pin assembly 102 and the staple driver plate 103, on the premise of ensuring the offset structure of the retaining pin assembly 102 and the overall compact structure of the staple cartridge. In this embodiment, the staple driver plate 103 is formed at its distal end portion adjacent to the retaining pin assembly 102 with an avoidance feature 131, for example, a notch formed at the distal end portion of the staple driver plate adjacent to the retaining pin assembly. The notch extends along the longitudinal direction F of the stapler and is configured to bypass the retaining pin assembly 102, and in particular to allow the pin base 122 of the retaining pin assembly to pass through the notch. In this manner, the retaining pin assembly 102 can advance toward the distal end of the surgical stapler 1 and completely pass through the staple driver plate 103, as shown in FIG. 10. According to this embodiment, the retaining pin assembly 102 can be pushed distally until it reaches an end position.

[0075] In addition to the end effector located at the distal end of the stapler, the surgical stapler further includes a closure and firing mechanism located at a proximal end of the stapler for closing the staple cartridge and anvil to clamp the tissue to be stapled and to implement the cutting and stapling action on the tissue. The closure and firing mechanism generally includes a pistol grip connected to the handle 70 of the surgical stapler, a closure trigger pivotally secured on the handle 70 of the surgical stapler and coupled to a drive mechanism of the staple cartridge or anvil, and a firing trigger pivotally secured on the handle 70 and coupled to a drive mechanism of the staple.

[0076] During surgery, a clinician can grasp the pistol grip and then pivotally pull the closure trigger, which actuates a closure drive mechanism of the staple cartridge, thus moving the staple cartridge relative to the anvil to close the end effector and clamp tissue. A firing trigger is located to one side of the closure trigger, away from the pistol grip, and can be pivotally pulled by the clinician, which causes actuation of the firing drive mechanism of the stapler, further driving the staple driver plate to push staples against the tissue to staple the tissue.

[0077] In practice, after gripping the grip, the user first actuates the closure trigger, manipulates the retaining pin assembly for positioning when satisfied with the relative position of the staple cartridge and the anvil of the end effector, and then locks the closure trigger in a fully closed, locked position to clamp the tissue. The user then actuates the firing trigger to activate and move the firing bar 401 toward the end effector, and further moves the staple driver plate toward the tissue to implement stapling. During the process, the user needs to continuously apply force to the firing trigger to fire the staples toward the tissue. After stapling is completed, the user stops applying force and the firing trigger is restored. For example, when the release button 504 on the handle 70 is pressed, the lock of the closure trigger is released, and the retaining pin assembly is released accordingly, and the stapled tissue is finally released. If the length of the tissue to be stapled is long, this process needs to be repeated until all the tissue is stapled.

[0078] It will be understood that conventional surgical staplers often rely on the user's experience to determine whether the staple is in place and whether stapling is complete to determine whether to stop applying force. However, this creates a large variation in the average user and does not lead to standardization of surgical procedures. Furthermore, conventional surgical staplers may extend the firing operation time per one shot, reducing operation efficiency, and thus bringing certain risks to the operation and the patient.

[0079] In view of the above, and in accordance with the present disclosure, there is further provided an indication mechanism that perceptibly indicates to a user that a firing operation is complete, allowing a user operating the surgical stapler to be perceptibly indicated that a firing operation is complete and to allow the user to complete stapling in a timely manner or to reset the end effector and closure and firing mechanisms and then continue to repeat the operations as described above to perform additional firing operations.

[0080] According to a first implementation of the indication mechanism, the indication may be implemented visually. More specifically, a mark is provided at a specific location on the top surface of the firing bar 401 of the firing drive mechanism coupled to the firing trigger. The mark may be located in a left and / or right spacer of the firing bar 401, which is assembled on the firing bar 401 and moves with the firing bar 401. The mark may be a circle, a square, or any other shape or pattern that is visually noticeable. The mark may be a laser mark, an engraved mark, an ink mark, etc. With the actuation of the firing trigger, the mark may move with the firing bar toward the end effector. The mark is hidden within the stapler shroud 505 until the complete firing operation is completed, at which point the mark is just fully exposed from the stapler shroud 505 to be visually spotted by the user, thus prompting the user that the firing operation is completed.

[0081] In addition, according to a second implementation of the indication mechanism, the indication can be achieved audibly and / or tactilely. More specifically, a protrusion is arranged on the rear side of the firing trigger of the closure and firing mechanism, away from the end effector, and a button that produces a sound when pressed is arranged on the front side of the closure trigger facing the end effector. For example, the button is made of rubber. Of course, a technical solution is also possible in which the button is arranged on the rear side of the firing trigger and the protrusion is arranged on the front side of the firing trigger. The protrusion and the button are designed such that when the firing trigger is pivoted to the firing completion position, the protrusion can fully depress the button, causing the button to generate a clicking sound or the like, thus prompting the user that the firing operation is completed. Furthermore, the button can be configured, for example, to provide force feedback when fully depressed by the protrusion, allowing the user to tactilely sense with a finger an indication that the firing operation is completed.

[0082] In addition to the two types of indication mechanisms that can provide an indication that the firing operation is complete, as described above, there may be other technical solutions that can enable a user to perceptibly (e.g., audibly, visually, or tactilely) recognize that the firing operation of the surgical stapler is complete, and these are also within the scope of what is disclosed in this specification.

[0083] 11a-11c are schematic diagrams illustrating the relative positions of the closure trigger 502 and firing trigger 503 of a closure and firing mechanism according to the present disclosure in different states, where only a truncated portion of the closure and firing mechanism of a surgical stapler is shown. The closure and firing mechanism can be adapted to various types of end effectors 1 and therefore can be applied in particular to open or endoscopic surgery as required.

[0084] As shown in FIG. 11a, the closure and firing mechanism is disposed in the body frame 30 of the surgical stapler. The closure and firing mechanism includes a pistol grip 501 fixedly connected to the body frame 30, and a closure trigger 502 and a firing trigger 503 configured to be pivotable relative to the grip. The closure trigger 502 and the firing trigger 503 are coupled to the firing drive mechanism 40. The closure trigger 502 can push the staple cartridge 10 and the retaining pin assembly 102 through the firing drive mechanism 40 to move them toward the anvil 20, thereby allowing the end effector 1 to enter a closed state, and the firing trigger 503 can further drive the staple driver plate 103 to drive the respective staple drivers, and finally push the staples to implement firing. When the end effector 1 of the surgical stapler is in an inactivated or open state, the firing trigger 503, the closure trigger 502, and the pistol grip 501 are spaced apart from each other.

[0085] As shown in FIG. 11b, after the surgical procedure is initiated, the tissue to be stapled is first placed in a predetermined position relative to the end effector 1 of the surgical stapler, specifically between the anvil 20 and the staple cartridge 10. After the alignment is performed, the clinician manipulates the retaining pin assembly 102 to position the tissue to be stapled relative to the staple cartridge 10 and the anvil 20. The clinician then pulls the closure trigger 502 toward the grip 501. The closure trigger 502 then pivots counterclockwise, pushing the staple cartridge 10 and the retaining pin assembly 102, via the firing drive mechanism 40, toward the anvil 20, thereby clamping the tissue. After the tissue is fully clamped, the clinician can lock the closure trigger 502 relative to the grip by triggering a lock button (not shown), and the stapler end effector 1 is now in a closed state.

[0086] 11c, after the tissue is positioned and clamped, the clinician may begin stapling. The clinician pulls the firing trigger 503 toward the grip. The firing trigger 503 then actuates the staple driver plate 103 via a firing bar (not shown) to fire the staples. In the firing process, the clinician must continuously apply force to the firing trigger 503, and after the clinician determines that the firing motion is complete, the firing trigger 503 is pivoted to a fired position adjacent the closure trigger.

[0087] As previously mentioned, the firing process relies on the experience of the clinician to determine if the staples are in place and if stapling is complete to determine whether to stop applying force. In accordance with the present disclosure, an indication mechanism 60 is provided that allows the clinician to perceptibly sense an indication that the firing action is complete.

[0088] Reference is now made to show two possible implementations of the indicator mechanism 60. Figures 12 and 13 show implementations of the indicator mechanism 60, with Figure 12 being a top view of an implementation of the closure and firing mechanism of a surgical stapler according to the present disclosure in a fully fired state, and Figure 13 being a partially enlarged view of the indicator mechanism shown in Figure 12. The indicator mark 601 is used to indicate that the firing action is complete. More specifically, the indicator mark 601 is provided at a specific position on the top surface of the firing bar 401 coupled to the firing trigger 503. During firing, the indicator mark 601 moves together with the firing bar 401 relative to the shroud 505 of the pistol grip 501. In the implementation as shown in Figures 12 and 13, the mark 601 is a circle, which may also be a square or any other shape or pattern that is visually noticeable. With the actuation of the firing trigger 503, the mark 601 can move together with the firing bar 401 toward the end effector 1. The marking 601 is hidden within the shroud 505 of the pistol grip 501 until the full firing motion is completed, at which point the marking 601 is just fully exposed from the shroud 505 to be visually spotted by the user, thus prompting the user that the firing motion is complete.

[0089] 14-16 show a further implementation of the indication mechanism, in which a sound is used to indicate that the firing operation is completed. In this implementation, the indication can be implemented audibly and / or tactilely. The closure trigger 502 and the firing trigger 503 of the closure and firing mechanism each include a pivot and a trigger. As shown in FIGS. 14 and 15, a protrusion 602 is disposed at the connection between the pivot and the trigger of the firing trigger 503 on the side of the firing trigger 503 away from the end effector 1, and a button 603, particularly a rubber button, is provided at the connection between the pivot and the trigger of the closure trigger 502 on one side of the closure trigger 502 facing the end effector 1, which generates a sound when pressed down. As shown in FIG. 16, the protrusion 602 and the button 603 are designed such that when the firing trigger is pivoted to the firing completion position, the button 603 is fully pressed down by the protrusion 602 to generate a clicking sound or the like, thus prompting the clinician that the firing operation is completed. Additionally, for example, if a rubber button is utilized, it may be preset to provide force feedback when button 603 is fully depressed by protrusion 602 to allow the clinician to tactilely sense with their finger an indication that the firing action is complete.

[0090] Figure 15 is an enlarged partial perspective view of the closure trigger shown in Figure 14, showing the button 603, particularly the rubber button, at the connection between the pivot portion and the trigger portion of the closure trigger 502. Figure 16 shows the position of the firing trigger 503 relative to the closure trigger 502 upon completion of the firing stroke, from which it can be seen that the protrusion 602 on the firing trigger is fully pressed onto the button 603 of the closure trigger 502. At this point, the button makes an audible sound indicating that the firing stroke is complete.

[0091] Fig. 17 is a partial perspective view of a body frame of a surgical stapler at a distal end in accordance with the present disclosure, showing an anvil mounted on a hook plate, and Fig. 17 shows a hook plate 204 for a surgical stapler including an anvil 20 having varying edge widths and used in cooperation with the anvil 20.

[0092] As shown therein, the anvil 20 of the surgical stapler according to the present disclosure is fixedly connected to the stapler's body frame 30, which typically consists of two symmetrically configured support pieces 301. A slit is formed between the two support pieces 301. A firing bar 401 coupled to the stapler's closing and firing mechanism can be received in the slit (not shown) and driven by the closing and firing mechanism, and the staple cartridge 10 can be pushed toward the anvil 20 along the longitudinal direction of the stapler to implement staple firing. According to the present disclosure, a hook plate 204 is provided along the outer side of the anvil 20. The hook plate 204 forms a bent portion 206 at the end of the anvil 20. The hook plate 204 is fixedly connected to the side of the anvil 20 by gluing, riveting, welding, etc. In addition, the thickness of the hook plate 204 can be selected as required in practice, and anvils 20 with varying edge widths can be obtained.

[0093] FIG. 18 is a main view showing a schematic representation of a truncated portion at the end of the anvil 20 having a hook plate 204. The anvil 20 with a variable edge width provides support for the offset retaining pin assembly 102 of the surgical stapler. In the configuration of the anvil 20 with a variable edge width, the retaining pin receiving hole 203 is disposed offset from the longitudinal central axis of the anvil 20. In this way, a space-saving design is obtained, and the anvil 20 is structurally complete and has a suitable width. This is particularly advantageous when a thick pin rod 121 is applied, which can ensure a good staple forming effect.

[0094] 18, the anvil 20 includes a first portion 207 and a second portion 208 split along the median plane of the surgical stapler, with the retaining pin receiving hole 203 disposed on the first portion 207, and the width of the first portion 207 being greater than the width of the second portion 208. Additionally, the surgical stapler further includes an anvil mounting portion 209 to which the anvil 20 is fixedly attached, with a thin inner shim 205 disposed on a side of the anvil mounting portion 209 to offset the median plane of the anvil relative to the median plane of the surgical stapler. The shape of the inner shim 205 is identical to the shape of the side of the anvil mounting portion.

[0095] Preferred implementations according to the present disclosure have been described above with reference to the accompanying drawings. However, those skilled in the art will understand that the accompanying drawings and corresponding descriptions are only provided to illustrate the purpose of the present disclosure, and based thereon, various other substitutions or improvements are possible, all of which fall within the protection scope of the present disclosure. [Explanation of symbols]

[0096] [Table 1-1]

[0097] [Table 1-2]

Claims

1. A staple cartridge for use with a surgical stapler, Multiple staples, The cartridge itself, Organization contact platform and A plurality of staple cavities, each of which has an opening formed in the tissue contact platform, the staples are positioned within each of the staple cavities and extend out of the opening when deployed, and the plurality of staple cavities are arranged in a row along the longitudinal direction of the staple cartridge, A retaining pin assembly, slidably positioned on the outer end of the cartridge body adjacent thereto, operably connected to the closing drive mechanism of the surgical stapler, and which, when the closing drive mechanism is actuated, can extend distally from a retaining pin hole opened on the tissue contact platform along the longitudinal direction of the surgical stapler; A cartridge body comprising, The retaining pin assembly comprises a pin rod extending along the longitudinal direction of the retaining pin assembly, the pin rod having a circular cross-section, In the longitudinal direction of the staple cartridge, the outermost edge of the outermost staple cavity in at least one row of staple cavities is aligned with the longitudinal axis of the pin rod or extends beyond the longitudinal axis of the pin rod. A staple cartridge wherein the pin rods of the retaining pin assembly are offset with respect to the longitudinal centerline of the staple cartridge, or the pin rods of the retaining pin assembly are centered with respect to the longitudinal centerline of the staple cartridge, while the longitudinal centerlines of the multiple rows of staple cavities are offset with respect to the longitudinal centerline of the staple cartridge.

2. The staple cartridge according to claim 1, wherein the pin rod of the retaining pin assembly is offset with respect to the longitudinal centerline of the staple cartridge, and the longitudinal centerlines of the plurality of rows of the staple cavity coincide with the longitudinal centerline of the staple cartridge.

3. The staple cartridge according to claim 1, wherein the pin rod of the retaining pin assembly is offset with respect to the longitudinal centerline of the staple cartridge, and the longitudinal centerlines of the plurality of rows of the staple cavity are offset with respect to the longitudinal centerline of the staple cartridge.

4. The staple cartridge according to any one of claims 1 to 3, wherein the staple cavities are arranged in two rows, the outermost edge of the outermost staple cavity in one of the two rows of staple cavities extends beyond the longitudinal axis of the pin rod, and the other row of staple cavities is positioned adjacent to the retaining pin hole.

5. The pin rod comprises a free end that can extend from the retaining pin hole and another end opposite to the free end, and the retaining pin assembly further comprises a pin base fixedly connected to the other end of the pin rod. The staple cartridge according to any one of claims 1 to 3, wherein the pin rod is offset with respect to the longitudinal central axis of the pin base.

6. The staple cartridge according to claim 5, wherein the retaining pin assembly has an asymmetric structure on both sides of the offset pin rod.

7. The staple driver plate further comprises a staple driver plate that extends along the longitudinal direction of the staple cartridge and has a surface facing the distal end of the surgical stapler, on which a plurality of teeth are provided that extend toward the distal end of the surgical stapler and are configured to push the staple out of the staple cavity, The staple cartridge according to claim 5, wherein the staple driver plate is formed having a bypass feature in the distal end portion adjacent to the retaining pin assembly, which allows the retaining pin to advance toward the distal end of the surgical stapler by overriding the staple driver plate.

8. The staple cartridge according to claim 7, wherein the avoidance feature is a notch formed on one side of the staple driver plate adjacent to the retaining pin assembly, the notch extends along the firing direction of the staple cartridge and is configured to allow the retaining pin to pass through the notch.

9. The staple cartridge according to claim 5, wherein the retaining pin assembly further includes clips formed on both sides of the pin base, the clips being formed on two sides of the cartridge body and configured to extend out of the cartridge body along a slot extending along the firing direction of the staple cartridge, thereby allowing the retaining pin assembly to be operated by the user to slide along the slot.

10. The staple cartridge according to claim 9, wherein the clip has an ear-shaped structure.

11. The staple cartridge according to claim 10, wherein the ear-shaped clips located on both sides of the pin base are of different sizes.

12. The staple cartridge according to any one of claims 1 to 3, wherein the cartridge body further comprises a plurality of raised portions extending from the tissue contact platform, and at least a portion of each of the openings of the staple cavity is surrounded by a portion or part of the raised portions.

13. The staple cartridge according to any one of claims 1 to 3, wherein bumps are formed around at least a portion of the retaining pin holes.

14. The staple cartridge according to any one of claims 1 to 3, wherein the free end of the retaining pin assembly is configured as the tip.

15. The staple cartridge according to any one of claims 1 to 3, wherein the pin rod of the retaining pin assembly has a diameter greater than 1.7 mm.

16. A surgical stapler for stapling tissue in surgical procedures, A staple cartridge according to any one of claims 1 to 3, An anvil for forming staples within the staple cartridge, A firing drive mechanism operably connected to the staple cartridge, the staple firing mechanism comprising: a firing drive mechanism for operating the staple driver plate to drive a plurality of staple drivers distal to the surgical stapler so as to deploy the staples from the staple cavity; The aforementioned anvil, Tissue contact surface, A plurality of staple-forming pockets formed on the tissue contact surface, the plurality of staple-forming pockets arranged in rows corresponding to the plurality of staple cavities of the staple cartridge, A retaining pin receiving hole for receiving the free end of the retaining pin assembly of the staple cartridge, the retaining pin receiving hole being located at the end of the anvil adjacent to the outside, A surgical stapler wherein, in the longitudinal direction of the anvil, the outermost edge of the outermost staple-forming pocket in at least one row of the staple-forming pockets is aligned with the center of the retaining pin receiving hole on the anvil side, or extends beyond it.

17. The surgical stapler according to claim 16, wherein the retaining pin receiving hole on the anvil side is centered with respect to the longitudinal centerline of the anvil, and the longitudinal centerlines of the plurality of rows of staple-forming pockets are offset with respect to the longitudinal centerline of the anvil.

18. The surgical stapler according to claim 16, wherein the retaining pin receiving hole on the anvil side is offset with respect to the longitudinal centerline of the anvil, and the longitudinal centerlines of the plurality of rows of staple-forming pockets are offset with respect to the longitudinal centerline of the anvil.

19. The surgical stapler according to claim 16, wherein the retaining pin receiving hole on the anvil side is offset with respect to the longitudinal centerline of the anvil, and the longitudinal centerlines of the plurality of rows of staple-forming pockets coincide with the longitudinal centerline of the anvil.

20. The surgical stapler according to claim 18, wherein the anvil comprises a first portion and a second portion divided along the midline plane of the surgical stapler, the retaining pin receiving hole on the anvil side is located in the first portion, and the width of the first portion is greater than the width of the second portion.

21. The surgical stapler according to claim 20, further comprising an anvil mounting portion to which the anvil is fixedly attached, wherein the anvil mounting portion has a thin inner shim on its side such that the midline plane of the anvil is offset with respect to the midline plane of the surgical stapler.

22. The surgical stapler according to claim 21, wherein the shape of the inner shim is the same as the shape of at least a part of the side surface of the anvil mounting portion.

23. The surgical stapler according to claim 16, wherein the retaining pin receiving hole on the anvil side opens outward toward the side surface of the anvil along the lateral direction of the anvil.

24. The surgical stapler according to claim 23, wherein the retaining pin receiving hole on the anvil side is connected to the outside via a notch formed on the edge of one side of the anvil adjacent to the retaining pin receiving hole.