A non-fastener secured patch attachment method, apparatus

Abstract

This invention relates to the field of medical devices, specifically to a non-fastener-based patch attachment method and device. The patch is attached to at least one anastomosis arm of a stapler via a non-penetrating connector, allowing the patch to be non-penetratingly connected to the anastomosis arm. The anastomosis arm and patch achieve a mechanical self-locking connection and engagement without traditional fasteners through low normal force, normal support force, shear resistance, and / or friction, significantly reducing the risk of patch tearing associated with traditional fasteners. When the stapler is not fired, the constraint effect of this non-penetrating connector on the patch stably fixes the patch to the anastomosis arm, ensuring no relative displacement. Simultaneously, it avoids damage to surrounding tissue caused by the connector penetrating the patch during the stapler's delivery to the target location.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically to a non-fastener-fixed patch attachment method and device. Background Technology

[0002] Surgical staplers are core instruments for organ resection and reconstruction in clinical practice. They can simultaneously perform tissue cutting and stapling, significantly shortening operation time and improving surgical efficiency. Simple metal staple anastomosis suffers from poor compatibility between the staples and soft tissue, leading to complications such as anastomotic bleeding and exudation. Therefore, in clinical practice, patches are used in conjunction with staplers to reinforce and protect the anastomotic edges. The use of patches improves the mechanical fit of the anastomosis, buffers staple stress, effectively seals leakage, prevents anastomotic bleeding and exudation, enhances the tensile strength of the anastomosis, reduces the incidence of anastomotic leakage, and promotes wound healing. Currently, most of the mainstream staplers and patches in the industry adopt a separate independent design, and there is no dedicated matching structure between the two. For example, the anastomosis reinforcement and repair assembly described in patents CN107582123B and CN106821438B are all made by improving the shape of the patch, or making it into a tube, or adding a suture fastening device to the patch so that the operator can put it on the stapler arm when using it. Summary of the Invention

[0003] The aforementioned separate, independently designed patches and staplers lack a positioning structure, making them prone to displacement and slippage. The separate design relies on manual placement, demanding high surgeon skill and easily resulting in patches that are too large and loose, or too small and tight, hindering standardized and regulated use. Furthermore, uneven patch coverage can cause anastomotic leakage and fluid seepage, and patch accumulation can lead to long-term anastomotic stenosis. Intraoperative reassembly also increases the risk of contamination.

[0004] To address the aforementioned problems, in a first aspect, the present invention provides a non-fastener-fixed patch attachment method for use with an anastomosis device, the anastomosis device comprising two anastomosis arms having tissue contact surfaces, characterized in that the patch is attached to at least one anastomosis arm of the anastomosis device via a non-penetrating connector, such that the patch is non-penetratingly connected to the anastomosis arm, and the overlap strength between the patch and the anastomosis arm is in the range of 1-50 N / cm.

[0005] Furthermore, the patch is attached to at least one anastomotic arm of the stapler via a non-penetrating connector, such that the overlap strength between the patch and the anastomotic arm is in the range of 5-45 N / cm.

[0006] For example, the patch is attached to at least one anastomotic arm of the stapler via a non-penetrating connector, such that the overlap strength between the patch and the anastomotic arm is in the range of 5-30 N / cm.

[0007] For example, the lap strength can be tested according to YY / T0729.1-2009.

[0008] When the stapler is not fired, the stapler arm and patch achieve a mechanical self-locking connection and engagement without traditional fasteners through low normal force, normal support force, shear resistance, and / or friction, significantly reducing the risk of patch tearing caused by traditional fasteners. In the unfired state, the patch is stably fixed to the stapler arm by the constraint of this non-penetrating connector, ensuring no relative displacement. Simultaneously, during stapler use, before firing begins, it prevents damage to surrounding tissue from the connector penetrating the patch during delivery to the target location.

[0009] The patch is attached to at least one anastomotic arm of the stapler by normal support force and / or shear resistance.

[0010] As can be listed, the non-penetrating connector has a first state, a second state, and a third state. When the stapler is removed from its packaging and before use, the non-penetrating connector is in the first state; when the stapler is used to clamp and compress tissue but the staples are not fired, the non-penetrating connector is in the second state; and when the stapler has finished firing, the non-penetrating connector is in the third state.

[0011] In one embodiment, the patch is attached to at least one anastomotic arm of the stapler via a non-penetrating connector, and the patch is located on the tissue contact side of the anastomotic arm.

[0012] In the first state, the patch is attached to the tissue contact side of at least one anastomotic arm of the stapler via a non-penetrating connector.

[0013] In some implementations, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of less than 50% of the patch thickness, so that the patch is non-penetratingly connected to the anastomosis arm.

[0014] In some implementations, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of less than 50% of the patch thickness, so that the patch is non-penetratingly and minimally invasively connected to the anastomosis arm.

[0015] In some implementations, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of less than 45% of the patch thickness, and the patch is non-penetratingly connected to the anastomosis arm.

[0016] In some implementations, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of 0-0.6 mm.

[0017] Furthermore, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of 0-0.6 mm (excluding the left end value of 0).

[0018] Furthermore, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of 0-0.2 mm.

[0019] Furthermore, in the first state, the non-penetrating connector is embedded or anchored within the patch at a depth of 0.05-0.2 mm.

[0020] In some implementations, in the second state, the non-penetrating connector may further intrude into the patch, but without piercing it.

[0021] In some implementations, in the second state, the non-penetrating connector is embedded or anchored within the patch to a depth less than 100% of the patch thickness, so that the patch is non-penetratingly and minimally invasively connected to the anastomosis arm.

[0022] As can be listed, patches can be made of partially or fully bioabsorbable materials. It should be noted that patches can be selected from any synthetic or natural material, any combination of bioabsorbable or non-bioabsorbable materials, such as synthetic polyesters, block copolymers, extracellular matrix, collagen, gelatin, proteins, etc. Patch materials can also be any combination of non-porous or porous materials.

[0023] In some implementations, the patch thickness is 0.05-0.5 mm, and the bursting strength is >3 N.

[0024] Further examples include patches with a thickness of 0.1-0.3 mm and a bursting strength > 5 N.

[0025] In the first state, the non-penetrating connector is embedded or anchored within the patch to a depth of less than 50% of the patch thickness. This non-penetrating, low-invasive design also results in a slight protrusion on the side of the patch not embedded with the non-penetrating connector, which helps to increase the friction between the patch and tissue during the stapler's clamping process, improves the stapler's clamping stability, effectively inhibits intraoperative tissue slippage and displacement, ensures accurate puncture and uniform shaping of the staples and / or non-penetrating connectors, and avoids patch retraction, staple leg eversion, or material tearing caused by unstable clamping, thus achieving reliable fixation and mechanical balance of the anastomosis. For example, when anastomosing the pancreas, the smooth surface of the pancreas increases the difficulty of the anastomosis. However, using the stapler of this invention with a non-fastener-fixed patch attachment method can significantly reduce the difficulty of the anastomosis.

[0026] In some embodiments, the non-through-connector includes at least two support portions and a base portion that connects the at least two support portions and is integrally formed.

[0027] In some embodiments, the non-through-connector includes two support portions and a base portion that connects at least two support portions and is integrally formed.

[0028] Furthermore, the two support portions of the non-through connector extend from the base portion at a predetermined angle, forming an angle between the two support portions.

[0029] For example, the two support parts of the non-through connector extend from the base part at a predetermined angle, so that the extension lines of the two support parts form an angle of 2-30°.

[0030] In some implementations, the non-through-connector has an inward or outward angle.

[0031] In some embodiments, the two support portions of the non-penetrating connector extend outward from the base portion in an outwardly expanding arrangement, and the extension lines of the two support portions of the non-penetrating connector form an opening angle.

[0032] Examples of opening angles range from 5 to 30°.

[0033] Examples of opening angles include 10-15°, 8-12°, etc.

[0034] In some embodiments, the two support portions of the non-penetrating connector extend inward from the base portion in an inwardly tapered arrangement, and the extension lines of the two support portions of the non-penetrating connector form an inwardly tapering angle.

[0035] The range of inward angles that can be listed is 2-25°.

[0036] Examples of inward-retracting angles include 4-8° and 4-10°.

[0037] The inward angle is slightly smaller than the opening angle; preferably, the inward angle is 0.5-0.9 times the opening angle.

[0038] More preferably, the inner angle is 0.5-0.8 times the opening angle.

[0039] Non-penetrating couplings include at least inward-facing non-penetrating couplings.

[0040] Furthermore, non-penetrating connectors include inward-facing non-penetrating connectors and outward-facing non-penetrating connectors.

[0041] The inward-facing non-through-connector has an inward-facing angle and no open angle.

[0042] The outward-expanding non-through connector has an opening angle but no inward-retracting angle.

[0043] Furthermore, it can be understood that the tilting angle of the inward-facing non-penetrating connector is 0.5-0.8 times that of the outward-facing non-penetrating connector.

[0044] Generally, this type of inward-facing non-penetrating connector, or similar connectors with inward-facing legs, are rarely used in staplers. This is partly because these inward-facing legs result in relatively poor fastening, and partly because they are difficult to securely fix in the staple cartridge slot. Therefore, in practice, staplers most commonly use staples with parallel legs, followed by some with outward-expanding legs. It's important to note that when using outward-expanding legs in a stapler, special arrangement of these outward-expanding screws is often required. Unlike existing technologies, this technical solution includes at least an inward-facing non-penetrating connector because this type, with two support sections extending inwardly from the base, provides a tighter fit with the attachment patch after insertion. Simultaneously, the non-penetrating connector is embedded or anchored within the patch at a depth less than 50% of the patch thickness. Combined with an inward-facing non-penetrating connector with a specific tilt angle, the activation of the non-penetrating connector affects the resistance of the patch to the staples, thereby improving the staple formation effect of the inward-facing non-penetrating connector. Furthermore, the non-penetrating connector's low-intrusion anchoring of the patch also achieves the fixation of the inward-facing non-penetrating connector within the staple cartridge slot.

[0045] In some embodiments, the patch is attached to at least one anastomotic arm of the stapler by a plurality of non-penetrating connectors, such that the overlap strength between the patch and the anastomotic arm is in the range of 1-50 N / cm; wherein the non-penetrating connectors include inward non-penetrating connectors and outward non-penetrating connectors; the number of inward non-penetrating connectors is less than the number of outward non-penetrating connectors.

[0046] Examples of inward-facing and outward-facing non-penetrating connectors include those with a quantity ratio range of (2-8):10.

[0047] By using specific inward-facing angles, opening angles, and the number of inward-facing and outward-facing non-penetrating connectors, with the inward-facing angle slightly smaller than the opening angle, and the inward-facing and outward-facing non-penetrating connectors having a quantity ratio range of (2-8):10, the non-penetrating connectors, with their normal support force and shear resistance, effectively constrain the patch while minimizing physical damage to the patch from the constraint in the unfired state of the stapler. This significantly reduces the risk of tearing of the patch and the lateral pulling amplitude of the overall suture area when the stapler is fired, effectively improving the clamping effect of the stapler on tissue and reinforcement materials, preventing tissue slippage and misalignment during the clamping and closing process, ensuring accurate and reliable anastomosis position, improving anastomosis stability and surgical safety, and further helping to eliminate stress concentration in the patch, improving the structural strength and bending stability of the non-penetrating connectors during the firing and forming process of the stapler, and preventing breakage or abnormal plastic deformation during bending and forming.

[0048] In some embodiments, at least one support includes a shallow-penetrating element.

[0049] Non-penetrating connectors anchor the patch to a depth of ≤50% of the patch thickness using shallow penetrating elements, achieving a non-penetrating, low-intrusion connection.

[0050] Examples of shallow-penetrating elements include barbed units, Y-shaped anchoring units, serrated units, protrusion units, ribbed units, tapered units, or pointed units, etc. Alternatively, shallow-penetrating elements may include two or more of the following: barbed units, Y-shaped anchoring units, serrated units, protrusion units, ribbed units, tapered units, or pointed units.

[0051] In some implementations, the non-through-connector also has a chamfered angle.

[0052] In some embodiments, the end of the support portion away from the base portion of the non-through connector has a beveled surface, and the beveled surface forms a bevel angle with the direction of the support portion.

[0053] Examples of such bevel angles include 30-50° and 35-45°.

[0054] The beveled surface is a wedge-shaped surface that is inclined in one direction. The inward-facing non-through-connector is inclined in the direction of the inside of the support; the outward-facing non-through-connector is inclined in the direction of the outside of the support.

[0055] The non-penetrating connector is embedded in or anchored within the patch at the end of its support portion away from the substrate, with an embedding depth ≤ 50% of the patch thickness, so that the patch is non-penetratingly and minimally invasively connected to the anastomosis arm.

[0056] In some embodiments, the non-through connector includes at least two support portions and a base portion, each support portion and base portion being connected by a fillet, and the support portion, base portion and fillet are integrally formed.

[0057] In some implementations, the patch may also be attached to at least one anastomotic arm of the stapler via a limiting component.

[0058] The limiting components may include, for example, cylindrical protrusions extending from the anastomosis arm, and / or slots formed on the edge of the staple cartridge assembly housing.

[0059] Furthermore, the limiting component is integrally formed with the anastomosis arm.

[0060] In a second aspect, the present invention provides a non-penetrating connection kit for patch attachment method of non-fastener fixing, the non-penetrating connection kit including an inward non-penetrating connection member and an outward non-penetrating connection member.

[0061] Thirdly, the present invention provides an attachment device for patch attachment using a non-fastener-fixed method, the attachment device being used in conjunction with a surgical stapler, the surgical stapler including a staple arm having a plurality of staple slots, the staple arm having a first tissue contact surface, the attachment device comprising: (1) A staple cartridge arm with a tissue contact surface, wherein a plurality of staple cartridge slots are provided in the staple cartridge arm; (2) Multiple non-penetrating connectors disposed in the staple cartridge slot, each non-penetrating connector consisting of at least two support parts and a base part that connects the at least two support parts and is integrally formed; wherein, the non-penetrating connectors include inward-facing non-penetrating connectors with an inward-facing angle of 2-30° and outward-facing non-penetrating connectors with an outward-facing angle of 2-30°. (3) and patches; The patch is attached to the staple cartridge arm via a non-penetrating connector, ensuring that the overlap strength between the patch and the staple cartridge arm is in the range of 1-50 N / cm.

[0062] Furthermore, as can be listed, the non-penetrating connector has a first state, a second state, and a third state. When the stapler is removed from its packaging and before use, the non-penetrating connector is in the first state; when the stapler is used to clamp and compress tissue but the staples are not fired, the non-penetrating connector is in the second state; and when the stapler has finished firing, the non-penetrating connector is in the third state.

[0063] When the non-penetrating connector is in the first state, the patch is attached to the first tissue contact surface of the staple cartridge arm through the non-penetrating connector, so that the overlap strength between the patch and the staple cartridge arm is in the range of 1-50 N / cm.

[0064] When the non-penetrating connector is transitioning from the second state to the third state, the support part of the non-penetrating connector penetrates the patch and is formed inward. The patch exerts an outward clamping force and limiting effect on its support part, making the patch fit more tightly. This effectively suppresses the non-penetrating connector, especially the inward-curving non-penetrating connector, from over-curving, swaying, or not fitting tightly during the forming process, thus maintaining a stable forming shape. This further helps to improve the synergy with the outward-expanding non-penetrating connector and ensures balanced force in the stitching area.

[0065] In some implementations, the patch undergoes at least two different local strains simultaneously when stress is applied.

[0066] In some implementations, the patch undergoes at least three different local strains simultaneously when stress is applied.

[0067] In other words, during the transition from the second state to the third state of the non-penetrating connector, the patch undergoes three different local strains simultaneously under applied stress.

[0068] For example, the area where the patch contacts the outward-expanding non-penetrating connector experiences a strain in the range of 0.3-0.8, the area where the patch contacts the inward-retracting non-penetrating connector experiences a strain in the range of 0.3-0.8, and the area where the patch does not contact the non-penetrating connector experiences a strain in the range of 0.1-0.2.

[0069] Examples include the inner wall of the staple cartridge and the limiting step at the bottom of the staple cartridge.

[0070] In some embodiments, the base portion of the non-through connector abuts against the limiting step at the bottom of the staple cartridge groove, while being axially constrained in the staple cartridge groove by the frictional force between its support portion and the inner wall of the staple cartridge groove.

[0071] For example, the support part of the outward-expanding non-penetrating connector fits tightly with the inner wall of the staple cartridge groove, the base part of the outward-expanding non-penetrating connector abuts against the limiting step at the bottom of the staple cartridge groove, and is constrained in the staple cartridge groove by the axial action of the friction between its support part and the inner wall of the staple cartridge groove.

[0072] In some embodiments, the staple cartridge slot is provided with retaining protrusions for radially limiting the non-penetrating connector within the staple cartridge slot in scenarios where the stapler has not been fired. The number of retaining protrusions can be one or more, and their placement is unrestricted.

[0073] For example, when the retractable non-penetrating connector is assembled in the staple cartridge slot, the staple cartridge slot is provided with a retaining protrusion. The inwardly retracting support part forms an elastic compression fit with the retaining protrusion. Relying on the radial limiting effect of the retaining protrusion on the support part, the retractable non-penetrating connector is constrained in the staple hole.

[0074] In some embodiments, when the non-penetrating connector is in the first state, a portion of the support portion of the non-penetrating connector extends out from the staple cartridge slot, such that the end of the support portion away from the base portion is higher than the tissue contact surface of the staple cartridge arm and penetrates a portion of the patch.

[0075] In the first state, for example, the non-penetrating connector is embedded in or anchored within the patch at the end of its support portion away from the base portion, with an embedding depth ≤ 50% of the patch thickness, so that the patch is non-penetratingly and minimally invasively connected to the anastomosis arm.

[0076] As can be listed, in the first state, a portion of the support of the non-penetrating connector extends out from the staple cartridge slot, such that the end of the support away from the base portion is 0.2mm-0.6mm higher than the tissue contact surface of the staple cartridge arm.

[0077] In some embodiments, the support portion of the non-penetrating connector is provided with at least one shallow penetrating element, which is located at the end of the support portion of the non-penetrating connector away from the base portion.

[0078] The shallow-penetrating element is used to cooperate with the support to further improve the adhesion strength between the non-penetrating connector and the patch. In the first state, the non-penetrating connector anchors the patch with the shallow-penetrating element embedded in the patch to a depth of ≤50% of the patch thickness, achieving a non-penetrating, low-invasive connection, further reducing the displacement and detachment of the patch during the firing of the stapler. At the same time, after the stapler is fired, in the second state, the friction between the non-penetrating connector and the tissue is increased, improving the stability of tissue anastomosis clamping.

[0079] When the support portion of the non-through connector is provided with multiple shallow penetration elements, the multiple shallow penetration elements are distributed at intervals along the length direction of the support portion and start at the end of the support portion of the non-through connector that is away from the base portion.

[0080] In some embodiments, when the support portion of the non-through connector is provided with multiple shallow-penetrating elements, the multiple shallow-penetrating elements of the same non-through connector have the same orientation.

[0081] For example, for inward-facing non-through-connectors, the shallow-penetrating element is located on one side of the inner side of the support; for outward-facing non-through-connectors, the shallow-penetrating element is located on one side of the outer side of the support.

[0082] In some implementations, the direction of the shallow-penetrating element is symmetrical about the y-axis to the direction of the inclined extension of the support portion.

[0083] In some implementations, inward-facing non-penetrating connectors and outward-facing non-penetrating connectors are arranged alternately.

[0084] The inward-facing angle of the inward-facing non-penetrating connector and the outward-facing opening angle of the outward-facing non-penetrating connector have different angles. In particular, the inward-facing angle of the inward-facing non-penetrating connector is slightly smaller than the opening angle of the outward-facing non-penetrating connector. This angle setting allows different normal pressures to be applied to the anastomotic reinforcement material and tissue after the stapler is activated. The tissue interface forms a periodic local compression effect. High stress produces a local compression effect, resulting in a tighter fit. Low stress areas are buffered to prevent tissue ischemia and necrosis and improve the overall stapleability of the non-penetrating connector.

[0085] In some embodiments, a stop module is provided in the staple cartridge slot, which contacts the non-penetrating connector but not the patch.

[0086] In some embodiments, a stop module is provided in the staple cartridge slot. The stop module contacts the non-penetrating connector to limit the initial position and radial sway of the non-penetrating connector, and to provide guidance for the non-penetrating connector to switch between various states, further ensuring that the support part of the non-penetrating connector penetrates the patch and inserts into the tissue along a preset trajectory.

[0087] As can be listed, the stop module can be any mechanical structure with limiting or locking functions, and the stop module is selected from or includes any combination of rotary locking mechanisms, wedge locks, latch locks, snap-locking structures, etc. For example, the stop module can be a gel with partially embedded non-penetrating connectors, such as lyophilized in-situ gel, lyophilized gel, or oven-dried gel. In the first state, the stop module is in contact with the non-penetrating connector portion but not with the patch. The lyophilized in-situ gel exists in solid form in a dry or low-humidity environment outside the body. Upon contact with tissue fluid or under certain humidity and temperature conditions, it swells and reconstructs its network through mechanisms such as solvent exchange, temperature response, or ion-induced cross-linking, transforming into a three-dimensional gel form, such as chitosan, chitosan / α,β-glycerophosphate, gelatin, methacrylamide gelatin, or PLGA / polyethylene glycol copolymer. In some embodiments, a limiting component is provided on the tissue contact surface of the staple arm, the limiting component being used to facilitate the adhesion between the patch and the tissue contact surface of the staple arm. The limiting component may be integrally formed with the staple arm.

[0088] In some embodiments, the limiting component includes at least two cylindrical protrusions protruding from the tissue contact surface of the staple arm and / or a slot disposed on the edge of the staple arm and extending integrally along the edge of the staple arm.

[0089] For example, the limiting assembly includes at least two positioning posts protruding from the tissue contact surface of the staple cartridge arm. The positioning posts are distributed along the edge of the tissue contact surface of the staple cartridge arm. Simultaneously, the patch is provided with positioning holes for fixing to the positioning posts, and the distance C from the positioning hole to the nearest patch edge is ≥1mm. For example, the positioning posts can be cylindrical protrusions with a diameter L = 0.4-2mm and a height H = 0.5-1.5mm.

[0090] Examples of such limiting components include a slot disposed on the edge of the staple cartridge arm and extending integrally along the axial edge of the staple cartridge arm, such that the edge of the patch is embedded in the slot, wherein the slot has a depth X = 0.5-1.5 mm and a width Y = 0.4-2 mm.

[0091] Beneficial effects:

[0092] The patch and the anastomosis arm are attached solely by the normal support force and / or shear resistance of the non-penetrating connector, resulting in an overlap strength between the patch and the anastomosis arm ranging from 1-50 N / cm. This integrated design of the prefabricated patch in the anastomosis device completely eliminates the complex process of on-site patch assembly in traditional surgery, significantly reducing the risk of human error and greatly improving the success rate of anastomosis. This structural design optimizes the clamping force of the anastomosis device on tissue and reinforcement materials, effectively preventing patch slippage or misalignment during closure and ensuring precise and stable anastomosis position. At the same time, it ensures that the non-penetrating connector can smoothly penetrate and firmly fix the patch and target tissue during puncture, avoiding poor staple formation or patch material tearing due to abnormal puncture resistance. Meanwhile, the patch remains stably positioned throughout the process of pushing the anastomosis arm to the target position, and the non-penetrating connector is completely covered by the patch, eliminating the risk of the connector being exposed and damaging surrounding tissues, significantly improving surgical safety and operational reliability.

[0093] The non-penetrating connector is not equivalent to the staples of a traditional stapler. The non-penetrating connector is primarily used for non-fastening connections between the patch and the anastomotic arm. Even if its staple formation is not ideal (e.g., in the case of partial formation), it does not affect the practical application of this structure. In the non-fastener-fixed patch attachment method and device of this invention, the non-penetrating connector can be used in conjunction with traditional staples. For example, the non-penetrating connector can be used only in some of the staple slots in the staple cartridge, while the remaining slots still contain traditional staples whose function is solely to mechanically close tissue, with the entire tissue located within the staple cartridge slots. Alternatively, in the non-fastener-fixed patch attachment method and device of this invention, the non-penetrating connector can completely replace the traditional staples.

[0094] The specific inward and outward angle design of the non-penetrating connector effectively overcomes the defects of excessive inward retraction, swaying, and loose fit during the molding process of inward-retracting non-penetrating connectors, ensuring a stable molding shape and balanced stress distribution in the suture area. The specific inward and outward angle design of the non-penetrating connector generates a specific local compression and buffering effect, forming a low-stress-high-stress synergy, making the patch adhere more tightly to the tissue and providing more reliable fixation while preventing tissue ischemia and necrosis.

[0095] Building upon the aforementioned structural design, further controlling the non-penetrating connector to be embedded or anchored within the patch at a depth less than 50% of the patch thickness in the first state helps ensure the integrity and stability of the patch during firing, suppressing rollover, retraction, and detachment, thereby enhancing the mechanical support performance of the anastomosis. Furthermore, this partially anchored or embedded design of the non-penetrating connector results in a slight protrusion on the side of the patch not embedded in the connector, significantly increasing the friction between the patch and tissue during stapler clamping, improving stapler clamping stability, effectively suppressing intraoperative tissue slippage and displacement, ensuring precise puncture and uniform shaping of the staples and / or non-penetrating connectors, avoiding patch retraction, staple foot eversion, or material tearing due to unstable clamping, and achieving reliable fixation and mechanical balance of the anastomosis. Attached Figure Description

[0096] The present disclosure will be further described in conjunction with the accompanying drawings, wherein the same reference numerals in several figures denote the same parts, and wherein: Figure 1 This is an overall schematic diagram of the attachment device 1, which includes a patch attachment method that typically involves fastener fixation. Figure 2 A schematic diagram of the non-through connector and patch attachment structure in the patch attachment method that is not fixed by fasteners; Figure 3 The diagram shows the structure of the inward-facing non-penetrating connector 9 and the outward-expanding non-penetrating connector 8. Figure 3 (a) is a structural schematic diagram of the outward-expanding non-through connector 8; Figure 3 (b) is a structural schematic diagram of the inward-facing non-penetrating connector 9; Figure 4 This is a reference schematic diagram of a shallow penetration unit for a non-through-connector; Figure 5 This is a three-dimensional structural diagram showing the relative positions of the non-through connector and the stud slot. Figure 5 (a) is a three-dimensional structural diagram showing the relative positions of the inward-facing non-penetrating connector 9 and the nail slot. Figure 5 (b) is a three-dimensional structural diagram showing the relative positions of the outward-expanding non-through connector 8 and the nail slot. Figure 6 This is a cross-sectional structural diagram showing the relative positions of the non-through connector and the staple cartridge slot; Figure 7 A schematic diagram of the stop module 24, which is a freeze-dried in-situ gel with some non-penetrating connectors embedded in it; Figure 8 This is a cross-sectional structural diagram showing the relative positions of the non-penetrating connector and the patch in the unfired state of the stapler (i.e., the first state). Figure 9A cross-sectional structural diagram showing the relative positions of the non-penetrating connector and the patch after the stapler has been fired (i.e., in the third state); Figure 10 A schematic diagram of the staple cartridge arm with a limit component; Figure 11 A schematic diagram of the staple cartridge arm for setting the positioning post and positioning hole; Figure 12 This is a schematic diagram showing the spatially staggered arrangement of inward-facing non-penetrating connectors and outward-facing non-penetrating connectors. Detailed Implementation

[0097] Embodiments of the non-fastener-fixed patch attachment method and apparatus of this disclosure will now be described in detail with reference to the accompanying drawings, wherein the same reference numerals in the various figures denote the same or corresponding elements.

[0098] Now for reference Figure 1 The present invention discloses an attachment device 1 including the aforementioned non-fastener-fixed patch attachment method, which is used in conjunction with a linear surgical stapler. For the sake of brevity, this disclosure will focus primarily on the attachment device 1 for the non-fastener-fixed patch attachment method, particularly the staple cartridge arm 2 having a first tissue contact surface 3, the staple cartridge arm 2 having multiple staple cartridge slots 4, the non-penetrating connector 5, and the patch 6.

[0099] The attachment device includes a staple arm 2 with a tissue contact surface 3, multiple non-penetrating connectors 5 disposed within staple slots, and a patch 6. The staple arm 2 has multiple staple slots 4, and the patch is attached to one side of the tissue contact surface 3 on the staple arm 2 via the multiple non-penetrating connectors 5. The patch 6 is attached to the staple arm 2 by normal support force and shear resistance. Specifically, refer to... Figure 2 The non-penetrating connector 5 is embedded or anchored within the patch 6 at a depth of 48%, 45%, 30%, 15%, or 5% of the patch thickness. This non-penetrating, low-invasive design also results in a slight protrusion 7 on the side of the patch not embedded in the non-penetrating connector 5. In the second state of the stapler, the protrusion 7 protects the tissue while assisting in tissue fixation and reducing tissue slippage during firing. For example, with a patch thickness of 1.20 mm, the support portion of the non-penetrating connector 5 is embedded 0.48 mm deep; with a patch thickness of 0.75 mm, the support portion of the non-penetrating connector is embedded 0.27 mm deep; and with a patch thickness of 0.41 mm, the support portion of the non-penetrating connector is embedded 0.19 mm deep.

[0100] Non-penetrating connector 5 includes an inward-facing non-penetrating connector 9 with an inward-facing angle β of 2-30° and an outward-facing non-penetrating connector 8 with an outward-facing opening angle α of 2-30°; such as Figure 3a. The outwardly expanding non-penetrating connector 8 consists of two support portions 11 and a base portion 10 that connects the two support portions 11 and is integrally formed. The two support portions 11 of the outwardly expanding non-penetrating connector 8 extend outwardly from the base portion 10 in an outwardly expanding arrangement. The extension lines of the two support portions 11 of the outwardly expanding non-penetrating connector 8 form an opening angle α. For example, the range of the opening angle α is 5-30°, 10-15°, 8-12°, etc.; Figure 3 b. The inward-facing non-through connector 9 consists of two support portions 13 and a base portion 12 that connects the two support portions 13 and is integrally formed. The two support portions 13 of the inward-facing non-through connector 9 extend inwardly from the base portion 12 in an inward-facing arrangement. The extension lines of the two support portions of the inward-facing non-through connector 9 form an inward-facing angle β. For example, the range of the inward-facing angle β is 2-25°, 4-8°, 4-10°, etc. The inward-facing angle β is slightly smaller than the opening angle α, and the inward-facing angle β is 0.5-0.8 times the opening angle α. Further, the support portions 13 and the base portion 12 can also be connected by a fillet 14, and the support portions 13, the base portion 12, and the fillet 14 are integrally formed.

[0101] For reference Figure 12 The number of inward-facing non-penetrating connectors 8 is less than that of outward-facing non-penetrating connectors 9. The inward-facing non-penetrating connectors 8 and the outward-facing non-penetrating connectors 9 are arranged in a staggered spatial arrangement. For example... Figure 12 In the middle, the inward-facing non-penetrating connector 8 and the outward-expanding non-penetrating connector 9 are arranged in three rows of linear periodic staggered arrangement. Specifically, Figure 12 In row a, rows one, three, four, and six are all outward-expanding rows of anastomotic staples, while rows two and five are fewer inward-expanding rows of anastomotic staples. Similarly, Figure 12 b and Figure 12 Similar to c, this allows for the alternating arrangement of outward-expanding and inward-retracting anastomotic staples.

[0102] The inward-facing and outward-facing non-penetrating connectors have a quantity ratio range of (2-8):10, for example, (2-7):10, (2-3):10, and (4-5):10. Non-penetrating connectors can be used in conjunction with conventional staples, for example, by placing non-penetrating connectors only in some slots of the staple cartridge, while the remaining slots still contain conventional staples whose sole function is mechanical closure of tissues, all located within the cartridge slots. This specific non-penetrating connector kit, used in conjunction with conventional staples (generally with parallel staple legs), provides the aforementioned technical benefits without affecting the staple formation of conventional staples; alternatively, non-penetrating connectors can completely replace conventional staples. The two rows on either side are outward-facing non-penetrating connectors, while the middle row contains a smaller number of inward-facing non-penetrating connectors.

[0103] For reference Figure 4 Specifically, the support portion of a non-through connector may include shallow-penetrating elements, such as... Figure 4 a. The support portion 13 of the inward-facing non-penetrating connector 14 may include one or more shallow-penetrating elements 15 in the form of barbed units, located at the end of the support portion of the inward-facing non-penetrating connector away from the base portion. When the support portion of the non-penetrating connector has multiple shallow-penetrating elements, the multiple shallow-penetrating elements are distributed at intervals along the length direction of the support portion and originate at the end of the support portion of the non-penetrating connector away from the base portion. The multiple shallow-penetrating elements of the same non-penetrating connector have the same orientation. For the inward-facing non-penetrating connector, the shallow-penetrating elements are located on one side of the inner side of the support portion. For the outward-expanding non-penetrating connector, the shallow-penetrating elements are located on one side of the outer side of the support portion. The orientation of the shallow-penetrating elements is symmetrical about the y-axis to the direction of the inclined extension of the support portion. The non-penetrating connector anchors the patch with its shallow-penetrating elements embedded to a depth ≤50% of the patch thickness, achieving a non-penetrating, low-invasive connection. Figure 4 b. The support portion of the recessed, non-through connector may include one or more shallow-penetrating elements 15 in the form of protruding units, such as... Figure 4 c. The support portion of the inward-facing non-through connector may include one or more shallow-penetrating elements 15 in the form of rib units.

[0104] Still referencing Figure 3 In non-through connectors, the end of the support portion away from the base portion has a beveled surface, which is a unidirectionally inclined wedge-shaped surface. In inward-facing non-through connectors, the inclination direction points inward to the support portion; in outward-facing non-through connectors, the inclination direction points outward to the support portion. The beveled surface forms a bevel angle γ with the direction of the support portion. Examples of bevel angle γ include 30-50° and 35-45°.

[0105] For reference Figure 5-6 The staple cartridge slot 4 includes an inner wall 22 and a limiting step 23 at the bottom of the staple cartridge slot. For example... Figure 5 b、 Figure 6 a, Figure 6 b and Figure 8 b. The base portion 10 of the outward-expanding non-penetrating connector 8 abuts against the limiting step 23 at the bottom of the staple cartridge groove, and is axially constrained in the staple cartridge groove 4 by the friction between its support portion 11 and the inner wall 22 of the staple cartridge groove (especially by the friction between the end of its support portion 11 away from the base portion 10 and the inner wall 22 of the staple cartridge groove); the support portion 11 of the outward-expanding non-penetrating connector 8 is tightly fitted with the inner wall 22 of the staple cartridge groove, and is constrained in the staple cartridge groove 4 by the axial action of the friction between its support portion 11 and the inner wall 22 of the staple cartridge groove. Figure 5 a and Figure 8In step a, the retractable non-penetrating connector 9 is assembled in the staple cartridge slot 4. The base portion 12 of the retractable non-penetrating connector 9 abuts against the limiting step 23 at the bottom of the staple cartridge slot. At the same time, it is axially constrained in the staple cartridge slot 4 by the friction between its support portion 13 and the inner wall 22 of the staple cartridge slot (especially by the friction between the end of its support portion 13 near the base portion 12 and the inner wall 22 of the staple cartridge slot). Furthermore, a stop module 24 (specifically a locking protrusion) is provided in the staple cartridge slot 4. It contacts the retractable non-penetrating connector 9 but does not contact the patch 6. It is used to limit the initial position of the non-penetrating connector and its radial sway direction, as well as the radial limiting of the non-penetrating connector in the staple cartridge slot 4 when the stapler is not fired. The retractable non-penetrating connector 9 and the locking protrusion form an elastic compression fit. Relying on the radial limiting effect of the locking protrusion, the retractable non-penetrating connector 9 is constrained in the staple cartridge slot 4. Further examples include the provision of a stop module 24 (specifically a retaining protrusion) within the nail cartridge slot 4 for accommodating the outwardly expanding non-through connector 11, such as... Figure 6 c and Figure 6 d.

[0106] For reference Figure 7 The stop module 24 can also be a lyophilized in-situ gel embedding a portion of the non-penetrating connector. The lyophilized in-situ gel can have any regular or irregular shape. When the anastomosis device is in the first or second state, the stop module 24 is in contact with the non-penetrating connector portion, but not with the patch. The lyophilized in-situ gel exists in solid form in a dry or low-humidity environment outside the body. Upon contact with tissue fluid or under certain humidity and temperature conditions, it undergoes swelling and network reconstruction through mechanisms such as solvent exchange, temperature response, or ion-induced crosslinking, transforming into a three-dimensional gel form.

[0107] The non-penetrating connector has a first state, a second state, and a third state. When the stapler is in a non-firing scenario, the non-penetrating connector is in the first state, such as... Figure 8 As shown. Figure 8In the first state, the non-penetrating connector attaches the patch to the tissue contact surface of the staple arm via the non-penetrating connector, resulting in an overlap strength between the patch and the staple arm ranging from 1 to 50 N / cm. Examples of overlap strengths between the patch and the staple arm include 2-5 N / cm, 5-10 N / cm, 10-45 N / cm, and 20-40 N / cm. In the first state, a portion of the support part of the non-penetrating connector extends from the staple slot, with the end of the support part away from the base portion 0.2 mm-0.6 mm above the tissue contact surface of the staple arm, and penetrates a portion of the patch. In the second state, the non-penetrating connector is further embedded. When the stapler fires, the firing pusher moves forward from the rear end of the staple cartridge and acts on the base portion of the non-penetrating connector, pushing the entire non-penetrating connector forward. After the stapler has finished firing, the non-penetrating connector is in the third state, such as... Figure 9 . Figure 9 In the middle, the non-penetrating connector is in the third state. The non-penetrating connector is detached from the staple cartridge groove. The support parts of the inward-retracting non-penetrating connector 9 and the outward-expanding non-penetrating connector 8 both penetrate the patch and are rolled inward to form a shape, while wrapping the tissue 16 and the patch 6.

[0108] When the patch is under stress, that is, during the transition of the non-penetrating connector from the first state to the second state, three different local strains occur simultaneously. Specifically, the area where the patch is in contact with the outward-expanding non-penetrating connector experiences a strain in the range of 0.3-0.8 (referring to the range of patch thickness change), the area where the patch is in contact with the inward-retracting non-penetrating connector experiences a strain in the range of 0.3-0.8 (referring to the range of patch thickness change), and the area where the patch is not in contact with the non-penetrating connector experiences a strain in the range of 0.1-0.2 (referring to the range of patch thickness change).

[0109] For reference Figure 10-11 Patches can also be made through methods such as Figure 10 The limiting component shown is attached to one side of the tissue contact surface 3 on the staple arm 2. The limiting component 17 includes a groove 18 disposed on the edge of the staple arm and extending integrally along the axial edge of the staple arm, and is integrally formed with the anastomosis arm, such that the edge of the patch 6 is embedded in the groove 18. The groove 18 has a depth X = 0.5-1.5 mm and a width Y = 0.4-2 mm; or the patch 6 can also be positioned as follows: Figure 11The limiting component 17 shown is attached to one side of the tissue contact surface 3 on the staple cartridge arm 2. The limiting component 17 includes four positioning posts 19 protruding from the tissue contact surface 3 of the staple cartridge arm 2. The positioning posts 19 are distributed along the edge of the tissue contact surface 3 of the staple cartridge arm. Meanwhile, the patch 6 is provided with positioning holes 20 for fixing to the positioning posts 19. The distance C from the nearest edge of the positioning hole 20 to the positioning hole 6 is ≥ 1 mm. For example, the positioning posts 19 can be cylindrical protrusions 21 with a diameter L = 0.4-2 mm and a height H = 0.5-1.5 mm.

[0110] Exemplary combinations The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claim that may be provided at any time in this patent application or a subsequent filing thereof. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples.

[0111] Example 1

[0112] An attachment device for patch attachment using the aforementioned fastener-free fixing method and non-penetrating connection kit, the attachment device being used in conjunction with a surgical stapler, the surgical stapler including a staple arm having a plurality of staple slots and a first tissue contact surface, wherein the attachment device includes: (1) A staple cartridge arm with a tissue contact surface, wherein 40 staple cartridge slots are provided in the staple cartridge arm; (2) 40 non-penetrating connectors are correspondingly installed in the staple cartridge slot. The non-penetrating connectors include 12 inward-facing non-penetrating connectors and 28 outward-facing non-penetrating connectors. Each inward-facing non-penetrating connector consists of 2 support parts and a base part that connects the 2 support parts and is integrally formed. The 2 support parts of the inward-facing non-penetrating connector extend inward from the base part and are arranged in an inward-facing manner. The extension lines of the 2 support parts of the inward-facing non-penetrating connector form a 10° inward-facing angle. The outward-facing non-penetrating connector consists of 2 support parts and a base part that connects the 2 support parts and is integrally formed. The 2 support parts of the outward-facing non-penetrating connector extend outward from the base part and are arranged in an outward-facing manner. The extension lines of the 2 support parts of the outward-facing non-penetrating connector form a 15° opening angle.

[0113] (3) and patches; The patch is attached to the staple cartridge arm via a non-penetrating connector. The patch is 0.41 mm thick, and the support portion of the non-penetrating connector is embedded in the patch to a depth of 0.19 mm.

[0114] Example 2

[0115] The attachment device using the non-fastener fixing method for patch attachment is basically the same as that in Embodiment 1, except that: the extension lines of the two support parts of the inward-facing non-penetrating connector form a 6° inward angle, and the extension lines of the two support parts of the outward-facing non-penetrating connector form a 10° opening angle; the patch is attached to the staple cartridge arm through the non-penetrating connector, the patch thickness is 0.75mm, and the depth of the support part of the non-penetrating connector embedded in the patch is 0.27mm.

[0116] The rest are the same as in Example 1.

[0117] Example 3

[0118] An attachment device for patch attachment using the aforementioned non-fastener fixing method and a non-penetrating coupling kit, the attachment device being used in conjunction with a surgical stapler, the non-penetrating coupling kit being used in conjunction with conventional staples (generally having mutually parallel staple legs), the surgical stapler including a staple arm having a plurality of staple slots, the staple arm having a first tissue contact surface, wherein the attachment device includes: (1) A staple cartridge arm with a tissue contact surface, wherein 45 staple cartridge slots are provided in the staple cartridge arm; (2) 30 conventional staples (referring to parallel non-penetrating connectors with two parallel support parts, and the support parts are perpendicular to the horizontal direction, i.e., the support parts of the parallel non-penetrating connectors are perpendicular to their base parts) and 15 non-penetrating connectors are correspondingly set in the staple cartridge slot, including 10 inward non-penetrating connectors and 20 outward non-penetrating connectors; each inward non-penetrating connector consists of two support parts and a base part that connects the two support parts and is integrally formed, the two support parts of the inward non-penetrating connector extend inward from the base part in an inward arrangement, and the extension lines of the two support parts of the inward non-penetrating connector form an 8° inward angle; the outward non-penetrating connector consists of two support parts and a base part that connects the two support parts and is integrally formed, the two support parts of the outward non-penetrating connector extend outward from the base part in an outward arrangement, and the extension lines of the two support parts of the outward non-penetrating connector form a 12° opening angle;

[0119] (3) and patches; The patch is attached to the staple cartridge arm via a non-penetrating connector. The patch is 1.20 mm thick, and the support portion of the non-penetrating connector is embedded in the patch to a depth of 0.48 mm.

[0120] Example 4

[0121] The attachment device using the non-fastener fixing method for patch attachment is basically the same as that in Embodiment 1. The only difference from Embodiment 1 is that the extension lines of the two support parts of the inward-facing non-penetrating connector form a 4° inward angle, and the extension lines of the two support parts of the outward-facing non-penetrating connector form an 8° opening angle. The patch is attached to the staple cartridge arm through the non-penetrating connector. The patch thickness is 0.44 mm, and the depth of the support part of the non-penetrating connector embedded in the patch is 0.1 mm.

[0122] The rest are the same as in Example 1.

[0123] Example 5

[0124] According to Embodiment 1, the patch attachment method and non-through-connector kit using the non-fastener fixing method are described, and the non-through-connector has a chamfered surface at the end of the support portion away from the base portion. The chamfered surface is a unidirectionally inclined wedge-shaped surface. The inward-facing non-through-connector has its inclination direction pointing towards the inside of the support portion; the outward-facing non-through-connector has its inclination direction pointing towards the outside of the support portion. The chamfered surface forms a 45° chamfer angle with the direction of the support portion.

[0125] Example 6

[0126] According to Embodiment 1, the patch attachment method and non-penetrating connection kit using the non-fastener fixing method are provided, and each non-penetrating connection member has three shallow penetration elements in the form of barbed units starting from the end of the support portion of the non-penetrating connection member away from the base portion. All shallow penetration elements are embedded to a depth of 0.19 mm into the patch thickness, achieving a non-penetrating, low-intrusion connection. Furthermore, for the same non-penetrating connection member, multiple shallow penetration elements are spaced apart along the length direction of the support portion and have the same orientation. For an inward-facing non-penetrating connection member, the shallow penetration elements are located on one side of the inner side of its support portion; for an outward-facing non-penetrating connection member, the shallow penetration elements are located on one side of the outer side of its support portion.

[0127] Example 7

[0128] According to Embodiment 6, the patch attachment method and non-through-connector kit using the non-fastener fixing method are described, and the non-through-connector has a chamfered surface at the end of the support portion away from the base portion. The chamfered surface is a unidirectionally inclined wedge-shaped surface. The inward-facing non-through-connector has its inclination direction pointing towards the inside of the support portion; the outward-facing non-through-connector has its inclination direction pointing towards the outside of the support portion. The chamfered surface forms a 30° chamfer angle with the direction of the support portion.

[0129] Comparative Example 1 The attachment device using the non-fastener fixing method for patch attachment is basically the same as in Example 1, except that the non-penetrating connectors are all parallel non-penetrating connectors. Each non-penetrating connector consists of two support parts and a base part that connects the two support parts and is integrally formed. The two support parts of each parallel non-penetrating connector are perpendicular to the horizontal plane. The rest is the same as in Example 1. (This is equivalent to the attachment method in this example being: with the stapler not fired, the height of the conventional staple protruding from the staple groove is 0.19 mm, and the conventional staple is inserted non-penetratingly into a patch with a thickness of 0.41 mm to a depth of 0.19 mm.)

[0130] Test results showed that the bonding strength between the patch and the stapler arm in this example was significantly lower than that in Example 1. This significant reduction in bonding strength means that the patch is prone to detachment and falling off during delivery to the target site using the stapler with this bonding method, especially for smooth-surfaced anastomotic sites such as the pancreas that may require multiple clamping operations, making it unsuitable for these sites. Furthermore, the staples with the patch protruding from the stapler slot and partially inserted into the patch had a staple formation rate of less than 95% after the stapler was activated, mainly due to an increased probability of the staples being partially formed.

[0131] Comparative Example 2 The attachment device using the non-fastener fixing patch attachment method is basically the same as that in Embodiment 1, except that the extension lines of the two support parts of the inward-facing non-penetrating connector form a 15° inward angle, and the extension lines of the two support parts of the outward-facing non-penetrating connector form a 10° opening angle.

[0132] The rest are the same as in Example 1.

[0133] Comparative Example 3 The attachment device using the non-fastener fixing patch attachment method is basically the same as that in Embodiment 1, except that the extension lines of the two support parts of the inward-facing non-penetrating connector form a 20° inward angle, and the extension lines of the two support parts of the outward-facing non-penetrating connector form a 35° opening angle.

[0134] The rest are the same as in Example 1.

[0135] Comparative Example 4 The attachment device using the non-fastener fixing method for patch attachment is basically the same as that in Embodiment 1, except that the non-penetrating connectors include 28 inward-facing non-penetrating connectors and 12 outward-facing non-penetrating connectors.

[0136] The rest are the same as in Example 1.

[0137] Comparative Example 5 The attachment device using the non-fastener fixing method for patch attachment is basically the same as that in Embodiment 1, except that the patch thickness is 0.45mm and the depth of the support portion of the non-through connector embedded in the patch is 0.35mm.

[0138] The rest are the same as in Example 1.

[0139] Comparative Example 6 The attachment device using the non-fastener fixing method for patch attachment is basically the same as that in Embodiment 1, except that the patch thickness is 0.62mm and the depth of the support portion of the non-through connector embedded in the patch is 0.10mm.

[0140] The rest are the same as in Example 1.

[0141] Relevant staple formation tests: Staple formation rate tests were conducted on non-penetrating connectors of non-fastener-fixed patch attachment devices according to YY / T 1797—2021 "Endoscopic Surgical Instruments, Laparoscopic Cutting Anastomosing Devices and Components". The results showed that the staple formation pass rates of both the outward-expanding and inward-retracting non-penetrating connectors in Examples 1-7 were above 95%, approaching 100%, specifically within the range of 98.29%-99.62%; and the staple formation rate of the parallel non-penetrating connector in Example 3 was 99.84%. The staple formation pass rates of both the outward-expanding and inward-retracting non-penetrating connectors in Comparative Examples 2-6 were below 95%, especially in Comparative Examples 2-3, where the staple formation pass rates of both were below 80%.

Claims

1. A non-fastener-fixed patch attachment method, said non-fastener-fixed patch attachment method being used in a stapler, the stapler including two stapler arms, each stapler arm having a tissue contact surface, characterized in that, The patch is attached to at least one anastomotic arm of the stapler via a non-penetrating connector, thereby non-penetratingly connecting the patch to the anastomotic arm.

2. The patch attachment method without fastener fixation according to claim 1, characterized in that, The patch is attached to at least one anastomotic arm of the stapler by normal support force and / or shear resistance.

3. The patch attachment method without fastener fixation according to claim 1, characterized in that, The non-penetrating connector has a first state, a second state, and a third state; in the first state, the non-penetrating connector is embedded or anchored in the patch at a depth of less than 50% of the patch thickness, so that the patch is non-penetratingly connected to the anastomosis arm.

4. The patch attachment method without fastener fixation according to claim 3, characterized in that, In the second state, the non-penetrating connector is embedded or anchored within the patch to a depth less than 100% of the patch thickness, so that the patch is non-penetratingly connected to the anastomosis arm.

5. The patch attachment method without fastener fixation according to claim 1, characterized in that, Non-penetrating couplings include inward-facing non-penetrating couplings.

6. The patch attachment method without fastener fixation according to claim 1, characterized in that, Non-penetrating connectors include inward-facing non-penetrating connectors and outward-facing non-penetrating connectors.

7. The patch attachment method without fastener fixation according to claim 6, characterized in that, The tilting angle of an inward-facing non-through connector is 0.5-0.9 times that of an outward-facing non-through connector.

8. The patch attachment method without fastener fixation according to claim 6, characterized in that, The number of inward-facing non-penetrating connectors is less than that of outward-facing non-penetrating connectors.

9. The patch attachment method without fastener fixation according to claim 8, characterized in that, The inward-facing non-penetrating connector and the outward-facing non-penetrating connector have a quantity ratio range of (2-8):

10.

10. The patch attachment method without fastener fixation according to claim 1, characterized in that, Non-through connectors also have beveled angles and beveled surfaces.

11. The patch attachment method without fastener fixation according to claim 10, characterized in that, The bevel angle is 30-50° or 35-45°.

12. The patch attachment method without fastener fixation according to claim 8, characterized in that, The non-penetrating connector includes at least two support parts and a base part.

13. The patch attachment method without fastener fixation according to claim 12, characterized in that, A shallow-penetrating element is provided on the support part of the non-through connector.

14. The patch attachment method without fastener fixation according to claim 13, characterized in that, For inward-facing non-through-connectors, the shallow-penetrating element is located on one side of the inner side of the support; for outward-facing non-through-connectors, the shallow-penetrating element is located on one side of the outer side of the support.

15. The patch attachment method without fastener fixation according to any one of claims 1-4, characterized in that, The patch is also attached to at least one anastomotic arm of the stapler via a limiting component.

16. A non-through-connection kit for patch attachment method of non-fastener fixing as described in claim 1, characterized in that, Non-penetrating coupling kits include inward-facing non-penetrating couplings and outward-facing non-penetrating couplings.

17. An attachment device using the non-fastener-fixed patch attachment method of claim 1 or the non-penetrating connection kit of claim 17, said attachment device being used in conjunction with a surgical stapler, the surgical stapler including a staple arm having a plurality of staple slots, the staple arm having a first tissue contact surface, characterized in that, The attachment device includes: (1) A staple cartridge arm having a first tissue contact surface, wherein a plurality of staple cartridge slots are provided in the staple cartridge arm; (2) Multiple non-penetrating connectors disposed in the staple cartridge slot, each non-penetrating connector consisting of at least two support parts and a base part that connects the at least two support parts and is integrally formed; wherein, the non-penetrating connectors include inward-facing non-penetrating connectors with an inward-facing angle of 2-30° and outward-facing non-penetrating connectors with an outward-facing angle of 2-30°. (3) and patches.

18. The attachment device according to claim 17, characterized in that, The patch is attached to the staple cartridge arm via a non-penetrating connector, ensuring that the overlap strength between the patch and the staple cartridge arm is in the range of 1-50 N / cm.

19. The attachment device according to claim 18, characterized in that, The patch is attached to the staple cartridge arm via a non-penetrating connector, ensuring that the overlap strength between the patch and the staple cartridge arm is in the range of 5-45 N / cm.

20. The attachment device according to claim 17, characterized in that, The patch undergoes at least three different local strains simultaneously when stress is applied.

21. The attachment device according to claim 20, characterized in that, The non-penetrating connector has a first state, a second state, and a third state. During the transition from the second state to the third state, the area where the patch contacts the outward-expanding non-penetrating connector experiences a strain in the range of 0.3-0.8, the area where the patch contacts the inward-retracting non-penetrating connector experiences a strain in the range of 0.3-0.8, and the area where the patch does not contact the non-penetrating connector experiences a strain in the range of 0.1-0.

2.

22. The attachment device according to claim 17, characterized in that, The staple cartridge groove includes an inner wall and a limiting step at the bottom of the staple cartridge groove; the base of the non-through connector abuts against the limiting step at the bottom of the staple cartridge groove, and is axially constrained in the staple cartridge groove by the friction between its support and the inner wall of the staple cartridge groove.

23. The attachment device according to claim 17, characterized in that, The staple cartridge slot is equipped with retaining protrusions for radial positioning of the non-penetrating connector within the staple cartridge slot when the stapler is not fired.

24. The attachment device according to claim 21, characterized in that, When the non-penetrating connector is in the first state, a portion of the support portion of the non-penetrating connector extends out from the staple cartridge groove, such that the end of the support portion away from the base portion is higher than the first tissue contact surface of the staple cartridge arm, and penetrates a portion of the patch.

25. The attachment device according to claim 17, characterized in that, The support portion of the non-through connector is provided with at least one shallow penetration element, and the at least one shallow penetration element is located at the end of the support portion of the non-through connector away from the base portion.

26. The attachment device according to claim 25, characterized in that, When the support portion of a non-through connector is provided with multiple shallow-penetrating elements, the multiple shallow-penetrating elements of the same non-through connector have the same orientation.

27. The attachment device according to claim 17, characterized in that, The inward-facing non-penetrating connectors and the outward-facing non-penetrating connectors are arranged alternately.

28. The attachment device according to claim 21, characterized in that, The staple cartridge slot is equipped with a stop module, which contacts the non-penetrating connector to limit the initial position and radial sway of the non-penetrating connector, and to provide guidance for the transition of the non-penetrating connector in each state, further ensuring that the support part of the non-penetrating connector penetrates the patch and inserts into the tissue along a preset trajectory.

29. The attachment device according to claim 28, characterized in that, The stop module is a gel that embeds part of the non-penetrating connector.

30. The attachment device according to claim 29, characterized in that, When the stop module is a gel that embeds part of the non-penetrating connector, in the first state and the second state, the stop module is in contact with the non-penetrating connector but not with the patch.

31. The attachment device according to claim 17, characterized in that, A limiting component is provided on the first tissue contact surface of the staple cartridge arm.

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