Device with anastomotic reinforcement patch and anvil assembly

Abstract

This application provides a device with an anastomosis reinforcement patch that can be applied to an anvil, comprising: a patch base, an anvil base assembled to the anvil to support anastomosis repair operations; a double-layer protective membrane, including an inner membrane and an outer membrane, the bottom edge of the outer membrane being fixedly connected to the patch base via a suture, the top ends of the inner membrane and the outer membrane being integrally connected, the bottom end of the inner membrane being a closed plane, a connecting hole being provided in the center of the closed plane, configured to connect to the anvil end cap of the anvil; the surface of the patch base is provided with cutting marks, in response to the anastomosis repair operation, at least a portion of the patch base is cut by the cutting marks under the action of an external structure to form a circular cutting hole; the anvil end cap is configured to pull the inner membrane through the cutting hole, causing the outer membrane to flip around the suture as a fulcrum, so that the double-layer protective membrane isolates the edge of the cutting hole from the cavity.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a device with an anastomosis reinforcement patch and an anvil assembly. Background Technology

[0002] In the field of cavity repair medical devices, patches, as the core integrated component for anastomosis, cutting, and repair of cavity tissues, are widely used in minimally invasive surgical procedures for cavities such as the esophagus and intestines. However, existing devices suffer from problems such as easy misalignment between the patch and anvil, easy traction on the cavity repair tissue during postoperative anvil removal, and untimely response of the protective membrane. These issues increase the difficulty of clinical procedures and raise the risk of secondary damage to the cavity tissue. Therefore, developing a device and anvil assembly with anastomotic reinforcement patch that features precise assembly, smooth anvil removal, and synchronous response of the protective membrane has become a key problem that urgently needs to be solved in the field of cavity repair medical devices. Summary of the Invention

[0003] The purpose of this application is to address the technical problems in related technologies by providing a device and anvil assembly with anastomotic reinforcement patch. The specific solution is as follows:

[0004] A first aspect of this application provides an apparatus with an anastomosis reinforcement patch, applied to an anvil, comprising: a patch base configured to be mounted on the anvil to support anastomosis repair operations; a double-layer protective membrane including an inner membrane and an outer membrane, the bottom edge of the outer membrane being fixedly connected to the patch base via a suture, the top ends of the inner membrane and the outer membrane being integrally connected, the bottom end of the inner membrane being a closed plane, a connecting hole being provided in the middle of the closed plane, configured to connect to the anvil end cap of the anvil; wherein, the surface of the patch base is provided with a cutting notch, and in response to the anastomosis repair operation, at least a portion of the patch base is cut by an external structure to form a circular cutting hole; the anvil end cap is configured to pull the inner membrane through the cutting hole, thereby causing the outer membrane to flip around the suture as a fulcrum, so that the double-layer protective membrane isolates the edge of the cutting hole from the cavity.

[0005] In some embodiments, the outer membrane includes a side groove penetrating the outer membrane and extending axially along the double protective membrane, configured to facilitate assembly of the anvil end cap with the connection hole.

[0006] In some embodiments, a first mounting hole is provided in the center of the patch base, and the cutting marks surround the first mounting hole.

[0007] In some embodiments, the connecting hole is coaxially arranged with the first mounting hole.

[0008] In some embodiments, the patch base includes: a body portion having a plurality of anvil grooves and a plurality of cut groove groups on its surface, each cut groove group including three equally spaced cuts; the cutting marks penetrate the cuts.

[0009] In some embodiments, with the center of the body portion as the vertex of the central angle, along the axial direction of the patch base: within the same groove group, the central angle of two non-adjacent slits is ∠a; within the same groove group, the central angle of two adjacent slits is ∠b; the central angle of the opening of a single anvil groove 2120 is ∠A; the central angle of the distance between two adjacent anvil grooves is ∠B, where ∠b < ∠B < ∠A < ∠a; ∠a = 2∠b.

[0010] In some embodiments, the length of the side cut groove is not less than the axial assembly stroke of the anvil end cap.

[0011] In some embodiments, the distance between the end of the side cut groove adjacent to the patch base and the suture is not less than 1 mm.

[0012] In some embodiments, the patch base and the double protective film are made of a biodegradable material.

[0013] A second aspect of this application provides an anvil assembly, comprising: a device with anastomosis reinforcement patch as provided in the first aspect of this application; an anvil base having an mounting boss configured to be adapted and connected to the patch base of the device with anastomosis reinforcement patch; an anvil end cap penetrating the connection hole of the device with anastomosis reinforcement patch and movably connected to the anvil base; and a central rod assembly penetrating the anvil base and engaging with the anvil end cap, wherein the anvil end cap and the central rod assembly form a clamping structure for clamping the inner membrane of the device with anastomosis reinforcement patch, and under external force, causing the double-layer protective membrane of the device with anastomosis reinforcement patch to flip over.

[0014] Compared with related technologies, the above-described solutions of this application have at least the following beneficial effects:

[0015] The device and anvil assembly with anastomotic reinforcement patch provided in this application utilize a double-layer protective membrane combined with the clamping and transmission mechanism of the anvil end cap and central rod assembly. This allows the inner membrane to be pulled by the anvil end cap after cutting, causing the outer membrane to flip synchronously and quickly cover the edge of the circular cutting hole. This effectively isolates the cutting edge from the cavity tissue, reducing mucosal irritation and secondary damage, and lowering the risk of patient trauma and infection. It offers advantages such as simple and efficient operation, shortened surgical preparation time, and a guaranteed postoperative repair environment.

[0016] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0017] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort. In the drawings:

[0018] Figure 1 This is a schematic diagram of the structure of an anvil assembly according to an exemplary embodiment.

[0019] Figure 2 This is a structural cross-sectional view of an anvil assembly according to an exemplary embodiment.

[0020] Figure 3 This is a schematic diagram of a device with an anastomotic reinforcement patch according to an exemplary embodiment.

[0021] Figure 4 This is a structural cross-sectional view of an apparatus with an anastomotic reinforcement patch according to an exemplary embodiment.

[0022] Figure 5 This is a schematic diagram of the structure of a body part 1110 according to an exemplary embodiment.

[0023] Figure 6 This is a schematic diagram of the structure of an abutment groove 2120 and a slot assembly according to an exemplary embodiment.

[0024] Figure label:

[0025] The device 1000 with anastomosis reinforcement patch includes a patch base 1100, a first assembly hole 1101, a body part 1110, a cutting mark 1111, a groove group 1121, a cut slit 1122, a connecting part 1120, a double protective film 1200, an inner film 1210, a connecting hole 1201, an outer film 1220, a side groove 1202, and a suture 1300.

[0026] Anvil assembly 2000, anvil base 2100, mounting boss 2110, anvil groove 2120, center rod assembly 2200, anvil end cap 2300, and matching nail 3000. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0028] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to limit the application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms, unless the context clearly indicates otherwise. “Multiple” generally includes at least two, and other quantifiers are similar.

[0029] It should be understood that although the terms "first," "second," "third," etc., may be used in the embodiments of this application, these descriptions should not be limited to these terms. These terms are only used to distinguish the described objects. For example, "first" may also be referred to as "second," and similarly, "second" may also be referred to as "first," without departing from the scope of the embodiments of this application. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0030] It should be understood that the term "and / or" as used herein is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, and B alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship. The singular forms "a," "the," and "the" are also intended to include the plural forms unless the context clearly indicates otherwise.

[0031] It is further understood that the terms “center,” “longitudinal,” “lateral,” “front,” “rear,” “up,” “down,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this embodiment and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0032] In the description of this application, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0033] Depending on the context, the words “if” or “suppose” as used here can be interpreted as “when” or “in response to determination” or “in response to detection.” Similarly, depending on the context, the phrases “if determination” or “if detection (of the stated condition or event)” can be interpreted as “when determination” or “in response to determination” or “when detection (of the stated condition or event)” or “in response to detection (of the stated condition or event).”

[0034] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0035] In related technologies, during cavity repair surgery, the patch cannot quickly cover the cutting edge after cutting at the anastomosis site, which can easily scratch the cavity mucosa, causing inflammation or secondary damage, increasing the patient's risk of trauma and infection. In addition, the poor assembly and alignment accuracy of the patch and anvil assembly can easily lead to misalignment between the anastomosis groove 2120 and the anastomosis staple, as well as between the suture and the cutting blade, affecting the quality of anastomosis and the regularity of the cutting.

[0036] To address the aforementioned technical problems, this application provides an apparatus with an anastomosis reinforcement patch, applied to an anvil, comprising: a patch base configured to be assembled into the anvil assembly to support anastomosis repair operations; and a double-layer protective membrane comprising an inner membrane and an outer membrane, the bottom edge of the outer membrane being fixedly connected to the patch base via a suture, the top ends of the inner and outer membranes being integrally connected, the bottom end of the inner membrane being a closed plane, and a connecting hole being provided in the center of the closed plane, configured to connect to the anvil end cap of the anvil assembly; wherein, the surface of the patch base is provided with cutting marks, and in response to the anastomosis repair operation, at least a portion of the patch base is cut by an external structure to form a circular cutting hole; the anvil end cap is configured to pull the inner membrane through the cutting hole, thereby causing the outer membrane to flip around the suture as a fulcrum, so that the double-layer protective membrane isolates the edge of the cutting hole from the cavity.

[0037] The device and anvil assembly with anastomotic reinforcement patch provided in this application utilize a double-layer protective membrane combined with the clamping and transmission mechanism of the anvil end cap and central rod assembly. This allows the inner membrane to be pulled by the anvil end cap after cutting, causing the outer membrane to flip synchronously and quickly cover the edge of the circular cutting hole. This effectively isolates the cutting edge from the cavity tissue, reducing mucosal irritation and secondary damage, and lowering the risk of patient trauma and infection. It offers advantages such as simple and efficient operation, shortened surgical preparation time, and a guaranteed postoperative repair environment.

[0038] The optional embodiments of this application are described in detail below with reference to the accompanying drawings.

[0039] This application provides a device 1000 with anastomotic reinforcement patch and a stapler assembly 2000, such as Figure 1 , Figure 2 As shown, the device 1000 with anastomosis reinforcement patch includes a patch base 1100 and a double-layer protective film 1200; the anvil assembly 2000 includes an anvil base 2100, a central rod assembly 2200, and an anvil end cap 2300. The anvil end cap 2300 and the central rod assembly 2200 form a clamping structure to clamp the device 1000 with anastomosis reinforcement patch. It is configured to rotate the double-layer protective film 1200 under external force to quickly cover the edge of the circular cutting hole and effectively isolate the cutting edge from the cavity tissue.

[0040] In some embodiments, such as Figure 2 , Figure 3 , Figure 4As shown, the patch base 1100 is adapted to be assembled with the anvil base 2100 and configured to provide the support base required for anastomosis repair operations. The patch base 1100 includes a body portion 1110 and a connecting portion 1120. The body portion 1110 has an annular structure and is configured to fit against the anvil end face of the anvil base 2100. A first mounting hole 1101 is axially provided in the middle of the body portion 1110. The first mounting hole is located in the middle of the patch base 1100 and extends axially through the patch base 1100, which can quickly calibrate the relative position of the patch base 1100 and the anvil base 2100, making the connection between the patch base 1100 and the anvil base 2100 more stable and improving the stability of the surgical operation.

[0041] In some embodiments, the first mounting hole 1101 is a circular through hole, the diameter of which is slightly larger than the outer diameter of the center rod assembly 2200, and is configured to allow the center rod assembly 2200 of the anvil assembly 2000 to pass through. The first mounting hole 1101 is coaxially arranged with the connection hole 1201 of the inner membrane 1210, that is, the central axis of the first mounting hole 1101 and the connection hole 1201 coincides. This coaxial design ensures that the anvil end cap 2300 can simultaneously and accurately pass through the connection hole 1201 and the first mounting hole 1101, making the assembly and positioning of the anvil assembly 2000 and the patch device more accurate, ensuring that the clamping force of the anvil end cap 2300 on the inner membrane 1210 is evenly distributed, thereby ensuring the stability of the inner membrane 1210 traction process and improving the accuracy of the flipping action of the double protective film 1200.

[0042] In some embodiments, such as Figure 5 , Figure 6 As shown, the surface of the body portion 1110 is evenly distributed with a plurality of anvil grooves 2120 and a plurality of grooving groups 1121 around the center of the patch base 1100. Each grooving group 1121 includes three equally spaced slits 1122, which extend radially along the body portion 1110. With the center of the body portion 1110 as the vertex of the central angle, along the axial direction of the patch base 1100, within the same groove group 1121, the central angle of two non-adjacent slits 1122 is ∠a; within the same groove group 1121, the central angle of two adjacent slits 1122 is ∠b; the central angle of the opening of a single anvil groove 2120 is ∠A; the central angle of the distance between two adjacent anvil grooves 2120 is ∠B, where ∠b < ∠B < ∠A < ∠a; ∠a = 2∠b. This configuration ensures that the slits 1122 do not affect the smoothness of cutting, that the anvil grooves 2120 have sufficient width to avoid abnormal deformation of the staples 3000, and that the already formed staples are not damaged during cutting, thereby reducing the risk of leakage and tissue damage.

[0043] In some embodiments, ∠b is used to define the density of the slits 1122. The three slits 1122 are evenly distributed within the grooving group 1121 to ensure the continuous cutting path and that the spacing between adjacent slits 1122 is small enough to avoid incomplete cutting. At the same time, ∠b < ∠B to ensure that the width of a single grooving group 1121 is smaller than the gap between adjacent anvil grooves 2120, thus avoiding circumferential overlap between the grooving group 1121 and the anvil groove 2120.

[0044] In some embodiments, such as Figure 6 As shown, the central angle between two adjacent anvil grooves 2120 is ∠B. ∠B serves as the interval angle between the grooving group 1121 and the anvil groove 2120, providing independent installation space for the grooving group 1121 and preventing the anvil grooves 2120 from being too far apart, which would lead to discontinuous sealing of the mating joint. Therefore, ∠b < ∠B < ∠A.

[0045] Since the anvil groove 2120 guides the forming area to be wide enough to avoid straight nails, ∠B < ∠A is required to ensure that the anvil groove 2120 has enough space to accommodate the staples and to form them. At the same time, ∠A < ∠a is required to prevent the width of the anvil groove 2120 from exceeding the span of the cutting groove group 1121, which would damage the formed staples during cutting.

[0046] In some embodiments, within the same groove group 1121, the central angle between two non-adjacent slits 1122 is ∠a, where ∠a is the maximum angle in the groove group 1121, and ∠a = 2∠b. This configuration ensures that the three slits 1122 within the groove group 1121 are symmetrically distributed. ∠a < ∠A is configured so that the groove group 1121 only covers the gap between adjacent anvil grooves 2120 without intruding into the engagement area of ​​the anvil groove 2120.

[0047] In some embodiments, 5° < ∠B < 20°; if ∠B < 5°, the spacing of the slits 1122 is too narrow, resulting in insufficient installation space for the groove assembly 1121, and the slits 1122 and the anvil groove 2120 may overlap circumferentially, affecting the continuous cutting of the cutting blade and resulting in incomplete cutting; if ∠B > 20°, the spacing of the slits 1122 is too wide, causing discontinuous sealing of the mating joint and increasing the risk of leakage.

[0048] In some embodiments, 10° < ∠A < 35° is configured to ensure that the anvil groove 2120 has sufficient width to accommodate the staples and meet their forming space requirements. If ∠A < 10°, the staples are very likely to not be firmly attached or the staple body may deform abnormally; if ∠A > 35°, the anvil groove 2120 is too wide and will encroach on the installation area of ​​the cutting groove assembly 1121. The cutting process may easily damage the formed staples and cannot guarantee the integrity of the cut guide channel.

[0049] In some embodiments, such as Figure 5 , Figure 6 As shown, the surface of the first assembly hole 1101 is also provided with a cutting mark 1111. The cutting mark 1111 and the first assembly hole 1101 are concentric circles, forming a pre-set annular path around the first assembly hole 1101 and penetrating all the cuts 1122. When the cutting blade cuts the body part 1110 along the cutting mark 1111, it can accurately cut the cutting mark 1111 with the first assembly hole 1101 as the center, ensuring that the formed cutting hole is a regular circle, further ensuring that the edge of the cutting hole is smooth, avoiding irregular edges that scratch the cavity mucosa, and providing a smooth structural basis for the subsequent penetration of the inner layer membrane 1210 and the flipping of the protective membrane.

[0050] In some embodiments, the patch base 1100 is adapted to the anvil base 2100 via a mounting boss 2110, and the anvil groove 2120 on its surface is used to accommodate the staples of the stapler. The anvil groove 2120 is an arc-shaped groove structure, and multiple anvil grooves 2120 are evenly distributed along the circumference of the patch base 1100. The groove shape of each anvil groove 2120 is adapted to the forming shape of the staple.

[0051] The grooving assembly 1121 is used to adapt to the cutting path of the cutting blade. This structural design enables the patch base 1100 to form a precise operational fit with the anvil base 2100. The setting of the cutting trace 1111 provides a preset path for the subsequent formation of a circular cutting hole, avoiding irregular edges during the cutting process and reducing secondary damage to the cavity tissue. At the same time, the design of the angle parameters ∠b<∠B<∠A<∠a and ∠a=2∠b ensures the operation sequence of stapled before cutting, improving the stability and reliability of anastomosis repair.

[0052] In some embodiments, the device 1000 with anastomotic reinforcement patch includes a double protective membrane 1200, such as Figure 2 As shown, the double-layer protective film 1200 includes an inner film 1210 and an outer film 1220.

[0053] The bottom edge of the outer membrane 1220 is fixedly connected to the patch base 1100 via a suture 1300, and the top edge is integrally connected to the inner membrane 1210, forming a closed top structure. The bottom of the inner membrane 1210 is a complete closed plane, and a circular connecting hole 1201 is provided in the middle of the closed plane. The connecting hole 1201 is coaxial with the first assembly hole 1101, and the diameter of the connecting hole 1201 is adapted to the outer diameter of the anvil end cap 2300, configured to connect with the anvil end cap 2300 of the anvil assembly 2000.

[0054] The inner membrane 1210 is connected to the anvil cap 2300 through the connecting hole 1201 and is fixed by the clamping structure formed by the anvil cap 2300 and the central rod assembly 2200. This allows the inner membrane 1210 to drive the outer membrane 1220 to move synchronously under the traction of the anvil cap 2300. The overall structure of the double protective membrane 1200 not only ensures the adaptability to the cavity tissue, but also provides a structural basis for subsequent flipping isolation. The design of the inner membrane 1210 and the outer membrane 1220 being integrally connected at the top ensures the synchronicity of the flipping action of the inner and outer membranes 1220, avoiding misalignment or jamming, and effectively improving the isolation effect of the protective membrane.

[0055] In some embodiments, the device 1000 with anastomotic reinforcement patch includes a suture 1300, which is a medical-grade fixation suture with high strength and good biocompatibility. The suture 1300 is distributed in a ring along the bottom edge of the outer membrane 1220, fixing the bottom of the outer membrane 1220 to the edge of the patch base 1100, forming a closed ring connection structure. This configuration provides a stable flipping fulcrum for the outer membrane 1220 while ensuring the connection strength between the outer membrane 1220 and the patch base 1100, preventing detachment or loosening during assembly, repair operations, or flipping.

[0056] In some embodiments, the connection hole 1201 at the bottom end of the inner membrane 1210 is a circular hole structure penetrating the closed plane, and the diameter of the connection hole 1201 is clearance-fitted with the outer diameter of the anvil cap 2300. This configuration enables the connection between the inner membrane 1210 and the anvil cap 2300, allowing the anvil cap 2300 to stably clamp the closed plane of the inner membrane 1210 and thus transmit traction force.

[0057] In some embodiments, the connecting hole 1201 and the first mounting hole 1101 are coaxially arranged. When the anvil cap 2300 pulls the inner membrane 1210 to move, the coaxially arranged connecting hole 1201 and the first mounting hole 1101 can limit the radial displacement of the inner membrane 1210, prevent the inner membrane 1210 from wrinkling or getting stuck, and ensure that the inner membrane 1210 smoothly passes through the cutting hole, thereby driving the outer membrane 1220 to rotate smoothly with the suture 1300 as the fulcrum, realizing the rapid isolation of the cutting hole edge and the cavity.

[0058] In some embodiments, the side groove 1202 of the outer membrane 1220 is a strip-shaped groove structure that penetrates the sidewall of the outer membrane 1220 and extends axially along the double-layer protective membrane 1200. The width of the side groove 1202 is slightly larger than the radial dimension of the anvil cap 2300, and the length is not less than the axial assembly stroke of the anvil cap 2300. The distance between the end of the side groove 1202 adjacent to the patch base 1100 and the suture line 1300 is not less than 1 mm. This provides a clearance channel for the assembly of the anvil cap 2300 and the connecting hole 1201, facilitating the quick and accurate penetration of the anvil cap 2300 through the connecting hole 1201 to achieve connection with the inner membrane 1210. The side groove 1202 ensures smooth assembly and avoids pulling damage to the membrane material during assembly.

[0059] In some embodiments, there is a preset distance between the side cut groove 1202 and the suture 1300. The preset distance ensures the connection strength at the bottom of the outer membrane 1220, prevents the suture from breaking due to stress concentration caused by the side cut groove 1202 being too close, improves the assembly efficiency of the device 1000 with the anastomosis reinforcement patch and the anvil base 2100, and ensures the structural stability after assembly, providing a reliable guarantee for subsequent repair operations and protective membrane flipping.

[0060] In some embodiments, the preset spacing is not less than 3mm to prevent the liquid in the cavity from leaking out from the side slot after reversal.

[0061] In some embodiments, the patch base 1100 is made of a biodegradable material, which may be a medical-grade biodegradable polymer material that can be gradually degraded into non-toxic and harmless metabolites under specific conditions in the body and eventually absorbed by the human body.

[0062] In some embodiments, both the patch base 1100 and the double-layer protective membrane 1200 are made of biodegradable materials. These biodegradable materials can be medical-grade biodegradable polymers that can gradually degrade into non-toxic and harmless metabolites under specific in vivo conditions, ultimately being absorbed by the body. Simultaneously, the biodegradable materials exhibit good biocompatibility, reducing irritation to cavity tissues and lowering the probability of inflammatory responses. The degradation rate of the biodegradable materials matches the repair cycle of the cavity tissues, continuously providing support and isolation until the tissue is fully repaired, and gradually degrading after the affected area is repaired, thus improving the clinical applicability of the device and the patient's treatment experience.

[0063] In some embodiments, the degradable material is one of polyglycolic acid (PGA), polylactic acid (PLA), polylactic-glycolic acid copolymer (PLGA), or animal-derived material, such as animal-derived material that has undergone immunogen removal treatment. These animal-derived materials include the submucosa, amnion, peritoneum, or pericardium, etc.; preferably, decellularized small intestinal submucosa matrix material is used.

[0064] In some embodiments, the anvil assembly 2000 includes an anvil base 2100, which is a ring-shaped support structure. The outer surface of the anvil base 2100 is provided with a plurality of mounting bosses 2110 evenly distributed in the circumferential direction. The shape of the mounting bosses 2110 matches the connecting portion 1120 of the patch base 1100. The configuration is such that the patch device is stably connected to the patch base 1100, ensuring that the patch device will not wobble or shift axially during the repair operation, thereby ensuring the precise engagement of the cutting blade and the kerf 1122, and the staple and the anvil groove 2120.

[0065] In some embodiments, the anvil end cap 2300 is a cylindrical structure, and the outer diameter of the anvil end cap 2300 is adapted to the diameter of the connecting hole 1201, for passing through the connecting hole 1201 of the patch device and being movably connected to the anvil base 2100.

[0066] In some embodiments, the central rod assembly 2200 can penetrate the anvil base 2100 and engage with the anvil end cap 2300 to form a stable clamping structure. It is configured to cooperate with the anvil end cap 2300 to clamp the inner membrane 1210, while simultaneously transmitting external driving force to move the anvil end cap 2300 axially.

[0067] One end of the anvil cap 2300 is engaged with the central rod assembly 2200, and the other end is fitted with the closed plane of the inner membrane 1210. The anvil cap 2300, through its cooperation with the central rod assembly 2200, forms a clamping structure, firmly clamping the closed plane of the inner membrane 1210. The configuration allows the inner membrane 1210 to move axially under external force, thereby pulling the outer membrane 1220 to flip. The clearance fit between the anvil cap 2300 and the connecting hole 1201 ensures smooth movement, while the engagement structure between the anvil cap 2300 and the central rod assembly 2200 ensures stable transmission of clamping force, preventing slippage or detachment during traction. This allows the anvil cap 2300 to accurately and reliably drive the double-layer protective membrane 1200 to complete the flipping action, ensuring that the protective membrane covers the circular cutting hole and achieving isolation between the edge of the cutting hole and the cavity.

[0068] In some embodiments, during the assembly of the anvil assembly 2000, the patch base 1100 equipped with the center rod assembly 2200 is first aligned with the mounting boss 2110 of the anvil base 2100, so that the mounting boss 2110 is embedded between the body portion 1110 and the connecting portion 1120 of the patch base 1100, thus completing the adaptation connection between the patch base 1100 and the anvil base 2100. Further, the anvil end cap 2300 is aligned with the side groove 1202 of the outer film 1220, so that the anvil end cap 2300 penetrates the connecting hole 1201 of the inner film 1210, thus achieving the initial docking of the anvil end cap 2300 and the patch device. Finally, the anvil end cap 2300 and the center rod assembly 2200 form a clamping structure through the center rod assembly 2200, firmly clamping the closed plane of the inner film 1210, thus completing the overall assembly. After the anvil assembly 2000 is assembled, the stable cooperation of each connecting structure ensures the overall structure is firm, preventing the anvil assembly 2000 from loosening or misaligning during surgery, and providing a reliable structural foundation for subsequent repair operations and the flipping of the double protective membrane 1200.

[0069] In some embodiments, the steps of the anvil assembly 2000 in the repair operation are as follows: First, the assembled device is implanted into the cavity, and the patch base 1100 is aligned with the anastomosis position. The anvil assembly 2000 is precisely positioned by the combined action of the central rod assembly 2200 and the anvil end cap 2300. Then, the stapler is activated, and the staples are pressed into the anvil groove 2120 of the patch base 1100 to form a stapled fixation of the cavity tissue. Further, the cutting blade of the stapler moves along the axial direction of the patch base 1100 to cut the cutting mark 1111 around the first assembly hole 1101, so that part of the patch base 1100 is disengaged to form a circular cutting hole. Finally, under the drive of external force, the central rod assembly 2200 moves the anvil cap 2300 axially. The anvil cap 2300 pulls the inner membrane 1210 through the circular cutting hole, which in turn causes the outer membrane 1220 to flip around the fixation point of the suture 1300, so that the double protective membrane 1200 completely covers the edge of the circular cutting hole, achieving isolation between the edge of the cutting hole and the cavity, effectively avoiding stimulation of the cavity tissue by the cutting edge, and improving the safety and repair effect of the operation.

[0070] The specific structure, working principle, and beneficial effects of the device and anvil assembly with anastomosis reinforcement patch provided in this application embodiment can be referred to the device and anvil assembly with anastomosis reinforcement patch described in any of the above embodiments, and will not be repeated here.

[0071] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems or apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.

[0072] The above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A device with an anastomotic reinforcement patch, characterized in that, Applicable to anvils, including: A patch base is configured as an anvil base to be fitted onto the anvil to support repair operations at the anastomosis site; The double-layer protective film includes an inner layer film and an outer layer film. The bottom edge of the outer layer film is fixedly connected to the patch base by a suture. The top ends of the inner layer film and the outer layer film are integrally connected. The bottom end of the inner layer film is a closed plane. A connection hole is provided in the middle of the closed plane, which is configured to connect with the anvil end cap of the anvil. In response to the anastomosis, a repair operation is performed, and at least a portion of the patch base forms an annular cutting hole under the action of an external structure. The anvil end cap is configured to pull the inner membrane through the cutting hole, thereby causing the outer membrane to flip around the suture line as a fulcrum, so that the double protective membrane isolates the edge of the cutting hole from the cavity.

2. The device with anastomotic reinforcement patch according to claim 1, characterized in that, The outer membrane comprises: A side-cut groove penetrates the outer membrane and extends axially along the double-layer protective membrane, configured to facilitate the assembly of the anvil end cap with the connecting hole.

3. The device with anastomotic reinforcement patch according to claim 1, characterized in that, The patch base has a first mounting hole in the middle, and the cutting marks surround the first mounting hole.

4. The device with anastomotic reinforcement patch according to claim 3, characterized in that, The connecting hole is coaxially arranged with the first assembly hole.

5. The device with anastomotic reinforcement patch according to claim 1, characterized in that, The surface of the patch base is provided with cutting marks, which form circular cutting holes. The patch base includes: The main body has multiple anvil grooves and multiple cutting groove groups on its surface, each of the cutting groove groups including three equally spaced cutting slits; the cutting marks penetrate the cutting slits.

6. The device with anastomotic reinforcement patch according to claim 5, characterized in that, With the center of the main body as the vertex of the central angle, along the axial direction of the patch base: Within the same group of grooves, the central angle between two non-adjacent slits is ∠a; Within the same group of grooves, the central angle between two adjacent kerfs is ∠b; The central angle of the groove opening of a single anvil groove is ∠A; The central angle between two adjacent anvil grooves is ∠B. Among them, ∠b<∠B<∠A<∠a; ∠a=2∠b.

7. The device with anastomotic reinforcement patch according to claim 2, characterized in that, The length of the side cut groove is not less than the axial assembly stroke of the anvil end cap.

8. The device with anastomotic reinforcement patch according to claim 2, characterized in that, The distance between the end of the side cut groove adjacent to the patch base and the suture line is not less than 1 mm.

9. The device with anastomotic reinforcement patch according to claim 1, characterized in that, The patch base and the double-layer protective film are made of biodegradable materials.

10. A nail-anvil assembly, characterized in that, include: The apparatus with anastomotic reinforcement patch as described in any one of claims 1-9; The anvil base is provided with a mounting boss and is configured to be adapted and connected to the patch base of the device with the mating joint reinforced repair patch; The anvil end cap passes through the connection hole of the device with the anastomosis reinforcement patch and is movably connected to the anvil base; The central rod assembly passes through the anvil base and engages with the anvil end cap. The anvil end cap and the central rod assembly form a clamping structure, which clamps the inner membrane of the device with the anastomosis reinforcement patch. Under the action of external force, the double protective membrane of the device with the anastomosis reinforcement patch is flipped.

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