Anastomosis buttress patches, staple anvil assemblies, and staple cartridge assemblies
By designing a ring-shaped anastomosis reinforcement patch and using a combination of groove groups and cutting marks, the problems of high fluid resistance and poor versatility of existing cavity repair patches are solved. This achieves improved fluid flow efficiency and reduced leakage risk, and is compatible with anvils or staple cartridges to meet clinical needs.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BEIJING BIOSIS HEALING BIOLOGICAL TECH CO LTD
- Filing Date
- 2026-03-05
- Publication Date
- 2026-06-02
Smart Images
Figure CN121774570B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and more specifically, to an anastomosis reinforcement patch, an anvil assembly, and a staple cartridge assembly. Background Technology
[0002] In the field of cavity repair medical devices, patches, as core integrated components 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, most existing patches can only be fitted to anvils or staple cartridges, resulting in poor versatility. Furthermore, cut patches can create significant resistance to fluid flow at the anastomosis site, leading to partial thrombosis. Therefore, developing an anastomosis reinforcement patch that combines smooth flow guidance, bidirectional adaptability, and stable staplement effect has become a critical issue that urgently needs to be addressed in the current 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 an anastomosis reinforcement patch, an anvil assembly, and a staple cartridge assembly. The specific solution is as follows:
[0004] A first aspect of this application provides an anastomosis reinforcement patch applicable to an anvil or staple cartridge, comprising: a body portion having an annular structure and a first mounting hole extending axially through the center; the body portion comprising: a set of grooves uniformly arranged circumferentially on the surface of the body portion, each set of grooves including a plurality of slits extending radially along the body portion, configured to allow fluid to flow more smoothly through the anastomosis; and a cutting mark disposed on the surface of the body portion and surrounding the first mounting hole, configured to penetrate all the slits, wherein the distance between two sets of grooves is greater than the distance between two adjacent slits in the set of grooves.
[0005] In some embodiments, each of the slot groups includes three equally spaced slits, and the three slits are arranged at a preset interval, configured such that at least two of the slits can avoid the engagement point of the staples.
[0006] In some embodiments, in the radial direction of the body portion, the slit has a first end adjacent to the inner ring and a second end adjacent to the outer ring, and the distance from the slit to the second end is greater than 1 / 2 of the distance from the slit to the edge of the outer ring.
[0007] In some embodiments, the body portion further includes a nail groove portion disposed between the cutting mark and the outer edge of the body portion, configured to cover the nail anchor or the nail pusher groove covering the nail cartridge.
[0008] In some embodiments, with the center of the body portion as the vertex of the central angle, along the axial direction of the body portion: 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 groove opening of the nail slot portion is ∠A; the central angle of the distance between two adjacent slits 1122 is ∠B; wherein, ∠b < ∠B < ∠A < ∠a, and ∠a = 2∠b.
[0009] In some embodiments, the length of the slit in the radial direction of the body portion is 1 / 3 to 2 / 3 of the radius of the body portion.
[0010] In some embodiments, the body portion further includes a connecting portion disposed at the edge of the body portion and configured to adapt and connect the anastomosis reinforcement patch to the anvil or the staple cartridge, thereby defining the relative position of the body portion and the anvil or the staple cartridge.
[0011] In some embodiments, the body portion is made of a biodegradable material, which is one of polyglycolic acid, polylactic acid, polylactic acid-glycolic acid copolymer, or animal-derived material that has undergone immunogen removal treatment.
[0012] A second aspect of this application provides an anvil assembly, comprising: an anastomosis reinforcement patch provided in the first aspect of this application; an anvil, including an anvil end face, configured to be adapted and connected to the anastomosis reinforcement patch, such that the body portion is attached to the end face of the anvil; an anvil end cap, penetrating a first mounting hole in the anastomosis reinforcement patch and movably connected to the anvil; and a center rod assembly, penetrating the anvil and engaging with the anvil end cap, configured to drive the anvil end cap to move axially.
[0013] A third aspect of this application provides a staple cartridge assembly, comprising: an anastomosis reinforcement patch provided in the first aspect of this application; a staple cartridge, the staple cartridge being a tubular structure having a staple cartridge end face, the body portion of the patch covering the staple cartridge end face, and a connecting portion fitting snugly to the side wall of the staple cartridge; the staple cartridge having a staple pushing groove aligned with the staple groove portion on the surface of the body portion.
[0014] Compared with related technologies, the above-described solutions of this application have at least the following beneficial effects:
[0015] In the anastomosis reinforcement patch provided in this application, the groove group and the cutting trace work together to disperse fluid resistance and improve the fluid flow efficiency of the anastomosis. The pre-set spacing of the cutting sutures enables the anastomosis staples to be avoided in order to reduce the risk of leakage. The anastomosis reinforcement patch has strong versatility and can be assembled into the anvil and staple cartridge. The assembly and surgical procedures are simple and it is suitable for clinical needs.
[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 illustrating the structure of an anastomosis reinforcement patch applied to an anvil according to an exemplary embodiment.
[0019] Figure 2 This is a schematic diagram illustrating the structure of an anastomosis reinforcement patch applied to a staple cartridge according to an exemplary embodiment.
[0020] Figure 3 This is a schematic diagram of the main body structure of an anastomosis reinforcement patch according to an exemplary embodiment.
[0021] Figure 4 This is a perspective view of the body portion of an anastomotic reinforcement patch according to an exemplary embodiment.
[0022] Figure 5 This is a schematic diagram of the structure of an anastomosis reinforcement patch with a double protective membrane, according to an exemplary embodiment.
[0023] Figure 6 This is a cross-sectional view of an anastomosis reinforcement patch with a double protective membrane, according to an exemplary embodiment.
[0024] Figure 7 This is a cross-sectional view illustrating an anastomosis reinforcement patch applied to a staple cartridge according to an exemplary embodiment.
[0025] Figure 8 This is a schematic diagram illustrating a structure in which a body portion is disposed on the end face of a staple cartridge according to an exemplary embodiment.
[0026] Figure label:
[0027] Anastomosis reinforcement repair piece 1000, first assembly hole 1101, body part 1110, cutting mark 1111, groove group 1121, cut slit 1122, connecting part 1120, nail groove part 1130.
[0028] Double-layer protective film 1200, connecting hole 1201, inner film 1210, connecting hole 1201, outer film 1220, side groove 1202;
[0029] Patch protective film 1300, annular limiting part 1310;
[0030] Anvil assembly 2000, anvil 2100, mounting boss 2110, nail groove 2111, center rod assembly 2200, anvil end cap 2300;
[0031] 3000 staple cartridge assembly, 3100 staple cartridge, 3101 staple pusher groove, 3110 staple cartridge end face, 3200 central shaft assembly, 3300 cutting blade;
[0032] First suture 4100, second suture 4200, suture segment 4210, free segment 4220;
[0033] 5000 staples. Detailed Implementation
[0034] 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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).”
[0041] 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.
[0042] The optional embodiments of this application are described in detail below with reference to the accompanying drawings.
[0043] The first aspect of this application provides an anastomosis reinforcement repair patch 1000, a stapler assembly, and a staple cartridge assembly 3000, such as... Figure 1 , Figure 2 As shown, the anastomosis reinforcement patch 1000 can be applied to the anvil or staple cartridge 3100.
[0044] In some embodiments, such as Figure 1 As shown, the anastomosis reinforcement patch 1000 includes a body portion 1110 and a connecting portion 1120. The body portion 1110 has an annular structure and its size is adapted to the end face of the staple cartridge 3100 that contacts the anastomosis. This end face is the anvil end face or the staple cartridge end face 3110.
[0045] The main body 1110 has a first assembly hole 1101 that extends through the middle along the axial direction. The first assembly hole 1101 can provide an assembly clearance channel for the center rod assembly 2200 of the anvil assembly 2000, and can also serve as a positioning reference to calibrate the relative position of the main body 1110 and the anvil 2100 or the staple cartridge 3100. This provides a stable foundation for the subsequent anastomosis staple 5000 forming and ring knife cutting, ensuring accurate positioning during cavity tissue anastomosis and avoiding anastomosis deviation caused by reference offset.
[0046] In some embodiments, the surface of the body portion 1110 is further provided with a nail groove portion 1130, which is configured to correspond to the position of the nail groove 2111 of the anvil 2100 or the nail push groove 3101 of the nail magazine 3100, so that the anastomotic staple 5000 can pass through the nail groove portion 1130 to achieve anastomotic staplement.
[0047] In some embodiments, such as Figure 1 As shown, the connecting portion 1120 is located on the outer ring edge of the body portion 1110 and extends along the side wall of the anvil 2100 in a direction away from the anvil end face. The inner wall shape of the connecting portion 1120 is adapted to the outer wall of the anvil 2100, and can fit tightly against the outer wall of the anvil 2100 after assembly.
[0048] In some embodiments, such as Figure 2 As shown, the connecting part 1120 is located on the outer ring edge of the body part 1110 and extends axially along the side wall of the staple cartridge 3100 in a direction away from the staple cartridge end face 3110. The inner wall shape of the connecting part 1120 is adapted to the outer wall of the staple cartridge 3100, and can fit tightly against the outer wall of the staple cartridge 3100 after assembly.
[0049] In some embodiments, the body portion 1110 and the connecting portion 1120 are integrally formed. The integrally formed design of the connecting portion 1120 and the body portion 1110 ensures the structural strength of the body portion 1110, while limiting the relative position of the body portion 1110 and the staple cartridge 3100. This prevents the body portion 1110 from rotating circumferentially or shifting radially relative to the staple cartridge 3100 during surgery, ensuring that the staple groove portion 1130 on the body portion 1110 can be precisely aligned with the staple pusher groove 3101 of the staple cartridge 3100, thus providing a guarantee for the stable firing of the anastomotic staples 5000.
[0050] In some embodiments, such as Figure 3 As shown, on the surface of the body portion 1110, a plurality of nail groove portions 1130 and a plurality of cutting groove groups 1121 are evenly distributed circumferentially around the center of the body portion 1110. Each cutting groove group 1121 includes three equally spaced cutting slits 1122, which extend radially along the body portion 1110. Each cutting groove group 1121 includes three equally spaced cutting slits 1122, and the three cutting slits 1122 are arranged at a preset interval, configured so that at least two of the cutting slits 1122 can avoid the engagement point of the matching nail 5000.
[0051] In some embodiments, in the radial direction of the body portion 1110, the slit 1122 has a first end adjacent to the inner ring and a second end adjacent to the outer ring, and the distance from the cutting mark 1111 to the second end is greater than 1 / 2 of the distance from the cutting mark 1111 to the edge of the outer ring. This allows the second end of the slit 1122 to be closer to the edge of the outer ring, so that after the body portion 1110 is cut, the resulting flow channel can extend to the peripheral gap of the stapled area, preventing excessive fluid accumulation below the stapled area. Simultaneously, it ensures that the slit 1122 maintains a safe distance from the staple groove portion 1130, neither interfering with the firing and shaping of the staple 5000, nor hindering the flow of fluid around the staple 5000's engagement point through the radial extension of the slit 1122, thus reducing the impact of fluid on the tissue at the stapled site and lowering the risk of leakage.
[0052] In some embodiments, the length of the slit 1122 in the radial direction of the body portion 1110 is 1 / 3 to 2 / 3 of the radius of the body portion 1110. If the length of the slit 1122 is less than 1 / 3, insufficient radial extension will result in a short flow channel around the shorter slit 1122 after cutting, which cannot effectively disperse the fluid resistance at the center of the anastomosis, resulting in poor flow. If the length exceeds 2 / 3, the slit 1122 will be too close to the stapling area of the outer ring edge of the patch, which may damage the structural integrity of the stapling groove portion 1130 and affect the support stability of the anastomosis stapling 5000 during molding. Limiting the length range to 1 / 3 to 2 / 3 allows the slit 1122 to form a sufficiently long radial flow channel without intruding into the stapling portion of the body portion 1110. Combined with the circumferentially uniform distribution of the groove group 1121, this significantly reduces the fluid resistance.
[0053] In some embodiments, such as Figure 4 As shown, with the center of the body portion 1110 as the vertex of the central angle, along the axial direction of the body portion 1110, 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 groove opening of the single staple groove portion 1130 is ∠A; the central angle of the distance between two adjacent staple groove portions 1130 is ∠B, where ∠b < ∠B < ∠A < ∠a; ∠a = 2∠b, ensuring that the slits 1122 are set without affecting the cutting smoothness, allowing the staple groove portion 1130 to have sufficient width to avoid abnormal deformation of the staples 5000, while preventing damage to the formed staples 5000 during cutting, reducing the risk of leakage and tissue damage.
[0054] In some embodiments, 5° < ∠B < 20°; if ∠B < 5°, the spacing of the slits 1122 is easily too narrow, resulting in insufficient installation space for the groove assembly 1121, and there may also be circumferential overlap between the slits 1122 and the nail groove portion 1130, affecting the continuous cutting of the cutting blade and resulting in incomplete cutting; if ∠B > 20°, the spacing of the slits 1122 is easily too wide, causing discontinuous sealing of the mating joint and increasing the risk of leakage.
[0055] In some embodiments, 10° < ∠A < 35° is configured to ensure that the staple groove has sufficient width to accommodate the staple 5000 and meet its forming space requirements. If ∠A < 10°, the staple 5000 is very likely to be not firmly attached or the staple body may deform abnormally; if ∠A > 35°, the staple groove 1130 is too wide and will encroach on the installation area of the cutting groove assembly 1121. The cutting process may easily damage the formed staple 5000 and cannot guarantee the integrity of the cut guide channel.
[0056] 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 that the path of the cutting blade 3300 is continuous and that the distance 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 nail grooves 1130, thus avoiding circumferential overlap between the grooving group 1121 and the nail groove 1130.
[0057] In some embodiments, the central angle between two adjacent nail groove portions 1130 is ∠B. ∠B serves as the interval angle between the cutting group 1121 and the nail groove portion 1130, providing independent installation space for the cutting group 1121 while avoiding discontinuous sealing of the mating joint due to excessive spacing between adjacent nail groove portions 1130. Therefore, ∠b < ∠B < ∠A.
[0058] Since the guide forming area of the nail groove 1130 needs to be wide enough to avoid straight nails, ∠B < ∠A is required to ensure that the nail groove 1130 has enough space to accommodate the staples 5000 and to form them. At the same time, ∠A < ∠a is required to prevent the width of the nail groove 1130 from exceeding the span of the cutting groove group 1121, which would damage the formed staples 5000 during cutting.
[0059] 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 nail slots 1130 without intruding into the nailing area of the nail slot 1130.
[0060] In some embodiments, such as Figure 3 , Figure 4 As shown, the surface of the body portion 1110 is also provided with a cutting mark 1111. The cutting mark 1111 and the first mounting hole 1101 are concentric circles, forming a pre-set annular path around the first mounting hole 1101, and the cutting mark 1111 penetrates all the cuts 1122. When the cutting blade 3300 cuts the body portion 1110 along the cutting mark 1111, it can accurately cut the cutting mark 1111 with the first mounting 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, and avoiding irregular edges that scratch the mucosa of the cavity.
[0061] In some embodiments, the body portion 1110 is made of a biodegradable material, which is one of polyglycolic acid (PGA), polylactic acid (PLA), polylactic-glycolic acid copolymer (PLGA), or animal-derived materials, such as animal-derived materials that have 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. This type of material has excellent biocompatibility and a controllable degradation cycle. Its core function is to provide stable support during the repair of cavity tissues, while avoiding the drawbacks of non-degradable materials requiring secondary surgery for removal. This reduces the trauma and infection risk to patients due to secondary surgery, and allows the degradation cycle of the material to match the repair cycle of the cavity tissues. It continuously provides support and reinforcement before the tissue is completely healed, and after healing, it gradually degrades into non-toxic metabolites that are absorbed by the body, improving the patient's treatment experience.
[0062] A second aspect of this application provides an anvil assembly 2000, such as... Figure 1 As shown, the anvil assembly 2000 includes an anvil 2100, a central rod assembly 2200, an anvil end cap 2300, and an anastomosis reinforcement patch 1000 provided in the first aspect of this application. The anastomosis reinforcement patch 1000 applied to the anvil assembly 2000 may include a double-layer protective film 1200. The anvil end cap 2300 and the central rod assembly 2200 form a clamping structure, clamping the anastomosis reinforcement patch 1000. It is configured to cause the double-layer protective film 1200 to flip under external force, thereby quickly covering the edge of the circular cutting hole and effectively isolating the cutting edge from the cavity tissue.
[0063] In some embodiments, such as Figure 1 , Figure 5 , Figure 6 As shown, the double-layer protective film 1200 includes an inner film 1210 and an outer film 1220. The bottom edge of the outer film 1220 is fixedly connected to the body part 1110 through a first stitch 4100, and the top edge is integrally connected to the inner film 1210 to form a closed top structure. The bottom end of the inner film 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.
[0064] 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.
[0065] In some embodiments, the anastomosis reinforcement patch 1000 includes a first suture 4100, which is a medical-grade fixation suture with high strength and good biocompatibility. The first suture 4100 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 body portion 1110, 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 body portion 1110, preventing detachment or loosening during assembly, repair operations, or flipping.
[0066] 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.
[0067] 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 first suture line 4100 as the fulcrum, realizing the rapid isolation of the cutting hole edge and the cavity.
[0068] 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 body portion 1110 and the first stitch line 4100 is not less than 1 mm. It 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.
[0069] In some embodiments, there is a preset distance between the side cut groove 1202 and the first suture 4100. 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 anastomosis reinforcement patch 1000 and the anvil 2100, and ensures the structural stability after assembly. This provides a reliable guarantee for subsequent repair operations and protective membrane flipping. The preset distance is not less than 3mm to prevent the fluid in the cavity from leaking out from the side cut groove after flipping.
[0070] In some embodiments, both the body portion 1110 and the double-layer protective film 1200 are made of biodegradable materials.
[0071] In some embodiments, such as Figure 1 As shown, the anvil assembly 2000 includes an anvil 2100, which is a ring-shaped support structure. The outer surface is provided with a plurality of mounting bosses 2110 evenly distributed along the circumference. The shape of the mounting bosses 2110 matches the connecting part 1120 of the body part 1110. The configuration is to ensure that the patch device is stably connected to the body part 1110, and to ensure that the patch device will not wobble or shift axially during the repair operation, thereby ensuring the precise fit between the cutting blade and the kerf 1122, and between the anastomosis staple 5000 and the anastomosis groove 2111.
[0072] In some embodiments, the anvil cap 2300 is a cylindrical structure, and the outer diameter of the anvil 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 2100.
[0073] In some embodiments, the central rod assembly 2200 can pass through the anvil 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.
[0074] 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.
[0075] In some embodiments, during assembly, the anvil assembly 2000 is first aligned with the mounting boss 2110 of the anvil 2100, which is equipped with the center rod assembly 2200, so that the mounting boss 2110 is embedded between the body portion 1110 and the connecting portion 1120 of the body portion 1110, thus completing the adaptation connection between the body portion 1110 and the anvil 2100. Further, the anvil end cap 2300 is aligned with the side groove 1202 of the outer membrane 1220, so that the anvil end cap 2300 penetrates the connecting hole 1201 of the inner membrane 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 membrane 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.
[0076] 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 body part 1110 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 5000 are pressed into the anvil groove 2111 of the body part 1110 to form a stapled and fixed cavity tissue. Further, the cutting blade of the stapler moves along the axial direction of the body part 1110 to cut the cutting mark 1111 around the first assembly hole 1101, so that part of the body part 1110 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, thereby causing the outer membrane 1220 to flip around the fixation point of the first suture 4100, so that the double protective membrane 1200 completely covers the edge of the circular cutting hole, realizing the isolation between the edge of the cutting hole and the cavity, effectively avoiding the stimulation of the cavity tissue by the cutting edge, and improving the safety and repair effect of the operation.
[0077] A third aspect of this application provides a staple cartridge assembly 3000, such as... Figure 2 , Figure 7 As shown, the staple cartridge assembly 3000 includes a staple cartridge 3100 and an anastomosis reinforcement patch 1000 provided in the first aspect of this application. The staple cartridge 3100 has a staple cartridge end face 3110 adapted to the body portion 1110 of the body portion 1110, and has a staple pusher groove 3101 and a cavity for accommodating the anastomotic staples 5000 inside.
[0078] In some embodiments, the anastomosis reinforcement patch 1000 applied to the staple cartridge assembly 3000 may further include a patch protective membrane 1300. The patch protective membrane 1300 is a cylindrical flexible membrane made of a medical flexible material compatible with the material of the body portion 1110, possessing good flexibility and biocompatibility. The patch protective membrane 1300 is movably connected to the connecting portion 1120 via the second suture 4200, reserving operational space for subsequent dislodgement of the protective membrane, thus balancing insertion safety and postoperative operational convenience.
[0079] In some embodiments, such as Figure 7 As shown, the patch protective film 1300 is completely wrapped around the outside of the connecting part 1120. The length of the patch protective film 1300 is adapted to the axial length of the connecting part 1120, so that the length of the patch protective film 1300 can cover the connecting part 1120 and part of the side wall of the staple cartridge 3100, without affecting the insertion operation of the staple cartridge 3100.
[0080] In some embodiments, such as Figure 2 , Figure 7As shown, the end of the patch protective film 1300 away from the connecting portion 1120 is provided with an annular limiting portion 1310. The annular limiting portion 1310 is a circular rubber ring made of medical-grade elastic rubber material. The inner diameter of the annular limiting portion 1310 is larger than the outer diameter of the staple cartridge 3100, and the outer diameter of the annular limiting portion 1310 is consistent with the outer diameter of the patch protective film 1300. The thickness of the annular limiting portion 1310 is controlled between 0.5-1.2 mm to ensure that the annular limiting portion 1310 has elasticity and shaping ability.
[0081] In some embodiments, the annular limiting part 1310 and the patch protective film 1300 are integrally formed. The integral forming design can naturally improve the shaping ability of the patch protective film 1300. The elastic tension of the rubber ring can naturally bind the cylindrical protective film into a regular circle, which solves the problem that the flexible film material is easy to deform, making it difficult to insert the staple cartridge 3100. This allows the staple cartridge 3100 to be inserted into the cavity anastomosis more smoothly, while enhancing the fit between the patch and the inner wall of the cavity, making it easier for doctors to accurately position it when holding it.
[0082] In some embodiments, the second suture 4200 of the connecting patch protective film 1300 and the connecting portion 1120 is a detachable structure, including an integrally connected suture segment 4210 and a free segment 4220.
[0083] The end of the suture segment 4210 is fixedly connected to the edge of the patch protective film 1300 by knotting or heat pressing. The middle section of the suture segment 4210 is distributed circumferentially along the connecting part 1120 and passes through the connecting part 1120 and the patch protective film 1300, so that the connecting part 1120 and the patch protective film 1300 form a movable connection. The second suture 4200 does not restrict the shaping of the patch protective film 1300 and can prevent the film material from shifting.
[0084] The end of the suture segment 4210 that is away from the fixed connection is integrally formed. The length of the free segment 4220 is greater than the axial length of the patch protective film 1300. After assembly, at least part of the free segment 4220 is exposed outside the body part 1110 to facilitate doctor's operation.
[0085] The second suture 4200 is configured as a detachable connection between the protective membrane and the connecting part 1120. When the free segment 4220 is pulled by external force, the suture segment 4210 can quickly detach from the connecting part 1120, thereby driving the patch protective membrane 1300 to completely detach from the cavity, avoiding membrane material residue that may cause inflammation. At the same time, the detachable design eliminates the need for additional removal tools, improving surgical efficiency.
[0086] When the anastomosis reinforcement patch 1000 is assembled with the staple cartridge 3100, the main body 1110 of the main body 1110 covers the end face 3110 of the staple cartridge, the connecting part 1120 extends axially along the side wall of the staple cartridge 3100 and fits tightly, and the annular limiting part 1310 is located on the outside of the connecting part 1120 away from the end face 3110 of the staple cartridge, forming a movable assembly structure with the main body 1110.
[0087] The staple cartridge assembly 3000 is configured to work with a tubular stapler to achieve anastomosis and repair of cavity tissues. The staple cartridge 3100 with the anastomosis reinforcement patch 1000 can reduce the assembly steps of the stapler before surgery and improve surgical efficiency. The shaping function of the annular limiting part 1310 reduces the difficulty of inserting the staple cartridge 3100 into the cavity, thus improving the overall safety and reliability of the surgery.
[0088] In some embodiments, such as Figure 7 , Figure 8 As shown, the assembly process of the anastomosis reinforcement patch 1000 and the staple cartridge 3100 must be performed in a sterile environment. The operator first aligns the body portion 1110 of the main body 1110 with the staple cartridge end face 3110 of the staple cartridge 3100, ensuring that the main body 1110 completely covers the staple cartridge end face 3110, while simultaneously ensuring that the first assembly hole 1101 is coaxial with the central shaft assembly 3200 of the staple cartridge 3100; then, the connecting portion 1120 is axially fitted along the side wall of the staple cartridge 3100, so that the connecting portion 1120... The inner wall of the 20 is tightly fitted to the outer wall of the staple cartridge 3100, completing the initial positioning of the main body 1110 and the staple cartridge 3100; finally, check the state of the patch protective film 1300 to ensure that it is connected to the connecting part 1120 through the second suture 4200, the free section 4220 is exposed on the outside, and the annular limiting part 1310 remains regular and round. This assembly process is simple and efficient. The integrated positioning structure does not require additional positioning tools and can achieve precise fitting between the patch and the staple cartridge 3100.
[0089] In some embodiments, during the insertion of the staple cartridge assembly 3000, the operator holds the staple cartridge 3100 away from the end of the annular limiting part 1310. Due to the elastic tension of the annular limiting part 1310, the patch protective membrane 1300 is shaped into a circular shape, preventing scratches on the cavity tissue. This allows the staple cartridge 3100 to smoothly penetrate the cavity under the guidance of the annular limiting part 1310 until the body part 1110 reaches the preset position of the anastomosis. During this process, the flexible wrapping of the patch protective membrane 1300 and the close support of the annular limiting part 1310 reduce frictional damage between the staple cartridge 3100 and the inner wall of the cavity, and also help the surgeon quickly locate the device, reducing the operational difficulty caused by limited visibility in minimally invasive surgery.
[0090] In some embodiments, the stapling operation of the cavity tissue is achieved by the firing mechanism of the tubular stapler. After the stapler is fired, the staples 5000 in the staple cartridge 3100 are pushed out through the staple pusher groove 3101, pass through the body part 1110 and the cavity tissue, and are finally squeezed and deformed at the anvil end face of the stapler, so that the staples 5000 penetrate the staple groove part 1130 of the body part 1110 to form a tight clamping structure.
[0091] Because the staple groove 1130 is precisely aligned with the pusher groove 3101, and the staples 5000 are evenly distributed and have regular deformation shapes, the stress on the tissue can be effectively dispersed, avoiding tissue damage caused by excessive local pressure. At the same time, the supporting role of the body part 1110 enhances the strength of the anastomosis and reduces the risk of postoperative complications such as leakage and bleeding.
[0092] In some embodiments, after stapling, the body portion 1110 and the human tissue need to be cut. The annular blade of the tubular stapler moves along a preset trajectory. Guided by the cutting groove 1111 of the body portion 1110, the annular blade precisely cuts the body portion 1110, forming a regular circular cutting hole. The cutting slits 1122 of the cutting groove assembly 1121 assist the body portion 1110 to break quickly and smoothly, avoiding problems such as rough edges and tearing, while ensuring that fluid can flow more easily in the internal cutting channel. The discarded central part of the cut patch is removed together with the central shaft assembly of the stapler. The remaining body portion 1110 remains fixed to the cavity tissue. The edges of the cutting hole are smooth and will not irritate the cavity mucosa, ensuring the patency and safety of the cavity after surgery.
[0093] In some embodiments, after the cutting operation is completed, the operator uses surgical instruments to clamp the exposed free segment 4220 of the second suture 4200 and gently pulls it away from the cavity. Under the pulling force, the suture segment 4210 of the second suture 4200 separates from the patch connection portion 1120, thereby driving the patch protective membrane 1300 to move out of the cavity along the outer wall of the staple cartridge 3100, and finally completely exiting the cavity. Because the second suture 4200 is detachable and the protective membrane and the connection portion 1120 are movably connected, the pulling process is smooth and will not cause traction damage to the fixed anastomosis, avoiding inflammatory reactions caused by residual protective membrane, simplifying the postoperative operation process, and improving surgical efficiency.
[0094] During the postoperative recovery phase, the main body 1110 continues to play a supporting and repairing role. The biodegradable material gradually adapts to the human body environment. The degradation rate of the main body 1110 matches the repair cycle of the cavity tissue, providing stable support for the anastomosis before the tissue is completely healed and enhancing the strength of the anastomosis.
[0095] After the tissue heals, the 1110 body gradually degrades into non-toxic and harmless metabolic products, which are naturally absorbed by the body. This eliminates the need for a second surgery to remove it, reducing the patient's trauma and risk of infection. It also avoids the foreign body reaction that may be caused by the long-term retention of non-degradable materials in the body, ensuring the safety and comfort of postoperative recovery.
[0096] The specific structure, working principle, and beneficial effects of the anastomosis reinforcement patch, anvil assembly, and staple cartridge assembly provided in this application embodiment can be found in any of the above embodiments, and will not be repeated here.
[0097] 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.
[0098] 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. An anastomotic stricture reinforcement patch, characterized in that, It can be applied to anvils or nail magazines, including: The main body is a ring-shaped structure with a first assembly hole extending through its center along the axial direction. The main body includes: The groove group is uniformly arranged circumferentially on the surface of the body part, and each groove group includes multiple slits extending radially along the body part, configured to make the fluid flow more smoothly through the anastomosis. A pre-defined annular cutting path surrounds the first assembly hole and passes through all the cuts; The nail groove is located between the annular preset cutting path and the outer edge of the main body, and is configured as a nail abutment covering the nail anvil or a nail pusher groove covering the nail cartridge; The distance between the two groove groups is greater than the distance between two adjacent cuts in the groove group; With the center of the main body as the vertex of the central angle, along the axial direction of the main body: 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 the nail slot is ∠A; The central angle between two adjacent cuts is ∠B; Among them, ∠b<∠B<∠A<∠a, and ∠a=2∠b.
2. The anastomotic reinforcement patch according to claim 1, characterized in that, Each of the groove groups includes three equally spaced slits, and the three slits are arranged at a preset interval, configured such that at least two of the slits can avoid the engagement point of the staples.
3. The anastomotic reinforcement patch according to claim 2, characterized in that, In the radial direction of the body portion, the slit has a first end adjacent to the inner ring and a second end adjacent to the outer ring, and the distance from the annular preset cutting path to the second end is greater than 1 / 2 of the distance from the annular preset cutting path to the edge of the outer ring.
4. The anastomotic reinforcement patch according to claim 1, characterized in that, In the radial direction of the body portion, the length of the slit is 1 / 3 to 2 / 3 of the radius of the body portion.
5. The anastomotic reinforcement patch according to claim 1, characterized in that, The body portion also includes: A connecting portion is provided at the edge of the body portion and configured to adapt and connect the anastomosis reinforcement patch to the anvil or the staple cartridge, thereby defining the relative position of the body portion and the anvil or the staple cartridge.
6. The anastomotic reinforcement patch according to claim 1, characterized in that, The body is made of a biodegradable material, which is one of polyglycolic acid, polylactic acid, polylactic acid-glycolic acid copolymer, or animal-derived material that has undergone immunogen removal treatment.
7. A nail-anvil assembly, characterized in that, include: The anastomosis reinforcement patch according to any one of claims 1-6; An anvil, including an anvil end face, is configured to be adapted and connected to the anastomosis reinforcement patch, so that the body part is attached to the end face of the anvil; An anvil end cap passes through the first assembly hole of the anastomosis reinforcement patch and is movably connected to the anvil. A center rod assembly passes through the anvil and engages with the anvil end cap, configured to drive the anvil end cap to move axially.
8. A staple cartridge assembly, characterized in that, include: The anastomosis reinforcement patch according to any one of claims 1-6; The staple cartridge has a tubular structure and a staple cartridge end face. The body of the patch covers the staple cartridge end face, and the connecting part fits snugly to the side wall of the staple cartridge. The staple cartridge is provided with a staple pusher groove, which is aligned with the staple groove on the surface of the main body.