Anastomosis reinforcement

Abstract

This utility model relates to the field of medical devices, specifically to an anastomosis reinforcement component. The anastomosis reinforcement component is used on the clamping arm of a stapler, wherein the clamping arm of the stapler is a staple cartridge arm and / or a staple anvil arm, and the staple cartridge arm has staple grooves; the anastomosis reinforcement component includes a reinforcing tab and multiple transient structural connectors. Through the innovative coupling design formed by the synergistic effect of the reinforcing tab and the transient structural connectors, direct fixation of the reinforcing tab is achieved, completely abandoning the traditional operation method of circumferential fixation using long continuous sutures. This significantly reduces secondary tissue damage caused by long sutures, ensuring that the reinforcing tab is not easily shaken, displaced, or curled during stapler operation, and does not obstruct the release of staples, while ensuring that the reinforcing tab can accurately and smoothly reach the predetermined position.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and more specifically, to anastomosis reinforcement. Background Technology

[0002] When using a stapler for anastomosis, a patch is often pre-attached to the clamping arm of the stapler to protect fragile tissues from the shearing force of the staples, while also sealing the microscopic gaps between the staple feet and the tissue to reduce the risk of air leakage and fluid seepage. However, because anastomotic patches can slip, curl, or turn over, backing material and sutures are often added to the patch to fix it in place. After the anastomosis is completed, the backing material and sutures are removed, as described in patent publication CN220327483U. However, while this suture fixation method can effectively control patch displacement, it is difficult to completely avoid edge curling. More importantly, when dealing with fragile tissues such as soft tissues that have undergone degenerative changes, the local pressure generated by the sutures can not only cause tissue abrasions, but their narrow contact surface can also easily cut into the damaged tissue, leading to secondary damage. In addition, the free end of the suture is prone to entanglement with the stapler or trocar during the operation, which may lead to premature separation of the patch-backing assembly or cause the assembly to remain, ultimately affecting the surgical repair effect. Summary of the Invention

[0003] To address the aforementioned problems, this utility model provides an anastomosis reinforcement component, which is used on the clamping arm of a stapler, wherein the clamping arm of the stapler is a staple cartridge arm and / or a staple anvil arm, and the staple cartridge arm has an anastomosis staple groove; the anastomosis reinforcement component includes a reinforcing auxiliary piece and multiple transient structural connectors.

[0004] In the dry state, the upper end of the transient structural connector is fixedly connected to the reinforcing auxiliary piece, and the lower end of the transient structural connector is fixedly connected to the clamping arm.

[0005] Furthermore, the fixed connection is selected from at least one of adhesive bonding, abutment bonding, freeze-drying bonding, hook bonding, and chemical cross-linking bonding.

[0006] Furthermore, the fixed connection is selected from at least two of adhesive bonding, abutment bonding, freeze-drying bonding, hook bonding, and chemical cross-linking bonding.

[0007] Examples of fixed connections include, at a minimum, adhesive and freeze-dried connections.

[0008] As can be listed, the fixed connection is selected from at least three types: adhesive bonding, abutment bonding, freeze-drying bonding, hook bonding, and chemical cross-linking bonding.

[0009] For example, the upper end of the transient structural joint is bonded to the reinforcing auxiliary sheet, then chemically crosslinked using a crosslinking agent solution, and freeze-dried, so that a freeze-dried connection is formed on the basis of the aforementioned bonding and chemical crosslinking connection.

[0010] For example, after the lower end of the transient structural joint is bonded to the clamping arm, it is freeze-dried to form a freeze-dried connection based on the aforementioned bonding.

[0011] For example, when the lower end of the transient structural joint and the clamping arm are bonded, a mold with a radially outward expanding unfolding structure is used. After bonding and freeze-drying, the lower end of the transient structural joint and the clamping arm also form a retaining connection due to the introduction of the mold.

[0012] Furthermore, in the dry state, the peel strength of each transient structural joint and reinforcing tab is 0.5-5 N / cm.

[0013] The reinforcing sheet has a layered, flexible, porous structure, and its tensile strength in the dry state is ≥10 N / cm.

[0014] Examples of reinforcing patches include polymer patches, biological patches, or composite material patches.

[0015] Biological patches, for example, are decellularized matrix patches.

[0016] Acellular matrix patches can be derived from the submucosa of the small intestine, the basement membrane of the bladder, the pericardium, the pleura, the peritoneum, the dermis, etc. of mammals.

[0017] The transient structural joint is a brittle porous structure.

[0018] Furthermore, in the dry state, the transient structural joint is a brittle porous structure.

[0019] The material of the transient structural joint is a biocompatible adhesive.

[0020] Biocompatible adhesives are derived from fibrin adhesive, mussel adhesive protein adhesive, gelatin, cyanoacrylate adhesive, polyethylene glycol adhesive, polyurethane adhesive, hyaluronic acid adhesive, sodium alginate adhesive, etc.

[0021] Biocompatible adhesives, for example, are derived from gelatin.

[0022] Furthermore, the transient structural joint is in a gel state when wet.

[0023] The lower end of the transient structural joint has a radially outward expanding unfolding structure.

[0024] Furthermore, the radially outward expanding unfolding structure includes unfolding units distributed along the circumferential direction, each unfolding unit having an outwardly expanding working surface.

[0025] Examples include the unfolding units being uniformly or / and non-uniformly distributed along the circumferential direction.

[0026] Examples include continuous or discontinuous working surfaces.

[0027] Examples include continuous or discontinuous working surfaces formed by the radially outward expansion structure at the lower end of the transient structural joint, which form a retaining connection with the clamping arm of the stapler.

[0028] Examples of radially outward expanding structures include conical expanding structures, umbrella-shaped expanding structures, figure-eight expanding structures, calyx-shaped expanding structures, or petal-shaped expanding structures.

[0029] The biocompatible adhesive temporary structural connector forms a fixed abutment connection with the clamping arm of the stapler. Combined with the specific fixed connection method of the temporary structural connector, it helps to maintain a fixed relative position between the temporary structural connector and the clamping arm of the stapler. This not only makes the reinforcing strip less prone to shaking, displacement, and curling when the stapler is in operation, but also does not hinder the release of the staples and ensures that the reinforcing strip can accurately and smoothly reach the predetermined position.

[0030] Furthermore, the transient structural connector is embedded in the stapling arm, and the unfolded structure forms a fixed abutment connection with the stapling arm.

[0031] In a preferred embodiment, a cross-linking module is provided on the reinforcing auxiliary sheet.

[0032] Furthermore, a portion of the crosslinking module is embedded with a reinforcing auxiliary sheet, and another portion is embedded with a transient structural connector, to further strengthen the fixed connection between the reinforcing auxiliary sheet and the transient structural connector in the dry state.

[0033] For example, the upper end of the transient structural connector is bonded to the reinforcing auxiliary sheet, and then a crosslinking agent solution is applied to form a crosslinking unit. All the crosslinking units on the reinforcing auxiliary sheet form a crosslinking module.

[0034] In a preferred embodiment, the crosslinking module consists of multiple rows of parallel dot coating arrays, wherein the dot coating array consists of multiple dot coating units with the same horizontal height and spacing between the dot coating units.

[0035] In a preferred embodiment, the spacing between the dotting units is ≥1.5mm.

[0036] Furthermore, the spacing between the dots is ≤2.2mm.

[0037] The spacing between dot-painting units in the same row of the dot-painting array is equal.

[0038] The spacing between non-aligned dotted units can be equal or unequal.

[0039] Furthermore, the crosslinking module includes at least two rows of dot-coating arrays with equal spacing between the dot-coating units.

[0040] In a preferred embodiment, the straight-line distance between the dot coating arrays is less than the interval between the dot coating units in any row of the dot coating array.

[0041] For example, the linear distance between dot arrays is ≥0.5mm.

[0042] Furthermore, the straight-line distance between the dot arrays is 0.5mm ≤ 1.5mm.

[0043] In a preferred embodiment, the straight-line distance from the dotted array to the long side of the reinforcing auxiliary sheet is ≥1.5mm.

[0044] In a preferred embodiment, the number of rows in the dot pattern is even, and the dot pattern is symmetrical about the horizontal axis.

[0045] In a preferred embodiment, when the dot coating array has ≥4 rows, the dot coating array includes at least a first dot coating array and a second dot coating array, and the shortest distance from the starting point of the first dot coating array to the short side of the reinforcing auxiliary piece is greater than the shortest distance from the starting point of the second dot coating array to the short side of the reinforcing auxiliary piece.

[0046] When the dot coating array has ≥4 rows, the crosslinking module includes at least two rows of dot coating arrays with equal spacing between dot coating units and two rows of dot coating arrays with unequal spacing between dot coating units.

[0047] It can be listed that the spacing between the dots in the second dot coating array is greater than the spacing between the dots in the first dot coating array.

[0048] The fixed abutment connection formed by the aforementioned biocompatible adhesive transient structural connector and the clamping arm of the stapler, with a cross-linking module set at a specific position of the reinforcing patch, further facilitates the reinforcing patch to be less prone to displacement and curling, improves the peel performance between the reinforcing patch and the enhanced transient structural connector, and ensures good adhesion between the repair patch and the tissue. At the same time, such enhancement will not interfere with the release of the staples.

[0049] This utility model also provides an anastomosis reinforcement component, which is used on the clamping arm of an anastomosis device. The clamping arm of the anastomosis device is a staple cartridge arm and / or an anvil arm. The staple cartridge arm has an anastomosis staple groove, and the clamping arm includes a first tissue contact surface defining the anastomosis staple groove. The anvil arm has a notch defining a shape formed after the anastomosis staple is released, and the anvil arm includes a second tissue contact surface defining the notch. The anastomosis reinforcement component includes a reinforcing auxiliary piece and multiple rows of parallel transient structural connectors. The reinforcing auxiliary piece and the clamping arm are connected by the transient structure... The connectors are detachably connected; the transient structural connectors are located on the first tissue contact surface and / or the second tissue contact surface of the clamping arm, and the transient structural connectors do not contact the anastomosis slots and notches; the transient structural connectors are spaced ≥1.5mm apart along the length of the clamping arm; the shortest distance between each row of transient structural connectors is ≥0.5mm; the reinforcing auxiliary sheet is a layered flexible porous structure, and the tensile strength of the reinforcing auxiliary sheet in the dry state is ≥10N / cm; the transient structural connectors are brittle porous structures in the dry state.

[0050] In this solution, the anastomosis reinforcement component, consisting of a transient structural connector and a reinforcing patch, maintains the clamping pressure of the anastomosis device after the anastomotic staples are released. After 30-80 seconds, the biocompatible adhesive transient structural connector undergoes a phase transition in the wet environment within the body, restoring to a hydrophilic gel state, thus allowing the reinforcing patch to gently separate from it. This gentle phase transition process enables the reinforcing patch to achieve gradual separation without causing mechanical damage. Finally, under the mechanical fixation of the anastomotic staples, the reinforcing patch forms a stable spatial anchoring structure with the target tissue, ensuring a durable and reliable reinforcement effect at the anastomosis site.

[0051] In this technology, the reinforcing patch does not require additional sutures for fixation in general scenarios. Stable fixation of the reinforcing patch is achieved through the interlocking mechanism between the reinforcing patch and the transient structural connector. Optionally, short positioning sutures can be used for certain special locations or high-tension areas.

[0052] For example, the reinforcing patch is provided with a detachable suture; the suture includes a fastening section and a traction section connected to the fastening section, the fastening section of the suture passing through the reinforcing patch to strengthen the connection between the reinforcing patch and the stapler clamping arm.

[0053] Beneficial Effects: The innovative coupling design, achieved through the synergistic effect of the reinforcing patch and the transient structural connector, enables direct fixation of the reinforcing patch. This completely eliminates the traditional method of circumferential fixation using long, continuous sutures, significantly reducing secondary tissue damage caused by long sutures. It ensures that the reinforcing patch is less prone to shaking, displacement, or curling during operation, and it does not obstruct the release of the staples, guaranteeing that the reinforcing patch accurately and smoothly reaches the predetermined position. Especially for special areas near the intestines, such as the groin, it effectively resists the mechanical stress generated by intestinal dynamics, ensuring the reinforcing patch remains stable and flat under dynamic physiological conditions, preventing curling or displacement, and ensuring a good fit to the predetermined position.

[0054] The product is biodegradable and is less likely to cause inflammatory reactions or foreign body rejection. It meets both short-term mechanical support needs and long-term tissue compatibility requirements, achieving a balance between mechanical support and biocompatibility, and providing a safer and more reliable solution for anastomosis reinforcement. Attached Figure Description

[0055] Figure 1 This is a schematic diagram of the anastomosis reinforcement component in Example 1, where 1-anastomosis device, 2-anastomosis reinforcement component, and 3-clamping arm of the anastomosis device; Figure 2 This is a side view of the anastomosis reinforcement component of Example 1, wherein 4-reinforcing auxiliary piece, 5-anastomosis slot of the anastomosis device, 6-crosslinking module, 7-transient structural joint, 8-unfolding unit, 9-dotting unit, 10-first dotting array, and 11-second dotting array. Figure 3 A schematic diagram of the staple cartridge arm surface of the reinforcing auxiliary piece for the anastomosis reinforcement; Figure 4 This is a schematic diagram of the shape of the transient structural joint of the anastomosis reinforcement in Examples 2-3, wherein, Figure 4 (a) is a schematic diagram of the shape of the transient structural joint in Example 2. Figure 4 (b) is a schematic diagram of the shape of the transient structural joint in Example 3; Figure 5 This is a schematic diagram of the anastomosis reinforcement in Example 4, where 12 represents the first tissue contact surface. Detailed Implementation

[0056] Example 1

[0057] This example provides a joint reinforcement component, such as... Figure 1 The anastomosis reinforcement 2 is used on the clamping arm 3 of the stapler 1, wherein the clamping arm of the stapler is a staple cartridge arm, and the anastomosis reinforcement component includes a reinforcing auxiliary piece 4 and multiple transient structural connectors 7, such as... Figure 2 .

[0058] The reinforcing patch 4 is a layered flexible porous structure. In this example, the reinforcing patch is derived from the decellularized matrix patch of Zhuoran Medical Technology (Suzhou) Co., Ltd. (derived from the porcine bladder basement membrane). The transient structural connector 7 is a brittle porous structure (dry state) made of biocompatible adhesive, which is formed by freeze-drying a gelatin aqueous solution with a concentration of 1-6wt%.

[0059] In the dry state, the upper end of the transient structural connector 7 is fixedly connected to the reinforcing auxiliary piece 4 (specifically, by bonding, chemical cross-linking and / or freeze-drying), and the lower end of the transient structural connector 7 is fixedly connected to the clamping arm (specifically, by bonding, freeze-drying and / or abutting).

[0060] The upper end of the transient structural connector 7 is bonded to the reinforcing auxiliary sheet 4, and then a crosslinking agent solution is used for dotting to form a dotting unit 9. All the dotting units 9 on the reinforcing auxiliary sheet 4 are crosslinking modules. After freeze-drying, a freeze-dried connection is formed on the basis of the aforementioned bonding and chemical crosslinking connection. When the lower end of the transient structural connector 7 is bonded to the clamping arm, a mold with a radially outward expanding unfolding structure is used. After bonding, the connection is freeze-dried. The lower end of the transient structural connector 7 and the mating nail groove 5 also form a retaining connection due to the introduction of the mold.

[0061] The transient structural connector 7 is embedded in the staple groove 5. The lower end of the transient structural connector 7 has a radially outward expanding unfolding structure, which is a figure-eight shaped unfolding structure. The radially outward expanding unfolding structure includes unfolding units 8 distributed along the circumferential direction. The unfolding unit 8 has an outwardly expanding working surface, which forms a resisting connection with the staple groove 5 of the stapler.

[0062] A crosslinking module 6 is provided on the reinforcing auxiliary sheet 4. A part of the crosslinking module 6 is embedded in the reinforcing auxiliary sheet 4, and another part is embedded in the transient structural connector 7 to further strengthen the fixed connection between the reinforcing auxiliary sheet 4 and the transient structural connector 7 in the dry state.

[0063] Crosslinking module 6 includes multiple dotting units 9, such as Figure 3 .

[0064] The crosslinking module 6 consists of six parallel dot coating arrays. The crosslinking module 6 is symmetrical about the horizontal axis, and from top to bottom, it consists of a first dot coating array 10, a second dot coating array 11, a first dot coating array 10, a first dot coating array 10, a second dot coating array 11, and a first dot coating array 10. The dot coating array is composed of multiple dot coating units 9, which are spaced apart.

[0065] In the same row, the dot-painting units 9 of the dot-painting array have the same horizontal height, and the spacing between the dot-painting units is equal.

[0066] The spacing L2 between the dot coating units 9 of the second dot coating array 11 is greater than the spacing L1 between the dot coating units 9 of the first dot coating array 10; 1.5mm ≤ L1 ≤ 2.2mm; 1.5mm ≤ L2 ≤ 2.2mm; The straight-line distance H1 between dot-paint arrays is less than the interval L1 or L2 between dot-paint units in any row of the dot-paint array; 0.5mm ≤ H1 ≤ 1.5mm; The shortest distance S1 from the starting point of the first dot coating array 10 to the short side of the reinforcing auxiliary piece is greater than the shortest distance S2 from the starting point of the second dot coating array 11 to the short side of the reinforcing auxiliary piece. The straight-line distance S3 from the dot coating array to the long side of the reinforcing auxiliary piece 4 is greater than or equal to 1.5 mm.

[0067] Specifically, L1=1.5mm, L2=2.1mm, S1=2.1mm, S2=1.5mm, S3=1.5mm, and H1=1.0mm.

[0068] In this example, the peel strength test of the reinforcing auxiliary piece 4 and the transient structural joint 7 is 0.5-5 N / cm, and the tensile strength of the reinforcing auxiliary piece in the dry state is ≥10 N / cm.

[0069] Example 2

[0070] The difference between this example and Example 1 is that the transient structural connector is a calyx-shaped unfolding structure, such as... Figure 4 (a).

[0071] Example 3

[0072] The difference between this example and Example 1 is that the transient structural connector is an umbrella-shaped unfolding structure, such as... Figure 4 (b).

[0073] Example 4

[0074] This example provides an anastomosis reinforcement component, which includes a reinforcing auxiliary piece and multiple rows of parallel transient structural connectors; the reinforcing auxiliary piece and the clamping arm are detachably connected via the transient structural connectors; the transient structural connectors are located on the first tissue contact surface 12 of the staple cartridge arm, and the transient structural connectors do not contact the staple grooves or notches, such as... Figure 5 .

[0075] The shortest distance between each row of transient structural joints is 1 mm; for any row of transient structural joints along the length of the clamping arm, each transient structural joint has an equal interval of 1.5 mm; the reinforcing auxiliary sheet is a layered flexible porous structure, and the transient structural joint is a brittle porous structure in the dry state.

[0076] In this example, the peel strength test of the reinforcing auxiliary piece 4 and the transient structural joint 7 is 0.5-5 N / cm, and the tensile strength of the reinforcing auxiliary piece in the dry state is ≥10 N / cm.

Claims

1. An anastomosis reinforcement component, said anastomosis reinforcement component being used on the clamping arm of an anastomosis device, wherein, The clamping arm of the stapler is a staple cartridge arm and / or anvil arm, the staple cartridge arm having a staple groove, characterized in that the staple reinforcement component includes a reinforcing auxiliary piece and multiple transient structural connectors; in the dry state, the upper end of the transient structural connector is fixedly connected to the reinforcing auxiliary piece, and the lower end of the transient structural connector is fixedly connected to the clamping arm. The reinforcing sheet has a layered flexible porous structure, and its tensile strength in the dry state is ≥10N / cm. The transient structural connector is a brittle porous structure. The lower end of the transient structural connector has a radially outward expanding structure. The expanding structure forms a fixed abutting connection with the clamping arm of the stapler, so that after the transient structural connector is embedded in the clamping arm of the stapler, it remains in a state that is not easy to loosen or fall off.

2. The anastomosis reinforcement according to claim 1, characterized in that, The transient structural connector is embedded in the nail cartridge, and the unfolded structure forms a fixed abutment connection with the nail cartridge.

3. The anastomosis reinforcement according to claim 1, characterized in that, The reinforcing auxiliary sheet is provided with a cross-linking module.

4. The anastomosis reinforcement according to claim 3, characterized in that, The crosslinking module consists of multiple rows of parallel dot coating arrays, wherein each dot coating array consists of multiple dot coating units with the same horizontal height and spacing between the dot coating units.

5. The anastomosis reinforcement according to claim 4, characterized in that, The spacing between the dotting units is ≥1.5mm.

6. The anastomosis reinforcement according to claim 4, characterized in that, The straight-line distance between the dot-paint arrays is less than the interval between the dot-paint units in any row of the dot-paint array.

7. The anastomosis reinforcement according to claim 4, characterized in that, The straight-line distance from the dotted array to the long side of the reinforcing auxiliary sheet is ≥1.5mm.

8. The anastomosis reinforcement according to any one of claims 4-7, characterized in that, When the dot coating array has ≥4 rows, the dot coating array includes at least a first dot coating array and a second dot coating array. The shortest distance from the starting point of the first dot coating array to the short side of the reinforcing auxiliary piece is greater than the shortest distance from the starting point of the second dot coating array to the short side of the reinforcing auxiliary piece.

9. The anastomosis reinforcement according to any one of claims 1-4, characterized in that, The reinforcing patch is provided with a detachable suture; the suture includes a fastening section and a traction section connected to the fastening section, and the fastening section of the suture passes through the reinforcing patch to strengthen the connection between the reinforcing patch and the stapler clamping arm.

10. An anastomosis reinforcement member, said anastomosis reinforcement member being used on the clamping arm of an anastomosis device, wherein, The clamping arm of the anastomosis device is a staple cartridge arm and / or an anvil arm. The staple cartridge arm has an anastomosis staple groove. The clamping arm includes a first tissue contact surface defining the anastomosis staple groove. The anvil arm has a notch defining a shape formed after the anastomosis staple is released. The anvil arm includes a second tissue contact surface defining the notch. The device is characterized in that the anastomosis reinforcement includes a reinforcing tab and multiple rows of parallel transient structural connectors. The reinforcing tab and the clamping arm are detachably connected via the transient structural connectors. The transient structural connectors are located on the first and / or second tissue contact surfaces of the clamping arm, and the transient structural connectors do not contact the anastomosis staple groove or the notch. The transient structural connectors are spaced ≥1.5 mm apart along the length of the clamping arm. The reinforcing sheet has a layered flexible porous structure, and its tensile strength in the dry state is ≥10N / cm. The transient structural joint is a brittle porous structure in the dry state.

Images