Tubular anastomat repair patch

Abstract

The invention relates to the technical field of surgical anastomat medical instruments, in particular to a tubular anastomat repair patch, which is characterized in that the outer edge of a repair patch main body is provided with at least one strip extending outwards, and the strip is connected around the repair patch main body; an opening is defined by the inner edge of the strip and the repair patch main body; during installation, the belt strip can be arranged on the tubular anastomat in a sleeving mode and is configured to generate clamping force through elastic recovery to be fixed to the tubular anastomat. An auxiliary fixing suture line can be arranged on the strap in a penetrating mode, and double fixing guarantee is provided. Preferably, a buckle can be arranged at the tail end of the suture line, the suture line can be fixed to the anastomat after being tensioned, a through hole for a center rod of the anastomat to penetrate through can be formed in the repairing piece body, and sleeving is firmer. The invention further discloses various configurations to meet the requirements of different clinical scenes. The structure is simple, installation is convenient, and fixation is reliable.

Description

Technical Field

[0001] This invention relates to the field of surgical stapler medical device technology, and in particular to a tubular stapler repair patch. Background Technology

[0002] In surgical procedures, especially gastrointestinal surgery, organ resection and reconstruction are common procedures. Anastomosis, which connects the severed ends of two hollow organs (such as the esophagus, stomach, and intestines), is a crucial step in the reconstruction process. The quality of the anastomosis directly affects the success of the surgery and the patient's postoperative recovery. To improve the efficiency and consistency of anastomosis, surgical staplers have been widely used clinically and have largely replaced traditional manual sutures. However, even with staplers, the risk of postoperative complications remains, the most serious and common of which include anastomotic bleeding and leakage. These complications can lead to serious consequences such as abdominal infection and sepsis, increasing patient mortality and prolonging hospital stays. To reinforce the anastomotic sutures and prevent these complications, a component called a "reinforcing patch" or "shim" is often added to the stapler in clinical practice. This patch is usually made of biodegradable and absorbable materials and is stapled to the tissue along with the staples during anastomosis, sealing and supporting the staple holes, thereby enhancing the seal and strength of the anastomosis.

[0003] For reinforcing repairs to function stably during surgery, they must be reliably and easily installed and secured to the corresponding components of the stapler. Various technical solutions for securing reinforcing repairs have been proposed in the prior art, but they generally suffer from complex structures, cumbersome installation procedures, and less than ideal fixation results.

[0004] For example, patent CN107595344B discloses an anastomosis reinforcement repair. This repair is secured by multiple "wings" formed by the incision and a "line" (i.e., a pull cord) passing through these wings. In use, the repair is placed on the anvil assembly of a tubular stapler, and then the pull cord is tightened, causing the wings to fold inward and contract, forming a tapered sleeve-like structure that "hoops" the anvil assembly. This fixation process relies on an active, multi-step operation: first, the repair is placed, then the pull cord is carefully and evenly tightened. This process not only increases the operation time and complexity of the surgery but also poses potential risks. Uneven tightening of the pull cord may cause wrinkles in the repair, affecting its adhesion to the tissue; excessive force may damage the repair or the pull cord itself; and during surgery, the pull cord may loosen, causing the repair to shift or fall off at a critical moment.

[0005] Another patent, CN115998352A, discloses a more complex modular solution. This solution includes a biomaterial membrane and a backing with a "cap". During fixation, the "extension" on the membrane is first inserted into the cap of the backing to form a socket structure. Then, sutures are used to suture the membrane and backing together, and finally, this assembled composite is installed onto the stapler. This design is essentially a multi-part, multi-step assembly process. It not only requires precise pre-assembly but also introduces more potential failure points. Problems in any step, such as misalignment of the membrane and backing, incomplete insertion of the extension, or loose sutures, can lead to installation failure or the repair malfunctioning during surgery.

[0006] In summary, existing reinforcement and repair devices, whether secured by pull-string tightening or by multi-part interlocking and stitching, share a common drawback: they fail to provide a simple, integrated solution with inherent fixation capabilities. There is an urgent need in the field for a tubular stapler reinforcement and repair device with a significantly simplified structure, easier installation, and more reliable fixation. This device should achieve rapid and stable fixation to the stapler through its own geometric design, without relying on complex auxiliary fasteners or cumbersome installation steps. Summary of the Invention

[0007] The technical problem this invention aims to solve is to overcome the shortcomings of existing technologies and provide a tubular anastomosis patch with a significantly simplified structure, convenient installation process, and reliable fixation effect. This patch achieves rapid and stable fixation to the anastomosis device through its own structural design, without relying on complex auxiliary fasteners or cumbersome installation steps.

[0008] To achieve the above objectives, the present invention provides the following technical solution: A tubular stapler repair patch is disclosed, comprising a patch body, wherein at least one strip is connected to the edge of the patch body, and the inner edge of the strip and the patch body together form an opening for fitting. The strip has structural elasticity and is configured to be fitted onto the tubular stapler. The main body of the repair patch is fixed onto the tubular stapler by the clamping force generated by the elastic recovery force after the strip undergoes elastic deformation.

[0009] Furthermore, the main body of the repair patch has a circular sheet-like structure; Alternatively, the outer periphery of the repair patch body may have an annular flange extending downwards, forming a cap-shaped structure.

[0010] Furthermore, the number of the strips is at least two, and the at least two strips are connected to the same side or different sides of the patch body; When the patch is fitted onto the tubular stapler, at least two of the strips are arranged in a staggered, parallel, or cross arrangement.

[0011] Furthermore, two strips are connected to the same side of the patch body to form two openings. The two strips are configured to be staggered and fitted onto both sides of the staple cartridge sleeve of the tubular stapler to form a "V" shaped structure. Alternatively, a strip can be connected to each side of the patch body, and the two strips are configured to extend vertically downwards or cross each other and be fitted onto the staple cartridge sleeve of the tubular stapler.

[0012] Furthermore, the number of the strips is three, with two strips located on the same side of the repair patch body. When fitted onto the tubular stapler, the two strips can be staggered and fitted onto both sides of the stapler cartridge sleeve to form a "V" shape. The third strip is located on the other side of the patch body. When it is fitted onto the tubular stapler, the third strip crosses the strip on the opposite side.

[0013] Furthermore, the strip is provided with a suture through hole, and an auxiliary fixing suture is inserted into the suture through hole.

[0014] Furthermore, the length of the auxiliary fixing suture is adjustable; and the end of the auxiliary fixing suture is detachably connected to a buckle, which is configured to detachably engage and fix with the body of the tubular stapler.

[0015] Furthermore, the strip is a pre-formed arc or straight shape; The width of the strip can be uniform or unequal.

[0016] Furthermore, the central area of ​​the repair patch body is provided with a circular or cross-shaped through hole; The repair patch body and strip are made of biodegradable polymer materials or biodegradable biomaterials.

[0017] Furthermore, the tubular stapler repair patch is used in conjunction with the tubular stapler; The tubular stapler repair patch is fitted and fixed to the head of the tubular stapler.

[0018] In summary, the present invention has the following beneficial effects: 1. This invention provides a tubular stapler repair patch that achieves a self-locking function by extending from the edge of the main body and being designed as a structurally elastic strip. In use, first, the through hole on the repair patch body is passed through the central rod of the stapler, and then the strip is fitted onto the stapler body. This design allows it to fit more closely to the cylindrical or frustum-shaped contour of the stapler head, ensuring convenient installation and reliable fixation. It avoids warping or wrinkling that may occur with purely planar repair patches during installation, and also avoids the risk of fixation failure due to loosening of auxiliary parts or improper operation.

[0019] 2. This invention provides a tubular stapler repair patch, offering two main patch body configurations. In addition to the basic circular patch body, a cap-shaped body is also proposed, featuring an annular flange extending downwards integrally from the periphery of the main body. This "bottle cap" structure, when fitted onto the tubular stapler, provides an annular contact surface, effectively preventing the repair patch from tilting or wobbling, resulting in more precise positioning and a more stable fit.

[0020] 3. This invention provides a tubular stapler repair patch, which combines two main body configurations (circular and cap-shaped) with four strip layouts (asymmetrical cross, double-strip vertical, double-strip cross, and triple-strip cross) to generate eight different embodiments. This provides surgeons with a wide range of choices, enabling them to select the most suitable repair patch based on the complexity of different surgeries and varying requirements for fixation stability.

[0021] 4. This invention provides a tubular stapler repair patch. On one hand, the self-locking structure of the strap allows for self-locking; on the other hand, in any embodiment, a dedicated suture through-hole can be added to the strap for auxiliary suture fixation, allowing the surgeon to apply continuous tension during surgery as a "safety tether." Furthermore, this invention innovatively optimizes the auxiliary suture fixation. By setting an adjustable-length suture with a buckle at its end, after the patch is fixed, medical personnel can easily adjust the suture to a suitable length and directly engage the buckle with the stapler body, eliminating the need for continuous manual pulling. This not only frees up the hands of medical personnel to perform other operations but also ensures reliable and convenient fixation, further improving surgical safety. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the structure of Embodiment 1; Figure 2 This is an installation diagram of Example 1; Figure 3 This is a schematic diagram of the structure of Embodiment 2; Figure 4 This is an installation diagram of Example 2; Figure 5This is a schematic diagram of the structure of Embodiment 3; Figure 6 This is an installation diagram of Example 3; Figure 7 This is a schematic diagram of the structure of Embodiment 4; Figure 8 This is an installation diagram of Example 4; Figure 9 This is a schematic diagram of the structure in Embodiment 5; Figure 10 This is a schematic diagram of the structure of Embodiment Six; Figure 11 This is a schematic diagram of the structure of Embodiment Seven; Figure 12 This is a schematic diagram of the structure of Example 8; Figure 13 This is a schematic diagram of the structure of the auxiliary suture with a buckle of the present invention.

[0023] Explanation of reference numerals in the attached drawings: 110-main body of the repair patch, 120-through hole, 130-opening, 140-strip, 160-suture through hole, 170-auxiliary fixation suture, 180-buckle, 200-tubular stapler. Detailed Implementation

[0024] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] It should be noted that in the description of this invention, the terms "center", "upper", "lower", "left", "right", 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 invention 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 this invention.

[0026] This invention discloses a tubular anastomosis repair patch, mainly comprising a repair patch body 110. The repair patch body 110 is made of a biocompatible and biodegradable material, such as biodegradable polymeric materials (e.g., polylactic acid PLA, polyglycolic acid PGA, or their copolymers PGLA) or biodegradable biological materials (e.g., treated porcine dermis, submucosal tissue of the small intestine, collagen, and sheep intestinal mucosa).

[0027] Provide a through hole 120, which is (e.g.) Figure 1The cross-shaped hole shown is used for the central rod of the tubular stapler to pass through, and it is also preferably a circular through hole 120.

[0028] On the repair patch body 110, a strip 140 can be installed on the side of the repair patch body, and the inner edge of the strip 140 and the repair patch body 110 enclose to form an opening 130.

[0029] Preferably, the tubular stapler repair patch disclosed in this invention has a through hole 120 at the center of the patch body 110 for the stapler's central rod to pass through. A strip 140 can also be connected to the side of the patch body 110, with the inner edge of the strip 140 forming an opening 130 with the patch body 110. The strip 140 is pre-made of a structurally elastic biomaterial and shaped into a specific arc or straight line. It can conform to the shape of the head of the tubular stapler 200, thus allowing the patch body 110 to be more securely fitted onto the head of the tubular stapler 200 during installation.

[0030] The tubular stapler repair patch disclosed in this invention also has a self-locking function. This function is achieved by the opening 130 on the main body and the elastic strip 140. The effective inner diameter of the inner contour of the strip 140 is designed to be slightly smaller than the outer diameter of the stapler mounting part. During installation, the strip 140 undergoes elastic deformation to pass over the stapler components, and then rebounds by elastic restoring force, generating a clamping force to self-lock the repair patch body 110 in a predetermined position, making it difficult to fall off or slide.

[0031] Furthermore, based on the basic solution, this invention further provides a solution by adding suture through-holes 160 and auxiliary fixation sutures 170 to the band strip to provide double fixation protection, suitable for clinical scenarios with higher requirements for fixation reliability. At appropriate positions on the outermost edge of the band strip 140, suture through-holes 160 are provided specifically for threading the auxiliary fixation sutures 170, which pass through these through-holes. Both ends can be kept taut by the surgeon during surgery, acting like a safety tether, providing additional fixation protection for the repair patch and ensuring it does not slip accidentally during complex operations. The length of the auxiliary fixation sutures 170 is adjustable, allowing for the insertion of the most suitable suture length as needed during surgery. After surgery, the sutures can be quickly removed, preventing them from remaining at the patient's wound site. Furthermore, this invention optimizes the auxiliary sutures 170 by attaching a buckle 180 to its end. Figure 13As shown, the buckle 180 is designed to be easily and detachably engaged at any suitable position on the body or operating lever of the tubular stapler 200. During the surgical procedure, after the repair patch is initially fixed by the band 140, medical staff can tighten the auxiliary fixation suture 170 to adjust to a suitable tension, and then directly fix the buckle 180 to the stapler. This achieves continuous and stable tension fixation of the repair patch, completely freeing the hands of medical staff. The auxiliary fixation suture 170 can be made of biodegradable materials (such as polylactic acid PLA, polyglycolic acid PGA, copolymer PGLA, collagen, and sheep intestinal mucosa) or non-biodegradable biomaterials (such as nylon and polypropylene).

[0032] The innovation of this invention lies in providing two main body configurations and four strip layouts, which can be combined to form eight specific embodiments.

[0033] Group 1: Circular repair patch body (Examples 1 to 4) The repair patch body 110 in this embodiment is a circular patch structure.

[0034] Example 1 The structure of this embodiment can be referred to Figure 1 It includes a circular patch body 110, with two strips 140 on the same side of the patch body 110. Its key feature is the asymmetrical design of the opening 130: the opening 130 on the side closer to the through hole 120 is wider than the opening 130 on the side farther from the through hole 120.

[0035] This asymmetrical design is intended to guide specific cross-installation operations. For example... Figure 2 As shown, its key feature is that the two strips 140 are configured to be staggered in a "V" shape on both sides of the stapler cartridge sleeve when fitted onto the tubular stapler 200. During installation, the two strips 140 can also be cross-fitted; this "V" shaped fitting structure (one strip 140 pressing on top of the other) enhances fixation. Furthermore, this embodiment can also provide suture through-holes 160 on the edges of the strips 140 for threading auxiliary fixing sutures 170, providing additional fixation assurance.

[0036] Example 2 The structure of this embodiment can be referred to Figure 3 It includes a circular patch body 110, on both sides of which are symmetrically arranged two pre-designed arc-shaped elastic strips 140. These two strips 140, together with the patch body 110, form two openings 130. The lengths of the strips 140 are configured so that they cannot cross each other during installation. The installation method is as follows... Figure 4As shown: the two strips 140 are pre-formed and are vertically downward when fitted onto the tubular stapler 200. Furthermore, in this embodiment, suture through-holes 160 can also be provided on the edges of the two strips 140 to allow auxiliary fixing sutures 170 to pass through, providing double fixation protection.

[0037] Example 3 The structure of this embodiment can be referred to Figure 5 Its structure is similar to that of Embodiment 2, with two strips 140 arranged on both sides of the patch body 110. However, compared to Embodiment 2, the two strips 140 have structural features sufficient to allow them to cross each other during installation (e.g., longer length or larger opening area). During installation, one strip 140 can be first placed on the stapler 200, and then the other strip 140 can be crossed over the first strip, ultimately forming an "X"-shaped locking structure. Compared to the non-crossing type, the cross-fixation provides restraint forces in multiple directions, which can more effectively prevent the patch from rotating or sliding during surgical use. In addition, this embodiment can also provide suture through holes 160 on the edges of the two strips 140 to pass through auxiliary fixation sutures 170, providing double fixation protection.

[0038] Example 4 The structure of this embodiment can be referred to Figure 7 It includes a circular patch body 110 with three strips 140 on its outer edge. For example, two strips can be placed on one side and one strip on the opposite side, forming openings 130 of varying sizes to facilitate complex interlocking. The outermost two strips 140 are located at their edges. Figure 8 As shown, during installation, two strips 140 on the same side are staggered in a "V" shape and fitted onto both sides of the stapler cartridge sleeve; the strip 140 on the other side is fitted across the strip 140 on the opposite side, and the three strips 140 can be fitted onto the stapler 200 in a crisscrossing manner, forming three support and clamping points. Due to the increased number of support points, the clamping force is more evenly distributed, thus its fixation effect is "more stable," making it suitable for precision surgeries with extremely high requirements for anastomotic stability. In addition, this embodiment can also provide a suture through-hole 160 on the outermost strip 140 to pass through an auxiliary fixation suture 170.

[0039] Group 2: Cover-shaped repair patch body (Examples 5 to 8) Based on the previous four embodiments, this set of embodiments further optimizes the repair patch body 110. The outer periphery of the repair patch body 110 extends an annular flange downward to form a cap-like structure. This structural design makes the repair patch more stable when it is fitted onto the tubular stapler.

[0040] Example 5 The structure of this embodiment corresponds to that of Embodiment 1, and its structure can be referred to as follows. Figure 9 The repair patch body 110 has a cap-shaped structure, meaning that an annular flange extends downward integrally from the periphery of the circular body. Its strip layout is exactly the same as in Embodiment 1: two strips 140 are configured to be staggered in a "V" shape on both sides of the stapler cartridge sleeve when fitted onto the stapler 200. Both strips 140 are located on the same side of the repair patch body 110 and are designed with asymmetrical openings 130 to guide specific cross-installation operations. During installation, the two strips 140 can also be cross-fitted as in Embodiment 1 to enhance fixation. In this embodiment, the repair patch is more stable on the stapler 200 because the repair patch body 110 has an annular flange. Furthermore, this embodiment can also provide suture through-holes 160 on the edges of the strips 140 for inserting auxiliary fixing sutures 170.

[0041] Example 6 The structure of this embodiment corresponds to that of Embodiment 2, and its structure can be referred to as follows. Figure 10 The main body 110 of the repair patch has a cap-shaped structure, that is, an annular flange extends downward integrally from the periphery of the main body. Its strip layout is exactly the same as in Embodiment 2: two pre-arc-shaped elastic strips 140 are symmetrically arranged on both sides of the main body 110. During installation, the main body 110 is first fitted onto the head of the tubular stapler 200. The two strips 140 are pre-shaped and are vertically downward during fitting. Then, the strips 140 are fitted onto the head of the tubular stapler 200 from both sides. Furthermore, this embodiment can also provide suture through-holes 160 on the edges of the strips 140 to pass through auxiliary fixing sutures 170.

[0042] Example 7 The structure of this embodiment corresponds to that of Embodiment 3, and its structure can be referred to as follows. Figure 11 The repair patch body 110 has a cap-shaped structure, meaning that an annular flange extends downward integrally from the periphery of the body. Its strip layout is exactly the same as in Embodiment 3: two longer, more flexible strips 140 are provided on both sides of the repair patch body 110. These two strips 140 have structural features sufficient to allow them to intersect during installation (e.g., a longer length), as detailed in [reference needed]. Figure 6 During installation, one strip 140 can be first placed on the stapler 200, and then another strip 140 can be placed crosswise on top of the first strip, so that the two strips are intersecting and ultimately forming an "X"-shaped locking structure, which can more effectively prevent the repair patch from rotating or sliding during surgical use. In addition, this embodiment can also provide suture through holes 160 on the edge of the strip 140 to pass through auxiliary fixation sutures 170.

[0043] Example 8 The structure of this embodiment corresponds to that of Embodiment 4, and its structure can be referred to as follows. Figure 12 The main body 110 of the repair patch has a cap-shaped structure, that is, an annular flange extends downward integrally from the outer periphery of the main body, and three strips 140 are connected below the flange. The layout of the strips is exactly the same as in Embodiment 4: for example, two strips can be set on one side and one strip can be set on the opposite side, and the openings 130 formed are of different sizes to facilitate complex cross-over fitting. For details, please refer to... Figure 8 The key feature lies in the use of three straps 140 for combined fixation. During installation, the three straps 140 can be interlocked on the stapler 200, forming three support and clamping points. Specifically, two straps 140 on the same side are staggered in a "V" shape, while the strap 140 on the other side is interlocked with the strap 140 on the opposite side. Due to the increased number of support points, the clamping force is more evenly distributed, resulting in a more stable fixation effect, suitable for precision surgeries requiring extremely high anastomotic stability. Furthermore, this embodiment can also provide a suture through-hole 160 on the outermost strap 140 for threading auxiliary fixation sutures 170.

[0044] The above are all preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Therefore, all equivalent changes made in accordance with the structure, shape and principle of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A tubular stapler repair patch, comprising a repair patch body (110), characterized in that: The edge of the patch body (110) is connected to at least one strip (140), and the inner edge of the strip (140) and the patch body (110) together form an opening (130) for fitting. The strip (140) has structural elasticity and is configured to be sleeved on the tubular stapler (200). The main body (110) of the repair patch (210) is fixed on the tubular stapler (200) by the clamping force generated by the elastic recovery force after the strip (140) undergoes elastic deformation.

2. The tubular anastomosis repair patch according to claim 1, characterized in that: The main body (110) of the repair patch has a circular structure; Alternatively, the outer periphery of the repair patch body (110) may have an annular flange extending downwards, forming a cap-shaped structure.

3. The tubular anastomosis repair patch according to claim 1, characterized in that: The number of the strips (140) is at least two, and at least two of the strips (140) are connected to the same side or different sides of the patch body (110); When the patch is fitted onto the tubular stapler (200), at least two of the strips (140) are arranged in a staggered, parallel, or cross arrangement.

4. The tubular anastomosis repair patch according to claim 3, characterized in that: Two strips (140) are connected to the same side of the patch body (110) to form two openings (130). The two strips (140) are configured to be staggered and fitted on both sides of the staple cartridge sleeve of the tubular stapler to form a "V" shaped structure. Alternatively, a strip (140) may be connected to each side of the patch body (110), and the two strips (140) may be configured to extend vertically downward or cross each other and be fitted onto the staple cartridge sleeve of the tubular stapler.

5. A tubular anastomosis repair patch according to claim 3, characterized in that: The number of the strips (140) is three, with two strips located on the same side of the repair patch body (110). When fitted onto the tubular stapler (200), the two strips (140) can be staggered and fitted onto both sides of the stapler cartridge sleeve to form a "V" shape. The third strip is located on the other side of the patch body (110). When it is fitted onto the tubular stapler (200), the third strip (140) crosses the strip (140) on the opposite side.

6. The tubular anastomosis repair patch according to claim 1, characterized in that: The strip (140) is provided with a suture through hole (160), and an auxiliary fixing suture (170) is inserted into the suture through hole (160).

7. A tubular anastomosis repair patch according to claim 6, characterized in that: The length of the auxiliary fixation suture (170) is adjustable; and the end of the auxiliary fixation suture (170) is detachably connected to a buckle (180), which is configured to be detachably engaged with the body of the tubular stapler (200).

8. A tubular anastomosis repair patch according to claim 1, characterized in that: The strip (140) is a pre-formed arc or straight shape; The width of the strip (140) can be equal or unequal.

9. A tubular anastomosis repair patch according to claim 1, characterized in that: The central area of ​​the repair patch body (110) is provided with a circular or cross-shaped through hole (120). The patch body (110) and strip (140) are made of biodegradable polymer material or biodegradable biomaterial.

10. A tubular anastomosis repair patch according to claim 1, characterized in that: The tubular stapler repair patch is used in conjunction with the tubular stapler (200); The tubular stapler repair patch is fitted and fixed to the head of the tubular stapler (200).

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