A radially collapsible absorbable enterostomy support stent and method of making

Abstract

The present application relates to the technical field of medical devices, and discloses a radially retractable absorbable intestinal anastomosis support stent, which comprises a stent body, the stent body is a hollow mesh tube structure, a plurality of mesh holes are arranged on the stent body, and the stent body has elasticity. The stent of the present application adopts an elastic mesh structure, the specification is slightly larger than the inner diameter of the intestinal tube, the elastic constraint of the intestinal wall is utilized to make the final outer diameter consistent, and the seamless fitting and non-supporting and non-collapsing are realized. The present application has uniform structure and is simple to manufacture. The present application is moderately soft and hard, safe and effective, can significantly improve the suturing quality and prevent mis-suturing, can continuously support after operation and prevent stenosis and leakage, does not need a special placement device, is simple to operate, and is suitable for open and laparoscopic operations.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a radially expandable absorbable intestinal anastomosis support stent and its manufacturing method. Background Technology

[0002] Current intestinal end-to-end anastomosis mainly relies on the following products and methods:

[0003] 1. Manual suturing: Only needles and sutures are used, without any auxiliary devices. Disadvantages: Suturing is difficult when the intestine is edematous; the stitch spacing and edge distance are not easy to be uniform; it is easy to accidentally suture the contralateral intestinal wall, leading to anastomotic closure or stenosis; there is no support in the early postoperative period, resulting in a high rate of anastomotic leakage.

[0004] 2. Circular stapler: Consists of a staple cartridge, anvil, and firing handle, and uses titanium staples to complete the anastomosis. Disadvantages: High cost, permanent metal staple residue, unsuitable for edematous intestinal walls, and lack of postoperative support.

[0005] 3. Biodegradable anastomotic ring: A ring-shaped device made of absorbable material that heals the intestinal wall by compressing necrosis. Disadvantages: Fixed diameter, overly rigid ring (radial support force often greater than 6N), prone to compressing the intestinal wall leading to ischemia and necrosis, unsuitable for edematous intestinal segments, and lacks auxiliary suturing function.

[0006] 4. Existing absorbable stents (for blood vessels / biliary tract): Most are made of metal or non-absorbable materials, have a fixed diameter or require complex adjustment mechanisms, and are not designed for intestinal anastomosis, lacking suture support functions.

[0007] In summary, existing intestinal anastomosis methods lack a dedicated intestinal anastomosis stent that is structurally uniform, radially expandable, self-expanding after placement to precisely match the intestinal diameter, moderately soft and firm, can assist in suturing, provides continuous postoperative support, and is absorbable. Summary of the Invention

[0008] The technical problem to be solved by the present invention is that existing intestinal anastomosis has various problems and lacks a special intestinal anastomosis stent with uniform structure, radial extensibility, self-expansion after placement to precisely match the inner diameter of the intestinal tract, moderate softness and hardness, which can assist suturing, provide continuous postoperative support, and is absorbable.

[0009] To address the aforementioned problems, the present invention provides a radially expandable absorbable intestinal anastomosis support stent, comprising a stent body, wherein the stent body is a hollow mesh tube structure with multiple mesh openings, and the stent body is elastic.

[0010] Optionally, the support body is made of an absorbable copolymer material.

[0011] Optionally, the mesh of the support body is rhomboid or hexagonal.

[0012] A method for fabricating a radially expandable absorbable intestinal anastomosis support scaffold includes the following steps: Step 1: The absorbable copolymer is melt-spun into monofilaments with a diameter of 0.5 mm; Step 2: Weave a mesh cylinder on a 36-spindle braiding machine at a density of 16 intersections per inch, with a mesh side length of 1.8 mm; Step 3: Heat set at 110℃ for 30 minutes to produce a support body with an outer diameter of 22 mm and a length of 4 cm; Step 4: After sterilization with ethylene oxide, vacuum pack the product.

[0013] Optionally, in step three, after the main body of the support is manufactured, the edges of the mesh are rounded using a laser.

[0014] In summary, the stent of this invention adopts an elastic mesh structure, selects a size slightly larger than the inner diameter of the intestinal tract, and utilizes the elastic constraint of the intestinal wall to ensure a consistent final outer diameter, achieving "seamless fit, no stretching or collapse"; the structure of this invention is uniform and simple to manufacture; it has moderate softness and hardness, is safe and effective; it significantly improves suture quality and prevents mis-sutures; it provides continuous postoperative support, preventing stenosis and leakage; it does not require a special inserter, making operation simple; and it is suitable for both open and laparoscopic procedures. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the radially expandable absorbable intestinal anastomosis support structure of the present invention. In the diagram: 1. Main body of the support frame; 2. Mesh. Detailed Implementation

[0016] The following combination Figure 1 The present invention will be described in further detail below.

[0017] This invention discloses a radially expandable absorbable intestinal anastomosis support stent for end-to-end anastomosis in intestinal surgery, particularly for reconstruction after resection of the small intestine, colon, and other digestive tract segments. Before manual suturing, the stent is placed at both ends of the intestinal segment. The stent expands to match the inner diameter of the intestinal segment, providing a perfectly matched rigid padding, making the suturing process more uniform, precise, and stable, while preventing accidental suturing of the contralateral intestinal wall. Postoperatively, it provides continuous support to the anastomosis, preventing stenosis and anastomotic leakage or rupture due to distal obstruction. The stent degrades and is absorbed spontaneously after the anastomosis heals (approximately 4-6 weeks), eliminating the need for a second surgery for removal. Figure 1 It includes a support body 1, which is a hollow mesh tube structure made of absorbable copolymer material, and has multiple mesh holes 2. The mesh holes 2 of the support body 1 are rhomboid or hexagonal, and the support body 1 is elastic.

[0018] Specifically, the material of the scaffold body 1 can be selected as polylactic acid (PLLA) and polycaprolactone (PCL) in a mass ratio of 70:30. This material has an elastic modulus of about 1.2 GPa and combines flexibility and rigidity. A method for fabricating a radially expandable absorbable intestinal anastomosis support scaffold includes the following steps: Step 1: The absorbable copolymer is melt-spun into monofilaments with a diameter of 0.5 mm (0.4~0.6 mm). Step 2: Weave a mesh cylinder on a 36-spindle braiding machine at a density of 16 intersections per inch, with the mesh openings having a side length of 1.8 mm. Specifically, the mesh has a side length of 1.5~2.0mm. In addition to weaving, it can also be made by laser cutting. The entire structure of the bracket is completely identical, without any adjustment rings, barbs, fixing holes or other local structures.

[0019] Step 3: Heat set at 110℃ for 30 minutes to form the main body 1 of the support with an outer diameter of 22 mm and a length of 4 cm; after the main body 1 is made, use a laser to round the edges of the mesh 2 (radius of curvature 0.1 mm) to avoid cutting the intestinal wall; Step 4: After sterilization with ethylene oxide, vacuum pack the product.

[0020] The bracket of the present invention is elastic and can be radially compressed to less than 30% of its original outer diameter (e.g., from 25 mm to 7 mm), and then recovers to the preset outer diameter by its own elasticity after release. The preset outer diameter of the bracket has several specifications (18 mm, 22 mm, 26 mm, 30 mm, all manufactured in the same way), and the length is 3 to 5 cm.

[0021] When using it, select a specification with an outer diameter 0-1 mm larger than the inner diameter of the intestinal tract. Use your thumb and forefinger to radially and evenly compress the stent into a thin strip (outer diameter about 5-8 mm). After insertion, the stent will self-expand. Due to the elastic constraint of the intestinal wall, the final outer diameter of the stent will be consistent with the inner diameter of the intestinal tract, generating a gentle radial pressure (12-15 mmHg) on ​​the intestinal wall. It will neither rupture the intestinal tract nor loosen it. The degradation cycle is 4-6 weeks, which matches the healing time of the intestinal anastomosis. When the two ends of the intestine are far apart, the compressed stent is broken. The front end is inserted 1.5-2 cm into the proximal intestinal break, and the other end of the stent is placed into the distal intestinal segment. The two broken ends are pulled together so that they are aligned in the middle of the stent. The stent is then released, and it expands on its own and automatically adjusts to match the inner diameter of the intestine. The stent can be fixed to the intestinal wall using 3-0 or 4-0 absorbable sutures. Additionally, 1-2 stitches can be made on each end of the stent through the mesh of the stent using the same suture or another suture, with a wide stitch spacing (5 mm) and low tension.

[0022] This invention controls the support force to 2.5-3.5 N through material ratio (PLLA / PCL 70:30) and weaving parameters, while simultaneously preventing stenosis and ischemia; the stent occupies the intestinal lumen and physically isolates the contralateral intestinal wall; the stent provides a rigid pad to ensure uniform force on the suture needle; maintains circular alignment; and disperses suture tension.

[0023] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A radially expandable absorbable intestinal anastomosis support stent, characterized in that, It includes a support body (1), which is a hollow mesh tube structure with multiple mesh holes (2) on it, and the support body (1) is elastic.

2. The radially expandable absorbable intestinal anastomosis support stent according to claim 1, characterized in that, The support body (1) is made of absorbable copolymer material.

3. The radially expandable absorbable intestinal anastomosis support stent according to claim 1, characterized in that, The mesh (2) of the main body (1) of the support is rhomboid or hexagonal.

4. The method for manufacturing the radially expandable absorbable intestinal anastomosis support stent as described in claim 2, characterized in that, Includes the following steps: Step 1: The absorbable copolymer is melt-spun into monofilaments with a diameter of 0.5 mm; Step 2: Weave a mesh cylinder on a 36-spindle braiding machine at a density of 16 intersections per inch, with the mesh (2) having a side length of 1.8 mm; Step 3: Heat set at 110℃ for 30 minutes to produce a support body with an outer diameter of 22 mm and a length of 4 cm (1). Step 4: After sterilization with ethylene oxide, vacuum pack the product.

5. The method for manufacturing the radially expandable absorbable intestinal anastomosis support stent according to claim 4, characterized in that, In step three, after the support body (1) is made, the edges of the mesh (2) are rounded using a laser.

Images