A device for preventing fistula after intestinal surgery

Abstract

This invention provides a postoperative fistula prevention device for the intestine, comprising a fistula prevention membrane assembly and a degradable proximal ring mechanism. The fistula prevention membrane assembly includes a thin film tube and a first placement cavity. The first placement cavity is located at one end of the thin film tube and is formed by flipping one end of the thin film tube. The degradable proximal ring mechanism is provided inside the first placement cavity. A distal support ring is fixedly connected to the end of the thin film tube away from the first placement cavity. This invention uses the degradable proximal ring mechanism in conjunction with the thin film tube to fix it to the intestinal tract by suturing. Then, the distal support ring is moved to drive the thin film tube to completely cover the anastomosis, and the distal support ring supports the thin film tube to isolate the intestinal contents from contact with the anastomosis, thus fully protecting the anastomosis. Furthermore, the entire internal structure of the fistula prevention device is a smooth channel, reducing the resistance of the intestinal contents and effectively reducing the risk of premature dislodgement.

Description

Technical Field

[0001] This invention relates to an anti-fistula device, specifically an anti-fistula device for postoperative intestinal surgery, and belongs to the field of medical device technology. Background Technology

[0002] Preventing fistulas after intestinal surgery is an important nursing and treatment goal. A fistula is a situation where intestinal contents leak out of the body cavity or outside the body through an abnormal channel, which can easily lead to serious complications such as infection and malnutrition. The incidence of anastomotic fistulas in small bowel surgery is about 3%-5%, which is relatively low. However, the incidence of anastomotic fistulas in colon surgery is usually between 5% and 15%. In low rectal cancer surgery, due to the lower surgical site, the risk of anastomotic fistulas is relatively high, with an incidence of about 10%-20%.

[0003] An anastomotic leakage prevention device is a medical device used to prevent anastomotic leakage after intestinal surgery. It is used during intestinal anastomosis to strengthen the anastomosis, reduce the risk of leakage of intestinal contents, and thus lower the incidence of anastomotic leakage.

[0004] Chinese patent CN113520704B, entitled "An Anastomotic Fistula Prevention Device, Sealed Storage Box, and Loader," discloses an anastomotic fistula prevention technology. This technology utilizes a fully biodegradable material with self-expanding properties for the stent braid, and also uses a fully biodegradable membrane covering the surface of the stent braid. This addresses the problem that existing colonic fistula prevention devices require retrieval, increasing surgical complexity and patient suffering. However, the structure of the stent braid and membrane combination in this device is relatively complex, resulting in high production and usage costs. Furthermore, the membrane, covering the surface of the stent braid, experiences significant resistance as intestinal contents pass through the braid due to the mesh structure of the stent braid, potentially causing premature dislodgement and increasing postoperative risks. Therefore, this patent proposes a postoperative intestinal fistula prevention device. Summary of the Invention

[0005] In view of this, the present invention provides a postoperative fistula prevention device for the intestine to solve or alleviate the technical problems existing in the prior art, or at least provide a beneficial alternative.

[0006] The technical solution of this invention is implemented as follows: a postoperative fistula prevention device for intestinal surgery, comprising a fistula prevention membrane assembly and a degradable proximal ring mechanism, wherein the fistula prevention membrane assembly comprises a thin film tube and a first placement cavity;

[0007] The first storage cavity is located at one end of the film tube. The first storage cavity is formed by flipping one end of the film tube. The interior of the first storage cavity is provided with a degradable proximal ring mechanism. The end of the film tube away from the first storage cavity is fixedly connected with a distal support ring. The outer wall of the first storage cavity is uniformly provided with degradable through holes.

[0008] The degradable proximal ring mechanism is used to fix the membrane tube to the intestinal tract by suturing.

[0009] The distal support ring is used to provide support for one end of the film tube and can extend and retract with the film tube.

[0010] More preferably, the distal support ring consists of three first branch rings and three second branch rings;

[0011] The three first support rings and the three second support rings are spaced apart and connected end to end to form a complete ring. One end of the film tube is fixedly connected to one side of the three first support rings and the two second support rings. The thickness of the first support ring is 2 mm and the thickness of the second support ring is 1 mm.

[0012] More preferably, the thin film tube and the degradable proximal ring mechanism are made of elastic PGA+barium sulfate material.

[0013] More preferably, the degradation and shedding time of the anti-fistula membrane assembly and the degradable proximal ring mechanism is 10-14 days, and the surface of the membrane tube is coated with a lubricant.

[0014] In a further preferred embodiment, the degradable proximal ring mechanism is sutured to the intestinal tract using barbed sutures.

[0015] More preferably, the degradable proximal ring mechanism is a circular degradable ring, which is covered by the inner wall of the first placement cavity. The outer diameter of the circular degradable ring is 33 mm and the width is 3 mm.

[0016] More preferably, the degradable proximal ring mechanism is a wavy degradable ring, which is covered by the inner wall of the first placement cavity. The outer diameter of the wavy degradable ring is 33 mm, the maximum width is 3.5 mm, and the minimum width is 3 mm.

[0017] More preferably, the intestinal postoperative fistula prevention device can be applied to prevent fistula after anterior resection or ultra-low rectal cancer sphincter-preserving surgery.

[0018] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions:

[0019] I. This invention uses a degradable proximal ring mechanism in conjunction with a thin film tube to fix it to the intestinal tract by suturing. Then, the distal support ring is moved to drive the thin film tube to completely cover the anastomosis. The distal support ring supports the thin film tube to isolate the intestinal contents from contact with the anastomosis, thus fully protecting the anastomosis. In addition, the entire anti-fistula device is a smooth channel, which reduces the resistance of intestinal contents and effectively reduces the risk of premature dislodgement.

[0020] Second, this invention uses a thin film tube to constrain the degradable proximal ring mechanism by means of a flange, and with the help of a degradable through hole, the degradable proximal ring mechanism can be decontaminated in the first placement cavity. Both the thin film tube and the distal support ring are made of non-degradable materials, which makes the time for the anti-fistula device to degrade and fall off more stable. Moreover, the overall structure of the anti-fistula device is relatively simple, which effectively reduces the production and use costs.

[0021] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a structural diagram of the present invention;

[0024] Figure 2 This is a partial cross-sectional view of the present invention;

[0025] Figure 3 This is a side view of the first and second branch rings of the present invention.

[0026] Figure 4 This is a top view of the structure of the first and second branch rings of the present invention;

[0027] Figure 5 This is a schematic diagram of the circular degradation ring of the present invention;

[0028] Figure 6 This is a schematic diagram of the wavy degradation ring structure of the present invention.

[0029] Reference numerals: 1. Anti-fistula membrane assembly; 2. Degradable proximal ring mechanism; 3. Distal support ring; 4. Degradable through hole; 101. Membrane tube; 102. First storage cavity; 201. Circular degradable ring; 202. Wavy degradable ring; 301. First branch ring; 302. Second branch ring. Detailed Implementation

[0030] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0031] It is important to note that terms such as "first," "second," "symmetric," and "array" are used only to distinguish between descriptive and positional descriptions and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features specified with terms such as "first" or "symmetric" may explicitly or implicitly include one or more of that feature; similarly, when the quantity of certain features is not limited by words such as "two" or "three," it should be noted that such features also explicitly or implicitly include one or more features.

[0032] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0033] Example 1

[0034] like Figures 1-5 As shown, this embodiment of the invention provides a postoperative fistula prevention device for intestinal surgery, including a fistula prevention membrane assembly 1 and a degradable proximal ring mechanism 2. The fistula prevention membrane assembly 1 includes a thin film tube 101 and a first placement cavity 102.

[0035] The first storage cavity 102 is located at one end of the film tube 101. The first storage cavity 102 is formed by flipping one end of the film tube 101. The interior of the first storage cavity 102 is provided with a degradable proximal ring mechanism 2. The end of the film tube 101 away from the first storage cavity 102 is fixedly connected with a distal support ring 3. The outer wall of the first storage cavity 102 is uniformly provided with degradable through holes 4.

[0036] Among them, the degradable proximal ring mechanism 2 is used to cooperate with the membrane tube 101 to be fixed to the intestinal tube by suturing;

[0037] The distal support ring 3 is used to provide support for one end of the membrane tube 101 and can extend and retract with the membrane tube 101.

[0038] In one embodiment, the distal support ring 3 is composed of three first branch rings 301 and three second branch rings 302;

[0039] Among them, three first support rings 301 and three second support rings 302 are spaced apart and connected end to end to form a complete ring. One end of the film tube 101 is fixedly connected to one side of the three first support rings 301 and the second support rings 302. The thickness of the first support ring 301 is 2mm and the thickness of the second support ring 302 is 1mm.

[0040] By using three first support rings 301 and three second support rings 302 to form a ring, one end of the membrane tube 101 is supported, so that the membrane tube 101 can be effectively attached to the intestinal wall, and it is easy to move the distal support ring 3 outside the intestine to drive the membrane tube 101 to move.

[0041] In one embodiment, the membrane tube 101 and the degradable proximal ring mechanism 2 are made of elastic PGA+barium sulfate material, the degradation and shedding time of the anti-fistula membrane assembly 1 and the degradable proximal ring mechanism 2 is 10-14 days, and the surface of the membrane tube 101 is coated with a lubricant.

[0042] By using elastic PGA+barium sulfate material to fabricate the degradable proximal ring mechanism 2, the membrane tube 101 can protect the anastomosis before the anastomosis heals, and the degradable proximal ring mechanism 2 can degrade after the anastomosis heals, causing the membrane tube 101 to fall off. By coating the surface of the membrane tube 101 with lubricant, the resistance of intestinal contents passing through the membrane tube 101 is further reduced.

[0043] The in vitro degradation test results of the degradable proximal ring mechanism 2 are shown in the table below:

[0044] date 12 / 17 / 23 12 / 24 / 23 12 / 30 / 23 1 / 16 / 24 1 / 23 / 24 1 / 23 / 24 Experimental period (days) 0 7 12 21 28 35 Material PGA + Barium Sulfate PGA + Barium Sulfate PGA + Barium Sulfate PGA + Barium Sulfate PGA + Barium Sulfate PGA + Barium Sulfate Strength (N) 54.153 48.147 42.509 28.057 11.932 5.223 Degradation retention rate 100% 88.91% 78.50% 51.81% 22.03% 9.64% Remark

[0045] In one embodiment, the degradable proximal ring mechanism 2 is sutured to the intestinal tract with barbed sutures. The degradable proximal ring mechanism 2 is a circular degradable ring 201, which is covered by the inner wall of the first placement cavity 102. The outer diameter of the circular degradable ring 201 is 33 mm and the width is 3 mm.

[0046] By using a flanged end, a first placement cavity 102 is formed at one end of the membrane tube 101. The first placement cavity 102 is then used to limit the circular degradation ring 201. The circular degradation ring 201 is used to suture and fix the intestinal tube with the barbed suture. The circular degradation ring 201 can also gradually degrade in conjunction with the degradation through hole 4 during the anastomosis healing process.

[0047] In one embodiment, the postoperative fistula prevention device for the intestine can be applied to prevent fistula after sphincter-preserving surgery for low rectal or ultra-low rectal cancer.

[0048] Example 2

[0049] like Figures 1-6 As shown, this embodiment of the invention also provides a postoperative fistula prevention device for intestinal surgery, including a fistula prevention membrane assembly 1 and a degradable proximal ring mechanism 2. The fistula prevention membrane assembly 1 includes a thin film tube 101 and a first placement cavity 102.

[0050] The first storage cavity 102 is located at one end of the film tube 101. The first storage cavity 102 is formed by flipping one end of the film tube 101. The interior of the first storage cavity 102 is provided with a degradable proximal ring mechanism 2. The end of the film tube 101 away from the first storage cavity 102 is fixedly connected with a distal support ring 3. The outer wall of the first storage cavity 102 is uniformly provided with degradable through holes 4.

[0051] Among them, the degradable proximal ring mechanism 2 is used to cooperate with the membrane tube 101 to be fixed to the intestinal tube by suturing;

[0052] The distal support ring 3 is used to provide support for one end of the membrane tube 101 and can extend and retract with the membrane tube 101.

[0053] In one embodiment, the degradable proximal ring mechanism 2 is a wave-shaped degradable ring 202, which is covered by the inner wall of the first placement cavity 102. The outer diameter of the wave-shaped degradable ring 202 is 33 mm, the maximum width is 3.5 mm, and the minimum width is 3 mm.

[0054] Compared with Example 1, by replacing the circular degradation ring 201 with a wavy degradation ring 202, it has a larger support area, and the wavy degradation ring 202 is easier to suture.

[0055] In one embodiment, the postoperative fistula prevention device for the intestine can be applied to prevent fistula after sphincter-preserving surgery for low rectal or ultra-low rectal cancer.

[0056] In operation, the present invention works as follows: Before intestinal anastomosis, the entire anti-fistula device is placed in the proximal intestinal lumen. Then, the degradable proximal ring mechanism 2 and the film tube 101 are sutured and fixed to the proximal colon using barbed sutures. Then, the excess film tube 101 and distal support ring 3 are compressed into the proximal intestinal segment. Then, the anastomosis device head is placed in the proximal intestinal segment, and intestinal anastomosis is performed. After successful anastomosis, the distal support ring 3 and film tube 101 are pulled towards the distal intestinal segment using medical instruments or by hand, so that the film tube 101 can completely cover the anastomosis, isolate the intestinal contents from contact with the anastomosis, and fully protect the anastomosis.

[0057] During the anastomosis healing process, the degradable proximal ring mechanism 2 is gradually degraded in the first placement cavity 102 in conjunction with the degradation through-hole 4. After the anastomosis is healed, the membrane tube 101 is detached by intestinal peristalsis and absorption by the suture. The degradation products, the remaining membrane tube 101, the degradable proximal ring mechanism 2 and the distal support ring 3 are excreted from the body with the intestines, leaving no residue in the patient's body.

[0058] Taking Example 1 as an example, a pig experiment was conducted:

[0059] 1. White pigs were selected as experimental pigs and were subjected to general anesthesia and endotracheal intubation.

[0060] 2. After opening the abdomen, the sigmoid colon is used for testing. The intestinal wall is cut open, the stool in the large intestine is removed, and the intestine is thoroughly disinfected. The anti-fistula device is inserted through the intestinal wall incision, and then the anastomosis is sutured. The entire thickness and seromuscular layer are sutured with barbed sutures, and 3 sutures are used to fix the loop.

[0061] 3. Image after anastomosis is completed. The left side is the head end, the right side is the tail end, and the anastomosis is in the center.

[0062] 4. On the second day after surgery, the wound was healing well, with no oozing, normal eating and drinking, urination, and no bowel movements.

[0063] 5. On the fourth day after surgery, the patient had unformed stools, ate well, and was in good condition.

[0064] 6. On the fifth day after surgery, the patient passed formed stool.

[0065] 7. On the ninth day after surgery, the laparotomy was performed to check the condition of the anti-fistula device. The anti-fistula device was not found in the intestine, and it was speculated that it might be expelled with the stool. A new and reinforced anti-fistula device was inserted, and several more stitches were made to prevent it from being expelled with the stool.

[0066] 8. On the tenth day after the operation, the anti-fistula device was found in the pig's feces.

[0067] In summary, after intestinal incision and anastomosis and placement of the anti-fistula device, the patient ate and defecate normally without any signs of obstruction, indicating that the anti-fistula device was patent. The anti-fistula device was fixed to the intestinal tract with 3 sutures, which was not secure enough. More sutures could be used to increase stability.

[0068] Taking Example 2 as an example, a pig experiment was conducted:

[0069] 1. White pigs were also selected as experimental pigs, and general anesthesia and endotracheal intubation were performed.

[0070] 2. After opening the abdomen, place an anti-fistula device 1 cm away from the anastomosis, fix the degradable proximal ring mechanism 2 and the membrane tube 101 with barbed sutures, and close the anastomosis with full-thickness sutures using 3-0 absorbable sutures, leaving a 1 cm opening.

[0071] 3. To ensure complete suturing and fixation of the intestinal tube and the ring, the intestinal tube is everted to locate any areas that are not properly closed. 3-0 absorbable sutures are then used to close the gaps, making the sutures more secure.

[0072] 4. 3-5 days after the operation, bowel movements were smooth, food and water intake were normal, mental state and general condition were good, and the anti-fistula device was not pulled out.

[0073] 5. On the 13th day after surgery, the anti-fistula device was expelled with the stool.

[0074] In summary, the anti-fistula device can effectively block feces, and even if there is an intestinal leak, it can fully protect the anastomosis, promote anastomotic healing, and has good permeability.

[0075] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A postoperative fistula prevention device for intestinal surgery, comprising a fistula prevention membrane assembly (1) and a degradable proximal ring mechanism (2), characterized in that, The anti-fistula membrane assembly (1) includes a membrane tube (101) and a first storage cavity (102); The first storage cavity (102) is located at one end of the film tube (101). The first storage cavity (102) is formed by flipping one end of the film tube (101). The interior of the first storage cavity (102) is provided with a degradable proximal ring mechanism (2). The end of the film tube (101) away from the first storage cavity (102) is fixedly connected with a distal support ring (3). The outer wall of the first storage cavity (102) is uniformly provided with degradable through holes (4). The degradable proximal ring mechanism (2) is used to cooperate with the film tube (101) to be fixed to the intestinal tract by suturing. The distal support ring (3) is used to provide support for one end of the film tube (101) and can extend and retract with the film tube (101); The distal support ring (3) consists of three first branch rings (301) and three second branch rings (302); The three first support rings (301) and the three second support rings (302) are spaced apart and connected end to end to form a complete ring. One end of the film tube (101) is fixedly connected to one side of the three first support rings (301) and the two second support rings (302). The thickness of the first support ring (301) is 2 mm and the thickness of the second support ring (302) is 1 mm.

2. The postoperative fistula prevention device for the intestine according to claim 1, characterized in that: The film tube (101) and the degradable proximal ring mechanism (2) are made of elastic PGA + barium sulfate material.

3. The postoperative fistula prevention device for the intestine according to claim 2, characterized in that: The degradation and shedding time of the anti-fistula membrane assembly (1) and the degradable proximal ring mechanism (2) is 10-14 days, and the surface of the membrane tube (101) is coated with a lubricant.

4. The postoperative fistula prevention device for the intestine according to claim 1, characterized in that: The degradable proximal ring mechanism (2) is sutured to the intestinal tract using barbed sutures.

5. The postoperative fistula prevention device for the intestine according to any one of claims 1-4, characterized in that: The degradable proximal ring mechanism (2) is a circular degradable ring (201), which is covered by the inner wall of the first placement cavity (102). The outer diameter of the circular degradable ring (201) is 33 mm and the width is 3 mm.

6. The postoperative fistula prevention device for the intestine according to any one of claims 1-4, characterized in that: The degradable proximal ring mechanism (2) is a wave-shaped degradable ring (202), which is covered by the inner wall of the first placement cavity (102). The outer diameter of the wave-shaped degradable ring (202) is 33 mm, the maximum width is 3.5 mm, and the minimum width is 3 mm.

7. The postoperative fistula prevention device for the intestine according to claim 1, characterized in that: The intestinal postoperative fistula prevention device can be used to prevent fistula after sphincter-preserving surgery for low rectal or ultra-low rectal cancer.

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