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Implant for preventing anastomotic fistula

An anastomotic leakage and implant technology, which is applied in the field of implants for preventing anastomotic leakage, can solve the problems of increasing cost, cannot reduce anastomotic leakage, etc., so as to increase anti-leakage pressure, prevent early anastomotic leakage, prevent Effects of mid- and late-stage anastomotic leaks and anastomotic strictures

Active Publication Date: 2022-04-29
SHANGHAI P & P BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the commonly used preventive methods mainly include mechanical bowel preparation and / or oral antibiotics, surgical stapler, air leak test, outflow drainage, and transanal surgery. Among the above preventive methods, according to the current research, there is not enough evidence to prove that mechanical Bowel preparation and / or oral antibiotics are directly related to reducing the occurrence of anastomotic leakage, and the air leak test cannot reduce the occurrence of anastomotic leakage; while the use of surgical staplers is only superior to manual anastomosis in colectomy; external drainage And transanal surgery can reduce the occurrence of anastomotic leakage to a certain extent, but colon surgery does not need drainage, which will increase the cost

Method used

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  • Implant for preventing anastomotic fistula
  • Implant for preventing anastomotic fistula
  • Implant for preventing anastomotic fistula

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] This embodiment provides a disc-shaped implant (with a hole in the middle) with a diameter of 2.9 cm, which is specifically prepared by the following method:

[0076] (1) Dissolving the fibrinogen complex in physiological saline with a concentration of 15g%;

[0077] (2) poly(lactic acid polycaprolactone) copolymer is dissolved in hexafluoroisopropanol solvent with a mass concentration percentage of 8%;

[0078] (3) Mix the solution obtained in step (1) and step (2) and add it into the same capacity tube of the electrospinning machine, so that the mass ratio of the fibrinogen complex to the poly(lactic acid polycaprolactone) copolymer is 0.56: 1. Prepare by electrospinning (electrospinning machine model: NS1WS 500Elmarco Czech Republic); the voltage difference of spinning is 50kv, the spinning distance is 40cm, and the spinning solution propulsion speed is 50ml / h;

[0079] (4) Residual organic solvent in the implant obtained by electrospinning is removed, and then ster...

Embodiment 2

[0082] In this embodiment, the disc-shaped implant with a diameter of 2.9 cm (open hole in the middle), the specific preparation method is the same as that in Embodiment 1.

[0083] This embodiment specifically provides 5 kinds of implants with different porosities; the porosities of the 5 kinds of implants are respectively 10%, 20%, 40%, 80% and 95%, and the corresponding thickness is between 0.2mm-0.38mm. In the range of mm, the water absorption rate is in the range of 50%-100%, and the bursting strength is in the range of 20N-80N.

Embodiment 3

[0085] This embodiment provides a disc-shaped implant with a diameter of 2.9 cm (with a hole in the middle), and the specific preparation method is the same as that in Embodiment 1.

[0086] This embodiment specifically provides 6 kinds of implants with different water absorption rates; the water absorption rates of the 6 kinds of implants are respectively 10%, 20%, 50%, 100%, 200% and 300%, and the corresponding thickness is 0.2 In the range of mm-0.38mm, the porosity is in the range of 40%-80%, and the bursting strength is in the range of 20N-80N.

[0087] performance test 1

[0088] 1. Test method:

[0089] Take the fresh small intestine of pigs with a weight of 100-150kg, intercept the fresh small intestine with a length of 10cm, and cut each section into two sections of equal length from the middle; use a tubular stapler (CN-CS29, Jiangsu Chennuo Medical Instrument Co., Ltd.) for anastomosis, The implant provided by the embodiment is placed between the distal and proxim...

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Abstract

The invention provides an implant for preventing anastomotic fistula, the interior of the implant has a three-dimensional nano net structure, and the implant is prepared from raw materials including a fibrinogen compound and a polylactic acid-polycaprolactone copolymer. The implant provided by the invention can increase local anti-leakage pressure of an anastomotic stoma, reduce local tension and induce regeneration of intestinal wall tissues of the anastomotic stoma in situ, so that early-stage anastomotic fistula can be prevented; and meanwhile, proliferation of capillary vessels of anastomotic stoma tissues, regeneration of intestinal wall tissues of the anastomotic stoma and healing of the anastomotic stoma can be promoted, so that middle-stage and late-stage anastomotic fistula and anastomotic stoma stenosis can be effectively prevented.

Description

technical field [0001] The invention belongs to the technical field of medical devices and relates to an implant for preventing anastomotic leakage. Background technique [0002] Acute peritoneal (pleurisy) inflammation after gastrointestinal surgery is a serious complication with a high mortality rate between 6-22%, and about 19% of the cases are secondary to anastomotic leakage (AL). has not been effectively reduced. [0003] The causes of anastomotic leakage are complex and have many factors. The most important ones are closely related to the anastomotic technique and operation, and are related to local infection of the anastomosis and excessive tension after anastomosis. In addition, other risk factors worthy of attention: first, frequent and severe cough after surgery, which causes the change of airway pressure to be transmitted to the digestive tract, causing a sharp change in the pressure in the esophagus and gastric cavity to generate a huge shock wave; The pull of...

Claims

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Application Information

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IPC IPC(8): A61L31/04A61L31/06A61L31/14A61L31/08A61L31/16
CPCA61L31/046A61L31/06A61L31/148A61L31/14A61L31/08A61L31/16A61L2300/406A61L2300/606C08L89/00C08L67/04
Inventor 何红兵尹荣鑫周星宇杨莉苏岭闫侃
Owner SHANGHAI P & P BIOTECH
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