Preparation method of woven artificial blood vessel with side branches

Abstract

The invention belongs to the technical field of biomedical material manufacturing, and particularly relates to a preparation method of a woven artificial blood vessel with side branches. The preparation method of the woven artificial blood vessel with the side branches comprises the following five steps: step 1, weaving an artificial blood vessel trunk and the artificial blood vessel side branches, cleaning, and respectively carrying out pattern making; 2, punching the artificial blood vessel trunk, and sealing the edges of the artificial blood vessel trunk and the head and tail ends of the artificial blood vessel side branches; thirdly, the artificial blood vessel trunk and the artificial blood vessel side branches are coated with liquid coating liquid; fourthly, the coated artificial blood vessel trunk and the coated artificial blood vessel side branches are sewn together through a sewing technology; and 5, coating the sutured and spliced parts of the artificial blood vessel trunk and the artificial blood vessel side branches by using a gel coating. According to the step-by-step preparation mode of the woven blood vessel with the side branches, the coating uniformity of the artificial blood vessel trunk and the artificial blood vessel side branches can be effectively guaranteed, and the probability of errhysis in clinical use of the woven blood vessel with the side branches is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of biomedical material manufacturing, and in particular to a method for preparing a braided artificial blood vessel with side branches. Background Art

[0002] In vascular replacement surgery, artificial blood vessels with side branches account for a large proportion of usage, and it is an extremely dangerous surgery. Once the replacement blood vessels have quality problems, it will greatly threaten the patient's life safety. The braided artificial blood vessel with side branches is not formed in one piece. First, the artificial blood vessel trunk and the artificial blood vessel side branches are spliced ​​together by suturing technology, and then a pre-coagulation coating treatment is performed to become an artificial blood vessel for clinical use. Under current technology, the sutured braided artificial blood vessels with side branches are coated as a whole. Due to the presence of side branches, it is very easy to cause the coating material to be unevenly distributed inside the artificial blood vessel side branches, resulting in bleeding during clinical use. In order to avoid this situation, the present invention adopts a step-by-step method to prepare the braided artificial blood vessel with side branches. First, the artificial blood vessel trunk and the artificial blood vessel side branches are coated with a liquid coating liquid to ensure the uniformity of the coating inside the artificial blood vessel trunk and the artificial blood vessel side branches. Then, the artificial blood vessel trunk and the artificial blood vessel side branches are sutured together by suturing technology to obtain the braided artificial blood vessel with side branches. Finally, the suture is coated with a coating gel to prevent leakage at the suture. Summary of the Invention

[0003] In order to solve the above-mentioned problems in the prior art, the present invention provides a method for preparing a braided artificial blood vessel with side branches. The braided artificial blood vessel with side branches provided by the present invention has good anti-seepage effect and can improve the success rate of surgery.

[0004] To achieve the above object, the present invention adopts the following technical solutions: A method for preparing a braided artificial blood vessel with side branches comprises the following steps: (1) Weaving the artificial blood vessel trunk and artificial blood vessel side branches, and then patterning them separately after cleaning; (2) using a punching device to punch holes in the artificial blood vessel trunk obtained in step (1), and using a slitting device to seal the edges of the artificial blood vessel trunk and the artificial blood vessel side branches. The punching device is a laser cutting machine or an ultrasonic device. The power of the laser punching should not be too large to prevent the punching edge from plasticizing, hardening or carbonizing. The slitting device used is a hot cutting machine, an ultrasonic slitting machine or a laser cutting machine. (3) preparing a liquid coating solution with a viscosity controlled at 10-20 cp·s, wherein the active ingredient is one of gelatin and collagen, with a weight fraction of 3% to 5%; the cross-linking agent is one of formaldehyde, glutaraldehyde, and genipin, with a weight fraction of 0.01% to 0.03%; a toughening agent is also added to the coating solution, and the toughening agent is one of glycerol and polyethylene glycol, with a weight fraction of 3% to 15%; the gelatin is bovine bone gelatin with a dynamic value of 200-300 Bloomg; the collagen is type I collagen; the glycerol is of high purity extracted from plants; the molecular weight of the polyethylene glycol is 700 to 2000; the artificial blood vessel trunk and artificial blood vessel side branches obtained in step (2) are coated with the liquid coating solution 3-5 times respectively, and then dried; (4) Suturing the artificial blood vessel side branches obtained in step (3) to the puncture point of the artificial blood vessel trunk obtained in step (3) to obtain a braided artificial blood vessel with side branches. The suture strength is ≥150N, and there should be no thread ends on the inner and outer walls of the splicing part. (5) preparing a coating gel, wherein the active ingredient is one of gelatin and collagen, with a weight fraction of 5% to 10%; the cross-linking agent is one of formaldehyde, glutaraldehyde, and genipin, with a weight fraction of 0.05% to 0.1%; a toughening agent is also added to the coating gel, which is one of glycerol and polyethylene glycol, with a weight fraction of 3% to 15%; the gelatin is bovine bone gelatin with a dynamic value of 200-300 Bloomg; the collagen is type I collagen; the glycerol is of high purity and extracted from plants; the polyethylene glycol has a molecular weight of 700 to 2000; after preparation, the coating gel is kept at a constant temperature of 37°C for 5-60 minutes to obtain a coating gel; the coating gel is used to coat and seal the sutures of the artificial blood vessel trunk and the artificial blood vessel side branches obtained in step (4), and then dried to prevent bleeding. Beneficial effects

[0005] The method for preparing a braided artificial blood vessel with side branches described in the present invention comprises the following steps: in the second step, a laser cutting machine or an ultrasonic device is used to punch holes in the artificial blood vessel trunk. While ensuring the punching, the edges of the holes can also be sealed to solve the problem of edge peeling when the punched part of the artificial blood vessel trunk and the artificial blood vessel side branches are spliced ​​and sutured; when the artificial blood vessel trunk and the artificial blood vessel side branches are cut, the edges are also sealed to prevent edge peeling from occurring during suturing or use. In the third step, a liquid coating liquid is used to coat the artificial blood vessel trunk and the artificial blood vessel side branches respectively to ensure the uniformity of the internal coating of the artificial blood vessel trunk and the artificial blood vessel side branches. In the fifth step, a coating gel is used to coat the suture site. This method of using a coating liquid with a higher viscosity can effectively ensure the leakage resistance of the artificial blood vessel side branches at the suture site. This method of preparing a braided artificial blood vessel with side branches in steps can effectively solve the uneven coating phenomenon that is easy to occur when the braided artificial blood vessel with side branches is coated as a whole, and reduce the probability of bleeding in the artificial blood vessel. DETAILED DESCRIPTION

[0006] In order to further understand the present invention, the present invention is described below in conjunction with embodiments. However, it should be understood that these descriptions are only for further illustrating the features and advantages of the present invention, rather than limiting the claims of the present invention.

[0007] Permeability is tested according to the method of 8.7.2.1.2 Overall water permeability / leakage in YY / T 0500-2021 "Cardiovascular Implants, Vascular Prostheses, Tubular Vascular Grafts and Vascular Patches". Example 1

[0008] A method for preparing a braided artificial blood vessel with side branches comprises the following steps: (1) Weaving a φ20mm artificial blood vessel trunk and φ10mm and φ8mm artificial blood vessel side branches, and then patterning them after cleaning; (2) Use a laser cutting machine to punch holes in the artificial blood vessel trunk obtained in step (1). The power of the laser punching should not be too large to prevent the punching edge from plasticizing, hardening or carbonizing. Use a hot cutting machine to seal the ends of the artificial blood vessel trunk and the artificial blood vessel side branches. (3) Prepare 500 ml of a 3% by weight gelatin solution, add 3% by weight glycerol to the solution after it forms a homogeneous transparent solution, add 0.03% by weight glutaraldehyde to the solution after the glycerol is completely dissolved, and stir evenly to obtain a liquid coating solution; the liquid coating solution is kept at 37°C and has a viscosity of 10 cp·s, and is immediately sprayed onto the artificial blood vessel trunk and artificial blood vessel side branches obtained in step (2), and dried in a 37°C oven for 60 minutes after coating, and the coating is repeated 5 times; (4) Suturing the artificial blood vessel side branches obtained in step (3) to the puncture point of the artificial blood vessel trunk obtained in step (3) to obtain a braided artificial blood vessel with side branches. The suture strength is ≥150N, and there should be no thread ends on the inner and outer walls of the splicing part. (5) Prepare 50 ml of a 10% gelatin solution by weight, add 15% glycerol to the solution after it forms a homogeneous transparent solution, add 0.05% glutaraldehyde to the solution after the glycerol is completely dissolved, and stir evenly; after preparation, let it stand at a constant temperature of 37°C for 5 minutes to obtain a coating gel; apply the coating gel to the sutures of the artificial blood vessel trunk and artificial blood vessel side branches obtained in step (4) and 0.2 to 0.5 mm above and below the sutures by brushing, and dry in an oven at 40°C for 30 minutes. Example 2

[0009] A method for preparing a braided artificial blood vessel with side branches comprises the following steps: (1) Weaving a φ26mm artificial blood vessel trunk and φ10mm and φ8mm artificial blood vessel side branches, and then patterning them after cleaning; (2) using an ultrasonic device to perform a hole treatment on the artificial blood vessel trunk obtained in step (1), and using an ultrasonic device to perform an edge sealing treatment on both ends of the artificial blood vessel trunk and the artificial blood vessel side branches; (3) Prepare 500 ml of a 4% by weight collagen solution, add polyethylene glycol at a weight fraction of 10% after forming a uniform transparent solution, add genipin at a weight fraction of 0.02% after the polyethylene glycol is completely dissolved, and stir evenly to obtain a liquid coating solution; the liquid coating solution is kept at 37°C, the viscosity is 15 cp·s, and the artificial blood vessel trunk and artificial blood vessel side branches obtained in step (2) are immediately coated by spraying, and dried in a 37°C oven for 60 minutes after coating, and the coating is repeated 4 times; (4) Suturing the artificial blood vessel side branches obtained in step (3) to the puncture point of the artificial blood vessel trunk obtained in step (3) to obtain a braided artificial blood vessel with side branches. The suture strength is ≥150N, and there should be no thread ends on the inner and outer walls of the splicing part. (5) Prepare 50 ml of 8% collagen solution by weight, add polyethylene glycol at a weight fraction of 8% after forming a uniform transparent solution, add genipin at a weight fraction of 0.075% after the polyethylene glycol is completely dissolved, and stir evenly; after preparation, let it stand at a constant temperature of 37°C for 30 minutes to obtain a coating gel; use a brushing method to apply the coating gel to the artificial blood vessel trunk and artificial blood vessel side branch sutures obtained in step (4) and 0.2~0.5mm above and below the sutures, dry in a 40°C oven for 30 minutes, and repeat the brushing once. Example 3

[0010] A method for preparing a braided artificial blood vessel with side branches comprises the following steps: (1) Weaving a φ32mm artificial blood vessel trunk and φ12mm and φ10mm side branches, and then patterning them after cleaning; (2) Use a laser cutting machine to punch holes in the artificial blood vessel trunk obtained in step (1). The power of the laser punching should not be too large to prevent the punching edge from plasticizing, hardening or carbonizing. Use a laser cutting machine to seal the edges of the artificial blood vessel trunk and the artificial blood vessel side branches. (3) Prepare 500 ml of a 5% gelatin solution by weight, add 15% glycerol to the solution after it forms a homogeneous transparent solution, add 0.01% formaldehyde to the solution after the glycerol is completely dissolved, and stir evenly to obtain a liquid coating solution; the liquid coating solution is kept warm at 37°C, and the viscosity is 20 cp·s. Immediately coat the artificial blood vessel trunk and artificial blood vessel side branches obtained in step (2) by spraying, dry in a 37°C oven for 60 minutes after coating, and repeat the coating three times; (4) Suturing the artificial blood vessel side branches obtained in step (3) to the puncture point of the artificial blood vessel trunk obtained in step (3) to obtain a braided artificial blood vessel with side branches. The suture strength is ≥150N, and there should be no thread ends on the inner and outer walls of the splicing part. (5) Prepare 50 ml of a 5% by weight gelatin solution, add 3% by weight glycerol to the solution after it forms a homogeneous transparent solution, add 0.1% by weight formaldehyde to the solution after the glycerol is completely dissolved, stir evenly, and let it stand at a constant temperature of 37°C for 60 minutes to obtain a coating gel; apply the coating gel to the artificial blood vessel trunk and artificial blood vessel side branch sutures obtained in step (4) and 0.2 to 0.5 mm above and below the sutures by brushing, dry in a 40°C oven for 30 minutes, and repeat the brushing twice.

[0011] The permeability test under 120mmHg showed that the braided artificial blood vessel with side branches that was sewn first and then coated had bleeding, with an overall leakage of 2.24ml / cm 2 ·min, the average leakage at the suture is 0.5ml / min·branch; the overall leakage of the coated braided artificial blood vessels with side branches in Examples 1 to 3 of the present invention is 0, and the leakage at the suture is 0.

Claims

1. A method for preparing a braided artificial blood vessel with side branches, characterized in that: The following steps are involved: (1) Weaving the artificial vascular trunk and artificial vascular side branches, and then patterning them after cleaning; (2) punching holes in the artificial blood vessel trunk obtained in step (1), wherein the diameter of the holes is consistent with the diameter of the artificial blood vessel side branches obtained in step (1), and sealing the ends of the artificial blood vessel trunk and the artificial blood vessel side branches; (3) preparing a liquid coating liquid, wherein the active ingredient is one of gelatin and collagen, with a weight fraction of 3% to 5%, the cross-linking agent is one of formaldehyde, glutaraldehyde, and genipin, with a weight fraction of 0.01% to 0.03%, and the remainder is water for injection, and the viscosity of the liquid coating liquid is controlled at 10-20 cp·s; coating the artificial blood vessel trunk and the artificial blood vessel side branches obtained in step (2) with the liquid coating liquid for 3-5 times, respectively, and drying; (4) Suturing the side branches of the artificial blood vessel obtained in step (3) to the holes punched in the main trunk of the artificial blood vessel obtained in step (3) to obtain a braided artificial blood vessel with side branches; (5) preparing a coating gel, wherein the active ingredient is one of gelatin and collagen, with a weight fraction of 5% to 10%, the cross-linking agent is one of formaldehyde, glutaraldehyde, and genipin, with a weight fraction of 0.05% to 0.1%, and the balance is water for injection; after preparation, the gel is kept at a constant temperature of 37° C. for 5 to 60 minutes to obtain a coating gel; the coating gel is used to coat and seal the sutured parts of the artificial blood vessel trunk and the artificial blood vessel side branches obtained in step (4), and then dried to prevent bleeding.

2. The method for preparing a braided artificial blood vessel with side branches according to claim 1, characterized in that: The punching process described in step (2) is to use a laser cutting machine or an ultrasonic device to punch holes; the edge sealing process is to use a heat cutting machine, an ultrasonic slitting machine or a laser cutting machine to cut and seal the edges.

3. The method for preparing a braided artificial blood vessel with side branches according to claim 1, characterized in that: The suturing described in step (4) is performed using surgical sutures with a suture strength of not less than 150N.

4. The method for preparing a braided artificial blood vessel with side branches according to claim 1, characterized in that: The gelatin described in step (3) and step (5) is bovine bone gelatin with a dynamic value of 200-300 Bloomg; and the collagen described is type I collagen.

5. The method for preparing a braided artificial blood vessel with side branches according to claim 1, characterized in that: A toughening agent is also added to the liquid coating solution, and the toughening agent is one of glycerol and polyethylene glycol, and the weight fraction is 3% to 15%.

6. The method for preparing a braided artificial blood vessel with side branches according to claim 1, characterized in that: A toughening agent is also added to the coating gel, and the toughening agent is one of glycerol and polyethylene glycol, and the weight fraction is 3% to 15%.