阅读说明：本技术 一种胶原质覆涂可吸收医用缝合线的制备方法 (Preparation method of collagen-coated absorbable medical suture ) 是由 张玉福 李�学 张硕 于 2021-08-23 设计创作，主要内容包括：本发明涉及一种胶原质覆涂可吸收医用缝合线的制备方法,包括以下步骤：(1)、胶原蛋白纤维分离；(2)、提纯；(3)、漂洗；(4)、切割；(5)、两次病毒灭活；(6)、铬蹂；(7)、洗涤；(8)、交联；(9)、脱水；(10)、涂覆；(11)、磨光。其线体柔软,易于操作,定位性能好,抗张强度及打结强度高；加入医用、食用添加剂及维生素,避免了化学残留物对人体产生的危害,生物相溶性好,降低了伤口愈合中的炎症反应；而且,其针线连接圆顺,操作阻力小,拖曳轻微,损伤极小。(The invention relates to a preparation method of a collagen-coated absorbable medical suture, which comprises the following steps: (1) separating collagen fibers; (2) purifying; (3) rinsing; (4) cutting; (5) virus inactivation is carried out twice; (6) chromium tanned; (7) washing; (8) crosslinking; (9) dehydrating; (10) coating; (11) and polishing. The wire body is soft, easy to operate, good in positioning performance, high in tensile strength and knotting strength; medical and edible additives and vitamins are added, so that the harm of chemical residues to human bodies is avoided, the biocompatibility is good, and the inflammatory reaction in wound healing is reduced; moreover, the needle and thread connection is smooth, the operation resistance is small, the dragging is slight, and the damage is extremely small.)

1. A preparation method of a collagen-coated absorbable medical suture line is characterized by comprising the following steps:

(1) separating collagen fibers: cleaning the inner wall of a fresh sausage casing which is free from diseases after quarantine, driving a rubber wheel to scrape off a mucous membrane layer in the sausage casing by using an automatic sausage scraping machine, retaining a serous membrane in the sausage casing, and then soaking the sausage casing in a 6% sodium bicarbonate solution for 24 hours;

(2) and purifying: flatly paving the sausage casing soaked in the step (1) on a fine scraper for fine scraping, scraping fat on the surface of a serous membrane in the sausage casing, pressing out water in fibers, then putting the sausage casing into a 4% sodium bicarbonate solution, and soaking for 2 hours at the temperature of 45 ℃;

(3) and rinsing: putting the casing soaked in the step (2) into a water tank, and rinsing the casing with softened water for 4 times at the temperature of 45 ℃;

(4) and cutting: automatically cutting the casing rinsed in the step (3) by using an automatic cutting machine to form a sausage line, wherein the cutting size is uniform and no burr is generated;

(5) and virus inactivation twice: putting the split catgut in the step (4) into a water basin, separating the catgut, performing virus inactivation by using a sodium hydroxide solution, performing virus inactivation by using hydrogen peroxide, and cleaning for 2 times by using softened water;

(6) chromium tanned: placing the catgut treated in the step (5) into a 0.2 per mill trivalent chromium solution for soaking for 10 hours for chromium tanning, wherein in the chromium tanning process, vitamin A, vitamin C and amino acid are added into the trivalent chromium solution for polymerization, sizing and adsorption;

(7) and washing: washing the steamed stuffed bun strings which are subjected to chromium tanned in the step (6) for 3 times by using softened water, so that the surfaces of the steamed stuffed bun strings are clean and not decolored;

(8) and crosslinking: putting the sausage string washed in the step (7) into an aluminum sulfate solution for crosslinking, breaking fiber molecular chains in the sausage casing, and recombining new molecular chains;

(9) and dehydrating: dehydrating the crosslinked catgut in the step (8) to reduce the humidity of the gut from 95% to 40%;

(10) and coating: coating the surface of the dehydrated sausage in the step (9) with calcium stearate to ensure that the surface is smooth and uniform;

(11) and polishing: polishing the coated gut in step (10), scrubbing with 75% alcohol for 2 times, and removing the excess tip.

2. The method of claim 1, wherein in step (2), the pressure is 30kg and the time is 2 hours.

3. The method of claim 1, wherein in step (3), the water tank is provided with a heating rod to maintain the temperature at 45 ℃, and an ultrasonic generator is provided to flow softened water by ultrasonic waves, so that the water can be rinsed cleanly and thoroughly.

4. The method of claim 1, wherein in step (4), the width of the segmented intestine is 13 mm.

5. The method according to claim 1, wherein in the step (5), the virus is inactivated with 0.8% sodium hydroxide solution at 45 ℃ for 2 hours, and then inactivated with 3% hydrogen peroxide at 45 ℃ for 10 hours.

6. The method of claim 1, wherein in step (6), 0.02g vitamin A, 0.03g vitamin C, and 0.02g amino acid are added to 5 liters of the trivalent chromium solution.

7. The method of claim 1, wherein the crosslinking in step (8) is performed by soaking the suture in a three-thousandth solution of aluminum sulfate at 45 ℃ for 2 hours.

8. The method of claim 1, wherein the dehydration step (9) is performed in a closed space and the suture is dried at 65 ℃ and 40% humidity for 8 hours.

9. The method of claim 1, wherein in step (10), the coating has a thickness of 0.002 mm.

10. The method of preparing a collagen-coated absorbable medical suture according to any one of claims 1 to 9, further comprising:

(12) sorting: and (5) sorting by using an automatic sorting machine to detect uneven gut.

Technical Field

The invention belongs to the technical field of medical equipment, relates to a preparation method of a medical suture, and particularly relates to a preparation method of a collagen coating absorbable medical suture.

Background

At present, the absorbable medical suture line widely used in clinic is a novel suture material which can be degraded and absorbed by human body after being implanted into human tissue in the process of surgical suture, does not need to be removed, and avoids the pain of removing the suture line. The quality of the product is good and bad, which is directly related to the recovery of postoperative patients and marks the manufacturing technical level of products in the field of modern medical instruments.

The current absorbable synthetic suture (PGA) for clinical use, which is a multi-strand woven structure, has certain disadvantages: foreign matters and dead bacteria are easily hidden in gaps of the line body structure, the surface is rough, and the damage to human tissues is large. Meanwhile, chemical substances and ethylene oxide residues of the thread body have potential side effects to influence the recovery of the patient; the chemical synthesis line has short shelf life, strict requirement on storage environment and high storage risk.

Since the eighties, the bio-absorbable suture line widely used in clinic has hard line body, unstable knot tying and easy slipping of the knot, chemical residues in the manufacturing process have rejection reaction to human tissues, inflammation is easy to generate during healing, the operation quality is directly influenced, and the pain of patients is increased. The needle and thread connection of the common suture needle adopts a punch press for punching and slotting the thread wrapping needle, the tail part of the needle is easy to generate special shapes such as flat openings, ellipses, edges and the like, the surface of a connecting part is rough, and the dragging wound to human tissues is large.

In view of the above technical shortcomings of the prior art, there is a strong need to develop a new type of medical suture.

Disclosure of Invention

The invention aims to overcome the defects in the prior art, and provides a preparation method of a collagen-coated absorbable medical suture line, which has the advantages of reasonable design, advanced process, convenient operation and superior product performance, abandons the defects of a primitive biological line in the manufacturing process of the suture line, and adds effective elements capable of promoting the synthesis and repair functions of human tissue cells.

In order to achieve the above purpose, the invention provides the following technical scheme:

a preparation method of a collagen-coated absorbable medical suture line is characterized by comprising the following steps:

(1) separating collagen fibers: cleaning the inner wall of a fresh sausage casing which is free from diseases after quarantine, driving a rubber wheel to scrape off a mucous membrane layer in the sausage casing by using an automatic sausage scraping machine, retaining a serous membrane in the sausage casing, and then soaking the sausage casing in a 6% sodium bicarbonate solution for 24 hours;

(2) and purifying: flatly paving the sausage casing soaked in the step (1) on a fine scraper for fine scraping, scraping fat on the surface of a serous membrane in the sausage casing, pressing out water in fibers, then putting the sausage casing into a 4% sodium bicarbonate solution, and soaking for 2 hours at the temperature of 45 ℃;

(3) and rinsing: putting the casing soaked in the step (2) into a water tank, and rinsing the casing with softened water for 4 times at the temperature of 45 ℃;

(4) and cutting: automatically cutting the casing rinsed in the step (3) by using an automatic cutting machine to form a sausage line, wherein the cutting size is uniform and no burr is generated;

(5) and virus inactivation twice: putting the split catgut in the step (4) into a water basin, separating the catgut, performing virus inactivation by using a sodium hydroxide solution, performing virus inactivation by using hydrogen peroxide, and cleaning for 2 times by using softened water;

(6) chromium tanned: placing the catgut treated in the step (5) into a 0.2 per mill trivalent chromium solution for soaking for 10 hours for chromium tanning, wherein in the chromium tanning process, vitamin A, vitamin C and amino acid are added into the trivalent chromium solution for polymerization, sizing and adsorption;

(7) and washing: washing the steamed stuffed bun strings which are subjected to chromium tanned in the step (6) for 3 times by using softened water, so that the surfaces of the steamed stuffed bun strings are clean and not decolored;

(8) and crosslinking: putting the sausage string washed in the step (7) into an aluminum sulfate solution for crosslinking, breaking fiber molecular chains in the sausage casing, and recombining new molecular chains;

(9) and dehydrating: dehydrating the crosslinked catgut in the step (8) to reduce the humidity of the gut from 95% to 40%;

(10) and coating: coating the surface of the dehydrated sausage in the step (9) with calcium stearate to ensure that the surface is smooth and uniform;

(11) and polishing: polishing the coated gut in step (10), scrubbing with 75% alcohol for 2 times, and removing the excess tip.

Preferably, in the step (2), the pressure for fine scraping is 30kg, and the time is 2 hours.

Preferably, in the step (3), a heating rod is arranged in the water tank so as to maintain the temperature at 45 ℃, and an ultrasonic generator is arranged in the water tank so as to flow softened water through ultrasonic waves, so that rinsing is cleaner and more thorough.

Preferably, in the step (4), the width of the segmented gut is 13 mm.

Preferably, in the step (5), virus inactivation is performed for 2 hours at a temperature of 45 ℃ by using a 0.8% sodium hydroxide solution, and then virus inactivation is performed for 10 hours at a temperature of 45 ℃ by using 3% hydrogen peroxide.

Preferably, in the step (6), 0.02g of vitamin A, 0.03g of vitamin C and 0.02g of amino acid are added to every 5 liters of the trivalent chromium solution.

Preferably, the crosslinking in the step (8) is soaking the catgut in a three-thousandth concentration aluminum sulfate solution at a temperature of 45 ℃ for 2 hours.

Preferably, in the step (9), the dehydration is performed in a closed space, and the drying is performed for 8 hours under the conditions that the temperature is 65 ℃ and the humidity is 40%.

Preferably, in the step (10), the coating thickness is 0.002 mm.

Preferably, the method for preparing the collagen-coated absorbable medical suture further comprises the following steps:

(12) sorting: and (5) sorting by using an automatic sorting machine to detect uneven gut.

Compared with the prior art, the preparation method of the collagen-coated absorbable medical suture line has the following beneficial technical effects:

1. the prepared suture line is soft, easy to operate, good in positioning performance, and high in tensile strength and knotting strength.

2. Medical and edible additives and vitamins are added in the formula, so that harm of chemical residues to a human body is avoided, the biocompatibility is good, and the inflammatory reaction in wound healing is reduced.

3. The prepared suture can adopt a tail laser-punched nondestructive suture needle, the connection of the needle and the thread is smooth and firm, the suture is incomparable with the existing biological thread, the perfect combination of the suture and the suture needle is achieved, the connection of the needle and the thread is smooth, the operation resistance is small, the dragging is slight, and the damage is extremely small.

Detailed Description

The present invention is further illustrated by the following examples, which are not intended to limit the scope of the present invention.

The invention relates to a preparation method of a collagen-coated absorbable medical suture, which has the advantages of reasonable design, advanced process, convenient operation and excellent product performance, abandons the defects of a primitive biological thread in the thread manufacturing process, and adds effective elements capable of promoting the synthesis and repair functions of human tissue cells. In addition, the collagen is adopted as the raw material and coated with the high-strength coating, so that the effect is better.

The preparation method of the collagen-coated absorbable medical suture line comprises the following steps:

first, collagen fiber separation

Cleaning the inner wall of the fresh sausage casing which is free from diseases after quarantine, and using an automatic sausage scraper to drive a rubber wheel to scrape off a mucous membrane layer in the sausage casing, so as to retain a serous membrane in the sausage casing. Thereafter, the mixture was soaked in a 6% sodium bicarbonate solution for 24 hours.

Wherein the casing can be fresh goat casing, white goat casing, cow casing and the like.

In the invention, the sausage casing is used as a raw material, so that the main material is collagen, and the biocompatibility is better.

Secondly, purification

And (3) flatly paving the sausage casing soaked in the step (I) on a fine scraper for fine scraping, scraping fat on the surface of a serous membrane in the sausage casing, and pressing water in the fibers.

Wherein, in the fine scraping, in order to ensure that the fat on the surface of the serosa is scraped off and the moisture in the fiber is pressed out, the pressure in the fine scraping is preferably 30kg for 2 hours.

The finely scraped casings were immersed in a 4% sodium bicarbonate solution at 45 ℃ for 2 hours.

Third, rinsing

And (5) putting the sausage casing soaked in the step (II) into a water tank, and rinsing the sausage casing with softened water for 4 times at the temperature of 45 ℃. The surface of the substrate is rinsed to remove impurities and a sodium bicarbonate solution for soaking.

In the present invention, it is preferable that the water tank is provided with a heating rod so as to maintain the temperature at 45 ℃.

More preferably, an ultrasonic generator is arranged in the water tank to make the softened water flow by ultrasonic waves, so that the rinsing is cleaner and thorough.

Fourthly, cutting

And (5) automatically cutting the casing rinsed in the step (III) by using an automatic cutting machine to form the sausage line. When the cutting is carried out, the uniform cutting size and no burr are ensured.

In the present invention, it is preferable that the width of the divided intestine line is made 13 mm. Therefore, after subsequent treatment, the prepared suture can better meet the suture requirement.

Five and two times of virus inactivation

And (3) putting the split catgut in the step (IV) into a water basin, separating the catgut, performing virus inactivation by using a sodium hydroxide solution, and performing virus inactivation by using hydrogen peroxide. By two virus inactivation treatments, the virus in the gut can be removed, making it suitable for medical use.

Wherein, when the virus inactivation is carried out by using the sodium hydroxide solution, the virus inactivation is carried out for 2 hours by using 0.8 percent sodium hydroxide solution under the condition that the temperature is 45 ℃.

When the virus is inactivated by hydrogen peroxide, the virus is inactivated by 3 percent hydrogen peroxide at the temperature of 45 ℃ for 10 hours.

After two virus inactivations, the cells were washed 2 more times with demineralized water. And (4) removing residual hydrogen peroxide and the like during virus inactivation by cleaning.

Six, chromium tanned

And (5) soaking the gut in a 0.2 thousandth trivalent chromium solution for 10 hours to conduct chromium tannage. Wherein, in the chromium tanning process, vitamin A, vitamin C and amino acid are added into the trivalent chromium solution for polymerization, shaping and adsorption.

Preferably, the vitamin A, the vitamin C and the amino acid are added in an amount of 0.02g of the vitamin A, 0.03g of the vitamin C and 0.02g of the amino acid per 5 liters of the trivalent chromium solution.

In the invention, medical and edible additives such as vitamin A, vitamin C, amino acid and the like and vitamins are added, so that the harm of chemical residues to human bodies is avoided, the biocompatibility is good, and the inflammatory reaction in wound healing is reduced.

Seven, washing

And (5) washing the steamed stuffed bun strings which are subjected to chromium tanned in the step (six) for 3 times by using softened water, so that the surfaces of the steamed stuffed bun strings are clean and not decolored.

In the invention, by washing, the excessive unfixed adsorbed components on the surface of the catgut can be washed clean.

Octal, crosslinking

And (5) putting the washed gut in the step (VII) into an aluminum sulfate solution for crosslinking. Through crosslinking, fiber molecular chains in the casing can be broken and new molecular chains can be recombined.

In the present invention, preferably, the crosslinking is performed by immersing the catgut in a three-thousandth concentration of aluminum sulfate solution at a temperature of 45 ℃ for 2 hours. Thus, fiber molecular chains in the casing can be better broken and new molecular chains can be recombined.

Ninth, dehydration

And (5) dehydrating the crosslinked catgut in the step (eight) to reduce the humidity of the catgut from 95% to 40%.

In the present invention, the dehydration may be performed in a closed space and dried for 8 hours under the conditions of a temperature of 65 ℃ and a humidity of 40%. Thereby, excess moisture in the catgut can be removed.

10. Coating of

The surface of the dehydrated sausage in the step (nine) is coated with calcium stearate, and the surface is smooth and uniform during coating. By coating, a high strength coating can be formed on the surface, increasing its strength and reducing bacterial survival.

In the present invention, it is preferable that the coating thickness is 0.002 mm. Therefore, the strength can be ensured to be enough, and the biocompatibility of the catgut can not be influenced.

Eleven step of polishing

And (5) polishing the coated gut in the step (ten). During polishing, the gut may be polished using an automatic centerless grinder. Through the polishing operation, the surface of the sausage can be smoother and more round.

After buffing, the excess tips generated during buffing were removed by scrubbing with 75% alcohol 2 times.

Twelve sorting

The gut treated in the step (eleven) can be sorted by an automatic sorting machine, uneven gut is detected, and even gut is left. By sorting, the uniform gut obtained is more easily needled.

And finally, carrying out physical property detection on the uniform intestinal line, and adding a preservation solution to package and sterilize after the physical property detection is qualified, thus preparing the absorbable medical suture line.

The above examples of the present invention are merely examples for clearly illustrating the present invention and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. Not all embodiments are exhaustive. All obvious changes and modifications which are obvious to the technical scheme of the invention are covered by the protection scope of the invention.