Barbed silk suture

Abstract

The application discloses a barbed silk suture, which comprises a thread body in the inside, a silk surface body wrapped on the surface of the thread body, and a plurality of barbs protruding outward from the silk surface body; the barbed silk suture is prepared by the following method: after degumming and activation, the silk suture is immersed into a ginsenoside finishing liquid for padding treatment, and then baked and dried; the drug-loaded silk suture is put into a mold, a silk fibroin solution is poured into the mold, and after removing bubbles, the silk suture is dried; the dried suture is taken out and subjected to wet heat treatment to obtain the barbed silk suture. The barbed silk suture of the application applies ginsenoside and silk fibroin to the preparation and formation of the barbed suture; the polysaccharide chain in the ginsenoside can form stable hydrogen bonds with the silk fibroin, so that the ginsenoside can act on the wound persistently (long-term sustained release), prolong the drug effect, effectively improve the inflammation of the wound, and promote the wound healing.

Description

[0001] This application is a divisional application of the invention patent application with the application number 2021103593761 and the application date of April 2, 2021, and the invention name of "a barbed silk suture and a preparation method thereof". TECHNICAL FIELD

[0002] The present application relates to the technical field of sutures, in particular to a new type of barbed silk suture for promoting wound healing without knotting. BACKGROUND

[0003] In the field of medical aesthetics, barbed sutures are often used in line sculpture, facial lifting and other operations. The tension generated by the barbs is used to anchor and lift the soft tissues that are aging and affected by gravity, and then reset them to achieve the purpose of rejuvenation.

[0004] The materials of existing knotless sutures are mostly composite materials. Studies have shown that absorbable degradable materials can cause different degrees of swelling at the implantation site after implantation, resulting in "aseptic hydrops" phenomenon. Material degradation fragments, monomers, catalyst release, and dead cell content release can all cause acute inflammatory reactions, making them unsuitable for use in the field of beauty. In addition, the strength of absorbable sutures may not be able to meet the requirements in some places with high tension, limiting their use. Because the current preparation of knotless sutures is to cut the barbs on the suture, the strength of the suture is uneven, which increases the risk of suture breakage during surgery and after surgery.

[0005] Silk is a natural protein material that does not adversely affect the human body. A large number of hospital clinical experiments using silk sutures have shown that silk sutures that have been completely degummed will not cause any inflammatory reaction after being implanted into human tissues, are not prone to cause biological rejection, and have a good promoting effect on wound healing and repair as a natural protein with excellent performance. It can promote early wound healing and has a lower scarring rate compared to other composite material sutures, making it a material with great market potential.

[0006] On the other hand, Chinese herbal medicine resources are abundant and cost-effective, with unique advantages such as natural sourcing, stable effects, and fewer side effects that cannot be matched by Western medicine. Ginseng is a well-known traditional Chinese medicinal material in China with high medicinal value. Its chemical composition has been gradually revealed through modern biochemical analysis. Ginseng contains rich proteins, polysaccharides, and saponin substances. Ginsenosides, the main active substance in ginseng, contain multiple subtypes and have a wide range of pharmacological activities, including anti-inflammatory and detoxification, anti-tumor, anti-myocardial ischemia, anti-aging, and improving memory. In addition, ginsenosides have the functions of removing free radicals, improving antioxidant capacity, increasing the content of skin collagen fibers and collagen, regulating immune function, and improving microcirculation.

[0007] If ginsenoside can be combined with silk fibroin in barbed surgical suture, ginsenoside can act on the wound for a long time, prolong the drug effect, effectively improve the inflammation of the wound, and promote wound healing. SUMMARY

[0008] Therefore, in order to overcome the defects of the prior art and achieve the above-mentioned purposes, the purpose of the present application is to provide a barbed silk suture, which combines ginsenoside with silk fibroin in barbed surgical suture.

[0009] In order to achieve the above-mentioned purposes, the present application adopts the following technical solutions:

[0010] A preparation method of a barbed silk suture, comprising the following steps:

[0011] (1) degumming of silk suture: immerse the silk suture in alkali solution, treat for 30-60 minutes under micro-boiling condition, and then wash with warm water;

[0012] (2) activation of silk suture: immerse the degummed silk suture in strong alkali solution with a concentration of 5g / L-50g / L, treat for 1-10 minutes at 20-55℃, then wash with acetic acid solution and deionized water after taking out;

[0013] (3) preparation of ginsenoside finishing liquor: add ginsenoside aqueous solution to silk fibroin solution with a mass ratio of ginsenoside:silk fibroin = 1:10-100, mix uniformly, and age at room temperature for 1-5 hours to obtain ginsenoside finishing liquor;

[0014] (4) drug loading of silk suture: immerse the activated silk suture in step (2) in the ginsenoside finishing liquor prepared in step (3), perform pad-dry treatment, and then bake and dry;

[0015] (5) formation of barbs: place the drug-loaded silk suture into a mold, which is provided with a plurality of barb areas for forming barb structures, then pour silk fibroin solution into the mold, dry after vacuum removal of air bubbles;

[0016] (6) shaping: take out the dried suture from the mold, and perform wet heat treatment at 120-130℃ to obtain the barbed silk suture.

[0017] In order to facilitate the formation of barbs, the concentration of the silk fibroin solution added in step (5) is 3%-10%. If the concentration is too low, the shrinkage during drying of the solution will be severe, and the barbs will be deformed. If the concentration is too high, the silk fibroin will be unstable and gel will be easily formed.

[0018] According to some preferred embodiments of the present application, the alkali solution in step (1) is a sodium carbonate solution with a mass concentration of 0.02-0.08%.

[0019] According to some preferred embodiments of the present invention, the strong alkaline solution in step (2) is an aqueous solution of sodium hydroxide and / or potassium hydroxide, and the concentration of the strong alkaline solution is 5 g / L to 50 g / L. Activation treatment with a strong alkaline solution is used to form more amino groups. These amino groups react with the hemiacetal structure on ginsenosides to form Schiff bases, thereby increasing the binding force between ginsenosides and silk fibroin. After the strong alkaline solution treatment, a weak acid is used to remove the influence of the strong alkaline solution and prevent a decrease in suture strength.

[0020] According to some preferred embodiments of the present invention, the padding process in step (4) includes the following steps:

[0021] First impregnation: Impregnation pressure is 0.4 kg / cm² 2 ~2kg / cm 2 The rolling allowance is 10% to 20%;

[0022] Second rolling: Rolling pressure is 0.2 kg / cm² 2 ~1kg / cm 2 The rolling allowance is 20%–40%;

[0023] Third impregnation: impregnation pressure is 0.1 kg / cm² 2 ~0.5kg / cm 2 The rolling allowance is 40%–60%.

[0024] According to some preferred embodiments of the present invention, the baking and drying conditions in step (4) are as follows: baking temperature of 110-130°C and time of 1-30 minutes. The baking temperature is set above 100°C, but not too high, to avoid damaging the silk fibers, and the time is not too long. Baking is to improve the fastness of drug loading.

[0025] According to some preferred embodiments of the present invention, the drying conditions in step (5) are: temperature of 20°C to 40°C and humidity of 50% to 70%.

[0026] In some embodiments of the present invention, using silkworm silk as raw material, a silk fibroin solution is obtained through degumming, dissolution, and dialysis, and using silk suture as substrate, the preparation method of the knot-free, barbed silk suture for promoting wound healing of the present invention specifically includes the following steps:

[0027] (1) Degumming of silk sutures: Immerse the silk sutures in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100, treat for 30-60 minutes under a slight boiling state, and wash three times with warm water at 30℃-40℃.

[0028] (2) Activation of silk suture: after degumming treatment, the silk suture is immersed in a strong alkali solution with a concentration of 5g / L-50g / L at a bath ratio of 1:500, treated at 20-55℃ for 1-10 minutes, and then washed with 0.5%-3% (v / v) acetic acid solution and deionized water for 3 times;

[0029] (3) Preparation of ginsenoside finishing solution: prepare a 1% mass concentration ginsenoside aqueous solution, and add silk fibroin solution to the ginsenoside aqueous solution at a mass ratio of ginsenoside:silk fibroin = 1:10-100, mix uniformly, and age at room temperature for 1-5 hours;

[0030] (4) Drug loading of silk suture: the activated silk suture is immersed in the ginsenoside finishing solution, treated by 3 immersions and 3 rolls, and then quickly baked and dried, with a baking temperature of 110-130℃ and a time of 1-30 minutes;

[0031] (5) Formation of barbs: the drug-loaded silk suture is placed in a mold, the mold is provided with a plurality of barb areas for forming barb structures, then silk fibroin solution is poured into the mold, and the mold is dried after vacuum removal of bubbles;

[0032] (6) Shaping: the dried suture is taken out of the mold and subjected to moist heat treatment at 120℃-130℃ for 10-100 minutes, to obtain the non-knotting silk suture for promoting wound healing.

[0033] The application also provides a barbed silk suture prepared by the preparation method.

[0034] The silk fibroin body and the barbs are made of silk fibroin solution, so that the suture has good biocompatibility, does not cause irritation and immune response of the wound, can absorb cell growth factors, and promotes tissue healing. During the surgical suturing process, the barbs are self-fixed, the suturing time is fast, and the suture does not need to be knotted after completion of the suturing, and the wound can be automatically closed. The spiral barbs are uniformly distributed, so that the wound tension is more evenly distributed after completion of the suturing, and no pain is felt, and no large scar is generated after the wound heals.

[0035] According to some preferred embodiments of the application, the silk fibroin body has two groups of barb units, and each group of the barb units includes a plurality of barbs, and the barbs in each group of the barb units are spirally and uniformly distributed on the surface of the silk fibroin body. By arranging two or more groups of barb unit structures, the stress is more dispersed and uniform, and the suturing effect is better.

[0036] According to some preferred embodiments of the present application, the two groups of barb units are symmetrically distributed along the central axis of the thread body. The symmetric arrangement of the two or more groups of barb structures makes the suture thread have more stable tissue anchoring effect and more excellent mechanical properties.

[0037] According to some preferred embodiments of the present application, the helix angle of the helix line formed by the spiral distribution of each group of barb units is 45°-60°; the helix pitch of the helix line formed by the spiral distribution of each group of barb units is 0.1 cm-1 cm; and the spiral distribution of the barbs is left-handed or right-handed.

[0038] According to some preferred embodiments of the present application, the silk fibroin shell and the barbs are integrally formed. In some embodiments of the present application, a three-dimensional silicone mold is made by 3D printing, the mold is marked with barb holes arranged in a spiral, and during preparation, a silk fibroin solution is poured into the mold, and after drying, the silk fibroin solution can be cast in one time.

[0039] According to some preferred embodiments of the present application, the included angle between the length direction of the barbs and the length extension direction of the thread body is 20°-60°. Different barb angles can be set according to different suture occasions. The uniform arrangement of the barbs in a spiral also makes the tissue tension distribution after wound suture more uniform, reducing postoperative pain.

[0040] According to some preferred embodiments of the present application, the barbs are conical, the length of the barbs is 0.1 mm-5 mm, and the diameter of the bottom of the barbs is 0.01 mm-1 mm. Different sizes of barbs can be set on the suture thread according to the size and depth of the wound, so as to reduce the scarring of the wound.

[0041] According to some preferred embodiments of the present application, the thread body is a silk thread, and the silk fibroin shell is wrapped on the surface of the silk thread and filled between adjacent silk threads. The silk suture thread has good mechanical properties and is not easy to break, so that the suture thread of the present application retains the superior performance of the silk suture thread and also adds the rigid barb structure.

[0042] According to some preferred embodiments of the present application, the diameter of the thread body is 0.05 mm-2 mm.

[0043] According to some preferred embodiments of the present application, the silk fibroin is silk fibroin with silk II crystal structure. The barbs made of silk fibroin material can be well combined with the silk thread, and have the same biocompatibility, and the silk II crystal structure can make the barbs have a more rigid structure and have a better anchoring effect on tissue suture.

[0044] Compared with the prior art, the barbed silk suture line of the present application has the following advantages: the barbed silk suture line of the present application uses ginsenoside and silk fibroin in the preparation and formation of the barbed suture line, and a new type of non-knotting barbed silk suture line for promoting wound healing is prepared; the polysaccharide chain in the ginsenoside can form stable hydrogen bonds with the silk fibroin, so that the ginsenoside can act on the wound for a long time (long-term sustained release), prolong the drug effect, effectively improve the inflammation of the wound, promote wound healing, and improve the mechanical properties of the suture line. BRIEF DESCRIPTION OF DRAWINGS

[0045] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0046] Fig. 1 It is a front view schematic diagram of the spiral barbed silk fibroin suture line in the embodiment of the present application.

[0047] Fig. 2 It is a top view schematic diagram of the spiral barbed silk fibroin suture line in the embodiment of the present application.

[0048] In the drawings: 1-barb; 2-silk surface body; 3-wire body. DETAILED DESCRIPTION

[0049] In order to make those skilled in the art better understand the technical solutions of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should be within the scope of protection of the present application.

[0050] Embodiment 1

[0051] As Figs. 1-2As shown, the barbed silk suture (spiral barbed silk fibroin suture) in the embodiment includes a line body 3 inside, a silk surface body 2 wrapped on the surface of the line body 3, and a plurality of barbs 1 protruding outward from the silk surface body 2. The silk surface body 2 in the embodiment has two groups of barb 1 units, each group of barb 1 unit includes a plurality of barbs 1, and the plurality of barbs 1 in each group of barb 1 unit are uniformly distributed on the surface of the silk surface body 2 in a spiral shape, and the two groups of barb 1 units are symmetrically distributed along the central axis of the line body 3. By symmetrically arranging two or more groups of barb 1 unit structures, the suture has stable tissue anchoring effect, excellent mechanical properties, and other advantages, and has better suture effect.

[0052] In the embodiment, the spiral angle of the spiral line formed by the spiral distribution of the barb 1 is 60°, the pitch of the spiral line formed by the spiral distribution of the barb 1 is 0.5 cm, and the spiral distribution of the barb 1 is left-handed or right-handed to make the different barb 1 units arranged in a symmetrical arrangement. In other embodiments, the spiral angle of the spiral distribution of the barb 1 is 45°-60°, and the length (pitch) of one spiral of the barb 1 is 0.1 cm-1 cm. The uniform arrangement of the barb 1 also makes the tissue tension distribution after wound suture more uniform and reduces postoperative pain.

[0053] In the embodiment, the included angle between the length direction of the barb 1 and the length extension direction of the line body 3 is 45°. In other embodiments, the included angle between the length direction of the barb 1 and the length extension direction of the line body 3 is 20°-60°, and different angles of the barb 1 can be set according to different suture occasions.

[0054] In the embodiment, the barb 1 is conical, the length of the barb 1 is 0.5 cm, and the diameter of the bottom of the barb 1 is 0.1 mm. In other embodiments, the length of the barb 1 is 0.1 mm-5 mm, and the diameter of the bottom of the barb 1 is 0.01 mm-1 mm. Different sizes of barbs 1 can be set according to the size and depth of the wound to suture, thereby reducing the scarring of the wound.

[0055] The diameter of the line body 3 is 0.05 mm-2 mm, preferably 1.2 mm in the embodiment, and the line body 3 in the embodiment is a woven silk suture formed by weaving a plurality of silk threads. The silk surface body 2 is wrapped on the surface of the silk thread and filled between adjacent silk threads. The silk suture has good mechanical properties and is not easy to break, so that the suture in the embodiment retains the superior performance of the silk suture, and also adds the rigid barb 1 structure, and has good biocompatibility and harmless degradation in the body.

[0056] The silk body 2 and barb 1 in the embodiment are formed by one-step molding after the silk fibroin solution is solidified. The silk fibroin in the silk body 2 is silk fibroin with silk II crystal structure, and the barb 1 is made of the crystal silk fibroin. The barb 1 made of silk fibroin material can be well combined with the silk thread, and has the same biocompatibility. The silk II crystal structure can make the barb 1 have a more rigid structure, and has a better anchoring effect on tissue suture.

[0057] Example 2 Preparation of silk fibroin solution

[0058] 80 g of cocoon shells of Bombyx mori were weighed by a balance and put into a container, 4000 mL of a sodium bicarbonate / sodium carbonate aqueous solution with a mass fraction of 0.01 M and pH = 9.5 was added, and the aqueous solution was heated to boiling by an electromagnetic oven. The power of the electromagnetic oven was adjusted to keep the aqueous solution continue to boil for 30 min. The cocoon silk was taken out and cleaned with deionized water. The operation was repeated three times to ensure that the sericin was completely removed.

[0059] Then, the cocoon silk was taken out and dried in an oven at 60°C to obtain pure silk fibroin fibers. The pure silk fibroin fibers were dissolved in a lithium bromide solution with a concentration of 9.3 mol / L at a bath ratio of 20:150, and dissolved in a constant-temperature magnetic stirrer at 60±2°C for about 1 h. After cooling, the solution was taken out, sealed in a dialysis bag, and placed in deionized water for dialysis for 3-4 days. The solution was filtered with absorbent cotton to obtain a pure silk fibroin solution. The mass fraction of the pure silk fibroin solution was calculated by drying and weighing, and the solution was placed in a 4°C refrigerator for standby.

[0060] Example 3 Preparation of barbed silk suture

[0061] (1) Degumming of silk suture

[0062] The silk suture was immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100, treated for 40 min under boiling, and washed with 35°C warm water for 3 times.

[0063] (2) Activation of silk suture

[0064] The degummed silk suture was immersed in a 25 g / L sodium hydroxide solution at a bath ratio of 1:500, treated for 5 min at 40°C, and taken out to be washed with 0.8% (v / v) acetic acid solution, and then washed with deionized water for 3 times.

[0065] (3) Preparation of ginsenoside finishing solution

[0066] A 1% mass concentration ginsenoside aqueous solution was prepared, and silk fibroin solution was added to the ginsenoside aqueous solution at a mass ratio of ginsenoside:silk fibroin = 1:30, and mixed uniformly. The mixture was aged at room temperature for 3 hours.

[0067] (4) Drug loading of silk suture

[0068] The activated silk suture is immersed in the ginsenoside finishing solution, and is treated by 3 immersions and 3 rollings, as follows: the first time, the pressure is 0.4 kg / cm 2 , and the rolling rate is 10%; the second time, the silk fibroin solution is immersed, and then the rolling machine is passed, the pressure is 0.2 kg / cm 2 , and the rolling rate is 20%; the third time, the solution is immersed, and then the rolling machine is passed, the pressure is 0.1 kg / cm 2 , and the rolling rate is 40%. Then, rapid baking drying is performed, the baking temperature is 120 DEG C, and the time is 10 minutes.

[0069] (5) Formation of barbs

[0070] The drug-loaded silk suture is placed in a silicon rubber mold of a barb negative mold, the silicon rubber mold is prepared by 3D printing technology, and a plurality of barb areas for forming barb structures are arranged in the silicon rubber mold, the included angle between the length extension direction of the barb area and the length extension direction of the silk suture is 45 DEG, and the length of the barb area is 0.5 cm. Then, the silk fibroin solution is poured into the mold, vacuum degassing is performed in a vacuum drying box for 1 min, and then drying is performed in a constant temperature and humidity chamber (temperature 25 DEG C, humidity 60%).

[0071] (6) Shaping

[0072] The dried suture is taken out of the mold, and is subjected to hydrothermal treatment at 126 DEG C for 20 minutes, to obtain the barb silk suture for promoting wound healing without knotting.

[0073] (7) Cutting and packaging

[0074] The shaped suture is dried, is cut into 30 cm in length, and is packaged to obtain a finished product.

[0075] Use of the suture: during clinical operation suturing, different specifications of barb sutures can be selected according to the size of the wound, the suturing position, the suturing tissue and the like, and after the suturing is completed, the excess suture is removed, and no knotting treatment is required.

[0076] Preparation of a barb silk suture in Example 4

[0077] (1) Degumming of the silk suture

[0078] The silk suture is immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100, is treated under a micro-boiling state for 30 minutes, and is washed with warm water at 40 DEG C for 3 times.

[0079] (2) Activation of the silk suture

[0080] The degummed silk suture was immersed in a potassium hydroxide solution with a concentration of 50 g / L at a bath ratio of 1:500, treated at 20°C for 2 minutes, and then washed with 3% (v / v) acetic acid solution and deionized water for 3 times.

[0081] (3) Preparation of ginsenoside finishing solution

[0082] A 1% mass concentration ginsenoside aqueous solution was prepared, and silk fibroin solution was added at a mass ratio of ginsenoside:silk fibroin = 1:100, mixed uniformly, and aged at room temperature for 5 hours.

[0083] (4) Drug loading of silk suture

[0084] The activated silk suture was immersed in the ginsenoside finishing solution and treated by 3 immersions and 3 rollings, as follows: the first time, the pressure was 2 kg / cm 2 , and the rolling rate was 10%; the second time, the silk fibroin solution was immersed, and then passed through the rolling machine, the pressure was 1 kg / cm 2 , and the rolling rate was 20%; the third time, the solution was immersed, and then passed through the rolling machine, the pressure was 0.5 kg / cm 2 , and the rolling rate was 40%. Then, rapid baking and drying were performed at a baking temperature of 130°C for 3 minutes.

[0085] (5) Formation of barbs

[0086] The drug-loaded silk suture was placed in a silicone mold of a barb negative mold, the silicone mold was prepared by 3D printing technology, and a plurality of barb regions for forming barb structures were arranged in the silicone mold, the included angle between the length extension direction of the barb region and the length extension direction of the silk suture was 45°, and the length of the barb region was 0.5 cm. Then, the silk fibroin solution was poured into the mold, vacuum degassing was performed in a vacuum drying oven for 1 min, and then the mold was placed in a constant temperature and humidity chamber (temperature 25°C, humidity 70%) for drying.

[0087] (6) Shaping

[0088] The dried suture was taken out of the mold, and wet heat treatment was performed at 130°C for 10 minutes to obtain the non-knotting silk suture for promoting wound healing.

[0089] (7) Cutting and packaging

[0090] The shaped suture was dried, cut into 30 cm long, and packaged to obtain the finished product.

[0091] Example 5: Preparation of barbed silk suture

[0092] (1) Degumming of silk suture

[0093] The silk sutures were immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100, treated for 40 minutes under a micro-boiling state, and washed with warm water at 35°C for 3 times.

[0094] (2) Activation of the silk sutures

[0095] The degummed silk sutures were immersed in a 5 g / L sodium hydroxide solution at a bath ratio of 1:500, treated for 9 minutes at 20°C, and then washed with a 0.5% (v / v) acetic acid solution and deionized water for 3 times.

[0096] (3) Preparation of the ginsenoside finishing solution

[0097] A 1% mass concentration ginsenoside aqueous solution was prepared, and silk fibroin solution was added to the ginsenoside aqueous solution at a mass ratio of ginsenoside:silk fibroin = 1:10, mixed uniformly, and aged at room temperature for 1 hour.

[0098] (4) Drug loading of the silk sutures

[0099] The activated silk sutures were immersed in the ginsenoside finishing solution and subjected to 3 immersions and 3 rollings, as follows: the first rolling was performed at a pressure of 0.4 kg / cm 2 and a rolling rate of 20%; the second immersion was performed in the silk fibroin solution, followed by rolling at a pressure of 0.2 kg / cm 2 and a rolling rate of 40%; the third immersion was performed in the solution, followed by rolling at a pressure of 0.1 kg / cm 2 and a rolling rate of 60%. Then, the silk sutures were rapidly baked and dried at a temperature of 115°C for 25 minutes.

[0100] (5) Formation of barbs

[0101] The drug-loaded silk sutures were placed in a silicone mold of a barb negative mold, the silicone mold was prepared by 3D printing technology, and the silicone mold was provided with a plurality of barb regions for forming barb structures, the included angle between the length extension direction of the barb regions and the length extension direction of the silk sutures was 45°, and the length of the barb regions was 0.5 cm. Then, the silk fibroin solution was poured into the mold, vacuum degassing was performed in a vacuum drying oven for 1 minute, and then the mold was placed in a constant temperature and humidity chamber (temperature 40°C, humidity 50%) for drying.

[0102] (6) Shaping

[0103] The dried sutures were taken out of the mold, subjected to hydrothermal treatment at 120°C for 100 minutes, and the silk sutures for promoting wound healing without knotting were obtained.

[0104] (7) Cutting and packaging

[0105] The shaped sutures were dried, cut into 30 cm long, and packaged to obtain the finished product.

[0106] Preparation of barbed silk sutures

[0107] (1) Degumming of silk sutures

[0108] The silk sutures were immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100 and treated under a micro-boiling condition for 30 minutes, and then washed with warm water at 30°C for 3 times.

[0109] (2) Activation of silk sutures

[0110] The degummed silk sutures were immersed in a 7 g / L sodium hydroxide solution at a bath ratio of 1:500 and treated at 30°C for 7 minutes, and then washed with a 2% (v / v) acetic acid solution and deionized water for 3 times.

[0111] (3) Preparation of ginsenoside finishing solution

[0112] A 1% mass concentration ginsenoside aqueous solution was prepared, and a silk fibroin solution was added to the ginsenoside aqueous solution at a mass ratio of ginsenoside:silk fibroin = 1:10, mixed uniformly, and aged at room temperature for 1 hour.

[0113] (4) Drug loading of silk sutures

[0114] The activated silk sutures were immersed in the ginsenoside finishing solution and subjected to 3 immersions and 3 rollings, as follows: the first rolling was performed at a pressure of 2 kg / cm 2 and a rolling rate of 20%; the second immersion was performed in the silk fibroin solution, and then the rolling machine was passed, the pressure was 1 kg / cm 2 , and the rolling rate was 40%; the third immersion was performed in the solution, and then the rolling machine was passed, the pressure was 0.5 kg / cm 2 , and the rolling rate was 60%. Then, rapid baking and drying were performed at a temperature of 120°C for 20 minutes.

[0115] (5) Formation of barbs

[0116] The drug-loaded silk sutures were placed in a silicone mold of a barb negative mold, the silicone mold was prepared by 3D printing technology, and a plurality of barb regions for forming barb structures were arranged in the silicone mold, the included angle between the length extension direction of the barb regions and the length extension direction of the silk sutures was 45°, and the length of the barb regions was 0.5 cm. Then, the silk fibroin solution was poured into the mold, vacuum degassing was performed in a vacuum drying oven for 1 min, and then drying was performed in a constant temperature and humidity chamber (temperature 40°C, humidity 50%).

[0117] (6) Shaping

[0118] The dried suture is taken out of the mold, and is subjected to hydrothermal treatment at 126 DEG C for 50 minutes, to obtain the knot-free silk suture for promoting wound healing.

[0119] (7) Cutting package

[0120] The shaped suture is dried, cut into 30 cm in length, and packaged to obtain the finished product.

[0121] The present application relates to a kind of barb structure, can promote wound healing knot-free silk suture and preparation method thereof, 1.It is based on existing barbed silk suture, by mold, casting silk fibroin solution around line body, form several barbs on suture, barb is evenly distributed in helical shape on line body surface;2.Ginsenoside is used in the manufacture and formation of barbed suture, and the polysaccharide chain in ginsenoside can form stable hydrogen bond with silk fibroin, which can achieve long-term sustained release, so that ginsenoside can act on wound persistently, prolong the efficacy, effectively improve the condition of wound inflammation, promote wound healing, and improve the mechanical properties of suture. That is, the silk suture of the present application utilizes the superiority of the performance of silk thread itself, and adopts helical arrangement, so that the stress during suture is more uniform, and the wound suture effect is good, and postoperative infection is not easy to cause. The suture retains the good biocompatibility of the original suture, and has the effects of promoting skin wound healing, improving body immunity and antioxidant, etc., and the effect is stable and persistent, and quick-acting.

[0122] The above examples are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and implement it, and cannot limit the protection scope of the present application, and any equivalent changes or modifications made according to the spirit and essence of the present application should be covered within the protection scope of the present application.

Claims

1. A barbed silk suture, characterized in that, It includes an inner thread, a silk fibroin cover wrapped around the surface of the thread, and multiple barbs protruding outward from the silk fibroin cover; The barbed silk suture is prepared by the following method: after degumming and activating the silk suture, it is immersed in ginsenoside finishing solution for padding treatment, and then baked and dried; the drug-loaded silk suture is placed in a mold, and silk fibroin solution is poured into the mold, and after removing air bubbles, it is dried; the dried suture is taken out and subjected to moist heat treatment at 120℃~130℃ to obtain the barbed silk suture. The degumming process involves immersing the silk sewing thread in an alkaline solution and treating it at a gentle boil for 30-60 minutes, followed by rinsing with warm water. The activation process involves immersing the degummed silk suture in a strong alkaline solution at 20-55°C for 1-10 minutes, then rinsing it with acetic acid solution followed by deionized water; the strong alkaline solution is an aqueous solution of sodium hydroxide and / or potassium hydroxide. The silk suture is activated by a strong alkali to form more amino groups, which then react with the hemiacetal structure on the ginsenosides to form Schiff bases. The ginsenoside finishing solution is prepared by the following method: Ginsenoside aqueous solution is added to silk fibroin solution at a mass ratio of ginsenoside:silk fibroin = 1:10-100, mixed evenly, and aged at room temperature for 1-5 hours to obtain the ginsenoside finishing solution. The baking and drying conditions are as follows: baking temperature is 110-130℃, and time is 1-30 minutes.

2. The barbed silk suture according to claim 1, characterized in that, Multiple barbs are evenly distributed in a spiral shape on the surface of the silk fibroin body.

3. The barbed silk suture according to claim 1, characterized in that, The silk fibroin body has two sets of barbed units, each set of barbed units includes multiple barbs, and the multiple barbs in each set of barbed units are evenly distributed in a spiral shape on the surface of the silk fibroin body.

4. The barbed silk suture according to claim 3, characterized in that, The two sets of barb units are symmetrically distributed along the central axis of the line.

5. The barbed silk suture according to claim 3, characterized in that, The spiral angle of the spiral line formed by the spiral distribution of each group of barbs is 45° to 60°; the pitch of the spiral line formed by the spiral distribution of each group of barbs is 0.1cm to 1cm; the spiral distribution of the barbs is either left-handed or right-handed.

6. The barbed silk suture according to claim 1, characterized in that, The angle between the length direction of the barb and the length extension direction of the line is 20° to 60°.

7. The barbed silk suture according to claim 1, characterized in that, The barb is conical, with a length of 0.1 mm to 5 mm and a diameter of 0.01 mm to 1 mm at the bottom.

8. The barbed silk suture according to claim 1, characterized in that, The diameter of the line is 0.05mm to 2mm.

9. The barbed silk suture according to any one of claims 1-8, characterized in that, Both the silk fibroin body and the barbs are formed by the solidification of silk fibroin protein solution; the thread is a silk thread, and the silk fibroin body wraps around the surface of the silk thread and fills the spaces between adjacent silk threads.

10. The barbed silk suture according to claim 9, characterized in that, The silk fibroin is a silk fibroin composed of a silk fibroin II crystal structure.

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