A method for preparing a barbed silk suture

Abstract

The application discloses a preparation method of barbed silk suture, which comprises the following steps: after degumming and activation, the silk suture is immersed in a ginsenoside finishing liquid for padding treatment, and then is 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 silk suture is taken out and subjected to wet heat treatment to obtain the barbed silk suture; during the degumming process, an alkali solution with a mass concentration of 0.02-0.08% is used for degumming; and during the activation process, a strong alkali solution with a concentration of 5g / L-50g / L is used for activation. The preparation method of the barbed silk suture applies ginsenoside and silk fibroin to the production 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 a wound for a long time (long-term sustained release), the drug effect is prolonged, the inflammation of the wound is effectively improved, and the wound healing is promoted.

Description

[0001] This application is a divisional application of the invention patent application filed on April 2, 2021, with application number 2021103593761 and invention title "A barbed silk suture and its preparation method". Technical Field

[0002] This invention relates to the field of suture technology, and specifically to a method for preparing a novel knot-free barbed silk suture that promotes wound healing. Background Technology

[0003] In the field of medical aesthetics, barbed sutures are often used in procedures such as thread lifting and facial lifting. By using the tension generated by the barbs, the aging and sagging soft tissue affected by gravity is anchored and lifted to achieve the goal of rejuvenation.

[0004] Most existing knotless sutures are made of composite materials. Studies have shown that absorbable and biodegradable materials can cause varying degrees of swelling at the implantation site, resulting in "sterile effusion." The release of material degradation fragments, monomers, catalysts, and dead cell contents can all trigger acute inflammatory reactions, making them unsuitable for cosmetic applications. Furthermore, in areas of high tension, the strength of absorbable sutures may be insufficient, limiting their use. Because current knotless sutures are manufactured by cutting and barbing the suture itself, uneven suture strength can lead to the risk of suture breakage during and after surgery.

[0005] Silk, as a natural protein material, does not have adverse effects on the human body. Numerous clinical trials using silk sutures in hospitals have demonstrated that, after complete degumming, silk sutures do not cause any inflammatory reactions after implantation into human tissue and are less likely to cause biological rejection. Furthermore, as a high-performance natural protein, it effectively promotes wound healing and repair, accelerating wound healing. Compared to other composite material sutures, it has a lower chance of leaving scars, indicating significant market potential.

[0006] On the other hand, traditional Chinese medicine (TCM) has abundant resources and low cost, possessing unique advantages that Western medicine cannot match, such as natural ingredients, stable effects, and fewer toxic side effects. Ginseng, a well-known and precious traditional Chinese medicinal herb, has high medicinal value. Modern biochemical analysis has gradually revealed its chemical components. Ginseng contains abundant proteins, polysaccharides, and saponins. Ginsenosides are the main active substances in ginseng, encompassing multiple subtypes. They not only possess broad-spectrum pharmacological activities such as anti-inflammatory and detoxifying, anti-tumor, anti-myocardial ischemia, anti-aging, and memory improvement, but also have functions such as scavenging free radicals, enhancing antioxidant capacity, increasing skin collagen fiber and collagen content, regulating the body's immune function, and improving microcirculation.

[0007] If ginsenosides and silk fibroin from silk can be combined and incorporated into barbed surgical sutures, ginsenosides can act on the wound for a longer period, prolonging the therapeutic effect, effectively improving wound inflammation, and promoting wound healing. Summary of the Invention

[0008] In view of this, in order to overcome the defects of the prior art and achieve the above objectives, the purpose of this invention is to provide a method for preparing barbed silk sutures, in which ginsenosides and silk fibroin are combined into the barbed surgical sutures.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A method for preparing barbed silk suture includes the following steps:

[0011] (1) Degumming of silk sutures: Immerse the silk sutures in an alkaline solution and treat them at a slight boil for 30-60 minutes, then rinse with warm water.

[0012] (2) Activation of silk sutures: Immerse the degummed silk sutures in a strong alkaline solution with a concentration of 5g / L to 50g / L and treat them at 20-55℃ for 1-10 minutes. After taking them out, wash them with acetic acid solution first, and then wash them with deionized water.

[0013] (3) Preparation of ginsenoside finishing solution: Add ginsenoside aqueous solution to silk fibroin solution at a mass ratio of ginsenoside: silk fibroin = 1:10-100, mix evenly, and age at room temperature for 1-5 hours to obtain ginsenoside finishing solution.

[0014] (4) Drug loading of silk sutures: The activated silk sutures in step (2) are immersed in the ginsenoside finishing solution prepared in step (3) for padding treatment, and then baked and dried.

[0015] (5) Formation of barbs: The drug-loaded silk suture is placed in a mold, which has multiple barb areas for forming barb structures. Then, silk fibroin solution is poured into the mold, and the air bubbles are removed by vacuum and then dried.

[0016] (6) Shaping: Take the dried suture out of the mold and perform wet heat treatment at 120℃~130℃ to obtain the barbed silk suture.

[0017] To facilitate the formation of barbs, the concentration of the silk fibroin solution added in step (5) is 3% to 10%. If the concentration is too low, it will cause severe shrinkage during the drying process of the solution, resulting in barb deformation; if the concentration is too high, the silk fibroin will be unstable and easily form a gel.

[0018] According to some preferred embodiments of the present invention, the alkaline solution in step (1) is a sodium carbonate solution with a mass concentration of 0.02 to 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 impregnation: Impregnation 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 sutures: The degummed silk sutures are immersed in a strong alkaline solution with a concentration of 5g / L to 50g / L at a bath ratio of 1:500 and treated at 20-55℃ for 1-10 minutes. After removal, they are first cleaned with 0.5%-3% (v / v) acetic acid solution and then washed with deionized water 3 times.

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

[0030] (4) Drug loading of silk sutures: The activated silk sutures are immersed in ginsenoside finishing solution and subjected to 3 dips and 3 rolls. Then they are quickly baked and dried at a temperature of 110-130℃ for 1-30 minutes.

[0031] (5) Formation of barbs: The drug-loaded silk suture is placed into a mold, which has several barb areas for forming barb structures. Then, silk fibroin solution is poured into the mold, and the air bubbles are removed by vacuum and then dried.

[0032] (6) Shaping: Take the dried suture out of the mold and perform wet heat treatment at 120℃~130℃ for 10-100 minutes to obtain the knotless silk suture that promotes wound healing.

[0033] The present invention also provides a barbed silk suture prepared according to the preparation method described above, comprising an inner thread body, a silk fibroin outer layer wrapped around the surface of the thread body, and a plurality of barbs protruding outward from the silk fibroin outer layer, wherein the plurality of barbs are evenly distributed in a spiral shape on the surface of the silk fibroin outer layer; both the silk fibroin outer layer and the barbs are formed by the coagulation of a silk fibroin protein solution.

[0034] The use of silk fibroin as the outer layer and barbs ensures excellent biocompatibility of the suture, preventing wound irritation and immune responses. It can also absorb cell growth factors, promoting tissue healing. During surgical suturing, the barbs self-fix, resulting in faster suturing times and eliminating the need for knotting; the wound closes automatically. Furthermore, the spiral distribution of the barbs ensures more even tension distribution after suturing, reducing pain and minimizing scarring.

[0035] According to some preferred embodiments of the present invention, the silk fibroin sheet has two sets of barbed units, each set of barbed units including 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 sheet. By setting two or more sets of barbed unit structures, the force is more dispersed and uniform, resulting in a better sewing effect.

[0036] According to some preferred embodiments of the invention, the two sets of barb units are symmetrically distributed along the central axis of the suture. The symmetrical arrangement of two or more sets of barb structures provides advantages such as more stable tissue anchoring and superior mechanical properties for the suture.

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

[0038] According to some preferred embodiments of the present invention, the silk fibroin body and the barbs are integrally formed. In some embodiments of the present invention, a three-dimensional silicone mold is fabricated using 3D printing, the mold having spirally distributed barb holes imprinted on it. During preparation, a silk fibroin solution is poured into the mold, and after drying, it can be cast into shape in one step.

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

[0040] According to some preferred embodiments of the present invention, 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 base of the barb. Sutures with barbs of different sizes can be used to suture the wound according to its size and depth, thereby reducing scarring.

[0041] According to some preferred embodiments of the present invention, the suture is a silk thread, and the fibroin sheath wraps around the surface of the silk thread and fills the spaces between adjacent silk threads. Silk sutures have good mechanical properties and are not easily broken, allowing the suture of this application to retain the superior properties of silk sutures while also adding a rigid barbed structure.

[0042] According to some preferred embodiments of the invention, the diameter of the wire is 0.05 mm to 2 mm.

[0043] According to some preferred embodiments of the present invention, the silk fibroin is a silk fibroin with a silk fibroin II crystalline structure. The barbs made of silk fibroin can bond well with silk thread while possessing the same biocompatibility. The silk fibroin II crystalline structure allows the barbs to have a more rigid structure, providing better anchoring for tissue sutures.

[0044] Due to the adoption of the above technical solutions, the present invention has the following advantages compared with the prior art: The preparation method of the barbed silk suture of the present invention applies ginsenosides and silk fibroin to the production and formation of barbed sutures, and prepares a novel knot-free barbed silk suture that promotes wound healing; the polysaccharide chains in ginsenosides can form stable hydrogen bonds with silk fibroin, so that ginsenosides can act on the wound for a long time (long-term sustained release), prolong the efficacy, effectively improve wound inflammation, promote wound healing, and improve the mechanical properties of the suture. Attached Figure Description

[0045] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0046] Figure 1 This is a front view schematic diagram of the spiral barbed silk fibroin suture in an embodiment of the present invention;

[0047] Figure 2 This is a top view schematic diagram of the spiral barbed silk fibroin suture in an embodiment of the present invention;

[0048] In the attached diagram: 1-barbs; 2-silk fibroin body; 3-thread. Detailed Implementation

[0049] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0050] Example 1

[0051] like Figure 1-2As shown, the barbed silk suture (spiral barbed silk fibroin suture) in this embodiment includes an inner suture body 3, a silk fibroin outer layer 2 wrapped around the surface of the suture body 3, and multiple barbs 1 protruding outward from the silk fibroin outer layer 2. In this embodiment, the silk fibroin outer layer 2 has two sets of barb 1 units, each set including multiple barbs 1. The multiple barbs 1 in each set are evenly distributed spirally on the surface of the silk fibroin outer layer 2, and the two sets of barb 1 units are symmetrically distributed along the central axis of the suture body 3. By symmetrically setting two or more sets of barb 1 unit structures, the suture has advantages such as more stable tissue anchoring, superior mechanical properties, and better suturing effect.

[0052] In this embodiment, the spiral angle of the helical distribution of barbs 1 is 60°, and the pitch of the helical distribution of barbs 1 is 0.5 cm. The spiral distribution of barbs 1 is either left-handed or right-handed so that the different barb units 1 are arranged symmetrically. In other embodiments, the spiral angle of the helical distribution of barbs 1 is 45° to 60°, and the length (pitch) of one turn of barb 1 is 0.1 cm to 1 cm. The uniform spiral arrangement of barbs 1 also makes the tissue tension distribution after wound closure more uniform, reducing postoperative pain.

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

[0054] In this embodiment, the barb 1 is conical in shape, with a length of 0.5 cm and a diameter of 0.1 mm at the base. In other embodiments, the length of the barb 1 is 0.1 mm to 5 mm, and the diameter of the base is 0.01 mm to 1 mm. Different sizes of barbs 1 can be used with suture lines according to the size and depth of the wound to reduce scarring.

[0055] The diameter of the thread 3 is 0.05mm to 2mm, preferably 1.2mm in this embodiment. The thread 3 in this embodiment is a braided silk suture formed by multiple silk threads. The fibroin coating 2 wraps around the surface of the silk threads and fills the spaces between adjacent silk threads. The silk suture has good mechanical properties and is not easily broken, allowing the suture in this embodiment to retain the superior properties of silk sutures. It also features a rigid barb structure 1 and good biocompatibility, enabling it to degrade harmlessly in vivo.

[0056] In this embodiment, both the silk fibroin body 2 and the barbs 1 are integrally formed by solidifying a silk fibroin solution. The silk fibroin in the silk fibroin body 2 is silk fibroin with a silk fibroin II crystalline structure, and the barbs 1 are composed of crystalline silk fibroin. The silk fibroin material barbs 1 can bond well with silk threads and have the same biocompatibility. The silk fibroin II crystalline structure allows the barbs 1 to have a more rigid structure, providing better anchoring for tissue sutures.

[0057] Example 2: Preparation of Silk Fiber Solution

[0058] Weigh 80g of silkworm cocoon shells using a balance and place them in a container. Add 4000mL of a 0.01M sodium bicarbonate / sodium carbonate aqueous solution with pH=9.5. Heat the solution to boiling using an induction cooker, then adjust the power to maintain a gentle boil for 30 minutes. Remove the cocoon silk and rinse it thoroughly with deionized water. Repeat this process three times to ensure complete removal of sericin.

[0059] The cocoon fibers were then removed and dried in an oven at 60°C to obtain pure silk fibroin fibers. These pure silk fibroin fibers were dissolved in a 9.3 mol / L lithium bromide solution at a bath ratio of 20:150, and dissolved at 60±2°C for approximately 1 hour using a constant-temperature magnetic stirrer. After cooling, the solution was removed, sealed in a dialysis bag, and dialyzed in deionized water for 3–4 days. The solution was then filtered through defatted 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 stored at 4°C for later use.

[0060] Example 3: Preparation of barbed silk suture

[0061] (1) Degumming of silk sutures

[0062] The silk suture was immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100 and treated for 40 minutes at a gentle boil. It was then washed three times with warm water at 35°C.

[0063] (2) Activation of silk sutures

[0064] After degumming, the silk sutures were immersed in a sodium hydroxide solution with a concentration of 25 g / L at a bath ratio of 1:500 and treated at 40°C for 5 minutes. They were then removed and first washed with water in a 0.8% (v / v) acetic acid solution, and then washed three times with deionized water.

[0065] (3) Preparation of ginsenoside finishing solution

[0066] Prepare a 1% (w / w) ginsenoside aqueous solution. Add ginsenoside to silk fibroin solution at a (w / w) ratio of 1:30. Mix well and age at room temperature for 3 hours.

[0067] (4) Drug loading in silk sutures

[0068] The activated silk sutures were immersed in a ginsenoside finishing solution and subjected to a 3-dip, 3-roll treatment, as follows: the first pressure was 0.4 kg / cm². 2 The residual rate was 10%; it was then immersed again in a silk fibroin solution and passed through a rolling mill at a pressure of 0.2 kg / cm². 2 The rolling residue was 20%; it was then immersed in the solution for the third time, and then passed through a rolling mill at a pressure of 0.1 kg / cm². 2 The roll residue was 40%. Then it was quickly baked and dried at 120°C for 10 minutes.

[0069] (5) Formation of barbs

[0070] The drug-loaded silk suture was placed into a silicone mold of a barbed negative mold. The silicone mold was made by 3D printing technology and had several barbed areas for forming the barbed structure. The angle between the length extension direction of the barbed area and the length extension direction of the silk suture was 45° and the length of the barbed area was 0.5 cm. Then, silk fibroin solution was poured into the mold and placed in a vacuum drying oven for vacuum degassing for 1 minute. After that, it was placed in a constant temperature and humidity room (temperature 25℃, humidity 60%) for drying.

[0071] (6) Finalization

[0072] After drying, the suture is removed from the mold and subjected to moist heat treatment at 126°C for 20 minutes to obtain the knotless silk suture that promotes wound healing.

[0073] (7) Cutting and packaging

[0074] After the sutures have been dried, they are cut into 30cm lengths and packaged to obtain the finished product.

[0075] Use of sutures: During clinical surgical suturing, different specifications of barbed sutures can be selected according to the suturing situation, such as wound size, suture location, and sutured tissue. After suturing is completed, excess sutures should be removed, and knotting is not required.

[0076] Example 4: Preparation of barbed silk suture

[0077] (1) Degumming of silk sutures

[0078] The silk suture was immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100 and treated for 30 minutes at a gentle boil. It was then washed three times with warm water at 40°C.

[0079] (2) Activation of silk sutures

[0080] After degumming, the silk sutures were immersed in a 50 g / L potassium hydroxide solution at a bath ratio of 1:500 and treated at 20°C for 2 minutes. They were then removed and first washed with water in a 3% (v / v) acetic acid solution, and then washed three times with deionized water.

[0081] (3) Preparation of ginsenoside finishing solution

[0082] Prepare a 1% (w / w) ginsenoside aqueous solution. Add ginsenoside to silk fibroin solution at a (w / w) ratio of 1:100. Mix well and age at room temperature for 5 hours.

[0083] (4) Drug loading in silk sutures

[0084] The activated silk sutures were immersed in a ginsenoside finishing solution and subjected to a 3-immersion, 3-roll treatment, as follows: the first pressure was 2 kg / cm². 2 The residual rate was 10%; it was then immersed again in a silk fibroin solution and passed through a rolling mill at a pressure of 1 kg / cm². 2 The rolling residue was 20%; it was then immersed in the solution a third time, and then passed through a rolling mill at a pressure of 0.5 kg / cm². 2 The roll residue was 40%. Then it was quickly baked and dried at 130°C for 3 minutes.

[0085] (5) Formation of barbs

[0086] The drug-loaded silk suture was placed into a silicone mold of a barbed negative mold. The silicone mold was made by 3D printing technology and had several barbed areas for forming barbed structures. The angle between the length extension direction of the barbed area and the length extension direction of the silk suture was 45° and the length of the barbed area was 0.5 cm. Then, silk fibroin solution was poured into the mold and placed in a vacuum drying oven for vacuum degassing for 1 minute. After that, it was placed in a constant temperature and humidity room (temperature 25℃, humidity 70%) for drying.

[0087] (6) Finalization

[0088] After drying, the suture is removed from the mold and subjected to moist heat treatment at 130°C for 10 minutes to obtain the knotless silk suture that promotes wound healing.

[0089] (7) Cutting and packaging

[0090] After the sutures have been dried, they are cut into 30cm lengths and packaged to obtain the finished product.

[0091] Example 5: Preparation of barbed silk suture

[0092] (1) Degumming of silk sutures

[0093] The silk suture was immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100 and treated for 40 minutes at a gentle boil. It was then washed three times with warm water at 35°C.

[0094] (2) Activation of silk sutures

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

[0096] (3) Preparation of ginsenoside finishing solution

[0097] Prepare a 1% (w / w) ginsenoside aqueous solution. Add ginsenoside to silk fibroin solution at a (w / w) ratio of 1:10. Mix well and age at room temperature for 1 hour.

[0098] (4) Drug loading in silk sutures

[0099] The activated silk sutures were immersed in a ginsenoside finishing solution and subjected to a 3-dip, 3-roll treatment, as follows: the first pressure was 0.4 kg / cm². 2 The residual rate was 20%; it was then immersed again in a silk fibroin solution and passed through a rolling mill at a pressure of 0.2 kg / cm². 2 The rolling residue was 40%; it was then immersed in the solution for the third time, and then passed through a rolling mill at a pressure of 0.1 kg / cm². 2 The roll residue was 60%. Then it was quickly baked and dried at 115°C for 25 minutes.

[0100] (5) Formation of barbs

[0101] The drug-loaded silk suture was placed into a silicone mold of a barbed negative mold. The silicone mold was made by 3D printing technology and had several barbed areas for forming the barbed structure. The angle between the length extension direction of the barbed area and the length extension direction of the silk suture was 45° and the length of the barbed area was 0.5 cm. Then, silk fibroin solution was poured into the mold and placed in a vacuum drying oven for vacuum degassing for 1 minute. After that, it was placed in a constant temperature and humidity room (temperature 40℃, humidity 50%) for drying.

[0102] (6) Finalization

[0103] After drying, the suture is removed from the mold and subjected to moist heat treatment at 120°C for 100 minutes to obtain the knotless silk suture that promotes wound healing.

[0104] (7) Cutting and packaging

[0105] After the sutures have been dried, they are cut into 30cm lengths and packaged to obtain the finished product.

[0106] Example 6: Preparation of barbed silk suture

[0107] (1) Degumming of silk sutures

[0108] The silk suture was immersed in a 0.05% (w / v) sodium carbonate solution at a bath ratio of 1:100 and treated for 30 minutes at a gentle boil. It was then washed three times with warm water at 30°C.

[0109] (2) Activation of silk sutures

[0110] After degumming, the 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. They were then removed and first washed with water in a 2% (v / v) acetic acid solution, and then washed three times with deionized water.

[0111] (3) Preparation of ginsenoside finishing solution

[0112] Prepare a 1% (w / w) ginsenoside aqueous solution. Add ginsenoside to silk fibroin solution at a (w / w) ratio of 1:10. Mix well and age at room temperature for 1 hour.

[0113] (4) Drug loading in silk sutures

[0114] The activated silk sutures were immersed in a ginsenoside finishing solution and subjected to a 3-immersion, 3-roll treatment, as follows: the first pressure was 2 kg / cm². 2 The residual rate was 20%; it was then immersed again in a silk fibroin solution and passed through a rolling mill at a pressure of 1 kg / cm². 2 The rolling residue was 40%; it was then immersed in the solution for the third time, and then passed through a rolling mill at a pressure of 0.5 kg / cm². 2 The roll residue was 60%. Then it was quickly baked and dried at 120°C for 20 minutes.

[0115] (5) Formation of barbs

[0116] The drug-loaded silk suture was placed into a silicone mold of a barbed negative mold. The silicone mold was made by 3D printing technology and had several barbed areas for forming the barbed structure. The angle between the length extension direction of the barbed area and the length extension direction of the silk suture was 45° and the length of the barbed area was 0.5 cm. Then, silk fibroin solution was poured into the mold and placed in a vacuum drying oven for vacuum degassing for 1 minute. After that, it was placed in a constant temperature and humidity room (temperature 40℃, humidity 50%) for drying.

[0117] (6) Finalization

[0118] After drying, the suture is removed from the mold and subjected to moist heat treatment at 126°C for 50 minutes to obtain the knotless silk suture that promotes wound healing.

[0119] (7) Cutting and packaging

[0120] After the sutures have been dried, they are cut into 30cm lengths and packaged to obtain the finished product.

[0121] This invention relates to a knotless silk suture with a barbed structure that promotes wound healing, and its preparation method. 1. Based on existing barbed silk sutures, a silk fibroin solution is cast around the suture body using a mold, forming several barbs on the suture body. The barbs are evenly distributed spirally on the surface of the suture body. 2. Ginsenosides are used in the production and formation of the barbed suture. The polysaccharide chains in ginsenosides can form stable hydrogen bonds with silk fibroin, achieving long-term sustained release. This allows ginsenosides to act on the wound for a prolonged period, prolonging the efficacy, effectively improving wound inflammation, promoting wound healing, and improving the mechanical properties of the suture. In other words, the silk suture of this application utilizes the superior properties of silk thread itself, and the spiral arrangement makes the stress more even during suturing, resulting in better wound closure and reducing the risk of postoperative infection. This suture retains the good biocompatibility of the original suture and also has the effects of promoting skin wound healing, improving the body's immunity, and anti-oxidation. Its effects are stable, long-lasting, and fast-acting.

[0122] The above embodiments are only for illustrating the technical concept and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A method for preparing a barbed silk suture, characterized in that, Includes the following steps: After degumming and activating, the silk sutures are immersed in a ginsenoside finishing solution for padding treatment, and then baked and dried. The drug-loaded silk suture is placed into a mold, and a silk fibroin solution is poured into the mold. After removing air bubbles, the mold is dried, and the mold is provided with multiple barb areas for forming barb structures. The dried suture is removed and subjected to moist heat treatment to obtain the barbed silk suture. The degumming process uses an alkaline solution with a mass concentration of 0.02~0.08% for degumming; the activation process uses a strong alkaline solution with a concentration of 5g / L~50g / L for activation; the activation involves immersing the degummed silk suture in the strong alkaline solution and treating it at 20-55℃ for 1-10 minutes, then taking it out and washing it first with acetic acid solution, and then washing it with deionized water. The baking and drying conditions are as follows: baking temperature is 110-130℃, and time is 1-30 minutes; The strong alkaline solution is an aqueous solution of sodium hydroxide and / or potassium hydroxide; The preparation process of the ginsenoside finishing solution is as follows: 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 ginsenoside finishing solution.

2. The preparation method according to claim 1, characterized in that, The degumming process involves immersing the silk suture in an alkaline solution and treating it at a gentle boil for 30-60 minutes, followed by rinsing with warm water. The alkaline solution is a sodium carbonate solution with a mass concentration of 0.02-0.08%.

3. The preparation method according to claim 1, characterized in that, The volume concentration of the acetic acid solution is 0.5%-3%.

4. The preparation method according to claim 1, characterized in that, The concentration of the silk fibroin solution used in the preparation of the ginsenoside finishing solution is 3%~10%.

5. The preparation method according to claim 1, characterized in that, The drying conditions after degassing are: temperature 20℃~40℃, humidity 50%~70%.

6. The preparation method according to claim 1, characterized in that, The damp heat treatment is carried out at 120℃~130℃.

7. The preparation method according to any one of claims 1-6, characterized in that, The barbed silk suture includes an inner thread body, a silk fibroin outer layer wrapped around the surface of the thread body, and multiple barbs protruding outward from the silk fibroin outer layer.

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