Polymer-modified absorbable suture

Abstract

The application relates to the technical field of medical devices, in particular to a polymer modified absorbable suture, which comprises an outer antibacterial layer, a connecting line and a tie, the inner part of the outer antibacterial layer is internally provided with an inner antibacterial layer, the inner part of the inner antibacterial layer is internally provided with a toughness layer, and the toughness layer is fixedly connected with a reinforcing layer in the inner part, when suturing, the device is cut to select a proper length, the connecting line between the two outer antibacterial layers is cut, the connecting line is then passed through a needle hole to connect the device to the needle hole, the needle is penetrated, the flat-elliptical connecting line is more convenient for a user to penetrate the needle, the needle penetration time is effectively reduced, and the device is more convenient to use.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a polymer-modified absorbable suture. Background Technology

[0002] Surgical sutures are special sutures used in surgical procedures or trauma treatment for ligation and hemostasis, suturing and tissue repair. They are generally divided into two main categories: absorbable sutures and non-absorbable sutures. Absorbable sutures are further divided into catgut sutures, chemically synthesized sutures, and pure natural collagen sutures, depending on their material and degree of absorption.

[0003] When using absorbable sutures, the suture needs to be threaded through the needle eye for connection. However, due to the small needle eye and the large cross-sectional area of ​​the suture, threading the needle is difficult, time-consuming, and inconvenient. Furthermore, when tying the suture after suturing, the knot is tied using the suture body itself, resulting in a large joint volume. This hinders the simultaneous degradation of the joint and the suture body, increasing degradation time. Additionally, as biodegradable sutures gradually degrade, their strength and toughness decrease, making them prone to breakage. Moreover, after suturing, the operator disinfects the patient's surface, but cannot guarantee antibacterial disinfection during wound healing. This can lead to bacterial growth and complications during wound healing, hindering proper healing. Summary of the Invention

[0004] To address the aforementioned problems in the existing technology, a polymer-modified absorbable suture is provided.

[0005] The specific technical solution is as follows:

[0006] Design a polymer-modified absorbable suture, including an outer antibacterial layer, a connecting suture, and frenulum. The outer antibacterial layer has an inner antibacterial layer inside, and the inner antibacterial layer has a toughening layer inside. A reinforcing layer is fixedly connected inside the toughening layer. The outer antibacterial layer has adapter blocks at both ends. The connecting suture is located on the side of the adapter block away from the outer antibacterial layer. The frenulum is located at both ends of the connecting suture.

[0007] Preferably, the connecting line is in the shape of a flat ellipse, and the connecting line is located between two adjacent transition blocks and is fixedly connected to the transition blocks.

[0008] Preferably, the tie is located at both the upper and lower ends of the connecting line, with two ties provided at each end of the connecting line, and the tie is fixedly connected to the connecting line.

[0009] Preferably, the outer antibacterial layer is provided with a plurality of drug-applying grooves, which are evenly distributed on the outer side of the outer antibacterial layer with the outer antibacterial layer as the center.

[0010] Preferably, an adhesive layer is fixedly connected inside the reinforcing layer.

[0011] Preferably, a drug layer is fixedly connected inside the adhesive layer.

[0012] Preferably, the outer antibacterial layer is coated with an antibacterial liquid, the raw materials for which the antibacterial liquid is prepared include: a biodegradable polymer, an emulsifier, an antibacterial drug, and a solvent.

[0013] The biodegradable polymers include modified polycaprolactone, polylactic acid, and polyglycolic acid.

[0014] Preferably, the modified polycaprolactone is amino-polyethylene glycol polycaprolactone, and the amino-polyethylene glycol polycaprolactone has a weight-average molecular weight of 0.1-10,000.

[0015] More preferably, the modified polycaprolactone is amino-polyethylene glycol polycaprolactone, the amino-polyethylene glycol polycaprolactone has a weight-average molecular weight of 10,000, and is purchased from Shenzhen MeloPEG Technology Co., Ltd.

[0016] Preferably, the glass transition temperature of the polylactic acid is 50-60°C.

[0017] More preferably, the polylactic acid has a glass transition temperature of 57.8°C and is purchased from Dongguan Yili Plastics Co., Ltd., model: NatureWorks / 4032D.

[0018] Preferably, the weight-average molecular weight of the polyglycolic acid is 0.5-20,000.

[0019] More preferably, the polyglycolic acid has a weight-average molecular weight of 10,000 and is purchased from Shandong Xindongneng Chemical Co., Ltd.

[0020] The applicant discovered that when the weight ratio of modified polycaprolactone, polylactic acid, and polyglycolic acid is 1:(0.5-1):(0.2-0.5), the mechanical properties of the coating can be improved. As the amount of modified polycaprolactone increases, the overall tensile strength of the drug-loaded coating shows an upward trend. However, excessive modified polycaprolactone causes a rapid decrease in the tensile strength and elongation at break of the coating. The reason for this is that when the content of modified polycaprolactone is higher than that of polylactic acid and polyglycolic acid, there is no dominant component in the film-forming process. Instead, the three polymers with significantly different crystallization rates restrain each other, resulting in poor film formation and poor mechanical properties of the drug-loaded coating. Polyglycolic acid is a flexible and hydrophilic material. The addition of a small amount of polyglycolic acid does not affect the dominance of polycaprolactone, but it can reduce the crystallinity of the coating, leading to improved tensile properties of the drug-loaded coating. Further research revealed that when the weight ratio of modified polycaprolactone, polylactic acid, and polyglycolic acid was 1:0.5:2, the film-forming properties of the coating could be improved. This may be because the specific ratio improved the compatibility of the polymer network with the antibacterial drug.

[0021] Preferably, the weight ratio of the modified polycaprolactone, polylactic acid, and polyglycolic acid is 1:(0.5-1):(0.2-0.5).

[0022] More preferably, the modified polycaprolactone, polylactic acid, and polyglycolic acid are in a weight ratio of 1:0.5:0.5.

[0023] Preferably, the emulsifier is potassium polysorbate 60 and potassium polysorbate 80, and the weight ratio of potassium polysorbate 60 and potassium polysorbate 80 is 1:(1-2).

[0024] More preferably, the emulsifier is potassium polysorbate 60 and potassium polysorbate 80, both purchased from Jinan Prahua Chemical Co., Ltd., and the weight ratio of potassium polysorbate 60 and potassium polysorbate 80 is 1:1.

[0025] The antibacterial drug is glycyrrhizin and tea polyphenols, and the weight ratio of glycyrrhizin to tea polyphenols is 1:(1-2).

[0026] More preferably, the antibacterial drug is glycyrrhizin (purchased from Chengdu Pufeed Biotechnology Co., Ltd., JOT-10442) and tea polyphenols (purchased from Sichuan Cuiyirun Biotechnology Co., Ltd., model: CYR-C0015), and the weight ratio of glycyrrhizin to tea polyphenols is 1:1.

[0027] Preferably, the solvent is ethyl acetate and deionized water.

[0028] The outer antibacterial layer is coated with an antibacterial liquid.

[0029] The preparation of the antibacterial solution includes the following steps:

[0030] S1, dissolve the biodegradable polymer in a solvent to obtain mixture A;

[0031] S2, Dissolve the antibacterial drug and emulsifier in deionized water to obtain mixture B;

[0032] S3. Add mixture B to mixture A and mix thoroughly to obtain the antibacterial solution for the outer skin.

[0033] The outer antibacterial layer is prepared by applying an outer antibacterial liquid to the surface of the inner antibacterial layer through a pad-coating process.

[0034] The above technical solution has the following advantages or beneficial effects:

[0035] 1. During the suturing process, the device is cut to the appropriate length. The connecting line between the two outer antibacterial layers is cut in the middle. Then, the connecting line is passed through the needle hole and the device is inserted into the needle hole for needle threading. The flat oval shape of the connecting line makes it easier for the user to thread the needle, effectively reducing the needle threading time and making it more convenient to use.

[0036] 2. After suturing the wound, tie the frenulum at both ends of the suture together to complete the suturing. Tightening the frenulum with smaller frenulum can reduce the volume at the suture connection, making the subsequent overall degradation faster.

[0037] 3. The outer antibacterial layer can resist external bacteria during use. After the outer antibacterial layer degrades, the inner antibacterial layer continues to play the same role, ensuring the initial healing of the wound. The inner toughness layer, reinforcement layer and adhesive layer will strengthen the device, improving the device's antibacterial properties, toughness and strength.

[0038] 4. When the weight ratio of the modified polycaprolactone, polylactic acid, and polyglycolic acid is 1:(0.5-1):(0.2-0.5), the mechanical properties and film-forming properties of the coating can be improved, and it also has good degradation properties. Attached Figure Description

[0039] Embodiments of the invention will be described more fully with reference to the accompanying drawings. However, the drawings are for illustration and explanation only and do not constitute a limitation on the scope of the invention.

[0040] Figure 1 This is a schematic diagram of the structure of a polymer-modified absorbable suture proposed in this invention;

[0041] Figure 2 This is a schematic diagram of the cross-sectional structure of a polymer-modified absorbable suture proposed in this invention;

[0042] Figure 3 This is a schematic diagram of the structure of a polymer-modified absorbable suture connector proposed in this invention;

[0043] Figure 4 This is a schematic diagram of the internal structure of the antibacterial layer of a polymer-modified absorbable suture outer sheath proposed in this invention.

[0044] The above-mentioned reference numerals indicate: outer antibacterial layer 1, connecting line 2, transition block 3, ties 4, drug loading groove 5, inner antibacterial layer 6, toughening layer 7, reinforcing layer 8, adhesive layer 9, and drug layer 10. Detailed Implementation

[0045] 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 are within the scope of protection of the present invention.

[0046] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0047] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the scope of the invention.

[0048] Example 1

[0049] Reference Figure 1-4 A polymer-modified absorbable suture includes an outer antibacterial layer 1, a connecting suture 2, and ties 4. The outer antibacterial layer 1 has an inner antibacterial layer 6, and the inner antibacterial layer 6 has a toughening layer 7. A reinforcing layer 8 is fixedly connected inside the toughening layer 7. The outer antibacterial layer 1 has adapter blocks 3 at both ends, and the connecting suture 2 is located on the side of the adapter block 3 away from the outer antibacterial layer 1. Ties 4 are located at both ends of the connecting suture 2. During suturing, the device is cut to a suitable length, and the connecting suture 2 between the two outer antibacterial layers 1 is cut in the middle. The connecting suture 2 then passes through the needle hole and the connecting device to enter the needle hole for needle insertion. The flat, oval-shaped connecting suture 2 makes it easier for the user to insert the needle, effectively reducing needle insertion time and making it more convenient to use.

[0050] Furthermore, the connecting line 2 is in the shape of a flat ellipse, and is located between two adjacent adapter blocks 3 and is fixedly connected to the adapter blocks 3. The flat ellipse shape of the connecting line 2 makes it easier for users to thread needles, effectively reducing the needle threading time and making it easier to use.

[0051] Furthermore, the tie 4 is located at both ends of the connecting line 2, with two ties at each end of the connecting line 2. The tie 4 is fixedly connected to the connecting line 2. The tie 4 can tighten and close the device after the sewing is completed. Tightening the tie 4 can reduce the volume of the connection point, making the subsequent overall degradation faster.

[0052] Furthermore, the outer antibacterial layer 1 is provided with several drug application grooves 5. The drug application grooves 5 are evenly distributed on the outer antibacterial layer 1 with the outer antibacterial layer 1 as the center. The drug application grooves 5 can increase the application area of ​​the drug on the outer antibacterial layer 1, so as to improve the treatment effect during suturing.

[0053] Furthermore, an adhesive layer 9 is fixedly connected inside the reinforcing layer 8, which increases the overall strength and toughness of the device.

[0054] Furthermore, a drug layer 10 is fixedly connected inside the adhesion layer 9. The drug layer 10 is located at the innermost part of the device. After the external device degrades, the drug carried on the drug layer 10 can assist the complete healing of the wound.

[0055] The outer antibacterial layer 1, connecting line 2, adapter block 3, tie 4, medicine loading tank 5, inner antibacterial layer 6, toughness layer 7, reinforcement layer 8, adhesive layer 9, and drug layer 10 are all made of biodegradable materials and are all commercially available materials.

[0056] Working principle: When using this device, cut it to the required suture length. During cutting, cut one of the connecting lines 2 in the middle. Then, use tweezers to hold the outer antibacterial layer 1 and align the cross-section of the connecting line 2 with the needle hole of the suture needle, so that the connecting line 2 passes through the needle hole, and simultaneously pulls the adapter block 3, the ties 4, and the outer antibacterial layer 1 through the needle hole to complete the threading. After suturing, tie the ties 4 at both ends of the connecting line 2 at one end of the suture with the ties 4 at both ends of the connecting line 2 at the other end of the suture to complete the wound suturing. When the device is in use, the outer antibacterial layer 1 will play a role in resisting external bacteria. After the outer antibacterial layer 1 degrades, the inner antibacterial layer 6 continues to play the same role. After the inner antibacterial layer 6 degrades, the wound completes the initial healing. The inner toughness layer 7, reinforcing layer 8, and adhesive layer 9 will reinforce the device. Finally, the drug contained in the drug layer 10 will ensure the complete healing of the wound.

[0057] The outer antibacterial layer 1 is coated with an antibacterial liquid, the raw materials for which the antibacterial liquid is prepared include: biodegradable polymer, emulsifier, antibacterial drug, and solvent.

[0058] The biodegradable polymer includes modified polycaprolactone, polylactic acid, and polyglycolic acid; the weight ratio of the modified polycaprolactone, polylactic acid, and polyglycolic acid is 1:0.5:0.5.

[0059] The modified polycaprolactone is amino-polyethylene glycol polycaprolactone, with a weight-average molecular weight of 10,000, purchased from Shenzhen MeloPEG Technology Co., Ltd.

[0060] The polylactic acid with a glass transition temperature of 57.8℃ was purchased from Dongguan Yili Plastics Co., Ltd., model: NatureWorks / 4032D.

[0061] The polyglycolic acid with a weight-average molecular weight of 10,000 was purchased from Shandong Xindongneng Chemical Co., Ltd.

[0062] The emulsifiers are potassium polysorbate 60 and potassium polysorbate 80, both purchased from Jinan Prahua Chemical Co., Ltd., and the weight ratio of potassium polysorbate 60 to potassium polysorbate 80 is 1:1.

[0063] The antibacterial drugs are glycyrrhizin (purchased from Chengdu Pufeed Biotechnology Co., Ltd., model: JOT-10442) and tea polyphenols (purchased from Sichuan Cuiyirun Biotechnology Co., Ltd., model: CYR-C0015), and the weight ratio of glycyrrhizin to tea polyphenols is 1:1.

[0064] The solvent is ethyl acetate and deionized water.

[0065] The outer antibacterial layer 1 is coated with an antibacterial liquid.

[0066] The preparation of the antibacterial solution includes the following steps:

[0067] S1, Dissolve 7g of biodegradable polymer in 100mL of ethyl acetate to obtain mixture A;

[0068] S2, Dissolve 0.1g of antibacterial drug and 0.02g of emulsifier in 100mL of deionized water to obtain mixture B;

[0069] S3. Add 10g of mixture B to 70g of mixture A and mix well to obtain the antibacterial solution for the outer skin.

[0070] The outer antibacterial layer 1 is prepared by padding coating process (immersion time 8 min), coating the outer antibacterial liquid onto the surface of the inner antibacterial layer 6, drying at 50°C for 1 h.

[0071] Example 2

[0072] The specific implementation method of this embodiment is the same as that of Embodiment 1, except that the weight ratio of the modified polycaprolactone, polylactic acid, and polyglycolic acid is 1:0.2:0.3.

[0073] Example 3

[0074] The specific implementation method of this embodiment is the same as that of Embodiment 1, except that the antibacterial drug is glycyrrhizin, which was purchased from Chengdu Pufeed Biotechnology Co., Ltd., model: JOT-10442.

[0075] Performance Evaluation

[0076] 1. Mechanical property testing: The antibacterial liquid coating prepared according to Examples 1-3 was used to prepare 80mm × 20mm samples. Tensile properties of the coated samples were tested using an electronic fabric strength tester (YG026T type electronic fabric strength tester). Breaking strength and elongation at break (%) were recorded on the electronic display screen. The sample clamping distance was 50mm, and the lower clamp descent rate was 30.00mm / min. Each sample was tested three times, and the average value was taken. The breaking strength (N / m²) was calculated using the following formula. 2 The sample cross-sectional area is 16 cm². 2 The test results are recorded in Table 1.

[0077] Fracture strength = Fracture force / Cross-sectional area

[0078] 2. Antibacterial performance test

[0079] The antibacterial properties of the antimicrobial solution were evaluated using Staphylococcus aureus and Escherichia coli. First, 1 mL of bacterial suspension was taken from each agar plate using sterilized pipettes on a clean bench and spread evenly with a glass spreader. Then, 5 g of each of the antimicrobial solutions prepared in Examples 1-3 was placed on the agar surface. Finally, the agar plates (10 cm in diameter) were incubated at 37°C for 24 hours, and the diameter of the inhibition zone (cm) was measured. The test results are recorded in Table 1.

[0080] Table 1

[0081]

Claims

1. A polymer-modified absorbable suture, characterized in that: It includes an outer antibacterial layer (1), a connecting line (2) and a tie (4). The outer antibacterial layer (1) has an inner antibacterial layer (6) inside. The inner antibacterial layer (6) has a toughness layer (7) inside. The toughness layer (7) has a reinforcing layer (8) fixedly connected inside. The outer antibacterial layer (1) has a transition block (3) at both ends. The connecting line (2) is provided on the side of the transition block (3) away from the outer antibacterial layer (1). The tie (4) is provided at both the upper and lower ends of the connecting line (2). The outer antibacterial layer (1) is provided with a plurality of drug loading grooves (5), which are evenly distributed on the outer antibacterial layer (1) with the outer antibacterial layer (1) as the center. The outer antibacterial layer (1) is coated with an antibacterial liquid, the raw materials for preparing the antibacterial liquid include: biodegradable polymer, emulsifier, antibacterial drug, and solvent; The biodegradable polymer includes modified polycaprolactone, polylactic acid, and polyglycolic acid; the weight ratio of the modified polycaprolactone, polylactic acid, and polyglycolic acid is 1:(0.5-1):(0.2-0.5).

2. The polymer-modified absorbable suture according to claim 1, characterized in that: The connecting line (2) is in the shape of a flat ellipse, and the connecting line (2) is located between two adjacent transition blocks (3) and is fixedly connected to the transition blocks (3).

3. The polymer-modified absorbable suture according to claim 1, characterized in that: The tie (4) is located at both ends of the connecting line (2), and there are two ties at both ends of the connecting line (2), and the tie (4) is fixedly connected to the connecting line (2).

4. The polymer-modified absorbable suture according to claim 1, characterized in that: An adhesive layer (9) is fixedly connected inside the reinforcing layer (8).

5. The polymer-modified absorbable suture according to claim 4, characterized in that: The adhesive layer (9) has a drug layer (10) fixedly connected inside it.

6. The polymer-modified absorbable suture according to claim 1, characterized in that: The modified polycaprolactone is amino-based polyethylene glycol polycaprolactone.

7. The polymer-modified absorbable suture according to claim 6, characterized in that: The glass transition temperature of the polylactic acid is 50-60℃.

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