Composite rotator cuff patch and preparation method therefor

Abstract

Disclosed in the present application are a composite rotator cuff patch and a preparation method therefor. The composite rotator cuff patch is divided into an electrospun layer and a collagen layer. An electrospun nanofiber membrane is coated with a layer of cross-linked collagen gel, and then composite freeze-drying is carried out to obtain the composite rotator cuff patch of the present application. The rotator cuff patch has good biocompatibility and proper tissue adhesion, does not require sutures for fixation, can be degraded in vivo, and, as the degradation time of the patch is close to the repair time of the rotator cuff, does not require postoperative removal.

Description

Composite rotator cuff patch and preparation method thereof Technical Field

[0001] The present invention relates to the field of biomedical materials, in particular to a double-layer composite rotator cuff patch. Background Art

[0002] A rotator cuff tear is a tear in the rotator cuff tendon. Symptoms of a rotator cuff tear include shoulder pain, weakness, and limited mobility. It is common in middle-aged and elderly individuals and those with shoulder trauma, accounting for approximately 30% of shoulder disorders and about 40% of those over 60. Spontaneous healing is highly unlikely, and while most rotator cuff tears can be alleviated with conservative treatment, severe rotator cuff tears require surgery. Rotator cuff patches can be used during rotator cuff surgery, providing a layer of collagen over the injured tendon to reduce rotator cuff pain and promote limb recovery.

[0003] Currently, rotator cuff patches include collagen-based patches, acellular matrix patches, three-dimensional parallel collagen fiber-silk scaffold patches, electrospinning patches, woven structure patches, and three-dimensional patches. Collagen materials can provide a space for cell adhesion, but their poor mechanical properties and short degradation time limit their clinical application.

[0004] An ideal rotator cuff patch possesses excellent biocompatibility and suitable tissue adhesion, requiring no suture fixation and providing a limited degree of tissue adhesion prevention. It can completely cover the wound surface, maintaining a similar recovery time to the rotator cuff, remaining in place long enough to fully function as a barrier, and being biodegradable and resorbable, eliminating the need for secondary surgical removal. It can also aid in tissue repair and provide hemostasis and analgesia. Technical issues

[0005] In view of the shortcomings of the single-layer patch in the current prior art, the purpose of the present invention is to provide a double-layer composite collagen sponge rotator cuff patch and a preparation method thereof. Technical Solutions

[0006] The technical solutions of the present invention are as follows:

[0007] A composite rotator cuff patch comprises an electrospinning layer and a collagen layer.

[0008] Furthermore, the electrospinning layer is formed by electrospinning poly(L-lactic acid) and chitosan together, and can slowly release chitosan.

[0009] Furthermore, the electrospinning layer has a thickness of 0.01-0.03 mm and a pore size of 50-250 μm.

[0010] Preferably, the pore size of the electrospinning layer is 100-200 μm.

[0011] Furthermore, the collagen layer has a thickness of 2-4 mm and a porosity of 60-99%.

[0012] Preferably, the porosity of the collagen is 70-80%.

[0013] Furthermore, the collagen layer serves as a drug carrier.

[0014] Furthermore, the drug is ibuprofen.

[0015] The present invention also provides a method for preparing the composite rotator cuff patch, comprising the following steps:

[0016] (1) Dissolve L-polylactic acid and chitosan in trifluoroacetic acid to obtain an electrospinning solution with a final concentration ratio of 2 to 6:1. The electrospinning process was as follows: needle No. 20, electrostatic high voltage 20 kV, propulsion speed 0.2 mm / min, receiving distance 20 cm, and spinning time 90 min.

[0017] (2) Mix the cross-linked collagen gel with ibuprofen (1%-2%) and apply it to the electrospun layer to a thickness of 2 mm. Apply the collagen evenly and then freeze-dry the composite. Freeze-drying process: cool at -40-5°C for 2-6 hours, pre-cool at -40-15°C for 1-3 hours, and vacuum dry at -20-5°C for 20-100 hours.

[0018] (3) The composite film material obtained by freeze-drying is packaged and then irradiated for sterilization to finally obtain a composite rotator cuff patch. Beneficial effects

[0019] The beneficial effects of the present invention are:

[0020] (1) The electrospun layer in the rotator cuff patch is a nanofiber membrane electrospun from chitosan and poly(L-lactic acid) dissolved in a certain proportion in the same solvent. Chitosan has a good hemostatic effect, while poly(L-lactic acid) has high mechanical strength and a long degradation time, which is close to the rotator cuff repair time. It can also prevent adhesion of the affected tissue after surgery and fully exert its barrier function.

[0021] (2) The collagen in the rotator cuff patch's collagen layer is extracted from pig skin and is type I collagen. After cross-linking, the mechanical strength of the collagen layer is increased, and its degradation rate is close to the rotator cuff repair time. Collagen has a good adhesion effect on tissue and can induce tissue regeneration. The rotator cuff patch can be directly attached to the affected area, eliminating the need for suturing.

[0022] (3) The collagen layer in the rotator cuff patch contains ibuprofen, which has a good analgesic effect and can relieve patients' postoperative pain. The collagen in the rotator cuff patch is extracted from pig skin. The collagen is sterilized, degreased, and cross-linked to prepare the collagen layer of the rotator cuff patch. Best Mode for Carrying Out the Invention

[0023] Example 1

[0024] A method for preparing a composite rotator cuff patch comprises the following steps:

[0025] (1) Poly(L-lactic acid) and chitosan were dissolved in trifluoroacetic acid to obtain electrospinning solutions with final concentrations of 100 g / L and 50 g / L, respectively. The electrospinning process was as follows: needle No. 20, electrostatic high voltage 20 kV, propulsion speed 0.2 mm / min, receiving distance 20 cm, and spinning time 90 min.

[0026] (2) The cross-linked collagen gel was mixed with ibuprofen (1%-2%) and applied to the electrospun layer to a thickness of 2 mm. After the collagen was applied evenly, the composite was freeze-dried. The freeze-drying process was as follows: cooling at -40-5°C for 2-6 hours, pre-cooling at -40-15°C for 1-3 hours, and vacuum drying at -20-5°C for 20-100 hours.

[0027] (3) The freeze-dried composite film material is packaged and then irradiated for sterilization to obtain a composite rotator cuff patch. Modes for Carrying Out the Invention

[0028] Example 2

[0029] A method for preparing a composite rotator cuff patch comprises the following steps:

[0030] (1) Poly(L-lactic acid) and chitosan were dissolved in trifluoroacetic acid to obtain electrospinning solutions with final concentrations of 200 g / L and 50 g / L, respectively. The electrospinning process was as follows: needle No. 20, electrostatic high voltage 20 kV, propulsion speed 0.2 mm / min, receiving distance 20 cm, and spinning time 90 min.

[0031] (2) The cross-linked collagen gel was mixed with ibuprofen (1%-2%) and applied to the electrospun layer to a thickness of 2 mm. After the collagen was applied evenly, the composite was freeze-dried. The freeze-drying process was as follows: cooling at -40-5°C for 2-6 hours, pre-cooling at -40-15°C for 1-3 hours, and vacuum drying at -20-5°C for 20-100 hours.

[0032] (3) The freeze-dried composite film material is packaged and then irradiated for sterilization to obtain a composite rotator cuff patch.

[0033] Example 3

[0034] A method for preparing a composite rotator cuff patch comprises the following steps:

[0035] (1) Poly(L-lactic acid) and chitosan were dissolved in trifluoroacetic acid to obtain electrospinning solutions with final concentrations of 300 g / L and 50 g / L, respectively. The electrospinning process was as follows: needle No. 20, electrostatic high voltage 20 kV, propulsion speed 0.2 mm / min, receiving distance 20 cm, and spinning time 90 min.

[0036] (2) The cross-linked collagen gel was mixed with ibuprofen (1%-2%) and applied to the electrospun layer to a thickness of 2 mm. After the collagen was applied evenly, the composite was freeze-dried. The freeze-drying process was as follows: cooling at -40-5°C for 2-6 hours, pre-cooling at -40-15°C for 1-3 hours, and vacuum drying at -20-5°C for 20-100 hours.

[0037] (3) The freeze-dried composite film material is packaged and then irradiated for sterilization to obtain a composite rotator cuff patch. Industrial Applicability

[0038] The composite rotator cuff patch provided by the present invention has good biocompatibility and suitable tissue adhesion, does not require suturing and fixation, can be degraded in the body, and the degradation time is close to the rotator cuff repair time. It does not need to be removed after surgery and can be widely used in surgical operations.

Claims

1. A composite rotator cuff patch, characterized in that, the rotator cuff patch includes an electrospun layer and a collagen layer.

2. The composite rotator cuff patch according to claim 1, characterized in that, the electrospun layer is formed by co-electrospinning of poly(L-lactic acid) and chitosan, and can slowly release chitosan.

3. The composite rotator cuff patch according to claim 1, characterized in that, the electrospun layer has a thickness of 0.01 - 0.03 mm and a pore size of 50 - 250 μm.

4. The composite rotator cuff patch according to claim 3, characterized in that, the pore size of the electrospun layer is preferably 100 - 200 μm.

5. The composite rotator cuff patch according to claim 1, characterized in that, the collagen layer has a thickness of 2 - 4 mm and a porosity of 60 - 99%.

6. The composite rotator cuff patch according to claim 5, characterized in that, the porosity of the collagen is preferably 70 - 80%.

7. The composite rotator cuff patch according to claim 1, characterized in that, the collagen layer serves as a drug carrier.

8. The composite rotator cuff patch according to claim 1, characterized in that, the drug is ibuprofen.

9. A preparation method of the composite rotator cuff patch according to any one of claims 1 - 7, characterized in that, it includes the following steps: (1) Dissolve poly(L-lactic acid) and chitosan in trifluoroacetic acid to obtain an electrospinning solution with a final concentration ratio of 2 - 6:

1. Electrospinning process: 20-gauge needle, 20 kV electrostatic high voltage, 0.2 mm / min propulsion speed, 20 cm receiving distance, 90 min spinning time; (2) Mix the cross-linked collagen gel with ibuprofen (1% - 2%) evenly, apply it to the electrospun layer, the collagen thickness is 2 mm, and perform composite freeze-drying after leveling. Freeze-drying process: sequentially cool at -40 - 5 °C for 2 - 6 h, pre-cool at -40 - -15 °C for 1 - 3 h, and vacuum dry at -20 - 5 °C for 20 - 100 h; (3) The composite membrane material obtained by freeze-drying is irradiated and sterilized after packaging to finally obtain the composite rotator cuff patch.