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Sleeve patch and preparation method thereof

A technology of rotator cuff and patch, which is applied in the field of rotator cuff patch and its preparation, can solve the problems of inability to obtain mechanical strength, prone to failure of repaired parts, and inability to reproduce tendon-bone healing, etc., and achieve the goal of reducing cost and logistics complexity Effect

Pending Publication Date: 2022-05-06
SHANGHAI P & P BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the repair of rotator cuff tears mainly uses anchors with wires to fix the tendon to the bone end, and its limitations can be summarized into three categories: (1) The normal healing process of the tendon cannot be reproduced, and the tissue formed after repair is mainly composed of fibrovascular scar tissue composition
(2) Four areas where tendon-bone healing cannot be reproduced at the interface (starting point) where the tendon attaches to the bone tissue
The mechanical properties of the fibrovascular scar tissue formed at the repaired interface differ from normal tendon structures, making the repair site prone to failure
(3) Sufficient mechanical strength cannot be obtained after repair
[0010] Julie E reported the results of dog animal experiments using human skin acellular matrix, although the maximum force at 3 months (538.6N) and 6 months (552.4N) after surgery was 8 times higher than that immediately after surgery (65.5N). -9 fold, however, only recovered to 58-60% of the normal control (918.7N)
[0011] None of the current meshes are ideal for the repair of rotator cuff tears, so research on implants with better results for the treatment of rotator cuff tears remains to be done

Method used

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  • Sleeve patch and preparation method thereof
  • Sleeve patch and preparation method thereof
  • Sleeve patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] The present embodiment provides a kind of rotator cuff patch, and its preparation method is as follows:

[0072] (1) Dissolving PLCL in hexafluoroisopropanol to form a PLCL solution with a concentration of 8g / 100mL;

[0073] Dissolve the fibrinogen complex (hereinafter referred to as F-Fg) in distilled water to form a F-Fg solution, and its component concentrations are as follows: fibrinogen (Fg) 12.61g / 100mL, arginine hydrochloride 3.29g / 100mL, sodium chloride 3.27g / 100mL and sodium citrate 9.83g / 100mL;

[0074] (2) The PLCL solution and the F-Fg solution were stirred and mixed for 5 hours at a volume ratio of 0.77:0.23 to form a mixed electrospinning solution, wherein the mass ratio of F-Fg to PLCL was 1.08:1;

[0075] (3) Transfer the mixed solution to the liquid carrier device of a mass-produced electrospinning machine (model: NS1WS 500Elmarco Czech Republic) for electrospinning. The process conditions are: voltage difference 100kV, electrospinning solution flow r...

Embodiment 2-5

[0077] Examples 2-5 each provide a rotator cuff patch, the difference between the preparation method and Example 1 is that the concentration of F-Fg in the mixed electrospinning solution and the mass ratio of F-Fg to PLCL are different, as shown in the following table 1.

[0078] Table 1

[0079]

[0080]

[0081] physical characterization

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Abstract

The invention provides a rotator cuff patch and a preparation method thereof. The rotator cuff patch has a three-dimensional nano net structure and is prepared from raw materials containing a fibrinogen compound and polylactic acid-caprolactone. The rotator cuff patch is prepared by adding a fibrinogen compound solution and a polylactic acid-caprolactone solution into the same volume tube of an electrostatic spinning machine, or respectively adding the fibrinogen compound solution and the polylactic acid-caprolactone solution into different volume tubes of the electrostatic spinning machine, carrying out electrostatic spinning, and then drying. The rotator cuff patch provided by the invention has a nanoscale three-dimensional structure similar to an extracellular matrix and good hydrophilicity; the tendon can be formed in the shoulder joint cavity after being implanted for about 6 weeks, and the tendon and the shoulder joint bone tissue form tendon-bone healing; about 24 weeks after implantation, the maximum force of the regenerated rotator cuff tissue is recovered to 95-100% of that of the normal side. The rotator cuff patch can be used for bridging or strengthening treatment of large and ultra-large rotator cuff tissue tearing.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and in particular relates to a rotator cuff patch and a preparation method thereof. Background technique [0002] Shoulder stability and function depend heavily on the integrity of the rotator cuff muscles. Acute rotator cuff tears are common in athletes, and chronic degenerative tendon changes and subsequent tears are common in older and sedentary patients. The frequency and size of rotator cuff tears increase with age. Rotator cuff injuries are not easy to heal on their own, which is related to the complex anatomical structure of the shoulder joint, large range of motion, relative weakening of tendons and low vascularization. Untreated partial rotator cuff tears, whether traumatic or degenerative, can develop into large and very large tears. It is manifested as local pain and inhibition of muscle movement reflexes, decreased exercise capacity, and even endangers daily activities. As...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/50A61L27/22A61L27/18A61L27/54A61L27/56D04H1/728D04H1/42
CPCA61L27/50A61L27/225A61L27/18A61L27/54A61L27/56D04H1/728D04H1/42A61L2430/10A61L2400/12A61L2300/404A61L2300/41C08L67/04
Inventor 何红兵尹荣鑫周星宇杨莉苏岭闫侃
Owner SHANGHAI P & P BIOTECH
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