Degradable human amniotic membrane and bovine dorsal tendon composite dural repair scaffold and preparation method

A human amniotic membrane and dura mater technology, applied in medical science, prosthesis and other directions, can solve the problems of lax sticking, cerebrospinal fluid leakage, production process, production cost and commodity circulation cost increase, etc. The effect of increasing biosafety and preserving biological properties

Active Publication Date: 2016-06-15
JIANGXI RUIJI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are two clinical treatment methods for dura mater repair: 1. Suture type, using artificial dura mater repair materials (such as "meningeal guard", which is processed from bovine pericardium) to directly suture the defect, and suture it with its own meninges. This method is suitable for small leaks. For patients with acute hypertensive cerebral herniation and encephalocele after decompression, the suturing operation is difficult and the brain tissue is easily damaged during suturing.
2. Adhesive type, using artificial dura mater repair materials (such as collagen sponge) to directly attach to the defect, clinically, the adhesive is not strict, cerebrospinal fluid leaks, and epimeningeal effusion is easy to form
[0012] 1. The combination of small intestinal submucosa (about 0.08mm) and human amniotic membrane (about 0.05mm) is used. The thickness is quite different from that of dura mater, and the suture performance and mechanical properties are poor and cannot meet the requirements of clinical application;
[0013] 2. Attach a layer of cultivated and survived autologous vascular endothelial cells or neonatal umbilical vein endothelial cells on the bovine pericardium or porcine pericardium. These living cells have high requirements for culture, storage conditions and pre-operative preparation, and are inconvenient to use. The production process, production cost and commodity circulation cost of the product are also increased accordingly;
[0014] 3. Collagen sponge is made of animal tendon collagen, but in its production, the collagen is partially hydrolyzed after acid or alkali treatment, the structure of collagen fibers has undergone great changes, and its mechanical properties are not as good as those in the natural state;
[0015] 4. The mechanical properties of synthetic polymer materials can meet the clinical requirements of dura mater repair, but their biological properties, including tissue regeneration and repair, biocompatibility, etc. are not as good as natural polymer materials

Method used

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  • Degradable human amniotic membrane and bovine dorsal tendon composite dural repair scaffold and preparation method
  • Degradable human amniotic membrane and bovine dorsal tendon composite dural repair scaffold and preparation method
  • Degradable human amniotic membrane and bovine dorsal tendon composite dural repair scaffold and preparation method

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preparation example Construction

[0035] A preparation method for a dura mater repair bracket compounded with degradable human amniotic membrane and bovine dorsal tendon, comprising the following steps:

[0036] (1) Preparation of amnion: According to the national standard YZB / National 0593-2005, the amnion is obtained and prepared; in the production of human amnion, the amnion epithelial cells can be retained or the epithelial cells can be removed by enzymatic hydrolysis;

[0037] (2) Preparation of beef back tendon slices: use repeated freezing and thawing to make the cells in the material form ice crystals, increase the salt concentration of the remaining cytosol and cause the cells to swell and break, and change the material and cell surface antigens to significantly reduce the antigen of the biological material sex. Studies have shown that repeated freezing and thawing combined with enzyme treatment of 0.3mm tendon thin slices has a good decellularization effect, collagen will not disintegrate, and the na...

Embodiment 1

[0047] see figure 1 , a degradable dural repair scaffold composed of human amniotic membrane and bovine dorsal tendon, comprising the amnion 100 prepared above and bovine dorsal tendon sheet 200, the epithelial layer of the amniotic membrane 100 is laid down, and then the treated bovine The dorsal tendon sheet 200 is laid on the amniotic membrane 100, and the dura mater repair bracket is obtained by compounding the human amniotic membrane and the bovine dorsal tendon sheet through non-toxic cross-linking.

Embodiment 2

[0049] see figure 2 , a dural repair scaffold composed of degradable human amniotic membrane and bovine dorsal tendon, comprising the amnion 100 prepared above and bovine dorsal tendon sheet 200, the bovine dorsal tendon sheet 200 includes two layers, and the two-layer bovine dorsal tendon sheet 200 according to The tendon collagen fibers are stacked horizontally and vertically, and then the stacked two-layer bovine dorsal tendon sheet 200 is laid on the amniotic membrane 100, and the human amniotic membrane obtained through nontoxic cross-linking and the bovine dorsal tendon sheet are composited Dural repair stents. ( figure 2 There is also a case of adding a layer of amniotic membrane on top,)

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Abstract

The preparation method of the degradable human amniotic membrane and bovine dorsal tendon composite dura mater repair scaffold includes (1) preparing amniotic membrane; (2) preparing bovine dorsal tendon slice; (3) non-toxic crosslinking of amnion and bovine dorsal tendon slice. A dural repair scaffold composited with human amniotic membrane and bovine dorsal tendon sheet, including prepared amniotic membrane and bovine dorsal tendon sheet, and a dural repair scaffold composited with human amniotic membrane and bovine dorsal tendon sheet through non-toxic cross-linking. The amnion processing method conforms to the national standard and can retain the bioactive function of the amnion; the preparation of the bovine dorsal tendon sheet is different from other collagen membrane preparation methods, which not only removes immunogenic substances such as cells and nucleic acids, but also does not destroy the natural bovine dorsal tendon The structure of collagen preserves its mechanical properties and improves its biological safety. After the two kinds of natural collagen membranes are non-toxic cross-linked and freeze-dried, their various properties meet the clinical requirements of dura mater repair.

Description

technical field [0001] The invention relates to a dura mater repair bracket, in particular to a dura mater repair bracket capable of degradable human amniotic membrane and bovine dorsal tendon compounding and a preparation method thereof. Background technique [0002] The dura mater is an important barrier to protect brain tissue. It is a thick and tough double-layer membrane. The outer layer of the dura mater is the periosteum on the inner surface of the skull, which is loosely attached to the calvaria, especially in the occipital and temporal parts, and is called the periosteum layer; the inner layer is thicker and tougher than the outer layer, and is connected with the dura mater in the occipital bone The large hole is continuous and is called the meningeal layer. Trauma, tumor erosion, and surgery can cause dural defects, which must be repaired to prevent complications such as cerebrospinal fluid leakage, intracranial infection, and epilepsy caused by cerebral cortical ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/36
Inventor 苗春云傅筱冲滕志强熊贞燕贺雅琳
Owner JIANGXI RUIJI BIOTECH CO LTD
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