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Acellular biological dermal material, and preparation method and application thereof

A decellularized and biological technology, applied in the field of decellularized dermal materials and their preparation, can solve the problems of shortage of tissue sources, high price, application limitations, etc., and achieve the effects of low cost, easy operation, good toughness and strength

Active Publication Date: 2017-04-19
浙江华臻医疗器械有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The source of human dermal tissue has huge ethical controversy, and it is often necessary to pay a considerable amount of compensation to related organizations or the family members of the donor. Therefore, products using human skin materials will increasingly face a series of shortages of tissue sources and high prices. disadvantage
At present, ADM products derived from porcine dermal tissue are launched in China, but due to the fact that the immunogenicity of heterogeneous ADM tissue is significantly higher than that of the same species, the application is obviously limited

Method used

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  • Acellular biological dermal material, and preparation method and application thereof
  • Acellular biological dermal material, and preparation method and application thereof
  • Acellular biological dermal material, and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0044] Example 1: Preparation of decellularized biological dermis material.

[0045] The full-thickness skin of the flank wall and back of a healthy adult pig was taken, cleaned and disinfected, cut into an appropriate size, disinfected and rinsed with 10mM Tris-Hcl containing 0.5wt% sodium phosphate and pH 7.2 aqueous solution, and then heated at 37°C with 0.02wt% EDTA and 0.15wt% trypsin (product number T4799 | CAS No. 9002-07-7 | SIGMA) and pH 7.4 sodium phosphate buffer soaked for 24 hours, the skin piece was taken out, and added with 0.5wt % sodium phosphate 10mM Tris-HCl and pH 7.2 aqueous solution for washing. With ionic detergent 0.1wt% TritonX-200 and 0.03wt% sodium lauryl sulfate and pH is 7.2 sodium phosphate buffer solution room temperature vibration soaking for 20 hours, further with 10mM Tris-HCl added with 0.5wt% sodium phosphate And the pH is 7.2 aqueous solution washing. Treat with 680U / L neutral protease (Dispase II product number: 04942078001|Roche) in 10m...

Embodiment 2

[0046] Example 2: Preparation of decellularized biological dermis material.

[0047] Take the full-thickness skin of the flank wall and back of a healthy adult pig, cut it into an appropriate size after cleaning and disinfection, disinfect and rinse it with 10mM Tris-Hcl containing 0.9wt% sodium chloride and a pH of 6.7 aqueous solution, and then heat it at 30°C. There are 0.03wt% EDTA and 0.3wt% trypsin (product number T4799 | CAS No. 9002-07-7 | SIGMA) and pH is 6.5 sodium phosphate buffer solution for 12 hours, the skin piece is taken out, and added with 0.9 Wash with 10 mM Tris-Hcl of wt% sodium chloride and pH 6.7. With 0.03wt% TritonX-200 and 0.08wt% sodium lauryl sulphate of ionic scale remover and pH is the sodium phosphate buffer of 6.7 and soaks for 18 hours at room temperature shaking, further adds 10mM Tris- with the sodium chloride of 0.9wt% Wash with Hcl and pH 6.7 aqueous solution. Add the 10mM Tris-Hcl of the sodium chloride of 0.9wt% with the dispase (Dispas...

Embodiment 3

[0048] Example 3: Preparation of decellularized biological dermis material.

[0049] The full-thickness skin of the flank wall and back of a healthy adult pig was taken, cleaned and disinfected, cut into an appropriate size, disinfected and rinsed with 10mM Tris-Hcl containing 0.7wt% sodium chloride and pH 7.8 aqueous solution, and then heated at 34°C There are 0.03wt% EDTA and 0.2wt% trypsin (product number T4799 | CAS No. 9002-07-7 | SIGMA) and pH is 7.8 Sodium phosphate buffer soaking treatment for 18 hours, the skin piece was taken out, and added with 0.7 The 10mM Tris-Hcl of wt% sodium chloride and the pH is 7.8 aqueous solution rinses. Sodium phosphate buffer solution with 0.03wt% TritonX-200 and 0.03wt% sodium lauryl sulfate and pH of 0.03wt% TritonX-200 ion scale remover and pH is soaked at room temperature for 24 hours, and further added with 10mM Tris- Wash with Hcl and pH 7.8 aqueous solution. Use 600U / L neutral protease (Dispase II product number: 04942078001|Roc...

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Abstract

The invention discloses a preparation method of an acellular biological dermal material. The method comprises the following steps: 1, processing pigskins with an EDTA-containing trypsin solution, flushing the processed pigskins, immersing and vibrating the flushed pigskins in a scale remover solution, and flushing the immersed pigskins; 2, processing the above obtained processed material with a neutral protease solution, flushing the processed material, immersing and vibrating the flushed material in the scale remover solution, and flushing the immersed material; and 3, carrying out step 1 and step 2 1-3 times, processing the processed material with an alpha-1,3-galactosidase solution, and flushing the material to obtain the acellular biological dermal material. The acellular biological dermal material which is prepared after a series of physical and chemical treatments in the invention has the characteristics of safety, no toxicity, decellularization, no alpha-1,3-galactosidase and no immunogenicity, reserves the structure of natural collagen, has very good toughness and strength, can be used as an implantable biological tissue material in the fields of surgery, shaping, hernia restoration, abdominal cavity restoration and pelvic cavity restoration, and also can be used for restoring skin wounds.

Description

technical field [0001] The invention relates to bio-skin materials and implanted bio-materials in the fields of surgery, plastic surgery, hernia repair, abdominal cavity repair, pelvic cavity repair, etc., in particular to a decellularized dermis material and its preparation method and application. Background technique [0002] Biomaterials have been increasingly widely used in clinical practice in the world, but at present, my country's research and development work in this area is still lagging behind. There is a huge demand for absorbable medical devices made of biomaterials. However, the skin is the largest tissue and organ of the human body and is the outer barrier of the human body. The integrity of the skin plays an important role in human beings. Burns (wounds) and other reasons cause large-area skin defects, which can lead to serious dysfunction of the human body, even life-threatening. At present, the most effective method for repairing skin defects is autologous ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/60A61L27/36
CPCA61L27/362A61L27/3687A61L27/60A61L2430/02A61L2430/12A61L2430/40
Inventor 周鹤赵子建孙雪丽史啟潘璐琪
Owner 浙江华臻医疗器械有限公司
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