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Fine particle tissue hydraulic fill for injection and preparation method thereof

A technology of particulate tissue and filling material, applied in the field of medical biomaterials, can solve the problems of limited material source, delayed allergic reaction, insufficient material source, etc., achieve high biocompatibility, promote wound healing, and facilitate storage and transportation.

Active Publication Date: 2009-02-18
SHAANXI RUISHENG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current product types are: (1) Synthetic polymer materials, Artecoll (produced by Rofil Medical Products Company in the Netherlands) uses collagen solution as a carrier to suspend polymethyl methacrylate (PMMA) round smooth microspheres Among them; its main disadvantage is that because PMMA is non-degradable and remains in the human body for a long time, it affects the normal physiological activities of the skin, and there is a risk of carcinogenesis
(2) Collagen, Zyderm product (manufactured by McGhanMedical Company) is the first injection plastic cosmetic material approved by the U.S. FDA in 1981. Collagen is extracted from cattle as a raw material, and its effect can be maintained for about 6 months; its disadvantages are , 30 days before the injection, a skin test is required, and repeated injections are required. After the injection, the skin has immediate allergies, delayed allergic reactions, and systemic discomfort.
Dermalogen (produced by Collagenesis) and Cosmoderm (produced by Mcghan Medical) are injectable allogeneic skin collagen fibers and collagen tissue matrix suspension products approved by the U.S. FDA; these materials are all composed of collagen and elastic fibers, dextran, The long-term effect is poor, and the source of materials is also insufficient
(3) Allogeneic acellular dermis products are materials formed by removing the epidermis of human skin, decellularized and freeze-dried; such products include Alloderm produced by Life Cell, which is the first allogeneic acellular dermis approved by the US FDA product; the company manufactures Cymetra, a micronized injectable allogeneic acellular dermal product that acts as a filler material; the main disadvantages of this type of product are limited sources of material and the use of sodium lauryl sulfate in the decellularization process , disodium edetate and other chemicals are not only difficult to completely remove, but also cause toxicity to the body; more importantly, it is difficult to control the distribution of Cymetra after injection into the body, and it cannot be shaped

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0014] Step 1). Preparation of micronized decellularized bio-derived materials: cut the pig skin from which the fat layer has been removed into 1cm×2cm blocks, wash with phosphate buffer and freeze at -80°C for 40 minutes to bring the inside and outside temperature of the pig skin After being taken out, thaw naturally at room temperature. Repeated freezing and thawing 4 times to completely rupture and disintegrate the cells; wash with deionized water and soak it in 1M NaOH solution for 4 hours; then soak it with PBS solution until The pH value is about 7.2. Soak it in 40 units / ml DNA enzyme solution for 1 hour. After washing, it will be freeze-dried to become decellularized pig skin; it is pulverized into fine particles with a high-speed cutter and sieved to a particle size of 100-300μm The size is made into a micronized decellularized pig skin material. The temperature of the entire operation is maintained at 2-8°C, and finally it is sterilized by irradiation with cobalt 60.

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example 2

[0019] Step 1). Preparation of micronized decellularized biologically-derived materials: the pig small intestine is mechanically scraped off the mucosal layer, muscle layer and serosa to obtain the small intestinal submucosa (SIS), which is cut into 1cm×1cm slices, and phosphate is used After washing with buffer solution, place it at -80℃ and freeze for 35 minutes. After the internal and external temperature of the SIS reach the same temperature, it will be naturally thawed at room temperature. Repeat freezing and thawing twice to completely rupture and disintegrate the cells; wash with deionized water and place at 0.5 Soak in M ​​NaOH solution for 1 hour; then soak with PBS solution to pH 7.0, place it in 50 units / ml DNase solution for half an hour, wash and freeze-dry to become decellularized small intestinal submucosa material; Use a high-speed rotary pulverizer (Fritsch, Germany) to pulverize into particles (add liquid nitrogen before pulverization to make them embrittled), si...

example 3

[0023] Step 1). Preparation of micronized decellularized biological-derived material: mechanically scrape the pig bladder to obtain the submucosal layer, muscle layer and serosal layer, cut into 1cm×1cm slices, and use phosphate buffer solution After washing, place it at -80℃ and freeze for 30 minutes. After the internal and external temperature of the material is consistent, it will be naturally thawed at room temperature. Repeated freezing and thawing three times to completely rupture and disintegrate the cells; wash with deionized water and place in 0.5M Soak in NaOH solution for 2 hours; then soak with PBS solution to pH 7.1, place it in 40 units / ml DNase solution for 40 minutes, wash and freeze-dry to become decellularized bladder submucosa material; then use high speed Rotary pulverizer pulverized into particles (add liquid nitrogen before pulverization to make them embrittled), sieved to a particle size of 100-200μm, and prepared into a micronized decellularized bladder sub...

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Abstract

The invention discloses an injectable filling material of particle tissues, wherein particulate acellular bio-derived materials are mixed with drug-containing release microspheres, after the filling material is evenly mixed with a gel solution before use, the filling material is injected into a recipient site, an operator can arbitrarily model the particle tissue before gel is solidified according to the condition of the recipient site so as to achieve a satisfactory cosmetic effect. The particle tissue material which can be moulded rapidly is implanted in the body to fill defective soft tissues and promote wound healing. Compared with the prior art, the injectable filling material of the particle tissues has high biocompatibility, and is capable of rapid arbitrarily modeling and rapid filling the defect of tissue organs, and can promote fibroblast ingrowth, the formation of new capillary, generation of granulation tissue and wound healing. The injectable filling material of the particle tissues has the following clinical functions that the injectable filling material can be used as a filler of defective soft tissues which is used for repairing body depression deformity; for filling wrinkles or ruga of skins; and for demands of cosmetic surgeries, such as soft tissue arthroplasty and so on.

Description

Technical field [0001] The invention belongs to the technical field of medical biological materials, and in particular relates to an injectable particulate tissue filling material capable of rapid shaping and a preparation method thereof. Background technique [0002] The emergence of injectable soft tissue filling materials is to meet the needs of patients and cosmetic doctors for minimally invasive surgery in the field of plastic surgery, and it is also one of the current trends in the development of plastic surgery clinical technology. The application of injectable plastic and cosmetic surgery materials can abandon traditional plastic surgery techniques for clinical application of tissue repair, deformity correction and facial rejuvenation. [0003] The current product types are: (1) Synthetic polymer materials, Artecoll (Artecoll, manufactured by Rofil Medical Products Company, Netherlands) uses collagen solution as a carrier to suspend polymethylmethacrylate (PMMA) round smo...

Claims

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Application Information

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IPC IPC(8): A61L27/40A61L27/26A61L27/52A61L27/54A61L27/50
Inventor 王爱军
Owner SHAANXI RUISHENG BIOTECH
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