Fine particle tissue filling material 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 insufficient material source, limited material source, delayed allergic reaction, etc., and achieve the effect of easy storage and transportation, high biocompatibility, and promotion of injury healing.

Active Publication Date: 2013-06-05
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 acellular biologically derived material: Cut the pig skin with the fat layer removed into 1cm×2cm blocks, wash with phosphate buffer and freeze at -80°C for 40 minutes to keep the temperature inside and outside the pigskin After reaching the consistency, take it out and thaw it naturally at room temperature, and repeat the freezing and thawing 4 times so that the cells are completely broken and disintegrated; after washing with deionized water, soak it in 1M NaOH solution for 4 hours; then soak it in PBS until The pH value is about 7.2, soak it in 40 units / ml DNase solution for 1 hour, and then freeze-dry it to become decellularized pigskin; use a high-speed cutting machine to crush it into particles, and sieve it to a particle size of 100-300 μm The size is made into micronized decellularized pigskin material, the temperature is kept at 2-8°C throughout the operation, and finally sterilized by irradiation with cobalt 60.

[0015] Step...

example 2

[0019] Step 1). Preparation of micronized decellularized biologically derived materials: the small intestine submucosa (SIS) was obtained by mechanically scraping off the mucosal layer, muscle layer and serosa of the pig small intestine, cut into 1cm×1cm slices, and treated with phosphate After washing with the buffer solution, freeze at -80°C for 35 minutes to make the internal and external temperatures of the SIS consistent, then thaw naturally at room temperature, and repeat the freezing and thawing process twice to completely rupture and disintegrate the cells; wash with deionized water and place in 0.5 Soak in NaOH solution of M for 1 hour; then soak it with PBS solution until the pH value is about 7.0, put it in 50 units / ml DNase solution and soak it for half an hour, and then freeze-dry it to become the decellularized small intestinal submucosa material; Use a high-speed rotary pulverizer (German Fritsch company) to pulverize into particles (add liquid nitrogen to make i...

example 3

[0023] Step 1). Preparation of micronized acellular biologically derived material: Scrape off the mucosal layer, muscle layer and serosal layer of the porcine bladder mechanically to obtain the submucosa material, cut into 1cm×1cm slices, and wash with phosphate buffer saline After cleaning, freeze at -80°C for 30 minutes to make the internal and external temperatures of the material consistent, then thaw naturally at room temperature, and repeat the freezing and thawing process 3 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 in PBS solution until the pH value is about 7.1, put it in 40 units / ml DNase solution and soak for 40 minutes, and then freeze-dry to become the decellularized bladder submucosa material; Grinding into particles with a rotary pulverizer (adding liquid nitrogen to make them embrittled before crushing), sieving to a particle size of 100-200 μm, and preparing mi...

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PUM

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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 biomaterials, and in particular relates to a rapidly prototyping injectable particulate tissue filling material 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 patients for minimally invasive surgical techniques in the field of plastic surgery, and it is also one of the current trends in the development of clinical techniques in plastic surgery. The application of injectable cosmetic plastic surgery materials can abandon the 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 (produced by Rofil Medical Products Company in the Netherlands) uses collagen solution as a carrier to suspend polymethyl methacrylate (PMMA) round smo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/40A61L27/26A61L27/52A61L27/54A61L27/50
Inventor 王爱军
Owner SHAANXI RUISHENG BIOTECH
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