A periosteal patch for guided bone regeneration, preparation method and application

A technology for guiding bone regeneration and patching, which is used in tissue regeneration, prosthesis, medical science, etc. It can solve problems such as tissue infection, excessive acidity, and difficult self-healing of bone defects, and achieve tissue protection, high porosity, and high porosity. The effect of increasing the repair speed

Active Publication Date: 2020-09-29
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, once the periosteum loss cannot be restored, the bone defect will be difficult to heal itself
[0003] The currently reported periosteum repair materials all have deficiencies. The use of acellular matrix materials has greater matrix damage, excessive DNA residues, incomplete removal of immunogenicity, and easy to cause immune rejection; chitosan, silk fibroin and other natural Biomaterials mostly use electrospinning technology to construct three-dimensional structures, which cannot achieve the porous network effect of natural extracellular matrix; artificially synthesized degradable polymer materials will cause local acidity to be too strong during the degradation process, which can easily cause inflammatory reactions; and collagen The protein film has insufficient mechanical strength and degrades too quickly. The use of chemical cross-linking agents will cause tissue infection, inflammation, and fiber wrapping; or growth factors such as BMP, VEGF, and bFGF need to be added to the matrix to improve the ability of the material to induce tissue regeneration.
Therefore, there is still no good periosteum repair material, which can not only play a barrier role, but also effectively isolate the bone injury site from the surrounding tissue, prevent the fibroblasts in the surrounding tissue from invading the bone injury site and the prolapse of the bone graft material, and can Guide the regeneration and repair of periosteal tissue, form vascularized tissue, provide nutrients and oxygen for bone regeneration, and provide a growth microenvironment for osteoblasts and mesenchymal stem cells to rebuild bone tissue

Method used

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  • A periosteal patch for guided bone regeneration, preparation method and application
  • A periosteal patch for guided bone regeneration, preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] A periosteal patch for guided bone regeneration, prepared as follows:

[0051] (1) Organization pre-processing:

[0052] Get small intestinal submucosa tissue material (for example, it can be porcine small intestinal submucosa SIS, or bovine small intestinal submucosa, all applicable to the embodiment of the present invention) and divide it into specified sizes, remove useless tissues (such as lymphatic tissue), wash with water, and then The cleaned small intestinal submucosa tissue material is placed on a water filter device such as a sieve, allowed to stand for more than five minutes, and the water is drained.

[0053] (2) Virus inactivation:

[0054] Use peracetic acid-ethanol solution to soak the small intestinal submucosa tissue material. This process can be carried out in a stainless steel bucket. The concentration of peracetic acid is 0.1% by volume, and ethanol is 5% by volume. The inactivation time is 2 hours. The solution is mixed with the small intestinal mu...

Embodiment 2

[0070] The preparation method of the present invention may further comprise the following steps:

[0071] (11) Packaging

[0072] After the dried product is taken out, it is cut on the mold and packed in a double-layer Tyvek packaging bag. This process requires aseptic transfer and operation.

[0073] (12) Sterilization analysis: the product is sterilized by ethylene oxide, sterilization conditions: temperature 40°C, holding time 4h, humidity 70%, concentration 500mg / L, sterilization time 6h; analysis process: ventilated analysis room , the temperature is controlled between 20°C, and the time is about 14 days.

[0074] Depend on figure 1 It can be seen that the periosteal patch for guided bone regeneration includes two parts: a freeze-dried loose part 1 and a dried dense part 2 . Freeze-dried loose fraction 1 includes lyophilized particles of small intestinal submucosa, and includes bone morphogenetic protein; while dense fraction 2 includes one or more layers of small inte...

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Abstract

Disclosed are a periosteal repair sheet for guided bone regeneration, a preparation method and the use. The periosteal repair sheet comprises a high-porosity loose active layer and a low-porosity dense basal layer, collagen, polysaccharide substances and active factors; the loose active layer further comprises active factors for guided bone regeneration; and the periosteal repair sheet, when implanted into the body, can be degraded and absorbed. The preparation method and use thereof are also addressed. The repair sheet, forming a dual-layer composite structure with a loose upper layer and a dense lower layer, is conducive to growth-in of cells, and is capable of improving the repair speed of tissues; the dense layer is an immunogen-removed substrate, and the substrate layer has an isolating effect, effectively protecting the repaired tissues; and a morphogenetic bone protein is added for the repair of periosteal injuries and defects.

Description

technical field [0001] The invention relates to the field of medical biomaterials, and specifically relates to a periosteal patch for repairing periosteal damage or defect caused by trauma, fracture, tumor, etc., or implanting with bone graft materials to prevent material prolapse, a preparation method and application. Background technique [0002] Fractures, nonunions, delayed unions, and bone defects caused by aging, trauma, and tumors are common orthopedic diseases in clinical practice. The treatment research focuses on bone graft materials, while ignoring the importance of periosteum repair. In fact, the periosteum is rich in microvessels that can restore blood supply to bone tissue, thereby promoting the healing of bone defects and increasing the success rate of bone repair; and it can serve as an important interface between bone tissue and surrounding tissues, preventing muscle, tendon, tendon Membrane and other tissues grow into the bone defect, providing a growth mic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/48A61L27/54A61L27/58A61L27/56A61L27/36
CPCA61L27/20A61L27/24A61L27/3629A61L27/365A61L27/3687A61L27/3691A61L27/54A61L27/56A61L27/58A61L2300/236A61L2300/252A61L2300/412A61L2300/414A61L2300/416A61L2430/02A61L2430/12
Inventor 赵博王洪权夏磊磊赵延瑞李学军张晋辉
Owner BEIJING BIOSIS HEALING BIOLOGICAL TECH
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