Periosteal repair sheet for guiding bone generation as well as preparation method and application of periosteal repair sheet

A technology for guiding bone regeneration and patch repair, applied in tissue regeneration, medical science, prostheses, etc., can solve problems such as tissue infection, excessive acidity, and difficulty in self-healing of bone defects, and achieve tissue protection, large porosity, and The effect of improving the repair speed

Active Publication Date: 2017-08-11
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 have deficiencies. The use of acellular matrix materials has a large matrix damage, high DNA residues, incomplete removal of immunogenicity, and easy to cause immune rejection; chitosan, silk fibroin and other natural Most biomaterials 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 during the degradation process, which can easily cause inflammation; and collagen The protein film has insufficient mechanical strength and degrades too quickly. The...

Method used

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  • Periosteal repair sheet for guiding bone generation as well as preparation method and application of periosteal repair sheet
  • Periosteal repair sheet for guiding bone generation as well as preparation method and application of periosteal repair sheet

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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 and small intestinal mucosa The volu...

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 comprises lyophilized particles of small intestinal submucosa, and includes bone morphogenetic protein; while dense fraction 2 comprises one or more layers of small in...

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Abstract

The invention relates to a periosteal repair sheet for guiding bone generation as well as a preparation method and an application of the periosteal repair sheet. The periosteal repair sheet is characterized by comprising a loose active layer high in porosity and a dense substrate layer low in porosity, wherein the loose active layer and the dense substrate layer comprise collage, polysaccharide substances and active factors; the loose active layer further comprises bone regeneration guiding active factors; and the periosteal repair sheet, when implanted into a body, can be degraded and absorbed. The repair sheet, which is of a dual-layer composite structure that the upper layer is loose and the lower layer is dense, is conducive to growth-in of cells and is capable of promoting repair speed of tissues; the dense layer is immunogen and the substrate layer has an isolating effect, so that the repaired effects can be effectively protected; and bone morphogenetic protein is added for periosteal injury and defect repair.

Description

technical field [0001] The invention relates to the field of medical biomaterials, specifically 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 an 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 microenvironmen...

Claims

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Application Information

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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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