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Bone injury repairing and fixing apparatus and preparation method thereof

A technology for bone damage repair and equipment, applied in the field of medical equipment, can solve the problems of implant and bone loosening and dislocation, poor tissue compatibility, insufficient strength of bone nails and bone plates, etc.

Active Publication Date: 2015-04-15
上海发微医用材料有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But it also has significant defects: the mechanical and histocompatibility between metal materials and bone tissue is poor, the mismatch of mechanical properties will lead to uneven stress distribution, and the relative movement between the implant and the bone will cause loosening and dislocation , easy to cause osteoporosis, bone resorption or bone atrophy and prone to secondary fractures; poor tissue compatibility, lack of sufficient mechanical stress stimulation can easily lead to delayed initial bone healing
The main problem is that the bone nails and plates made of these materials are not strong enough, easy to break, and take too long to degrade.

Method used

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  • Bone injury repairing and fixing apparatus and preparation method thereof
  • Bone injury repairing and fixing apparatus and preparation method thereof
  • Bone injury repairing and fixing apparatus and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1: Synthesis of 3-arm star polylactic acid copolymer prepolymer and functionalization of prepolymer

[0057] Synthesis: Before polymerization, a 3-liter glass reactor was vacuum-dried at 80 ° C for 1 hour, and 2000 g of L-lactide (L-lactide), 100 g of glycolide (glycolide) and 14 g of 1,2,6 - Hexatriol was added into the reactor, and vacuum-dried at 60° C. for 1 hour. Then add 2g of stannous octoate, increase the temperature to 140°C, and keep it at 140°C for 3 hours to obtain a star-shaped polylactic acid prepolymer with a number average molecular weight of 20,000 (see reaction formula 1). The molecular weight of the star-shaped polylactic acid copolymer prepolymer is controlled by the relative content of the initiator and the monomer, and the number average molecular weight is controlled between 5,000 and 50,000. When the molecular weight of the star-shaped polylactic acid copolymer prepolymer reached the experimental design requirements, directly drop the fr...

Embodiment 2

[0070] Embodiment 2: crosslinking agent synthesis

[0071] Such as Figure 6As shown, firstly, cyclic monomers or cyclic comonomers, such as L-lactide and ε-caprolactone (L-LA / ε-CL molar ratio of 95 / 5) were synthesized into stars by ring-opening polymerization. Shaped degradable polymer copolymers as prepolymers (including linear or star-shaped polymers with 2, 3 or 4 arms, preferably star-shaped polymers with 3 or 4 arms to facilitate cross-linking reactions ), such as tetrahydroxy polymers. The number average molecular weight of the tetrahydroxyl polymer is controlled between 500 and 100,000. Then, through polycondensation, isocyanate is introduced at the end of the tetrahydroxy polymer, and the remaining isocyanate is removed by polymer precipitation washing to ensure that there is no isocyanate residue, thereby synthesizing a crosslinking agent.

[0072] Mix linear or multi-arm degradable polymers (the number average molecular weight is between 50,000 and 1.2 million, a...

Embodiment 3

[0073] Embodiment 3: performance test

[0074] Fully mix the prepolymer or the prepolymer and the blend of the above-mentioned embodiment 1, heat and melt between two glasses, put a polytetrafluoroethylene cut frame film between the glasses to control the thickness of the plate, use Heating or UV light irradiation cross-linking polymerization to make a standard plate, the mechanical properties and thermal properties of the polymer are shown in Table 1 below. The degradation rate experiment was carried out in a constant temperature oscillating degrader. Samples of a certain size and weight were placed in a buffer solution with pH 7, and the temperature of the water bath was controlled at 37°C. Take out the sample at regular intervals and weigh it after drying, so as to measure the weight loss rate (weight loss wt%) of the sample.

[0075] Table 1: Mechanical and thermal behavior of cross-linked degradable polymers

[0076]

[0077] Note:

[0078] PLGA: L-lactide and glyco...

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Abstract

A bone injury repair fixation instrument and a method of manufacturing same. A crosslinked biodegradable polymer material is adopted for the instrument. The polymer material is a homopolymer of monomers, a copolymer of multiple monomers or a blend of 2 or 3 kinds of the homopolymer and copolymer, and has a three-dimensional crosslinked network structure. The instrument comprises a bone nail, a bone screw, a bone plate or a fixing support, and has great mechanical performance, structural stability, controllable degradation speed, and excellent biocompatibility.

Description

technical field [0001] The invention relates to the field of medical instruments. More specifically, the present invention relates to a bone injury repair and fixation instrument and a preparation method thereof. Background technique [0002] Bone trauma is a common disease in surgical clinic. With the aging of the population structure, the development of transportation and manufacturing, and the increasing environmental pollution, the number of patients requiring bone repair due to bone trauma is increasing. The lesions and injuries of bone tissue directly affect people's quality of life, so the repair of bone tissue has always been a medical research topic that people have paid close attention to. Implantation of artificial materials into the body to repair or replace diseased and damaged bone tissue is the main clinical treatment method. [0003] During the repair of fractures, broken bones, or other types of bone repair, bone nails, nails, bone screws, bone plates, et...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/06
CPCA61L31/06C08L67/04
Inventor 姜洪焱康亚红侯娟汪璟罗七一
Owner 上海发微医用材料有限公司
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