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A kind of bone injury repair fixation device and preparation method thereof

A technology for bone damage repair and equipment, applied in the field of medical equipment, can solve problems such as resorption or bone atrophy, delayed bone healing, osteoporosis, etc.

Active Publication Date: 2018-01-12
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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  • A kind of bone injury repair fixation device and preparation method thereof
  • A kind of bone injury repair fixation device and preparation method thereof
  • A kind of bone injury repair fixation device and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0057] Synthesis: Before polymerization, dry a 3 liter glass reactor under vacuum at 80°C for 1 hour. Under the protection of nitrogen, 2000g of L-lactide, 100g of glycolide and 14g of 1, 2, 6 -Hexantriol was added to the reactor and dried under vacuum at 60°C for 1 hour. Then 2g of stannous octoate was added, the temperature was increased to 140°C, and the reaction was maintained 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 polylactic acid copolymer prepolymer is controlled by the relative content of initiator and 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 meets the requirements of the experime...

Embodiment 2

[0070] Example 2: Crosslinking agent synthesis

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

[0072] Mix linear or multi-arm degradable polymers (number average molecular weight between 50,000 and 1.2 million, arms number 2, 3, 4) and the ab...

Embodiment 3

[0073] Example 3: Performance test

[0074] The prepolymer or the prepolymer and the blend of the above-mentioned Example 1 are fully mixed, heated and melted between the two glasses, and a frame film cut by PTFE is placed between the glasses to control the thickness of the board. Heat or UV light irradiates cross-linking polymerization to make a standard sheet. The mechanical and thermal properties of the polymer are shown in Table 1. The degradation rate experiment was carried out in a constant temperature oscillating degrader. A sample of a certain size and weight was placed in a buffer solution of pH 7 and the temperature of the water bath was controlled at 37°C. The sample is taken out at regular intervals and dried and weighed, so that the weight loss rate (weight loss wt%) of the sample is measured.

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

[0076]

[0077] Note:

[0078] PLGA: L-lactide and glycolide copolymer, PLGA (95 / 5) means t...

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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 equipment. More specifically, the present invention relates to a bone injury repair and fixation device and a preparation method thereof. Background technique [0002] Bone trauma is a common disease in surgical clinics. With the aging of the population structure, the development of transportation and manufacturing, and the increasingly serious environmental pollution, the number of patients who need bone repair due to bone trauma is constantly increasing. Lesions and injuries of bone tissue directly affect people's quality of life, so bone tissue repair has always been a medical research topic of great concern. Implanting artificial materials into the body to repair or replace diseased and damaged bone tissue is the main clinical treatment method. [0003] In the process of repairing fractures, bone fractures or other types of bone repair, bone nails, nails, bone screws, bone plates, etc. are usually used to j...

Claims

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Application Information

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Patent Type & Authority Patents(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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