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High-strength absorbable composite active internal fixing device and preparation method thereof

A fixation device and bioactive technology, applied in the field of high-strength absorbable composite active internal fixation device and its preparation, can solve the problems of brittle fracture, low strength, material mechanical attenuation, etc.

Pending Publication Date: 2020-06-19
EAST CHINA UNIV OF SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing absorbable internal fixation implant products represented by polylactic acid generally have problems such as low strength and brittleness, which are the main reasons for implant failure. Among them, the mechanical attenuation of materials caused by processing is a problem that has not yet been solved.

Method used

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  • High-strength absorbable composite active internal fixing device and preparation method thereof
  • High-strength absorbable composite active internal fixing device and preparation method thereof
  • High-strength absorbable composite active internal fixing device and preparation method thereof

Examples

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preparation example Construction

[0064] The invention provides a method for preparing the internal fixation device, comprising the following steps:

[0065] 1) Bioactive nanoparticles in situ trigger the polymerization of biomedical grade monomers;

[0066] 2) After the polymerized medical-grade polylactic acid-based polymer is removed and collected, it is made into a blank through non-destructive processing;

[0067] 3) The blank is processed into a profile through self-reinforcing technology;

[0068] 4) Precisely process the profiles to make organic-inorganic composite high-strength absorbable internal fixation devices.

[0069] Preferably, the biomedical-grade monomers include, but are not limited to, L-lactide, D-lactide, racemic lactide, trimethylene carbonate, caprolactone, glycolide or the above monomers mixture;

[0070] Preferably, the number-average molecular weight of the polylactic acid-based polymer is 100-600kDa, and the components include but are not limited to L-polylactic acid, racemic po...

Embodiment 1

[0103] The preparation of embodiment 1 internal fixation device

[0104] 1) Synthesis. Weigh L-lactide, stannous octoate, and modified hydroxyapatite (average particle size 50nm) into the reactor in a glove box, take it out after sealing, heat to 135°C in an oil bath, and protect it with an inert gas. After reacting for 6 hours, use dichloromethane and absolute ethanol to collect the polymer and dry it;

[0105] 2) Single-screw granulation is used for granulation, the temperature is 200°C, and the screw speed is 40rpm;

[0106] 3) For injection molding, add the pellets to the barrel, the temperature of the barrel is 170°C, the temperature of the mold is 30°C, the injection pressure is 10MPa, the injection time is 3s, the holding pressure is 8MPa, and the holding time is 10s;

[0107] 4) Annealing: Anneal the billet together with the mold, the cooling rate is 30°C / min, and the cooling time is 5 minutes;

[0108] 5) Cold extrusion Add the billet obtained in 4) into the extrusi...

Embodiment 2

[0113] The measurement of the mechanical property of embodiment 2 internal fixation device

[0114]The bar stock obtained by cold extrusion in 5) of Example 1 was taken, and the bending properties of the material were tested by the three-point bending method. The length of each sample is 40mm, the span is 20mm, the test speed is 1mm / min, and the test temperature is 25°C. The reference sample is the same raw material after 2) granulation, and the bar stock obtained by melt extrusion, the data is as attached figure 2 . The extruded reinforced bar has a flexural strength of 224.74MPa and a flexural modulus of 3.5GPa, while the unreinforced bar has a flexural strength of 54.48MPa and a flexural modulus of 1.45GPa. Using the enhanced method described in this patent, the flexural strength can be enhanced by 3.13 times and the flexural modulus can be enhanced by 1.41 times.

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Abstract

The invention relates to a high-strength absorbable composite active internal fixing device and a preparation method thereof. Specifically, the internal fixing device and the preparation method thereof are disclosed, and the internal fixing device has both excellent biological activity and mechanical properties.

Description

technical field [0001] The invention relates to the field of biomedical devices, in particular to a high-strength absorbable composite active internal fixation device and a preparation method thereof. Background technique [0002] Bone injury is a high-incidence disease with a large amount and a wide range in clinical practice, and internal fixation is the most common treatment. After the traditional metal internal fixation material heals, it must be removed through a second operation, which increases the pain and economic burden of the patient. It has become a development trend to replace traditional non-absorbable materials with bioabsorbable materials. Although existing products have come out, their poor mechanical properties and inflammatory response often lead to implant failure. [0003] Polylactic acid is a degradable polymer material that is safe for the human body and friendly to the environment. It can be used to make medical sutures, microcapsules for injection,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B29C69/02B29B9/12B29C71/02B29C48/92B29C45/78B29C45/77
CPCB29C69/02B29B9/12B29C71/02B29C48/92B29C45/78B29C45/77B29L2031/753B29C2071/022B29K2067/046A61L27/58A61L31/127A61L27/54A61L27/12A61L27/18B29C45/0001A61B17/866A61B2017/00004A61B17/68A61B17/80B29C2948/92704B29C2948/92514A61B17/86B29K2105/162B29K2309/00B29K2995/006B29L2031/7532
Inventor 刘昌胜李玉林罗炜陈璨
Owner EAST CHINA UNIV OF SCI & TECH
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