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Magnesium alloy sheet-reinforced absorbable intrabony fixing composite material and preparation method thereof

A composite material and magnesium alloy technology, applied in medical science, surgery, etc., can solve problems such as non-degradable absorption, re-fracture, stress shielding, etc., and achieve the effect of overcoming acidity too high and too strong, and improving strength and toughness

Inactive Publication Date: 2012-07-11
SOUTHEAST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Internal bone fixation is a routine method in orthopedic trauma surgery, bone defect repair surgery, and plastic surgery. Currently, internal fixation plates and screws are most commonly made of pure titanium or titanium alloy, which have stable fixation effects and superior biocompatibility. It provides a good internal environment for bone tissue healing, but it also has the following problems: (1) The elastic modulus of titanium metal is 8 times that of cortical bone, and it has a stress shielding effect on normal bone tissue, which is easy to cause osteoporosis and relapse Fracture; (2) It cannot be degraded and absorbed. If it is used for a long time, it will block X-rays and affect imaging examinations and chemotherapy for cancer patients.
[0007] Therefore, in order to solve the above-mentioned existing problems, a kind of bone internal fixation composite material prepared by the present invention is composed of absorbable magnesium alloy flakes or strips as a reinforcing phase and polylactic acid as a matrix. Materials and biodegradable magnesium alloys have their respective advantages, but at the same time they can overcome their respective shortcomings. They have good application prospects in orthopedic trauma surgery, bone defect repair surgery, plastic surgery, especially in internal fixation of high-stress fractures. , but so far there have been no relevant research reports at home and abroad

Method used

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Examples

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preparation example Construction

[0032] The preparation method of the composite material can also be: select a magnesium alloy flake (or thin strip) with a suitable aspect ratio and thickness as the reinforcing phase, and weigh the corresponding weight of the magnesium alloy flake (or thin strip) and poly Lactic acid, using the micro-arc oxidation method to prepare a ceramic protective film on the surface of the magnesium alloy sheet (or thin strip), and according to the arrangement and distribution requirements of the reinforcing phase in the matrix, the magnesium alloy sheet (or thin strip) with the ceramic protective layer on the surface is first Use a mold for directional dispersion arrangement and fixation; dissolve polylactic acid in organic solvents such as dichloromethane, chloroform, ethyl acetate and tetrahydrofuran; then, mix the polylactic acid solution with magnesium alloy flakes (or strips) and stir evenly. Then vacuum-dry at 40°C-90°C for later use; then the mixture is molded or extruded into ro...

Embodiment 1

[0036] Select 5 pieces of 90mmx10mmx0.5mm AZ31B magnesium alloy strips as the reinforcing phase, use 10g / L sodium silicate, 2g / L NaOH and 10g / L hydroxyapatite nanoparticles as the micro-arc oxidation electrolyte system, and the magnesium alloy strips Immerse in it, apply 400V voltage, and carry out micro-arc oxidation treatment for 20 minutes, so that a layer of ceramic protective film rich in magnesium oxide, magnesium silicate and hydroxyapatite is formed on the surface in situ. Arrange the reinforcing phase thin strips in the mold cavity of 80mmx16mmx8mm by fixing the two ends. Weigh 10.4g of polylactic acid with a molecular weight of 200,000 and dissolve it in a sufficient amount of ethyl acetate. The solution is then injected into the mold cavity, stirred evenly and then dried in vacuum at 70°C for later use; then the mixture is kept at 145°C and 15MPa 20 minutes, molded, cooled to room temperature. Finally, it is processed into the required internal fixation device for ...

Embodiment 2

[0038] Select 1.8g of AZ31B magnesium alloy flakes with a size of 70mmx10mmx0.5mm as the reinforcing phase, and pass it through the micro-arc oxidation treatment method as shown in Example 1 to obtain a film layer rich in magnesium oxide, magnesium silicate, and hydroxyapatite. Arrange the reinforcing phase in the mold cavity of 60mmx16mmx6mm through fixed orientation at both ends, take 8g of polylactic acid with a molecular weight of 400,000, heat it to 220°C and melt it, inject it into the mold cavity, mix the polylactic acid solution and magnesium alloy flakes evenly, 200°C, 15MPa pressure for 20 minutes, molded, cooled to room temperature. Finally, it is processed into the required internal fixation device for orthopedics by means of machining.

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Abstract

The invention discloses a magnesium alloy sheet (strip)-reinforced absorbable intrabony fixing composite material and a preparation method thereof. The preparation method comprises the following steps of: dispersing and arranging magnesium alloy sheets or thin strips which are subjected to micro arc oxidation in an absorbable high molecular material serving as a substrate in an oriented way to enhance the mechanical performance of the absorbable composite material; mixing degradable polymer substrates such as poly(lactic acid) and the like with a magnesium alloy sheets or thin strip reinforced phase; manufacturing a bar and a plate by performing die pressing or extruding at the temperature of 80-235 DEG C under the pressure of 0.5-40 MPa; and performing subsequent machining to obtain various intrabony fixing products. The method has the characteristic of easiness in operating process conditions; a product has excellent mechanical performance, high biocompatibility, and safe, stable and controllable product degradation, is suitable for intrabony fixing products of various shapes, and has a wide market prospect; and pain of a patient caused by the need of secondary surgery or advanced failure of an orthopaedic fixing product.

Description

technical field [0001] The invention relates to an orthopedic internal fixation material in medical equipment, belongs to the field of biomedical equipment, and is particularly suitable for the fields of orthopedic trauma surgery, bone defect repair surgery, and medical equipment for plastic surgery. Specifically, it is a magnesium alloy sheet or strip reinforced resorbable bone internal fixation composite material, which is an bone internal fixation composite material formed by compounding a resorbable magnesium alloy sheet or thin strip reinforcement phase with a polylactic acid matrix. Background technique [0002] Internal bone fixation is a routine method in orthopedic trauma surgery, bone defect repair surgery, and plastic surgery. Currently, internal fixation plates and screws are most commonly made of pure titanium or titanium alloy, which have stable fixation effects and superior biocompatibility. It provides a good internal environment for bone tissue healing, but ...

Claims

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Application Information

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IPC IPC(8): A61L31/12A61L31/14
Inventor 储成林薛烽韩啸董寅生白晶郭超盛晓波王世栋
Owner SOUTHEAST UNIV
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