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Biomedical magnesium or magnesium alloy implantation material with multiple surface protection

A technology of magnesium alloys and polymer materials, applied in the field of biomedical materials and devices, can solve the problems of long research and development time, harm, and large research and development investment.

Pending Publication Date: 2017-10-24
NANJING NORMAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some treatment methods have potential hazards to human health, such as chromate treatment, surface nickel plating, aluminum, iron, etc.; some treatment methods cannot meet the requirements of degradability, such as ceramic layers prepared by anodic oxidation or micro-arc oxidation , titanium layer and most organic coatings are difficult to degrade in the human environment
In addition, many methods that can provide protection in theory may not be able to achieve the actual protection effect in practice.
For example, the combination of degradable magnesium / magnesium alloys and degradable polymer materials can theoretically delay the corrosion rate of magnesium / magnesium alloys and prolong the service life of implanted devices. The penetration of water molecules cannot be prevented, and the magnesium / magnesium alloy will start the degradation reaction at the same time as the polymer material. The hydrogen gas generated during the magnesium degradation process will directly cause the bubbling of the polymer film on its surface, or even fall off.
[0009] To sum up, although in the development of biomedical equipment, in vivo biodegradable magnesium and its alloy materials have received high attention, long research and development time, and large investment in research and development, so far, there has not been an ideal one that has long-lasting effective performance. Magnesium and its alloy materials with controllable degradation rate, complete degradability, good biocompatibility and simple preparation process

Method used

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  • Biomedical magnesium or magnesium alloy implantation material with multiple surface protection
  • Biomedical magnesium or magnesium alloy implantation material with multiple surface protection
  • Biomedical magnesium or magnesium alloy implantation material with multiple surface protection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0153] Embodiment 1, the preparation of the biomedical material or device of the magnesium alloy of tool composite protective coating or pure magnesium

[0154] (1) Processing magnesium / magnesium alloy materials into biomedical devices with specific shapes

[0155] The processing method adopted can be mechanical processing methods such as die-casting, extrusion and cutting commonly used for magnesium / magnesium alloys, and laser cutting or engraving can also be used.

[0156] (2) Surface cleaning

[0157] Surface cleaning includes mechanical cleaning and chemical cleaning. According to the surface oxidation degree of pure magnesium / magnesium alloy, common mechanical cleaning, chemical cleaning and ultrasonic cleaning methods can be used: the surface of pure magnesium / magnesium alloy is polished by abrasive belt, and mechanically removed Oxide on the surface, adjust the surface roughness; use a chromium trioxide aqueous solution with a concentration of 10-30wt.%, soak the magne...

Embodiment 2

[0176] Embodiment 2, the preparation of the pure magnesium needle of tool composite protective coating

[0177] (1) Processing and preparation of medical pure magnesium needles

[0178] Pure magnesium is made into needles with diameters of 0.6 mm and 1.2 mm and lengths of 30 mm and 50 mm respectively by die-casting. One end is sharpened with sandpaper and the surface is polished.

[0179] (2) Surface cleaning

[0180] 1) Cleaning with a chromium trioxide aqueous solution with a concentration of 10-30 wt.%.

[0181] 2) Ultrasonic cleaning with acetone.

[0182] 3) Ultrasonic cleaning with deionized water.

[0183] 4) Ultrasonic cleaning with absolute ethanol.

[0184] The ultrasonic frequency is 50kHz. The cleaning time of each step is 10 minutes, and the magnesium needles after cleaning are blown dry with nitrogen gas.

[0185] (3) Chemical conversion treatment

[0186] Soak the cleaned magnesium needle substrate in an aqueous solution containing 100g / L potassium perman...

Embodiment 3

[0192] Embodiment 3, the preparation of the magnesium alloy needle of tool composite protective coating

[0193] (1) Processing and preparation of magnesium alloy needles

[0194] The WE43 magnesium alloy was extruded to produce needles with diameters of 0.6mm and 1.2mm and lengths of 30mm and 50mm, one end was sharpened with sandpaper, and the surface was polished.

[0195] (2) Surface cleaning

[0196] 1) Use a chromium trioxide aqueous solution with a concentration of 15wt.% for cleaning.

[0197] 2) Ultrasonic cleaning with acetone.

[0198] 3) Ultrasonic cleaning with deionized water.

[0199] 4) Ultrasonic cleaning with absolute ethanol.

[0200] The ultrasonic frequency is 50kHz. The cleaning time of each step is 10 minutes, and the magnesium needles after cleaning are blown dry with nitrogen gas.

[0201] (3) Chemical conversion treatment

[0202] Soak the cleaned WE43 substrate in a hydrofluoric acid aqueous solution with a concentration of 16% (mass percentage...

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Abstract

The invention discloses a magnesium or magnesium alloy material or device with multiple surface protection layers and a production method. The magnesium or magnesium alloy material or device with multiple surface protection treatment has the aims that the initial mechanical attenuation of magnesium / magnesium alloy in a physiological environment is decelerated, the corrosion resisting property of the magnesium / magnesium alloy is improved, and the time of service is effectively prolonged. The protection treatment comprises the steps: 1) manufacturing a magnesium / magnesium alloy substrate, and cleaning the surface of the substrate; 2) carrying out chemical conversion treatment on the surface of the magnesium / magnesium alloy substrate, so as to grow a chemical conversion film, of which the thickness is several nanometers, on the surface of the substrate; 3) coating the chemical conversion film with an adhesive layer; 4) coating the outside surface of the adhesive layer with a degradable polymer film. The magnesium or magnesium alloy material or device with multiple surface protection treatment, provided by the invention, can be applied to biomedical implantation or intervention therapy and has the advantages of being good in initial corrosion resisting property in a human physiological environment, meeting clinical requirements of medical treatment and being finally in-vivo degradable.

Description

technical field [0001] The invention belongs to the field of biomedical materials and devices for implantation or interventional therapy, in particular to a biomedical magnesium or magnesium alloy implant material with multiple protective layers on the surface. Background technique [0002] With the aging trend of my country's population increasing year by year, orthopedic diseases such as cardiovascular disease, osteoporosis and arthritis, as well as diseases such as general surgery and stomatology, the market demand for materials and devices for implantation and interventional therapy is also increasing. rising day by day. Among such medical materials and devices, metal materials have been widely used in clinical treatment because of their good mechanical strength and toughness, resistance to fracture fatigue, suitable for load bearing, and easy processing and forming. At present, stainless steel, titanium or cobalt-chromium alloys are routinely used for implantation or in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/04A61L31/02A61L27/58A61L31/14A61L31/10A61L27/34C23C22/34
CPCA61L27/047A61L27/34A61L27/58A61L31/022A61L31/10A61L31/148C23C22/34A61L2420/08A61L2420/02A61L2300/608
Inventor 朱丹吴奇张翼锋沈健
Owner NANJING NORMAL UNIVERSITY
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