Degradable zinc base alloy implant material and preparation method and application thereof

A technology for implanting materials and alloys, which is applied in the field of medical devices, can solve problems such as uncertainty and potential safety hazards, and achieve the effects of improving mechanical properties, easy processing and shaping, and beneficial to the recovery of body functions

Active Publication Date: 2017-06-27
SHANDONG RIENTECH MEDICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The main purpose of introducing magnesium in this patent application is to improve the mechanical properties of zinc, but it has not yet solved the possible damage to the body caused by the degradation of magnesium on the pH of the tissue environment around the implant
Publication No. CN103736152A discloses a zinc-based alloy containing Ce, Mg, Ca, and Cu. Various metal elements are introduced into the material to improve the mechanical properties of zinc. Implantation brings many uncertainties and safety hazards

Method used

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  • Degradable zinc base alloy implant material and preparation method and application thereof
  • Degradable zinc base alloy implant material and preparation method and application thereof
  • Degradable zinc base alloy implant material and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: Zinc-iron-copper alloy

[0043] The degradable zinc-based alloy implant material in this embodiment is a zinc-iron-copper alloy, and the preparation process specifically includes the following steps:

[0044] 1) According to the mass percentage content, 1wt% of Fe, 1wt% of Cu and the remainder of Zn (total impurity content 6 (1vol.%) and CO 2 In the atmosphere, add high-purity graphite crucible to mix and smelt to obtain zinc-based alloy.

[0045] 2) After smelting, extrude the obtained zinc-based alloy into rods with a diameter of 10 mm and a length of 50 cm.

[0046] 3) After repeated annealing (temperature 200°C-500°C, 30min), the obtained rod is drawn into a pipe with an outer diameter of 0.15mm±0.013mm and a wall thickness of 0.1mm±0.013mm, and the design pattern is 3.0 The bracket of ×20 is formed by femtosecond laser engraving (see engraving pattern figure 1 ), the electrochemical polishing method removes the edges and corners of the material to ...

Embodiment 2

[0052] Embodiment 2: zinc-iron-copper alloy

[0053] The degradable zinc-based alloy implant material in this embodiment is zinc-iron-copper alloy, containing 0.14wt% iron-1.8wt% copper, the balance is zinc, and the total content of impurities is controlled to be <0.001wt%. The preparation process is the same as the implementation example 1.

[0054] Effect verification:

[0055] The zinc-based alloy implant material prepared by the above method has an elastic modulus of 75GPa, a yield strength of 210MPa, and a tensile strength of 240MPa. Ideal coronary stent material. The degradation rate measured according to the ASTM_G31-1972 method is 0.19mm / year; the blood compatibility is tested according to the GB16886 series method, and the hemolysis rate is 1%, which is 5% lower than the standard value; the cytotoxic reaction is grade I, no intradermal Stimulation, sensitization rate 0%.

Embodiment 3

[0056] Example 3: Zinc-iron-strontium-calcium alloy

[0057] The degradable zinc-based alloy implant material in this embodiment is a zinc-iron-strontium-calcium alloy, containing 0.5wt% iron-0.5wt% strontium-0.5wt% calcium, and the balance is zinc. The preparation process is the same as in Example 1. .

[0058] Effect verification:

[0059] The zinc-based alloy implant material prepared by the above method has an elastic modulus of 80GPa, a yield strength of 233MPa, and a tensile strength of 270MPa, which can meet the mechanical performance requirements of fracture and bone fixation in load-bearing parts. The degradation rate measured according to the ASTM_G31-1972 method is 0.38mm / year; according to the GB16886 series of methods, there is no obvious cytotoxicity, intradermal irritation, sensitization rate and genotoxicity. Since the elastic modulus (60-70Gpa) of the zinc-based alloy implant material is closer to human cortical bone (about 20Gpa) than traditional internal f...

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Abstract

The invention discloses a degradable zinc base alloy implant material and a preparation method and application of the degradable zinc base alloy implant material. The degradable zinc base alloy implant material comprises 0.01 wt%-14 wt% of Fe, 0 wt%-13 wt% of functional elements and the balance of Zn according to mass percentage. In the preparation, Zn, Fe and the functional elements are evenly mixed, and the mixture is placed in a high-purity graphite crucible, and smelted under the atmosphere of mixed gases SF6 and CO2, so as to obtain the degradable zinc base alloy implant material. The mechanical properties of the zinc base alloy implant material are remarkably improved, the implant material is easy to process and form, the properties like strength and plasticity meet the basic requirements of the body implant material of an intravascular stent, an orthopedic internal fixation system and the like; the introduction of the functional elements further enables the product to achieve the certain effects of resisting bacteria, maintaining and inducing angiogenesis, repairing bones, promoting calcification and being beneficial for recovery of body functions.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a degradable zinc-based alloy implant material and its preparation method and application. Background technique [0002] Implantable medical devices refer to "insert into the human body or cavity or mouth in whole or in part by means of surgery, or are used to replace the human epithelial surface or ocular surface, and remain in the human body for 30 days (including 30 days) after the operation process is over." above or absorbed by the human body". Implantable medical devices are classified as high-risk medical devices (Category III) because they are in direct contact with the internal tissues of the human body for a relatively long period of time. With the aging of my country's population and the development of medical technology, the application of implantable medical devices is becoming more and more extensive, and a market scale of tens of billions of dollars has be...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/04A61L27/54A61L27/58C22C18/00C22C18/02C22C1/02C22F1/16
CPCA61L27/047A61L27/54A61L27/58C22C1/02C22C18/00C22C18/02C22F1/165A61L31/022A61L31/10A61L31/14A61L31/148A61L31/16A61L2430/22A61L2430/02A61L2420/06A61L2300/606A61L2300/604A61L2300/102A61L2300/416A61L2300/412A61L2300/404C08L67/04C08L5/08A61L27/04A61L2300/216A61L2420/02
Inventor 张海军王鲁宁周超尹玉霞鲁守涛赵彦伟
Owner SHANDONG RIENTECH MEDICAL TECH
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