阅读说明：本技术 一种体内可降解镁合金吻合钉及其制备方法 (In-vivo degradable magnesium alloy anastomosis nail and preparation method thereof ) 是由 丁雨田 张鸿飞 高钰璧 王兴茂 陈建军 雷健 于 2019-10-22 设计创作，主要内容包括：一种体内可降解镁合金吻合钉及其制备方法,按质量百分比计,所用镁合金组分依次为2.0~5.0%Zn、0.2~1.0%Ca、余量为Mg。制备方法的步骤：将所用Mg、Zn、Ca烘干；在通有氩气保护的真空感应熔炼炉中将纯镁熔化并按照上述比例依次加入Zn、Ca,经搅拌保温后进行浇铸得到铸造坯料,机加工成棒材,将棒材放入温度为400℃的热处理炉中,保温12h,进行均匀化处理；将棒材加热至250℃放入预热的模具中进行挤压,挤压比为25；将挤压得到的棒材在410℃~420℃热处理炉中进行固溶处理,保温16h；将处理后棒材进行拉拔,以中间退火工艺相配合,得到丝材,将丝材进一步加工,得到吻合器用吻合钉。(A method for preparing an in-vivo degradable magnesium alloy anastomosis nail comprises the steps of drying 2.0 ~ 5.0.0% of Zn, 0.2 ~ 1.0.0% of Ca and the balance Mg. of Mg, Zn and Ca in sequence according to mass percentage, melting pure magnesium in a vacuum induction melting furnace with argon protection, adding Zn and Ca in sequence according to the proportion, stirring and preserving heat, casting to obtain a cast blank, machining to obtain a bar, placing the bar into a heat treatment furnace with the temperature of 400 ℃, preserving heat for 12 hours, carrying out homogenization treatment, heating the bar to 250 ℃, placing the bar into a preheated die for extrusion with the extrusion ratio of 25, carrying out solid solution treatment on the bar in the heat treatment furnace with the temperature of 410 ℃ of ~ 420 ℃, preserving heat for 16 hours, drawing the bar after solid solution treatment, carrying out an annealing process with intermediate cooperation to obtain a wire, and further processing the wire to obtain the anastomosis nail.)

1. An in vivo degradable magnesium alloy anastomosis nail is characterized in that the anastomosis nail can be degraded, absorbed or discharged after being implanted into a living body to complete biological functions and mechanical functions, and the magnesium alloy comprises 2.0 ~ 5.0.0% of Zn, 0.2 ~ 1.0.0% of Ca and the balance of Mg in sequence according to mass percentage.

2. The in vivo degradable magnesium alloy staple according to claim 1, wherein said Mg has a purity of 99.99%.

3. The in vivo degradable magnesium alloy anastomosis nail according to claim 1, wherein the Zn purity is 99.99%; .

4. The in vivo degradable magnesium alloy staple according to claim 1, wherein said Ca has a purity of 99.99%.

5. The method for preparing the in vivo degradable alloy anastomosis nail according to claim 1, which comprises the following steps:

(1) putting the Mg, Zn and Ca into a drying oven for drying;

melting pure magnesium in a vacuum induction melting furnace with argon protection, sequentially adding Zn and Ca according to the proportion, stirring, preserving heat and then casting to obtain a casting blank;

(2) turning the cast blank to obtain a machined bar with a set size;

(3) putting the machined bar into a heat treatment furnace with the temperature of 400 ℃, preserving heat for 12 hours, carrying out homogenization treatment, and cooling along with the furnace;

(4) heating the homogenized bar to 250 ℃, putting the bar into a preheated die for extrusion, wherein the extrusion ratio is 25, and obtaining an extruded bar;

(5) carrying out solution treatment on the bar obtained by extrusion in a heat treatment furnace at 410 ℃ and ~ 420 ℃ for 16h, and then air-cooling;

(6) carrying out multi-pass drawing on the bar subjected to the solution treatment, and matching with an intermediate annealing process to obtain a wire with the diameter of phi 0.3 ~ 0.5.5 mm;

(7) and further processing the wire to obtain the anastomosis nail for the anastomat.

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to an in-vivo degradable magnesium alloy anastomosis nail and a preparation method thereof.

Background

The anastomosis nail is a medical instrument clinically used for suturing human skin and tissues, most of the currently used anastomosis nail materials are titanium alloy, and after the titanium alloy anastomosis nail is implanted into a human body, scraps generated due to abrasion can cause local allergy or inflammatory reaction of the human body, so that adverse effects are caused on the human body. The titanium alloy has excellent corrosion resistance, and the titanium alloy anastomosis nail can exist for a long time when being implanted into a human body, so that CT and MRI detection results are influenced, so that the anastomosis nail needs to be taken out after human body tissues are healed, a patient can suffer from pain caused by secondary injury in the taking-out process, and the operation cost is increased.

Based on the above problems, the related art has proposed degradable staples. The anastomotic nail is applied to the body of a patient, can be degraded by the human body after the tissue is healed, and the degradation products can be absorbed or discharged by the human body. The mental and economic pressure of the patient is relieved while the pain of the patient caused by secondary injury is avoided.

In recent years, a new generation of medical metal materials represented by degradable medical magnesium alloys have been developed rapidly, and magnesium alloys have received wide attention due to their excellent comprehensive mechanical properties, high specific strength and high specific stiffness. The standard electrode of magnesium has low potential and can be degraded in the environment of body fluid of a human body so as to be absorbed or discharged by the human body, and a series of problems caused by secondary operations can be avoided. Magnesium is the fourth ion in the human body, participates in various vital activities in the human body, has an important effect on the health of the human body, and has good biocompatibility.

At present, the application of magnesium alloy in the biomedical field has the following hidden troubles. (1) The biological safety is to be improved. Al is taken as an element with better strengthening effect of Mg alloy, and can damage the nervous system after being absorbed by human body, thereby causing senile dementia. Rare earth elements can be accumulated in human bodies, and the influence of the rare earth elements on the human bodies is not yet clarified clearly. (2) The mechanical properties of magnesium and its alloys need to be further improved to meet the requirements for use in vivo. (3) Magnesium alloys degrade at a rate that is too fast and often fail to degrade before the body tissue has fully recovered, resulting in surgical failure.

Disclosure of Invention

The invention aims to provide an in-vivo degradable magnesium alloy anastomosis nail and a preparation method thereof.

The invention relates to an in vivo degradable magnesium alloy anastomosis nail and a preparation method thereof, the in vivo degradable magnesium alloy anastomosis nail can be degraded, absorbed or discharged after being implanted into organisms to complete biological functions and mechanical functions, and the magnesium alloy components used are 2.0 ~ 5.0.0% of Zn, 0.2 ~ 1.0.0% of Ca and the balance of Mg in sequence according to mass percentage.

The preparation method of the in-vivo degradable alloy anastomosis nail comprises the following steps:

(1) putting the Mg, Zn and Ca into a drying oven for drying;

melting pure magnesium in a vacuum induction melting furnace with argon protection, sequentially adding Zn and Ca according to the proportion, stirring, preserving heat and then casting to obtain a casting blank;

(2) turning the cast blank to obtain a machined bar with a set size;

(3) putting the machined bar into a heat treatment furnace with the temperature of 400 ℃, preserving heat for 12 hours, carrying out homogenization treatment, and cooling along with the furnace;

(4) heating the homogenized bar to 250 ℃, putting the bar into a preheated die for extrusion, wherein the extrusion ratio is 25, and obtaining an extruded bar;

(5) carrying out solution treatment on the bar obtained by extrusion in a heat treatment furnace at 410 ℃ and ~ 420 ℃ for 16h, and then air-cooling;

(6) carrying out multi-pass drawing on the bar subjected to the solution treatment, and matching with an intermediate annealing process to obtain a wire with the diameter of phi 0.3 ~ 0.5.5 mm;

(7) and further processing the wire to obtain the anastomosis nail for the anastomat.

The invention has the following beneficial effects:

(1) the degradable magnesium alloy anastomosis nail in vivo can be degraded in the organism, and the degraded product is harmless to the human body and can be absorbed or discharged by the human body, thereby avoiding the mental and economic pressure on patients caused by secondary operation;

(2) the degradable magnesium alloy anastomosis nail raw material in the body uses Mg, Zn and Ca which are harmless to the human body, so that the use of elements harmful to the human body is avoided, and the degradable magnesium alloy anastomosis nail raw material has good biological safety;

(3) the in-vivo degradable magnesium alloy anastomosis nail has good comprehensive mechanical property and biocompatibility, and the degradation rate of the anastomosis nail meets the requirement of degrading after finishing mechanical and biological functions after implantation;

(4) the preparation process of the in-vivo degradable magnesium alloy anastomosis nail improves the comprehensive mechanical property of magnesium alloy in the extrusion process.

Detailed Description

The invention relates to an in vivo degradable magnesium alloy anastomosis nail and a preparation method thereof, the in vivo degradable magnesium alloy anastomosis nail can be degraded, absorbed or discharged after being implanted into organisms to complete biological functions and mechanical functions, and the magnesium alloy components used are 2.0 ~ 5.0.0% of Zn, 0.2 ~ 1.0.0% of Ca and the balance of Mg in sequence according to mass percentage.

The in vivo degradable magnesium alloy anastomosis nail has the Mg purity of 99.99%.

In the in vivo degradable magnesium alloy anastomosis nail, the Zn purity is 99.99%; .

In the above in vivo degradable magnesium alloy anastomosis nail, the purity of the Ca is 99.99%.

The preparation method of the in-vivo degradable alloy anastomosis nail comprises the following steps:

(1) putting the Mg, Zn and Ca into a drying oven for drying;

melting pure magnesium in a vacuum induction melting furnace with argon protection, sequentially adding Zn and Ca according to the proportion, stirring, preserving heat and then casting to obtain a casting blank;

(2) turning the cast blank to obtain a machined bar with a set size;

(3) putting the machined bar into a heat treatment furnace with the temperature of 400 ℃, preserving heat for 12 hours, carrying out homogenization treatment, and cooling along with the furnace;

(4) heating the homogenized bar to 250 ℃, putting the bar into a preheated die for extrusion, wherein the extrusion ratio is 25, and obtaining an extruded bar;

(5) carrying out solution treatment on the bar obtained by extrusion in a heat treatment furnace at 410 ℃ and ~ 420 ℃ for 16h, and then air-cooling;

(6) carrying out multi-pass drawing on the bar subjected to the solution treatment, and matching with an intermediate annealing process to obtain a wire with the diameter of phi 0.3 ~ 0.5.5 mm;

(7) and further processing the wire to obtain the anastomosis nail for the anastomat.

The invention is further developed with the following more specific examples.