CN110694121A - In-vivo degradable magnesium alloy anastomosis nail and preparation method thereof - Google Patents

Abstract

An in vivo degradable magnesium alloy staple and a preparation method thereof, in terms of mass percentage, the magnesium alloy components used are 2.0-5.0% Zn, 0.2-1.0% Ca, and the balance is Mg. The steps of the preparation method: drying the used Mg, Zn and Ca; melting pure magnesium in a vacuum induction melting furnace with argon protection, adding Zn and Ca in sequence according to the above ratio, and performing casting after stirring and heat preservation to obtain a casting billet , machined into a bar, put the bar into a heat treatment furnace with a temperature of 400 ° C, keep it for 12 hours, and conduct homogenization treatment; heat the bar to 250 ° C and put it into a preheated die for extrusion, the extrusion ratio is is 25; the extruded bar is solution-treated in a heat treatment furnace at 410°C~420°C, and kept for 16 hours; the treated bar is drawn, and the intermediate annealing process is used to obtain a wire, and the wire is After further processing, staples for staplers are obtained.

Description

In vivo degradable magnesium alloy staple and preparation method thereof

technical field

The invention belongs to the field of medical devices, in particular to an in vivo degradable magnesium alloy staple and a preparation method thereof.

Background technique

Stapling staples are medical devices clinically used to suture human skin and tissue. Most of the staple materials currently used are titanium alloys. After the titanium alloy staples are implanted in the human body, the debris generated by wear and tear will cause local allergies or inflammation in the human body. reaction, causing adverse effects on the human body. Titanium alloy has excellent corrosion resistance. Titanium alloy staples will exist in the human body for a long time and affect the results of CT and MRI. Therefore, these staples must be removed after the human tissue is healed. During the removal process, the patient will be affected. The pain caused by the secondary injury, but also increased the cost of surgery.

Based on the above problems, relevant technicians have proposed degradable staples. The staple is applied to the patient's body, and can be degraded by the human body after the tissue is healed, and the degradation product can be absorbed or excreted by the human body. It also reduces the mental and economic pressure of the patient while avoiding the pain caused by the secondary injury.

In recent years, a new generation of medical metal materials represented by degradable medical magnesium alloys has developed rapidly. Magnesium alloys have received extensive attention due to their excellent comprehensive mechanical properties, high specific strength and specific stiffness. The standard electrode potential of magnesium is low, and it can be degraded in the human body fluid environment, so that it can be absorbed or excreted by the human body, which can avoid a series of problems caused by secondary surgery. Magnesium is the fourth most abundant ion in the human body. It participates in various life activities in the human body and plays an important role in the health of the human body. Magnesium alloys have good biocompatibility.

At present, the application of magnesium alloys in the biomedical field has the following hidden dangers. (1) Biosafety needs to be improved. As an element with better strengthening effect of Mg alloy, Al can damage the nervous system after being absorbed by the human body, leading to the occurrence of Alzheimer's disease. Rare earth elements will accumulate in the human body, and the impact of rare earth elements on the human body has not been clearly explained. (2) The mechanical properties of magnesium and its alloys need to be further improved to meet the requirements of in vivo use. (3) The degradation rate of magnesium alloys is too fast, and it usually degrades and fails before the human tissue is fully recovered, resulting in the failure of the operation.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide an in vivo degradable magnesium alloy staple and a preparation method thereof.

The invention relates to an in vivo degradable magnesium alloy staple and a preparation method thereof. An in vivo degradable magnesium alloy staple can be degraded, absorbed or discharged after being implanted in a living body to complete biological functions and mechanical functions; , the magnesium alloy components used are 2.0~5.0% Zn, 0.2~1.0% Ca, and the balance is Mg.

The preparation method of the in vivo degradable alloy staple of the present invention comprises the following steps:

(1) Put the Mg, Zn and Ca used in a drying oven for drying;

Pure magnesium is melted in a vacuum induction melting furnace with argon protection, and Zn and Ca are added in sequence according to the above ratio, and the casting blank is obtained by casting after stirring and heat preservation;

(2) Turning the cast billet to obtain a machined bar of a set size;

(3) Put the machined bar into a heat treatment furnace with a temperature of 400 °C, keep it for 12 hours, carry out homogenization treatment, and cool it with the furnace;

(4) Heat the homogenized bar to 250°C and put it into a preheated die for extrusion, and the extrusion ratio is 25 to obtain an extruded bar;

(5) The extruded bar is solution-treated in a heat treatment furnace at 410°C to 420°C, kept for 16 hours, and then air-cooled;

(6) Multi-pass drawing of the solution-treated bar, matched with intermediate annealing process, to obtain Φ0.3~0.5mm wire;

(7) The wire is further processed to obtain staples for staplers.

The beneficial effects of the present invention are as follows:

(1) The degradable magnesium alloy staples of the present invention can be degraded in vivo, and the degraded products are harmless to the human body and can be absorbed or excreted by the human body, avoiding the mental and economical effects of secondary surgery on patients. pressure;

(2) The biodegradable magnesium alloy staple material of the present invention uses Mg, Zn, and Ca, which are harmless to the human body, avoids the use of harmful elements to the human body, and has good biological safety;

(3) The in vivo degradable magnesium alloy staple of the present invention has good comprehensive mechanical properties and biocompatibility, and its degradation rate meets the requirements of degrading after completing mechanical and biological functions after implantation;

(4) The preparation process of the degradable magnesium alloy staple in the present invention improves the comprehensive mechanical properties of the magnesium alloy during the extrusion process.

Detailed ways

The invention relates to an in vivo degradable magnesium alloy staple and a preparation method thereof. An in vivo degradable magnesium alloy staple can be degraded, absorbed or discharged after being implanted in a living body to complete biological functions and mechanical functions; , the magnesium alloy components used are 2.0~5.0% Zn, 0.2~1.0% Ca, and the balance is Mg.

In the above-mentioned degradable magnesium alloy staples in vivo, the purity of the Mg is 99.99%.

In the above-mentioned degradable magnesium alloy staples in vivo, the purity of the Zn is 99.99%;

In the above-mentioned degradable magnesium alloy staples in vivo, the purity of the Ca is 99.99%.

The preparation method of the in vivo degradable alloy staple of the present invention comprises the following steps:

(1) Put the Mg, Zn and Ca used in a drying oven for drying;

Pure magnesium is melted in a vacuum induction melting furnace with argon protection, and Zn and Ca are added in sequence according to the above ratio, and the casting blank is obtained by casting after stirring and heat preservation;

(2) Turning the cast billet to obtain a machined bar of a set size;

(3) Put the machined bar into a heat treatment furnace with a temperature of 400 °C, keep it for 12 hours, carry out homogenization treatment, and cool it with the furnace;

(4) Heat the homogenized bar to 250°C and put it into a preheated die for extrusion, and the extrusion ratio is 25 to obtain an extruded bar;

(5) The extruded bar is solution-treated in a heat treatment furnace at 410°C to 420°C, kept for 16 hours, and then air-cooled;

(6) Multi-pass drawing of the solution-treated bar, matched with intermediate annealing process, to obtain Φ0.3~0.5mm wire;

(7) The wire is further processed to obtain staples for staplers.

The present invention is further developed with more specific embodiments below.

Example 1:

(1) Put the Mg, Zn and Ca used in the drying oven to dry. Pure magnesium was heated to 700°C in a vacuum induction melting furnace protected by argon gas. After all the pure magnesium was melted, Zn and Ca were added according to the composition requirements, and the temperature was raised to 750°C for 20 minutes. Casting at 700°C to obtain an ingot;

(2) Turning the ingot to obtain a machined bar of Φ40×50mm;

(3) Put the machined bar into a heat treatment furnace with a temperature of 400 °C, keep it for 12 hours, carry out homogenization treatment, and cool it with the furnace;

(4) Heat the homogenized bar to 250°C and put it into a preheated die for extrusion, and the extrusion ratio is 25 to obtain a Φ8mm extruded bar;

(5) The extruded bar is solution-treated in a heat treatment furnace at 410°C to 420°C, kept for 16 hours, and then air-cooled;

(6) Multi-pass drawing is performed on the solution-treated bar, and the intermediate annealing process is used to obtain a wire with a diameter of 0.3~0.5mm;

(7) The wire is further processed to obtain staples for staplers.

The above descriptions are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention shall be included in the protection of the present invention. within the range.

Claims (5)

1. A degradable magnesium alloy staple in the body is characterized in that it can be degraded and absorbed or discharged after being implanted in the body to complete biological function and mechanical function; By mass percentage, the magnesium alloy components used are successively 2.0 to 5.0% Zn, 0.2~1.0% Ca, and the balance is Mg. 2 . The in vivo degradable magnesium alloy staple according to claim 1 , wherein the purity of the Mg is 99.99%. 3 . 3 . The in vivo degradable magnesium alloy staple as claimed in claim 1 , wherein the purity of the Zn is 99.99%; 3 . 4 . The in vivo degradable magnesium alloy staple according to claim 1 , wherein the purity of the Ca is 99.99%. 5 . 5. The preparation method of in vivo degradable alloy staples as claimed in claim 1, wherein the steps are: (1) Put the Mg, Zn and Ca used in a drying oven for drying; Pure magnesium is melted in a vacuum induction melting furnace with argon protection, and Zn and Ca are added in sequence according to the above ratio, and the casting blank is obtained by casting after stirring and heat preservation; (2) Turning the cast billet to obtain a machined bar of a set size; (3) Put the machined bar into a heat treatment furnace with a temperature of 400 °C, keep it for 12 hours, carry out homogenization treatment, and cool it with the furnace; (4) Heat the homogenized bar to 250°C and put it into a preheated die for extrusion, and the extrusion ratio is 25 to obtain an extruded bar; (5) The extruded bar is solution-treated in a heat treatment furnace at 410°C to 420°C, kept for 16 hours, and then air-cooled; (6) Multi-pass drawing of the solution-treated bar, matched with intermediate annealing process, to obtain Φ0.3~0.5mm wire; (7) The wire is further processed to obtain staples for staplers.