CN116392644A

CN116392644A - Magnesium-based embedded wire, preparation method thereof, wire embedding device and wire embedding method

Info

Publication number: CN116392644A
Application number: CN202310381128.6A
Authority: CN
Inventors: 宗洁; 徐海东; 王晓; 曹颖佳; 冯新怡
Original assignee: Suzhou Origin Medical Technology Co ltd
Current assignee: Suzhou Origin Medical Technology Co ltd
Priority date: 2023-04-11
Filing date: 2023-04-11
Publication date: 2023-07-07

Abstract

The invention provides a magnesium-based embedded wire and a preparation method thereof, a wire embedding device and a wire embedding method, wherein the preparation method comprises the following steps: (1) Processing a magnesium-based metal ingot into a magnesium-based metal rod, and sequentially carrying out heat preservation treatment and extrusion on the magnesium-based metal rod to form a first magnesium-based wire rod; (2) Sequentially cold drawing and annealing the first magnesium-based wire rod in the step (1) to form a second magnesium-based wire rod, wherein the diameter of the second magnesium-based wire rod is smaller than that of the first magnesium-based wire rod; (3) And (3) performing fixed length, polishing, cleaning, vacuum packaging and sterilization on the second magnesium-based wire rod in the step (2) to obtain the magnesium-based implantation wire. The magnesium-based implantation line has low storage and transportation requirements, small inflammatory reaction and good mechanical properties; push pins of the wire embedding device can be effectively buckled on the needle seat, the push pins are prevented from sliding or falling at will, accurate positioning of wires can be realized, and the wire embedding device has a wide application prospect.

Description

Magnesium-based embedded wire, preparation method thereof, wire embedding device and wire embedding method

Technical Field

The invention relates to the technical field of medical equipment, in particular to a magnesium-based implantation line, a preparation method thereof, a line implantation device and a line implantation method.

Background

With the increase of the acceptance of the public to medical and aesthetic behaviors, the buried line beauty is increasingly applied to the beauty fields of facial rejuvenation, weight reduction and the like. Catgut embedding beauty is a cosmetic method of embedding solid wires absorbable by the human body into tissues. The method can fill or pull the loosened and sagged tissues, and simultaneously stimulate the generation of collagen in the process of degrading the solid wire in the human body so as to achieve the aim of beautifying and shaping; can also continuously stimulate the acupoints of human body to achieve the effect of losing weight.

At present, two common methods for using commercial buried wire products are available, one is to inject buried wire, and the other is to fold and rotate the buried wire in half. The former is to place the solid wire in the head of burial needle tubing, then insert the push pin needle core from the needle file in the needle tubing with the push pin, push the solid wire into the tissue, the implantation direction and the degree of depth need be controlled through the needle file in the implantation process, but the needle file lacks the handle, and the degree of accuracy is poor, and the push pin needle core still adopts manual withdrawal, and the operation is inconvenient. In addition, when the solid wire is arranged at the head part of the needle tube of the buried wire needle, the push needle which is pushed out easily slides backwards or falls off at will, thereby influencing the operation. The latter is to pre-load half of the solid wire into the needle tube of the buried wire needle, fold the other half of the wire in half, insert the buried wire needle into the tissue, then rotate, pull out the buried wire needle, leave the solid wire in the tissue, this process can't limit the length of the needle tube penetrating into the human body, cause the human body to damage easily.

The solid wire material used in commercial buried wire products is typically a degradable material such as collagen or polydioxanone wire. The materials have poor mechanical properties and high storage and transportation requirements, and have certain discharge or inflammatory reaction after being implanted into tissues.

Therefore, there is a need to develop a novel wire embedding device and a method for embedding a wire, wherein push pins are not easy to slide or drop at will during wire installation, and the wire embedding device and the method can accurately insert and pull the wire embedding pins during wire embedding.

Disclosure of Invention

In view of the problems existing in the prior art, the invention provides a magnesium-based embedded wire, a preparation method thereof, a wire embedding device and a wire embedding method, which solve the problems of poor mechanical property, high storage and transportation requirements and easy inflammation initiation of the existing embedded wire, and simultaneously the wire embedding device can realize accurate insertion and extraction of a wire embedding needle.

To achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the present invention provides a method for preparing a magnesium-based implant wire, the method comprising:

(1) Processing a magnesium-based metal ingot into a magnesium-based metal rod, and sequentially carrying out heat preservation treatment and extrusion on the magnesium-based metal rod to form a first magnesium-based wire rod;

(2) Sequentially cold drawing and annealing the first magnesium-based wire rod in the step (1) to form a second magnesium-based wire rod, wherein the diameter of the second magnesium-based wire rod is smaller than that of the first magnesium-based wire rod;

(3) And (3) performing fixed length, polishing, cleaning, vacuum packaging and sterilization on the second magnesium-based wire rod in the step (2) to obtain the magnesium-based implantation wire.

The preparation method can prepare the magnesium-based implantation line with good mechanical property by adopting heat preservation treatment, extrusion, cold drawing and annealing.

The preparation method of the invention firstly enables the magnesium-based metal rod to reach the recrystallization temperature through heat preservation treatment, is convenient for subsequent extrusion, prevents cracking in the extrusion process, then adopts a cold drawing process to further reduce the diameter of the magnesium-based metal rod, and controls annealing in the cold drawing process, wherein the annealing function is stress relief.

The magnesium-based implantation line is made of metal material, and has low storage and transportation conditions, and only room temperature is needed. In addition, the magnesium-based implantation line has good biocompatibility and can be gradually degraded in body fluid, alkaline products can be generated in the degradation process, and the occurrence probability of inflammation is reduced.

The invention may also consist of.

Preferably, the machining in step (1) comprises turning the skin and cutting in sequence.

Preferably, the magnesium-based metal ingot in the step (1) is made of any one or at least two of pure magnesium, magnesium-zinc alloy or magnesium-zinc-copper alloy, wherein typical but non-limiting combinations are combinations of pure magnesium and magnesium-zinc alloy, combinations of magnesium-zinc-copper alloy and magnesium-zinc alloy, and combinations of pure magnesium and magnesium-zinc-copper alloy.

The mass fraction of zinc in the magnesium-zinc alloy according to the present invention is 1.75 to 6.0wt%, for example, 1.75wt%, 1.9wt%, 2.0wt%, 2.2wt%, 2.5wt%, 3.0wt%, 3.5wt%, 4.0wt%, 4.5wt%, 5.0wt%, 5.5wt% or 6.0wt%, etc., but the present invention is not limited to the above-mentioned values, and other values not mentioned in the above range are equally applicable.

The mass fraction of zinc in the magnesium-zinc-copper alloy of the present invention is 1.75 to 5.2wt%, for example, 1.75wt%, 1.9wt%, 2.0wt%, 2.2wt%, 2.5wt%, 3.0wt%, 3.5wt%, 4.0wt%, 4.5wt%, 5.0wt%, 5.2wt%, etc., and the content of copper is 0.2 to 0.8wt%, for example, 0.2wt%, 0.3wt%, 0.4wt%, 0.5wt%, 0.6wt%, 0.7wt%, 0.8wt%, etc.

The magnesium-based metal ingot contains unavoidable impurities, and the content of the unavoidable impurities is less than or equal to 0.03 weight percent.

The temperature of the heat-retaining treatment is preferably 280 to 430 ℃, and may be 280 ℃, 297 ℃, 314 ℃, 330 ℃, 347 ℃, 364 ℃, 380 ℃, 397 ℃, 414 ℃, 430 ℃ or the like, for example, but is not limited to the values recited, and other values not recited in the range are equally applicable.

The temperature of the heat preservation treatment is 280-430 ℃, when the temperature is lower than the heat preservation temperature, the recrystallization temperature cannot be reached, the bar extrusion is difficult, when the temperature is higher than 430 ℃, the crystal grains grow gradually to influence the material performance, and when the temperature is higher than the melting point of the material, the material cannot be molded.

The time of the heat-retaining treatment is preferably 3.0 to 8.0 hours, and may be, for example, 3.0 hours, 3.6 hours, 4.2 hours, 4.7 hours, 5.3 hours, 5.8 hours, 6.4 hours, 6.9 hours, 7.5 hours, or 8.0 hours, etc., but not limited to the recited values, and other non-recited values within this range are equally applicable.

Preferably, the extrusion ratio of the extrusion is (200-400): 1, for example, it may be 200:1, 220:1, 240:1, 260:1, 280:1, 310:1, 330:1, 350:1, 370:1 or 400:1, etc., but not limited to the recited values, and other non-recited values within the range are equally applicable.

The extrusion temperature is preferably 250 to 400 ℃, and may be 250 ℃, 260 ℃, 280 ℃, 300 ℃, 310 ℃, 330 ℃, 350 ℃, 360 ℃, 380 ℃, 400 ℃, or the like, for example, but not limited to the values recited, and other values not recited in the range are equally applicable.

The diameter of the first magnesium-based wire rod is preferably 1.0 to 3.0mm, and may be, for example, 1.0mm, 1.3mm, 1.5mm, 1.7mm, 1.9mm, 2.2mm, 2.4mm, 2.6mm, 2.8mm, or 3.0mm, etc., but not limited to the values recited, and other values not recited in the range are equally applicable. Preferably, the cold drawing and annealing in step (2) are alternately performed, and each time four cold drawing passes, the annealing is performed.

According to the invention, the magnesium-based implantation line with the up-to-standard mechanical property can be obtained by strictly optimizing the annealing once after four times of cold drawing.

The annealing temperature is preferably 150 to 260 ℃, and may be 150 ℃, 160 ℃, 175 ℃, 180 ℃, 190 ℃, 210 ℃, 220 ℃, 230 ℃, 240 ℃, 260 ℃ or the like, for example, but is not limited to the values recited, and other values not recited in the range are equally applicable.

The annealing temperature is preferably 150-260 ℃, when the temperature is lower than the heat preservation annealing temperature, stress cannot be removed completely, the wire rod is easy to break in the drawing process, and when the temperature is higher than 260 ℃, the crystal grains are too large, and the wire rod performance is affected.

The diameter of the second magnesium-based wire rod is preferably 0.10 to 0.60mm, and may be, for example, 0.10mm, 0.16mm, 0.22mm, 0.25mm, 0.33mm, 0.35mm, 0.44mm, 0.45mm, 0.55mm, or 0.60mm, etc., but not limited to the values recited, and other values not recited in the range are equally applicable.

Preferably, the length of the fixed length in the step (3) is 5 to 60mm, for example, 5mm, 12mm, 18mm, 24mm, 30mm, 36mm, 42mm, 48mm, 54mm or 60mm, etc., but not limited to the recited values, and other non-recited values within the range are equally applicable.

Preferably, the cleaning comprises ultrasonic cleaning.

Preferably, the cleaning solution comprises absolute ethanol.

The drying in the above process is not particularly limited, and any device and method known to those skilled in the art for drying may be used, or may be modified according to the actual process, for example, air drying, vacuum drying, drying or freeze drying, or may be a combination of different methods.

The polishing in the above-described process is not particularly limited, and any means and method for polishing known to those skilled in the art can be used, and can be adjusted according to the actual process.

In a second aspect, the present invention provides a magnesium-based implant wire, the magnesium-based implant wire being made by the manufacturing method of the first aspect.

The magnesium-based implantation line provided by the second aspect of the invention has excellent linear performance and good mechanical property, and can be used as an implantation line better.

The diameter of the magnesium-based implant wire is preferably 0.1 to 0.6mm, and may be, for example, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, or 0.6mm, etc., but is not limited to the values recited, and other values not recited in the range are equally applicable.

In a third aspect, the present invention provides a wire embedding device comprising the magnesium-based embedded wire according to the second aspect.

Preferably, the wire embedding device comprises: push pin, spring, needle handle, needle tube and sheath. The push needle, the needle handle and the needle tube are sequentially and coaxially connected, and the sheath is detachably and coaxially sleeved on the needle handle; the magnesium-based implantation line is arranged in the needle tube; the push pin comprises a pin cap, a pin inserting column, a fixed length, a fixed buckle and a pin core; the needle cap is connected with the needle core through the inserting column; the fixed length scales are arranged on two sides of the needle cap, and the fixed length scales are parallel to the axis of the needle core; the fixed length scale is provided with scales, and one end, far away from the needle cap, of the fixed length scale is connected to the needle handle through a fixed buckle; the plunger is sleeved by the spring, and the diameter of the spring is smaller than that of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, the spring is driven to compress and the fixed length scale is driven to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube.

According to the invention, when the needle cap is pressed down to press the spring, the fixed length scale slides downwards, and the pressed length of the push needle can be judged by reading the scale on the fixed length scale at the top end of the needle handle, so that the fixed length line implantation can be realized more accurately. According to the invention, the spring can be compressed after being pressed, and can rebound after the pressure is removed, so that the wire embedding device can be reset. The push needle can effectively buckle the needle seat and prevent the push needle from sliding or falling randomly.

Preferably, the length of the spring is 10 to 30mm, for example, 10mm, 13mm, 15mm, 17mm, 19mm, 22mm, 24mm, 26mm, 28mm or 30mm, etc., but not limited to the recited values, and other values not recited in the range are equally applicable.

Preferably, the spring is made of medical grade metal and is resiliently compressible.

Preferably, the needle handle comprises an anti-slip handle, a push needle fixing port, an anti-slip part, a push needle sliding port, a needle seat tail part and a connecting part. The anti-slip handle is provided with a push needle fixing opening, and the fixed length scale is connected with the push needle fixing opening in a matching way through the fixing buckle at the end part of the fixed length scale; the anti-slip handle is connected with the tail part of the needle seat through the anti-slip part; a push needle sliding port is arranged at one end of the anti-sliding part far away from the anti-sliding handle, and a connecting line of the push needle fixing port and the push needle sliding port forms a sliding route of the fixed length; the tail part of the needle seat is coaxially connected with the needle tube through the connecting part.

The anti-skid part can enable an operator to precisely control the implantation direction. The anti-slip handle enables an operator to operate with one hand when pushing in the wire rod, and the implantation direction of the wire rod is better controlled. The push needle fixing opening and the push needle sliding opening can prevent the push needle from sliding or falling at will, so that the push needle can only be pushed to the push needle sliding opening along the push needle fixing opening. The needle handle is connected with the needle tube by the connecting part, so that the needle tube is not easy to separate.

Preferably, the material of the needle tube is medical metal, and medical stainless steel is preferred.

The length of the needle tube is preferably 30 to 70mm, and may be, for example, 30mm, 35mm, 39mm, 44mm, 48mm, 53mm, 57mm, 62mm, 66mm, or 70mm, etc., but the present invention is not limited to the above-mentioned values, and other values not mentioned in the above range are equally applicable.

The inner diameter of the needle tube is preferably 0.165 to 0.750mm, and may be, for example, 0.165mm, 0.23mm, 0.295mm, 0.36mm, 0.425mm, 0.49mm, 0.555mm, 0.62mm, 0.685mm or 0.750mm, etc., but not limited to the values recited, and other values not recited in the range are equally applicable.

The outer diameter of the needle tube is preferably 0.3 to 1.1mm, and may be, for example, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, or 1.1mm, etc., but not limited to the values recited, and other values not recited in the range are equally applicable.

Preferably, the surface of the needle tube is provided with graduations.

Preferably, the material of the sheath comprises any one or a combination of at least two of polycarbonate, ABS plastic, resin-containing composite material or metal, wherein typical but non-limiting combinations are combinations of polycarbonate and ABS plastic, combinations of polycarbonate and resin-containing composite material, combinations of resin-containing composite material and ABS plastic, and combinations of polycarbonate and metal.

Preferably, the material of the needle handle comprises any one or a combination of at least two of polycarbonate, ABS plastic, resin-containing composite material or metal, wherein typical but non-limiting combinations are combinations of polycarbonate and ABS plastic, combinations of polycarbonate and resin-containing composite material, combinations of resin-containing composite material and ABS plastic, and combinations of polycarbonate and metal.

Preferably, the material of the push pin comprises any one or a combination of at least two of polycarbonate, ABS plastic, resin-containing composite material or metal, wherein typical but non-limiting combinations are combinations of polycarbonate and ABS plastic, combinations of polycarbonate and resin-containing composite material, combinations of resin-containing composite material and ABS plastic, and combinations of polycarbonate and metal.

Preferably, the sheath is connected with the tail of the needle seat in a matched manner and can be detached.

In a fourth aspect, the present invention provides a wire embedding method performed using the wire embedding device according to the third aspect.

The wire burying method can realize fixed-length automatic resetting wire burying, and can be used for fixed-length wire burying and folding rotary wire burying.

Preferably, the wire embedding method comprises the following steps: the magnesium-based implantation line is put into a needle tube of the line burying device, a needle handle is pinched to be accurately inserted into a preset position, or when the magnesium-based implantation line is in a double-folded state, the needle handle is rotated and a push needle is used for pressing a spring to a first scale of a fixed length; pushing the magnesium-based embedded wire into a preset position, and pulling out the embedded wire needle to finish the embedding of the wire.

Compared with the prior art, the invention has at least the following beneficial effects:

(1) The magnesium-based implantation line prepared by the invention has good biocompatibility, small inflammatory reaction, low storage and transportation requirements and can be stored for more than three years at room temperature; and the maximum elongation is more than or equal to 7.908%, preferably more than or equal to 10.00%;

(2) The push pin of the thread burying device can effectively buckle the needle seat, and prevent the push pin from sliding or falling at will; the anti-slip part and the anti-slip handle are arranged on the needle seat, so that the stability of the contact pin is improved, and the contact pin is convenient to operate by one hand; the spring is arranged, after the push pin pushes the fixed-length implantation line into the tissue, the push pin can rebound automatically, the manual needle withdrawal is not needed, and the accurate needle insertion and extraction can be realized;

(3) The wire embedding device is provided with the spring, and the section of the head part of the needle core, which is away from the tip end part of the needle tube, is empty in the state that the push needle is not stressed, so that the wire embedding method can be used for embedding wires in fixed length and folding and rotating.

Drawings

FIG. 1 is a metallographic view showing a magnesium-based implant wire obtained in example 1-2 of the present invention.

FIG. 2 is a metallographic view showing the magnesium-based implant wire obtained in examples 1 to 6 of the present invention.

FIG. 3 is a metallographic view showing the magnesium-based implant wire obtained in examples 1 to 4 of the present invention.

FIG. 4 is a metallographic view showing the magnesium-based implant wire obtained in comparative example 1 of the present invention.

Fig. 5 is a schematic view showing the overall structure of the wire embedding device according to application examples 1 to 3 of the present invention.

Fig. 6 is a cross-sectional view A-A of the buried wire device in application example 1.

FIG. 7 is a cross-sectional view A-A of the buried wire device in application example 2.

FIG. 8 is a cross-sectional view A-A of the buried wire device in application example 3.

Fig. 9 is a schematic perspective view of a push pin of the wire embedding device according to application examples 1 to 3 of the present invention.

Fig. 10 is a schematic view of the structure of a spring of the wire embedding device according to application examples 1 to 3 of the present invention.

Fig. 11 is a schematic perspective view of a needle holder and a needle tube in the thread-burying device according to application examples 1 to 3 of the present invention.

Fig. 12 is a schematic perspective view of the sheath of the wire embedding device according to application examples 1 to 3 of the present invention.

Wherein, 1-push needle; 101-a needle cap; 102-inserting a column; 103-fixed length; 104-fixing buckle; 105-needle core; 2-a spring; 3-needle handle; 301-a slip-resistant handle; 302-push pin fixing port; 303-an anti-slip portion; 304-pushing needle sliding port; 305-the tail of the needle seat; 306-a connection; 4-needle tube; 5-a sheath; 6-magnesium-based implant wire.

Detailed Description

The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.

As one embodiment of the present invention, there is provided a magnesium-based implant wire, the method of manufacturing the same comprising the steps of:

(1) Processing magnesium-based metal ingot into magnesium-based metal rod, wherein the magnesium-based metal rod is extruded at the temperature of 280-430 ℃ for 3.0-8.0 h and 250-400 ℃ in sequence, and the extrusion ratio is (200-400): 1, so as to form a first magnesium-based wire rod with the diameter of 1.0-3.0 mm;

(2) The first magnesium-based wire rod in the step (1) is subjected to cold drawing and annealing in sequence, the cold drawing and the annealing are alternately performed, and each time four cold drawing processes are performed, the annealing temperature is 150-260 ℃, and a second magnesium-based wire rod with the diameter of 0.10-0.60 mm is formed;

(3) And (3) performing fixed length, polishing, ultrasonic ethanol cleaning, vacuum packaging and sterilization on the second magnesium-based wire rod in the step (2) to obtain the magnesium-based implantation wire.

As one embodiment of the present invention, there is provided a buried wire device including: push needle, spring, needle handle, needle tube and sheath; the push needle, the needle handle and the needle tube are sequentially and coaxially connected, and the sheath is detachably and coaxially sleeved on the needle handle; the magnesium-based implantation line is arranged in the needle tube;

the push pin comprises a pin cap, a pin inserting column, a fixed length, a fixed buckle and a pin core; the needle cap is connected with the needle core through the inserting column; the fixed length scales are arranged on two sides of the needle cap, and the fixed length scales are parallel to the axis of the needle core; the fixed length scale is provided with scales, and one end, far away from the needle cap, of the fixed length scale is connected to the needle handle through a fixed buckle; the plunger is sleeved by the spring, and the diameter of the spring is smaller than that of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, the spring is driven to compress and the fixed length scale is driven to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube.

The needle handle comprises an anti-slip handle, a push needle fixing port, an anti-slip part, a push needle sliding port, a needle seat tail part and a connecting part; the anti-slip handle is provided with a push needle fixing opening, and the fixed length scale is connected with the push needle fixing opening in a matching way through the fixing buckle at the end part of the fixed length scale; the anti-slip handle is connected with the tail part of the needle seat through the anti-slip part; a push needle sliding port is arranged at one end of the anti-sliding part far away from the anti-sliding handle, and a connecting line of the push needle fixing port and the push needle sliding port forms a sliding route of the fixed length; the tail part of the needle seat is coaxially connected with the needle tube through the connecting part.

The sheath is connected with the tail of the needle seat in a matched manner and can be detached.

As one embodiment of the present invention, there is provided a wire embedding method including loading the magnesium-based implant wire into a needle tube of the wire embedding device, pinching a needle handle to be precisely inserted into a predetermined portion, or rotating the needle handle and pressing a spring to a first scale of a fixed length with a push pin when the magnesium-based implant wire is in a doubled state; pushing the magnesium-based embedded wire into a preset position, and pulling out the embedded wire needle to finish the embedding of the wire.

The present invention will be described in further detail below. The following examples are merely illustrative of the present invention and are not intended to represent or limit the scope of the invention as defined in the claims.

It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus are not to be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.

It should be noted that in the description of the present invention, unless explicitly stated and limited otherwise, the terms "disposed," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected or integrally connected. Can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art in a specific case.

The room temperature refers to the natural temperature without additional heat source or cold source, and generally refers to about 25 ℃ and can be naturally changed according to the ambient temperature. It is noted that the magnesium-based implant wire of the present invention does not age in a temperature environment of 60 ℃ or less.

Example 1

The embodiment provides a magnesium-based implantation line, and the preparation method of the magnesium-based implantation line comprises the following steps:

(1) Turning the crust of a magnesium-based metal ingot (the zinc content is 2wt%, and the balance is magnesium and unavoidable impurities), cutting the magnesium-based metal ingot into magnesium-based metal rods, and sequentially carrying out heat preservation treatment at 350 ℃ for 3 hours and extrusion at 300 ℃, wherein the extrusion ratio is 200:1, so as to form a first magnesium-based wire rod with the diameter of 1 mm;

(2) The first magnesium-based wire rod in the step (1) is subjected to cold drawing and annealing in sequence, the cold drawing and the annealing are alternately carried out, the annealing is carried out once every four times of cold drawing, the annealing temperature is 200 ℃, the annealing time is 20 minutes each time, and a second magnesium-based wire rod with the diameter of 0.3mm is formed;

(3) And (3) carrying out fixed length 25mm, polishing, ultrasonic ethanol cleaning, vacuum packaging and sterilization on the second magnesium-based wire rod in the step (2) to obtain the magnesium-based implantation wire.

Test 1 for the specific procedure in example 1, annealing was performed at different times or at different temperatures, and the wire diameter was adjusted, and the mechanical properties thereof are shown in table 1.

TABLE 1

As can be seen from table 1, at the same annealing temperature, the annealing time is gradually prolonged, so that the tensile strength is gradually reduced; the tensile strength does not differ much when the annealing temperature is increased from 180 to 250 c for the same annealing time. In addition, the elongation at maximum force is significantly increased after annealing compared to before annealing. For wires with different diameters, the mechanical properties of the wires can be in a more ideal state by properly adjusting the annealing temperature in the same time.

The metallographic structure of the magnesium-based implant lines obtained in examples 1-2 is shown in FIG. 1, the metallographic structure of the magnesium-based implant lines obtained in examples 1-6 is shown in FIG. 2, and the metallographic structure of the magnesium-based implant lines obtained in examples 1-4 is shown in FIG. 3. As can be seen from fig. 1 to 3, as the annealing temperature increases or the annealing time increases, the metallographic structure of the magnesium zinc alloy wire changes from a deformed structure to a static recrystallized structure, and the structure becomes more uniform.

Example 2

(1) Turning the crust of a magnesium-based metal ingot (pure magnesium Mg 9998), cutting the magnesium-based metal ingot into a magnesium-based metal rod, and sequentially carrying out heat preservation treatment at 400 ℃ for 5h and extrusion at 350 ℃ with the extrusion ratio of 300:1 to form a first magnesium-based wire rod with the diameter of 3 mm;

(2) The first magnesium-based wire rod in the step (1) is subjected to cold drawing and annealing in sequence, the cold drawing and the annealing are alternately carried out, the annealing is carried out once every four times of cold drawing, the annealing temperature is 150 ℃, the annealing time is 15s each time, and a second magnesium-based wire rod with the diameter of 0.6mm is formed;

(3) And (3) performing fixed-length 5mm on the second magnesium-based wire rod in the step (2), polishing, ultrasonic cleaning by ethanol, vacuum packaging and sterilizing to obtain the magnesium-based implantation wire.

Test 2 for the specific procedure in example 2, the wire diameter was adjusted at the same annealing temperature and time, and the mechanical properties are shown in table 2.

TABLE 2

As can be seen from Table 2, the pure magnesium wire has better mechanical properties after annealing for 15s at 150 ℃, and wires with different diameters can obtain better mechanical properties.

Example 3

(1) Turning the crust of a magnesium-based metal ingot (magnesium zinc copper alloy, zinc content of 4.5wt%, copper content of 0.3wt%, and the balance magnesium and unavoidable impurities), cutting into magnesium-based metal rods, and sequentially carrying out heat preservation treatment at 430 ℃ for 8h and extrusion at 400 ℃, wherein the extrusion ratio is 400:1, so as to form a first magnesium-based wire rod with the diameter of 1 mm;

(2) The first magnesium-based wire rod in the step (1) is subjected to cold drawing and annealing in sequence, the cold drawing and the annealing are alternately carried out, the annealing is carried out once every four times of cold drawing, the annealing temperature is 260 ℃, the annealing time is 20 minutes each time, and a second magnesium-based wire rod with the diameter of 0.2mm is formed;

(3) And (3) carrying out fixed-length 50mm on the second magnesium-based wire rod in the step (2), polishing, ultrasonic cleaning by ethanol, vacuum packaging and sterilizing to obtain the magnesium-based implantation wire.

Example 4

This example provides a magnesium-based implant wire that is identical to examples 1-10 except that the temperature of annealing is only 130 ℃.

Example 5

This example provides a magnesium-based implant wire that is identical to examples 1-10 except that the temperature of annealing is 300 ℃.

Example 6

This example provides a magnesium-based implant wire that is identical to examples 1-10 except that the temperature of the insulation treatment is only 200 ℃.

The temperature of the heat preservation treatment in this example makes it difficult to perform the next extrusion operation, and the magnesium-based implant wire cannot be obtained.

Example 7

This example provides a magnesium-based implant wire that is the same as examples 1-10 except that the temperature of the insulation treatment is 500 ℃.

In this embodiment, the temperature of the insulation is too high, so that the grains of the extruded material are too large, and the material is easily broken in the drawing process.

Example 8

This example provides a magnesium-based implant wire that is identical to examples 1-10 except that it is annealed once every 6 cold drawing passes.

The magnesium-based implantation line of the comparative example is easily broken during the drawing process, and continuous production is affected.

Comparative example 1

This comparative example provides a magnesium-based implant wire that is not annealed as compared to example 1, and the remainder are the same as examples 1-10.

As shown in FIG. 4, the metallographic structure of the magnesium-based implant wire of the comparative example shows that the structure without annealing treatment is disordered and the maximum elongation is low from FIG. 4 and Table 3.

Comparative example 2

This comparative example provides a magnesium-based implant wire that is not annealed as compared to example 2, and the remainder are the same as examples 2-4.

Comparative example 3

This comparative example provides a magnesium-based implant wire that is not heat-insulated as compared to example 1, and the remainder are the same as example 1.

This comparative example is difficult to perform the next extrusion operation, and a magnesium-based implant wire cannot be manufactured.

Application example 1

The present application example provides a wire embedding device, as shown in fig. 5 to 6, including: push needle, spring, needle handle, needle tube and sheath; the push needle, the needle handle and the needle tube are sequentially and coaxially connected, and the sheath is detachably and coaxially sleeved on the needle handle; the wire embedding device comprises the magnesium-based implant wire according to the embodiment 1, and the magnesium-based implant wire is arranged in the needle tube.

As shown in fig. 9, the push pin comprises a pin cap, a pin, a fixed length, a fixed buckle and a pin core, wherein the rest parts of the push pin are made of ABS plastic except that the pin core is made of medical stainless steel; the needle cap is connected with the needle core through the inserting column; the fixed length scales are arranged on two sides of the needle cap, and the fixed length scales are parallel to the axis of the needle core; the fixed length scale is provided with scales, and one end, far away from the needle cap, of the fixed length scale is connected to the needle handle through a fixed buckle; the plunger is sleeved by the spring, and the diameter of the spring is smaller than that of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, the spring is driven to compress and the fixed length scale is driven to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube. The spring is shown in fig. 10.

As shown in FIG. 11, the needle handle is made of ABS plastic and comprises an anti-slip handle, a push needle fixing port, an anti-slip part, a push needle sliding port, a needle seat tail part and a connecting part; the anti-slip handle is provided with a push needle fixing opening, and the fixed length scale is connected with the push needle fixing opening in a matching way through the fixing buckle at the end part of the fixed length scale; the anti-slip handle is connected with the tail part of the needle seat through the anti-slip part; a push needle sliding port is arranged at one end of the anti-sliding part far away from the anti-sliding handle, and a connecting line of the push needle fixing port and the push needle sliding port forms a sliding route of the fixed length; the tail part of the needle seat is coaxially connected with the needle tube through the connecting part.

The sheath is made of ABS plastic, and is connected with the tail of the needle seat in a matched manner and can be detached. The sheath is schematically shown in fig. 12.

The spring is made of medical stainless steel and can rebound under pressure, the length of the spring is 30mm, the needle tube is made of medical stainless steel, the length of the needle tube is 70mm, the inner diameter of the needle tube is 0.350mm, and the outer diameter of the needle tube is 0.580mm.

The method for embedding the magnesium-based embedded wire in the wire embedding device comprises the steps of filling the magnesium-based embedded wire in the needle tube of the wire embedding device in the embodiment 1, pinching a needle handle to accurately insert a preset position, then pressing a spring by a push needle until the spring is fully compressed, pushing the magnesium-based embedded wire into the preset position, and pulling out the embedded wire needle to finish the wire embedding.

The thread embedding device provided by the application example is packaged by a paper plastic bag before use, and can be used after sterilization, and push pins in the thread embedding device can effectively buckle a needle seat to prevent the push pins from sliding or falling at will; the anti-slip part and the anti-slip handle are arranged on the needle seat, so that the stability of the contact pin is improved, and the contact pin is convenient to operate by one hand; the spring is arranged, after the push pin pushes the fixed-length implantation line into the tissue, the push pin can rebound automatically, the manual needle withdrawal is not needed, and the accurate needle insertion and extraction can be realized; the spring is arranged, and the section of the head part of the needle core, which is away from the tip end part of the needle tube, is empty in the state that the push needle is not stressed, so that the thread burying method can be used for burying threads in fixed length and folding and rotating.

Application example 2

The present application example provides a wire embedding device, as shown in fig. 5 and 7, including: push needle, spring, needle handle, needle tube and sheath; the push needle, the needle handle and the needle tube are sequentially and coaxially connected, and the sheath is detachably and coaxially sleeved on the needle handle; the wire embedding device comprises the magnesium-based implant wire according to embodiment 2, wherein the magnesium-based implant wire is arranged in the needle tube.

As shown in fig. 9, the push pin comprises a pin cap, a pin, a fixed length, a fixed buckle and a pin core, wherein the rest part of the push pin is made of polycarbonate except that the pin core is made of medical stainless steel; the needle cap is connected with the needle core through the inserting column; the fixed length scales are arranged on two sides of the needle cap, and the fixed length scales are parallel to the axis of the needle core; the fixed length scale is provided with scales, and one end, far away from the needle cap, of the fixed length scale is connected to the needle handle through a fixed buckle; the plunger is sleeved by the spring, and the diameter of the spring is smaller than that of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, the spring is driven to compress and the fixed length scale is driven to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube. The spring is shown in fig. 10.

As shown in fig. 11, the needle handle is made of polycarbonate and comprises an anti-slip handle, a push needle fixing port, an anti-slip part, a push needle sliding port, a needle seat tail part and a connecting part; the anti-slip handle is provided with a push needle fixing opening, and the fixed length scale is connected with the push needle fixing opening in a matching way through the fixing buckle at the end part of the fixed length scale; the anti-slip handle is connected with the tail part of the needle seat through the anti-slip part; a push needle sliding port is arranged at one end of the anti-sliding part far away from the anti-sliding handle, and a connecting line of the push needle fixing port and the push needle sliding port forms a sliding route of the fixed length; the tail part of the needle seat is coaxially connected with the needle tube through the connecting part.

The sheath is made of polycarbonate, is connected with the tail of the needle seat in a matched mode and can be detached. The sheath is schematically shown in fig. 12.

The spring is made of medical stainless steel, can rebound under pressure, the length of the spring is 15mm, the needle tube is made of medical stainless steel, the length of the needle tube is 38mm, the inner diameter of the needle tube is 0.640mm, and the outer diameter of the needle tube is 0.900mm.

The method for embedding the magnesium-based embedded wire in the wire embedding device comprises the steps of filling the magnesium-based embedded wire in the needle tube of the wire embedding device in the embodiment 2, pinching a needle handle to accurately insert a preset position, then pressing a spring by a push needle until the spring is fully compressed, pushing the magnesium-based embedded wire into the preset position, and pulling out the embedded wire needle to finish the wire embedding.

Application example 3

The present application example provides a wire embedding device, as shown in fig. 5 and 8, including: push needle, spring, needle handle, needle tube and sheath; the push needle, the needle handle and the needle tube are sequentially and coaxially connected, and the sheath is detachably and coaxially sleeved on the needle handle; the wire embedding device comprises the magnesium-based implant wire according to embodiment 3, wherein the magnesium-based implant wire is arranged in the needle tube.

As shown in fig. 9, the push pin is made of medical stainless steel and comprises a pin cap, a pin, a fixed length, a fixed buckle and a pin core; the needle cap is connected with the needle core through the inserting column; the fixed length scales are arranged on two sides of the needle cap, and the fixed length scales are parallel to the axis of the needle core; the fixed length scale is provided with scales, and one end, far away from the needle cap, of the fixed length scale is connected to the needle handle through a fixed buckle; the plunger is sleeved by the spring, and the diameter of the spring is smaller than that of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, the spring is driven to compress and the fixed length scale is driven to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube. The spring is shown in fig. 10.

The spring is made of medical stainless steel and can rebound under pressure, the length of the spring is 30mm, the needle tube is made of medical stainless steel, the length of the needle tube is 70mm, the inner diameter of the needle tube is 0.250mm, and the outer diameter of the needle tube is 0.410mm.

The method for embedding the magnesium-based embedded wire in the wire embedding device comprises the steps of loading the magnesium-based embedded wire in the needle tube of the wire embedding device in the embodiment 3, pinching the needle handle to accurately insert the needle handle into a preset position, rotating the needle handle, then pressing the spring to a fixed length by using the push pin to slide downwards for 5mm, pushing the magnesium-based embedded wire into the preset position, and pulling out the embedded wire needle, thus completing the wire embedding.

The thread embedding device provided by the application example is packaged by a paper plastic bag before use, and can be used after sterilization, and push pins in the thread embedding device can effectively buckle a needle seat to prevent the push pins from sliding or falling at will; the anti-slip part and the anti-slip handle are arranged on the needle seat, so that the stability of the contact pin is improved, and the contact pin is convenient to operate by one hand; the spring is arranged, and after the push pin pushes the fixed-length implantation wire into the tissue, the push pin can rebound automatically, and the accurate insertion and extraction of the needle can be realized without manual needle withdrawal.

The testing method comprises the following steps: mechanical property tests were performed on magnesium-based implant lines of examples 1 to 5 and comparative examples 1 to 2, using the GB/T228.1-2010 Metal Material tensile test part 1: room temperature test method tensile strength and ultimate elongation were measured.

The test results of the above examples and comparative examples are shown in table 3.

TABLE 3 Table 3

From tables 1 and 3, the following points can be seen:

(1) For magnesium zinc alloy, wires with the same diameter have reduced tensile strength after annealing, but improved maximum force elongation; wires of the same diameter have little change in tensile strength but increase in maximum force elongation at the same annealing temperature from 150 ℃ to 250 ℃ for the same annealing time. For pure magnesium, the tensile strength after annealing also decreases, while the maximum force elongation does not change much. For magnesium zinc copper alloys, the addition of copper elements increases the tensile strength of the wire. From the above table, the tensile strength and the maximum elongation of the wire rod can be well controlled by heat preservation treatment and annealing in combination, so that the wire rod meets the requirement of implantation.

(2) It can be seen from a combination of examples 1-10 and comparative example 1 that annealing provided a better maximum elongation at force for magnesium-zinc alloy for magnesium-based implant lines, and that annealing used in example 1 increased the maximum elongation at force for magnesium-based implant lines not annealed from 2.058% to 15.634% for comparative example 1, with the same other conditions. Also, from examples 2-4 and comparative example 2, annealing slightly improved the maximum force elongation for magnesium-based implant lines of pure magnesium material.

(3) It can be seen from a combination of examples 1 to 10 and examples 4 to 5 that the annealing temperature in examples 1 to 10 is 200℃and the maximum force elongation in examples 1 to 10 is 15.634% and the maximum force elongation in examples 4 to 5 is only 7.908% and 9.846%, respectively, compared to 130℃and 300℃in examples 4 to 5, respectively, thus indicating that the present invention can better control the tensile strength and the maximum force elongation of the magnesium-based implant wire by controlling the annealing temperature in an appropriate range.

The detailed structural features of the present invention are described in the above embodiments, but the present invention is not limited to the above detailed structural features, that is, it does not mean that the present invention must be implemented depending on the above detailed structural features. It should be apparent to those skilled in the art that any modifications of the present invention, equivalent substitutions of selected components of the present invention, addition of auxiliary components, selection of specific modes, etc., are within the scope of the present invention and the scope of the disclosure.

Claims

1. A method for preparing a magnesium-based implant wire, the method comprising:

2. The method according to claim 1, wherein the temperature of the heat-retaining treatment in step (1) is 280 to 430 ℃;

preferably, the time of the heat preservation treatment is 3.0-8.0 h;

preferably, the extrusion ratio of the extrusion is (200-400): 1;

preferably, the extrusion temperature is 250-400 ℃;

preferably, the diameter of the first magnesium-based wire rod is 1.0-3.0 mm.

3. The method according to claim 1 or 2, wherein the cold drawing and annealing are alternately performed in step (2), and the annealing is performed once every four cold drawing passes;

preferably, the deformation of the cold drawing is 5-10% in each pass;

Preferably, the annealing temperature is 150-260 ℃;

preferably, the annealing time is 5-20 min;

preferably, the diameter of the second magnesium-based wire rod is 0.10-0.60 mm.

4. A method according to any one of claims 1 to 3, wherein the fixed length in step (3) is 5 to 60mm.

5. A magnesium-based implant wire, characterized in that it is manufactured by the method for manufacturing a magnesium-based implant wire according to any one of claims 1 to 4.

6. A wire embedding device, characterized in that the wire embedding device comprises the magnesium-based embedded wire as claimed in claim 5.

7. The buried wire device according to claim 6, wherein said buried wire device comprises: push needle, spring, needle handle, needle tube and sheath; the push needle, the needle handle and the needle tube are sequentially and coaxially connected, and the sheath is detachably and coaxially sleeved on the needle handle; the magnesium-based implantation line is arranged in the needle tube;

8. The wire embedding apparatus as claimed in claim 7, wherein the length of the spring is 10 to 30mm;

preferably, the needle handle comprises an anti-slip handle, a push needle fixing port, an anti-slip part, a push needle sliding port, a needle seat tail part and a connecting part; the anti-slip handle is provided with a push needle fixing opening, and the fixed length scale is connected with the push needle fixing opening in a matching way through the fixing buckle at the end part of the fixed length scale; the anti-slip handle is connected with the tail part of the needle seat through the anti-slip part; a push needle sliding port is arranged at one end of the anti-sliding part far away from the anti-sliding handle, and a connecting line of the push needle fixing port and the push needle sliding port forms a sliding route of the fixed length; the tail part of the needle seat is coaxially connected with the needle tube through the connecting part;

preferably, the length of the needle tube is 30-70 mm;

preferably, the inner diameter of the needle tube is 0.165-0.750 mm;

preferably, the outer diameter of the needle tube is 0.3-1.1 mm;

preferably, the surface of the needle tube is provided with scales;

9. A wire embedding method, characterized in that the wire embedding method is performed by using the wire embedding device according to any one of claims 6 to 8.

10. The method of claim 9, wherein the method of burying a wire comprises:

the magnesium-based implantation line is put into a needle tube of the line burying device, a needle handle is pinched to be accurately inserted into a preset position, or when the magnesium-based implantation line is in a doubling state, the needle handle is rotated and a push needle is used for pressing a spring to a first scale of a fixed length; pushing the magnesium-based embedded wire into a preset position, and pulling out the embedded wire needle to finish the embedding of the wire.