A magnesium-based embedded wire, its preparation method, embedding device, and embedding method.

Abstract

This invention provides a magnesium-based implantable wire and its preparation method, implantation device, and implantation method. The preparation method includes: (1) processing a magnesium-based metal ingot into a magnesium-based metal rod, wherein the magnesium-based metal rod is subjected to heat preservation treatment and extrusion in sequence to form a first magnesium-based wire material; (2) in step (1), the first magnesium-based wire material is subjected to cold drawing and annealing in sequence to form a second magnesium-based wire material, wherein the diameter of the second magnesium-based wire material is smaller than the diameter of the first magnesium-based wire material; (3) in step (2), the second magnesium-based wire material is subjected to length determination, polishing, cleaning, vacuum sealing, and sterilization to obtain the magnesium-based implantable wire. The magnesium-based implantable wire has low storage and transportation requirements, low inflammatory reaction, and good mechanical properties; the pusher of the implantation device can effectively hold the needle seat, preventing the pusher from sliding or falling off at will, and can achieve precise positioning of the wire, with broad application prospects.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a magnesium-based implantable thread, its preparation method, implantation device, and implantation method. Background Technology

[0002] As public acceptance of cosmetic procedures increases, thread lifting is increasingly being used in areas such as facial rejuvenation and weight loss. Thread lifting is a cosmetic procedure that involves embedding absorbable solid threads into the tissue. This method can fill or lift sagging tissue, and as the solid threads degrade within the body, it stimulates collagen production, achieving cosmetic results. It can also provide continuous stimulation to acupoints, thus promoting weight loss.

[0003] Currently, commercially available thread embedding products commonly use two methods: injection and folded-in, rotating-injection. The former involves placing the solid thread at the head of the needle tube, then using a pusher to insert the pusher needle core from the needle hub into the tube, pushing the solid thread into the tissue. During implantation, the direction and depth need to be controlled by the needle hub; however, the needle hub lacks a handle, resulting in poor accuracy, and the pusher needle core must be manually withdrawn, making the operation inconvenient. Furthermore, when loading the solid thread into the needle tube, the pusheder needle can easily slide backward or fall off, affecting the operation. The latter involves pre-loading half of the solid thread into the needle tube, folding the exposed half in half, inserting the needle into the tissue, rotating it, and then pulling out the needle, leaving the solid thread in the tissue. This process cannot limit the length of the needle tube inserted into the body, easily causing injury.

[0004] Commercially available thread lifting products typically use solid threads made of biodegradable materials such as collagen or polydioxanone. These materials have poor mechanical properties, require strict storage and transportation conditions, and may cause rejection or inflammatory reactions after implantation.

[0005] Therefore, there is a need to develop a new type of embedded wire material, as well as an embedded wire device and method that prevents the push pin from sliding or falling off during installation and allows for precise insertion and removal of the embedded wire pin during the embedded wire process. Summary of the Invention

[0006] In view of the problems existing in the prior art, the present invention provides a magnesium-based implanted thread and its preparation method, implantation device and implantation method, which solves the problems of poor mechanical properties, high storage and transportation requirements and easy inflammation caused by existing implanted threads. At the same time, the implantation device can realize precise insertion and removal of implantation needles.

[0007] To achieve this objective, the present invention adopts the following technical solution:

[0008] In a first aspect, the present invention provides a method for preparing a magnesium-based embedded wire, the method comprising:

[0009] (1) A magnesium-based metal ingot is processed into a magnesium-based metal rod, and the magnesium-based metal rod is successively subjected to heat preservation treatment and extrusion to form a first magnesium-based material;

[0010] (2) Step (1) The first magnesium base material is cold drawn and annealed in sequence to form the second magnesium base material, the diameter of the second magnesium base material is smaller than the diameter of the first magnesium base material;

[0011] (3) Step (2) The second magnesium base material is lengthened, polished, cleaned, vacuum-sealed and sterilized to obtain the magnesium-based embedded wire.

[0012] The preparation method of the present invention can produce magnesium-based embedded wires with excellent mechanical properties by employing heat preservation treatment, extrusion, cold drawing and annealing.

[0013] The preparation method of the present invention first uses heat preservation treatment to bring the magnesium-based metal rod to the recrystallization temperature, which facilitates subsequent extrusion and prevents cracking during extrusion. Then, the diameter is further reduced by cold drawing process, and annealing is controlled during cold drawing process. The purpose of annealing is to relieve stress. Through the above preparation process, the present invention can produce magnesium-based embedded wire with excellent mechanical properties.

[0014] Magnesium-based implants are metallic materials with low storage and transportation requirements, requiring only room temperature. Furthermore, magnesium-based implants have good biocompatibility and gradually degrade in body fluids, producing alkaline products during degradation, which reduces the probability of inflammation.

[0015] The invention may also include or be composed of.

[0016] Preferably, the processing in step (1) includes turning the outer skin and cutting in sequence.

[0017] Preferably, the material of the magnesium-based metal ingot in step (1) includes any one or a combination of at least two of pure magnesium, magnesium-zinc alloys or magnesium-zinc-copper alloys, wherein typical but non-limiting combinations are a combination of pure magnesium and magnesium-zinc alloys, a combination of magnesium-zinc-copper alloys and magnesium-zinc alloys, and a combination of pure magnesium and magnesium-zinc-copper alloys.

[0018] The zinc mass fraction in the magnesium-zinc alloy described in this invention is 1.75 to 6.0 wt%, for example, it can be 1.75 wt%, 1.9 wt%, 2.0 wt%, 2.2 wt%, 2.5 wt%, 3.0 wt%, 3.5 wt%, 4.0 wt%, 4.5 wt%, 5.0 wt%, 5.5 wt%, or 6.0 wt%, etc., but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0019] The zinc content in the magnesium-zinc-copper alloy of the present invention is 1.75-5.2 wt%, for example, it can be 1.75 wt%, 1.9 wt%, 2.0 wt%, 2.2 wt%, 2.5 wt%, 3.0 wt%, 3.5 wt%, 4.0 wt%, 4.5 wt%, 5.0 wt%, 5.2 wt%, etc., and the copper content is 0.2-0.8 wt%, for example, it can be 0.2 wt%, 0.3 wt%, 0.4 wt%, 0.5 wt%, 0.6 wt%, 0.7 wt%, or 0.8 wt%, etc.

[0020] The magnesium-based metal ingots described in this invention contain unavoidable impurities, and the content of unavoidable impurities is ≤0.03wt%.

[0021] Preferably, the temperature of the heat preservation treatment is 280 to 430°C, for example, it can be 280°C, 297°C, 314°C, 330°C, 347°C, 364°C, 380°C, 397°C, 414°C or 430°C, etc., but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0022] The present invention further preferably uses a heat preservation temperature of 280-430°C. When the temperature is lower than this heat preservation temperature, the recrystallization temperature cannot be reached, which makes it difficult to extrude the rod. When the temperature is higher than 430°C, the grains gradually grow, affecting the material properties. When the temperature is too high and reaches the melting point of the material, the material cannot be formed.

[0023] Preferably, the heat preservation treatment time is 3.0 to 8.0 hours, for example, it can be 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, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0024] Preferably, the extrusion ratio is (200-400):1, for example, it can be 200:1, 220:1, 240:1, 260:1, 280:1, 310:1, 330:1, 350:1, 370:1 or 400:1, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0025] Preferably, the extrusion temperature is 250 to 400°C, for example, it can be 250°C, 260°C, 280°C, 300°C, 310°C, 330°C, 350°C, 360°C, 380°C or 400°C, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0026] Preferably, the diameter of the first magnesium baseline material is 1.0–3.0 mm, for example, it can be 1.0 mm, 1.3 mm, 1.5 mm, 1.7 mm, 1.9 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, or 3.0 mm, but is not limited to the listed values; other unlisted values ​​within this range are also applicable. Preferably, the cold drawing and annealing in step (2) are performed alternately, with annealing performed after every four cold drawing passes.

[0027] This invention strictly selects an annealing process after every four cold drawing cycles to obtain magnesium-based embedded wires with satisfactory mechanical properties.

[0028] Preferably, the annealing temperature is 150 to 260°C, for example, it can be 150°C, 160°C, 175°C, 180°C, 190°C, 210°C, 220°C, 230°C, 240°C or 260°C, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0029] The present invention further preferably uses an annealing temperature of 150-260°C. When the temperature is lower than this holding annealing temperature, the stress cannot be completely relieved, which will make the wire easy to break during the drawing process. When the temperature is higher than 260°C, the grains are too large, which will affect the wire performance.

[0030] Preferably, the diameter of the second magnesium baseline material is 0.10 to 0.60 mm, for example, it can be 0.10 mm, 0.16 mm, 0.22 mm, 0.25 mm, 0.33 mm, 0.35 mm, 0.44 mm, 0.45 mm, 0.55 mm or 0.60 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0031] Preferably, the fixed length mentioned in step (3) is 5 to 60 mm, for example, it can be 5 mm, 12 mm, 18 mm, 24 mm, 30 mm, 36 mm, 42 mm, 48 mm, 54 mm or 60 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0032] Preferably, the cleaning includes ultrasonic cleaning.

[0033] Preferably, the cleaning solution used for cleaning includes anhydrous ethanol.

[0034] The present invention does not impose any special restrictions on the drying process described above. Any device and method known to those skilled in the art for drying can be used. The process can also be adjusted according to the actual process. For example, it can be air drying, vacuum drying, oven drying or freeze drying, or a combination of different methods.

[0035] The present invention does not impose any special restrictions on polishing in the above process. Any device and method known to those skilled in the art for polishing can be used, and adjustments can be made according to the actual process.

[0036] In a second aspect, the present invention provides a magnesium-based embedded wire, which is prepared by the preparation method described in the first aspect.

[0037] The magnesium-based embedding wire provided by the second aspect of the present invention has excellent performance and good mechanical properties, and can be used as an embedding wire.

[0038] Preferably, the diameter of the magnesium-based implantation wire is 0.1 to 0.6 mm, for example, it can be 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm or 0.6 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0039] Thirdly, the present invention provides a wire embedding device, the wire embedding device comprising the magnesium-based embedded wire described in the second aspect.

[0040] Preferably, the implantation device includes: a pusher needle, a spring, a needle handle, a needle tube, and a sheath. The pusher needle, needle handle, and needle tube are coaxially connected in sequence, and the sheath is detachably coaxially sleeved on the needle handle; the magnesium-based implantation thread is disposed inside the needle tube; the pusher needle includes a needle cap, a post, a length ruler, a fixing buckle, and a needle core; the needle cap is connected to the needle core through the post; the length ruler is disposed on both sides of the needle cap, and the axis of the length ruler is parallel to that of the needle core; the length ruler has a scale, and the end of the length ruler away from the needle cap is connected to the needle handle by the fixing buckle; the post is sleeved by the spring, and the diameter of the spring is smaller than the diameter of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, it causes the spring to compress and causes the length ruler to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube.

[0041] In this invention, when the needle cap is pressed down and the spring is pushed, the length ruler slides downwards accordingly. By reading the scale on the length ruler at the top of the needle handle, the length of the push needle can be determined, thus achieving more precise thread embedding. In this invention, the spring can compress under pressure and spring back after the pressure is released, thereby resetting the thread embedding device. The push needle of this invention can effectively hold the needle seat, preventing the push needle from sliding or falling off.

[0042] Preferably, the length of the spring is 10 to 30 mm, for example, it can be 10 mm, 13 mm, 15 mm, 17 mm, 19 mm, 22 mm, 24 mm, 26 mm, 28 mm or 30 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0043] Preferably, the spring is made of medical-grade metal and can rebound when compressed.

[0044] Preferably, the needle handle includes an anti-slip handle, a needle-pushing fixing port, an anti-slip part, a needle-pushing sliding port, a needle seat tail, and a connecting part. The anti-slip handle has a needle-pushing fixing port, and the length ruler is connected to the needle-pushing fixing port via a fixing buckle at its end; the anti-slip handle is connected to the needle seat tail via the anti-slip part; the anti-slip part has a needle-pushing sliding port at its end away from the anti-slip handle, and the line connecting the needle-pushing fixing port and the needle-pushing sliding port forms the sliding path of the length ruler; the needle seat tail is coaxially connected to the needle tube via the connecting part.

[0045] In this invention, the anti-slip part allows the operator to precisely control the implantation direction. The anti-slip handle allows the operator to operate with one hand when pushing in the suture, providing better control over the implantation direction. The pusher fixing port and pusher sliding port prevent the pusher from sliding or falling off, ensuring it can only be pushed in along the pusher fixing port to the pusher sliding port. The connecting part connects the needle handle and the needle tube, making them difficult to separate.

[0046] Preferably, the needle is made of medical-grade metal, and more preferably medical-grade stainless steel.

[0047] Preferably, the length of the needle is 30 to 70 mm, for example, it can be 30 mm, 35 mm, 39 mm, 44 mm, 48 mm, 53 mm, 57 mm, 62 mm, 66 mm or 70 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0048] Preferably, the inner diameter of the needle is 0.165 to 0.750 mm, for example, it can be 0.165 mm, 0.23 mm, 0.295 mm, 0.36 mm, 0.425 mm, 0.49 mm, 0.555 mm, 0.62 mm, 0.685 mm or 0.750 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0049] Preferably, the outer diameter of the needle is 0.3 to 1.1 mm, for example, it can be 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm or 1.1 mm, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0050] Preferably, the surface of the syringe is provided with graduations.

[0051] Preferably, the material of the sheath includes 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 a combination of polycarbonate and ABS plastic, a combination of polycarbonate and resin-containing composite material, a combination of resin-containing composite material and ABS plastic, and a combination of polycarbonate and metal.

[0052] Preferably, the needle handle is made of 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 a combination of polycarbonate and ABS plastic, a combination of polycarbonate and resin-containing composite material, a combination of resin-containing composite material and ABS plastic, and a combination of polycarbonate and metal.

[0053] Preferably, the material of the pusher includes 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 a combination of polycarbonate and ABS plastic, a combination of polycarbonate and resin-containing composite material, a combination of resin-containing composite material and ABS plastic, and a combination of polycarbonate and metal.

[0054] Preferably, the sheath is connected to the tail of the needle hub and is detachable.

[0055] Fourthly, the present invention provides a method for burying wires, wherein the method is performed using the burying device described in the third aspect.

[0056] The wire embedding method of the present invention can realize fixed-length automatic reset embedding, and can be used for both fixed-length embedding and folded rotation embedding.

[0057] Preferably, the embedding method includes: inserting the magnesium-based embedding thread into the needle tube of the embedding device, pinching the needle handle to accurately insert it into a predetermined position, or when the magnesium-based embedding thread is folded in half, rotating the needle handle and pressing the spring with the push needle to the first mark of the length ruler; pushing the magnesium-based embedding thread into the predetermined position, pulling out the embedding needle, and completing the embedding.

[0058] Compared with the prior art, the present invention has at least the following beneficial effects:

[0059] (1) The magnesium-based implanted thread prepared by the present invention has good biocompatibility, low inflammatory response, and low storage and transportation requirements. It can be stored at room temperature for more than three years; and the maximum force elongation is ≥7.908%, preferably ≥10.00%.

[0060] (2) The push needle of the embedding device provided by the present invention can effectively hold the needle seat to prevent the push needle from sliding or falling off at will; moreover, the needle seat is provided with an anti-slip part and an anti-slip handle, which improves the stability of the needle insertion and facilitates one-handed operation; it is provided with a spring, and after the push needle pushes the fixed-length embedding thread into the tissue, it can automatically rebound, without the need for manual needle withdrawal, and can achieve precise needle insertion and withdrawal.

[0061] (3) The embedding device prepared by the present invention is equipped with a spring. When the needle is not under force, there is a gap between the head of the needle core and the tip of the needle tube. Therefore, the embedding method of the present invention can be used for embedding of fixed length or for embedding of folded and rotated needles. Attached Figure Description

[0062] Figure 1 These are metallographic images of the magnesium-based embedded wires obtained in Examples 1-2 of this invention.

[0063] Figure 2 These are metallographic images of the magnesium-based embedded wires obtained in Examples 1-6 of this invention.

[0064] Figure 3 These are metallographic images of the magnesium-based embedded wires obtained in Examples 1-4 of this invention.

[0065] Figure 4 This is a metallographic diagram of the magnesium-based embedded wire obtained in Comparative Example 1 of this invention.

[0066] Figure 5 This is a schematic diagram of the overall structure of the buried wire device described in Application Examples 1 to 3 of the present invention.

[0067] Figure 6 This is a cross-sectional view AA of the buried wire device in Application Example 1.

[0068] Figure 7 This is a cross-sectional view AA of the buried wire device in Application Example 2.

[0069] Figure 8 This is a cross-sectional view AA of the buried wire device in Application Example 3.

[0070] Figure 9 This is a three-dimensional structural schematic diagram of the pusher of the buried wire device described in Application Examples 1 to 3 of the present invention.

[0071] Figure 10 This is a schematic diagram of the structure of the spring in the buried wire device described in Application Examples 1 to 3 of the present invention.

[0072] Figure 11 This is a three-dimensional structural diagram of the needle holder and needle tube in the suture embedding device described in Application Examples 1 to 3 of the present invention.

[0073] Figure 12 This is a three-dimensional structural schematic diagram of the sheath of the buried wire device described in Application Examples 1 to 3 of the present invention.

[0074] Among them, 1-push needle; 101-needle cap; 102-insertion post; 103-length ruler; 104-fixing buckle; 105-needle core; 2-spring; 3-needle handle; 301-anti-slip handle; 302-push needle fixing port; 303-anti-slip part; 304-push needle sliding port; 305-needle seat tail; 306-connecting part; 4-needle tube; 5-sheath; 6-magnesium-based implantation thread. Detailed Implementation

[0075] The technical solution of the present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0076] As a specific embodiment of the present invention, a magnesium-based embedded wire is provided, the preparation method of which includes the following steps:

[0077] (1) Magnesium-based metal ingots are processed into magnesium-based metal rods, which are then subjected to heat treatment at 280-430℃ for 3.0-8.0h and extrusion at 250-400℃ in sequence, with an extrusion ratio of (200-400):1, to form a first magnesium-based material with a diameter of 1.0-3.0mm;

[0078] (2) Step (1) The first magnesium base material is cold drawn and annealed in sequence. The cold drawing and annealing are carried out alternately. After every four cold drawing passes, an annealing is carried out. The annealing temperature is 150-260℃ to form a second magnesium base material with a diameter of 0.10-0.60mm.

[0079] (3) In step (2), the second magnesium base material is lengthened, polished, ultrasonically cleaned with ethanol, vacuum-sealed and sterilized to obtain the magnesium-based embedded wire.

[0080] As a specific embodiment of the present invention, a thread embedding device is provided, the thread embedding device comprising: a push needle, a spring, a needle handle, a needle tube, and a sheath; the push needle, the needle handle, and the needle tube are coaxially connected in sequence, and the sheath is detachably coaxially sleeved on the needle handle; the magnesium-based implanted thread is disposed inside the needle tube;

[0081] The pusher needle includes a needle cap, a post, a length ruler, a fixing buckle, and a needle core; the needle cap is connected to the needle core via the post; the length ruler is located on both sides of the needle cap, and the axis of the length ruler is parallel to that of the needle core; the length ruler has graduations, and the end of the length ruler away from the needle cap is connected to the needle handle by the fixing buckle; the post is held in place by a spring, and the diameter of the spring is smaller than the diameter of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, it causes the spring to compress and the length ruler to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube.

[0082] The needle handle includes an anti-slip handle, a needle fixing port, an anti-slip part, a needle sliding port, a needle seat tail, and a connecting part; the anti-slip handle is provided with a needle fixing port, and the length ruler is connected to the needle fixing port through the fixing buckle at its end; the anti-slip handle is connected to the needle seat tail through the anti-slip part; the anti-slip part is provided with a needle sliding port at one end away from the anti-slip handle, and the line connecting the needle fixing port and the needle sliding port forms the sliding path of the length ruler; the needle seat tail is coaxially connected to the needle tube through the connecting part.

[0083] The sheath is connected to the tail of the needle hub and is detachable.

[0084] As a specific embodiment of the present invention, a method for embedding a magnesium-based implantable thread is provided. The method includes inserting the magnesium-based implantable thread into the needle tube of the implantation device, pinching the needle handle to accurately insert it into a predetermined position, or rotating the needle handle and pressing the spring with a push needle to the first mark of the length ruler when the magnesium-based implantable thread is folded in half; pushing the magnesium-based implantable thread into the predetermined position, pulling out the implantation needle, and completing the implantation.

[0085] The present invention will now be described in further detail. However, the examples described below are merely simplified examples of the present invention and do not represent or limit the scope of protection of the present invention. The scope of protection of the present invention is determined by the claims.

[0086] It should be understood that in the description of this invention, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0087] It should be noted that, in the description of this invention, unless otherwise explicitly specified and limited, the terms "set," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection or an integral connection. They can be a direct connection or an indirect connection through an intermediate medium, or a connection within two components. Those skilled in the art will understand the specific meaning of these terms in this invention based on the specific circumstances.

[0088] The room temperature mentioned in this invention refers to the natural temperature without an additional heating or cooling source, generally around 25°C, but can also vary naturally depending on the ambient temperature. It is worth noting that the magnesium-based embedded wire of this invention will not age at temperatures below 60°C.

[0089] Example 1

[0090] This embodiment provides a magnesium-based implantable wire, the preparation method of which includes the following steps:

[0091] (1) Magnesium-based metal ingots (zinc content 2wt%, the remainder being magnesium and unavoidable impurities) are machined and cut into magnesium-based metal rods. The magnesium-based metal rods are then subjected to heat treatment at 350℃ for 3h and extrusion at 300℃ in sequence, with an extrusion ratio of 200:1, to form a first magnesium-based material with a diameter of 1mm.

[0092] (2) Step (1) The first magnesium base material is subjected to cold drawing and annealing in sequence. The cold drawing and annealing are carried out alternately. After every four cold drawing passes, annealing is carried out once. The annealing temperature is 200℃ and the annealing time is 20min each time, forming a second magnesium base material with a diameter of 0.3mm.

[0093] (3) In step (2), the second magnesium base material is cut to a fixed length of 25mm, polished, ultrasonically cleaned with ethanol, vacuum-sealed and sterilized to obtain the magnesium-based embedded wire.

[0094] Experiment 1, following the specific process in Example 1, involved annealing at different times or temperatures, and adjusting the diameter of the wire. The mechanical properties of the wire are shown in Table 1.

[0095] Table 1

[0096]

[0097]

[0098] As shown in Table 1, at the same annealing temperature, gradually increasing the annealing time leads to a gradual decrease in tensile strength; however, at the same annealing time, the tensile strength shows little difference when the annealing temperature increases from 180℃ to 250℃. Furthermore, the maximum elongation at maximum force is significantly higher after annealing than before. For wires of different diameters, by appropriately adjusting the annealing temperature within the same time period, the mechanical properties of the wires can be brought to a relatively ideal state.

[0099] The metallographic images of the magnesium-based implanted wires obtained in Examples 1-2 are shown below. Figure 1 As shown, the metallographic structures of the magnesium-based embedded wires obtained in Examples 1-6 are as follows. Figure 2 As shown, the metallographic structures of the magnesium-based embedded wires obtained in Examples 1-4 are as follows. Figure 3As shown. From Figures 1-3 It can be seen that as the annealing temperature increases or the annealing time is prolonged, the microstructure of the magnesium-zinc alloy wire changes from a deformed structure to a static recrystallized structure, and the structure becomes more uniform.

[0100] Example 2

[0101] This embodiment provides a magnesium-based implantable wire, the preparation method of which includes the following steps:

[0102] (1) Magnesium-based metal ingots (pure magnesium Mg9998) are machined and cut into magnesium-based metal rods. The magnesium-based metal rods are then subjected to heat treatment at 400℃ for 5 hours and extrusion at 350℃ in sequence. The extrusion ratio is 300:1 to form a first magnesium-based material with a diameter of 3mm.

[0103] (2) Step (1) The first magnesium base material is cold-drawn and annealed in sequence. The cold drawing and annealing are carried out alternately. After every four cold drawing passes, an annealing is carried out. The annealing temperature is 150°C and the annealing time is 15s, forming a second magnesium base material with a diameter of 0.6mm.

[0104] (3) In step (2), the second magnesium base material is fixed to a length of 5mm, polished, ultrasonically cleaned with ethanol, vacuum-sealed and sterilized to obtain the magnesium-based embedded wire.

[0105] Experiment 2, following the specific process in Example 2, adjusted the diameter of the wire under the same annealing temperature and time, and the mechanical properties are shown in Table 2.

[0106] Table 2

[0107]

[0108] As can be seen from Table 2, pure magnesium wire has good mechanical properties after annealing at 150℃ for 15s, and wires of different diameters can achieve good mechanical properties.

[0109] Example 3

[0110] This embodiment provides a magnesium-based implantable wire, the preparation method of which includes the following steps:

[0111] (1) Magnesium-based metal ingots (magnesium-zinc-copper alloy, zinc content 4.5wt%, copper content 0.3wt%, the remainder being magnesium and unavoidable impurities) are machined and cut into magnesium-based metal rods. The magnesium-based metal rods are then subjected to heat treatment at 430℃ for 8 hours and extrusion at 400℃ in sequence, with an extrusion ratio of 400:1, to form a first magnesium-based material with a diameter of 1mm.

[0112] (2) Step (1) The first magnesium base material is subjected to cold drawing and annealing in sequence. The cold drawing and annealing are carried out alternately. After every four cold drawing passes, annealing is carried out once. The annealing temperature is 260℃ and the annealing time is 20min each time, forming a second magnesium base material with a diameter of 0.2mm.

[0113] (3) In step (2), the second magnesium base material is fixed to a length of 50 mm, polished, ultrasonically cleaned with ethanol, vacuum-sealed and sterilized to obtain the magnesium-based embedded wire.

[0114] Example 4

[0115] This embodiment provides a magnesium-based embedded wire, which is the same as that in Examples 1-10 except that the annealing temperature is only 130°C.

[0116] Example 5

[0117] This embodiment provides a magnesium-based embedded wire, which is the same as that in Examples 1-10 except that the annealing temperature is 300°C.

[0118] Example 6

[0119] This embodiment provides a magnesium-based embedded wire, which is the same as that in Examples 1-10 except that the temperature of the heat preservation treatment is only 200°C.

[0120] In this embodiment, the temperature during the heat preservation process makes it difficult to perform the next extrusion operation, thus preventing the production of magnesium-based embedded wires.

[0121] Example 7

[0122] This embodiment provides a magnesium-based embedded wire, which is the same as that in Examples 1-10 except that the temperature of the heat preservation treatment is 500℃.

[0123] In this embodiment, the excessively high insulation temperature resulted in excessively large extruded material grains, which ultimately made the material prone to breakage during the drawing process.

[0124] Example 8

[0125] This embodiment provides a magnesium-based embedded wire, which is identical to that in Examples 1-10 except that it is annealed only after every 6 cold drawing processes.

[0126] The magnesium-based embedded wire in this comparative example is prone to breakage during the drawing process, which affects continuous production.

[0127] Comparative Example 1

[0128] This comparative example provides a magnesium-based implantable wire, which is not annealed compared to Example 1, but otherwise is the same as Examples 1-10.

[0129] The metallographic diagram of the magnesium-based embedded wire in this comparative example is as follows: Figure 4 As shown, from Figure 4 As can be seen from Table 3, the microstructure of the unannealed product is relatively disordered and the maximum elongation is low.

[0130] Comparative Example 2

[0131] This comparative example provides a magnesium-based implantable wire, which is not annealed compared to Example 2, but otherwise is the same as Examples 2-4.

[0132] Comparative Example 3

[0133] This comparative example provides a magnesium-based embedded wire, which, compared to Example 1, does not undergo heat preservation treatment, but is otherwise the same as Example 1.

[0134] The comparative sample is difficult to extrude further, and magnesium-based embedded wires cannot be produced.

[0135] Application Example 1

[0136] This application example provides a buried wire device, such as Figures 5-6 As shown, the implantation device includes: a push needle, a spring, a needle handle, a needle tube, and a sheath; the push needle, needle handle, and needle tube are coaxially connected in sequence, and the sheath is detachably coaxially sleeved on the needle handle; the implantation device includes the magnesium-based implantation thread described in Example 1, and the magnesium-based implantation thread is disposed inside the needle tube.

[0137] like Figure 9 As shown, the push needle includes a needle cap, a post, a length ruler, a fixing buckle, and a needle core. Except for the needle core, which is made of medical-grade stainless steel, the rest of the push needle is made of ABS plastic. The needle cap is connected to the needle core via the post. The length ruler is located on both sides of the needle cap, and its axis is parallel to that of the needle core. The length ruler has graduations, and one end of the length ruler away from the needle cap is connected to the needle handle by the fixing buckle. The post is held in place by a spring, and the diameter of the spring is smaller than the diameter of the needle cap. The needle core is inserted into the needle handle and the needle tube. When the needle cap is pressed down, it compresses the spring and causes the length ruler 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... Figure 10 As shown.

[0138] like Figure 11As shown, the needle handle is made of ABS plastic and includes an anti-slip handle, a needle fixing port, an anti-slip part, a needle sliding port, a needle seat tail, and a connecting part. The anti-slip handle has a needle fixing port, and the length ruler is connected to the needle fixing port through the fixing buckle at its end. The anti-slip handle is connected to the needle seat tail through the anti-slip part. The anti-slip part has a needle sliding port at one end away from the anti-slip handle, and the line connecting the needle fixing port and the needle sliding port forms the sliding path of the length ruler. The needle seat tail is coaxially connected to the needle tube through the connecting part.

[0139] The sheath is made of ABS plastic, mates with the tail of the needle hub, and is detachable. See the schematic diagram of the sheath. Figure 12 .

[0140] The spring is made of medical-grade stainless steel and can rebound when compressed. The spring is 30mm long. The needle tube is made of medical-grade stainless steel, with a length of 70mm, an inner diameter of 0.350mm, and an outer diameter of 0.580mm.

[0141] The embedding method of the embedding device includes inserting the magnesium-based embedding thread described in Example 1 into the needle tube of the embedding device, pinching the needle handle to accurately insert it into the predetermined position, then using the push needle to press the spring until the spring is fully compressed, so that the magnesium-based embedding thread is pushed into the predetermined position, and then pulling out the embedding needle to complete the embedding.

[0142] The suture embedding device provided in this application example is packaged in a paper-plastic bag and sterilized before use. The push needle in the suture embedding device can effectively lock the needle seat, preventing the push needle from sliding or falling off at will. Moreover, the needle seat is equipped with an anti-slip part and an anti-slip handle, which improves the stability of needle insertion and facilitates one-handed operation. A spring is provided, so after the push needle pushes the fixed-length suture into the tissue, it can automatically spring back without manual needle withdrawal, which can achieve precise needle insertion and withdrawal. Moreover, because of the spring, when the push needle is not under force, there is a section between the head of the needle core and the tip of the needle tube that is empty. Therefore, the suture embedding method of the present invention can be used for fixed-length suture embedding as well as for folded and rotated suture embedding.

[0143] Application Example 2

[0144] This application example provides a buried wire device, such as Figure 5 and Figure 7 As shown, the implantation device includes: a push needle, a spring, a needle handle, a needle tube, and a sheath; the push needle, needle handle, and needle tube are coaxially connected in sequence, and the sheath is detachably coaxially sleeved on the needle handle; the implantation device includes the magnesium-based implantation thread described in Example 2, and the magnesium-based implantation thread is disposed inside the needle tube.

[0145] like Figure 9As shown, the push needle includes a needle cap, a post, a length ruler, a fixing buckle, and a needle core. Except for the needle core, which is made of medical-grade stainless steel, the rest of the push needle is made of polycarbonate. The needle cap is connected to the needle core via the post. The length ruler is located on both sides of the needle cap, and its axis is parallel to that of the needle core. The length ruler has graduations, and one end of the length ruler away from the needle cap is connected to the needle handle by the fixing buckle. The post is held in place by a spring, and the diameter of the spring is smaller than the diameter of the needle cap. The needle core is inserted into the needle handle and the needle tube. When the needle cap is pressed down, it compresses the spring and causes the length ruler 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... Figure 10 As shown.

[0146] like Figure 11 As shown, the needle handle is made of polycarbonate and includes an anti-slip handle, a needle fixing port, an anti-slip part, a needle sliding port, a needle seat tail, and a connecting part. The anti-slip handle has a needle fixing port, and the length ruler is connected to the needle fixing port through the fixing buckle at its end. The anti-slip handle is connected to the needle seat tail through the anti-slip part. The anti-slip part has a needle sliding port at one end away from the anti-slip handle, and the line connecting the needle fixing port and the needle sliding port forms the sliding path of the length ruler. The needle seat tail is coaxially connected to the needle tube through the connecting part.

[0147] The sheath is made of polycarbonate, mates with the tail of the needle hub, and is detachable. See the schematic diagram of the sheath. Figure 12 .

[0148] The spring is made of medical-grade stainless steel and can rebound when compressed. The spring is 15mm long. The needle is made of medical-grade stainless steel, with a length of 38mm, an inner diameter of 0.640mm, and an outer diameter of 0.900mm.

[0149] The embedding method of the embedding device includes inserting the magnesium-based embedding thread described in Example 2 into the needle tube of the embedding device, pinching the needle handle to accurately insert it into the predetermined position, then using the push needle to press the spring until the spring is fully compressed, so that the magnesium-based embedding thread is pushed into the predetermined position, and then pulling out the embedding needle to complete the embedding.

[0150] The suture embedding device provided in this application example is packaged in a paper-plastic bag and sterilized before use. The push needle in the suture embedding device can effectively lock the needle seat, preventing the push needle from sliding or falling off at will. Moreover, the needle seat is equipped with an anti-slip part and an anti-slip handle, which improves the stability of needle insertion and facilitates one-handed operation. A spring is provided, so after the push needle pushes the fixed-length suture into the tissue, it can automatically spring back without manual needle withdrawal, which can achieve precise needle insertion and withdrawal. Moreover, because of the spring, when the push needle is not under force, there is a section between the head of the needle core and the tip of the needle tube that is empty. Therefore, the suture embedding method of the present invention can be used for fixed-length suture embedding as well as for folded and rotated suture embedding.

[0151] Application Example 3

[0152] This application example provides a buried wire device, such as Figure 5 and Figure 8 As shown, the implantation device includes: a push needle, a spring, a needle handle, a needle tube, and a sheath; the push needle, needle handle, and needle tube are coaxially connected in sequence, and the sheath is detachably coaxially sleeved on the needle handle; the implantation device includes the magnesium-based implantation thread described in Example 3, and the magnesium-based implantation thread is disposed inside the needle tube.

[0153] like Figure 9 As shown, the push needle is made of medical-grade stainless steel and includes a needle cap, a post, a length ruler, a fixing buckle, and a needle core. The needle cap is connected to the needle core via the post. The length ruler is located on both sides of the needle cap, and its axis is parallel to that of the needle core. The length ruler has graduations, and one end of the length ruler away from the needle cap is connected to the needle handle by the fixing buckle. The post is held in place by a 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, it compresses the spring and causes the length ruler 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... Figure 10 As shown.

[0154] like Figure 11 As shown, the needle handle is made of ABS plastic and includes an anti-slip handle, a needle fixing port, an anti-slip part, a needle sliding port, a needle seat tail, and a connecting part. The anti-slip handle has a needle fixing port, and the length ruler is connected to the needle fixing port through the fixing buckle at its end. The anti-slip handle is connected to the needle seat tail through the anti-slip part. The anti-slip part has a needle sliding port at one end away from the anti-slip handle, and the line connecting the needle fixing port and the needle sliding port forms the sliding path of the length ruler. The needle seat tail is coaxially connected to the needle tube through the connecting part.

[0155] The sheath is made of polycarbonate, mates with the tail of the needle hub, and is detachable. See the schematic diagram of the sheath. Figure 12 .

[0156] The spring is made of medical-grade stainless steel and can rebound when compressed. The spring is 30mm long. The needle is made of medical-grade stainless steel, with a length of 70mm, an inner diameter of 0.250mm, and an outer diameter of 0.410mm.

[0157] The embedding method of the embedding device includes inserting the magnesium-based embedding thread described in Example 3 into the needle tube of the embedding device, pinching the needle handle to accurately insert it into the predetermined position, rotating the needle handle, and then using the push needle to press the spring until the fixed length ruler slides down 5mm to push the magnesium-based embedding thread into the predetermined position, and then pulling out the embedding needle to complete the embedding.

[0158] The thread embedding device provided in this application example is packaged in a paper-plastic bag and sterilized before use. The push needle in the device can effectively hold the needle seat, preventing the push needle from sliding or falling off at will. Moreover, the needle seat is equipped with an anti-slip part and an anti-slip handle, which improves the stability of needle insertion and facilitates one-handed operation. It is equipped with a spring, so after the push needle pushes the fixed-length implantation thread into the tissue, it can automatically spring back, eliminating the need for manual needle withdrawal and enabling precise needle insertion and removal.

[0159] Test methods: Mechanical properties of magnesium-based embedded wires in Examples 1-5 and Comparative Examples 1-2 were tested. Tensile strength and maximum force elongation were tested according to GB / T228.1-2010 Metallic materials, tensile testing - Part 1: Test method at room temperature.

[0160] The test results of the above embodiments and comparative examples are shown in Table 3.

[0161] Table 3

[0162]

[0163]

[0164] The following points can be observed from Tables 1 and 3:

[0165] (1) For magnesium-zinc alloys, for wires of the same diameter, annealing reduces tensile strength but increases maximum elongation. For wires of the same diameter, under the same annealing time, increasing the annealing temperature from 150℃ to 250℃ does not significantly change tensile strength, but increases maximum elongation. For pure magnesium, annealing also reduces tensile strength, while maximum elongation does not significantly change. For magnesium-zinc-copper alloys, the addition of copper increases the tensile strength of the wire. As shown in the table above, by combining heat preservation treatment with annealing, the tensile strength and maximum elongation of the wire can be well controlled, meeting the requirements for embedded wires.

[0166] (2) As can be seen from Examples 1-10 and Comparative Example 1, annealing can improve the maximum elongation at force for magnesium-zinc alloys. Under the same conditions, annealing in Example 1 can increase the maximum elongation at force of the magnesium-based embedded wire in Comparative Example 1 (which did not use annealing) from 2.058% to 15.634%. Similarly, from Examples 2-4 and Comparative Example 2, annealing can also slightly improve the maximum elongation at force for magnesium-based embedded wires made of pure magnesium.

[0167] (3) It can be seen from the combined examples 1-10 and examples 4-5 that the annealing temperature in examples 1-10 is 200℃. Compared with the annealing temperatures of 130℃ and 300℃ in examples 4-5, the maximum elongation at maximum force in examples 1-10 is 15.634%, while the maximum elongation at maximum force in examples 4-5 is only 7.908% and 9.846%, respectively. This shows that by controlling the annealing temperature within a suitable range, the present invention can better control the tensile strength and maximum elongation at maximum force of magnesium-based embedded wires.

[0168] The present invention has been illustrated with the above embodiments to illustrate its detailed structural features. However, the present invention is not limited to the above detailed structural features, that is, it does not mean that the present invention must rely on the above detailed structural features to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent substitutions for the components used in the present invention, additions of auxiliary components, and selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

Claims

1. A method for preparing a magnesium-based embedded wire, characterized in that, The preparation method includes: (1) Magnesium-based metal ingots are processed into magnesium-based metal rods, and the magnesium-based metal rods are successively subjected to heat preservation treatment and extrusion to form a first magnesium-based material; (2) Step (1) The first magnesium base material is cold drawn and annealed in sequence to form the second magnesium base material, the diameter of the second magnesium base material is smaller than the diameter of the first magnesium base material; (3) In step (2), the second magnesium base material is lengthened, polished, cleaned, vacuum-sealed and sterilized to obtain the magnesium-based embedded wire; In step (2), cold drawing and annealing are performed alternately, and annealing is performed after every four cold drawing passes; the deformation amount of each cold drawing pass is 5~10%; the annealing temperature is 150~260℃.

2. The preparation method according to claim 1, characterized in that, The temperature of the heat preservation treatment in step (1) is 280~430℃.

3. The preparation method according to claim 1, characterized in that, The heat preservation treatment time is 3.0~8.0h.

4. The preparation method according to claim 1, characterized in that, The extrusion ratio is (200~400):

1.

5. The preparation method according to claim 1, characterized in that, The extrusion temperature is 250~400℃.

6. The preparation method according to claim 1, characterized in that, The diameter of the first magnesium baseline material is 1.0~3.0 mm.

7. The preparation method according to claim 1, characterized in that, The annealing time is 5 to 20 minutes.

8. The preparation method according to claim 1, characterized in that, The diameter of the second magnesium baseline material is 0.10~0.60mm.

9. The preparation method according to claim 1, characterized in that, The fixed length mentioned in step (3) is 5~60mm.

10. A magnesium-based embedded wire, characterized in that, The magnesium-based implanted wire is prepared using the method described in any one of claims 1 to 9.

11. A wire embedding device, characterized in that, The buried wire device includes the magnesium-based buried wire as described in claim 10.

12. The wire embedding device according to claim 11, characterized in that, The implantation device includes: a push needle, a spring, a needle handle, a needle tube, and a sheath; the push needle, needle handle, and needle tube are coaxially connected in sequence, and the sheath is detachably coaxially sleeved on the needle handle; the magnesium-based implantation thread is disposed inside the needle tube; The pusher needle includes a needle cap, a post, a length ruler, a fixing buckle, and a needle core; the needle cap is connected to the needle core via the post; the length ruler is located on both sides of the needle cap, and the axis of the length ruler is parallel to that of the needle core; the length ruler has graduations, and the end of the length ruler away from the needle cap is connected to the needle handle by the fixing buckle; the post is held in place by a spring, and the diameter of the spring is smaller than the diameter of the needle cap; the needle core is inserted into the needle handle and the needle tube; when the needle cap is pressed down, it causes the spring to compress and the length ruler to slide; when the spring is fully compressed, the head of the needle core is flush with the tip of the needle tube.

13. The wire embedding device according to claim 12, characterized in that, The length of the spring is 10~30mm.

14. The wire embedding device according to claim 12, characterized in that, The needle handle includes an anti-slip handle, a needle fixing port, an anti-slip part, a needle sliding port, a needle seat tail, and a connecting part; the anti-slip handle is provided with a needle fixing port, and the length ruler is connected to the needle fixing port through the fixing buckle at its end; the anti-slip handle is connected to the needle seat tail through the anti-slip part; the anti-slip part is provided with a needle sliding port at one end away from the anti-slip handle, and the line connecting the needle fixing port and the needle sliding port forms the sliding path of the length ruler; the needle seat tail is coaxially connected to the needle tube through the connecting part.

15. The buried wire device according to claim 12, characterized in that... The length of the needle is 30~70mm.

16. The wire embedding device according to claim 12, characterized in that, The inner diameter of the needle is 0.165~0.750mm.

17. The wire embedding device according to claim 12, characterized in that, The outer diameter of the needle is 0.3~1.1mm.

18. The wire embedding device according to claim 12, characterized in that, The surface of the syringe is marked with graduations.

19. The wire embedding device according to claim 12, characterized in that, The sheath is connected to the tail of the needle hub and is detachable.

Images