Bidirectional barb implant line as well as preparation method and application thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to a bidirectional barb implant line and a preparation method and application thereof. The invention provides a bidirectional barb implant line. The bidirectional barb implant line is made of a magnesium-based alloy; the barb structure of the bidirectional barb embedding line is a crescent barb structure; and the crescent barb structures are positioned on four side surfaces of the bidirectional barb embedding line. The bidirectional barb implant line has good biocompatibility, low storage and transportation requirements and strong tissue anchoring force.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a bidirectional barbed implant wire and a preparation method and application thereof. Background Art

[0002] Thread embedding is a medical aesthetic method to fill or lift loose or sagging tissues. The thread body implanted in the tissue fills the human body to increase the tissue volume, and can stimulate collagen production or reduce fat cells during degradation, thereby achieving the effect of cosmetic surgery. Currently, the commonly used implanted threads are degradable smooth threads and barbed threads. Among them, smooth threads stimulate a small area of ​​skin after being implanted in the tissue, and are prone to freeing, resulting in the exposure of the thread ends; barbed threads are unidirectional barbed threads and bidirectional barbed threads. After the unidirectional barbed thread is implanted in the tissue, it is necessary to tie a knot at the end of the thread to easily anchor the tissue. After the bidirectional barbed thread is implanted in the tissue, the initial force of anchoring the tissue is sufficient. As the degradation time in the body increases, the mechanical maintenance gradually weakens. Once the middle section of the bidirectional barb breaks, it becomes a unidirectional barb, and the tissue anchoring force will be greatly weakened. At the same time, the materials of the current single-phase barbed thread and the bidirectional barbed thread are mainly polymers, and the thread body is injection molded. The mold needs to be opened before production. Once the shape and spacing of the barbs are changed, the mold needs to be opened again, which is easy to cause large economic losses. In addition, polymer materials are prone to aging and have high requirements for storage and transportation. Summary of the invention

[0003] The purpose of the present invention is to provide a bidirectional barbed implant wire and a preparation method and application thereof. The bidirectional barbed implant wire has good biocompatibility, low storage and transportation requirements, and strong tissue anchoring force.

[0004] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0005] The present invention provides a bidirectional barbed implant wire, wherein the material of the bidirectional barbed implant wire is a magnesium-based alloy;

[0006] The barb structure of the bidirectional barb implant wire is a crescent-shaped barb structure;

[0007] The crescent-shaped barb structure is located on four sides of the bidirectional barb implant line.

[0008] Preferably, the length of the bidirectional barbed implant wire is 10 to 200 mm; the main wire diameter of the bidirectional barbed implant wire is 0.3 to 0.48 mm.

[0009] Preferably, the magnesium-based alloy is pure magnesium, a magnesium-zinc alloy or a magnesium-zinc-copper alloy.

[0010] Preferably, the interval between two crescent-shaped barb structures located on two adjacent surfaces of the bidirectional barb implant line is 0.8-1.2 mm.

[0011] Preferably, the angle between any side of the crescent in the crescent-shaped barb structure and the main line direction of the bidirectional barb implant line is 10° to 30°;

[0012] The distance between the two tips of the same crescent in the crescent-shaped barb structure is 0.5 to 1 mm;

[0013] The vertical distance between the tips of the two crescents on the opposite sides of the bidirectional barbed implant wire is 1.2 to 4 times the diameter of the wire head segment.

[0014] The present invention also provides a method for preparing the bidirectional barbed implant wire described in the above technical solution, comprising the following steps:

[0015] After laser cutting is performed on both ends of the magnesium-based alloy sheet to form a hole structure as a clamping area, a first laser cutting is performed on the two sides of the non-clamping area of ​​the magnesium-based alloy sheet to form a crescent-shaped barb structure as a bidirectional barb structure area, thereby obtaining a magnesium-based alloy sheet with a clamping end with a hole;

[0016] Inserting the hole of the magnesium-based alloy sheet with a clamping end with a hole on a movable matching carrier, tightening the magnesium-based alloy sheet with a clamping end with a hole by using the movable matching carrier, fixing the carrier, and performing a second laser cutting on the other two side surfaces of the bidirectional barb structure area to obtain the bidirectional barb implant wire;

[0017] The movable matching carrier comprises a movable clamping end and a sliding groove for fixing the movable clamping end.

[0018] Preferably, the movable clamping end is L-shaped;

[0019] The cross-sectional shape of the exposed end of the L-shape matches the hole shape of the clamping end with a hole.

[0020] Preferably, the preparation of the magnesium-based alloy sheet comprises: subjecting the magnesium-based metal ingot to homogenization treatment, extrusion, rolling and annealing in sequence.

[0021] Preferably, the deformation of the extrusion is ≤30%, the number of rolling passes is 2 to 5, and the deformation of each rolling pass is ≤30%;

[0022] The annealing temperature is 100-300° C. and the annealing time is 1-120 min.

[0023] The present invention also provides the use of the bidirectional barbed implant wire described in the above technical solution or the bidirectional barbed implant wire prepared by the preparation method described in the above technical solution in medical devices.

[0024] The present invention provides a bidirectional barb implant wire, wherein the material of the bidirectional barb implant wire is a magnesium-based alloy; the barb structure of the bidirectional barb implant wire is a crescent-shaped barb structure; the crescent-shaped barb structure is located on the four sides of the bidirectional barb implant wire. The bidirectional barb implant wire of the present invention has good biocompatibility and low requirements for storage and transportation; it has strong tissue anchoring force, is not easy to be free, can be self-degraded in the body, and the shape and length of the barb segment are adjustable, which can be customized, and the preparation method is simple and controllable.

[0025] The present invention also provides a method for preparing the bidirectional barb implant wire described in the above technical solution, comprising the following steps: after laser cutting the two ends of the magnesium-based alloy sheet to form a hole structure as a clamping area, a first laser cutting is performed on the two sides of the non-clamping area of ​​the magnesium-based alloy sheet to form a crescent-shaped barb structure as a bidirectional barb structure area, thereby obtaining a magnesium-based alloy sheet with a clamping end with a hole; the hole of the magnesium-based alloy sheet with a clamping end with a hole is inserted into a movable matching carrier, and after tightening the magnesium-based alloy sheet with a clamping end with a hole by using the movable matching carrier, the carrier is fixed, and a second laser cutting is performed on the other two sides of the bidirectional barb structure area to obtain the bidirectional barb implant wire; the movable matching carrier includes a movable clamping end and a sliding groove for fixing the movable clamping end. The present invention uses the movable matching carrier to perform multi-faceted cutting to obtain a magnesium-based implant wire with crescent-shaped barbs on all four sides. The method is simple, and the shape and length of the crescent-shaped barb structure are controllable. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic diagram of the structure of the bidirectional barbed implant wire of the present invention;

[0027] Figure 2 It is a schematic diagram of the positions of various structural parameters in the bidirectional barbed implant wire of the present invention;

[0028] Figure 3 This is a schematic structural diagram of the embodiment 1 of the present invention, in which the movable matching carrier is used to tighten the pure magnesium sheet with a clamping end with a hole;

[0029] Figure 4 This is a partial enlarged view of the embodiment 1 of the present invention, in which the pure magnesium sheet with a clamping end with a hole is tightened by using the movable matching carrier;

[0030] Figure 5 This is a schematic structural diagram of a pure magnesium sheet having a clamping end with a hole as described in Example 1;

[0031] Figure 6 This is a schematic diagram of the structure of the bidirectional barbed implant wire described in Example 1;

[0032] Figure 7This is a schematic structural diagram of the magnesium-zinc sheet with a clamping end with a hole described in Example 2;

[0033] Figure 8 It is a partial enlarged view of the magnesium-zinc sheet with a clamping end with a hole described in Example 2;

[0034] Fig. 9 This is a schematic structural diagram of the use of the movable matching carrier to tighten the magnesium-zinc sheet material with a clamping end with holes in Example 2 of the present invention;

[0035] Fig.10 This is a partial enlarged view of Example 2 in which the movable matching carrier is used to tighten the magnesium-zinc sheet material with a clamping end with a hole;

[0036] Fig.11 This is a schematic diagram of the structure of the bidirectional barbed implant wire described in Example 2;

[0037] Fig.12 A partial enlarged view of the bidirectional barbed implant wire described in Example 2;

[0038] Fig.13 This is a real picture of the pull force test of the bidirectional barbed implant wire described in Example 2 in Application Example 1. DETAILED DESCRIPTION

[0039] The present invention provides a bidirectional barbed implant wire, wherein the material of the bidirectional barbed implant wire is a magnesium-based alloy;

[0040] The barb structure of the bidirectional barb implant wire is a crescent-shaped barb structure;

[0041] The crescent-shaped barb structure is located on four sides of the bidirectional barb implant line (such as Figure 1 shown).

[0042] In the present invention, the length of the bidirectional barbed implant wire (such as Figure 2 The diameter of the bidirectional barbed implant wire is preferably 0.3 to 0.48 mm, more preferably 0.33 to 0.43 mm, and most preferably 0.35 to 0.39 mm.

[0043] In the present invention, the magnesium-based alloy is preferably pure magnesium, magnesium-zinc alloy or magnesium-zinc-copper alloy; in the present invention, the purity of the pure magnesium is preferably ≥99.98%. In the present invention, the mass percentage of magnesium in the magnesium-zinc alloy or magnesium-zinc-copper alloy is preferably ≥94%. In the present invention, the mass percentage of zinc in the magnesium-zinc alloy is preferably 1% to 6%, more preferably 2% to 4%. In the present invention, the mass percentage of zinc in the magnesium-zinc-copper alloy is preferably 1% to 6%, more preferably 2% to 4%; the mass percentage of copper in the magnesium-zinc-copper alloy is preferably 1% to 2%, more preferably 1.2% to 1.8%, and most preferably 1.4% to 1.6%. In the present invention, the thickness of the magnesium-based alloy is preferably 0.6 to 2 mm, more preferably 0.7 to 1.5 mm, and most preferably 1.0 to 1.3 mm.

[0044] In the present invention, the interval between the two crescent-shaped barb structures on the two adjacent sides of the bidirectional barb implant line (such as Figure 2 (as shown in L4 in FIG. 1 ) is preferably 0.8 to 1.2 mm, and more preferably 0.9 to 1.1 mm.

[0045] In the present invention, the angle between any side of the crescent in the crescent-shaped barb structure and the main line direction of the bidirectional barb implant line is preferably 10° to 30°, more preferably 15° to 25°, and most preferably 20° to 25°; the distance between the two tips of the same crescent in the crescent-shaped barb structure (such as Figure 2 The vertical distance between the tips of the two crescents on the opposite sides of the bidirectional barbed implant line (as shown in L3 in FIG) is preferably 0.5 to 1 mm, more preferably 0.6 to 0.9 mm, and most preferably 0.7 to 0.8 mm; Figure 2 L2 in FIG. 1 is preferably the diameter of the thread end segment (as shown in FIG. Figure 2 1.2 to 4 times the diameter of the wire end segment (as shown in L1), more preferably 1.6 to 3.2 times the diameter of the wire end segment, and most preferably 2.3 to 2.8 times the diameter of the wire end segment.

[0046] The present invention also provides a method for preparing the bidirectional barbed implant wire described in the above technical solution, comprising the following steps:

[0047] After laser cutting is performed on both ends of the magnesium-based alloy sheet to form a hole structure as a clamping area, a first laser cutting is performed on the two sides of the non-clamping area of ​​the magnesium-based alloy sheet to form a crescent-shaped barb structure as a bidirectional barb structure area, thereby obtaining a magnesium-based alloy sheet with a clamping end with a hole;

[0048] Inserting the hole of the magnesium-based alloy sheet with a clamping end with a hole on a movable matching carrier, tightening the magnesium-based alloy sheet with a clamping end with a hole by using the movable matching carrier, fixing the carrier, and performing a second laser cutting on the other two side surfaces of the bidirectional barb structure area to obtain the bidirectional barb implant wire;

[0049] The movable matching carrier comprises a movable clamping end and a sliding groove for fixing the movable clamping end.

[0050] In the present invention, unless otherwise specified, all preparation raw materials are commercially available products well known to those skilled in the art.

[0051] In the present invention, after laser cutting is performed on both ends of a magnesium-based alloy plate to form a hole structure as a clamping area, a first laser cutting is performed on two side surfaces of a non-clamping area of ​​the magnesium-based alloy plate to form a crescent-shaped barb structure as a bidirectional barb structure area, thereby obtaining a magnesium-based alloy sheet with a clamping end with a hole.

[0052] In the present invention, the preparation of the magnesium-based alloy sheet preferably comprises: subjecting the magnesium-based metal ingot to homogenization treatment, extrusion, rolling and annealing in sequence.

[0053] In the present invention, the temperature of the homogenization treatment is preferably 250-400°C, more preferably 280-400°C, and most preferably 300-350°C; the holding time is preferably 2-8h, more preferably 3-6h, and most preferably 4-5h. The present invention does not have any special limitation on the atmosphere of the homogenization treatment, and a conventional homogenization treatment atmosphere familiar to those skilled in the art can be used.

[0054] In the present invention, the extrusion temperature is preferably 140-400°C, more preferably 200-400°C, and most preferably 300-400°C; the extrusion ratio is preferably (10-100):1, more preferably (30-80):1, and most preferably (40-60):1; the deformation of the extrusion is preferably ≤30%. In the present invention, the number of rolling passes is preferably 2-5, more preferably 3-4; the rolling deformation of each pass is preferably ≤30%;

[0055] In the present invention, the annealing temperature is preferably 100-330°C, more preferably 150-300°C, and most preferably 180-250°C; the time is preferably 1-120 min, more preferably 30-100 min, and most preferably 40-80 min. The present invention does not have any special restrictions on the atmosphere of the annealing treatment, and a conventional annealing treatment atmosphere familiar to those skilled in the art can be used.

[0056] In the present invention, the purpose of the homogenization treatment, extrusion, rolling and annealing is to remove stress, so as to improve the elongation of the bidirectional barbed implant wire.

[0057] In the present invention, the length of the clamping zones at both ends of the magnesium-based alloy plate preferably accounts for 1% to 25% of the total length of the magnesium-based alloy plate.

[0058] In the present invention, the laser cutting and the first laser cutting are preferably performed in a protective atmosphere, and the protective atmosphere is preferably a nitrogen atmosphere or an argon atmosphere. In the present invention, the laser cutting and the first laser cutting are performed in a protective atmosphere to prevent the magnesium-based alloy sheet from being excessively oxidized or ablated during cutting.

[0059] The present invention does not have any special limitation on the specific process of the laser cutting, and the laser cutting process may be performed using a process well known to those skilled in the art.

[0060] In the present invention, the two side surfaces cut by the first laser are arranged opposite to each other, and the two side surfaces cut by the first laser are preferably different from the two side surfaces through which the hole in the hole-carrying clamping end passes.

[0061] The present invention does not have any special limitation on the specific process of the first laser cutting, and the process well known to those skilled in the art can be used.

[0062] In the present invention, the shape of the holed clamping end of the magnesium-based alloy sheet with a holed clamping end is preferably a paddle shape; the shape of the hole in the holed clamping end is preferably square, rectangular or hexagonal.

[0063] After obtaining the magnesium-based alloy sheet with a clamping end with a hole, the present invention inserts the hole of the magnesium-based alloy sheet with a clamping end with a hole into a movable supporting carrier, tightens the magnesium-based alloy sheet with a clamping end with a hole by using the movable supporting carrier, fixes the carrier, and performs a second laser cutting on the other two side surfaces of the bidirectional barb structure area to obtain the bidirectional barb implant line; the movable supporting carrier includes a movable clamping end, a sliding groove (such as Figure 3 As shown, wherein 1 is the clamping end and 2 is the sliding groove).

[0064] In the present invention, the movable clamping end can move along the sliding slot to match the length of the wire section cut.

[0065] In the present invention, the movable clamping end is preferably L-shaped; the cross-sectional shape of one exposed end of the L-shaped end is preferably matched with the hole shape of the clamping end with a hole.

[0066] In the present invention, the second laser cutting is preferably performed by rotating the magnesium-based alloy sheet with a clamping end with a hole by 90° and then fixing it on a carrier to ensure that the other two side surfaces of the magnesium-based alloy sheet with a clamping end with a hole can be laser cut.

[0067] In the present invention, the second laser cutting is preferably performed in a protective atmosphere, and the protective atmosphere is preferably a nitrogen atmosphere or an argon atmosphere. In the present invention, the second laser cutting is performed in a protective atmosphere to prevent the magnesium-based alloy sheet with a clamping end with a hole from being excessively oxidized or ablated during cutting.

[0068] The present invention does not have any special limitation on the specific process of the second laser cutting, and the process well known to those skilled in the art can be used.

[0069] In the present invention, the second laser cutting not only cuts the other two side surfaces of the bidirectional barb structure area into crescent-shaped barb structures, but also separates the bidirectional barb structure area from the clamping area.

[0070] In the present invention, the movable matching carrier is used to perform multi-faceted cutting to obtain a magnesium-based implant wire with crescent-shaped barbs on all four sides. The method is simple, and the shape and length of the crescent-shaped barb structure are controllable.

[0071] After the second laser cutting is completed, the present invention also preferably includes chemical polishing, ultrasonic cleaning, drying, vacuum packaging and sterilization performed in sequence. The present invention does not have any special restrictions on the processes of chemical polishing, ultrasonic cleaning, vacuum packaging and sterilization, and can be performed using processes well known to those skilled in the art. In the present invention, the drying temperature is preferably 50 to 80°C, more preferably 55 to 75°C, and most preferably 60 to 70°C.

[0072] The present invention also provides the use of the bidirectional barbed implant wire described in the above technical solution or the bidirectional barbed implant wire prepared by the preparation method described in the above technical solution in medical devices. The present invention does not have any special limitation on the method of the application, and the method well known to those skilled in the art can be used.

[0073] The bidirectional barbed implant wire provided by the present invention and its preparation method and application are described in detail below in conjunction with the embodiments, but they should not be understood as limiting the protection scope of the present invention.

[0074] Example 1

[0075] The pure magnesium ingot was subjected to homogenization treatment (temperature of 250°C, holding time of 8h), extrusion (temperature of 140°C, extrusion ratio of 10:1, deformation of 30%), rolling (2 passes, rolling deformation of each pass of 30%) and annealing (temperature of 120°C, holding time of 80min) in sequence to obtain a pure magnesium plate with a thickness of 2mm;

[0076] Under nitrogen protection, after laser cutting the two ends of the pure magnesium plate into a hole structure as a clamping area, a first laser cutting is performed on the two opposite sides of the non-clamping area of ​​the pure magnesium plate to form a crescent-shaped barb structure as a bidirectional barb structure area (the clamping area is located at both ends of the pure magnesium plate, and the length of the clamping area accounts for 25% of the total length of the pure magnesium plate), and a pure magnesium sheet with a clamping end with a hole (such as Figure 5 As shown, the hole shape is rectangular);

[0077] After the pure magnesium sheet with the hole clamping end is rotated 90°, the hole in the pure magnesium sheet with the hole clamping end is inserted into a movable matching carrier (comprising a movable clamping end and a sliding groove for fixing the movable clamping end, the clamping end is L-shaped; the cross-sectional shape of one end exposed by the L-shape matches the hole shape of the hole in the hole clamping end) (such as Figure 3 As shown in the figure, after the pure magnesium sheet with a clamping end with a hole is tightened by the movable matching carrier, the carrier is fixed, and the pure magnesium sheet with a clamping end with a hole is further laser cut on the other two sides (while the other two sides of the bidirectional barb structure area are cut into crescent-shaped barb structures, the bidirectional barb structure area is also separated from the clamping area), chemical polishing, ultrasonic cleaning, drying (50°C), vacuum packaging and sterilization are performed in sequence to obtain the bidirectional barb implant wire (as shown in the figure). Figure 6 As shown, the length of the bidirectional barb implant line is 25 mm, the interval between the two crescent-shaped barb structures located on the two adjacent surfaces of the bidirectional barb implant line is 0.8 mm, the angle between any side of the crescent-shaped barb structure and the main line direction of the bidirectional barb implant line is 30°, the distance between the two tips of the same crescent in the crescent-shaped barb structure is 0.5 mm, and the vertical distance between the tips of the two crescents located on the opposite sides of the bidirectional barb implant line is twice the diameter of the thread head segment).

[0078] Example 2

[0079] The magnesium-zinc ingot (mass percentage of zinc is 2%) is subjected to homogenization treatment (temperature is 400°C, holding time is 2h), extrusion (temperature is 400°C, extrusion ratio is 100:1, deformation is 10%), rolling (5 passes, rolling deformation is 20% in each pass) and annealing (temperature is 330°C, holding time is 40min) in sequence to obtain a magnesium-zinc plate with a thickness of 0.6mm;

[0080] Under argon protection, after laser cutting the two ends of the magnesium-zinc plate into a hole structure as a clamping area, a first laser cutting is performed on the two opposite sides of the non-clamping area of ​​the magnesium-zinc plate to form a crescent-shaped barb structure as a bidirectional barb structure area (the clamping area is located at the two ends of the magnesium-zinc plate, and the length of the clamping area accounts for 1% of the total length of the magnesium-zinc plate), and a magnesium-zinc plate with a clamping end with a hole (such as Figure 7 and 8 As shown (where Figure 8 For the Figure 7 A partial enlarged view of the hole, the hole shape is hexagonal);

[0081] After rotating the Mg-Zn sheet with a hole clamping end by 90°, insert the hole in the Mg-Zn sheet with a hole clamping end into a movable matching carrier (comprising a movable clamping end and a sliding groove for fixing the movable clamping end, the clamping end is L-shaped; the cross-sectional shape of one end exposed by the L-shaped end matches the hole shape of the clamping end with a hole), tighten the Mg-Zn sheet with a hole clamping end by using the movable matching carrier, and then fix the carrier (such as Figures 9-10 As shown, Fig.10 For the Fig. 9 The magnesium-zinc sheet with a clamping end with a hole is further laser cut on the other two sides (while the other two sides of the bidirectional barb structure area are cut into crescent-shaped barb structures, the bidirectional barb structure area is separated from the clamping area), and then chemical polishing, ultrasonic cleaning, drying (80° C.), vacuum packaging and sterilization are performed in sequence to obtain the bidirectional barb implant wire (such as Figures 11-12 As shown, Fig.12 for Fig.11 A local enlarged view shows that the length of the bidirectional barb implant line is 200 mm, the interval between the two crescent-shaped barb structures on the two adjacent surfaces of the bidirectional barb implant line is 1.2 mm, the angle between any side of the crescent-shaped barb structure and the main line direction of the bidirectional barb implant line is 15°, the distance between the two tips of the same crescent in the crescent-shaped barb structure is 1 mm, and the vertical distance between the tips of the two crescents on the opposite sides of the bidirectional barb implant line is 3 times the diameter of the wire head segment).

[0082] Application Example 1

[0083] The bidirectional barbed wire implanted in Example 2 was respectively embedded in the fat layer or muscle layer of commercially available pork (length * width = 150mm * 30mm), one end of the pork was fixed on the tensile testing machine, and the other end of the bidirectional barbed wire implanted was also fixed on the tensile testing machine, and a tensile force test was performed at 50mm / min (such as Fig.13The test results show that the pulling forces of the bidirectional barbed implant thread in the fat layer and muscle layer are 14N and 11N respectively.

[0084] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A bidirectional barbed implant wire, characterized in that: The material of the bidirectional barbed implant wire is a magnesium-based alloy; The barb structure of the bidirectional barb implant wire is a crescent-shaped barb structure; The crescent-shaped barb structure is located on four sides of the bidirectional barb implant line.

2. The bidirectional barbed implant wire according to claim 1, characterized in that: The length of the bidirectional barbed implant wire is 10 to 200 mm; the main wire diameter of the bidirectional barbed implant wire is 0.3 to 0.48 mm.

3. The bidirectional barbed implant wire according to claim 1, characterized in that: The magnesium-based alloy is pure magnesium, a magnesium-zinc alloy or a magnesium-zinc-copper alloy.

4. The bidirectional barbed implant wire according to claim 3, characterized in that: The interval between two crescent-shaped barb structures located on two adjacent surfaces of the bidirectional barb implant line is 0.8-1.2 mm.

5. The bidirectional barbed implant wire according to claim 4, characterized in that: The angle between any side of the crescent in the crescent-shaped barb structure and the main line direction of the bidirectional barb implant line is 10° to 30°; The distance between the two tips of the same crescent in the crescent-shaped barb structure is 0.5 to 1 mm; The vertical distance between the tips of the two crescents on the opposite sides of the bidirectional barbed implant wire is 1.2 to 4 times the diameter of the wire head segment.

6. The method for preparing the bidirectional barbed implant wire according to any one of claims 1 to 5, characterized in that: The following steps are involved: After laser cutting is performed on both ends of the magnesium-based alloy sheet to form a hole structure as a clamping area, a first laser cutting is performed on the two sides of the non-clamping area of ​​the magnesium-based alloy sheet to form a crescent-shaped barb structure as a bidirectional barb structure area, thereby obtaining a magnesium-based alloy sheet with a clamping end with a hole; Inserting the hole of the magnesium-based alloy sheet with a clamping end with a hole on a movable matching carrier, tightening the magnesium-based alloy sheet with a clamping end with a hole by using the movable matching carrier, fixing the carrier, and performing a second laser cutting on the other two side surfaces of the bidirectional barb structure area to obtain the bidirectional barb implant wire; The movable matching carrier comprises a movable clamping end and a sliding groove for fixing the movable clamping end.

7. The preparation method according to claim 6, characterized in that: The movable clamping end is L-shaped; The cross-sectional shape of the exposed end of the L-shape matches the hole shape of the clamping end with a hole.

8. The preparation method according to claim 6, characterized in that: The preparation of the magnesium-based alloy plate comprises: subjecting the magnesium-based metal ingot to homogenization treatment, extrusion, rolling and annealing in sequence.

9. The preparation method according to claim 8, characterized in that: The deformation of the extrusion is ≤30%, the number of rolling passes is 2 to 5, and the deformation of each rolling pass is ≤30%; The annealing temperature is 100-300° C. and the annealing time is 1-120 min.

10. Use of the bidirectional barbed implantable wire according to any one of claims 1 to 5 or the bidirectional barbed implantable wire prepared by the preparation method according to any one of claims 6 to 9 in medical devices.

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