CN111939330A - Zinc alloy anastomosis nail and preparation method thereof - Google Patents
Zinc alloy anastomosis nail and preparation method thereof Download PDFInfo
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- CN111939330A CN111939330A CN202010711130.1A CN202010711130A CN111939330A CN 111939330 A CN111939330 A CN 111939330A CN 202010711130 A CN202010711130 A CN 202010711130A CN 111939330 A CN111939330 A CN 111939330A
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
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- A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
- B21G3/00—Making pins, nails, or the like
- B21G3/005—Nails or pins for special purposes, e.g. curtain pins
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
- B21G3/00—Making pins, nails, or the like
- B21G3/18—Making pins, nails, or the like by operations not restricted to one of the groups B21G3/12 - B21G3/16
- B21G3/20—Making pins, nails, or the like by operations not restricted to one of the groups B21G3/12 - B21G3/16 from wire of indefinite length
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- C—CHEMISTRY; METALLURGY
- C21—METALLURGY OF IRON
- C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
- C21D9/00—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor
- C21D9/52—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor for wires; for strips ; for rods of unlimited length
- C21D9/525—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor for wires; for strips ; for rods of unlimited length for wire, for rods
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C18/00—Alloys based on zinc
- C22C18/02—Alloys based on zinc with copper as the next major constituent
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
- C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
- C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
- C22F1/165—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon of zinc or cadmium or alloys based thereon
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C26/00—Coating not provided for in groups C23C2/00 - C23C24/00
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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Abstract
The invention discloses a zinc alloy gastrointestinal anastomosis nail and a preparation method thereof, wherein the zinc alloy gastrointestinal anastomosis nail comprises a zinc alloy anastomosis nail matrix and a composite film layer, the zinc alloy anastomosis nail matrix is subjected to surface sand blasting treatment to form a frosted layer, the frosted layer is subjected to electrostatic spinning treatment to enable the outer layer to be uniformly covered with an electrostatic spinning film, and the frosted layer and the electrostatic spinning film form the composite film layer together. The zinc alloy anastomosis nail matrix and the composite film layer covered on the surface are both biodegradable materials, have excellent biocompatibility and safety, and solve the problem and negative influence of long-term retention of the titanium alloy anastomosis nail; meanwhile, the zinc alloy has better corrosion resistance in human body environment, and the problem of too high degradation rate of the magnesium alloy anastomosis nail is solved.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a zinc alloy anastomosis nail and a preparation method thereof.
Background
Staples are important components of staplers used for suturing tissues or organs in clinical anastomosis operations, and have various types. At present, the most commonly used staples for the anastomat are made of titanium alloy wires, and have stable chemical properties and excellent mechanical properties, so the staples are not degradable after the operation and are permanently remained in the human body, and can cause certain influence on the postoperative life of a patient, for example, the titanium staples after gastrointestinal suture operation have the risk of falling off to scratch the gastrointestinal tract or cause local rupture due to long-term friction, and are easy to cause inflammation and bacterial infection.
Therefore, researchers have proposed that degradable staples are used for replacing the existing titanium staples, most of the degradable staples are magnesium alloy staples at present, and the staples are not required to be retained for a long time and only need to meet the mechanical property requirement in the healing period. Magnesium is used as a major element necessary for a human body, has good biocompatibility, can be degraded in the human body environment, cannot be left for a long time to cause adverse effects, but has the problem of high degradation rate, and particularly can accelerate the degradation of the magnesium alloy in the gastrointestinal tract environment by digestive juice.
The Chinese patent ZL201020202038.4 provides a medical suture anastomosis nail with the functions of preventing and treating wound infection, solves the problem of inflammation or infection caused by retention of a titanium anastomosis nail, but still adopts no degradable material and is still retained in vivo for a long time after operation.
Chinese patent 'CN 201910213726.6' provides a degradable anastomosis nail material in a living body, which can be degraded and absorbed in the human body, and solves the problem of long-term retention, but the component of the degradable anastomosis nail material contains trace silver element, although the degradable anastomosis nail material has an antibacterial effect, the influence on the human body is not clear, and meanwhile, effective measures for improving corrosion resistance are not provided, and the risk of premature degradation and failure exist in the gastrointestinal environment.
In order to solve the defects in the prior art, the degradable anastomosis nail which has the degradation rate meeting the clinical requirement and has the functions of inhibiting inflammation and bacterial infection has important significance.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a zinc alloy gastrointestinal anastomosis nail which can effectively reduce stress concentration in the preparation and use processes, improve the corrosion resistance of the anastomosis nail, simultaneously has a certain tumor inhibition effect, and meets the requirements of clinical degradation rate and functionality. The invention also aims to provide a preparation method of the zinc alloy gastrointestinal anastomosis nail.
In order to achieve the purpose, the zinc alloy gastrointestinal anastomosis nail comprises a zinc alloy anastomosis nail base body and a composite film layer, wherein the zinc alloy anastomosis nail base body is subjected to surface sand blasting treatment to form a frosted layer, the frosted layer is subjected to electrostatic spinning treatment to enable the outer layer to be uniformly covered with an electrostatic spinning film, and the frosted layer and the electrostatic spinning film (containing metal powder) form the composite film layer together.
Furthermore, the zinc alloy anastomosis nail matrix comprises 0.2-0.5wt% of copper, 0.1-0.15wt% of magnesium and the balance of zinc.
Furthermore, the nail tip of the zinc alloy anastomosis nail is provided with an inclined surface, and the included angle O between the inclined surface and the nail leg is 30-60 degrees.
Further, the thickness of the composite film layer is 30-80 μm.
Further, the zinc alloy anastomosis nail is a U-shaped nail.
A preparation method of the zinc alloy gastrointestinal anastomosis nail comprises the following specific steps:
1) carrying out hot extrusion on the zinc alloy cast ingot at the temperature of 260-320 ℃ to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the obtained zinc alloy bar to obtain a zinc alloy wire with the diameter of 0.2-0.4 mm;
3) carrying out surface sand blasting treatment on the obtained zinc alloy wire at room temperature;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at the temperature of 250-300 ℃ for 5-8min, and cleaning, drying and sterilizing the zinc alloy wire;
5) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), and uniformly covering a layer of electrostatic spinning film on the outer layer of the wire, wherein the electrostatic spinning time is 1-2 h;
6) and 5) making the zinc alloy wire processed in the step 5) into nails, drying and sterilizing to obtain the zinc alloy anastomosis nails.
Further, in the step 1), the extrusion ratio of hot extrusion is 20: 1.
Further, in the step 3), a circumferential sand blasting mode is adopted for the zinc alloy wire, the sand blasting time of the wire with unit length is 30s, and the grit particle size is larger than 3000 meshes.
Further, in the step 4), the electrostatic spinning solution adopted in the electrostatic spinning treatment is a mixed solution of a polymer solution and magnesium powder, wherein the content of the magnesium powder is 5-20 wt%; the polymer is monomer polymer or copolymer or mixture of polylactic acid, polycaprolactone, polyglycolic acid, polyvinyl alcohol and gelatin; the solvent is dichloromethane, and the mass ratio of the solute to the solvent is 1: 2.
Further, after the zinc alloy anastomosis nail is implanted into a human body, the magnesium powder in the composite film layer is preferentially degraded and magnesium ions are released.
The invention has the following beneficial effects:
1) the surface of the zinc alloy wire is subjected to sand blasting treatment, so that the roughness is obviously increased, the adhesion of a composite film layer subjected to subsequent electrostatic spinning treatment is facilitated, the binding force with the zinc alloy wire is improved, and the zinc alloy wire is not easy to peel or fall off.
2) The invention adopts electrostatic spinning treatment, so that the surface of the anastomotic nail matrix is coated with the electrostatic spinning film layer, and the anastomotic nail has better corrosion resistance even in gastrointestinal environment, thereby avoiding too fast degradation.
3) The composite film layer contains magnesium powder particles, which can be degraded and release magnesium ions preferentially after being implanted into a human body, and the magnesium ions have certain antibacterial and inflammation-inhibiting effects in the human body, so that the rehabilitation of postoperative patients is facilitated.
4) The zinc alloy composition can realize continuous deformation processing at room temperature, and the production efficiency of the zinc alloy wire is improved.
5) The zinc alloy anastomosis nail matrix and the composite film layer covered on the surface are both biodegradable materials, have excellent biocompatibility and safety, and solve the problem and negative influence of long-term retention of the titanium alloy anastomosis nail; meanwhile, the zinc alloy has better corrosion resistance in human body environment, and the problem of too high degradation rate of the magnesium alloy anastomosis nail is solved.
Drawings
FIG. 1 is a schematic view of a zinc alloy U-shaped staple of the present invention;
FIG. 2 is a microscopic morphology of a composite film layer of the zinc alloy staple;
labeled as:
the zinc alloy anastomosis nail comprises a zinc alloy anastomosis nail substrate 1, a composite film layer 2, magnesium powder particles 3, polylactic acid wires 4 and an inclined surface 5.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
The following detailed description of embodiments of the invention refers to the accompanying drawings. It should be understood that the detailed description and specific examples, while indicating the present invention, are given by way of illustration and explanation only, not limitation.
As shown in fig. 1 and 2, the invention relates to a zinc alloy gastrointestinal staple, which comprises a zinc alloy staple base body 1 and a composite film layer 2.
In the invention, the zinc alloy gastrointestinal anastomosis nail is a U-shaped nail, and the whole body of the nail is of a U-shaped structure. The zinc alloy anastomosis nail matrix is a zinc alloy matrix, and the components of the zinc alloy anastomosis nail matrix do not contain non-human body essential elements except inevitable impurities. The zinc alloy anastomosis nail matrix comprises 0.2-0.5wt% of copper, 0.1-0.15wt% of magnesium and the balance of zinc.
The zinc alloy anastomosis nail matrix 1 is subjected to surface sand blasting treatment to form a frosted layer, the frosted layer is subjected to electrostatic spinning treatment, so that the outer layer of the frosted layer is uniformly covered with an electrostatic spinning film, and the frosted layer and the electrostatic spinning film form a composite film layer 2 together. The thickness of the composite film layer is 30-80 μm. The electrostatic spinning solution adopted in the electrostatic spinning treatment is a mixed solution of a polymer solution and magnesium powder, wherein the content of the magnesium powder is 5-20 wt%; the polymer is monomer polymer or copolymer or mixture of polylactic acid, polycaprolactone, polyglycolic acid, polyvinyl alcohol and gelatin; the solvent is dichloromethane, and the mass ratio of the solute to the solvent is 1: 2.
In order to facilitate use, the nail tip of the zinc alloy anastomosis nail is provided with an inclined surface 5, and the included angle O between the inclined surface 5 and the nail leg is 30-60 degrees. The bevel 5 is arranged to facilitate the puncture of human muscle or other tissues to enable the wound to be anastomosed and fixed.
Example 1
The preparation method of the zinc alloy anastomosis nail comprises the following steps:
1) selecting a zinc alloy ingot with the components of 0.2wt% of copper and 0.15wt% of magnesium, and carrying out hot extrusion at 260 ℃ with the extrusion ratio of 20:1 to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the zinc alloy bar obtained in the step 1) to obtain a zinc alloy wire with the diameter of 0.2 mm;
3) carrying out surface sand blasting treatment on the zinc alloy wire obtained in the step 2) at room temperature, selecting 5000-mesh gravel, treating for 30s, and increasing the roughness;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at 250 ℃ for 8min, and cleaning, drying and sterilizing the zinc alloy wire;
5) and (3) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), wherein the electrostatic spinning solution is a polylactic acid solution containing 5wt% of magnesium powder, and the outer layer of the wire is covered with an electrostatic spinning film for 1 h.
6) Making nails from the zinc alloy wire processed in the step 5), drying and sterilizing to obtain zinc alloy anastomosis nails;
the thickness of the obtained zinc alloy anastomosis nail is 30 micrometers, and the included angle O between the inclined plane and the nail leg is 30 degrees.
Example 2
The preparation method of the zinc alloy anastomosis nail comprises the following steps:
1) selecting a zinc alloy ingot with the components of 0.5wt% of copper and 0.1wt% of magnesium, and carrying out hot extrusion at 320 ℃ with the extrusion ratio of 20:1 to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the zinc alloy bar obtained in the step 1) to obtain a zinc alloy wire with the diameter of 0.4 mm;
3) carrying out surface sand blasting treatment on the zinc alloy wire obtained in the step 2) at room temperature, selecting 3000-mesh gravel, treating for 30s, and increasing the roughness;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at 300 ℃ for 5min, and cleaning, drying and sterilizing the zinc alloy wire;
5) and (3) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), wherein the electrostatic spinning solution is a polycaprolactone solution containing 20wt% of magnesium powder, so that an electrostatic spinning film covers the outer layer of the wire, and the electrostatic spinning time is 2 h.
6) Making nails from the zinc alloy wire processed in the step 5), drying and sterilizing to obtain zinc alloy anastomosis nails;
the thickness of the obtained zinc alloy anastomosis nail is 80 microns, and the included angle O between the inclined plane and the nail leg is 30 degrees.
Example 3
The preparation method of the zinc alloy anastomosis nail comprises the following steps:
1) selecting a zinc alloy ingot with the components of 0.3wt% of copper and 0.1wt% of magnesium, and carrying out hot extrusion at 300 ℃, wherein the extrusion ratio is 20:1, so as to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the zinc alloy bar obtained in the step 1) to obtain a zinc alloy wire with the diameter of 0.3 mm;
3) carrying out surface sand blasting treatment on the zinc alloy wire obtained in the step 2) at room temperature, selecting 4000-mesh gravel, treating for 30s, and increasing the roughness;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at 280 ℃ for 6min, and cleaning, drying and sterilizing the zinc alloy wire;
5) and (3) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), wherein the electrostatic spinning solution is a mixed solution of polycaprolactone containing 15wt% of magnesium powder and polylactic acid, and the outer layer of the wire is covered with an electrostatic spinning film, and the electrostatic spinning time is 1.5 h.
6) Making nails from the zinc alloy wire processed in the step 5), drying and sterilizing to obtain zinc alloy anastomosis nails;
the thickness of the obtained zinc alloy anastomosis nail is 50 mu m, and the included angle O between the inclined plane and the nail leg is 45 degrees.
Example 4
The preparation method of the zinc alloy anastomosis nail comprises the following steps:
1) selecting a zinc alloy ingot with the components of 0.4wt% of copper and 0.12wt% of magnesium, and carrying out hot extrusion at 280 ℃ with the extrusion ratio of 20:1 to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the zinc alloy bar obtained in the step 1) to obtain a zinc alloy wire with the diameter of 0.35 mm;
3) carrying out surface sand blasting treatment on the zinc alloy wire obtained in the step 2) at room temperature, selecting 4000-mesh gravel, treating for 30s, and increasing the roughness;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at 270 ℃ for 7min, and cleaning, drying and sterilizing the zinc alloy wire;
5) and (3) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), wherein the electrostatic spinning solution is a mixed solution of polycaprolactone containing 18wt% of magnesium powder, polyglycolic acid, polyvinyl alcohol and polylactic acid, and the outer layer of the wire is covered with an electrostatic spinning film, and the electrostatic spinning time is 1.6 h.
6) Making nails from the zinc alloy wire processed in the step 5), drying and sterilizing to obtain zinc alloy anastomosis nails;
the thickness of the obtained zinc alloy anastomosis nail is 60 mu m, and the included angle O between the inclined plane and the nail leg is 60 degrees.
Example 5
The preparation method of the zinc alloy anastomosis nail comprises the following steps:
1) selecting a zinc alloy ingot with the components of 0.25wt% of copper and 0.14wt% of magnesium, and carrying out hot extrusion at 260 ℃ with the extrusion ratio of 20:1 to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the zinc alloy bar obtained in the step 1) to obtain a zinc alloy wire with the diameter of 0.28 mm;
3) carrying out surface sand blasting treatment on the zinc alloy wire obtained in the step 2) at room temperature, selecting 3500-mesh gravel, treating for 30s, and increasing the roughness;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at 280 ℃ for 8min, and cleaning, drying and sterilizing the zinc alloy wire;
5) and (3) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), wherein the electrostatic spinning solution is a mixed solution of polyglycolic acid, polyvinyl alcohol, gelatin and polylactic acid containing 18wt% of magnesium powder, and the outer layer of the wire is covered with an electrostatic spinning film, and the electrostatic spinning time is 1.8 h.
6) Making nails from the zinc alloy wire processed in the step 5), drying and sterilizing to obtain zinc alloy anastomosis nails;
the thickness of the obtained zinc alloy anastomosis nail is 70 mu m, and the included angle O between the inclined plane and the nail leg is 50 degrees.
Example 6
The preparation method of the zinc alloy anastomosis nail comprises the following steps:
1) selecting a zinc alloy ingot with the components of 0.35wt% of copper and 0.11wt% of magnesium, and carrying out hot extrusion at 310 ℃ with the extrusion ratio of 20:1 to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the zinc alloy bar obtained in the step 1) to obtain a zinc alloy wire with the diameter of 0.38 mm;
3) carrying out surface sand blasting treatment on the zinc alloy wire obtained in the step 2) at room temperature, selecting 3500-mesh gravel, treating for 30s, and increasing the roughness;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at 290 ℃ for 6min, and cleaning, drying and sterilizing the zinc alloy wire;
5) and (3) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), wherein the electrostatic spinning solution is a mixed solution of polyvinyl alcohol, gelatin and polycaprolactone containing 18wt% of magnesium powder, and the outer layer of the wire is covered with an electrostatic spinning film, and the electrostatic spinning time is 1.8 h.
6) Making nails from the zinc alloy wire processed in the step 5), drying and sterilizing to obtain zinc alloy anastomosis nails;
the thickness of the obtained zinc alloy anastomosis nail is 60 mu m, and the included angle O between the inclined plane and the nail leg is 40 degrees.
Claims (10)
1. The zinc alloy gastrointestinal anastomosis nail is characterized by comprising a zinc alloy anastomosis nail base body and a composite film layer, wherein the zinc alloy anastomosis nail base body is subjected to surface sand blasting treatment to form a frosted layer, the frosted layer is subjected to electrostatic spinning treatment to enable the outer layer to be uniformly covered with an electrostatic spinning film, and the frosted layer and the electrostatic spinning film form the composite film layer together.
2. The zinc alloy gastrointestinal staple according to claim 1, wherein the zinc alloy staple base comprises 0.2-0.5wt% of copper, 0.1-0.15wt% of magnesium, and the balance of zinc.
3. The zinc alloy gastrointestinal staple according to claim 1, wherein the tip of the zinc alloy staple is provided with a bevel, and the bevel forms an angle O of 30-60 ° with the leg.
4. The zinc alloy gastrointestinal staple according to claim 1, wherein the thickness of the composite film layer is 30-80 μm.
5. The zinc alloy gastrointestinal staple of claim 1, wherein said zinc alloy staple is a staple.
6. A preparation method of a zinc alloy gastrointestinal anastomosis nail is characterized by comprising the following steps:
1) carrying out hot extrusion on the zinc alloy cast ingot at the temperature of 260-320 ℃ to obtain a zinc alloy bar;
2) carrying out multi-pass continuous drawing deformation on the obtained zinc alloy bar to obtain a zinc alloy wire with the diameter of 0.2-0.4 mm;
3) carrying out surface sand blasting treatment on the obtained zinc alloy wire at room temperature;
4) carrying out heat treatment on the zinc alloy wire obtained in the step 3) at the temperature of 250-300 ℃ for 5-8min, and cleaning, drying and sterilizing the zinc alloy wire;
5) carrying out electrostatic spinning treatment on the zinc alloy wire obtained in the step 4), and uniformly covering a layer of electrostatic spinning film on the outer layer of the wire, wherein the electrostatic spinning time is 1-2 h;
6) and 5) making the zinc alloy wire processed in the step 5) into nails, drying and sterilizing to obtain the zinc alloy anastomosis nails.
7. The method for preparing a zinc alloy gastrointestinal anastomosis staple according to claim 6, wherein in the step 1), the extrusion ratio of hot extrusion is 20: 1.
8. The preparation method of the zinc alloy gastrointestinal anastomosis nail according to claim 6, wherein in the step 3), a circumferential sand blasting mode is adopted for the zinc alloy wire, the sand blasting time of the wire per unit length is 30s, and the grit diameter is larger than 3000 meshes.
9. The method for preparing a zinc alloy gastrointestinal anastomosis staple according to claim 6, wherein in the step 4), the electrostatic spinning solution adopted in the electrostatic spinning treatment is a mixed solution of a polymer solution and magnesium powder, wherein the content of the magnesium powder is 5-20 wt%; the polymer is monomer polymer or copolymer or mixture of polylactic acid, polycaprolactone, polyglycolic acid, polyvinyl alcohol and gelatin; the solvent is dichloromethane, and the mass ratio of the solute to the solvent is 1: 2.
10. The method of making a zinc alloy gastrointestinal staple according to claim 9, wherein said magnesium powder in said composite membrane layer preferentially degrades and releases magnesium ions after said zinc alloy staple is implanted in a human body.
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