CN115068699B - Absorbable fixing nail, preparation method thereof and application thereof in fixing oral cavity guiding bone regeneration barrier membrane - Google Patents
Absorbable fixing nail, preparation method thereof and application thereof in fixing oral cavity guiding bone regeneration barrier membrane Download PDFInfo
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- 239000012528 membrane Substances 0.000 title abstract description 30
- 230000004888 barrier function Effects 0.000 title abstract description 28
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- 238000002360 preparation method Methods 0.000 title abstract description 12
- 210000000214 mouth Anatomy 0.000 title abstract description 5
- 238000000576 coating method Methods 0.000 claims abstract description 59
- 239000011248 coating agent Substances 0.000 claims abstract description 57
- 229910001297 Zn alloy Inorganic materials 0.000 claims abstract description 38
- 239000011159 matrix material Substances 0.000 claims abstract description 33
- 238000000034 method Methods 0.000 claims abstract description 21
- 239000013078 crystal Substances 0.000 claims abstract description 11
- ROOXNKNUYICQNP-UHFFFAOYSA-N ammonium persulfate Chemical compound [NH4+].[NH4+].[O-]S(=O)(=O)OOS([O-])(=O)=O ROOXNKNUYICQNP-UHFFFAOYSA-N 0.000 claims description 32
- 229910001870 ammonium persulfate Inorganic materials 0.000 claims description 16
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 16
- 238000006243 chemical reaction Methods 0.000 claims description 11
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- 238000004519 manufacturing process Methods 0.000 claims description 2
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- 210000000988 bone and bone Anatomy 0.000 abstract description 18
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- 239000010936 titanium Substances 0.000 description 8
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- 230000000694 effects Effects 0.000 description 7
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- 108020004774 Alkaline Phosphatase Proteins 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 244000137852 Petrea volubilis Species 0.000 description 4
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 4
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- 229910021642 ultra pure water Inorganic materials 0.000 description 3
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- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- WZUVPPKBWHMQCE-UHFFFAOYSA-N Haematoxylin Chemical compound C12=CC(O)=C(O)C=C2CC2(O)C1C1=CC=C(O)C(O)=C1OC2 WZUVPPKBWHMQCE-UHFFFAOYSA-N 0.000 description 2
- PLXBWHJQWKZRKG-UHFFFAOYSA-N Resazurin Chemical group C1=CC(=O)C=C2OC3=CC(O)=CC=C3[N+]([O-])=C21 PLXBWHJQWKZRKG-UHFFFAOYSA-N 0.000 description 2
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 description 2
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- 238000011161 development Methods 0.000 description 2
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- 210000004373 mandible Anatomy 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
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- LRXTYHSAJDENHV-UHFFFAOYSA-H zinc phosphate Chemical compound [Zn+2].[Zn+2].[Zn+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O LRXTYHSAJDENHV-UHFFFAOYSA-H 0.000 description 2
- 229910000165 zinc phosphate Inorganic materials 0.000 description 2
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- 229910021607 Silver chloride Inorganic materials 0.000 description 1
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- 239000006011 Zinc phosphide Substances 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004763 bicuspid Anatomy 0.000 description 1
- 230000002146 bilateral effect Effects 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
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- 239000007979 citrate buffer Substances 0.000 description 1
- 238000004737 colorimetric analysis Methods 0.000 description 1
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- 210000003460 periosteum Anatomy 0.000 description 1
- 230000008823 permeabilization Effects 0.000 description 1
- HOKBIQDJCNTWST-UHFFFAOYSA-N phosphanylidenezinc;zinc Chemical compound [Zn].[Zn]=P.[Zn]=P HOKBIQDJCNTWST-UHFFFAOYSA-N 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
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- 229920006395 saturated elastomer Polymers 0.000 description 1
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- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 description 1
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- 229940048462 zinc phosphide Drugs 0.000 description 1
Classifications
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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
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- 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
- A61L31/082—Inorganic materials
- A61L31/086—Phosphorus-containing materials, e.g. apatite
-
- 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
- A61L31/14—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
-
- 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
- A61L31/14—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
-
- 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
- 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
- A61L2300/112—Phosphorus-containing compounds, e.g. phosphates, phosphonates
-
- 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
- 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
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
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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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
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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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/02—Methods for coating medical devices
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Materials For Medical Uses (AREA)
Abstract
The application discloses an absorbable fixing nail, a preparation method thereof and application thereof in fixing an oral cavity guiding bone regeneration barrier membrane, and belongs to the field of medical appliances. The fixing nail comprises a zinc alloy matrix and ZnP coating arranged on the surface of the zinc alloy matrix, wherein the ZnP coating comprises a plurality of cluster structures which are uniformly distributed on the surface of the matrix, and each cluster ZnP structure is composed of a plurality of linear ZnP crystal lines. And the in-situ ion exchange coating technology is adopted to prepare ZnP coating on the zinc alloy matrix, the morphology of the coating is adjustable, the process is simple and easy to operate, the time is short, and the cost is low. The absorbable fixing nail can be used for regeneration and repair of alveolar bones in oral implantation operation, is particularly suitable for an absorbable barrier film, can be completely degraded and absorbed after bone tissues in a defect area are regenerated after the nail body is stabilized, and can avoid secondary operation injury by a patient without taking out the fixing nail or the barrier film through a skin flap of a secondary operation incision, and the medical operation cost is reduced.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to an absorbable fixing nail, a preparation method thereof and application thereof in fixing an oral cavity guiding bone regeneration barrier membrane.
Background
With the continued advancement of biological material research and the development of implant repair surgical techniques, guided bone regeneration techniques (Guide Bone Regeneration, GBR) have been widely used in the repair and immediate implantation of bone defects in the implant area. The basic principle of the GBR technology is that a guided tissue regeneration membrane is used as a physical barrier to protect the blood clot in a bone defect area from being stable, allow osteoblasts to migrate preferentially and grow, prevent surrounding non-osteoblastic connective tissue cells and epithelial cells from invading into the defect area, avoid the generation of competitive inhibition, form a regeneration space favorable for the growth of osteoblasts, promote the reconstruction of bone removed tissues of the defect and increase bone mass. In the bone regeneration guiding operation, the combined application of the bone grafting material and the barrier membrane can effectively prevent the collapse of the barrier membrane, on the other hand, the barrier membrane can also play roles in maintaining an effective biological barrier, allowing the dominant growth of osteoblasts and the like, and the synergistic effect of the two can effectively promote the repair process of bone defects. Cell shielding of the barrier membrane is a critical part of GBR surgery. Studies have shown that in the early stages of bone tissue healing, 10-20 um activity is sufficient to transform mesenchymal cells, which are convertible into osteoblasts, into fibroblasts, while the barrier membrane should be effective to block the permeabilization of the fibroblasts, allowing bone-forming cells to preferentially grow into the defect area, maintaining a relatively stable environment at the bone defect site, thereby promoting healing and regeneration of the bone defect. In clinical operations, due to the characteristic of weak mechanical strength of the biological barrier membrane, it is generally difficult to adjust the morphology of the membrane and effectively fix and maintain the space under the membrane, so how to improve the defects of poor barrier membrane maintenance space capability, influence on soft tissues and the like become important points of GBR technology application.
At present, the mode of stably maintaining the space capacity aiming at the barrier membrane is two modes of applying metal nails (titanium nails or stainless steel nails) and applying periosteum suture lines for suturing and fixing. Compared to sutures, metal staple fixation simplifies the incision technique and procedure, while post-operative complications such as membrane exposure, dehiscence, and gingival retraction are minimized. Chinese patent (CN 203458491U) discloses a supporting and retaining screw assembly of barrier membrane for alveolar bone regeneration, the screw assembly is composed of self-tapping screw and screw, and the screw is made of titanium metal. The clinical application of Kirsch et al study on the fixation of non-absorbable barrier membranes with small titanium nails (Axel kirsch,karl L,etal.Development and clinical application of titanium minipins for fixation of nonresorbable barrier membranes.Quintessense Int 1998;29:368-381), showed that titanium nails stabilized the fixation membrane, the titanium nail head healed in soft tissue without irritation, and the wound healed without complications. However, although the titanium nail-fixing barrier membrane has proved its clinical application value and safety and effectiveness in GBR surgery, there is a problem that after tissue regeneration of the defect area is completed, the skin flap needs to be cut again to take out the titanium nail, so that secondary surgical injury is inevitably brought to the patient. Therefore, the design and application of a fixation pin that can well fix the barrier membrane and can be completely degraded after the defect area is healed can effectively solve the problems.
Disclosure of Invention
In view of the above-described shortcomings of the prior art, an object of the present invention is to provide an absorbable staple for an oral guided bone regeneration barrier membrane, which has a fixation time longer than 6 months to cover a bone regeneration time period in an oral environment, and which is slowly degraded and zinc ions to be slowly released to reduce toxicity.
The first aspect of the present invention provides an absorbable staple for an oral guided bone regeneration barrier membrane, the staple comprising a zinc alloy matrix and a ZnP coating (zinc phosphide coating) provided on a surface of the zinc alloy matrix;
the ZnP coating comprises a plurality of cluster structures which are uniformly distributed on the surface of the substrate;
Each cluster structure is composed of a plurality of linear ZnP crystal lines.
In some embodiments of the invention, the ZnP coating has a thickness of 2 to 300 μm.
A second aspect of the present invention provides the use of an absorbable staple as described above for securing an oral guided bone regeneration barrier membrane.
A third aspect of the present invention provides a method for preparing the absorbable staple described above, comprising the steps of:
S1, providing a zinc alloy matrix;
S2, placing the zinc alloy matrix in a mixed solution of ammonium persulfate and disodium hydrogen phosphate, and performing incubation reaction;
S3, post-processing to obtain the absorbable fixing nail with ZnP coating.
In some embodiments of the invention, the ZnP coating has a thickness of 2-300 μm and a degradation time in the oral environment of 6 months or more.
The beneficial effects are that:
1) The fixing nails are completely degradable, so that secondary operation is avoided: the absorbable fixing nail can be used for regeneration and repair of alveolar bone in oral implantation operation, is particularly suitable for an absorbable barrier membrane, is completely degraded and absorbed after bone tissue in a defect area is regenerated after the bone tissue in the nail body is stabilized, and can avoid secondary operation injury by a patient without taking out the fixing nail through a skin flap of a secondary operation incision, and the medical operation cost is reduced.
2) The coating is uniform and the degradation is controllable: the ZnP coating of the fixing nail is of a cluster structure formed by a plurality of linear ZnP crystal lines, is uniformly distributed on the surface of a substrate, has strong corrosion resistance, and can control the morphology of the ZnP coating and the distribution density of the ZnP coating on the surface of the substrate so as to control the degradation time of the ZnP coating by adopting the preparation process.
3) Good biocompatibility and low toxicity: the application can effectively inhibit Zn 2+ from suddenly releasing by adding ZnP coating on the surface of the absorbable fixing nail, improve biocompatibility and corrosion resistance of the fixing nail, reduce biotoxicity, and obtain the most suitable balance effect between promoting osteoblast growth and inhibiting excessive osteoclast formation by ZnP coating treatment of the zinc nail, thereby further promoting bone tissue regeneration and healing.
4) The production process is green and mild: the preparation method of the staple coating adopts a green and mild ion exchange coating deposition technology, has simple and easy operation process, does not have strict reaction conditions, does not use dangerous chemical reagents with strong corrosiveness, and has short time and low cost.
Drawings
FIG. 1 is an electron microscope scan of ZnP coatings in example 1 of the present invention;
FIG. 2 is an electron microscope scan of ZnP coating in example 2 of the present invention;
FIG. 3 is a polarization graph of a zinc alloy staple, staple of examples 1 and 2;
FIG. 4 is an electron microscope scan of ZnP coating in example 4 of the present invention;
FIG. 5 is an electron microscope scan of ZnP coating in example 5 of the present invention.
Detailed Description
The absorbable fixing nail for guiding the bone regeneration barrier film in the oral cavity is characterized in that ZnP coating layers are prepared on the surface of zinc alloy, znP coating layers are of cluster structures uniformly distributed on the surface of a zinc alloy matrix, the cluster structures are formed by a plurality of linear ZnP crystal lines, the corrosion of the zinc nail can be effectively delayed by adopting the structure, the degradation time of the fixing nail can be adjusted by adjusting the thickness and the appearance of ZnP coating layers, meanwhile, the Zn 2+ burst can be avoided, the cytotoxicity is relieved, and the zinc fixing nail after ZnP coating treatment can obtain the most suitable balance effect between promoting the growth of osteoblasts and inhibiting the formation of excessive osteoclasts, so that the regeneration and healing of bone tissues are further promoted. In addition, znP coating is obtained on the surface of the zinc nail through the surface modification technology and the in-situ ion exchange deposition technology, the preparation method is simple, the ion exchange reaction is directly carried out on the surface layer zinc ions of the fixing nail, the uniformity of the coating is good, and the thickness and the shape of the coating can be adjusted by adjusting the parameters of the preparation method. On this basis, the present invention has been completed. The materials and methods used in the examples below, unless otherwise indicated, are conventional in the art.
The invention provides an absorbable fixing nail, which comprises a zinc alloy matrix and a ZnP coating arranged on the surface of the zinc alloy matrix, wherein the ZnP coating comprises a plurality of cluster structures which are uniformly distributed on the surface of the matrix, and each cluster structure is composed of a plurality of linear ZnP crystal lines.
Specifically, the nut of the absorbable fixing nail is disc-shaped, the diameter is 2-4 mm, and the diameter of the nail body is 0.6-1.5 mm.
In some embodiments of the application, the ZnP coating has a thickness of 2-300 μm, preferably a coating thickness of 2-50 μm, optionally a coating thickness of 2-10 μm, 10-30 μm or 30-50 μm. The absorbable staple prepared by the same preparation process has a ZnP coating thickness variation of less than 10%. In addition, the density of the cluster structure on the surface of the substrate is 150-3000 pieces/mm 2, preferably 175-2000 pieces/mm 2, and optionally 150-300 pieces/mm 2, 300-800 pieces/mm 2 and 800-2000 pieces/mm 2. Experiments prove that the stability of the fixing nail is related to the thickness of ZnP coating, the morphology of the cluster structure and the distribution density of the cluster structure on the surface of the fixing nail matrix. The thickness of the coating and the technological parameters according to the preparation method can be obtained, in addition, the preparation method of the application has simple process and can obtain a cluster structure formed by radial crystal lines, and the morphology of the cluster structure and the distribution density of the cluster structure on the surface of the fixed nail matrix can be adjusted by adjusting the specific preparation technological parameters of the application so as to meet the application requirements.
In some embodiments of the invention, the zinc alloy comprises Zn element and an alloying element selected from one or more combinations of Mg, ca, sr, li, mn, fe, cu, ag, ge, zr.
In some embodiments of the invention, the zinc alloy has a mass fraction of alloying elements greater than 0.1%, the mass fraction being adjusted according to specific medical requirements.
In a second aspect, the present invention provides the use of an absorbable staple as described above for the fixation of an oral guided bone regeneration barrier membrane, i.e. an absorbable staple as a tool for the fixation of an oral guided bone regeneration barrier membrane.
A third aspect of the present invention provides a method for preparing the absorbable staple described above, comprising the steps of:
s1, providing a zinc alloy matrix.
S2, placing the zinc alloy into a mixed solution of ammonium persulfate and disodium hydrogen phosphate for incubation reaction;
Specifically, the surface roughness of the zinc alloy matrix is less than 0.8.
Specifically, the concentration of the ammonium persulfate is 0.1-2 mol/L, and the concentration of the disodium hydrogen phosphate is 0.1-1 mol/L. Optionally, the concentration of ammonium persulfate is 0.1-0.4 mol/L, and the concentration of disodium hydrogen phosphate is 0.1-0.3 mol/L; optionally, the concentration of ammonium persulfate is 0.1-0.3 mol/L, and the concentration of disodium hydrogen phosphate is 0.1-0.3 mol/L; optionally, the concentration of ammonium persulfate is 0.4-0.7 mol/L, and the concentration of disodium hydrogen phosphate is 0.1-0.3 mol/L; optionally, the concentration of ammonium persulfate is 0.7-2 mol/L, and the concentration of disodium hydrogen phosphate is 0.1-0.3 mol/L; the thickness and morphology of ZnP coatings can be adjusted by adjusting the concentration of ammonium persulfate and disodium hydrogen phosphate.
Specifically, the molar ratio of the ammonium persulfate to the disodium hydrogen phosphate is 1-8:1, and can be selected to be 1-3:1 or 3-8:1.
Specifically, the temperature of the incubation reaction is 25-60 ℃, the temperature can be 25-30 ℃, the temperature can be 30-40 ℃, the temperature can be 40-60 ℃, the incubation reaction time is 1-24 hours, 1-6 hours, 6-8 hours, 8-12 hours, 12-16 hours, 16-20 hours and 20-14 hours, and the morphology and thickness of the ZnP coating can be adjusted by adjusting the incubation time.
S3, post-processing to obtain the absorbable fixing nail with ZnP coating.
The post-treatment mainly adopts deionized water to wash the sample, removes the absorbed impurity ions, and places the washed sample in a 60 ℃ incubator for drying for 6-24 hours.
The advantageous effects of the present invention are further illustrated below with reference to examples.
In order to make the objects, technical solutions and advantageous technical effects of the present invention more clear, the present invention is described in further detail below with reference to examples. It should be understood that the examples of the present invention are for the purpose of illustration only and are not intended to be limiting, and that the examples of the present invention are not limited to the examples given in the specification. The specific experimental or operating conditions were not noted in the examples and were made under conventional conditions or under conditions recommended by the material suppliers.
Furthermore, it is to be understood that the reference to one or more method steps in this disclosure does not exclude the presence of other method steps before or after the combination step or the insertion of other method steps between these explicitly mentioned steps, unless otherwise indicated; it should also be understood that the combined connection between one or more devices/means mentioned in the present invention does not exclude that other devices/means may also be present before and after the combined device/means or that other devices/means may also be interposed between these two explicitly mentioned devices/means, unless otherwise indicated. Moreover, unless otherwise indicated, the numbering of the method steps is merely a convenient tool for identifying the method steps and is not intended to limit the order of arrangement of the method steps or to limit the scope of the invention in which the invention may be practiced, as such changes or modifications in their relative relationships may be regarded as within the scope of the invention without substantial modification to the technical matter.
In the examples described below, reagents, materials and apparatus used are commercially available unless otherwise specified.
Example 1
1-1) Grinding the Zn-0.5Li alloy nails subjected to CNC processing by using 300-mesh, 600-mesh and 1200-mesh sand paper in sequence until the surface roughness is less than 0.8, then placing the nails in an absolute ethyl alcohol solution for ultrasonic cleaning for 10min, and placing the nails in a60 ℃ incubator for drying for 12h to obtain a zinc alloy matrix, wherein the mass fraction of Li in the zinc alloy matrix is 0.5%.
1-2) Preparing ammonium persulfate with the concentration of 0.3M and disodium hydrogen phosphate with the concentration of 0.2M, placing a zinc alloy matrix into the solution, and standing at 60 ℃ for reaction for 12 hours to obtain a sample A.
1-3) Washing the sample with deionized water, removing the adsorbed impurity ions, and drying the washed sample in a 60 ℃ incubator for 12 hours. As shown in figure 1, the scanning electron microscope shows that the prepared sample coating is uniform and compact, no obvious cracks exist on the surface of the sample, a plurality of cluster structures are arranged in the ZnP coating, each cluster structure is composed of a plurality of linear ZnP crystal lines, the ZnP coating is uniformly distributed on the surface of the zinc alloy matrix, the linear ZnP crystal lines are uniformly dispersed in a radial manner, and the density of the cluster structures is 200/mm 2. The cross section of the exposed staple was cut and the ZnP coating thicknesses were measured at 10 points randomly, and the ZnP coating thickness of the staple prepared in this example was measured to be 35 μm with no more than 10% change in each point thickness.
Example 2
2-1) Grinding the Zn-0.5Li alloy nails subjected to CNC processing by using 300-mesh, 600-mesh and 1200-mesh sand paper in sequence until the surface roughness is less than 0.8, then placing the nails in an absolute ethyl alcohol solution for ultrasonic cleaning for 10min, and placing the nails in a60 ℃ incubator for drying for 12h to obtain a zinc alloy matrix, wherein the mass fraction of Li in the zinc alloy matrix is 0.5%.
2-2) Preparing ammonium persulfate with the concentration of 0.2M and disodium hydrogen phosphate with the concentration of 0.2M, placing the zinc alloy into the solution, and standing at 30 ℃ for reaction for 24 hours to obtain a sample B.
2-3) Washing the sample with deionized water, removing the adsorbed impurity ions, and drying the washed sample in a 60 ℃ incubator for 12 hours. As shown in FIG. 2, the scanning electron microscope results show that the prepared sample coating is uniform and compact, no obvious cracks exist on the surface of the sample, the linear ZnP crystal line structures are uniformly dispersed in a radial shape, and the density of cluster structures is 175/mm 2. The ZnP coating thickness of the staples prepared in this example was 40 μm and the thickness of each point varied by no more than 10%.
Experimental example 1
Samples prepared as described in examples 1 and 2, respectively, were evaluated for corrosion resistance using an electrochemical workstation.
The corrosion area is about 1cm 2, and the electrolyte is simulated body fluid. A platinum sheet was used as an auxiliary electrode and saturated Ag/AgCl as a reference electrode. The sample is immersed in the simulated body fluid before testing, and nitrogen is introduced for not less than 12 hours. The test method selects polarization curve scanning, the scanning speed is 1.0mV/s, and the scanning range is-2.0V-0V. The parameters such as the current density, the polarization resistance and the like of the sample can be obtained according to the Taffel extrapolation method.
Experimental example 2
Simulated body fluid
The samples were placed in 24-well plates, simulated body fluid-infiltrated samples were added, and placed in a 37 ℃ incubator. The time is set to be 1, 4, 7, 14 and 28 days, and after taking out the sample according to the time node, the sample is rinsed with ultrapure water and dried for standby. And observing the surface morphology of the sample by using a scanning electron microscope, and testing the element distribution of the surface of the sample by using an energy spectrum analyzer.
As shown in FIG. 3, FIG. 3 is labeled ZnP-12h for the A sample prepared in example 1 and ZnP-24h for the B sample prepared in example 2. As shown in fig. 3, compared with the zinc alloy, the corrosion potential of the sample loaded with the zinc phosphate coating is more positive, the corrosion current is smaller, the simulated body fluid coating can still maintain the original surface morphology after 28 days, and the elements are uniformly distributed, which indicates that the zinc phosphate coating greatly improves the corrosion resistance of the zinc alloy.
Example 3
3-1) Grinding the Zn-0.5Li alloy nails subjected to CNC processing by using 300-mesh, 600-mesh and 1200-mesh sand paper in sequence until the surface roughness is less than 0.8, then placing the nails in an absolute ethyl alcohol solution for ultrasonic cleaning for 10min, and placing the nails in a 60 ℃ incubator for drying for 12h to obtain a zinc alloy matrix, wherein the mass fraction of Li in the zinc alloy matrix is 0.5%.
3-2) Preparing ammonium persulfate with the concentration of 0.6M and disodium hydrogen phosphate with the concentration of 0.2M, placing the zinc alloy into the solution, and standing at 37 ℃ for reaction for 12 hours to obtain a C sample.
3-3) Washing the sample with deionized water, removing the adsorbed impurity ions, and drying the washed sample in a 60 ℃ incubator for 12 hours. As shown in FIG. 4, the prepared sample coating is uniform and compact, no obvious cracks exist on the surface of the sample, the linear ZnP crystal line structures are uniformly dispersed in a radial shape, and the density of the cluster structures is 720 clusters/mm 2. The ZnP coating thickness of the staples prepared in this example was 10 μm and the thickness of each point varied by no more than 10%.
Example 4
4-1) Grinding the Zn-0.1Ca alloy nails subjected to CNC processing by using 300-mesh, 600-mesh and 1200-mesh sand paper in sequence until the surface roughness is less than 0.8, then placing the Zn-0.1Ca alloy nails in an absolute ethyl alcohol solution for ultrasonic cleaning for 10min, and placing the Zn-0.1Ca alloy nails in a constant temperature oven at 60 ℃ for drying for 12h to obtain a zinc alloy matrix, wherein the mass fraction of Ca in the zinc alloy matrix is 0.1%.
4-2) Preparing ammonium persulfate with the concentration of 1.6M and disodium hydrogen phosphate with the concentration of 0.2M, placing the zinc alloy into the solution, and standing at 37 ℃ for reaction for 12 hours to obtain a D sample.
4-3) Washing the sample with deionized water, removing the adsorbed impurity ions, and drying the washed sample in a 60 ℃ incubator for 12 hours. The scanning electron microscope result shows that as shown in fig. 5, the prepared sample coating is uniform and compact, no obvious cracks exist on the surface of the sample, and the density of the cluster structure is 2000 pieces/mm 2. The ZnP coating thickness of the staples prepared in this example was 2 μm and the thickness of each point varied by no more than 10%.
Experimental example 3
Cell experiment
The biocompatibility of the samples was evaluated using mouse osteoblasts (MC 3T 3-E1) and Almarblue reagent. MC3T3-E1 was inoculated onto the surface of a sample in a 24-well plate and placed in a 37℃cell culture incubator for 1,4, 7 days at an inoculation density of 5X 10 4 cells/ml. After 1 day of incubation, the cell-inoculated samples were transferred to a new 24-well plate and washed twice with 500. Mu.L of PBS, and 500. Mu.L of medium containing 10% Almarblue was added and incubated for 2h. The fluorescence intensity was measured by means of an enzyme-labeled instrument, the excitation wavelength of the test being 560nm and the emission wavelength being 590nm. Then the medium containing alma blue was removed and fresh medium was added for further culture. After 4 days and 7 days of culture, the medium containing alamar blue was replaced and examined. The percent reduction change of alamar blue was calculated.
Experimental results
The reduction percentage of the cell experiment is greater than 50%, and the growth trend is shown in 1,4 and 7 days, which suggests that the coating realized by the technology can remarkably reduce the killing effect of osteoblasts compared with the uncoated material.
| For 1 day | For 4 days | For 7 days | |
| Example 1 | 70％ | 78％ | 83％ |
| Example 2 | 72％ | 82％ | 92％ |
| Example 3 | 70％ | 76％ | 85％ |
| Example 4 | 65％ | 69％ | 71％ |
| Positive control group | 5％ | 0％ | 0％ |
Experimental example 4
Alkaline phosphatase assay
And (3) analyzing the alkaline phosphatase relative activity of the rat bone marrow mesenchymal stem cells MSCs by using an alkaline phosphatase staining kit, and judging the osteogenic differentiation condition. Cells were inoculated onto the surface of the sample at a density of 5X 10 4 cells/ml and placed in a 37℃cell culture incubator for 14 days, during which time the medium was changed every 3 days. After 14 days, the medium was removed, washed twice with 500 μl of PBS, the samples were transferred to a new 24-well plate, cells were fixed with a mixture of citrate buffer solution and acetone, then 500 μl of mixed alkaline dye solution of phosphotheal and solid blue RR salt was added, left at room temperature for 30min in the dark, the dye solution was removed, washed once with ultrapure water, and then each sample was stained with alkaline phosphatase by adding 500 μl of hematoxylin dye solution, and left at room temperature for 10min in the dark. The dye liquor is removed, the dye liquor is washed by ultrapure water until the dye liquor becomes clear, and the alkaline phosphatase content is detected by a colorimetry method.
| A405 | |
| Example 1 | 0.209 |
| Example 2 | 0.235 |
| Example 3 | 0.185 |
| Example 4 | 0.174 |
| Positive control group | 0.068 |
Experimental example 5
Implant degradation experiments
The animals were anesthetized and the third fourth premolars, the first second molars, were extracted from the mandible. After 8 weeks, the flap was turned under anesthesia, the mandibular body was fully exposed, flushed with a large amount of physiological saline, and 3 standardized bone defects were prepared on each of the buccal sides of the bilateral mandibles. The defect is 10mm long, 5mm wide and 5mm deep. Filling 6 defects according to the experimental groups, covering the membrane, respectively nailing 4 fixing nails into four corners of the membrane, and sewing the skin flap. 3, 6, 9 and 12 months after operation, and tissue staining is used for observing the degradation condition of the fixing nails.
| 3 Months after operation | 6 Months after operation | 9 Months after operation | 12 Months after operation | |
| Example 1 | No degradation | Little partial degradation | Partial degradation | Completely degrade |
| Example 2 | No degradation | Little partial degradation | Partial degradation | Completely degrade |
| Example 3 | Partial degradation | Partial degradation | Completely degrade | Completely degrade |
| Example 4 | Partial degradation | Completely degrade | Completely degrade | Completely degrade |
Experimental examples 3-5 prove that the absorbable fixing nail with ZnP coating can effectively improve the biocompatibility and corrosion resistance of the fixing nail, inhibit Zn 2+ burst release, reduce biotoxicity, achieve the most suitable balance effect between promoting the growth of osteoblasts and inhibiting excessive formation of osteoclasts, and further promote the regeneration and healing of bone tissues.
The above embodiments are merely illustrative of the principles of the present application and its effectiveness, and are not intended to limit the application. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the application. Accordingly, it is intended that all equivalent modifications and variations of the application be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.
Claims (5)
1. A method of preparing an absorbable staple comprising the steps of:
S1, providing a zinc alloy matrix;
S2, placing the zinc alloy matrix in a mixed solution of ammonium persulfate and disodium hydrogen phosphate for incubation reaction, wherein the incubation reaction time is 12-24 hours, and the incubation reaction temperature is 30-60 ℃; the concentration of the ammonium persulfate is 0.1-2 mol/L; the concentration of the disodium hydrogen phosphate is 0.1-1 mol/L;
S3, post-processing to obtain an absorbable staple with ZnP coating;
The fixing nail comprises a zinc alloy matrix and ZnP coating layers positioned on the surface of the zinc alloy matrix; the thickness of the ZnP coating is 10-40 mu m, and the thickness variation of the ZnP coating is less than 10%; the ZnP coating comprises a plurality of cluster structures, the cluster structures are uniformly distributed on the surface of the substrate, and the density of the cluster structures on the surface of the substrate is 150-3000/mm 2;
Each cluster structure is composed of a plurality of linear ZnP crystal lines.
2. The method for preparing the absorbable fixing nail according to claim 1, wherein the density of the cluster structure on the surface of the matrix is 175-2000 pieces/mm 2.
3. The method for preparing an absorbable staple according to claim 1, wherein in step S2, the molar ratio of the ammonium persulfate to the disodium hydrogen phosphate is 1-3:1.
4. The method of making an absorbable staple of claim 1 wherein the zinc alloy matrix comprises Zn and alloying elements; the alloy element is selected from one or more combinations of Mg, ca, sr, li, mn, fe, cu, ag, ge, zr; and/or the surface roughness of the zinc alloy matrix is less than 0.8.
5. The absorbable staple prepared by the method for preparing absorbable staples as set forth in any one of claims 1-4.
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| CN1169165A (en) * | 1994-12-09 | 1997-12-31 | 金属股份有限公司 | Method for applying phosphate coating on metal surface |
| CN110087615A (en) * | 2016-12-21 | 2019-08-02 | 高露洁-棕榄公司 | Oral care composition |
| CN110448728A (en) * | 2019-09-23 | 2019-11-15 | 上海交通大学 | The magnesium on medical Zr-based materials surface-phosphorus biocompatible coating and preparation and use |
| CN111996521A (en) * | 2020-08-26 | 2020-11-27 | 西南交通大学 | Method for constructing inorganic micro-flower embedded metal-organic composite nanocluster modified functional layer on surface of biodegradable zinc |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1169165A (en) * | 1994-12-09 | 1997-12-31 | 金属股份有限公司 | Method for applying phosphate coating on metal surface |
| CN110087615A (en) * | 2016-12-21 | 2019-08-02 | 高露洁-棕榄公司 | Oral care composition |
| CN110448728A (en) * | 2019-09-23 | 2019-11-15 | 上海交通大学 | The magnesium on medical Zr-based materials surface-phosphorus biocompatible coating and preparation and use |
| CN111996521A (en) * | 2020-08-26 | 2020-11-27 | 西南交通大学 | Method for constructing inorganic micro-flower embedded metal-organic composite nanocluster modified functional layer on surface of biodegradable zinc |
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