CN113230456A - Porous metal implant containing artificial bone powder and preparation method thereof - Google Patents
Porous metal implant containing artificial bone powder and preparation method thereof Download PDFInfo
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- CN113230456A CN113230456A CN202110570233.5A CN202110570233A CN113230456A CN 113230456 A CN113230456 A CN 113230456A CN 202110570233 A CN202110570233 A CN 202110570233A CN 113230456 A CN113230456 A CN 113230456A
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- hyaluronic acid
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/12—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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
- A61L27/365—Bones
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
The invention relates to the technical field of surgical implant materials, in particular to a porous metal implant containing artificial bone powder and a preparation method thereof. The preparation method comprises the following steps: dissolving hyaluronic acid in a solvent I to obtain a hyaluronic acid solution with the concentration of 0.01-0.1%; dispersing the artificial bone powder into the hyaluronic acid solution, and performing homogenization treatment to obtain hyaluronic acid gel; immersing the porous metal implant in the hyaluronic acid gel, giving a pressure of 2-20 atm to the hyaluronic acid gel, and stirring to obtain the porous metal implant containing the hyaluronic acid gel; and drying and irradiating the porous metal implant containing the hyaluronic acid gel for sterilization to obtain the porous metal implant containing the artificial bone powder. According to the invention, the artificial bone powder is introduced into the porous metal implant pores, so that osteoinductive ingrowth and fusion automization can be realized more quickly, and the porous metal framework can exert excellent bone bearing and bone guiding characteristics.
Description
Technical Field
The invention relates to the technical field of surgical implant materials, in particular to a porous metal implant containing artificial bone powder and a preparation method thereof.
Background
With the mature application of the additive manufacturing technology in the development process of medical instrument products, porous metal implants such as porous titanium alloy implants, porous tantalum implants and the like are more and more widely applied in clinic, and can play roles of bone filling, bone guiding, force bearing conduction and the like in bone defects, repair and other diseases such as joints, spines, wounds and the like.
Although the porous structure can better guide autologous bone tissue to grow in to realize bone fusion, the bone guide growth time is relatively long at a large defect part or a defect part with large depth, and the rapid bone growth is difficult to realize only by adopting the porous implant. In addition, the artificial bone particles can realize bone induction growth and fusion automization, but the prior art does not disclose how to organically combine two matrix materials so as to jointly solve the technical problems of bone defect and repair.
Disclosure of Invention
Aiming at the problems in the prior art, the artificial bone powder is combined with the porous metal implant, the artificial bone powder is introduced into the gaps of the porous metal implant, the artificial bone powder is dispersed by using a hyaluronic acid solution, and the porous metal implant containing the artificial bone powder is obtained by pressurization and impregnation treatment and drying so as to realize the induced growth of bone tissues.
In order to realize the aim, the invention provides a preparation method of a porous metal implant containing artificial bone powder, which comprises the following steps:
dissolving hyaluronic acid in a solvent I to obtain a hyaluronic acid solution with the concentration of 0.01-0.1%;
dispersing the artificial bone powder into the hyaluronic acid solution, and performing homogenization treatment to obtain hyaluronic acid gel;
immersing the porous metal implant in the hyaluronic acid gel, giving a pressure of 2-20 atm to the hyaluronic acid gel, and stirring to obtain the porous metal implant containing the hyaluronic acid gel;
and drying and irradiating the porous metal implant containing the hyaluronic acid gel for sterilization to obtain the porous metal implant containing the artificial bone powder.
Further, the solvent I is any one of water, phosphate buffer solution and 0.9% sodium chloride solution.
Further, the molecular weight of the hyaluronic acid is 100-150 ten thousand daltons.
Further, the artificial bone powder is any one of allogeneic bone powder, animal-derived inorganic bone powder, hydroxyapatite powder and beta-tricalcium phosphate powder, and the particle size range of the artificial bone powder is 20-100 μm.
Further, the homogenization treatment is stirring treatment by a homogenizer under an ultrasonic vibration environment.
Further, the drying treatment is low-temperature drying treatment or freeze drying treatment.
Further, the radiation sterilization method comprises the following steps: alpha rays, beta rays, gamma rays, electron beams, neutron beams, and X-ray sterilization processes.
Based on the same inventive concept, the invention also provides a porous metal implant containing the artificial bone powder, and the porous metal implant containing the artificial bone powder is prepared by the preparation method.
Has the advantages that:
(1) according to the invention, the artificial bone powder is introduced into the gaps of the porous metal implant, so that osteoinductive growth and fusion autogenesis can be realized more quickly, and the porous metal framework can exert excellent bone bearing and bone guiding characteristics.
(2) According to the invention, the artificial bone powder is dispersed by using the hyaluronic acid macromolecular solution, and the artificial bone powder is added, dipped and dried, wherein the hyaluronic acid macromolecular network can be adhered and wound with the artificial bone powder, so that the fixation of the artificial bone powder in gaps of the porous metal implant is well realized, the artificial bone powder is prevented from leaking before and after the implant is used, and the hyaluronic acid macromolecules belong to a cytoplasm matrix component, have extremely strong hydrophilicity, and can be matched with the artificial bone powder to better realize the induced growth of bone tissues.
Drawings
Fig. 1 is a graph showing the bone ingrowth effect of a porous metal implant containing a hyaluronic acid gel according to example 1 of the present invention;
fig. 2 is a graph illustrating the bone in-growth effect of an untreated porous metal implant according to an embodiment of the present invention.
Detailed Description
In order to make the technical problems, technical solutions and advantages of the present invention more apparent, the following detailed description is given with reference to specific embodiments, but the scope of the present invention is not limited to the following specific embodiments.
Unless otherwise defined, all terms of art used hereinafter have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention.
Unless otherwise specifically stated, various raw materials, reagents, instruments, equipment and the like used in the present invention are commercially available or can be prepared by existing methods.
Example 1
(1) Preparing a hyaluronic acid solution with the concentration of 0.1% by using a phosphate buffer solution; the hyaluronic acid has a molecular weight of 100 kilodaltons.
(2) Dispersing artificial bone powder (allogeneic bone) in a hyaluronic acid solution, and homogenizing to form hyaluronic acid gel in which the artificial bone powder is uniformly dispersed; the homogenization treatment is stirring by a homogenizer in an ultrasonic oscillation environment; the particle size range of the artificial bone powder is 20-100 um.
(3) Immersing the porous metal implant in hyaluronic acid gel uniformly dispersed in the artificial bone powder, and giving pressure of 5 atm to the hyaluronic acid gel under the condition of keeping the gel in stirring state to promote the hyaluronic acid gel to be fully filled into the pores in the porous metal implant.
(4) Taking out the porous metal implant fully filled with the hyaluronic acid gel, and removing water molecules in the hyaluronic acid gel in the porous metal implant through a freeze-drying process to form the porous metal implant containing the artificial bone powder and the sodium hyaluronate matrix network; the artificial bone powder in the pores is adhered, wound and fixed through a space network formed by the sodium hyaluronate macromolecules.
(5) Packaging the porous metal implant containing the artificial bone powder and the hyaluronic acid matrix network, and then sterilizing by adopting an irradiation process; the packaging materials are an inner bag aluminum foil bag, an inner bag blister shell and an outer bag paper box. The irradiation sterilization is gamma ray; the irradiation dose range is 25 KGy.
Example 2
(1) 0.5% hyaluronic acid solution was prepared with 0.9% sodium chloride solution. The hyaluronic acid has a molecular weight of 150 kilodaltons.
(2) Dispersing artificial bone powder (bovine inorganic bone powder) in a hyaluronic acid solution, and homogenizing to form hyaluronic acid gel in which the artificial bone powder is uniformly dispersed; the homogenization treatment is stirring by a homogenizer in an ultrasonic oscillation environment; the particle size range of the artificial bone powder is 20-100 um.
(3) Immersing the porous metal implant in hyaluronic acid gel B uniformly dispersed in the artificial bone powder, and giving pressure of 10 atmospheric pressure to the hyaluronic acid gel under the condition of keeping the gel in stirring state to promote the hyaluronic acid gel to be fully filled into the pores in the porous metal implant.
(4) And taking out the porous metal implant fully filled with the hyaluronic acid gel, and removing water molecules in the hyaluronic acid gel in the porous metal implant through a drying process to form the porous metal implant containing the artificial bone powder and the sodium hyaluronate matrix network. The artificial bone powder in the pores is adhered, wound and fixed through a space network formed by the sodium hyaluronate macromolecules.
(5) Packaging the porous metal implant containing the artificial bone powder and the hyaluronic acid matrix network, and then sterilizing by adopting an irradiation process; the packaging materials are an inner-packaging aluminum foil bag, an inner-packaging blister shell and an outer-packaging paper box; the radiation sterilization is electron beam. The irradiation dose range is 30 KGy.
Example 3
(1) A 0.02% hyaluronic acid solution was prepared with water. The hyaluronic acid has a molecular weight of 20 ten thousand daltons.
(2) Dispersing artificial bone powder (hydroxyapatite powder) in a hyaluronic acid solution, and performing homogenization treatment to form hyaluronic acid gel in which the artificial bone powder is uniformly dispersed, wherein the homogenization treatment is stirring by a homogenizer under an ultrasonic oscillation environment, and the particle size of the artificial bone powder is 20-100 um.
(3) Immersing the porous metal implant in hyaluronic acid gel uniformly dispersed in the artificial bone powder, and giving a pressure of 2 atm to the hyaluronic acid gel under the condition of keeping the gel in a stirring state to promote the hyaluronic acid gel to be fully filled into pores in the porous metal implant.
(4) And taking out the porous metal implant fully filled with the hyaluronic acid gel, and removing water molecules in the gel in the porous metal implant through a freeze-drying process to form the porous metal implant containing the artificial bone powder and the sodium hyaluronate matrix network. The artificial bone powder in the pores is adhered, wound and fixed through a space network formed by the sodium hyaluronate macromolecules.
(5) And packaging the porous metal implant containing the artificial bone powder and the hyaluronic acid matrix network, and then sterilizing by adopting an irradiation process, wherein the packaging materials comprise an inner-packaging aluminum foil bag, an inner-packaging blister shell and an outer-packaging paper box. The irradiation sterilization is electron beam, and the irradiation dose range is 15 KGy.
The porous metal implants (treated experimental group) containing the artificial bone powder and the hyaluronic acid matrix network obtained in examples 1 to 3 and the corresponding untreated porous metal implants (untreated control group) were used as implants, respectively, and after a certain period of time, analyzing the pathological hard tissue sections after the operation of the untreated control group and the treated experimental group by using Image J software, calculating the bone tissue area of the bone grafting area and the total area of the bone grafting area, evaluating the bone ingrowth condition by using the ratio of the two areas, the experimental results are shown in table 1, wherein the treated experimental group has significantly higher percent bone ingrowth than the untreated control group, taking the example of the untreated metal implant of example 1 and its control as an example, figures 1 and 2 show the effect of bone ingrowth, it is known that the bone ingrowth effect of the porous metal implant comprising the artificial bone powder and the hyaluronic acid matrix network is significantly superior to that of the untreated porous metal implant.
TABLE 1 control table of percent bone in growth for treated and untreated control materials of each example
The above-mentioned embodiments are only preferred embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered as the technical scope of the present invention, and equivalents and modifications of the technical solutions and concepts of the present invention should be covered by the scope of the present invention.
Claims (8)
1. The preparation method of the porous metal implant containing the artificial bone powder is characterized by comprising the following steps:
dissolving hyaluronic acid in a solvent I to obtain a hyaluronic acid solution with the concentration of 0.01-0.1%;
dispersing the artificial bone powder into the hyaluronic acid solution, and performing homogenization treatment to obtain hyaluronic acid gel;
immersing the porous metal implant in the hyaluronic acid gel, giving a pressure of 2-20 atm to the hyaluronic acid gel, and stirring to obtain the porous metal implant containing the hyaluronic acid gel;
and drying and irradiating the porous metal implant containing the hyaluronic acid gel for sterilization to obtain the porous metal implant containing the artificial bone powder.
2. The method for preparing a porous metal implant containing artificial bone powder according to claim 1, wherein the solvent I is any one of water, phosphate buffer solution, and 0.9% sodium chloride solution.
3. The method for preparing porous metal implant containing artificial bone powder as claimed in claim 1, wherein the molecular weight of hyaluronic acid is 100-150 ten thousand daltons.
4. The method for preparing a porous metal implant containing artificial bone powder according to claim 1, wherein the artificial bone powder is any one of allogeneic bone powder, animal-derived inorganic bone powder, hydroxyapatite powder, and β -tricalcium phosphate powder, and the particle size of the artificial bone powder is in the range of 20-100 μm.
5. The method for preparing a porous metal implant containing artificial bone powder according to claim 1, wherein the homogenization treatment is a homogenizer stirring treatment under an ultrasonic vibration environment.
6. The method for preparing a porous metal implant containing artificial bone powder according to claim 1, wherein the drying process is a low temperature drying process or a freeze drying process.
7. The method for preparing a porous metal implant containing artificial bone powder according to claim 1, wherein the irradiation sterilization method comprises: alpha rays, beta rays, gamma rays, electron beams, neutron beams, and X-ray sterilization processes.
8. A porous metal implant containing artificial bone powder, characterized in that it is prepared by the preparation method according to any of claims 1 to 7.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114569798A (en) * | 2022-02-22 | 2022-06-03 | 湖南华耀百奥医疗科技有限公司 | Porous implant and preparation method and application thereof |
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Application publication date: 20210810 |