CN114788900A - Human body implant material and preparation method thereof - Google Patents
Human body implant material and preparation method thereof Download PDFInfo
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- CN114788900A CN114788900A CN202210260405.3A CN202210260405A CN114788900A CN 114788900 A CN114788900 A CN 114788900A CN 202210260405 A CN202210260405 A CN 202210260405A CN 114788900 A CN114788900 A CN 114788900A
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- 239000000463 material Substances 0.000 title claims abstract description 74
- 239000007943 implant Substances 0.000 title claims abstract description 57
- 238000002360 preparation method Methods 0.000 title claims abstract description 9
- 239000000654 additive Substances 0.000 claims abstract description 67
- 230000000996 additive effect Effects 0.000 claims abstract description 58
- 239000004696 Poly ether ether ketone Substances 0.000 claims abstract description 46
- 229920002530 polyetherether ketone Polymers 0.000 claims abstract description 46
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 29
- 229910052749 magnesium Inorganic materials 0.000 claims abstract description 29
- 239000011777 magnesium Substances 0.000 claims abstract description 29
- 239000002994 raw material Substances 0.000 claims abstract description 23
- 229910000861 Mg alloy Inorganic materials 0.000 claims abstract description 14
- 238000002156 mixing Methods 0.000 claims abstract description 14
- 238000001816 cooling Methods 0.000 claims abstract description 12
- 239000000835 fiber Substances 0.000 claims description 31
- 238000001035 drying Methods 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 14
- 238000001125 extrusion Methods 0.000 claims description 9
- 239000012535 impurity Substances 0.000 claims description 9
- 239000013067 intermediate product Substances 0.000 claims description 9
- 239000002245 particle Substances 0.000 claims description 9
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
- 238000004506 ultrasonic cleaning Methods 0.000 claims description 6
- 238000010438 heat treatment Methods 0.000 claims description 5
- 238000012545 processing Methods 0.000 claims description 5
- 239000000047 product Substances 0.000 claims description 5
- 238000005303 weighing Methods 0.000 claims description 5
- 238000000465 moulding Methods 0.000 claims 2
- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 claims 1
- 210000000988 bone and bone Anatomy 0.000 abstract description 12
- 230000006698 induction Effects 0.000 abstract description 3
- 238000009740 moulding (composite fabrication) Methods 0.000 abstract description 2
- 239000000956 alloy Substances 0.000 description 4
- 230000004071 biological effect Effects 0.000 description 4
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- 230000006835 compression Effects 0.000 description 3
- 238000007906 compression Methods 0.000 description 3
- 230000004927 fusion Effects 0.000 description 3
- 230000003014 reinforcing effect Effects 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 208000010392 Bone Fractures Diseases 0.000 description 2
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 230000009931 harmful effect Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 229910001425 magnesium ion Inorganic materials 0.000 description 2
- 210000000963 osteoblast Anatomy 0.000 description 2
- 230000008929 regeneration Effects 0.000 description 2
- 238000011069 regeneration method Methods 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 238000001291 vacuum drying Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010068975 Bone atrophy Diseases 0.000 description 1
- 229920000049 Carbon (fiber) Polymers 0.000 description 1
- 208000037408 Device failure Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
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- 238000005516 engineering process Methods 0.000 description 1
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- 238000002474 experimental method Methods 0.000 description 1
- 239000003365 glass fiber Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000001192 hot extrusion Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
- 229920000620 organic polymer Polymers 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- 230000002188 osteogenic effect Effects 0.000 description 1
- 238000011056 performance test Methods 0.000 description 1
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- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
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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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- 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
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
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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
- A61L2300/40—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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- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
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Abstract
The invention relates to a human body implant material and a preparation method thereof, wherein the human body implant material comprises a main body and an additive, the main body is made of PEEK (polyether ether ketone), the additive is made of magnesium or magnesium alloy, and the additive is partially exposed on the surface of the main body. The preparation method of the human body implant material comprises the steps of raw material pretreatment, raw material mixing, cooling and forming. The human body implant material has excellent mechanical property and good bone induction capability.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a human body implant material and a preparation method thereof.
Background
The traditional metal materials for orthopaedics, such as titanium and its alloy, have too high elastic modulus, which can cause the effect of stress shielding, cause bone absorption and bone atrophy around the implant, cause great pain to the patient and result in implant failure. PEEK (polyether ether ketone) is a novel organic polymer material, has strong stability and good mechanical compatibility, has an elastic modulus close to that of bones, and cannot cause bone absorption and interface loosening. However, PEEK is a biologically inert material, has poor osteogenic properties, and cannot form bony fusion; after the PEEK implant material is implanted into a human body, a fibrous boundary membrane is easily formed between the PEEK material and tissues, so that the PEEK implant body is loosened and even separated, and the wide clinical application of the PEEK implant material as a medical implant material is seriously hindered.
For example, in the domestic patent "a preparation method of a special skeleton material of polyetheretherketone rubber" (publication No. CN 110804275 a) and the domestic patent "a friction pair of joint surface for high wear-resistant self-lubricating orthopedic implant" (publication No. CN 110115778A), the PEEK material is modified by using glass fiber and carbon fiber, which can improve the mechanical properties of PEEK, but does not mention whether the biological activity of PEEK can be improved. Therefore, it is very important to select a proper fiber to improve the mechanical property of the polyetheretherketone material and enable the polyetheretherketone material to have better biological activity.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a human body implant material which takes PEEK as a main body and has higher biological activity and excellent mechanical property.
In order to achieve the above object, the body implant material of the present invention includes a body made of PEEK and an additive made of magnesium or a magnesium alloy, wherein the additive is partially exposed on a surface of the body.
Further, the additive accounts for 5-30% by mass.
Furthermore, the additive is fiber with the length of 2-15mm and the diameter of 50-100 μm.
The invention also relates to a preparation method of the human body implant material, which comprises the following steps of raw material pretreatment: pretreating raw materials, drying particles of the main body, processing magnesium fibers into additives, removing impurities on the surfaces of the additives, and drying; mixing the raw materials, namely weighing the pretreated raw materials, and then putting the raw materials into a mixing device for mixing to obtain an intermediate product comprising the main body and the additives; and cooling and forming to obtain the human body implant material.
Further, in the raw material pretreatment process, the drying temperature of the main body drying process is set to be 140-160 ℃, and the drying time is set to be 24-48 h.
Further, in the raw material pretreatment process, the additive needs to be put into an acetone solution, ultrasonic cleaning is carried out, impurities on the surface are washed off, cold air blow drying is carried out, and then drying is carried out in a vacuum drying oven at the temperature of 30 +/-5 ℃ for 24 hours.
Further, in the raw material mixing process, the mixing device is a twin-screw extruder.
Further, the heating temperature of the double-screw extruder is set to 385 +/-10 ℃, the extrusion speed is set to be 2.0m/min, and the pressure of an extrusion rod is 80-100 MPa.
Further, in the cooling and forming stage, the temperature of the intermediate product needs to be controlled to be 50-60 ℃.
Still further, in the cooling forming process, the ultrasonic cleaning is carried out on the product after cooling forming by using 70% of absolute ethyl alcohol.
The human body implant material of the present invention uses magnesium or magnesium alloy as an additive, and has the advantages that: firstly, the density and the elastic modulus of magnesium are similar to those of human bones; secondly, magnesium can be degraded in vivo, and the product has no toxic or harmful effect on human body; most importantly, magnesium ions stimulate osteoblasts and induce and promote regeneration of bone tissue cells. Therefore, the outstanding effects of the invention are as follows:
(1) the additive in the human body implant material is partially exposed on the surface of the main body, so that good bone induction capability is provided for the later period of implantation into a human body.
(2) The invention adds the additive into the body implant material which takes the PEEK material as the main body, so that the mechanical property of the body implant material is better than that of the body implant material of pure PEEK.
Drawings
Fig. 1 is a schematic view of different shapes of the human implant material of the present invention.
Fig. 2 shows the results of testing the compressive strength of PEEK materials modified with different levels of additives.
Fig. 3 shows the results of testing the mechanical properties of PEEK materials modified with additives of different diameters.
Fig. 4 shows mechanical property test data of pure PEEK material, first and second examples, and human bone.
Detailed Description
The technical means adopted by the invention to achieve the predetermined purpose is further described below by combining the drawings and the preferred embodiments of the invention.
The invention relates to a human body implant material, which comprises a main body and an additive, wherein the main body is made of PEEK, and the additive is made of magnesium or magnesium alloy. As shown in fig. 1, the additive 1 is exposed on the surface of the body 2.
In the human body implant material, the additive 1 accounts for 5 to 30 percent by mass. Fig. 2 is a bar graph of the compressive strength of PEEK implant materials modified with different levels of additive 1. Wherein the additive 1 is magnesium alloy fiber with the diameter of 100 μm, and the mass percentages of the additive 1 are 5%, 10%, 15%, 20%, 25%, 30%, 35% and 40%, respectively. As can be seen from figure 2, the PEEK implant material modified by the additives 1 with different contents has obviously improved compressive strength, the highest compression strength can reach about 156MPa, and is improved by 41.8 percent compared with the pure PEEK material, and the content of the magnesium alloy fiber is 30 percent at the moment. The compression resistance of the human body implant material can be linearly increased along with the increase of the content of the additive 1, but if the content of the additive 11 is excessive, the PEEK main body 2 is not enough fused, so that the interface of the human body implant material is not well bonded, gaps are generated, and the compression resistance of the human body implant material is reduced. Therefore, in the present invention, the additive 1 is set to 5 to 30 mass%.
The length of the additive 1 in the human implant material of the present invention is 2 to 15 mm. According to the inclusion theory, the length and arrangement of the fibers of the additive 1 affect the reinforcing effect of the human implant material of the present invention. Specifically, in the case where the additive 1 is contained in the same volume, the larger the aspect ratio of the fiber, the more remarkable the reinforcing effect on the body 2, and the more excellent the reinforcing effect when the long fibers are aligned in a straight line. In the present invention, if the additive 1 is processed into long fibers and aligned: on one hand, during the process of fusing with the PEEK main body material, the fiber is broken, so that the length of the additive 1 in the final human body implant material is far less than that of the additive 1 in the raw material, and the additive 1 cannot be kept in a linear state; on the other hand, too long a fiber length of the additive 1 affects fluidity of the host 2, and further affects mutual fusion between the additive 1 and the host 2. For the reasons mentioned above, the additive 1 according to the invention is selected to be short fibers having a fiber length of between 2mm and 15mm, in which state the additive 1 does not need to be oriented and does not break during fusion with the body 2.
In the human implant material of the present invention, the additive 1 has a diameter of 50 μm to 100 μm. Fig. 3 is a graph showing the performance test of the PEEK implant material modified by the additive 1 with the same content (5%) and different diameters. As shown in fig. 3, the abscissa is the diameter of the additive 1, and the ordinate is the tensile, flexural and shear strength of the human implant material modified with the additive 1. Wherein the additive 1 is magnesium alloy fiber, and the diameters of the additive 1 are respectively set to 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, and 0.6 mm. As can be seen from FIG. 3, when the diameter of the additive 1 is 0.6mm, the tensile strength and the bending strength of the human implant material both tend to be reduced, and the shear strength is only slightly increased. On the other hand, in experiments, the standard deviation of the mechanical property of the modified human body implant material is reduced to a certain extent compared with the standard deviation of the mechanical property of the pure PEEK human body implant material, and the standard deviation is reduced along with the reduction of the diameter of the additive, which shows that the smaller the diameter of the additive is, the more the stability of the human body implant material in the invention can be improved. In order to maintain product stability, the diameter of the additive 1 is set to 50 μm to 100 μm in the present invention.
The invention also relates to a method for preparing the human body implant material, which comprises the following steps:
s1 pretreatment of raw materials: drying the PEEK particles at the temperature of 140-160 ℃ for 24-48 h; processing magnesium or magnesium alloy materials into magnesium fibers with the diameter of 50-100 mu m and the length of 2-15mm by the technologies of melting, hot extrusion, cold drawing, heat treatment and the like, and taking the magnesium fibers as the raw material of the additive 1; the magnesium fiber is placed in a beaker filled with acetone solution, impurities on the surface of the magnesium fiber are removed by ultrasonic cleaning, and then the magnesium fiber is cleaned for three times by distilled water. The surface impurities are removed, so that the corrosion resistance of the magnesium fiber can be improved, inflammation reaction caused by too many impurities when the magnesium fiber is implanted into a body can be prevented, the interface compatibility with a PEEK material is improved, and the magnesium fiber is dried for 24 hours at the temperature of 30 ℃ for later use.
S2, mixing the raw materials, weighing the dried PEEK particles and the magnesium fibers, and putting the weighed PEEK particles and the magnesium fibers into a mixing device, wherein the mixing device is a double-screw extruder, but not limited to. The double screw extruder is used for melt extrusion of the intermediate product comprising the additive 1 and the main body 2 under the conditions that the heating temperature is 385 +/-10 ℃, the extrusion speed is 2.0m/min and the extrusion rod pressure is 80MPa-100 MPa. The discharge end of the extruder can be connected with a die.
S3 cooling and shaping, processing the intermediate product into the needed shape, or directly extruding the intermediate product into a mould, cooling and solidifying in the environment of 50-60 ℃ to obtain the human body implant material. After curing, the material is ultrasonically cleaned for three times in 70 percent absolute ethyl alcohol, and impurities on the surface of the human body implant material are removed. And finally, drying and sterilizing the human body implant material.
Types of human implant materials in the present invention include, but are not limited to, granules, rods, plates, and the like.
The human body implant material of the present invention uses magnesium or magnesium alloy as an additive, and has the advantages that: firstly, the density and the elastic modulus of magnesium are similar to those of human bones; secondly, magnesium can be degraded in vivo, and the product has no toxic or harmful effect on human body; most importantly, magnesium ions stimulate osteoblasts and induce and promote regeneration of bone tissue cells. Therefore, the outstanding effects of the invention are as follows:
(1) the additive 1 in the human body implant material is partially exposed on the surface of the main body 2, so that good bone induction capability is provided for later implantation into a human body.
(2) The invention adds the additive into the body implant material which takes the PEEK material as the main body, so that the mechanical property of the body implant material is better than that of the body implant material of pure PEEK.
The technical solutions and technical effects of the present invention are further described below by specific embodiments.
The first embodiment is as follows:
the human implant material of the present invention in this embodiment needs to be prepared into a PEEK bone plate. In this example, magnesium alloy is used as the material of additive 1, PEEK (450PF) is used as the material of main body 2, and the preparation method of this example is as follows:
A) pretreatment of raw materials: drying the PEEK (450PF) particles in a vacuum drying oven at the temperature of 160 ℃ for 24 hours to obtain dried PEEK (450PF) particles; processing a magnesium alloy material into magnesium fibers with the length of 2mm and the diameter of 100 mu m, putting the magnesium fibers into a beaker filled with acetone solution for ultrasonic cleaning for 10min, washing off surface impurities, then cleaning with distilled water for three times, and drying.
B) Weighing 200g of dried PEEK (450PF) particles, weighing 40g of dried magnesium fibers, putting the particles and the magnesium fibers into an SJZS-10B extruder, and connecting a die at the discharge end of the extruder. Directly extruding an intermediate product comprising a PEEK (450PF) material and a magnesium alloy material into a die by using an extruder under the conditions of a heating temperature of 385 ℃, an extrusion speed of 2.0m/min and an extrusion pressure of 80MPa-100 MPa.
C) And (3) placing the mould filled with the intermediate product in an environment of 50-60 ℃ for cooling and solidifying to prepare a bone fracture plate with the size of 120mm and the cross section of 10mm multiplied by 22mm, taking out after cooling and forming, cleaning with an ethanol solution, sterilizing and drying to obtain the PEEK bone fracture plate with good biological activity.
In the human body implant material of the embodiment, the additive 1 is 16.7% by mass, and as shown in fig. 2, the mechanical properties of the material of the embodiment are superior to those of a pure PEEK material.
Example two:
in this example, the raw material of the additive 1 was magnesium fiber having a length of 5mm, a diameter of 100 μm and a mass of 50g, and the other operation steps were the same as those of the first example.
In the human body implant material in this example, the additive 1 was 20% by mass. As shown in FIG. 2, the mechanical properties of the present example are superior to those of pure PEEK, and also superior to those of the first example.
Although the present invention has been described with reference to the preferred embodiments, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (10)
1. The human body implant material is characterized by comprising a main body and an additive, wherein the main body is made of PEEK, the additive is made of magnesium or magnesium alloy, and the additive is locally exposed on the surface of the main body.
2. The human implant material of claim 1, wherein said additive is present in an amount of 5% to 30% by weight.
3. The additive of claim 1 wherein the additive is a magnesium or magnesium alloy fiber having a length of 2 to 15mm and a diameter of 50 to 100 μm.
4. A method of preparing a human implant material according to any of claims 1 to 3, comprising:
raw material pretreatment, which comprises drying particles of a main body and processing magnesium fibers into additives, removing surface impurities of the additives and then drying;
mixing the raw materials, namely weighing the pretreated raw materials, and then putting the raw materials into a mixing device for mixing to obtain an intermediate product comprising the main body and the additives;
and cooling and forming to obtain the human body implant material.
5. The method of claim 4, wherein the drying temperature of the body is set to 140 ℃ to 160 ℃ and the drying time is set to 24 to 48 hours during the raw material pretreatment.
6. The preparation method of claim 4, wherein in the raw material pretreatment process, the additive is put into an acetone solution, subjected to ultrasonic cleaning, washed to remove surface impurities, blown dry by cold air, and then dried in a drying oven at 30 +/-5 ℃ for 24 h.
7. The method of claim 4, wherein the mixing device is a twin-screw extruder during the mixing of the raw materials.
8. The method of claim 7, wherein the heating temperature of the twin-screw extruder is set to 385 ± 10 ℃, the extrusion speed is set to 2.0m/min, and the extrusion rod pressure is 80Mpa to 100 Mpa.
9. The method according to claim 4, wherein the temperature of the intermediate product is controlled to 50 to 60 ℃ in the cooling molding stage.
10. The method according to claim 4, wherein the cooling molding process comprises subjecting the cooling-molded product to ultrasonic cleaning using 70% absolute ethanol.
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| CN202210260405.3A CN114788900A (en) | 2022-03-16 | 2022-03-16 | Human body implant material and preparation method thereof |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104921845A (en) * | 2015-07-03 | 2015-09-23 | 江苏奥康尼医疗科技发展有限公司 | Bone defect filler |
| CN108606860A (en) * | 2018-05-22 | 2018-10-02 | 广州迈普再生医学科技股份有限公司 | A kind of 3D printing Invasive lumbar fusion device of personalization and preparation method thereof |
| CN109996512A (en) * | 2016-11-14 | 2019-07-09 | 安德烈亚斯·施维塔拉 | The implantation material made of fibre-reinforced plastics |
| CN111867643A (en) * | 2018-03-26 | 2020-10-30 | 赢创运营有限公司 | Thermoplastic material incorporating bioactive inorganic additives |
| CN112368333A (en) * | 2018-06-29 | 2021-02-12 | 赢创运营有限公司 | Biodegradable polymer blends for the manufacture of medical devices |
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2022
- 2022-03-16 CN CN202210260405.3A patent/CN114788900A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104921845A (en) * | 2015-07-03 | 2015-09-23 | 江苏奥康尼医疗科技发展有限公司 | Bone defect filler |
| CN109996512A (en) * | 2016-11-14 | 2019-07-09 | 安德烈亚斯·施维塔拉 | The implantation material made of fibre-reinforced plastics |
| CN111867643A (en) * | 2018-03-26 | 2020-10-30 | 赢创运营有限公司 | Thermoplastic material incorporating bioactive inorganic additives |
| CN108606860A (en) * | 2018-05-22 | 2018-10-02 | 广州迈普再生医学科技股份有限公司 | A kind of 3D printing Invasive lumbar fusion device of personalization and preparation method thereof |
| CN112368333A (en) * | 2018-06-29 | 2021-02-12 | 赢创运营有限公司 | Biodegradable polymer blends for the manufacture of medical devices |
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