CN114569223B - Body implant with filler and method for producing the same - Google Patents
Body implant with filler and method for producing the same Download PDFInfo
- Publication number
- CN114569223B CN114569223B CN202210087616.1A CN202210087616A CN114569223B CN 114569223 B CN114569223 B CN 114569223B CN 202210087616 A CN202210087616 A CN 202210087616A CN 114569223 B CN114569223 B CN 114569223B
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- filler
- framework structure
- framework
- peripheral
- body implant
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- 239000000945 filler Substances 0.000 title claims abstract description 65
- 239000007943 implant Substances 0.000 title claims abstract description 27
- 238000004519 manufacturing process Methods 0.000 title description 5
- 230000002093 peripheral effect Effects 0.000 claims abstract description 33
- 230000008093 supporting effect Effects 0.000 claims abstract description 28
- 238000011049 filling Methods 0.000 claims abstract description 25
- 238000002347 injection Methods 0.000 claims abstract description 24
- 239000007924 injection Substances 0.000 claims abstract description 24
- 229910000861 Mg alloy Inorganic materials 0.000 claims description 22
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 21
- 239000002639 bone cement Substances 0.000 claims description 21
- 229910052749 magnesium Inorganic materials 0.000 claims description 21
- 239000011777 magnesium Substances 0.000 claims description 21
- 238000009766 low-temperature sintering Methods 0.000 claims description 9
- 238000007789 sealing Methods 0.000 claims description 8
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 230000009969 flowable effect Effects 0.000 claims description 2
- 238000005245 sintering Methods 0.000 abstract description 7
- 230000015556 catabolic process Effects 0.000 abstract description 6
- 238000006731 degradation reaction Methods 0.000 abstract description 6
- 238000002360 preparation method Methods 0.000 abstract description 6
- 230000011164 ossification Effects 0.000 abstract description 4
- 230000006698 induction Effects 0.000 abstract 1
- 239000000463 material Substances 0.000 description 10
- 239000004568 cement Substances 0.000 description 8
- 239000007769 metal material Substances 0.000 description 6
- 230000009286 beneficial effect Effects 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 239000000395 magnesium oxide Substances 0.000 description 5
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 5
- GVALZJMUIHGIMD-UHFFFAOYSA-H magnesium phosphate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O GVALZJMUIHGIMD-UHFFFAOYSA-H 0.000 description 5
- 239000004137 magnesium phosphate Substances 0.000 description 5
- 229910000157 magnesium phosphate Inorganic materials 0.000 description 5
- 229960002261 magnesium phosphate Drugs 0.000 description 5
- 235000010994 magnesium phosphates Nutrition 0.000 description 5
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 4
- 239000004327 boric acid Substances 0.000 description 4
- 239000001506 calcium phosphate Substances 0.000 description 4
- 229910000389 calcium phosphate Inorganic materials 0.000 description 4
- 235000011010 calcium phosphates Nutrition 0.000 description 4
- 239000008367 deionised water Substances 0.000 description 4
- 229910021641 deionized water Inorganic materials 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 4
- 239000000956 alloy Substances 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 3
- 235000019799 monosodium phosphate Nutrition 0.000 description 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 3
- 230000017423 tissue regeneration Effects 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 208000010392 Bone Fractures Diseases 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 206010017076 Fracture Diseases 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 230000001976 improved effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000007711 solidification Methods 0.000 description 2
- 230000008023 solidification Effects 0.000 description 2
- GBNXLQPMFAUCOI-UHFFFAOYSA-H tetracalcium;oxygen(2-);diphosphate Chemical compound [O-2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O GBNXLQPMFAUCOI-UHFFFAOYSA-H 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 206010020649 Hyperkeratosis Diseases 0.000 description 1
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 229910001297 Zn alloy Inorganic materials 0.000 description 1
- PGTXKIZLOWULDJ-UHFFFAOYSA-N [Mg].[Zn] Chemical compound [Mg].[Zn] PGTXKIZLOWULDJ-UHFFFAOYSA-N 0.000 description 1
- 238000000137 annealing Methods 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 239000004566 building material Substances 0.000 description 1
- 230000022159 cartilage development Effects 0.000 description 1
- 230000007248 cellular mechanism Effects 0.000 description 1
- 210000003850 cellular structure Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 229910001425 magnesium ion Inorganic materials 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 235000001968 nicotinic acid Nutrition 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000002138 osteoinductive effect Effects 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000008929 regeneration Effects 0.000 description 1
- 238000011069 regeneration method Methods 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7061—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7064—Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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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
- A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
-
- 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
- A61L27/50—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
- 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
- A61L27/58—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30968—Sintering
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Transplantation (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Vascular Medicine (AREA)
- Inorganic Chemistry (AREA)
- Cardiology (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Manufacturing & Machinery (AREA)
- Dispersion Chemistry (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
A body implant having a filler, comprising: peripheral structure, skeleton structure, filler and injection port. The framework structure comprises a plurality of supporting walls, and the supporting walls are spliced with each other to form a honeycomb structure with an upper top surface and a lower bottom surface; the supporting wall is of a porous net structure; the supporting walls positioned at the edges of the framework structure are connected with the peripheral structure, an upper top surface and a lower bottom surface are formed to be communicated together in a space surrounded by the peripheral structure and the framework structure, and the filling space with the four closed sides is used for containing the filler. The injection port is arranged on the peripheral structure or the framework structure and is used for injecting the filler. The invention also discloses a preparation method of the body implant, which comprises the steps of processing and connecting the peripheral structure and the framework structure, injecting filler and sintering at low temperature. The body implant has excellent mechanical property, generates less gas during degradation, and has excellent bioactivity and osteogenesis induction capability.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a body implant with a filler and a preparation method thereof, wherein the body implant can be used for manufacturing the medical instrument.
Background
The honeycomb structure originates from bionics and is a combined structure with regular hexagons arranged without gaps, and the structure has the excellent mechanical properties of light weight, small density, high strength, good rigidity, impact resistance and the like, and is widely applied to the aspects of building materials, aerospace manufacturing, transportation equipment and the like. For example, patent CN201710428356.9 discloses a magnesium alloy helmet using honeycomb reinforcing ribs, which adopts a magnesium alloy skeleton of a honeycomb structure, and greatly reduces the weight of the helmet skeleton on the basis of having good impact resistance. If the characteristics of the honeycomb structure are utilized in the field of medical instruments, after some metal materials with bioactivity or degradability, such as pure magnesium, magnesium-zinc alloy and the like are manufactured into the honeycomb structure, the corresponding medical instruments are manufactured, so that the metal consumption can be greatly reduced, and meanwhile, the mechanical strength of the honeycomb structure can be ensured.
However, for some degradable medical devices that require implantation in the body, the cellular mechanism can lead to premature failure of the device by accelerated degradation, while the simple metallic cellular structure is detrimental to regeneration of blood vessels and tissues. If the honeycomb structure is filled with a bioactive material, the filler is discontinuous in the honeycomb structure, and it is difficult to maintain a certain connection strength with the honeycomb structure, although the above problems can be solved.
Disclosure of Invention
Aiming at the defects of the prior art, the technical problem to be solved by the invention is to provide the body implant which has excellent biomechanical property and has bioactivity and osteogenesis inducing capacity.
To achieve the above object, the present invention provides a body implant with a filler, comprising: a peripheral structure; the framework structure comprises a plurality of supporting walls, wherein the supporting walls are spliced with each other to form a honeycomb structure with an upper top surface and a lower bottom surface; the supporting wall is of a porous net structure; the supporting walls positioned at the edges of the framework structure are connected with the peripheral structure, and a filling space with a through upper top surface and a through lower bottom surface and a closed periphery is formed in the space surrounded by the peripheral structure and the framework structure; the filler is used for filling the filling space formed after the outer supporting wall of the peripheral structure is connected with the framework structure; and the injection port is arranged on the peripheral structure or the framework structure and is used for injecting the filler into the filling space.
Further, the peripheral structure and the skeleton structure are made of metal magnesium or magnesium alloy.
Further, the thickness of the supporting wall is 0.3-3 mm, and the mesh diameter of the porous net structure of the supporting wall is 0.1-0.5 mm.
Further, the filler is a porous structure.
Further, the filler is bone cement.
Further, the peripheral structure further includes an outer support wall and an outer seal plate; the outer supporting wall is connected with the side face of the framework structure, the outer sealing plate is connected with the upper top face and the lower bottom face of the framework structure, is connected with the outer supporting wall at the same time, and seals the framework structure.
Further, the injection ports are reserved at four corners and the center of the outer sealing plate.
The invention also provides a preparation method for preparing the body implant, which comprises the following steps: processing and connecting the peripheral structure and the framework structure to form a filling space of a honeycomb structure; injecting a filler, pre-adjusting the filler into a flowable state, injecting the filler into a filling space through an injection port, and standing and solidifying the honeycomb structure injected with the filler; and (3) low-temperature sintering, namely heating the solidified honeycomb structure to 250-450 ℃ integrally, and performing low-temperature sintering to obtain the body implant.
Further, in the step of injecting the filler, the injection pressure is set to be 0.2-0.6 MPa, the injection time is controlled within 30 minutes, the filling rate of the filler is controlled to be 80-99%, and the standing and curing time is 1-2 hours.
Further, in the step of low-temperature sintering, the heat preservation time is 30-120 min.
The advantages of the body implant according to the invention are the following:
(1) The body implant with the filler can reduce the dosage of the degradable metal material and improve the strength and the rigidity. When the metal material is a degradable material such as magnesium or magnesium alloy, the bone cement filler can prolong the degradation time of the honeycomb structure and reduce the gas generated during degradation.
(2) The inner side plate is designed to be net-shaped, so that the filler can flow in the framework structure, and the injection pressure during injection can be reduced. Meanwhile, the filler forms a continuous state after solidification, on one hand, after the framework structure is degraded, the filler can maintain a whole body without breaking, so that the stability of the honeycomb structure is ensured; on the other hand, the binding force between the filler and the skeleton structure is improved, so that even if the body implant with the filler is processed into various shapes, certain mechanical properties can be ensured, and the filler is not fallen off.
(3) By adopting the preparation method, the bone cement can be filled into the honeycomb structure made of magnesium or magnesium alloy by using low-temperature sintering, so that the internal stress of the magnesium or magnesium alloy is reduced, and the bone cement can be sintered into a porous filler. And thereby, the excellent mechanical property and biochemical property of magnesium or magnesium alloy can be utilized, and the effect of guiding blood vessels and tissue regeneration of bone cement can be utilized.
Drawings
Fig. 1 is a schematic view of a honeycomb structure of the present invention.
Fig. 2 is a schematic illustration of the honeycomb structure of the present invention with the upper plate removed.
Detailed Description
The technical means adopted by the invention to achieve the preset aim are further described below by matching with the drawings and the preferred embodiments of the invention.
As shown in fig. 1 and 2, the body implant with a filler according to the present invention includes a peripheral structure 1, a skeleton structure 2, a filler 3, and an injection port 4. Wherein the peripheral structure 1 is connected with the framework structure 2, and an upper top surface and a lower bottom surface are communicated in a space surrounded by the peripheral structure and the framework structure together to form a filling space with closed periphery. The filler 3 is used to fill the filling space. An injection port 4 is provided on the peripheral structure 1 or the skeleton structure 2 near or at an upper top surface and/or a lower bottom surface of the skeleton structure for injecting the filler 3 into the filling space.
In the preferred embodiment of the invention, the peripheral structure 1 comprises a plurality of outer support walls 11 and two outer closing plates 12. As shown in fig. 1, a plurality of outer support walls 11 are spliced into a prism structure with a closed periphery and a hollow center. The two outer sealing plates 12 are connected with the plurality of outer supporting walls 11, and seal the upper top surface and the lower bottom surface of the prism structure formed by splicing the outer supporting walls 11.
In the preferred embodiment of the invention, the skeletal structure 2 comprises a plurality of support walls 21. As shown in fig. 1, a plurality of support walls 21 are spliced with each other to form a skeleton structure 2 having a honeycomb structure on upper and lower surfaces. As shown in fig. 2, the upper top surface and the lower bottom surface of the framework structure 2 are penetrated. The skeleton structure 2 is installed in the hollow prism that the peripheral structure 1 encloses, and the support wall 21 that lies in the edge is connected with outer support wall 11, and two outer shrouding 12 are connected with the upper top surface and the lower bottom surface of skeleton structure 2 respectively, and the whole perpendicular to outer shrouding 12 of support wall 21. Wherein the supporting wall 21 is a porous net structure with a thickness of 0.3-3 mm. The shape of the mesh 210 on the support wall 21 is circular, the aperture is 0.1 to 0.5mm, and the shape of the mesh 210 is not limited thereto, and may be designed as a polygon such as a square, a triangle, or the like. The mesh openings of the supporting walls 21 increase the flowability of the filling material 3 during filling, which is advantageous for filling the filling material, while ensuring that the filling material 3 assumes a continuous state in the skeleton structure 2, whereby the filling material 3 remains intact without breaking even if the skeleton structure 2 is degraded. On the other hand, the mesh design of the supporting wall 21 is also beneficial to improving the adhesion force between the filler 3 and the framework structure 2, thereby improving the mechanical property of the honeycomb structure and being beneficial to manufacturing the honeycomb structure into various shapes.
In the preferred embodiment of the present invention, the material of the skeleton structure 2 may be a degradable metal material, preferably pure magnesium or magnesium alloy material, because pure magnesium or magnesium alloy has good biomechanical compatibility, biodegradability, bioactivity and osteoinductive property, and its elastic modulus is closer to that of normal bone tissue than the implant material commonly used at present, so that the influence of stress shielding effect on new bone formation and shaping can be avoided, and at the same time, magnesium ions can also stimulate the formation of hard callus at the fracture end, induce bone formation, promote fracture healing, and stimulate cartilage formation.
In the preferred embodiment of the present invention, the filler 3 has a porous structure, which is advantageous for the formation of tissues such as blood vessels in the filler. Preferably, the filler is a degradable bone cement, since bone cement has the advantages of self-curing, strong plasticity, good bioactivity, and the effect of guiding vascular and tissue regeneration. Wherein the degradable bone cement comprises: calcium phosphate cement, magnesium phosphate cement or cement compounded by calcium phosphate cement and magnesium phosphate cement.
In the preferred embodiment of the present invention, as shown in fig. 1, the injection ports 4 are provided at four corners and centers of the upper and lower outer sealing plates 12, whereby gravity acts to promote the flow of the filler within the skeletal structure 2, facilitating injection of the filler.
In another aspect, the present invention also relates to a method for preparing the preferred embodiment of the present invention, comprising:
step one: the peripheral structure 1 and the framework structure 2 are processed by magnesium or magnesium alloy, and the peripheral structure 1 and the framework structure 2 are connected and built into a honeycomb structure with sealed periphery and filled space.
Step two: injecting the filler 3, mixing and stirring the filler 3, namely bone cement, injecting the mixture into a filling space formed by the peripheral structure 1 and the framework structure 2 through five injection ports 4 on the upper outer sealing plate 12, and standing and solidifying for 1-2 h. Wherein the injection pressure is 0.2-0.6 MPa, the injection time is controlled within 30min, and the filling rate of the bone cement is 80-90%. Due to the mesh design of the supporting wall 21, the injection pressure can be reduced to 0.2-0.6 MPa, which is beneficial to preventing the bone cement from leaking due to the too large injection pressure.
Step three: sintering at low temperature, placing the solidified honeycomb structure into an atmosphere furnace, setting a heating rate of 5 ℃/min, heating the honeycomb structure to 250-450 ℃, preserving heat for 30-120 min, setting vacuum pressure to 0.1MPa, and sintering the honeycomb structure in nitrogen. The preferred embodiment of the present invention is finally obtained after sintering is completed.
In the third step, the low-temperature sintering temperature is set to 250-450 ℃ so as to be beneficial to sintering of magnesium or magnesium alloy and bone cement, and on one hand, the stress relief annealing effect can be realized on the peripheral structure 1 and the framework structure 2 of the magnesium or magnesium alloy material, so that the residual internal stress of the magnesium or magnesium alloy is reduced; in another aspect, the hydration reaction of the bone cement is terminated at a temperature of 250-450 ℃, unreacted water and phosphate are removed, and pores are formed, which is conducive to the preparation of a porous structure and the generation of blood vessels. The mechanical properties of magnesium or magnesium alloys can be affected by too high temperatures, approaching the melting point of magnesium or magnesium alloys. The sintering of the bone cement needs to be carried out at a relatively high pressure, which deforms the peripheral structure 1 and the skeleton structure 2 of magnesium or magnesium alloy, at a temperature that is too low.
The body implant with filler according to the invention has the following advantages:
(1) The body implant with the filler can reduce the dosage of the degradable metal material and improve the strength and the rigidity. When the metal material is a degradable material such as magnesium or magnesium alloy, the bone cement filler can prolong the degradation time of the honeycomb structure and reduce the gas generated during degradation.
(2) The inner side plate 21 in the invention is designed into a net shape, which is beneficial to the filler flowing in the framework structure 2 and reduces the injection pressure during injection. Meanwhile, the filler 3 forms a continuous state after solidification, on one hand, after the framework structure 2 is degraded, the filler 3 can maintain a whole body without breaking, so that the stability of the honeycomb structure is ensured; on the other hand, the adhesion between the filler 3 and the skeleton structure 2 is improved, so that even if the body implant with the filler in the invention is processed into various shapes, certain mechanical properties can be ensured, and the filler is not fallen off.
(3) By adopting the preparation method, the bone cement can be filled into the honeycomb structure made of magnesium or magnesium alloy by using low-temperature sintering, so that the internal stress of the magnesium or magnesium alloy is reduced, and the bone cement can be sintered into a porous filler. And thereby, the excellent mechanical property and biochemical property of magnesium or magnesium alloy can be utilized, and the effect of guiding blood vessels and tissue regeneration of bone cement can be utilized.
The body implant with filler of the present invention can be processed into various shapes when in use, and made into bone implant medical devices with various functions, including bone plates, implant prostheses, intraspinal fixation implants, artificial joints, etc., but are not limited to the above devices. The following is a description of specific examples.
Embodiment one:
in this embodiment, the skeleton structure 2 and the peripheral structure 1 are made of pure magnesium material, and the filler 3 is calcium phosphate bone cement
In this example, the formulation of the calcium phosphate bone cement was: the weight ratio of the powder is as follows: 30-40% of tetracalcium phosphate, 30-40% of anhydrous calcium hydrophosphate, 1-5% of boric acid and liquid: 10-30% of deionized water; the purity of the tetracalcium phosphate is 99 percent, and the granularity of the powder is 30-70 mu m; the purity of the anhydrous calcium hydrophosphate is 99 percent, and the granularity is 30-70 mu m; deionized water conductivity <0.5us/cm; boric acid (retarder) has purity of 99% and granularity of 30-70 μm.
Embodiment two:
in this embodiment, the skeleton structure 2 and the peripheral structure 1 are both made of magnesium alloy material, and the filler 3 is magnesium phosphate cement.
In this example, the formulation of magnesium phosphate cement was: magnesium phosphate cement, powder weight ratio: 33-55% of magnesium oxide, 10-15% of monopotassium phosphate, 5-10% of sodium dihydrogen phosphate and 1-5% of boric acid, wherein the weight ratio of liquid is as follows: 10-20% of deionized water; the magnesium oxide is fused magnesium oxide, the purity of the magnesium oxide is 98 percent, the sintering temperature is 2700 ℃, and the granularity of the magnesium oxide powder is 30-70 mu m; sodium dihydrogen phosphate has purity of 99 percent and granularity of 30-70 mu m; sodium dihydrogen phosphate has purity of 99 percent and granularity of 30-70 mu m; deionized water conductivity <0.5us/cm; boric acid (retarder) has purity of 99% and granularity of 30-70 μm.
The present invention is not limited to the above embodiments, but is capable of modification and variation in all embodiments without departing from the spirit and scope of the present invention.
Claims (5)
1. A body implant having a filler, comprising:
a peripheral structure;
the framework structure comprises a plurality of supporting walls, wherein the supporting walls are spliced with each other to form a honeycomb structure with an upper top surface and a lower bottom surface; the supporting wall is of a porous net structure; the supporting walls positioned at the edges of the framework structure are connected with the peripheral structure, and a filling space with a through upper top surface and a through lower bottom surface and a closed periphery is formed in the space surrounded by the peripheral structure and the framework structure; the thickness of the supporting wall is 0.3-3 mm, and the mesh diameter range of the porous net structure of the supporting wall is 0.1-0.5 mm;
the peripheral structure comprises an outer supporting wall and an outer sealing plate; the outer supporting wall is connected with the side face of the framework structure, the outer sealing plate is connected with the upper top face and the lower bottom face of the framework structure, and is connected with the outer supporting wall at the same time, and the framework structure is sealed; the peripheral structure and the framework structure are made of metal magnesium or magnesium alloy;
the filler is used for filling the filling space formed after the peripheral structure is connected with the framework structure; the filler is bone cement;
and the injection ports are arranged at four corners and the center of the outer sealing plate.
2. The body implant of claim 1, wherein the filler is a porous structure.
3. A method for preparing a body implant with a filler according to claim 1 or 2, comprising:
processing and connecting the peripheral structure and the framework structure to form a filling space of a honeycomb structure;
injecting a filler, injecting the filler into the filling space through an injection port after the filler is pre-adjusted to a flowable state, and then standing and solidifying the honeycomb structure into which the filler has been injected;
and (3) low-temperature sintering, namely heating the solidified honeycomb structure to 250-450 ℃ integrally, and performing low-temperature sintering to obtain the body implant.
4. The method according to claim 3, wherein in the step of injecting the filler, the injection pressure is set to 0.2 to 0.6MPa, the injection time is controlled within 30 minutes, the filling rate of the filler is controlled within 80 to 99%, and the time for standing and curing is 1 to 2 hours.
5. The method according to claim 3, wherein the low-temperature sintering step is performed for a period of 30 to 120 minutes.
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| US8974541B2 (en) * | 2010-06-15 | 2015-03-10 | Innotere Gmbh | Bone implant comprising a magnesium-containing metallic material with reduced corrosion rate, and methods and kit for producing the bone implant |
| WO2015164982A1 (en) * | 2014-05-02 | 2015-11-05 | The Royal Institution For The Advancement Of Learning/Mcgill University | Structural porous biomaterial and implant formed of same |
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| WO2004084964A1 (en) * | 2003-03-03 | 2004-10-07 | National Institute Of Advanced Industrial Science And Technology | Porous calcium phosphate high molecular weight hydrogel composite having through hole, method for preparing the same, artificial bone or sustained release material for drug using the same |
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