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TWI379670B - Process for producing an implant from a titanium alloy, and corresponding implant - Google Patents

Process for producing an implant from a titanium alloy, and corresponding implant Download PDF

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Publication number
TWI379670B
TWI379670B TW095106330A TW95106330A TWI379670B TW I379670 B TWI379670 B TW I379670B TW 095106330 A TW095106330 A TW 095106330A TW 95106330 A TW95106330 A TW 95106330A TW I379670 B TWI379670 B TW I379670B
Authority
TW
Taiwan
Prior art keywords
implant
alloy
titanium alloy
temperature
titanium
Prior art date
Application number
TW095106330A
Other languages
English (en)
Other versions
TW200640432A (en
Inventor
Sevki Baliktay
Arnold Keller
Original Assignee
Link Waldemar Gmbh Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Link Waldemar Gmbh Co filed Critical Link Waldemar Gmbh Co
Publication of TW200640432A publication Critical patent/TW200640432A/zh
Application granted granted Critical
Publication of TWI379670B publication Critical patent/TWI379670B/zh

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C14/00—Alloys based on titanium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/20—Methods or devices for soldering, casting, moulding or melting
    • A61C13/206—Injection moulding
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • 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
    • A61L27/06—Titanium or titanium alloys
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
    • C22F1/18—High-melting or refractory metals or alloys based thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
    • A61C8/0022—Self-screwing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0048—Connecting the upper structure to the implant, e.g. bridging bars
    • A61C8/0075—Implant heads specially designed for receiving an upper structure
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2/32—Joints for the hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/367—Proximal or metaphyseal parts of shafts
    • 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
    • A61F2/38—Joints for elbows or knees
    • 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
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    • 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
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    • A61F2/40—Joints for shoulders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2002/30084—Materials having a crystalline structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30606—Sets comprising both cemented and non-cemented endoprostheses
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2002/30795—Blind bores, e.g. of circular cross-section
    • A61F2002/308—Blind bores, e.g. of circular cross-section oblong
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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    • 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
    • A61F2002/30904—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
    • 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
    • A61F2002/30957—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 using a positive or a negative model, e.g. moulds
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625—Necks
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625—Necks
    • A61F2002/3631—Necks with an integral complete or partial peripheral collar or bearing shoulder at its base
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2002/3678—Geometrical features
    • A61F2002/368—Geometrical features with lateral apertures, bores, holes or openings, e.g. for reducing the mass, for receiving fixation screws or for communicating with the inside of a hollow shaft
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2002/4631—Special tools for implanting artificial joints the prosthesis being specially adapted for being cemented
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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Description

1379670 九、發明說明： 發明領域 本發明係關於一種鈦合金醫療植入物的製造方法及其 5 植入物。 發明背景
鈦合金已廣泛增加其作為製造植入物之材料的用途。 此使用作為假體的材料之優勢包括一些重要性質’諸如尚 10機械承重能力、高化學穩定性及優良的生物共存性（此並非 最不重要）。就材料性質的觀點來看，該鈦合金材料為許多 不同型式的植入物之選擇，包括骨板、螺栓、人造膝蓋及 髋關節和人工椎間盤。 先述技藝已揭示出多種植入物的製造方法。不僅依欲 15 製造的植入物型式，而且亦依在每個例子中所使用的鈦合 金來選擇合適之方法。對塑形目的來說，有二種主要使用 於鈦合金的方法，換句話說，一方面為鍛造及另一方面為 熔模鑄造。原理上，鈦合金為一鍛造合金(彼得斯(Peters)/ 李恩斯(Leyens) : Titan及Titanlegierungen[欽及鈦合金]，威 20 利（Wiley)-VCH-伏雷格(Verlag)，2002)。但是，熔模鑄造具 有容易製造出甚至複雜形狀的優點，而這些複雜形狀無法 藉由鍛造來達成或僅可藉由連結複數個零件來達成。但 是，鈦合金之溶模鎮造通常會由於敛的高炫點及高反應性 而發生問題；其它問題為該合金的密度低。僅有少數幾組 5 的鈦合金合適於熔模鑄造。這些特別包括已熟知的α_欽人 金及一些α/卩-欽合金。對植入物之製造來說，後組(特別a 包含釩及鋁的合金，諸如TiAUV4)已變得很重要。可利用炫 模鑄造法，從此合金成功地製造出植入物(諸如，人工關節 或牙科植入物）。 但是，已對典型使用α/β-鈦合金(諸如TiΑ1δV4)之合金元 件其長時間的相容性有某種程度之關心。再者，這些合金 的彈性模數相當大於天然骨頭材料，此會對骨頭導致病理 學改變。 【發明内容3 發明概要 本發明以提供一種可減輕這些缺點之醫療植入物的目 標為基礎。 可在獨立凊求項之特徵中發現根據本發明之解答。優 良的精細部分則形成相依請求項之主題。 本發明提供一種鈦合金醫療植入物之製造方法，其步 驟包括在一與欲製造的植入物相符合之鑄塑模具中熔模鑄 造該鈦合金；且根據本發明，其關條件為使盼欽合金、 熱等壓加壓、固溶退火、然後淬火。 根據本發明之方法可從β-鈦合金，利用溶模鑄造來製 造-醫療植人物。能制β_欽合金可將相當大的優點帶至 相關的醫療植人物中。例如，β·鈦合金具有適合的機械性 質’特別是其具有比熟头口的略鈦合金更低之彈性模數。然 而，後者之模量通常大約1〇〇〇〇〇牛頓/平方毫米而欽_钥合 金能獲得實際上減半的模量，大約60000牛頓/平方毫米 再者，使用β-鈦合金可增加生物共存性。然而，時常使用 之α/β-鈦合金(Ti A10V4)，已某種程度上關心其將釋玫出的鋁 或釩離子毒性；從毒性觀點來看，可成功地將無害的人金 元素（諸如，鉬）使用於β-鈦合金中。經發現， ° 合金可在機械性f及亦在生物共存性上獲得優良的結果。 鉬含量或鉬當量值在7.5至25%間較佳，在12至16%間更 佳。此允許在鑄塑後，藉由快速冷卻來獲得一亞穩的卜相。 已証明鉬含量15%的TiM〇〗5特別合適。 再者，使用β-鈦合金的優點為可經濟地製造出甚至形 狀複雜之植入物。概括來說，熔模鑄造為一種塑形方法， 其可使用來比利用鍛造塑形更經濟地製造出甚至更複雜的 形狀。但是，經發現特別當使用先述技藝已熟知的α -或導. 欽&金時’溶模鎿造已無法在植人物上充分製造出鮮明的 邊緣。因此’尚無法完全實現熔賴造的时優勢，換句 話°兒，為其可製造出任何想要的複雜形狀之能力。但是， 特別在植入物的實例中，時常想要提供鮮明的邊緣以改善 植入物之蚊。植人物的鮮明邊緣對無黏㈣植入非常重 要’，此在許多實例中為選擇具長時間機械穩定性的植入物 ,理由。已驚人地發現，根據本發明之方法可達成經 2的模具充填°此意謂著甚至可對複雜形狀的植入物獲 付同°°質之鮮明邊緣。因此，本發明不僅ϋ·具有更適合的 性質（關於機械及生物共存性)之植人物提供門路，而且亦可 利用炫模轉造來獲得關於塑形之改良。 在固溶退火期間，可以該鈦合金無ω-相的方式來權宜 地選擇該溫度曲線β此可抵消機械性質將受.相形成而相 反地影響之風險。 對熱等壓加壓（HIP)來說，溫度低於β·相轉變溫度（特別 是至多低於β-相轉變溫度lOOt:)有利。已証明71〇t至76〇 °c的溫度範圍（大約740它較佳），在氬壓力大約11〇〇巴至 1200巴下合適於鉬含量15%之鈦_鉬合金。 已言正明溫度至少7〇(TC至㈣。C (範圍從獅。c至86〇〇c 較佳）’於氬i«氣體環境下合適於該退火。因此，可 改。該。金的延展性。已不需要在熱等壓加壓前後進行初 步時效硬化。在冷水中進行隨後的淬火較佳。 對該目標亦優良的是，可在結束時硬化。此允許若需 要村進—步增加雜植。為此目的，在大觸(TC至大 約· C的溫度範圍内進行硬化較佳。 ^發㈣關於根據上述方法所製造㈣療植入物及根 金所制t1求項的醫療植人物。於此提供—從卜欽合 醫療植人物，其具有平均 毫 水。參考上述所提供的說明來進-步解釋。 應該加入下列其它 假體，較佳為一人' 該植入物可為-整形外科的 離、岸力。將_卫關郎。人工關節將遭受到高靜止及動 心應力。將負載傳輸至骨士 可能為生理學上私力構周圍特別重要。此應該儘 自^^ _ 。。在此上下文中的關鍵因素為，若來 自假體的負載不適宜地傳輪 組織變性。此時常舍道 碩周圍時，此會導致骨頭 ^會導致假體變鬆散。測試已顯示出由具 有較低彈性模數的材料所製得之假體會產生—比從堅硬材 =製得的假體更生理正常之負載狀況。此特別可應用至 :八長幹的假體，諸如人卫㈣節或其它人卫關節的股骨 p °習知的鈦合金(例如TiAl6v4)之彈性模數大約麵〇 貝平方毫米’ ϋ此相當大於皮質骨材料的彈性模數(大約 250旦00牛頓/平方毫米）。根據本發明之植人物可獲得較低的 模里。例如，根據本發明’從雇。15所製造的植入物之彈 性模數大綱GO怖平方毫米，其即僅龍多於氧％ 的模數之—半。此為主要優點，特別是對具有長幹的人工 關節（諸如人工m讀關節）來說，因為此結果可明 顯改善傳輸至骨頭的力量。 相符合的考慮亦可將根據本發明之植入物應用於假牙 的具體實施例中。 圖式簡單說明 本發明將於下列參考圖形來解釋，其闡明出優良的典 型具體實施例，且其中： 第1圖為立即在鑄塑後，於鑄塑狀態中之微結構影像； 第2圖為在熱等壓加壓後之微結構影像； 第3圖為在固溶退火與隨後的淬火後之微結構影像； 第4圖為根據本發明之典型植入物具體實施例之股骨 部分的圖式； 第5圖為一牙科植體圖式，其作為進一步的典型具體實 施例；及 第6圖為一表，其提供已根據本發明加工之鈦合金的機 域性質 t實施方式】 較佳實施狀詳細說明 攻進仃根據本發明之製程的方法。 將以人工髋關節之俨其A 晚後， 植入物 ，i 叔月部分的實例為基礎來解釋所製1 T材料為含量㈣邮·鈦合金⑽。"）。此合金 、可以小坯料形式(鑄塊)購得。 第一步驟包括熔模鑄造一欲鑄塑的物體。於本上下文 中’該物體之意義經了解為—已塑形而合適於其最後用途 的植入物，諸如假骨架(例如，人工髋關節或其它人工關節） 或固定用植入物(例如，板或栓)或牙科植體。此項目不包括 10 15 意欲藉由塑形方法進一步加工的坯料，即，特別不包括利 用耐久模具來鑄塑製造，且利用鍛造或其它塑形方法來進 一步加工之鑄塊。 提供一鑄塑裝置，以用於熔化及鑄塑TiMo15i目的。 該鑄塑裝置為一冷壁坩堝真空誘導熔融及鑄塑裝置較佳。 此型式之裝置可到達熔模鑄造時，能信賴地熔融TiMo15K 需要之高溫》耵1\4〇15的熔點為1770°C，再加上大約60°C之 2〇 補充溫度，以利於可信賴的熔模鑄造。因此，整體來說， 需要到達溫度1830°C。然後，利用本身已熟知的方法來進 行熔融物之熔模鑄造，例如可使用蠟蕊及陶瓷模具作為無 功模具（lost mold)。此型式之熔模鑄造技術已熟知可用於 TiAl6V4的溶模鎮造。 10 如可從第1圖之影像(放大1000倍）中看見，已形成樹模 石且在枝晶間區域發生相當大量的析出物。此為已熟知為 欽-銷合金的負偏析之結果。此效應以鈦鉬合金之液線及固 線溫度的特定曲線為基礎。在熔融時，高鉬含量的區域將 首先固化’可在圖形中看見樹模石形成。此會耗盡該溶融 物的殘餘物質’即，其鉬含量將降低。在該鑄塑微結構中 之枝晶間區域中的鉬含量低於15%，其甚至可降至大約 10%。由於鉬耗盡，該枝晶間區域缺乏足夠量的β-安定劑， 結果將局部建立出α/β轉變溫度增加而導致析出，其現成地 顯現在第1圖中。 可有利地利用浸蝕來移除一在鑄塑期間所形成之表面 、 I m. 區域(其為一硬而易碎的層，熟知為((^殼)）。此層的厚度通 常大約0.03毫米。 為了抵消在該枝晶間區域中之析出物其不利的負偏析 效應，根據本發明，在該鑄塑模具已於熔模鑄造後移除後， 讓該鑄件接受加熱處理。此包括熱等壓加壓(HIP)，特別是 在溫度僅低於β_相轉變溫度下進行。其範圍可在71〇它至 760°C内，且大約74〇。(：較佳。使用壓力1100至12〇〇巴的氬 來進行加壓。此可使得在該枝晶間區域中不想要的析出物 再次溶解。但是，在冷卻期間，於熱等壓加壓後，再次析 出細微的次生相，此會優先在原始枝晶間區域（參照第2 圖，放大ΙΟΟΟχ)中產生。此將導致不想要的材料脆化。 該物體在熱等壓加壓後僅具有低延展性。 為了消除此破裂性析出，在艙爐中，於氬遮蔽氣體環 1379670 境下退火該鑄件。為此目的’選擇大的 度範圍持續數小時(通常二小時）。在此上下々击 /m 「，在溫度盍 週期間有倒數關係；於較高溫度下，較短的時間即 、 反之亦然。在固溶退火後，於冷水中淬火該禱件。第^放 5大丨〇〇〇><)闡明在固溶退火後之微結構。可看見一 '吸β·晶粒， 且在該些晶粒内有非常細微的枝晶間析出物（參左 上部的雲狀堆積物）。已使用根據本發明之方法進时模 造的物體，在其結晶結構中具有平均尺寸大於〇·3毫米^ 晶粒。此尺寸為利用根據本發明之方法所獲得的血型全士曰 10結構。 、！、·〇日日 在固溶退火後所獲得的機械性質則提供在第5圖之 中。 纟第4圖中所_的典型具體實施例顯示出人工髋關 節的股骨部分i。其由β_鈦合金(換句話說TiM015)所組成。 15其在室溫下具有體心立方的結晶結構。 • 股骨部分1意欲在股骨的上端處植入。其具有一伸長抽 10及-以純角錢的頸部n。在綱部遠離該軸之終端處 有-關❹12,其與如部分2-起形成關節。植入包括完 全或部分切除fiboneck頭，且對股骨的骨髓腔打開一入口。 2〇 =由此人口，將股骨部分引進骨趟腔+ 猫 定。可依特別的設計提供黏固粉作為該錨定方法’或可沒 有使用霉占固粉來進行錯定。 ,該股骨！會將作用在人工體關節上之機械負載(不論是 靜止負載(當靜置時)或動態負載(當走路時)Η丨進股骨。在股 12 骨之骨頭材料中，對股骨部分1之耐久性可信賴的錨定來 說，生理學相容的負載傳輸很重要》若該股骨部分1為一堅 硬設計時，其將吸收相當大部分的負載，因此將減輕在骨 頭材料上（待別是在該股骨的上區域中）之負載。就長遠來 看’此將導致股骨在此區域中變質。此將導致股骨部分1變 鬆散，最終該假體損壞的風險。為了防止此損壞模式，股 骨部分1可適合地採用較不堅硬的設計》特別是，該股骨部 分1的軸10在此方面上為關鍵。在該皮質區域中，該股骨的 骨頭材料之彈性模數大約20000至25000牛頓/平方毫求。根 據本發明，該股骨部分1之彈性模數僅大約60000牛頓/平方 毫米。習知使用的材料（諸如TiAl6V4)之彈性模數大約 100000牛頓/平方毫米或甚至200000牛頓/平方毫米（在鈷_ 鉻合金的實例中）。因此，根據本發明之股骨部分丨具有一 生理學相容的低彈性模數。此低彈性模數為該假體具長時 1相谷性的主要優點，特別是在軸1〇的區域中，其在此方 面為關鍵。 本發明允許利用熔模鑄造來簡單地製造出甚至複雜的 形狀。例如’股骨部分丨在其抽1G上具有乡重时及鑛齒狀 凸出物。這些已使用來改善股骨部分1在股骨中之錯定，而 允許進行無黏固粉植人。可在該軸1G的縱方向上看見其佈 置有複數條溝紋14 1們安排在該㈣的前後邊二者上， 但是其亦可提供在橫向邊上。在該軸_上區域中提供複 數個鑛齒凸出物15列。再者，在轉換至頸部U處提供-環 繞環。其可設計成—分㈣元件，但是本判意欲將其 1379670 與軸ίο及頸部i1整合。此複雜形狀的假體組件習知上僅可 從TiAl6V4來製造。但是’已如上述所解釋，此材料具有不 合意的高彈性模數。雖然亦已熟知可從β-鈦合金來製造出 股骨部份，但其僅可使用鍛造方法來進行。鍛造無法製造 5 出如此複雜的形狀，且從醫療的觀點來看，如闡明在第4圖 之優良形狀。本發明之優勢為可從β-鈦合金獲得此複雜形 狀，甚至可用來製得人工髋關節。 【圖式簡單說明3 第1圖為立即在鑄塑後，於鑄塑狀態中之微結構影像； 10 第2圖為在熱等壓加壓後之微結構影像； 第3圖為在固溶退火與隨後的泮火後之微结構影像； 第4圖為根據本發明之典型植入物具體實施例之股骨 部分的圖式； 第5圖為一牙科植體圖式，其作為進一步的典型具體實 15 施例；及 第6圖為-表’其提供已根據本發明心之欽合金的機 械性質。 【主要元件符號說明】 12…關節頭 13…環繞環 14…溝紋 15…鋸齒凸出物 1···股骨部分 2…髖白部分 10…轴 ll···頸部 14

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1379670 |1>1年9月1日修正替 第95106330號專利申請1案申請專而两換本.」1〇1919 十、申請專利範圍： 1. 一種鈦合金醫療植入物之製造方法，其步驟包括： 在與欲製造的植入物相符合之鑄塑模具中熔模 鑄造該鈦合金； 該方法包括 使用β-鈦合金，該鈦合金包含鉬且該合金之鉬含量 係介於7.5%與25%之間； "、專壓加壓，該熱等塵加壓在介於β-相轉變溫度與 低於該Μ目轉變溫度1〇(rc之間的溫度進行； 固办退火，用於該固溶退火步驟的溫度係介於 °〇與90〇。(：之間； . ； 然後淬火。 λ2.如申請專利範圍第1項之方法，其包括在淬火後硬化。 如申吻專利範圍第1或2項之方法’其包括使用一鈦-钥 合金。 4. ^申請專利範圍第1或2項的方法，其中以紐合金無ω- 5目的方絲鄉在111溶敎顚之溫度曲線。 申崎專利㈣第1或2項的方法，其巾㈣冷水來進行 s亥淬火較佳。 造種^療植入物’其已從鈦合金使用熔模鎮造方法來製 〇 °亥欽合金為卜欽合金且具有平均晶粒尺寸至少 毫米以及彈性模數介於59.4 kN/mm2與68 kN/mm2之 間。 I如申請專利範圍第6項之植入物，其經熱等壓加壓及固 15 1379670 mm月η日修(^)正替換頁 第95106330號專利申請專利範圍替換本 101.9.19 溶退火。 8. 如申請專利範圍第6或7項之植入物，其中鉬含量在7.5 至25%間。 9. 如申請專利範圍第6或7項的植入物，其中該鈦合金無ω-相0 10. 如申請專利範圍第6或7項的植入物，其中該鈦合金無釩 及鋁。 11. 如申請專利範圍第6或7項的植入物，其為一整形外科假 體。 12. 如申請專利範圍第11項之植入物，其中該假體為一人工 關節。 13. 如申請專利範圍第12項之植入物，其為一人工髋關節的 股骨部分。 14. 如申請專利範圍第6或7項的植入物，其為一牙科植體。 16
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