TWI441623B - 鈦合金義肢 - Google Patents

鈦合金義肢 Download PDF

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Publication number
TWI441623B
TWI441623B TW095106327A TW95106327A TWI441623B TW I441623 B TWI441623 B TW I441623B TW 095106327 A TW095106327 A TW 095106327A TW 95106327 A TW95106327 A TW 95106327A TW I441623 B TWI441623 B TW I441623B
Authority
TW
Taiwan
Prior art keywords
titanium alloy
artificial joint
shaft
prosthesis
joint
Prior art date
Application number
TW095106327A
Other languages
English (en)
Other versions
TW200640431A (en
Inventor
Sevki Baliktay
Arnold Keller
Original Assignee
Link Waldemar Gmbh Co
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Filing date
Publication date
Application filed by Link Waldemar Gmbh Co filed Critical Link Waldemar Gmbh Co
Publication of TW200640431A publication Critical patent/TW200640431A/zh
Application granted granted Critical
Publication of TWI441623B publication Critical patent/TWI441623B/zh

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Classifications

    • 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
    • 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
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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
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral 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
    • 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
    • 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
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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
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    • 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
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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
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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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    • 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
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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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    • 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
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    • 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
    • A61F2002/30084—Materials having a crystalline structure
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • 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
    • 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
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    • 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 or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4631—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor 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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  • Epidemiology (AREA)
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  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Description

鈦合金義肢
本發明係有關於具有一軸的一鈦合金人工關節。
人體之主要關節承受高機械應力。例如，運動器官(locomotor apparatus)之關節必需承受大部分的身體重量，此外，其在每次踏一步時移動。因此，支撐關節的骨頭具有強有力的皮層結構。就關節充分發揮功能性而言，其之整體性係為重要的。對於手臂關節亦為同等重要，儘管其所必需支撐的重量較低，但是其移動更為頻繁並因而受到高程度磨損。此外，其之尺寸較小並更易受到傷害。
對於永久性植入的義肢(人工義肢(endoprosthesis))不僅必需具有充分的機械特性用以確保所需功能性，而且必需具有儘可能高的生物適應性(biocompatiblity)，用以確保為病患能夠容忍涵蓋一段延長的時間。特別地，該後者觀點係極為重要，因為一般而言在需植入義肢時會發生任何的不適應性。如此等同於義肢失敗。
所熟知的是不充分地將負荷自義肢傳輸至周圍骨頭，會導致骨組織退化。如此通常會導致義肢鬆開。因此，為避免發生此退化狀況，儘可能確保藉由義肢使負荷維持生理上正常係為重要的。測試顯示具有一較低彈性模數的人工髖關節(hip prostheses)，與使用剛性人工髓關節相較，所產生的負荷狀況更為生理上正常的。例如，就股骨義肢(femoral prostheses)而言，已由使用一般地具有位在約200,000 N/mm2 的區域中之極高彈性模數的鈷鉻合金(Cobalt－Chromium alloys)而傾向採用鈦合金，其之彈性模數較低，例如，諸如TiA16V4，彈性模數約為100000 N/mm2 。然而，該等程度仍完全高於皮質骨之彈性模數，約為25000 N/mm2 。
 發明概要
本發明之目的在於改良一於技術領域中所說明類型的人工關節，俾便達到更具生理上正常的負荷傳輸。
本發明之解決方案在於具有獨立項申請專利範圍之特性的一人工關節。有利的精華部分構成子申請專利範圍之主題。
根據本發明，於一具有一軸的鈦合金人工關節中，至少該軸係為包埋鑄件(investment－cast)並具有一體心立方晶體結構(即為所熟知的β－鈦合金)。
本發明之人工關節能夠用以達到顯著的低彈性模數。視所使用的鈦合金及所進行的熱處理而定，能夠達到約60000 N/mm2 之彈性模數。如此實際上係與先前利用鈦合金所達到之彈性模數的一半相當。再者，本發明之軸至少係為包埋鑄件。如此容許更為複雜的義肢塑造。至今主要用於鈦義肢的鍛造處理，僅容許生產相對簡單的結構。本發明能夠克服此限制。因此，本發明之義肢對於所吸收的負荷有較佳的配合。例如，義肢之塑造可根據局部應力更為精確地加以變化。義肢僅需在出現高應力的特定區域中具因而更具彈性設計。如此容許進一步改善義肢與解剖狀況之配合。此外，對於緊固元件，諸如突出部分，係易於與義肢一體成型。能夠提供較大數目且更為複雜的緊固元件。因此，義肢係更適於無接合質(cement-free)植入。本發明之優點在於其之複雜形狀，其係為甚至對於β-鈦合金義肢的鍛造處理於實務上所無法達成。一般地，儘管不排除義肢能夠由包括軸的複數元件裝配的可能性，但本例連同軸之義肢係為包埋鑄造且經熱處理為一單件。
本發明能夠有利地用於人工髖關節，特別地用於股骨義肢。其係為承受最高應力義肢，並具有一複雜形狀軸用以植入於股骨中。頃發現假若所植入義肢具太大剛性，則特別是在股骨之上區域易於出現退化現象。如此通常會造成義肢故障。就本發明之股骨義肢而言，其軸的彈性模數係位在59.4kN/mm2 至68kN/mm2 之間的範圍中，該彈性模數相當低並因而更為接近股骨之上區域之骨質的生理位階。本發明之股骨義肢成功地抵銷退化的風險。其亦能更應用在人工膝關節之形式的一具體實施例，其通常具有極長軸。
鈦合金較佳地係為一鈦-鉬合金。添加鉬加以穩定化，即為所熟知的β相之鈦合金。如此容許形成所需的體心立方晶體結構。作為合金元素的鉬具有較其他合金元素為低的毒性，其同樣地使β相穩定，特別是鈮或釩。就長期植入而言，降低毒性係為義肢之重要優點。
合金中鉬或鉬等效物所佔比例有利地位在自7.5至25%的範圍內。此結果，特別是就至少為10%之鉬成分的例子而言，一直降至室溫範圍係具β相之充分穩定性。該成分較佳地係介於12與16%之間。如此容許藉由鑄造作業後急速冷卻而達到次穩態β相。晶體結構的平均晶粒尺寸係至少為0.3公厘，較佳地係為0.5公厘。一般而言不需添加另外的合金構成成分。特別地，不需添加釩或鋁。排除該等成分所具有的優點在於，如上所述，能夠避免自該等合金構成成分散發出毒性。相同的情況可應用在鉍，其之生物適應性同樣地與鈦不相配合。再者，與所熟知合金相較，諸如TiAl6V4，鈦－鉬合金之優點在於具有改良的模塑充填特性。如此使能夠藉由包埋鑄造法構成尖銳邊緣結構。
經證實對於至少本發明之軸經均衡熱壓及固溶退火(solution annealing)係特別地適合。頃發現利用已以此方式進行熱處理的一材料能夠達到與脆性有關的顯著改良。均衡熱壓作業抵銷樹狀突中富含鉬以及藉由溶解枝晶間沈澱而熔化殘餘物的不利效果。低於β－transus溫度的一溫度係為有利的，特別地最多低於β－transus溫度100℃。位在自710℃至760℃之範圍內的溫度，較佳地係為740℃，經證實適於鉬成分為15%的一鈦－鉬合金。固溶退火改良合金之延展性。為此，已經證實適合溫度至少為700℃上至880℃，較佳地位在自780℃至860℃的溫度範圍內。不需在均衡熱壓之前或之後進行初步時效硬化(age－hardening)。就固溶退火後的冷卻而言，有利地將軸以水淬火。
圖式簡單說明
以上係將關於圖式更為詳細地說明本發明，其係圖示一有利的示範具體實施例，其中：第1圖係為本發明之一人工關節的一第一示範具體實施例的一概略視圖；第2圖係為本發明之一人工關節的另一示範具體實施例的一概略視圖；第3圖係為在緊接包埋鑄造之後的晶體結構的一影像(放大1000倍)；第4圖係為在均衡熱壓及固溶退火之後的晶體結構的一影像；以及第5圖係為本發明之義肢的機械性質表。
第1圖中所示的示範具體實施例係顯示一人工髖關節的一股骨義肢。股骨義肢1係由一β－鈦合金，即TiMo15，所組成。此合金在室溫下具有一體心立方晶體結構。
股骨義肢1係意欲植入在股骨之上端部處。其能夠與已植入盆骨中的髖臼組件2相互作用。股骨義肢1具有一伸長軸10作為骨固定元件，以及一頸部分11其係與之毗連成一鈍角。於其之遠離軸之端部處，配置有一關節頭12其連同髖臼組件2之一軸承嵌入物22構成一球關節。植入包含完整或部分切除大腿骨頸頭，打開進入股骨之髓腔。此進入係用以將股骨義肢1之軸10導入髓腔中，於該處固定。視特定具體實施例而定，提供接合質作為固定構件或是不使用接合質而產生固定作用。
股骨義肢1將作用在髖關節上的機械負荷，無論是站立時的靜態負荷或是行走時的動態負荷，引進股骨。生理上相容的負荷傳輸對於股骨之骨質中股骨義肢1之永久可靠的固定作用係為重要的。假若股骨義肢1係為極度剛性設計，則其吸收負荷的一相當大部分，從而釋放骨質上的負荷，特別是位在股骨之上區域。於較長時間，如此造成此區域中股骨的退化。如此造成股骨義肢1鬆開並且最後發生義肢失去作用的風險。為防止此故障狀況，所熟知地就股骨義肢1本身而言製作為較不具剛性，亦即，利用一生理上適合的低彈性模數設計而更具彈性。特別地，就此觀點而言，股骨義肢1之軸10係為緊要的。於皮層區域中，股骨之骨質的一彈性模數約為20000至25000 N/mm2 。根據本發明，股骨義肢1之彈性模數約為60000 N/mm2 。此係為一適合的彈性模數，其遠低於傳統上使用材料，諸如TiAl6V4，的彈性模數。就鈷－鉻合金之例子而言，該等材料的彈性模數約為100000 N/mm2 或甚至為200000。N/mm2 。
本發明容許藉由包埋鑄造法簡單地構成更為複雜的形狀。例如，股骨義肢1在其之軸10上具有多重凹口及鋸齒狀突出部分。其係用以改良股骨中股骨義肢1之固定作用，容許無接合質植入。於軸10之縱方向上提供複數之溝槽14。其係配置位在軸10之前部及後部二側邊上，但亦可配置位在橫向側邊上。在軸10之上區域中配置複數列之鋸齒狀突出部分15。再者，一包圍環件13係配置位在頸部分11的轉變區域。其能經設計作為一分開元件，但於本發明其亦可與軸10及頸部分11一體成型。一般地，除了可替換或可任擇的附裝元件或磨耗元件外，單件式設計的義肢係為較佳的。再者，將一固定突出部分16配置位在與環件13相鄰的軸10上，用以防止轉動。人工關節的該等複雜形狀傳統上僅能以TiAl6V4構成。然而，此材料具有一不同、較不適合的晶體結構，以及一不合意的高彈性模數。
本發明亦能夠有利地用於其他類型的人工關節。第2圖所示係為一進一步示範具體實施例的一人工膝關節3。其包含一股骨組件31及一脛骨組件30。股骨組件31具有一長軸33作為骨固定元件。其經設計用以植入於股骨之髓腔中，該髓腔已藉由切開自身膝關節而打開。就股骨義肢之例子而言，假若人工膝關節3，特別在於其之軸33，製作得太具剛性，則會發生周圍皮層結構退化的問題。相同的狀況亦可應用在脛骨組件30之一軸32上。
本發明之人工關節亦能夠用於，例如，位在手肘或肩部處的其他關節。
以下將說明實行本發明之一方法。
原材料係為具有15%之鉬含量的一β－鈦合金(TiMo15)。此合金係以小坯料(鑄塊)的形式作商業販售。
第一步驟包含人工髖關節之元件的包埋鑄造。配置一鑄造設備用以將TiMo15熔煉並鑄造。鑄造設備較佳地係為一冷壁坩堝式真空感應熔煉及鑄造設備。此型式之一設備能夠達到將TiMo15進行包埋鑄造之確實熔煉所需的高溫。TiMo15之熔點係為1770℃加上進行確實包埋鑄造所需約60℃之增補溫度。總的來說，因此，需達1830℃之一溫度。因而熔煉物之包埋鑄造係藉由，例如，就其本身而言使用蠟芯及陶瓷模具作為脫模的熟知方法而實行。此型式之包埋鑄造技術即為所熟知的TiAl6V4之包埋鑄造。完成物係為一體心立方晶體結構。第3圖中所示係為微結構的一影像。
在包埋鑄造作業之後，自鑄造模具取出之鑄件接受熱處理。此係包含在恰好低於β－transus溫度的一溫度下所進行的均衡熱壓(HIP)。此溫度係位在自710℃至760℃的溫度範圍中，且較佳地在1100至1200 bar的一氬壓力下係約為740℃。為此目的，將在鑄造作業期間構成為一硬、脆層(即為所熟知的α－case層)形式的表面區域，藉由酸洗方式去除係為有利的。此層厚度通常約為0.03公厘。
於均衡熱壓之後，鑄件僅具低延展性。假定此脆化現象係歸因於在均衡熱壓期間的二次沉澱，以及接續的大體上自均衡熱壓溫度緩慢的冷卻。
為溶解該等破裂的沉澱物，鑄件係在氬屏蔽氣體下於一室式爐(chamber furnace)中退火。為此目的，在自約700℃至860℃的溫度範圍內持續數小時，大體上為二小時。於本文中，溫度與持續時間之間係為倒數關係；在較高溫度下，較短的時間係為足夠的，反之亦然。在固溶退火後，鑄件係使用冷水進行淬火。第4圖中所示係為最終的微結構。
在固溶退火後所達到的機械性質係複製於第5圖中所示表中。
於固溶退火期間，彈性模數隨著溫度上升而下降，特別地下降低至60000 N/mm2 的程度。降低強度及硬度而改良延展性。例如，在800℃的溫度下持續二小時的固溶退火後，所得結果為具有約40%之拉斷伸長率及約為730 N/mm2 的斷裂強度Rm的一60000 N/mm2 之彈性模數。
1．．．股骨義肢
2．．．髖臼組件
3．．．人工膝關節
10．．．伸長軸
11．．．頸部分
12．．．關節頭
13．．．包圍環件
14．．．溝槽
15．．．鋸齒狀突出部分
16．．．固定突出部分
22．．．軸承嵌入物
30．．．脛骨組件
31．．．股骨組件
32．．．軸
33．．．長軸
第1圖係為本發明之一人工關節的一第一示範具體實施例的一概略視圖；第2圖係為本發明之一人工關節的另一示範具體實施例的一概略視圖；第3圖係為在緊接包埋鑄造之後的晶體結構的一影像(放大1000倍)；第4圖係為在均衡熱壓及固溶退火之後的晶體結構的一影像；以及第5圖係為本發明之義肢的機械性質表。
1．．．股骨義肢
2．．．髖臼組件
10．．．伸長軸
11．．．頸部分
12．．．關節頭
13．．．包圍環件
14．．．溝槽
15．．．鋸齒狀突出部分
16．．．固定突出部分
22．．．軸承嵌入物

Claims (9)

  1. 一種具有一軸由鈦合金製成之人工關節(joint prosthesis)，其中至少該軸係為包埋鑄件(investment-cast)並具有一體心立方晶體結構，其中該鈦合金係為一鈦-鉬合金且有一鉬含量位在12至16%的範圍中，以及其中該軸的彈性模數係位在59.4kN/mm2 至68kN/mm2 之間的範圍中。
  2. 如申請專利範圍第1項之人工關節，其係經設計作為一股骨義肢(femoral prosthesis)。
  3. 如申請專利範圍第1項之人工關節，其係經設計作為一人工膝關節(knee prosthesis)。
  4. 如申請專利範圍第1項之人工關節，其中該晶體結構之平均晶粒尺寸至少係為0.3公厘。
  5. 如申請專利範圍第1項之人工關節，其中該晶體結構之平均晶粒尺寸係為0.5公厘。
  6. 如申請專利範圍第1至5項中任一項之人工關節，其中至少該軸係經均衡熱壓(hot isostatically pressed)及經固溶退火(solution annealed)。
  7. 如申請專利範圍第6項之人工關節，其中進行該均衡熱壓的一溫度係至多等於該鈦合金之一β-transus溫度，且低於該β-transus溫度至多100℃。
  8. 如申請專利範圍第1項之人工關節，其中該鈦合金並無釩及鋁。
  9. 如申請專利範圍第1項之人工關節，其中該鈦合金並無鉍。
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