TWI554257B - 內膺復物組件(一) - Google Patents
內膺復物組件(一) Download PDFInfo
- Publication number
- TWI554257B TWI554257B TW097132523A TW97132523A TWI554257B TW I554257 B TWI554257 B TW I554257B TW 097132523 A TW097132523 A TW 097132523A TW 97132523 A TW97132523 A TW 97132523A TW I554257 B TWI554257 B TW I554257B
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- TW
- Taiwan
- Prior art keywords
- ceramic
- coating
- component
- roughness
- assembly
- Prior art date
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Classifications
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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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
- 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
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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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
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
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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
- A61L27/10—Ceramics or glasses
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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
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B24—GRINDING; POLISHING
- B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
- B24C1/00—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods
- B24C1/08—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods for polishing surfaces, e.g. smoothing a surface by making use of liquid-borne abrasives
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
- C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
- C04B35/10—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on aluminium oxide
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
- C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
- C04B35/48—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
- C04B41/009—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone characterised by the material treated
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
- C04B41/45—Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements
- C04B41/50—Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements with inorganic materials
- C04B41/51—Metallising, e.g. infiltration of sintered ceramic preforms with molten metal
- C04B41/5133—Metallising, e.g. infiltration of sintered ceramic preforms with molten metal with a composition mainly composed of one or more of the refractory metals
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- C—CHEMISTRY; METALLURGY
- C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
- C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
- C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
- C04B41/80—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone of only ceramics
- C04B41/81—Coating or impregnation
- C04B41/85—Coating or impregnation with inorganic materials
- C04B41/88—Metals
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C4/00—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge
- C23C4/04—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the coating material
- C23C4/06—Metallic material
- C23C4/08—Metallic material containing only metal elements
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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
- A61F2/3094—Designing or manufacturing processes
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- 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
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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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- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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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
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
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- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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Description
本發明係與由陶瓷材料所形成之內膺復物組件有關,且其中該陶瓷材料係被部份地以一鈦合金來包覆。內膺復物組件之未包覆表面部分,係被設計以作為另一內膺復物組件之滑動表面而互相作用。該內膺復物組件的塗覆表面部分,係被設計以產生與骨頭之連結。本發明進一步與一種用於生產此一內膺復物組件的方法有關。本發明最終係與一種用來生產一種其上可以施加鈦合金塗覆物之陶瓷組件有關。在該方法中,一起始材料係以粉狀形式導入一預先界定該陶瓷組件之形狀的模具內。該陶瓷組件然後在一些步驟中進行燒結。
陶瓷材料結合了高度的機械強度與尺寸安定性以及良好的生物相容性。陶瓷材料因此係被用來製造內膺復物。
在用來替換一關節之內膺復物中,在該內膺復物與該骨質結構之間必須要形成一穩定的連接作用。在此一方面,陶瓷材料比起其他材料係較為不利的,因為其等之緻密表面不容易建立有效之與骨質物質的連接作用。由WO99/30634中,已知可以施加一鈦合金來塗覆該內膺復物組件欲與骨質物質形成連接之部分。該塗覆物具有一比該陶瓷材料更大之多孔性。該骨質物質可以生長至該等孔洞內並此此方式來形成與該內膺復物組件之穩定的連接作用。
鈦合金無法與該陶瓷材料進行化學性或治金性連接作用。該鈦合金與該陶瓷材料之間因此係為一純粹機械性的連結。依據WO99/30634,該鈦合金應該以電漿噴灑作用來施加至該陶瓷材料上。就一良好的機械性連接作用而言,該欲被塗覆之陶瓷材料的表面應該要是粗糙的。
測試顯示以此一方式來施加之塗覆物並無法與每種粗糙表面形成足夠穩定之連結。如果該粗糙度Ra
係低於2μm,該所施加的層就會從在負載下自該陶瓷材料翹起。
本發明之目的係要得到在一開始所描述之內膺復物組件,其中該塗覆物係比陶瓷材料更易於附著。提供一種用於生產此一內膺復物組件之方法,以及一種用於生產一對應的陶瓷組件之方法,也是本發明之目的。該目的係藉由該等獨立項之特徵來達成。有利之具體例係被描述於該等獨立項中。依據本發明,會與該塗覆物形成一界面之該陶瓷材料部分係具有介於2.5μm和7μm之間的粗糙度Ra
,較佳地為介於3.5μm和5μm之間。
首先將描述一些術語。粗糙度這個術語會將一表面的不平順度量化。在本發明的內容中該粗糙度值Ra
係依據DINEN ISO 4288和3274而定。
該內膺復物組件係由一陶瓷材料所形成。以該陶瓷材料所形成的該表面,係被部份地以一鈦合金來塗覆。該鈦塗覆物並不一定會形成該內膺復物組件之最外層;一例如由可以刺激骨骼生長之材料所製成之進一步層可以被施加
至該鈦塗覆物。部分的該表面係並未被塗覆,並且係被設計以作為與另一個內膺復物組件互相作用之滑動表面。該未包覆區域與該滑動表面並不一是相同的。
在該經塗覆的區域中,在該陶瓷材料與該鈦合金之間具有一界面。在該塗覆物與陶瓷材料之間的連結強度,係由在該界面之陶瓷材料的形式所界定。測試顯示,如果在該界面之該陶瓷材料的粗糙度Ra
係少於2μm,在該塗覆物與陶瓷材料之間的連結作用將會不足。由一係為2.5之粗糙度Ra
可以得到良好的黏附作用。如果該粗糙度Ra
係大於3.5μm的話,該黏附作用將被進一步改善。
該塗覆物係較佳地可以在單一作業中進行施加。如果該粗糙度過大就必須被陸續地施加數個層,以確保該陶瓷表面可以被完全地覆蓋,並且在各處之該層的厚度係為足夠的。因此,該陶瓷材料在該界面的粗糙度Ra
不應大於7μm,較佳地係不大於5μm。
食品藥物管理局(美國的授權機關)規定,在該塗覆物與該陶瓷材料之間的該黏著劑拉曳強度(依據ASTMF1147所界定者)必須要至少為22MPa。為了要觀測與此一限制有關之安全界限,在依據本發明之該內膺復物組件中之該塗覆物與該陶瓷材料之間的該黏著劑拉曳強度,係至少為25MPa,較佳地為至少30MPa,更佳地至少40MPa。該塗覆物之層厚度(依據ASTMF1854所界定者),係較佳地為介於100μm和250μm之間,較佳地為介於150μm和200μm之間。
如果該塗覆物具有以下的性質,就可以在該骨質物質
與該塗覆物之間達成良好的連結作用。該孔洞比例(依據ASTMF 1854所界定者)係介於20%和40%之間。該孔洞寬度(同樣也是依據ASTMF 1854所界定者)係介於30μm和70μm之間,較佳地為介於40μm和60μm之間。
氧化鋯、氧化鋁以及其等之混合物,已經被證實係適合於依據本發明之該內膺復物組件的陶瓷材料。"鈦合金"這個術語包含有純質鈦。
該內膺復物組件係較佳地為一椎間盤膺復物的數個組件之一。該被設計為滑動表面之部分會形成該椎間盤膺復物的滑動表面。
依據本發明之用於產生一內膺復物組件的方法,包括有首先選擇一經適當成形之陶瓷結構部件,其中該欲被加以塗覆之表面係具有係介於2.5μm和7μm之間的粗糙度Ra
,較佳地為介於3.5μm和5μm之間。一鈦合金係藉著電漿噴灑作用而施加至該欲被塗覆之該表面上。電漿噴灑是作用係為一種其中一氣體係通過一電弧來輸送並藉以離子化之方法。該塗覆物材料係以粉末形式而導入該離子化氣體內,並藉由通至該欲被塗覆之工作件上之氣體流來加以運送。
目前已經發現其中該欲被塗覆之表面係具有介於2.5μm和7μm之間的粗糙度Ra
的陶瓷組件之製造,並不完全是件簡單的事。在傳統的製造方法中,該表面粗糙度係更少得多,而且其係不容易在之後用來提供一粗糙度更大的陶瓷組件。為了要生產陶瓷的組件,係為粉末形式之陶瓷
起始材料係首先被導入一預先界定陶瓷組件之形狀的模具。因為該陶瓷組件的體積會在之後的作業階段減少,該模具係比該所完成之陶瓷組件更大。該陶瓷組件之穩定的內部結構係由之後的燒結作用所達成。該燒結作用會導致在該粉末的顆粒之間牢固的連結作用。
該燒結作用係以數個步驟來進行。在第一階段,該陶瓷組件係在一較低的溫度下加以預先燒結,以使得在該粉末的顆粒之間僅形成一狹窄的橋狀結構。該陶瓷組件可以在該預先燒結的狀態下進行機械性作業。在一方面,該內部結構是如此堅固而儘管有機械性作用,該陶瓷組件仍可以維持其之形狀。在另一方面,該橋狀結構係易於再次瓦解,因此該材料係可以相對容易地進行加工。該所選擇的預先燒結溫度的越高該橋狀結構就越穩定,而結果其就越難以進行機械加工。該預先燒結溫度因此係被選擇為儘可能低的,以確保該橋狀結構僅具有足夠穩定性以維持該陶瓷組件之形狀。以鋯氧化物(ZrO2
)和氧化鋁(Al2
O3
)所製成之陶瓷組件,係在該機械加工作用之前在低於850℃的溫度下加以預先燒結。在該機械加工作用中之典型的步驟係為鑽與磨。目前並沒有已知的機械加工步驟可以在之後將該表面的粗糙度Ra
增加至2.5μm和7μm之間的數值。
依據本發明,該陶瓷組件係在一介於880℃和980℃之間的溫度下家底預先燒結,較佳地係介於900℃和950℃之間。該陶瓷組件的表面然後以一沖刷材料來加以處理。經測試顯示在於此一溫度下加以預先燒結的組件之情況
中,以一沖刷材料進行處理會導致該所需要的表面粗糙度。因此在預先燒結之後該陶瓷組件的內部結構,就剛好可以使得所需要之尺寸的碎片可以被沖刷材料所打碎。
在依據本發明之該內膺復物組件中,僅有部份的該表面會被覆蓋而該表面的另一部分則係被設計以與另一個內膺復物組件形成互相作用的滑動表面。在該滑動表面上之該表面粗糙度應該要儘可能的低。如果一表面係要儘可能的光滑,其就不應該預先以一沖刷材料來處理而增加表面的粗糙度。因此,較佳地,僅有該部份的該陶瓷組件之表面係以沖刷材料來加以處理,而該表面的其他部分則是被排除於該沖刷材料之處理以外。
該沖刷材料之顆粒尺寸係較佳地具有與該陶瓷起始材料的顆粒尺寸相同的大小層級。該沖刷材料然後能夠特別地有效地作用於該陶瓷組件上。然而,在使用此一沖刷材料的時候,在該等碎片被排出時,其會造成該沖刷材料的顆粒落入形成於該陶瓷材料中之空隙的風險。該等顆粒然後會在該陶瓷材料中構成雜質。此一類型的雜質可以藉由使用一對應於該陶瓷起始粉末材料之粉末來作為沖刷材料而避免。如果此一材料的顆粒落入該陶瓷組件中,其等無論如何都不會改變該陶瓷材料之均勻組成成分。
本發明係在下述中參照該等隨附的圖式並依據一有利的例示具體例為基礎來加以描述,在該等圖式中:第1圖顯示一椎間盤膺復物之剖面圖,第2圖顯示一依據第1圖之椎間盤膺復物的放大詳細
圖,第3圖顯示在起始狀態中的陶瓷材料之內部結構的概要例示說明,第4圖顯示在預先燒結之後的第3圖之示意圖,並且第5圖顯示在加以燒結之後的第3圖之示意圖。
在第1圖中,一被設計成一椎間盤膺復物之內膺復物係被插入至二個椎體6,7之間的椎間間隙內。該椎間盤膺復物包含也有一第一接觸板1以及一第二接觸板2。該第一接觸板1係為被設計以與一第一椎體6連接之內膺復物組件,而該第二接觸板2係為被設計以與一第二椎體7連接之內膺復物組件。
該第一接觸板1與該第二接觸板2係藉由相配合之滑動表面3而彼此抵靠。該滑動表面3會在該上接觸板1與下接觸板2之間形成一用來移動之鉸合連結。
突起12係在該接觸板1,2抵靠椎體6,7之骨質物質處,被形成於該接觸板1,2表面區域13中。該等突起12在該接觸板1,2被推入椎間間隙的方向上係具有一較緩的側邊,而在該相對方向上具有一較陡的側邊。該較緩的側邊可以使其易於將該接觸板1,2推入該椎間間隙內。該較陡側邊可以在該等突起12已經刺入椎體6,7之骨質物質時提供該接觸板1,2一固定作用。該較陡的側邊可以避免該等接觸板1,2被再次由相反方向而自該椎間間隙拉出。
該等接觸板1,2的凸緣4,5係要抵靠在該椎體6,7之腹
面。該等凸緣4,5可以具有使得該等接觸板1,2無法在該背側的方向上,比起所欲的位置被再進一步推入椎間間隙內。
該接觸板1與該接觸板2係由一陶瓷材料9所形成。在該等接觸板1,2上之該滑動表面3係被形成在該陶瓷材料9的一表面上。會在其上行成一與該骨質物質之連結作用的該等區域13係以一鈦合金塗覆物10來包覆。
第2圖顯示一接觸板1,2的一放大詳細圖,其中顯示介於該陶瓷材料9與塗覆物10之間的界面8。該陶瓷材料9在與塗覆物10之界面8上具有至少係為2.5μm的粗糙度Ra。此一在界面8之粗糙度係足以與塗覆物10形成穩定的連接作用,但是其並不足以形成與骨質物質之穩定的連接作用。該塗覆物10具有一比陶瓷材料9更大粗糙度以及更大的多孔性,並因此可以形成與骨質物質之穩定連接作用。
為了產生其中部分的該表面係具有所需要的粗糙度之係為內膺復物組件的形式之陶瓷組件,一係為粉末形式之起始物質係首先被導入一其之形狀係對應於該所欲生產的陶瓷組件之模具內。因為該陶瓷組件會在後來的方法步驟中耗損體積,該模具會據有比該所完成之陶瓷組件更大的尺寸。該粉末係被機械性地(舉例來說,藉著振動與施壓)填滿於該模具中,之後該在粉末之顆粒14會如第3圖所概要地顯示的彼此依靠。如在第4圖中所顯示的,在一係為920℃的溫度下之預先燒結作用的結果,會在顆粒14之間會形成橋接結構。該材料的內部結構目前係為穩定的,因而該陶瓷組件係可以自該模具移出。
藉由該橋接結構15,該陶瓷材料本身之結構會具有一比可以選擇進行鑽或磨之機械作業更大的穩定性。該結構的穩定性係被精確地設定以使得碎片可以在以一對應於該起始材料的粉末的沖刷下,自該經預先燒結的陶瓷材料被分離。該等碎片係具有可以獲得所需之表面粗糙度的尺寸。
在達成所需之表面結構並包且該機械性作業完成時,該陶瓷組件係以一比該預先燒結溫度更高之溫度來進行燒結。在之前僅以該等橋接結構15來連接的該等顆粒之界面上會形成平面連結16。因為該等空腔會自該內部消失,該陶瓷組件的體積會進一步減少。在以沖刷材料來處理之部分的該表面上,該表面現在係具有大約為4μm的粗糙度Ra
。一係被施加至此一表面部分上之鈦合金塗覆物,會牢固地附接於該表面上。
1‧‧‧第一接觸板
2‧‧‧第二接觸板
3‧‧‧滑動表面
4,5‧‧‧凸緣
6‧‧‧第一椎體
7‧‧‧第二椎體
8‧‧‧界面
9‧‧‧陶瓷材料
10‧‧‧鈦合金塗覆物
12‧‧‧突起
13‧‧‧表面區域
14‧‧‧粉末顆粒
15‧‧‧橋接結構
16‧‧‧平面連結
第1圖顯示一椎間盤膺復物之剖面圖,第2圖顯示一依據第1圖之椎間盤膺復物的放大詳細圖,第3圖顯示在起始狀態中的陶瓷材料之內部結構的概要例示說明,第4圖顯示在預先燒結之後的第3圖之示意圖,並且第5圖顯示在加以燒結之後的第3圖之示意圖。
1‧‧‧第一接觸板
2‧‧‧第二接觸板
3‧‧‧滑動表面
4,5‧‧‧凸緣
6‧‧‧第一椎體
7‧‧‧第二椎體
8‧‧‧界面
9‧‧‧陶瓷材料
10‧‧‧鈦合金塗覆物
12‧‧‧突起
13‧‧‧表面區域
Claims (23)
- 一種由一陶瓷材料所形成的內膺復物組件,其中該陶瓷材料係被部份地以一鈦合金來塗覆、一未經塗覆表面部分係被設計以作為一與另一膺復物組件相互作用之滑動表面,而一經塗覆表面部分係被設計以與一骨頭連接,其中該陶瓷材料之與該塗覆物形成一界面的部分係具有介於2.5μm和7μm之間的粗糙度Ra,其中該塗覆物為多孔性塗覆物。
- 如申請專利範圍第1項的內膺復物組件,其中該陶瓷材料之與該塗覆物形成一界面的部分係具有介於3.5μm和5μm之間的粗糙度Ra。
- 如申請專利範圍第1項的內膺復物組件,其中介於該塗覆物與該陶瓷材料之間的黏著劑拉曳強度係大於25MPa。
- 如申請專利範圍第1項的內膺復物組件,其中介於該塗覆物與該陶瓷材料之間的黏著劑拉曳強度係大於30MPa。
- 如申請專利範圍第1項的內膺復物組件,其中介於該塗覆物與該陶瓷材料之間的黏著劑拉曳強度係大於40MPa。
- 如申請專利範圍第1項的內膺復物組件,其中該塗覆物的表面具有介於15μm與35μm之間的粗糙度Ra。
- 如申請專利範圍第1項的內膺復物組件,其中該塗覆物的表面具有介於20μm和30μm之間的粗糙度Ra。
- 如申請專利範圍第1項的內膺復物組件,其中該塗覆物 的層厚度係介於100μm和250μm之間。
- 如申請專利範圍第1項的內膺復物組件,其中該塗覆物的層厚度係介於150μm和200μm之間。
- 如申請專利範圍第1至9項中之任一項的內膺復物組件,其中該塗覆物由孔洞所佔有之比例為介於20%和40%之間。
- 如申請專利範圍第1至9項中之任一項的內膺復物組件,其中該塗覆物的孔洞寬度係介於30μm和70μm之間。
- 如申請專利範圍第1至9項中之任一項的內膺復物組件,其中該塗覆物的孔洞寬度係介於40μm和60μm之間。
- 如申請專利範圍第1至9項中之任一項的內膺復物組件,其中該陶瓷材料係包含有氧化鋯及/或氧化鋁。
- 如申請專利範圍第1至9項中之任一項的內膺復物組件,其中該陶瓷表面之被設計為滑動表面的部分係欲形成一椎間盤膺復物的一滑動表面。
- 一種用於生產如申請專利範圍第1至14項中之任一項的內膺復物組件之方法,其具有以下的步驟:a.選擇一被形成為一內膺復物組件之陶瓷結構部件,且其中一欲被塗覆之表面係具有一介於2.5μm和7μm之間的粗糙度Ra;b.藉由電漿噴灑作用之方式來將一鈦合金施加至欲被塗覆之該表面上;其中該塗覆物為多孔性塗覆物。
- 如申請專利範圍第15項之方法,其中該欲被塗覆之表面係具有一介於3.5μm和5μm之間的粗糙度Ra。
- 如申請專利範圍第15項之方法,其中該塗覆物係在一作業中進行施加。
- 一種用於生產一被使用於如申請專利範圍第1至14項中任一項之內膺復物組件的陶瓷組件的方法,其中一表面部分係具有介於2.5μm與7μm之間的粗糙度Ra,該方法具有以下的步驟:a.取得係為粉末形式之一陶瓷起始材料;b.取得一預先界定該陶瓷組件的形狀之模具;c.將該陶瓷起始材料導入該模具內;d.將該陶瓷組件在一介於880℃和980℃之間的溫度下預先燒結;e.將該陶瓷組件自該模具移除;f.以一沖刷材料(blasting material)來處理該陶瓷組件的表面;g.以一比該預先燒結溫度更高之溫度來燒結該陶瓷組件。
- 如申請專利範圍第18項的方法,其中該步驟d係在一介於900℃和950℃之間的溫度下進行。
- 如申請專利範圍第18項的方法,其中係使用一顆粒尺寸係對應於該陶瓷起始材料之顆粒尺寸的沖刷材料。
- 如申請專利範圍第18項的方法,其中一對應於該陶瓷起始材料之材料係被用來作為沖刷材料。
- 如申請專利範圍第18至21項中之任一項的方法,其中一鈦合金塗覆物係被施加至該陶瓷組件的表面。
- 如申請專利範圍第18至21項中之任一項的方法,其中 該陶瓷組件之被設計以作為滑動表面的表面之部分係被排除在以該沖刷材料所進行的處理之外。
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DE102006007205A1 (de) * | 2006-02-15 | 2007-08-16 | Uhlmann Pac-Systeme Gmbh & Co Kg | Formstation |
EP2187843B1 (de) | 2007-09-13 | 2015-10-07 | DERU GmbH | Endoprothesenkomponente |
JP5535212B2 (ja) | 2008-08-07 | 2014-07-02 | デル・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | セラミック部材の製造方法 |
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2008
- 2008-08-07 EP EP08785430.3A patent/EP2187843B1/de active Active
- 2008-08-07 JP JP2010524366A patent/JP5393683B2/ja active Active
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- 2008-08-07 WO PCT/EP2008/006524 patent/WO2009036845A2/de active Application Filing
- 2008-08-26 TW TW097132523A patent/TWI554257B/zh not_active IP Right Cessation
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Also Published As
Publication number | Publication date |
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TW200918030A (en) | 2009-05-01 |
US8241361B2 (en) | 2012-08-14 |
EP2187843B1 (de) | 2015-10-07 |
US20090082849A1 (en) | 2009-03-26 |
CN102006838A (zh) | 2011-04-06 |
JP2010538713A (ja) | 2010-12-16 |
WO2009036845A3 (de) | 2009-07-16 |
ES2557179T3 (es) | 2016-01-22 |
WO2009036845A2 (de) | 2009-03-26 |
CN102006838B (zh) | 2014-07-23 |
JP5393683B2 (ja) | 2014-01-22 |
AR068437A1 (es) | 2009-11-18 |
EP2187843A2 (de) | 2010-05-26 |
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