JP3553622B2 - 金属製多孔質表層を有する移植片及びその製法 - Google Patents

金属製多孔質表層を有する移植片及びその製法 Download PDF

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JP3553622B2
JP3553622B2 JP00460893A JP460893A JP3553622B2 JP 3553622 B2 JP3553622 B2 JP 3553622B2 JP 00460893 A JP00460893 A JP 00460893A JP 460893 A JP460893 A JP 460893A JP 3553622 B2 JP3553622 B2 JP 3553622B2
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implant
porous
mold
surface layer
insert
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JPH05344986A (ja
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デバナサン シラマル
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Bristol Myers Squibb Co
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • B29C70/681—Component parts, details or accessories; Auxiliary operations
    • B29C70/683—Pretreatment of the preformed part, e.g. insert
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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
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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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
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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
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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
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    • A—HUMAN NECESSITIES
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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
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    • A61F2/32—Joints for the hip
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    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625—Necks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • B29C45/14778—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles the article consisting of a material with particular properties, e.g. porous, brittle
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Description

【０００１】
【産業上の利用分野】
本発明は多孔質表層を有する移植片（インプラント）に関する。より詳しくは本発明は、成形により多孔質表層に移植体を結合せしめることによって作られた、多孔質表層を有する移植片に関する。
【０００２】
【従来の技術】
人工器官整形外科用移植片の作製に関して、非金属性材料の利用に注目が集まってきている。材料、例えば熱可塑性樹脂、熱可塑性樹脂複合物、セラミック他は、骨の曲げ剛性によりよく適合し、且つ金属イオンに対する患者の暴露をなくすことで利用されてきている。これらの材料は通常経済的な成形加工、例えば射出成形又は圧縮成形により好適に造形されている。その他の材料により作製された移植体と同様に、骨の内方生長（ｂｏｎｅ ｉｎｇｒｏｗｔｈ）又はセメント質指状突起（ｃｅｍｅｎｔ ｉｎｔｅｒ ｄｉｇｉｔａｔｉｏｎ）を調整するために移植片表層上に多孔質表層を施すことが所望される。典型的には、この多孔質表層はワイヤーメッシュ又はじゅず状もしくは小波紋状の表層を含んで成る。
【０００３】
米国特許第４，９７８，３５５号、第４，９５５，９１１号、第４，８１３，９６０号及び英国特許出願ＧＢ２，２１６，４２５Ａ号は、熱したワイヤーメッシュをプラスチック製移植体にプレスするとこによりプラスチック製移植片上に多孔質表層を施すことを教示している。米国第４，９５５，９１１号及びＧＢ２，２１６，４２５Ａ号はこのメッシュの外孔がプラスチックによって充満されることを防ぐための、ワイヤーメッシュ内の氷久固体層を教示している。米国特許第４，７７８，４６９号はプラスチック製移植片上に模様付き表層を形成せしめることを教示しており、これは熱した模様付きプレートをこの移植片表層にプレスし、次いでこのプレートを溶かしてプレートにくぼみを残すことによる。最後に、米国第４，４７９，２７１号はプラスチック製移植片をワイヤメッシュへと成形せしめることを教示する。
【０００４】
【発明が解決しようとする課題】
本発明の目的は高速且つ再現性のある製造に適している移植片の提供にある。
【０００５】
本発明の他の目的は、同時に最終形態へと形成され且つ多孔質表層に結合させることのできる移植片の提供にある。
【０００６】
本発明の更なる目的は、多孔質表層と移植体との間に強い定着性を有する移植片の提供にある。
【０００７】
本発明の他の目的は製造価格が安い移植片の提供にある。
【０００８】
本発明の更なる他の目的は射出成形によって簡単に製造できる移植片の提供にある。
【０００９】
本発明の最後の目的は、安価であり、再現性があり、且つ多孔質表層と移植体との間に強い定着性を提供するような移植片を製造するための方法の提供にある。
【００１０】
簡単に述べると、本発明はプラスチック製本体、及びこの本体にしっかりと固定されている金属性の多孔質表層を含んで成る移植片を提供する。この移植片は、まず多孔質金属構造及びこの孔の一部に充填されている可溶性充填材料を有する多孔質成形モルドインサートを製造することにより作られる。次にこのモルドインサートをモルドの中に入れ、そしてこのモルドの中にプラスチックを注入して移植体を形成せしめる。次にこの移植片にこの充填材料を溶解せしめる溶媒を接触させ、このインサートの充填されている部分を露出させる。好ましい態様において、この移植片は金属コアを含むことができ、これは成形する前にモルドの中に入れておく。
【００１１】
【課題を解決するための具体的手段】
図１に関して、典型的な人工器官移植片を大腿骨股関節幹として示す。この股関節幹１は本体２及び多孔質表層３を含む。移植片を製造するため、多孔質パッド９をまず任意の種々の知られている方法によって適当な材料から作る。好ましくはこれはチタニウム及びその合金又はコバルトクロム合金のような金属ファイバーを含む。これは焼結金属ビーズ、焼結セラミック又はその他の適当な多孔質材料より作られていることもできる。次に図２のａ）に示す多孔質モルドインサート４を、この多孔質パッド９の一部に充填材料５を充填することによって作り、これは図２のｂ）においてより明確に示す。この充填材料５はアモルファスポリマー、例えばポリスルホンであることが好ましく、その理由はアモルファスポリマーの加工のし易さ及び一定の溶媒の中でのその溶解性にある。適当なアモルファスポリマーのその他の例にはポリエーテルスルホン、ホリカーボネート、ポリエーテルイミド及びポリメチルメタクリレートが含まれる。いくつかの水溶性ポリマー、例えばポリエチレンオキシドも利用できる。この多孔質材料の中に充填材料を導入する好ましい方法は、この多孔質材料をこの充填材のガラス転移温度付近で熱しながらこれら二種類の材料を互いにプレスし合うことによる。この充填材は調節可能な状態においてこの多孔質材料の中に進み入るであろう。これらのアモルファスポリマーは熱に非常に安定であり、且つガラス転移相を示すため、これらは無秩序にこの多孔質材料の中に流入するのではなく、所望する深さへと押し出されるであろう。例えば、もし厚さ０．０１６インチのポリスルホンフィルムを多孔率５０％のパッドに完全にプレスしたら、これは高い度合いの再現性を伴って約０．０３２インチの深さにまで侵入するであろう。この充填剤は、多孔質材料をその最終形態へと成形せしめる前後でこの多孔質材料に組込むことができる。本例においては、この多孔質材料を所望の形態に切り、インサートを形成するために充填材を包埋し、次いで（所望するならば）その最終形態へと折り曲げている。このインサートは穴１０を含んでおり、これは例えばこの穴１０にかみ合うようにモルドから伸びているピンにより、このモルドの中にこのインサートが位置づけられ且つ固定されるのに役立つ。
【００１２】
この多孔質表層モルドインサートを次に、図３に示す通り、モルドキャビティーに連絡したいくつかの未充填孔を有する適当な半モルド６に入れる。対応の半モルドは示していない。本体材料も適当な熱及び圧力のもとでこのモルドの中に導入して移植体を形成させ且つこのインサートと組合わせる。射出成形、圧縮成形及び注型を含む種々の成形技術が利用できる。しかしながら、射出成形を利用することが好ましい。安定な充填材料は、このインサートの充填された孔にこの本体材料が侵入することを防ぐが、この本体に対するインサートのしっかりとした固定を樹立するよう、保護されていない孔にそれがしみ込むことが可能である。好ましくは、この本体材料は半結晶ポリマー、例えばポリエーテルエーテルケトンである。半結晶ポリマーは、その強さ、加工のし易さ、及び一般の溶媒における不溶性に起因して所望される。その他の適当な半結晶ポリマーにはポリアリールエーテルケトン及びポリフェニリンスルフィドが含まれる。好都合には、カーボンファイバー又はその他の補強剤をこの本体材料の中に含ませることができる。図４はモルドから取り出した成形移植片７を示す。最後に、この充填材料をこの多孔質材料から除去する。上記の好ましい態様において、塩化メチレン、メチルエチルケトン又はアセトンのような溶媒が、この半結晶ポリマーに悪影響を及ぼすことなくこのアモルファスポリマー充填剤を溶かすことができる。
【００１３】
以上にて本発明の典型的且つ好ましい態様を説明してきたが、変更が可能である。例えば、この材料及び方法は身体のあらゆる部分に適する多孔質表層を有する移植片を製造するために用いられうる。更に、本体を成形する前にこのモルドの中にその他の構造体を含ませることができる。このような構造体には固体及び複合コア、固定ピン、及び中空インサートが含まれる。本例において、金属製コア８を二つのインサートの間でこのモルドの中に入れている。このコア８はネック１１、ステム１２及びボタン１３を有する。このネック１１とボタン１３はこのモルド６とかみ合ってシールを形成し、従って注入された材料がその表層を覆うことを防ぐ。更に多孔質パッドを上記の方法を利用して実質的に完全に形成された移植片に結合させることができ、この場合、インサートを部分的に充填させ、そしてこのインサートとこの移植片の間に流体材料を導入し、従ってこの流体材料の固形化に基づいて、この流体材料はインサートが包埋され、且つ充填剤が除去されうるような本体の表層が形成される。更には、この多孔質表層は好都合には例に示す通りこの本体の実質的に全てを覆っていてよく、又は特定の用途に適するようにこの本体の一部分のみを覆っていることができることが理解されるであろう。最後に、この充填材料が一定の状態においてこの多孔質材料の中に合体することができ、且つこの本体が形成される加工環境にかけられる際にこの充填材料が安定である限り、この本体及び充填材料に関してその他の材料が利用されうる。この加工環境は温度、圧力、化学的反応性及び機械的力のような条件によって決定される。更に、この充填剤はこの本体に悪影響を及ぼすことなく除去されるべきである。射出及び圧縮成形の場合、この本体材料が成形される温度及び圧力にて、この温度及び圧力が維持されている期間の間、この充填材料が安定であることが必要である。例えばエポキシ又は溶解材料による注型の場合、この充填剤は適当な溶剤の利用により、溶融により、又はその他の手段によって除去されうる。これらのどの方法においても、この充填材料は機械的手段により、同様に化学的又は熱的手段により除去されうる。
【００１４】
以上の改良等は本発明の範囲を逸脱することなく好ましい態様となりうることが当業者に理解される。
【図面の簡単な説明】
【図１】本発明に関する典型的な骨移植片の透視図。
【図２】ａ）典型的な多孔質パッドの透視図であり、その孔は部分的に充填されてモルドインサートを形成している。
ｂ）ａの円内の詳細図。
【図３】典型的な移植片及びモルドの分解透視図。
【図４】多孔質表層に充填材料が包埋されている多孔質表層を有する本発明に関する典型的な骨移植片の透視図。
【符号の説明】
１…股関節幹
２…本体
３…多孔質表層
４…多孔質モルドインサート
５…充填材料
６…半モルド
７…移植片
８…金属コア
９…多孔質パッド
１０…穴
１１…ネック
１２…ステム
１３…ボタン

Claims (1)

  1. 移植片であって：
    加工環境の中で形成され、且つ半結晶ポリマーを含んで成る本体；
    この本体の表層に結合している多孔質インサート；及び
    この多孔質インサートの中に包埋され、且つアモルファスポリマーを含んで成る充填材料；
    を含んで成り、
    ここでこの充填材料は、この本体を形成せしめる加工環境に暴露されたときに、予め決定された期間にわたり安定であることを特徴とする移植片。
JP00460893A 1992-02-27 1993-01-14 金属製多孔質表層を有する移植片及びその製法 Expired - Lifetime JP3553622B2 (ja)

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JPH05344986A (ja) 1993-12-27
DE69304572T2 (de) 1997-04-17
EP0560418A1 (en) 1993-09-15
AU3041692A (en) 1993-09-02
CA2086798A1 (en) 1993-08-28
CA2086798C (en) 2004-05-11
AU661745B2 (en) 1995-08-03
US5571187A (en) 1996-11-05
EP0560418B1 (en) 1996-09-11
ES2090837T3 (es) 1996-10-16
DE69304572D1 (de) 1996-10-17
US5236457A (en) 1993-08-17

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