JP2003535643A - 経皮的プロテーゼ - Google Patents

経皮的プロテーゼ

Info

Publication number
JP2003535643A
JP2003535643A JP2002503196A JP2002503196A JP2003535643A JP 2003535643 A JP2003535643 A JP 2003535643A JP 2002503196 A JP2002503196 A JP 2002503196A JP 2002503196 A JP2002503196 A JP 2002503196A JP 2003535643 A JP2003535643 A JP 2003535643A
Authority
JP
Japan
Prior art keywords
component
prosthesis
bone
surface
prosthesis according
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2002503196A
Other languages
English (en)
Inventor
アンウィン,ポール
グッドシップ,アレン
コッブ,ジャスティン
ブルン,ゴードン
Original Assignee
ユニバーシティー カレッジ ロンドン
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
Priority to GB0015479.9 priority Critical
Priority to GBGB0015479.9A priority patent/GB0015479D0/en
Application filed by ユニバーシティー カレッジ ロンドン filed Critical ユニバーシティー カレッジ ロンドン
Priority to PCT/GB2001/002771 priority patent/WO2001097718A1/en
Publication of JP2003535643A publication Critical patent/JP2003535643A/ja
Application status is Pending legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/50Prostheses not implantable in the body
    • A61F2/60Artificial legs or feet or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0018Means 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
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
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    • A61F2/00Filters 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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Abstract

(57)【要約】 骨(2)に埋め込みできるような形状の第1部品(1)と、線維芽細胞の拡散および上皮細胞の付着を刺激できるような表面処理部を有し、骨(2)と皮膚との間に位置決めされるようになっている第2部品(4)と、バクテリアの付着を阻害する低表面エネルギーを有し、皮膚表面の外側に位置決めされるようになっている第3部品(5)とを備えた、経皮的プロテーゼが開示されるようになっている。第2部品(4)は接着促進性蛋白質を支持できる。

Description

【発明の詳細な説明】 【0001】 本発明は経皮的プロテーゼに関し、経皮的部品を有するプロテーゼを患者に取
り付ける方法を含む。 【0002】 外傷に起因し、または手術による除去のために、手足または指を切断すること
が有り得る。外傷の例としては、機械の事故による指の喪失、自動車事故または
鉱山の爆発の結果として生じる手足の喪失が挙げられる。心臓−血管の疾患、糖
尿病および骨または軟質組織での不治の腫瘍の結果として、手術による除去も行
われることがある。 【0003】 切断後、皮膚境界部を介して身体に取り付けられる外端部−プロテーゼ装置を
嵌合することが一般的である。これには、一般にストラップまたはクランプを使
用して断端部に固定されるソケットを注文製造しなければならない。かかる端部
プロテーゼ装置を使用することにより多くの欠陥が生じる。例えば次の欠陥があ
る。 【0004】 (1) 皮膚は大きい負荷を支持するのに満足できる構造体ではないので、負
荷により破壊され、炎症が生じたり、不快となることが多く、深刻なケースでは
治療が困難な、とこずれが形成される。 【0005】 (2) 断端部の形状が変化するので、新しく、注文製造されるソケットが必
要となる。 【0006】 (3) 断端部を支持するためのソケットを使用することにより、一般に発汗
が生じ、不快となる。 【0007】 (4) ジョイントが使用される場合、取り付けられたプロテーゼから所定距
離にある筋肉群により、通常外側プロテーゼが動くので、運動が非効率的となり
、かつ不自然となる。 【0008】 本発明の主な目的は、上記欠点の一部またはすべてを解消できるプロテーゼを
提供することにある。 【0009】 本発明の1つの特徴によれば、骨に埋め込みできるような形状の第1部品と、
線維芽細胞の拡散および上皮細胞の付着を刺激できるような表面処理部を有する
第2部品と、バクテリアの付着を阻害する低表面エネルギーを有する皮膚表面の
外側に位置決めされるようになっている第3部品とを備えた、経皮的プロテーゼ
が提供される。 【0010】 従って、本発明によって提供されるプロテーゼは骨内経皮的プロテーゼ(IT
AP)であり、多くの利点を有する。例えば第1部品は骨を通して負荷が伝えら
れるように、骨格の負荷支承部分に直接取り付けられる。このことは、患者がプ
ロテーゼにより大きい動力をかけることができることを意味する。更に、骨への
取り付けにより動きおよび運動の認識がより自然となる。更に皮膚は骨からプロ
テーゼの外側部品まで負荷を伝える役割を果たさないので、炎症を起こしたり、
または不快感を生じさせる圧力が皮膚表面にかかることはない。 【0011】 第1部品には骨内で部品が回転するのを防止するための適当な手段が形成され
ており、この手段はフルート溝または機能的に同様な形状をした表面を含むこと
ができる。骨髄内キャビティが存在する場合にはこれら表面をこのキャビティの
プロフィルに嵌合できるような形状とすることができる。更に、第1部品には骨
の一体化を促進する表面処理部を設けることが好ましい。適当な表面処理材料と
しては水和カルシウムリン酸塩であるヒドロキシアパタイトが挙げられる。この
表面には更に骨と第1部品との一体化を促進するよう、小さい開口部またはピッ
トを設けることもできる。表面にマイクロピットが形成される場合、これらピッ
トは20〜500ミクロンの大きさ、好ましくは20〜100ミクロンの大きさ
にすることができる。 【0012】 第2部品は骨と上皮表面との間で延びている。この第2部品には線維組織の内
部成長を刺激するための表面処理部が設けられている。更に、この部品はヒドロ
キシアパタイトまたは酸化アルミニウムのコーティングで処理することができ、
このコーティングは上皮細胞の第2部品に対する付着を促進する材料で処理され
ている。この第2部品は軟質組織の内部成長を促進するよう、多孔質であるコー
ティングを有することもできる。かかる成長を促進する材料としては、付着促進
蛋白質、例えばフィブロネクチンまたはラミニンが挙げられる。線維組織の第2
部品への付着を補助するためにプロテーゼを設置する手術中に皮下組織を手術に
より除去することが望ましい。この目的は、皮膚を移植体に付着させ、皮膚の運
動を防止すると共に、境界部および下方の真皮にある皮下細胞を分離し、よって
皮膚とプロテーゼとの間に進入する感染を可能にする剪断力を防止することにあ
る。 【0013】 第3部品はプロテーゼの外部部分を含み、この第3部品はバクテリアの付着を
阻害する低表面エネルギーを有する。プロテーゼのこの部分を非付着性材料、例
えばダイヤモンド状カーボン、フッ化ポリマーまたはシリコーンポリマーでコー
ティングすることにより、低表面エネルギーを得ることができる。 【0014】 このプロテーゼは一体になるように接続された別個の部品から構成してもよい
し、また部品の2つ以上を一体に形成し、適当な表面処理を施してもよい。 【0015】 外部部品は、例えば患者の転倒によって生じるような、通常でない負荷を受け
て破壊されるリンクを含む安全装置を含むことが望ましい。これによって骨また
は皮膚に損傷を与えることなく、骨格および経皮的部品から外部部品を外すこと
ができる。脊髄ポストの固定を保護する別の部品は、調節可能な固定具に伝えら
れるトルクを制限する外部装置である。内部部品が骨と一体化するにつれ、伝え
られるトルクを時間の経過と共に増加できるように伝えられるトルクを調節可能
にしてもよい。 【0016】 本発明の別の好ましい実施例では、第2部品の外側表面積を増すように第1部
品および第3部品から外側に延びるように、第2部品を設けることができる。こ
の第2部品には外側表面積を更に増し、第2部品を通る組織の成長を可能にする
ように貫通孔を設けてもよい。貫通孔を設けることによって部品と線維状組織の
成長とを有利に促進できることが判っている。 【0017】 添付図面によって本発明を示す。 【0018】 添付図面を参照する。本発明は赤鹿の枝角のまわりの、皮膚と骨との境界部の
研究に一部が基づいてなされたものである。この鹿の枝角はユニークな構造であ
り、経皮的移植体のための生物学的モデルと見なすことができる。何年間も経過
した枝角は発情中に極めて大きい負荷を受ける。長年にわたる検査によれば、上
皮層が枝角に近づくにつれて皮膚の上皮細胞の層はより薄くなるので、枝角の皮
膚との境界部における上皮層は約1つの細胞の厚みしかないことが判っている。
骨(柄)の境界部には真皮が密についている。この付着は真皮および骨について
いる一連の「シャーペー線維」により行われており、差動的な皮膚の運動を防止
している。枝角は通常、感染することはなく骨の構造体には直径が18〜40ミ
クロンの小さい孔が陥入している。これにより真皮と骨との間の境界部が剪断応
力に耐えられるようになっている。これら特徴は、添付図面のうちの図1および
2に示されている。 【0019】 図3には本発明のプロテーゼが示されており、このプロテーゼは鹿の枝角の人
造的類似物と見なすことができる。このプロテーゼは骨(2)の骨髄道内に挿入
された第1部品(1)を含む。この部品(1)には長手方向に延びる切断フルー
ト溝が形成されており、これらフルート溝は骨髄道にプロテーゼが挿入される際
に骨に係合し、部品(1)の回転を防止するようになっている。部品(1)の表
面にはヒドロキシアパタイト材料のような骨の一体化を促進する材料をコーティ
ングしてもよいし、および/または微小なピットを設けてもよい。骨の端部から
皮膚の表面まで第2部品(4)が延びている。この部品は、図示するように円筒
形でもよいし、またキノコ状となるように平らにし、軟質組織が付着できる表面
積を増すようにしてもよい。部品(4)は上皮の移植体への付着を促進するよう
に表面処理が施されている。かかる表面処理としては、表面を微小ピットが設け
られた構造にしたり、および/またはプロテーゼの部品(4)の表面内への繊維
の成長を促進するラミニンまたはフィブロネクチンのような接着性蛋白質で表面
をコーティングすることが挙げられる。 【0020】 プロテーゼを設置する前に皮下組織を手術によって除去することが好ましい。
更に多孔質で線維組織の内部成長を促進する第2部品に表面を設ける。この表面
をコーティングするのに適した材料は、アルミナ酸化物セラミックスおよびヒド
ロキシアパタイトが挙げられる。この表面は好ましくは多孔質の表面処理を施さ
れた後に、付着促進蛋白質、例えばプロテーゼに付着を促進する蛋白質の溶液を
噴霧し、プロテーゼを蛋白質の濃縮溶液内に浸漬し、フリーズ乾燥するか、また
は移植前に付着促進蛋白質の殺菌溶液内に浸漬することによって、付着促進蛋白
質がコーティングされる。 【0021】 切断および設置手術中の手術による皮下組織の除去は皮膚の移植体への付着を
刺激することを助けるので、境界部における上皮細胞を分離するよう皮膚にかか
る剪断力を防止する。 【0022】 プロテーゼの第3部品(5)は皮膚を貫通し、その外部部分に付着しない表面
を形成している。適当な材料としては、フッ化ポリマー、例えばポリテトラフル
オロエチレン、シリコーン化ポリマーおよびダイヤモンド状カーボンが挙げられ
る。非付着性表面が存在していることによりバクテリアがプロテーゼに付着する
のが抑制され、感染の防止を助ける。化学的気相方法(CVD)技術を使って第
3部品(5)の外側部分に非付着性表面を塗布できる。ダイヤモンド状カーボン
の表面を塗布するのにCVDを使用することは当技術分野で周知である。ダイヤ
モンドの表面層を塗布する際は、欧州特許第EP-B-0545542号に開示されているよ
うに、この方法は一般に水素または酸素ガスと適当なガス状炭素化合物、例えば
炭化水素との混合物を設け、この混合ガスにエネルギーを加え、水素を原子状の
水素に解離したり、また酸素を原子状酸素に解離したり、炭素を活性炭素イオン
、原子またはCHラジカルに解離し、かかる活性種を基板上にデポジットし、ダ
イヤモンドを形成することを行う。解離させるためのエネルギーは当技術分野で
一般的な多数の方法、例えば高温フィラメントまたはマイクロウェーブソースを
使って提供できる。フッ化ポリマーまたはシリコーン化ポリマーの非付着性表面
は第3部品に接触した状態でモノマーまたはプレポリマーを重合することによっ
て、この第3部品に塗布することができる。 【0023】 プロテーゼの第3部品以外の部品をマスクしながら、第3部品に低エネルギー
表面処理を施すことが好ましい。更にこの第3部品に低エネルギー表面を塗布し
た後に、付着促進蛋白質でプロテーゼの第2部品を処理することができ、更に付
着促進蛋白質を塗布しながら、第3部品をマスクすることが望ましい。 【0024】 この第3部品は人造手足または指に接続できる。例えば置換用の指または部分
指の場合、第2部品が経皮的部分を構成し、第3部品が切断された断端を越えて
延びた状態で残りの骨に第1部品を埋め込むことができる。次に、第3部品に人
造指または部分指を取り付けできる。 【0025】 このプロテーゼは第1部品が骨に埋め込まれ、経皮部分が取り付けられる前に
一体化できる場合、ワンステージの手術または2ステージの手術のいずれかで移
植できる。 【0026】 図4には第2部品(4)が第1および第3部品に対して垂直に外側方向にプレ
ート状に延びている本発明の別の好ましい実施例が示されている。この特徴によ
って、第2部品(4)には広い表面積が設けられ、この広い表面積によって線維
組織の成長と第2部品(4)との一体化が好ましく促進されている。図4にも示
されるように、第2部品(4)のプレート状延長部内には貫通孔(6)を設ける
ことができる。これら貫通孔は外側の表面積を更に増すと共に、第2部品の通る
組織の成長を可能にし、更に一体化を促進できる。上記説明は一連の部品につい
て述べたものであるが、各部品はある材料の単一部品から製造された一体的要素
の一部でもよい。しかしながら、第3部品またはこの第3部品に取り付けられた
部材に大きい負荷が加えられた場合に、リンクが破損し、プロテーゼが埋め込ま
れた骨が損傷しないように骨を保護するように、第3部品と第2部品との間、ま
たは第2部品と第1部品との間に脆弱なリンクを設けることが望ましい。 【0027】 以上で、喪失した指または手足と置換するためのプロテーゼを設けることを特
に参照して本発明を説明したが、本発明は皮膚を貫通する他のプロテーゼ、例え
ば歯科用インプラントにも適用できる。 【図面の簡単な説明】 【図1】 鹿の枝角の一部および頭蓋骨の断面を示す図である。 【図2】 鹿の枝角の一部および頭蓋骨の断面を示す図である。 【図3】 患者に取り付けられた、本発明に係わる経皮的プロテーゼを示す部分断面図で
ある。 【図4】 図3と比較して、より大きい縮尺で描かれた、本発明に係わるプロテーゼの好
ましい実施例の斜視図である。

───────────────────────────────────────────────────── フロントページの続き (81)指定国 EP(AT,BE,CH,CY, DE,DK,ES,FI,FR,GB,GR,IE,I T,LU,MC,NL,PT,SE,TR),OA(BF ,BJ,CF,CG,CI,CM,GA,GN,GW, ML,MR,NE,SN,TD,TG),AP(GH,G M,KE,LS,MW,MZ,SD,SL,SZ,TZ ,UG,ZW),EA(AM,AZ,BY,KG,KZ, MD,RU,TJ,TM),AE,AG,AL,AM, AT,AU,AZ,BA,BB,BG,BR,BY,B Z,CA,CH,CN,CO,CR,CU,CZ,DE ,DK,DM,DZ,EE,ES,FI,GB,GD, GE,GH,GM,HR,HU,ID,IL,IN,I S,JP,KE,KG,KP,KR,KZ,LC,LK ,LR,LS,LT,LU,LV,MA,MD,MG, MK,MN,MW,MX,MZ,NO,NZ,PL,P T,RO,RU,SD,SE,SG,SI,SK,SL ,TJ,TM,TR,TT,TZ,UA,UG,US, UZ,VN,YU,ZA,ZW (72)発明者 グッドシップ,アレン イギリス国 ハートフォードシャー エイ エル4 8イーティ ウィートハムステッ ド コールマン グリーンレーン フォッ クスグローブ (72)発明者 アンウィン,ポール イギリス国 ハートフォードシャー ダブ リュウデー7 9エルディ ラッドレッド ローワン クローズ 2 Fターム(参考) 4C081 AB03 BA13 BA14 CA131 CA271 CD171 4C097 AA01 BB09 CC06 CC08 CC12 CC13 CC14 CC15 DD07 EE06 EE13 EE18 TA10 TB17

Claims (1)

  1. 【特許請求の範囲】 【請求項1】 骨に埋め込みできるような形状の第1部品と、線維芽細胞の
    拡散および上皮細胞の付着を刺激できるような表面処理部を有し、骨と皮膚との
    間に位置決めされるようになっている第2部品と、バクテリアの付着を阻害する
    低表面エネルギーを有し、皮膚表面の外側に位置決めされるようになっている第
    3部品とを備えた、経皮的プロテーゼ。 【請求項2】 前記部品が一体的に形成されており、異なる表面処理部を有
    する、請求項1記載のプロテーゼ。 【請求項3】 前記第1部品が骨の成長および骨の一体化を刺激する表面処
    理部を有する、請求項1または2記載のプロテーゼ。 【請求項4】 前記第2部品がマイクロピットの設けられた表面を有する、
    前の請求項のいずれかに記載のプロテーゼ。 【請求項5】 前記第2部品の表面がフィブロネクチンまたはラミニンのコ
    ーティングを支持する、前の請求項のいずれかに記載のプロテーゼ。 【請求項6】 前記第1および第3部品から外側に前記第2部品が延びてい
    る、前の請求項のいずれかに記載のプロテーゼ。 【請求項7】 前記第2部品が貫通孔を有する、請求項6記載のプロテーゼ
    。 【請求項8】 前記第3部品がフッ化ポリマーまたはシリコンポリマーを含
    むコーティングを支持する、前の請求項のいずれかに記載のプロテーゼ。 【請求項9】 前記第3部品がダイヤモンド状カーボンを含むコーティング
    を支持する、前の請求項のいずれかに記載のプロテーゼ。 【請求項10】 プロテーゼに通常でないほど高い負荷が加えられた場合、
    外部部品を外すことができる脆弱または取り外し可能なリンクを前記第3部品が
    含む、前の請求項のいずれかに記載のプロテーゼ。 【請求項11】 前記第3部品が人造手足または指に接続されている、前の
    請求項のいずれかに記載のプロテーゼ。
JP2002503196A 2000-06-23 2001-06-22 経皮的プロテーゼ Pending JP2003535643A (ja)

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GBGB0015479.9A GB0015479D0 (en) 2000-06-23 2000-06-23 Transcutaneous Prosthesis
PCT/GB2001/002771 WO2001097718A1 (en) 2000-06-23 2001-06-22 Transcutaneous prosthesis

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US7014661B2 (en) 2006-03-21
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