JP2005511143A - 椎間板プロテーゼまたは核代替プロテーゼ - Google Patents
椎間板プロテーゼまたは核代替プロテーゼ Download PDFInfo
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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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- A61F2/02—Prostheses implantable into the body
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- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
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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
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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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
- 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
- A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
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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
- 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
- A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
- A61F2002/30583—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with hardenable fluid, e.g. curable in-situ
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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
- 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
- A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
- A61F2002/30586—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid having two or more inflatable pockets or chambers
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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
- A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
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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
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
- A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
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Abstract
Description
従来技術の上記の考察は、発明の背景を説明するために行われ、引用された従来技術が本出願の時点またはその優先日に実際に刊行され、または公知であったことを意味するものではない
椎間板インプラントのまだ空のエンベロープは、折畳まれた状態で椎間腔に容易に導入され、次いで注射器によって適切なカニューレを経て流動性のモノマー混合物が充填される。エンベロープ(またはバルーン)は、隣接した椎体のカバープレートへの付加のための一定の側面に特殊な表面および/または厚さおよび/または特殊な材料、例えばポリカーボネートウレタン(PCU)またはポリカーボネートを有しうる。
対応する与圧によって、エンベロープは、椎間板の高さが解剖学的に正しい元の高さへ戻されるまで、重合可能なモノマー混合物で膨張されうる。さらに、3気圧以下、好ましくは最大1.1気圧の超過気圧で物質をエンベロープへ取り入れることができる。しかし、物質は、当該脊椎が適切な器具によって伸ばされる場合は、実質的に超過気圧なしにエンベロープへ取り入れることもできる。
これによって、ヒドロゲルが一方では過付加の場合に水(体液)を供給しうるとともに、他方では休止期に水を摂取しうる利点が達成可能である。その結果、減衰効果および椎間板を元の高さに復元する追加の可能性が得られる。
別の実施形態では、エンベロープはメモリー効果を有する材料で構成され、体温によって前もって記憶された幾何学的形を取り入れる。
別の実施形態では、硬化可能な流動性の物質は、重合触媒、および好ましくは追加的に重合促進剤を含有する。
はジメチルアクリルアミドと共重合されうる。自家重合に対する青色光による重合における利点は、タンパク質を破壊しうる高い熱の発生が生じないことである。さらに、それによって青色光がバルーンへ放射される光導体の取扱いが無害である。青色光照射の頻度と継続時間は、光源の簡単な制御によって設定されうる。
a)ポリエチレングリコール、好ましくはポリエチレングリコール(ジ)アクリレート、
b)N−ビニルピロリドン、および
c)ビニル、好ましくはビニルアルコール、および
d)スチレン
からなる群から適切に選択されうる。それとともに含有する重合剤は、その弾性に関して広範囲で変化しうる。
硬化可能な流動性の物質は、30〜160重量%、好ましくは40〜90重量%の水を含有することが有利である。45〜55重量%の割合の水が特に適切である。特にそれがヒドロゲルである場合、重合物質がのちに取り入れるべき水の量を決定することによって(膨張因子)、脊椎部分への追加の分散が制御されうる。
A)2つの隣接した椎体の椎間腔へ生体適合性エンベロープを植込むステップと、
B)モノマー、コモノマー、オリゴマー、またはその混合物を含有する硬化可能な流動性の物質を植込まれた生体適合性エンベロープの内部へ導入し、ここで充填されたエンベロープは椎間腔内で中心に置かれているステップと、
C)エンベロープ内にある硬化可能な流動性の物質を原位置で硬化させるステップと、
を包含する。
本発明による方法の変形態様では、エンベロープはステップAとBとの間で空気で膨張されうる。この予備分散によって、脊椎部分の分散能の検査を行うことができる。
本発明による方法の別の変形態様では、エンベロープはステップAとBとの間でレントゲン造影剤で充填されうる。レントゲン造影剤は、画像変換器によって脊椎部分のエンベロープの位置を可視化する。これにより、エンベロープが正しく配置されているかどうかの情報が得られる。
物質の硬化は、自家重合によって、または光重合によって、好ましくは可視光または紫外線光で行うことができる。
図1には、核代替プロテーゼの形の椎間板プロテーゼが示されており、すなわち、生体適合性エンベロープ1が2つの隣接した椎体11、12の椎間腔10にすでに植込まれた状態であり、弁15およびカニューレ16を経て硬化可能な流動性の物質2により、ヒドロゲルの形で矢印17の方向の植込まれた生体適合性エンベロープの内部へ充填される。この場合、充填されたエンベロープは椎間腔10の中心に置かれたままであり、隣接した椎体11、12の2つの終板13,14に接している。
椎間板プロテーゼの一重壁および二重壁を物質2で充填しうるために、図4に示された特殊な弁15が備えられている。弁15は、実質的に、逆止め弁としてばね22によって保持された球23を有する中央穴21と、逆止め弁としてばね26によって保持された球25を有する周辺穴24とで構成される。中央穴21は一重壁変形態様の充填のために使用され(図1および2による)、周辺穴24は二重壁変形態様の充填のために使用される(図3による)。後者の場合、中央穴21は、空気またはレントゲン造影剤の導入のために使用されうる。
以下、本発明を2、3の実施例によって説明する。
3、4 壁 5 椎間板プロテーゼの中心
6、7 特定壁 10 椎間腔
11、12 椎体 13、14 カバープレート
15 弁 16 カニューレ
18 光導体 21 中央孔
22、26 ばね 23、25 球
24 周辺孔
Claims (20)
- モノマー、コモノマー、ホモポリマー、オリゴマー、またはその混合物を含有する硬化可能な流動性の物質(2)がその中にある生体適合性エンベロープ(1)を有する椎間板プロテーゼまたは核代替プロテーゼ。
- 前記物質(2)が光開始剤、好ましくは光ラジカル開始剤を含有することを特徴とする、請求項1に記載の椎間板プロテーゼ。
- 前記光開始剤が、好ましくは約340〜420nmの範囲の光を吸収することを特徴とする、請求項2に記載の椎間板プロテーゼ。
- 前記光開始剤が、ホスフィンオキシド、好ましくはアシルホスフィンオキシドであることを特徴とする、請求項2または3に記載の椎間板プロテーゼ。
- 前記ホスフィンオキシドがジメチルアクリルアミドと共重合化されることを特徴とする、請求項4に記載の椎間板プロテーゼ。
- 前記モノマー、前記コモノマー、前記ホモポリマー、前記オリゴマー、またはその前記混合物が、
a)ポリエチレングリコール、好ましくはポリエチレングリコール(ジ)アクリレート、
b)N−ビニルピロリドン、および
c)ビニル、好ましくはビニルアルコール、および
d)スチレン
からなる群から選択されることを特徴とする、請求項1〜5のいずれか1つに記載の椎間板プロテーゼ。 - 前記物質(2)が、30〜160重量%、好ましくは40〜90重量%の水を含有することを特徴とする、請求項1〜6のいずれか1つに記載の椎間板プロテーゼ。
- 前記物質(2)がヒドロゲルを含有することを特徴とする、請求項1〜7のいずれか1つに記載の椎間板プロテーゼ。
- 前記エンベロープ(1)が二重壁で形成され、前記物質(2)が両壁(3、4)間に導入されており、椎間板プロテーゼの中心(5)が中空であることを特徴とする、請求項1〜8のいずれか1つに記載の椎間板プロテーゼ。
- 前記エンベロープ(1)がメモリー効果を有する物質で構成され、体温によって前もって記憶された幾何学的形を取り入れることを特徴とする、請求項1〜9のいずれか1つに記載の椎間板プロテーゼ。
- 前記物質(2)が、重合触媒、好ましくは追加的に重合促進剤を含有することを特徴とする、請求項1または6〜10のいずれか1つに記載の椎間板プロテーゼ。
- 前記エンベロープ(1)が、前記エンベロープ(1)内にある前記物質(2)と化学的に同じ材料で構成されることを特徴とする、請求項1〜11のいずれか1つに記載の椎間板プロテーゼ。
- 前記エンベロープ(1)が、隣接した椎体(11、12)のカバープレート(13、14)への添加のための特定の壁(6、7)にその他の壁領域におけるよりも厚く形成されており、好ましくはポリカーボネートウレタン(PCU)またはポリカーボネートで構成されていることを特徴とする、請求項1〜11のいずれか1つに記載の椎間板プロテーゼ。
- 以下の方法ステップ、すなわち、
A)2つの隣接した椎体(11、12)の椎間腔(10)へ生体適合性エンベロープ(1)を植込むステップと、
B)モノマー、コモノマー、オリゴマー、またはその混合物を含有する硬化可能な流動性の物質(2)を植込まれた前記生体適合性エンベロープ(1)の内部へ導入し、ここで充填された前記エンベロープ(1)は前記椎間腔(10)内で中心に置かれているステップと、
C)前記エンベロープ(1)内にある硬化可能な流動性の前記物質(2)を原位置で硬化させるステップ、
を特徴とする、前記椎間板プロテーゼまたは前記核代替プロテーゼを製造するための方法。 - 前記物質(2)の硬化が、光重合、好ましくは可視光または紫外線光によって行われることを特徴とする、請求項14に記載の方法。
- 前記エンベロープ(1)が、ステップAとBとの間で空気で膨張されることを特徴とする、請求項14または15に記載の方法。
- 前記エンベロープ(1)が、ステップAとBとの間でレントゲン造影剤で充填されることを特徴とする、請求項14または15に記載の方法。
- 前記物質(2)の硬化が自家重合によって行われることを特徴とする、請求項14〜17のいずれか1つに記載の方法。
- 前記物質(2)が、実質的に超過気圧なしに前記エンベロープ(1)へ取り入れられることを特徴とする、請求項14〜18のいずれか1つに記載の方法。
- 前記物質(2)が、3気圧以下、好ましくは最大1.1気圧の超過気圧で前記エンベロープへ取り入れられることを特徴とする、請求項14〜18のいずれか1つに記載の方法。
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Also Published As
Publication number | Publication date |
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AU2002223365B2 (en) | 2005-06-30 |
CA2468908C (en) | 2009-03-31 |
KR20040083060A (ko) | 2004-09-30 |
CZ2004681A3 (cs) | 2005-02-16 |
DE50111393D1 (de) | 2006-12-14 |
EP1450735B1 (de) | 2006-11-02 |
MXPA04005138A (es) | 2005-02-17 |
CA2468908A1 (en) | 2003-06-12 |
ES2276747T3 (es) | 2007-07-01 |
BR0117187A (pt) | 2004-11-09 |
IL162273A0 (en) | 2005-11-20 |
KR100824440B1 (ko) | 2008-04-23 |
CN100512777C (zh) | 2009-07-15 |
HU226158B1 (en) | 2008-05-28 |
US20050090901A1 (en) | 2005-04-28 |
HUP0402274A2 (hu) | 2005-02-28 |
BR0117187B1 (pt) | 2011-04-05 |
CN1561185A (zh) | 2005-01-05 |
EP1450735A1 (de) | 2004-09-01 |
JP4230912B2 (ja) | 2009-02-25 |
WO2003047472A1 (de) | 2003-06-12 |
AU2002223365A1 (en) | 2003-06-17 |
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