JP4412901B2 - 組織部、特に骨格部への接続を作製するためのインプラント、ならびにインプラントの埋込のための装置および方法 - Google Patents
組織部、特に骨格部への接続を作製するためのインプラント、ならびにインプラントの埋込のための装置および方法 Download PDFInfo
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- JP4412901B2 JP4412901B2 JP2002569000A JP2002569000A JP4412901B2 JP 4412901 B2 JP4412901 B2 JP 4412901B2 JP 2002569000 A JP2002569000 A JP 2002569000A JP 2002569000 A JP2002569000 A JP 2002569000A JP 4412901 B2 JP4412901 B2 JP 4412901B2
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- implant
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- liquefiable material
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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
- A61L27/14—Macromolecular materials
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- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/866—Material or manufacture
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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
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Description
り、組織部は、互いと接続されるか、または組織部を支持するもしくは置換える手段もしくはその他の治療用補助装置に接続される。この発明は、対応の独立特許クレームのプリアンブルに記載の装置および方法にさらに関する。装置および方法はインプラントを埋込む働きをする。
トを提供することである。さらに、インプラントは、公知のインプラントのうち少なくともいくつかの場合よりも熱量および応力集中についての問題が少なく、かつ埋込むべき異物の体積をさらに低減できることが望ましい。この発明のさらなる目的は、インプラントを埋込むための装置および方法を提供することである。
ルギ(特に超音波)を加えることにより、しかも温度を上昇させることなく、そのようなセメントを粘性の高い状態から流体状態にすることができる。
的エネルギ(発振エネルギ、振動エネルギ)、すなわち内部および/または外部摩擦の結果として液化される。これにより、周囲組織に対する熱の負担(thermal burden)は低いままとなる。機械的エネルギにより、異なる材料相の間で非常に高い剪断効果が達成される。これは、均一な液化、低い粘性の達成、および周囲に対するさらに低い負担に寄与する。この態様で液化される材料は、次に、静水圧によって周囲組織の孔または開口の中に押込まれて周囲組織に浸透し、これを実現する。
を固定することができる。より表面的な接続は、たとえば、骨への接続のために骨の上に位置決めされ、その後機械的エネルギ(たとえば超音波振動)で少なくとも局所的に励起される、一体化された液化ゾーンまたは完全液化層を有するプレートまたは他の支持もしくは固定装置によって達成される。液化可能領域には、有利にはエネルギディレクタ(energy director)が設けられるか、または液化可能領域はエネルギディレクタと接する。
振動エネルギの集中によって局所的液化を促進するエネルギディレクタは、たとえば、ピラミッド状、円錐状、半球またはリブ状の要素などの突出要素である。
それに押付けられる)インプラントに、約2から200kHzの周波数領域の波、好ましくは超音波(たとえば20または40kHz)を伝える。インプラントは骨または組織に結合されて、音響エネルギが液化材料によって内部でまたは表面で吸収されるように接続され、これによりこの材料が少なくとも局所的に液化される。液化プロセスは大きな剪断効果によって達成される。内部摩擦およびしたがって内部液化は、(たとえば小球のような)液化されるべき材料に局所的に埋込まれかつ異なる密度を有する第2の成分によって高めることができる。インプラントまたはインプラント部としてシキソトロピックな粒状セメントを用いると、同様の効果が得られる。
は、制御された態様で低減されるか、または、インプラントが再吸収可能な材料で少なくとも部分的に作られている場合は、再生組織によって引継がれる(二次安定性(secondary stability))。
材料が再吸収可能なものである場合、上記一次安定性は、再生された骨組織による二次安定性によって少なくとも部分的に後で置換えられる。
ントにおける駆動の際、この材料嵌合接続は接続場所26で形成し始める。この場合も、有利には、インプラント7が遠くまで駆動されるので、これが端部ではプレート21の外側と同じ高さになる。
。上記範囲の力は、結果的に5mm/sよりも大きな駆動スピードを生じる。
この互生は、組織の中に残るインプラントまたはインプラントコアの理想的な二次安定性を構成する(図28も参照)。
例示的な適用例を示す。ホルダはたとえば、図9および図10に示されるような押込み嵌めホルダであってもよい。押込み嵌めは、たとえば、共振器6の遠端の対応する開口15の中に導入されるインプラントコア11またはインプラント7の弾力的に設計された近位延長部14のスナップ閉止部(図9)として実現される。押込み嵌めは、インプラントコア11またはインプラントの近位延長部14および共振器6を通って延びる好適に固定されたピン16によって実現されてもよい。有利には、押込み嵌めは、共振器の遠端に対して距離dを空けて配置されるので、これは、z方向の発振のノード点、すなわちz方向の振幅が本質的に0である位置に存在する。
ラントは、延在する外側空隙領域の中に位置決めされ、発振エネルギを当てられる。これにより、インプラント材料が液化し、一方側で頭蓋冠29の孔の中に押込まれ、他方側で、たとえば骨からなるカバープレート30の対応の孔の中にまたは人工プレートの中の対応して配置される人工的に作られた開口(たとえば一点鎖線で示された溝)の中に押込まれる。押込み嵌め固定はこのように両側に作製されて、頭蓋冠29とカバープレート30とを接続する。
圧力で十分である。
によっては一時的な態様で脊柱領域を支持する。この発明の文脈では、支持要素40は、これが対応して液化可能な材料からなる場合は椎体に固定され、液化不可能な材料からなる場合は(図16に示されるように)深さに対する効果なしに固定される。また、(図17に示されるように)深さに対する効果なしにまたは(図2から図4に示されるように)予めドリルで孔をあけておよび深さに対して効果的に膜を介して椎体に接続される。図19に示されるピン状インプラント7は、たとえば、支持要素を超えて突出しかつ図13に従って作られるヘッドを有する。持続的な支持のためには、接続インプラントおよび支持要素は再吸収可能な材料から作られ、一時的な支持のためには、これは再吸収不可能な材料から作られる。
て説明されたように多孔質である)、すなわち、骨組織との互生を促進するように備えられる。埋込のすぐ後、そのようなインプラントは、歯、ブリッジまたは人工器官の固定、およびその通常の使用に十分な一次安定性を有する。中央インプラント部の生物作用表面によって促進されて、再生された組織は次に再吸収可能材料を連続的に置換えて、中央インプラント部とともに成長する。したがって、この発明に従うインプラントは、セメントを適用しなくても即時に一次安定性を提供し、再吸収および再生段階の後、公知のインプラントの安定性と等しい永久的二次安定性を提供する。しかしながら、公知の埋込方法と比較すると、現行技術に従い、開口41が閉じられ、歯、ブリッジまたは人工器官が再生骨に直接に固定される前に骨組織の再生を待つ遷移段階は存在しない。
。現行技術に従うと、そのような固定はバイコーティカル(bicortical)固定によってしか達成できない。
インプラントは、埋込のすぐ後に一次安定性を有し、これにより少なくとも部分的な荷重が可能になる。一次安定性は、後に、チタンステム63の多孔質表面に生存骨組織が互生することによってもたらされる二次安定性によって引継がれる。このことは、人工関節要素が、セメントを使用しなくても埋込の本質的にすぐ後に荷重され得ることを意味する。その早期の荷重は生存組織の再生に有利であり、萎縮(骨粗鬆症)を防止する。さらなる段階においても同様に、生存組織がチタンステムと互生する。
図30に示されるように、シキソトロピックセメントの代わりに熱可塑性材料を用いる場合、図30(下図)に二点鎖線で示すように、ワイヤ84または縫合用の固定要素を収容するように開口80を特に作製してもよい。たとえば刺激器として治療用補助装置を同じ態様で固定してもよい。
射出成形で製造され、かつ直径が3.5から4.25mmの丸い断面、26から40mmの長さ(20kHzでの理想的な長さ:35mm)、先が丸くなるようにテーパされた遠端、および遠端から10mm超えて軸方向に延びる4つの溝を有する、PLLAおよびポリカーボネートからなるピンが、20kHzの励起周波数で、新しく屠殺された牛の海綿状骨(大腿骨の頭部)に固定された。埋込のため、海綿状骨の上に存在する薄い皮質物質層が開かれたが、海綿状骨には予めドリルで孔をあけなかった。埋込の際、60から130Nの圧力でインプラントが組織に押付けられ、励起周波数(ソノトロード振幅約20から25μm)で励起された。進入は10mmに限定され、これは2秒未満で達成された。次にインプラントは励起せずに5秒間保持された。
は、埋込後約10秒に、最高44℃(室温よりも約22°高い)の温度を記録した。温度上昇は約30秒後にその値の半分になった。
Claims (45)
- 第1の組織部への押込嵌め接続を作製するためのインプラント(7)であって、これは、他の組織部に前記第1の組織部を接続する、または前記他の組織部を置換えるもしくは支持するもしくは治療用補助装置である人工要素に前記第1の組織部を接続するためのものであり、
インプラント(7)は熱可塑性であって、2から200kHzの周波数領域の機械振動によって液化可能な材料から少なくとも部分的になり、前記液化可能材料は、前記液化可能材料の少なくとも一部を液化しかつ少なくとも前記第1の組織部の開口の中にこれを押込むように、少なくとも前記第1の組織部と接することができ、機械振動によって励起可能であり、かつ同時に少なくとも前記第1の組織部に押付けられるようにインプラント(7)上に配置されることを特徴とする、インプラント。 - 液化可能材料は少なくとも1つの再吸収可能成分を含むことを特徴とする、請求項1に記載のインプラント。
- 液化可能材料はさらなる機能を有する物質をさらに含むことを特徴とする、請求項1または2に記載のインプラント。
- インプラントはピンまたはだぼの形状を有することを特徴とする、請求項1から3のいずれかに記載のインプラント。
- 液化可能材料は、インプラント遠端のインプラント表面上および/または円筒形インプラント表面上に配置され、インプラントは液化不可能な材料からなるコア(11)を含むことを特徴とする、請求項4に記載のインプラント。
- インプラントは液化不可能な材料からなるスリーブ(13)を含み、液化可能材料はスリーブの内側に配置され、スリーブは液化された材料の出口用の開口(58)を含むことを特徴とする、請求項4に記載のインプラント。
- 液化可能材料は再吸収可能であり、コア(11)またはスリーブ(13)の表面の少な
くとも一部は生物に作用することを特徴とする、請求項6に記載のインプラント。 - インプラントは、インプラント近端に配置される保持手段(14,15)を含むことを特徴とする、請求項3から7のいずれかに記載のインプラント。
- インプラントはプレート(35および36)または膜(35)の形状を有することを特徴とする、請求項1から3のいずれかに記載のインプラント。
- プレートまたは膜(35)は1層からなることを特徴とする、請求項9に記載のインプラント。
- プレート(35および36)または膜は、液化可能な材料からなる層および液化不可能な材料からなる層を含み、液化可能な材料は液化不可能な材料の1つの表面の少なくとも一部を覆い、2つの層は、押込嵌めまたは材料嵌合によって互いに接続されることを特徴とする、請求項9に記載のインプラント。
- インプラントは、人工支持もしくは固定要素、人工関節要素、義歯、ブリッジもしくは人工歯、縫合ねじ山、締結ワイヤまたは治療用補助装置のための固定手段として設計されることを特徴とする、請求項1から11のいずれかに記載のインプラント。
- 請求項1から12のいずれかに記載のインプラント(7)を埋込むための埋込装置(1)であって、
発振器(2)、発振要素および共振器(6)を含み、発振器(2)は発振要素を励起して機械発振させるように設計され、共振器(6)および発振要素は発振ユニット(3)を形成するように接続され、共振器(6)は、機械発振の伝達のため、インプラント(7)に能動的に接続可能であり、かつインプラント(7)を組織部に押付けるように設計され、
装置は、ハウジングの上に支持されるインプラントガイドをさらに含むことを特徴とする、埋込装置。 - 装置は、2から200kHzの周波数での共振器(6)の機械発振のために設計されることを特徴とする、請求項13に記載の埋込装置。
- 装置は、機械発振のさまざまな周波数、さまざまな周波数パターン、および/またはさまざまなエネルギ脈動を設定するように備えられることを特徴とする、請求項13または14に記載の埋込装置。
- 共振器(6)または共振器(6)の遠端部は交換可能でありかつ無菌化することができることを特徴とする、請求項13から15のいずれかに記載の埋込装置。
- 共振器(6)は、ピン状またはだぼ状インプラント(7)を保持するように設計されることを特徴とする、請求項13から16のいずれかに記載の埋込装置。
- 組織部への接続を作製するためのキットであって、前記キットは埋込装置(1)を含み、埋込装置(1)は、発振器(2)、発振要素および共振器(6)を含み、発振器(2)は発振要素を励起して機械発振させるように設計され、共振器(6)および発振要素は発振ユニット(3)を形成するように接続され、共振器(6)は、機械発振の伝達のため、インプラント(7)に能動的に接続可能であり、かつインプラント(7)を組織部に押付けるように設計され、前記キットは、請求項1から12のいずれかに記載の複数のインプラント(7)とをさらに含む、キット。
- 埋込装置(1)の共振器(6)はその遠端に保持手段を含み、インプラント(7)はピン状またはだぼ状であり、それらの近端は、共振器(6)の保持手段に適合される保持手段を含むことを特徴とする、請求項18に記載のキット。
- キットは、さまざまなピン状またはだぼ状のインプラントと、共振器(6)または遠位共振器部とを含み、その遠位表面はインプラントの近位断面に対応することを特徴とする、請求項18または19に記載のキット。
- インプラント(7)の少なくとも一部はピン状であり、キットは、摩擦嵌めのために直径がインプラント(7)の最大直径に適合されたドリルをさらに含むことを特徴とする、請求項18から20のいずれかに記載のキット。
- インプラント(7)の少なくとも一部は、開口(58)を有するスリーブ(13)中に液化可能材料を含み、キットは、少なくとも1つの共振器(6)または遠位共振器部をさらに含み、その断面はスリーブ(13)の近位内側断面に適合されることを特徴とする、請求項18から21のいずれかに記載のキット。
- キットは、開口を備えるガイド(82)と、少なくとも1つの共振器(6)または遠位共振器部とをさらに含み、その断面は開口に適合されることを特徴とする、請求項18から22のいずれかに記載のキット。
- キットは埋込装置(1)用の無菌カバーをさらに含むことを特徴とする、請求項18から23のいずれかに記載のキット。
- 埋込装置(1)は、さまざまな発振周波数、さまざまな周波数パターン、および/またはさまざまなエネルギ脈動を設定するために備えられ、キットは、さまざまなインプラント用の設定指示をさらに含むことを特徴とする、請求項18から24のいずれかに記載のキット。
- 請求項1から12のいずれかに記載の1つ以上のインプラント(7)を備える追加キットであって、前記追加キットは、機械発振エネルギの補助によってインプラントを埋込むための指示をさらに含む、追加キット。
- 埋込装置の補助によって請求項1から12のいずれかに記載のインプラント(7)を人間以外の動物の組織部に埋込むための方法であって、埋込装置(1)は、発振器(2)、発振要素および共振器(6)を含み、発振器(2)は発振要素を励起して機械発振させるように設計され、共振器(6)および発振要素は発振ユニット(3)を形成するように接続され、共振器(6)は、機械発振の伝達のため、インプラント(7)に能動的に接続可能であり、かつインプラント(7)を組織部に押付けるように設計され、前記方法は、
押込嵌め手段として好適な表面凹凸もしくは開口を組織部が有するか、またはそのような表面凹凸もしくは開口を静水圧によって作製可能な領域において、液化可能な材料からなるインプラント領域が組織部と接するまたは組織部と接触できるように、組織部上にインプラント(7)を位置決めするステップと、
液化可能材料のうち少なくとも一部が液化され、前記表面凹凸または開口の中に押込まれるまで、インプラントに機械発振を当て、かつ同時にインプラントを組織部に押付けるステップと、
依然としてインプラントを組織部に押付けながら液化可能材料を再凝固させるステップとを含む、方法。 - 組織部は、人間以外の動物の骨部、軟骨部、靭帯部または腱部(10,20,50,72,73)であることを特徴とする、請求項27に記載の方法。
- 作製すべき接続は、点ごとの、深さに対して効果的な接続であることを特徴とする、請求項27または28に記載の方法。
- 開口は埋込前に組織部の中に作製され、インプラント(7)は開口の中に位置決めされることを特徴とする、請求項27から29のいずれかに記載の方法。
- 組織部は、皮質骨物質(22)および海綿状骨(23)を備える骨であり、埋込前は少なくとも皮質層(22)が開いていることを特徴とする、請求項27から30のいずかに記載の方法。
- 作製すべき接続は、表面が大きく、表面的な接続であることを特徴とする、請求項27または28に記載の方法。
- 好適な組織表面領域は、インプラント(7)の位置決めの前にでこぼこをつけられることを特徴とする、請求項32に記載の方法。
- インプラントをプレート(21)に固定するため、インプラントの近位領域は、前記機械振動によって液化可能な材料を含むことを特徴とする、請求項4に記載のインプラント。
- ヘッド状の近位領域を含むことを特徴とする、請求項4または34に記載のインプラント。
- 液化可能材料はインプラント遠端のインプラント表面上および/または円筒形インプラント表面上に配置され、液化可能材料はエネルギディレクタとして働く段差を含むことを特徴とする、請求項5に記載のインプラント。
- 保持手段はプレス嵌め接続のために設けられることを特徴とする、請求項8に記載のインプラント。
- 共振器はプレス嵌め接続のために設けられることを特徴とする、請求項17に記載の埋込装置。
- 複数のピン状インプラントと、前記ピン状インプラント(7)に適合される開口を備える少なくとも1つのプレート(21)とを含むことを特徴とする、請求項18に記載のキット。
- プレート(21)は金属であり、プレート(21)との接続のため、ピン状インプラント(7)の近位領域は前記機械振動によって液化可能な材料を含み、開口は、液化可能材料との押込み嵌め接続のために設けられることを特徴とする、請求項39に記載のキット。
- 開口はねじ山を含むことを特徴とする、請求項40に記載のキット。
- プレート(21)および/またはピン状インプラントの近位領域は液化可能材料を含み、これによりプレートおよびインプラントの近端領域は、機械振動を加えることによってともに溶接または接着され得ることを特徴とする、請求項39に記載のキット。
- ピン状インプラント(7)が用いられ、プレート(21)は組織部上に位置決めされ、プレートはピン状インプラント(7)に適合される開口を含み、ピン状インプラント(7)は開口を通して組織部上に位置決めされることを特徴とする、請求項27から31のいずれかに記載の方法。
- ピン状インプラント(7)は、インプラント近位領域中および/またはプレート上に配置された液化可能材料が液化されてインプラントとプレート(21)との間に押込み嵌め接続、溶接または接着接続を形成するまで、機械振動を当てられることを特徴とする、請求項43に記載の方法。
- インプラント(7)はその近位領域がプレート(21)と同じ高さに整列されるまで組織部に押付けられることを特徴とする、請求項43または44に記載の方法。
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