JP2013172996A - ヒトまたは動物組織内に埋入されるデバイスならびに該デバイスの埋入および組立て方法 - Google Patents
ヒトまたは動物組織内に埋入されるデバイスならびに該デバイスの埋入および組立て方法 Download PDFInfo
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- JP2013172996A JP2013172996A JP2013093462A JP2013093462A JP2013172996A JP 2013172996 A JP2013172996 A JP 2013172996A JP 2013093462 A JP2013093462 A JP 2013093462A JP 2013093462 A JP2013093462 A JP 2013093462A JP 2013172996 A JP2013172996 A JP 2013172996A
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Abstract
【解決手段】インサイチュで接合される2つ(または2つより多く)のパーツを備えているヒトまたは動物の組織内に埋入するのに適したインプラント材またはエンドプロテーゼであって、該パーツはそれぞれ、接合区域を備えており、この2つの接合区域は、該デバイスパーツが一体化されるように配置されると、互いに対向し、この場合、接合区域の一方は、機械的振動により液化性の材料を備えており、他方の接合区域は、機械的振動によって液化性とならない材料と、液化性材料との積極嵌合連結の形成に適した構造部(例えば、アンダーカット空洞部または突起部)を備えているインプラント材またはエンドプロテーゼ。
【選択図】図1
Description
本発明によるデバイスは、2つ(または2つより多く)のパーツを備えており、かかるパーツは、機械的発振、特に超音波振動をパーツの1つに対して、このパーツを機械的振動ツールと接触させることにより適用して用いて組み立てられる、すなわち一体化されるように具備される。デバイスパーツは、通常、人工材料からなるが、一部のパーツは骨組織からなるものであってもよい。デバイスの該2つのパーツは各々、接合区域を備えており、パーツを接合するように配置すると、この2つの接合区域が互いに適合して互いに接触した状態となり、接合プロセス後に互いに連結した状態となり、このとき、もたらされる接合は積極(positive)嵌合連結である。
・態様A:第1のデバイスパーツは、骨組織内において第2のデバイスパーツの支持部を構成する。支持部パーツは、骨組織内において液化性材料と機械的振動の補助によって係留されるように具備され、好ましくは、第1接合区域を備えている。第2のデバイスパーツ(被支持部パーツ)の遠位端は、支持部パーツによって骨組織に固定され、好ましくは、第2接合区域を備えている。支持部パーツは、機械的振動によって骨組織内に係留される。被支持部パーツは支持部パーツに、やはり機械的振動によって接合される。支持部パーツおよび被支持部パーツの具体的な設計にもよるが、骨組織内での支持部パーツの係留および被支持部パーツとの接合は、振動を最初に支持部パーツに適用し、次いで被支持部パーツに適用する連続する2つの工程で行なうか、または振動を支持部パーツに適用する1つの工程で行なう。
R208で入手可能)、ならびに対応するコポリマーおよび混合ポリマー、または前記ポリマーと充填材もしくは強化材(例えば、繊維、ウィスカー、ナノプレートレットもしくはナノチューブなど)とを含有する複合材料である。
図57および58は、脊柱を支え、椎体間に所望の間隔を維持するための、ロッド(可動性パーツ101)を近接する椎体51に固定するためのロッドロック適用を示す。ロッドロックデバイスは、実質的には、図56によるデバイスであって、取り外し不可能なベアリングパーツに突起部105が具備され、該突起部は、例えば、ロックデバイスが、椎体内に設けられた対応する穴に係留されるように具備される。図57は、ロッドの周囲に密封されたロックデバイスを拡大して示し、図58は、椎体に載置されたロックデバイスを示す。
Claims (91)
- (態様A)デバイスを患者に埋入し、組み立てるための方法であって、
骨組織(11)内に、第1の液化性材料と機械的振動の補助によって係留されるように具備される該デバイスの支持部パーツ(1)と、該デバイスの被支持部パーツ(2)とを準備する工程(ここで、該2つのデバイスパーツ(1,2)は各々、接合区域を備えており、該接合区域の第1のもの(F)は第2の液化性材料を備えており、該接合区域の第2のもの(S)は非液化性材料および該第2の液化性材料との積極嵌合連結を形成するのに適した構造を備えている)、
支持部パーツ(1)を該骨組織内に配置し、該第1の液化性材料の少なくとも一部が液化するのに充分な時間、支持部パーツ(1)に機械的振動を連動させ、支持部パーツ(1)を骨組織(11)内に押圧することにより、支持部パーツ(1)を患者の骨組織(11)内に係留する工程
被支持部パーツ(2)を支持部パーツ(1)に対して、該2つの接合区域(F,S)が互いに接触するように配置する工程、および
第1接合区域(F)の第2の液化性材料の少なくとも一部が液化して第2接合区域(S)の構造に浸透するのに充分な時間、被支持部パーツ(2)または支持部パーツ(1)に機械的振動を連動させることより被支持部パーツ(2)を支持部パーツ(1)に接合させる工程
を含む、方法。 - 係留する工程が、被支持部パーツ(2)を配置する工程の前に行なわれ、接合させる工程において機械的振動が該被支持部パーツに適用される、請求項1に記載の方法。
- 係留する工程において、支持部パーツ(1)が、適切に下準備した管状骨(45)の骨組織(11)内または髄腔(86)内に設けられた開口部(10)内に配置される、請求項1または2のいずれか1項に記載の方法。
- 接合させる工程において、被支持部パーツ(2)が、支持部パーツ(1)の隣接面上の開口部(5)内に配置される、請求項2または3のいずれか1項に記載の方法。
- 被支持部パーツ(2)が、開口部(5)内にスナップ留めされることにより支持部パーツ(1)に対して配置される、請求項4に記載の方法。
- 接合させる工程において、被支持部パーツ(2)が、支持部パーツ(1)の骨組織(11)または管状骨(45)から突出している部分に接合される、請求項2または3のいずれか1項に記載の方法。
- 接合させる工程において、支持部パーツ(1)の該突出している部分が変形される、請求項6に記載の方法。
- 1つだけの被支持部パーツ(2)に複数の支持部パーツ(1)が接合される、請求項1〜7のいずれか1項に記載の方法。
- さらなる組織またはさらなるデバイスパーツが、接合された支持部パーツと被支持部パーツ(1,2)との間に、または該接合されたパーツによって保持される、請求項1〜8のいずれか1項に記載の方法。
- 被支持部パーツ(2)を支持部パーツ(1)に対して配置する工程が、係留する工程の前に行なわれ、係留する工程が接合させる工程と同時に行なわれる、請求項1に記載の方法。
- (態様A)請求項1に記載の方法により患者に埋入され、組み立てられ、骨組織(11)内に第1の液化性材料と機械的振動の補助によって係留されるように具備された支持部パーツ(1)と、被支持部パーツ(2)とを備えるデバイスであって、該2つのデバイスパーツ(1,2)が対応する接合区域の各々またはペアを備えており、該接合区域の第1のもの(F)は第2の液化性材料を備えており、第2のもの(S)は非液化性材料、および該第2の液化性材料との積極嵌合連結を形成するのに適した構造を備えており、支持部パーツ(1)の接合区域はその隣接側または側面側に存在し、被支持部パーツ(2)の接合区域はその遠位側または側面側に存在する、デバイス。
- 第1および第2の液化性材料が同じ材料であり、支持部パーツ(1)が前記同じ材料からなり、第1接合区域(F)を備える、請求項11に記載のデバイス。
- 第1および第2の液化性材料が同じ材料であり、支持部パーツ(1)が非液化性材料の有孔スリーブ(1.1)を備えており、前記同じ材料が有孔スリーブ(1.1)内に存在している、請求項11に記載のデバイス。
- 第1および第2の液化性材料が同じ材料であり、支持部パーツ(1)が非液化性材料のコア部(22)を備えており、該コア部の少なくとも一部分が前記同じ材料でコーティングされている、請求項11に記載のデバイス。
- 被支持部パーツ(2)の隣接端が、これに縫合糸、ワイヤ、ロッドまたはさらなるデバイスパーツが固定されるように具備される、請求項11〜14のいずれか1項に記載のデバイス。
- 縫合糸係留体、関節部分と置換されるエンドプロテーゼ、または外固定デバイスである、請求項11〜14のいずれか1項に記載のデバイス。
- 支持部パーツ(1)がピンまたはプレートの形状であり、被支持部パーツ(2)が、支持部パーツ(1)の1つまたは複数の隣接端に接合されるように適応させられた、請求項12に記載のデバイス。
- さらに、椎間部材または縫合糸、ワイヤもしくはロッドであるさらなるデバイスパーツを備えた、請求項17に記載のデバイス。
- 支持部パーツ(1)が複数のピン形状の部材を備えており、該ピン形状の部材は支持部プレート(55)によって連結されているか、または連結され得、被支持部パーツ(2)が、支持部プレート(55)に接合される硬化性部材(57)を備えている、請求項11に記載のデバイス。
- (態様B、第1、第2および第3の群)デバイスを患者に埋入し、組み立てるための方法であって、
該支持部パーツは患者の骨組織(11)内に、第1の液化性材料と機械的振動の補助によって係留されるように具備される該デバイスの少なくとも1つの支持部パーツ(1)と、該デバイスの被支持部パーツ(2)とを準備する工程(ここで、該2つのデバイスパーツ(1,2)のそれぞれが適合接合区域ペアの接合区域を備えており、該2つの接合区域の第1のもの(F)は第2の液化性材料を備えており、該2つの接合区域の第2のもの(S)は、非液化性材料、および該第2の液化性材料との積極嵌合連結を形成するのに適した構造とを備えている)、
被支持部パーツ(2)を骨組織(11)に対して、被支持部パーツ(2)の接合区域が骨組織(11)に面するように配置する工程;
支持部パーツ(1)を骨組織(11)と被支持部パーツ(2)との間に押し入れ、対応する該接合区域のペアの接合区域が互いに接触するようにする工程と、該第1の液化性材料の少なくとも一部が液化して骨組織内に押圧されるのに充分な時間、および第1接合区域(F)の第2の液化性材料の少なくとも一部が液化して第2接合区域(S)の構造部に浸透するのに充分な時間、支持部パーツ(1)にその隣接面を介して、振動を連動させる工程
を含む、方法。 - 第1および第2の液化性材料が同じ材料であり、支持部パーツ(1)が第1接合区域を備えている、請求項20に記載の方法。
- 押し入れる工程が、支持部パーツ(1)上に設けられた自己リーミング構造部(74)により骨表面に入り込ませることを含む、請求項20または21のいずれか1項に記載の方法。
- 配置する工程が、被支持部パーツ(2)を、骨組織(11)内に設けられた開口部(10)内に配置することを含み、押し入れる工程が、支持部パーツ(1)を被支持部パーツ(2)のそばの開口部(10)に押し入れることを含む、請求項20〜22のいずれか1項に記載の方法。
- 開口部(10)がアンダーカット底面を備えており、被支持部パーツ(2)が、アンダーカット底面内に配置された遠位突起部を備えている、請求項23に記載の方法。
- 複数の支持部パーツ(1)が被支持部パーツ(2)のそばの開口部(10)内に押し入れられる、請求項23に記載の方法。
- 配置する工程が、被支持部パーツ(2)を骨表面に対して配置することを含み、押し入れる工程が、支持部パーツ(1)を被支持部パーツ(2)と骨表面との間に押し入れる工程を含む、請求項20〜22のいずれか1項に記載の方法。
- チャネル(45,45’)が骨表面内および/または被支持部パーツ(2)内に設けられる、請求項26に記載の方法。
- 骨表面が椎体(51)表面または管状骨(45)の内側表面である、請求項26または27のいずれか1項に記載の方法。
- 被支持部パーツ(2)が、第2接合区域(S)を構成する骨組織を備えている、請求項20〜22のいずれか1項に記載の方法。
- 被支持部パーツ(2)が、骨開口部(10)もしくはトンネル部内に固定される腱−骨移植片(81)、またはさらなる骨断片(11.2)に対して固定される骨断片(11.1)であり、該2つの骨断片は骨折部(65)で分離している、請求項29に記載の方法。
- (態様B、第1、第2および第3の群)請求項20に記載の方法により患者に埋入され、組み立てられ、患者の骨組織(11)内に第1の液化性材料と機械的振動の補助によって係留されるように具備された支持部パーツ(1)と、被支持部パーツ(2)とを備えるデバイスであって、該2つのデバイスパーツ(1,2)のそれぞれが対応する接合区域のペアの一方を備えており、該2つの接合区域の第1のもの(F)は第2の液化性材料を備えており、該2つの接合区域の第2のもの(S)は非液化性材料と、該第2の液化性材料との積極嵌合連結を形成するのに適した構造とを備えており、支持部パーツ(1)の接合区域はその第1側面に存在し、支持部パーツ(1)は、その第2側面側で骨組織(11)内に係留されるように具備され、被支持部パーツ(2)の接合区域はその側面側に存在する、デバイス。
- 第1および第2の液化性材料が同じ材料であり、支持部パーツ(1)が第1接合区域(F)を構成し、支持部パーツ(1)が、前記同じ材料からなるか、または少なくとも一部分が前記同じ材料でコーティングされた非液化性材料のコア部(22)を備えているか、または内部に前記同じ材料が配置された有孔スリーブ(1.1)を備えている、請求項31に記載のデバイス。
- ピン、プレートまたはくさび型の形状である、請求項31または32のいずれか1項に記載のデバイス。
- コア部(22)または有孔スリーブ(1.1)が自己リーミング構造部を備えている、請求項32または33のいずれか1項に記載のデバイス。
- 被支持部パーツ(2)が、縫合糸(21)、ワイヤ、ロッドまたはさらなるデバイスパーツを固定するように具備される、請求項31〜34のいずれか1項に記載のデバイス。
- 被支持部パーツ(2)が椎間固定または非固定部材(50)である、請求項31〜34のいずれか1項に記載のデバイス。
- 被支持部パーツ(2)がピン形状であり、ヘッド部(30)を備えており、支持部パーツ(1)がくさび型形状であり、ヘッド部(30)と、被支持部パーツ(2)が配置および固定される骨組織の表面との間に押し入れられるように設計されている、請求項31〜34のいずれか1項に記載のデバイス。
- 被支持部パーツ(2)が、管状骨(45)の髄腔内に導入されるように設計されている、請求項31〜34のいずれか1項に記載のデバイス。
- (態様B、第4の群)デバイスを患者に埋入し、組み立てるための方法であって、
デバイスの支持部パーツ(1)と、該デバイスの2つの被支持部パーツ(2,2’)とを準備する工程(ここで、該支持部パーツは、その対辺側面に2つの接合区域を備えており、該2つの被支持部パーツは、各々がその一側面に支持部パーツ(1)の接合区域の一方に対応した接合区域と、第2の液化性材料との積極嵌合連結を形成するのに適した構造を備え、対応する各ペアの該接合区域のうち第1のもの(F)は液化性材料を備えており、第2のもの(S)は非液化性材料を備えている)、
該2つの被支持部パーツ(2,2’)を患者に、その接合区域が互いに面するように配置する工程、
支持部パーツ(1)を該2つの被支持部パーツ(2,2’)間に押し入れ対応する接合区域の該ペアを互いに接触するようにする工程と、適合接合区域の各ペアの第1接合区域(F)の液化性材料の少なくとも一部が液化して該ペアの第2接合区域(S)の構造部に浸透するのに充分な時間、支持部パーツ(1)にその隣接面を介して、振動を連動させる工程
を含む、方法。 - さらに、被支持部パーツ(2,2’)を骨組織(11)内に、さらなる液化性材料の補助によって係留する工程を含む、請求項39に記載の方法。
- 被支持部パーツ(2,2’)が、近接する椎体に面して係留される、請求項40に記載の方法。
- 被支持部パーツ(2,2’)がプレートユニットであり、骨表面に対して配置され、支持部パーツ(1)が該ユニット間に押し入れられ、骨組織内の骨表面の下方に係留される、請求項40に記載の方法。
- (態様B、第4の群)請求項39に記載の方法により患者に埋入され、組み立てられ、支持部パーツ(1)と、2つの被支持部パーツ(2,2’)とを備えるデバイスであって、該支持部パーツは2つの側面に2つの接合区域を備えており、該2つの被支持部パーツは、各々がその一側面に接合区域と、液化性材料との積極嵌合連結を形成するのに適した構造部とを備えており、該支持部パーツの一方の接合区域が、該2つの被支持部パーツ(2,2’)のそれぞれの接合区域に対応しており、対応するペアの接合区域のうち第1のもの(F)は該液化性材料を備えており、第2のもの(S)は非液化性材料を備えている、デバイス。
- 被支持部パーツ(2,2’)および支持部パーツ(1)がくさび型形状である、請求項43に記載のデバイス。
- 椎間円板と置換するための椎間固定または非固定部材(50)として設計された、請求項44に記載のデバイス。
- 被支持部パーツ(2,2’)が、側方溝(54)を備えたプレートユニットであり、支持部パーツ(1)が、互いに一直線上である2つの側方溝(54)の断面に適応させた断面と、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備された遠位端とを有する、請求項43に記載のデバイス。
- (態様C)デバイスを患者に埋入し、組み立てるための方法であって、
該デバイスの支持部パーツ(1)と、被支持部パーツ(2)とを準備する工程(ここで、該2つのパーツ(1,2)のそれぞれが、対応する接合区域ペアの一方を備えており、その第1のもの(F)は液化性材料を備えており、第2のもの(S)は、非液化性材料と、液化性材料との積極嵌合連結を形成するのに適した構造部とを備えており、支持部パーツ(1)の接合区域は、その遠位端または遠位部分に存在する)、
患者の骨組織(11)内またはさらなるデバイスパーツ内に貫通開口部(10)設ける工程(ここで、貫通開口部(10)は隣接口と遠位口とを備えている)、
被支持部パーツ(2)を骨組織(11)またはさらなるデバイスパーツに対して、その接合区域が、貫通開口部(10)の遠位口またはこの遠位口を超えて存在するように配置する工程、
支持部パーツ(1)を貫通開口部(10)内に配置する工程であって、遠位端またはその一部分が被支持部パーツ(2)の接合区域と接触しており、その隣接面が開口部(10)の隣接口領域内に存在するように配置する工程、
支持部パーツ(1)を被支持部パーツ(2)に対して押圧する工程と、支持部パーツ(1)に、第1接合区域(F)の液化性材料が液化して第2接合区域(S)の構造部に浸透するのに充分な時間、機械的振動を連動させる工程
を含む、方法。 - 支持部パーツ(1)がピン形状であり、貫通開口部(10)が穴である、請求項47に記載の方法。
- 支持部パーツ(1)の隣接部分が骨組織(11)内に、さらなる液化性材料と機械的振動の補助によって係留されるように具備されており、支持部パーツ(1)が貫通開口部(10)の壁面内に係留されると同時に被支持部パーツ(2)に接合される、請求項47または48のいずれか1項に記載の方法。
- 該液化性材料と該さらなる液化性材料が同じ材料であり、支持部パーツ(1)がピン形状であり、前記同じ材料を隣接部と遠位端または遠位部に備えている、請求項49に記載の方法。
- 支持部パーツ(1)の隣接部が、貫通開口部(10)内にヘッド部によって保持されるように具備される、請求項48に記載の方法。
- 貫通開口部(10)が非直線状の軸を有し、支持部パーツ(1)が、該貫通開口部内に保持されるように圧力と振動の影響下で屈曲している、請求項48に記載の方法。
- 被支持部パーツ(2)が、骨断片(11.1)が支持部パーツ(1)の補助によって接合される関節置換プロテーゼである、請求項48〜52のいずれか1項に記載の方法。
- 被支持部(2)パーツが、関節のベアリング表面の表面再形成のためのエンドプロテーゼ、または幹部を有するエンドプロテーゼであり、相応して下準備した骨組織(11)に複数の支持部パーツ(1)の補助によって固定される、請求項48〜52のいずれか1項に記載の方法。
- 被支持部パーツ(2)が、髄内釘(85)またはプレートであり、管状骨(45)の一方の壁面を貫通して延在している複数の支持部パーツ(1)の補助によって環状骨(45)の髄腔内に固定される、請求項48〜52のいずれか1項に記載の方法。
- 貫通開口部(10)がさらなるデバイスパーツ内に設けられており、該さらなるデバイスパーツが、骨断片が支持部パーツ(1)の補助によって固定される関節のベアリング表面と置換するためのエンドプロテーゼ、または2つの近接する椎体(51)に複数の支持部パーツ(1)の補助によって固定される椎間円板と置換するための椎間部材(50)である、請求項48〜52のいずれか1項に記載の方法。
- (態様C)請求項47に記載の方法により患者に埋入され、組み立てられ、支持部パーツ(1)と、被支持部パーツ(2)とを備えるデバイスであって、該2つのデバイスパーツ(1,2)のそれぞれが対応する接合区域ペアの接合区域を備えており、該ペアの接合区域の第1のもの(F)は液化性材料を備えており、第2のもの(S)は、非液化性材料と、該液化性材料との積極嵌合連結を形成するのに適した構造部とを備えており、支持部パーツ(2)の接合区域がその遠位側に存在している、デバイス。
- 支持部パーツ(1)が、隣接領域において、さらなる液化性材料と機械的振動の補助によって骨組織(11)内に係留されるように具備される、請求項57に記載のデバイス。
- 該液化性材料と該さらなる液化性材料が同じ材料であり、支持部パーツ(1)が、前記同じ材料からなるか、または前記同じ材料でコーティングされている、請求項58に記載のデバイス。
- 支持部パーツ(1)が、ヘッド部セクションまたは肩部を備えている、請求項57に記載のデバイス。
- 支持部パーツ(1)がピン形状である、請求項57〜60のいずれか1項に記載のデバイス。
- 被支持部パーツが、関節部分と置換されるエンドプロテーゼまたはかかるエンドプロテーゼの幹部、関節のベアリング表面と置換されるエンドプロテーゼ、管状骨の骨折部(65)を安定させるための髄内釘(85)またはプレートまたはピンである、請求項61に記載のデバイス。
- 内部に開口部(10)が延在するさらなるデバイスパーツを備え、該さらなるデバイスパーツが、関節のベアリング表面と置換されるエンドプロテーゼまたは椎間円板と置換するための椎間部材(50)である、請求項61に記載のデバイス。
- 該開口部が非直線状の軸を有する、請求項63に記載のデバイス。
- (態様D、第1の群)デバイスを患者に埋入し、組み立てるための方法であって、
複数のデバイスパーツ(90)の仮組立体を準備する工程(ここで、該仮組立体において、該デバイスパーツは互いに連結されているが、選択されたものがなお互いに対して可動性である)、またはかかる仮組立体となるように具備された複数のデバイスパーツ(90)を準備する工程(ここで、該仮組立体の近接するデバイスパーツペアが、各適合接合区域ペアの一方の接合区域を備え、適合接合区域ペアの第1接合区域(F)は液化性材料を備えており、第2接合区域(S)は非液化性材料と、該液化性材料との積極嵌合連結を形成するのに適した構造部とを備えている)、
該仮組立体をインプラント材埋入部位に配置する工程、または該デバイスパーツをインプラント材埋入部位内で仮組み立てし、該仮組立体を形成する工程、
該仮組立体を部位特異的構成で、デバイスパーツのうち選択したものを互いに対して移動させることにより導入する工程、および
対応するペアの第1と第2の接合区域(F,S)を備えたデバイスパーツ(90)を互いに対して押圧する工程と、機械的振動を該デバイスパーツペアの一方のデバイスパーツに、第1接合区域(F)の液化性材料が液化して第2接合区域(S)の構造部内に流入するのに充分な時間カップリングさせる工程
を含む、方法。 - 少なくとも一部のデバイスパーツ(90)がさらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備される、請求項65に記載の方法。
- 仮組立体が連接チェーンのチェーンを備えており、アーチまたは環形状のインプラント材が形成されるように該チェーンが仮組み立てされる、請求項65または66のいずれか1項に記載の方法。
- デバイスパーツ(90)は、ハーモニカ様構造部が形成されるように仮組み立てされ、該構造部は、骨折部(65)と交差し、かつ該部位特異的構成で載置され、一緒に押し入れられて骨折部(65)を閉鎖する、請求項65または66のいずれか1項に記載の方法。
- 該デバイスパーツが、貫通開口部を有するプレート(20)と、プレート(20)の該貫通開口部内に移動可能に載置され、さらなる貫通開口部を備えた挿入部(92)と、該さらなる貫通開口部に適応させ、骨組織内にさらなる液化性材料と機械的振動の補助によって係留されるように具備されるピンパーツ(93)とを備え、該プレートは骨表面に対して配置され、圧力と機械的振動をピンパーツ(93)に適用することにより、ピンパーツ(93)が挿入部(92)に接合され、挿入部(92)がプレート(20)に接合され、ピンパーツ(93)が骨組織内に係留される、請求項65または66のいずれか1項に記載の方法。
- (態様D、第1の群)請求項65に記載の方法により患者に埋入され、組み立てられ、仮組み立てされたまたは仮組み立てされ得る複数のデバイスパーツ(90)を備えるデバイスであって、仮組み立てされたデバイスパーツ(90)の近接するペアの各々が、対応する接合区域ペアの一方の接合区域を備え、対応する該ペアの接合区域の第1のもの(F)は液化性材料を備えており、第2のもの(S)は非液化性材料と、第1接合区域(F)の液化性材料との積極嵌合連結を形成するのに適した構造を備えており、該デバイスパーツの近接するペアの接合区域が、該仮組み立てされたデバイスにおいて互いに面し、該仮組み立てされデバイスパーツの選択されたものが、該仮組立体が部位特異的構成となるように互いに対して可動性である、デバイス。
- 移動可能に連結されてチェーンを形成する連接体である複数のデバイスパーツ90を備えた、請求項70に記載のデバイス。
- ハーモニカ様構造部に仮組み立てされる複数のデバイスパーツ(90)を備えた、請求項70に記載のデバイス。
- デバイスパーツとして、プレート(20)と、プレート(20)の貫通開口部内に移動可能に載置され、さらなる貫通開口部を備える挿入部(92)と、該さらなる貫通開口部に適応させられ、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備されるピンパーツ(93)とを備えた、請求項70に記載のデバイス。
- デバイスパーツとして、プレートの1つの表面を横断して延在する溝を備えたプレート(20)と、中央パーツが該溝内で回動して嵌合するような寸法であり、側部のパーツは、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備される、ステープル形状のデバイスパーツ(97)とを備えた、請求項70に記載のデバイス。
- (態様D、第2の群)デバイスを患者に埋入し、組み立てるための方法であって、
機械的振動の補助によって液化され得る液化性材料の遠位端を備えた少なくとも1つのロックパーツ(100)を準備する工程、
複数のデバイスパーツの仮組立体を設ける工程(ここで、該仮組立体において、該デバイスパーツは互いに連結されているが、選択されたものがなお互いに対して可動性である)、またはかかる仮組立体となるように具備された複数のデバイスパーツを設ける工程(ここで、仮組立体内の互いに対して可動性であるデバイスパーツペアの各デバイスパーツが、非液化性材料と、ロックパーツ(100)の液化性材料との積極嵌合連結を形成するのに適した構造部とを備えた第2接合区域とを備えており、該2つの第2接合区域(S)は、該ペアのデバイスパーツ上に互いに面するように配列され、該2つの第2接合区域(S)間の空間は、ロックパーツ(100)が、該デバイスパーツペアの一方と接触するように到達可能である)、
該仮組立体をインプラント材埋入部位に配置する工程、または該デバイスパーツをインプラント材埋入部位内で仮組み立てし、該仮組立体を形成する工程、
該仮組立体を部位特異的構成で、デバイスパーツのうち選択したものを互いに対して移動させることにより導入する工程、および
ロックパーツ(100)の遠位端を該2つの第2接合区域(S)間の空間内に導入する工程、
ロックパーツ(100)の該遠位端を、該デバイスパーツペアの一方に対して押圧する工程と、該ロックパーツまたはデバイスパーツの1つに、該液化性材料が充分液化し、該2つの第2接合区域(S)の間に押圧され、該2つのデバイスパーツの該部位特異的構成がロックされるのに充分な時間、機械的振動を適用する工程
を含む、方法。 - 第2接合区域(S)を備えたデバイスパーツペアが可動性パーツ(101)であり、該可動性パーツは、ベアリングパーツ(102)を貫通して、または複数のベアリングパーツ(102)の組立体を貫通して延在し、仮組立体を部位特異的構成で導入する工程において、可動性パーツ(101)は、ベアリングパーツ(1つまたは複数)(102)対して、軸方向に移動させること、および/または回転させることにより移動させられる、請求項75に記載の方法。
- ロックパーツ(100)が、可動性パーツ(101)に対して押圧され、ロックパーツ(100)の隣接面に適用される振動ツールによって振動させられる、請求項76に記載の方法。
- ロックパーツ(100)が、さらなる液化性材料と機械的振動の補助によって骨組織内に係留され、まず、ロックパーツ(100)が、その遠位端が骨組織から突出するように骨組織内に係留され、次いで、ベアリングパーツ(102)またはベアリングパーツ組立体が、ロックパーツ(100)の遠位端上に配置され、これに対して押圧され、振動させられる、請求項76に記載の方法。
- (態様D、第2の群)請求項75に記載の方法により患者に埋入され、組み立てられ、
機械的振動によって液化され得る液化性材料を遠位領域に備えた少なくとも1つのロックパーツ(100)と、複数のデバイスパーツの仮組立体とを備えるデバイスであって、
該仮組立体において、該デバイスパーツは、互いに連結されているが、デバイスパーツの選択されたもののペアがなお互いに対して可動性であるか、またはかかる仮組立体となるように具備された複数のデバイスパーツを提供する(ここで、仮組立体内の互いに対して可動性であるデバイスパーツペアの各デバイスパーツが、非液化性材料と、ロックパーツ(100)の液化性材料との積極嵌合連結を形成するのに適した構造部とを備えた第2接合区域とを備えており、該2つの第2接合区域(S)は、該ペアのデバイスパーツ上に互いに面するように配列され、該2つの第2接合区域(S)間の空間は、ロックパーツ(100)が到達可能である)、
デバイス。 - 互いに対して可動性であり、該2つの第2接合区域(S)を備えた該デバイスパーツペアにおいて、一方が、ベアリングパーツ(102)またはベアリングパーツ(102)の組立体であり、他方が可動性パーツ(101)であり、該可動性パーツは、ベアリングパーツ(102)またはベアリングパーツ組立体を貫通して延在し、該ベアリングパーツまたはベアリングパーツ組立体に対して軸方向に移動可能および/または回転可能であり、該ベアリングパーツまたはベアリングパーツ組立体は、その外側表面からそのベアリング表面までに延在する開口部を備えており、ロックパーツ(100)がピン形状であり、該ベアリングパーツまたはベアリングパーツ組立体内の開口部を介して導入されるように適応させられている、請求項78に記載のデバイス。
- ベアリングパーツ組立体のベアリングパーツ(102)が、可逆的な様式で互いに連結されている、請求項80に記載のデバイス。
- ベアリングパーツの1つが、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備される突起部(105)を備えている、請求項80または81のいずれか1項に記載のデバイス。
- 椎体(51)内に係留されるロッドクランプである、請求項82に記載のデバイス。
- 複数の支持部(110)、ロッド(111)および複数のダブルベアリングパーツ(112)を備えた外固定デバイスである、請求項80または81のいずれか1項に記載のデバイス。
- ロックパーツ(100)が、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備され、骨組織から突出した係留ロックパーツ(100)の一端が、該2つの第2接合区域(S)間の空間内に配置される遠位端を構成する、請求項80または81いずれか1項に記載のデバイス。
- (態様E)デバイスを患者に埋入し、組み立てるための方法であって、
該デバイスを形成するために、接合させる複数のデバイスパーツを準備する工程(ここで、デバイスパーツのそれぞれは、少なくとも1つの接合区域を備えており、第1の接合区域(F)は液化性材料を備えており、第2の接合区域(S)は、非液化性材料と、該液化性材料との積極嵌合連結を形成するのに適した構造部を備えており、該接合区域は、該デバイスパーツ上において該第1と第2の対応する接合区域ペアで配列され、各ペアの接合区域は互いに面しており、このときにデバイスパーツは接合される)、
該デバイスパーツをインプラント材埋入部位に、互いに対向する対応する接合区域ペアにより配置する工程、
接合させる該デバイスパーツペアを互いに対して押圧する工程と、振動ツールを該各ペアのデバイスパーツの1つに、第1接合区域(F)の充分な液化性材料が液化して第2接合区域(S)の構造部に浸透するのに充分な時間適用する工程
を含む、方法。 - 該デバイスパーツの選択されたものが、さらに、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備される、請求項86に記載の方法。
- (態様E)患者に埋入され、組み立てられるのに適し、一体化させると該デバイスが形成される複数のデバイスパーツを備えるデバイスであって、該デバイスパーツのそれぞれが、少なくとも1つの接合区域を備えており、第1の接合区域(F)は液化性材料を備えており、第2の接合区域(S)は、非液化性材料と、第2の液化性材料との積極嵌合連結を形成するのに適した構造部とを備えており、該接合区域は、対応するペアの第1と第2の接合区域のデバイスパーツ上に配列され、各ペアの接合区域は互いに面しており、このときにデバイスパーツは接合される、
デバイス。 - デバイスが椎間部材(50)であり、デバイスパーツがその半端部である、請求項88に記載のデバイス。
- デバイスが髄内釘(85)またはプレートであり、該デバイスパーツの選択されたものが、さらに、さらなる液化性材料と機械的振動の補助によって骨組織内に係留されるように具備される、請求項88に記載のデバイス。
- デバイスパーツがプレートユニット(127)であり、各々が、少なくとも2つの貫通開口部と、プレートユニット(127)内の該貫通開口部に適応させたピン(91)とを備えている、請求項88に記載の方法。
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JP2015226388A Pending JP2016055184A (ja) | 2006-09-20 | 2015-11-19 | ヒトまたは動物組織内に埋入されるデバイスならびに該デバイスの埋入および組立て方法 |
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