JP4292081B2 - 内部抑制部を備え拡張可能な本体を使用する海綿骨圧迫用装置および方法 - Google Patents
内部抑制部を備え拡張可能な本体を使用する海綿骨圧迫用装置および方法 Download PDFInfo
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- JP4292081B2 JP4292081B2 JP2003559380A JP2003559380A JP4292081B2 JP 4292081 B2 JP4292081 B2 JP 4292081B2 JP 2003559380 A JP2003559380 A JP 2003559380A JP 2003559380 A JP2003559380 A JP 2003559380A JP 4292081 B2 JP4292081 B2 JP 4292081B2
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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
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- A61M25/00—Catheters; Hollow probes
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Description
本発明の一態様は海綿骨圧迫用装置および方法を提供する。一構成によれば、本装置および方法は、内部抑制部が結合された拡張可能な本体を利用する。内部抑制部は、本体の拡張を方向付けるものである。一構成によれば、骨の処置方法は、内部抑制部を有する装置を骨の内部に挿入し、海綿骨中で本体をある方向に拡張させる。ある方向に拡張させることによって、海綿骨を圧縮する。
I. 解剖学的構造体に対するバルーン
本発明は、骨折または崩壊を受けやすい骨の処置に使用することができるバルーンに関する。これらのバルーンは、前記骨へ挿入するための一つ以上の膨張可能なバルーン本体を含む。本体が実質上膨張したときの形およびサイズは、骨折または崩壊が起こった場合に、内部の海綿骨の少なくとも一部を圧迫して海綿骨中にキャビティを作るのに十分であるか、および/または外部の皮質骨を元の位置に戻すのに十分である好ましい形およびサイズを有する。前記骨が骨折していない場合または崩壊されていない場合、種々の実施の形態では、完全に膨張したバルーン本体によって、望ましくは外側の皮質骨の内面上の単一ポイントに実質的な圧力がかかるのを阻害するように、バルーン本体が抑制を受け前記のような好ましい形およびサイズを作り出す。
本発明の教示に従って構築されるバルーンの第1の実施の形態(図1)は、番号10で全体が示されており、柔軟材料で構成される1対の中空膨張パーツ12および14を有するバルーン本体11を含む。柔軟材料としては、PET、マイラー、またはケルバー(Kevlar(登録商標))のような非弾性材料、ポリウレタン、ラテックス、またはゴムのような弾性材料、シリコーンのような半弾性材料、あるいは他の材料が挙げられる(上記に限定されるものではない)。パーツ12および14の間には吸引チューブ16を有し、脂肪および他の残屑を吸引によってチューブ16へ吸引し、遠隔の処置位置へ移送させる。吸引源(不図示)からの吸引力がチューブ16の開口端にかかるように、カテーテル16が1つ以上の吸引ホールを有している。
本発明のバルーンの使用によって処置することができる長骨として、橈骨遠位端(手首にある大きい方の腕骨)、脛骨高原近位(膝のちょうど下の脚骨)、上腕骨近位端(肩側の腕の上端)、および大腿部骨頭(脚骨の腰にある部分)が挙げられる(これに限定されるものではない)。
橈骨遠位端に関し、一実施の形態のバルーン160が橈骨遠位端152中にあるところを示す。このバルーンは、内部表面156または皮質骨158に対して海綿骨154を押し付けるようにして、バルーンが橈骨遠位端のスペースの内部を実質的に満たすように、ピラミッド状に近い形状を有するが、背中の曲がったバナナの形を有していると考えるほうがより近い。
橈骨遠位端の特定の骨折の処置に適しているバルーンサイズの選択は、橈骨遠位端の放射線測定によるサイズおよび骨折位置のほか、処置の目的にも依存することが多い。
脛骨の骨折を図19Aに示す。図中、一実施の形態のバルーン180が脛骨183の片側182に置かれている。好適には、バルーンは、膨張時に、バルーン180を囲む層184の海綿骨を圧縮する。本実施の形態のバルーンの断面を図19Cに示す。図中、バルーンは、ストリングまたは任意の適切な構成の柔軟部材の形をとる抑制部188によって相互に連結される1対の対向する側面185および187を有する。本実施の形態では、抑制部によって、側面185および187は互いに実質上平行にかつ非球状に好適に維持される。バルーン180には、膨張用液体をバルーンに案内し且つバルーンから除去するためのチューブ190が結合されている。抑制部の端部を図19Bおよび図19Dに示し、番号191によって表す。椎骨について既に記載した方法と同じ方法によって、バルーンを脛骨へ挿入し、脛骨から取り出す。図19Bは、バルーンが実質上円形状であるものを示し、一方、図19Dは、バルーンが実質上楕円であるものを示す。
大腿骨頭の場合の一実施の形態であるバルーン200が大腿骨頭の皮質骨202の内部に挿入されているところを示す。皮質骨は、大腿骨の外部端部204では薄く、大腿骨の低端部206では厚みが増している。皮質骨は海綿骨207を囲み、この骨は、バルーン200の膨張によって好適に圧縮される。バルーンに膨張用液体を案内するチューブを番号209によって表示する。これは大腿頚部に沿って伸び、ほぼ球状の大腿部ハッドへ導かれている。図20Aは番号200aによって表示されているバルーンを示す。このバルーンは半球であってもよいし、図20に示されているように球状であってもよい。椎骨について既に記載した方法と同じ方法によって、バルーン200を大腿骨頭へ挿入し、大腿骨頭から取り出す。この例では、底のオーバーラップ部分を接合させ、図20Aに示されるようなひだ200bを作ることによって、半球形状を維持する。
図21は、腰骨折の防止および/または処置に適応させた一実施の形態である「ブーメラン」バルーン210を図示する。「ブーメラン」バルーン210は、膨張すると、ブーメランのように、中間部で徐々に湾曲する円筒状であり、大腿骨頭211の端部から約0.5cmのところから、大腿頸部212を過ぎ、小転子214から約5〜7cm離れた大腿骨骨幹近位213にまで及ぶ。バルーン210のこの実施の形態は、好ましくは、バルーンの側長に沿う短い方の非弾性バンド216に非弾性材料のリング(そのうちの一つを215で示す)の片側を密になるように連結し、長い方の非弾性バンド217にリングの反対側を広がるようにして連結することによって、その形を維持する。なお、本明細書に開示の種々の他の抑制部であっても十分である。
大腿骨頭の骨密度が最低である患者は、大腿骨頭中の圧縮をさらに大きくする必要があるときもある。これは、二つのバルーンを続けて使用するなどして、実現することができる。たとえば、「ブーメラン」を使用した後、大腿骨頭バルーンを使用する(同じポイントから挿入し、拡張してから、任意の支持材料を挿入する)。または、大腿骨頭バルーンの形に近い遠位部分を有するように「ブーメラン」バルーンを適合させてもよい。
言うまでもないが、本明細書に示すバルーンの種々の実施の形態の用途は、体内のある部分の処置のみの利用に限定されるものではない。処置する典型的な部位についてそれぞれ実施の形態を示すこともできるが、これらの実施の形態は、むしろ、処置目的のほか、対象の骨の解剖学的構造に応じて、体内の種々の位置に利用することができる。たとえば、橈骨遠位端の骨折の処置に有用であるとして上に示したバルーンの実施の形態を、以下に限定されるものではないが大腿骨、橈骨、尺骨、脛骨、上腕骨、踵骨、または脊椎の骨折および/または切迫骨折など体内の種々の他のエリアの骨折の処置に対し同じように使用することができる。同様に、種々の他の開示の実施の形態は、処置の目的および/または対象の骨の解剖学的構造によって多様な結果になるが、体内の全体で利用することができる。
A. 複雑な拡張可能構造体
単一の膨張領域を有する拡張可能な本体を使用しても、特定の海綿骨領域内に所望の均一性および圧縮エリアを達成することが困難な時もある。図27は複雑なプレフォーム構造体280を示し、この構造体は、その長さに沿って一定間隔で配置されている拡張性セグメント領域262および284を含む。構造体280は、体積増加が可能な長い外形を提供する。
図23および図24A〜24Cは、本発明の教示に従って構築されるキャビティ形成装置の別の実施の形態の断面図を表す。本実施の形態の特徴の多くが上記の実施の形態について記載した特徴と似ているので、同様のコンポーネントについては同じ参照番号を用いて記載する。
図24A,24Bおよび24Cは、上記記載の実施の形態のバルーン300を大気中で広げたときの断面図を示す。好適には、バルーン300は、椎体のような対象骨の内部でも同じ形に拡大する。
* バルーンの小さい方の直径(DX1−幅):7.7mm
* バルーンの大きい方の直径(DY1−高さ−):7.7mm
2cc(流体)までの膨張
* バルーンの小さい方の直径(DX2−幅):9.2mm
* 小さい方の(水平)直径の増分:1.5mm(幅)−[全体で19.5%の増加]
* バルーンの大きい方の直径(DY2−高さ):10.9mm
* 大きい方の(垂直)直径の増分:2.2mm(高さ)−[全体で28.6%の増加]
4cc(流体)までの膨張:
* バルーンの小さい方の直径(DX3−幅):12.7mm
* 小さい方の(水平)直径の増分:5mm(幅)−[全体で65%の増加]
* バルーンの大きい方の直径(DY3−高さ):15.4mm
* 大きい方の(垂直)直径の増分:7.7mm(高さ)−[全体で100%の増加]
(上記のように)バルーンが拡大するにつれて、バルーン300の軸方向が成長するとともに、バルーンの縦の長さも膨張中にさらに増える傾向を示す。これは、バルーン材料にかかっている圧力が、通常2種以上の寸法に作用し(その結果、複数軸に沿って材料変形が生じる)、増加した内部圧力に応じてバルーン300の縦の全長が拡張するからである。しかし本実施の形態では、内部膜320によって膨張中のバルーンの縦成長も抑えられがちである。たとえば、上記記載の実施の形態のバルーン300の場合、2ccから4ccまで体積が増加すると、バルーンの縦長さの増加は27.1%にしかならない。内部膜を組込まないほかは同じように構築されているバルーンの場合、2ccから4ccまで体積が増加すると、縦長さの増加は37.1%になる。したがって、本発明の内部膜320は、ある外形の周辺拡張を抑制するだけでなく、外形の縦方向の拡張も抑制する。
バルーン300が対象の骨(この例では椎体)の内部の所望の位置に入れば、膨張用媒体をバルーンに導入し、対象の骨の内部のバルーンを好適に拡張することができる。好適には、バルーンは、対象の骨の内部でも、バルーンを大気中で膨張させたときと同じ形およびサイズになり、これによって膨張したバルーンと実質的に同じ形およびサイズであるキャビティを骨の内部に作る。一方、当然のことではあるが、海綿骨密度および質における変化によって、膨張したバルーンの最終的な拡張サイズおよび形がゆがみ、このため拡張したバルーンのサイズおよび形が大気中で拡張した時とは著しく異なることもある。
バルーンによって作り出されるキャビティは、薬材または成長因子といった医学的に適切な製剤によって満たすことができる。薬剤を送達する例として局所骨髄炎(骨感染症)を治療する場合、抗生物質のゲンタマイシンの典型的な投与量は1グラムである(治療条件、および症状が広がっているエリアのサイズに応じて、ゲンタマイシンの治療量の範囲は1ナノグラムから100グラムまでとさらに広くすることができる)。ポリエチレングリコールなどの適切なゲル材料によって処方される医学的に適切なゲルでは、10ccなどの規定体積のゲルに1グラムのゲンタマイシンを含ませることができる。被感染の海綿骨を圧縮するために、処置対象の部位で適切な形およびサイズになるような体積のバルーン(すなわち、好適には、選択した部位で膨張させても皮質骨を壊すことのないバルーン)を使用することができる。これを用いれば、観血処置、または最小侵襲性の処置によって、抗生物質ゲルで満たすことのできるスペースを作り出せる。これによって、処置を必要とする部位に必要な量の薬剤を入れて保持し、薬剤が血液または他の流体によって素早く押し流されることのないように薬剤を保護することができる。投与量を最適化することができるほか、後に観血療法をすることなく追加量を投与することができ、これによって治療結果が向上する。最適の薬剤投与に必要なキャビティが骨を弱めることになる場合、鋳造物、または既存の金属またはプラスチックの内部または外部固定装置によって、今後起こりうる骨折から骨を保護することができる。骨の中に入れた治療剤は、骨の外部に対しても作用すると考えられる。化学療法剤を含む製剤を使用すれば、その骨の近くにある局所固形骨肉腫または他の腫瘍を処置することができる。
Claims (8)
- 海綿骨圧迫用装置であって:
長軸を有する拡張可能な本体(300)を備え、該拡張可能な本体が、該長軸に対する第1の方向に、該長軸に対する第2の方向により多く該本体の拡張を方向付ける内部膜(320)を含むことを特徴とする、装置。 - 前記内部膜(320)が、前記長軸に沿って伸び、そして前記拡張可能な本体(300)を2つの管腔に分割する、請求項1に記載の装置。
- 前記拡張可能な本体(300)が対向する開口部端部面を含み、そして前記内部膜(320)が該対向する端部面間で前記長軸に沿って伸びる、請求項1または2に記載の装置。
- 前記内部膜(320)が、前記拡張可能な本体(300)の対向する端部面間で前記長軸に沿う1方向、および該拡張可能な本体の対向する内部側面間で前記長軸を横切る方向の第2の方向に伸びる、請求項1または2に記載の装置。
- 前記内部膜(320)が、前記長軸に対する1つの半径方向に、該長軸に対する第2の半径方向におけるよりも大きく前記拡張可能な本体(300)の拡張を方向付ける、請求項1または2に記載の装置。
- 前記拡張可能な本体(300)が、所定長さの管材を備える、請求項1〜5のいずれか1項に記載の装置。
- 前記拡張可能な本体(300)が、押出し成形されたユニットを備える、請求項6に記載の装置。
- 前記拡張可能な本体(300)が、海綿骨中の拡張の間に、骨折した皮質骨を移動し得る力を付与し得る、請求項1〜7のいずれか1項に記載の装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/044,843 US20030032963A1 (en) | 2001-10-24 | 2002-01-11 | Devices and methods using an expandable body with internal restraint for compressing cancellous bone |
PCT/US2002/036320 WO2003059214A2 (en) | 2002-01-11 | 2002-10-23 | Devices and methods using an expandable body with internal restraint for compressing cancellous bone |
Publications (3)
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EP (4) | EP1820463B1 (ja) |
JP (1) | JP4292081B2 (ja) |
KR (1) | KR100959444B1 (ja) |
CN (2) | CN101548906B (ja) |
AT (3) | ATE364361T1 (ja) |
AU (2) | AU2002359386A1 (ja) |
CA (1) | CA2472594C (ja) |
DE (3) | DE60233609D1 (ja) |
ES (2) | ES2288569T3 (ja) |
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2002
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