JP2007021244A - 内部身体領域で空洞を作製するための構造体 - Google Patents
内部身体領域で空洞を作製するための構造体 Download PDFInfo
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- JP2007021244A JP2007021244A JP2006267402A JP2006267402A JP2007021244A JP 2007021244 A JP2007021244 A JP 2007021244A JP 2006267402 A JP2006267402 A JP 2006267402A JP 2006267402 A JP2006267402 A JP 2006267402A JP 2007021244 A JP2007021244 A JP 2007021244A
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Abstract
【解決手段】経皮経路を通る通過によって皮質骨構造の内側に展開するためのサイズの細長いシャフト12、該シャフトの遠位端部分によって保持される空洞形成構造体20であって、海綿質骨容量内に空洞を形成し得る寸法を有するループの少なくとも一部分を規定する湾曲面を形成する空洞形成構造体、および該空洞を生成するために、該遠位端部分の回転と同時に上記少なくとも1つの開口部を通じて該海面質骨容量内の該空洞形成構造体の後退および進行を制御するような形態の、該空洞形成構造体に連結された該近位端部分上の制御装置30を備える、装置。
【選択図】図3
Description
本発明は、使用中にて、診断または治療の目的で、ヒトおよび他の動物の内部身体領域で空洞を形成する構造体および処置に関する。
ある種の診断または治療処置では、内部身体領域に空洞を形成する必要がある。
本発明は、海綿質骨で空洞を作製する新規な用具を提供する。これらの用具は、海綿質骨を切断して空洞を形成する構造体を備える。
(1)海綿質骨で空洞を作製するための用具であって、該用具は、以下の部分を含む:シャフトであって、該シャフトは、骨への挿入に適合されている;およびフィラメントであって、該フィラメントは、該シャフトに備えられ、そして該シャフトの操作に応答して、海綿質骨を切断して空洞を形成する、用具。
(2)前記フィラメントが、ループを形成する、項目(1)に記載の用具。
(3)フィラメントのアレイが、前記シャフトに備えられる、項目(1)に記載の用具。
(4)前記フィラメントのアレイが、ブラシを形成する、項目(3)に記載の用具。
(5)前記シャフトが、軸を有し、そして前記フィラメントが、ほぼ該軸に沿って伸長する、項目(1)に記載の用具。
(6)前記シャフトが、軸を有し、そして前記フィラメントが、ほぼ該軸から放射状に伸長する、項目(1)に記載の用具。
(7)前記シャフトが、可撓性である、項目(1)に記載の用具。
(8)前記フィラメントが、骨内部の構造体を視覚化するのを助ける少なくとも1個のマーカーを備える、項目(1)に記載の用具。
(9)前記マーカーが、放射線不透過性材料から製造される、項目(8)に記載の用具。
(10)前記フィラメントが、弾力性材料を含有する、項目(1)に記載の用具。
(11)前記弾力性材料が、金属である、項目(10)に記載の用具。
(12)前記弾力性材料が、プラスチックである、項目(10)に記載の用具。
(13)前記フィラメントが、形状記憶材料を含有する、項目(1)に記載の用具。
(14)前記シャフトが、骨の内側で回転されるように適合されている、項目(1)に記載の用具。
(15)さらに、前記シャフトを超える前記フィラメントの伸長を調整する要素を含む、項目(1)に記載の用具。
(16)海綿質骨で空洞を作製するための用具であって、該用具は、以下の部分を含む:シャフトであって、該シャフトは、骨への挿入に適合されている;および構造体であって、該構造体は、該シャフトに備えられ、そして該シャフトの回転に応答して、海綿質骨を切断して空洞を形成する用具。
(17)前記構造体が、ループを含む、項目(16)に記載の用具。
(18)前記構造体が、ブラシを含む、項目(16)に記載の用具。
(19)前記構造体が、ブレードを含む、項目(16)に記載の用具。
(20)前記シャフトが、可撓性である、項目(16)に記載の用具。
(21)前記構造体が、骨内部の該構造体を視覚化するのを助ける少なくとも1個のマーカーを備える、項目(16)に記載の用具。
(22)前記マーカーが、放射線不透過性材料から製造される、項目(21)に記載の用具。
(23)海綿質骨で空洞を作製するための用具であって、該用具は、以下の部分を含む:シャフトであって、該シャフトは、骨への挿入に適合されている;および伝達装置であって、該伝達装置は、該シャフトに備えられ、そして海綿質骨を切断して空洞を形成するエネルギー源に連結されるように適合されている用具。
(24)前記伝達装置が、超音波エネルギーを伝達する、項目(23)に記載の用具。
(25)前記伝達装置が、レーザーエネルギーを伝達する、項目(23)に記載の用具。
(26)さらに、前記シャフトに対して前記伝達装置を移動する要素を含む、項目(23)に記載の用具。
(27)前記伝達装置が、骨内部の該伝達装置を視覚化するのを助ける少なくとも1個のマーカーを備える、項目(23)に記載の用具。
(28)前記マーカーが、放射線不透過性材料から製造される、項目(27)に記載の用具。
(29)骨を処置するためのシステムであって、該システムは、以下の部分を含む:カニューレであって、該カニューレは、骨の内側に至る皮下経路を確立する;シャフトであって、該シャフトは、該カニューレを通って骨の内側で展開されるように適合されている;および構造体であって、該構造体は、該シャフトに備えられ、そして該カニューレ内の該シャフトの操作に応答して、海綿質骨を切断して空洞を形成する、システム。
(30)前記構造体が、フィラメントを含む、項目(29)に記載のシステム。
(31)前記構造体が、ブレードを含む、項目(29)に記載のシステム。
(32)前記構造体が、海綿質骨を切断するエネルギーの伝達装置を含む、項目(29)に記載のシステム。
(33)骨を処置するためのシステムであって、該システムは、以下の部分を含む:シャフトおよびフィラメントを含む装置であって、該シャフトは、骨の内側で展開されるように適合されており、そして該フィラメントは、該シャフトの操作に応答して、海綿質骨を切断するために、該シャフトに備えられる;および
以下の工程を包含する方法に従って該装置を使用するための説明書:該フィラメントを骨の内側で展開する工程;および該シャフトを操作して、該フィラメントに海綿質骨を切断させて空洞を形成する工程。
(34)使用方法が、前記空洞に材料を充填する工程を包含する、項目(33)に記載のシステム。
(35)骨を処置するためのシステムであって、該システムは、以下の部分を含む:骨への挿入に適合されているシャフトを含む装置、該シャフトに備えられ、該シャフトの回転に応答して、海綿質骨を切断して空洞を形成する、構造体;ならびに以下の工程を包含する方法に従って該装置を使用するための説明書該構造体を骨の内側で展開する工程;および該シャフトを回転して、該構造体に海綿質骨を切断させて空洞を形成する工程。
(36)使用方法が、前記空洞に材料を充填する工程を包含する、項目(35)に記載のシステム。
(37)骨を処置するためのシステムであって、該システムは、以下の部分を含む:シャフトおよび伝達装置を含む装置であって、該シャフトは、骨への挿入に適合されており、そして該伝達装置は、該シャフトに備えられ、海綿質骨を切断して空洞を形成するエネルギー源に連結されるように適合されている;ならびに以下の工程を包含する方法に従って該装置を使用するための説明書:該伝達装置を骨の内側で展開する工程;および該伝達装置からエネルギーを伝達して、海綿質骨を切断して空洞を形成する工程。
(38)使用方法が、前記空洞に材料を充填する工程を包含する、項目(37)に記載のシステム。
(39)骨を処置するためのシステムであって、該システムは、以下の部分を含む:カニューレであって、該カニューレは、骨の内側に至る皮下経路を確立する;シャフトであって、該シャフトは、該カニューレを通って骨の内側で展開されるように適合されている;構造体であって、該構造体は、該シャフトに備えられ、そして該カニューレ内の該シャフトの操作に応答して、海綿質骨を切断して空洞を形成する;および以下の工程を包含する方法に従った使用説明書:該カニューレを皮下で展開して、骨の内側に至る経路を確立する工程;該シャフトを該カニューレを通って導入して、該構造体を骨の内側で展開する工程;および該シャフトを該カニューレ内で操作して、該構造体に海綿質骨を切断させて空洞を形成する工程。
(40)使用方法が、前記空洞に材料を充填する工程を包含する、項目(39)に記載のシステム。
(1)経皮経路を通る通過によって皮質骨構造の内側に展開するためのサイズの細長いシャフトであって、近位端部分と遠位端部分を有し、該遠位端部分が、該皮質骨構造内側の海綿質骨容量内に配置するためのサイズであり、該近位端部分の操作に応答して、該近位端部分から該遠位端部分まで軸方向および回転方向力を伝達し得る材料を含むシャフト、
該シャフトの遠位端部分によって保持される空洞形成構造体であって、該シャフト内で本質的に完全に引かれた後退位置と、該シャフトの遠位端部分の外側に突出する進行位置との間の該シャフト中の少なくとも1つの開口部を通って後退および進行するためのサイズであり、進行位置にあるとき、充填剤の容量を受容するために海綿質骨容量内に空洞を形成し得る寸法を有するループの少なくとも一部分を規定する湾曲面を形成する空洞形成構造体、および
該空洞を生成するために、該遠位端部分の回転と同時に上記少なくとも1つの開口部を通じて該海面質骨容量内の該空洞形成構造体の後退および進行を制御するような形態の、該空洞形成構造体に連結された該近位端部分上の制御装置を備える、装置。
(2)充填剤の容量を前記空洞中に運搬する用具をさらに含む、項目(1)に記載の装置。
(3)前記湾曲面が、前記皮質骨構造の内側で前記空洞形成構造体を支援して可視化する少なくとも1つのマーカーを保持する、項目(1)に記載の装置。
(4)前記シャフトが軸を含み、そしてここで、前記空洞形成構造体が進行位置にあるとき、前記ループが該シャフトの軸を横切る軸に沿って前記少なくとも1つの開口部から突出する、項目(1)に記載の装置。
(5)前記シャフトが可撓性である、項目(1)に記載の装置。
(6)前記湾曲面が、本質的に丸い断面を含む、項目(1)に記載の装置。
(7)前記湾曲面が、本質的に直線で囲まれる断面を含む、項目(1)に記載の装置。
(8)前記制御装置の動きが、前記少なくとも1つの開口部を通って前記空洞形成構造体を漸次後退または進行し、前記ループの寸法を変える、項目(1)に記載の装置。
(9)前記充填剤が、骨セメントを含む、項目(1)に記載の装置。
(10)前記用具が、充填剤を前記空洞中に運搬するために、前記シャフト中に通路を備える、項目(2)に記載の装置。
(11)前記シャフトが軸を含み、そして
ここで、前記空洞形成構造体が進行位置にあるとき、前記面が、前記遠位端部分の該シャフトの軸の周りの回転に応答して海綿質骨をせん断する、項目(1)に記載の装置。
(12)前記経皮経路を確立するカニューレをさらに含み、そして
ここで、前記シャフトが該カニューレを通過し、そして該カニューレ内で回転するためのサイズである、項目(1)に記載の装置。
(13)前記カニューレを通って前記空洞中に充填剤の容量を運搬するためのツールをさらに含む、項目(1)に記載の装置。
(14)前記シャフトが、流動可能な材料を運搬するための通路を備える、項目(1)に記載の装置。
本発明を使用するシステムおよび方法は、事実上、任意の内部身体領域(この場所では、治療目的または診断目的のために、組織内で空洞を形成する必要がある)での使用に適合できる。その好ましい実施態様は、骨を治療するのに使用するシステムおよび方法に関連して、本発明を示す。この理由は、本発明を具体化するシステムおよび方法が、この環境での使用に適しているからである。本発明の特徴を具体化するシステムおよび方法は、同様に、他の内部身体領域で使用できることを理解すべきである。
I.回転可能空洞形成構造体
A.回転可能ループ構造体
図1は、標的治療領域で空洞を形成できる回転可能用具10を示す。用具10は、カテーテルチューブ12を含み、これは、近位末端および遠位末端(それぞれ、14および16)を有する。好ましいカテーテルチューブ12は、チューブ12を握って操縦するのを助けるハンドル18を含む。ハンドル18は、発泡材料から製造でき、これは、カテーテルチューブ12の周りに固定されている。
図5は、標的治療領域で空洞を形成できる回転可能用具38の代替実施態様を示す。用具38は、駆動シャフト40を含み、これは、良好なねじり伝達性能を与えるために、堅い材料(ステンレス鋼、ニッケル−チタン合金(Nitinol(登録商標)材料)および他の金属合金)から製造されている。
剛毛46のアレイは、好ましくは、先に記述したように、1個またはそれ以上の放射線不透過性マーカー62を含む。マーカー62により、使用中に、標的治療領域内に存在する間、ブラシ構造体44を放射線学的に視覚化できるようになる。制御装置60はまた、刻印64を含むことができ、それによって、医師は、この剛毛の伸長距離を視覚的に概算できる。駆動シャフト40の遠位末端42もまた、1個またはそれ以上のマーカー62を備えることができる。
図12は、標的治療領域で空洞を形成できる回転可能用具106の代替実施態様を示す。用具106は、用具38と同様に、一般に堅い駆動シャフト108を含み、これは、良好な捻れ伝達性能を与えるために、例えば、ステンレス鋼、ニッケル−チタン合金(Nitinol(登録商標)材料)および他の金属合金から製造されている。
図16で示すように、用具10、38、106または138のいずれかは、内部管腔128を含むことができる。管腔128は、Y形弁132を介して、外部流体源130および外部真空源134に連結されている。
II.直線運動空洞形成構造体
A.切断ブレード
図17〜21は、標的治療領域で空洞を形成できる直線運動用具66を示す。用具10のように、用具66は、チューブ68の握りおよび操縦をし易くするためにその近位末端72にハンドル70(図20を参照)を有するカテーテルチューブ68を含む。
図22は、標的治療領域で空洞を形成できる直線運動用具90の代替実施態様を示す。用具90は、物理的には、たった今記述した直線運動用具66と同じ様式で構成されており、そこで、共通の参照番号が割り当てられる。
III.空洞形成用具の使用
ヒト椎骨150での展開に関連して、今ここで、種々の用具10(図1〜4)、38(図5〜8)、138(図9〜11)、106(図12〜15)、66(図17〜21)および90(図22)の使用を記述する。
例えば、ループ用具10を使用するとき、ループ構造体20は、伸長するなら、ガイドシース34を通って通過している間、(図4で示すように)ガイドシース34により崩壊されるか、または、そうでなければ、(図2で示すように)カテーテルチューブ12内で後退される。
例えば、ブラシ用具38を使用するとき、医師は、好ましくは、図6で示した様式で、ガイドシース34を通って剛毛46を通過させている間にて、それらを引き出す。
例えば、直線運動用具66または90の一方を使用するとき、医師は、好ましくは、カテーテルチューブ68の遠位末端76がガイドシース34から離れるまで、図20で示す様式で、ブレード78または伝達装置92をカテーテルチューブ68へと引き入れる。
一旦、所望の空洞Cが形成されると、選択した用具10、38、66、90、106または138は、ガイドシース34を通って引き出される。図29で示すように、今ここで、ガイドシース34を通って、形成した空洞Cへと、他の用具104が展開できる。第二用具104は、例えば、診断処置を実行できる。あるいは、第二用具104は、例えば、空洞Cに材料106(例えば、骨セメント、同種異系移植片材料、合成骨代替物、薬剤、または硬化状態に固化する流動可能材料)を分配することにより、治療処置を実行できる。治療目的のためにこのような材料106を空洞Cに注入することのそれ以上の詳細は、米国特許第4,969,888号および第5,108,404号、および同時係属中米国特許出願第08/485,394号(これらの内容は、本明細書中で参考として援用されている)で見られる。
空洞Cのサイズは、実行する治療処置または診断処置に従って、変わる。
IV.1回使用無菌キット
用具10、38、66、90、106または138の任意の1つを1回使用すると、それを取り囲んでいる皮質骨および海綿質骨と接触する。この接触より、これらの用具が損傷し得、局在化した弱体領域が生じ、これは、検出にかからない場合がある。局在化した弱体領域が存在すると、引き続いた使用中にて、全体的な構造上の破損を引き起こし得、これは、予想できない。
20 空洞形成構造体
22 フィラメント
24 スロット
30 制御装置
40 駆動シャフト
66 直線運動用具
Claims (1)
- 経皮経路を通る通過によって皮質骨構造の内側に展開するためのサイズの細長いシャフトであって、近位端部分と遠位端部分を有し、該遠位端部分が、該皮質骨構造内側の海綿質骨容量内に配置するためのサイズであり、該近位端部分の操作に応答して、該近位端部分から該遠位端部分まで軸方向および回転方向力を伝達し得る材料を含むシャフト、
該シャフトの遠位端部分によって保持される空洞形成構造体であって、該シャフト内で本質的に完全に引かれた後退位置と、該シャフトの遠位端部分の外側に突出する進行位置との間の該シャフト中の少なくとも1つの開口部を通って後退および進行するためのサイズであり、進行位置にあるとき、充填剤の容量を受容するために海綿質骨容量内に空洞を形成し得る寸法を有するループの少なくとも一部分を規定する湾曲面を形成する空洞形成構造体、および
該空洞を生成するために、該遠位端部分の回転と同時に上記少なくとも1つの開口部を通じて該海面質骨容量内の該空洞形成構造体の後退および進行を制御するような形態の、該空洞形成構造体に連結された該近位端部分上の制御装置を備える、装置。
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1999
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- 1999-04-06 WO PCT/US1999/007652 patent/WO1999051149A1/en active IP Right Grant
- 1999-04-06 CA CA002327702A patent/CA2327702C/en not_active Expired - Fee Related
- 1999-04-06 AU AU34788/99A patent/AU764518B2/en not_active Ceased
- 1999-04-06 EP EP99916476A patent/EP1073371B2/en not_active Expired - Lifetime
- 1999-04-06 DE DE69932610T patent/DE69932610T3/de not_active Expired - Lifetime
- 1999-04-06 AT AT99916476T patent/ATE334625T1/de active
- 1999-04-06 JP JP2000541925A patent/JP4250743B2/ja not_active Expired - Fee Related
- 1999-04-06 PL PL99343370A patent/PL343370A1/xx not_active Application Discontinuation
- 1999-04-06 IL IL13889199A patent/IL138891A0/xx active IP Right Grant
- 1999-04-06 NZ NZ507330A patent/NZ507330A/en unknown
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2000
- 2000-10-05 NO NO20005019A patent/NO20005019L/no not_active Application Discontinuation
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2002
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2004
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2006
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2007
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2008
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2010527705A (ja) * | 2007-05-21 | 2010-08-19 | エーオーアイ メディカル インコーポレイテッド | 折れ曲がり式の空洞形成デバイス |
JP2012523901A (ja) * | 2009-04-17 | 2012-10-11 | スパイン ビュー, インコーポレイテッド | 弓状ルーフカッターのための装置および方法 |
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