JP6116066B2 - 標的組織の迅速切除のための安全な切削ヘッドおよび切削システム - Google Patents
標的組織の迅速切除のための安全な切削ヘッドおよび切削システム 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
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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
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Description
本願は、2011年12月3日付出願の米国特許仮出願第61/566629号、および2012年2月9日付出願の米国特許仮出願第61/596865号の利益を主張するものであり、各出願を参照によりその全文を本明細書に組み入れる。
本明細書に提示する教示は、一般的には、外科手術中に対象から標的組織を除去するための、安全で効率的な切削ヘッドを対象とする。標的組織としては、小さな外科用開口からアクセスすることのできる任意の組織、例えば、半月板などの関節組織、または髄核などの椎間組織をあげることができる。いくつかの態様において、本明細書において教示される装置は、整形外科組織除去装置と呼ぶことができる。いくつかの態様において、本明細書において教示される、この装置は、X−LIF(lateral approach to an intervertebral fusions:椎間固定に対する側方アプローチ)処置、T−LIF(transforaminal approach to intervertebral fusions:椎間固定に対する経椎間孔アプローチ)処置、P−LIF(posterior approach to intervertebral fusions:椎間固定に対する後方アプローチ)処置、または経皮的、経椎間孔アプローチ(Kambinの三角形アプローチ(Kambin triangle access))において有用である。
様々な切削ヘッドが、3つの死体実験室で28の椎間板について試験された。結果は、最も効率的なカッターヘッド設計を判定するために比較された。望ましいカッターヘッド設計は、髄核、椎骨終板(vertebral endplates)、および内部輪部(inner annulus)組織を含む、すべての標的組織上で切れ味がよいものである。しかしながら、カッターヘッドはまた、周囲組織にほとんど、またはまったく損傷を与えないで、所望の方法で標的組織を切削しなくてはならず、そのような組織としては、望ましい周囲構造として保存しなくてはらない、周囲線維輪が含まれる。さらに、この設計は、ヘッドの構成が、吸引下での組織の除去を容易化するように、吸引力の下で迅速に組織を除去しなくてはならない。
この実施例は、切削ヘッドの設計をさらに発展させた。図8Gおよび8Hの設計が、7つの死体実験室において28の椎間板についてさらに調査された。
1. 高さおよび幅で5〜8mmのパイロット穴を切開する;
2. 15°先端を椎骨終板に平行に向けて、中間および横方向に空洞を切開して拡大する;
3. 終板を硬質組織(軟骨または骨)まで徐々にシェービング(shaving)で落し;蛍光透視法を使用して、遠端の深さを検証し;先端を使用して終板の曲率に沿ってシェービングし;骨が露出されたとき(硬質で、粗く、粘着性で、かつ赤色の吸引物を終点と識別)、シェービングは停止され;装置のハンドルを、(i)中間方向に傾けて横側を剥皮するとともに、(ii)横方向に傾けて中間側を剥皮し;
4. 切削ヘッドを輪前部(anterior annulus)に対して中間方向‐横方向を掃引して、必要に応じて輪体および内部輪体に付着した核を除去し;
5. 40°先端を対側に向けて、ハンドルを横方向に傾けてバルク核を除去しながら、輪後部(posterior annulus)からシェービングを開始し;
6. 終板に向かってハンドルを回転させて、さらに剥皮する。
この実施例は、剛性吸引管488が、少なくとも2つの角度;角度θ1および角度θ3を有することのできる、蛇行型(serpentine)構成またはバヨネット型構成と呼ばれる、試験された代替態様について示す。
Claims (30)
- 対象の標的組織を除去するための管状切削ヘッドであって、該切削ヘッドが、
遠位端を有する外周を有する、管であって、該外周は該切削ヘッドを通過させる内腔を取り囲み、該内腔は中心軸を有し、および少なくとも実質的に剛性な管と動作可能に連絡している、前記管、および
該外周の遠位端にある切削面であって、該切削面の遠位に突き出しているブレードガードを含む、前記切削面
を有し、
ここで、該ブレードガードは、
第1の側方を向いた切削面、および
該第1の側方を向いた切削面に対峙する、第2の側方を向いた切削面
を含み、
該切削ヘッドがブレードガード上に、該切削ヘッドの後方ストロークにおいて標的組織を切削するための、後方切削ブレードを有し、該ブレードガード上のブレード先端が、90°よりも大きい角度で後向きに内腔中を指している、二重刃のブレード先端を有する、
前記切削ヘッド。 - ブレードガードが鈎爪の形態である、請求項1に記載の切削ヘッド。
- ブレードガードが二重刃のブレード先端を有する、請求項1に記載の切削ヘッド。
- 外科的組織除去システムであって、
請求項1〜3のいずれか一項に記載の切削ヘッドを含み、
ここで、該切削ヘッドは、内腔と吸引源との間の動作可能な連絡をするように構成されており、
前記切削ヘッドと動作可能に連絡している、吸引アセンブリであって、該吸引アセンブリは、中心軸を有する少なくとも実質的に剛性な吸引管を含み、該内腔を通して標的組織を対象の外へと除去するための吸引流を生成する、前記吸引アセンブリ
を含む前記システム。 - 少なくとも実質的に剛性な吸引管が、切削ヘッドとの単一のユニットとして形成されている、請求項4に記載のシステム。
- 内腔の中心軸が、剛性な吸引管の中心軸から、約5°〜約90°の範囲の角度θ1にあり、および前方切削ブレードが、前記角度θ1の頂点から約3mm〜約25mmに位置している、請求項4に記載のシステム。
- 切削ヘッドと吸引アセンブリとの間の動作可能な連絡が関節接合であり、および角度θ1が調節可能である、請求項6に記載のシステム。
- 切削ヘッドと吸引アセンブリとの間の動作可能な連絡が剛性であり、および角度θ1が固定されている、請求項6に記載のシステム。
- 内腔の中心軸が前方切削ブレードの位置である出口点を有し、該出口点は、剛性な吸入管の中心軸と直交する方向に、約3mm〜約25mmの横方向距離に位置している、請求項6に記載のシステム。
- 内腔の中心軸が、剛性な吸引管の中心軸から、1°〜180°の範囲の角度θ1にあり、および前方切削ブレードが、前記角度θ1の頂点から3mm〜25mmに位置し、ここで
追加の角度θ3が、θ1に5mm〜25mm近接して位置しており;
角度θ1およびθ3が、
(i)切削ヘッドの内腔の中心軸と、θ3に近接して位置する前記剛性な吸入管の中心軸との間の正味角度θ4が、0°〜90°の範囲であること;および
(ii)該内腔の中心軸が、該前方切削ブレードにおいて出口点を有し、および該出口点が、該剛性な吸引管の中心軸に直交する、約3mm〜約25mmの横方向距離に位置していること
を限定として、約0°〜約180°の範囲になるように独立して選択される、
請求項4に記載のシステム。 - 標的組織が髄核であり、および周囲組織が線維輪である、請求項4に記載のシステム。
- 対象からの標的組織の除去方法における使用のための、請求項1に記載の切削ヘッドであって、該方法が:
標的組織にアクセスするために、対象に開口を生成すること、
該切削ヘッドを該開口を通して挿入し、該対象における該標的組織にアクセスすること、
該標的組織を含む表面において、該切削ヘッドを、前方方向に押し進めて、該標的組織を除去すること、該前方方向は(i)少なくとも実質的に、該切削ヘッドの内腔の中心軸を包含する面において、(ii)少なくとも実質的に、該標的組織を含む表面において、かつ(iii)ブレードガードによって保護されている周囲組織に向かって、動く、力ベクトルを含む;
該切削ヘッドの内腔内の該標的組織を捕捉すること、および
該標的組織を内腔を通して該対象の外に除去すること
を含む、前記切削ヘッド。 - 請求項12に記載の切削ヘッドであって、
方法が、標的組織を含む表面において、切削ヘッドを、後方方向に押し進めて、該標的組織を除去することをさらに含み、該後方方向が(i)少なくとも実質的に、該切削ヘッドの内腔の中心軸を包含する面において、(ii)少なくとも実質的に、該標的組織を含む表面において、かつ(iii)ブレードガードによって保護されている周囲組織から離れて、動く、力ベクトルを含む、前記切削ヘッド。 - 請求項12に記載の切削ヘッドであって、
方法がさらに、標的組織を含む表面において、該切削ヘッドを、横断方向に押し進めて、該標的組織を除去することを含み、該横断方向が(i)該切削ヘッドの内腔の中心軸を包含する面から約15°〜約150°の範囲の角度で、(ii)少なくとも実質的に、該標的組織を含む表面において、かつ(iii)ブレードガードで保護されている周囲組織に接触して、動く、力ベクトルを含む、前記切削ヘッド。 - 標的組織が髄核であり、および周囲組織が線維輪である、請求項12に記載の切削ヘッド。
- 外科的組織除去キットであって、
管状切削ヘッドであって、
遠位端を有する外周を有する、管であって、該外周は該切削ヘッドを通過する内腔を取り囲み、該内腔は中心軸を有し、少なくとも実質的に剛性な管と動作可能に連絡している、前記管、
該外周の遠位端にある切削面であって、切削面の遠位に突き出しているブレードガードを含む、前記切削面
を含み、ここで、該ブレードガードが、
第1の側方を向いた切削面、および
該第1の側方を向いた切削面に対峙する、第2の側方を向いた切削面
を含み、
ここで、該切削ヘッドが内腔と吸引源との間で動作可能な連絡をするように構成されている、前記管状切削ヘッド;
前記切削ヘッドと動作可能に連絡している、吸引アセンブリであって、該吸引アセンブリは、中心軸を有する少なくとも実質的に剛性な吸引管を含み、内腔を通して標的組織を対象の外へと除去するための吸引流を生成する、前記吸引アセンブリ;
および、
前記外科的組織除去システムを出し入れする間に対象を保護する、閉塞式ガードカニューレであって、該ガードカニューラは、
内周、外周、および該内周と該外周との間を連絡する洗浄ポートを有する、エントリーハブ、および
近位端、遠位端および内腔を有する、直線状の細長い分割管
を含み、
ここで該分割管の近位端は、
該ハブの内周の少なくとも一部分を取り囲み、および、
該洗浄ポートと動作可能に連絡して、該洗浄ポートからの洗浄液体を受け入れる動作が可能であり、洗浄流体の移送は、該分割管の内腔表面における該洗浄ポートから該分割管の遠位端への洗浄流体の移動を含み、
該分割管の遠位端は、該遠位端が入口組織と接触するときに、該入口組織への損傷を避けるために、少なくとも実質的に鈍くされており、
該分割管は、約10cm〜約60cmの範囲の長さおよび約5mm〜約16mmの範囲の幅を有し、および
該分割管における割れ目は、約4mm〜約14mmの範囲の幅を有する間隙を構成し、該割れ目は外科的装置における非線形性を吸収する、
前記閉塞式ガードカニューレ
を含み、
該切削ヘッドが、該ブレードガード先端に、該切削ヘッドの後方ストロークにおいて標的組織を切削するための後方切削ブレードを有することを特徴とする、または
該1つまたは2つ以上のブレードガードが、該内腔の横方向断面の幅の半分以下の幅を有することを特徴とする、
前記キット。 - 少なくとも実質的に剛性な吸引管が、切削ヘッドとの単一のユニットとして形成されている、請求項16に記載のキット。
- 内腔の中心軸が、剛性な吸引管の中心軸から、約5°〜約90°の範囲の角度θ1にあり、および前方切削ブレードが、前記角度θ1の頂点から約3mm〜約25mmに位置している、請求項16に記載のキット。
- 内腔の中心軸が前方切削ブレードにおいて出口点を有し、および該出口点が、剛性な吸入管の中心軸と直交する、約3mm〜約25mmの横方向距離に位置している、請求項16に記載のキット。
- 切削ヘッドと吸引アセンブリとの間の動作可能な連絡が関節接合であり、および角度θ1が調節可能である、請求項18に記載のキット。
- 切削ヘッドと吸引アセンブリとの間の動作可能な連絡が剛性であり、および角度θ1が固定されている、請求項18に記載のキット。
- 内腔の中心軸が、剛性な吸引管の中心軸から、1°〜180°の範囲の角度θ1にあり、および前方切削ブレードが、前記角度θ1の頂点から3mm〜25mmに位置し、ここで
追加の角度θ3が、θ1に5mm〜25mm近接して位置しており;
角度θ1およびθ3が、
(i)切削ヘッドの内腔の中心軸と、θ3に近接して位置する前記剛性な吸入管の中心軸との間の正味角度θ4が、0°〜90°の範囲であること;および
(ii)前記内腔の中心軸が、前方切削ブレードにおいて出口点を有し、および該出口点が、該剛性な吸引管の中心軸に直交する、約3mm〜約25mmの横方向距離に位置していること
を限定として、約0°〜約180°の範囲になるように独立して選択される、
請求項16に記載のキット。 - 切削ヘッドがブレードガード上に、該切削ヘッドの後方ストロークにおいて標的組織を切削するための、後方切削ブレードを有し、該ブレードガードが二重刃のブレード先端を有する、請求項16に記載のキット。
- 請求項16に記載のキットであって、
標的組織が髄核であり、
周囲組織が線維輪であり、および
入口組織が、髄核につながる、対象の上皮組織、筋肉組織、神経組織、結合組織、血管、骨、軟骨、またはそれらの組合せを含む、
前記キット。 - 対象からの標的組織の除去方法において用いるための、請求項1に記載の切削ヘッドであって、該方法が、
標的組織にアクセスするために対象に開口を生成すること、
切削ヘッドを、ガードカニューラのエントリーハブおよび細長い分割管を通して挿入すること、
切削ヘッドを、該開口を通して挿入して、対象における標的組織に、該分割管の鈍い遠位端で入口組織を保護しながら、アクセスすること、
標的組織を含む表面において、該切削ヘッドを、前方方向に押し進めて、該標的組織を除去すること、該前方方向は(i)少なくとも実質的に、該切削ヘッドの内腔の中心軸を包含する面において、(ii)少なくとも実質的に、前記標的組織を含む表面において、かつ(iii)ブレードガードによって保護されている周囲組織に向かって、動く、力ベクトルを含む、
該切削ヘッドの内腔内の該標的組織を捕捉すること、および
該標的組織を内腔を通して該対象の外に除去すること
を含む、前記切削ヘッド。 - 請求項25に記載の切削ヘッドであって、方法がさらに、標的組織を含む表面において、該切削ヘッドを後方方向に押し進めて、該標的組織を除去することを含み、該後方方向は(i)少なくとも実質的に、該切削ヘッドの内腔の中心軸を包含する面において、(ii)少なくとも実質的に、該標的組織を含む表面において、かつ(iii)ブレードガードによって保護されている周囲組織から離れるように、動く、力ベクトルを含む、前記切削ヘッド。
- 請求項25に記載の切削ヘッドであって、方法がさらに、標的組織を含む表面において、該切削ヘッドを横断方向に推し進めて、該標的組織を除去することを含み、該横断方向は(i)該切削ヘッドの内腔の中心軸を包含する面から約15°〜約165°の範囲の角度で、(ii)少なくとも実質的に、標的組織を含む表面において、かつ(iii)ブレードガードによって保護されている周囲組織と接触して、動く、力ベクトルを含む、前記切削ヘッド。
- 請求項25に記載の切削ヘッドであって、
標的組織が髄核であり、
周囲組織が線維輪であり、および
入口組織が、髄核につながる、対象の上皮組織、筋肉組織、神経組織、結合組織、血管、骨、軟骨、またはそれらの組合せを含む、
前記切削ヘッド。 - 請求項1〜3のいずれか一項に記載の切削ヘッドであって、ブレードガードが、内腔の横方向断面の幅の半分以下の幅を有することを特徴とする、前記切削ヘッド。
- 請求項4〜11のいずれか一項に記載のシステムであって、ブレードガードが、内腔の横方向断面の幅の半分以下の幅を有することを特徴とする、前記システム。
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EP2785264B1 (en) | 2015-12-09 |
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US20130144292A1 (en) | 2013-06-06 |
KR20140109924A (ko) | 2014-09-16 |
US20130144320A1 (en) | 2013-06-06 |
JP2015083137A (ja) | 2015-04-30 |
US10448967B2 (en) | 2019-10-22 |
US9220528B2 (en) | 2015-12-29 |
HK1197964A2 (en) | 2015-02-27 |
CN103327913A (zh) | 2013-09-25 |
HK1188105A1 (en) | 2014-04-25 |
JP5723035B2 (ja) | 2015-05-27 |
US20160066946A1 (en) | 2016-03-10 |
US8663227B2 (en) | 2014-03-04 |
EP2785264A4 (en) | 2014-11-12 |
CN103327913B (zh) | 2015-09-09 |
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