JP6461971B2 - 飛散パルスを用いた組織切除および処置 - Google Patents
飛散パルスを用いた組織切除および処置 Download PDFInfo
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- JP6461971B2 JP6461971B2 JP2016540442A JP2016540442A JP6461971B2 JP 6461971 B2 JP6461971 B2 JP 6461971B2 JP 2016540442 A JP2016540442 A JP 2016540442A JP 2016540442 A JP2016540442 A JP 2016540442A JP 6461971 B2 JP6461971 B2 JP 6461971B2
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Description
本PCT出願は、2014年6月30日に出願された「AUTOMATED IMAGE−GUIDED TISSUE RESECTION AND TREATMENT」と題する米国仮特許出願番号第62/019,305号[代理人書類番号41502−708.103];2014年3月31日に出願された「AUTOMATED IMAGE−GUIDED TISSUE RESECTION AND TREATMENT」と題する米国仮特許出願番号第61/972,730号[代理人書類番号41502−708.102];2013年9月6日に出願された「AUTOMATED IMAGE−GUIDED TISSUE RESECTION AND TREATMENT」と題する米国仮特許出願番号第61/874,849号[代理人書類番号41502−708.101]に基づく優先権を主張しており、これらの全体の開示は本明細書中に参考として援用される。
本発明の分野は、エネルギーを用いた組織の処置に関し、より具体的には、流体流れのエネルギーを用いた前立腺等の器官の処置に関する。
本発明の実施形態は、尿道内にエネルギーの供給源を位置付けることによって、前立腺組織切除等の組織切除を行うための改良された方法および装置を提供する。
のある側面はまた、脳、心臓、肺、腸、眼、皮膚、腎臓、肝臓、膵臓、胃、子宮、卵巣、
精巣、膀胱、耳、鼻、口等の他の器官、骨髄、脂肪組織、筋肉、腺および粘膜組織、脊髄
および神経組織、軟骨等の軟組織、歯、骨等の硬質静物組織、ならびに洞、尿管、結腸、
食道、肺の通路、血管、および喉等の身体管腔ならびに通路を処置および修正するために
使用されてもよい。本明細書で開示されるデバイスは、既存の身体管腔を通して挿入され
るか、または身体組織に作成される開口部を通して挿入されてもよい。
本願明細書は、例えば、以下の項目も提供する。
(項目1)
組織を切除する方法であって、
複数の飛散する雲を生成するように、前記組織に向かって流体流れを方向付けるステッ
プと、
前記複数の飛散する雲が異なる重複する場所に到達するように、前記流体流れをスキャ
ンするステップと、
を含む、方法。
(項目2)
前記複数の飛散する雲のそれぞれは、前記組織の一部を除去する、項目1に記載の方法。
(項目3)
前記飛散する雲は、ユーザに見えるキャビテーションを含む、項目1に記載の方法。
(項目4)
前記流体流れは、前記飛散する雲を生成するように第2の液体の中へ放出される第1の
液体を含む、項目1に記載の方法。
(項目5)
前記第1の液体は、生理食塩水を含み、前記第2の液体は、生理食塩水を含む、項目4に記載の方法。
(項目6)
前記流体流れは、ハンドヘルドプローブまたは連鎖部に連結されるプローブのうちの1
つ以上を用いてスキャンされる、項目1に記載の方法。
(項目7)
組織を切除する装置であって、
加圧流体の供給源と、
流体流れを放出するように前記加圧流体の供給源に連結されるノズルであって、その流
体流れは、複数の飛散する雲を生成し、前記複数の飛散する雲のそれぞれは、前記組織の
一部分を除去する、ノズルと、
を備える、装置。
(項目8)
部分的に重複する飛散する雲を用いて前記組織の各部分を切除するように前記ノズルに
連結される、スキャナをさらに備える、項目7に記載の装置。
(項目9)
前記流体流れは、液体を含み、前記装置はさらに、第2の液体で前記組織を洗浄するよ
うに洗浄開口部を備える、項目7に記載の装置。
(項目10)
前記第1の液体は、生理食塩水を含み、前記第2の液体は、生理食塩水を含む、項目7に記載の装置。
(項目11)
前記ノズルは、約0.02〜約0.03の範囲内のストローハル数を含む、項目7に記載の装置。
(項目12)
流体の供給源は、飛散するパルスの周波数より小さい周波数を有する、ポンプを含む、
項目7に記載の装置。
(項目13)
前記飛散するパルスは、約1kHz〜約10kHzの範囲内の周波数を含む、項目7に記載の装置。
(項目14)
患者の組織を処置する装置であって、
近位端および遠位端を有する、剛性シースと、
切除エネルギーの供給源と、前記切除エネルギーの供給源より遠位の少なくとも1つの
開口部とを備える、プローブであって、前記プローブは、前記シースの前記遠位端を越え
て前記少なくとも1つの開口部および前記切除エネルギーの供給源が前進し得るように、
前記シース内で嵌合するようなサイズにされ、吸引チャネルが、前記少なくとも1つの開
口部を通して手術部位から流体を除去するように、吸上源に連結される前記少なくとも1
つの開口部から近位に延在する、プローブと、
を備える、装置。
(項目15)
所定の速度で前記少なくとも1つの開口部を通して物質を除去するように、前記少なく
とも1つの開口部に連結されるポンプをさらに備える、項目14に記載の装置。
(項目16)
ポンプと、前記吸引チャネルおよび前記ポンプに連結される圧力センサとをさらに備え
、前記ポンプは、前記チャネル内で一定の圧力を維持するために、前記圧力センサに応答
して可変速度で物質を除去する、項目15に記載の装置。
(項目17)
前記速度は、前記切除エネルギーの供給源のノズルを通る流体の流量より大きい量を含
む、項目15に記載の装置。
(項目18)
前記手術部位の洗浄を提供するように、洗浄流体の供給源に連結される開口部をさらに
備える、項目14に記載の装置。
(項目19)
前記洗浄流体の供給源に連結される前記開口部および内視鏡視認窓は、前記内視鏡視認
窓および組織処置部位から離れて前記少なくとも1つの開口部に向かって、切除された物
質を押勢して、切除された物質を除去し、組織が切除されるときに前記手術部位の可視性
を前記内視鏡に提供するように、前記切除エネルギーの供給源より近位に位置する、項目18に記載の装置。
(項目20)
前記患者の中に配置されたときに、前記剛性シースを支持するように前記シースに連結
される、係止可能なアームをさらに備える、項目14に記載の装置。
(項目21)
前記プローブの少なくとも1つの開口部は、前記シースを通して前進させられることが
可能であり、前記アームが前記患者の尿道に挿入されたプローブとの係止構成を含むときに回転および並進される、項目20に記載の装置。
(項目22)
ディスプレイに連結されるプロセッサをさらに備え、前記プロセッサは、前記ディスプ
レイ上に基準場所を表示する命令を備え、前記プローブおよび前記アームは、前記プロー
ブが前記プローブの遠位端上にアンカを伴わずに前記患者の中に配置されたとき、前記デ
ィスプレイ上に示される前記基準場所への前記患者の処置を参照するように、連鎖部に連
結される、項目20に記載の装置。
(項目23)
前記プローブが前記患者に挿入されるとき、前記シースを前記アームと係合させ、そし
て前記シースを前記アームに係止するように、前記シースの近位端上に位置する支持構造
の突起に連結する、前記アームの遠位端上のドッキング機構をさらに備える、項目20に記載の装置。
(項目24)
トラス(TRUS)プローブが軸方向に移動させられるときに組織の移動を阻止するように、前記トラスプローブの少なくとも一部分を覆って配置される、第2の剛性シースをさらに備える、項目14に記載の装置。
(項目25)
前記第2の剛性シースは、前記トラスプローブの遠位端と前記剛性シースの遠位端との
間の糞便物質の堆積を阻止ための閉鎖端を備える、項目24に記載の装置。
(項目26)
前記トラスプローブが遠位に前進させられるとき、内部チャンバから超音波カップリン
グ流体を受容するように、そして前記トラスプローブが近位に引かれるとき、流体を前記
内部チャンバに提供するように、前記第2の剛性シースおよび前記トラスプローブの前記
遠位端で画定される前記内部チャンバに連結される、コンテナをさらに備える、項目25に記載の装置。
(項目27)
前記剛性シースの内径は、カップリング流体が内面と外面との間の空間に沿って通過す
ることを阻止するように、前記トラスプローブの外径に近似する、項目25に記載の装置。
(項目28)
前記処置部位の超音波画像を提供するために、前記切除エネルギーの供給源の近傍の前
記プローブのキャリア上に位置する超音波アレイをさらに備える、項目14に記載の装置。
(項目29)
前記患者に連結するように構成される音響センサと、前記センサからの音響信号に応答
して、組織貫通の深さ、除去される組織の容量、ジェットの流速、組織壁の穿孔、または
組織密度の1つ以上を決定する命令を備える、プロセッサとをさらに備える、項目14に記載の装置。
(項目30)
狭いプロフィール構成において前記シースの内側管腔に沿って前記処置部位まで前進さ
せられ、組織を焼灼するように前記処置部位に配置されたときに、広いプロフィール構成
まで拡張するように構成される、1つ以上の電極を備える、電気焼灼プローブをさらに備
える、項目14に記載の装置。
(項目31)
前記プロセッサシステムに連結される複数のフットペダルであって、流体ジェットの貫
通の深さを減少させる第1のフットペダルと、前記患者の処置を一時停止する第2のフッ
トペダルと、流体ジェットの貫通の深さを増加する第3のフットペダルとを備える、複数
のフットペダルをさらに備える、項目14に記載の装置。
(項目32)
水の切除ジェットを発するようにオリフィスの近傍に位置する吸引開口部に延在する、
吸引チャネルをさらに備え、前記ジェットは、前記吸引チャネルを通して切除された物質
を吸引するために、減圧を前記吸引開口部に提供する、項目14に記載の装置。
(項目33)
前記処置プローブは、細長いスロットを画定する細長い支持体を備え、前記細長い支持
体は、前記患者の膀胱頸部まで延在するようなサイズにされ、前記細長いスロットは、キ
ャリアのキーを受容するようなサイズにされ、前記キャリアは、切除エネルギーの供給源
を備え、前記細長いスロットおよび前記支持体は、前記キャリアが連鎖部とともに駆動さ
れるときに前記キャリアとともに回転し、そして前記スロットは、前記連鎖部が前記処置
プローブの細長い軸に沿って近位および遠位に前記キャリアを駆動すると、前記キャリア
の前記キーを受容するようなサイズにされ、前記連鎖部の固定された構成要素から前記支
持体の遠位端までの距離は、前記キーが前記スロットに沿って摺動するとき実質的に固定
されたままである、項目14に記載の装置。
(項目34)
前記プローブは中間キャリアを備え、前記中間キャリアは内視鏡を受容する第1のチャ
ネルと、切除エネルギーの供給源のキャリアを受容するようなサイズにされる第2のチャ
ネルとを備え、前記第1のチャネルは、前記第1のチャネルの周囲で前記第2のチャネル
および前記切除エネルギーの供給源を回転させて、前記内視鏡で前記処置を見るるために
、前記中間キャリアの中心軸に沿って延在する、項目14に記載の装置。
(項目35)
内視鏡を前記シースに連結する細長い摺動支持体をさらに備える、項目14に記載の装置。
(項目36)
組織を切除する装置であって、
ハンドルと、
前記ハンドルに連結されるキャリアであって、流体流れを放出するノズルを備える、キ
ャリアと、
前記キャリアおよび前記ハンドルに連結される、RF電極と、
キャリッジが前記ハンドルに関して移動するときに、前記RF電極および前記キャリア
がともに長手方向に移動するように、前記RF電極および前記キャリアに連結される、キ
ャリッジと、
を備える、装置。
(項目37)
組織を切除する方法であって、
標的組織に向かってRF電極およびノズルをともに前進させるステップであって、前記ノ
ズルは、組織を切除する流れを放出し、前記RF電極は、前記組織を焼灼する、ステップ
を含む、方法。
(項目38)
部分的に重複する飛散する雲で前記組織の各部分を切除するように、前記ノズルに連結
されるスキャナをさらに備える、項目7に記載の装置。
(項目39)
患者を処置する装置であって、
近位端および遠位端を有する管と、
光源に連結される光ファイバと、
前記遠位端上にオリフィスを有するノズルを備える流体送達要素と、
前記光ファイバを前記オリフィスと整列させる整列構造と、
を備え、
前記オリフィスを通したエネルギー伝達および流体流れを可能にするように、前記光フ
ァイバから発せられる光ビームが発散するように、前記整列構造と前記オリフィスとの間
に距離が延在する、装置。
(項目40)
前記オリフィスを通した前記エネルギー伝達は、少なくとも約80%を含み、前記距離
は、約200um〜約2mmの範囲内である、項目39に記載の装置。
(項目41)
前記整列構造は、整列オリフィスを備え、そして前記光ファイバはクラッディングを含
み、前記整列オリフィスの円筒形チャネルより小さい直径を含む、項目39に記載の装置。
(項目42)
前記管は、カテーテルを備える、項目39に記載の装置。
(項目43)
前記カテーテルは、市販の剛性および可撓性の導入器およびスコープとともに使用する
ためなサイズにされる、項目39に記載の装置。
(項目44)
患者を処置する装置であって、
流体流れとともにエネルギーを送達する光ファイバを備える細長い管と、
遠位先端から発せられる光エネルギーおよび流体流れの角度を調節する制御と、
を備える、装置。
(項目45)
操縦する制御が、前記光エネルギーの前記角度を調節するハンドヘルド制御を備え、前
記ハンドヘルド制御は、2自由度に沿って前記光ビームを標的に方向付けるために、ほぼ
第2の角度で前記先端を回転させるために、前記細長い管の細長い軸の周りで回転可能で
ある、項目44に記載の装置。
(項目46)
前記制御は、複数のチャネルを有する内視鏡の制御を備え、前記細長い管は、前記ユー
ザが流体流れを操作するために前記制御を操作することができるように、前記複数のチャ
ネルの1つ以上のチャネルの遠位端まで前記管を前進させるために、前記複数のチャネル
の1つ以上のチャネル内に嵌合するようなサイズにされる断面直径を備える、項目44に記載の装置。
(項目47)
前記細長い管は、前記制御に応答して、前記内視鏡が屈曲するとき、曲がるに十分な可
撓性と、前記複数のチャネルの1つ以上のチャネルの前記遠位端まで、ノズルを備える前
記細長い管の遠位端を前進させるために十分な剛性とを備える、項目46に記載の装置。
(項目48)
前記制御は、前記細長い管の制御を備え、前記制御は、前記細長い管を操縦するために
前記細長い管に接続され、前記細長い管は、前記制御を用いて前記遠位端を偏向させるた
めに、前記制御と前記遠位端との間の前記遠位管の壁に沿って延在する、1つ以上の細長
い要素を備える、項目44に記載の装置。
(項目49)
方法であって、前記項目のいずれか1項に記載の装置を使用することを含む、方法。
本発明の実施形態の原理が利用される、例証的実施形態を記載する以下の詳細な説明、および添付図面を参照することにより、本開示の特徴および利点のより良い理解が得られ得る。
異なる腎臓組織組成の例示的な臨界圧。組織臨界圧が、ブタ腎臓において測定された。その組成が前立腺組織の組成に類似するため、腎臓組織が選択された。直径約200ミクロンの柱状流体流れが、組織切除に使用された。腺組織(腎臓のピンク色の外側部分)は、非常に軟質であり、指圧で容易に断裂する一方で、腎臓の内側は、より強靭な脈管組織を備える。この流体流れを用いた腺組織の臨界圧は、以下の表1で見られるように、約80psiであり、血管組織については約500psiであることが分かった。
Claims (16)
- 患者の組織を切除する装置であって、前記装置は、
加圧流体の供給源と、
流体流れを放出するように前記加圧流体の供給源に連結されるノズルであって、前記ノズルが約0.02〜約0.3の範囲内のストローハル数を含むことにより、前記流体流れが複数の飛散する雲になるようになっており、前記複数の飛散する雲のそれぞれは、前記組織の一部分を除去する、ノズルと
を備える、装置。 - 部分的に重複する飛散する雲を用いて前記組織の各部分を切除するように前記ノズルに連結されるスキャナをさらに備える、請求項1に記載の装置。
- 前記流体流れは、第1の液体を含み、前記装置はさらに、第2の液体で前記組織を洗浄するように洗浄開口部を備える、請求項1に記載の装置。
- 前記第1の液体は、生理食塩水を含み、前記第2の液体は、生理食塩水を含む、請求項3に記載の装置。
- 前記ノズルは、約0.02〜約0.03の範囲内のストローハル数を含む、請求項1に記載の装置。
- 流体の供給源は、脈動周波数を有するポンプを含み、前記脈動周波数は、前記流体流れが飛散する雲になる周波数より小さい、請求項1に記載の装置。
- 前記流体流れが飛散する雲になる周波数は、約1kHz〜約10kHzの範囲内にある、請求項1に記載の装置。
- 近位端および遠位端を有する剛性シースと、
切除エネルギーの供給源と、前記切除エネルギーの供給源より遠位の少なくとも1つの開口部とを備えるプローブであって、前記プローブは、前記剛性シースの前記遠位端を越えて前記少なくとも1つの開口部および前記切除エネルギーの供給源が前進し得るように、前記剛性シース内で嵌合するようなサイズにされ、吸引チャネルが、前記少なくとも1つの開口部を通して組織処置部位から流体を除去するように、前記少なくとも1つの開口部から吸上源へと近位に延在する、プローブと
をさらに備える、請求項1に記載の装置。 - 前記組織処置部位の洗浄を提供するために洗浄流体の供給源に連結するように洗浄開口部をさらに備え、前記組織を洗浄する前記開口部および内視鏡視認窓は、前記内視鏡視認窓および前記組織処置部位から離れて前記切除エネルギーの供給源より遠位の前記少なくとも1つの開口部に向かって、切除された物質を押勢して、切除された物質を除去し、組織が切除されるときに前記組織処置部位の可視性を内視鏡に提供するように、前記切除エネルギーの供給源より近位に位置する、請求項8に記載の装置。
- 前記患者の中に配置されたときに前記剛性シースを支持するように前記剛性シースに連結される係止可能なアームをさらに備える、請求項8に記載の装置。
- 前記プローブの前記少なくとも1つの開口部は、前記剛性シースを通して前進させられることが可能であり、前記アームが前記患者の尿道に挿入された前記プローブとの係止構成にあるときに回転および並進させられることが可能である、請求項10に記載の装置。
- ディスプレイに連結されるプロセッサをさらに備え、前記プロセッサは、前記ディスプレイ上に基準場所を表示する命令を備え、前記プローブおよび前記アームは、前記プローブが前記プローブの遠位端上にアンカを伴わずに前記患者の中に配置されたとき、前記ディスプレイ上に示される前記基準場所への前記患者の処置を参照するように、連鎖部に連結される、請求項10に記載の装置。
- 前記プローブが前記患者に挿入されるとき、前記剛性シースを前記アームと係合させ、そして前記剛性シースを前記アームに係止するように、前記剛性シースの近位端上に位置する支持構造の突起に連結する、前記アームの遠位端上のドッキング機構をさらに備える、請求項10に記載の装置。
- TRUSプローブが軸方向に移動させられるときに組織の移動を阻止するように前記TRUSプローブの少なくとも一部分を覆って配置される第2の剛性シースをさらに備える、請求項8に記載の装置。
- 前記スキャナは、ハンドヘルドプローブである、請求項2に記載の装置。
- 手術部位において実質的に一定の圧力調整を提供するように構成された洗浄ポートに連結される流体の第2の供給源をさらに備える、請求項1に記載の装置。
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US20180263647A1 (en) | 2018-09-20 |
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BR112016005036A2 (pt) | 2020-04-07 |
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CN105764436B (zh) | 2019-04-26 |
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