JP2013505103A - 種々の治療デバイス群の使用および動作を制御するためのシステムおよび方法 - Google Patents
種々の治療デバイス群の使用および動作を制御するためのシステムおよび方法 Download PDFInfo
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Abstract
Description
本願は、2009年9月22日に出願された仮特許出願番号61/277,260号の利益を主張する。
本発明は、概して、身体の内部組織領域を治療するためのシステムおよび方法に関する。より具体的には、本発明は、身体の括約筋および近隣の組織における機能不全を治療するためのシステムおよび方法を対象とする。
消化管とも呼ばれる胃腸(GI)管は、食物が体内に摂取され、消化される、長い管である。消化管は、口から始まり、咽頭、食道、胃、小腸および大腸、ならびに直腸を含む。ヒトにおいて、この通路は、約30フィート(9メートル)の長さである。
本発明の一態様は、治療デバイスを使用して、軸方向に間隔が空いた複数の病変レベルを含む、身体領域において、病変のパターンを形成するプロセスを実施することを、段階的な態様でユーザに視覚的に促すための図形表示を生成するステップであって、各病変レベルは、円周方向に間隔が空いた複数の病変を含む、ステップを含む、身体組織を治療するためのシステムおよび方法を提供する。該システムおよび方法は、各円周方向に間隔が空いたレベル内および各円周方向に間隔が空いたレベル間の両方で、それらがリアルタイムに生成される際に、病変の形成を登録するステップを含み、それによって、図形表示は、ユーザに、開始から終了までのプロセスの進捗の視覚的記録を表示し、所与のレベル内で所望される個々の病変が全て形成され、かつ所与のレベルの病変がスキップされないように、ユーザを誘導する。
図1は、一体化身体の異なる領域における、括約筋および近隣の組織の機能不全を診断および/または治療するためのシステム24を示す。例解される実施形態において、システム24は、身体内の少なくとも2つの別個の括約筋領域における機能不全を診断および治療するように構成される。
動作要素36の構造は、変化し得る。種々の代表的な実施形態を説明する。
図2から4は、上部胃腸管における括約筋領域、より具体的には、GERDを治療するために、下部食道括約筋および近隣の胃の噴門を治療するためのカテーテルに基づくデバイス26aを示す。示される実施形態において、デバイス26aは、その近位端にハンドル28を担持する、可撓性カテーテル管30を含む。カテーテル管30の遠位端は、動作要素36aを担持する。
図6および7は、下部胃腸管における括約筋領域、より具体的には、便失禁を治療するように、肛門管における内部および/または外部括約筋肉を治療するための手操作デバイス302の形態を採る、デバイス26bの代表的な実施形態を示す。デバイス302は、動作要素36bを担持する、ハンドグリップ304を含む。
例解される実施形態(図10Aおよび10Bを参照されたい)において、無線周波数発電機38、I/Oデバイス54を伴うコントローラ52、および流体送達装置44(例えば、冷却液体の送達のための)は、単一の筐体400内に統合される。
CPUのブートアップ後(図11を参照されたい)、動作システムは、GUI500のためのセットアップ機能を実装する。GUIは、適切なスタートアップロゴ、および表題画像(図示せず)を表示し、一方で、コントローラ52は、セルフテストを実施する。セットアッププロンプトアレイ502は、発電機およびデバイスの使用を可能にするように必要とされるタスクを通じて、オペレータを段階的に導く。医師は、冷却液体源を、デバイス26a/26bのハンドル上の適切なポートに結合させ(先に説明されるように、図10Aを参照されたい)、冷却液体源(例えば、滅菌水を含有する袋)から、ポンプロータ428(図10Bを参照されたい)につながる管を装着することができる。医師はまた、吸引源46を、治療デバイス26a/26bのハンドル上の適切なポートに結合させることができる(同様に既に説明されるように)。医師はまた、パッチ電極412およびフットペダル416(図10Aに図示)を結合させることができる。セットアッププロンプトアレイ502において、GUI500のグラフィックフィールドは、帰線パッチ電極412を接続させ、フットペダルまたはスイッチ416を接続させ、選択された治療デバイス26a(その商標STRETTA(登録商標)によって示される)または26b(その商標SECCA(登録商標)によって示される)を接続させ、潅注ポンプ44をプライミングするように、オペレータに促す、1つ以上のアイコンおよび/または英数値的指標502を表示する。
セットアップ動作の完了後、コントローラ52は、動作モードの順序を通って、段階的に開始するように、発電機および付属機器を調整することを開始する。動作モードは、治療プロトコル、および選択されたデバイス26a/26bの目的を達成するように、事前プログラムされている。これらの動作モードの遂行、ならびに選択された処置の過程において、ユーザを誘導する、およびユーザに通知する、グラフィカルユーザインターフェースの外観は、デバイス26aと、26bとの間で異なることが可能である。
UGUI504(図14Aを参照されたい)において、図5で既に説明され示される、病変レベルに対応するように、6つの番号を付けられている病変レベル1、2、3、4、5、および6が表示される。UGUI504はまた、曲がりくねった線514を表示し、これは、医師が、治療のための食道内の病変の形成に対する、選択された解剖学的拠点基準を視覚化した場所をマークする。UGUI504によって誘導され、病変は、この解剖学的拠点に対して配置される。
LGUI506(図15A)は、図9に示されるように、肛門管において、規定の病変パターンを形成するように、デバイス26bを操作する際に、医師を誘導する、グラフィカルユーザ表示を生成する。病変パターンは、軸方向に間隔が空いた複数の病変レベルを含み(例解される実施形態において、1から5と番号を付けられている)、各病変レベルは、円周方向に間隔が空いた複数の病変(例解される実施形態において、1組4つで配設される、16の病変が存在する)を含む。
Claims (7)
- グラフィカルユーザインターフェースであって、
コントローラを備え、
該コントローラは、軸方向に間隔が空いた複数の病変レベルを含む身体領域において、病変のパターンを形成するプロセスを実施することを、段階的な態様でユーザに視覚的に促すための手段を含み、各病変レベルは、円周方向に間隔が空いた複数の病変を含み、各円周方向に間隔が空いたレベル内および各円周方向に間隔が空いたレベル間の両方で、病変がリアルタイムに生成される際に、病変の形成を登録するための手段をさらに含み、該コントローラは、該ユーザに、開始から終了までの該プロセスの進捗の視覚的記録を表示し、所与のレベル内で所望される個々の病変が全て形成され、かつ所与のレベルの病変がスキップされないように、該ユーザを誘導する、グラフィカルユーザインターフェース。 - グラフィカルユーザインターフェースであって、
コントローラを備え、該コントローラは、
軸方向に間隔が空いた複数の病変レベルを含む身体領域において、病変のパターンを形成するプロセスを実施することを、段階的な態様でユーザに視覚的に促すための手段を含み、各病変レベルは、円周方向に間隔が空いた複数の病変を含み、各病変レベルにおいて、各病変レベルの番号識別を有する第1の定型化された図形画像を生成するための手段と、所与のレベルでの病変の該形成が示されるときに生成され、該第1の定型化された図形画像とは異なる第2の定型化された図形画像を生成するための手段であって、所与のレベルにおいて形成されるべき病変の数をさらに示す、手段と、該第2の図形画像を、リアルタイムで病変の形成を反映するように追加された指標を含む、第1の画像または第2の画像とは異なる第3の図形画像に変更するための手段と、それぞれの病変レベルで、該所望の病変パターンを形成する際に、該第1の図形画像、第2の図形画像、および第3の図形画像とは異なり、全ての所望の病変が、該レベルで形成されたことを示すためのインジケータを備える、第4の図形画像を生成するための手段とを含み、治療されるべき次の病変レベルを該ユーザに指示し、連続的な病変レベルが治療される際に更新されるマーカを生成するための手段をさらに含む、グラフィカルユーザインターフェース。 - 治療デバイス群の動作を制御するためのシステムであって、
該システムは、
少なくとも第1および第2の異なる治療デバイスを備える治療デバイス群であって、該少なくとも第1および第2の異なる治療デバイスは、異なる組織領域において使用するために個々に展開されることが意図される、治療デバイス群と、
該第1または第2の治療デバイスのうちの選択された治療デバイスが、使用のために結合されるコネクタを含むコントローラであって、該コントローラは、該第1および第2の異なる治療デバイスのうちのどちらが接続されたかを識別するための手段を含む、コントローラと
を含み、
該コントローラは、表示画面上で、該第1の治療デバイスが接続されるときにのみ、該第1の治療デバイスの使用を誘導する、第1のグラフィックインターフェースと、少なくとも一部において、該第1のグラフィックインターフェースとは異なり、かつ該第2の治療デバイスが接続されるときにのみ、該第2の治療デバイスの使用を誘導する、第2のグラフィックインターフェースとを実行するための動作システムをさらに含み、該コントローラは、該第1および第2のグラフィックインターフェースのうちの少なくとも1つに対して、該接続された治療デバイスを使用して、軸方向に間隔が空いた複数の病変レベルを含む、身体領域において、病変のパターンを形成するプロセスを実施することを、段階的にユーザに視覚的に促すための手段であって、各病変レベルは、円周方向に間隔が空いた複数の病変を含む、手段を含み、各円周方向に間隔が空いたレベル内および各円周方向に間隔が空いたレベル間の両方で、それらがリアルタイムに生成される際に、病変の該形成を登録するための手段をさらに含み、該グラフィカルユーザインターフェースは、該ユーザに、開始から終了までの該プロセスの進捗の視覚的記録を表示し、所与のレベル内で所望される個々の病変が全て形成され、かつ所与のレベルの病変がスキップされないように、該ユーザを誘導する、システム。 - 前記治療デバイスのうちの1つは、下部食道括約筋において、または、下部食道括約筋の近傍で、病変を形成するようにサイズ決定および構成される、請求項3に記載のシステム。
- 前記治療デバイスのうちの1つは、肛門括約筋において、または、肛門括約筋の近傍で、病変を形成するようにサイズ決定および構成される、請求項3に記載のシステム。
- 軸方向に間隔が空いた複数の病変レベルを含む身体領域において、病変のパターンを形成するプロセスを実施することを、段階的にユーザに視覚的に促すための図形表示を生成することであって、各病変レベルは、円周方向に間隔が空いた複数の病変を含む、ことを含み、各円周方向に間隔が空いたレベル内および各円周方向に間隔が空いたレベル間の両方で、それらがリアルタイムに生成される際に、病変の該形成を登録することをさらに含み、該図形表示は、該ユーザに、開始から終了までの該プロセスの進捗の視覚的記録を表示し、所与のレベル内で所望される個々の病変が全て形成され、かつ所与のレベルの病変がスキップされないように、該ユーザを誘導する、方法。
- 軸方向に間隔が空いた複数の病変レベルを含む身体領域において、病変のパターンを形成するプロセスを実施することを、段階的な態様でユーザに視覚的に促すための図形表示を生成することであって、各病変レベルは、円周方向に間隔が空いた複数の病変を含み、該生成することは、各病変レベルにおいて、各病変レベルの番号識別を有する第1の定型化された図形画像を生成することと、該第1の定型化された図形画像とは異なり、所与のレベルでの病変の該形成が示されるときに生成され、さらにそのレベルで形成されるべき病変の数を示す、第2の定型化された図形画像を生成することと、該第2の図形画像を、リアルタイムで病変の該形成を反映するように追加された指標を含む、該第1または第2の画像とは異なる、第3の図形画像に変更することと、該それぞれの病変レベルで、該所望の病変パターンを形成すると、該第1、第2、および第3の図形画像とは異なり、全ての所望の病変が、該レベルで形成されたことを示すためのインジケータを備える、第4の図形画像を生成することとによって行われ、該生成することは、治療されるべき次の病変レベルを該ユーザに指示し、連続的な病変レベルが治療される際に更新されるマーカを生成することとを含む、方法。
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- 2010-09-22 JP JP2012530861A patent/JP5764564B2/ja not_active Expired - Fee Related
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- 2010-09-22 EP EP10819150.3A patent/EP2480152B1/en active Active
- 2010-09-22 US US12/924,155 patent/US20110112529A1/en not_active Abandoned
- 2010-09-22 WO PCT/US2010/002588 patent/WO2011037621A2/en active Application Filing
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2002542891A (ja) * | 1999-05-04 | 2002-12-17 | キューロン メディカル,インコーポレイテッド | 一体型組織加熱および冷却装置 |
JP2003526407A (ja) * | 1999-09-08 | 2003-09-09 | キューロン メディカル,インコーポレイテッド | 1組の治療デバイスを制御するシステム |
JP2004105502A (ja) * | 2002-09-19 | 2004-04-08 | Toshiba Corp | 超音波治療装置 |
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US20160374745A1 (en) | 2016-12-29 |
JP2015013203A (ja) | 2015-01-22 |
US10624690B2 (en) | 2020-04-21 |
CN104905875B (zh) | 2017-11-14 |
CN102711642A (zh) | 2012-10-03 |
US20160220317A1 (en) | 2016-08-04 |
US9448681B2 (en) | 2016-09-20 |
US20160074133A1 (en) | 2016-03-17 |
WO2011037621A2 (en) | 2011-03-31 |
US20130117669A1 (en) | 2013-05-09 |
US9513761B2 (en) | 2016-12-06 |
US20110112529A1 (en) | 2011-05-12 |
WO2011037621A3 (en) | 2012-07-05 |
US20130197509A1 (en) | 2013-08-01 |
US20130197512A1 (en) | 2013-08-01 |
US10639090B2 (en) | 2020-05-05 |
CN102711642B (zh) | 2015-04-29 |
EP2480152A4 (en) | 2013-09-11 |
US9310956B2 (en) | 2016-04-12 |
JP5764564B2 (ja) | 2015-08-19 |
EP2480152B1 (en) | 2018-08-29 |
US9292152B2 (en) | 2016-03-22 |
CN104905875A (zh) | 2015-09-16 |
EP2480152A2 (en) | 2012-08-01 |
US9495059B2 (en) | 2016-11-15 |
US20130197508A1 (en) | 2013-08-01 |
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