JP4887141B2 - 圧力と温度を制御可能なバルーン治療システム - Google Patents
圧力と温度を制御可能なバルーン治療システム Download PDFInfo
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
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- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
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- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
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- A—HUMAN NECESSITIES
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Description
本発明は、一般に、冷却を利用する血管の治療のための装置及び方法に関する。詳しくは、本発明は、冷却バルーンの圧力状態を制御しながら患者の血管系内の病巣を低温治療するためのシステム、装置及び方法を提供する。
本発明は、血管その他の体管腔を制御可能に冷却するための改良された装置、システム及び方法を提供する。血管は、しばしば、その周囲の管壁を係合するようにバルーンを膨張させることによって、アテローム性動脈硬化又はその他の疾患について治療される。バルーンの冷却の制御は、前記バルーン内における低温流体の相変化、通常は液相から気相への相変化、によって行うことができる。冷却温度を選択された範囲内にとどめながら、選択された治療圧を提供することができ、バルーンの中間状態(挿入と位置決めに適した小プロファイル未膨張形態と、所望の圧力及び温度での完全に膨張した形態との間)を制御することができる。好ましくは、バルーンの制御された漸進的膨張(圧力の「段階状(stair-step)」増加等のよってバルーン内の圧力変化率を制御することによる)によって、損傷を抑制することができる。液相から気相への変化によって引き起こされる低温冷却とバルーン内での圧力環境との結合にも拘わらず、冷却流体流動特性が大幅に異なる代替選択可能な種々のバルーンカテーテルのいずれに対しても、単一の制御システムによって膨張制御を行うことが可能である。
本発明は、一般的には、体管腔その他の体組織における管腔壁の冷却治療のための、改良された装置、システム及び方法を提供するものである。本発明は、多くの場合、管壁(又は他の周囲組織)に径方向に係合するように冷却流体によって膨張されるバルーンを使用する。前記冷却流体は、多くの場合、少なくとも部分的に前記バルーン内において第1相から第2相へと変化し、気化の潜熱によって周囲の組織が冷却される。適当な冷却流体を導入すると、その冷却流体が液相から気相へと沸騰し始めると直ぐに(多くの場合、流体がカテーテルに流入した直後に)前記バルーンを非常に急速に膨張させることができるので、本発明は、このバルーンの膨張プロセスを好適に制御することができる。具体的には、前記バルーンが(バルーンの挿入と位置決めに適している)収縮形態と完全膨張状態(この完全膨張状態では、バルーン内での温度と圧力との所望の組合せによって、管腔表面冷却と組織拡張の両方、バルーン/標的組織係合等を起こすことが可能である)との間にある時に、前記バルーン内での中間圧状態、通常は中間圧又は圧力の中間変化率、を制御することができる。
Claims (13)
- 血管の部位を冷却するためのカテーテルシステムであって、
近端部と遠端部とを備えるカテーテル本体と、前記遠端部の近傍に配設されたバルーンとを有するバルーンカテーテルと、前記カテーテル本体は、前記バルーンと流体連通する供給ルーメンと排出ルーメンとを備えることと、
前記カテーテル本体の前記近端部に接続されて、遠位側において前記供給ルーメンに沿って、前記バルーンを通って延出するとともに、近位側において前記排出ルーメンに沿って戻り延出する冷却流体路を形成可能な流体供給源と、前記流体供給源は、液体から気体へ相変化して冷却を行う冷却流体を有することと、
前記流体路に接続された冷却流体制御システムと、該流体制御システムは、前記バルーンが未膨張状態である第1形態と、前記バルーンが治療圧へと膨張されて前記部位を治療温度へと冷却する第2形態と、前記バルーンの中間圧状態が制御される中間形態とを有することと、前記流体制御システムは、前記バルーンの上流側で前記冷却流体路に沿って配設された逃がし弁を含むことと、
前記逃がし弁を開放状態と閉鎖状態とで周期的に循環させるように構成されたタイマーとを備えることを特徴とするカテーテルシステム。 - 請求項1に記載のカテーテルシステムであって、前記中間圧状態は、前記治療圧よりも低い圧力を含むカテーテルシステム。
- 請求項1に記載のカテーテルシステムであって、前記中間圧状態は、バルーン膨張圧の変化率を含むカテーテルシステム。
- 請求項3に記載のカテーテルシステムであって、前記変化率は、前記バルーンの前記第1形態から前記第2形態への膨張が少なくとも約025秒間となるように構成されているカテーテルシステム。
- 請求項4に記載のカテーテルシステムであって、前記冷却流体は亜酸化窒素を含み、前記治療圧は、約7気圧〜約11気圧の範囲であるカテーテルシステム。
- 請求項4に記載のカテーテルシステムであって、前記変化率は、複数の増加する圧力段階によって規定されるカテーテルシステム。
- 請求項1に記載のカテーテルシステムであって、更に、互いに異なる冷却流体流動特性を有する複数の代替選択可能なバルーンカテーテルを有し、各代替バルーンカテーテルは前記流体供給源に接続してそれに対応する代替流体路を形成可能であり、前記流体制御システムは、所望の温度範囲の少なくとも1つの治療温度と、所望の治療圧範囲の治療圧と、所望の圧力変化率範囲の圧力変化率との少なくとも1つを提供するべく前記互いに異なる流動特性を補償するカテーテルシステム。
- 請求項1に記載のカテーテルシステムであって、前記流体制御システムは、更に、前記流体供給源と前記バルーンとの間に配設された流体デリバリ弁を有するカテーテルシステム。
- 請求項8に記載のカテーテルシステムであって、前記冷却流体は亜酸化窒素を含み、前記システムは、更に、サイクル時間によって前記逃がし弁を開放状態と閉鎖状態とで周期的に循環させるタイマーを有し、前記タイマーは、前記流体デリバリ弁を同じサイクル時間で周期的に開放状態と閉鎖状態とで循環させ、前記逃がし弁は前記流体デリバリ弁よりも前記サイクル時間のうち長い部分開放されるカテーテルシステム。
- 請求項1に記載のカテーテルシステムであって、前記流体制御システムは、初期冷却流体流を導入し、前記バルーンの下流側においてこの初期流の特性に応じて適切な冷却流体流の逃がし弁開閉のサイクルを決定するカテーテルシステム。
- 請求項10に記載のカテーテルシステムであって、前記冷却流体流の逃がし弁開閉のサイクルはバルブサイクル時間を含み、前記下流側特性は排出圧を含むカテーテルシステム。
- 請求項1に記載のカテーテルシステムであって、前記流体制御システムは、前記バルーンの下流側に代替選択可能な複数の圧力放出弁を有するカテーテルシステム。
- 血管の部位を冷却するカテーテルシステムであって、
第1及び第2の交替選択可能なバルーンカテーテルと、各バルーンカテーテルは、近端部と遠端部とを備えるカテーテル本体と、前記遠端部の近傍に配設されたバルーンとを有し、前記カテーテル本体は、前記バルーンと流体連通する供給ルーメンと排出ルーメンとを有することと、
各カテーテル本体の前記近端部に接続されて、前記選択されたバルーンカテーテルに関連し、第1冷却流体路及び第2冷却流体路を含む冷却流体路を形成可能な流体供給源と、該流体供給源は、液体から気体へ相変化して冷却を行う冷却流体を有し、前記第1バルーンカテーテル側の第1冷却流体路の特性は、前記第2バルーンカテーテル側の第2冷却流体路の特性と大幅に異なることと、
前記冷却流体路に接続された冷却流体制御システムと、該流体制御システムは、前記冷却流体路に接続されたセンサを有し、該センサは、較正モードにおいて前記供給源からの較正流体流に応答して較正信号を生成し、前記流体制御システムは、治療モードにおいて前記較正信号に少なくとも部分的に基づいてバルーン圧を制御することと、前記流体制御システムは、前記バルーンの上流側で前記冷却流体路に沿って配設された逃がし弁を含むことと、
前記逃がし弁を開放状態と閉鎖状態とで周期的に循環させるように構成されたタイマーとを備えることを特徴とするカテーテルシステム。
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US10/455,253 | 2003-06-04 | ||
US10/455,253 US7060062B2 (en) | 2003-06-04 | 2003-06-04 | Controllable pressure cryogenic balloon treatment system and method |
PCT/US2004/017400 WO2004108207A2 (en) | 2003-06-04 | 2004-06-02 | Controllable pressure cryogenic balloon treatment system and method |
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EP (1) | EP1628587B1 (ja) |
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JP2006526476A (ja) | 2006-11-24 |
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CA2528011A1 (en) | 2004-12-16 |
EP1628587A4 (en) | 2009-05-06 |
EP1628587A2 (en) | 2006-03-01 |
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