JP2005512630A - 血液の流れの再開の判定 - Google Patents
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Abstract
Description
米国特許第6,001,069号明細書に教示されているように、かかる超音波カテーテルを用いると、プラーク、血栓、塞栓又は血管の血液運搬能力を低下させる他の物質によって部分的又は完全に閉塞された状態になっている人の血管を治療することができる。閉塞部を除去し又は減少させるため、超音波カテーテルを用いて溶解用製剤を含む溶液を直接閉塞部位に送り出す。超音波組立体によって生じた超音波エネルギは、溶解用製剤の治療効果を高める。例えば、かかる超音波カテーテルの一用途では、超音波によって高められた血栓崩壊治療は、例えば末梢性動脈閉塞又は深静脈血栓症のような病気の治療の際に動脈及び静脈中の血餅を溶解させる。かかる用途では、超音波エネルギは、例えばウロキナーゼ、組織プラスミノゲン賦活剤(TPA)等の治療薬で血栓崩壊を高める。
上述したように、種々の特徴及び利点を備えた超音波カテーテルを提供することが望ましい。かかる特徴及び利点の例としては、血餅溶解治療の進展又は効能をモニタできることが挙げられる。別の実施形態では、カテーテルは、血餅溶解治療の進展具合に基づいて治療薬の投与を調節する性能又は機能を備えている。これら特徴及び利点のうちの幾つかを備えた超音波カテーテルの好ましい実施形態が本明細書に記載されている。かかる超音波カテーテルを用いる方法も又本明細書において記載されている。
先ず最初に図1を参照すると、患者の解剖学的構造の太い又は大径の血管内に用いられるよう構成された超音波カテーテル10が概略的に示されている。例えば、図1に示す超音波カテ−テル10は、例えば脚の血管系中の長いセグメントの末梢性動脈閉塞部を治療するために使用できる。
上述したように、本明細書に開示する超音波カテーテルの種々の実施形態を治療薬と共に用いると血餅を溶解させて血管中の血液の流れを再開させることができる。血餅を十分溶解させて血液の流れを再開させた後、一般的に言って、治療薬及び(又は)超音波エネルギの投与を続けることは望ましくない。例えば、治療薬は一般的に言って、血液の流れを再開させた後に治療薬を投与し続けることは望ましくないような副作用を持つ場合がある。加うるに、超音波エネルギを発生させることは、熱を生じさせる傾向があり、それにより血管が損傷を受ける場合がある。したがって、一般的に言えば、血餅を十分に溶解させた後は超音波放射部材の作動を続行することは望ましくない。さらに、血液の流れを再開させた後、患者の治療は別の段階に移ることが必要な場合がある。かくして、血餅を十分に溶解させた時点及び(又は)血液の流れが十分に再開されて治療を停止させると共に(或いは)加減することができるようになった時点を判定できる方法及び装置を開発することが望ましい。
別の実施形態では、1以上の電磁流れセンサを用いて血餅が生じた領域の近くの再開された血液の流れを検出することができる。
別の実施形態では、外部プレチスモグラフ(体積変動記録器)を用いて血液の流れを判定することができる。これをカテーテルに対し半径方向又は別の寸法方向に差し向けるのがよい。
別の実施形態では、血液への酸素付与を利用して血液の流れの存在を判定することができる。
Claims (33)
- 患者の血管系中の血餅溶解をモニタする方法であって、
(a)カテーテルを患者の血管系中の治療部位に位置決めし、
(b)治療部位のところで血餅溶解治療手技を行うことを含み、血餅溶解治療手技は、超音波エネルギ及び治療薬をカテーテルから治療部位に送り出すことから成り、
(c)血餅溶解治療中、熱測定信号をカテーテルの第1の部分から治療部位に送り、
(d)熱測定信号をカテーテルの第2の部分で受け取り、
(e)送った熱測定信号と受け取った熱測定信号を比較して治療部位のところでの血液流量を評価することを含む、
方法。 - 段階(c)及び段階(d)を複数回繰り返すことを更に含む、請求項1記載の方法。
- 血餅溶解治療中、治療部位のところの温度のプロフィールを作成することと、前記プロフィールと少なくとも1つの基準プロフィールを比較して治療部位のところでの血液流量を更に評価することとを更に含む、請求項2記載の方法。
- 熱測定信号は、カテーテル内に位置決めされた超音波放射部材から送られることを特徴とする請求項1記載の方法。
- 熱測定信号は、カテーテル内に位置決めされた超音波放射部材のところで受け取られることを特徴とする請求項4記載の方法。
- 熱測定信号は、温度センサのところで受け取られることを特徴とする請求項4記載の方法。
- 送った熱測定信号は、増大した温度の周期的パルスであることを特徴とする請求項1記載の方法。
- 送った熱測定信号は、振動する熱信号であることを特徴とする請求項1記載の方法。
- 段階(e)は、送った熱測定信号と受け取った熱測定信号の位相差を測定する段階から成ることを特徴とする請求項8記載の方法。
- カテーテルを患者の血管系中の治療部位に位置決めする段階を有し、閉塞が前記治療部位のところに存在し、
医学的治療を治療部位のところで行う段階を有し、医学的治療は、閉塞を減少させるよう構成されており、
医学的治療が行われている間、複数回の熱エネルギ測定を治療部位のところで行う段階を有し、
複数回の熱エネルギ測定に基づいて閉塞の減少を評価する段階を有していることを特徴とする方法。 - カテーテルは、複数の超音波放射部材及び冷却用流体を通過させるよう構成された流体送出しルーメンを有していることを特徴とする請求項10記載の方法。
- 複数回の熱エネルギ測定は、熱電対を用いて行われることを特徴とする請求項11記載の方法。
- 熱電対は、流体送出しルーメン内に位置決めされていて、流体送出しルーメンを通過している冷却用流体の温度を測定するようになっていることを特徴とする請求項12記載の方法。
- 閉塞の減少の評価に基づいて医学的治療を調整する段階を更に有していることを特徴とする請求項10記載の方法。
- 血餅溶解治療の効能を評価する超音波カテーテルであって、上流側領域と、上流側領域と反対側に位置した下流側領域と、上流側領域と下流側領域の両方の中へ部分的に延びる治療ゾーンと、治療ゾーン内に位置決めされた超音波組立体とを有し、超音波組立体は、血餅溶解治療を行うよう構成された少なくとも1つの超音波放射部材を有し、前記超音波カテーテルは、上流側領域内に位置決めされていて、血餅溶解治療中、熱測定信号を治療ゾーンに送るよう構成された熱エネルギ源と、下流側領域内に位置決めされていて、熱測定信号を治療ゾーンから受け取るよう構成された熱エネルギ検出器と、熱エネルギ源から送られた熱測定信号と熱エネルギ検出器のところで受け取った熱測定信号を比較するよう構成された制御回路構成とを更に有する、超音波カテーテル。
- 前記カテーテルは、血餅溶解治療中、治療薬を治療ゾーンに送り出すよう構成された治療薬送出しルーメンを更に有する、請求項15記載のカテーテル。
- 熱エネルギ源及び熱エネルギ検出器は、治療薬を送出しルーメン内に位置決めされている、請求項15記載のカテーテル。
- 熱エネルギ源は、治療薬送出しルーメンの外部に位置決めされ、熱エネルギ検出器は、治療薬送出しルーメン内に位置決めされている、請求項15記載のカテーテル。
- 熱測定信号は、増大した温度の周期的パルスから成る、請求項17記載のカテーテル。
- 制御回路構成は、熱エネルギ源から送り出された熱測定信号のピーク強度と熱エネルギ検出器のところで受け取った熱測定信号のピーク強度を比較するよう構成されている、請求項18記載のカテーテル。
- カテーテルは、血餅溶解治療中、冷却用流体を超音波組立体の近位側に流すよう構成された冷却用流体ルーメンを更に有する、請求項15記載のカテーテル。
- 熱エネルギ源及び熱エネルギ検出器は、冷却用流体ルーメン内に位置決めされている、請求項21記載のカテーテル。
- 熱測定信号は、増大した温度の周期的パルスから成る、請求項22記載のカテーテル。
- 制御回路構成は、熱エネルギ源から送り出された熱測定信号のピーク強度と熱エネルギ検出器のところで受け取った熱測定信号のピーク強度を比較するよう構成されている、請求項23記載のカテーテル。
- 上流側領域、下流側領域及び上流側領域と下流側領域の両方の中へ部分に延びる治療ゾーンを有するカテーテルと、治療ゾーン内に位置決めされた超音波組立体とを有する装置であって、超音波組立体は、血餅溶解治療を行うよう構成された少なくとも1つの超音波放射部材を有し、前記装置は、治療ゾーン内に位置決めされていて、血餅溶解治療中、複数回の熱エネルギ測定を行うよう構成された熱エネルギ検出器と、血餅溶解治療中、治療ゾーン内の熱による希釈度を測定する手段とを更に有する、装置。
- 超音波放射部材を有するカテーテルを患者の血管系中の閉塞部の近位側に位置決めする段階と、治療薬及び超音波エネルギを前記閉塞部に送り出して閉塞部が少なくとも部分的に溶解されるようにすることにより閉塞部溶解治療を行う段階と、部分的に溶解した閉塞部を越える血液の流れの少なくとも部分的な再開を検出する段階と、血液の流れの少なくとも部分的な再開に応答して閉塞部溶解治療を調整する段階とを有していることを特徴とする方法。
- 血液の流れの少なくとも部分的な再開は、患者の血管系中で複数回の熱測定を行うことにより検出されることを特徴とする請求項26記載の方法。
- 複数回の熱測定は、熱測定信号を患者の血管系中へ上流側の場所に導入する段階と、患者の血管系からの熱測定信号を下流側の場所で受け取る段階と、導入した熱測定信号と受け取った熱測定信号を比較する段階とから成ることを特徴とする請求項27記載の方法。
- 導入した熱測定信号は、増大した温度の周期的パルスであることを特徴とする請求項28記載の方法。
- 導入した熱測定信号は、振動する熱信号であることを特徴とする請求項28記載の方法。
- 導入した熱測定信号と受け取った熱測定信号の位相差を測定する段階を更に有していることを特徴とする請求項30記載の方法。
- 血液の流れの少なくとも部分的な再開は、患者の血管系中で複数回の音響測定を行うことにより検出されることを特徴とする請求項26記載の方法。
- 血液の流れの少なくとも部分的な再開は、患者の血管系中で複数回の光学測定を行うことにより検出されることを特徴とする請求項26記載の方法。
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2002
- 2002-12-16 JP JP2003552145A patent/JP4167178B2/ja not_active Expired - Fee Related
- 2002-12-16 CA CA002468975A patent/CA2468975A1/en not_active Abandoned
- 2002-12-16 AU AU2002357316A patent/AU2002357316A1/en not_active Abandoned
- 2002-12-16 EP EP02805204A patent/EP1463454A1/en not_active Withdrawn
- 2002-12-16 US US10/320,847 patent/US6979293B2/en not_active Expired - Lifetime
- 2002-12-16 WO PCT/US2002/040466 patent/WO2003051208A1/en active Application Filing
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Also Published As
Publication number | Publication date |
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CA2468975A1 (en) | 2003-06-26 |
US6979293B2 (en) | 2005-12-27 |
JP4167178B2 (ja) | 2008-10-15 |
US20060106308A1 (en) | 2006-05-18 |
US20030220568A1 (en) | 2003-11-27 |
EP1463454A1 (en) | 2004-10-06 |
WO2003051208A1 (en) | 2003-06-26 |
AU2002357316A1 (en) | 2003-06-30 |
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