JP2019514505A - 極性切り替えを伴う衝撃波デバイス - Google Patents
極性切り替えを伴う衝撃波デバイス Download PDFInfo
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- A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B17/2202—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
- A61B2017/22021—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter electric leads passing through the catheter
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- A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
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- A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
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Abstract
Description
概して、血管形成術および/または弁形成術手技のための衝撃波デバイスが、本明細書において説明される。本明細書に説明されるデバイスおよび方法は、「LOW PROFILE ELECTRODES FOR AN ANGIOPLASTY SHOCK WAVE CATHETER」と題された米国特許第8,888,788号に説明される1つ以上のデバイスまたは要素、および/または「SHOCK WAVE BALLOON CATHETER WITH MULTIPLE SHOCK WAVE SOURCES」と題された米国特許第9,011,463号に説明される1つ以上のデバイスまたは要素(それらの各々は、参照することによってその全体が本明細書に組み込まれる)を使用し得る。
概して、衝撃波を形成する方法が、本明細書において説明される。本明細書に説明される衝撃波デバイスのいずれかは、血管形成術および/または弁形成術手技において使用され得る。本明細書に説明される方法は、ガイドワイヤを患者における進入部位(例えば、脚部の鼠径部エリア内の動脈)から脈管の標的領域(例えば、破壊される必要がある石灰化プラークを有する領域)まで前進させることを含み得る。衝撃波デバイスは、ガイドワイヤ管腔を伴う軸方向に延びている細長い部材、第1の電極および第2の電極を備えている電極対、および/または細長い部材の長さに沿って提供される電極アセンブリを備え得る。電極対および/または電極アセンブリは、本明細書に説明される電極のいずれかであり得る。
以下の実施例では、全てのパルスに対して一定である極性(静的デバイス)および上で説明されるような交互極性(切り替えデバイス)を使用して受信する、電極の組への電気エネルギー送達を比較するための電極に対する試験結果が、提供される。パルスの関数として、電流、電圧、エネルギー測定、および視覚的点検が、8ギャップ銅コイルエミッタから求められ、浸食、電極完全性、および電極寿命を決定した。
Claims (26)
- 衝撃波デバイスであって、前記デバイスは、
軸方向に延びている細長い部材と、
第1の電極および第2の電極を備えている第1の電極対であって、前記第1の電極対は、前記細長い部材上に提供され、伝導性流体中に位置付けられている、第1の電極対と、
前記第1の電極対に結合されているントローラと
を備え、
前記コントローラは、一連の個々のパルスを前記第1の電極対に送達するように構成され、それによって、前記パルスの各々は、前記伝導性流体中に衝撃波を作成し、前記コントローラは、前記一連のパルスの一部に対して第1の方向に、および残りの前記一連のパルスに対して前記第1の方向と反対の第2の方向に、電流に前記電極対を通って流動させ、前記電流は、前記一連のパルスの25パーセント〜50パーセントに対して前記第2の方向に流動する、デバイス。 - 前記コントローラは、前記一連のパルスの3分の1〜半分に対して前記電流に前記第2の方向に流動させる、請求項1に記載のデバイス。
- 前記コントローラは、前記一連のパルスの少なくとも約半分に対して前記電流に前記第2の方向に流動させる、請求項1に記載のデバイス。
- 前記コントローラは、正と負との間で前記電極の極性を切り替えるための電圧極性スイッチを備え、前記電極は、反対極性を有する、請求項1に記載のデバイス。
- 前記第1の電極の第1の伝導性領域の第1の表面積は、前記第2の電極の第2の伝導性領域の第2の表面積より小さい、請求項1に記載のデバイス。
- 前記コントローラは、電圧源を備え、第1のワイヤが、前記第1の電極を前記電圧源の第1の端子に接続し、第2のワイヤが、前記第2の電極を前記電圧源の第2の端子に接続する、請求項1に記載のデバイス。
- 電流フローの前記第1の方向において、前記第1の端子は、正であり、前記第2の端子は、負であり、前記第2の方向いにおいて、前記第1の端子は、負であり、前記第2の端子は、正である、請求項6に記載のデバイス。
- 第2の電極対をさらに備え、前記コントローラは、前記一連のパルスを前記第1の電極対および前記第2の電極対に選択的に送達するように構成されているマルチプレクサを備えている、請求項1に記載のデバイス。
- 前記電極対を包囲する流体エンクロージャをさらに備えている、請求項1に記載のデバイス。
- 前記流体エンクロージャは、前記細長い部材の一部を包囲するバルーンを備え、前記バルーンは、伝導性流体で充填されるように構成され、前記第1の電極対は、前記バルーン内に封入され、前記バルーンから間隔を置かれている、請求項9に記載のデバイス。
- 衝撃波デバイスであって、前記デバイスは、
軸方向に延びている細長い部材と、
第1の電極対および第2の電極対を備えている第1の電極アセンブリであって、前記第1の電極アセンブリは、前記細長い部材上に提供され、伝導性流体中に位置付けられている、第1の電極アセンブリと、
前記第1の電極アセンブリに結合されているントローラと
を備え、
前記コントローラは、一連の個々のパルスを前記第1の電極アセンブリに送達するように構成され、それによって、前記パルスの各々は、前記伝導性流体中に衝撃波を作成し、前記コントローラは、前記一連のパルスの一部に対して第1の方向に、および残りの前記一連のパルスに対して前記第1の方向と反対の第2の方向に、電流に前記電極アセンブリを通って流動させ、前記電流は、前記一連のパルスの25パーセント〜50パーセントに対して前記第2の方向に流動する、デバイス。 - 前記第1の電極アセンブリは、第1の電極と、第2の電極と、共通電極とを備え、前記第1の電極対は、前記第1の電極と、前記共通電極とを備え、前記第2の電極対は、前記第2の電極と、前記共通電極とを備えている、請求項11に記載のデバイス。
- 前記コントローラは、正と負との間で前記第1の電極および前記第2の電極の極性を切り替えるための電圧極性スイッチを備え、前記第1の電極および前記第2の電極は、反対極性を有する、請求項12に記載のデバイス。
- 前記第1の電極の第1の伝導性領域の第1の表面積および前記第2の電極の第2の伝導性領域の第2の表面積は、前記共通電極の第3の伝導性領域の第3の表面積と異なる、請求項12に記載のデバイス。
- 前記コントローラは、電圧源を備え、第1のワイヤが、前記第1の電極を前記電圧源の第1の端子に接続し、第2のワイヤが、前記第2の電極を前記電圧源の第2の端子に接続する、請求項12に記載のデバイス。
- 前記コントローラは、電圧源を備え、第1のワイヤが、前記第1の電極を前記電圧源の第1の端子に接続し、第2のワイヤが、前記第2の電極を前記電圧源の第2の端子に接続し、第3のワイヤが、前記共通電極を前記電圧源の第3の端子に接続する、請求項12に記載のデバイス。
- 前記第1の電極アセンブリに直列に結合されている第2の電極アセンブリをさらに備えている、請求項11に記載のデバイス。
- 前記コントローラは、電圧源を備え、第1のワイヤが、前記第1の電極アセンブリを前記電圧源の第1の端子に接続し、第2のワイヤが、前記第1の電極アセンブリを前記第2の電極アセンブリに接続し、第3のワイヤが、前記第2の電極アセンブリを前記電圧源の第2の端子に接続する、請求項17に記載のデバイス。
- 第2の電極アセンブリをさらに備え、前記コントローラは、前記一連のパルスを前記第1の電極アセンブリおよび前記第2の電極アセンブリに選択的に送達するように構成されているマルチプレクサを備えている、請求項11に記載のデバイス。
- 前記第1の電極アセンブリを包囲する流体エンクロージャをさらに備えている、請求項11に記載のデバイス。
- 前記流体エンクロージャは、前記細長い部材の一部を包囲するバルーンを備え、前記バルーンは、伝導性流体で充填されるように構成され、前記第1の電極アセンブリは、前記バルーン内に封入され、前記バルーンから間隔を置かれている、請求項20に記載のデバイス。
- 衝撃波を形成する方法であって、前記方法は、
衝撃波デバイスを血管の中に前進させることであって、前記衝撃波デバイスは、軸方向に延びている細長い部材と、第1の電極および第2の電極を備えている第1の電極対とを備え、前記第1の電極対は、前記細長い部材上に提供され、伝導性流体中に位置付けられている、ことと、
一連の個々のパルスを前記第1の電極対に送達し、前記伝導性流体中に衝撃波を作成し、前記一連のパルスの一部に対して第1の方向に、および残りの前記一連のパルスに対して前記第1の方向と反対の第2の方向に電流に前記電極対を通って流動させることと
を含み、
前記電流は、前記一連のパルスの25パーセント〜50パーセントに対して前記第2の方向に流動する、方法。 - 前記電流は、前記一連のパルスの3分の1〜半分に対して前記第2の方向に流動する、請求項22に記載の方法。
- 前記電流は、前記一連のパルスの少なくとも約半分に対して前記第2の方向に流動する、請求項22に記載の方法。
- 電圧パルス幅を測定し、前記衝撃波デバイスの状態を監視することをさらに含む、請求項22に記載の方法。
- 前記第2の方向に電流に流動させるパルスのパーセンテージは、前記測定された電圧パルス幅に従って調節される、請求項25に記載の方法。
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US10226265B2 (en) | 2019-03-12 |
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