JP6571719B2 - 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 - Google Patents
経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 Download PDFInfo
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- A61M25/00—Catheters; Hollow probes
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- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
- A61B2017/00318—Steering mechanisms
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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
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1047—Balloon catheters with special features or adapted for special applications having centering means, e.g. balloons having an appropriate shape
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1068—Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0004—Applications of ultrasound therapy
- A61N2007/0021—Neural system treatment
- A61N2007/0026—Stimulation of nerve tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0043—Ultrasound therapy intra-cavitary
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Description
本願は、米国仮特許出願第61/256429号(2009年10月30日出願)及び第61/292618号(2010年1月6日出願)の出願日の恩恵を主張するものであり、その開示の全体が、参照により本明細書に組み込まれる。
式:V=πr2 2h−πr1 2h(r1は前記振動子の半径、r2は前記衝撃領域の半径、hは前記振動子の長さ)
近位端部と遠位端部との間を延伸し、線32は、振動子30から管腔34を通り抜けて、カテーテル18の近位端部14まで延伸する。
方の圧力センサが、カテーテル18の遠位に流れる液体を監視して閉塞があるか否かを判定し、他方が、カテーテル18における液漏を監視する。バルーンが膨張状態にある間は、圧力センサ38は、バルーン内を所望の圧力、好ましくは約3ポンド/平方インチ(20KPa)に維持する。
カテーテルにおけるバルーン24は、カテーテルの遠位端部が腎動脈内の所望の位置に配置されるまで収縮状態を維持することが好ましい。カテーテル18及び振動子30の挿入中(ステップ56)、医師は、腎臓6又は存在するであろう腎動脈10のあらゆる分岐の前であっても、腎動脈10内での振動子30の配置を確認できる。このような確認は、蛍光透視法などのX線技術を利用して実現され得る。
コー信号における時間遅延の幅をもたらすことがある。超音波システム20は、その幅の平均を取得して腎動脈10の平均サイズを決定し、その平均サイズに基づいて出力レベルを調節できる。
V=πr2 2h−πr1 2h
ここで、r1は振動子30の半径であり、r2は衝撃領域11の半径であり、hは振動子30の長さである。
の変更では、カテーテル18が身体内に導かれ、その後、腎臓6に近接して配置される経路は、前述の心房へ近づく経路とは異なる。静脈への進入は、カテーテル18を取り出した後の閉鎖の問題を低減し得るという利点により、利用されることができる。
Claims (11)
- 哺乳類対象において腎神経伝達を不活性化するための装置であって、
超音波振動子と、
前記超音波振動子に電気的に接続されるアクチュエータと、
前記超音波振動子を包含するように構成された拡張可能なバルーンと、
を備え、
当該超音波振動子は、前記哺乳類対象の腎動脈へ挿入され、非集束超音波エネルギーを、前記腎動脈へ伝達し、
前記アクチュエータは、当該腎動脈の内膜層を損傷させることなく、衝撃容積全体の腎神経伝達を不活性化するために、治療用量の非集束超音波エネルギーを360度の円筒形態で前記超音波振動子に伝達させ、
前記超音波振動子及び前記腎動脈の内面を冷却するために、拡張された前記バルーンを通じる冷却された液体の流れの循環を制御する冷却装置をさらに備える、装置。 - 前記アクチュエータは、10〜30ワットの音響出力レベルで前記非集束超音波エネルギーを10〜30秒間前記超音波振動子に伝達させる、請求項1に記載の装置。
- 前記アクチュエータは、前記腎動脈壁の温度を65℃未満に維持しながら、前記衝撃容積内の腎神経を含む固形組織の温度が42℃超に達するように、前記超音波振動子を制御する、請求項1または2に記載の装置。
- 前記超音波振動子は、前記腎動脈の軸に沿った少なくとも2mmの長さに沿って前記腎神経伝達を不活性化するように、前記超音波エネルギーを伝達する、請求項1から3のいずれかに記載の装置。
- 前記超音波振動子は、2〜10mmの長さを有する、請求項1から4のいずれかに記載の装置。
- 上部に取り付けられた前記拡張可能なバルーンを備えるカテーテルをさらに備え、前記カテーテルは、前記超音波振動子を前記腎動脈壁に接触せずに保持するように構成及び配置される、請求項1から5のいずれかに記載の装置。
- 上部に取り付けられた前記拡張可能なバルーンを備えるカテーテルをさらに備え、前記カテーテルは、前記腎動脈の軸と略平行に前記超音波振動子の軸を保持するように構成及び配置されている、請求項1から5のいずれかに記載の装置。
- 前記超音波振動子はさらに、超音波エネルギーを受信して、前記受信した超音波エネルギーを表す信号を生成し、
前記アクチュエータはさらに、
前記超音波振動子にある測定レベルで超音波エネルギーを伝達させ、反射された測定用超音波エネルギーを表すエコー信号を前記超音波振動子から受信し、
前記受信したエコー信号を解析し、
前記受信したエコー信号に基づいて前記腎動脈のサイズを決定する、請求項1から7のいずれかに記載の装置。 - 前記アクチュエータは、前記腎動脈の決定サイズに応じ、治療効果のある前記非集束超音波エネルギーを伝達するのに用いられる音響出力を変えるよう、前記超音波振動子を制御する、請求項8に記載の装置。
- 前記衝撃容積は、略円筒状であり、前記腎動脈と略同軸である、請求項1から9のいずれかに記載の装置。
- 前記衝撃容積(V)は、以下の式によって決定される、請求項1から10のいずれかに記載の装置。
式:V=πr22h−πr12h(r1は前記振動子の半径、r2は前記衝撃領域の半径、hは前記振動子の長さ)
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US25642909P | 2009-10-30 | 2009-10-30 | |
US61/256,429 | 2009-10-30 | ||
US29261810P | 2010-01-06 | 2010-01-06 | |
US61/292,618 | 2010-01-06 |
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JP2014255602A Division JP6412790B2 (ja) | 2009-10-30 | 2014-12-17 | 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 |
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JP2017196461A JP2017196461A (ja) | 2017-11-02 |
JP6571719B2 true JP6571719B2 (ja) | 2019-09-04 |
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JP2012537097A Active JP5768056B2 (ja) | 2009-10-30 | 2010-10-29 | 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 |
JP2014255602A Active JP6412790B2 (ja) | 2009-10-30 | 2014-12-17 | 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 |
JP2017125690A Active JP6571719B2 (ja) | 2009-10-30 | 2017-06-27 | 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 |
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JP2014255602A Active JP6412790B2 (ja) | 2009-10-30 | 2014-12-17 | 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 |
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US (5) | US9981108B2 (ja) |
EP (3) | EP2995350B1 (ja) |
JP (3) | JP5768056B2 (ja) |
KR (2) | KR101673574B1 (ja) |
CN (1) | CN102596320B (ja) |
AU (2) | AU2010313379B2 (ja) |
CA (1) | CA2779386C (ja) |
HK (1) | HK1220153A1 (ja) |
IL (1) | IL219252A0 (ja) |
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