JP5074926B2 - リード無し心臓刺激システム - Google Patents
リード無し心臓刺激システム Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
- A61N1/37223—Circuits for electromagnetic coupling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
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- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Physics & Mathematics (AREA)
- Cardiology (AREA)
- Electromagnetism (AREA)
- Acoustics & Sound (AREA)
- Electrotherapy Devices (AREA)
Description
本書は、心臓または他の組織を電気的に刺激し、心臓または他の周囲組織または臓器内に延びるリード(リード線、線、導線)を使用せずにそれを実行するシステム、ならびにこのような刺激を導入するシステムおよび方法に関する。
さらなる実施形態では、リード無し組織励起システムは、被験者に移植するよう構成された制御ユニットを含んでよく、アンテナは、被験者の心臓の近傍で被験者の皮膚の下に位置するように構成される。
さらなる実施形態では、リード無し組織励起システムは、それぞれが線コイルに取り付けられた1対の電極を備える1つまたは複数の無線電極組立体を含んでよい。電極の対は、浸透性芯の両端に装着された1対の円形キャップを備えてよい。1つまたは複数の無線電極組立体はそれぞれ、長さが約5ミリメートルでよく、端部キャップの対は、直径が約3ミリメートルでよい。
他の実施形態では、リード無しペーシング電極組立体は、第1端付近に固定される取付機構も含んでよい。取付機構は螺旋形尖叉を含んでよい。追加的または代替的に、取付機構は、電極組立体の第1端から延在するように作用可能である複数の半径方向に延在する尖叉を含んでよい。リード無しペーシング電極組立体は、電極組立体の第2端付近に分離機構も含んでよい。分離機構はねじ式取付具を含んでよい。
さらなる態様では、リード無しペーシング電極組立体は、受動無線受信器を含んでよい。組立体は、1対の隔置された電極、および隔置された電極の対間に励起パルスを提供する手段も含んでよい。
・閾値ペーシング電圧=2.5ボルト
・典型的なリードインピーダンス=600オーム
・典型的なパルス継続時間=0.4m秒
・導出された閾値エネルギ=4マイクロジュール
である。
任意のアンテナ形状、位置および方向、およびアンテナの電流波形、I(t)について、
1)アンテナに対して任意の位置および任意の方向でシードコイル410につながり、導電性および誘電率の周波数に依存する現実的な値を有する組織媒質内に存在する磁束を計算する。
3)スイッチ418が位置1にある状態で、シード回路の式を使用して、時間に対する蓄電器405の電荷、したがって蓄電器に蓄積されたエネルギ(405のキャパシタンスの2倍で割った電荷の2乗に等しい)を計算する。
−全シードに送達されるエネルギ=NE0
−充電中にシード回路内に(オーム熱として)散逸する電力
−充電中にアンテナ回路内に(オーム熱として)散逸する電力
−導電性身体組織内に誘導される渦電流によって(オーム熱として)散逸する電力
次に、エネルギ結合効率は、NE0を、充電時間の継続時間にわたる上記で列挙した損の合計で割ることによって与えられる。アンテナ回路内のオーム熱は主に、アンテナ自体のI2R損、およびアンテナ設計に含まれる全ての磁性材料のヒステリシス損によるものである。これは、シード回路内のオーム熱にも当てはまる。ペーシング閾値エネルギまで最弱リンクシードを充電するために必要なアンテナ電流波形のパラメータが決定されたら、これらの損を計算することができる。アンテナ電流波形パラメータが決定されると、体内のいずれの点で発生する電界Eも計算することができる。次に、アンテナの影響を受ける身体の全部分の導電性に関する知識があるので、身体のいずれの点でも電流密度をJ=σEとして計算することができ、ここでσはその点における導電率である。次に、渦電流によるオーム加熱は、患者の身体の体積で電力損密度J・E=σ|E|2を積分することによって求められる。空間のいずれの点でもアンテナ波形によって発生する磁界および電界は両方とも、磁気ベクトルポテンシャルから導出することができるので、以下のさらなる工程を使用して、結合効率を計算することができる。
5)シードの部位における磁界をB=curl(A)として計算する。
7)工程6)で判明した電流波形について、アンテナ回路損を計算する。
9)空間内の複数の点における電界をE=−∂A/∂tとして計算する。
11)シードに送達される充電エネルギを、充電エネルギに7)から10)で計算した損を足した値で割った値として、効率を計算する。
Vind=ボルト単位の誘導電圧
A=m2単位の表面積
B=テスラ単位の印加磁界
である。
β=μN(π/12)(Di 2+DiDo+Do 2)
μ=芯の有効透磁率(無単位)
N=コイルの総巻数
Di=メートル単位のコイル内径
Do=メートル単位のコイル外径
である。
μo=真空の透磁率=4π×10-7ウェーバ/アンペア・メートル
Na=アンテナ上の巻数
D=メートル単位のアンテナ直径
z=メートル単位のアンテナ中心からの軸沿いの距離
γ=テスラ/アンペア単位の(μoNa/D)[1+(2z/D)2]-3/2
である。
C=ファラド単位のキャパシタンス
V=ボルト単位の印加電圧
Q=性質係数(無単位)=(I/R)(L/C)1/2
τ=秒単位のL/R(時定数)
L=ヘンリ単位のアンテナインダクタンス
R=オーム単位のアンテナおよび蓄電器抵抗
S=(1−[2Q]2)1/2
である。
Claims (17)
- 磁界を発生するサイズおよび形状のアンテナを有する制御ユニットと、
移植可能な無線電気刺激電極組立体と
を含むシステムであって、
前記移植可能な無線電気刺激電極組立体は、電気化学格納デバイスを有しておらず、前記移植可能な無線電気刺激電極組立体は、透磁性芯を取り囲む線コイルと、前記線コイルに取り付けられる1対の電極とを備え、前記1対の電極は、前記透磁性芯の対向する端部に装着され、
前記線コイルおよび前記透磁性芯は、前記磁界から磁気エネルギを受け取るように構成され、
前記移植可能な無線電気刺激電極組立体は、
前記受け取られたエネルギを別の容量性格納デバイスに格納することなく、かつ、前記受け取られたエネルギを電気化学格納デバイスに格納することなく、前記1対の電極による送達のために、前記受け取られた磁気エネルギを特定の組織電気刺激波形に直接的に変換するように構成され、かつ、
心腔内から心腔内壁組織部位に移植され、かつ、前記磁界に応答して、前記組織電気刺激波形を前記1対の電極から前記心腔内壁組織部位に送達するように構成され、かつ、
前記磁界が存在しないことに応答して、前記組織電気刺激波形の前記送達を阻止するように構成されている、システム。 - 前記アンテナが1つ以上の線ループを備える、請求項1に記載のシステム。
- 前記制御ユニットが、被験者に移植されるように構成され、前記アンテナが、前記被験者の心臓付近で前記被験者の皮下にあるように構成される、請求項1に記載のシステム。
- 前記制御ユニットが、電池と、前記アンテナに電気通信する蓄電器と、前記蓄電器の充電および放電を制御する制御可能なスイッチとを備える、請求項1に記載のシステム。
- 前記制御ユニットが、磁界を発生し、前記磁界が、前記移植可能な無線電気刺激電極組立体に対して、心臓の組織に調整パルスを提供するために十分な励起電圧を発生させるために適切な波形を有する、請求項4に記載のシステム。
- 前記1対の電極が、前記透磁性芯の前記対向する端部に装着される1対の円形キャップを備える、請求項1に記載のシステム。
- 前記移植可能な無線電気刺激電極組立体が、約5ミリメートルの長さであり、前記端部の1対のキャップが、約3ミリメートルの直径である、請求項6に記載のシステム。
- リード無しペーシング電極組立体であって、
電気化学格納デバイスを有していない受動無線受信器と、
前記受動無線受信器に取り付けられる2つ以上の電極と
を含み、
前記ペーシング電極組立体は、心腔内から心腔内壁組織部位に移植されるように構成されており、前記受動無線受信器は、透磁性芯と、前記透磁性芯を取り囲むコイルとを備え、前記2つ以上の電極は、前記コイルに取り付けられる1対の電極を備え、前記1対の電極は、前記透磁性芯の対向する端部に装着され、
前記ペーシング電極組立体は、前記コイルおよび前記透磁性芯を用いて前記受動無線受信器が磁界からエネルギを受け取った場合に、前記受け取られたエネルギを別の容量性格納デバイスに格納することなく、かつ、前記受け取られたエネルギを電気化学格納デバイスに格納することなく、前記1対の電極による送達のために、前記受け取られた磁気エネルギを特定の組織電気刺激波形に直接的に変換し、
前記1対の電極は、前記磁界に応答して、前記組織電気刺激波形を前記心腔内壁組織部位に送達し、
前記ペーシング電極組立体は、前記磁界が存在しないことに応答して、前記組織電気刺激波形の前記送達を阻止する、リード無しペーシング電極組立体。 - 前記1対の電極が、前記透磁性芯の前記対向する端部に配置される2つのリング電極を備える、請求項8に記載のリード無しペーシング電極組立体。
- 前記2つのリング電極が、前記透磁性芯の前記対向する端部で前記透磁性芯の周囲に装着される、請求項9に記載のリード無しペーシング電極組立体。
- 前記ペーシング電極組立体が、約5ミリメートルの長さであり、前記2つのリング電極が、約3ミリメートルの直径である、請求項10に記載のリード無しペーシング電極組立体。
- 前記ペーシング電極組立体が、9フレンチの送達カテーテルを通して導入するよう構成される、請求項8に記載のリード無しペーシング電極組立体。
- 前記電極組立体の第1端付近に固定される取付機構をさらに備える、請求項8に記載のリード無しペーシング電極組立体。
- 前記取付機構が螺旋形の尖叉を含む、請求項13に記載のリード無しペーシング電極組立体。
- 前記取付機構が、複数の放射状に延在する尖叉を含み、前記尖叉が、前記電極組立体の第1端から延在されて作動可能である、請求項13に記載のリード無しペーシング電極組立体。
- 前記電極組立体の第2端付近に分離機構をさらに備える、請求項13に記載のリード無しペーシング電極組立体。
- 前記分離機構がねじ式取付具を含む、請求項16に記載のリード無しペーシング電極組立体。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/971,550 | 2004-10-20 | ||
US10/971,550 US7532933B2 (en) | 2004-10-20 | 2004-10-20 | Leadless cardiac stimulation systems |
US11/075,375 US7650186B2 (en) | 2004-10-20 | 2005-03-07 | Leadless cardiac stimulation systems |
US11/075,375 | 2005-03-07 | ||
PCT/US2005/037977 WO2006045073A1 (en) | 2004-10-20 | 2005-10-19 | Leadless cardiac stimulation systems |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008516739A JP2008516739A (ja) | 2008-05-22 |
JP5074926B2 true JP5074926B2 (ja) | 2012-11-14 |
Family
ID=35788751
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Application Number | Title | Priority Date | Filing Date |
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JP2007538087A Expired - Fee Related JP5074926B2 (ja) | 2004-10-20 | 2005-10-19 | リード無し心臓刺激システム |
Country Status (6)
Country | Link |
---|---|
US (3) | US7650186B2 (ja) |
EP (2) | EP2929908B1 (ja) |
JP (1) | JP5074926B2 (ja) |
CA (1) | CA2584497A1 (ja) |
ES (1) | ES2881387T3 (ja) |
WO (1) | WO2006045073A1 (ja) |
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EP2929908B1 (en) | 2021-05-26 |
WO2006045073A1 (en) | 2006-04-27 |
EP1835962A1 (en) | 2007-09-26 |
US20060085041A1 (en) | 2006-04-20 |
US20060085042A1 (en) | 2006-04-20 |
EP2929908A1 (en) | 2015-10-14 |
ES2881387T3 (es) | 2021-11-29 |
US20070219590A1 (en) | 2007-09-20 |
CA2584497A1 (en) | 2006-04-27 |
US7647109B2 (en) | 2010-01-12 |
JP2008516739A (ja) | 2008-05-22 |
US7650186B2 (en) | 2010-01-19 |
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