JP2008541986A - 神経刺激システムおよび方法 - Google Patents
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Abstract
【解決手段】神経を刺激するシステムおよび方法において、そのシステムは、哺乳類の予め決められた神経を刺激することができる周波数を有する第1の波形を生成するように構成された第1の波形発生器104と、哺乳類の組織を通過することができる周波数を有する搬送波波形を生成するように構成された第2の波形発生器106と、第1および第2の波形発生器に電気的に接続され、第1の波形および搬送波波形を変調して変調された波形を生成するように構成された、変調装置108と、変調装置に電気的に接続され、哺乳類の皮膚にほぼ隣接して位置付けられ、変調された波形を皮膚に加えるように構成された、電極110と、を含む。
【選択図】図1
Description
本出願は、2005年1月26日に出願された同時係属中の米国特許出願第11/043830号の一部継続出願であり、上記米国特許出願は、2004年2月11日に出願された米国仮特許出願第60/543722号に基づく優先権を主張している。
〔1.技術分野〕
本発明は、大まかに言って、体内の神経を刺激するシステムおよび方法に関し、より詳しく言うと、陰部神経を刺激する装置および方法に関する。
女性が、1100万件を超える失禁の事例を占めている。失禁の一つの種類は、腹圧性尿失禁(SUI)であり、この失禁では、女性は、笑う、せきをする、くしゃみをする、および、一定の運動をする、などの通常の日常的な行動および運動の間に尿の意図しない漏れを経験する。SUIは、膣壁を骨盤の筋肉および恥骨に結合する組織または靭帯の機能的な欠陥によっておそらく引き起こされる。一般的な原因には、骨盤の筋肉の反復的な緊張、出産、骨盤の筋肉の緊張の喪失、エストロゲンの減少、などがある。そのような欠陥は、尿道を不適正に機能するようにする。その他の種類の失禁とは異なり、SUIは膀胱の問題ではない。
本発明は、哺乳類に用いるための神経刺激装置を提供し、その装置は、哺乳類の予め決められた神経を刺激することができる周波数を有する第1の波形を生成するように構成された第1の波形発生器と、哺乳類の組織を通過することができる周波数を有する搬送波波形を生み出すように構成された第2の波形発生器と、第1および第2の波形発生器に電気的に接続され、変調された波形を生成するために第1の波形および搬送波波形を変調するように構成された、変調装置と、変調装置に電気的に接続され、哺乳類の皮膚にほぼ隣接して位置付けられていて、哺乳類の皮膚に変調された波形を供給するように構成された、電極と、を具備する。
本発明を詳細に説明する前に、本発明はその適用すなわち使用を、添付の図面および記載に例示された構造および部品の配置の詳細に限定されないことが注意されなければならない。本発明の例示的な実施の形態は、その他の実施の形態、変形、および、変更によって実施されるか、または、それらに組み込まれてもよく、さまざまな方法で実現または実行されてもよい。例えば、本発明は女性での神経の刺激に関連して詳細に記載されているが、本発明が男性に対して用いるために容易に構成されることが理解されなければならない。さらに、本明細書に開示された発明性のある原理、装置、および、方法は、陣痛および分娩時の神経の刺激のような、さまざまな別の神経を刺激するための適用をも有することがある。加えて、本明細書に記載された技術は、以下の状態、すなわち、腹圧性尿失禁、肛門および大便失禁、性的機能障害、間質性膀胱炎、骨盤疼痛に限定されないが骨盤疼痛のような慢性疼痛、および、夜間頻尿、のような状態に寄与する、または、それらの状態をもたらす、神経系のさまざまな構成要素に適用することができる。
この発明の具体的な実施態様は以下の通りである。
(1)哺乳類に用いるための神経刺激装置において、
前記哺乳類の予め決められた神経を刺激することができる周波数を有する第1の波形を生成するように構成された、第1の波形発生器と、
前記哺乳類の組織を通過することができる周波数を有する搬送波波形を生成するように構成された、第2の波形発生器と、
前記第1および第2の波形発生器に電気的に接続され、前記第1の波形および前記搬送波波形を変調して変調された波形を生成するように構成された、変調装置と、
前記変調装置に電気的に接続され、前記哺乳類の皮膚にほぼ隣接して位置付けられ、前記変調された波形を前記皮膚に加えるように構成された、電極と、
を具備する、神経刺激装置。
(2)実施態様(1)に記載の神経刺激装置において、
前記第1および第2の波形発生器ならびに前記電極は、パッチ装置内に位置付けられていて、
前記パッチ装置は、前記パッチ装置を前記皮膚にしっかりと留めるための、前記パッチ装置の表面に設けられた接着剤を有する、神経刺激装置。
(3)実施態様(1)に記載の神経刺激装置において、
導電性ゲル、
をさらに具備し、
前記導電性ゲルは、前記電極とほぼ電気的に接触した位置から、前記哺乳類の組織中の通路を通って、前記予め決められた神経に近接した位置まで、延びている、神経刺激装置。
(4)実施態様(3)に記載の神経刺激装置において、
前記導電性ゲルは、前記予め決められた神経にほぼ隣接した、前記哺乳類の体内の位置まで延びている、神経刺激装置。
(5)実施態様(1)に記載の神経刺激装置において、
前記予め決められた神経は、陰部神経であり、
前記パッチ装置は、前記哺乳類の体のほぼ腹部領域または仙骨領域に位置付けられている、神経刺激装置。
(6)実施態様(1)に記載の神経刺激装置において、
前記第1の波形は、ほぼ10Hz〜40Hzまでの範囲内の周波数を有する、神経刺激装置。
(7)実施態様(6)に記載の神経刺激装置において、
前記第1の波形は、方形波である、神経刺激装置。
(8)実施態様(7)に記載の神経刺激装置において、
前記搬送波波形は、ほぼ10kHz〜400kHzまでの範囲内の周波数を有する、神経刺激装置。
(9)実施態様(8)に記載の神経刺激装置において、
前記搬送波波形は、正弦波波形である、神経刺激装置。
(10)実施態様(1)に記載の神経刺激装置において、
前記第1の波形発生器による前記第1の波形の生成、および前記第2の波形発生器による前記搬送波波形の生成を制御するように構成されたマイクロプロセッサ、
をさらに具備する、神経刺激装置。
バイオフィードバックデータを無線で受信するように構成された受信装置、
をさらに具備し、
前記受信装置は、前記マイクロプロセッサに前記バイオフィードバックデータを供給するために、前記マイクロプロセッサに電気的に接続されている、神経刺激装置。
(12)実施態様(11)に記載の神経刺激装置において、
前記哺乳類の体内に植え込まれた少なくとも一つのバイオフィードバック装置、
をさらに具備し、
前記少なくとも一つのバイオフィードバック装置は、前記哺乳類の体内の一つ以上の生理学的状態を感知するように構成された少なくとも一つのセンサー装置を含む、神経刺激装置。
(13)実施態様(12)に記載の神経刺激装置において、
前記バイオフィードバック装置は、前記センサー装置に電気的に接続された少なくとも一つの伝送装置をさらに含み、
前記バイオフィードバック装置は、前記センサー装置から信号を受信し、前記信号を表現するバイオフィードバックデータを前記哺乳類の体の外側の点に無線で伝送する、ように構成されている、神経刺激装置。
(14)実施態様(13)に記載の神経刺激装置において、
前記バイオフィードバックデータは、前記受信装置を介して、前記マイクロプロセッサに伝送され、
前記マイクロプロセッサは、前記バイオフィードバックデータに少なくとも部分的に基づいて、前記第1および第2の波形発生器を制御する、神経刺激装置。
(15)実施態様(13)に記載の神経刺激装置において、
前記バイオフィードバックデータは、膀胱内圧を表現する、神経刺激装置。
(16)実施態様(13)に記載の神経刺激装置において、
前記バイオフィードバックデータは、腹圧を表現する、神経刺激装置。
(17)哺乳類の予め決められた神経を刺激する方法において、
前記予め決められた神経を刺激することができる周波数を有する第1の波形を生成する過程と、
前記哺乳類の組織を通過することができる周波数を有する搬送波波形を生成する過程と、
前記第1の波形を前記搬送波波形で変調して、変調された信号を生成する過程と、
前記変調された信号を前記哺乳類の皮膚に加える過程と、
を具備する、方法。
(18)実施態様(17)に記載の方法において、
前記変調された信号は、前記哺乳類の体の腹部領域または仙骨領域内で前記哺乳類の皮膚に加えられる、方法。
(19)実施態様(17)に記載の方法において、
前記第1の波形は、ほぼ10Hz〜40Hzまでの範囲内の周波数を有し、
前記搬送波波形は、ほぼ10kHz〜400kHzまでの範囲内の周波数を有する、方法。
(20)実施態様(19)に記載の方法において、
前記第1の波形は、方形波である、方法。
前記搬送波波形は、正弦波波形である、方法。
(22)実施態様(17)に記載の方法において、
少なくとも一つのセンサーを前記哺乳類の体内に植え込む過程と、
前記体内の一つ以上の生理学的特性を感知するために植え込まれた前記センサーを用いる過程と、
感知された前記生理学的特性を表現するバイオフィードバックデータを無線で伝送する過程と、
前記第1の波形発生器による前記第1の波形の生成、および前記第2の波形発生器による前記搬送波波形の生成を制御するために、前記バイオフィードバックデータを用いる過程と、
をさらに具備する、方法。
(23)実施態様(22)に記載の方法において、
前記バイオフィードバックデータは、マイクロプロセッサに伝送され、
前記マイクロプロセッサは、前記第1および第2の波形発生器に電気的に接続され、前記第1および第2の波形発生器を制御する、方法。
(24)実施態様(17)に記載の方法において、
前記信号を加える過程の前に、導電性ゲルを前記哺乳類の体内の通路内に注入する過程であって、前記通路は、前記哺乳類の前記皮膚のほぼ表面に設けられた第1の端部から、前記予め決められた神経に近接して位置付けられた第2の端部まで延びている、過程、
をさらに具備し、
前記信号を加える過程は、
前記通路の前記第1の端部内の前記導電性ゲルとほぼ電気的に接触した位置で、変調された前記波形を加える過程、
をさらに含む、方法。
(25)実施態様(24)に記載の方法において、
前記通路の前記第2の端部は、前記予め決められた神経にほぼ隣接して位置付けられていて、
前記導電性ゲルは、前記通路をほぼ満たしている、方法。
(26)実施態様(25)に記載の方法において、
前記予め決められた神経は、陰部神経である、方法。
(27)神経刺激装置において、
ほぼ10Hz〜40Hzまでの範囲内の周波数を有する第1の波形を生成するように構成された、第1の波形発生器と、
ほぼ10kHz〜400kHzまでの範囲内の周波数を有する搬送波波形を生成するように構成された、第2の波形発生器と、
前記第1の波形および前記搬送波波形を変調し、それによって変調された波形を生成するために、前記第1および第2の波形発生器に電気的に接続された、変調装置と、
前記変調装置に電気的に接続され、哺乳類の皮膚に前記変調された波形を加えるために前記哺乳類の前記皮膚にほぼ隣接して位置付けられる、電極と、
を具備する、神経刺激装置。
(28)実施態様(27)に記載の神経刺激装置において、
前記第1および第2の波形発生器ならびに前記変調装置は、パッチ内に位置付けられていて、
前記パッチは、前記パッチを前記皮膚に留めるために、接着性表面を有する、神経刺激装置。
(29)実施態様(27)に記載の神経刺激装置において、
前記第1の波形は、方形波である、神経刺激装置。
(30)実施態様(29)に記載の神経刺激装置において、
前記搬送波波形は、正弦波波形である、神経刺激装置。
前記第1および第2の波形発生器に電気的に接続されたマイクロプロセッサと、
前記マイクロプロセッサに電気的に接続されていて、伝送されたバイオフィードバックデータを受信し、前記バイオフィードバックデータを前記マイクロプロセッサに供給する、ように構成された、受信装置と、
をさらに具備する、神経刺激装置。
(32)実施態様(31)に記載の神経刺激装置において、
前記哺乳類の体内に植え込まれた少なくとも一つのバイオフィードバック装置、
をさらに具備し、
前記バイオフィードバック装置は、
前記哺乳類の前記体内の一つ以上の生理学的特性を感知するように構成された、少なくとも一つのセンサーと、
前記センサーに電気的に接続されていて、感知された前記生理学的特性を表現する信号を受信し、感知された前記生理学的特性を表現するバイオフィードバックデータを第2の位置へ伝送する、ように構成された、少なくとも一つの伝送器と、
を含む、神経刺激装置。
(33)哺乳類の予め決められた体の部分を選択的に刺激する経皮的刺激装置において、
前記予め決められた体の部分を刺激するために選択された周波数を有する第1の波形を生成するように構成された、第1の波形発生器と、
前記哺乳類の皮膚および組織を通過して前記予め決められた体の部分に到達することができる周波数を有する第2の搬送波波形を生成するように構成された、第2の波形発生器と、
前記第1および第2の波形発生器に電気的に接続されていて、前記第1の波形および前記第2の搬送波波形を変調して変調された波形を生成するように構成された、変調装置と、
前記変調装置に電気的に接続されていて、前記哺乳類の前記皮膚にほぼ隣接して位置付けられた活性電極であって、前記変調された波形を前記皮膚に加えるように構成されている、活性電極と、
前記哺乳類の前記皮膚にほぼ隣接して位置付けられていて、前記活性電極によって加えられた前記変調された波形を受信するように構成された、戻り電極と、
を具備し、
前記活性電極および前記戻り電極は、加えられた前記変調された波形の少なくとも一部が前記哺乳類の組織をほぼ通過せずに前記活性電極から前記戻り電極まで通過することができるように、互いに対して位置付けられている、装置。
(34)実施態様(33)に記載の装置において、
前記活性電極および前記戻り電極は、前記哺乳類の皮膚に固定されることができるパッチ内に収容されている、装置。
(35)実施態様(33)に記載の装置において、
前記予め決められた体の部分は、神経、または、神経の一部、である、装置。
(36)実施態様(35)に記載の装置において、
前記予め決められた体の部分は、陰部神経である、装置。
(37)哺乳類の予め決められた体の部分を選択的に刺激する方法において、
経皮的刺激装置を提供する過程であって、前記装置は、
前記予め決められた体の部分を刺激するために選択された周波数を有する第1の波形を生成するように構成された、第1の波形発生器、
前記哺乳類の皮膚および組織を通過して前記予め決められた体の部分に到達することができる周波数を有する第2の搬送波波形を生成するように構成された、第2の波形発生器、
前記第1および第2の波形発生器に電気的に接続されていて、前記第1の波形および前記第2の搬送波波形を変調して変調された波形を生成するように構成された、変調装置、
前記変調装置に電気的に接続されていて、前記哺乳類の前記皮膚にほぼ隣接して位置付けられた活性電極であって、前記変調された波形を前記皮膚に加えるように構成された、活性電極、ならびに、
前記哺乳類の前記皮膚にほぼ隣接して位置付けられていて、前記活性電極によって加えられた前記変調された波形を受信するように構成された、戻り電極、
を含む、過程と、
加えられた前記変調された波形の少なくとも一部が前記哺乳類の組織をほぼ通過せずに前記活性電極から前記戻り電極まで通過することができるように、前記活性電極および前記戻り電極を、前記哺乳類の前記皮膚にほぼ隣接して、かつ、互いに対して、位置付ける過程と、
前記予め決められた体の部分を刺激するために、前記活性電極を介して前記変調された波形を前記哺乳類の皮膚に加える過程と、
を具備する、方法。
(38)実施態様(37)に記載の方法において、
前記活性電極および前記戻り電極は、パッチ内に収容されている、方法。
(39)実施態様(38)に記載の方法において、
前記位置付ける過程は、
前記哺乳類のほぼ腹部領域または仙骨領域に前記パッチを置く過程、
をさらに含む、方法。
(40)実施態様(37)に記載の方法において、
前記予め決められた体の部分は、神経、または、神経の一部、である、方法。
前記予め決められた体の部分は、陰部神経である、方法。
Claims (27)
- 哺乳類に用いるための神経刺激装置において、
前記哺乳類の予め決められた神経を刺激することができる周波数を有する第1の波形を生成するように構成された、第1の波形発生器と、
前記哺乳類の組織を通過することができる周波数を有する搬送波波形を生成するように構成された、第2の波形発生器と、
前記第1および第2の波形発生器に電気的に接続され、前記第1の波形および前記搬送波波形を変調して変調された波形を生成するように構成された、変調装置と、
前記変調装置に電気的に接続され、前記哺乳類の皮膚にほぼ隣接して位置付けられ、前記変調された波形を前記皮膚に加えるように構成された、電極と、
を具備する、神経刺激装置。 - 請求項1に記載の神経刺激装置において、
前記第1および第2の波形発生器ならびに前記電極は、パッチ装置内に位置付けられていて、
前記パッチ装置は、前記パッチ装置を前記皮膚にしっかりと留めるための、前記パッチ装置の表面に設けられた接着剤を有する、神経刺激装置。 - 請求項1に記載の神経刺激装置において、
導電性ゲル、
をさらに具備し、
前記導電性ゲルは、前記電極とほぼ電気的に接触した位置から、前記哺乳類の組織中の通路を通って、前記予め決められた神経に近接した位置まで、延びている、神経刺激装置。 - 請求項3に記載の神経刺激装置において、
前記導電性ゲルは、前記予め決められた神経にほぼ隣接した、前記哺乳類の体内の位置まで延びている、神経刺激装置。 - 請求項1に記載の神経刺激装置において、
前記予め決められた神経は、陰部神経であり、
前記パッチ装置は、前記哺乳類の体の腹部領域または仙骨領域にほぼ位置付けられている、神経刺激装置。 - 請求項1に記載の神経刺激装置において、
前記第1の波形は、ほぼ10Hz〜40Hzまでの範囲内の周波数を有する、神経刺激装置。 - 請求項6に記載の神経刺激装置において、
前記第1の波形は、方形波である、神経刺激装置。 - 請求項7に記載の神経刺激装置において、
前記搬送波波形は、ほぼ10kHz〜400kHzまでの範囲内の周波数を有する、神経刺激装置。 - 請求項8に記載の神経刺激装置において、
前記搬送波波形は、正弦波波形である、神経刺激装置。 - 請求項1に記載の神経刺激装置において、
前記第1の波形発生器による前記第1の波形の生成、および前記第2の波形発生器による前記搬送波波形の生成を制御するように構成されたマイクロプロセッサ、
をさらに具備する、神経刺激装置。 - 請求項10に記載の神経刺激装置において、
バイオフィードバックデータを無線で受信するように構成された受信装置、
をさらに具備し、
前記受信装置は、前記マイクロプロセッサに前記バイオフィードバックデータを供給するために、前記マイクロプロセッサに電気的に接続されている、神経刺激装置。 - 請求項11に記載の神経刺激装置において、
前記哺乳類の体内に植え込まれた少なくとも一つのバイオフィードバック装置、
をさらに具備し、
前記少なくとも一つのバイオフィードバック装置は、前記哺乳類の体内の一つ以上の生理学的状態を感知するように構成された少なくとも一つのセンサー装置を含む、神経刺激装置。 - 請求項12に記載の神経刺激装置において、
前記バイオフィードバック装置は、前記センサー装置に電気的に接続された少なくとも一つの伝送装置をさらに含み、
前記バイオフィードバック装置は、前記センサー装置から信号を受信し、前記信号を表現するバイオフィードバックデータを前記哺乳類の体の外側の点に無線で伝送する、ように構成されている、神経刺激装置。 - 請求項13に記載の神経刺激装置において、
前記バイオフィードバックデータは、前記受信装置を介して、前記マイクロプロセッサに伝送され、
前記マイクロプロセッサは、前記バイオフィードバックデータに少なくとも部分的に基づいて、前記第1および第2の波形発生器を制御する、神経刺激装置。 - 請求項13に記載の神経刺激装置において、
前記バイオフィードバックデータは、膀胱内圧を表現する、神経刺激装置。 - 請求項13に記載の神経刺激装置において、
前記バイオフィードバックデータは、腹圧を表現する、神経刺激装置。 - 哺乳類の予め決められた神経を刺激する方法において、
前記予め決められた神経を刺激することができる周波数を有する第1の波形を生成する過程と、
前記哺乳類の組織を通過することができる周波数を有する搬送波波形を生成する過程と、
前記第1の波形を前記搬送波波形で変調して、変調された信号を生成する過程と、
前記変調された信号を前記哺乳類の皮膚に加える過程と、
を具備する、方法。 - 神経刺激装置において、
ほぼ10Hz〜40Hzまでの範囲内の周波数を有する第1の波形を生成するように構成された、第1の波形発生器と、
ほぼ10kHz〜400kHzまでの範囲内の周波数を有する搬送波波形を生成するように構成された、第2の波形発生器と、
前記第1の波形および前記搬送波波形を変調し、それによって変調された波形を生成するために、前記第1および第2の波形発生器に電気的に接続された、変調装置と、
前記変調装置に電気的に接続され、哺乳類の皮膚に前記変調された波形を加えるために前記哺乳類の前記皮膚にほぼ隣接して位置付けられる、電極と、
を具備する、神経刺激装置。 - 請求項18に記載の神経刺激装置において、
前記第1および第2の波形発生器ならびに前記変調装置は、パッチ内に位置付けられていて、
前記パッチは、前記パッチを前記皮膚に留めるために、接着性表面を有する、神経刺激装置。 - 請求項18に記載の神経刺激装置において、
前記第1の波形は、方形波である、神経刺激装置。 - 請求項20に記載の神経刺激装置において、
前記搬送波波形は、正弦波波形である、神経刺激装置。 - 請求項18に記載の神経刺激装置において、
前記第1および第2の波形発生器に電気的に接続されたマイクロプロセッサと、
前記マイクロプロセッサに電気的に接続されていて、伝送されたバイオフィードバックデータを受信し、前記バイオフィードバックデータを前記マイクロプロセッサに供給する、ように構成された、受信装置と、
をさらに具備する、神経刺激装置。 - 請求項22に記載の神経刺激装置において、
前記哺乳類の体内に植え込まれた少なくとも一つのバイオフィードバック装置、
をさらに具備し、
前記バイオフィードバック装置は、
前記哺乳類の前記体内の一つ以上の生理学的特性を感知するように構成された、少なくとも一つのセンサーと、
前記センサーに電気的に接続されていて、感知された前記生理学的特性を表現する信号を受信し、感知された前記生理学的特性を表現するバイオフィードバックデータを第2の位置へ伝送する、ように構成された、少なくとも一つの伝送器と、
を含む、神経刺激装置。 - 哺乳類の予め決められた体の部分を選択的に刺激する経皮的刺激装置において、
前記予め決められた体の部分を刺激するために選択された周波数を有する第1の波形を生成するように構成された、第1の波形発生器と、
前記哺乳類の皮膚および組織を通過して前記予め決められた体の部分に到達することができる周波数を有する第2の搬送波波形を生成するように構成された、第2の波形発生器と、
前記第1および第2の波形発生器に電気的に接続されていて、前記第1の波形および前記第2の搬送波波形を変調して変調された波形を生成するように構成された、変調装置と、
前記変調装置に電気的に接続されていて、前記哺乳類の前記皮膚にほぼ隣接して位置付けられた活性電極であって、前記変調された波形を前記皮膚に加えるように構成されている、活性電極と、
前記哺乳類の前記皮膚にほぼ隣接して位置付けられていて、前記活性電極によって加えられた前記変調された波形を受信するように構成された、戻り電極と、
を具備し、
前記活性電極および前記戻り電極は、加えられた前記変調された波形の少なくとも一部が前記哺乳類の組織をほぼ通過せずに前記活性電極から前記戻り電極まで通過することができるように、互いに対して位置付けられている、装置。 - 請求項24に記載の装置において、
前記活性電極および前記戻り電極は、前記哺乳類の皮膚に固定されることができるパッチ内に収容されている、装置。 - 請求項24に記載の装置において、
前記予め決められた体の部分は、神経、または、神経の一部、である、装置。 - 請求項26に記載の装置において、
前記予め決められた体の部分は、陰部神経である、装置。
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CA2611241C (en) | 2015-11-03 |
BRPI0611808A2 (pt) | 2008-12-09 |
KR101266019B1 (ko) | 2013-05-22 |
US20050277998A1 (en) | 2005-12-15 |
MX2007015456A (es) | 2008-02-25 |
AU2006255708A1 (en) | 2006-12-14 |
US8583256B2 (en) | 2013-11-12 |
CN104474633B (zh) | 2017-11-17 |
WO2006132810A2 (en) | 2006-12-14 |
EP1893283A2 (en) | 2008-03-05 |
KR20080028866A (ko) | 2008-04-02 |
EP1893283B1 (en) | 2017-06-21 |
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