JP2015037595A - 患者の循環系の循環を操作するための装置及び方法 - Google Patents
患者の循環系の循環を操作するための装置及び方法 Download PDFInfo
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Abstract
Description
本出願は、2009年2月12日に出願された米国仮出願番号第61/151,843号、2009年3月6日に出願された米国仮出願番号第61/158,341号、2009年4月17日に出願された米国仮出願番号第61/170,107号、2009年10月9日に出願された米国仮出願番号第61/250,494号及び2009年12月3日に出願された米国仮出願番号第61/266,327号の優先権を主張する。
該当なし
圧電アクチュエータ(直径1インチ)をコントローラユニットにより制御されるプラスチックの筐体内に封入した。筐体は、接着テープをアクチュエータ上に貼ることによりヒト患者の仙骨に取り付けた。15から30分の順応期間の後、振動刺激を開始(20Hz、8ミル(mils)の振幅)し5分のオン/オフサイクルの断続的な刺激として継続させた。THI(全ヘモグロビン指数)を時間に対して記録した。50分後、THIのレベルは水平状態に到達し、刺激が停止した。減少期間及びTHIレベルの基底線への戻りの後、刺激が再開し、267分で新しいサイクルを開始した。装置を自己制御して血流を長期間にわたり増加させることができるよう、血流刺激サイクルを連続動作アルゴリズムの発展に使用することができる。例えば、図13の時間に対するTHIのプロットから、動作の同等なパラメータを有するアクチュエータが皮膚に取り付けられた場合に5分のオン/オフサイクルで50分間駆動され、その後刺激の新しいサイクルが開始する前に200分間停止されたことが分かる。オンとオフのサイクルは、対象間及び体の位置間で変化可能である。この動的特性がどのように対象間及び/又は体の位置間で変化するかについての測定は、長期(数時間から数日)動作における特定のアルゴリズムの発展に使用することができる。本研究では、InSpectra(登録商標)StO2組織酸素化モニタを用いた。類似の装置又は血流測定に使用されるその他の装置を用いて、振動に基づく血流シミュレーションと共に用いられる長期動作アルゴリズムの発展における組織血流、温度、組織酸素化度(oxygenation)又はTHIを測定することができる。
Claims (16)
- 対象の体の部分を覆う寸法に形成された柔軟な支持体と、前記支持体に埋め込まれた又は取り付けられた振動発生素子と、を有する対象の体の循環系の循環を操作する装置であって、
前記支持体が、パッチと、該パッチに設けられた取付け層と、を有し、
前記取付け層が、前記対象の前記体の前記部分の皮膚に前記パッチを取り付ける、生体適合性を有する接着剤を有し、そして、
前記対象の前記体の前記部分の皮膚に前記パッチが取り付けられた時に前記振動発生素子が前記皮膚に振動を伝えるよう、前記振動発生素子が前記支持体の内部又は上に配置され、
前記振動発生素子の振動の周波数が、1Hzから15,000Hzの範囲内であり、これにより血管収縮及び/又は血管拡張を引き起こし、
前記振動発生素子が圧電アクチュエータである
ことを特徴とする対象の体の循環系の循環を操作する装置。 - 前記支持体が開口を有し、該開口の寸法は、前記対象の前記体の前記部分の皮膚の上に前記パッチが配置された時に前記対象の前記体の前記部分の創傷を完全に又は部分的に囲む寸法に形成されていることを特徴とする請求項1記載の対象の体の循環系の循環を操作する装置。
- 電源と、前記振動発生素子及び前記電源と電気通信するコントローラと、をさらに有し、
前記コントローラは、前記振動発生素子の動作のタイミング、周波数、振幅、波形、力及びその他のパラメータを制御する電気信号を前記振動発生素子に提供するために、前記コントローラに格納されたプログラムを実行するよう構成され、
前記電気信号が、(i)単一又は複数の波形、(ii)一方向性又は多方向性、(iii)正弦波、矩形波、パルス、三角波又はそれらの組み合わせである
ことを特徴とする請求項1又は2記載の対象の体の循環系の循環を操作する装置。 - 前記コントローラは、以下のプログラムをさらに実行するよう構成され、該プログラムにより、
(i)第一期間中、前記振動発生素子に前記電気信号を提供することを停止する又は前記振動発生素子に提供される前記電気信号の強度を減少させる又は前記振動発生素子に提供される前記電気信号の強度を増大させ、
(ii)第二期間中、前記振動発生素子への前記電気信号の提供を再開する又は前記振動発生素子に提供される前記電気信号の強度を増大させる又は前記振動発生素子に提供される前記電気信号の強度を減少させる
ことを特徴とする請求項3に記載の対象の体の循環系の循環を操作する装置。 - 第三期間中の前記振動発生素子の振動の周波数、振幅及び力のうちの少なくとも一つが、第一期間中の前記振動発生素子の振動の周波数、振幅及び力と異なることを特徴とする請求項3又は4に記載の対象の体の循環系の循環を操作する装置。
- 前記支持体に埋め込まれた又は取り付けられた第二の振動発生素子と、電源と、前記第一の振動発生素子、前記第二の振動発生素子及び前記電源と電気通信するコントローラと、をさらに有し、
前記コントローラは以下のプログラムを実行するよう構成され、該プログラムにより、
(i)第一期間中、前記振動発生素子に、該振動発生素子の振動の周波数、振幅及び力を制御する第一電気信号を提供し、
(ii)第二期間中、前記振動発生素子に前記第一電気信号を提供することを停止し、
(iii)第三期間中、前記第二の振動発生素子に、該第二の振動発生素子の振動の周波数、振幅及び力を制御する第二電気信号を提供する
ことを特徴とする請求項1又は2に記載の対象の体の循環系の循環を操作する装置。 - 電源と、前記振動発生素子及び前記電源と電気通信するコントローラと、をさらに有し、
前記コントローラは、以下のプログラムを実行するよう構成され、該プログラムにより、
(i)前記振動発生素子に、該振動発生素子の振動の周波数、振幅及び力を制御する第一電気信号を提供し、
(ii)前記振動発生素子の振動の周波数又は振幅又は力のうちの少なくとも一つが変化するよう、前記振動発生素子への前記第一電気信号を変化させる
ことを特徴とする請求項1又は2に記載の対象の体の循環系の循環を操作する装置。 - 前記対象の前記体の第二部分を覆うかん流センサと、電源と、前記振動発生素子及び前記電源及び前記かん流センサと電気通信するコントローラと、をさらに有し、
前記対象の前記体の前記第二部分は、前記対象の前記体の前記一部分に隣接する又は該第一部分の内側にあり、
前記コントローラは、該コントローラに格納されたプログラムを実行するよう構成され、該プログラムにより、
(i)第一期間中、前記振動発生素子に、該振動発生素子の振動の周波数、振幅及び力を制御する第一電気信号を提供し、
(ii)前記かん流センサから受信した第二電気信号に基づいて、前記振動発生素子へ提供される前記第一電気信号を変化させる
ことを特徴とする請求項1又は2に記載の対象の体の循環系の循環を操作する装置。 - 前記かん流センサは、圧電薄膜センサ、温度センサ、光電脈波センサ、歪み計電脈波センサ、レーザドップラセンサ、レーザスペックルセンサ、赤外イメージング、赤外分光器及び超音波センサから選択されることを特徴とする請求項8に記載の対象の体の循環系の循環を操作する装置。
- 前記対象の前記体の第二部分を覆う振動センサと、電源と、前記振動発生素子及び前記電源及び前記振動センサと電気通信するコントローラと、をさらに有し、
前記対象の前記体の前記第二部分は、前記対象の前記体の前記一部分に隣接する又は該第一部分の内側にあり、
前記コントローラは、該コントローラに格納されたプログラムを実行するよう構成され、該プログラムにより、
(i)第一期間中、前記振動発生素子に、該振動発生素子の振動の周波数、振幅及び力を制御する第一電気信号を提供し、
(ii)前記振動センサから受信した第二電気信号に基づいて、前記振動発生素子へ提供される前記第一電気信号を変化させる
ことを特徴とする請求項1又は2に記載の対象の体の循環系の循環を操作する装置。 - 前記支持体が、シリコーン、人工フォーム、ポリエチレン、ポリウレタン、ポリ塩化ビニル、プラスチック、熱可塑性ポリウレタン、ポリプロピレン、織物、ヒドロゲル、コラーゲン、アルギン酸塩、ゼラチン又はそれらの組み合わせから選択される材料から作成されたパッチを備えることを特徴とする請求項1〜10の何れか一項に記載の対象の体の循環系の循環を操作する装置。
- 前記振動発生素子の振動の振幅が0.001ミリメータから2.5ミリメータであることを特徴とする請求項1〜11の何れか一項に記載の対象の体の循環系の循環を操作する装置。
- 前記振動発生素子の振動の力が0.001ニュートンから100ニュートンであることを特徴とする請求項1〜12の何れか一項に記載の対象の体の循環系の循環を操作する装置。
- 前記対象の前記体の前記部分が創傷を含み、
前記創傷が、糖尿病性潰瘍、虚血性潰瘍、静脈性潰瘍、動脈性潰瘍、虚血性創傷、床擦れ、けが、手術、外科的切開痕、手術創傷、やけど、炎症、筋肉損傷、筋肉炎症、筋骨格損傷及び内部損傷からなる群から選択され、
前記対象の体の循環系の循環を操作する装置が、前記創傷を覆うヒドロゲルマトリックスを有し、
前記ヒドロゲルマトリックスが、ポリ乳酸、ポリグリコール酸、その他の多価酸、複数の多価酸の共重合体、ポリオルトエステル、ポリ酸無水物、ゼラチン、コラーゲン、セルロース、誘導体化セルロース、キトサン、アルギン酸塩、チオール修飾ヒアルロナン、エマルジョン及びそれらの組み合わせ又はそれらの共重合体から選択される
ことを特徴とする請求項1〜13の何れか一項に記載の対象の体の循環系の循環を操作する装置。 - 前記支持体の下又は近傍に負圧を加える装置、高圧酸素装置、圧縮装置、衝撃波装置、加熱装置、冷却装置、発光装置、超音波装置、電磁気刺激装置、磁気刺激装置及び電流刺激装置のうちの少なくとも一つをさらに有することを特徴とする請求項1〜14の何れか一項に記載の対象の体の循環系の循環を操作する装置。
- 前記振動発生素子を駆動制御する電源及びコントローラが前記支持体の内部又は上面に設けられていることを特徴とする請求項1〜15の何れか一項に記載の対象の体の循環系の循環を操作する装置。
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JP2012517324A (ja) | 2012-08-02 |
CA2752229A1 (en) | 2010-08-19 |
EP2395958B1 (en) | 2017-12-13 |
ES2662530T3 (es) | 2018-04-06 |
US20120059294A1 (en) | 2012-03-08 |
WO2010093753A1 (en) | 2010-08-19 |
CA2752229C (en) | 2018-11-20 |
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