JP6502612B2 - モジュール式刺激アプリケータシステムおよび方法 - Google Patents
モジュール式刺激アプリケータシステムおよび方法 Download PDFInfo
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- JP6502612B2 JP6502612B2 JP2013550659A JP2013550659A JP6502612B2 JP 6502612 B2 JP6502612 B2 JP 6502612B2 JP 2013550659 A JP2013550659 A JP 2013550659A JP 2013550659 A JP2013550659 A JP 2013550659A JP 6502612 B2 JP6502612 B2 JP 6502612B2
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2205/00—Devices for specific parts of the body
- A61H2205/08—Trunk
- A61H2205/081—Back
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2230/00—Measuring physical parameters of the user
- A61H2230/50—Temperature
- A61H2230/505—Temperature used as a control parameter for the apparatus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
- A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
-
- 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
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
- A61N1/0432—Anode and cathode
- A61N1/044—Shape of the electrode
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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
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
-
- 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
- A61N1/322—Electromedical brushes, combs, massage devices
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Description
米国政府は、米国国立衛生研究所によって与えられた補助金交付1R43CA099305−01A2、2R44CA099305−02および2R44CA099305−03の約定によって規定されるように、この発明における一括払いのライセンス、および限定された状況下で特許所有者が妥当な条件で他にライセンスを与えるように要求する権利を有する。
臨床研究用の刺激ポッドシステムが、熱レベル、間欠性および分布を最適化するように、策定され構築された。刺激ポッドシステムは、ソフトウェアコントローラ、ラップトップコンピュータに対するインストラクションのセット、および様々な刺激ポッドをラップトップコントローラに接続するハードウェアインターフェースを含んでいた。当業者は、モジュール式の刺激アプリケータシステムのために、たとえば市販の専用コントローラ、および刺激ポッドシステムに無線または有線のインターフェースを通じて接続されるスマートフォンまたはタブレットコンピュータに基づくソフトウェアベースのコントローラを含む多くのタイプのコントローラおよびインターフェースを使用することができるはずであることを知っているはずである。ソフトウェアコントローラは、温度変数を制御するために使用された。これらの変数は、
を含む。
図8A〜8Cに、刺激ポッドシステムが、PMSおよび月経困難症(月経期間中に感じる月経痛)を処置するために適用されたときの臨床研究の結果を例示する。PMSは、大きいパーセンテージの女性、すなわち月経期間を経験するすべての女性の50パーセントを超える女性に影響を及ぼしている。女性の約20%から40%が、生活に支障をきたす症状を経験している。これらの女性の約5から15パーセントが、日常の活動を妨げる、ひどい苦痛を感じている。さらに、2.5%から5%の女性が、衰弱させるPMSを経験している。熱は、PMSに付随する差し込みおよび疼痛(背中、腹部および骨盤)を緩和するのに役立てるために使用される、十分に認められている自己処置法である。経験による証拠および公式研究の両方にもかかわらず、PMS緩和に有効なメカニズムまたは熱の適用について、ほとんど知られていない。最近の研究は、低レベルの熱が、PMS疼痛をかなり軽減させることができ、PMSを処置するために使用される鎮痛剤の量を減少させることさえできることを明らかにしている。
図9A〜9Cに、背下部疼痛研究の結果を例示する。全米国人の1/3が、所与の年度の間のある時点で背痛を患っている。慢性痛を患う米国人の見積もられた人数は、1億6千万人からずっと下の方まで幅があるが、しかし、一般に、5千万人に近いとして言及されている。腰痛によって、雇用主は、生産性の損失のために、1年に6百億ドルより多くを失っている。処置の費用をその額に加えた場合、費用は、1年に約1千億ドルと見積もられる。男性および女性が、背痛によって等しく影響される。疼痛は、一部分老化の過程から、しかし、また、いつも座っていて、運動不足である(たまには、運動が多すぎることによって中断される)ライフスタイルの結果として、ほとんどの場合、年齢が30と50歳の間の人に起こる。また、椎間板疾患または脊髄変性から腰痛を経験するリスクは、年齢とともに増加する。背痛は、米国において、2番目に一般的な神経の病気であり、それより一般的なのは頭痛だけである。
Claims (19)
- 患者の身体の様々な部分を処置するためのシステムであって、
前記患者の身体と接触するように構成された接触表面、バッテリ、および刺激ポッドのための制御ロジックを含む回路基板を含む、再充電可能な刺激ポッドであって、前記回路基板は、前記刺激ポッドを通じて前記患者の身体に刺激を送達するための処置計画を決定し、前記処置計画は、上昇動作、最大刺激強度動作、下降動作、刺激浸透動作およびロックアウト期間の少なくとも1つを含む、刺激ポッドと、
前記患者の身体に貼り付けられるように構成された接着性表面、および前記接触表面が孔を貫通して留め具の前記接着性表面を越えて突き出し、そして前記患者の身体を押し付けている状態で、前記刺激ポッドの前記接触表面を受け入れるように構成された前記孔を有する、留め具と、
前記刺激ポッドの前記接触表面が前記患者の身体と接触している状態で、前記刺激ポッドを前記留め具に取り付けられるように構成されたカプラとを含み、
前記刺激ポッドは、前記留め具に取り外し可能に取り付けられ、
前記刺激ポッドは、前記回路基板によって指示されたとき、前記制御ロジックに従って刺激を前記患者の身体に送達するように構成され、
前記刺激は、温度、又は、熱であり、
前記上昇動作は、前記刺激ポッドの加熱表面によって加えられる温度を徐々に上昇させることを含み、
前記最大刺激強度動作は、予め定めた最大エネルギーレベルに前記刺激を維持することを含み、
前記下降動作は、前記刺激を徐々に低下させることを含み、
前記刺激浸透動作は、前記予め定めた最大エネルギーレベルより低い予め定めた浸透刺激レベルに前記刺激を維持することを含む、
前記ロックアウト期間は、前記刺激ポッドからの刺激を中断することを含むことを特徴とするシステム。 - 前記カプラは、磁性リンク、弾力がある機械的なファスナ、マジックテープ(登録商標)、またはねじ付きファスナの少なくとも1つを含むことを特徴とする請求項1に記載のシステム。
- 前記刺激ポッドは、無線通信リンクを含み、
前記システムは、無線通信リンクを通じて、前記刺激ポッドと通信するように構成された制御スタンドをさらに含むことを特徴とする請求項1に記載のシステム。 - 少なくとも1つの刺激ポッドを受け入れ、前記刺激ポッドの前記バッテリに充電するように形作られた複数のソケットを有する充電スタンドをさらに含むことを特徴とする請求項1に記載のシステム。
- 前記接触表面は、平坦なプロフィール、凸状のプロフィール、一連の突起部、または正弦曲線のプロフィールの少なくとも1つを有することを特徴とする請求項1に記載のシステム。
- 前記カプラは、押し付けられて一緒になったときに係合するように構成された弾力のある機械的な突起部/窪みの対を含むことを特徴とする請求項1に記載のシステム。
- 前記カプラは、マジックテープ(登録商標)を含むことを特徴とする請求項1に記載のシステム。
- 前記カプラは、ねじ付きファスナを含むことを特徴とする請求項1に記載のシステム。
- 前記カプラは、
前記留め具中の金属製取り付けリングと結合し、それによって前記刺激ポッドが前記留め具に保持され、
刺激を前記患者の身体に送達する
ように構成された磁化された金属塊を含むことを特徴とする請求項1に記載のシステム。 - 前記カプラは、前記刺激ポッド内の磁石、及び、前記留め具の対応する磁性のリング、前記磁性のリングは、前記磁石に磁気的に係合することを特徴とする請求項1に記載のシステム。
- 前記刺激ポッドの前記接触表面の突起部は、それぞれから分離されることを特徴とする請求項5に記載のシステム。
- 前記刺激ポッドの全体の接触表面は、前記留め具の前記接着性表面を越えて突き出すことを特徴とする請求項1に記載のシステム。
- 患者の身体(人間は除く)に対して複数の再充電可能な無線刺激ポッドを前記刺激ポッドに取り外し可能に取り付けられた留め具を介して位置決めするステップと、
前記刺激ポッドを通じて前記患者の身体(人間は除く)に刺激を送達するための処置計画を決定するステップであって、前記処置計画は、上昇動作、最大刺激強度動作、下降動作、刺激浸透動作およびロックアウト期間の少なくとも1つを含む、ステップと、
前記刺激のアプリケーションを前記複数の刺激ポッドに指示する、操作員の入力を受け取るステップであって、前記操作員の入力は、前記上昇動作、前記下降動作、前記刺激浸透動作および前記ロックアウト期間の中からの選択を含む、ステップと、
前記処置計画および前記操作員の入力に従って前記刺激を送達するように、前記刺激ポッドに指示するステップとを含み、
前記刺激は、温度、又は、熱であり、
前記上昇動作は、前記刺激ポッドの加熱表面によって加えられる温度を徐々に上昇させることを含み、
前記最大刺激強度動作は、予め定めた最大エネルギーレベルに前記刺激を維持することを含み、
前記下降動作は、前記刺激を徐々に低下させることを含み、
前記刺激浸透動作は、前記予め定めた最大エネルギーレベルより低い予め定めた浸透刺激レベルに前記刺激を維持することを含む、
前記ロックアウト期間は、前記刺激ポッドからの刺激を中断することを含むことを特徴とする方法。 - 前記複数の無線刺激ポッドを位置決めするステップは、制御スタンドで、前記刺激ポッドから場所の表示を無線で受け取るステップを含むことを特徴とする請求項13に記載の方法。
- 前記操作員の入力を受け取るステップは、制御スタンドのユーザインターフェースを通じて入力を受け取るステップを含み、
前記刺激ポッドに指示するステップは、制御スタンドから前記刺激を送達するように、前記刺激ポッドに指示するステップを含むことを特徴とする請求項13に記載の方法。 - エネルギー送達レベルを検出するステップと、
前記エネルギー送達レベルを予め定めた閾値と比較するステップとをさらに含み、
前記ロックアウト期間は、前記エネルギー送達レベルが前記予め定めた閾値を超えた場合、適用されることを特徴とする請求項13に記載の方法。 - 前記刺激は、熱であり、
前記方法は、前記刺激ポッドの温度を検出するステップをさらに含み、
前記ロックアウト期間は、前記刺激ポッドの前記温度が予め定めた閾温度より低下するまで継続されることを特徴とする請求項16に記載の方法。 - 前記ロックアウト期間は、前記刺激が予め定めた閾時間より長い間、連続的に加えられた後、始動されることを特徴とする請求項13に記載の方法。
- 前記無線刺激ポッドを位置決めして前記刺激ポッドに指示するステップは、ベーススタンドから指標刺激ポッドに、および前記指標刺激ポッドから少なくとも1つのダミー刺激ポッドに通信するステップを含むことを特徴とする請求項13に記載の方法。
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JP2019034212A (ja) | 2019-03-07 |
EP2665457A4 (en) | 2014-09-17 |
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