JP2015521495A - 過活動膀胱の診断および治療のためのデバイス、システム、および方法 - Google Patents
過活動膀胱の診断および治療のためのデバイス、システム、および方法 Download PDFInfo
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Abstract
Description
本出願は、本明細書にその全体が参照により組み込まれている、2012年6月14日に出願したLandy Tothらの米国仮出願第61/659,463号、名称「Devices,systems,and methods for diagnosis and treatment of overactive bladder」の利益および優先権を主張する国際出願である。
Claims (74)
- 膀胱機能を神経調節するための手術道具であって、
尿道を通して膀胱内に挿入される構成および寸法を有する細長送達部材と、
前記送達部材と結合された治療送達要素であって、標的領域に治療を施すため膀胱壁の前記標的領域内の組織と接触するように構成された治療送達要素と、
前記送達部材と電気的に、および機械的に結合された1つまたは複数の感知先端部であって、前記膀胱壁および/または前記尿道の1つまたは複数の組織表面と接触するように構成され、前記治療を行う前、行っている間、および/または行った後に前記組織表面に関連する1つまたは複数の電気生理学的信号を伝送するように構成された1つまたは複数の感知先端部とを備える手術道具。 - 前記電気生理学的信号は、水濃度、組織緊張、誘発電位、遠隔刺激神経活動、圧力刺激神経応答、電気的に刺激された移動、交感神経活性、筋電図信号[EMG]、筋音図信号[MMG]、局所電場電位、電子音響事象、血管拡張、膀胱壁剛性、筋交感神経活動[MSNA]、中枢交感神経衝動、神経連絡、またはこれらの組み合わせのうちの1つまたは複数に関係する、請求項1に記載の手術道具。
- 前記感知先端部のうちの1つまたは複数は、前記治療送達要素を備える、請求項1または2に記載の手術道具。
- 前記組織表面の少なくとも1つは、前記標的領域と実質的に一致する、請求項3に記載の手術道具。
- 前記感知先端部のうちの1つまたは複数は、前記関連する組織表面と接触するように構成された1つまたは複数の電極を備える、請求項1乃至4のいずれか1項に記載の手術道具。
- 前記電極のうちの1つまたは複数は、付勢され当接したときに前記関連する組織表面内に突き出るように構成された、エンボス加工され、メッキされ、および/またはフィラメント装填された構造物をその上に備える、請求項5に記載の手術道具。
- 前記感知先端部のうちの1つまたは複数は、マイクロ回路と電気的に結合され、前記マイクロ回路は前記信号を調整するように構成されている、請求項1乃至6のいずれか1項に記載のマイクロ手術道具。
- 前記マイクロ回路は、前記手術道具内に埋め込まれ、前記電気的結合の少なくとも一部は、前記送達部材を介して用意される、請求項7に記載の手術道具。
- 1つまたは複数の感知先端部は、1つまたは複数の針電極および/または1つまたは複数のウィスカーを備え、そのそれぞれが特徴的な長さおよび先端部を有し、前記針電極および/またはウィスカーは前記感知先端部から前記関連する組織表面内に延在するように配置構成される、請求項1乃至8のいずれか1項に記載の手術道具。
- 1つまたは複数の感知先端部は、前記関連する組織表面から筋音図信号(MMG)を生成するように構成された筋音図信号(MMG)感知要素を備える、請求項1乃至9のいずれか1項に記載の手術道具。
- 1つまたは複数の感知先端部は、組織緊張信号を生成するように構成された、コンプライアンス・センサーを備える、請求項1乃至10のいずれか1項に記載の手術道具。
- 1つまたは複数の感知先端部は、前記関連する組織表面と接触するように構成された微小電極を備え、前記微小電極は5000sqμm未満、1000sqμm未満、250sqμm未満、または100sqμm未満の面積を有する、請求項1乃至11のいずれか1項に記載の手術道具。
- 1つまたは複数の感知先端部および/または前記治療送達要素は、前記関連する組織表面および/または標的領域への刺激および/またはアブレーションをそれぞれ行うように構成されている、請求項1乃至12のいずれか1項に記載の手術道具。
- 前記感知先端部および/または前記治療送達要素の1つまたは複数は、前記関連する組織表面および/または標的領域への電気的刺激および/またはアブレーションをそれぞれ行うように構成されている、請求項13に記載の手術道具。
- 前記感知先端部および/または前記治療送達要素の1つまたは複数は、前記関連する組織表面および/または標的領域への機械的刺激および/または超音波アブレーションをそれぞれ行うように構成されている、請求項13に記載の手術道具。
- 1つまたは複数の感知先端部は、前記組織表面および/または標的領域に対する前記刺激および/またはアブレーションの効果を監視するように構成されている、請求項13乃至15のいずれか1項に記載の手術道具。
- 前記治療送達要素は治療剤を前記標的領域に送達するように構成されている、請求項1乃至16のいずれか1項に記載の手術道具。
- 前記感知先端部の1つまたは複数は、前記標的領域に対する前記治療剤の前記効果を監視するように構成されている請求項17に記載の手術道具。
- 前記治療剤は、化学薬品、原薬、神経調節物質、神経遮断物質、酸、塩基、除神経剤、またはこれらの組み合わせから選択される、請求項17または18に記載の手術道具。
- 前記治療剤は、神経毒、ボツリヌス毒素、テトロドトキシン、テトラエチルアンモニウム、クロロトキシン、クラーレ、コノトキシン、ブンガロトキシン、ヒ素、アンモニア、エタノール、ヘキサン、一酸化窒素、グルタミン酸塩、レシニフェラトキシン、アルコール、フェノール、カプサイシン、麻酔薬、リドカイン、破傷風菌毒素、第四級アンモニウム塩、パッチークラーレ、レプトクラーレ、アセチルコリン、アミノステロイド、またはこれらの組み合わせから選択される、請求項17乃至19のいずれか1項に記載の手術道具。
- 前記送達部材は、前記膀胱と前記膀胱の外側に配置された流体源との間を流体的に連通させるための管腔を備える、請求項1乃至20のいずれか1項に記載の手術道具。
- 前記送達部材に機械的に結合され、流体を充填されたときに前記膀胱壁と接触する構成および寸法を有するバルーンを備え、前記感知先端部および/または前記試料送達要素の1つまたは複数は前記バルーンに取り付けられ、前記バルーンを充填した後に前記関連する組織表面および/または標的領域と接触するように配置構成される、請求項1乃至21のいずれか1項に記載の手術道具。
- 前記送達部材は、前記バルーンと前記膀胱の外側に位置決めされた流体源との間を流体的に連通させるように配置構成されている管腔を備える、請求項22に記載の手術道具。
- 前記バルーンと流体的に連通する、前記バルーン充填圧力を測定するように構成された圧力センサーを備える、請求項22または23に記載の手術道具。
- 1つまたは複数の感知先端部は、前記バルーンと前記関連する組織表面との間の界面圧力を測定するように構成されている、請求項22乃至24のいずれか1項に記載の手術道具。
- 前記治療送達要素は、熱的エネルギーを前記標的領域に送達するように構成されている、請求項1乃至25のいずれか1項に記載の手術道具。
- 前記治療送達要素は、無線周波エネルギーを前記標的領域に送達するように構成されている、請求項1乃至25のいずれか1項に記載の手術道具。
- 前記送達部材と電気的にかつ機械的に結合され、前記膀胱内から配置された後に前記膀胱壁に対して少なくともその一部を付勢するように構成された、実質的に細長い構造および長さを有するマイクロフィンガーを備える、請求項1乃至27のいずれか1項に記載の手術道具。
- 前記マイクロフィンガーは、前記膀胱内から配置された後に前記膀胱壁の方へ前記感知先端部を付勢するように構成された、前記感知先端部のうちの1つを備える、請求項28に記載の手術道具。
- 前記マイクロフィンガーは、前記長さに沿って延在する電気伝導性コアと前記コアの周りにある電気的絶縁クラッド層とを備える、請求項28または29に記載の手術道具。
- 100個より多いマイクロフィンガー、500個より多いマイクロフィンガー、または1,000個より多いマイクロフィンガーを備える、請求項28乃至30のいずれか1項に記載の手術道具。
- 前記標的領域および/または前記組織表面の1つまたは複数に組織造影剤を送達するように構成されている、請求項1乃至31のいずれか1項に記載の手術道具。
- 前記信号、前記標的領域、または前記組織表面の1つまたは複数の可視化を使用者に伝送するように構成されたディスプレイに結合される、請求項1乃至32のいずれか1項に記載の手術道具。
- 前記膀胱に関する尿流動態検査を実施するように構成され、前記感知先端部の1つまたは複数は前記関連する組織表面および/または前記標的領域に対する尿流動態検査の効果を監視するように構成されている、請求項1乃至33のいずれか1項に記載の手術道具。
- 前記標的領域を生成するために前記信号を分析するように構成された処理装置を備える、請求項1乃至34のいずれか1項に記載の手術道具。
- 前記治療送達要素は、排尿、失禁、頻尿、疼痛、夜間頻尿、または膀胱容量のうちの少なくとも1つを調節するように構成されている、請求項1乃至35のいずれか1項に記載の手術道具。
- 前記治療送達要素は、前記膀胱壁の少なくとも一部における神経活動を調節するように構成されている、請求項1乃至36のいずれか1項に記載の手術道具。
- 前記膀胱または尿道の少なくとも一部における電気生理学的活動を調節するための、請求項1乃至37のいずれか1項に記載の手術道具の使用。
- 被験者に対して外科手術を行うための、請求項1乃至37のいずれか1項に記載の手術道具の使用。
- 過活動膀胱(OAB)、間質性膀胱炎(IC)、膀胱癌、または尿管ステント疼痛/排尿機能不全を治療するための、請求項1乃至37のいずれか1項に記載のマイクロ手術道具の使用。
- 膀胱の電気生理学的機能を判定するための方法であって、
尿流動態検査実施時に前記膀胱内の複数の部位における電気生理学的活動を監視することと、
前記尿流動態検査時に膀胱充填圧力または容積のうちの1つまたは複数を監視することと、
前記監視されている活動を前記充填圧力または容積と比較することとを含む方法。 - 前記監視されている電気生理学的活動および膀胱充填圧力または容積から計量を生成することを含み、前記計量は前記膀胱の電気生理学的機能を表す、請求項41に記載の方法。
- 前記部位のうちの1つで測定された活動を前記計量と比較して前記部位に異常な活動があるかどうかを判定することを含む、請求項42に記載の方法。
- 前記監視されている活動だけから、または前記計量と組み合わせて、前記膀胱の前記電気生理学的機能性のマップを生成することを含む、請求項41乃至43のいずれか1項に記載の方法。
- 前記部位の1つまたは複数に治療が効くかどうかを判定することを含む、請求項41乃至43のいずれか1項に記載の方法。
- 神経遮断を前記部位の1つまたは複数に施すことと、前記膀胱の電気生理学的機能を再評価することとを含む、請求項41乃至45のいずれか1項に記載の方法。
- 前記神経遮断の前後の活動を比較して永久的な外科手術が必要とされるかどうかを判定することを含む、請求項46に記載の方法。
- 前記ステップのうちの1つまたは複数は、請求項1乃至37のいずれか1項に記載の手術道具を使用して行われる、請求項41乃至47のいずれか1項に記載の方法。
- 膀胱機能を調節するための方法であって、
前記膀胱内の1つまたは複数の部位における第1の電気生理学的活動を監視することと、
前記膀胱の標的領域に治療を施すことと、
前記膀胱内の1つまたは複数の部位における第2の電気生理学的活動を監視することと、
前記第1の監視されている活動と前記第2の監視されている活動とを比較して前記治療が成功したかどうかを判定することを含む方法。 - 追加の治療を前記標的領域に施すこと、および/または前記治療が不成功であると判定された場合に治療を代替的標的領域に施すことを含む、請求項49に記載の方法。
- 前記第1の監視されている活動に基づき前記標的領域を選択することを含む、請求項49または50に記載の方法。
- 前記第2の監視されている活動に少なくとも部分的に基づき代替的標的領域を選択することを含む、請求項49乃至51のいずれか1項に記載の方法。
- 前記監視されている電気生理学的活動は、水濃度、組織緊張、誘発電位、遠隔刺激神経活動、圧力刺激神経応答、電気的に刺激された移動、交感神経活性、筋電図信号[EMG]、筋音図信号[MMG]、局所電場電位、電子音響事象、血管拡張、膀胱壁剛性、筋交感神経活動[MSNA]、中枢交感神経衝動、膀胱、尿道、脊椎、子宮、もしくは直腸の付近で測定されるような神経連絡を含む、請求項49乃至52のいずれか1項に記載の方法。
- 前記第1の監視されている活動を使用して前記膀胱内の電気生理学的活動をマッピングすることを含む、請求項49乃至53のいずれか1項に記載の方法。
- 前記膀胱と神経的に、および/または神経筋的に連通する組織に刺激を印加することを含む、請求項49乃至54のいずれか1項に記載の方法。
- 前記刺激を印加する前、印加している間、印加した後の電気生理学的活動を記録して前記膀胱に対するその効果を判定することを含む、請求項55に記載の方法。
- 神経遮断を前記膀胱の一領域に施すことを含む、請求項49乃至56のいずれか1項に記載の方法。
- 前記神経遮断を行う前、行っている間、行った後の電気生理学的活動を記録して前記膀胱に対するその効果を判定することを含む、請求項57に記載の方法。
- 前記神経遮断によって引き起こされる電気生理学的活動の変化が望ましいものかどうかを評価して、もしそうならば、十分な治療を前記領域に施して実質的に不可逆的な神経遮断を形成することを含む、請求項57乃至58のいずれか1項に記載の方法。
- 治療は、無線周波電流、冷凍アブレーション、超音波、マイクロ波、化学剤、または熱的エネルギーの形態で施される、請求項49乃至59のいずれか1項に記載の方法。
- 前記ステップのうちの1つまたは複数は、請求項1乃至37のいずれか1項に記載のマイクロ手術道具を使用して行われる、請求項49乃至60のいずれか1項に記載の方法。
- 膀胱内の電気生理学的活動を監視するための埋め込み型デバイスであって、
信号を捕捉し伝達するように構成されたマイクロ回路と電力を前記マイクロ回路に供給するための電源またはエネルギー収穫要素とを備えるハウジングであって、前記膀胱内に留置し、前記膀胱の壁に取り付ける構成および寸法を有するハウジングと、
前記膀胱の前記壁と接触するように構成された前記マイクロ回路と電気的に結合された1つまたは複数の感知先端部であって、前記マイクロ回路に前記活動と関連する1つまたは複数の電気生理学的信号を伝送するように構成された1つまたは複数の感知先端部とを備える埋め込み型デバイス。 - 前記電気生理学的信号は、水濃度、組織緊張、誘発電位、遠隔刺激神経活動、圧力刺激神経応答、電気的に刺激された移動、交感神経活性、筋電図信号[EMG]、筋音図信号[MMG]、局所電場電位、電子音響事象、血管拡張、膀胱壁剛性、筋交感神経活動[MSNA]、中枢交感神経衝動、神経連絡、またはこれらの組み合わせのうちの1つまたは複数に関係する、請求項62に記載の埋め込み型デバイス。
- 前記膀胱内の充填圧力を測定するように構成された前記マイクロ回路と電気的に結合された圧力センサーを備える、請求項62または63に記載の埋め込み型デバイス。
- 1つまたは複数の感知先端部は、前記膀胱の前記関連する壁と接触するように構成された微小電極を備え、前記微小電極は5000sqμm未満、1000sqμm未満、250sqμm未満、または100sqμm未満の面積を有する、請求項62乃至64のいずれか1項に記載の埋め込み型デバイス。
- 前記膀胱の前記壁と接触するように配置構成された、前記ハウジングと電気的に結合された1つまたは複数の刺激電極であって、前記膀胱の前記壁に刺激および/またはアブレーション電流を流すように構成された1つまたは複数の刺激電極を備える、請求項62乃至65のいずれか1項に記載の埋め込み型デバイス。
- 複数の刺激電極を備え、それぞれの刺激電極は、前記膀胱の前記壁を介して前記刺激電極のうちの2つまたはそれ以上の電極の間の刺激および/またはアブレーション電流を調整するように構成された前記マイクロ回路と電気的に結合されている、請求項62乃至66のいずれか1項に記載の埋め込み型デバイス。
- 前記感知先端部の1つまたは複数は、前記膀胱の前記壁に対する前記刺激および/またはアブレーション電流の効果を監視するように構成されている、請求項62乃至67のいずれか1項に記載の埋め込み型デバイス。
- 治療剤を前記膀胱の前記壁に送達するように構成されている、請求項62乃至68のいずれか1項に記載の埋め込み型デバイス。
- 前記感知先端部の1つまたは複数は、前記膀胱に対する前記治療剤の前記効果を監視するように構成されている、請求項62乃至69のいずれか1項に記載の埋め込み型デバイス。
- 前記治療剤は、化学薬品、原薬、神経調節物質、神経遮断物質、酸、塩基、除神経剤、またはこれらの組み合わせから選択される、請求項62乃至70のいずれか1項に記載の埋め込み型デバイス。
- 前記治療剤は、神経毒、ボツリヌス毒素、テトロドトキシン、テトラエチルアンモニウム、クロロトキシン、クラーレ、コノトキシン、ブンガロトキシン、ヒ素、アンモニア、エタノール、ヘキサン、一酸化窒素、グルタミン酸塩、レシニフェラトキシン、アルコール、フェノール、カプサイシン、麻酔薬、リドカイン、破傷風菌毒素、第四級アンモニウム塩、パッチークラーレ、レプトクラーレ、アセチルコリン、アミノステロイド、またはこれらの組み合わせから選択される、請求項62乃至71のいずれか1項に記載の埋め込み型デバイス。
- 前記治療剤は、抑制マトリックス内に収められている、請求項62乃至72のいずれか1項に記載の埋め込み型デバイス。
- 前記抑制マトリックスは、少なくとも部分的に生体分解性を有する、請求項62乃至73のいずれか1項に記載の埋め込み型デバイス。
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US20190110732A1 (en) | 2019-04-18 |
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CA2876080C (en) | 2023-03-14 |
AU2013274158A1 (en) | 2015-01-22 |
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