JP5254965B2 - 圧力データ処理機能付き自己制御式胃バンド - Google Patents
圧力データ処理機能付き自己制御式胃バンド Download PDFInfo
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Description
本願は、2006年1月4日付けで出願された国際特許出願第PCT/US2006/000013号の一部継続出願であり、その内容がここに一体のものとして参考に統合される。
1.CardioMems and Tronics Microsystem, SA から入手可能な圧力センサ。
2.CardioMems and Tronics Microsystem, SA から入手可能な、これらの企業が単独に開発した、あるいはInamed(本願の譲受人)と共同して開発した移植可能グレードの応力歪みセンサ。
3.Microstrain株式会社から入手可能なリニアモーションセンサ。
(http://www.microstrain.com/images/sensorman.jpg を参照されたい。その内容に一体のものとして統合される。)
4.Microstrain株式会社から頒布された、2点間距離を測定するための距離センサ。
5.Microstrain株式会社から頒布された、領域に対して生理食塩水により生じた力を測定するためのフォースセンサ。
6.Verichipから入手可能または開発中であるか、VerichipとInamed(本願の譲受人)から入手可能な、低レベル熱源からの温度勾配を測定して、距離を近似する温度センサ。
7.拡張時の延伸に起因したシェル壁厚の減少を検出するためのシェル壁厚ゲージ。
内側拡張可能リング514内の流体の圧力値が予め設定された高圧側の限界値より高いと判断されると、コントローラ826は、センサ822が検出する圧力値が再び所定範囲に入るまで(あるいは高圧側限界値より所定値だけ低い圧力になるまで)、バルブ846,848を開口して、内側拡張可能リング514内の高圧の流体が充填/排出ライン516,517を介して外側リングリザーバ512へ流れるようにして、圧力を(これに伴いリング514の大きさ)調節する。
(a)RHC1150が制御する移植可能なポンプ1170は、電源を自給し、電源をコントローラ1150から供給されなくてもよいこと、
(b)移植可能なポンプ1170は、(所望の容量ではなくて)所望のバンド圧力が得られるまでバンド1190を調節すること、
(c)RHC1150は、ブルートゥースまたはジグビーなどの標準的な無線インターフェイス1158を有し、この無線インターフェイスがRHC1150をRABクレードル1110内の遠隔操作インターフェイス1114に接続され、この遠隔操作インターフェイスがインターフェイス1112および接続ライン1103を介して遠隔のコンピュータまたはコントローラ(図示せず)に接続され、データをダイアルアップアクセスまたは他の通信を可能とし、RHC1150に対する情報を制御すること、
(d)RHC1150は、クレードル1110および無線インターフェイス1158により提供される電話インターフェイスを介して遠隔的なコンピュータからの接続を実現する、コントローラ1156により実行されるネットワークソフトウェアを含むこと、
(e)RHC1150は、ダイアルアップネットワーク接続が電話インターフェイスを介して確立された後に、調節指令を含むRHC1150の全機能に対してウェブによりアクセス可能とする、システムコントローラ1156により実行されるウェブサーバを含み、アクセスするコンピュータに対するソフトウェアに特定のアプリケーションをインストールする必要性を排除すること(たとえば、1つの実施形態では、安全インターネットイクスプローラまたは同様の接続が用いられる。)である。
(a)患者はクレードル1110を標準的な電話コード1103を用いて有効な電話ジャック1102に接続する。このとき臨床医は、通常、遠隔アクセスを試みる前にクレードル/ジャックの電話番号を承知している。
(b)臨床医は、標準的なウィンドウズ(登録商標)のダイアルアップのネットワークソフトウェアを用いて、RABシステム1100にダイアルする。
(c)クレードル1110は、電話インターフェイスおよびモデム回路部1112を有し、電話回線1103に電話受信信号を検出すると、自動的に「電話を取り」、モデムを起動させる。
(d)クレードル1110内のモデム1112は、臨床医のコンピュータモデム(図示せず)との接続を確立する。
(e)クレードル1110は、モデムまたはインターフェイス1114とRAB携帯コントローラ1150との間の無線データリンクを確立し、ネットワークソフトウェア(たとえば、システムコントローラ1156および/または無線インターフェイス1158で実行されるTCP/IPスタック)を有する。
(f)RHC1150は、臨床医のコンピュータとネットワーク接続を確立する。このとき接続は、通常、暗号化され、マイクロソフトのインターネット・イクスプローラの安全な接続などと互換性を有するものである。
(g)臨床医は、自らのコンピュータまたは他の遠隔コントローラにマイクロソフトのインターネット・イクスプローラまたは同様のアプリケーションを起動し、所定のウェブアドレスを用いて、RHC1150上で作動するアプリケーションに基づいてウェブへアクセスし、RHC機能を完全に制御することができる。
(h)臨床医は、適当なアクセスコード(ユーザネームおよび/またはパスワード)を入力した後、通常操作モードで許容されたすべての機能(図15で示す方法1500)を実行する。
(i)そして患者またはRHC1150のオペレータは、臨床医による移植されたポンプアセンブリ1170の遠隔的な調節/制御を支援するためにどのように処理すべきか、RHC画面またはディスプレイ装置上でプロンプト要求される。数多くの場合、無線データリンクは、ブルートゥース、ジグビー、または他の通信プロトコル/技術準拠の内のいずれかである。
移植可能ポンプは、圧電性20PSI(あるいは別の容量)のポンプ、たとえば設計に組み込まれる能動バルブ付きのポンプとして具現化することができる。移植可能なポンプは、長時間移植可能に設計されたカスタム仕様の移植可能な電池により、電力自給型であることが好ましい。ポンプは入口と出口を有する。頑健な設計のために、ポンプ入口に設けたチェックバルブ、およびポンプ出口に設けたチェックバルブは、マイクロチェックバルブなどを用いて、漏れを解消または制御する。圧力解放および圧力均衡のために、このシステムは、圧電性バルブまたは能動バルブなど用いてもよい。このシステムは、流体をリザーバからバンドへ直接的に送出して、バンド圧力を変更する。バンド圧力の解放は個別のサブシステムを用いて実現される。バンド内の圧力の増大は、ポンプを用いて直接的に行われ、バンド内の圧力の減少は、圧力解放した後、適正な圧力値まで再度ポンプ送出することにより実現される。
Claims (16)
- 移植可能な胃バンドを患者の体内に移植するための胃バンド調節装置であって、
胃バンドの拡張可能部分のルーメン内にある流体の圧力を検出するセンサと、
ルーメンに接続されたポンプアセンブリと、
胃バンドの圧力検出値および圧力目標値に基づいてルーメン内にある流体の容量を調整するようにポンプアセンブリを操作するコントローラと、
圧力検出値を処理し、圧力検出値の処理結果に基づいて圧力目標値を設定する圧力調節モジュールとを備え、
圧力検出値の処理には、流体の容量を第1および第2の容量としたときの流体の容量の最小圧力と最大圧力とを含む圧力変動を特定することが含まれ、
圧力目標値は、流体の容量を第1および第2の容量としたとき、それぞれの流体の容量において複数回検出された一連の圧力検出値に対して圧力調節モジュールが分析した圧力検出値のデータ分析結果に基づいて得られた許容可能な圧力以下の圧力であるか、または許容可能な圧力範囲内の圧力に相当し、
圧力目標値を設定することには、
・流体の容量を第1の容量としたときの圧力変動が、圧力調節モジュールの最大許容可能圧力変動より小さくなるように特定すること、
・流体の容量を第2の容量としたときの圧力変動が、少なくとも前記最大許容可能圧力変動とほぼ同程度となるように特定すること、および
・第1の流体の容量に対応するように圧力目標値を設定することが含まれることを特徴とする胃バンド調節装置。 - 請求項1に記載の胃バンド調節装置であって、
圧力調節モジュールは、圧力変動を事前設定された最大許容可能圧力変動より小さくするように拡張可能部分内に充填する流体の充填容量を決定するために圧力検出値を処理することを特徴とする胃バンド調節装置。 - 請求項2に記載の胃バンド調節装置であって、
事前設定された最大の圧力変動が約0.3PSIより小さいことを特徴とする胃バンド調節装置。 - 請求項2に記載の胃バンド調節装置であって、
圧力調節モジュールは、流体の充填容量より少量のわずかな量の流体が拡張可能部分に充填された後に、流体の充填容量を決定することを特徴とする胃バンド調節装置。 - 請求項1に記載の胃バンド調節装置であって、
コントローラは、圧力検出値から検出された流体圧力が圧力下限値より低いとき、ルーメン内にある流体の容量を増大させ、検出された流体圧力が圧力上限値より高いとき、ルーメン内にある流体の容量を低減させることにより、圧力目標値が圧力下限値と圧力上限値の間に含まれるように制御することを特徴とする胃バンド調節装置。 - 請求項5に記載の胃バンド調節装置であって、
圧力調節モジュールは、圧力下限値と圧力上限値を記憶するためのメモリを有し、
圧力調節モジュールは、検出された流体圧力が圧力下限値と圧力上限値の間にあるか否かを判断するように機能し、
圧力が圧力下限値と圧力上限値との間にある圧力目標値となるまで、ポンプアセンブリはコントローラにより作動することを特徴とする胃バンド調節装置。 - 請求項5に記載の胃バンド調節装置であって、
患者の外部にあるモニタデバイスから指令信号を受信するための通信モジュールをさらに有し、
指令信号は、新規の圧力下限値、新規の圧力上限値、および新規の圧力目標値のうちの少なくとも1つのものに関する信号を有し、
新規の圧力下限値、新規の圧力上限値、および新規の圧力目標値は、メモリ内に記憶され、その後に圧力調節モジュールが圧力検出値を処理するときに利用されることを特徴とする胃バンド調節装置。 - 請求項1に記載の胃バンド調節装置であって、
ルーメン内の流体容量を調節する際に用いられる所定容量の流体を貯蔵するように構成された流体リザーバをさらに有し、
流体リザーバは、ポンプアセンブリと流体連通することを特徴とする胃バンド調節装置 - 請求項1に記載の胃バンド調節装置であって、
胃バンド調節装置のコントローラと通信して、ポンプアセンブリを操作する指令信号を供給するとともに、胃バンド調節装置のコントローラにより得られた、圧力調節モジュールにより特定された情報を収集するローカルコントローラをさらに有し、
圧力検出値の少なくとも一部がローカルコントローラの表示部品上にグラフで表されることを特徴とする胃バンド調節装置。 - 請求項1に記載の胃バンド調節装置であって、
胃バンド調節装置のコントローラに連結された通信モジュールと、
圧力検出値および圧力調節モジュールによる処理結果に基づいて流体の容量を調節するために、ルーメンに作動可能に接続された手動ポートとをさらに有し、
圧力検出値および圧力調節モジュールによる処理結果はともに、少なくとも部分的に外部モニタデバイスに送信され、外部モニタデバイス上に表示されることを特徴とする胃バンド調節装置。 - 移植可能な胃バンドを患者の体内に移植するための胃バンド調節装置であって、
胃バンドの拡張可能部分のルーメン内にある流体の圧力を検出するセンサと
患者の体内にある胃バンドによりルーメン近傍で形成されるストーマを調節する手段と、
胃バンドの圧力検出値および圧力目標値に応じて調節手段を操作するコントローラと、
圧力検出値を処理し、圧力検出値の処理結果に基づいて圧力目標値を設定する圧力調節モジュールとを備え、
圧力検出値の処理には、流体の容量を第1および第2の容量としたときの流体の容量の最小圧力と最大圧力とを含む圧力変動を特定することが含まれ、
圧力目標値は、流体の容量を第1および第2の容量としたとき、それぞれの流体の容量において複数回検出された一連の圧力検出値に対して圧力調節モジュールが分析した圧力検出値のデータ分析結果に基づいて得られた許容可能な圧力以下の圧力であるか、または許容可能な圧力範囲内の圧力に相当し、
圧力目標値を設定することには、
・流体の容量を第1の容量としたときの圧力変動が、圧力調節モジュールの最大許容可能圧力変動より小さくなるように特定すること、
・流体の容量を第2の容量としたときの圧力変動が、少なくとも前記最大許容可能圧力変動とほぼ同程度となるように特定すること、および
・第1の流体の容量に対応するように圧力目標値を設定することが含まれることを特徴とする胃バンド調節装置。 - 請求項11に記載の胃バンド調節装置であって、
圧力調節モジュールは、圧力変動を事前設定された最大許容可能圧力変動より小さくするように拡張可能部分内に充填する流体の充填容量を決定するために圧力検出値を処理することを特徴とする胃バンド調節装置。 - 請求項12に記載の胃バンド調節装置であって、
事前設定された最大の圧力変動が約0.3PSIより小さいことを特徴とする胃バンド調節装置。 - 請求項11に記載の胃バンド調節装置であって、
コントローラは、圧力検出値から検出された流体圧力が圧力下限値以下であるとき、ストーマがより小さくなるように調節手段を操作し、検出された流体圧力が圧力上限値以上であるとき、ストーマがより大きくなるように調節手段を操作することにより、圧力目標値が圧力下限値と圧力上限値の間に含まれるように制御することを特徴とする胃バンド調節装置。 - 請求項14に記載の胃バンド調節装置であって、
圧力調節モジュールは、圧力下限値、圧力上限値、および圧力目標値を記憶するためのメモリを有することを特徴とする胃バンド調節装置。 - 請求項15に記載の胃バンド調節装置であって、
患者の外部にあるモニタデバイスから指令信号を受信するための通信モジュールをさらに有し、
指令信号は、新規の圧力下限値、新規の圧力上限値、および新規の圧力目標値のうちの少なくとも1つのものに関する信号を有し、
新規の圧力下限値、新規の圧力上限値、および新規の圧力目標値は、メモリ内に記憶され、その後に圧力調節モジュールが圧力検出値を処理するときに利用されることを特徴とする胃バンド調節装置。
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US20110275887A1 (en) | 2011-11-10 |
EP2032094B1 (en) | 2012-08-15 |
ATE539715T1 (de) | 2012-01-15 |
CN101505690B (zh) | 2012-06-20 |
HK1126954A1 (en) | 2009-09-18 |
AU2007260917A1 (en) | 2007-12-27 |
BRPI0713091A2 (pt) | 2012-10-16 |
ES2380068T3 (es) | 2012-05-08 |
CN101505690A (zh) | 2009-08-12 |
WO2007149992A1 (en) | 2007-12-27 |
CA2657994A1 (en) | 2007-12-27 |
KR20090028632A (ko) | 2009-03-18 |
EP2319467A1 (en) | 2011-05-11 |
EP2319467B1 (en) | 2012-01-04 |
US20070156013A1 (en) | 2007-07-05 |
JP2009540964A (ja) | 2009-11-26 |
US8043206B2 (en) | 2011-10-25 |
EP2032094A1 (en) | 2009-03-11 |
US8905915B2 (en) | 2014-12-09 |
ES2392886T3 (es) | 2012-12-14 |
MX2008016279A (es) | 2009-01-15 |
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