JP4845739B2 - 多重セクション式非経口薬物送達装置 - Google Patents
多重セクション式非経口薬物送達装置 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/07—Endoradiosondes
- A61B5/076—Permanent implantations
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
- A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M2039/0205—Access sites for injecting media
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3507—Communication with implanted devices, e.g. external control
- A61M2205/3523—Communication with implanted devices, e.g. external control using telemetric means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3561—Range local, e.g. within room or hospital
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3569—Range sublocal, e.g. between console and disposable
Description
本出願は、特許法第119条(e)に基づいて、2003年12月12日に提出された米国仮出願番号第60/529,162号に対する優先権を主張するものである。
幾つかの実施形態において、アクセス・ポートは、効果的には次の主要な3つの構成部分、即ち、a)上記構造体の少なくとも1つの部分上に存在する、例えば少なくとも1つの内腔空間から少なくとも幾つかの身体組織へ至る流体経路である、1つ以上の非経口流体送達ロケーションと、b)上記アクセス・ポート内に流体通路を供給する1つ以上の内腔空間を有する1つ以上の可撓性管またはカテーテル状の構成物と、c)使い捨てセクションと上記アクセス・ポート内の少なくとも1つの内腔空間との間に、例えば流体通路である少なくとも1つの流体伝達路を確立できるように、1つ以上のカテーテル状の構造体が少なくとも1つの使い捨てセクションへ接合することを可能にする、体外の1つ以上の接続ポイントと、を含む。本発明の様々な実施形態では、追加のエレメントが存在する場合もある。
使い捨てセクションを有する本発明の一実施形態を、図1に示す。使い捨てセクション110は、患者に非経口的に投与する1種または複数の治療薬を含む格納エリア114と、このような薬剤を送達するためのポンプ・デバイス112と、このような薬剤の投与を調整するための制御回路116および上記回路およびポンプの電源と、使い捨てセクション110を患者の身体上へ取り付けるための接着部分120とを有する。
DDPの好適な動作態様においては、アクセス・ポートは、遠位端が患者の体内の皮下ロケーションに存在するように、臨床医により、トロカール状のツールを使用して設置される。第1の使い捨てセクションは、患者へ取り付けられ、アクセス・ポートへ接続される。使い捨てセクションの回路を使用するプラットフォームの起動は、接続時に実行される。このような起動には、アクセス・ポートへの接続が達成されているという検証、包含される命令に従った治療薬送達の開始、およびDDPが起動されていて治療薬の基質が送達スケジュール通りに送達されているという情報の送信が含まれてもよいが、これに限らない。このような情報は、LANを介してローカル・ディスプレイ/データ入力デバイスへ送信され、かつ/またはロギングおよび外部審査のために遠隔のデータ管理システムへさらに送信されてもよい。
Claims (26)
- 非経口治療薬の送達デバイスであって、
内腔空間、前記内腔空間の近位端に接続される第1の接続ポイント、前記内腔空間の遠位端に接続されて非経口流体の治療薬を患者に送るための生物流体ヘッドを有するアクセス・ポートと、
治療薬を収納するように構成されるリザーバ、ポンプ・デバイス、治療薬の送達を調整するための制御回路、前記第1の接続ポイントと係合するよう構成される第2の接続ポイントを有し、患者の身体へ装着されるように構成される使い捨てセクションと、
を備え、
前記生物流体ヘッドは、前記内腔空間からの流体の通過を許可する複数の通路を有する生物流体ヘッドインサートを含み、前記通路は最も狭いところで1μm未満である、デバイス。 - 前記使い捨てセクションは、トランシーバ回路と、アンテナと、電源と、をさらに有する、請求項1に記載のデバイス。
- 前記制御回路は、治療薬の送達の調整に際して、前記アンテナおよび前記トランシーバ回路を介して受信される信号を利用するように構成される、請求項2に記載のデバイス。
- 前記使い捨てセクションは、入力デバイスをさらに有する、請求項1に記載のデバイス。
- 前記制御回路は、治療薬の送達の調整に際して、前記入力デバイスからの信号を利用するように構成される、請求項1に記載のデバイス。
- 生理学的パラメータを検出するセンサをさらに備える請求項1に記載のデバイス。
- 前記制御回路は、前記センサから受信する信号を処理するように構成される、請求項6に記載のデバイス。
- 前記制御回路は、治療薬の送達の調整に際して、前記センサからの処理された信号を利用するように構成される、請求項7に記載のデバイス。
- 前記使い捨てセクションは、トランシーバ回路とアンテナとをさらに備え、前記制御回路は、処理された信号を前記トランシーバ回路およびアンテナを介して外部デバイスへ中継するように構成される、請求項7に記載のデバイス。
- 前記制御回路は、治療薬の送達に関する情報を前記トランシーバ回路およびアンテナを介して送信するように構成される、請求項2に記載のデバイス。
- 非経口流体の送達デバイスであって、
第1の接続ポイント、前記第1の接続ポイントと流体伝達する内腔空間、生物流体ヘッドを有し、前記生物流体ヘッドは、細胞の内方生長を促進しかつ前記生物流体ヘッドの少なくとも一部の外面における繊維性被包を抑制するための1つ以上の柔軟な有孔材料を有することにより長期埋め込み用として構成される、アクセス・ポートと、
流体を収納するように構成されるリザーバ、ポンプ・デバイス、流体の送達を調整するための制御回路、第2の接続ポイントを有し、患者の身体へ装着するように構成される使い捨てセクションと、
を備え、
前記生物流体ヘッドは、前記内腔空間からの流体の通過を許可する複数の通路を有する生物流体ヘッドインサートを含み、前記通路は最も狭いところで1μm未満である、デバイス。 - 前記生物流体ヘッドは、前記内腔空間から前記生物流体ヘッドの外面へ延びる複数の通路を備える、請求項11に記載のデバイス。
- 前記生物流体ヘッドは、前記複数の通路を備えるインサート構造体を含む、請求項12に記載のデバイス。
- 前記通路の直径は、周辺組織および細胞が前記内腔空間へ侵入する能力を制限する断面寸法を有する、請求項12に記載のデバイス。
- 前記複数の通路の直径は、その長さ方向に添った1つのポイントにおいて約1ミクロン未満の断面寸法を有する、請求項12に記載のデバイス。
- 前記複数の通路の直径は、その長さ方向に添った1つのポイントにおいて約250ナノメートル未満の断面寸法を有する、請求項12に記載のデバイス。
- 前記生物流体ヘッドの外面の少なくとも一部は、当該生物流体ヘッドの少なくとも前記一部における繊維性被包を低減する機能を有する、請求項12に記載のデバイス。
- 前記アクセス・ポートは、前記生物流体ヘッドに近いポイントに配置される第1の電極を有し、前記第1の電極は、前記生物流体ヘッドの当該第1の電極近傍の領域における繊維性被包が最小限に抑えられるように、対電極と共働して電流を発生するように構成される、請求項11に記載のデバイス。
- 前記アクセス・ポートは、対電極をさらに有し、前記第1の電極と前記対電極とは、前記アクセス・ポートの前記対電極近傍の領域へ向かう細胞の移動が増大するように電流を発生させるよう構成される、請求項18に記載のデバイス。
- 前記アクセス・ポートは、周辺組織によって当該アクセス・ポートを安定化させるための安定化機能をさらに備え、前記対電極は前記安定化機能近傍へ配置される、請求項19に記載のデバイス。
- 前記安定化機能は、前記内腔空間の外表面に形成された内方生長カラーを備える、請求項20に記載のデバイス。
- 非経口流体の送達デバイスであって、
非経口流体の治療薬を患者に送るための生物流体ヘッド、内腔を画定するカテーテル状の構造体、第1の接続ポイントを有し、長期埋め込みに適する埋め込み部分と、
流体を収納するように構成されるリザーバ、ポンプ・デバイス、流体の放出を調整するための制御回路、前記第1の接続ポイントと着脱可能式に係合するように構成される第2の接続ポイントを有し、患者の身体へ装着するように構成される使い捨て部分と、
を備え、
前記生物流体ヘッドは、前記内腔からの流体の通過を許可する複数の通路を有する生物流体ヘッドインサートを含み、前記通路は最も狭いところで1μm未満である、デバイス。 - 生理学的パラメータを検出するセンサをさらに備え、
前記制御回路は、前記センサから受信する信号を処理し、かつ流体の放出を調整する際に前記処理された信号を利用するように構成される、請求項22に記載のデバイス。 - 前記埋め込み部分は、周辺組織によって当該アクセス・ポートを安定化させるための安定化機能をさらに有する、請求項22に記載のデバイス。
- 前記安定化機能は、前記カテーテル状の構造体の外表面に形成された内方生長カラーを備える、請求項24に記載のデバイス。
- 前記アクセス・ポートは、対電極と共働して電流を発生させるように構成される第1の電極をさらに備え、前記アクセス・ポートの対電極に近い領域へ向かう細胞の移動を増大させる、請求項22に記載のデバイス。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US52916203P | 2003-12-12 | 2003-12-12 | |
US60/529,162 | 2003-12-12 | ||
PCT/US2004/041208 WO2005058385A2 (en) | 2003-12-12 | 2004-12-09 | Multiple section parenteral drug delivery apparatus |
Publications (2)
Publication Number | Publication Date |
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JP2007513704A JP2007513704A (ja) | 2007-05-31 |
JP4845739B2 true JP4845739B2 (ja) | 2011-12-28 |
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JP2006543964A Expired - Fee Related JP4845739B2 (ja) | 2003-12-12 | 2004-12-09 | 多重セクション式非経口薬物送達装置 |
Country Status (6)
Country | Link |
---|---|
US (2) | US20050197654A1 (ja) |
EP (1) | EP1706170A4 (ja) |
JP (1) | JP4845739B2 (ja) |
AU (1) | AU2004298980B2 (ja) |
CA (1) | CA2552976A1 (ja) |
WO (1) | WO2005058385A2 (ja) |
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US20120041355A1 (en) | 2012-02-16 |
EP1706170A4 (en) | 2010-03-24 |
AU2004298980B2 (en) | 2011-08-18 |
CA2552976A1 (en) | 2005-06-30 |
WO2005058385A3 (en) | 2005-08-18 |
US20050197654A1 (en) | 2005-09-08 |
WO2005058385A2 (en) | 2005-06-30 |
EP1706170A2 (en) | 2006-10-04 |
JP2007513704A (ja) | 2007-05-31 |
AU2004298980A1 (en) | 2005-06-30 |
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