JP2015107337A - 薬物送達のための方法及びデバイス - Google Patents
薬物送達のための方法及びデバイス Download PDFInfo
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- JP2015107337A JP2015107337A JP2014265292A JP2014265292A JP2015107337A JP 2015107337 A JP2015107337 A JP 2015107337A JP 2014265292 A JP2014265292 A JP 2014265292A JP 2014265292 A JP2014265292 A JP 2014265292A JP 2015107337 A JP2015107337 A JP 2015107337A
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- 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
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- 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
- A61M5/42—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 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
- A61M5/422—Desensitising skin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
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- A—HUMAN NECESSITIES
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Abstract
【解決手段】接着剤層1によって組織に取り付けられた処理デバイス7は、組織を温めインスリンを温めないようにするために、注射されるインスリン自体に影響を与える温度変更が最小である一方、最大の熱刺激が組織に適用されて、局所血液かん流を増大させるために、加熱要素2はインスリンインフュージョンカテーテル5と接触させず、カテーテルと加熱要素との間には熱的分離物も使用し得る。また、追加の又は代替的な温度センサ3、4が、ケ−ブル6を介して加熱要素及びカテーテルチューブの内部に配置され、薬物注入組織領域の温度がより良好に制御される。
【選択図】図1
Description
本願は、2007年3月19日出願の米国仮出願第60/895,518号、2007年3月19日出願の米国仮出願第60/895,519号、2007年4月19日出願の米国仮出願第60/912,698号、2007年5月30日出願の米国仮出願第60/940,721号、2007年6月21日出願の米国登録特許第11/821,230号、2007年12月18日出願の米国仮出願第61/008,278、2007年8月19日出願の米国仮出願第60/956,700号、2007年9月10日米国号仮出願第60/970,997号、2007年12月18日出願の米国仮出願第61/008,325号、2007、2007年12月18日出願の米国仮出願第61/008,274号、及び2007年12月18日出願の米国仮出願第61/008,277号の優先権を主張する。上記の各開示は、その全体が参照により本明細書に組み入れられる。
本発明は、カテーテルにより組織内へ注入され、血液又はリンパ系内へ吸収される薬物の薬物動態学的及び/又は薬力学的プロファイルを改善、修正及び/又は安定化するためのデバイスに関する。本願のいくつかの実施形態に記載されるデバイスは、薬物送達部位の近辺に追加の処置又は刺激を適用する。処置は、以下の組織処置様式の一つ又は組み合わせであってもよい:加熱、温度の変更、マッサージング、機械的振動、音響振動、超音波、吸引、追加の物質又は化学物質の注入、低電界の適用、低磁場の適用、光照射、赤外線(「RF」)照射、マイクロ波(「MW」)照射、等。いくつかの実施形態において、デバイスは、組織内に挿入して、物質を注入組織領域内へ注入するためのカテーテルを有する。注入組織領域(即ち、注入領域)は、皮膚層若しくは皮下組織、又は任意の器官内若しくは内臓内のより深い組織要素の一つであり得る。
本発明のいくつかの実施形態は、埋め込み式デバイス又は皮膚上に配置されるデバイスの性能を改善するための方法及びデバイスに関する。本発明のデバイスを、センサ、カテーテル又は組織に分泌するモジュールのいずれか(第一のデバイス)として働く埋め込み式デバイス、経皮カテーテル、又は皮膚上に配置されるデバイスに隣接して取り付けることによって、放射源及び/又は熱及び/又は機械的振動及び/又は吸引の組み合わせを、組織に自動的に適用する。本発明のデバイスは、一セクションを組織内に有し、他のセクションを組織の外部のユニットに接続されるカテーテルの部分でもあり得る。個々の励起源の性質、又は励起源の組み合わせ、及び各励起源の性質(例えば振幅、位相、周波数)、並びに様々な励起源間の相対的な比及びタイミングは、プロセッサにより自動的に制御されて、デバイスに隣接する組織からの所望の反応を達成し得る。第一のデバイスの起動は、本発明のデバイスの動作を自動的に始動させ、又は本発明のデバイスが第一のデバイスの動作を検出し、組織に励起を適用することにより動作を開始し、又は本発明のデバイスは、所定の時間に所定の長さの時間動作される。励起に対する組織反応は、第一のデバイスの機能を向上させる。この向上は、第一のデバイスと組織間の分子輸送の動力学の変更(これに限定されない)により誘導され得る。あるいは、励起に対する組織反応は、組織内部に配置されたカテーテル先端と、その周囲の組織との間の分子輸送の動力学を向上させる。
本発明のいくつかの実施形態は、カテーテルにより組織内へ注入され、血液系内へ吸収される薬物の薬物動態学及び薬力学を改善及び安定化するための装置、方法及びデバイスに関する。本明細書に記載する装置及びデバイスは、薬物が注入される組織の領域に追加の処置又は刺激を適用する。追加の処置は、本明細書に記載するように、組織の光照射をより含む電磁放射を含む。
いくつかの実施形態において、本発明は、カテーテルにより組織内に注入され、血液又はリンパ系内に吸収される薬物の薬物動態学的及び/又は薬力学的プロファイルを改善、修正及び/又は安定化するためのデバイスに関する。本願のいくつかの実施形態に記載したデバイスは、薬物送達部位の近辺に追加の処置又は刺激を適用する。処置は、米国特許出願第11/812,230号に記載されている組織処置様式、例えば:加熱、温度の変更、マッサージング、機械的振動、音響振動、超音波、吸引、追加の物質又は化学物質の注入、低電界の適用、低磁場の適用、光照射、無線周波(「RF」)照射、マイクロ波(「MW」)照射等の一つ又は組み合わせであってもよい。いくつかの実施形態において、デバイスは組織内に挿入して物質を注入組織領域内に注入するためのカテーテルを有する。注入組織領域(即ち、注入領域)は、皮膚層又は皮下組織、又は任意の器官内若しくは内臓内のより深い組織要素の一つであり得る。
図面を参照すると、図40A〜図40Cは、同一の機能要素を指すために同様の符号が使用される。図40Aは、標的組織への制御された薬物送達のための本発明による薬物送達デバイス4000の概略ブロック図である。薬物送達デバイス4000は、ユーザインターフェイス4002、連絡モジュール4004、コントローラ4006、薬物送達モジュール4008、薬物区画4010、組織処置要素4014、外部薬物供給4012、及びセンサ4016を含む。デバイス4000は身体内部に埋め込まれ、改善された制御可能な薬物送達システムを提供する。埋め込み部位は変更してもよく、標的組織及び送達される薬物に応じて選択される。例えば、デバイス4000は、インスリン薬物送達システム用に、皮下に又は消化管の近傍に埋め込まれ得る。しかしながら、デバイス4000が心血管系用の薬物を含む場合、デバイス4000は、例えば、心血管系の近辺における皮下腔内に埋め込まれ得る。
以下図面を参照すると、図45は、本発明による神経刺激方法と共に使用して標的組織への薬物送達を制御し得る、制御可能な組織神経刺激を有する薬物送達デバイス4500の概略ブロック図である。薬物送達デバイス4500は、コントローラ4502、データベース4504、組織処置要素4508及びセンサ4506を含む。複数の他の構成要素、例えば組織処置要素4518及びセンサ4516は、薬物送達デバイス4500と関連していなくてもよい。薬物送達デバイス4500は、経皮、皮下、埋め込み、又は外部を含むが、これらに限定されない異なる位置に配置され得る。薬物送達デバイス4500の配置は、処置及び送達される薬物に依存する。
Claims (26)
- 患者の身体に治療的物質を送達するためのデバイスであって、
前記患者の身体に位置する挿入部位の身体組織に挿入されるよう構成され、さらに前記治療的物質を前記患者の身体の注入領域に送達するよう構成されたインフュージョンカテーテルであって、前記注入領域が、ある量の前記挿入部位の周囲の身体組織を含むインフュージョンカテーテルと、
患者の皮膚に接着するよう構成され、さらに前記インフュージョンカテーテルを前記患者の皮膚に固定するよう構成されたカテーテル固定要素と、
ハウジングであって、前記治療的物質を前記注入領域に送達するために、前記治療的物質を前記インフュージョンカテーテルに注入するための物質送達デバイスを有するハウジングと、
前記治療的物質の注入を検出するよう構成されたセンサと、
前記注入領域の近辺に処置を適用して、前記治療的物質の薬物動態学的および/または薬力学的プロファイルを変更するよう構成された処置要素と、
前記処置要素と通信し、前記処置要素により前記処置の適用を開始するよう構成された制御装置とを含むことを特徴とするデバイス。 - 請求項1に記載のデバイスにおいて、前記処置が、前記治療的物質の前記患者の身体への送達前、前記治療的物質の前記患者の身体への送達中、および前記治療的物質の前記患者の身体への送達後からなる群から選択される時期に適用されることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記物質送達デバイスが、送達ポンプであることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記処置要素が、前記注入領域に注入される前記治療的物質の作用のより早い開始を可能にすること、前記注入領域に注入される前記治療的物質の作用のより早いピークを可能にすること、前記注入領域から患者の循環系への前記治療的物質のより早い移動を可能にすること、前記治療的物質の注入に応答する薬物動力学的および/または薬力学的プロファイルの再現性を改善すること、前記治療的物質の患者の血液系および/またはリンパ系への吸収の変動性を低減すること、前記治療的物質の作用の開始の変動性を低減すること、前記治療的物質の作用のピークに至る時間の変動性を低減すること、前記注入領域から前記患者の循環系へ前記治療的物質の移動の変動性を低減することからなる群から選択される機能の少なくとも1つを実行するために処置を適用するよう構成されることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記物質が、皮下に注入されるよう構成され、さらに全身的作用を有するよう構成されることを特徴とするデバイス。
- 請求項3に記載のデバイスにおいて、前記治療的物質が、インスリン、インスリン類似体、およびインスリン模倣体からなる群から選択されることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記処置要素がさらに、前記注入領域の近辺で血液の灌流を調整するよう構成されることを特徴とするデバイス。
- 請求項6に記載のデバイスにおいて、前記処置要素が、前記注入領域の近辺で前記身体組織の温度を変更するよう構成されるヒータであり、
当該ヒータが、前記治療的物質を限界温度より上の温度に加熱しないことを特徴とするデバイス。 - 請求項6に記載のデバイスにおいて、前記処置要素が、ボーラス注入開始後、所定時間の間37℃乃至39℃の範囲の温度まで、前記注入領域の近辺の前記患者の皮膚を加熱するよう構成されることを特徴とするデバイス。
- 請求項9に記載のデバイスにおいて、インスリンが、即効性のインスリンであることを特徴とするデバイス。
- 請求項10に記載のデバイスにおいて、インスリンが、スクエアまたは分割ボーラスモードのような長期間のボーラスモードを用いて患者に注入され、インスリンを薬物動態学的および/または薬力学的に調整することを特徴とするデバイス。
- 請求項10に記載のデバイスにおいて、インスリンが、速いボーラスモードを用いて患者に注入されることを特徴とするデバイス。
- 請求項9に記載のデバイスにおいて、インスリンが、レギュラーインスリンであることを特徴とするデバイス。
- 請求項6に記載のデバイスにおいて、前記センサが、インスリンボーラスの注入を検出するよう構成されることを特徴とするデバイス。
- 請求項14に記載のデバイスにおいて、前記センサが、前記送達ポンプの電磁放射を測定する電磁検出要素を含むことを特徴とするデバイス。
- 請求項3に記載のデバイスにおいて、前記制御装置が、前記送達ポンプ内に配置されていることを特徴とするデバイス。
- 請求項8に記載のデバイスにおいて、前記ハウジングがさらに、前記治療的物質およびインフュージョンチューブを含むリザーバを有し、前記物質送達デバイスおよび前記リザーバとともに前記処置要素を囲むよう構成され、
前記処置要素が、前記リザーバおよび前記インフュージョンチューブを前記限界温度より上の温度に加熱することなく、前記注入領域の近辺に熱を適用するよう構成されることを特徴とするデバイス。 - 請求項1に記載のデバイスにおいて、前記物質送達デバイスが、使い捨て可能であることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記処置要素が、前記カテーテル固定要素内に配置されていることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記処置要素がヒータを含み、かつ前記注入領域の加熱を調整し、注入された治療的物質の薬物動力性を安定させるために、その温度を所定の温度に安定させるよう構成されることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、適用される処置は、加熱、冷却、間欠性の温度変化、光照射、マイクロ波、無線周波数、電磁照射、振動装置、物理刺激、注入領域のマッサージ、吸引、減圧、電場、磁場、音響信号、超音波、および注入された物質を薬物動態学的に変更するための1またはそれ以上のさらなる物質の適用、および/または上述の前記処置の少なくとも2つの組み合わせからなる群から選択されることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記処置要素が、ヒータを有しており、前記カテーテル固定要素と前記身体組織との間に配置されていることを特徴とするデバイス。
- 請求項3に記載のデバイスにおいて、前記制御装置が、前記ハウジングの中に配置され、又は前記送達ポンプに取り付けられていることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、さらに、グルコースセンサを具えることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記センサが、前記ハウジングに内蔵されていることを特徴とするデバイス。
- 請求項1に記載のデバイスにおいて、前記処置要素と通信する前記制御装置が、前記治療的物質の注入開始を検出すると、前記処置要素により前記処置の適用を開始するよう構成されていることを特徴とするデバイス。
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JP (2) | JP2010522012A (ja) |
KR (1) | KR101509827B1 (ja) |
CN (2) | CN101715354B (ja) |
AU (1) | AU2008227870B2 (ja) |
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CA (1) | CA2681397C (ja) |
IL (2) | IL201046A (ja) |
MX (1) | MX2009009999A (ja) |
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IL201046A (en) | 2013-02-28 |
CA2681397A1 (en) | 2008-09-25 |
CN101715354A (zh) | 2010-05-26 |
KR101509827B1 (ko) | 2015-04-06 |
MX2009009999A (es) | 2010-03-17 |
IL224505A (en) | 2016-03-31 |
EP2139539A2 (en) | 2010-01-06 |
RU2009135624A (ru) | 2011-04-27 |
RU2012151965A (ru) | 2014-06-10 |
JP2010522012A (ja) | 2010-07-01 |
AU2008227870B2 (en) | 2013-10-17 |
RU2477151C2 (ru) | 2013-03-10 |
EP2139539B1 (en) | 2021-08-04 |
WO2008114218A2 (en) | 2008-09-25 |
AU2008227870A1 (en) | 2008-09-25 |
RU2618952C2 (ru) | 2017-05-11 |
BRPI0808290A2 (pt) | 2017-08-01 |
CA2681397C (en) | 2015-08-11 |
CN103418052A (zh) | 2013-12-04 |
CN101715354B (zh) | 2013-12-04 |
KR20100015672A (ko) | 2010-02-12 |
IL201046A0 (en) | 2010-05-17 |
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