JP4813490B2 - 血液接触センサ - Google Patents
血液接触センサ Download PDFInfo
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- JP4813490B2 JP4813490B2 JP2007531352A JP2007531352A JP4813490B2 JP 4813490 B2 JP4813490 B2 JP 4813490B2 JP 2007531352 A JP2007531352 A JP 2007531352A JP 2007531352 A JP2007531352 A JP 2007531352A JP 4813490 B2 JP4813490 B2 JP 4813490B2
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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
- A61B5/15—Devices for taking samples of blood
- A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
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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
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
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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
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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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
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/15003—Source of blood for venous or arterial blood
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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
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
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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
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150847—Communication to or from blood sampling device
- A61B5/150862—Communication to or from blood sampling device intermediate range, e.g. within room or building
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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
- A61B5/15—Devices for taking samples of blood
- A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
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- Computer Networks & Wireless Communication (AREA)
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- Optics & Photonics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- External Artificial Organs (AREA)
Description
本発明は、血液中の検体を検出するための方法および機器を提供する。この機器は、特にセンサを生体内の血液に直接接触させるのに適している。本機器は、検体の存在を検出するセンサ及び組立手段を備える。組立手段はセンサ端末を有し、組立手段のセンサ端末はセンサに取付けられ、組立手段は静脈還流機器との連結に適応する。静脈還流機器との連結により、組立手段は、センサを、静脈還流機器を通じて血流と直接接触させる。被検者の血液にセンサを直接接触させる静脈還流機器の例は、これに限らないが、例えば、外部身体膜の酸化又は血液透析といった静脈カテーテル及び外部血液ループが含まれる。
組立手段14は、センサ16を血液と接触させるように、機器を静脈還流機器10に連結する。組立手段14は、センサ端末20及び外部表面を有する。センサ端末20は、組立手段14が静脈還流機器10に連結されると閉鎖される組立手段14の表面の一部である。センサ16は、組立手段14のセンサ端末20に取り付けられ、組立手段14が静脈還流機器10に連結する際に静脈還流機器10内に位置する。
ある実施形態において、機器は、更に組立手段14に連結された静脈還流機器10を備える。その静脈還流機器10は血流が通る内腔22を有し、センサ16は静脈還流機器10の内腔22の内部に吊下げられる。静脈還流機器10は、例えば、末梢カテーテル、中心カテーテル又は末梢挿入カテーテルといった静脈カテーテル90であって良い。ある実施形態では、静脈還流機器10は、例えば、外部身体膜の酸化又は血液透析などに用いられる外部血液ループを備える。静脈還流機器10は、1つ又はそれ以上の内腔22を持つことができる。内腔は、同軸に並べることもでき、並置することもできる。オプションとして、内腔の間には開口が設けられる。内腔間の開口には、センサが吊下げられている領域に、例えば抗凝血剤などの薬剤を導入することができる。一つ又は複数の開口を設置することで、特定の部位又はセンサの領域に薬剤又は他の医薬品を導入するように設計できる。一つの実施形態では、組立手段14は、更に組立手段の外部から静脈還流機器10の内腔22まで延長された通路を供給する側面導入口92を備える。
センサは、生体適合性センサとすることができ短期間又は長期間の使用に適する。好ましい実施形態では、センサは、光学、光化学、分子認識、酵素、又は電気化学センサである。センサの一つの例としてブドウ糖センサが含まれる。センサは、血糖濃度に加えて、又は代えて、酸素濃度、カリウム濃度、水素イオン濃度(pH)、乳酸塩濃度、1つ又はそれ以上のミネラル濃度、検体(analytes)濃度、化学薬品濃度、たんぱく質濃度、分子濃度、ビタミン濃度といったもの、及び/又は温度、心拍数、呼吸数、血圧といった他の身体的特性を測定しても良い。
ある実施形態において、センサは親水性コーティングを含む。本発明のセンサの実施形態に適用されるコーティングは、親水性高分子化合物を含む。親水性材料の例は、それに限定されないが、ポリ尿素、ポリアミド、ポリウレタン、アクリレート、ポリエステル、ポリエチレン・オキシド(PEO)又は交差結合されたPEOである。本発明での使用に合致した好適な親水性材料は、PEO含有ポリ尿素である。気体プラズマの使用を通じること、又は、例えば電子又はガンマ線源といった電離放射線を含む本技術分野で公知である多様な方法により、PEOは交差結合され得る。
医薬又は治療上の溶剤は、センサのコーティングのための親水性材料に組み込まれ得る。溶剤は好ましい効果に従って選択される。例えば、その目的物は、炎症又は細菌感染を避けるか又は最小とするようなものである。治療溶剤の例には、それに限定されないが、例えば、デキサメタゾン、セファゾリン、及び塩化ベンザルコニウム、及び/又は増殖因子といった消炎性、抗菌性、抗ウイルス性、抗凝血性及び殺菌活性を有する溶剤が含まれる。ある実施形態では、治療溶剤は、例えば、微生物組織又は反応細胞のような成長細胞を殺す抗増殖性溶剤であっても良い。好ましい実施形態では、親水性コーティングは、例えば、デキサメタゾン又はその中の塩といった消炎性溶剤を含む。デキサメタゾンの中の適切な水溶性塩は、これに限定されないが、リン酸塩又は酢酸塩を含む。デキサメタゾンは、炎症を低減し、またマクロファージを非活性化させ、センサ性能を高める。
好ましい実施形態では、高分子化合物層は、ポリ尿素を備える(例えば、米国特許第5,777,060号及び第5,786,439号参照)。バイオセンサのための好適な高分子化合物層は、これに限定されないが、ブドウ糖制限ポリマー(GLP;カリフォルニア州のノースリッジのミニメド社)を含む。ポリマー層の他の処方は望ましい使用に従って選択され得る。例えば、米国特許第5,777,060号及び第5,786,439号には、バイオセンサに用いるのに適したコーティング、特にブドウ糖酸化酵素及びグルコース検出に用いる場合が記載されている。これらのコーティングは、GLPと共通の特徴をもち、他の型のセンサの使用に適用できる。
ある実施形態では、センサは、モニター又は他の機器と動作可能なように連結される。この連結は、直接又は遠隔のいずれでも良く、対象となる検体のレベルについて連続的な又は定期的な測定を容易にする。例えば、病院における設定では、機器は、例えばナースステーションのような遠隔から患者のブドウ糖又は他の検体のレベルの測定に使用することができる。
本発明は、被検者において循環する血液内にセンサを導入する方法を追加して提供する。この方法は、静脈還流機器を被検者において循環する血液に接触させ、本発明の機器を静脈還流機器に導入することを備える。センサは、血液が静脈還流機器を通って流れることから、被検者において循環する血液に接触する。一つの実施形態では、静脈還流機器は、機器を受け取るために適用される導入口を有する外部血液ループを備える。オプションとして、外部血液ループは、更に配置手段を受け取るために適用される第2の導入口を備える。この方法は、更に、配置手段を、機器を導入する前に機器を受け取る導入口と反対側から外部血液ループ内に導入することを備えることができる。
Claims (23)
- 検体の存在を検出するセンサと、
センサ端末と外部表面とを有し、センサは組立手段のセンサ端末に取り付けられ、組立手段は静脈還流機器との連結に適応する組立手段と、
を備え、
組立手段は、更に組立手段の外部表面から接近可能な側面口と、組立手段の外部表面から組立手段のセンサ端末まで延びる通路と、を備えることを特徴とする血液の検体を検出する機器。 - 組立手段に連結する静脈還流機器を更に備え、静脈還流機器は内腔を有し、センサは静脈還流機器内で吊下げられることを特徴とする請求項1に記載の機器。
- 静脈還流機器は、静脈カテーテルであることを特徴とする請求項2に記載の機器。
- 静脈カテーテルは、単一の内腔を有することを特徴とする請求項3に記載の機器。
- 静脈カテーテルは、1つ以上の内腔を有することを特徴とする請求項3に記載の機器。
- 内腔間には開口が設けられていることを特徴とする請求項5に記載の機器。
- 静脈還流機器は、外部血液ループを備えることを特徴とする請求項2に記載の機器。
- 外部血液ループは、更に注射を受け取るために適用される隔膜を備えることを特徴とする請求項7に記載の機器。
- 外部血液ループは、更に外部血液ループの反対側から注射を受け取るために適用される十字接続器を備えることを特徴とする請求項7に記載の機器。
- 組立手段は、更にセンサの静脈還流機器への挿入をガイドする配置手段(alignment means)を備えることを特徴とする請求項1に記載の機器。
- 配置手段は、内腔を有する針を備えることを特徴とする請求項10に記載の機器。
- 針は取替え可能であることを特徴とする請求項11に記載の機器。
- 組立手段は、ルアーロック(luer lock)接続器を備えることを特徴とする請求項1に記載の機器。
- 更に薬剤供給システムを備え、薬剤供給システムは、薬剤を静脈還流機器に注入する手段を備えることを特徴とする請求項1に記載の機器。
- フィードバックループを備え、センサからの出力は薬剤供給システムに伝達されることを特徴とする請求項14に記載の機器。
- センサは、酵素、分子認識、光化学、又は電気化学センサであることを特徴とする請求項1に記載の機器。
- センサはブドウ糖センサであることを特徴とする請求項1に記載の機器。
- センサは、硬化剤を用いたポリイミドによるコーティングを備えることを特徴とする請求項1に記載の機器。
- センサは、ガラス基板に取り付いたポリイミド・フィルムを備えることを特徴とする請求項1に記載の機器。
- センサは、親水性材料によりコーティングされていることを特徴とする請求項1に記載の機器。
- 親水性材料は、ポリウレタン、アクリレート、ポリエステル、又は交差結合されたPEOであることを特徴とする請求項20に記載の機器。
- センサは、抗凝血剤によりコーティングされていることを特徴とする請求項1に記載の機器。
- センサは、抗菌剤によりコーティングされていることを特徴とする請求項1に記載の機器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/935,954 | 2004-09-08 | ||
US10/935,954 US7468033B2 (en) | 2004-09-08 | 2004-09-08 | Blood contacting sensor |
PCT/US2005/032102 WO2006029293A1 (en) | 2004-09-08 | 2005-09-08 | Blood contacting sensor |
Publications (2)
Publication Number | Publication Date |
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JP2008512202A JP2008512202A (ja) | 2008-04-24 |
JP4813490B2 true JP4813490B2 (ja) | 2011-11-09 |
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Application Number | Title | Priority Date | Filing Date |
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JP2007531352A Expired - Fee Related JP4813490B2 (ja) | 2004-09-08 | 2005-09-08 | 血液接触センサ |
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US (4) | US7468033B2 (ja) |
EP (1) | EP1796538B1 (ja) |
JP (1) | JP4813490B2 (ja) |
CA (1) | CA2579339C (ja) |
WO (1) | WO2006029293A1 (ja) |
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Also Published As
Publication number | Publication date |
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EP1796538A1 (en) | 2007-06-20 |
JP2008512202A (ja) | 2008-04-24 |
US8032198B2 (en) | 2011-10-04 |
WO2006029293A1 (en) | 2006-03-16 |
US8352011B2 (en) | 2013-01-08 |
US7468033B2 (en) | 2008-12-23 |
US8600470B2 (en) | 2013-12-03 |
US20120004524A1 (en) | 2012-01-05 |
CA2579339C (en) | 2014-07-15 |
CA2579339A1 (en) | 2006-03-16 |
US20090149728A1 (en) | 2009-06-11 |
US20060052745A1 (en) | 2006-03-09 |
US20060293576A1 (en) | 2006-12-28 |
EP1796538B1 (en) | 2017-04-05 |
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