JP2013542008A - 診断装置 - Google Patents
診断装置 Download PDFInfo
- Publication number
- JP2013542008A JP2013542008A JP2013532101A JP2013532101A JP2013542008A JP 2013542008 A JP2013542008 A JP 2013542008A JP 2013532101 A JP2013532101 A JP 2013532101A JP 2013532101 A JP2013532101 A JP 2013532101A JP 2013542008 A JP2013542008 A JP 2013542008A
- Authority
- JP
- Japan
- Prior art keywords
- guide needle
- skin
- diagnostic element
- active surface
- diagnostic
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- 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
-
- 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
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150229—Pumps for assisting the blood sampling
-
- 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
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion 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
- 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
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Animal Behavior & Ethology (AREA)
- Pathology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Optics & Photonics (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
活性表面を含む診断要素の先端部は、体液と直接接触しており、例えば、センサー、開口部、又は半透過性/透析膜を露出させており、微小透析として知られる技術によって、体液から、診断要素を通過する流体へ、検体が通過することを可能にする。活性表面は、分析システム又はサンプル収集システムの一部であり、診断要素の導体部分を通して、注入されない診断要素の部品の中の他のシステム・エレメントに接続されている。
センサーの活性表面は、その表面において、検体の濃度にしたがって、(例えば、電気化学的な、光学的な、温度測定の、圧電性の、又は、磁気的な)何らかの信号を提供するプローブを含有する。センサーの表面は、センサーが機械的に保護されるように滑らかに又は形作られる。さらに、表面は、適当な幾何形状によって増加され、センサーによって発生させられる信号を増大させることが可能である。適切なセンサーの構成及び構造化に関する様々な方法が、文献に記載されてきた。また、これらは、皮膚の中に注入されているときにセンサーのコンポーネントの漏れを防止する方法を含み、同時に、適切な生体適合性ポリマーの使用によって、又は、半透過性の膜をコーティングすることによって、関心検体の拡散を可能にする。
Claims (17)
- 検体の濃度の測定のために、中空の案内針を備えた診断要素の活性表面を体液に露出させる方法であって、
前記中空の案内針が、患者の皮膚を貫通し、前記活性表面及び前記診断要素の測定手段への接続線を収容する、方法において、
前記中空の案内針のみが、前記中空の案内針の挿入の後に、部分的に後退させられ、前記診断要素の前記活性表面、前記接続線、及び、前記測定手段の間の固定された接続部に干渉することなく、前記診断要素の先端部にある前記活性表面を体液に露出させることを特徴とする、方法。 - 前記診断要素は、前記透析液のためのポンプ・システム、及び、体液に露出させられる活性表面として半透過性の境界面又は透析膜を含有する微小透析システムであることを特徴とする、請求項1に記載の方法。
- 前記透析液の中の検体の濃度が、前記測定装置の中で、オンラインで分析されることを特徴とする、請求項1から請求項2までのいずれか一項に記載の方法。
- 前記透析液が、時間にわたって混合することを最小化する手段によって、前記測定装置の中に保管され、後に、検体の濃度を分析するために除去されることを特徴とする、請求項1から請求項3までのいずれか一項に記載の方法。
- 前記活性表面は、センサーによって構成されていることを特徴とする、請求項1に記載の方法。
- 可撓性表面を備えたコンポーネントであって、前記表面を、接着層を介して前記皮膚へ接着することを確実にする、コンポーネントと、1つ又は複数の案内針の中に含有された1つ又は複数の診断要素を保持する剛体部分と、第1の位置において、前記案内針が前記表面によって隠されており、第2の位置において、前記案内針の注入可能な部分が前記表面を越えて露出させられるように、前記案内針に対して前記可撓性表面を位置決めする手段と、前記表面を前記第1の位置から前記第2の位置へもたらす機構とを含有する、請求項5に記載の装置。
- 前記診断要素は、内部に固定して位置決めされている、請求項5又は請求項6のいずれかに記載の装置。
- 前記案内針の皮膚の中への挿入機構、及び、前記案内針の部分的な後退が、解除部材によって連続的に始動させられるように構成されている滑動ボルト機構を含有する、請求項5から請求項7までのいずれか一項に記載の装置。
- 前記滑動ボルト機構を始動させる前記解除部材が、ノブであり、前記ノブは、押すことによって、前記案内針の皮膚の中への挿入機構を駆動し、引き続いて、前記ノブを解除することによって、前記案内針の部分的な後退を駆動し、前記測定を駆動するように構成されている、請求項8に記載の装置。
- 前記診断要素の前記活性表面及び/又は導体部分は、可撓性であり、又は、案内針なしで皮膚の中へ確実に配置することを妨げる他の特性を有する、請求項5から請求項8までのいずれか一項に記載の装置。
- 前記診断要素の前記活性表面は、250μm未満の直径、及び、1〜5mmの注入深さを有し、前記案内針は、1〜3mmだけ後退させられる、請求項5から請求項9までのいずれか一項に記載の装置。
- 前記診断要素の前記活性表面は、センサーを含有する、請求項5から請求項10までのいずれか一項に記載の装置。
- 皮膚への接着を確実にするための前記手段が、身体に一時的に着けるための接着層であり、前記接着層は、皮膚へ接着する接着表面と比べて低減された表面によって、前記装置の前記可撓性表面に固定される、請求項5から請求項12までのいずれか一項に記載の装置。
- 前記装置は、機能的パッケージを使用して皮膚に付され、前記機能的パッケージは、意図しない始動から前記装置の前記解除及び駆動エレメントを保護し、前記接着層を皮膚に向かって押して確実に接着するすリムを有する、請求項5から請求項13までのいずれか一項に記載の装置。
- a)前記装置の正しい機能性を調査し、b)センサー信号を検体測定値へ変換し、c)検体測定値をオンラインで又はバッチ式に記憶、表示及び伝送し、かつ、d)検体測定値が所定の範囲にないときには警告信号を与える、制御及び測定手段を含有する、請求項5から請求項14までのいずれか一項に記載の装置。
- 前記装置は、注入流体を患者の中へ送達するためのユニットをさらに備え、注入流体の前記送達を制御するために検体測定値が使用される、請求項15に記載の装置。
- 前記装置は、全ての制御要素を含む再利用可能部分と、少なくとも皮膚に接着するための前記部材、前記案内針、並びに、前記診断要素の前記活性表面及び導電性部分を含む使い捨て部分と、から構成されている、請求項5から請求項16までのいずれか一項に記載の装置。
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EP10186398.3 | 2010-10-04 | ||
EP10186398A EP2436311A1 (en) | 2010-10-04 | 2010-10-04 | Diagnostic device |
PCT/EP2011/066074 WO2012045561A1 (en) | 2010-10-04 | 2011-09-16 | Diagnostic device |
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JP2013542008A true JP2013542008A (ja) | 2013-11-21 |
JP5876056B2 JP5876056B2 (ja) | 2016-03-02 |
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JP2013532101A Active JP5876056B2 (ja) | 2010-10-04 | 2011-09-16 | 診断装置 |
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US (1) | US10420488B2 (ja) |
EP (2) | EP2436311A1 (ja) |
JP (1) | JP5876056B2 (ja) |
CN (1) | CN103188995B (ja) |
CA (1) | CA2808782C (ja) |
DK (1) | DK2624757T3 (ja) |
ES (1) | ES2856300T3 (ja) |
HK (1) | HK1181986A1 (ja) |
WO (1) | WO2012045561A1 (ja) |
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CA2808782C (en) | 2021-03-30 |
US20130253289A1 (en) | 2013-09-26 |
JP5876056B2 (ja) | 2016-03-02 |
WO2012045561A1 (en) | 2012-04-12 |
ES2856300T3 (es) | 2021-09-27 |
US10420488B2 (en) | 2019-09-24 |
EP2436311A1 (en) | 2012-04-04 |
CN103188995A (zh) | 2013-07-03 |
CA2808782A1 (en) | 2012-04-12 |
CN103188995B (zh) | 2016-06-22 |
EP2624757A1 (en) | 2013-08-14 |
DK2624757T3 (da) | 2021-02-15 |
HK1181986A1 (zh) | 2013-11-22 |
EP2624757B1 (en) | 2020-11-11 |
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