JP2009509645A - 流体の移送を容易にする装置と方法 - Google Patents
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Abstract
Description
本発明によれば、少なくとも毛細管またはその他の移送部材を満たすのに十分な量の体液試料を得る必要はないので、試験を行う時間が節約され、皮膚表面に設けられる傷をより小さくする機会が得られ、および/またはその傷口から血液を抜き出す必要が低減されるかまたは解消され、それによって穿刺またはその他の傷を作る処置に関係する痛みや不快さが最小化される。
本発明の一観点によれば、次の部材、すなわち、
基体であって、基体第1表面から第2表面を貫通して延びる孔を有するものと、
第1端部と、第1端部の反対側の第2端部と、或る内径を備えた内腔とを有し、チューブの少なくとも第2端部が基体の孔に受容された流体移送チューブと、
基体第2表面に形成された少なくとも一部分を含み、孔と流体連通する少なくとも一つの流体移送促進溝とを含む装置が得られる。
基体であって、基体第1表面から基体第2表面を貫通して延びる孔を有するものと、
皮膚を穿刺するようにされた第1端部と、第1端部の反対側の第2端部と、或る内径を備えた内腔とを有し、チューブの少なくとも第2端部が基体の孔に受容された針と、
基体の第2表面に配置された少なくとも一部分を含み、孔と流体連通する少なくとも一つの流体移送促進溝と、
孔と少なくとも一つの流体移送促進溝の一方と流体連通する検体定量化部材とを備えている。
別の観点によれば、本発明は、本明細書で説明する装置のいずれかを含む着用可能な血中グルコース・モニタを提供するものである。
以下に述べる複数特性の少なくとも一つ、またはそれらの幾つかの組み合わせ、またはそれらのすべてを含むように、器具、装置、それらに関係する方法が構成されている。
本発明の原理により形成される溝は、また、その少なくとも一部に、流体の流れを促進させる付加的な特徴を含む。例えば、溝には、流体流促進用の被覆を施すことができる。例えば、溝の少なくとも一部にポリジメタクセラン(PDMS)またはSilwet(登録商標)の被覆を施すことができる。あるいはまた、もしくは前記被覆に加えて、固有の流れ促進特性を有する材料の表面に溝を形成することができる。例えば、親水性のポリマー材料の表面に溝を形成できる。あるいはまた、前記のことと組み合わせて、流体の流れを促進させる表面テクスチャーを溝に設けることもできる。
理解を要する点は、溝形成のための種々の特性、特徴、技術についての前記説明は、本出願で説明した溝の全てに、それらが関連する特定の装置に関係なく広く適用される点である。したがって、前記説明は、ここに記載される本発明のその他の可能な各実施例については繰り返さないことにするが、溝形成の前記特徴、特性、方法は、ここに記載のすべての実施例に適用される。
図1および図2に示すように、実施例100は、更に、溝31を含み、この溝は、例えば、溝30の前記特徴および特性、または本発明の原理により形成されたどの溝の特徴および特性をも有することができる。このように、装置100は、少なくとも一つの流体移送促進溝30を含むことができ、かつまた複数の溝30,31をも含むことができる。
溝の第1と第2の部分30´、30´´間の移行部は、適当などのような幾何形状でもよい。別の実施例によれば、第1と第2の部分30´、30´´間の移行部は、丸みを付けられることで、溝の第1と第2の部分30´、30´´間の毛細管流に対する不利な影響が最小化される。
図14に示したように、基体20の第2表面26には複数の溝を設けることができ、複数の溝の各々は、一端が孔22と、他端が第2表面の縁部と流体連通している。図示例では、溝32,34,36,38が、前記のように、第2表面に配置されている。この場合、溝32,34,36,38の各々は、一端が孔22と交差または流体連通し、他端が第2表面26の縁部へ延びている。
既に記したように、図14〜図18に示した実施例の溝は、前記いずれかの特徴、特性を有し、本発明の溝についての既出の包括的な説明に従って製造可能である。前記溝形状は、また、本出願内部で説明されるその他の実施例および/または装置のどれとも組み合わせることができる。
図示されていないが、装置190も、また前記光度測定検出素子、例えば光源S、検出素子D、任意のレンズL、その他前記実施例に関連する特徴のいずれかを含むことができる。
装置230は、また前記特徴の一つまたはそれらの組み合わせを備えることができる。
本発明による装置および/または実施例のいずれもが、前記の種類の器具に全体的または部分的に利用できる。したがって、ここに種々の装置に関連して説明した特徴は、独立的、選択的に利用することもできれば、多くの異なる組み合わせで利用することもできる。
本発明の前記代表的な装置のすべてが、単独で、またその他の器具、装置、システムとの組み合わせで使用できる。その他の種類の器具に、着用式、非着用式を問わず包含することも、本発明では特に考えられている。これらの個別の、独立的な、統合された試験器具の付加的な細かな点は、米国特許出願番号―――の「試料の抽出および移送を伴う流体分析器具」(代理人事件整理番号023095.0118PLUS)と題する出願の開示内容から収集できる。その全内容は、ここに該出願を引用することで、本明細書に取り入れられるものである。
一観点によれば、本発明は、体液等の流体の移送を改善する方法、それも、
第1表面から第2表面へ延びる孔が形成された基体を得る段階と、
第1端部、第1端部と反対側の第2端部、或る内径を有する内腔を備えた流体移送チューブを設け、基体の孔内にチューブの少なくとも第2端部を挿入する段階と、
少なくとも第1部分を含む少なくとも一つの流体移送溝を基体第2表面に設けることで、該溝を孔と流体連通させる段階とを含む方法を提供する。
前記の方法のいずれの場合も、内腔の少なくとも一部が、流体移送を促進する特徴、例えば被覆と表面テクスチャーの少なくとも一つを含むことができる。
本発明の方法は、孔に第1部分を備える作業を含むことができる。該第1部分は、基体の第1表面から延び、流体移送チューブの少なくとも第2端部を受容する端ぐり部を形成する。孔は、また流体移送チューブの第2端部から基体の第2表面へ延びる第2部分を含むことができる。
本発明の方法によれば、溝の第1部分と第2部分のうちの少なくとも一方が、平坦な底部、曲面状の底部、山形の底部のいずれかを含む断面幾何形状を備えることができる。任意だが、溝の第1と第2の部分のうちの少なくとも一方の横断面積を、針の第2端部から離れる方向に減少させることもできる。
本発明の方法によれば、基体は、概ね円筒形のハブを含むことができる。ハブには作動部材を取り付け可能である。
第1表面から第2表面へ延びる孔を有する基体を得る段階と、
皮膚に穿刺するようにされた第1端部、第1端部と反対側の第2端部、或る内径を有する内腔を有する針を得て、基体の孔にチューブの少なくとも第2端部を挿入する段階と、
基体第2表面に設けられ、孔と流体連通する少なくとも一つの第1部分を含む少なくとも一つの流体移送促進溝を形成する段階と、
少なくとも一つの孔および少なくとも一つの流体移送促進溝と流体連通する検体定量化部材を得る段階とを含む。
本発明の方法によれば、着用式または手持ち式のグルコース・モニタが、前記方法の少なくとも一部またはすべてを含む方法により形成および/または操作される。
Claims (48)
- 基体と、流体移送チューブと、少なくとも一つの流体移送促進溝とを含む器具において、前記基体が、その第1表面からその第2表面まで延在する孔を有し、
前記流体移送チューブが、第1端部と、該第1端部とは反対側の第2端部と、内径を有する内腔とを有し、少なくとも前記第2端部が前記基体の前記孔内に受容されており、
前記少なくとも一つの流体移送促進溝が、前記第2表面に設けた少なくとも第1部分を含み、かつ、前記孔と流体連通している器具。 - (i)前記孔と、
(ii)前記少なくとも一つの流体移送促進溝のうちの少なくとも一方と流体連通する検体定量化部材を更に含む請求項1に記載された器具。 - 前記流体移送チューブが針を含み、この針の第1端部が皮膚を穿刺するように構成されている請求項1に記載された器具。
- 前記針が、金属で形成され、前記基体が、少なくとも部分的に金属、ポリマー、ガラスまたはセラミックで形成されている請求項3に記載された器具。
- 前記内腔の少なくとも一部が流体移送を促進する特徴を含み、該特徴が、被覆と表面テクスチャーのうちの少なくとも一方を含む請求項1に記載された器具。
- 前記孔が第1部分を含み、該第1部分が、前記基体の前記第1表面から延び、かつ、前記流体移送チューブの少なくとも前記第2端部を受容する端ぐり部を作っている請求項1に記載された器具。
- 前記孔が、前記流体移送チューブの前記第2端部から前記基体の前記第2表面まで延びる第2部分を含む請求項1に記載された器具。
- 前記少なくとも一つの流体移送促進溝が、前記孔の前記第2部分に設けた第2部分を更に含む請求項7に記載された器具。
- 前記少なくとも一つの流体移送促進溝の前記第2部分が、事実上直線的であり、前記孔の前記第2部分に沿って長手方向に延在している請求項8に記載された器具。
- 前記少なくとも一つの流体移送促進溝の前記第2部分が、前記孔の前記第2部分に事実上螺旋状に形成されている請求項8に記載された器具。
- 前記少なくとも一つの流体移送促進溝の前記第2部分が、前記第2表面に向って減少する幅を有する請求項8に記載された器具。
- 前記流体移送促進溝の前記第1および第2部分のうちの少なくとも一方が、平坦な底部、曲線状の底部、または、山形の底部を含む幾何学的断面形状を有する請求項8に記載された器具。
- 前記流体移送促進溝の前記第1および第2部分のうちの少なくとも一方が、前記流体移送チューブの前記第2端部から離れる方向で減少する横断面積を含む請求項8に記載された器具。
- 前記流体移送促進溝の前記第1と第2の部分のうちの少なくとも一方が、流体移送チューブの第2端部から離れる方向へ増大する横断面積を含む請求項8に記載された器具。
- 前記基体第2表面に設けられた複数の流体移送促進溝を更に含む請求項1に記載された器具。
- 前記複数の流体移送促進溝のうちの少なくとも二つが、前記基体の前記第2表面で前記孔と交差する請求項15に記載された器具。
- 前記複数の流体移送促進溝が、更に、前記基体の前記第2表面に設けた少なくとも一つの溝を含み、この少なくとも一つの溝が前記複数の溝のうちの別の一つの溝と交差するが、前記孔とは交差しない請求項16に記載された器具。
- 前記少なくとも一つの溝が、前記基体の前記第2表面の孔と接線方向に交差する請求項1に記載された器具。
- 前記少なくとも一つの溝が、前記孔を螺旋状に取り巻いている請求項1に記載された器具。
- 更に、前記孔を取り囲み、かつ前記少なくとも一つの流体移送促進溝と流体連通する溝を含む請求項1に記載された器具。
- 更に、前記孔を取り囲む溝内に吸収材料を含む請求項20に記載された器具。
- 更に、前記孔を取り囲む溝と流体連通する少なくとも一つの通気溝を含む請求項20に記載された器具。
- 前記溝の第1と第2の部分のうちの少なくとも一方が流体移送を促進する特徴を含み、この特徴が、被覆と表面テクスチャーのうちの少なくとも一方を含む請求項8に記載された器具。
- 前記孔の第2部分が付加的な流体移送を促進する特徴を含み、この特徴が、被覆と表面テクスチャーのうちの少なくとも一方を含む請求項7に記載された器具。
- 前記定量化部材が、前記孔と前記少なくとも一つの流体移送促進溝の少なくとも一方と直接に流体連通する請求項2に記載された器具。
- 前記定量化部材が、予め決められた検体と反応するように選択された化学試薬を内包する定量分析パッドを含む請求項23に記載された器具。
- 更に、定量化部材を覆うカバーを含む請求項23に記載された器具。
- 前記カバーが、定量化部材と光学的相互通信可能に構成される請求項23に記載された器具。
- 前記カバーがキャップ形状である請求項27に記載された器具。
- 更に、前記定量化部材と前記カバーとの間に間挿されたスペーサを含む請求項27に記載された器具。
- 更に、前記基体の第2表面に前記定量化部材を受容する端ぐり部を含む請求項2に記載された器具。
- 前記端ぐり部が、平坦な底面と曲線状の底面のうちの少なくとも一方を有する請求項31に記載された器具。
- 前記流体移送チューブの端面が基体の第2表面と事実上同一平面になるように、流体移送チューブが基体に受容される請求項1に記載された器具。
- 前記少なくとも一つの流体移送促進溝が、また前記チューブ端面にも形成されている請求項33に記載された器具。
- 更に、前記流体移送チューブに少なくとも一つの流体移送促進溝を含む請求項1に記載された器具。
- 前記基体が、概ね円筒形のハブを含む請求項1に記載された器具。
- 更に、前記ハブに取り付けられた作動部材を含む請求項36に記載された器具。
- 請求項1に記載された器具を含む統合型検体検出装置。
- 前記装置が、着用式または手持ち式に構成されている請求項38に記載された装置。
- 前記装置が、少なくとも一回の血中グルコース濃度測定を行うように構成されている請求項39に記載された装置。
- 前記装置が、複数回の血中グルコース濃度測定を行うように構成されている請求項40に記載された装置。
- 前記装置が、使い捨てカートリッジを含む請求項40に記載された装置。
- 基体と、針と、少なくとも一つの流体移送促進溝と、検体定量化部材とを含む器具において、前記基体が、その第1表面からその第2表面まで延在する孔を有し、
前記針が、皮膚を穿刺するようにされた第1端部、該第1端部とは反対側の第2端部、および、内径を有する内腔を有し、少なくとも前記第2端部が前記基体の前記孔内に受容されており、
前記少なくとも一つの流体移送促進溝が、前記基体の前記第2表面に設けた少なくとも第1部分を含み、かつ、前記孔と流体連通しており、
前記検体定量化部材が、前記孔と前記少なくとも一つの流体移送促進溝のうちの少なくとも一方と流体連通している器具。 - 請求項43に記載された器具を含む統合型検体検出装置。
- 着用式または手持ち式に構成される請求項44に記載された装置。
- 少なくとも一回の血中グルコース濃度測定を行うように構成されている請求項45に記載された装置。
- 複数回の血中グルコース濃度測定を行うように構成されている請求項46に記載された装置。
- 使い捨てカートリッジを含む請求項46に記載された装置。
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US11/239,123 US8801631B2 (en) | 2005-09-30 | 2005-09-30 | Devices and methods for facilitating fluid transport |
PCT/US2006/037245 WO2007041062A2 (en) | 2005-09-30 | 2006-09-26 | Devices and methods for facilitating fluid transport |
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WO2007041062A2 (en) | 2007-04-12 |
EP1928315B1 (en) | 2016-11-30 |
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US10433780B2 (en) | 2019-10-08 |
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CA2996122A1 (en) | 2007-04-12 |
EP1928315A4 (en) | 2010-05-26 |
EP3165165A1 (en) | 2017-05-10 |
EP1928315A2 (en) | 2008-06-11 |
US8801631B2 (en) | 2014-08-12 |
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