JP4489372B2 - 生理学的サンプル採取装置 - Google Patents
生理学的サンプル採取装置 Download PDFInfo
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- 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
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- A61B5/14514—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
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- 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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- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
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- A61B5/15101—Details
- A61B5/15103—Piercing procedure
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- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
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- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
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Description
上述に要約されているように、この発明の検査細片装置は、バイオセンサと、このバイオセンサと構造的に一体化した少なくとも1つの皮膚穿刺要素すなわち微細針とを含むものである。この発明のバイオセンサは、図1、図2、図3および図5に示されているように電気化学的構造を有してもよく、あるいは図4A、図4B、図6Aおよび図6Bに示されているように比色または光度測定的構造(この明細書では両者を区別せずに使用する)を有してもよい。同様に、この発明の皮膚穿刺要素は種々の構造を採用しており、図1、図2、図3および図5には第1の実施の形態が示され、図4A、図4B、図6Aおよび図6Bには第2の実施の形態が示されている。
ここで同様の参照番号は同様の構成要素を指すものとして図1、図2、図3および図5を参照すると、この発明の2つの電気化学的検査細片装置2および電気化学的検査細片装置100がそれぞれ示されている。検査細片装置2および検査細片装置100は、この明細書に一括して記述される同一構造の電気化学的バイオセンサを有しているが、各皮膚穿刺要素すなわち微細針6および微細針102はそれぞれ異なる構造を有している。検査細片装置2および検査細片装置100では、バイオセンサは、下部電極3および上部電極5として参照される空間的に離れた対向電極3および対向電極5を概して有する電気化学セルによって規定されている。互いに対向する電極3および電極5の少なくとも表面は、金属等の導電層8および導電層16から構成されている。
ここで同様の参照番号は同様の構成要素を指すものとして図4A、図4B、図6Aおよび図6Bを参照すると、この発明の2つの比色/光度測定的検査細片装置80および120が示されている。検査細片装置80および検査細片装置120は、異なる構成の比色/光度測定的バイオセンサと、それぞれ異なる構成の皮膚穿刺要素すなわち微細針86および微細針122とを有している。より詳細には、検査細片装置80の一部は不活性材料で構成されており、他方、検査細片装置120の対応する一部は金属材料で構成されている。
図1、図2、図3、図4Aおよび図4Bに示した検査細片装置2および検査細片装置80並びに図5、図6Aおよび図6Bに示した検査細片装置100および検査細片装置120を参照すると、この発明の皮膚穿刺要素/微細針の種々の構成は、この明細書でさらに詳細に議論されるであろう。上述したように、検査細片装置100は図1乃至図3に示した検査細片装置2と同様の構成を有する電気化学的バイオセンサを含む一方、検査細片装置120は図4Aおよび図4Bに示した検査細片装置80と同様の構成を有する比色/光度測定的バイオセンサを含むものである。しかしながら、図5、図6Aおよび図6Bに示した検査細片装置100および検査細片装置120は、それぞれ異なる構成の微細針を有する点で図1、図2、図3、図4Aおよび図4Bに示した検査細片装置2および検査細片装置80と異なる。両方の実施の形態では、上記微細針は各検査細片の基質から延在している。詳細には、図1、図2、図3および図5に示した実施の形態における電気化学的検査細片装置では、微細針は2つの基質すなわちバイオセンサ電極のうち、いずれか1つから延在してよい。この場合には、上記微細針とこれに関連した電極とは互いに一体化されている。
さらに、この発明の検査細片装置は、サンプル流体の移送または抽出流路すなわち図1乃至図6Bに示し、各微細針の開かれた空間からバイオセンサ内へ延在する流路10,88,108および128をそれぞれ含むものである。上記流路の近位端側の少なくとも一部は検査細片装置のバイオセンサ部内に存在している。上記流路の遠位端は微細針構造(図4Aおよび図4B参照)の近位側で終点となってもよく、あるいは皮膚突刺し構造(図1、図3、図5、図6Aおよび図6B参照)内に存在する部分を有してもよい。後者の構造では、そのような遠位部は外部環境に晒されてもよい。
上述したように、この発明の装置はこの発明のシステムという状況で使用可能であり、概ね、生理学的サンプルを採取しかつ当該サンプルの特性を決定することが可能なシステムを含むものである。この場合には、対象となるサンプルの特性を決定することは自動計測器、例えば計測器によって自動的に達成されてもよい。この発明のシステムは、特定成分の濃度決定という状況で、この明細書により詳細に記述されている。従って、図7に示されているように、この発明の特定成分濃度決定システムは、上述したように少なくとも1つの皮膚穿刺要素64を有する少なくとも1つの検査細片装置60(上述したように電気化学的あるいは比色的な構成のいずれかを有するもの)と、これに関連した計測器40とを含むものである。この発明の検査細片装置は、電気化学的または比色的な構成であろうとなかろうと、上記計測器40内に挿入されるのに適合するように構成されている。より詳細には、図8乃至図10に示されているように、検査細片装置60は第1の端部62と第2の端部66とを有しており、上記皮膚穿刺要素64は第1の端部62に関連付けられており、少なくとも第2の端部66は計測器40内に挿入されるように構成されている。
上述に要約されているように、この発明は、サンプルの特性、例えばサンプル中に存在する特定成分の濃度を決定するための方法を与える。この発明の方法は、種々の特定成分の濃度決定に使用するものであり、代表的な特定成分はグルコース、コレステロール、乳酸、アルコール、およびこれらに類似したものを含む。多くの実施の形態では、この発明の方法は、生理学的サンプル中に存在するグルコースの濃度を決定するのに用いられる。
上述したように、この発明の皮膚穿刺要素は、好ましくは、対応する基質(比色的測定を行なう実施の形態において)、または1つの一体部品または構造として製造され、両者は同一材料で形成された基質/電極の組み合わせ(電気化学的測定を行なう実施の形態において)で製造されている。一方、皮膚穿刺要素は分離した複数の構成要素または部品として製造され、その後に、対応する基質または基質/電極層の組み合わせに対して、任意の適切な手段、例えばこの発明の属する技術分野において周知の接着剤によって固定または付着されるようにしてもよい。
図8乃至図10に示した電気化学的検査細片装置のウェブ200は、そのウェブ200の長さ方向に沿って左右に配列された状態で製造された複数の検査細片装置201(図10には完全に組付けられた状態で示されている)を含むものである。各検査細片装置201は、2つの空間的に離れた下部電極202および上部電極204と、両電極間に配された絶縁スペーサ層206とを含む。スペーサ層206は、酸化還元試薬システムを含む電気化学的バイオセンサの反応領域を規定する切除部分208を有している。図6Aおよび図6Bに示した微細針122と同様の構成を有する微細針212は下部電極202から拡張しかつ下部電極202と面一となっている。下部電極202の一部および微細針212の近位部内には、微細針212の開口部内に貯留された流体を移送するための流路214が形成されている。上記電気化学的バイオセンサの反応領域内への採取された流体の移送および分配を容易にする複数の副流路216は流路214の両側から外側に延在している。
この発明の電気化学的検査細片装置を製造するために、上記で議論された多くの技術およびプロセスと同一の技術およびプロセスもまた、この発明の光度測定/比色的検査細片装置を製造するのに使用可能である。
この発明の製造方法を実施するのに使用されるキットもまた、この発明によって与えられている。この発明のキットは少なくとも1つの検査細片装置、しばしば複数の検査細片装置を含むもので、複数の検査細片装置のうち、少なくとも1つの検査細片装置は少なくとも1つの皮膚穿刺要素を含むものである。また、キットは、使い捨てタイプの検査細片装置との使用が可能である再使用可能または使い捨てタイプの計測器を含む。複数の検査細片装置が与えられている場合には、これらの検査細片装置は1つの再使用可能または使い捨てタイプのカートリッジ内に一括して収容されてもよい。特定のキットは、種々のタイプの検査細片装置、例えば電気化学的および/または比色的検査細片装置を含めてもよい。このような種々の検査細片装置は同一または異なる試薬を含めてもよい。最後に、上記キットは、生理学的サンプル中に存在する特定成分の濃度を決定する際に、この発明の検査細片装置および計測器を使用するための指示をさらに含めてもよい。これらの指示は、キットにおける1つまたはそれ以上のパッケージ、ラベル挿入物、容器およびこれらに類似するものに存在してもよい。
(A)
生理学的流体の特性を決定するバイオセンサと、該バイオセンサと一体化しかつ該バイオセンサから延在する少なくとも1つの微細針と、該微細針に前記バイオセンサから延在する流路とを含み、前記微細針はその幅寸法、径寸法または長さ寸法の実体部分を占有する開口部を含み、前記流路は前記微細針の開口部および前記バイオセンサと流体を介して連通している生理学的サンプル採取装置。
(1)バイオセンサは電気化学的構造を有している実施態様(A)記載の検査細片装置。
(2)バイオセンサは少なくとも2つの電極を含むものであり、少なくとも1つの微細針は前記少なくとも2つの電極のうちの1つの平面的な拡張部である実施態様(1)記載の検査細片装置。
(3)微細針から延在する電極は基質材料上に形成された導電材料を含み、前記微細針は前記基質材料から形成されている実施態様(2)記載の検査細片装置。
(4)微細針は、前記導電材料から形成されている実施態様(3)記載の検査細片装置。
(5)微細針およびこれに関連した電極は一体構造で形成されている実施態様(2)記載の検査細片装置。
(7)検査細片は電極間に設けられた反応領域と少なくとも該反応領域内に含まれる酸化還元試薬システムとを含むものである実施態様(2)記載の検査細片装置。
(8)酸化還元試薬システムは流路の少なくとも一部に含まれている実施態様(A)記載の検査細片装置。
(9)流路の近位部は反応領域内に存在している実施態様(A)記載の検査細片装置。
(10)バイオセンサは比色的構造を有している実施態様(A)記載の検査細片装置。
(12)膜は多孔質である実施態様(11)記載の検査細片装置。
(13)膜は非多孔性の透明フィルムである実施態様(11)記載の検査細片装置。
(14)流路から延在しかつ該流路と流体を介して連通している複数の副流路をさらに含む実施態様(A)記載の検査細片装置。
3 下部電極
4 基質
5 上部電極
6 微細針(皮膚穿刺要素)
8 導電層
9 反応領域
10 流路
10a 近位端
10b 遠位端
12 スペーサ層
14 酸化還元試薬システム
15 副流路
16 導電層
18 基質
20 凹み
22 開口部
24 微細針の先端部
40 計測器
42 ハウジング
44 ディスプレイ
46 レバー
48 押下げボタン
50 ボタン
52 ボタン
54 圧力センサ
56 ハウジングの遠位部
58 圧力リング
60 検査細片装置
62 第1の端部
64 微細針
66 第2の端部
68 穴
70 検査細片受け入れ機構
72 圧力センサインジケータ
80 比色検査細片装置
82 基質
84 基材
85 上部透明層
86 微細針(皮膚穿刺要素)
88 流路
88a 近位端
90 開口部
92 微細針の先端部
94 凹み
96 副流路
100 検査細片装置
102 微細針(皮膚穿刺要素)
104 開口部
106 微細針の先端部
108 流路
110 開口部
112a 側壁
112b 側壁
120 検査細片装置
122 微細針(皮膚穿刺要素)
124 開口部
126 微細針の先端部
128 流路
130 開口部
132a 側壁
132b 側壁
140 基質
142 膜
144 両面粘着層
148 基材
150 切除部分
200 ウェブ
201 検査細片装置
202 下部電極
204 上部電極
206 スペーサ層
208 切除部分
210 反応領域
212 微細針
214 流路
216 副流路
220 ウェブ
221 検査細片装置
222 金属基質シート
224 膜状シート
226 両面粘着層
228 切除部分
230 副流路
232 微細針(皮膚穿刺要素)
234 開口部
236 基材
238 流路
300 シート
302 微細針(皮膚穿刺要素)
304 流体移送流路
306 副流路
308 切除部分
310 領域
312 空間規定構造
Claims (11)
- 電気化学的構造を有しており、生理学的流体の特性を決定するバイオセンサと、
前記バイオセンサと一体化しかつ前記バイオセンサから延在する少なくとも1つの微細針であって、前記微細針の幅寸法、径寸法または長さ寸法の一部を占有する開口部を含む少なくとも1つの微細針と、
前記バイオセンサから前記微細針に延在する流路であって、前記微細針の開口部および前記バイオセンサと流体連通している流路と
を有する検査細片装置であって、
前記バイオセンサは少なくとも部分的に互いに向かい合っている、間隔を開けて配された2つの電極を有し、前記流路の少なくとも一部は前記2つの電極の間に配されており、
前記少なくとも1つの微細針は、前記2つの電極のうちのいずれか一方の電極の平面的な拡張部である、検査細片装置。 - 前記微細針から延在する前記電極は基質材料上に形成された導電材料を含み、前記微細針は前記基質材料から形成されている請求項1に記載の検査細片装置。
- 前記微細針は、さらに前記導電材料から形成されている請求項2に記載の検査細片装置。
- 前記微細針およびこれに関連した前記電極は一体構造で形成されている請求項1から3のいずれか一つに記載の検査細片装置。
- 前記バイオセンサは前記2つの電極間に設けられたスペーサ層をさらに含む請求項1から4のいずれか一つに記載の検査細片装置。
- 前記2つの電極のうち少なくとも1つの電極は、反応領域を有している請求項1から5のいずれか一つに記載の検査細片装置。
- 前記反応領域の少なくとも一部は前記2つの電極の間に配されている請求項6に記載の検査細片装置。
- 前記検査細片は前記電極間に設けられた反応領域と少なくとも前記反応領域内に含まれる酸化還元試薬システムとを含む請求項1から7のいずれか一つに記載の検査細片装置。
- 前記酸化還元試薬システムは前記流路の少なくとも一部に含まれている請求項8記載の検査細片装置。
- 前記流路の近位部は前記反応領域内に存在している請求項6から9のいずれか一つに記載の検査細片装置。
- 前記流路から延在しかつ前記流路と流体連通している複数の副流路をさらに含む請求項1から10のいずれか一つに記載の検査細片装置。
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EP1360931A1 (en) | 2003-11-12 |
SG111107A1 (en) | 2005-05-30 |
CN1456890A (zh) | 2003-11-19 |
IL155343A0 (en) | 2003-11-23 |
TWI312675B (en) | 2009-08-01 |
JP2004000599A (ja) | 2004-01-08 |
HK1057159A1 (en) | 2004-03-19 |
US20030143113A2 (en) | 2003-07-31 |
IL155343A (en) | 2009-07-20 |
EP1598011A3 (en) | 2006-03-01 |
CN1307420C (zh) | 2007-03-28 |
DE60303089D1 (de) | 2006-03-30 |
EP1598011A2 (en) | 2005-11-23 |
CA2428365A1 (en) | 2003-11-09 |
EP1360931B1 (en) | 2006-01-04 |
TW200404514A (en) | 2004-04-01 |
US20020168290A1 (en) | 2002-11-14 |
DE60303089T2 (de) | 2006-08-31 |
CA2428365C (en) | 2011-10-25 |
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