JP2016033519A - グルコースセンサ - Google Patents
グルコースセンサ Download PDFInfo
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- JP2016033519A JP2016033519A JP2015234819A JP2015234819A JP2016033519A JP 2016033519 A JP2016033519 A JP 2016033519A JP 2015234819 A JP2015234819 A JP 2015234819A JP 2015234819 A JP2015234819 A JP 2015234819A JP 2016033519 A JP2016033519 A JP 2016033519A
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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
- A61B5/0002—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
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
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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
- A61B5/1455—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 using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—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 using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
- A61B5/14556—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 using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases by fluorescence
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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
- A61B5/1455—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 using optical sensors, e.g. spectral photometrical oximeters
- A61B5/1459—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 using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
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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
- A61B5/1468—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 using chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1473—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 using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
- A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
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- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6848—Needles
- A61B5/6849—Needles in combination with a needle set
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- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
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- 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
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- 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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- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N21/6408—Fluorescence; Phosphorescence with measurement of decay time, time resolved fluorescence
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
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- G01N21/7703—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator using reagent-clad optical fibres or optical waveguides
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/20—Blood composition characteristics
- A61M2230/201—Glucose concentration
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- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
- G01N2021/6439—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" with indicators, stains, dyes, tags, labels, marks
- G01N2021/6441—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" with indicators, stains, dyes, tags, labels, marks with two or more labels
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- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
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- G01N21/645—Specially adapted constructive features of fluorimeters
- G01N2021/6484—Optical fibres
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- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
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- G01N2021/772—Tip coated light guide
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
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- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
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Abstract
Description
本願は、2011年9月6日出願の米国仮出願第61/531449号、2011年9月6日出願の米国仮出願第61/531451号、2011年9月6日出願の米国仮出願第61/531456号、2011年11月1日出願の米国仮出願第61/554057号、2011年11月17日出願の米国仮出願第61/561146号、2012年1月18日出願の米国仮出願第61/587819号、及び2012年4月5日出願の米国仮出願第61/620563号の優先権を主張し、また、本願と同時出願の“Orthogonally Redundant Sensor Systems and Methods”との名称の米国特許出願(整理番号第040088−0405699号)に関し、これら全てはそれら全体が参照として本願に組み込まれる。
fopt=1/(2×π×τ) 式(1)
従って、例えば、3nsの寿命に対して、最適な変調周波数(fopt)は略50MHzから略60GHzの範囲内にある。
NA=√(n1 2−n2 2) 式(2)
NA=nsinθmax 式(3)
A1Ω1=A2Ω2 式(4)
C2r2+2(CSz+aP2)r+(z2S2−2aCQz−a2Pt)=0
式(5)
ここで、C=cosθ、S=sinθ、P=1+S、Q=1+P、T=1+Qである。
105 発振器
110 ドライバ回路
123 励起光
130 多層誘電体フィルタ
140 ダイクロイックビームスプリッタ
150 レンズ
160 発光フィルタ
170 レンズ
180 光検出器
300 センサ
301 蛍光
307 参照蛍光
309 アッセイ蛍光
310 ドライバ回路
323 励起光
330 多層誘電体フィルタ
340 第一ダイクロイックビームスプリッタ
344 第二ビームスプリッタ
350 レンズ
360 アッセイ発光フィルタ
364 参照発光フィルタ
370 レンズ
374 レンズ
380 光検出器
384 光検出器
400 センサ
410 光ファイバ
412 ファイバ先端部
420 アッセイコンパートメント
430 グルコース浸透性膜
500 フィルタ基体
520 励起フィルタ
525 発光フィルタ
530 第一ミラー
540 第二ミラー
550 光学窓
560 光トラップ
570 第三ミラー
575 第四ミラー
580 第一検出器
585 第二検出器
590 センサ
591 励起光
593 励起光
595 アッセイコンパートメント
Claims (38)
- 光源と、
励起フィルタ及び/又は発光フィルタを有するフィルタ基体と、
少なくとも一つの検出器と、
光学グルコースセンサとを備えたSPIOS(積層平坦集積光学システム)であって、
前記光学グルコースセンサが、
近位端及び反対側の遠位端を有する光ファイバと、
中空内部、開近位端、及び閉遠位端を有するグルコース浸透性膜であって、該膜の近位端が前記光ファイバの遠位端に結合されて、前記光ファイバの遠位端と該膜の遠位端との間において前記中空内部にコンパートメントが画定されている、グルコース浸透性膜と、
前記コンパートメント内部に配置され、グルコース受容体及びグルコース類似体を含む競合グルコース結合親和性アッセイとを備える、SPIOS。 - 前記コンパートメントが使用者の組織内部に配置される、請求項1に記載のSPIOS。
- 前記光ファイバの近位端が前記使用者の体外にある、請求項2に記載のSPIOS。
- 前記光ファイバの近位端が前記フィルタ基体に光学的に結合される、請求項3に記載のSPIOS。
- 前記アッセイが、蛍光体標識されたアッセイである、請求項1に記載のSPIOS。
- 前記グルコース受容体が、第一蛍光体で標識されている、請求項1に記載のSPIOS。
- 前記アッセイが、前記第一蛍光体とは異なる参照蛍光体を更に含む、請求項6に記載のSPIOS。
- 前記第一蛍光体及び前記参照蛍光体が、異なる吸収スペクトル若しくは異なる発光スペクトルのいずれかを有するか、又は、異なる吸収スペクトル及び異なる発光スペクトルの両方を有する、請求項7に記載のSPIOS。
- 前記第一蛍光体が、Alexa Fluor594(AF594)である、請求項7に記載のSPIOS。
- 前記参照蛍光体が、Alexa Fluor700(AF700)である、請求項7に記載のSPIOS。
- 前記参照蛍光体が、巨大分子上に標識されている、請求項7に記載のSPIOS。
- 前記グルコース受容体が、コンカナバリンA、グルコースガラクトース結合タンパク質、抗体、ボロン酸、及びマンナン結合レクチン(MBL)から成る群から選択されている、請求項1に記載のSPIOS。
- 前記グルコース類似体がデキストランである、請求項1に記載のSPIOS。
- 前記グルコース類似体が色素で標識されている、請求項1に記載のSPIOS。
- 前記グルコース受容体が蛍光体で標識されていて、前記グルコース類似体が色素で標識されていて、前記蛍光体及び前記色素がフェルスター共鳴エネルギー移動ペアを形成する、請求項1に記載のSPIOS。
- 前記グルコース受容体がマンナン結合レクチン(MBL)であり、前記グルコース類似体がデキストランである、請求項1に記載のSPIOS。
- 前記マンナン結合レクチン(MBL)が、Alexa Fluor蛍光体で標識されている、請求項16に記載のSPIOS。
- 前記蛍光体が水溶性である、請求項17に記載のSPIOS。
- 前記蛍光体がAlexa Fluor594(AF594)である、請求項17に記載のSPIOS。
- 前記デキストランが色素で標識されている、請求項16に記載のSPIOS。
- 前記色素が水溶性である、請求項20に記載のSPIOS。
- 前記色素が、ヘキサメトキシクリスタルバイオレット‐1(HMCV1)である、請求項20に記載のSPIOS。
- 前記グルコース受容体が、Alexa Fluor594(AF594)で標識されたマンナン結合レクチン(MBL)であり、前記グルコース類似体が、ヘキサメトキシクリスタルバイオレット‐1(HMCV1)で標識されたデキストランである、請求項1に記載のSPIOS。
- 前記アッセイが、参照蛍光体として、Alexa Fluor700(AF700)で標識された巨大分子を更に含む、請求項23に記載のSPIOS。
- 前記膜がチューブ状である、請求項1に記載のSPIOS。
- 前記膜が生体適合性ポリマーを備える、請求項1に記載のSPIOS。
- 前記ポリマーが生分解性である、請求項26に記載のSPIOS。
- 前記膜の開近位端が、前記光ファイバの遠位端に封止されている、請求項1に記載のSPIOS。
- 前記光ファイバの遠位端が真っ直ぐに切断されて研磨されている、請求項1に記載のSPIOS。
- 前記光ファイバの遠位端が、前記アッセイと直接接触している、請求項1に記載のSPIOS。
- 前記光ファイバの遠位端が、複合パラボラ集光器の形状である、請求項1に記載のSPIOS。
- 前記複合パラボラ集光器が、前記コンパートメント内部に広がって、前記コンパートメント内のアッセイと直接接触している、請求項31に記載のSPIOS。
- 前記複合パラボラ集光器の遠位端から長手方向に離隔されて配置された反射体を更に含む請求項31に記載のSPIOS。
- 前記反射体が、前記アッセイから放出された蛍光を、前記光ファイバの遠位端に向けて反射する、請求項33に記載のSPIOS。
- 前記反射体が凹ミラーである、請求項33に記載のSPIOS。
- 前記アッセイが、前記反射体と前記複合パラボラ集光器の遠位端との間の空間内に配置されている、請求項33に記載のSPIOS。
- 前記複合パラボラ集光器が矩形の断面を有する、請求項31に記載のSPIOS。
- 前記光ファイバ及び前記複合パラボラ集光器が円形の断面を有する、請求項31に記載のSPIOS。
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JP5851614B2 (ja) | 2016-02-03 |
CA2845804A1 (en) | 2013-03-14 |
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JP6196279B2 (ja) | 2017-09-13 |
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EP2753232B1 (en) | 2017-12-06 |
US20170215775A1 (en) | 2017-08-03 |
CN103917154B (zh) | 2016-01-27 |
US11931145B2 (en) | 2024-03-19 |
CA3067983A1 (en) | 2013-03-14 |
CN103917858A (zh) | 2014-07-09 |
CA3067983C (en) | 2022-08-02 |
US20190117137A1 (en) | 2019-04-25 |
EP2753232A1 (en) | 2014-07-16 |
CA2845636A1 (en) | 2013-03-14 |
JP2014528788A (ja) | 2014-10-30 |
EP2753918A1 (en) | 2014-07-16 |
US20220087578A1 (en) | 2022-03-24 |
US20130060106A1 (en) | 2013-03-07 |
CN103917858B (zh) | 2016-05-04 |
US11229384B2 (en) | 2022-01-25 |
WO2013036492A1 (en) | 2013-03-14 |
JP5788099B2 (ja) | 2015-09-30 |
EP2753918B1 (en) | 2019-07-17 |
US20130060105A1 (en) | 2013-03-07 |
US9642568B2 (en) | 2017-05-09 |
JP2014529481A (ja) | 2014-11-13 |
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