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US006625479B1

(12) United States Patent ao) Patent No.: us 6,625,479 Bi

Weber et al. (45) Date of Patent: *Sep. 23,2003 Page 2

(54) OPTICAL SENSOR FOR IN SITU MEASUREMENT OF ANALYTES

(75) Inventors: Anders Weber, Skibby (DK);

Christopher J. Stanley, Woodhurst
(GB)

(73) Assignee: Torsana Diabetes Diagnostics A/S,
Horsholm (DK)

( * ) Notice: Subject to any disclaimer, the term ol this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.

This patent is subject to a terminal disclaimer.

(21) Appl. No.: 09/937,717

(22) PCT Filed: Jul. 2, 1999

(86) PCT No.: PCT/GB99/02104

§ 371 (c)(1),

(2), (4) Date: Oct. 1, 2001

(87) PCT Pub. No.: WO00/02048 PCT Pub. Date: Jan. 13, 2000

(30) Foreign Application Priority Data

Jul. 3, 1998 (GB) 9814506

(51) Int. CI.7 A61B 5/00; G01N 21/64;

G01N 33/53

(52) U.S. CI 600/310; 600/316; 422/82.07;

436/501

(58) Field of Search 600/310, 316,

600/322, 323, 347, 365; 604/890.1, 891.1; 422/82.07, 82.08; 436/95, 501, 805, 807;

435/4, 7.9, 7.72, 7.92

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OTHER PUBLICATIONS

CRC Press, 1988, p86, Controlled Release Systems: Fabrication technology.

Frank ML and DiMaria C; Drug. Sal. vol. 17 No. 6, 12/97,

p 360-368, "Levonorgestrel subdermal . . . ".

Mansouri and Schultz; Biotechnology, 10/84, p 885-890, "A

Miniature optical glucose sensor . . . ".

Meadows and Schultz; Talanta 35,1997, p 1-6, "Fiber-optic

Biosensors Based on Fluorescence . . . ".

Jaremko J and Rorstad O; Diabetes Care vol. 21 No. 3, 3/98,

p 444—450, "Advances Toward the Implantable . . . ".

Jackson AJ; Drug Metab. Dispos. vol. 9 No. 6, 7/81, p

535-540, "Intramuscular Absorption and Regional . . . ".

(List continued on next page.)

Primary Examiner—Eric F. Winakur

Assistant Examiner—David J. McCrosky

(74) Attorney, Agent, or Firm—Nixon & Vanderhye PC.

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An implantable sensor for use in the detection or quantitative measurement ol an analyte in subcutaneous fluid, the sensor being biodegradable or hydrolysable in vivo. The sensor incorporates an assay for the analyte, the readout ol which is a detectable or measurable optical signal which can, when the sensor is in operation in a subcutaneous location, be interrogated transcutaneously by external optical means.

15 Claims, 2 Drawing Sheets

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OTHER PUBLICATIONS

Tyagi et al; Nature Biotechnology 16, 1/98, p 49-53, "Multicoulor molecular beacons for allele discrimination". Meadows and Schultz; Anal. Chim Acta 280,1993, p 21-30, "Design, manufacture and characterization of . . . ". Wilkins E and Atanasov P; Med. Eng.Phys. vol. 18 No. 4, 1996, p 273-288, "Glucose monitoring: state of . . . ". The Immunoassay Handbook, ed. David Wild, Macmillan 1994#.

Atsanasov et al Med. Eng. Phys. (1996) 18: 632-640. Barnikol WK and Weiler N; Biomed. Tech (Berl(. vol. 40, No. 5, 5/95, p 114—120 "Experiments aimed . . . ".

Wilkins et al; Biosens. Bioelectron vol. 10, No. 5, 1995, p. 485-494, "Integrated implantable device . . . ". Brunfield et al; Berlin, 6/98, Conference abstract, "A Prototype Transdermal Biosensor".

Fogt, "Continuous ex vivo and in vivo monitoring with chemical sensors", Clinical Chemistry 36(8(b)): 1573-1580 (1990).

Jeong et al, "Biodegradable Block Copolymers As Injectable Drug-Delivery Systems", Nature 388(6645):860-862 (1997).

Fogt, E.J., Clin. Chem. (1990) 36:1573-80. * cited by examiner

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