Optical sensor for in situ measurement of analytes

• US 6,625,479 B1
• Filed: 10/01/2001
• Issued: 09/23/2003
• Est. Priority Date: 07/03/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Torsana Diabetes Diagnostics A/S
• Inventors: Stanley, Christopher J., Weber, Anders
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): McCrosky, David J.
• Application Number:
  US09/937,717
• Time in Patent Office: 722 Days
• Field of Search: 600/310, 600/316, 600/322, 600/323, 600/347, 600/365, 604/890.1, 604/891.1, 422/82.07, 422/82.08, 436/95, 436/501, 436/805, 436/807, 435/4, 435/7.9, 435/7.72, 435/7.92
• US Class Current: 600/310
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings

Abstract

An implantable sensor for use in the detection or quantitative measurement of an analyte in subcutaneous fluid, the sensor being biodegradable or hydrolysable in vivo. The sensor incorporates an assay for the analyte, the readout of 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.

Claims

1. A sensor for the detection or quantitative measurement of an analyte in fluid, said sensor being characterized in that it can function in a location beneath the surface of the skin with no physical connection to the external environment, said sensor incorporating an assay for said analyte a readout of which is a detectable or measurable optical signal, which optical signal can, when the sensor is in operation in said location, be interrogated transcutaneously by external optical means and said sensor being biodegradable or hydrolysable in vivo, biodegradable or hydrolysable material of the sensor having a pore size that permits diffusing the analyte but not assay components.

2. A sensor as claimed in claim 1 wherein said assay is a binding assay, the readout of which is a detectable or measurable optical signal.

3. A sensor as claimed in claim 2 wherein said binding assay is a competitive binding assay components of which include an analyte binding agent and an analyte analog.

4. A sensor as claimed in claim 3 wherein said analyte analog is labelled with a first chromophore and said analyte binding agent is labelled with a second chromophore, an emission spectrum of said first chromophore overlapping with the absorption spectrum of said second chromophore.

5. A sensor as claimed in claim 3 or claim 4 wherein the analyte binding agent is an antibody, an Fab fragment, a lectin, a hormone receptor, a drug receptor, an aptamer or a molecularly-imprinted polymer.

6. A sensor as claimed in claim 2 wherein said detectable or measurable optical signal is generated by fluorescence energy transfer, fluorescence polarisation, fluorescence quenching, phosphorescence, luminescence enhancement, luminescence quenching, diffraction or plasmon resonance.

7. A sensor as claimed in claim 1 which comprises an injectable or implantable matrix material, the components of said assay being suspended in said matrix material.

8. sensor as claimed in claim 1 which comprises a plurality of microparticles.

9. A sensor as claimed in claim 8 wherein said microparticles are solid microparticles and the components of said assay are uniformly dispersed in said solid microparticles.

10. A sensor as claimed in claim 8 wherein said microparticles are hollow microparticles and the components of said assay are encapsulated inside said hollow microparticles.

11. A sensor as claimed in claim 1 which comprises a plurality of liposomes, the components of said assay being encapsulated inside said liposomes.

12. A sensor as claimed in claim 1 which comprises a hollow chamber having a wall portion enclosing a central space containing the components of said assay.

13. A sensor as claimed in claim 1 which comprises a plurality of empty erythrocytes which have been loaded with the components of said assay.

14. An analytical system for the detection or quantitative measurement of an analyte in subcutaneous fluid, which analytical system comprises, a sensor as claimed in claim 1 together with optical means suitable for trans-cutaneous interrogation of said sensor.

15. A method of detecting or quantitatively measuring an analyte in the subcutaneous fluid of a mammal, which method comprises the steps of,

(a) injecting or implanting a sensor for the detection or quantitative measurement of an analyte in subcutaneous fluid as claimed in claim 1 into a subcutaneous location on said mammal;

(b) allowing the assay of said sensor to reach thermodynamic equilibrium;

(c) interrogating the readout of said assay using optical means; and

(d) relating a measurement obtaining in (c) to the concentration of analyte.