Subcutaneous analyte sensor

Abstract

Assembly and method for measuring the concentration of an analyte in a biological matrix. The assembly includes an implantable optical-sensing element that comprises a body, and a membrane mounted on the body in a manner such that the membrane and the body define a cavity. The membrane is permeable to the analyte, but is impermeable to background species in the biological matrix. A refractive, element is positioned in the cavity. A light source transmits light of a first intensity onto the refractive element, and a light detector receives light of a second intensity that is reflected from the cavity. A controller device optically coupled to the detector compares the first and second light intensities, and relates the intensities to analyte concentration.

Description

BACKGROUND OF THE INVENTION [0001] The present invention relates to implantable sensors, and more specifically, to implantable sensors for monitoring levels of analytes, such as glucose. [0002] Several designs for implantable sensors that allow continuous in vivo monitoring of levels of analytes such as glucose have been previously described. Many such designs are based on electrochemical analyte detection principles. As such, they are prone to inherent signal instability of the sensor, and they require that chemicals (e.g., enzymes and mediators) be introduced into the patient's body. [0003] A second approach involves physical (i.e. reagent-free) methodology. A review of physical methods for determinations of glucose in vivo is given in J. D. Kruse-Jarres “Physicochemical Determinations of glucose in vivo,” J. Clin. Chem. Clin. Biochem. 26 (1988), pp. 201-208. Nuclear magnetic resonance (No), electron spin resonance (ESR), and infrared (IR) spectroscopy are named, among others, as ...

AI Technical Summary

Benefits of technology

The present invention is an assembly for measuring the concentration of an analyte in a biological matrix. It includes an implantable optical-sensing element with a membrane that is permeable to the analyte and impermeable to background species in the matrix. The membrane defines a cavity in which a refractive element is placed. The assembly also includes a light source and a light-detecting device. The intensity of the reflected light is measured, and the analyte concentration is determined by comparing the intensity of the reflected light with the intensity of the transmitted light. The invention provides a non-invasive and accurate method for measuring analyte concentration in a biological matrix.

Problems solved by technology

As such, they are prone to inherent signal instability of the sensor, and they require that chemicals (e.g., enzymes and mediators) be introduced into the patient's body.

However, none of these methods has as yet acquired practical significance.

Some of them require large and expensive apparatus, generally unsuitable for routine analysis and home monitoring of a patient.

This spectral region is not suitable for invasive analytical determination of glucose because of the strong absorption of water, which is present in high concentration in biological matrices.

Developing a practical implantable glucose sensor on the basis of these principles presents certain problems.

These problems result particularly from the fact that the effective signal (the change in the absorption spectrum due to a change in glucose concentration) is generally very small.

Sensitivity is always an issue in absorption measurements because of the difficulty in observing a small effective signal superimposed on a relatively much larger background signal.

However, in this case the difficulty is enhanced due to background signals resulting from the spectral absorption of water.

Some attempts have been made to solve this problem (see e.g., EP-A-0 160 768; U.S. Pat. No. 5,028,787; and WO 93 / 00856); however, these attempts have not been successful in providing a practical and functional implantable glucose sensor based on absorption principles.

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