System, device and method for determining the concentration of an analyte
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Abstract
There are many inventions described and illustrated herein. In one aspect, the present invention is a system, a device and a method for sensing the concentration of an analyte in a fluid (for example, a fluid sample) or matrix. The analyte may be glucose or other chemical of interest. The fluid or matrix may be, for example, the fluid or matrix in the body of an animal (for example, human), or any other suitable fluid or matrix in which it is desired to know the concentration of an analyte. In one embodiment, the invention is a system and/or device that includes one or more layers having a plurality of analyte-equivalents and mobile or fixed receptor molecules with specific binding sites for the analyte-equivalents and analytes under analysis (for example, glucose). The receptor molecules, when exposed to or in the presence of analyte (that resides, for example, in a fluid in an animal), bind with the analyte (or vice versa). As such, some or all (or substantially all) of the receptor molecules within a given layer may bind with the analyte, which results in a change in the optical properties of one or more of the layers. These layer(s) may be examined or interrogated, via optical techniques, whereby the optical response of the layers and/or, in particular, the substance within the layer(s), may be measured, evaluated and/or analyzed.
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Citations
65 Claims
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1-24. -24. (canceled)
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25. An analyte sensing device for sensing a concentration of analyte in a fluid, the analyte sensing device comprising:
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a housing;
a first layer, disposed in the housing, having a first optical property that is responsive to the concentration of analyte in communication therewith, the first layer including;
a matrix having a plurality of first analyte equivalent residues disposed therein; and
a plurality of first analyte binding receptor molecules, wherein the first analyte binding receptor molecules are capable of reversibly binding with the first analyte equivalent residues and the analyte; and
a second layer, disposed in the housing, having at least one optical property that is insensitive to the concentration of analyte in communication therewith;
wherein the first optical property is a scattering of optical radiation incident on the first layer. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. An analyte sensing device for sensing a concentration of analyte in a fluid, the analyte sensing device comprising:
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a housing having;
a first portion that is permeable to the analyte and non-permeable to the first layer; and
a reflecting portion;
a first layer, disposed in the housing, having a first optical property that is responsive to the concentration of analyte in communication therewith wherein the first optical property is a scattering of optical radiation incident on the first layer, the first layer including;
a matrix having a plurality of first analyte equivalent residues disposed therein; and
a plurality of first analyte binding receptor molecules, wherein the first analyte binding receptor molecules are capable of reversibly binding with the first analyte equivalent residues and the analyte; and
wherein the reflecting portion is disposed distal to a path of optical radiation that is incident on the first layer. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. An analyte sensing system for sensing a concentration of analyte in a fluid, the analyte sensing system comprising:
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a first device including;
a first layer having a first optical property that is responsive to the concentration of analyte in communication therewith wherein the first optical property is a scattering of optical radiation incident on the first layer, the first layer including;
a matrix having a plurality of first analyte equivalent residues disposed therein; and
a plurality of first analyte binding receptor molecules, wherein the first analyte binding receptor molecules are capable of reversibly binding with the first analyte equivalent residues and the analyte; and
a second device including a first layer having at least one optical property that includes a predetermined response to the concentration of analyte in communication therewith. - View Dependent Claims (51, 52, 53, 54, 55, 56, 57, 58)
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59. A method to detect the concentration of an analyte in a fluid using an analyte sensing device comprising (1) a first layer disposed within a housing, wherein the first layer exhibits at least one optical property that is responsive to the concentration of analyte in communication therewith, the first layer including a matrix having a plurality of analyte equivalent residues disposed therein, and a plurality of analyte binding receptor molecules, wherein the analyte binding receptor molecules are capable of reversibly binding with the analyte equivalent residues and the analyte, and (2) a second layer, disposed in the housing, having at least one optical property that is insensitive to the concentration of analyte in communication therewith, the method comprising:
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placing an analyte sensing device in communication with the fluid;
providing incident optical radiation to the analyte sensing device;
receiving responsive optical radiation from the analyte sensing device;
determining the concentration of analyte by using (i) the responsive optical radiation to measure a change in scattering of optical radiation by the first layer and (ii) a response to the optical radiation by the second layer; and
outputting data which is representative of the concentration of analyte. - View Dependent Claims (60, 61, 62, 63, 64, 65)
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Specification