Bio-adaptable implantable sensor apparatus and methods
First Claim
1. An analyte sensor, comprising:
- a biocompatible housing having a size and a shape suitable for implantation in a body;
a plurality of glucose-modulated oxygen detectors, at least a working electrode of each of the plurality of glucose-modulated oxygen detectors in communication with at least one glucose oxidase and catalase-embedded material, the at least one glucose oxidase and catalase-embedded material enclosed in a membrane structure, the membrane structure configured to provide a barrier between biological tissues of the body and the at least one glucose oxidase and catalase-embedded material at least when the analyte sensor is implanted in a tissue environment within the body;
circuitry operatively connected to the plurality of glucose-modulated oxygen detectors and configured to process at least a portion of signals generated by at least a portion of said plurality of glucose-modulated oxygen detectors to produce processed signals;
one or more wireless data transmission apparatus configured to transmit at least a portion of said processed signals; and
an electrical power source operatively coupled to at least the circuitry and the data transmission apparatus and configured to provide electrical power thereto;
wherein said circuitry at least in part comprises processing logic which is configured to;
identify one or more of the plurality of glucose-modulated oxygen detectors which each experience signal variations caused by biological processes within the body after the analyte sensor has been implanted in the tissue environment within the body;
based at least in part on the identification, selectively remove glucose-modulated signals respectively generated by the identified one or more of the plurality of glucose-modulated oxygen detectors from processing of a composite glucose-modulated signal; and
generate the composite glucose-modulated signal from other glucose-modulated signals respectively generated by one or more remaining non-identified ones of the plurality of glucose-modulated oxygen detectors which have not experienced the signal variations, the composite glucose-modulated signal useful for calculation of a blood glucose level value.
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Accused Products
Abstract
Biocompatible implantable sensor apparatus and methods of implantation and use. In one embodiment, the sensor apparatus is an oxygen-based glucose sensor having biocompatibility features that mitigate the host tissue response. In one variant, these features include use of a non-enzymatic membrane over each of the individual analyte detectors so as to preclude contact of the surrounding tissue with the underlying enzyme or other matrix, and mitigate vascularization, and insulation of the various electrodes and associated electrolytic processes of the sensor from the surrounding tissue. In one implementation, the sensor region of the implanted apparatus is configured to interlock or imprint the surrounding tissue so as to promote a high degree of glucose molecule diffusion into the individual detectors, and a constant and predictable sensor to blood vessel interface, yet preclude the tissue from bonding to the sensor, especially over extended periods of implant.
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Citations
43 Claims
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1. An analyte sensor, comprising:
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a biocompatible housing having a size and a shape suitable for implantation in a body; a plurality of glucose-modulated oxygen detectors, at least a working electrode of each of the plurality of glucose-modulated oxygen detectors in communication with at least one glucose oxidase and catalase-embedded material, the at least one glucose oxidase and catalase-embedded material enclosed in a membrane structure, the membrane structure configured to provide a barrier between biological tissues of the body and the at least one glucose oxidase and catalase-embedded material at least when the analyte sensor is implanted in a tissue environment within the body; circuitry operatively connected to the plurality of glucose-modulated oxygen detectors and configured to process at least a portion of signals generated by at least a portion of said plurality of glucose-modulated oxygen detectors to produce processed signals; one or more wireless data transmission apparatus configured to transmit at least a portion of said processed signals; and an electrical power source operatively coupled to at least the circuitry and the data transmission apparatus and configured to provide electrical power thereto; wherein said circuitry at least in part comprises processing logic which is configured to; identify one or more of the plurality of glucose-modulated oxygen detectors which each experience signal variations caused by biological processes within the body after the analyte sensor has been implanted in the tissue environment within the body; based at least in part on the identification, selectively remove glucose-modulated signals respectively generated by the identified one or more of the plurality of glucose-modulated oxygen detectors from processing of a composite glucose-modulated signal; and generate the composite glucose-modulated signal from other glucose-modulated signals respectively generated by one or more remaining non-identified ones of the plurality of glucose-modulated oxygen detectors which have not experienced the signal variations, the composite glucose-modulated signal useful for calculation of a blood glucose level value. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. An analyte sensor, comprising:
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a biocompatible housing having a size and a shape suitable for implantation in a body; a plurality of glucose-modulated oxygen detectors each comprising an enzymatic material, the enzymatic material enclosed in a membrane structure, the membrane structure configured to provide a barrier between biological tissues of the body and the enzymatic material at least when the analyte sensor is implanted in a tissue environment within the body; circuitry operatively connected to the plurality of glucose-modulated oxygen detectors and configured to process at least a portion of signals generated by at least a portion of said plurality of glucose-modulated oxygen detectors to produce processed signals; wireless data transmission apparatus configured to transmit data relating to said processed signals; and an electrical power source operatively coupled to at least the circuitry and the data transmission apparatus and configured to provide electrical power thereto; wherein said circuitry at least in part comprises processing logic which is configured to; identify at least one of the plurality of glucose-modulated oxygen detectors which experiences unacceptable signal performance after the analyte sensor has been implanted in the tissue environment within the body; based at least in part on the identification, selectively remove glucose-modulated signals generated by the identified at least one of the plurality of glucose-modulated oxygen detectors from generation of a composite glucose-modulated signal, the composite glucose-modulated signal generated using only one or more remaining non-identified ones of the plurality of glucose-modulated oxygen detectors, the composite glucose-modulated signal useful for calculation of a blood glucose level value. - View Dependent Claims (24, 25, 26, 27)
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28. An analyte sensor, comprising:
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a biocompatible housing having a size and a shape suitable for implantation in a body; a plurality of glucose-modulated oxygen detectors each comprising an enzymatic material, the enzymatic material enclosed in a membrane structure, the membrane structure configured to provide a barrier between biological tissues of the body and the enzymatic material at least when the analyte sensor is implanted in a tissue environment within the body; circuitry operatively connected to the plurality of glucose-modulated oxygen detectors and configured to process signals generated by said plurality of glucose-modulated oxygen detectors to produce processed signals, the signals generated by each of the plurality of glucose-modulated oxygen detectors having a weight associated therewith; wireless data transmission apparatus configured to transmit data relating to said processed signals; and an electrical power source operatively coupled to at least the circuitry and the wireless data transmission apparatus and configured to provide electrical power thereto; wherein said circuitry at least in part comprises processing logic which is configured to; identify, after the analyte sensor has been implanted in the tissue environment within the body, at least one of the plurality of glucose-modulated oxygen detectors whose signal performance is experiencing progressive degradation; based at least in part on the identification, progressively reduce over time a weight of signals generated by the identified at least one of the plurality of glucose-modulated oxygen detectors relative to weights of respective signals from others of the plurality of glucose-modulated oxygen detectors during generation of composite glucose-modulated signals such that the generated composite glucose-modulated signals are, over time, increasingly based on the others of the plurality of glucose-modulated oxygen detectors; and wherein the composite glucose-modulated signals are useful for calculation of a blood glucose level value. - View Dependent Claims (29, 30, 31)
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32. A method of operating an implanted analyte sensor having a plurality of glucose-modulated analyte detectors comprising at least one enzymatic material enclosed in a membrane structure, the membrane structure configured to provide a barrier between biological tissues of a body within which the analyte sensor is implanted and the at least one enzymatic material, the method comprising:
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identifying, during a period of implantation, one or more of the plurality of glucose-modulated analyte detectors which experience unacceptable signal variations; based at least in part on the identification, selectively removing first signals generated by the identified one or more of the plurality of glucose-modulated analyte detectors from inclusion in a composite analyte detector signal; and generating the composite analyte detector signal from second signals generated by one or more remaining non-identified ones of the plurality of glucose-modulated analyte detectors which have not experienced the unacceptable signal variations. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40)
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41. A method of operating a fully implanted analyte sensing device so as to extend a useful implanted operating lifetime of the analyte sensing device within a tissue environment of a body, the analyte sensing device comprising a plurality of glucose-modulated detectors, the method comprising:
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identifying, when the analyte sensor is implanted in the tissue environment of the body, at least one of the plurality of glucose-modulated detectors which provide degraded glucose-modulated signals; based at least in part on the identifying, selectively either (i) reducing a weighting associated with, or (ii) removing, glucose-modulated signals generated by the identified at least one of the plurality of glucose-modulated detectors from processing to generate a composite glucose-modulated signal, the reducing weighting or removing increasing an accuracy of the composite glucose-modulated signal relative to a composite glucose-modulated signal generated without the reducing weighting or removing, the increased accuracy enabling said extension of the useful implanted operating lifetime.
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42. An implantable analyte sensor, comprising:
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a biocompatible housing having a size and a shape each suitable for implantation in a body; a sensing region comprising at least a plurality of enzymatic analyte detectors; circuitry operatively connected to the plurality of enzymatic analyte detectors and configured to process at least a portion of signals generated by one or more of the plurality of enzymatic analyte detectors to produce processed signals; wireless data transmission apparatus configured to transmit data to a receiver at least when the implanted analyte sensor is disposed in a tissue environment within said body; an electrical power source operatively coupled to at least the circuitry and the wireless data transmission apparatus and configured to provide electrical power thereto; and at least one membrane apparatus associated with each of the plurality of enzymatic analyte detectors, the at least one membrane apparatus configured to, when the implantable analyte sensor is disposed in the tissue environment within the body, both (i) at least mitigate vascularization therein, and (ii) permit migration of blood analyte therethrough; wherein the circuitry at least in part comprises processing logic configured to; identify at least one of the plurality of enzymatic analyte detectors with degraded performance, the degraded performance caused by changing of an interface between the at least one enzymatic analyte detector and surrounding tissue of the body, the changing of the interface due to one or more biological processes within the body; based at least in part on the identification, selectively either reduce a weighting of or remove signals generated by the identified at least one enzymatic analyte detector from processing of a composite signal; and generate the composite signal from other signals respectively produced by one or more remaining non-identified ones of the plurality of enzymatic analyte detectors. - View Dependent Claims (43)
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Specification