BIOCOMPATIBLE IMPLANTABLE SENSOR APPARATUS AND METHODS
2 Assignments
0 Petitions
Accused Products
Abstract
Enzymatic and non-enzymatic detectors and associated membrane apparatus, and methods of use, such as within a fully implantable sensor apparatus. In one embodiment, detector performance is controlled through selective use of membrane configurations and enzyme region shapes, which enable accurate detection of blood glucose level within the solid tissue of the living host for extended periods of time. Isolation between the host'"'"'s tissue and the underlying enzymes and reaction byproducts used in the detectors is also advantageously maintained in one embodiment via use of a non-enzyme containing permeable membrane formed of e.g., a biocompatible crosslinked protein-based material. Control of response range and/or rate in some embodiments also permits customization of sensor elements. In one variant, heterogeneous detector elements are used to, e.g., accommodate a wider range of blood glucose concentration within the host. Methods of manufacturing the membranes and detectors, including methods to increase reliability, are also disclosed.
4 Citations
51 Claims
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1-31. -31. (canceled)
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32. A method of manufacturing an analyte detector element, comprising:
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embedding at least one electrode within a substrate; disposing an electrolyte over at least a portion of the substrate, the at least portion of the substrate comprising at least a portion of the electrode; forming a membrane structure over the electrolyte, the membrane structure comprising a cavity and an aperture communicating with the cavity; disposing an enzyme matrix material into the cavity via the aperture such that the enzyme matric material contacts at least a portion of an interior wall of the membrane structure; and disposing a non-enzymatic material at least partly within the aperture such that the non-enzymatic material contacts at least a portion of the enzyme matrix material. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A method of manufacturing an analyte detector element, comprising:
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disposing an electrolyte material over at least a portion of an active surface of an electrode; forming a hydrophobic membrane structure over the electrolyte material, the hydrophobic membrane structure comprising at least (i) a cavity and (ii) a spout region in communication with the cavity; forming an enzyme matrix within the cavity such that the enzyme matrix contacts at least a portion of a bottom interior wall of the cavity; and forming a hydrophilic membrane at least partly within the spout region such that the hydrophilic membrane contacts at least a portion of a top surface of the enzyme matrix. - View Dependent Claims (44, 45, 46, 47, 48)
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49. A method of manufacturing an analyte detector, comprising:
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seating one or more electrodes within a detector substrate; disposing an electrolyte material over at least a portion of an active surface of each of the one or more electrodes; forming a membrane structure over the electrolyte material, the hydrophobic membrane structure comprising at least a cavity and an aperture communicating with the cavity, the cavity disposed over at least one of the one or more electrodes; disposing a flowable enzyme matrix material within the cavity via the aperture while substantially preventing contamination of an outer surface of the membrane structure and one or more inner walls of the aperture, the flowable enzyme matrix material at least in part comprising a first cross-linkable material and one or more classes of enzymes; applying a first crosslinking agent to the flowable enzyme matrix material disposed in the cavity, thereby forming a cross-linked enzyme matrix; and disposing a non-enzymatic material within the aperture; and forming a seal between the non-enzymatic material and the at least one inner wall of the aperture, the seal configured to substantially cause enclosure of the cross-linked enzyme matrix within the cavity. - View Dependent Claims (50, 51)
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Specification