Bio-adaptable implantable sensor apparatus and methods

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.

1 - 32 . (canceled) 
     
     
         33 . A sensor apparatus, comprising:
 a first detector element configured to detect blood analyte within a first analyte concentration range, the first detector element comprising an electrolyte material, and enzymatic material, and at least one electrode, the at least one electrode in communication with at least a portion of the electrolyte material and configured to utilize an interaction between the blood analyte and the enzymatic material to enable generation of a first electrical signal;   a second detector element configured to detect blood analyte within a second analyte concentration range, the second detector element comprising an electrolyte material, and enzymatic material, and at least one electrode, the at least one electrode in communication with at least a portion of the electrolyte material and configured to utilize an interaction between the blood analyte and the enzymatic material to enable generation of a second electrical signal; and   signal processing logic in communication with each of the first detector element and the second detector element, the signal processing logic configured to process at least one of the first electrical signal or the second electrical signal to identify at least one trend of blood analyte concentration over time and based on the identification, cause transfer from the first detector element to the second detector element for purposes of generating blood analyte concentration output data for use by a user of the sensor apparatus.   
     
     
         34 . The sensor apparatus of  claim 33 , wherein the signal processing logic is further configured to determine a blood analyte concentration estimate at a future time, the causation of transfer from the first detector element to the second detector element based at least in part on the determined blood analyte concentration estimate. 
     
     
         35 . The sensor apparatus of  claim 33 , wherein each of the first detector element and the second detector element further comprise:
 one or more second electrodes;   a membrane structure in communication with at least a portion of the electrolyte material, the membrane structure comprising (i) a cavity having the enzymatic material disposed therein and (ii) an aperture in communication with the cavity; and   a non-enzymatic membrane disposed at least partly within the aperture, and configured to (i) at least partly occlude at least a portion of the aperture and (ii) isolate tissue of the human being from the enzymatic material, yet permit blood analyte migration therethrough.   
     
     
         36 . The sensor apparatus of  claim 35 , wherein the first detector element being configured to detect blood analyte within the first analyte concentration range and the second detector element being configured to detect blood analyte within the second analyte concentration range are each based at least in part on a dimension of the at least one aperture being different for the first detector element relative to the second detector element. 
     
     
         37 . The sensor apparatus of  claim 35 , wherein the first detector element being configured to detect blood analyte within the first analyte concentration range and the second detector element being configured to detect blood analyte within the second analyte concentration range are each based at least on a fill level of the enzymatic material within a cavity of the membrane being different for the first detector element relative to the second detector element. 
     
     
         38 . The sensor apparatus of  claim 33 , wherein the first analyte concentration range partly overlaps with the second analyte concentration range but is not co-extensive therewith. 
     
     
         39 . The sensor apparatus of  claim 38 , wherein the processing of the at least one of the first electrical signal or the second electrical signal to identify at least one trend of blood analyte concentration over time comprises utilization to identify degradation of an analyte concentration value associated the first electrical signal. 
     
     
         40 . The sensor apparatus of  claim 33 , wherein at least one of the first analyte concentration range or the second analyte concentration range are selected based at least on a level of accuracy or performance associated with the respective detector element within the respective first or second concentration range. 
     
     
         41 . Fully implantable blood analyte sensor apparatus, comprising:
 a first detector element configured to detect blood analyte within a first analyte concentration range, the first detector element comprising an electrolyte material, and enzymatic material, and at least one electrode, the at least one electrode in communication with at least a portion of the electrolyte material and configured to utilize an interaction between the blood analyte and the enzymatic material to enable generation of a first electrical signal;   a second detector element configured to detect blood analyte within a second analyte concentration range, the second detector element comprising an electrolyte material, and enzymatic material, and at least one electrode, the at least one electrode in communication with at least a portion of the electrolyte material and configured to utilize an interaction between the blood analyte and the enzymatic material to enable generation of a second electrical signal; and   signal processing logic in communication with each of the first detector element and the second detector element, the signal processing logic configured to process at least one of the first electrical signal or the second electrical signal to generate blood analyte concentration output data for wireless transmission from the blood analyte sensor apparatus;   wherein at least one of the first analyte concentration range or the second analyte concentration range is selected so as to include a range of optimal accuracy of the respective first detector element or second detector element.   
     
     
         42 . The blood analyte sensor apparatus of  claim 41 , wherein the first analyte concentration range and the second analyte concentration range are further selected so as to provide one substantially continuous analyte concentration range, the one substantially continuous analyte concentration range being (i) broader than either the first analyte concentration range or the second analyte concentration range. 
     
     
         43 . The blood analyte sensor apparatus of  claim 42 , wherein the one substantially continuous analyte concentration range is further selected such that both a first range of optimal accuracy for the first detector element, and a second range of optimal accuracy for the second detector element, are included within the one substantially continuous analyte concentration range. 
     
     
         44 . The blood analyte sensor apparatus of  claim 42 , further comprising a third analyte detector apparatus having a third analyte concentration range associated therewith, the third range being at least one of (i) contiguous with, or (ii) partly overlapping with, the one substantially continuous analyte concentration range. 
     
     
         45 . The blood analyte sensor apparatus of  claim 41 , wherein the first detector element and the second detector element are characterized during at least one of (i) time of manufacture, or (ii) operational use, the characterization comprising generation of respective data specific to each of the first detector element and second detector element, the respective data each indicative of an accuracy or performance as a function of blood analyte concentration. 
     
     
         46 . The blood analyte sensor apparatus of  claim 45 , wherein the signal processing logic is further configured to enable filtration of first and second data sets generated by the first detector element and the second detector element, respectively, the filtration based at least on the respective data specific to each of the first detector element and second detector element. 
     
     
         47 . Fully implantable blood analyte sensor apparatus, comprising:
 a first detector element configured to detect blood analyte within a first analyte concentration range, the first detector element comprising an electrolyte material, and enzymatic material, and at least one electrode, the at least one electrode in communication with at least a portion of the electrolyte material and configured to utilize an interaction between the blood analyte and the enzymatic material to enable generation of a first electrical signal;   a second detector element configured to detect blood analyte within a second analyte concentration range, the second detector element comprising an electrolyte material, and enzymatic material, and at least one electrode, the at least one electrode in communication with at least a portion of the electrolyte material and configured to utilize an interaction between the blood analyte and the enzymatic material to enable generation of a second electrical signal; and   signal processing logic in communication with each of the first detector element and the second detector element, the signal processing logic configured to process at least one of the first electrical signal or the second electrical signal to generate output data for wireless transmission from the blood analyte sensor apparatus;   wherein at least one of the first analyte concentration range or the second analyte concentration range is dynamically selected during implanted operation of the blood analyte sensor apparatus so as to optimize at least one of (i) a dynamic range of the blood analyte sensor apparatus, or (ii) an accuracy of the blood analyte sensor apparatus.   
     
     
         48 . The blood analyte sensor apparatus of  claim 47 , wherein the dynamic selection during implanted operation of the blood analyte sensor apparatus so as to optimize at least one of (i) a dynamic range of the blood analyte sensor apparatus, or (ii) an accuracy of the blood analyte sensor apparatus comprises dynamic selection of at least one limit of either the first or second analyte concentration ranges based at least on detection of an effect on the operation of the respective first or second detector element over a period of time by foreign body response (FBR) of a user within which the blood analyte sensor apparatus is implanted. 
     
     
         49 . The blood analyte sensor apparatus of  claim 48 , wherein the dynamic selection of at least one limit of either the first or second analyte concentration ranges based at least on detection of an effect on the operation of the respective first or second detector element over a period of time by foreign body response (FBR) comprises selection of the at least one limit relative to an analyte concentration range of another detector element of the blood analyte sensor apparatus so that the another detector element can assume detection of the blood analyte concentration within a portion of the first or second analyte concentration range eliminated by the dynamic selection.