Tissue implantable sensor with hermetically sealed housing

Abstract

A tissue-implantable sensor for measurement of solutes in fluids and gases, such as oxygen and glucose, is provided. The sensor includes: i) a detector array including at least one detector; ii) a telemetry transmission portal; iii) an electrical power source; and iv) circuitry electrically connected to the detector array including signal processing means for determining an analyte level, such as glucose level, in a body fluid contacting the detectors. The sensor components are disposed in a hermetically sealed housing having a size and shape suitable for comfortable, safe, and unobtrusive subcutaneous implantation allowing for in vivo detection and long term monitoring of tissue glucose concentrations by wireless telemetry.

1 .- 100 . (canceled) 
     
     
         101 . An implantable blood glucose sensor apparatus, comprising:
 at least one detector element configured to generate signals related to a blood glucose level when the implantable blood glucose sensor apparatus is implanted within tissues of a subject;   wireless interface apparatus configured for wireless data communication with a receiver apparatus;   data processor apparatus in data communication with each of the wireless interface apparatus and the at least one detector element;   data storage apparatus in data communication with the data processor apparatus, the data storage apparatus having at least one computer program stored thereon, the at least one computer program comprising a plurality of instructions, the plurality of instructions configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor apparatus to:
 collect signals generated by the at least one detector apparatus; 
 process at least a portion of the signals to produce processed signal data; and 
 utilize at least a portion of the processed signal data to generate data indicative of blood glucose level measurement. 
   
     
     
         102 . The implantable blood glucose sensor apparatus of  claim 101 , wherein:
 the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to receive calibration data from the receiver apparatus; and   the utilization of the at least portion of the processed signal data to generate the data indicative of blood glucose level measurement comprises utilization of at least a portion of the calibration data and the at least portion of the processed signal data to generate data indicative of a calibrated blood glucose level measurement.   
     
     
         103 . The implantable blood glucose sensor apparatus of  claim 101 , wherein the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to transmit to the data indicative of the blood glucose level measurement to the receiver apparatus. 
     
     
         104 . The implantable blood glucose sensor apparatus of  claim 103 , wherein:
 the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to translate the data indicative of blood glucose level measurement into an encrypted format prior to the transmission to the receiver apparatus; and   the transmission of the data indicative of the blood glucose level measurement to the receiver apparatus comprises transmission of the data indicative of blood glucose level measurement in the encrypted format to the receiver apparatus.   
     
     
         105 . The implantable blood glucose sensor apparatus of  claim 101 , wherein the utilization of the processed signal data to generate the data indicative of blood glucose level measurement at least in part comprises correlation of the processed signal data to a clinically relevant blood glucose level. 
     
     
         106 . The implantable blood glucose sensor apparatus of  claim 101 , wherein the processing of the at least portion of the signals comprises generation of the processed signal data within a prescribed delay period. 
     
     
         107 . The implantable blood glucose sensor apparatus of  claim 101 , wherein the prescribed delay period comprises a maximum delay of 15 minutes when the implantable glucose sensor apparatus is implanted within the tissues of the body. 
     
     
         108 . The implantable blood glucose sensor apparatus of  claim 101 , wherein:
 the at least one detector element comprises a plurality of detector elements, each of the plurality of detector elements configured to generate respective signals related to the blood glucose level when the implantable blood glucose sensor apparatus is implanted within tissues of a subject; and   the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to identify whether one or more of the plurality of detector elements has a level of activity below a prescribed minimum level.   
     
     
         109 . The implantable blood glucose sensor apparatus of  claim 108 , wherein:
 the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to, based at least on an identification that the one or more of the plurality of detector elements has the level of activity below the prescribed minimum level, exclude a portion of the processed signal data corresponding to the signals generated by the identified one or more of the plurality of detector elements; and   the utilization of the at least portion of the processed signal data to generate the data indicative of blood glucose level measurement comprises utilization of a non-excluded portion of the processed signal data to generate the data indicative of blood glucose level measurement.   
     
     
         110 . The implantable blood glucose sensor apparatus of  claim 101 , wherein the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to:
 detect one or more signal artifacts; and   based at least in part on the detection, adjust the processed signal data to correct for the detected one or more signal artifacts.   
     
     
         111 . The implantable blood glucose sensor apparatus of  claim 101 , wherein the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor to:
 encode the data indicative of blood glucose level measurement into a plurality of encoded segments of blood glucose data; and   transmit the plurality of encoded segments of blood glucose data to the receiver apparatus.   
     
     
         112 . The implantable blood glucose sensor apparatus of  claim 111 , wherein the transmission of the plurality of encoded segments of blood glucose data to the receiver apparatus comprises transmission, at regular intervals, of one or more segments of the plurality of encoded segments of blood glucose data to the receiver apparatus. 
     
     
         113 . An implantable analyte sensor apparatus, comprising:
 a plurality of detector elements each configured to generate signals related to a blood analyte level when the implantable analyte sensor apparatus is implanted within tissues of a subject;   wireless interface apparatus configured for wireless data communication with a receiver apparatus;   data processor apparatus in data communication with each of the wireless interface apparatus and the plurality of detector elements;   data storage apparatus in data communication with the data processor apparatus, the data storage apparatus having at least one computer program stored thereon, the at least one computer program comprising a plurality of instructions, the plurality of instructions configured to, when executed by the data processor apparatus, cause the implantable analyte sensor apparatus to:
 receive signals respectively generated by each of the plurality of detector elements; 
 process at least a portion of the signals to produce processed signal data; 
 access calibration data stored at the data storage apparatus; and 
 utilize at least a portion of the processed signal data and at least a portion of the calibration data to generate calibrated blood analyte level data. 
   
     
     
         114 . The implantable analyte sensor apparatus of  claim 113 , wherein the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable analyte sensor apparatus to:
 perform analysis on the processed signal data to detect of one or more signal artifacts; and   adjust the processed signal data to correct for the detected one or more signal artifacts.   
     
     
         115 . The implantable analyte sensor apparatus of  claim 113 , wherein:
 the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable analyte sensor apparatus to perform analysis on the processed signal data to identify one or more minimally active detector elements of the plurality of detector elements, the one or more minimally active detector elements each having an activity level below a predetermined minimum activity level; and   the utilization of the at least portion of the processed signal data and the at least portion of the calibration data to generate the calibrated blood analyte level data comprises (i) exclusion of a first portion of the processed signal data corresponding to the one or more minimally active elements, and (ii) utilization of a second portion of the processed signal data corresponding to others of the plurality of detector elements and the at least portion of the calibration data for generation of the calibrated blood analyte level data.   
     
     
         116 . The implantable analyte sensor apparatus of  claim 113 , wherein the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor apparatus to:
 establish a wireless data communication session with the receiver apparatus at a predetermined frequency; and   based at least in part on the established wireless data communication session at the predetermined frequency, wirelessly transmit the calibrated blood analyte level data to the receiver apparatus.   
     
     
         117 . The implantable analyte sensor apparatus of  claim 113 , wherein the plurality of instructions are further configured to, when executed by the data processor apparatus, cause the implantable blood glucose sensor apparatus to:
 translate the calibrated blood analyte level data into a plurality of encoded segments; and   transmit one or more of the plurality of encoded segments to the receiver apparatus at regular intervals.   
     
     
         118 . A method of operating an implantable blood glucose sensor apparatus, the implantable blood glucose sensor apparatus comprising at least: (i) a plurality of detector elements, (ii) wireless interface apparatus configured for wireless data communication with at least a receiver apparatus, (iii) data processor apparatus, and (iv) data storage apparatus, the method comprising:
 collecting signals respectively generated by each of the plurality of detector elements;   processing at least a portion of the signals to produce processed signal data;   accessing calibration data stored at the data storage apparatus;   utilizing at least a portion of the processed signal data and at least a portion of the calibration data to generate calibrated blood analyte level data; and   transmitting the calibrated blood analyte level data to the receiver apparatus.   
     
     
         119 . The method of  claim 118 , wherein:
 the collecting signals respectively generated by each of the plurality of detector elements comprises sampling electrical currents from individual ones of the plurality of detector elements; and   the method further comprises, based at least in part on the sampling, identifying one or more of the plurality of detector elements which each meet a predetermined minimum signal activity.   
     
     
         120 . The method of  claim 119 , wherein the utilizing the at least portion of the processed signal data and the at least portion of the calibration data to generate the calibrated blood analyte level data comprises, based at least in part on the identifying, (i) utilizing a first portion of the processed signal data corresponding to the identified one or more of the plurality of detector elements and the at least portion of the calibration data for the generation of the calibrated blood analyte level data, and (ii) excluding a second portion of the processed signal data corresponding to one or more others of the plurality of detector elements from the generation of the calibrated blood analyte level data. 
     
     
         121 . The method of  claim 118 , further comprising:
 accessing predetermined detector element delay data stored at the data storage apparatus, the predetermined detector element delay data related to a plurality of characterized signal response delay periods, each associated with one of the plurality of detector elements; and   adjusting the processed signal data based at least in part on the predetermined detector element delay data.