HETEROGENEOUS ANALYTE SENSOR APPARATUS AND METHODS

• US 20180140239A1
• Filed: 11/22/2016
• Published: 05/24/2018
• Est. Priority Date: 11/22/2016
• Status: Abandoned Application

• Current Assignee: Mcnair Interests Limited
• Original Assignee: GlySens, Incorporated
• Inventors: Lucisano, Joseph, Markle, William, Gazdzinski, Robert
• Application Number:
  US15/359,406
• Publication Number:
  US 20180140239A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Implantable sensor and associated receiver apparatus, and methods of manufacturing, implantation, and use. In one embodiment, the sensor apparatus is a heterogeneous glucose sensor, including hydrogen peroxide-based detector elements and oxygen-based detector elements. The sensor apparatus utilizes one (type) of the detector elements to confirm the accuracy of, and/or calibrate, the second (type of) detector element, so as to among other things enable the second type of detector to operate more robustly, and/or for a longer period without external calibration and/or explants. In one variant, the heterogeneous detector types are contained within a common biocompatible implantable housing. In another variant, the first type of detector (e.g., oxygen based) is disposed within a separable module that can operate independently of (or mechanically and/or electrically interface with) the second type of detector. In yet another variant, an external receiver compatible with both the first and second types is disclosed.

Claims

1. An implantable blood analyte sensing device, comprising:

at least one first analyte detector of a first type;

at least one second analyte detector of a second type differing from the first type; and

logic in signal communication with the at least one first analyte detector and the at least one second analyte detector, the logic configured to utilize signals generated by the at least one second analyte detector to enable at least one of;

(i) confirmation of a blood analyte level estimate obtained from signals generated by the at least one first analyte detector; and

/or (ii) calibration of a blood analyte level estimate obtained from signals generated by the at least one first analyte detector.

2. The sensing device of claim 1, wherein the at least one first analyte detector of the first type comprises a peroxide-based blood glucose detector, and the at least one second analyte detector of the second type comprises a non-peroxide based blood glucose detector.

3. The sensing device of claim 2, wherein the at least one second analyte detector comprises an oxygen-based detector having a glucose oxidase (GOX) and catalase enzyme matrix.

4. The sensing device of claim 2, wherein the non-peroxide based blood glucose detector comprises:

a biocompatible housing having a size and shape suitable for implantation in a body;

a plurality of non-peroxide based analyte detector elements;

circuitry operatively connected to the plurality of detector elements and configured to process at least a portion of signals generated by one or more of the detector elements to produce processed signals;

and

an electrical power source operatively coupled to at least the circuitry and configured to provide electrical power thereto.

5. The sensing device of claim 4, wherein said non-peroxide based detector elements each further comprise a membrane configured for direct contact with a biological tissue of a host being after implantation of the sensor device, the membrane at least partly permeable to diffusion of the blood glucose therethrough, yet which is configured to frustrate blood vessel ingrowth.

6. The sensing device of claim 4, wherein each non-peroxide based detector element further comprises at least one membrane configured for direct contact with a biological tissue of a host being after implantation of the sensor device, the at least one membrane at least partly permeable to diffusion of the blood glucose therethrough, yet which is configured to frustrate blood vessel ingrowth.

7. A method of operating an implantable sensing device, comprising:

utilizing at least a first detector element of the sensing device to determine blood analyte level within a host being; and

utilizing at least a second detector element of the sensing device to confirm the determined blood analyte level.

8. The method of claim 7, wherein the utilizing at least a first detector element of the sensing device comprises using at least one peroxide-based detector element, and the utilizing at least a second detector element comprises using at least one oxygen-based detector element.

9. The method of claim 8, wherein the confirmation comprises determining that the determined blood analyte level is within a prescribed range of values, the prescribed range based at least in part on a blood analyte level determined by the at least second detector element.

10. The method of claim 9, wherein the at least second detector element comprises a plurality of individual detector elements, and the blood analyte level determined by the at least second detector element is determined using at least an algorithm operative to at least weight signals produced by certain of the plurality of individual detector elements over signals produced by others of the plurality.

11. The method of claim 9, wherein the weighting of the signals produced by certain of the plurality of individual detector elements over signals produced by others of the plurality comprises weighting based at least on a detected calibration drift of one or more of the plurality over time.

12. The method of claim 7, wherein the utilizing at least a first detector element of the sensing device comprises using at least one oxygen-based detector element, and the utilizing at least a second detector element comprises using at least one peroxide-based detector element on an intermittent or periodic basis only so as to mitigate formation of a foreign body response within the host being.

13. A method of operating an implantable sensing device, comprising:

utilizing at least a first detection enzyme apparatus of the sensing device to determine blood analyte level within a host being; and

at least periodically utilizing at least a second detection enzyme apparatus of the sensing device to calibrate the determined blood analyte level;

wherein the second detection enzyme apparatus comprises an enzyme matrix which is configured to mitigate foreign body response within the host being through elimination of a substance or compound formed within the second detector enzyme apparatus, which is also used within the first detector enzyme apparatus for said determination of blood analyte level.

14. A blood analyte sensing device configured for implantation in a living host being, comprising:

at least one first analyte detector of a first type;

at least one second analyte detector of a second type differing from the first type;

a communications interface; and

logic in signal communication with the at least one first analyte detector and the at least one second analyte detector and the communications interface, the logic configured to process signals generated by the at least one first analyte detector and the at least one second analyte detector so as to enable transmission via the communications interface to a receiving apparatus external to the host being.

15. The sensing device of claim 14, wherein:

the at least one first analyte detector of the first type comprises a peroxide-based blood glucose detector, and the at least one second analyte detector of the second type comprises a non-peroxide based blood glucose detector.

16. The sensing device of claim 15, wherein the processing of the signals generated by the at least one first analyte detector and the at least one second analyte detector enables transmission via an extant communications protocol associated with the at least one first analyte detector.

17. A blood analyte sensing module configured for implantation in a living host along with another sensing device, the module comprising:

at least one analyte detector utilizing an enzyme matrix for detection of blood analyte levels;

a wireless communications interface; and

logic in signal communication with the at least one analyte detector and the wireless communications interface, the logic configured to process signals generated by the at least one analyte detector for transmission via the wireless communications interface to a receiving apparatus external to the host, the receiving apparatus associated with the another sensing device.

18. The blood analyte sensing module of claim 17, wherein:

the another sensing device comprises a peroxide-based glucose sensing device; and

the at least one analyte detector comprises an oxygen-based glucose detector; and

wherein the transmission via the wireless communications interface to a receiving apparatus external to the host being comprises transmission according to a wireless transmission protocol utilized by the peroxide-based sensing device to transmit signals to the receiving apparatus.

19. The blood analyte sensing module of claim 17, wherein the module is configured to physically mate to or integrate with at least a portion of the another sensing device to permit implantation of the module and the another sensing device as a unitary structure.

20. A blood analyte sensing module configured for implantation in a living host being along with another sensing device, the module comprising:

at least one analyte detector utilizing an enzyme matrix for detection of blood analyte levels;

a first communications interface;

a wireless communications interface; and

logic in signal communication with the at least one analyte detector, the first communications interface, and the wireless communications interface, the logic configured to process at least signals generated by the at least one analyte detector for transmission via the wireless communications interface to a receiving apparatus external to the host being, the receiving apparatus associated with the sensing module.

21. The blood analyte sensing module of claim 20, wherein the processing at least signals generated by the at least one analyte detector for transmission via the wireless communications interface comprises processing at least both:

(i) signals generated by the at least one analyte detector; and

(ii) signals generated by the another sensing device and received by the module via the first communications interface.

22. Wireless receiver apparatus configured to receive data from each of:

(i) an implanted blood analyte sensing device; and

(ii) another blood analyte sensing device, the receiver apparatus comprising;

a wireless communications interface; and

computerized processing logic in signal communication with the wireless communications interface, the logic configured to process at least (i) data generated by the implanted blood analyte sensing device and received via the wireless communications interface; and

(ii) data generated by the another blood analyte sensing device and received via the wireless communications interface.

23. The receiver apparatus of claim 22, wherein:

the data received via the wireless communications interface from the implanted blood analyte sensing device are formatted according to a first communications protocol;

and the data received via the wireless communications interface from the another

blood analyte sensing device are formatted according to a second communications protocol different than the first communications protocol.

24. The receiver apparatus of claim 22, wherein:

the data received via the wireless communications interface from the implanted blood analyte sensing device are used to perform at least one of;

(i) a calibration of the data received via the wireless communications interface from the another blood analyte sensing device; and

/or (ii) confirmation of an accuracy of the data received via the wireless communications interface from the another blood analyte sensing device.