ANALYTE SENSOR RECEIVER APPARATUS AND METHODS

• US 20180153450A1
• Filed: 12/02/2016
• Published: 06/07/2018
• Est. Priority Date: 12/02/2016
• Status: Abandoned Application

• Current Assignee: Mcnair Interests Limited
• Original Assignee: GlySens, Incorporated
• Inventors: Routh, Timothy, Lucisano, Joseph, Markle, William, Perkins, Michael
• Application Number:
  US15/368,436
• Publication Number:
  US 20180153450A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/741 using synthesised speech
• CPC Class Codes: A61B 5/7415 Sound rendering of measured values, e.g. by pitch or volume variation A61B5/741 takes precedence
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units

Abstract

Receiver apparatus for use with an analyte sensor, and methods of operation and manufacturing. In one embodiment, the analyte sensor is an implanted/implantable blood glucose sensor, including oxygen-based detector elements. The receiver apparatus is a wireless-enabled small form-factor device with limited functionality that can be easily worn or kept with the user on a continual basis, thereby obviating the need for a more fully featured receiver or smartphone for extended periods of time (e.g., one week). The exemplary oxygen based analyte sensor, with high degree of stability over time, enables the user to divorce themselves from the more fully functioned receiver or smartphone, since no external calibration of the sensor is required during the extended period. In one variant, the device is a lightweight wristband. Other variants include e.g., pendants, finger-worn rings, arm or head bands, skin patches, and even dental, subcutaneous, or prosthetic implants.

Claims

1. Apparatus for use with an implanted blood analyte sensing device, comprising:

wireless receiver apparatus configured to receive wireless signals from the blood analyte sensing device, the wireless signals encoding data relating to levels of said blood analyte;

data processing apparatus in data communication with the wireless receiver apparatus and configured to utilize said encoded data to determine a blood analyte level;

an electrical power source configured to supply electrical power; and

indicator apparatus in communication with the data processing apparatus and electrical power source, the indicator apparatus configured to indicate to a user the determined blood analyte level.

2. The apparatus of claim 1, wherein said implanted blood analyte sensing device comprises at least one oxygen-based sensor, and said apparatus is configured to maintain sufficient output stability to enable operation without external calibration for at least a prescribed period of time, said prescribed period of time being at least one (1) week.

3. The apparatus of claim 1, wherein said implanted blood analyte sensing device comprises at least one oxygen-based sensor, and said apparatus is configured to communicate with an external calibration device on a periodic or opportunistic basis, said communication with said external calibration device comprising transfer of calibration-enabling data from the external calibration device to the apparatus via a wireless interface.

4. The apparatus of claim 1, wherein said wireless signals encoding data are scrambled according to a unique scrambling code prior to transmission from said device, and said apparatus is further configured to unscramble the received wireless signals based at least in part on the unique scrambling code.

5. The apparatus of claim 4, wherein said wireless signals are transmitted from device only at prescribed times or prescribed intervals, and said apparatus is configured to enable said wireless receiver apparatus to receive said wireless signals only during said prescribed times or at said prescribed intervals, and otherwise maintain at least a portion of said wireless receiver apparatus in a dormant or sleep state so as to conserve electrical power of said electrical power source.

6. The apparatus of claim 1, wherein said wireless signals are transmitted from device only at prescribed times, and said apparatus is configured to enable said wireless receiver apparatus to receive said wireless signals during a number n of said prescribed times, said number n less than a total number of transmissions of said wireless signals, said apparatus configured to dynamically vary said number n based at least on one or more operational parameters.

7. The apparatus of claim 6, wherein said one or more operational parameters comprise a remaining level of power in said electrical power source.

8. The apparatus of claim 6, wherein said one or more operational parameters comprises a time period from when a last prior calibration was applied to said data relating to levels of said blood analyte, or said determined blood analyte level.

9. The apparatus of claim 6, wherein said one or more operational parameters comprises detection of an ambulatory or non-ambulatory state of the user.

10. The apparatus of claim 6, wherein:

said apparatus is further configured to utilize at least said data relating to levels of said blood analyte to determine at least one of;

(i) a trend, and/or (ii) a rate of change of blood analyte level; and

said one or more operational parameters comprises said at least one of said determined (i) trend or (ii) rate of change.

11. The apparatus of claim 6, wherein said one or more operational parameters comprises a proximity to a prescribed boundary or warning criterion associated with determined blood analyte level.

12. The apparatus of claim 1, wherein said apparatus is configured to enable said indicator apparatus to indicate said determined blood analyte level only during a number n of said prescribed times, said number n less than a total number of transmissions of said wireless signals, said apparatus configured to dynamically vary said number n based at least on one or more operational parameters.

13. The apparatus of claim 1, wherein said apparatus is further configured to enable said indicator apparatus to:

(i) determine and (ii) indicate said determined blood analyte level, only during a number n of said prescribed times, said number n less than a total number of transmissions of said wireless signals, said apparatus configured to dynamically vary said number n based at least on one or more operational parameters.

14. The apparatus of claim 1, wherein said apparatus comprises a small form-factor wearable apparatus.

15. The apparatus of claim 14, wherein said small form-factor wearable apparatus comprises a wrist-worn apparatus, said wrist worn apparatus configured to indicate via the indicator apparatus only a prescribed subset of values, each value of the prescribed subset determined from the received wireless signals only.

16. The apparatus of claim 15, wherein said prescribed subset of values comprises one or more of:

(i) the determined blood analyte level;

(ii) a blood analyte level trend indication; and

/or (iii) a blood analyte level rate of change indication.

17. The apparatus of claim 14, wherein said small form-factor wearable apparatus comprises a wrist-worn apparatus comprising a primary function, and said use with said implanted blood analyte sensing device comprises a secondary function;

and

wherein said data processing apparatus and said indicator apparatus are configured to execute both said primary function and said secondary function.

18. The apparatus of claim 17, wherein said secondary function is enabled through at least one of a software and/or firmware download to the apparatus after its manufacture.

19. The apparatus of claim 1, wherein:

said apparatus further comprises a wireless transceiver apparatus in data communication with the data processing apparatus;

said wireless receiver comprises a narrowband radio frequency (RF) receiver; and

said wireless transceiver comprises a personal area network (PAN) RF transceiver configured to operate within a frequency range which does not interfere with said narrowband RF.

20. The apparatus of claim 19, wherein said apparatus is further configured to:

opportunistically establish a communication session with a parent platform via said PAN RF transceiver when such parent platform is at least one of;

(i) within sufficient range to establish said communication session; and

/or (ii) has sufficient signal strength at said apparatus to establish said communication session; and

upon establishment of said communication session, transfer at least one of calibration data and/or configuration data from the parent platform to the apparatus for use by the apparatus until a subsequent opportunistic communication session is established.

21. The apparatus of claim 1, wherein said apparatus comprises a small form-factor wearable apparatus configured to maintain contact with a user'"'"'s skin, and said indicator apparatus comprises a haptic output apparatus configured to generate haptic output cognizable by the user via the contact.

22. The apparatus of claim 21, wherein the haptic output encodes at least one of:

(i) said determined blood analyte level; and

/or (ii) one or more alerts or alarms via at least modulation of an intensity or amplitude of said haptic output.

23. The apparatus of claim 1, wherein said electrical power source comprises at least one of:

(i) triboelectric generation apparatus; and

/or (ii) a thermoelectric or Seebeck Effect generation apparatus.

24. The apparatus of claim 1, wherein said electrical power source comprises a solar or photoelectric effect power generation apparatus.

25. The apparatus of claim 1, wherein said apparatus further comprises:

a substantially flexible non-conductive substrate with a plurality of electrical traces disposed thereon; and

a skin-adherent material configured to enable adherence of the apparatus to a skin of the user such that the substrate at least partly flexes out of a planar geometry as part of said adherence; and

wherein said indicator apparatus comprises a plurality of light-emitting diodes (LEDs) configured to generate a numeric indication when illuminated corresponding to the determined blood analyte level.

26. The apparatus of claim 25, wherein said plurality of light-emitting diodes (LEDs) comprise organic LEDs (OLEDs), and said apparatus is configured to be used for only a prescribed duration, and disposable thereafter.

27. The apparatus of claim 1, wherein said apparatus is configured to be implanted within the user.

28. The apparatus of claim 27, wherein:

said apparatus is configured to be implanted within a tooth or other dental structure of the user, and

said indicator apparatus comprises a transducer configured to generate vibrations that can be transmitted to at least one ear of the user via at least a jawbone of the user.

29. The apparatus of claim 28, wherein said generated vibrations that can be transmitted to at least one ear of the user via at least a jawbone of the user comprise vibrations forming at least one audible tone within a range of 20 Hz to 20 KHz, said at least one tone encoding information relating to said determined blood analyte level.

30. The apparatus of claim 28, wherein said indicator apparatus further comprises a speech synthesis apparatus, and said generated vibrations that can be transmitted to at least one ear of the user via at least a jawbone of the user comprise synthesized speech communications within a range of 20 Hz to 20 KHz, said synthesized speech comprising a speech representation of said determined blood analyte level.

31. A method of operating a blood analyte evaluation system, the system comprising an implantable sensor, a local receiver, and a parent platform, the method comprising:

utilizing the local receiver to receive and process wireless data transmitted from the implantable sensor on a substantially continuous basis during a first period of time, the local receiver not having data communication with the parent platform during said first period; and

only incidentally establishing communication between said local receiver and said parent platform to at least receive calibration data at said local receiver from said parent platform.

32. The method of claim 31, wherein said incidentally establishing communication between said local receiver and said parent platform comprises incidentally establishing communication after said first period, and said method further comprises utilizing said received calibration data to perform at least one of:

(i) confirmation of a current calibration of said implantable sensor; and

/or (ii) adjustment to a current calibration of said implantable sensor.

33. The method of claim 32, wherein:

said utilizing the local receiver to receive wireless data transmitted from the implantable sensor comprises utilizing a dedicated narrowband wireless receiver to receive the wireless data; and

said incidentally establishing communication between said local receiver and said parent platform comprises using a multiband wireless transceiver apparatus, one or more frequencies of said dedicated narrowband receiver not overlapping with a frequency range utilized by said multiband transceiver apparatus.

34. The method of claim 31, wherein:

said only incidentally establishing communication between said local receiver and said parent platform to at least receive calibration data at said local receiver from said parent platform further comprises receiving user-provided configuration data at said local receiver from said parent platform; and

said method further comprises utilizing said received configuration data to configure at least one aspect of a user indicator function of the local receiver.

35. The method of claim 31, wherein said processing comprises determination of a blood glucose level, and the method further comprises causing providing to a user within which the implantable sensor is implanted, during the period, one or more representations of the determined blood glucose level.

36. Apparatus for use with an implanted blood glucose sensing device, the apparatus configured to generate an indication cognizable by a user and representative of the user'"'"'s blood glucose level according to the method comprising:

receiving at a power generation device of the apparatus incident first electromagnetic energy;

converting the received electromagnetic energy to electrical power;

providing the electrical power to at least a processing device of the apparatus and a wireless receiver of the apparatus;

receiving at the wireless receiver a plurality of wireless signals generated by the sensing device and encoding data relating to the blood glucose level;

processing the received plurality of signals using the processing device to generate an estimate of the blood glucose level; and

utilizing an indicator apparatus in communication with the processing device to generate said indication.

37. The apparatus of claim 36, wherein said apparatus comprises a skin-adherable patch form factor, and said incident first electromagnetic energy comprises solar radiation.

38. The apparatus of claim 36, wherein said incident first electromagnetic energy comprises electromagnetic energy emitted by said implanted sensing device.

39. The apparatus of claim 38, wherein said energy emitted by said implanted sensing device comprises said plurality of wireless signals.

40. The apparatus of claim 39, wherein said plurality of wireless signals are emitted predominantly at a prescribed center frequency within a range comprising 400 MHz to 450 MHz inclusive.

41. A method of monitoring blood glucose level while engaging in a physical activity, the method comprising wearing a limited functionality and limited form-factor local wireless receiver apparatus to:

(i) receive data wirelessly transmitted from an implanted blood glucose sensor;

(ii) process the received data to generate at least an estimated blood glucose level; and

(iii) provide indication of the estimated blood glucose level to the user during the physical activity;

wherein the limited form factor is enabled at least in part by the limited functionality; and

wherein the limited form factor enhances or enables performance of the physical activity.

42. The method of claim 41, wherein said limited functionality comprises indication via an indicator apparatus of the local wireless receiver apparatus of only a prescribed subset of values, each value of the prescribed subset determined from the received wirelessly transmitted data only.

43. The method of claim 42, wherein said prescribed subset of values comprises one or more of:

(i) the estimated blood glucose level;

(ii) a blood glucose level trend indication; and

/or (iii) a blood glucose level rate of change indication.

44. The method of claim 42, wherein said limited form factor comprises a form factor that is wearable during an entirety of the physical activity without removal.

45. The method of claim 44, wherein:

said physical activity is selected from the group consisting of;

(i) swimming, and (ii) competitive sport activity; and

the local wireless receiver apparatus is configured to be submersible.

46. A blood glucose monitoring patch for use on a living being, the patch comprising:

a wireless receiver apparatus;

data processor apparatus in signal communication with the wireless receiver apparatus;

indicator apparatus in communication with the data processing apparatus; and

a power supply configured to supply electrical power to at least the wireless receiver apparatus, the data processor apparatus, and the indicator apparatus;

wherein the wireless receiver apparatus, data processor apparatus, and indicator apparatus cooperate to enable (i) reception of wirelessly transmitted data from a sensor implanted in the living being, (ii) processing of the received data to produce an estimated blood glucose level, and (iii) cause indication of the estimated blood glucose level to the user; and

wherein the patch is at least partly flexible and is configured to adhere to skin of the living being for at least a period of time without removal.

47. The blood glucose monitoring patch of claim 46, wherein the power supply comprises a triboelectric generator apparatus that obviates use of a replaceable battery.

48. The blood glucose monitoring patch of claim 46, wherein the patch is configured to be disposable, and said period of time comprises at least one (1) week.

49. The blood glucose monitoring patch of claim 46, wherein the patch is configured to operate during said period of time, including said production of said estimated blood glucose level and indication thereof, without confirmation or calibration.

50. An implantable blood glucose sensor apparatus, comprising:

at least one detector element capable of generating data relating to a blood glucose level of a host being;

wireless interface apparatus configured to at least receive calibration-related data wirelessly transmitted from another device;

data storage apparatus; and

computerized logic in data communication with the at least one detector element, the data storage apparatus, and the wireless interface apparatus, the computerized logic configured to;

utilize the received calibration-related data and the data relating to blood glucose level to generate data indicative of a calibrated blood glucose level measurement; and

store the data indicative of the calibrated blood glucose level measurement in the data storage apparatus.

51. The implantable blood glucose sensor apparatus of claim 50, wherein:

the storage of the data indicative of the calibrated blood glucose level measurement in the data storage apparatus includes storage of a chronological reference associated with the stored data, the storage comprising storage of a plurality of data indicative of respective ones of calibrated blood glucose level measurements and their associated chronological references; and

the wireless interface comprises a personal area network (PAN) radio frequency interface capable of wireless transmission of data, and the computerized logic is further configured to transmit the stored plurality of data indicative of the calibrated blood glucose level measurements and associated chronological references to an external device for subsequent use thereby, the transmission comprising an opportunistic transmission initiated in response to a determination by the implantable blood glucose sensor apparatus that the external device is in data communication with the implantable blood glucose sensor apparatus.

52. A blood analyte evaluation system, comprising:

an implantable sensor apparatus;

a local receiver apparatus configured to receive and process wireless data transmitted from the implantable sensor apparatus on a substantially continuous basis during a first period of time; and

wherein the local receiver apparatus is further configured to at least receive data from computerized logic configured to run on a parent platform, the local receiver not having data communication with the parent platform during said first period, the data received from the parent platform comprising at least configuration data specifying a plurality of operational parameters relating to said receipt and processing of the wireless data transmitted from the implantable sensor.

53. The blood analyte evaluation system of claim 52, wherein said configuration data specifying a plurality of operational parameters relating to said receipt and processing of the wireless data transmitted from the implantable sensor comprises:

first data specifying one or more user interface parameters; and

second data specifying one or more data processing parameters, the one or more data processing parameters relating to processing of said wireless data transmitted from the implantable sensor by computerized processing logic operative to run on the local receiver apparatus to generate data indicative of measured blood glucose level.