Body-associated receiver and method

• US 9,149,577 B2
• Filed: 04/30/2013
• Issued: 10/06/2015
• Est. Priority Date: 12/15/2008
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Robertson, Timothy L., Omidvar, Fataneh, Behzadi, Yashar, Arne, Lawrence, Rowberry, Kenneth, Hutchison, James, Leichner, Robert, Savage, George, Thompson, Andrew, Zdeblick, Mark, Kreidler, Marc, Hafezi, Hooman, Duck, Robert
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US13/874,316
• Publication Number:
  US 20140236077A1
• Time in Patent Office: 889 Days
• Field of Search: 600300-301
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/308 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: H04B 13/005 : Transmission systems in which the medium consists of the human body
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Receivers, which may be external or implantable, are provided. Aspects of receivers of the invention include the presence of one or more of: a high power-low power module; an intermediary module; a power supply module configured to activate and deactivate one or more power supplies to a high power processing block; a serial peripheral interface bus connecting master and slave blocks; and a multi-purpose connector. Receivers of the invention may be configured to receive a conductively transmitted signal. Also provided are systems that include the receivers, as well as methods of using the same. Additionally systems and methods are disclosed for using a receiver for coordinating with dosage delivery systems.

Claims

1. A receiver for detection of physiological information associated with a subject, the receiver comprising:

a power source secured within a housing configured for mounting on an exterior surface of the subject;

a power management module electrically coupled to the power source and secured within the housing such that the power management module controls the power source;

a processing unit electrically coupled to the power management module and secured within the housing, wherein the processing unit is configured to detect, from a position external to the subject, a first signal having a first frequency and corresponding to a first current flow produced by a first device located internal to the subject and a second signal having a second frequency and corresponding to a second current flow associated with the physiology of the subject, wherein the first frequency is greater than the second frequency; and

a communication module electrically coupled to the processing unit and secured within the housing, wherein the communication module allows for communication between the receiver and a second device located external to the subject, wherein the receiver is configured to provide physiological information associated with the second current flow to the external second device and to provide control information to a third device located external to the subject based on the physiological information;

wherein the power management module comprises a beacon switching module configured to generate a third signal to transition the power management module to an operational state of the receiver depending on the first signal received from the first device; and

wherein the receiver is configured to be located external to the subject; and

wherein the first signal is communicated by the first device located internal to the subject through a body of the subject and each of the first signal and the second signal is received at the receiver as a transbody conductive signal.

2. The receiver of claim 1, further comprising a delivery apparatus secured within the housing, wherein the delivery apparatus comprises:

a containment unit that includes;

a chamber to contain a fluid;

a plunger secured to the chamber; and

a microneedle secured to the chamber and capable of piercing the subject'"'"'s skin; and

a control unit, which is electrically coupled to the processing unit, that controls the plunger based on dosage control information provided by the processing unit, wherein the control unit moves the plunger to expel the fluid through the microneedle.

3. The receiver of claim 2, wherein the dosage control information provided by the processing unit is based on the first signal having the first frequency and corresponding to the first current flow produced by the first device located internal to the subject.

4. The receiver of claim 1, wherein the power management module comprises:

a high power operation module that controls high power output from the power supply to the processing unit when the processing unit is in an active state;

an intermediate power operation module that controls intermediate power output from the power supply to the processing unit while the processing unit is in an active nonoperation state and that controls a transition of the processing unit from the active state, the active nonoperation state, or an inactive state to another operational state based on at least one of the first signal and the second signal; and

a lower power operation module that controls low power output from the power supply and monitors the subject'"'"'s skin for the first current flow from the first device located internal to the subject while the processing unit is in the inactive state.

5. The receiver of claim 4, wherein the beacon switching module is configured to send the third signal to the intermediate power operation unit, wherein the processing unit is configured to switch to the active non-operation state upon receiving the third signal such that the processing unit is capable of determining if information in the form of a predetermined frequency current flow is present and wherein the power management module supplies the high power output to the processing unit if the processing unit detects information in the form of the predetermined frequency current flow.

6. The receiver of claim 1, wherein the first signal having the first frequency and corresponding to the first current flow produced by the first device located internal to the subject is independent of the physiological information.

7. The receiver of claim 1, wherein the physiological information is detected by the first device internal to the subject.

8. A receiver for detection of physiological information associated with a subject, the receiver comprising:

a power source secured within a housing configured for mounting on an exterior surface of the subject;

a power management module electrically coupled to the power source and secured within the housing;

a processing unit electrically coupled to the power management module, wherein the processing unit is configured to detect and gather from a location external to the subject;

information associated with a first device located internal to the subject, wherein the information is expressed as a first electrical current signal in a first frequency band and produced by the first device; and

physiologic information associated with the subject expressed as a second electrical current signal in a second frequency band;

wherein the first frequency band is greater than the second frequency band; and

a communication module electrically coupled to the processing unit, wherein the communication module is configured to communicate between the receiver and a second device located external to the subject, wherein the receiver is configured to provide the physiological information to the second device and to provide control information to a third device located external to the subject;

wherein the receiver is located external to the subject and the first signal is communicated by the first device located internal to the subject through the body of the subject and the first signal is received at the receiver as a transbody conductive signal.

9. The receiver of claim 8, further comprising a delivery apparatus comprising:

a containment unit that includes;

a chamber to contain a fluid;

a plunger secured to the chamber; and

a microneedle secured to the chamber and capable of piercing the subject'"'"'s skin; and

a control unit electrically coupled to the processing unit and configured to control the plunger based on dosage control information provided by the processing unit, wherein the control unit is configured to move the plunger to expel the fluid through the microneedle.

10. The receiver of claim 9, wherein the dosage control information provided by the processing unit is based on the first signal having the first frequency and corresponding to the first current flow produced by the first device located internal to the subject.

11. The receiver of claim 8, wherein the power management module comprises:

a high power operation unit configured to control high power output from the power supply to the processing unit when the processing unit is in an active state;

an intermediate power operation unit configured to control intermediate power output from the power supply to the processing unit while the processing unit is in an active nonoperation state; and

a lower power operation unit configured to control low power output from the power supply and to monitor the skin of the subject for the first signal while the processing unit is in an inactive state.

12. The receiver of claim 11, wherein the power management module includes a beacon switching module configured to send a signal to the intermediate power operation unit to switch the processing unit to the active non-operation state to enable the processing unit to determine when a signal in the first frequency band is present and wherein the power management module is configured to supply high power to the processing unit when the processing unit detects information carried by the signal in the first frequency band.

13. The receiver of claim 8, wherein the first signal having the first frequency and corresponding to the first current flow produced by the first device located internal to the subject is independent of the physiological information.

14. The receiver of claim 8, wherein the physiological information is detected by the first device internal to the subject.

15. A receiver for detection of physiological information associated with a subject, the receiver comprising:

a power source secured within a housing configured for mounting on an exterior surface of the subject;

a power management module electrically coupled to the power source and secured within the housing;

a processing unit electrically coupled to the power management module, wherein the processing unit is configured to detect and gather from a location external to the subject;

information associated with a first device located internal to the subject, wherein the information is expressed as a first electrical current signal in a first frequency band and produced by the first device; and

physiologic information associated with the subject expressed as a second electrical current signal in a second frequency band;

wherein the first frequency band is greater than the second frequency band; and

a communication module electrically coupled to the processing unit, wherein the communication module is configured to communicate between the receiver and a second device located external to the subject, wherein the receiver is configured to provide the physiological information to the second device

wherein the receiver is located external to the subject and the first signal is communicated by the first device located internal to the subject through the body of the subject and the first signal is received at the receiver as a transbody conductive signal.

16. The receiver of claim 15, further comprising a delivery apparatus comprising:

a containment unit that includes;

a chamber to contain a fluid;

a plunger secured to the chamber; and

a microneedle secured to the chamber and capable of piercing the subject'"'"'s skin; and

a control unit electrically coupled to the processing unit and configured to control the plunger based on dosage control information provided by the processing unit, wherein the control unit is configured to move the plunger to expel the fluid through the microneedle.

17. The receiver of claim 16, wherein the dosage control information provided by the processing unit is based on the first signal having the first frequency and corresponding to the first current flow produced by the first device located internal to the subject.

18. The receiver of claim 15, wherein the power management module comprises:

a high power operation unit configured to control high power output from the power supply to the processing unit when the processing unit is in an active state;

an intermediate power operation unit configured to control intermediate power output from the power supply to the processing unit while the processing unit is in an active nonoperation state; and

a lower power operation unit configured to control low power output from the power supply and to monitor the skin of the subject for the first signal while the processing unit is in an inactive state.

19. The receiver of claim 18, wherein the power management module includes a beacon switching module configured to send a signal to the intermediate power operation unit to switch the processing unit to the active non-operation state to enable the processing unit to determine when a signal in the first frequency band is present and wherein the power management module is configured to supply high power to the processing unit when the processing unit detects information carried by the signal in the first frequency band.

20. The receiver of claim 15, wherein the first signal having the first frequency and corresponding to the first current flow produced by the first device located internal to the subject is independent of the physiological information.

21. The receiver of claim 15, wherein the physiological information is detected by the first device internal to the subject.