Body-Associated Receiver and Method

• US 20100312188A1
• Filed: 12/15/2009
• Published: 12/09/2010
• 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: Omidvar, Fataneh, Hutchison, James, Rowberry, Kenneth, Arne, Lawrence, Duck, Robert, Behzadi, Yashar, Savage, George, Thompson, Andrew, Hafezi, Hooman, Leichner, Robert, Robertson, Timothy, Kreidler, Marc, Zdeblick, Mark
• Granted Patent: US 8,114,021 B2
• Time in Patent Office: Days
• US Class Current: 604/156
• 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 physiological communication receiver that can be removably secured to a subject'"'"'s skin, the receiver comprising:

a housing;

a power source secured within the housing;

a processing unit electrically coupled to the power source and secured within the housing; and

at least two electrodes electrically coupled to the processing unit and secured to the perimeter of the housing such that the electrodes will contact the subject'"'"'s skin the skin,

wherein the processing unit detects and gathers information in the form of high frequency current flow through the electrodes and wherein the high frequency current flow is associated with a device associated with the subject.

2. The receiver of claim 1, wherein the processing unit detects and gathers physiological information in the form of low frequency current flow through the electrodes and wherein the low frequency information is associated with the subject'"'"'s physiology.

3. The receiver of claim 2, further comprising a communication module electrically coupled to the processing unit, wherein the communication module allows for wireless communication between the receiver and a device external to the subject such that the receiver can provide the physiological information to the device external to the subject.

4. The receiver of claim 3 wherein the communication module uses frequency hopping spread spectrum communication protocol.

5. The receiver of claim 2, further comprising a communication module electrically coupled to the processing unit, wherein the communication module allows for wireless communication between the receiver and a device external to the subject such that the receiver can provide control information to the device external to the body and wherein the control information is derived from the high frequency current information provided by the device associated with the subject.

6. The receiver of claim 5, wherein the device external to the subject is a control unit associated with a pharmaceutical delivery system that includes a pharmaceutical product and can alter the delivery dosage of a pharmaceutical product.

7. The receiver of claim 6, wherein the pharmaceutical delivery system comprises a fluid containment unit having a chamber configured to contain a fluid and a plunger secured to the fluid containment unit, wherein the plunger is controlled by the control unit based on the control information provided by the receiver.

8. The receiver of claim 7, wherein the fluid containment unit is an intravenous bag containing the fluid.

9. The receiver of claim 1 further comprising a power management module electrically coupled to the power source and the processing unit such that the power management module controls the power output from the power source to the processing unit and wherein the power management module monitors the surrounding environment to determine if high frequency current flow is present and wherein the power management module switches the processing unit from an inactive state to an active state if the high frequency current flow is detected.

10. The receiver of claim 9, 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 non-operation state; and

a lower power operation module that controls low power output from the power supply and monitors the subject'"'"'s skin for the high frequency current flow while the processing unit is in an inactive state.

11. The receiver of claim 10, wherein the power management module includes a beacon module for sending a signal to the intermediate power operation module to allow the processing unit to switch to the active non-operation.

12. The receiver of claim 11, wherein the beacon module comprises:

a counter;

a beacon signal generator coupled to the counter for generating a plurality of beacon signals; and

a memory unit coupled to the beacon signal generator, wherein the memory unit stores an algorithm that the beacon signal generator uses to determine the time lapse between each of the plurality of beacon signals,

wherein the power management module monitors the beacon module to determine if the beacon module has generated at least one beacon signal of the plurality of beacon signals.

13. The receiver of claim 1, further comprising:

a connector routing unit coupled to the processing unit and the power source; and

a multi-purpose connector electrically coupled to the connector routing unit, wherein the connector routing unit controls electrical connection paths between a device external to the subject and physically connected to the receiver and the power source as well as the processing unit.

14. The receiver of claim 13, wherein the electrical signal from the device external to the subject comes from an external power supply that charges the power source.

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

a power source secured within a housing;

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 detects and gathers the information in the form of high frequency current flow produced by a device internal to the subject and low frequency current flow associated with the subject'"'"'s physiology; 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 device external to the subject such that the receiver is able to provide the physiological information to the external device and to provide control information to another external device based on the physiological information.

16. The receiver of claim 15, further comprising a delivery apparatus secured within the housing, wherein the delivery apparatus includes:

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.

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

a high power operation unit 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 unit that controls intermediate power output from the power supply to the processing unit while the processing unit is in an active non-operation state; and

a lower power operation unit that controls low power output from the power supply and monitors the subject'"'"'s skin for the high frequency current flow while the processing unit is in an inactive state

18. The receiver of claim 17, wherein the power management module includes a beacon module for sending a signal to the intermediate power operation unit to allow the processing unit to switch to the active non-operation state such that the processing unit is capable of determining if information in the form of high frequency current flow is present and wherein the power management module supplies high power to the processing unit if the processing unit detects information in the form of high frequency current flow.

19. A receiver for detecting and collecting data encoded in current flow in a conducting fluid contained within a subject, the receiver comprising:

a housing;

a power source secured to the housing;

an operation unit secured to the housing for analyzing the data transmission, the operation unit comprising;

at least one sensor for detection of current flow;

a high frequency module for detecting data in the form of high frequency current flow from a device internal to the subject; and

a low frequency module for detecting data in the form of low frequency current flow associated with physiological parameters of the subject;

a power management module secured to the housing and electrically coupled to the power source and the operation unit, wherein the power management module controls the power supplied to the operation unit from the power source and wherein the power management module monitors the surrounding environment to determine if data transmission is present and wherein the power management module switches the operation unit from an inactive state to an active state if data transmission is present; and

a multipurpose connection unit secured to the hosing for controlling electrical connection between a device external to the subject that is physically connected to the receiver, the multipurpose connection unit comprising;

connector routing unit coupled to the operation unit and the power source; and

a multi-purpose connector electrically coupled to the connector routing unit.

20. The receiver of claim 19, wherein the power management module comprises:

a high power operation module for allowing high power supply to the operation unit when the operation unit is in an active state;

a intermediate power operation module for allowing power supply to the operation unit while the operation unit is in an active non-operation state; and

a lower power operation module for monitoring for the data transmission in the current flow while the operation unit is in an inactive state.

21. An ionic emission communication receiver for detecting data transmission using ionic emissions through a conducting fluid, the receiver comprising:

a housing including an outer case;

a power source secured within the housing; and

an operation unit secured within the house such that the operation unit receives power from the power source and wherein the operation unit comprises;

at least one electrode secured to the outer case of the housing and capable of coming into contact with the conducting fluid;

a processing unit electrically coupled to the at least one electrode; and

a memory unit electrically coupled to the processing unit,

wherein the at least one electrode detects the ionic emission communicated and wherein the data is encoded in the ionic emission and transmitted through the conducting fluid using a controlled dissolution of a material into solution.

22. A receiver for detecting and collecting data transmitted in the form of current flow through a conducting fluid contained within a medium, the receiver comprising:

a housing;

a power source secured to the housing;

an operation unit secured to the hosing for analyzing the data transmission, the operation unit comprising;

at least one sensor for detection of the current flow;

a high frequency module for detecting high frequency transmission data;

a low frequency module for detecting low frequency transmission data; and

a power management module secured to the housing and electrically coupled to the power source and the operation unit, wherein the power management module controls the power supplied to the operation unit from the power source and wherein the power management module comprises;

a high power operation module for allowing high power supply to the operation unit when the operation unit is in an active state;

a intermediate power operation module for allowing power supply to the operation unit while the operation unit is in an active non-operation state; and

a lower power operation module for monitoring for the data transmission in the current flow while the operation unit is in an inactive state,

wherein the power management module monitors the surrounding environment to determine if the data transmission in the current flow is present and wherein the power management module switches the operation unit from an inactive state to an active state if the data transmission in the current flow in present.

23. The receiver of claim 22, wherein the power management module reduces the power supply to the operation unit if data transmission in the current flow is not detected such that the operation unit returns to an inactive state.

24. The receiver of claim 22 further comprising a transmission module electrically coupled to the power management module and the operation unit, wherein the transmission module communicates information associated with analysis of the data transmission in the current flow.

25. The receiver of claim 22 further comprising a wireless communication module coupled to the power management module and secured to the housing, wherein the wireless communication module provides input and output communication for the receiver using frequency hopping spread spectrum communication protocol.

26. The receiver of claim 25 further comprising an external programming device capable of communicating through the wireless communication module, wherein the programming device alters the programming information stored in the memory unit of the beacon unit.

27. The receiver of claim 22 further comprising an accelerometer secured to the housing for detecting changes in orientation of the receiver and for generating an orientation signal in response to the change in orientation, wherein the power management module monitors the accelerometer to determine if a change in orientation has occurred and the power management module alters the state of the receiver in response to the detection change in orientation.

28. An ionic emission communication receiver for detecting data transmission using ionic emissions through a conducting fluid, the receiver comprising:

a housing;

a power source secured within the housing; and

an operation unit secured within the house such that the operation unit receives power from the power source and wherein the operation unit comprises;

at least one electrode;

a processing unit electrically coupled to the at least one electrode; and

a memory unit electrically coupled to the processing unit, wherein the at least one electrode detects the ionic emission communicated and wherein the data is encoded in the ionic emission and transmitted through the conducting fluid using a controlled dissolution of a material into solution.

29. The ionic receiver of claim 28 further comprising a power management module secured within the housing and electrically coupled to the power source and the operation unit, wherein the power management module controls the power supplied to the operation unit from the power source and wherein the power management module comprises:

a high power operation module for allowing high power supply to the operation unit when the operation unit is in an active state;

a intermediate power operation module for allowing power supply to the operation unit while the operation unit is in an active non-operation state; and

a lower power operation module for monitoring for the data transmission in the current flow while the operation unit is in an inactive state.

30. The receiver of claim 29 further comprising a transmission module electrically coupled to the power management module and the operation unit, wherein the transmission module communicates information associated with analysis of the ionic emission and wherein the transmission module comprises a wireless communication module for providing wireless input and output communication for the ionic receiver.

31. The ionic receiver of claim 30 further comprising an accelerometer secured to the housing for detecting changes in orientation of the ionic receiver and for generating an orientation signal in response to the change in orientation, wherein the power management module monitors the accelerometer to determine if a change in orientation has occurred and the power management module alters the state of the ionic receiver in response to the detection change in orientation.

32. The ionic receiver of claim 28 further comprising a protective membrane on the housing to prevent the conducting fluid from entering the housing.

33. The ionic receiver according to claim 28 wherein the operation unit includes:

an ECG sensor module;

an impedance measurement module;

a global position system module for tracking the location of a living subject; and

a microneedle coupled to a delivery control module that houses an active agent, wherein the delivery control module uses the microneedle to deliver an active agent to the living subject.

34. The ionic receiver according to claim 33, wherein the operation unit includes an epileptic seizure detection module.