Dual-mode physiologic monitoring systems and methods

• US 20070208262A1
• Filed: 03/03/2006
• Published: 09/06/2007
• Est. Priority Date: 03/03/2006
• Status: Active Grant

• Current Assignee: Physiowave, Inc. (Omron Corporation)
• Original Assignee: Physiowave, Inc. (Omron Corporation)
• Inventors: Kovacs, Gregory
• Granted Patent: US 7,668,588 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• 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 5/276 Protection against electrode failure
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor

Abstract

In some embodiments, a wearable physiologic monitor comprises an application-specific integrated circuit (ASIC) including signal conditioning circuitry, a real-time clock, digital control logic, and mode-selection logic for setting an operating mode of the ASIC to a stand-alone mode or a peripheral mode. In the stand-alone mode, the digital control logic periodically stores data packets including multiple sensor data types in a digital memory such as a removable flash memory card. In the peripheral mode, the data packets are transmitted to a microcontroller for processing. The monitor includes sensors such as electrocardiogram (ECG) electrodes, accelerometers, and a temperature sensor, some of which may be integrated on the ASIC. The same basic chip design may be used in the stand-alone mode in disposable patches, and in the peripheral mode in bedside devices. The operating mode may be chosen at monitor manufacture, by connecting input pins to mode-selection logic levels.

Claims

1. A physiologic monitoring system comprising:

a battery;

a plurality of electrocardiogram electrodes;

a digital memory; and

an integrated circuit connected to the battery, the plurality of electrocardiogram electrodes, and the digital memory, comprising;

a real-time clock for generating a set of real time indicators;

amplification and filtering circuitry for amplifying and filtering a set of physiologic electrical signals received from the plurality of electrocardiogram electrodes to generate a set of filtered electrical signals;

digital control logic connected to the real-time clock and the amplification and filtering circuitry; and

mode-selection logic connected to the digital control logic, for setting an operating mode of the integrated circuit to a mode selected from a stand-alone mode and a peripheral mode;

wherein, in the stand-alone mode, the digital control logic is configured to

generate a set of time-stamped physiologic data packets from the set of real-time indicators and a set of digital electrocardiogram data derived from the filtered electrical signals, and

transmit the time-stamped data packets for storage in the digital memory; and

wherein, in the peripheral mode, the integrated circuit is configured to transfer physiologic data derived from the digital electrocardiogram data to a programmable microcontroller.

2. The system of claim 1, wherein the operating mode of the integrated circuit is set to the stand-alone mode.

3. The system of claim 1, wherein the operating mode of the integrated circuit is set to the peripheral mode.

4. The system of claim 3, further comprising the programmable microcontroller connected to the integrated circuit.

5. The system of claim 1, further comprising a set of integrated circuit mode-selection input pins connected to the mode-selection logic, wherein the mode-selection logic is configured to set the operating mode of the integrated circuit according to a set of logic levels of the mode-selection input pins.

6. The system of claim 5, wherein the mode-selection input pins are bonded to a set of mode-selection logic levels.

7. The system of claim 1, wherein the peripheral mode is a self-clocked peripheral mode, and wherein in the self-clocked peripheral mode the digital control logic is configured to generate the set of time-stamped physiologic data packets from the set of real-time indicators and the digital electrocardiogram data, and transmit the set of time-stamped data packets to the programmable microcontroller.

8. The system of claim 1, wherein the peripheral mode is a passive peripheral mode, and wherein in the passive peripheral mode the digital control logic is substantially disabled.

9. The system of claim 1, wherein the integrated circuit is integrated in a wearable patch configured to be attached to a subject'"'"'s skin.

10. The system of claim 9, wherein the plurality of electrodes are integrated in the wearable patch.

11. The system of claim 9, wherein the patch comprises an encapsulant enclosing the integrated circuit.

12. The system of claim 9, further comprising an adhesive for coupling the patch to a subject'"'"'s skin.

13. The system of claim 1, wherein the amplification and filtering circuitry comprises a pacemaker pulse detection circuit for detecting a set of pacemaker pulses sensed by the electrocardiogram electrodes.

14. The system of claim 1, wherein the amplification and filtering circuitry comprises continuous-time analog filtering circuitry.

15. The system of claim 1, wherein the amplification and filtering circuitry comprises switched capacitor filtering circuitry.

16. The system of claim 1, wherein the amplification and filtering circuitry comprises a digital signal processor.

17. The system of claim 1, further comprising a timing resonator coupled to the real-time clock, for sending a set of periodic timing pulses to the real-time clock.

18. The system of claim 1, wherein the integrated circuit comprises the timing resonator.

19. The system of claim 1, further comprising a physiologic temperature sensor for generating a set of subject temperature indicators, the digital control logic being connected to the temperature sensor, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital temperature data derived from the set of subject temperature indicators.

20. The system of claim 1, further comprising an accelerometer for generating a set of subject acceleration indicators, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital acceleration data derived from the acceleration indicators.

21. The system of claim 20, wherein the integrated circuit comprises the accelerometer.

22. The system of claim 1, further comprising an impedance measurement circuit comprising an impedance measurement electrode, for generating a set of impedance indicators, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital impedance data derived from the impedance indicators.

23. The system of claim 1, further comprising a pulse oximeter for generating a set of blood oxygen indicators, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital blood oxygen data derived from the blood oxygen indicators.

24. The system of claim 1, further comprising a light detector for generating a set of ambient light intensity indicators, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital ambient light data derived from the ambient light intensity indicators.

25. The system of claim 1, further comprising a sound detector for generating a set of ambient sound intensity indicators, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital ambient sound data derived from the ambient sound intensity indicators.

26. The system of claim 1, further comprising an ionizing radiation detector for generating a set of ambient ionizing radiation indicators, wherein in the stand-alone mode the digital control logic is configured to include in the time-stamped data packets a set of digital ionizing radiation data derived from the ambient ionizing radiation indicators.

27. The system of claim 1, further comprising a subject sensory indicator device connected to the digital control logic, for providing a sensory indication to a subject.

28. The system of claim 27, wherein the sensory indicator device comprises a light-emitting device.

29. The system of claim 27, wherein the sensory indicator device comprises a speaker.

30. The system of claim 27, wherein the sensory indication comprises a voice prompt.

31. The system of claim 27, wherein the digital control logic comprises physiologic condition detection logic connected to the sensory indicator device, the physiologic condition detection logic being configured to activate the sensory indicator device when a physiologic parameter value meets a predetermined condition.

32. The system of claim 27, wherein the digital control logic comprises real-time detection logic connected to the sensory indicator device, the real-time detection logic being configured to activate the sensory indicator device when a current real time meets a predetermined condition.

33. The system of claim 1, wherein the digital control logic comprises electrode fault detection logic connected to the plurality of electrocardiogram electrodes, for detecting an electrocardiogram electrode fault.

34. The system of claim 1, further comprising an external event actuator, configured to generate an event signal in response to actuation by a subject, the digital control logic in the stand-alone mode being configured to include digital event data derived from the event signal in the time-stamped data packets.

35. The system of claim 1, further comprising a wearable visual display connected to the digital control logic, for generating a display of data derived from the digital electrocardiogram data.

36. The system of claim 1, wherein the set of time-stamped data packets include a first time-stamped data packet and a second time-stamped data packet, wherein the first time-stamped data packet and the second time-stamped data packet are temporally separated by a set of non-time-stamped physiologic data packets transmitted by the digital control logic in the stand-alone mode for storage in the digital memory.

37. The system of claim 1, wherein the digital control logic in the stand-alone mode is configured to assemble the set of data packets according to a predetermined inter-packet time period, wherein each packet in the set of data packets is separated by the inter-packet time period from an immediately preceding data packet and an immediately subsequent data packet.

38. A physiologic monitoring system comprising:

a battery;

a set of physiologic sensors;

a digital memory; and

an integrated circuit connected to the battery, the set of physiologic sensors, and the digital memory, comprising;

a real-time clock for generating a set of real time indicators;

amplification and filtering circuitry for amplifying and filtering a set of electrical signals received from the set of physiologic sensors to generate a set of filtered electrical signals;

digital control logic connected to the real-time clock and the amplification and filtering circuitry; and

mode-selection logic connected to the digital control logic, for setting an operating mode of the integrated circuit to a mode selected from a stand-alone mode and a peripheral mode;

wherein, in the stand-alone mode, the digital control logic is configured to

generate a set of time-stamped physiologic data packets from the set of real-time indicators and a set of digital physiologic data derived from the filtered electrical signals, and

transmit the time-stamped data packets for storage in the digital memory; and

wherein, in the peripheral mode, the integrated circuit is configured to transfer physiologic data derived from the digital physiologic data to a programmable microcontroller.

39. A physiologic monitoring integrated circuit comprising:

an integrated real-time clock for generating a set of real time indicators;

integrated amplification and filtering circuitry connected to a set of physiologic sensors, for amplifying and filtering a set of electrical signals received from the physiologic sensors to generate a set of filtered electrical signals;

integrated digital control logic connected to the real-time clock and the amplification and filtering circuitry; and

integrated mode-selection logic connected to the digital control logic, for setting an operating mode of the integrated circuit to a mode selected from a stand-alone mode and a peripheral mode;

wherein, in the stand-alone mode, the digital control logic is configured to

generate a set of time-stamped physiologic data packets from the set of real-time indicators and a set of digital physiologic data derived from the filtered electrical signals, and

transmit the time-stamped data packets for storage in a digital memory; and

wherein, in the peripheral mode, the integrated circuit is configured to transfer data derived from the digital physiologic data to a programmable microcontroller.

40. A physiologic monitoring system comprising:

a set of physiologic sensors;

a digital memory; and

an integrated circuit connected to the set of physiologic sensors, and the digital memory, comprising;

real-time means for generating a set of real time indicators;

amplification and filtering means for amplifying and filtering a set of electrical signals received from the set of physiologic sensors to generate a set of filtered electrical signals;

digital control means connected to the real-time means and the amplification and filtering means; and

mode-selection means connected to the digital control means, for setting an operating mode of the integrated circuit to a mode selected from a stand-alone mode and a peripheral mode;

wherein, in the stand-alone mode, the digital control means is configured to

generate a set of time-stamped physiologic data packets from the set of real-time indicators and a set of digital physiologic data derived from the filtered electrical signals, and

transmit the time-stamped data packets for storage in the digital memory; and

wherein, in the peripheral mode, the integrated circuit is configured to transfer physiologic data derived from the digital physiologic data to a programmable microcontroller.

41. A physiologic monitoring method comprising:

sensing a plurality of physiologic signals generated by a subject; and

employing an integrated circuit to

generate a set of real time indicators;

amplify and filter the physiologic signals to generate a set of filtered electrical signals;

generating a set of digital physiologic data from the set of filtered electrical signals; and

setting an operating mode of the integrated circuit to a mode selected from a stand-alone mode and a peripheral mode;

wherein, in the stand-alone mode, the integrated circuit is configured to

generate a set of time-stamped physiologic data packets from the set of real-time indicators and the digital physiologic data, and

transmit the time-stamped data packets for storage in a digital memory; and

wherein, in the peripheral mode, the integrated circuit is configured to transfer data derived from the digital physiologic data to a programmable microcontroller.