Adherent device for sleep disordered breathing

• US 8,688,190 B2
• Filed: 07/06/2012
• Issued: 04/01/2014
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis Inc (Medtronic Plc)
• Inventors: Libbus, Imad, Manicka, Yatheendhar D., Bly, Mark J.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/543,660
• Publication Number:
  US 20120277549A1
• Time in Patent Office: 634 Days
• Field of Search: 600/372, 600/382, 600391-393, 600/547, 600/529, 600533-536, 600/301
• US Class Current: 600/391
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• 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 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

An adherent device is configured to adhere to the skin of the patient with an adherent patch, for example breathable tape, coupled to at least four electrodes. The device comprises impedance circuitry coupled to the at least four electrodes and configured to measure respiration of the patient to detect sleep apnea and/or hypopnea. The impedance circuitry may be used to measure hydration of the patient. An accelerometer can be mechanically coupled to the adherent patch such that the accelerometer can be coupled to and move with the skin of the patient. Electrocardiogram circuitry to generate an electrocardiogram signal may be coupled to at least two of the at least four electrodes to detect the sleep apnea and/or hypopnea.

Claims

1. A system to monitor a sleep apnea and/or hypopnea of a patient, the system comprising:

an adhesive patch to adhere to a skin of the patient;

at least four electrodes connected to the adhesive patch and capable of electrically coupling to the patient;

impedance circuitry coupled to the at least four electrodes to measure an impedance signal of the patient; and

a processor system comprising a tangible medium configured to determine a respiration rate and detect the apnea and/or hypopnea in response to the impedance signal, and to provide information about the apnea and/or hypopnea to an algorithm configured to predict decompensation.

2. The system of claim 1, wherein the processor system is configured to determine an apnea hypopnea index of the patient in response to the impedance signal and to provide the apnea hypopnea index to the algorithm configured to predict decompensation.

3. The system of claim 1 wherein the impedance circuitry is configured to measure extra cellular fluid of the patient with at least one frequency within a range from about 0.5 kHz to about 200 kHz. and wherein the impedance circuitry is configured to determine a respiration of the patient.

4. The system of claim 1 wherein the processor system is configured to control a collection and transmission of data from the impedance circuitry.

5. The system of claim 1, further comprising at least one of electromyogram circuitry or an accelerometer mechanically coupled to a second adhesive patch to generate at least one of an electromyogram signal or an accelerometer signal when the second adhesive patch is adhered to the skin of the patient, wherein the at least one electromyogram signal or the accelerometer signal is communicated to the processor system.

6. The system of claim 1, further comprising an accelerometer mechanically coupled to a second adhesive patch to generate an accelerometer signal when the second adhesive patch is adhered to the skin of the patient, and wherein the second adhesive patch is configured to adhere to at least one of an ankle, a leg, a foot, or a jaw of the patient and wherein the processor system is configured to detect at least one of a restless leg or a bruxation of the patient in response to the accelerometer signal.

7. The system of claim 1 wherein the system comprises an accelerometer mechanically coupled to a second adhesive patch to generate an accelerometer signal when the second adhesive patch is adhered to the skin of the patient, and wherein the accelerometer is coupled to wireless communication circuitry supported with the second patch to transmit the accelerometer signal to the processor system.

8. The system of claim 1, further comprising at least one of electromyogram circuitry or an accelerometer mechanically coupled to at least one of the adhesive patch or a strap to generate at least one of an electromyogram signal or an accelerometer signal when the at least one of the adhesive patch or the strap is positioned on the patient, wherein the at least one electromyogram signal or the accelerometer signal is communicated to the processor system.

9. The system of claim 1, further comprising an accelerometer mechanically coupled to the adhesive patch to generate an accelerometer signal when the adhesive patch is positioned on the patient, and wherein the accelerometer is coupled to wireless communication circuitry supported with the adhesive patch to transmit the accelerometer signal to the processor system.

10. The system of claim 1, further comprising an accelerometer mechanically coupled to the adhesive patch to generate an accelerometer signal in response to at least one of an activity or a position of the patient when the adhesive patch is adhered to the skin of the patient and wherein the processor system is configured to determine that the patient is asleep in response to the accelerometer signal.

11. The system of claim 10 wherein the accelerometer comprises at least one of a piezoelectric accelerometer, capacitive accelerometer or electromechanical accelerometer and wherein the accelerometer comprises a 3-axis accelerometer to measure at least one of an inclination, a position, an orientation or acceleration of the patient in three dimensions.

12. The system of claim 10, further comprising:

electrocardiogram circuitry coupled to at least two of the at least four electrodes to measure an electrocardiogram signal of the patient.

13. The system of claim 12 wherein the processor system is configured to determine that the patient is asleep in response to the accelerometer signal and the electrocardiogram signal.

14. The system of claim 12 wherein the processor system is configured to detect the sleep apnea and/or hypopnea in response to a heart rate variability from the electrocardiogram signal.

15. The system of claim 12 wherein the adhesive patch is mechanically coupled to the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry, the accelerometer and at least one processor of the processor system, such that the adhesive patch is capable of supporting the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry the accelerometer and the at least one processor when the adhesive patch is adhered to the skin of the patient.

16. The system of claim 1 further comprising wireless communication circuitry coupled to the impedance circuitry to transmit the impedance signal to a remote center with a communication protocol.

17. The system of claim 16, further comprising electrocardiogram circuitry coupled to at least two of the at least four electrodes to measure an electrocardiogram signal of the patient, wherein at least one processor of the processor system is supported with the adhesive patch and wherein the at least one processor is configured to determine the respiration rate from the impedance signal and a heart rate from the electrocardiogram signal.

18. The system of claim 17, wherein the wireless communication circuitry is configured to transmit at least one of the heart rate or the respiration rate to the remote center to determine an apnea hypopnea index.

19. The system of claim 1 further comprising wireless communication circuitry coupled to the impedance circuitry, wherein the wireless communication circuitry transmits the respiration rate to a remote center with a communication protocol.

20. The system of claim 19, further comprising an intermediate device, wherein the wireless communication circuitry transmits the respiration rate to the remote center via the intermediate device.

21. The system of claim 20 wherein the communication protocol comprises at least one of Bluetooth, Zigbee, WiFi, WiMax, IR, a cellular protocol, amplitude modulation or frequency modulation.

22. The system of claim 20 wherein the intermediate device comprises a data collection system to collect and/or store data from the wireless communication circuitry and wherein the data collection system is configured to communicate periodically with the remote center with wireless connection and/or wired communication.

23. The system of claim 20 wherein the communication protocol comprises a two way protocol such that the remote center is capable of issuing commands to control data collection.

24. The system of claim 1 wherein the adhesive patch comprises a breathable tape, in which the breathable tape comprises a breathable material with an adhesive.

25. The system of claim 1 further comprising a temperature sensor to generate a temperature signal, the temperature sensor coupled to the processor system to determine when the patient is asleep.

26. A method of monitoring a sleep apnea of a patient, the method comprising:

adhering an adhesive patch to a skin of the patient to couple at least four electrodes to the skin of the patient;

measuring an impedance signal of the patient with impedance circuitry coupled to the at least four electrodes;

determining a respiration rate from the impedance signal to detect an apnea and/or hypopnea of the patient in response to the impedance signal; and

providing information about the apnea and/or hypopnea to a decompensation prediction algorithm.

27. The method of claim 26, further comprising determining an apnea hypopnea index of the patient in response to the impedance signal, and providing the apnea hypopnea index to the decompensation prediction algorithm.

28. The method of claim 26, further comprising:

generating an accelerometer signal with an accelerometer; and

determining that the patient is asleep in response to the accelerometer signal.

29. The method of claim 26, further comprising:

measuring an electrocardiogram signal of the patient with electrocardiogram circuitry coupled to at least two of the at least four electrodes; and

measuring a signal from an accelerometer in response to at least one of an activity, a restless leg, a bruxation or a position of the patient.

30. The method of claim 29 wherein the adhesive patch supports the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry and the accelerometer when the adhesive patch is adhered to the skin of the patient.