Adherent Device for Sleep Disordered Breathing

• US 20090076364A1
• Filed: 09/12/2008
• Published: 03/19/2009
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Bly, Mark J., Manicka, Yatheendhar D., Libbus, Imad
• Granted Patent: US 8,249,686 B2
• Time in Patent Office: Days
• 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. An adherent device to monitor a sleep apnea and/or hypopnea of a patient, the device comprising:

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

at least four electrodes connected to the 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.

2. The adherent device of claim 1, wherein the processor system is configured to determine an apnea hypopnea index of the patient in response to the impedance signal.

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

5. The adherent device 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.

6. The adherent device of claim 5 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 adherent device of claim 4 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 adherent device of claim 1, further comprising at least one of electromyogram circuitry or an accelerometer mechanically coupled to at least one of an 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 position on the patient.

9. The adherent device of claim 8, wherein the at least one of the electromyogram circuitry of the accelerometer is coupled to wireless communication circuitry supported with the second patch to transmit the accelerometer signal to the processor system.

10. The adherent device of claim 1, further comprising an accelerometer mechanically coupled to the adherent 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 adherent device 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 adherent device 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 adherent device 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 adherent device 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 adherent device 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 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 adherent patch is adhered to the skin of the patient.

16. The adherent device 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 adherent device of claim 12 wherein at least one processor of the processor system is supported with the adherent patch and wherein the at least one processor is configured to determine a respiration rate from the impedance signal and a heart rate from the electrocardiogram signal.

18. The adherent device 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 the apnea hypopnea index.

19. The adherent device of claim 1 further comprising wireless communication circuitry coupled to the impedance circuitry to transmit the respiration rate to a remote center with a communication protocol.

20. The adherent device of claim 19 wherein wireless communication circuitry is configured to transmit the respiration rate to the remote center with an intermediate device.

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

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

24. The adherent device 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 adherent device 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; and

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

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

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 adherent patch is adhered to the skin of the patient.

31. An adherent device to monitor an apnea and/or hypopnea of a patient for an extended period, the device comprising:

a breathable tape comprising a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient;

at least one electrode affixed to the breathable tape and capable of electrically coupling to a skin of the patient;

at least one gel disposed over a contact surface of the at least one electrode to electrically connect the electrode to the skin;

a printed circuit board supported with the breathable tape when the tape is adhered to the patient, the circuit board connected to the at one electrode with a flexible intermediate connector to provide strain relief between the printed circuit board and the at least one electrode;

electronic components electrically connected to the printed circuit board and the at least one electrode to measure breathing of the patient and determine the apnea and/or hypopnea of the patient; and

a breathable cover disposed over the circuit board and the electronic components, the breathable cover connected to at least one of the electronics components, the printed circuit board or the breathable tape.

32. The adherent device of claim 31 wherein the breathable cover comprises a water resistant cover.

33. The adherent device of claim 31 wherein the electronic components comprise a processor and wireless transmission circuitry, the processor comprising a tangible medium configured to determine an apnea hypopnea index from the breathing of the patient and wherein the wireless transmission circuitry is configured to transmit the apnea hypopnea index from the processor to a remote center.

34. The adherent device of claim 31 wherein the breathable tape, the at least one electrode, the at least one gel and the breathable cover are configured to couple the at least one electrode to the skin to measure breathing of the patient for at least one week and the extended period comprises at least one week.

35. The adherent device of claim 34 wherein the breathable tape comprises a stretchable breathable material with an adhesive and the breathable cover comprises a stretchable material connected to the breathable tape, and wherein the printed circuit board is slidably coupled with the breathable tape and the breathable cover such that the breathable tape and breathable cover are configured to stretch with the skin of the patient when the breathable tape is adhered to the skin of the patient.

36. The adherent device of claim 35 wherein the electronics components are affixed to the printed circuit board and wherein the electronics components and the printed circuit board are disposed between the stretchable breathable material with the adhesive and the stretchable material.

37. The adherent device of claim 36 wherein the printed circuit board is separated from the breathable tape with an air gap to allow the skin to release moisture and receive oxygen through the breathable tape and breathable cover.

38. The adherent device of claim 31 further comprising an electronics housing adhered to at least one of the electronics components or the printed circuit board, such that the electronics housing is disposed between the cover and electronics components.

39. The adherent device of claim 38 wherein the electronics housing is configured to keep water away from the at least one of the printed circuit board or the electronic components.

40. The adherent device of claim 38 wherein the electronics housing comprises at least one of a cover or a sealant configured to protect the at least one of the printed circuit board or the electronic components from water.

41. The adherent device of claim 38 the electronics housing comprises a water resistant coating disposed over the at least one the electronic components or the printed circuit board so as to seal the at least one of electronic components or the printed circuitry board and inhibit water penetration.

42. The adherent device of claim 32 wherein the water resistant coating comprises a dip coating disposed over the at least one of the electronics components or the printed circuit board.

43. The adherent device of claim 31 further comprising a gel cover positioned over the breathable tape.

44. The adherent device of claim 43 wherein the gel cover comprises a material to inhibit moisture penetration from outside the patch into the at least one gel.

45. The adherent device of claim 43 wherein the gel cover comprises a breathable water resistant cover to inhibit moisture penetration from outside the patch into the at least one gel.

46. The adherent device of claim 43 wherein the gel cover comprises a material to inhibit a flow of the gel through the breathable tape and wherein the printed circuit board is located over the gel cover such that the gel cover is disposed between the breathable tape and the printed circuit board.

47. The adherent device of claim 43 wherein the breathable tape comprises a tricot-knit polyester fabric backing and the gel cover comprises a polyurethane film backing.

48. The adherent device of claim 43 wherein the breathable tape comprises a first porosity and wherein the gel cover comprises a breathable tape with a second porosity, the second porosity less than the first porosity to minimize flow of the gel through the breathable tape having the first porosity.

49. The adherent device of claim 31 wherein breathable tape, the adhesive coating, the at least one electrode and gel are separable from the printed circuit board, electronic components and cover, such that the printed circuit board, electronic components, housing and cover are reusable.

50. The adherent device of claim 31 wherein the at least one electrode extends through at least one aperture in the breathable tape.