Methods and devices for activating brown adipose tissue using electrical energy

• US 9,044,606 B2
• Filed: 12/29/2010
• Issued: 06/02/2015
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson), The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson), The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Harris, Jason L., Stylopoulos, Nicholas, Kaplan, Lee M., Subbaroyan, Jeyakumar, Voegele, James W., Diubaldi, Anthony, Plescia, David N., Ortiz, Mark S., Stephens, Theodore L., Baynham, Tamara C., Aronhalt, Taylor
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US12/980,659
• Publication Number:
  US 20110270360A1
• Time in Patent Office: 1,616 Days
• Field of Search: 607/2, 607/62
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36192 Amplitude modulation
• CPC Class Codes: A61N 1/36196 Frequency modulation
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Methods and devices are provided for activating brown adipose tissue (BAT). Generally, the methods and devices can activate BAT to increase thermogenesis, e.g., increase heat production in the patient, which over time can lead to weight loss. In one embodiment, a medical device is provided that activates BAT by electrically stimulating nerves that activate the BAT and/or electrically stimulating brown adipocytes directly, thereby increasing thermogenesis in the BAT and inducing weight loss through energy expenditure.

Claims

1. A medical method, comprising:

positioning a device in contact with tissue of a patient proximate to a depot of brown adipose tissue; and

activating the device to deliver an electrical signal to the patient to activate the brown adipose tissue and increase energy expenditure of the brown adipose tissue, the electrical signal having a modulating signal and a carrier signal, wherein the electrical signal is continuously delivered to the patient for a predetermined amount of time in a range of one day to four weeks.

2. The method of claim 1, wherein the carrier signal has a carrier frequency in a range of about 10 to 400 kHz.

3. The method of claim 1, wherein the modulating signal has an activation frequency in a range of about 0.1 to 100 Hz.

4. The method of claim 1, wherein the modulating signal has an activation frequency in a range of about 0.1 to 100 Hertz, and the carrier signal has a carrier frequency in a range of about 10 to 400 kHz.

5. The method of claim 4, wherein the modulating signal has an activation frequency less than about 10 Hz, and the carrier signal has a carrier frequency in a range of about 200 to 250 kHz.

6. The method of claim 1, wherein the electrical signal has a pulse width in a range of about 10 us to 10 ms.

7. The method of claim 1, wherein the electrical signal has a voltage having an amplitude in a range of about 1 to 20 V.

8. The method of claim 1, wherein the electrical signal has a current having an amplitude in a range of about 2 to 6 mA.

9. The method of claim 1, wherein the depot of brown adipose tissue is in a supraclavicular region of the patient.

10. The method of claim 1, wherein positioning a device in contact with tissue of a patient comprises transcutaneously applying the device to an exterior skin surface of the patient.

11. The method of claim 1, wherein positioning a device in contact with tissue of a patient comprises subcutaneously positioning at least a portion of the device within the patient.

12. The method of claim 11, wherein positioning a device in contact with tissue of a patient comprises implanting the device entirely within the patient.

13. The method of claim 1, wherein the device is configured to be in continuous direct contact with the tissue of the patient for at least one day with the device generating the electrical signal and continuously delivering the electrical signal to the patient for at least one day.

14. The method of claim 1, further comprising removing the device from the patient;

repositioning the device in contact with tissue of the patient proximate to another depot of brown adipose tissue; and

activating the device to deliver another electrical signal to the patient to activate the other depot of brown adipose tissue and increase energy expenditure of the other depot of brown adipose tissue.

15. The method of claim 14, wherein the depot of brown adipose tissue is in a supraclavicular region on one of a left and right side of a sagittal plane of the patient, and the other depot of brown adipose tissue is in a supraclavicular region on the other of the left and right side of the sagittal plane of the patient.

16. The method of claim 14, wherein the device is removed and repositioned after the electrical signal has been delivered to the depot of brown adipose tissue for a threshold amount of time.

17. The method of claim 16, wherein the threshold amount of time is at least seven days.

18. The method of claim 14, wherein, in response to a trigger event, the device is removed from contact with tissue of the patient and repositioned to be in contact with another area of tissue of the patient proximate to another depot of brown adipose tissue, wherein the trigger event includes at least one of the patient eating, the patient resting, a threshold temperature of the patient, a directional orientation of the patient, a change in the patient'"'"'s weight, a change in the patient'"'"'s tissue impedance, manual activation by the patient or other human, a blood chemistry change in the patient, and a signal from a controller in electronic communication with the device.

19. The method of claim 1, further comprising, after activating the device, reducing power of the electrical signal until a first predetermined threshold event occurs;

and

after the first predetermined threshold event occurs, increasing the power of the electrical signal until a second predetermined threshold event occurs.

20. The method of claim 1, wherein the device is activated in response to a trigger event including at least one of the patient eating, the patient resting, a threshold temperature of the patient, a directional orientation of the patient, a change in the patient'"'"'s weight, a change in the patient'"'"'s tissue impedance, manual activation by the patient or other human, a blood chemistry change in the patient, and a signal from a controller in electronic communication with the device.

21. The method of claim 1, further comprising stopping application of the electrical signal;

waiting a predetermined amount of time; and

activating the device to deliver another electrical signal to the patient to activate the depot of brown adipose tissue and increase energy expenditure of the brown adipose tissue.

22. The method of claim 21, further comprising repeating the stopping, the waiting, and the activating until a threshold event occurs after the device is activated at least once.

23. The method of claim 22, wherein the threshold event comprises at least one of a predetermined amount of time and a predetermined physiological effect.

24. The method of claim 1, wherein the device is activated to deliver an electrical signal to the patient to activate the brown adipose tissue without cooling the patient or the brown adipose tissue.

25. The method of claim 1, wherein the brown adipose tissue is activated and energy expenditure of the brown adipose tissue is increased without any pharmaceutical administered to the patient to activate the brown adipose tissue.

26. The method of claim 1, wherein positioning a device in contact with tissue of a patient proximate to a depot of brown adipose tissue comprises positioning the device proximate to at least one of a supraclavicular region, a nape of a neck, a scapula, a spinal cord, proximal branches of the sympathetic nervous system that terminate in brown adipose tissue depots, and a kidney.

27. The method of claim 1, further comprising positioning a second device in contact with tissue of the patient proximate to another depot of brown adipose tissue;

and

activating the second device to deliver a second electrical signal to the patient to activate the other depot of brown adipose tissue and increase energy expenditure of the other depot of brown adipose tissue.

28. The method of claim 27, wherein the second device delivers the second electrical signal to the patient simultaneously with the device delivering the electrical signal to the patient.

29. The method of claim 1, further comprising imaging the patient to locate the depot of brown adipose tissue prior to positioning the device in contact with tissue of the patient proximate to the depot of brown adipose tissue.

30. The method of claim 1, wherein the device comprises:

a housing configured to be disposed in direct contact with the tissue of the patient proximate to the depot of brown adipose tissue; and

a signal generator coupled to the housing and configured to generate the electrical signal and to deliver the electrical signal to the patient.

31. The method of claim 30, wherein the signal generator is located within the housing.

32. The method of claim 30, wherein the housing comprises a housing of a patch attached to the patient.

33. The method of claim 30, wherein the device further comprises a controller configured to turn the signal generator on to start the signal generator generating the electrical signal, turn the signal generator off to stop the signal generator from generating the electrical signal, or both.

34. The method of claim 33, wherein the controller is configured to be located remotely from the patient and to be in electronic communication with the signal generator.

35. The method of claim 33, wherein the controller is configured to be implanted entirely within the patient.

36. A medical method, comprising:

positioning a device in contact with tissue of a patient proximate to a depot of brown adipose tissue in a supraclavicular region of the patient; and

activating the device to deliver an electrical signal to the patient to activate the brown adipose tissue and increase energy expenditure of the brown adipose tissue, the electrical signal having a modulating signal and a carrier signal and being continuously delivered to the patient for at least four weeks.

38. The method of claim 36, further comprising:

after the electrical signal has been continuously delivered to the patient for at least four weeks, removing the device from the patient;

repositioning the device in contact with tissue of the patient proximate to another depot of brown adipose tissue; and

delivering another electrical signal to the patient to activate the other depot of brown adipose tissue with the repositioned device and increase energy expenditure of the other depot of brown adipose tissue.

37. A medical method, comprising:

attaching a device tissue of a patient such that the device is in a fixed position relative to the tissue over a depot of brown adipose tissue and such that the device is located at least partially outside the patient;

activating the device located at least partially outside the patient and over the depot of brown adipose tissue to deliver an electrical signal to the patient to activate the brown adipose tissue underlying the device and increase energy expenditure of the brown adipose tissue, the electrical signal having a modulating signal and a carrier signal;

after the activating, removing the device from the patient;

repositioning the device in contact with tissue of the patient over another depot of brown adipose tissue; and

delivering another electrical signal to the patient to activate the other depot of brown adipose tissue underlying the repositioned device and increase energy expenditure of the other depot of brown adipose tissue.