Mobile phone for stimulating the trigeminal nerve to treat disorders

• US 10,376,695 B2
• Filed: 07/21/2014
• Issued: 08/13/2019
• Est. Priority Date: 01/15/2013
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Errico, Joseph P., Mendez, Steven, Simon, Bruce J.
• Primary Examiner(s): Hulbert, Amanda K
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/337,059
• Publication Number:
  US 20140330336A1
• Time in Patent Office: 1,849 Days
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/066 Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/7425 Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image geometric transforms for image registration G06T3/14; enhancement using image fusion G06T5/50; algorithms for registration of images G06T7/30
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: H04M 1/21 Combinations with auxiliary equipment, e.g. with clocks or memoranda pads
• CPC Class Codes: H04M 2250/12 including a sensor for measuring a physical value, e.g. temperature or motion telephones including GPS signal receivers H04M2250/10

Abstract

Devices and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache and trigeminal neuralgia and the like, by noninvasive electrical stimulation of nerves of the head, particularly supraorbital, supratrochlear, infraorbital, and mental nerves in the vicinity of their foramen or notch. The system comprises a handheld mobile device, such as a smartphone, that is applied to the surface of the patient'"'"'s head. One or more electrodes on the mobile device apply electrical impulses transcutaneously through the patient'"'"'s skin to the targeted nerve to treat the medical condition. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

Claims

1. A method for treating a patient with a medical condition, the method comprising:

wirelessly receiving one or more electrical signal at a handheld unit comprising a stimulator and a mobile device, wherein the one or more electrical signal comprises one or more electrical impulses;

contacting an outer surface of a head of the patient with a contact surface of the stimulator;

applying the one or more electrical impulses to the outer surface such that the one or more electrical impulses passes transcutaneously through the outer surface to a trigeminal nerve within the patient, wherein the one or more electrical impulses is sufficient to modulate the trigeminal nerve and modify the medical condition; and

prophylactically treating the medical condition with a treatment regimen, wherein the treatment regimen comprises continuously applying the one or more electrical impulses for a time period from 30 seconds to 300 seconds as a single dose, and wherein the treatment regimen comprises applying one or more doses on a daily basis.

2. The method of claim 1 wherein the medical condition is at least one of a headache, a trigeminal neuralgia, a trigeminal neuropathy, a facial pain, and a dental pain.

3. The method of claim 1 wherein the medical condition is primary headache.

4. The method of claim 1 wherein the one or more electrical impulses is sufficient to stimulate a branch of at least one of a trigeminal, a greater occipital, a lesser occipital, and a great auricular nerve of the patient.

5. The method of claim 4 wherein the branch is at least one of a supraorbital, a supratrochlear, an infraorbital, and a mental nerve.

6. The method of claim 1, wherein the treatment regimen comprises applying from 2 to 5 single doses per day.

7. The method of claim 1, wherein the wirelessly receiving comprises receiving the one or more electrical signal at the mobile device, wherein the stimulator is coupled to the mobile device.

8. The method of claim 1, wherein a housing comprises the stimulator and the mobile device, and wherein the stimulator is coupled to the mobile device.

9. The method of claim 1, wherein the stimulator is wirelessly coupled to the mobile device.

10. The method of claim 1, wherein the stimulator is attached to the mobile device.

11. The method of claim 1, wherein the wirelessly receiving comprises downloading a mobile application software onto the handheld unit.

12. The method of claim 1, wherein the contacting comprises contacting one or more electrodes to a forehead of the patient, wherein the one or more electrodes extend from a surface of the stimulator.

13. The method of claim 1, wherein the one or more electrical impulses comprises bursts of about 2 to about 20 pulses with each of the bursts having a frequency from about 1 burst per second to about 100 bursts per second and each of the pulses within each of the bursts having a frequency from about 1 KHz to about 20 KHz.

14. The method of claim 1, further comprising wirelessly receiving data for an electrical stimulation therapy at the handheld unit.

15. The method of claim 14, wherein the wirelessly receiving data comprises downloading a mobile application software program onto the handheld unit.

16. A method for treating a patient with a medical condition, the method comprising:

wirelessly receiving one or more electrical signal at a handheld unit comprising a stimulator and a mobile device, wherein the one or more electrical signal comprising one or more electrical impulses;

contacting an outer surface of a head of the patient with a contact surface of the stimulator;

applying the one or more electrical impulses to the outer surface such that the one or more electrical impulses passes transcutaneously through the outer surface to the trigeminal nerve, wherein the one or more electrical impulses is sufficient to modulate a trigeminal nerve within the patient and modify the medical condition; and

treating the medical condition with a treatment regimen, wherein the treatment regimen comprises applying the one or more electrical impulses for a time period from 30 seconds to one hour as a single dose, and wherein the treatment regimen comprises applying one or more single doses substantially on a daily basis.

17. The method of claim 16, wherein the medical condition is at least one of a headache, a trigeminal neuralgia, a trigeminal neuropathy, a facial pain, or a dental pain.

18. The method of claim 16, wherein the medical condition comprises a primary headache.

19. The method of claim 16, wherein the one or more electrical impulses is sufficient to stimulate a branch of at least one of a trigeminal, a greater occipital, a lesser occipital, or a great auricular nerve of the patient.

20. The method of claim 19, wherein the branch is at least one of a supraorbital, a supratrochlear, an infraorbital, or a mental nerve.

21. The method of claim 16, wherein the treatment regimen comprises applying from 2 to 5 single doses per day.

22. The method of claim 16, wherein the wirelessly receiving comprises receiving the one or more electrical signal at a mobile device, wherein the stimulator is coupled to the mobile device.

23. The method of claim 16, wherein a housing comprises the stimulator and the mobile device, and wherein the stimulator is coupled to the mobile device.

24. The method of claim 16, wherein the stimulator is wirelessly coupled to the mobile device.

25. The method of claim 16, wherein the stimulator is attached to the mobile device.

26. The method of claim 16, wherein the wirelessly receiving comprises downloading a mobile application software onto the stimulator.

27. The method of claim 16, wherein the contacting comprises contacting one or more electrodes to a forehead of the patient, wherein the one or more electrodes extend from a surface of the stimulator.

28. The method of claim 16, wherein the one or more electrical impulses comprises bursts of about 2 to about 20 pulses with each of the bursts having a frequency from about 1 burst per second to about 100 bursts per second and each of the pulses within each of the bursts having a frequency from about 1 KHz to about 20 KHz.

29. The method of claim 16, further comprising:

Wirelessly receiving data for an electrical stimulation therapy at the stimulator.

30. The method of claim 29, wherein the wirelessly receiving data comprises downloading a mobile application software program onto the stimulator.

31. A method for treating a patient with a medical condition, the method comprising:

wirelessly receiving one or more electrical signal at a mobile device, wherein the one or more electrical signal comprising one or more electrical impulses;

contacting an outer surface of a head of the patient with a contact surface of a handheld stimulator, wherein a housing comprises the handheld stimulator and the mobile device, and wherein the handheld stimulator is coupled to the mobile device; and

applying the one or more electrical impulses to the outer surface such that the one or more electrical impulses passes transcutaneously through the outer surface to a trigeminal nerve within the patient, wherein the one or more electrical impulses is sufficient to modulate the trigeminal nerve and modify the medical condition.

32. The method of claim 31, wherein the medical condition is at least one of a headache, a trigeminal neuralgia, a trigeminal neuropathy, a facial pain, or a dental pain.

33. The method of claim 31, wherein the medical condition comprises a primary headache.

34. The method of claim 31, wherein the one or more electrical impulses is sufficient to stimulate a branch of at least one of a trigeminal, a greater occipital, a lesser occipital, or a great auricular nerve of the patient.

35. The method of claim 34, wherein the branch is at least one of a supraorbital, a supratrochlear, an infraorbital, or a mental nerve.

36. The method of claim 31, further comprising:

treating the medical condition with a treatment regiment, wherein the treatment regimen comprises applying the one or more electrical impulses from 2 to 5 single doses per day.

37. The method of claim 31, wherein the wirelessly receiving comprises receiving the one or more electrical signal at a mobile phone, wherein the handheld stimulator is coupled to the mobile phone, wherein the mobile device comprises the mobile phone.

38. The method of claim 31, wherein the handheld stimulator is wirelessly coupled to the mobile device.

39. The method of claim 31, wherein the handheld stimulator is attached to the mobile device.

40. The method of claim 31, wherein the wirelessly receiving comprises downloading a mobile application software onto the mobile device.

41. The method of claim 31, wherein the contacting comprises contacting one or more electrodes to a forehead of the patient, wherein the one or more electrodes extend from a surface of the housing.

42. The method of claim 31, wherein the one or more electrical impulses comprises bursts of about 2 to about 20 pulses with each of the bursts having a frequency from about 1 burst per second to about 100 bursts per second and each of the pulses within each of the bursts having a frequency from about 1 KHz to about 20 KHz.

43. The method of claim 31, further comprising:

Wirelessly receiving data for an electrical stimulation therapy at the mobile device.

44. The method of claim 43, wherein the wirelessly receiving data comprises downloading a mobile application software program onto the mobile device.

45. A method for treating a patient with a medical condition, the method comprising:

wirelessly receiving one or more electrical signal comprising one or more electrical impulses at a handheld unit comprising a stimulator and a mobile device;

wherein the wirelessly receiving comprises downloading a mobile application software onto the handheld stimulator;

contacting an outer surface of a head of the patient with a contact surface of the handheld stimulator;

applying the one or more electrical impulses to the outer surface such that the one or more electrical impulses passes transcutaneously through the outer surface to the trigeminal nerve, wherein the one or more electrical impulses is sufficient to modulate the trigeminal nerve and modify the medical condition; and

prophylactically treating the medical condition with a treatment regimen, wherein the treatment regimen comprises continuously applying the one or more electrical impulses for a time period from 30 seconds to 300 seconds as a single dose, and wherein the treatment regimen comprises applying one or more doses on a daily basis.

46. A method for treating a patient with a medical condition, the method comprising:

wirelessly receiving from a mobile device one or more electrical signal comprising one or more electrical impulses at a stimulator, wherein a handheld unit comprises the stimulator and the mobile device;

contacting an outer surface of a head of the patient with a contact surface of the stimulator;

applying the one or more electrical impulses to the outer surface such that the one or more electrical impulses passes transcutaneously through the outer surface to a trigeminal nerve, wherein the one or more electrical impulses is sufficient to modulate the trigeminal nerve and modify the medical condition; and

prophylactically treating the medical condition with a treatment regimen, wherein the treatment regimen comprises continuously applying the one or more electrical impulses for a time period from 30 seconds to 300 seconds as a single dose, and wherein the treatment regimen comprises applying one or more doses on a daily basis.

47. The method of claim 46, wherein the wirelessly receiving comprises downloading a mobile application software onto the stimulator.