MOBILE PHONE FOR STIMULATING THE TRIGEMINAL NERVE TO TREAT DISORDERS

• US 20140330336A1
• Filed: 07/21/2014
• Published: 11/06/2014
• Est. Priority Date: 01/15/2013
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Errico, Joseph P., Mendez, Steven, Simon, Bruce J.
• Granted Patent: US 10,376,695 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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

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 system for treating a patient suffering from a medical condition, the system comprising:

a stimulator comprising a housing having a contact surface for contacting an outer skin surface of a head of a patient, wherein the housing is configured for attachment and electrical coupling to a mobile device configured to receive a wireless signal;

an energy source coupled to the stimulator and the mobile device, the energy source being configured to generate an electric field sufficient to transmit an electric current through the contact surface and the outer skin of the patient'"'"'s head to modulate a trigeminal nerve at a target region of the patient'"'"'s head; and

wherein the electric current is sufficient to modify the medical condition in the patient.

2. The system 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 system of claim 1 wherein the medical condition is primary headache.

4. The system of claim 1 wherein the electric current 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 system of claim 1 wherein the branch of the trigeminal nerve is at least one of a supraorbital, a supratrochlear, an infraorbital, and a mental nerve.

6. The system of claim 1 wherein the target region is restricted to the vicinity of at least one of a foramen and a notch.

7. The system of claim 1 wherein the mobile device is a mobile phone comprising the stimulator.

8. The system of claim 1 wherein the mobile device is a mobile phone and the stimulator attaches to a surface of the mobile phone.

9. The system of claim 1 wherein the mobile device is a mobile wireless network device capable of receiving and transmitting data over a network.

10. The system of claim 1 wherein the contact surface comprises one or more electrodes, the system further comprising a signal generator coupled to the energy source and the contact surface of the stimulator housing, wherein the signal generator is configured to generate an electrical impulse sufficient to modulate the nerve at the target region of the patient.

11. The system of claim 10 wherein the signal generator is situated within the housing of the stimulator.

12. The system of claim 10 wherein the signal generator is located exterior to the stimulator housing, the system further comprising a software program instructing the electrodes and the signal generator for transmitting the electrical impulse to the electrodes.

13. The system of claim 12 wherein the software program is a mobile application software program configured for downloading onto the mobile device.

14. The system of claim 10 further comprising an amplifier coupled to the signal generator and the electrodes for amplifying the signal to the electrodes.

15. The system of claim 1, further comprising a base station configured to receive data from a remote source, the base station being configured for coupling to the stimulator and transmitting the received data to the stimulator, wherein the data comprises a therapy regimen for treating the medical condition in the patient.

16. The system of claim 1 further comprising control software stored within the stimulator housing and a control panel on the mobile device coupled to the control software, wherein the control panel is configured to modulate properties of the electric current.

17. The system of claim 7 wherein the electric impulse comprises bursts of pulses with each of the bursts having a frequency from about 1 to about 100 bursts per second and each of the pulses having a frequency from about 1 to about 20 KHz.

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

generating an electric signal sufficient to modulate a trigeminal nerve within the patient;

wirelessly transmitting the electric signal to a handheld mobile device;

contacting an outer surface of a head of the patient with a contact surface of the mobile device; and

applying one or more electrical impulses to the outer surface of the patient'"'"'s skin such that the electrical impulses pass transcutaneously through the patient'"'"'s skin to the trigeminal nerve within a body of the patient, wherein the electric impulses are sufficient to modulate the nerve and modify the medical condition.

19. The method of claim 18 wherein the medical condition is at least one of a headache, a trigeminal neuralgia, a trigeminal neuropathy, a facial pain, and a dental pain.

20. The method of claim 18 wherein the medical condition is primary headache.

21. The method of claim 18 wherein the electric current 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.

22. The method of claim 21 wherein the branch is at least one of a supraorbital, a supratrochlear, an infraorbital, and a mental nerve.

23. The method of claim 18 further comprising prophylactically treating the medical condition with a treatment regimen, wherein the treatment regimen comprises continuously applying the electrical impulses for a time period from about 30 seconds to about 300 seconds as a single dose and wherein the treatment regimen comprises applying one or more single doses on a daily basis.

24. The method of claim 23 wherein the treatment regimen comprises applying from 2 to 5 single doses per day.

25. The method of claim 18 wherein the wirelessly transmitting step is carried out by transmitting the electric signal to a mobile phone, wherein the handheld stimulator is coupled to the mobile phone.

26. The method of claim 18 wherein the mobile device comprising the handheld stimulator.

27. The method of claim 18 wherein the handheld stimulator is wirelessly coupled to the mobile device.

28. The method of claim 18 wherein the handheld stimulator is attached to the mobile device.

29. The method of claim 18 wherein the transmitting the electric signal step is further carried out by downloading a mobile application software onto the mobile device.

30. The method of claim 18 wherein the contacting step is carried out by contacting one or more electrodes to a forehead of the patient, wherein the electrodes extend from a surface of the mobile device.

31. The method of claim 18 wherein the electric impulses comprise bursts of pulses with each of the bursts having a frequency from about 1 to about 100 bursts per second and each of the pulses having a frequency from about 1 to about 20 KHz.

32. The method of claim 18 further comprising wirelessly transmitting data for an electrical stimulation therapy to the mobile device.

33. The method of claim 32 wherein the wirelessly transmitting data step is carried out by downloading a mobile application software program onto the mobile device.