MOBILE PHONE FOR TREATING A PATIENT WITH DEMENTIA

• US 20140330335A1
• Filed: 07/18/2014
• 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 10,293,160 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/1125 Grasping motions of hands
• CPC Class Codes: A61B 5/1127 using markers
• CPC Class Codes: A61B 5/1128 using image analysis A61B5/1127 takes precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/4444 related to the probe
• 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 1/36031 : using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: H04M 1/026 : Details of the structure or mounting of specific components
• 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
• CPC Class Codes: H04M 2250/52 : including functional features of a camera constructional features concerning the integration of cameras in portable phones H04M1/0264

Abstract

Devices, systems and methods are disclosed that allow a patient to self-treat neurodegenerative diseases, such as dementia, Alzheimer'"'"'s disease, ischemic stroke, post-concussion syndrome, chronic traumatic encephalopathy and the like by electrical noninvasive stimulation of a vagus nerve. The system comprises a handheld stimulator that is applied to the surface of the patient'"'"'s neck, wherein the stimulator comprises or is joined to a smartphone. A camera of the smartphone may be used to position and reposition the stimulator to a particular location on the patient'"'"'s neck. The system may also comprise a base station that is used to meter the charging of a rechargeable battery within the stimulator. The base station and stimulator transmit data to one another regarding the status of a stimulation session.

Claims

1. A system for treating a patient suffering from a neurodegenerative disease, the system comprising:

a stimulator comprising a housing having a contact surface for contacting an outer skin surface of the 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 surface of the patient sufficient to modulate a vagus nerve at a target region within the patient; and

wherein the electric current is sufficient to modify the neurodegenerative disease in the patient.

2. The system of claim 1 wherein the electric current is sufficient to increase inhibitory neurotransmitters in a brain of a patient such that an activity of microglial cells is modified.

3. The system of claim 2 wherein the electric current is sufficient to transition the microglial cells from a M1 phenotype state to an M2 phenotype state.

4. The system of claim 1 wherein the neurodegenerative disease comprises dementia and/or Alzheimer'"'"'s disease.

5. The system of claim 1 wherein the neurodegenerative disease comprises post-traumatic concussion.

6. The system of claim 1 wherein the neurodegenerative disease comprises ischemic stroke.

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, and the signal generator being 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 14 wherein the amplifier is located within the stimulator housing.

16. The system of claim 14 wherein the amplifier is located exterior to the stimulator housing and is configured for electrical connection to the mobile device or the stimulator housing.

17. 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.

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

19. The system of claim 18 wherein the control panel is configured to modulate an amplitude of the electric current.

20. The system of claim 18 wherein the control panel is configured to disable functions of the mobile device when the stimulator is enabled.

21. 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.

22. A method for treating a patient with a neurodegenerative disease comprising:

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

wirelessly transmitting the electric signal to a handheld stimulator;

contacting an outer surface of a skin of the patient with a contact surface of the handheld stimulator; 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 vagus within a body of the patient, wherein the electric impulses are sufficient to modulate the nerve and modify the neurodegenerative disease.

23. The method of claim 22 wherein the electric current is sufficient to increase inhibitory neurotransmitters in a brain of a patient such that an activity of microglial cells is modified.

24. The method of claim 23 wherein the electric current is sufficient to transition the microglial cells from a M1 phenotype state to an M2 phenotype state, thereby counteracting neuroinflammation in the patient'"'"'s brain.

25. The method of claim 22 wherein the neurodegenerative disease comprises dementia and/or Alzheimer'"'"'s disease.

26. The method of claim 22 wherein the neurodegenerative disease comprises post-traumatic concussion.

27. The method of claim 22 wherein the neurodegenerative disease comprises ischemic stroke.

28. The method of claim 22 further comprising prophylactically treating the neurodegenerative disease 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.

29. The method of claim 28 wherein the treatment regimen comprises applying from 2 to 5 single doses per day.

30. The method of claim 22 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.

31. The method of claim 22 wherein a mobile phone comprising the handheld stimulator.

32. The method of claim 22 wherein the handheld stimulator is wirelessly coupled to a mobile phone.

33. The method of claim 22 wherein the handheld stimulator is attached to a mobile phone.

34. The method of claim 22 wherein the transmitting the electric signal step is further carried out by downloading a mobile application software onto a mobile phone.

35. The method of claim 34 further comprising amplifying the electric signal.

36. The method of claim 35 wherein the amplifying step is carried out within the handheld stimulator.

37. The method of claim 35 wherein the amplifying step is carried out by electrically coupling an amplifier to the mobile phone or the handheld stimulator.

38. The method of claim 22 wherein the contacting step is carried out by contacting one or more electrodes to a neck of the patient, wherein the electrodes extend from a surface of the mobile phone.

39. The method of claim 22 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.

40. The method of claim 22 further comprising wirelessly transmitting data for an electrical stimulation therapy to a mobile phone.

41. The method of claim 40 wherein the wirelessly transmitting data step is carried out by downloading a mobile application software program onto the mobile phone.