NON-INVASIVE TREATMENT OF BRONCHIAL CONSTRICTION

• US 20110319958A1
• Filed: 08/12/2011
• Published: 12/29/2011
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T., Mendez, Steven
• Granted Patent: US 9,119,953 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2005/0605 Ear
• CPC Class Codes: A61N 2007/0026 Stimulation of nerve tissue
• CPC Class Codes: A61N 5/0603 for treatment of body cavities
• CPC Class Codes: A61N 5/0622 Optical stimulation for exciting neural tissue

Abstract

Devices, systems and instructing methods are disclosed for treating bronchial constriction related to asthma, anaphylaxis or chronic obstructive pulmonary disease. The instructing method for treatment comprises transmitting impulses of energy non-invasively to selected nerve fibers that are responsible for smooth muscle dilation. The transmitted energy impulses, comprising magnetic and/or electrical, mechanical and/or acoustic, and optical and/or thermal energy, stimulate the selected nerve fibers.

Claims

1. A method of instructing an individual in the use of a device to treat bronchial constriction in a patient comprising:

instructing the individual to position the device to stimulate selected nerve fibers that control or mediate the dilation of smooth muscle,

wherein the stimulation comprises transmitting one or more pulses of energy to said nerve fibers to stimulate them non-invasively.

2. The method of claim 1, wherein the individual is instructed to position the device to stimulate the selected nerve fibers utilizing energy derived from an electric field and/or an electric current, and wherein the energy of said electric field and/or said electric current is transmitted non-invasively through the lead of an electrode or through an electrically-conducting garment.

3. The method of claim 1, wherein the individual is instructed to position the device to stimulate nerve fibers associated with a vagus nerve.

4. The method of claim 1, wherein the individual is instructed to position the device to stimulate the selected nerve fibers in a neck of the patient.

5. The method of claim 1, wherein the individual is instructed to position the device to stimulate the nerve fibers within a carotid sheath of the patient.

6. The method of claim 1, wherein the individual is instructed to position the device to stimulate the nerve fibers associated with an auricular branch of a vagus nerve.

7. The method of claim 1, wherein the individual is instructed to position the device to stimulate the nerve fibers that control or modulate the release of catecholamines.

8. The method of claim 1, wherein the individual is instructed to position the device to stimulate nerve fibers that control or modulate the systemic release of catecholamines from an adrenal gland of the patient.

9. The method of claim 1, wherein the individual is instructed to position the device to stimulate nerve fibers that are afferent parasympathetic nerve fibers.

10. The method of claim 1, wherein the bronchial constriction is associated with asthma.

11. The method of claim 1, wherein the bronchial constriction is associated with anaphylaxis.

12. The method of claim 1, wherein the bronchial constriction is associated with chronic obstructive pulmonary disease.

13. The method of claim 1, further comprising instruction the individual to position the non-invasive stimulator device on a right side of a individual'"'"'s neck.

14. The method of claim 13 further comprising instructing the individual to place conductive fluid on stimulation surfaces on the non-invasive stimulator device and to operate the non-invasive stimulator device to cause electrical impulses to pass through a skin surface to nerve fibers within the individual'"'"'s neck.

15. The method of claim 14 further comprising instructing the individual to turn the non-invasive stimulator on, increase a level of the non-invasive stimulator to a therapeutic level and hold the non-invasive stimulator device in place for the entire treatment period

16. A device for the treatment of bronchoconstriction in a patient comprising:

a power source;

an electrical impulse generator coupled to the power source;

a control unit in communication with the electrical impulse generator and coupled to the power source;

an energy transmitter coupled to the electrical impulse generator and having an interface positionable against an outer skin surface on a patient'"'"'s neck; and

wherein the source of power is configured to supply energy to the energy transmitter such that the energy transmitter applies one or more electrical impulses to a vagus nerve within the patient'"'"'s neck suitable for modulation of the vagus nerve sufficient to induce amelioration of the bronchoconstriction.

17. The device of claim 16, wherein the energy transmitter comprises a magnetic coil and wherein the source of power is configured to supply a pulse of electric charge to the coil such that said coil produces a pulse of magnetic energy that induces one or more electrical impulses at the vagus nerve of the patient sufficient to modulate the vagus nerve.

18. The device of claim 16 further comprising a housing for enclosing the coil and an electrically conducting medium within the housing and substantially surrounding the coil.

19. The device of claim 18 wherein the housing comprises a deformable material.

20. The device of claim 18 wherein the coil comprises a toroidal winding around a core material having a permeability equal to or greater than 10% of the permeability of Supermendur.

21. The device of claim 16 wherein the electrically conductive medium comprises a ferrofluid or a magnetorheological fluid.

22. The device of claim 16 wherein the electrical impulses have a frequency of about 15 Hz to 50 Hz.

23. The device of claim 16 wherein the electrical impulses have a frequency of about 25 Hz.

24. The device of claim 16 wherein the electrical impulses have a pulsed on-time of between about 50 to 500 microseconds.

25. The device of claim 16 wherein the electrical impulses have a pulsed on-time of about 200-400 microseconds.

26. A device for the treatment of bronchoconstriction in a patient comprising:

a power source;

an electrical impulse generator coupled to the power source;

a control unit in communication with the electrical impulse generator and coupled to the power source;

an energy transmitter coupled to the electrical impulse generator and having an interface positionable against an outer skin surface on a patient'"'"'s neck; and

wherein the source of power is configured to supply energy to the energy transmitter such that the energy transmitter applies one or more electrical impulses to a vagus nerve within the patient'"'"'s neck suitable for modulation of the vagus nerve sufficient to induce amelioration of the bronchoconstriction.

27. A kit comprising:

a non-invasive nerve stimulator device and instructions on the use of the non-invasive nerve stimulator device,

wherein the non-invasive nerve stimulator device comprises,

an energy transmitter to be placed in communication with a subject'"'"'s neck,

a power supply, and

an impulse generator.

28. The kit of claim 27, wherein the non-invasive nerve stimulator device is portable.

29. The kit of claim 27, wherein the non-invasive nerve stimulator device is handheld.

30. The kit of claim 27, wherein the non-invasive nerve stimulator is used to treat bronchial constriction.

31. The kit of claim 27, further comprising a conductive gel.

32. The kit of claim 27, wherein the instructions on the use of the non-invasive nerve stimulator device comprise:

instructions to position the non-invasive stimulator device on a right side of a individual'"'"'s neck;

instructions to place conductive fluid on stimulation surfaces on the non-invasive stimulator device;

instructions to operate the non-invasive stimulator device to cause electrical impulses to pass through a skin surface to nerve fibers within the individual'"'"'s neck.

33. The kit of claim 27 wherein the instructions to operate the non-invasive stimulator device comprise:

instructions to turn the non-invasive stimulator on;

instructions to increase a level of the non-invasive stimulator to a therapeutic level; and

instructions to hold the non-invasive stimulator device in place for the entire treatment period.

34. A system for instructing an individual to treat medical conditions comprising:

a non-invasive nerve stimulator configured to be placed in communication with a subject'"'"'s neck and an instruction sheet for using the non-invasive nerve stimulator.

35. The system of claim 34, wherein the medical condition is bronchial constriction.