NON-INVASIVE TREATMENT OF BRONCHIAL CONSTRICTION

• US 20110046432A1
• Filed: 08/19/2010
• Published: 02/24/2011
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Mendez, Steven, Simon, Bruce J., Raffle, John T., Errico, Joseph P.
• Granted Patent: US 9,037,247 B2
• Time in Patent Office: Days
• US Class Current: 600/14
• CPC Class Codes: A61H 2201/123 Linear drive
• CPC Class Codes: A61H 2201/1604 Head
• CPC Class Codes: A61H 2201/1609 Neck
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 23/00 Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61H 23/004 With mechanical drive, e.g. spring mechanism or vibrating unit being hit for starting vibration and then applied to the body of a patient
• CPC Class Codes: A61H 23/02 with electric or magnetic drive
• CPC Class Codes: A61H 23/0236 using sonic waves, e.g. using loudspeakers
• CPC Class Codes: A61H 31/00 Artificial respiration or heart stimulation, e.g. heart massage artificial respiration by treatment with gas or air, e.g. mouth-to-mouth respiration A61M16/00; applying electric currents by contact electrodes for stimulation, e.g. heart pace-makers A61N1/36 ; teaching or training models, demonstration models for medical purposes G09B23/288
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/002 in combination with another treatment
• 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 2005/063 : comprising light transmitting means, e.g. optical fibres
• 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
• CPC Class Codes: A61N 5/0625 : Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Devices, systems and methods are disclosed for treating bronchial constriction related to asthma, anaphylaxis or chronic obstructive pulmonary disease. The 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 treating bronchial constriction in a patient comprising:

stimulating selected nerve fibers that control or mediate the dilation of smooth muscle, wherein one or more pulses of energy are transmitted to said nerve fibers to stimulate them non-invasively.

2. The method set forth in claim 1 wherein an electric current and/or an electric field is induced by a time-varying magnetic field, wherein energy derived from said electric current and/or said electric field stimulates the selected nerve fibers, and wherein the energy of said magnetic field is transmitted non-invasively.

3. The method set forth in claim 1 wherein energy derived from mechanical and/or acoustical vibrations stimulates the selected nerve fibers, wherein said mechanical and/or acoustical vibration energy is transmitted non-invasively.

4. The method set forth in claim 1 wherein energy derived from light or heat stimulates the selected nerve fibers, wherein said light or said heat is transmitted non-invasively.

5. The method set forth in claim 1 wherein energy derived from an electric field and/or an electric current stimulates the selected nerve fibers, 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.

6. The method of claim 1 wherein the selected nerve fibers are associated with a vagus nerve of the patient.

7. The method of claim 1 wherein the selected nerve fibers are in a neck of the patient.

8. The method of claim 1 wherein the selected nerve fibers are within a carotid sheath of the patient.

9. The method of claim 1 wherein the selected nerve fibers are associated with an auricular branch of a vagus nerve of the patient.

10. The method of claim 1 wherein the selected nerve fibers are in an external auditory meatus of the patient.

11. The method of claim 1 wherein the selected nerve fibers control or modulate the release of catecholamines.

12. The method of claim 11 wherein the selected nerve fibers control or modulate the systemic release of catecholamines from an adrenal gland of the patient.

13. The method of claim 1 wherein the selected nerve fibers are efferent parasympathetic nerve fibers.

14. The method of claim 1 wherein the selected nerve fibers are afferent parasympathetic nerve fibers.

15. The method of claim 1 wherein the selected nerve fibers are efferent sympathetic nerves that directly innervate the smooth muscle.

16. The method of claim 1 wherein the selected nerve fibers are efferent sympathetic nerves that directly modulate parasympathetic ganglia transmission.

17. The method of claim 1 wherein the bronchial constriction is associated with an acute symptom of asthma.

18. The method of claim 1 wherein the bronchial constriction is associated with an acute symptom of anaphylaxis.

19. The method of claim 1 wherein the bronchial constriction is associated with an acute symptom of chronic obstructive pulmonary disease.

20. The method of claim 1 wherein the bronchial constriction is comorbid with hypotension.

21. The method of claim 1 wherein the stimulating step is carried out without substantially stimulating a second set of nerve fibers responsible for increasing the magnitude of constriction of smooth muscle.

22. The method of claim 1 further comprising blocking or inhibiting a second set of nerve fibers responsible for increasing the magnitude of constriction of smooth muscle.

23. The method of claims 21 wherein the second set of nerve fibers is associated with a vagus nerve of the patient.

24. The method of claims 22 wherein the second set of nerve fibers comprises parasympathetic cholinergic nerve fibers.

25. The method of claim 1 wherein the stimulating step is carried out by transmitting at least one impulse of energy to a target location adjacent to or in close proximity with a carotid sheath of the patient, or to a target region adjacent to or in close proximity with an auricular branch of a vagus nerve of the patient.

26. The method of claim 25 wherein the impulse of energy is of a frequency between about 15 Hz to 50 Hz.

27. The method of claim 25 wherein the impulse of energy is of a frequency about 25 Hz.

28. The method of claim 25 wherein the impulse of energy is of an amplitude that may displace particles within the target location, wherein said energy of said displacement is equivalent to between about 1 to 12 joules per coulomb of displaced charged particles.

29. The method of claim 25 wherein the impulse of energy has a pulsed on-time of between about 50 to 500 microseconds.

30. The method of claim 25 wherein the impulse of energy has a frequency of about 25 Hz, a pulsed on-time of about 200-400 microseconds, and an amplitude that may displace particles within the target location, wherein said energy of said displacement is equivalent to about 6-12 joules per coulomb of displaced charged particles.

31. The method of claim 1 wherein energy is transmitted only during a selected portion of a respiratory cycle of the patient, thereby counteracting phasic contraction of bronchial smooth muscle.

32. The method of claim 1 wherein energy is transmitted only during a selected portion of a respiratory cycle of the patient, thereby modulating the duration of a subsequent phase of respiration.

33. The method of claim 1 wherein power of the transmitted energy is controlled by the magnitude of a surrogate measurement of the patient'"'"'s FEV₁, wherein said surrogate measurement is selected from the group consisting of pulsus paradoxus, accessory muscle use, and airway resistance.

34. The method of claim 1 wherein a characteristic magnitude of a pulse of transmitted energy is randomized, wherein said characteristic magnitude is selected from the group consisting of:

power, frequency, amplitude, duty cycle, pulse width, and pulse shape.

35. The method of claim 34 wherein randomization of the characteristic magnitude of the pulse of energy occurs at random times.

36. A device for non-invasively treating a medical condition in a patient, selected from the group of medical conditions consisting of bronchoconstriction, bronchoconstriction with comorbid hypotension, bronchoconstriction with comorbid hypertension, bronchoconstriction with comorbid bradycardia, and bronchoconstriction with comorbid tachycardia, comprising:

a source of power and an energy transmitter, wherein said source of power supplies energy to said energy transmitter, wherein said energy transmitter transmits one or more pulses of energy that can non-invasively stimulate selected nerve fibers in said patient, and wherein said pulse of energy is selected from the group consisting of magnetic energy, electrical energy, electromagnetic energy, mechanical energy, acoustic energy, light energy, and thermal energy.

37. The device of claim 36, wherein the source of power supplies a pulse of electric charge to a coil and wherein said coil produces a pulse of magnetic energy when said source of power supplies a pulse of electric charge to said coil, whereby an electric current and/or an electric field can be induced by said pulse of magnetic energy, and whereby energy derived from said induced electric current and/or said induced electric field can stimulate the selected nerve fibers in the patient.

38. The device of claim 37 further comprising an electrically conducting medium that encloses essentially all of the coil, wherein said conducting medium has a shape that conforms to the contour of a target body surface of the patient when said conducting medium is applied to said target body surface.

39. The device of claim 38 wherein the target body surface is on a neck of the patient.

40. The device of claim 37 wherein the coil comprises a toroidal winding around core material having permeability greater than 10% of the permeability of Supermendur.

41. The device of claim 37 wherein the coil is cooled by a ferrofluid or by a magnetorheological fluid or by a mixture of ferrofluid and magnetorheological fluids.

42. The device of claim 36, wherein pulses of mechanical or acoustic energy can be transmitted through a target region on a body surface of the patient.

43. The device of claim 42, wherein the target region is on a surface of the neck of the patient.

44. The device of claim 42, wherein the pulses of mechanical or acoustic energy are generated by a linear actuator, an electromagnet, a bimorph, a piezo crystal, an electrostatic actuator, a speaker coil, crossed ultrasound beams, or a rotating magnet or mass.

45. The device of claim 36, wherein pulses of light energy or thermal energy can be transmitted through a target region on a surface of the patient.

46. The device of claim 45, wherein the target region is on the surface of an external auditory meatus of the patient.

47. The device of claim 46, wherein light energy or thermal energy is transmitted successively from a light source to a light modulator to an earplug and to the target region.

48. The device of claim 45 that contains a source of light having wavelengths in the range 10⁻

8 meters to 10<sup>−

3</sup> meters, wherein said source of light comprises;

a laser, an incandescent bulb, an arc lamp, a fluorescent lamp, a light-emitting diode, a super-luminescent diode, a laser diode, a cathodoluminescent phosphor that is excited by an electron beam, or a light source that is excited by another light source.

49. The device of claim 48, wherein the source of light has wavelengths in the infrared region of the electromagnetic spectrum.

50. The device of claim 49, wherein the source of light is a gallium aluminum arsenide laser or a gallium arsenide laser.

51. The device of claim 45 that contains a light modulator, wherein said light modulator comprises:

a movable variable neutral density filter, a mechanical light-chopper wheel, a deformable membrane-mirror, an acousto-optic device, an electro-optic device, a ferroelectric liquid crystal device, a magneto-optic device, a multiple quantum well device, a power source that modulates or switches-on/off power to a light source, rotating crossed polarizers, or a vibrating mirror, diffraction grating, or hologram.

52. The device of claim 36 that transmits a pulse of electrical energy through a target region on a surface of the patient via one or more electrodes and/or electrical leads.

53. The device of claim 52, wherein the target region is on a surface of the neck of the patient.

54. The device of claim 52, wherein the electrodes and/or electrical leads have a configuration that may comprise:

bipolar, tripolar, concentric ring, or double concentric ring, wherein said concentric ring or said double concentric ring configuration may be circular or elliptical.

55. The device of claim 54, wherein the configuration of electrodes and/or electrical leads focuses the transmitted pulse of electrical energy onto the selected nerve fibers, without the patient experiencing unpleasant currents at the target region on the surface of the patient.

56. The device of claim 36 wherein the selected nerve fibers are associated with a vagus nerve of the patient.

57. The device of claim 36 wherein the pulses of energy have a frequency of about 15 Hz to 50 Hz.

58. The device of claim 36 wherein the pulses of energy have a frequency of about 25 Hz.

59. The device of claim 36 wherein the pulse of energy has a pulsed on-time of between about 50 to 500 microseconds.

60. The device of claim 36 wherein the pulse of energy has a pulsed on-time of about 200-400 microseconds.

61. The device of claim 36 that can measure the phase of the patient'"'"'s respiratory cycle, wherein power of the pulse of energy may vary depending on the phase of the respiratory cycle.

62. The device of claim 36 wherein power of the pulse of energy may vary depending on the magnitude of a surrogate measurement of FEV₁, wherein said surrogate measurement is selected from the group consisting of pulsus paradoxus, accessory muscle use, and airway resistance.

63. The device of claim 36 wherein a characteristic magnitude of the pulse of energy is randomized, wherein said characteristic magnitude is selected from the group consisting of:

power, frequency, amplitude, duty cycle, pulse width, and pulse shape.

64. The device of claim 63 wherein the randomization of the characteristic magnitude of the pulse of energy occurs at random times.