Treatment of headache

• US 8,666,498 B2
• Filed: 10/23/2009
• Issued: 03/04/2014
• Est. Priority Date: 10/27/2008
• Status: Active Grant

• Current Assignee: Serene Medical, Inc.
• Original Assignee: Serene Medical, Inc.
• Inventors: Newman, James
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US12/605,295
• Publication Number:
  US 20100114191A1
• Time in Patent Office: 1,593 Days
• Field of Search: 607/46, 607/72, 607/51, 424/239.1, 600/13
• US Class Current: 607/46
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00321 Head or parts thereof
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61F 2007/0002 Head or parts thereof
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 2005/0663 : Coloured light
• CPC Class Codes: A61N 2007/0004 : Applications of ultrasound therapy
• CPC Class Codes: A61N 5/022 : Apparatus adapted for a specific treatment
• CPC Class Codes: A61N 5/0622 : Optical stimulation for exciting neural tissue
• CPC Class Codes: A61N 5/067 : using laser light
• CPC Class Codes: A61N 5/10 : X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy A61N5/01 takes precedence
• 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

Headache treatment methods are described and include providing an energy delivery device; locating a secondary or higher-order branch of a postganglionic nerve that provides innervation for a patient'"'"'s head, by identifying a target region of the patient'"'"'s head that includes the nerve branch; positioning, within the target region, a portion of the energy delivery device; and applying, from the positioned portion of the energy delivery device to the target region, an amount of energy effective to result in a stimulation activity of the nerve branch; and, after observing the stimulated nerve branch activity, delivering, from the energy delivery device to the nerve branch, energy in an amount effective to reduce a headache severity in the patient.

Claims

1. A headache treatment method comprising:

providing an energy delivery device comprising a single tip;

locating a secondary or higher-order branch of a postganglionic nerve that provides innervation for a patient'"'"'s head, wherein the locating comprises;

identifying a target region, of the patient'"'"'s head, comprising the nerve branch;

percutaneously advancing a portion of the energy delivery device through a single point to position the portion of the energy delivery device within the target region; and

applying, from the positioned portion of the energy delivery device to the target region, an amount of energy effective to result in a stimulation activity of the nerve branch; and

after observing the stimulated nerve branch activity, delivering, from the energy delivery device to the nerve branch, energy in an amount effective to reduce a headache severity in the patient.

2. The method of claim 1, wherein the headache severity comprises at least one of a degree of pain, a frequency, and a duration of the headache.

3. The method of claim 1, wherein the nerve branch comprises a motor neuron, a sympathetic neuron, or a tertiary or higher-order branch.

4. The method of claim 1, further comprising at least one of detecting the stimulated nerve branch activity with electromyography, and detecting the stimulated nerve branch activity as nerve conduction between two electrodes.

5. The method of claim 1, further comprising:

locating a sensory nerve innervating the patient'"'"'s head; and

applying, from the positioned portion of the energy delivery device to the sensory nerve, an amount of energy effective to reduce the headache severity in the patient.

6. The method of claim 5, wherein the sensory nerve comprises at least one of a second occipital nerve, a third occipital nerve, a zygomaticotemporal nerve, a trigeminal nerve, a glossopharyngeal nerve.

7. The method of claim 1, wherein the delivered energy comprises at least one of ultrasound energy, heat energy, cryogenic energy, electromagnetic energy, ultraviolet light energy, a blue light energy, an infrared light energy, an x-ray energy, a gamma-ray energy, and a microwave energy.

8. The method of claim 1, wherein the amount of delivered energy effective to reduce the headache pain is effective to ablate the neuron.

9. The method of claim 3, wherein the motor neuron innervates a muscle selected from the group consisting of a frontalis muscle, a corrugator superculii muscle, an orbicularis oculi muscle, a procerus muscle, a nasalis muscle, a levator labii superioris muscle, a zygomaticus major muscle, a zygomaticus minor muscle, a levator anguii oris muscle, a modialus muscle, a platysma paris muscle, a platysma labialis muscle, a depressor labii inferioris muscle, a depressor anguli oris muscle, a platysma pars modialaris muscle, a platysma pars labialis muscle, a platysma pars mandibularis muscle, a temporalis muscle, an occipatalis muscle, a risorius muscle, a masseter muscle, a splenius capitus muscle, a stylohyoid muscle, a suboccipital muscle, a digastric muscle, a buccinator muscle, a sternocleidomastoid muscle, a levator scapulae muscle, a scalenus medius muscle, a scalenus anterior muscle, a trapezius muscle, and an omohyoid muscle.

10. The method of claim 3, wherein the nerve is selected from at least one of a facial nerve, an abducens nerve, an oculomotor nerve, a trochlear nerve, a trigeminal nerve, a glossopharangeal nerve, a hypoglossal nerve, and an accessory nerve.

11. The method of claim 3, wherein the nerve branch comprises a branch of a facial nerve selected from a temporal branch, a zygomatic branch, a buccal branch, a mandibular branch, and a cervical branch.

12. The method of claim 3, wherein the nerve branch is selected from at least one of a superior division of the oculomotor nerve and an inferior division of the oculomotor nerve.

13. The method of claim 3, wherein the nerve branch comprises a mandibular branch of the trigeminal nerve, a mylohyoid branch of the mandibular branch, or a pharyngeal branch of the glossopharyngeal nerve.

14. The method of claim 3, wherein the nerve branch comprises a branch of the hypoglossal nerve selected from a meningeal branch, a thyrohyoid branch, a descending branch, and a muscular branch.

15. The method of claim 3, wherein the nerve branch comprises an angular nerve.

16. A method, of treating headache, comprising:

providing an energy delivery device having a single tip;

locating a secondary or higher-order branch of a postganglionic nerve that provides innervation for a patient'"'"'s head, wherein the locating comprises;

identifying a target region, of the patient'"'"'s head, comprising the nerve branch;

percutaneously advancing a portion of the energy delivery device through a single point to position the portion of the energy delivery device within the target region; and

applying, from the positioned portion of the energy delivery device to the target region, an amount of energy effective to result in a stimulation activity of the nerve branch;

after observing the stimulated nerve branch activity;

delivering, from the energy delivery device to the nerve branch, energy in an amount effective to reduce a headache severity in the patient; and

administering, to a target area of the patient'"'"'s head comprising a motor neuron, a neurotoxin;

wherein, in combination, the amount of delivered energy and the amount of administered neurotoxin are effective to reduce a headache severity in the patient.

17. The method of claim 16, wherein the delivered energy comprises at least one of ultrasound energy, heat energy, cryogenic energy, electromagnetic energy, ultraviolet light energy, a blue light energy, an infrared light energy, an x-ray energy, a gamma-ray energy, and a microwave energy.

18. The method of claim 16, wherein the nerve branch comprises a motor neuron, a sympathetic neuron, or a tertiary or higher-order branch.

19. The method of claim 18, wherein the motor neuron innervates a muscle selected from the group consisting of a frontalis muscle, a corrugator superculii muscle, an orbicularis oculi muscle, a procerus muscle, a nasalis muscle, a levator labii superioris muscle, a zygomaticus major muscle, a zygomaticus minor muscle, a levator anguii oris muscle, a modialus muscle, a platysma paris muscle, a platysma labialis muscle, a depressor labii inferiors muscle, a depressor anguli oris muscle, a platysma pars modialaris muscle, a platysma pars labialis muscle, a platysma pars mandibularis muscle, a temporalis muscle, an occipatalis muscle, a risorius muscle, a masseter muscle, a splenius capitus muscle, a stylohyoid muscle, a suboccipital muscle, a digastric muscle, a buccinator muscle, a sternocleidomastoid muscle, a levator scapulae muscle, a scalenus medius muscle, a scalenus anterior muscle, a trapezius muscle, and an omohyoid muscle.

20. The method of claim 18, wherein the nerve branch comprises a mandibular branch of the trigeminal nerve, a mylohyoid branch of the mandibular branch, or a pharyngeal branch of the glossopharyngeal nerve.