Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0526—Head electrodes
  • A61N1/0546—Nasal electrodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36031—Control systems using physiological parameters for adjustment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/12—Devices for heating or cooling internal body cavities
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy

Definitions

• the present invention relates to a system and method for non-invasive trigeminal neuro-modulation.
• the invention involves non-invasively stimulating the trigeminal nerve and the accompanying autonomic fibers within the nasal or oral cavity.
• DBS Deep brain stimulation
• VNS Vagal nerve stimulation
• epilepsy also requires a surgical procedure to position the stimulating wire around the vagus nerve in the neck.
• stimulating sympathetic and parasympathetic ganglia requires invasive procedures for access. For example, stimulating the cervical chain requires a cut down in the neck and stimulating the sphenopalatine ganglion requires needle insertion through the mucosa of the palate.
• the trigeminal branches to be accessed for neuromodulation can involve the surface branches of any of the 3 divisions of the trigeminal nerve, ophthalmic, maxillary and mandibular nerves. Further, the trigeminal and autonomic ganglia cannot be accessed non-invasively but the postganglionic fibers can be stimulated non-invasively by direct contact at the nerve endings.
• the method in accordance with the invention stimulates the trigeminal nerve and the accompanying autonomic fibers within the nasal or oral cavity, without having precise knowledge of the position of the catheter.
• a method of neuromodulation of postganglionic nerve fibers that does not require direct contact with the nerve or the ganglion is provided.
• a method of non-invasive stimulation of the trigeminal nerve for the purpose of increasing cerebral blood flow in cerebral ischemia is provided.
• the modulation may be performed non- invasively without requiring implantation or a surgical procedure.
• a method of non-invasively stimulating the trigeminal nerve for the purpose of increasing cerebral blood flow in Alzheimer's disease is provided.
• a method of non-invasively stimulating the trigeminal nerve for the purpose of decreasing neurogenic inflammation is provided.
• the trigeminal nerve and the accompanying autonomic fibers within the nasal or oral cavity are modulated using ultrasound, cryotherapy, radiofrequency, heat therapy, electrically, electromagnetic wave mediated treatment and combinations of the foregoing.
• the stimulation may be done in the nose, the mouth, any of the cutaneous or mucosal divisions of the three branches of the trigeminal nerve, and combinations of the foregoing.
• the non-invasive stimulation of the trigeminal nerve may be done for the purpose of decreasing neurogenic inflammation in the lung, such as acute respiratory distress syndrome and for increasing or decreasing blood pressure.
• an apparatus and method for non- invasively stimulating the trigeminal nerve to treat migraine or other forms of headache is provided.
• a method of neuromodulating post-ganglionic nerve fibers in a patient comprising: non-directly contacting of the nerve or the ganglion.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve of a patient; and increasing cerebral blood flow. 19. The method of clause 18 wherein the stimulating is done in any of the three divisions of the trigeminal nerve.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve in a patient; and increasing cerebral blood flow in cerebral ischemia.
• a method of neuromodulating a nerve comprising: non-invasively stimulating the trigeminal nerve; and increasing cerebral blood flow in patients having Alzheimer's disease.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve of a patient; and decreasing neurogenic inflammation.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve of a patient; and decreasing neurogenic inflammation in a brain of the patient suffering from stroke, head injury or cardiac arrest.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve of a patient; and decreasing neurogenic inflammation in the lung wherein said neurogenic inflammation is caused by acute respiratory stress syndrome.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve; and decreasing inflammation in a medical condition of a patient.
• a method of neuromodulating a nerve comprising: non-invasively stimulating a trigeminal nerve of a patient; and increasing or decreasing blood pressure of the patient.
• a method of modulating a trigeminal nerve of a patient comprising: non- invasively stimulating the trigeminal nerve; and increasing cerebral blood flow wherein the absorption of medication following oro-nasal or facial delivery is enhanced.
• a device comprising a stimulating electrode configured to contact the mucous membranes of the nose or mouth to neuromodulate the trigeminal nerve; and a conductive gel in contact with the electrode for enhancing electrical contact of said electrode.
• conductive gel is a hydrogel which is formed around the electrode wire.
• a device comprising: a plurality of stimulating electrodes configured to contact a portion of a skin of a patient over any of three divisions of a trigeminal nerve wherein the electrode contact is enhanced by means of a conductive gel.
• conductive gel is a hydrogel which is formed around the electrode wire.
• conductive gel contains a medication.
• a method of neuromodulating a nerve comprising non-invasively stimulating a trigeminal nerve; and dissipating the effects of a migraine headache.
• FIG. 1 is a graph illustrating the effect of non-specific intranasal electrical stimulation on cerebral blood flow.
• FIG. 2 is a perspective view of an intranasal delivery catheter for noninvasive neuromodulation of the trigeminal nerve and associated autonomic fibers in accordance with the invention.
• FIG. 3 is a perspective view of another aspect of an intranasal device for non-invasive neuromodulation of the trigeminal nerve and associated autonomic fibers in accordance with the invention.
• FIG. 4 is an illustration of the device of FIG. 4 inserted in intranasal cavity including a stimulator with electrodes in accordance with the invention. DETAILED DESCRIPTION OF THE INVENTION
• the method in accordance with the invention does not involve an invasive procedure or surgical procedure. There is no breach of the skin or of the mucous membrane, no direct contact with a ganglion or a post-ganglionic nerve and no requirement for implantation of the stimulating electrode.
• a stimulation wire is positioned within the nasal cavity, preferably several centimeters beyond the entrance to the nares and stimulation performed.
• the wires can be held in place by a variety of devices for the duration of the stimulation and then removed.
• the method has several advantages. Firstly, it would allow access to anatomically difficult locations and enable the procedure to be performed even by those not entirely familiar with the anatomy; secondly it would constitute a totally non-invasive method of neuromodulation, without any breach of skin or mucous membrane. Thirdly, it would enable treatment of a variety of conditions outside of catheterization laboratories and in places such as emergency rooms or ambulances.
• the inventors of the present invention have tested this method of neuromodulation intranasally and determined that stimulation "at a distance," as hereinafter disclosed, increases cerebral blood flow.
• Stimulating catheters were placed about 1cm into the nares in the rat and stimulation performed at varying stimulation parameters. Cerebral blood flow was measured in the brain using cortical Laser Doppler technique.
• stimulation at a distance from any of the known trigeminal branches increases cerebral blood flow in a dose-dependent fashion.
• the increase was observed at 5-7V, increased at 10V and increased further at 20V.
• Response occurred within seconds of initiating the stimulation and returned to baseline values immediately after discontinuing the stimulation.
• non-invasive trigeminal stimulation at a distance from the post-ganglionic nerve fibers increases cerebral blood flow in the rat
• the method in accordance with the invention may also be used to treat other conditions non-invasively.
• Such conditions may include hypertension, neurovascular conditions such as migraine or neurogenic inflammation as might occur after head injury, cardiac arrest or stroke, or even seizure disorders.
• the method in accordance with the invention is disclosed herein as being performed intranasally, it may also be performed intra- orally or over the anterior cranium and face or in any of the cutaneous dermatomes of the trigeminal nerve including the back of the pinna, the forehead or temple, the gums or palate and the skin over the face.
• the stimulating electrode may also be positioned in proximity of the target neural structure by being fastened alongside nasal prongs for gas delivery. Patients requiring oxygen or other gases, such as volatile anesthetic agents, may simultaneously be positioned for neuromodulation if the need arises.
• the electrode may be attached to a securing device such as a spring loaded nasal septal clip as best seen in FIGS. 3 and 4 to keep the electrode in position during the modulation.
• Stimulating branches of cranial nerves containing autonomic nerve fibers can generate a neurovascular response such as subcutaneous vascular dilatation. This may potentially, increase the absorption of drugs transcutaneously or transmucosally.
• a conductive (and/or medicated) gel may be placed in the location being stimulated separately from the stimulating wire or may be delivered through a second lumen on the catheter containing the stimulating wire.
• the branches of the trigeminal nerve may be accessed in this manner and stimulated without penetration through the nasal or oral mucosa or facial skin and without directly contacting the target nerve.
• the stimulator electrode would be positioned in close proximity of the nerve branch in the nose or mouth or on the surface of the skin following placement of a conductive gel containing medication. Following the discontinuation of the stimulation, the stimulator electrode would be easily removed since it was never in direct contact with the tissue in question.
• the pulse duration may be between 0.1-20 millisecond, preferably 0.2-2 millisecond, and more preferably 0.5 millisecond.
• the duration of the stimulation may be 3 seconds to 24 hours.
• the degree of stimulation may be coupled to feedback from cerebral or systemic physiologic parameters. For example, when stimulating the forehead or the retro-auricular space, feedback from cerebral oximetry or EEG may be used to modify the stimulation parameters. Furthermore, the stimulating wire may be physically coupled to the EEG or oximetry patch.
• the neuromodulation technique in accordance with the invention is limited to electrical stimulation but may also include ultrasound, radiofrequency, cryotherapy, heat treatment, infrared, ultraviolet or other electromagnetic spectrum frequencies as well as other methods of activating nerves.
• cerebral blood flow using the inventive method of stimulation may also be of value in chronic conditions involving diminished blood flow, such as Alzheimer's or other dementias or in neurogenic inflammation, such as brain swelling, acute respiratory stress syndrome or systemic inflammatory conditions.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Radiology & Medical Imaging (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Biophysics (AREA)
• Veterinary Medicine (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Physiology (AREA)
• Otolaryngology (AREA)
• Cardiology (AREA)
• Electrotherapy Devices (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=49514746

Family Applications (1)

Country Status (1)

Cited By (18)

Citations (4)

• 2013
  • 2013-04-18 WO PCT/US2013/037147 patent/WO2013165697A1/fr not_active Ceased

Patent Citations (4)

Similar Documents

Legal Events