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Patent Issued for Integrated Delivery and Visualization Tool for a Neuromodulation System

July 30, 2014



By a News Reporter-Staff News Editor at Journal of Engineering -- From Alexandria, Virginia, VerticalNews journalists report that a patent by the inventors Pless, Benjamin David (Atherton, CA); Boling, Carl Lance (San Jose, CA); Caparso, Anthony V. (San Jose, CA), filed on March 4, 2013, was published online on July 15, 2014.

The patent's assignee for patent number 8781574 is Autonomic Technologies, Inc. (Redwood City, CA).

News editors obtained the following quote from the background information supplied by the inventors: "Electrical stimulation of peripheral and central neural structures has shown increased interest due to the potential benefits it may provide to individuals suffering from many neurological and behavioral diseases. Many of these therapies today are not well accepted due to the invasive nature of the therapy, even though the efficacy is quite good. This has created a need for less invasive therapies that are directed toward patient and physician clinical needs.

"Headaches are one of the most debilitating ailments that afflict millions of individuals worldwide. The specific pathophysiology of headaches is unknown. Known sources of headache pain consist of trauma, vascular, autoimmune, degenerative, infectious, drug and medication-induced, inflammatory, neoplastic, metabolic-endocrine, iatrogenic, musculoskeletal and myofacial causes. Also, even though the possible underlying cause of the headache pain is identified and treated, the headache pain may persist.

"Currently, the sphenopalatine (pterygopalatine) ganglion (SPG) is a target of manipulation in clinical medicine to treat headaches. The SPG is an extracranial neuronal center located behind the nose. It consists of parasympathetic neurons that innervate (in part) the middle cerebral and anterior cerebral blood vessels, the facial blood vessels, and the lacrimal glands. The SPG also consists of sympathetic and sensory nerve fibers that pass through the SPG in route to their end organs. Manipulation of the SPG is mostly performed in attempted treatments of severe headaches, such as cluster headaches or chronic migraines.

"Various clinical approaches have been used for over 100 years to modulate the function of the SPG to treat headaches. These procedures vary from least invasive (e.g. transnasal anesthetic blocks) to much more invasive (e.g. surgical ganglionectomy) as well as procedures such as surgical anesthetic injections, ablations, gamma knife and cryogenic surgery. Most of these procedures have very good short term efficacy outcomes (days to months), however these results are usually temporary and the headache pain returns. A chronically implanted SPG neurostimulator may provide much better long term efficacy in these patients."

As a supplement to the background information on this patent, VerticalNews correspondents also obtained the inventors' summary information for this patent: "In one embodiment, a method of delivering a neurostimulator to within close proximity of a sphenopalatine ganglion is provided, comprising making an incision over the anterior maxilla, inserting a delivery tool having an integrated visualization system into the incision, visualizing tissue near a distal portion of the delivery tool with the visualization system, advancing the delivery tool sub-periosteally at a lateral edge of a zygomaticomaxillary buttress region towards a pterygopalatine fossa, and delivering the neurostimulator in close proximity to the sphenopalatine ganglion.

"The method can further comprise the step of elevating a periosteum away from the anterior maxilla with the delivery tool to expose a zygomaticomaxillary buttress region prior to the advancing step. In some embodiments, the advancing step further comprises advancing the delivery tool posteriorly, medially, and superiorly towards the pterygopalatine fossa.

"In one embodiment, the delivery tool includes a contoured distal portion that is shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection. The contoured distal portion can have a thickness of between 2-5 mm, for example. In some embodiments, the contoured distal portion has an elliptical cross-section.

"In one embodiment, the visualization system comprises a fiberscope.

"In some embodiments, the method further comprises the step of illuminating the delivery tool with a light source placed within a nasal cavity and positioned close to or within a sphenopalatine foramen.

"A delivery tool configured to deliver a neurostimulator into a patient is also provided, comprising a handle portion, an elongate shaft comprising a contoured distal portion, the contoured distal portion shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection, a visualization system embedded in the elongate shaft, and an insertion groove on the elongate shaft configured to deploy the neurostimulator.

"In some embodiments, the insertion groove is recessed into the elongate shaft. In other embodiments, the insertion groove is located on an opposing edge of the delivery tool from the visualization system, allowing for visualization of the deployment of the neurostimulator.

"In some embodiments, the visualization system is a fiberscope. In other embodiments, the visualization system comprises a light source contained in the handle portion.

"In one embodiment, the delivery tool further comprises a lens embedded at the distal portion, the lens constructed to allow for a focal length of between 2-15 mm.

"In other embodiments, the visualization system is configured to highlight differences between soft tissue and bone. In another embodiment, the visualization system comprises an electronic chip positioned within the distal portion and configured to provide video and/or still images to be sent to a viewing system.

"In one embodiment, the delivery tool further comprises an external light source configured to provide transillumination of the delivery tool. In another embodiment, the delivery tool further comprises an aperture configured to dispense a fluid to a distal end of the delivery tool. The delivery tool can further comprise a touch sensitive button coupled to the aperture, wherein a quick press of the button releases a bolus of fluid and a long press of the button releases a continuous stream of fluid.

"In some embodiments, the delivery tool further comprises a bifurcated distal dissecting tip having a lens positioned between the dissecting tips.

"In additional embodiments, the delivery tool further comprises a tissue clearance tip around the visualization system configured to provide increased tissue clearance around the visualization system.

"In some embodiments, the contoured distal portion has a thickness of between 2-5 mm. In other embodiments, the contoured distal portion has an elliptical cross-section.

"A method of treating a neurological disorder is also provided, comprising making an incision over an anterior maxilla, inserting a delivery tool having an integrated visualization system into the incision, visualizing tissue near a distal portion of the delivery tool with the visualization system, advancing the delivery tool sub-periosteally at a lateral edge of the zygomaticomaxillary buttress region towards the pterygopalatine fossa, delivering the neurostimulator in close proximity to the sphenopalatine ganglion, and applying an electrical current from the neurostimulator to the sphenopalatine ganglion to treat the neurological disorder.

"In some embodiments, the method further comprises the step of elevating a periosteum away from the anterior maxilla with the delivery tool to expose a zygomaticomaxillary buttress region prior to the advancing step.

"In another embodiment, the delivery tool includes a contoured distal portion that is shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection.

"In some embodiments, the neurological disorder is headache."

For additional information on this patent, see: Pless, Benjamin David; Boling, Carl Lance; Caparso, Anthony V.. Integrated Delivery and Visualization Tool for a Neuromodulation System. U.S. Patent Number 8781574, filed March 4, 2013, and published online on July 15, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8781574.PN.&OS=PN/8781574RS=PN/8781574

Keywords for this news article include: Autonomic Technologies, Autonomic Technologies Inc., Headache and Migraine, Medical Devices, Nervous System Diseases, Neurologic Manifestations, Neurology, Neurostimulator, Pain, Technology.

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Source: Journal of Engineering


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