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Researchers Submit Patent Application, "Devices and Methods for Treating Sleep Disordered Breathing", for Approval

June 26, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor Shalon, Tidhar (Palo Alto, CA), filed on July 19, 2012, was made available online on June 12, 2014.

The patent's assignee is Svip 7 Llc.

News editors obtained the following quote from the background information supplied by the inventors: "The present invention relates to devices and methods for treating sleep disordered breathing and, more particularly, to devices which are designed for preventing collapse of airway tissue.

"Snoring, excessive daytime somnolence, restless sleep, and obstructive sleep apnea (OSA) are manifestations of sleep-disordered breathing (SDB) which is characterized by abnormalities in respiratory patterns or the quantity of ventilation during sleep.

"Obstructive sleep apnea, which is a common SDB is caused by sleep time collapse of airway tissue forming the pharyngeal wall, soft palate, epiglottis, and/or tongue.

"Postural muscle tone is highest in wakefulness, decreased in non-REM sleep, and minimal or absent in REM sleep. Collapse of tissues experienced during REM sleep, leads to a cycle of air flow obstruction, disruption of sleep and arousal.

"The recurrent sleep arousal and associated intermittent hypoxia and hypercapnia have been implicated in the occurrence of adverse cardiovascular outcomes. In addition, there is evolving evidence that SDB may contribute to insulin resistance and other components of the metabolic syndrome.

"Numerous efforts have been made to treat sleep disordered breathing. These include uvulectomy, nasal reconstruction, adenotonsillectomy, uvulopalatopharyngoplasty (UPPP), genioglossal advancement as well as more complex surgical approaches such as maxillary-mandibular advancement, bimaxillary advancement, and tongue-base surgery.

"The type of intervention selected for treatment is based largely on patient physiology and anatomy. A patient with a large uvula who snores and has few or no symptoms of apnea may benefit from uvulectomy or from the Pillar.TM. implant which is used to stiffen the soft palate.

"Relief of nasal obstruction alone rarely cures OSA, however, patient tolerance and response to nasal CPAP are often improved, thus septoplasty, septorhinoplasty, and turbinate reduction may be indicated in patients who have predisposing anatomy.

"Adenotonsillectomy is often performed in the pediatric population to correct loud snoring and restless sleep.

"Uvulopalatopharyngoplasty (UPPP) is a procedure which is performed most often for treatment of OSA. This procedure includes tonsillectomy, reorientation of the anterior and posterior tonsillar pillars, and excision of the uvula and posterior rim of the soft palate.

"Genioglossal advancement involves performing a mandibular osteotomy with anterior repositioning of the genioglossus-attached segment of the mandible. This procedure results in anterior displacement of the tongue.

"Lingual tonsillectomy, lingualplasty, and laser midline glossectomy are procedures designed to reduce the mass of the tongue base. Temperature-controlled radiofrequency tissue ablation (TCRFTA) is used to reduce tissue mass of the tongue base and in the soft palate.

"Despite considerable progress in our understanding of these disorders and the development of numerous treatment options, the principal therapeutic approach, continuous positive airway pressure (CPAP) which has been available since 1981 and exhibits poor patient tolerability and compliance remains the mainstay SDB treatment to this day.

"There is thus a widely recognized need for, and it would be highly advantageous to have, an approach which is effective in treating sleep disordered breathing and yet is safe, minimally or non-invasive, reversible, and tolerable by patients."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "According to one aspect of the present invention there is provided a device for treating sleep disordered breathing comprising a device body designed for positioning within a pharyngeal lumen and being designed and configured for maintaining an open airway during involuntary closure of the pharyngeal lumen.

"According to further features in preferred embodiments of the invention described below, the involuntary closure of the pharyngeal lumen is caused by collapse of airway tissue during sleep.

"According to still further features in the described preferred embodiments the device body is configured as a cage of radially-spaced longitudinal ribs connected at tapering ends.

"According to still further features in the described preferred embodiments the device body is torpedo, football or banana-shaped.

"According to still further features in the described preferred embodiments the device body is made from a porous mesh material.

"According to still further features in the described preferred embodiments the device body has a porous surface and at least a part of it is axially curved to match the airway lumen with a radius of curvature of 40 mm or less, preferably about 20 mm.

"According to still further features in the described preferred embodiments the device body is an open-ended tube with one or more curved regions to conform to the airway lumen with minimal contact with airway tissues.

"According to still further features in the described preferred embodiments the curved region forms an arc of at least 30 degrees with a radius of curvature of 40 mm or less, preferably approximately 20 mm to match the curvature of the pharyngeal lumen along the resting soft palate.

"According to still further features in the described preferred embodiments, the device body comprises a straight (distal) region and a curved (proximal) region with a proximal opening.

"According to still further features in the described preferred embodiments, the angle formed by a vector normal to the proximal opening of the device body and the straight region is between 30 to 90 degrees.

"According to a still further feature in the described preferred embodiments the device body is a thin-wall open-ended tube made from an elastomeric material 0.5 mm or less in wall thickness with a curved top portion opening in the direction of the nasal cavity.

"According to a still further feature in the described preferred embodiments the device body is an open-ended tube with at least some portion having a circular, oval or elliptical cross sectional shape.

"According to still further features in the described preferred embodiments the device body is a crushable tube that can resist a maximum pressure of 100 grams (1 N) over a 1 cm length region before compressing to half width.

"According to a still further feature in the described preferred embodiments the device body is made from an elastomeric material covered in a hydrogel or other hydrophilic coating that is either permanent, or alternatively degrades, dissolves or detaches over a preset time period.

"According to still further features in the described preferred embodiments a patent airway is maintained during sleep.

"According to still further features in the described preferred embodiments the airway muscles can collapse the device body during swallowing.

"According to still further features in the described preferred embodiments the device body is reversibly and transiently compressed to a smaller cross sectional area during insertion and/or withdrawal of the device into or out of the nasal cavity.

"According to still further features in the described preferred embodiments the device body is compressed by a water-soluble element.

"According to still further features in the described preferred embodiments the device body is selected having a length of 3 to 8 cm and a diameter of 4 to 10 mm.

"According to still further features in the described preferred embodiments the device body has a maximum surface area of 6,000 square millimeters, preferably 3,000 square millimeters.

"According to still further features of the described preferred embodiments, the device body is a straight or curved tube with a dome or cone structure on its proximal end and a proximal opening positioned on a side wall of the tube.

"According to still further features in the described preferred embodiments the device further comprises an anchoring element attached to the device body, the anchoring element being anchorable to or within a columella (tissue between the nostrils), a nostril, a nares, nasal cavity or nasopharyngeal tissue.

"According to still further features in the described preferred embodiments the anchoring element is attached to the device body via a tether.

"According to still further features in the described preferred embodiments the tether is selected having a length of 0.5-15 cm.

"According to still further features in the described preferred embodiments, lateral bending forces of 10-100 grams would displace a 5 cm long section of the tether approximately 2-4 cm and the force required to cause a similar up and down displacement of the tether would preferably be 2-10 times as higher than those required for a lateral displacement.

"According to still further features in the described preferred embodiments the device body is made from or coated with a material with a coefficient of friction of 0.5 or less when wet.

"According to still further features in the described preferred embodiments the device body is coated by or fabricated from a material with a hardness of shore A 100 or softer, preferably 40 or softer and more preferably 20 or softer.

"According to still further features in the described preferred embodiments the device body, anchoring element and tether are selected such that when the anchoring element is anchored to or within a nostril, nasal cavity or a nasopharyngeal tissue, the device body resides within a nasopharyngeal or oropharyngeal lumen.

"According to another aspect of the present invention there is provided a device for treating sleep disordered breathing comprising a device body designed and configured for minimizing resistance to airflow through collapsed airway tissue while enabling sealing of the airway during swallowing.

"According to yet another aspect of the present invention there is provided a method of treating sleep disordered breathing comprising (a) positioning a device within a pharyngeal lumen, the device being designed and configured for: (i) maintaining an airway or minimizing resistance to airflow during sleep; and (ii) enabling sealing of the airway during swallowing.

"According to yet another aspect of the present invention there is provided system for treating sleep disordered breathing comprising the device of the present invention and delivering and positioning the device within a pharyngeal lumen through the nose.

"According to yet another aspect of the present invention, the device body is a fully collapsible sheath with or without an internal stiffener that is inflated by an external air source and introduced into the nasal or oral cavity.

"According to yet another aspect of the present invention, the device body extends down to or below the uvula.

"According to yet another aspect of the present invention, the device body extends down to or below the base of the tongue.

"According to yet another aspect of the present invention, the device body extends down to or below the epiglottis.

"The present invention successfully addresses the shortcomings of the presently known configurations by providing a device capable of maintaining an open airway in collapsed airway tissue or minimizing resistance to airflow therein, especially during sleep and periods of loss of muscle tone.

"Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

"The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

"In the drawings:

"FIGS. 1A-B illustrate an MRI image of a transverse cross section at the level of the oropharynx showing an airway opening (black opening with arrow) in a collapsed state (FIG. 1A) and in an open state (FIG. 1B).

"FIGS. 2A-B illustrate the relevant anatomy labeled in sagittal and posterior cut-away views.

"FIG. 3 illustrates an embodiment of a device body of the present device.

"FIGS. 4A-B illustrate insertion of an embodiment of the device through the nose into position behind the soft palate overlaid on a sagittal view of the relevant anatomy.

"FIG. 5 illustrates an embodiment of the device body, tether and anchor of the present device in its deployed configuration.

"FIGS. 6A-B illustrates an embodiment of the device of the present invention with and without a water soluble element compressing the device body for easier insertion.

"FIG. 7 is an endoscopic image showing the device illustrated in FIG. 4B positioned in the airway of a subject.

"FIGS. 8A-B are sound traces from two nights during which the subject slept without (FIG. 8A) and with (FIG. 8B) the device.

"FIGS. 9A-B illustrates an embodiment of the device of the present invention in a perspective view (FIG. 9A) and overlaid onto a sagittal section of the anatomy (FIG. 9B).

"FIGS. 10A-B illustrates an embodiment of the device of the present invention in a perspective view (FIG. 10A) and overlaid onto a sagittal section of the anatomy (FIG. 10B).

"FIGS. 11A-B illustrates an embodiment of the device of the present invention in a perspective view (FIG. 11A) and overlaid onto a sagittal section of the anatomy (FIG. 11B).

"FIGS. 12A-B illustrates two embodiments of the present invention wherein device body is a straight (FIG. 12A) or curved (FIG. 12B) tube with a proximal end comprising a dome or cone structure and a proximal opening positioned on the side wall of the tube.

"FIGS. 13A-C illustrates an embodiment of the device of the present invention in front, bottom, top and perspective views in the deployed state (FIG. 13A) and in the insertion state (FIG. 13B) with a removable stiffener inserted into the device body to make it roughly parallel to the tether. FIG. 13C illustrates how the nose clip anchor and stiffener are mounted on the columella between the two nostrils of a user.

"FIGS. 14A-B illustrate a front, side, bottom and perspective views of two embodiments of the present nasopharyngeal airway design with FIG. 14A illustrating an opaque design and FIG. 14B illustrating a transparent design.

"FIGS. 15A-D illustrate a device that does not have a curved upper portion placed in a nasopharnyx (FIG. 15A in schematic form and FIG. 15C as viewed using an endoscope), and which therefore impinges on sensitive airway tissues during swallowing causing discomfort (FIG. 15B in schematic form and FIG. 15D as viewed using an endoscope).

"FIGS. 16A-D illustrate an embodiment of the present invention that has a curved upper portion placed in a nasopharnyx (FIG. 16A in schematic form and FIG. 16C as viewed using an endoscope) which therefore does not impinge on sensitive airway tissues during swallowing (FIG. 16B in schematic form and FIG. 16D as viewed using an endoscope) and is more comfortable than the embodiment in FIG. 15.

"FIGS. 17A-C is an endoscopic image showing the internal lumen of the present invention before (FIG. 17A), part way through (FIG. 17B) and during (FIG. 17C) a swallow illustrating how swallowing forces are sufficient to collapse the device body of the present invention.

"FIGS. 18A-B illustrates an embodiment of the device of the present invention comprising a highly collapsible or lay flat tube in the collapsed state (FIG. 18A) introduced into the nasal cavity and in the inflated state (FIG. 18B) when pressurized by an external air source.

"FIGS. 19A-B illustrates an embodiment of the device of the present invention comprising a highly collapsible or lay flat tube in the collapsed state (FIG. 19A) introduced into the oral cavity and in the inflated state (FIG. 19B) when pressurized by an external air source."

For additional information on this patent application, see: Shalon, Tidhar. Devices and Methods for Treating Sleep Disordered Breathing. Filed July 19, 2012 and posted June 12, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=6668&p=134&f=G&l=50&d=PG01&S1=20140605.PD.&OS=PD/20140605&RS=PD/20140605

Keywords for this news article include: Svip 7 Llc.

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Source: Politics & Government Week


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