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Title:
NASOPHARYNGEAL DEVICE FOR OBSTRUCTIVE SLEEP APNEA SYNDROME
Document Type and Number:
WIPO Patent Application WO/2018/063183
Kind Code:
A1
Abstract:
The system and method for reducing or eliminating obstructive sleep apnea in patients with the use of a nasopharyngeal device. The nasopharyngeal device has an obturator including reversibly expandable projections located at a distal end and a guide portion on a proximal end. The reversibly expandable projections are adapted to maintain patency of the nasopharyngeal airway by advancing anteriorly the soft palate. The nasopharyngeal device also has a tube that has a proximal end, a distal end, and a passage through which at least a portion of the obturator may be inserted.

Inventors:
O'DAY JOHN M (US)
Application Number:
PCT/US2016/054123
Publication Date:
April 05, 2018
Filing Date:
September 28, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
ODAY JOHN M (US)
International Classes:
A61M16/04; A61F5/56; A61M15/08; A61M16/00; A61M29/00
Foreign References:
US20100217302A12010-08-26
US7100612B22006-09-05
US3568678A1971-03-09
US20090266365A12009-10-29
US20090064999A12009-03-12
US8428727B22013-04-23
US20130319427A12013-12-05
US20090044814A12009-02-19
US20110100376A12011-05-05
US20100242967A12010-09-30
US20130152940A12013-06-20
US20060283464A12006-12-21
US8833373B22014-09-16
Attorney, Agent or Firm:
BACA, Andrew J. et al. (P.O. Box 2550Salt Lake City, Utah, US)
Download PDF:
Claims:
CLAIMS

What is claimed is: 1. A nasopharyngeal device for reducing obstructive sleep apnea, comprising: an obturator comprising a plurality of reversibly expandable projections located at a distal end and a guide portion on a proximal end, wherein the reversibly expandable projections are adapted to maintain patency of the nasopharyngeal airway by advancing anteriorly the soft palate; and

a tube comprising a proximal end, a distal end, and a passage through which at least a portion of the obturator may be inserted.

2. The nasopharyngeal device of claim 1 , wherein the tube further comprises a tapered member.

3. The nasopharyngeal device of claim 2, wherein the tapered member comprises one or more openings adapted to permit air to pass through during breathing.

4. The nasopharyngeal device of claim 2, wherein the tapered member is disposed at or near the proximal end of the tube.

5. The nasopharyngeal device of claim 1 , wherein the tube comprises an adjustable clip member disposed at or near the proximal end of the tube and adapted to secure the tube to a nostril.

6. The nasopharyngeal device of claim 1 , wherein the plurality of reversibly expandable projections are flexible.

7. The nasopharyngeal device of claim 1 , wherein the plurality of reversibly expandable projections are attached to the obturator in a cantilevered manner.

8. The nasopharyngeal device of claim 1 , wherein the plurality of reversibly expandable projections are adapted to permit air to pass during breathing.

9. The nasopharyngeal device of claim 1, wherein the guide portion is adapted to facilitate insertion of the obturator in the tube and manipulation of a position of the reversibly expandable projections relative to the soft palate. 10. The nasopharyngeal device of claim 1, wherein the guide portion is adapted to be secured to the tube.

11. A method of reducing obstructive sleep apnea with a nasopharyngeal device having a catheter and an obturator that is reversibly expandable at a distal end, the method comprising:

inserting the nasopharyngeal device into the nasopharyngeal airway; and advancing the obturator through the catheter thereby expanding the distal end and opening the airway. 12. The method of reducing obstructive sleep apnea of claim 11, further comprising causing movement of the soft palate by expanding the distal end of the obturator.

13. The method of reducing obstructive sleep apnea of claim 11, further comprising securing the nasopharyngeal device to the nostril.

14. The method of reducing obstructive sleep apnea of claim 11, further comprising adjusting the catheter such that a tapered portion rests at the nostril. 15. The method of reducing obstructive sleep apnea of claim 11, further comprising adjusting the position of the nasopharyngeal device such that air is able to pass during breathing.

16. The method of reducing obstructive sleep apnea of claim 11, wherein the obturator comprises a plurality of reversibly expandable projections.

17. The method of reducing obstructive sleep apnea of claim 16, wherein the plurality of reversibly expandable projections are attached to the obturator in a cantilevered manner.

18. A nasopharyngeal device for reducing obstructive sleep apnea, comprising: a catheter comprising a proximal end, a distal end, and a passage; and

an obturator comprising:

means for projecting anteriorly the soft palate and thereby maintain patency of the nasopharyngeal airway; and

means for advancing and retracting the obturator through the catheter.

19. The nasopharyngeal device of claim 18, further comprising means for securing the nasopharyngeal device to the nostril.

20. The nasopharyngeal device of claim 18, further comprising means for securing the obturator's position relative to the soft palate.

AMENDED CLAIMS

received by the International Bureau on 19 January 2017 (19.01.2017)

What is claimed is:

1. A nasopharyngeal device for reducing obstructive sleep apnea, comprising: an obturator comprising a plurality of reversibly expandable projections located at a distal end and a guide portion on a proximal end, wherein the reversibly expandable projections are adapted to maintain patency of the nasopharyngeal airway by advancing anteriorly the soft palate due to tension in one or more of the projections in contact with the soft palate; and

a tube comprising a proximal end, a distal end, and a passage through which at least a portion of the obturator may be inserted.

2. The nasopharyngeal device of claim 1, wherein the tube further comprises a tapered member.

3. The nasopharyngeal device of claim 2, wherein the tapered member comprises one or more openings adapted to permit air to pass through during breathing.

4. The nasopharyngeal device of claim 2, wherein the tapered member is disposed at or near the proximal end of the tube.

5. The nasopharyngeal device of claim 1, wherein the tube comprises an adjustable clip member disposed at or near the proximal end of the tube and adapted to secure the tube to a nostril.

6. The nasopharyngeal device of claim 1, wherein the plurality of reversibly expandable projections are flexible.

7. The nasopharyngeal device of claim 1, wherein the plurality of reversibly expandable projections are attached to the obturator in a cantilevered manner.

8. The nasopharyngeal device of claim 1, wherein the plurality of reversibly expandable projections are adapted to permit air to pass during breathing.

9. The nasopharyngeal device of claim 1, wherein the guide portion is adapted to facilitate insertion of the obturator in the tube and manipulation of a position of the reversibly expandable projections relative to the soft palate.

10. The nasopharyngeal device of claim 1, wherein the guide portion is adapted to be secured to the tube.

11. A method of reducing obstructive sleep apnea with a nasopharyngeal device having a catheter and an obturator that is reversibly expandable at a distal end, the method comprising:

inserting the nasopharyngeal device into the nasopharyngeal airway; and advancing the obturator through the catheter thereby releasably expanding one or more flexible projections at the distal end and opening the airway.

12. The method of reducing obstructive sleep apnea of claim 11, further comprising causing movement of the soft palate by expanding the distal end of the obturator.

13. The method of reducing obstructive sleep apnea of claim 11, further comprising securing the nasopharyngeal device to the nostril.

14. The method of reducing obstructive sleep apnea of claim 11, further comprising adjusting the catheter such that a tapered portion rests at the nostril.

15. The method of reducing obstructive sleep apnea of claim 11, further comprising adjusting the position of the nasopharyngeal device such that air is able to pass during breathing.

16. The method of reducing obstructive sleep apnea of claim 11, wherein the obturator comprises a plurality of reversibly expandable projections.

17. The method of reducing obstructive sleep apnea of claim 16, wherein the plurality of reversibly expandable projections are attached to the obturator in a cantilevered manner. 18. A nasopharyngeal device for reducing obstructive sleep apnea, comprising: a catheter comprising a proximal end, a distal end, and a passage; and

an obturator comprising:

means under tension for projecting anteriorly the soft palate and thereby maintain patency of the nasopharyngeal airway; and

means for advancing and retracting the obturator through the catheter.

19. The nasopharyngeal device of claim 18, further comprising means for securing the nasopharyngeal device to the nostril. 20. The nasopharyngeal device of claim 18, further comprising means for securing the obturator's position relative to the soft palate.

Description:
NASOPHARYNGEAL DEVICE FOR

OBSTRUCTIVE SLEEP APNEA SYNDROME

TECHNICAL FIELD

The present invention relates to the amelioration of obstructive sleep apnea syndrome and more particularly to a nasopharyngeal device used to reduce or eliminate obstructive sleep apnea episodes.

BACKGROUND

Obstructive sleep apnea syndrome is characterized by obstruction to an individual's ability to breathe while sleeping and the two areas of obstruction are the soft palate and the base of the tongue.

Obstructive sleep apnea syndrome ("OSA") affects millions of Americans and currently, the gold standard of treatment is continuous positive airway pressure ("CPAP"). Unfortunately, although CPAP is almost uniformly effective in terms of facilitating a patient's ability to breathe while they sleep, the obtrusive, claustrophobic nature of the various facial interfaces translates into many patients refusing to use the units at night. Therefore, although CPAP therapy is effective, there is a very low long-term compliance seen in patients utilizing this modality of treatment. Consequently, health care

professionals have sought alternative treatments for nocturnal airway obstruction such as surgery of the palate and tongue base and mandibular advancement devices. No treatment has been found to be uniformly effective in ameliorating OSA. Because of the dynamics of airway obstruction, predicting success with any one treatment plan has also proven to be difficult.

Accordingly, there is a need for a treatment for OSA that overcomes the deficiencies of the existing methods described above.

DISCLOSURE

One aspect of the present invention is a nasopharyngeal device used to assist patients who suffer from OSA. An advantage of the design is that it is a non-intrusive nasal device that enables the patient to maintain patency of the nasopharyngeal airway by stenting open the palate, which, in the patient with OSA, would otherwise close upon laying down to sleep. According to one aspect of the present invention a nasopharyngeal device for reducing obstructive sleep apnea is provided. The nasopharyngeal device also includes an obturator that has a plurality of reversibly expandable projections located at a distal end and a guide portion on a proximal end. The reversibly expandable projections are adapted to maintain patency of the nasopharyngeal airway by advancing anteriorly the soft palate. The nasopharyngeal device also includes a tube that has a proximal end, a distal end, and a passage through which at least a portion of the obturator may be inserted.

In one embodiment, the tube may further include a tapered member. The tapered member may have one or more openings adapted to permit air to pass through during breathing. In one embodiment, the tapered member is disposed at or near the proximal end of the tube.

In another embodiment, the tube may have an adjustable clip member disposed at or near the proximal end of the tube and adapted to secure the tube to a nostril.

In yet another embodiment, the plurality of reversibly expandable proj ections may be flexible. In one embodiment, the plurality of reversibly expandable projections may be attached to the obturator in a cantilevered manner. In one embodiment, the plurality of reversibly expandable projections may be adapted to permit air to pass during breathing.

In yet another embodiment, the guide portion is adapted to facilitate insertion of the obturator in the tube and manipulation of a position of the reversibly expandable projections relative to the soft palate. In one embodiment, the guide portion may be adapted to be secured to the tube.

According to another aspect of the present invention, a method is provided for reducing obstructive sleep apnea with a nasopharyngeal device having a catheter and an obturator that is reversibly expandable at a distal end. The method includes: inserting the nasopharyngeal device into the nasopharyngeal airway; and advancing the obturator through the catheter thereby expanding the distal end and opening the airway.

In one embodiment, movement of the soft palate may be caused by expanding the distal end of the obturator.

In another embodiment, the nasopharyngeal device may be secured to the nostril. In another embodiment, the catheter may be adjusted such that a tapered portion rests at the nostril.

In another embodiment, the position of the nasopharyngeal device may be adjusted such that air is able to pass during breathing. In another embodiment, the obturator may include a plurality of reversibly expandable projections. In one embodiment, the plurality of reversibly expandable projections may be attached to the obturator in a cantilevered manner.

According to another aspect of the present invention, a nasopharyngeal device is provided for reducing obstructive sleep apnea. The nasopharyngeal device includes a catheter and an obturator. The catheter includes a proximal end, a distal end, and a passage. The obturator includes means for projecting anteriorly the soft palate and thereby maintaining patency of the nasopharyngeal airway, and means for advancing and retracting the obturator through the catheter.

In one embodiment, the nasopharyngeal device may also include means for securing the nasopharyngeal device to the nostril.

In another embodiment, the nasopharyngeal device may include means for securing the obturator's position relative to the soft palate.

These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will be readily apparent to those of ordinary skill in the art when read in conjunction with the following description, appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features, and advantages of the invention will be apparent from the following description of particular embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.

FIG. 1 shows a schematic of the anatomy of a human head and neck.

FIG. 2A and FIG. 2B show a prior art nasal trumpet inserted into an anatomical model.

FIG. 3A and FIG. 3B show one embodiment of the nasopharyngeal device of the present invention inserted into an anatomical model.

FIGS. 4A-4F show embodiments of the nasopharyngeal device of the present invention.

FIG. 4G is a cross-sectional view of an embodiment of the present invention in a user's nasopharyngeal airway.

FIG. 4H is a cross-sectional view of a device in the prior art. FIG. 5A shows a prior art nasal trumpet inserted into an anatomical model.

FIG. 5B shows one embodiment of the nasopharyngeal device of the present invention inserted into an anatomical model.

FIG. 6A shows a prior art nasal trumpet inserted into an anatomical model.

FIG. 6B shows one embodiment of the nasopharyngeal device of the present invention inserted into an anatomical model.

FIG. 7 A shows a prior art nasal trumpet inserted into the nose of an anatomical model with the distal end protruding past the nasal aperture.

FIG. 7B shows one embodiment of the nasopharyngeal device of the present invention inserted into the nose of an anatomical model with the distal end protruding past the nasal aperture.

FIG. 8A and FIG. 8B show embodiments of the nasopharyngeal device of the present invention inserted into the nose of an anatomical model with the distal end protruding past the nasal aperture.

FIG. 9 shows one embodiment of the nasopharyngeal device of the present invention inserted into the nose of an anatomical model.

FIG. 10 shows one embodiment of the nasopharyngeal device of the present invention inserted into the nose of an anatomical model.

FIG. 11 shows an embodiment of the nasopharyngeal device of the present invention.

FIG. 12 shows an embodiment of a catheter tube for use with the nasopharyngeal device of the present invention.

FIG. 13A - 13C show an embodiment of an obturator and a palatal expander for use with the nasopharyngeal device of the present invention.

FIGS. 14A and 14B show an embodiment of a palatal expander for use with the nasopharyngeal device of the present invention.

FIGS. 15A - 15C show an embodiment of a palatal expander for use with the nasopharyngeal device of the present invention.

FIG. 16 show one embodiment of the nasopharyngeal device of the present invention inserted into an anatomical model.

MODE(S) FOR CARRYING OUT THE INVENTION Obstructive sleep apnea syndrome is characterized by obstruction to an individual's ability to breathe while sleeping. The two areas of obstruction are the soft palate and the base of tongue. The nasopharyngeal airway is the most frequently obstructed area involved in patients with OSA.

One aspect of the present invention is a nasopharyngeal device to assist patients who suffer from OSA. The design is intended to be a non-intrusive nasal device that enables the patient to maintain patency of the nasopharyngeal airway by stenting open the palate, which, in the patient with OSA, closes upon laying down to sleep. By stenting open the nasopharyngeal airway with an embodiment of the present invention, the patient maintains his or her ability to breathe in a recumbent position.

Currently, the gold standard of treatment for OSA is continuous positive airway pressure ("CPAP"). However, the obtrusive, claustrophobic nature of the various facial interfaces causes many patients to refuse to use CPAP units over the long term. Also, patients with OSA can undergo a uvulopalatopharyngoplasty (UPPP) surgical procedure, which is surgically effective in opening up the nasopharyngeal space, but this method requires patients to experience all of the risks associated with a surgical procedure. In contrast, the device of the present invention is non-invasive and will help a large number of patients to reduce or eliminate OSA without any of the risks associated with surgical procedures.

Referring to FIG. 1, a schematic of the anatomy of a human head and neck is shown. More particularly, the nasopharynx 2 and the soft palate 4 are highlighted and will be referenced later when discussing the insertion and placement of certain embodiments of the present invention.

U.S. Patent Publication No. 2013/0152940 describes a nasopharyngeal trumpet as one possible treatment of OSA. U.S. Patent Publication No. 2006/0283464 describes a nasal trumpet or nasopharyngeal airway as a tube that is designed to be inserted into the nasal passageway to secure an open airway. When a patient becomes unconscious, the muscles in the jaw commonly relax and can allow the tongue to slide back and obstruct the airway. The purpose of the flared end (a.k.a., the trumpet) is to prevent the device from becoming lost inside the patient's nose.

There are several drawbacks to the trumpet design in treating OSA. To begin, the trumpet design obstructs the airway by blocking the nostril with the "trumpet," as seen in FIG. 2A. Still referring to FIG. 2A, a prior art nasal trumpet 10 inserted into the nose of an anatomical model is shown. More particularly, the flange 12 of the trumpet extends beyond the nostril of a patient and blocks air from entering. The patient's air supply is directed through the opening of the tube 14 in the trumpet 10 and the volume of air available to the patient per breath is limited by the diameter of the tube.

Another drawback of the nasal trumpet is the tube 14 extends past the soft palate. Referring to FIG. 2B, a prior art trumpet 10 inserted into the nose of an anatomical model is shown. More particularly, the tube 16 is of a uniform diameter and extends past the soft palate 4. The distal end of the tube 18 has an opening tor air and a conical extension (not shown) that can be inflated. The conical extension is located below the soft palate and is not effective in opening up the nasopharyngeal airway as described herein.

Referring to FIG. 3A and FIG. 3B, embodiments of the nasopharyngeal device of the present invention inserted into the nose of anatomical model are shown. More particularly, one embodiment of the nasopharyngeal device 100 of the present invention comprises a solid- walled, semi-rigid tube 110 with a proximal end 120 and a distal end 130. In certain embodiments, the proximal end has a cup 140 that attaches to the tube and prevents the tube from being inserted too far into the patient. In certain embodiments of the present invention, the cup extends minimally beyond the nostril. It is to be understood that the term "cup" as used herein also refers to tubular or conical structures or flatter structures commonly called buttons. In certain embodiments, the nasopharyngeal device of the present invention has two cups that attach to each nostril of the patient for improved comfort and stability. In certain embodiments of the present invention, the cup does not extend beyond the nostril of the patient when inserted. In certain embodiments, the cup further comprises a clip 150 for securing the cup to the patient's nostril. In certain embodiments, the device of the present invention comprises a reversibly inflatable balloon-cuff 160 near the distal end of the tube that is inflated and deflated via the tube.

Referring to FIGS. 4A-4F, embodiments of the nasopharyngeal device of the present invention are shown. More particularly, one embodiment of the nasopharyngeal device of the present invention comprises a solid- walled, semi-rigid tube 1 10 with a proximal end 120 and a distal end 130. In certain embodiments, a reversibly inflatable balloon-cuff 160 is located near or at the distal end of the tube such that it aligns with the soft palate for inflation and subsequent opening of the nasopharyngeal airway. It is understood that the placement of the balloon-cuff may vary for patients depending on their anatomy, but that the alignment must coincide with the soft palate for proper functioning. In certain embodiments, the balloon-cuff 160 can be inflated 165 via a port 175 in the tube 1 10 with the use of a bulb, a syringe 180, or other mechanisms known to those of skill in the art. In certain embodiments, the balloon-cuff is inflated using a syringe with a luer lock fitting.

As shown in FIG. 4G, when inserted into the nasopharyngeal airway and inflated the balloon-cuff 160 sterns the soft palate 165 thereby maintaining the patency of the nasopharyngeal airway 170 and allowing airflow through the airway around the tube.

It should be noted that, as shown in FIG. 4G, when inflated, the balloon-cuff 160 defines an area 180 through which airflow is not allowed except through the tube. This is in contrast to the prior art, as described in U.S. Patent No. 8,833,373 which discloses a tube 200 with an inflatable balloon-cuff 210 defining an interior through hole 220 extending the length of the balloon-cuff, allowing air flow through the hole, as shown in FIG. 4H. The present invention has the advantage of simpler, and less expensive, construction and a narrower balloon-cuff to insert through a patient's nose.

Still referring to FIGS. 4A-4F, in certain embodiments, the cup comprises a series of perforations, slots, holes, and the like 190 to allow more air to enter a patient's nostril when the device is installed. In prior art nasal trumpets, mechanisms for inflation, if present, are located on the trumpet and/or the trumpet is solid thus reducing the amount of air entering the patient with each breath. By doing so, current devices, by design, have occluded the nasal airway that surrounds the central lumen of the tube. One of the dangers associated with OSA is decreased oxygen intake. The nasopharyngeal device of the present invention helps to reduce or eliminate the risks associated with decreased oxygen intake in a multitude of ways.

According to one embodiment, the tube 110 may be formed from a variety of suitable materials known to those skilled in the art, for example, but not limited to, polyvinyl chloride. Likewise, the balloon-cuff 160 may be formed from a variety of suitable materials such as, for example, but not limited to, polyvinyl chloride or polyurethane.

The proximal end of the nasopharyngeal device of the present invention is designed with multiple perforations that enable the user to breathe, not only through the lumen of the tube, but also around the tube. See, for example, FIG. 5B. This design feature is extremely important since it allows the device to be thinner, thus it is more easily and painlessly passed through the nose. The tube's primary purpose is to carry the inflatable distal balloon-cuff down to the level of the soft palate for its ultimate inflation. The inflated balloon-cuff pushes the soft palate forward which opens up the nasopharyngeal airway, keeping it from collapsing. Moreover, because of the smaller, thinner size of the nasopharyngeal device of the present invention a standard, pliable balloon-cuff found on traditional endotracheal tubes is used in certain embodiments.

Referring to FIG. 6A, a prior art nasal trumpet inserted into an anatomical model is shown. More particularly, the trumpet is constructed of a thick-walled and wide-diameter tube with a flange at the proximal end to help prevent loss of the tube in the patient. The tube is large and causes patient discomfort when installed, thus leading to compliance problems. In contrast, referring to FIG. 6B, one embodiment of the nasopharyngeal device of the present invention inserted into the nose of an anatomical model is shown. More particularly, the nasopharyngeal device comprises a small, semi-rigid, solid-walled tube with a balloon-cuff located at the distal end and adjacent to the soft palate. In certain embodiments, the device comprises a cup with perforations, holes, slots, or the like, to allow for increased air intake for the patient.

In certain embodiments, the maximum outer diameter of the tube is fitted to suit the individual patient. In certain embodiments, the outer diameter of the tube is about 2 mm. In certain embodiments, the outer diameter of the tube is about 3 mm. In certain embodiments., the outer diameter of the tube is about 4 mm, although it can be larger.

Referring to FIG. 7 A, a prior art nasal trumpet inserted into the nose of an anatomical model and protruding past the nasal aperture is shown. More particularly, the tube of the prior art nasal trumpet is large and obscures and blocks the passageway, thus reducing the amount of air available to the patient.

Referring to FIG. 7B, one embodiment of the nasopharyngeal device of the present invention inserted into the nose of an anatomical model and protruding past the nasal aperture is shown. More particularly, the balloon-cuff is located just outside the nasal aperture and aligned with the soft palate, not shown, so as to provide an opening of the airway while not obscuring or blocking the airway. See also, FIG. 8A and FIG. 8B where embodiments of the nasopharyngeal device of the present invention are inserted into the nose of an anatomical model. There, the balloon-cuff protrudes just past the nasal aperture and does not block the airway.

In certain embodiments, the length of the tube is fitted to suit the individual patient. The outer diameter and length of the tube will vary with the patient's nasal anatomy and the size of their head and length of their soft palate. Measurements will be made in order to ensure that the balloon-cuff of the nasopharyngeal device is able to advance the palate appropriately in order to open up the retro palatal space. In certain embodiments, the balloon-cuff is comprised of soft polymers. Referring to FIG. 9, one embodiment of the nasopharyngeal device of the present invention inserted into the nose of a patient is shown. More particularly, in certain embodiments, there is a single cup on the proximal end of the device. In certain embodiments, the cup comprises a clip for holding the cup in place on the patient's nostril.

Referring to FIG. 10, one embodiment of the nasopharyngeal device of the present invention inserted into the nose of a patient is shown. More particularly, in certain embodiments, there is a pair of cups on the proximal end of the device. In certain embodiments, the cups comprise a clip for holding the cups in place on the patient's nostrils.

In certain embodiments of the present invention, the device is a modified, shortened, nasopharyngeal airway tube. In certain embodiments, the device has an elongated inflatable balloon-cuff near its distal end, which rests behind the soft palate and posterior nasopharyngeal wall. Upon inflation, the soft palate is moved forward, enabling the patient to breathe freely. In certain embodiments, the proximal end of the device is located at the nasal vestibule (nostril) and is tapered, flexible and has an attached soft plastic clamp, which keeps it secured to the nose during sleep.

In certain embodiments, the diameter and length of the tube will vary depending upon the anatomical dimensions of the patient.

Another embodiment of a nasopharyngeal device consistent with the present invention will now be described with reference to FIGS. 1 1 - 13. FIG. 11 shows a nasopharyngeal device 300 that is comprised of a semi-rigid solid-walled tube 310 and an obturator 320.

FIG. 12 illustrates an exemplary embodiment of the tube 310. The semi-rigid solid-walled tube 310 includes both a proximal end 311 and a distal end 312. The tube 310 may be an airway catheter-type. The proximal end may have an optional tapered portion 315 to secure the nasopharyngeal device 300 in the nasal opening and facilitate opening/widening the nasal vestibule and the nasal valve. One or more slits may optionally be at or near the tapered portion 315 of the tube 310 to facilitate air passing in and out of the nose during breathing. In other embodiments, the openings at or near the tapered portion may be circular, oval, slots, square, or a combination of shapes. The tube 310 is preferably flexible and shaped so that it can be introduced at the nasal vestibule and advanced through the nasopharynx to the inferior aspect of the nasopharynx such that the distal end 312 is able to be positioned substantially at the inferior aspect of the

nasopharynx near the soft palate. In one embodiment the tapered portion 315 may be adjustable to assist with positioning of the nasopharyngeal device 300, including for example, slidable along the length of the tube 310, and rotatable.

The tube 310 may be formed from a variety of suitable materials known to those skilled in the art, for example, but not limited to rubber, plastic, polyvinyl chloride, or a composite material.

In one embodiment the tube 310 may include a clip 313 disposed on the tapered end as shown in FIG. 12. The clip 313 may include a groove 314 that is configured to stabilize and orient the placement of the obturator 320. The clip 313 may be made of a pliable material or attached to the tube 310 in such a way to be adjustable in order to facilitate optimal placement of the obturator 320. Further, the clip 313 may be configured to catch at the edge of the nasal valve in order to prevent the nasopharyngeal device 300 from passing too far into the airway, which could cause aspiration. In one embodiment the clip 313 may fasten to part of the nostril or nasal valve in a clamping fashion. In another embodiment there are two or more clips 313 disposed on the tapered end of the tube.

FIGS. 13A - 13C illustrate an exemplary embodiment of the obturator 320. The obturator 320 is also semi-rigid and it has a proximal end 321 and a distal end 322. The distal end 322 of the obturator 320 includes a palatal expander 323, an exemplary embodiment of which is illustrated in FIG. 13B and FIG. 13C. In one embodiment, the palatal expander 323 is comprised of flexible projections 324. The flexible projections 324 may be attached to the distal end 322 in a cantilevered manner and operate as cantilevered springs. When a tension or compression force is applied to the flexible projections 324, the flexible projections 324 straighten and are bunched together into a group as illustrated in FIG. 13C. Without an external tension or compression force, the flexible projections 324 each fan-out due to their base tension into an arc or semi-elliptical shape. After fanning out, as a group the flexible projections 324 define a bulbous volume as illustrated in FIG. 13B. Thus, while the flexible projections 324 are in the tube 310, they will be bunched together, and while outside the tube they will fan out. If the obturator 320 is retracted through the tube 310 then the flexible projections 324 will straighten into a bunch. In one embodiment, the flexible projections 324 attach to the distal end 322 of

obturator 320, and in another embodiment they extend up through a portion or all of the length of the obturator 324. The obturator 320 may be formed from a variety of suitable materials known to those skilled in the art, for example, but not limited to metal, rubber, plastic, polyvinyl chloride, or a composite material.

The flexible projections 324 may be made of metal, plastic, polyvinyl chloride, or a composite material. Optionally, the flexible projections 324 may include a sheath that is made of rubber, plastic, polyvinyl chloride, or the like. Further, the number of flexible projections 324 and their respective girth and length is preferably sufficient to

expand/fan-out as described above in the interior part of the nasopharynx and project the soft palate forward (anterior) and open the airway. In one embodiment, one or more of the flexible projections 324 have a different girth and/or a different length.

The semi-rigid solid- walled tube 310 is configured to receive the obturator 320 as illustrated in FIG. 11. The obturator 320 is preferably shaped to pass into and reside in the tube 310, while still being slidable within the tube 310. The walls of the tube 310 provide sufficient force to collapse the flexible projections 324 as shown in FIG. 13C, while the obturator is in the tube 310.

In one embodiment the obturator 320 may include a clip or hook 325 to secure the obturator 320. The clip 35 may be optionally configured to fit into the groove 314 of the clip 313. The clip 325 helps prevent aspiration by preventing the obturator 320 from passing too far into the airway. Further, the clip 325 and groove 314 help to stabilize and orient the obturator 320 for optimal placement of the palatal expander 323.

The proximal end 321 and clip 325 may also serve as a handle or guide that is manipulatable by a user to advance the obturator 320 through the tube 310 and position the obturator 320 and the palatable expander 323 relative to a patient's airway anatomy, including the soft palate.

FIGS. 14A, 14B, 15A - 15C illustrate other exemplary embodiments of the palatal expander 323. FIG. 14A illustrates a palatal expander 323 comprised of a leaf spring 325comprised of two semi-elliptical portions that are connected at the ends. The leaf spring flattens when in the tube 320 as illustrated in FIG. 14 A, and expands into an oval or circular type shape as illustrated in FIG. 14B to advance the soft palate. In another embodiment the palatal expander 323 may include two or more leaf springs 325. The number of leaf springs 325, the diameters of the area they define, the girth of the springs, and their length may be based on the positioning and force needed to move/project the soft palate forward and open the airway. FIGS. 15A -15C illustrate a palatal expander 323 comprised of bristle like projections 326. The bristles lay flat against the body of the obturator while in the tube 320 as illustrated in FIG. 15B, and fan-out into an "upright" position as illustrated in FIG. 15 A to move the soft palate. The number of bristles 326, the size of the volume they define, the girth of the bristles, and the bristle length may be based on the positioning and force needed to move/project the soft palate forward (anteriorly) and open the airway. The bristle-like projections 326 lay flat against the obturator 320 as illustrated in FIG. 15C while the obturator is retracted through the tube 310.

FIG. 16 illustrates, with reference to FIGS. 11-13, the placement of the

nasopharyngeal device 300 consistent with the present invention within the airway anatomy. The semi-rigid solid-walled tube 310 provides the conduit for the obturator 320 to be advanced through the nose, through the nasopharynx, into the inferior aspect of the nasopharynx, and allows for the introduction of the obturator 320 and the palatal expander 323. The tube 310 is secured at the nasal valve by the proximal tapered end 311. In one embodiment the proximal tapered end 311 opens up the nasal valve. The device 300 is inserted such that the palatal expander 323 is positioned near the soft palate. The clip 313 is optionally configurable to engage the nasal opening after predetermined length of the device 300 has been inserted. The clip 313 and the tapered end secure the tube to prevent aspiration.

The obturator 320, which is slidably inserted into the tube 310, may be advanced through the tube 310 such that the palatal expander 323 exits the distal end 311 of the tube 310 and expands to move the soft palate. A user may manipulate the clip 323 to advance the obturator 320 through the tube 310 and position it relative to the patient's airway anatomy. As the expansion occurs, the palatal expander 323 pushes or projects the palate forward, away from the back wall of the throat, thereby opening up the retropalatal space to facilitate improved air flow during breathing. The clip 325 may engage in the groove 314 of the clip 313, securing the placement and position of the obturator 320 and helping to prevent aspiration due to any part of the obturator 320 (or the tube 310 for) advancing too far into the oropharynx or the hypopharynx. The clip 325 is optionally configurable to engage the clip 313 after a predetermined length of the obturator 320 has been inserted.

The nasopharyngeal device 300 may be inserted into the patient's airway with the obturator 320 already inserted in the tube 310. Alternatively, the tube 310 may be inserted and then the obturator 320 inserted. In one embodiment, the nasopharyngeal device 300 is inserted to project the soft palate forward when the patient is in a supine position, such that the patient is able to breathe substantially freely without experiencing apneas or hypopneas.

In certain embodiments, the length of the tube 310 and/or the obturator 320 is fitted to suit the anatomy of the individual patient. In this embodiment, the outer diameter and length of the tube and obturator are varied with the patient's nasal anatomy and the size of their head and length of their soft palate. Preferably, measurements are made in order to ensure that the palatal expander 323 is positioned to advance the palate appropriately in order to open up the retro palatal space. In certain embodiments, the balloon-cuff is comprised of soft polymers. In one embodiment the palatal expander 323 is attachable and detachable in order to fit an appropriately sized palatal expander 323 to the obturator 320.

In another embodiment of the nasopharyngeal device Transderm Xylocaine or another numbing agent is applied to and coats the outside of the nasal tube. This coating minimizes discomfort to the patient while introducing the tube into the nostril and reduces friction.

Those of ordinary skill in the art will appreciate that embodiments of the present invention may be used with other devices to assist with treating sleep apnea. For example, medical imaging devices and techniques, such as ultrasound and fluoroscopy may be used in conjunction with the nasopharyngeal device to assist with diagnosis and placement of the device.

While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are

contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention.

These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will readily be apparent to those of ordinary skill in the art when read in conjunction with the following descriptions, appendages, appended claims, and accompanied drawings. The foregoing and other objects, features, and advantages of the invention will be apparent from the following description of particular embodiments of the invention and as illustrated in the

accompanied drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed on illustrating the principals of the invention.