Sleep apnea prevention and relief device

• US 20090177124A1
• Filed: 11/10/2008
• Published: 07/09/2009
• Est. Priority Date: 11/08/2007
• Status: Abandoned Application

• Current Assignee: Bryan T. Oronsky, John W. Silwa
• Original Assignee: Bryan T. Oronsky, John W. Silwa
• Inventors: Silwa, John W., Oronsky, Bryan T.
• Application Number:
  US12/291,631
• Publication Number:
  US 20090177124A1
• Time in Patent Office: Days
• US Class Current: 601/6
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00

Abstract

A sleep apnea prevention and relief device is provided that is useful for a patient diagnosed with obstructive sleep apnea. For example, a form-fitting neck device is provided with a suction generation or creation means to create continuous or lasting negative pressure upon or around the neck in order to urge substantially outward expansion of the soft tissues that are compressing the pharynx and creating the obstruction.

Claims

1. A suction-establishing medical device for the treatment of sleep apnea mountable to a throat region useable to relax otherwise collapsed or potentially collapsing or contacting air-passage tissues comprising:

a neck mountable membrane or diaphragm capable of sustaining a pressure differential across its thickness, the pressure underneath it and adjacent the tissue being reduced relative to ambient pressure for at least a useful period;

a vacuum or suction seal mounted to the membrane, at or near its edges;

a vacuum or suction generation mechanism;

wherein the membrane with its suction seal being mountable on a patient'"'"'s neck portion overlying a region which requires reversal or avoidance of tissue collapse, said membrane/seal having a preformed general shape that approximately conforms to the neck region to which it is applied, at least at the edge gasket, the gasket providing a pneumatic seal against the neck tissues; and

wherein the vacuum or suction generation mechanism is able to apply or maintain a vacuum after said gasket seal is achieved, thereby establishing an outward tissue-pulling suction force on the underlying adjacent tissues within the seal to be uncollapsed.

2. The device of claim 1 wherein the vacuum or suction generation mechanism comprises either a plumbed suction pumping mechanism or comprises the membrane and/or membrane gasket itself acting to create suction underneath it as by it being mounted and sealed to the neck with a membrane deflection and/or gasket compression that creates a suctioning action underneath it as it attempts to recover from that deflection and/or compression.

3. The device of claim 1 wherein the gasket is any one or more of:

utilizes a sealing gel;

utilizes a sealing adhesive;

utilizes a wetting flowable medium or liquid to support sealing;

is disposable;

is reusable;

is replaceable;

includes both a sealing material and a conforming or compressible material;

contributes to a beneficial suctioning effect;

provides anatomical conformance to a degree;

or

makes the inward edge loading more comfortable.

4. The device of claim 1 wherein the membrane is sufficiently rigid or semi-rigid such that it can maintain a pressure differential across its thickness in at least one deflected or undeflected state without substantially collapsing and losing all or most of that suction.

5. The device of claim 1 wherein the membrane has an elastically deflected state whose desired recovery therefrom creates a suction beneath the membrane.

6. The device of claim 1 wherein any manner of continuously operating or periodically operated or operating suction-generation mechanism is utilized or applied.

7. The device of claim 1 wherein any manner of one-time operated suction generation mechanism is utilized or applied including as by attempted elastic recovery of the membrane and/or its gaskets from an applied one-time deflection or compression.

8. The device of claim 1 wherein a sealing gasket is also compressible and is compressed during device mounting, the gasket'"'"'s desired elastic recovery from that compression also or instead causing beneficial suction beneath the membrane, said membrane itself being or not being also elastically deformed and providing or not providing a similar suctioning effect.

9. The device of claim 1 wherein the membrane is any one or more of:

a) molded or cast, b) thermoformed, c) comprised substantially of a polymer, d) comprised of an elastic material, e) comprised of a deformable material, f custom-fit and fabricated utilizing stereolithography-like techniques, g) custom fit in any manner, h) shapeable, at least once, by the user or practitioner to some degree.

10. The device of claim 1 wherein the device includes a check valve or pressure relief valve for any purpose including such as for maintenance of suction or release of suction.

11. The device of claim 1 wherein the entire device is either reusable or disposable.

12. The device of claim 1 wherein any shape or dimension of the device is any one or more of:

chosen from a kit of multiple different devices or device portions;

formed to the anatomy at the time of use;

manufactured or fabricated by anyone to a particular customer'"'"'s anatomy shape;

adjustable;

different for children versus adults;

or

different for obese persons relative to non-obese persons.

13. The device of claim 1 wherein a sealing gasket includes any one or more of:

a) a topographically conforming non-leaking layer, b) an adhesive layer, c) a gel-sealing or conforming layer, d) a rubber or elastomer portion, e) a sealing surface that is wetted or lubricated at any point, f) any replaceable portion, g) a closed-cell foam portion, h) a load-cushioning action, or i) a compressible portion which, upon its attempted recovery, contributes useful suctioning.

14. The device of claim 1 wherein it includes an additional fastener capability, including a strap, band or wrap to provide additional anatomy fixation beyond what the suction itself provides.

15. The device of claim 1 wherein it is placed against the throat and the membrane is deflected and/or the gasket is compressed, thereby expelling air from underneath the membrane past the gasket or out a check valve, and upon release of the deflecting and/or compressing force the membrane and/or gasket establishes a beneficial suction as it as it attempts to recover from said deflection or compression.

16. The device of claim 1 wherein it is placed against the throat and a suctioning or evacuation means creates a suction under the membrane and that suction is preserved as by the closure of a valve or sealing of a flowpath.

17. The device of claim 16 wherein the suction means is one of a) a pump, b) a squeeze bulb, or c) any kind of manually operated evacuation means.

18. The device of claim 1 wherein the membrane has the general shape of:

a) a plate, b) a pyramid, c) a dome, d) a generally cylindrical or spherical shape, e) a generally symmetric shape, f) a generally trapezoidal shape, g) a generally rectangular shape, or h) a shape having stepped mesas.

19. The device of claim 1 wherein the device includes a jaw brace such that the patient is limited in his/her head articulation for any reason related to good or safe device operation.

20. The device of claim 1 wherein the device wraps around the neck to a degree, thus providing a radial decompression force to at least some neck tissues in the wrapping region.

21. The device of claim 1 wherein the suction magnitude is varied, including for at least one of:

timed operation with a breathing cycle;

triggered or adjusted operation with an apnea parameter or condition being sensed;

triggered or adjusted operation with a snoring parameter or condition being sensed;

or

optimization of the devices overall benefit.

22. The device of claim 1 wherein snoring is reduced or avoided.

23. The device of claim 1 wherein unsafe breathing stoppages are reduced or avoided.

24. The device of claim 1 wherein it is used together with a drug or electrotherapeutic measure to cooperatively suppress or eliminate apnea, hypopnea events or hypoxic or hyperbaric episodes.

25. The device of claim 1 wherein it is used to treat any one or more of the following specific conditions or health states:

a) sleep apnea, b) hypopnea, c) hypoxic episodes, d) hyperbaric episodes, or e) snoring.

26. The device of claim 1 wherein the device is used in cooperation with any of (n)-cPAP or BiPAP.

27. The device of claim 1 wherein said suction effect is instead provided by an adhering interface between the membrane and tissue, the deflected membrane and/or compressed gasket-seal providing outward or suction-equivalent loading of the tissues as said deflection and/or compression attempts to recover.

28. The device of claim 1 wherein also provided by the device is inward compression of the patient'"'"'s neck on the side of the neck to further beneficially deform or open-up blocked breathing passages.

29. The device of claim 28 wherein said additional inward compression of the side(s) of the neck is provided by an elastic property of the device or by a device-fixating strap, wrap or clamp.