PRESSURE DEVICE AND METHOD

FIELD OF THE INVENTION

The present invention relates generally to devices and methods for providing gases intra-orally, and more specifically to ergonomic apparatus and methods for saliva removal during continuous positive air pressure provision to a mammalian subject.

BACKGROUND OF THE INVENTION

Mammalian subjects require a semi-continuous supply of air, such that the oxygen level in the brain is retained above a threshold level. There are many conditions and situations under which the air supply is temporarily stopped or reduced. These may include, but are not limited to, sleep apnea, heart attack, epileptic seizure and drowning. If the subject does not receive oxygen within a number of seconds/minutes, the result can lead to irreversible brain damage, and, in some cases, death.

Many devices and methods have been developed to ensure a continuous air supply to human subjects, such as sleep apnea devices. However, many of the devices are cumbersome, uncomfortable and lead to patient non-compliance. Other devices are not adapted to deal with patient movement. The amount of saliva produced by a healthy person per day is estimated to be in the range of 0.75 liters per day to 1.5 liters per day. This suggests that the amount produced varies from person to person. It is generally accepted though that while sleeping the amount usually drops significantly, in some cases down to almost zero. A foreign object, such as a continuous positive airway pressure CPAP device, in the buccal sulcus may also induce increased salivation, especially at the beginning of intra-oral device use.

A significant reduction of saliva secretion will result after prolonged use, but nevertheless, a small but annoying amount of saliva may drool between the lips to the corner of the mouth. Although this problem has been reported for only a small number of patients, where it exists, it may cause annoyance and inconvenience to the patient. Some publications relating to sleep apnea devices include: US 4,305,387, US Patent Publication Nos. US2002005201, US2003075182, US2003183227, US2003089371, US2005236003, US2007131229A, World Patent Publication Nos. WO06079149A and WO08041237A.

Despite the advances of the inventions described hereinabove, there is still a need to provide CPAP devices and methods which are less cumbersome and of better ergonomics, thereby providing devices which lend themselves to greater patient compliance. Additionally, there is an unmet need for these devices to prevent saliva drooling during wake hours and during sleep.

SUMMARY OF THE INVENTION

It is an object of some aspects of the present invention to provide intra-oral devices and methods for enabling swallowing of saliva when the device is in situ in the patient's mouth, concomitantly with providing air to the patient, thereby preventing death and injury due to a temporary stoppage of their natural breathing process.

It is an object of some aspects of the present invention to provide intra-oral sleep apnea devices and methods for enabling swallowing of saliva when the device is in situ in the patient's mouth, concomitantly with providing air to the patient, thereby preventing death and injury due to a temporary stoppage of their natural breathing process.

It is an object of some aspects of the present invention to provide saliva removal intra-oral devices and methods for providing air to patients thereby preventing their death and injury due to a reduction of air intake during their natural breathing process. By "removal" is meant transfer from a place within the mouth from which the saliva cannot be easily swallowed to a place from which it can be swallowed.

In some embodiments of the present invention, improved ergonomic methods and apparatus are provided for preventing death and injury in patients suffering from sleep apnea, stroke, heart attack, trauma, COPD, Alzheimer and other conditions.

In other some embodiments of the present invention, a method and a saliva removal intra-oral interface for providing continuous positive airway pressure (CPAP) to a patient.

In additional some embodiments for the present invention, a saliva-removal intraoral interface is provided which is non-obtrusive, comfortable, does not impinge on or touch the soft palate, tongue or teeth. The interface is simple to use, lightweight and economically designed.

In additional embodiments for the present invention, an ergonomically formed intra-oral interface is provided for providing an unconscious, semi-conscious or sleeping patient with continuous or semi- continuous saliva removal coupled with continuous positive airway pressure (CPAP).

In further embodiments of the present invention, an interface provides for continuous positive airway pressure (CPAP) maintenance in a patient.

In further embodiments of the present invention, an interface provides for non invasive ventilation in a patient.

In order to prevent saliva from exiting the oral cavity via the lips and the accompanied patient inconvenience, some embodiments of the present invention are directed to methods and apparatus for enabling the accumulated saliva to move along its normal path. Thus devices of the present invention are constructed and configured for placing in between the teeth and gums, yet enabling saliva to flow from the posterior buccal sulcus where it is excreted by the parotis gland to a lingual side of the teeth in the interior of the oral cavity, where the combined action of the tongue and the muscles involved in swallowing enable the saliva to be swallowed.

Some of the devices of the present invention prevent the passage of saliva from a lingual side to a buccal side thereof.

When a sleeping patient has a device of the present invention in his mouth, saliva tends to accumulate in front of a posterior bulge of the device due to the device morphology. At the locations of saliva accumulation inside the oral cavity, the interface is structured in a way that directs the saliva elsewhere. The problem of saliva accumulation is solved by positioning one or more unidirectional valves at the site of saliva accumulation.

The valve is constructed and configured to transfer saliva to the lingual side of the device during a normal swallowing cycle, which involves various oral muscle contractions. The valve is preferably opened uni-directionally to allow for saliva transfer from a buccal side to a lingual side thereof.

The valve is activated by normal and regular muscle contraction which takes place during each swallowing cycle. Muscle relaxation after swallowing allows for valve closure. Closure of the valve is innate to the elastic property of the material. When the valve is closed, a complete seal of the oral cavity from the outside is restored.

Upon a swallowing reflex, the valve is opened for a short duration. Saliva is actively forced through the valve to the lingual side because the position of the valve in front of the posterior bulge allows the contracting muscles to sweep the saliva towards the opened orifice of the valve.

The valve is not a device implanted into the SomnuSeal but rather, is an integral part of the SomnuSeal silicone material and so its use is safe and it may not tear or depart from the main body of the device.

The valves are integral parts of the device/interface thereby enabling easy cleaning and hygienic and safe operation thereof.

The valves are designed such that air or saliva cannot pass from the lingual side of the valve to the buccal side thereof. These uni-directional valves, also known as "check valves", are located in the mouth at areas at which saliva accumulates. These places are either at the anatomical places of saliva accumulation and/or at places where the saliva accumulates as a result of the morphology of the device/interface.

This uni-directional valve allows saliva to move to the inside of the oral cavity using the mechanism of a uni-directional valve with or without the help of muscle contraction during the saliva swallowing, which occurs naturally during such a process. These uni-directional valves do not allow air or fluids to move from the direction of inside the oral cavity to the buccal sulcus.

This valve does not interfere with the oral device/interface sealing, and if it does, the interference will be for a very short period of less than 5 seconds (calculated according to normal time span of regular saliva swallowing).

The uni directional valves may be placed in parallel to the muscle contraction vectors.

The transfer of the saliva into the oral cavity through the uni-directional valve will occur when enough saliva accumulates near the valve and when the patient swallows. The swallowing action - contraction of the lips, will exert pressure on the accumulated saliva that will have to pass the uni-directional valve as it will be the least resistant path for it. Then, the accumulated saliva that passed the uni-directional path will be directed by a duct like structure to the sides of the interface where the saliva will be sucked by the saliva swallowing process of the patient.

Another solution, two channel like structures between the physical location where the saliva accumulates (either naturally or as a result of the interface morphology) and the distal part of the buccal sulcus.

This structure allows the saliva to flow freely towards the inner part of the oral cavity and be swallowed naturally from there on.

There is thus provided according to some embodiments of the present invention, an intra-oral saliva-removal device for introduction in the buccal vestibulum between teeth and inner part of lips and cheeks in a mouth of a patient, the device including at least one uni-directional valve adapted to transfer fluids from a buccal side of the device to a lingual side thereof.

Additionally, according to some embodiments of the present invention, the device is a saliva-removal continuous positive air pressure (SRCPAP) device.

Furthermore, according to some embodiments of the present invention, the device is a CPAP device.

Moreover, according to some embodiments of the present invention, the device includes at least two uni-directional valves.

Further, according to some embodiments of the present invention, the device includes at least four uni-directional valves.

Additionally, according to some embodiments of the present invention, the device is constructed and configured to transfer saliva from the buccal side of the device to the lingual side thereof.

According to some embodiments of the present invention, the saliva is adapted to swallowed on the lingual side.

Additionally, according to some embodiments of the present invention, the at least two uni-directional valves are constructed and configured to prevent backflow of fluids from the lingual side to the buccal side of the device.

Moreover, according to some embodiments of the present invention, the device may include;

a) a hollowed ellipsoid tube section which opens towards the teeth at a first end; b) an intra-oral section extending perpendicularly from a second end of the hollowed ellipsoid tube section, the intra-oral section including; i. a buccal hollowed ellipsoid surface; and

ii. a lingual rim projecting from a circumferential border of the hollowed ellipsoid surface, thereby forming a circumferential hollow lip, wherein the hollow lip is adapted to bulge upon receiving air thereby forming a circumferential air pocket within the circumferential hollow lip.

Further, according to some embodiments of the present invention, the intraoral section is adapted to be inserted within buccal sulci occupying substantially the entire volume of a buccal sulcus potential space upon receiving air in such a way that facilitates oral cavity sealing, and to retain oral cavity sealing in a sealed state without occupying the entire volume of a buccal sulcus potential space.

Furthermore, according to some embodiments of the present invention, the at least one valve is adapted to open when cheek muscles contract.

Yet further, according to some embodiments of the present invention, the at least one valve is adapted to close when cheek muscles relax.

Furthermore, according to some embodiments of the present invention, the device weighs less than 60 grams.

Additionally, according to some embodiments of the present invention, the device weighs 20 to 50 grams.

Furthermore, according to some embodiments of the present invention, the device is constructed and configured to conform to mouth physiology of a patient.

Moreover, according to some embodiments of the present invention, the device is constructed and configured to passively form a seal by occupying a potential space between the lips and gums of a user.

Furthermore, according to some embodiments of the present invention, the device is constructed and configured to supply sufficient air to the patient at an air pressure of 2-25 cm H ₂ 0.

Moreover, according to some embodiments of the present invention, the circumferential hollow lip is adapted to be inflated by exhaled air of the user.

Furthermore, according to some embodiments of the present invention, the device includes a biocompatible polymer.

Additionally, according to some embodiments of the present invention, the circumferential hollow lip includes collapsible portions.

Furthermore, according to some embodiments of the present invention, the collapsible portions exhibit a pre-loaded force which is adapted to press gently onto the gums and lips of the user upon insertion to a mouth of the user, thereby forming a seal.

Moreover, according to some embodiments of the present invention, the intra- oral section is provided with a central part formed with an aperture in communication with the tube, and right and left longitudinally extending projections adjoining, and of substantial bilateral symmetry with respect to, the central part, each of the projections having adjoining upper and lower regions and each of the regions having adjoining proximal and distal portions, and wherein each of the projections is dimensioned such that a distal portion has a thickness substantially equal to, or greater than, a buccal sulcus potential space gap, and is configured, when inserted within a buccal sulcus, in such a way so as to adhere to the oral mucosa, to occupy substantially the entire volume of buccal sulcus potential space, and to seal the oral cavity.

Furthermore, according to some embodiments of the present invention, a distal portion is considerably thicker than an adjoining proximal portion and than a corresponding distal portion of the buccal sulcus potential space to such a degree that upper and lower lip portions disposed buccally to the central part are urged to sealingly engage the tube; and wherein the distal portion is also wider buco-lingually, thereby adapted to form a larger air pocket than that formed at more proximal parts of the interface, thereby allowing for a good seal between posterior portions of the interface and the gums of the patient.

Yet further, according to some embodiments of the present invention, the device is constructed and configured to supply sufficient air to the patient at an air pressure of 2-10 cm H ₂ 0.

Additionally, according to some embodiments of the present invention, the device is constructed and configured to supply sufficient air to the patient at an air pressure of 4-8 cm H ₂ 0.

Furthermore, according to some embodiments of the present invention, the device is constructed and configured to supply sufficient air to the patient at an air pressure reduced by 10-60% relative to an existing CP AP interface.

Typically, the intra-oral saliva-removal device is constructed and configured to supply sufficient air to the patient at an air pressure reduced by 15-50% relative to an existing CPAP interface.

Furthermore, according to some embodiments of the present invention, there is provided a system for continuously providing a user with sufficient air, the system including;

a) a device as described herein;

b) at least one set of coils disposed in the device;

c) at least one sensor adapted to receive data from a device neighborhood;

d) a flow generator unit adapted to provide air to the device; and

e) a data processing unit constructed and configured to;

i. process and store the data; and

ii. provide signals responsive to the data to at least one of the coils and an air inlet controller.

iii. provide signals responsive to the data or signals from the flow generator unit.

Furthermore, according to some embodiments of the present invention, the system is adapted to prevent at least one of sleep apnea, snoring and hypopnea.

Additionally, according to some embodiments of the present invention, the sensor is selected from an integral pulse oximeter and a CO-oximeter.

Furthermore, according to some embodiments of the present invention, a method is provided for saliva removal during provision of continuous positive air pressure to a patient, the method including placing an intra-oral saliva-removal device as described herein in the buccal vestibulum between teeth and inner part of lips and cheeks in a mouth of the patient thereby enabling the flow of saliva from a buccal side of the device to the lingual side thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in connection with certain preferred embodiments with reference to the following illustrative figures so that it may be more fully understood.

With specific reference now to the figures 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:

Fig. 1 is a simplified pictorial illustration of a front view of a SRCPAP (saliva- removal continuous positive air pressure) intra oral device, in accordance with an embodiment of the present invention;

Fig. 2A is a simplified pictorial illustration of a side view of the SRCPAP device of Fig. 1, in accordance with an embodiment of the present invention;

Fig. 2B is a simplified pictorial illustration of a cross section of a buccal portion along A-A of the SRCPAP device of Fig. 1, in accordance with an embodiment of the present invention;

Fig. 3A is a simplified pictorial illustration of a side view of vertical cross section of the SRCPAP device of Fig. 1 with a valve in a closed position, in accordance with an embodiment of the present invention; and

Fig. 3B is a simplified pictorial illustration of a side view of vertical cross section of the SRCPAP device of Fig. 1 with a valve in an open position, in accordance with an embodiment of the present invention; and

In all the figures similar reference numerals identify similar parts. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In the detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that these are specific embodiments and that the present invention may be practiced also in different ways that embody the characterizing features of the invention as described and claimed herein.

All terms used herein are in accordance with the definitions and teachings of World Patent Publication No. WO08041237, incorporated herein by reference. '237 teaches a shield, having a buccal portion substantially equal to, or greater than, a buccal sulcus potential space gap. Additionally, Israel Patent Application No. 197330 to DISCOVER MEDICAL DEVICES LTD., teaches intra-oral self adaptable continuous positive airway pressure (CPAP) interface and method

The present invention provides intra-oral interfaces for providing continuous positive airway pressure (CPAP) to a patient. Various designs of the hollowed interfaces, adapted to create air pockets within the interfaces are described herein, but should not be deemed as limiting.

Reference is now made to Fig. 1 , which is a simplified pictorial illustration of a front view of a SRCPAP (saliva-removal continuous positive air pressure) intra oral device 100, in accordance with an embodiment of the present invention.

Device 100 comprises an intraoral hollowed ellipsoid tube section 122, and an intra-oral section 101, which serve as a barrier between the oral cavity and atmospheric pressure air. Section 101, in communication with the source of positive air pressure has left and right arcuate projections 105 and 107 of bilateral symmetry with respect to tube section 122. Projections 101 and 103 are configured to match the internal anatomy of a patient's mouth. Device 100 comprises at least one unidirectional valve 110, 120, 130, 140.

Tube section 122 is constructed and configured as a male portion to fit onto a female portion (not shown, but described in IL 197330) of an adapter element for connecting to an extra-oral gas supply. The tube section is made out of a biocompatible polymer and is shaped to conform to the mouth opening during rest. It is of a generally elliptical cross-section with flattened horizontal upper and lower sides.

Device 100 allows CPAP air or other gases to be delivered through tube section 122. Exhaled gases are discharged from the tube section (and in a small number of cases, some of it may exit through the patient's nostrils).

According to some embodiments, the patient is also provided with nostril bungs or stoppers to prevent exhaled air from escaping via the nostrils.

Some of the problems associated with prior art interfaces includes that they are heavy, cumbersome and are generally uncomfortable. In sharp contrast, the interfaces/devices of the present invention are:

a) much lighter, thinner in vertical cross-section and do not significantly weigh down on the gums and lips within the mouth, in comparison with the interfaces of WO08041237;

b) comprise a lingual rim which is constructed and configured to form circumferential hollow lip of the interface, wherein the hollow lip is adapted to bulge upon receiving exhaled and existing air, thereby forming a circumferential air pocket within the circumferential hollow lip;

c) do not press down on any part of the tongue, does not touch the tongue or soft palate and does not protrude into the oral cavity lingual to the teeth leading to a hyperactive gag reflex;

d) do not press down on any part of the skin and lips externally to the oral cavity; and

e) Self adaptable to the physical intra oral structure of each user.

The hollowed ellipsoid tube section 122 is connected perpendicularly at an intra-oral end to two thin central sections 113, 115, disposed respectively to the left and right of a central vertical axis 151. Surrounding the central sections are four buccal bulging portions, namely an upper left buccal portion 102, an upper right buccal portion 104, a lower right buccal portion 106 and a lower left buccal portion 108. At each distal part of the interface, there is a hollow section which acts as a collector of air. It comprises thicker silicon lips and occupies the space adjacent to the posterior teeth. Reference is now made to Fig. 2A, which is a simplified pictorial illustration of a side view 200 of the SRCPAP device of Fig. 1, in accordance with an embodiment of the present invention. Disposed between upper right buccal portion 104 and lower right buccal portion 106 is a one way valve 210 which allows passage of fluid from the buccal side of the device to the lingual side.

Reference is now made to Fig. 2B, which is a simplified pictorial illustration of a cross section 220 of a buccal portion along A-A of the SRCPAP device of Fig. 1, in accordance with an embodiment of the present invention.

The valve is constructed and configured to transfer saliva to the lingual side of the device during a normal swallowing cycle, which involves various oral muscle contractions. The valve is preferably opened uni-directionally to allow for saliva transfer from a buccal side to a lingual side thereof. It should be understood that there may be a number of valves 210, disposed at various positions on the device, which provide passage of fluids from the buccal side of the device to the lingual side. Moreover, though the figures show one type of device, this should not be construed as limiting. The devices of the present invention may be any suitable intra-oral device.

Reference is now made to Fig. 3 A, which is a simplified pictorial illustration of a side view 300 of vertical cross section of the SRCPAP device of Fig. 1 with a valve 330 in a closed position when the cheek muscles 310, 320 are relaxed.

Reference is also made to Fig. 3B, which is a simplified pictorial illustration of a side view 350 of vertical cross section of the SRCPAP device of Fig. 1 with valve 330 in an open position, in accordance with an embodiment of the present invention.

This uni-directional valve 330 allows saliva to move to the inside of the oral cavity using the mechanism of uni-directional valve 330, with or without the help of muscle contraction during the saliva swallowing, which occurs naturally during such a process. These uni-directional valves do not allow air or fluids to move from the direction of inside oral cavity 622 to the buccal sulcus.

This valve does not interfere with the oral device/interface sealing, and if it does, the interference will be for a very short period of less than 5 seconds (calculated according to normal time span of regular saliva swallowing).

The uni directional valves may be placed in parallel to the muscle contraction vectors.

The transfer of the saliva into the oral cavity through the uni directional valve will occur when enough saliva accumulates near the valve and when the patient swallows. The swallowing action - contraction of the lips, will exert pressure on the accumulated saliva that will have to pass the unidirectional valve as it will be the least resistant path for it.

Then, the accumulated saliva that passed the uni-directional path will be directed by a duct like structure to the sides of the interface where the saliva will be sucked by the saliva swallowing process of the patient.

In another solution may be applied with two channel-like structures (valves) between the physical location where the saliva accumulates (either naturally or as a result of the interface morphology) and the distal part of the buccal sulcus.

This structure allows the saliva to flow freely towards the inner part of the oral cavity and be swallowed naturally from there on.

The references cited herein teach many principles that are applicable to the present invention. Therefore the full contents of these publications are incorporated by reference herein where appropriate for teachings of additional or alternative details, features and/or technical background.

It is to be understood that the invention is not limited in its application to the details set forth in the description contained herein or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Those skilled in the art will readily appreciate that various modifications and changes can be applied to the embodiments of the invention as hereinbefore described without departing from its scope, defined in and by the appended claims.