Treating sleep apnea with negative pressure

An embodiment of a system for treating sleep apnea includes a collar, a pump, a motor, a sensor, and a controller. The collar is configured to maintain an airway of a subject open while the subject is sleeping by applying, to a throat of the subject, a negative pressure having a magnitude, and the pump is configured to generate the negative pressure. The motor is configured to drive the pump, and the sensor is configured to generate a sense signal that is related to a degree to which the airway is open. And the controller is configured to vary the magnitude of the negative pressure in response to the sense signal. For example, one or more of the pump, motor, sensor, and controller can be secured to the collar such that the system is self-contained, i.e., the entire sleep-apnea system can be worn by the subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

RELATED APPLICATIONS

U.S. patent application Ser. No. 15/406,372, titled OBTAINING, WITH A SLEEP-APNEA DEVICE, INFORMATION RELATED TO SLEEP-APNEA EVENTS AND SLEEP-APNEA TREATMENT, AND CORRELATING SLEEP-APNEA EVENTS AND SLEEP-APNEA TREATMENT WITH SUBJECT LIFESTYLE AND WELLBEING, naming Roderick A. Hyde, Kenneth G. Caldeira, Gary L. McKnight, Lowell L. Wood Jr., Dennis J. Rivet, Katherine Sharadin, Michael A. Smith as inventors, filed Jan. 13, 2017, is related to the present application and its contents are hereby incorporated by reference.

All subject matter of the Priority Applications and the Related Applications and of any and all parent, grandparent, great-grandparent, etc. applications of the Priority Applications and the Related Applications, including any priority claims, is incorporated herein by reference to the extent such subject matter is not inconsistent herewith.

SUMMARY

A system for treating sleep apnea includes a collar, a pump, a motor, a sensor, and a controller. The collar is configured to maintain an airway of a subject open while the subject is sleeping by applying, to a throat of the subject, a negative pressure having a magnitude, and the pump is configured to generate the negative pressure. The motor is configured to drive the pump, and the sensor is configured to generate a sense signal that is related to a degree to which the airway is open or obstructed. And the controller is configured to vary the magnitude of the negative pressure in response to the sense signal.

For example, one or more of the pump, motor, sensor, and controller can be secured to the collar such that the system is self-contained, i.e., the entire system can be worn by the subject, e.g., held over the subject's throat by strap assembly. Alternatively, the system can include a base unit that includes at least the pump and the motor, and can include an air hose that couples the base unit to the collar such that the pump can generate the negative pressure via the hose.

DETAILED DESCRIPTION

One or more embodiments are described with reference to the drawings, wherein like reference numerals may be used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the one or more embodiments. It may be evident, however, that one or more embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block-diagram form in order to facilitate describing one or more embodiments.

Sleep apnea is a disorder characterized by instances of abnormally low breathing, or by instances of abnormal pauses in breathing (e.g., “apneas,” or “apnea events”), during sleep; for example, such apneas can occur with a frequency of approximately 5-30 times or more per hour, and each apnea can last from approximately ten seconds to one or more minutes.

To prevent a subject who suffers from sleep apnea from suffocating during an apnea, the body produces a short “burst” of adrenaline, which burst typically rouses the subject enough to start him/her breathing again, but not enough to fully awaken him/her.

Unfortunately, these bursts of adrenaline can cause the subject to experience significant health problems. For example, because such bursts of adrenaline can stress the subject's heart by causing the subject's heart rate to increase relatively quickly, such bursts may increase the subject's risk of heart attack or stroke. Furthermore, because these bursts of adrenaline interrupt the subject's deep-sleep patterns, these bursts can be the underlying cause of health problems that are associated with a lack of sleep; examples of such lack-of-sleep-related health problems include an increase in non-lean (adipose tissue) body mass, arteriosclerosis, daytime fatigue, reduced cognitive function, reduced reaction time, and reduced attention span.

Because a subject suffering from sleep apnea is rarely aware of having difficulty breathing during sleep, or even after awakening, the subject may be unaware for many years that he/she suffers from sleep apnea until one or more symptoms, for example, in the form of one or more of the above-described health problems, manifest themselves to a degree that causes the subject to seek medical attention. But by then, the subject may have suffered serious injury (e.g., a heart attack), disability (brought on, e.g., by stroke), or even death (brought on, e.g., by the subject's failure to begin breathing after an apnea).

Consequently, proper treatment of sleep apnea can improve a subject's health in both the short term and in the long term, and, in some cases, can even prevent the subject's premature death.

The most common type of sleep apnea is obstructive sleep apnea.

FIG. 1is a cut-away view of a head-and-neck region10of a subject12.

Referring toFIG. 1, obstructive sleep apnea is characterized by an airway14of the subject12collapsing, i.e., becoming blocked during sleep by, e.g., the back of the tongue16, the soft palate18, or the uvula20; therefore, each instance of a blocked airway typically causes an “apnea” as described above. Causes of a blocked airway14during sleep can include poor muscle tone in, over relaxation of, or excess tissue in, the tongue16, soft palate18, or uvula20.

When the body of the subject12produces a burst of adrenaline during a blocked-airway-induced apnea to start the subject breathing again as described above, the adrenaline burst may unblock the airway14by causing the subject to, e.g., cough, move his/her neck22, head24, or jaw26, or to breathe more deeply (the stronger suction caused by a deeper breath may force open the airway).

Then, after the subject12falls back into a deeper sleep, the muscles of the neck22and jaw26relax, the subject's respiratory rate returns to a deeper-sleep level, and, therefore, another cycle of an apnea followed by an adrenaline burst may commence.

Still referring toFIG. 1, there are many treatments available for obstructive sleep apnea.

Examples of invasive treatments include surgery to remove tissue from the body part (e.g., the tongue16, soft palate18, or uvula20) responsible for the blockage of the airway14, and surgery to implant one or more members into the blocking body part (e.g., to implant plastic rods into the soft palate) to “stiffen” the body part.

Unfortunately, potential problems with such invasive treatments include the risks, recovery time, irreversibility, and pain associated with a surgical procedure, including the risk that the procedure will cause the subject post-recovery discomfort when he/she swallows or while he/she is eating, and the risk that the procedure will ultimately prove unsuccessful in preventing reoccurrence of the airway blockages that cause obstructive sleep apnea.

And examples of non-invasive treatments include the subject12losing weight, using an oral appliance that maintains the subject's jaw26in a slightly protruding position during sleep, and using a Continuous Positive Airway Pressure (CPAP) machine, which is described below in conjunction withFIG. 2.

Although such non-invasive treatments are generally preferred over invasive treatments because, e.g., they can have fewer risks and side effects than invasive treatments, some non-invasive treatments, such as losing weight and using an oral appliance, may be difficult to obtain, or ineffective, for some subjects who suffer from obstructive sleep apnea.

But fortunately, it has been found that a CPAP machine can successfully treat obstructive sleep apnea in the majority of subjects who would otherwise suffer from it.

FIG. 2is a view of a sleeping subject12using a CPAP machine30to prevent the occurrence of obstructive sleep apnea.

The CPAP machine30includes a base unit32, a hose34, and a mask assembly36.

The base unit32is configured to maintain the air pressure within the hose34, and thus within the airway14(FIG. 1) of the subject12, at approximately constant levels while the subject is breathing in (inspiration) and while the subject is breathing out (expiration). If the CPAP machine30maintains the airway pressure at a different approximately constant level during inspiration than it does during expiration, then it is more properly called a BiPAP machine, although in common usage, “CPAP” is used to denote both a machine that maintains the airway pressure at the same positive level during inspiration and expiration and a machine that maintains the airway pressure at different positive levels during inspiration and expiration. The base unit32typically includes a power cord that plugs directly into a household power outlet (e.g., 110/220 VAC), or is coupleable to an AC adapter.

The hose34is configured to couple the base unit32to the mask assembly36, and is typically long enough (e.g., six to ten feet) to allow the subject12to place the base unit on a floor or on a night stand while the subject is using the CPAP machine30.

The mask assembly36includes a fitting38, a mask40, and straps42. The fitting38is configured to couple the mask40to the hose34, and may be coupled to the mask with a swivel joint that allows the subject12some freedom of movement. The mask40is configured to form an airtight seal44around at least the nose of the subject12(although the mask may also form a seal around the subject's mouth as shown inFIG. 2), and includes one or more openings (not shown inFIG. 2) that allow air to flow constantly from the base unit32, through the hose34and fitting38, into the mask40, and out through the one or more openings, even during inspiration; without this constant airflow, the air inspired by the subject may become “stale.” And the straps42secure the mask40to the head24of the subject12with a degree of tightness sufficient to form the airtight seal44between the mask and the face of the subject.

Still referring toFIG. 2, although, as described above, the CPAP machine30is an effective non-invasive treatment for obstructive sleep apnea, the CPAP machine may still have some shortcomings. For example, the nature of the hose34effectively tethering the mask assembly36to the base unit32may rob the subject12of his/her full range of movement during sleep. As an example, the subject12may be unable to roll to his/her left without causing the hose34to pull the base unit32off of a nightstand; or, if the base unit is on the floor, then the subject rolling to his/her left may cause the hose34to become taught and, therefore, to dislodge the mask40from the subject's face and break the seal44. Furthermore, the subject12may be unable to sleep on his/her side without the pillow dislodging the mask40from the subject's face and breaking the seal44. Moreover, the force with which the straps42must hold the mask40against the face of the subject12to form an airtight seal may cause discomfort to the subject. In addition, the CPAP machine30may prove inconvenient for travel, because, for example, when carrying the machine aboard an airplane, the subject12must separate at least the base unit32from other items while going through security, and the dimensions of the base unit may make it difficult for carrying in a briefcase or overnight bag.

FIG. 3is a diagram of a neck50and a jaw52of a subject12, and of a throat54of the neck.

Referring toFIG. 3, applying a negative pressure (i.e., suction or a vacuum) to one or more regions of the neck50and/or the jaw52of the subject12can treat obstructive sleep apnea non-invasively. For example applying a negative pressure to an underside56of the jaw52, or to a region58, such as the mylohyoideus, of the throat54beneath the jaw, while the subject12is sleeping can assist to position the subject's jaw, tongue16(FIG. 1), or one or more other biological structures of the subject so as to open, and to maintain open, the subject's airway14(FIG. 1). In another example, applying a negative pressure to one or more portions of a throat region60(which is below the throat region58, above the sternal head62and clavicle64, and between the sternocleidomastoid muscles66) while the subject12is sleeping can also position one or more biological structures of the subject12so as to open, and to maintain open, the subject's airway14. In yet another example, applying a negative pressure to a region of the throat54between the anterior belly of Digastricus55, the thyroid cartilage (i.e., Adam's apple)57, and the sternocleidomastoid muscles66while the subject12is sleeping can also position one or more biological structures of the subject12so as to open, and to maintain open, the subject's airway14. In still another example, applying a negative pressure to a region of the throat54between the anterior belly of Digastricus55, the hyoid bone59, and the sternocleidomastoid muscles66while the subject12is sleeping can also position one or more biological structures of the subject12so as to open, and to maintain open, the subject's airway14.

FIG. 4is a diagram of a subject12using a negative-pressure sleep-apnea-treatment system70, which is configured to treat obstructive sleep apnea, according to an embodiment. As described below in conjunction withFIGS. 5-22, the system70is self-contained, and is configured to open, and to maintain open, the subject's airway14(FIG. 1) during sleep by applying and maintaining a negative pressure to one or more regions of the subject's neck50, jaw52, or throat54. As used above and hereinafter, “self-contained” means that the system70is configured to treat obstructive sleep apnea by itself. As compared to a CPAP machine such as the CPAP machine30ofFIG. 2, the system70can allow the subject12more freedom of movement because it is not tethered to any other item or location, can be more comfortable because it is worn around the neck and not over the face, and can be more suitable for travel because it can have fewer pieces, can be smaller, and can be foldable.

The negative-pressure sleep-apnea-treatment system70includes a collar assembly72and a component module74, which is configured to be secured to the collar.

The collar assembly72includes a collar76and fasteners (not visible inFIG. 4), such as straps, snaps, buttons, or Velcro® strips, that are configured to secure the collar to the subject's neck50such that the collar forms an airtight seal around the one or more regions of the subject's neck, jaw52, or throat54to which the system70is configured to apply a negative pressure. The collar76may be partially or fully flexible, may be formed from one or more suitable materials such as cloth, foam, metal, or plastic, and the collar or the fasteners may be configured to allow adjustment of the interior dimensions of the collar assembly72such that the assembly can fit subjects having a variety of neck circumferences, lengths, and shapes. The collar assembly72is further described below in conjunction withFIGS. 5-7.

And the module74is configured to include one or more components of the system70other than the collar assembly72. For example, the module74can include an air pump, motor, power supply, pressure, airway, and other sensors, and a controller circuit such as a microprocessor or microcontroller. The module74is further described below in conjunction withFIG. 8.

Still referring toFIG. 4, alternate embodiments of the negative-pressure sleep-apnea-treatment system70are contemplated. For example, instead of being flexible, the collar76may include two or more rigid portions that are hinged together such that these portions are configured to open and receive the subject's neck50, and then to close and attach around the neck. Furthermore, not all of the system components other than the collar assembly72may be disposed within the module74. For example, some or all of these other components can be secured to the outside of the collar76or the outsides of the fasteners, can be secured to the inside of the collar or the insides of the fasteners, or can be disposed inside of the collar76or fasteners. Moreover, the module74and collar76may have any suitable shapes other than those shown inFIG. 4.

FIG. 5is a view of the negative-pressure sleep-apnea-treatment system70ofFIG. 4, according to an embodiment.

The collar76is a single, flexible piece that is configured to fully surround the subject's neck50(FIG. 4) while the subject wears the system70, and the Velcro® fasteners78are adjustable so that the system70can fit a variety of neck sizes and shapes.

The system70also includes an AC adapter/charger90, which is configured to couple to a receptacle92of the component module74, and to power the system while the system is operating or to charge a battery (not shown inFIG. 5) of the system while the system is or is not operating. Alternatively, the receptacle92may be configured for coupling to a power cord that is configured for coupling to a standard power outlet (e.g., 110 VAC 220 VAC).

Furthermore, the system70includes one or more sealing surfaces94, which are configured to form respective airtight seals with respective opposing regions of the subject's neck50, and includes one or more vacuum surfaces96, which are bounded by the sealing surfaces94and which are configured to sit opposite the regions of the subject's neck50(FIG. 4), jaw52(FIG. 4), or throat54(FIG. 4) to which the system applies a negative pressure. The one or more sealing surfaces94and the one or more vacuum surfaces96are further described below in conjunction withFIGS. 14-21.

Moreover, the component module74includes an input-output device98, a power-switch assembly100, and an air-outlet assembly102. The input-output device98is, for example, a touch screen that allows the subject12(FIG. 4) to program, or otherwise to control, the system70, and to receive information, such as status information and confirmation of programming, from the system70. For example, the input-output device can be configured to allow the subject12to set the magnitude of the negative pressure, or of a maximum threshold thereof, and to allow the subject to set a wake-up time in anticipation of which the system70can adjust settings (e.g., the magnitude of the negative pressure) to gently awaken the subject. Alternatively, the input-output device98may include separate input (e.g., a keypad) and output (e.g., a display, a touchscreen display) devices. The power-switch assembly100is, for example, any suitable assembly (e.g., a toggle switch or a tactile slide switch displayed by a touchscreen) that allows the subject12(FIG. 4) to turn the system70“on” or “off.” And the air-outlet assembly102provides an outlet for the air that the system70sucks from between the collar76and the subject's neck50(FIG. 4), jaw52(FIG. 4), or throat54(FIG. 4) to create one or more regions of negative pressure between the collar and the neck, jaw, or throat.

FIG. 6is a view of the negative-pressure sleep-apnea-treatment system70ofFIG. 4, according to yet another embodiment. The system70ofFIG. 6is similar to the system70ofFIG. 5, except that the collar76is configured to surround the subject's neck50(FIG. 4) only partially when he/she wears the system, and the adjustable Velcro® fasteners78ofFIG. 6are longer than the fasteners78ofFIG. 5to compensate for the reduced length of the collar.

FIG. 7is a view of the negative-pressure sleep-apnea-treatment system70ofFIG. 4, according to still another embodiment. The system70ofFIG. 7is similar to the systems70ofFIGS. 5-6, except that the collar76includes a portion104, which is configured for positioning under the jaw52(FIG. 4) of the subject12(FIG. 4), and the system also includes a collar support106. The collar76is configured to surround the neck50(FIG. 4) of the subject12(FIG. 4) only partially, and includes the portion104, which is configured to allow for the application of negative pressure beneath the subject's jaw52(FIG. 4) or chin26(FIG. 1). And the collar support106, which can take the place of, or be in addition to, the fasteners78ofFIGS. 5 and 6, is configured to fit over the shoulders (not shown inFIG. 7) of the subject12. The support106can be made of any suitable material that is flexible, rigid, or semi-rigid, and can have a design that affords the subject12freedom of movement while sleeping. And although not shown inFIG. 7, the system70ofFIG. 7may include one or more of the AC adapter90, adapter receptacle92, sealing surfaces94, and vacuum surface96, or any suitable alternatives thereof.

Referring toFIGS. 4-7, alternate embodiments of the sleep-apnea-treatment system70are contemplated. For example, the position of the component module74relative to the collar assembly72can be different than described. Furthermore, the positions of the input-output device98, power switch100, and air outlet102relative to the component module74may be different than described. Moreover, the collars76ofFIGS. 4-6may have chin or jaw portions that perform the same function as the portion104ofFIG. 7. In addition, the system70may be modified any suitable manner.

FIG. 8is a block diagram of the component module74ofFIGS. 4-7, according to an embodiment. In addition to the power receptacle92, the input-output device98, the power-switch assembly100, and the air-outlet assembly102, the component module74includes the following components: a power source such as a battery110, an auxiliary power source112, a power supply114, a motor assembly116, a pump assembly118, a pressure-regulator assembly120, a valve assembly122, a sealant-dispenser assembly124, a pressure-sensor assembly126, an apnea-degree-sensor assembly128, a memory130, a temperature-control assembly132, a controller134, and a bus136. The module74may also include a package (not shown inFIG. 8) that houses these components. For example, the package may be formed from an epoxy resin and may be sealed to protect, or to prevent access to, the housed components, or may include a structure that allows access to one or more of the housed components for, e.g., repair or replacement. Furthermore, in addition to the power receptacle92, the component module74may include other suitable receptacles or connectors that allow, e.g., airflow between the pressure-regulator assembly120, the valve assembly122, and the collar76(FIGS. 4-7), sealant flow between the dispenser assembly124and the collar, and signal communication to or from the sensor assemblies126and128.

The power receptacle92is configured to receive a DC power signal, via the power-switch assembly100, from, e.g., the AC adapter90(FIGS. 5-6), or is configured to receive an AC power signal from, e.g., a standard power outlet (e.g., 110 VAC, 220 VAC).

The input-output device98is configured to receive data from, e.g., the subject12(FIG. 4), a sleep technician, or a sleep doctor, and to provide data to the subject, the technician, or the doctor. For example, the device98can be a touch screen that allows one to input data, and that displays data. Alternately, the device98may include a separate input device138, such as a keypad or card reader, and a separate output device140, such as a display screen or card writer. Examples of data that one may input to the component module74via the device98include program instructions for the controller134, and system-configuration and system-operating parameters such as pressure and temperature ranges and threshold levels.

The battery110is configured to store energy for powering the components of the component module74, and for powering the negative-pressure sleep-apnea-treatment system70(FIGS. 4-7) in general. The battery110can be any suitable type of battery, such as a nickel-cadmium battery, a lithium-ion battery, or an alkaline battery, can produce any suitable output voltage (e.g., in a range of 5-25 VDC), and can be one-time usable or rechargeable. Furthermore, the battery110can include more than one battery or battery cell coupled together in electrical series, electrical parallel, or both electrical series and electrical parallel. Moreover, the battery110can provide an alarm (e.g., an alarm signal) to, e.g., the controller134or the input-output device98, when the magnitude of the charge or voltage that the battery stores reduce to or below a low-charge threshold; alternatively, another component, e.g., the controller134, can monitor the battery charge or voltage and generate such an alarm. In addition, the component module74may include a receptacle to hold the battery110.

The auxiliary power source112is configured to generate energy for powering the components of the component module74, and for powering the negative-pressure sleep-apnea-treatment system70(FIGS. 4-7) in general. For example, the auxiliary power source112can include a spring and a manual winding mechanism that the subject12(FIG. 4) can turn to wind the spring so as to store energy in the wound spring; as it unwinds, the spring is configured to drive an electrical generator (also included in the auxiliary power source) that is configured to generate a power signal. Or, the auxiliary power source112can include an automatic winding mechanism that winds the spring in response to movement of the auxiliary power source, such as when the subject12moves while wearing the system70; such an automatic winding mechanism can be similar to a conventional mechanism used to wind a spring in a self-winding watch. Alternatively, the auxiliary power source112can include a mechanism for automatically driving an electrical generator in response to movement of the auxiliary power source; such a mechanism can be similar to a conventional mechanism used to drive an electrical generator in a self-powered watch. The auxiliary power source112can be configured to provide the power signal generated by the electrical generator directly to the power supply114, or can be configured to charge the battery110, or another battery that is part of the auxiliary power source, with the generated power signal.

The power supply114is configured to receive power from one or more of the receptacle92(via the power-switch assembly100), the battery110, and the auxiliary power source112, and to convert this power into one or more currents and voltages that are suitable for powering itself, the other components of the module74, and any other components of the system70(FIGS. 4-7). For example, the power supply114can be configured to sense a power signal at the receptacle92, and to convert this sensed signal into one or more DC power signals having respective DC voltages. Furthermore, the power supply114can be configured to charge the battery110(and any battery in the auxiliary power source112) while the power supply is receiving a power signal from the receptacle92. The power supply114also can be configured such that if it does not sense a power signal at the receptacle92, then it converts a power signal from the auxiliary power source112into the one or more DC power signals, and uses any excess power (i.e., a level of power above what is needed to power the components of the sleep-apnea-treatment system70) from the auxiliary power source to charge the battery110(and any battery in the auxiliary power source112). Further, the power supply114can be configured such that if it does not sense a power signal at the receptacle92and it senses that the power from the auxiliary power source112is insufficient to meet the power demands of the system70, then it converts a power signal from the battery110into the one or more DC power signals, and uses any power from the auxiliary power source to charge the battery. The power supply114can be, or can include, any suitable type of power supply, for example, a DC-DC converter such as a buck converter, a boost converter, or a buck-boost converter.

The motor assembly116includes one or more motors that are configured to convert electrical energy in the form of a power signal from the power supply114into mechanical energy for driving one or more pumps of the pump assembly118. For example, the motor assembly116may include any suitable electrical motor such as a DC motor, a brushless DC motor, a brushed AC synchronous motor, or an induction motor. Furthermore, the motor assembly116may include a motor-controller circuit for converting the power signal from the power supply114into one or more suitable signals for driving, commutating, and otherwise controlling, the one or more motors. Moreover, the motor assembly116can include one or more structures that are configured for cooling the one or more motors, arresting, or otherwise compensating for, vibrations generated by the one or more motors, or muffling sounds generated by the one or more motors so that the motor assembly does not disturb the subject12(FIG. 4) while he/she is sleeping.

The pump assembly118includes a main pump142, which is configured to generate a respective negative pressure within each pressure region—a pressure region is further described below in conjunction withFIGS. 14-21—between the collar76(FIGS. 4-7) and the neck50(FIG. 4) of the subject12(FIG. 4) while being driven by the motor assembly116, and includes an auxiliary pump144, which is configured to operate independently of the motor assembly. For example, the pump assembly118can be mechanically coupled to the motor assembly116with, e.g., one or more shafts and transmissions. The main pump142can be any suitable fluid pump or compressor, such as an impeller pump or a piston pump. And, like the main pump142, the auxiliary pump144can be any suitable fluid pump or compressor, such as an impeller pump or a piston pump; but unlike the main pump, the auxiliary pump is configured to be drivable independently of the motor assembly116. For example, the auxiliary pump144can include, and can be drivable by, a manual- or self-winding spring mechanism that can be similar to the spring mechanism described above in conjunction with the auxiliary power source112. Or, the auxiliary pump144can include, and can be drivable by, a self-electrical-generator mechanism that can be similar to the self-electrical-generator mechanism described above in conjunction with the auxiliary power source112.

The pump assembly118is configured to engage the main pump142while the power supply114is providing enough power to operate the motor assembly116, and to engage the auxiliary pump144, alone or together with the main pump, while the power supply is not providing enough power to operate the motor assembly. Consequently, the pump assembly118is configured to generate a negative pressure even in the absence of power from the supply114.

The air that the pump assembly118pumps from the pressure regions between the collar76(FIGS. 4-7) and the subject's neck50(FIG. 4) to create the respective negative pressures exits the pump assembly via the air outlet102.

Furthermore, although described as including a single main pump142and a single auxiliary pump144, the pump assembly118may include multiple main pumps or multiple auxiliary pumps.

In addition, to reduce the magnitude of a negative pressure within a pressure region faster than such reduction would occur by only deactivating the main and auxiliary pumps142and144, the pump assembly118can include one or more pumps that pump air into the pressure region. Or, the motor assembly116or pump assembly118can be configured to drive one or more of the main pumps142and auxiliary pumps144in reverse to pump air into the pressure region to more quickly reduce the magnitude of the negative pressure within the pressure region.

The pressure-regulator assembly120and the valve assembly122are configured to cooperate to provide a respective negative pressure to each of one or more pressure regions between the neck50(FIG. 4) of the subject12(FIG. 4) and the collar76(FIG. 4), and to regulate these one or more pressures. The valve assembly122includes one or more valves that are configured to direct one or more negative pressures to one or more respective pressure regions between the collar76(FIGS. 4-7) and the neck50(FIG. 4), and the pressure-regulator assembly120includes one or more pressure regulators coupled to the valves and configured to regulate these one or more negative pressures to respective pressure levels. For example, the one or more valves can each be one-way valves that allow air to flow from the collar76toward the pump assembly118. And the one or more pressure regulators can each be mechanical, open-loop regulators that bypass any air drawn by the pump assembly118in excess of the level of drawn air needed to maintain each of the one or more negative pressures at a respective level. Or, each pressure regulator can employ feedback to the pump assembly118or the motor assembly116, either directly or via the controller134, to regulate the respective pressures by controlling the pumping power. Furthermore, the one or more pressure regulators and one or more valves can be coupled to each other and to the pressure regions between the collar76and the neck50via a suitable network of hoses and couplings, which can be part of one or both of regulator and valve assemblies120and122, or which can be separate from these assemblies. Moreover, a pressure regulator of the regulator assembly120can be configured to detect an air leak in a pressure region between the collar76and the neck50, and to instruct the sealant dispenser124, directly or via the controller134, to dispense a sealant in the vicinity of the air leak in an effort to seal the leak. In addition, one or more of the pressure regulators can each be configured to limit the magnitude of the negative pressure in a respective pressure region to a threshold pressure level that has been determined to be approximately the maximum safe limit for the subject12. Furthermore, the regulator and valve assemblies120and122may form part, or all, of a rapid-re-pressurization assembly that is configured to quickly remove the application of negative pressure to the neck50of the subject12by rapidly increasing the pressure within one or more of the pressure chambers. This rapid re-pressurization may serve to prevent discomfort or injury to the subject12, and may be manually activated by the subject (e.g., by an emergency or panic button or a voice command) or may be triggered by a sensor in response to, e.g., detecting respiratory-distress sounds abnormal heart activity, or a low blood-oxygen level). And this rapid re-pressurization can include stopping one or more of the pumps of the pump assembly118, opening a valve (e.g., an emergency valve) or breaking a seal between the neck50and one or more sealing surfaces94to allow ambient air to enter the one or more of the pressure regions, or taking one or more similar actions.

The sealant-dispenser assembly124includes a sealant reservoir146, and is configured to dispense a sealant from the reservoir to, or near, one or more sealing surfaces94(FIGS. 5-6 and 14-15) for the purpose of facilitating, fortifying, and/or repairing an airtight seal between a sealing surface and the neck50(FIG. 4) of the subject12(FIG. 4). For example, the dispenser assembly124can include on or more sealant pumps that can be similar to one or both of the pumps142and144of the pump assembly118. Furthermore, the dispenser assembly124can include one or more pumps or other structures configured to pressurize the reservoir146, to apply force to (e.g., squeeze) the reservoir, to push the sealant from the reservoir via a piston, or to take one or more similar actions, so as to transport the sealant from the reservoir. Moreover, the dispenser assembly124can be coupled to the reservoir146and to the collar76via a suitable network of hoses, couplings, and ejection nozzles; these components may be part of, or separate from, the dispenser assembly.

The sealant held in the reservoir146can be any suitable substance such as a liquid, gel, cream, or foam that forms a flexible or rigid seal and that does not irritate the subject's skin; examples of such gels include silicone-based gels. Furthermore, the sealant can be configured to form a second seal separate from the seal formed by the sealing surfaces94(FIGS. 5-6).

For example, if a pressure regulator of the assembly120, or a pressure sensor of the assembly126, senses a leak in one of the pressure regions (described below in conjunction withFIGS. 14-21), then the pressure regulator can instruct the dispenser assembly124, directly or via the controller134, to dispense the sealant held in the reservoir146at or near one or more of the sealing surfaces94(FIGS. 5-6 and 14-15) that border the pressure region. For example, the pressure regulator can be configured to instruct the dispenser assembly124to dispense the sealant successively via each sealant-dispense nozzle (e.g., described below in conjunction withFIG. 15) near the one or more sealing surfaces94that border the pressure region until the pressure regulator detects that the leak has slowed or stopped. The controller134, pressure-regulator assembly120, or another one or more components of the component module74, can be configured to detect a leak in a pressure region in one or more of the following manners: determining that the speed of a pump within the pump assembly118exceeds a threshold level, determining that the energy consumed, or the heat generated, by the pump assembly118exceeds a threshold level, determining that the airflow level through the pump assembly exceeds a flow or leak threshold, or by detecting a space between a sealing surface94and portion of the subject's neck50(FIG. 4) opposite the sealing surface.

The pressure-sensor assembly126is configured to generate, and to provide to the controller134, a respective indication (e.g., a feedback signal) of the pressure in each of the one or more pressure regions formed between the collar76(FIG. 4) and the neck50(FIG. 4) of the subject12(FIG. 4). For example, the pressure-sensor assembly126can include a respective pressure sensor (e.g., a piezoelectric vacuum sensor) in each pressure region, or in an air hose coupled to each pressure region. In response to these pressure indications, the controller134can be configured to control the pump assembly118, the pressure-regulator assembly120, or the valve assembly122to maintain the pressure in each pressure region at a respective programmed, or otherwise set, level. Furthermore, if the controller134determines that there is a leak in one of the pressure chambers, then the controller can be configured to control the sealant-dispenser assembly124to dispense a sealant as described above in an attempt to seal the leak. Moreover, if the controller134determines that a pressure in a pressure region has exceeded a threshold pressure level, such as a safety threshold pressure level, then the controller can control the pump assembly118, the pressure-regulator assembly120, or the valve assembly122to maintain the pressure within the pressure region at or below the safety threshold pressure level. In addition, in response to the one or more pressure indications from the pressure-sensor assembly126, the controller134can implement a peristalsis procedure as described below in conjunction withFIGS. 16-18. In other words, the pump assembly118, the pressure-regulator assembly120, the valve assembly122, the pressure-sensor assembly124, and the controller134form at least part of a feedback loop for maintaining the respective pressure within each of the one or more pressure regions within a respective programmed, or otherwise set, range; alternatively, at least the controller134can be omitted from this feedback loop. Furthermore, the pressure-sensor assembly126can be configured to perform at least some of the functions of the pressure-regulator assembly120, and, therefore, can be configured to provide redundancy for these functions. Alternatively, the pressure-sensor assembly126can be configured to perform some pressure-related functions, and the pressure-regulator assembly120can be configured to perform other pressure-related functions; for example, the pressure-regulator assembly120can be configured to prevent the magnitude of the pressure within any pressure region from exceeding a safety threshold pressure level, and the pressure-sensor assembly126can be configured to perform all other pressure-related sensing functions.

The apnea-degree-sensor assembly128is configured to generate, and to provide to the controller134, an indication of the degree of sleep apnea being experienced by the subject12(FIG. 4) while he/she is sleeping. For example, the apnea-degree-sensor assembly128can include one or more sensors that are configured to generate an indication of the degree to which the subject's airway14(FIG. 1) is open. In response to this indication, the controller134is configured to control the pump assembly118or the pressure-regulator assembly120to change the pressure in at least one pressure region in a manner that lessens the degree of sleep apnea being experienced by the subject12. For example, if the apnea-degree-sensor assembly128indicates that the degree to which a subject's airway14is open is below a target range, then the controller134is configured to control the pump assembly118or the pressure-regulator assembly120to change (e.g., increase) the magnitude of the negative pressure within at least one pressure region so as to increase the degree to which the subject's airway is open in an effort to drive the degree of airway openness into the target range—increasing the degree to which the subject's airway is open can mean, for example, increasing the cross-sectional area of the airway at the location at which it is, or would otherwise become, blocked. In contrast, if the apnea-degree-sensor assembly128indicates that the degree to which the subject's airway14is open is above the target range, then the controller134is configured to control the pump assembly118or the pressure-regulator assembly120to change (e.g., decrease) the magnitude of the negative pressure within at least one pressure region so as to decrease the degree to which the subject's airway is open in an effort to drive the degree of airway openness into the target range. That is, the pump assembly118, the pressure-regulator assembly120, the valve assembly122, the apnea-degree-sensor assembly128, and the controller134form at least part of a feedback loop for maintaining the degree to which the subject's airway14is open within a programmed, or otherwise set, target range so as to reduce (e.g., to zero) the degree of apnea experienced by the subject12; alternatively, at least the controller134may be omitted from this feedback loop. The apnea-degree-sensor assembly128is further described below in conjunction withFIGS. 9-13.

The memory130can be any suitable type of volatile (e.g., DRAM, SRAM) or nonvolatile (e.g., EPROM, EEPROM, FLASH) memory circuit, is configured to store program instructions that the controller134is configured to execute, and is configured to store other software, firmware, and data for the system70. For example, the memory130can be configured to store one or more safety threshold levels, or other threshold levels, for each pressure chamber, to store one or more apnea-degree target ranges, and to store one more configuration or operation parameters for the negative-pressure sleep-apnea system70(FIGS. 4-7). Furthermore, the memory130can be configured to include a look-up table (LUT)148, which is configured to correlate a signal level received from the apnea-degree-sensor assembly128with a degree of apnea (e.g., a degree to which the subject's airway14(FIG. 1) is open) as further described below in conjunction withFIG. 13; the memory can also be configured to store a representation of a curve that correlates the signal level from the apnea-degree-sensor assembly with a degree of sleep apnea.

The temperature-control assembly132is configured to control the respective temperature of the one or more pressure regions between the collar76(FIGS. 4-7) and the subject's neck50(FIG. 4), for example, for the comfort of the subject12(FIG. 4) or to reduce the degree of an airway obstruction, or to eliminate an airway obstruction, that a subject experiences during a sleep-apnea event. The assembly132can be configured to be coupled to one or more heating elements (e.g., resistive heating elements) and cooling elements (e.g., thermoelectric cooling elements) that are strategically placed around the collar76(e.g., inside or on a surface of the collar), and can be configured to be coupled to one or more temperature sensors also so strategically placed; the heating elements, cooling elements, and temperature sensors may be included in the temperature-control assembly, or may be separate from the temperature-control assembly. In response to an indication (e.g., a temperature signal) from one such temperature sensor, the temperature-control assembly132can be configured to adjust the temperature in a corresponding pressure region to be within a programmed, or an otherwise set, temperature range. Alternatively, the assembly132can be configured to provide the respective indication of temperature for each pressure region to the controller134, which can be configured to control the heating and cooling elements to maintain the temperature within each of the pressure regions within a respective temperature range. Furthermore, the temperature-control assembly132can be coupled to valves that are strategically placed around the collar76to vent the one or more pressure regions to the ambient air to help control the respective level of humidity, or the temperature, within each pressure chamber; these valves may form part of the temperature-control assembly or the valve assembly122, or may be separate from these assemblies. Such valves are further described below in conjunction withFIGS. 14-22. Moreover, the controller134can be configured to adjust the temperature within one or more of the pressure regions to reduce a degree of sleep apnea experienced by the subject. For example, cooling the air or skin in one or more of the pressure regions can cause the subject's airway muscles to tense, which in turn can open the subject's airway. The controller134can be configured to implement a feedback loop that adjusts the temperature within one or more of the pressure regions to open, and to maintain open, the subject's airway. This loop can be independent of, or combined with, a feedback loop that the controller134is configured to implement by adjusting the negative pressure within one or more of the pressure regions to open, and to maintain open, the subject's airway with the smallest magnitude of negative pressure possible. Where these feedback loops are independent, then the controller134has at least two variables, pressure and temperature, that it can adjust to open, and maintain open, the subject's airway. The controller134and temperature-control assembly132can also be configured such that the controller134can adjust the temperatures of regions other than the pressure regions to reduce a degree of sleep apnea experienced by the subject. For example, the controller134can be configured to adjust the temperature of one or more regions of a subject's neck outside of the pressure regions to reduce a degree of sleep apnea experienced by the subject. In an embodiment, the device can be at a low or “off” pump position unless or until a sleep apnea event is detected, at which point the device pump is triggered “on” or higher power. In an embodiment, the device can have a continuous setting regardless of any sensed sleep apnea events or sleep disturbances.

The controller134can include a processor, microprocessor, microcontroller, or any other suitable instruction-executing or non-instruction-executing computing machine and computing circuitry, is configured to control the components of the component module74as described above, and can also be configured to control one or more other components of the sleep-apnea system70(FIGS. 4-7) in general. The controller134can be configured to execute program instructions that are stored in the memory130, and to use the memory as working memory when performing calculations or otherwise making determinations.

For example, the controller134can be configured to operate the sleep-apnea system70in a constant-pressure mode. While in this mode, the controller134is configured to activate the motor assembly116and the pump assembly118, and then to deactivate the motor assembly and pump assembly in response to one or more pressure sensors of the pressure-sensor assembly126indicating that the magnitude of the pressure in one or more pressure regions is at or above a respective first threshold. Next, in response to the one or more pressure sensors of the pressure-sensor assembly126indicating that the magnitude of the pressure in one or more of the pressure regions is at or below a respective second threshold, the controller134can activate the motor assembly116and the pump assembly118, and can repeat this cycle as often as needed (each of the second thresholds can be lower than the corresponding first threshold to provide hysteresis). In response to one or more sensors of the apnea-degree sensor assembly128detecting that the subject12(FIG. 4) is experiencing an apnea event, e.g., an airway obstruction, the controller134can be configured to increase the first thresholds, or the first and second thresholds, to levels that arrest the apnea event, e.g., remove the obstruction from the airway. Alternatively, the controller134can be configured to maintain the negative pressure in the one or more pressure regions inclusively between the first pressure thresholds and the respective second pressure thresholds regardless of whether the subject12experiences a sleep-apnea event.

Furthermore, the controller134can be configured to operate the sleep-apnea system70in an off-until-apnea-detected mode. While in this mode, the controller134is configured to deactivate the motor assembly116and the pump assembly118until one or more sensors of the apnea-degree sensor assembly128indicates that the subject12(FIG.4) is experiencing a sleep-apnea event. Then, in response to the one or more sensors detecting a sleep-apnea event, the controller134is configured to activate the motor assembly116and the pump assembly118until one or more sensors of the assembly128indicates that the subject is no longer experiencing the sleep-apnea event. Next, the controller deactivates the motor assembly116and the pump assembly118until the one or more sensors of the assembly128detect a next sleep-apnea event. The controller134also can be configured to deactivate the motor assembly116and the pump assembly118if the negative pressure in one or more pressure regions is greater than or equal to a respective first maximum-pressure threshold, regardless of whether the subject12is still experiencing the apnea event, and can be configured to reactivate the motor assembly116and the pump assembly118in response to the negative pressures in all of the pressure regions being less than or equal to respective second maximum-pressure thresholds that are less than the corresponding first maximum-pressure thresholds.

Moreover, the controller134can be configured to operate the sleep-apnea system70in a low-high mode. While in this mode, the controller134is configured to activate the motor assembly116and the pump assembly118until one or more sensors of the pressure-degree sensor assembly126indicate that the magnitude of the negative pressure within one or more pressure regions is, inclusively, between a first (higher) and a second (lower) threshold. Then, in response to one or more sensors of the apnea-degree sensor assembly128detecting that the subject12(FIG. 4) is experiencing a sleep-apnea event, the controller134is configured to activate the motor assembly116and the pump assembly118until one or more sensors of the pressure-degree sensor assembly126indicate that the magnitude of the negative pressure within one or more pressure regions is greater than or equal to the respective first pressure threshold, which is higher than the respective second pressure threshold. Next, in response to one or more sensors of the sleep-apnea sensor assembly128detecting that the subject12is no longer experiencing the previously detected sleep-apnea event, the controller134is configured to deactivate the motor assembly116and the pump assembly118, or otherwise to reduce their outputs, until the one or more sensors of the pressure-sensor assembly126indicate that the negative pressure within the one or more pressure regions are each inclusively between the corresponding first threshold and second threshold. The controller134can repeat the above cycle in response to one or more sensors of the apnea-degree sensor assembly128detecting that the subject12is experiencing another sleep-apnea event.

Furthermore, the controller134can be configured to change (e.g., reduce) the magnitude of the pressure within each of one or more pressure regions at a set time (e.g., ½ hour, or another set time, before a wakeup time that one has programmed into the system70via the input device88), or in response to an increase in ambient light (e.g., as an indication that it is morning), to assist the subject12(FIG. 4) in awakening, or to change (e.g., reduce) the pressure magnitude in response to an indication from the apnea-level-degree sensor assembly128that the subject is awakening. For example, the controller134can be programmed, or otherwise configured, to begin changing the respective pressure within each of one or more pressure regions at a settable start time, and to control the one or more pressures according to a settable pressure profile for a settable duration that ends at a settable stop time, where the pressure profile can include changing the one or more pressures linearly, or otherwise monotonically, over the settable duration, and where the pressure profile may be common to the one or more pressure regions, or where there may be multiple pressure profiles each associated with a respective group of the one or more pressure regions. As used herein, a “profile” is a plot, or a representation of a plot, of a quantity, such as pressure, over time. And the quantity can have units of, e.g., magnitude, phase, concentration, change in magnitude, change in phase, and change in concentration. Furthermore, a “profile” can include parameters for usage or function of the sleep-apnea system70itself, or can include sleep characteristics of the subject12(FIG. 4), or other parameters related to the subject, such as identification of the subject, the subject's diet, and the subject's exercise regime. Alternatively, instead of a settable stop time, the controller134may stop changing the one or more pressures individually when each of the one or more pressures exceeds a stop threshold, or may stop changing the one or more pressures at about the same time when any one of the one or more pressures exceeds the stop threshold. And, if after the duration of this wake-up procedure the controller134determines that the subject12(FIG. 4) is still asleep, then the controller can return to treating the subject's sleep apnea in the manner described above. Furthermore, although this wake-up procedure is described in conjunction with the system70, which generates one or more negative pressures for treating sleep apnea, this wake-up procedure can be modified for a system, such as a CPAP system, that generates one or more positive pressures for treating sleep apnea. Moreover, the controller134can implement this procedure for a reason other than waking the subject12.

Still referring toFIG. 8, alternate embodiments of the component module74are contemplated. For example, the module74may omit any one or more of the above-described components, or may include one or more other components. Furthermore, one or more of the above-described functions may be performed by one or more components other than the one or more components to which the operation is attributed. Moreover, at least the controller134may be implemented in software, firmware, hardware, or a combination or sub-combination of any of software, firmware, and hardware.

FIG. 9is a diagram of a portion of the apnea-degree-sensor assembly128ofFIG. 8, and a cross section of the neck50(FIG. 4) and airway14(FIG. 1) of the subject12(FIG. 4), according to an embodiment; although the neck is shown as having a circular cross section and the airway is shown as having a circular cross section, the neck and airway may each have a respective other cross section.

The sensor assembly128includes an energy-wave transmitter-receiver160, which is configured to transmit an energy wave toward the neck50and airway14, to receive portions of the transmitted energy wave redirected (e.g., reflected) by regions of the surface162of a wall of the airway, and to determine the degree to which the airway is open in response to the received portions of the energy wave, or to provide information related to the received portions of the energy wave to the controller134so that the controller can determine the degree to which the airway is open. Alternatively, the sensor assembly128can determine the degree to which the airway14is collapsed, or provide information so that the controller134can determine the degree to which the airway is collapsed. For example, the sensor assembly128, or the controller134, can use the received redirected portions of the energy wave to determine a dimension D of the airway14, with the value of D corresponding to the degree to which the airway is open (or collapsed). That is, the larger the value of D, the higher the degree to which the airway14is open (the lower the degree to which the airway is collapsed), and the smaller the value of D, the lower the degree to which the airway is open (the higher the degree to which the airway is collapsed)—hereinafter, only determining the degree to which the airway is open is described, it being understood that the corresponding description can also apply to determining the degree to which the airway is collapsed. Alternatively, the sensor assembly128, or the controller134, can use the received redirected portions of the energy wave to determine more than one dimension of the airway14, or to acquire an image of the airway and to determine one or more airway dimensions from the acquired image. For example, in an embodiment, the sensor assembly128, or the controller134, is configured to determine one or more dimensions of the airway14, and to determine a cross-sectional area of the airway in response to at least one of the determined one or more dimensions of the airway, and the controller is configured to determine the degree to which the airway is open in response to the determined cross-sectional area of the airway.

The transmitter-receiver160can be configured to transmit any suitable type of energy wave that the surface162of the airway14at least partially redirects. For example, the transmitter-receiver160can be configured to transmit an acoustic ultrasound wave such as used in conventional ultrasound machines, or a micro-impulse-radar wave. Furthermore, the transmitter-receiver160can be configured to transmit a continuous energy wave, a pulsed energy wave, or any other suitable type of energy wave.

The transmitter-receiver160can include multiple transmitters and receivers so as to obtain an “image” of an entire cross section of the airway14, or can include fewer, or one, transmitter that the sensor assembly128sweeps so as to cover an entire cross section of the airway, and fewer, or one, receiver that the sensor assembly sweeps in a similar manner, where the sensor assembly may sweep the transmitter or receiver mechanically or electronically (e.g., as in beam forming with a phased-array radar). If the transmitter-receiver160includes multiple transmitters or receivers, then these may be strategically located at various locations inside, or on a surface of, the collar76(FIGS. 4-7), or within the component module74(FIGS. 4-8). An example of a suitable transmitter and a suitable receiver includes a transducer, e.g., a piezoelectric transducer, that can operate as a transmitter at one time and a receiver at another time.

The sensor assembly128, or the controller134, is configured to determine the dimension D of the airway14by analyzing one or more of the time delay (e.g., relative to the time of wave transmission), the phase (e.g., relative to the transmitted phase), the frequency spectrum (e.g., relative to the frequency spectrum of the transmitted wave), the wave shape (e.g., relative to the wave shape of the transmitted wave), the power (e.g., relative to the transmitted power), and the amplitude (e.g., relative to the amplitude of the transmitted wave) of each of one or more of the received redirected portions of the energy wave in any suitable manner, such as, for example, in the manner in which an ultrasound machine analyzes received redirected portions of transmitted acoustic waves that are redirected by internal tissues of a subject.

FIG. 10is a diagram of a portion of the apnea-degree-sensor assembly128ofFIG. 8, and a cross section of the neck50(FIG. 4) and airway14(FIG. 1) of the subject12(FIG. 4), according to another embodiment; although the neck is shown as having a circular cross section and the airway is shown as having a circular cross section, the neck and airway may each have a respective other cross section.

The sensor assembly128includes an energy-wave transmitter164, which is configured to transmit an energy wave toward the airway14, and an energy-wave receiver166, which is configured to receive one or more portions of the transmitted energy wave that penetrate the neck50and airway14, and is configured to determine the degree to which the airway is open in response to the received portions of the energy wave, or to provide information related to the received portions of the energy wave to the controller134so that the controller can determine the degree to which the airway is open. For example, the sensor assembly128, or the controller134, can use the received portions of the energy wave to determine a dimension D of the airway14, with the value of D corresponding to the degree to which the airway is open. That is, the larger the value of D, the higher the degree to which the airway14is open, and the smaller the value of D, the lower the degree to which the airway is open. Alternatively, the sensor assembly128, or the controller134, can use the received portions of the energy wave to determine more than one dimension of the airway14.

The transmitter164can be configured to transmit any suitable type of energy wave that can pass, at least partially, through a first portion of the neck50between the transmitter and the airway14, through the airway, and through a second portion of the neck between the airway and the receiver166. For example, the transmitter164can be configured to transmit an x-ray wave such as used in conventional x-ray machines, or a micro-impulse-radar wave. Furthermore, the transmitter134can be configured to transmit a continuous energy wave, a pulsed energy wave, or any other suitable type of energy wave.

The transmitter164can include multiple transmitters, and the receiver166can include multiple receivers, so that the sensor assembly128can obtain an “image” of an entire cross section of the airway14. Or the transmitter164can include fewer, or one, transmitter that the sensor assembly128sweeps so as to cover an entire cross section of the airway14, and the receiver166can include fewer, or one, receiver that the sensor assembly sweeps in a similar manner, where the sensor assembly may sweep the transmitter or receiver mechanically or electronically (e.g., as in beam forming with a phased-array radar). If the transmitter164includes multiple transmitters, or the receiver166includes multiple receivers, then these may be strategically located at various locations inside, or on a surface of, the collar76(FIGS. 4-7), or within the component module74(FIGS. 4-8).

The sensor assembly128, or the controller134, is configured to determine the dimension D by analyzing one or more of the time delay (e.g., relative to the time of wave transmission), the phase (e.g., relative to the transmitted phase), the frequency spectrum (e.g., relative to the frequency spectrum of the transmitted wave), the wave shape (e.g., relative to the wave shape of the transmitted wave), the power (e.g., relative to the transmitted power), and the amplitude (e.g., relative to the amplitude of the transmitted wave), of each of one or more of the received portions of the energy wave in any suitable manner, such as, for example, in the manner in which an x-ray machine analyzes received portions of transmitted x-ray waves.

FIG. 11is a diagram of a portion of the apnea-degree-sensor assembly128ofFIG. 8, and of the subject12ofFIG. 4, according to yet another embodiment.

The sensor assembly128includes an energy-wave receiver168, which is configured to receive one or more portions of one or more energy waves generated by the subject12, and is configured to determine the degree to which the subject's airway14(FIGS. 9-10) is open in response to the received one or more energy-wave portions, or to provide information related to the received one or more energy-wave portions to the controller134so that the controller can determine the degree to which the airway is open. For example, the sensor assembly128, or the controller134, can use the received one or more energy-wave portions to determine a dimension D (FIGS. 9-10) of the airway14, with the value of D corresponding to the degree to which the airway is open. That is, the larger the value of D, the higher the degree to which the airway14is open, and the smaller the value of D, the lower the degree to which the airway is open. Alternatively, the sensor assembly128, or the controller134, can use the received one or more energy-wave portions to determine more than one dimension of the airway14.

The energy-wave receiver168can be configured to receive any suitable type of energy wave that the subject12generates. For example, the receiver168can be configured to receive an acoustic wave, such as generated when the subject12makes respiratory sounds (e.g., breathing or snoring sounds), a disturbance in a light wave, such as generated when the subject moves his eyes (even when the eyes are closed) or another body part (e.g., nose, mouth, jaw, or chin), or an electromagnetic wave such as a brain wave or a heart wave (e.g., an electrocardiogram wave).

The sensor assembly128can include multiple receivers168so as to be able to pick up energy waves emanating from anywhere around the head region, neck region, or other region of the subject12, or can include fewer, or one, receiver that the sensor assembly sweeps mechanically or electronically (e.g., as in beam forming with a phased-array radar). If the sensor assembly128includes multiple receivers168, then these may be strategically located at various locations inside, or on a surface of, the collar76(FIG. 4), or within the component module74(FIGS. 4-8). Furthermore, the one or more receivers168may be directed at regions (e.g., head, chest) of the subject other than the subject's neck.

The sensor assembly128, or the controller134, is configured to determine the dimension D by analyzing one or more of the phase, the frequency spectrum, the wave shape, the power, and the amplitude of each of one or more of the received energy-wave portions in a conventional manner, and then correlating the results of this analysis with a degree to which the airway14(FIGS. 9-10) is open using, for example, the look-up table148ofFIG. 8or a fitted curve. A procedure for developing and using such a correlation is described below in conjunction withFIG. 13.

FIG. 12is a diagram of a portion of the apnea-degree-sensor assembly128ofFIG. 8, and of the subject12ofFIG. 4, according to still another embodiment.

The sensor assembly128includes a biological-condition sensor170, which is configured to sense one or more biological conditions of the subject12, and is configured to determine the degree to which the subject's airway14(FIGS. 9-10) is open in response to the one or more sensed biological conditions, or to provide information related to the sensed one or more biological conditions to the controller134so that the controller can determine the degree to which the airway is open. For example, the sensor assembly128, or the controller134, can use the sensed one or more biological conditions to determine a dimension D (FIGS. 9-10) of the airway14, with the value of D corresponding to the degree to which the airway is open. That is, the larger the value of D, the higher the degree to which the airway14is open, and the smaller the value of D, the lower the degree to which the airway is open. Alternatively, the sensor assembly128, or the controller134, can use the sensed one or more biological conditions to determine more than one dimension of the airway14.

The sensor170can be configured to sense any suitable type of biological condition of the subject12. Examples of such a biological condition include respiratory rate, heart rate, blood-glucose level, blood-oxygen level, blood-adrenaline level, body temperature, body-perspiration level, body-cortisol level (from cortisol in the subject's sweat) body-movement level (e.g., the sensor can include an accelerometer), blood pressure, expiration-gas composition, and body-part position (e.g., chin position, the degree to which the subject's mouth is open, or the degree to which the subject's nostrils are flared).

The sensor assembly128can include multiple biological-condition sensors170so as to be able to sense multiple biological conditions of the subject12, and the one or more sensors may be strategically located at various locations inside, or on (removably or fixedly attached to) a surface of, the collar76(FIGS. 4-7), within the component module74(FIGS. 4-8), or even on or in the subject's body, in which case each such sensor can be tethered to the component module74(FIGS. 4-8) with a wire or other suitable connector, or can communicate with a base portion of the sensor assembly128wirelessly. For example, the sensor assembly128can utilize one or more motion sensors configured to monitor motion of the sleeping subject12. These one or more sensors can be on-board the collar assembly72(e.g., one or more accelerometers), or can be remote from the collar assembly (e.g., accelerometers attached to the limbs or torso of the subject, or remote imagers, e.g., low-light or IR cameras, or micro-impulse radar). A sensor that is remote from the collar assembly72can deliver its measurements to a portion of the sensor assembly128that is on-board the collar assembly wirelessly or via one or more signal cables. In response to readings provided by such one or more sensors, the controller134can interpret excessive motion (e.g., thrashing, or frequent posture changes) or lack of motion (e.g., excessive stillness) of the subject12as an indication that the subject is experiencing sleep apnea.

The sensor assembly128, or the controller134, is configured to determine the dimension D by analyzing one or more parameters of each of one or more of the sensed biological conditions in any suitable manner, and then correlating the results of this analysis with a degree to which the airway14(FIGS. 9-10) is open using, for example, the look-up table148ofFIG. 8, or a fitted curve stored in the memory130. A procedure for developing and using such a correlation is described below in conjunction withFIG. 13.

Referring toFIGS. 8-12, alternate embodiments of the apnea-degree-sensor assembly128are contemplated. For example, the sensor assembly128can include any combination or sub-combination of one or more of each of the energy-wave transmitter-receiver160, the energy-wave transmitter164, the energy-wave receivers166and168, and the biological-condition sensor170.

FIG. 13is a flow diagram180of a procedure for correlating one or more biological conditions of the subject12(e.g.,FIG. 12) to a degree of sleep apnea that the subject is experiencing, according to an embodiment. For example, the procedure may correlate the one or more biological conditions to a degree to which the subject's airway14(e.g.,FIGS. 9-10) is open, the degree of airway openness being related to the degree of sleep apnea that the subject is experiencing. In the example described below in conjunction with the flow diagram180, the correlated biological condition is the respiratory rate of the subject12, although it is understood that any one or more other biological conditions sensed by any of the embodiments of the apnea-degree-sensor assembly128described above in conjunction withFIGS. 8-12can be correlated in a similar manner. Furthermore, a sleep doctor or sleep technician can perform the correlation with the subject12in a sleep-laboratory setting, and then, for example, program the look-up-table (LUT)148(FIG. 8) of the subject's sleep-apnea-treatment system70with a correlation-data structure, or program the memory130(FIG. 8) of the system with a representation of a fitted curve that relates the biological condition to the degree of sleep apnea. Alternatively, the subject's system70, or a laboratory version of the system, may perform this procedure with or without the assistance of a sleep-medicine professional or the subject12.

At a step182, one, e.g., a sleep technician, monitors a degree to which the airway14(FIGS. 9-10) of the subject12(FIG. 4) is open while the subject is sleeping. For example, one may use ultrasound to monitor one or more dimensions D (FIGS. 9-10) of the airway14as described above in conjunction withFIG. 9. The ultrasound waves and resulting ultrasound images may be generated by an embodiment of the apnea-treatment system70described above in conjunction withFIG. 9, or may be generated by an independent ultrasound machine.

Simultaneously at a step184, one also monitors one or more biological conditions of the subject12(FIG. 4) that are related to the degree to which the subject's airway14(FIGS. 9-10) is open while the subject is sleeping. For example, one may monitor the volume or frequency spectrum of the subject's respiratory sounds (e.g., breathing, snoring), or, as in this example, the subject's respiratory rate.

Then, after performing steps182and184for a suitable period of time (e.g., 2-8 hours while the subject is sleeping), at a step186, one correlates each of the monitored one or more biological conditions to the degree of openness of the airway14(FIGS. 9-10). For example, one may digitize the observed values of the subject's respiratory rate at corresponding sample times, digitize the observed values of the degrees of openness of the subject's airway14at the same corresponding sample times, and match each value of the respiratory rate taken at a respective sample time with the corresponding degree of airway openness taken at the same respective sample time. Furthermore, in some cases, a predictive correlation can be derived. For example, it may be determined that during a period (e.g., two-minutes long) preceding an apnea-inducing closure of the airway14of the subject12, a particular pattern of respiratory sounds often precedes the airway closure. Therefore, such a correlation can be used to preemptively apply negative pressure to a selected one or more regions of the subject's neck50to prevent the onset of a sleep-apnea event before it even occurs.

Next, at a step188, one generates a respective data structure that represents the correlation between each of the biological conditions to the degree of airway openness.

For example, on may generate a data structure that represents the correlation of the digitized values of the respiratory rate with the corresponding digitized values of the degree of airway openness, and store this data structure in the LUT148(FIG. 8). That is, one may associate each of the values of the respiratory rate with a corresponding address of the LUT148, and, at each address, store the degree of airway openness corresponding to the value of the respiratory rate associated with the address.

When the apnea-degree-sensor assembly128(FIGS. 8 and 12) provides a digitized value of the subject's respiratory rate, a respiratory-rate-value-to-address converter (such a converter can be part of the assembly128, can be part of any other component of the component module74, or can be a separate component of the component module) converts the value into an address of the LUT148. And the sensor assembly128, or the controller134, obtains the corresponding value of the degree of airway openness from the location of the LUT148at this address, and uses this value of the degree of airway openness to control the pump assembly118(FIG. 8), pressure-regulator assembly120, or valve assembly122so as to control the level of sleep apnea experienced by the subject12. For example, if the value of the degree of airway openness obtained from the LUT148is below a programmed, or otherwise set, apnea-level target range, then the sensor assembly128or controller134can act to increase the degree of airway openness toward the target range; in contrast, if the value of the degree of airway openness obtained from the LUT is above the apnea-level target range, then the sensor assembly128or controller134can act to decrease the degree of airway openness toward the target range, or to maintain the degree of airway openness at its present level.

Alternatively, one may fit the digitized values of the respiratory rate and the corresponding digitized values of the degree of airway openness to a curve, and store a representation of this curve in the memory130(FIG. 8).

When the apnea-degree-sensor assembly128(FIGS. 8 and 12) provides a digitized value of the subject's respiratory rate, the controller134converts the value into a corresponding value of the degree of airway openness using the representation of the fitted curve, and uses this value of the degree of airway openness to control the pump assembly118(FIG. 8), pressure-regulator assembly120, or valve assembly122so as to control the level of sleep apnea experienced by the subject12. For example, if the fitted curve is a straight line, then the mathematical expression defining the line in terms of the respiratory-rate values and the degree-of-airway-openness values is stored in the memory130, and the controller134uses this mathematical expression to calculate the degree of airway openness that corresponds to the provided value of the respiratory rate. So, if the value of the degree of airway openness obtained from the fitted curve is below a programmed, or otherwise set, apnea-level target range, then the sensor assembly128or controller134can act to increase the degree of airway openness toward the target range; in contrast, if the value of the degree of airway openness obtained from the fitted curve is above the apnea-level target range, then the sensor assembly128or controller134can act to decrease the degree of airway openness toward the target range, or to maintain the degree of airway openness at its present level.

Still referring toFIG. 13, alternate embodiments of the procedure represented by the flow diagram180are contemplated. For example, any one or more of the recited steps182-188may be omitted, and one or more other steps may be added. Furthermore, any of the recited steps may be performed manually, by a computing apparatus, or by any other suitable apparatus.

FIG. 14is a plan view of an inner portion of the collar76ofFIGS. 4-7, including portions of two sealing surfaces94and a portion of vacuum surface96, according to an embodiment. “Inner portion” means a portion of the collar76that is configured to face the neck50(FIG. 4) of the subject12(FIG. 4) while the subject is wearing the sleep-apnea-treatment system70(FIGS. 4-7).

The sealing surfaces94are each configured to contact a respective portion of the neck50(FIG. 4) of the subject12(FIG. 4), and to form a respective airtight seal with the respective contacted neck portion.

And the vacuum surface96is configured to form a negative-pressure region200together with the sealing surfaces94, the contacted portions of the neck50, and the portion of the subject's neck opposite the vacuum surface—the vacuum surface may also be called a pressure surface, and the negative-pressure region may also be called a vacuum region, pressure chamber, or vacuum chamber. As described below in conjunction withFIGS. 16-22, the collar76can include a frame such that at least a portion of the vacuum surface96does not contact the subject's neck50.

Each sealing surface94can be rigid, semi-rigid, or flexible, and may be formed from any suitable sealing material, such as plastic, rubber, foam, or silicone.

The vacuum surface96also can be rigid, semi-rigid, or flexible, can be formed from any suitable material, such as plastic, rubber, foam, or silicone, and includes a set of one or more inlet openings202, and a set of one or more outlet openings204; the inlet and outlet openings can be arranged relative to each other in any suitable pattern, and can have any suitable sizes and shapes. Furthermore, nozzles, one-way valves, or other suitable components may be disposed within one or more of the openings202and204.

The one or more inlet openings202are configured to allow air to flow from an outer portion of the collar76, through one or more inlet valves (described below in conjunction withFIGS. 16-22), through the one or more inlet openings, and into the negative-pressure region200—“outer portion” means a portion of the collar76that is configured to face away from the neck50(FIG. 4) of the subject12(FIG. 4) while the subject is wearing the sleep-apnea-treatment system70(FIGS. 4-7). Hoses and couplings within the collar76can couple the one or more inlet openings202to the one or more inlet valves. Furthermore, some or all of these hoses and couplings, the one or more inlet valves, and the one or more inlet openings202can be considered to be part of the valve assembly122(FIG. 8).

And the one or more outlet openings204are configured to allow air to flow from the negative-pressure region200, through the one or more outlet openings, through the valve assembly122(FIG. 8) and the pressure-regulator assembly120(FIG. 8), through the pump assembly118(FIG. 8), and out through the outlet valve102(FIGS. 4-8). Hoses and couplings within the collar76can couple the one or more outlet openings204to the valve and pressure-regulator assemblies120and122(FIG. 8). Furthermore, some or all of these hoses and couplings and the one or more outlet openings204can be considered to be part of the valve assembly122(FIG. 8).

Allowing air to flow through the negative-pressure region200may be more comfortable for the subject12(FIG. 4) than if no inlet openings202were present, because without one or more inlet openings, the air within the pressure region could become hot or humid due to the subject perspiring, and could become otherwise “stale.” Even though the negative-pressure sleep-apnea treatment system70(FIGS. 4-7) can include the temperature-control assembly132(FIG. 8) to cool the air within the pressure region200, the above-described airflow can reduce or eliminate the need for such cooling, and, therefore, can reduce the energy that the system consumes, and can allow one to reduce the cost of the system by omitting the cooling capability from the temperature-control assembly.

Still referring toFIG. 14, alternate embodiments of the sealing surfaces94and vacuum surface96are contemplated. For example, although shown arranged parallel to one another, the sealing surfaces94can be arranged with any other suitable orientation relative to one another. Furthermore, the collar76can include fewer or more than two sealing surfaces94, and more than one vacuum surface96. Moreover, one or more of the sealing surfaces94can each include one or more outlet openings204to increase the strength of the seal that the respective surfaces make with the neck50(FIG. 4). In addition, one or more portions of a sealing surface94and one or more portions of a vacuum surface96can be parts of a same surface. Furthermore, the portion of the vacuum surface96that forms a respective pressure region200can be fully or partially surrounded by one or more sealing surfaces94(if partially surrounded, then part of the vacuum surface can form the remainder of the seal around the pressure region by forming an airtight seal with a portion of the subject's neck50(FIG. 4) opposite the sealing portion of the vacuum surface). Moreover, the airtight seal that the one or more sealing surfaces94and one or more vacuum surfaces96form with respective portions of the subject's neck50(FIG. 4) to form a pressure region200can extend only partially around the pressure region; this can, for example, eliminate the need for the inlet openings202, because the pump assembly118(FIG. 8) can draw in outside air through a side of the pressure region where no airtight seal is formed. In addition, one or more sealing surfaces94can each include one or more outlet openings204, which enable each sealing surface to use negative pressure to form a seal against the skin of the subject. The one or more sealing surfaces94can each include an array of closely spaced discrete outlet openings204, or can include a porous surface. The outlet openings204or pores in the one or more sealing surfaces can be coupled through a manifold or plenum to a pump (e.g., belonging to the pump assembly118, pressure-regulator assembly120, or valve assembly122), which is used to provide the negative pressure causing the sealing surface to adhere to the skin of the user. The one or more negative-pressure levels that form the one or more seals can be different from the one or more negative-pressure levels in the one or more pressure regions200. Alternatively, the pressure level used to form a seal and the pressure level in an adjacent pressure region200can be the same; for example, a manifold servicing the outlet openings/pores of a sealing surface94can couple the outlet openings/pores to the adjacent pressure region, thereby not requiring a separate pump.

FIG. 15is a plan view of a portion of a sealing surface94, according to an embodiment.

The portion of the sealing surface94ofFIG. 15can be similar to the portions of the sealing surfaces94ofFIG. 14, except that the portion of the sealing surface ofFIG. 15includes one or more sealant-dispensing openings210.

Each sealant-dispensing opening210is configured to eject a sealant from the sealant-dispersing assembly124ofFIG. 8, where the sealant is configured to fortify, or repair a leak in, the airtight seal that the sealing surface94is configured to form with a portion of the neck50(FIG. 4) of the subject12(FIG. 4) as described above in conjunction withFIG. 14. For example, the sealant may repair a leak formed around one or more strands of the subject's hair that lay between the sealing surface94and the subject's neck50(FIG. 4). Furthermore, nozzles, one-way valves, or other suitable components may be disposed within one or more of the openings210. Moreover, hoses and couplings within the collar76(FIG. 14) can couple the one or more sealant-dispensing openings210to the sealant-dispenser assembly124(FIG. 8); some or all of these hoses and couplings, and the one or more sealant-dispensing openings, can be considered to be part of the sealant-dispenser assembly. In addition, the one or more sealant-dispensing openings210can have any suitable sizes and shapes, and can be located at any suitable spacing and in any suitable pattern along the sealing surface94. Furthermore, an opening210can overlap an edge212of the sealing surface94such that one portion of the sealant-dispensing opening is formed in the sealing surface, and another portion is formed in the adjacent vacuum surface96(FIG. 14). Or, an opening210can be formed entirely in the vacuum surface96, for example, near an edge212of the sealing surface94.

In operation of the sleep-apnea system70(FIGS. 4-7), according to an embodiment, if, for example, the controller134(FIG. 8) detects a leak in a pressure region200(FIG. 14), then the controller can cause the sealant-dispenser assembly124(FIG. 8) to dispense a sealant from the reservoir146(FIG. 8) via one or more of the sealant-dispensing openings210along a portion of a sealing surface94that forms, or otherwise borders, the pressure region. For example, the controller134can cause the sealant-dispenser assembly124to dispense sealant from one opening210in the sealing surface94at a time until the controller detects that the leak has been sealed.

Still referring toFIG. 15, alternate embodiments are contemplated. For example, although only one sealing surface94is described, multiple sealing surfaces can include one or more sealant-dispensing openings210. Furthermore, the sealant-dispenser assembly124(FIG. 8) can be configured to selectively dispense a sealant from one or more, but not all, of the sealant-dispensing openings210at any one time. Moreover, if an opening210includes a nozzle, then the sealant-dispenser assembly124may be able to orient the nozzle in a selected direction before, while, or after dispensing the sealant.

FIG. 16is a view of a portion220of the collar76ofFIGS. 4-7 and 14, according to an embodiment.

FIG. 17is a cross-sectional view of a mid region of the collar portion220ofFIG. 16taken along a line A-A ofFIG. 16, and of a portion222of a subject's neck50and airway14, according to an embodiment.

FIG. 18is a cross-sectional view of an end region of the collar portion220ofFIG. 16, and of the portion222of the subject's neck50and airway14, according to an embodiment.

Referring toFIGS. 16-17, the collar76includes one or more segments224, which, while the negative-pressure sleep-apnea-treatment system70(FIGS. 4-7) is being worn by the subject12(FIG. 4), are configured to be oriented approximately in a circumferential direction around the subject's neck50.

Each segment224is formed by a respective rigid, or semi-rigid, portion226of a frame228. Each frame portion226has a curved shape, and can be made from any suitable material such as a plastic, a metal, or a wire mesh.

To each frame portion226is attached a respective portion of the vacuum surface96(described above in conjunction with, e.g.,FIG. 14), and a respective portion of an outer covering230, which can be made from any suitable material such as a plastic or a cloth. Any suitable attachment technique, such as cementing or gluing, may be used to attach the vacuum surface96and outer covering230to the frame portions226.

Each frame portion226is attached to an adjacent frame portion at a respective joint232by any suitable attachment technique such as welding, bonding, cementing, or gluing. Alternatively, the frame228may be made from one piece such that the frame portions226are integral with one another. Or, the joints232may be flexibly coupled together, e.g., with hinges.

A respective sealing surface94(described above in conjunction withFIGS. 14-15) is disposed along each joint232.

While the collar76is being worn by the subject12(FIG. 4), the sealing surfaces94engage respective portions234of the subject's neck50so as to form the pressure regions200, one pressure region per collar segment224in this example.

Each collar segment224also includes a respective inlet valve238, which allows the pump assembly118(FIG. 8) to draw outside air into the respective pressure regions200as described above in conjunction withFIG. 14.

Any hoses or couplings that may be disposed in the collar76, for example as described above in conjunction withFIGS. 8 and 14-15, are omitted fromFIGS. 16-18for clarity.

Referring toFIG. 18, the cross section of an end region of the collar76is similar to the cross section of the mid region of the collar as described above in conjunction withFIG. 17, but with the addition of segment terminators240.

The terminators240are configured to form airtight seals at the ends of the collar segments224, and may be made from any suitable rigid or semi-rigid material such as plastic, metal, or wire mesh.

The sealing surfaces94extend along the bottoms of the terminators240and are configured to make airtight seals with portions242of the neck50, and the curved tops of the terminators are attached to the vacuum surfaces96along seams244in any suitable airtight manner.

Alternately, the terminators240may be attached directly to the respective frame portions226, or may be formed integrally with the frame portions or as an integral part of the frame228as a whole.

Referring toFIGS. 16-18, in operation of the sleep-apnea-treatment system70(FIGS. 4-7), according to an embodiment, the pump assembly118(FIG. 8) is configured to cause a negative pressure to exist within the negative-pressure regions200by drawing air from these regions; although the inlet valves238allow a flow of air into the negative-pressure regions, the power of the pump assembly overcomes this airflow to create the negative pressures within the negative-pressure regions. Furthermore, the negative pressures within the regions200may be the same or different from one another.

Because the pressure outside of the collar76is greater than the pressure within the pressure regions200, the outside air effectively presses against the frame228, which in turn presses the sealing surfaces94against the neck portions234and242to form respective airtight seals. Or, viewed another way, the frame228is effectively “sucked” against the neck50such that the sealing surfaces94are forced against the respective neck portions234and242. This effect can be used as the primary mechanism for attaching the collar assembly72to the neck50of the subject12, thus enabling a collar assembly that does not need to be positively attached to the subject via straps or by fully encircling the neck. Such a collar assembly72can generically utilize, in one or more of the pressure regions200, a modest “gripping” level of negative pressure that is sufficient to hold the collar assembly against the subject's neck50, but that is too weak to appreciably open his/her airway14; and the collar assembly can increase the magnitude of the negative pressure in one or more of the pressure regions as needed to open the subject's airway14, or to maintain the airway open, so as to arrest an apnea, or to prevent an apnea from occurring.

Furthermore, because the frame228and terminators240are rigid or semi-rigid, the frame portions226and the terminators hold the vacuum surfaces96away from the portions246of the neck50covered by the frame portions. Therefore, the negative pressure within the regions200can cause the neck portions246to expand outward, thus giving the desired result of “pulling” open the subject's airway14. If the frame portions226and terminators240were not rigid or semi-rigid, then the vacuum surfaces96would collapse against the neck portions246such that the subject's airway14would not be “pulled” open as intended.

Still referring toFIGS. 16-18, in operation of the sleep-apnea-treatment system70(FIGS. 4-7), according to another embodiment, the system may regulate the pressures within the pressure regions200in a manner that mimics peristalsis. For example, the system70can so regulate the pressures to reduce or eliminate the chances that the system will cause a portion246of the neck50to form an edema (e.g., a “hickey”) caused by a prolonged continuous exposure to a negative pressure.

Peristalsis is a radially symmetrical contraction and relaxation of muscles that form a muscular tube, which contraction propagates in a wave down the muscular tube in an anterograde fashion. An example of such a muscular tube in humans is the esophagus, the muscles of which contract in a peristalsis manner to move food and drink from the mouth to the stomach.

In an embodiment, the pressure-regulator assembly120(FIG. 8) first increases the pressure (i.e., lessens the magnitude of the negative pressure) within the bottom pressure region200of the collar76while maintaining the pressures in the middle and top pressure regions unchanged. The amount and profile by which the pressure-regulator assembly120increases the pressure in the bottom pressure region200, and the duration of this pressure increase, can be suitable to reduce or eliminate the chances of an edema forming in the bottom neck portion246without breaking the airtight seal formed between the adjacent sealing surfaces94and neck portions234and242.

Next, the pressure-regulator assembly120(FIG. 8) decreases the pressure (i.e., increases the magnitude of the negative pressure) within the bottom pressure region200until it reaches the level that the controller134(FIG. 8) determines is suitable to treat the subject's sleep apnea. The profile by which the pressure-regulator assembly120reduces the pressure within the bottom pressure region200, and the duration of this pressure reduction, can be suitable to reduce or eliminate the chances of an edema forming in the bottom neck portion246.

Then, while or after reducing the pressure in the bottom negative-pressure region200, the pressure-regulator assembly120(FIG. 8) increases the pressure (i.e., lessens the magnitude of the negative pressure) within the middle pressure region200while maintaining the pressure in at least the top pressure region unchanged. The amount and profile by which the pressure-regulator assembly120increases the pressure within the middle pressure region200, and the duration of this pressure increase, can be suitable to reduce or eliminate the chances of an edema forming in the middle neck portion246without breaking the airtight seal formed between the adjacent sealing surfaces94and neck portions234and242.

Next, the pressure-regulator assembly120(FIG. 8) decreases the pressure (i.e., increases the magnitude of the negative pressure) within the middle pressure region200until it reaches the level that the controller134(FIG. 8) determines is suitable to treat the subject's sleep apnea. The profile by which the pressure-regulator assembly120reduces the pressure in the middle pressure region200, and the duration of this pressure reduction, may be suitable to reduce or eliminate the chances of an edema forming in the middle neck portion246.

Then, while or after reducing the pressure in the middle negative-pressure region200, the pressure-regulator assembly120(FIG. 8) increases the pressure (i.e., lessens the magnitude of the negative pressure) within the top pressure region200while maintaining the pressure in at least the bottom pressure region unchanged. The amount and profile by which the pressure-regulator assembly120increases the pressure within the top pressure region200, and the duration of this pressure increase, can be suitable to reduce or eliminate the chances of an edema forming in the top neck portion246without breaking the airtight seal formed between the adjacent sealing surfaces94and neck portions234and242.

Next, the pressure-regulator assembly120(FIG. 8) decreases the pressure (i.e., increases the magnitude of the negative pressure) within the top pressure region200until it reaches the level that the controller134(FIG. 8) determines is suitable to treat the subject's sleep apnea. The profile by which the pressure-regulator assembly120reduces the pressure within the top pressure region200, and the duration of this pressure reduction, may be suitable to reduce or eliminate the chances of an edema forming in the top neck portion246.

In summary of the above-described peristalsis procedure, the controller134changes the pressures within the bottom, middle, and top pressure regions so that these pressures are offset from each other in time, and, therefore, in phase, and so that the controller effectively generates a pressure “wave” that propagates up or down the collar76.

The controller134(FIG. 8) may perform this peristalsis procedure periodically at a programmed, or otherwise set, interval, or may do so in response to a sensor of the system70indicating that an edema of a threshold size has formed, or may soon form, in a region (e.g., a region246) of the subject's neck50. Furthermore, the controller134can cause one or more of the pressure regions200to have a respective positive pressure during respective portions of the peristalsis procedure, as long as the number of pressure regions having positive pressures at any one time is small enough so as not to cause the collar76to fully disengage from the subject's neck50(FIG. 4) or to otherwise cause a problem with the treatment of the subject's sleep apnea. For example, the controller134can be configured so that no more than one end pressure region (e.g., the top or the bottom pressure region)200has a reduced-magnitude negative pressure, or a positive pressure, at any one time.

Still referring toFIGS. 16-18, alternate embodiments of the collar76, and of the system70(FIGS. 4-7) in general, are contemplated. For example, the collar segments224can have different sizes or shapes from one another and from what is described. Furthermore, there can be fewer or more than three segments224. Moreover, the peristalsis action can propagate from top to bottom of the collar76instead of from bottom to top, can alternate propagation directions, and can be altered in any suitable manner.

FIG. 19is a view of a portion250of the collar76ofFIGS. 4-7 and 14, according to another embodiment.

FIG. 20is a cross-sectional view of the collar portion250ofFIG. 19taken along a line A-A ofFIG. 11, and of the portion222of the subject's neck50and airway14, according to an embodiment.

Referring toFIGS. 19-20, the collar portion250is similar to the collar portion220ofFIGS. 16-18but for the addition of one or more sealing surfaces252that are each transverse to the sealing surfaces94away from the terminators240, and the addition of a corresponding one or more pressure-region separators254, which may be similar to the terminators240and which support the transverse sealing surfaces. The transverse sealing surfaces252can be similar to the sealing surfaces94, and can be attached to the separators254in any suitable manner. And the separators254can be made from the same material as the frame portions226or the terminators240, and can be attached to the vacuum surface96or to the frame portions in a manner similar to the manner in which the terminators can be attached to the vacuum surface or the frame portions as described above in conjunction withFIG. 18. Alternatively, the separators254can be formed integrally with the frame portions226in a manner similar to the manner in which the terminators240can be formed integrally with the frame portions226as described above in conjunction withFIG. 18.

The transverse sealing surfaces252and separators254form additional pressure regions200(FIGS. 16-18) by dividing the collar segments224into multiple sections.

Furthermore, if the sleep-apnea-treatment system70(FIGS. 4-7) regulates the pressures within the pressure regions200(FIGS. 16-18) in a manner that mimics peristalsis, the controller134(FIG. 8) can be configured to change the pressures within the pressure regions belonging to the same collar segment224simultaneously. Alternatively, the controller134can be configured to regulate the pressures within the pressure regions200in a manner similar to the peristalsis technique described above in conjunction withFIGS. 16-18, but in a circumferential direction (i.e., in a direction around the neck50instead of in a direction up or down the neck). Or, the controller134system can be configured to so regulate the pressures within the pressure regions200both in a transverse direction (i.e., up or down the neck) and in a circumferential direction.

Still referring toFIGS. 19-20, alternate embodiments of the collar76, and of the system70(FIGS. 4-7) in general, are contemplated. For example, the same alternatives discussed above for the collar76ofFIGS. 16-18can be applicable to the collar76ofFIGS. 19-20.

FIG. 21is a view of a portion260of the collar76ofFIGS. 4-7 and 14, according to yet another embodiment.

FIG. 22is a cross-sectional view of the collar portion260ofFIG. 21taken along a line A-A ofFIG. 21, and of the portion222of the subject's neck50and airway14, according to an embodiment.

Referring toFIGS. 21-22, the collar portion260is similar to the collar portion220ofFIGS. 16-18, except that collar segments262are configured to extend in a transverse direction (i.e., up/down the neck50) while the subject12(FIG. 4) is wearing the sleep-apnea system70, unlike the collar segments224(FIGS. 16-18), which are configured to extend in a circumferential direction (i.e., around the neck). And although not shown, the collar portion260may be similar to the collar portion250ofFIGS. 19-20in that it can include sealing surfaces and separators that are similar to the sealing surfaces252and the separators254and that are approximately transverse to (i.e., in approximately the same direction as the line A-A inFIG. 21) the sealing surfaces92and joints264.

Still referring toFIGS. 21-22, alternate embodiments of the collar76, and of the system70(FIGS. 4-7) in general, are contemplated. For example, the same alternatives discussed above in conjunction withFIGS. 16-20can be applicable to the collar76ofFIGS. 21-22.

FIG. 23is a flow diagram270of an operational mode of the sleep-apnea-treatment system70(FIGS. 4-7), according to an embodiment.

Referring toFIGS. 4-8, and 14-22, operation of the sleep-apnea-treatment system70(FIGS. 4-7) is described, according to an embodiment.

After the subject12puts on and activates the treatment system70(e.g., via the power-switch assembly100), at a step272of the flow diagram270, the controller134causes the pump assembly118and the pressure-regulator assembly120to generate a respective initial pressure, for example, a respective negative pressure, within each pressure region200. That is, the pump assembly118generates the one or more negative pressures by drawing air from outside of the collar76into the inlet valves238, through the inlet openings202, into the one or more pressure regions100, through the outlet openings204, through the valve and pressure-regulator assemblies120and122, into the pump assembly118, and out through the outlet valve102. Alternatively, one or more of the inlet valves238and inlet openings202can be inactivated or omitted such that the pump assembly generates at least some of the one or more negative pressures without generating respective sustained airflows.

Next, at a step274of the flow diagram270, the controller134monitors the one or more pressure regions200for air leaks in response to one or more pressure indications from the pressure-sensor assembly126.

At a step276, the controller134determines whether there are any air leaks. If the controller134determines that there are no leaks, then the controller proceeds to a step280. But if the controller134determines that there is at least one leak, then the controller proceeds to a step278,

At the step278, the controller134causes the repair of each of the detected one or more leaks, for example, by causing the sealant-dispenser assembly124to dispense a sealant from the reservoir146via one or more of the sealant-dispensing openings210in the vicinity of the respective leak.

Then, at the step280, the controller134monitors the degree of sleep apnea that the subject12is experiencing via the apnea-degree-sensor assembly128. For example, the controller134can monitor the subject's respiratory rate.

Next, at a step282, the controller134determines whether the degree of sleep apnea that the subject12is experiencing is within a target range. For example, the controller134may determine whether the subject's respiratory rate is within a target range. If the controller134determines that the degree of sleep apnea is within the target range, then the controller proceeds to a step286. But if the controller134determines that the degree of sleep apnea is outside of the target range, then the controller proceeds to a step284.

At the step284, the controller134identifies one or more pressure regions200that the controller has determined are to be adjusted, and controls the pump assembly118or the pressure-regulator assembly120to adjust the pressure in the identified one or more pressure regions in an effort to drive the degree of sleep apnea toward the target range.

Then, at the step286, the controller134monitors one or more comfort conditions in one or more comfort sectors of the system70(FIGS. 4-7). For example, the controller134can monitor temperature or pressure in one or more of the pressure regions200.

Next, at a step288, the controller134determines whether the one or more comfort conditions in one or more comfort sections are within respective target ranges. For example, the controller134can determine whether the temperature within each pressure region200is within a respective target range. If the controller134determines that each of the one or more comfort conditions is within its respective target range, then the controller proceeds to a step292. But if the controller134determines that at least one of the one or more comfort conditions is outside of its respective target range, then the controller proceeds to a step290.

At the step290, the controller134identifies one or more comfort sectors that are to be adjusted, and controls the temperature-control assembly132to adjust one or more comfort parameters (e.g., temperature) in the identified one or more comfort sectors in an effort to drive the one or more comfort conditions toward their respective target ranges. In addition, or in the alternative, the controller134may control the pump assembly118and the pressure-regulator assembly120in a peristalsis manner so as to temporarily reduce the magnitude of the pressure within one or more pressure regions200to reduce the chances of an edema forming, or to otherwise give the respective regions246of the subject's neck50a “break” from the higher-magnitude pressures.

At the step292, the controller134determines whether it is time for the subject12to awaken or to otherwise power down the system (e.g., because the subject has removed the system70and turned the system “off” via the power-switch assembly100). If it is not time to awaken the subject12, then the controller134returns to the step274. But if it is time to awaken the subject12, then the controller134proceeds to a step294.

At the step294, the controller134implements an awakening routine and then deactivates the system70(FIG. 4), or, alternatively, the controller skips an awakening routing and deactivates the system. As example of an awakening routine, the controller134can be programmed to help awaken the subject12at a specified time, or in response to increasing ambient light, by sounding an audible alarm and slowly reducing the magnitude of the respective pressure within each pressure region200, or by varying the respective pressure within one or more pressure regions according to a sequence or pattern that gently awakens the subject.

After the step294, the above-described operational mode ends, and is repeated the next time that the subject12activates the sleep-apnea-treatment system70.

Additional embodiments of a negative-pressure sleep-apnea-treatment system are described below in conjunction withFIGS. 24-63. The sleep-apnea-treatment system70described above in conjunction withFIGS. 4-23may be modified to include any one or more features of any embodiment of any sleep-apnea-treatment system described below in conjunction withFIGS. 24-63; likewise, the sleep-apnea-treatment systems described below in conjunction withFIGS. 24-63may each be modified to include any one or more features of any embodiments of the sleep-apnea-treatment70. Furthermore, the embodiments of the sleep-apnea-treatment systems described below in conjunction withFIGS. 24-63may be structurally and operationally configured the same as one or more of the embodiments of the sleep-apnea-treatment system70unless otherwise noted.

FIGS. 24-25are an isometric front view, and an isometric side view, respectively, of a neck400, throat402, and chin404, of a subject405, and of throat areas406and407for applying a negative pressure to treat sleep apnea, such as obstructive sleep apnea, according to an embodiment.

Referring toFIGS. 3 and 24-25, in an embodiment, the negative-pressure-application area406is bounded on the bottom by the subject's sternal head62, on the sides by the subject's sternocleidomastoid muscles66, and on the top by the intersection408(i.e., the anterior belly of Digastricus55inFIG. 3) of the subject's chin404with the subject's throat402. In another embodiment, which is illustrated inFIGS. 24-25, the negative-pressure-application area406is bounded on the bottom by the subject's Adam's apple410(thyroid cartilage57inFIG. 3), on the sides by the subject's sternocleidomastoid muscles66, and on the top by the intersection408of the subject's chin404with the subject's throat402.

The negative-pressure-application area407is typically smaller than the area406, can be partially or fully within the area406, and can be a rectangle or square about the subject's Adam's apple410. For example, the side boundaries of the area407can be aligned with the respective corners of the subject's mouth, and the top boundary of the area407can be just under the subject's chin404. In an embodiment, the negative pressure application is sufficient to move the subject's tongue and/or other soft palate tissue anteriorly, thereby reducing or eliminating airway obstruction. In an embodiment, the negative pressure application is sufficient to move the subject's tongue and/or other soft palate tissue anteriorly, thereby reducing or eliminating snoring without airway obstruction.

As discussed above, a negative pressure (e.g., a suction) applied to the area406or to the area407can cause movement of tissue obstructing the subject's airway (airway14ofFIG. 1) sufficient to reduce or remove the obstruction. The negative pressure can “pull out” tissue within the area406or area407, which tissue, by virtue of being connected to the obstructing tissue or to other tissue adjacent to the subject's airway, can “pull” the obstructing tissue or other tissue adjacent to the subject's airway a distance sufficient to reduce or remove the obstruction. Alternatively, the negative pressure can cause the subject's jaw412to move (e.g., forward, down, or both forward and down) sufficiently to reduce or remove the obstruction. Or, the negative pressure can reduce or remove the airway obstruction by both “pulling out” tissue within the area406or407and by causing the jaw412to move.

Referring toFIGS. 24-25, other embodiments of the negative-pressure-application areas406and407are contemplated. For example, each of the above-described boundaries of the area406or the area407can be altered by any distance within a distance range of, e.g., ±25 millimeters (mm).

FIG. 26is an isometric front view of a subject405wearing a negative-pressure sleep-apnea-treatment system420, according to an embodiment. The system420is designed to apply negative pressure to the throat area406, the throat area407, or both the throat areas406and407, of the subject as described above in conjunction withFIGS. 24-25. In addition to the structural and operational features described below in conjunction withFIGS. 26-63, the system420can have any of the structural and operational features of any embodiment of the sleep-apnea-treatment system70described above in conjunction withFIGS. 4-23.

The sleep-apnea-treatment system420can be self-contained such that it requires no connection to an external device (e.g., a base station, a power outlet) to operate, and therefore, can be more comfortable than a conventional CPAP machine or other sleep-apnea-treatment system that includes, e.g., a base station and an air hose coupled between the base station and the system. For example, a self-contained version of the sleep-apnea system420can include a battery (e.g., the battery110) that is rechargeable while the subject405is not wearing/using the sleep-apnea system such that the sleep-apnea system needs no physical connection (e.g., no power cord, no hose, and no wired communication link) to another device or location while the subject is wearing, or otherwise using, the sleep-apnea system. But a self-contained version of the sleep-apnea system420can be configured to include a wireless communication link and a wireless power link.

FIGS. 27-28are respective isometric side views of the subject405wearing the negative-pressure sleep-apnea-treatment system420ofFIG. 26, according to an embodiment. The sleep-apnea system420includes a removable gasket assembly422, which is configured to form an airtight seal around the perimeter of the sleep-apnea system, and which includes a removable strap assembly424, which is configured to secure the sleep-apnea system around the neck400of the subject405. Alternatively, the strap assembly424can be configured to secure the sleep-apnea system420to, or around, a head425of the subject405.

FIG. 29is an isometric rear view of the subject405wearing the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-28, according to an embodiment. The strap assembly424can include a coupler426, which is configured to couple together rear ends of straps428and430of the strap assembly at the back of the subject's neck400. The coupler426is also configured to allow adjustment of the size of the neck loop formed by the straps428and430of the strap assembly424. That is, one can use the coupler426to adjust the loop size such that the fit of the sleep-apnea system420is not so “tight” that it causes the subject405discomfort, and is not so “loose” that it allows an air leak where the gasket assembly422contacts the neck400of the subject. The coupler426and ends of the straps428and430can include Velcro® or any other suitable material or structure that allows adjustably coupling together the straps. Alternatively, the coupler426can be omitted from the sleep-apnea system420, and one can couple the strap ends, which can include Velcro®, directly to one another.

FIG. 30is an isometric side view of the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-29, according to an embodiment.

FIG. 31is an isometric rear view of the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-30, according to an embodiment.

FIG. 32is an isometric exploded view of the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-31, according to an embodiment.

Referring toFIGS. 30-32, in addition to the gasket assembly422and the strap assembly424, the negative-pressure sleep-apnea-treatment system420includes a collar assembly (hereinafter “collar”)440.

The gasket assembly422is configured to be removably attachable to the collar440, e.g., by “snapping” onto a perimeter442of the collar. In an embodiment of the sleep-apnea system420, it is anticipated that the gasket assembly422will wear out, be upgraded, or will otherwise require repair or replacement more frequently than the collar440; therefore, configuring the gasket assembly to be removable can allow replacement of the gasket assembly independently of the collar.

The strap assembly424also is configured to be removably attachable to the collar440, e.g., by attaching to the sides of the collar. The straps428and430of the strap assembly424have respective front ends444and446, which are configured for removable attachment to respective side portions448and450of the collar440. For example, the strap front end444and the collar side portion448can include oppositely structured Velcro® pieces, as can the strap front end446and the collar side portion450. Furthermore, the positions of the strap front ends444and446can be adjustable relative to the collar side portions448and450to allow one to adjust the size of the neck loop formed by the straps428and430of the strap assembly424. Moreover, in an embodiment of the sleep-apnea system420, it is anticipated that the strap assembly424will wear out, be upgraded, or will otherwise require repair or replacement more frequently than the collar440; therefore, configuring the strap assembly to be removable can allow replacement of the strap assembly independently of the collar440.

Referring toFIG. 31, the collar440includes a rear side452(the side configured to faces the subject's neck400(e.g.,FIGS. 26-29when the sleep-apnea system420is worn), on, or through, which are disposed one or more outlet openings454(only one opening shown inFIG. 31) and one or more sensors456(only one sensor shown inFIG. 31). For example, the one or more outlet openings454can be structurally and functionally similar to the outlet openings204ofFIG. 14, and the one or more sensors456can be structurally and functionally similar to the sensors of the sensor assemblies126and128ofFIG. 8. As described above in conjunction withFIGS. 4-23, and as described below, a pump (not shown inFIG. 31) draws air through the one or more outlet openings454to create a volume, or region, of negative pressure between the rear side452of the collar440and the subject's throat area406or throat area407(FIGS. 24-25).

Drawing air through the one or more outlet opening454can also be referred to as drawing a vacuum, or drawing a partial vacuum, via the one or more outlet openings, and the volume or region of negative pressure can be called a vacuum, a partial-vacuum, or a pressure region, and can be structurally and functional similar to the pressure region200described above in conjunction with, e.g.,FIG. 17. Further as described above in conjunction withFIGS. 4-24, and as described below, the one or more sensors456can be configured to sense and to provide information, or to sense and to provide one or more physical parameters from which the sleep-apnea system420can derive information, that the sleep-apnea system can use to adjust the magnitude of the negative pressure, or to adjust other parameters (e.g., neck temperature), so as to open, or maintain open, an airway of the subject (e.g., the airway14ofFIG. 1). Moreover, the one or more sensors456can be configured to sense and to provide other information, or to sense and to provide one or more physical parameters from which the sleep-apnea system420can derive other information. For example, as described above in conjunction withFIG. 8and below, the one or more sensors456can be configured to sense and to provide information related to a physical, a mental, an emotional, a health, or a wellbeing condition or state of the subject405(e.g.,FIGS. 26-29), or information related to a subject's use, or the settings, of the sleep-apnea system420. In addition, the one or more outlet openings454and the one or more sensors456can have any suitable positions, shapes, and sizes, which positions, shapes, and sizes can be different than as shown inFIGS. 30-32.

Still referring toFIGS. 30-32, the collar440can be custom manufactured to better fit the neck400of the subject405(e.g.,FIG. 29). For example, a doctor or other person can use a conventional image-capture device or a conventional scanner to generate a three-dimensional (3D) image or map of the subject's neck400(at least the front and sides of the subject's neck). The 3D image or map can then be converted to a print file having a format suitable for a 3D printer, which can “print” the collar440. Or the collar440can be manufactured by a CNC or other machine from the 3D image or map. Other components (e.g., the gasket assembly422, the strap assembly424) of the sleep-apnea system420can be manufactured in a similar manner.

FIG. 33is an isometric front view of the gasket assembly422and of the collar440ofFIGS. 26-32, according to an embodiment.

FIG. 34is an isometric side view of the gasket assembly422and of the collar440ofFIGS. 26-33, according to an embodiment.

FIG. 35is an isometric side isometric view of the collar440ofFIGS. 26-34with transparent portions, according to an embodiment.

Referring toFIGS. 33-35, the collar440includes a semi-rigid housing460, and includes a compartment462, which is formed in the front of the housing and which is configured for holding one or more components of the sleep-apnea system420.

Referring toFIG. 35, the collar housing460includes a rigid internal frame464disposed in a flexible, elastomeric, overmold or package466.

The frame464includes slats468, and can be formed from a plastic metal, or any other material with strength and rigidity sufficient to allow the collar440to form a region of negative pressure between the rear surface452of the collar and the neck400of the subject405(e.g.,FIGS. 26-29) without the rear surface “collapsing” against the neck. Although shown as being oriented in a vertical dimension, one or more of the slats468can be oriented in a horizontal dimension or in a diagonal dimension, and the vertical slats can be coupled together by horizontal or diagonal cross slats (not shown inFIG. 35). Furthermore, the frame464can include optional strap-attachment sections470and472for engaging the strap assembly424(e.g.,FIG. 32), where the attachment sections can replace, or otherwise render unnecessary, the Velcro® strap-attachment sections444,446,448, and450described above in conjunction withFIGS. 30-32. Although each strap-attachment section470and472is shown as including two strap eyelets474and476, one or both of the strap-attachment sections can include fewer than two, or more than two, strap eyelets.

The overmold466can be formed from a plastic metal, or from any other suitable material with strength and rigidity sufficient to allow the collar440to form a region of negative pressure between the rear surface452of the collar and the throat area406or the throat area407(FIGS. 24-25) of the subject405(e.g.,FIGS. 27-28) without the rear surface “collapsing” against the throat, yet with sufficient flexibility and surface texture to allow the collar to comfortably fit against, and to conform to the shape of, the subject's neck400(e.g.,FIGS. 27-28). If the collar440is configured to form a region of negative pressure between the rear surface452of the collar and the throat area407, then the collar440can be smaller, or, for a given size, can have more room for components such as the components of the component module550, than if the collar is configured to form the region of negative pressure between the rear surface of the collar and the throat area406.

To form the housing460, one first can form the frame464by conventional injection molding, and then can form the overmold466over the frame also by conventional injection molding.

Referring again toFIGS. 33-35, the compartment462can be formed as a compartment integral to the overmold466, or can be formed as part of the frame464for additional strength. Furthermore, the compartment462can include an access panel (not shown inFIGS. 33-35) in the rear (the side facing the subject105) of the collar440, or in the front (the side facing away from the subject) of the collar, to allow repair or replacement of components within the compartment. Alternatively, the compartment462can include no access panel such that that the components are sealed within the compartment and cannot be repaired or replaced without dismantling or destroying (e.g., by cutting through the overmold466) the collar440. And examples of components that can be disposed within the compartment462include batteries, motors, pumps, valves, sensors, electronic circuitry and electronic components, and mechanical assemblies and mechanical components (further examples of such components are described above in conjunction with, e.g.,FIG. 8, and below in conjunction with, e.g.,FIG. 45.

FIG. 36is an isometric front view of the collar440ofFIGS. 26-35, and of an on/off switch480for the negative-pressure sleep-apnea-treatment system420, according to an embodiment. The switch480can be a tactile-type slide switch located, for example, on the front side of the component compartment462. That is, one can toggle the switch480between its “on” and “off” states by swiping a finger across the front side of the compartment462, much like how one can toggle a switch displayed on a smart phone's screen. For example, the collar440can include a display screen, a capacitance sensor, or other device exposed through, or located just behind, the front side of the compartment462, where the switch480is formed, or otherwise implemented, by the device. In its “on” state, the switch480is configured to activate the sleep-apnea system420by connecting the components of the system (e.g., motors and other components within the compartment462, and the sensor456ofFIG. 31) to a power source, such as a battery, disposed within the compartment; and in its “off” state, the switch is configured to deactivate the sleep-apnea system by disconnecting the components of the sleep-apnea system from the power source. The switch480is further configured such that it is difficult to impossible for the subject405(e.g.,FIG. 29) to inadvertently toggle the switch to its “off” state while the subject is sleeping and wearing the sleep-apnea system420. For example, the switch480can be configured such that it would be difficult or impossible for bedding to become entangled with the switch and to toggle the switch to its “off” state due to movement of the subject405(e.g., the subject rolling over to sleep on his/her stomach, or moving while sleeping on his/her stomach). Furthermore, although shown as being located on the front side of the compartment462, the switch480can be disposed at any other suitable location in or on the collar440. Moreover, the switch480can be configured for control by a controller (e.g., the controller134ofFIGS. 8 and 45) of the sleep-apnea system420. For example, the controller can be configured to toggle, automatically, the switch480to its “off” state in response to detecting that the subject405removed the sleep-apnea system420from around his/her neck400, and to toggle, automatically, the switch to its “on” state in response to detecting that the switch toggled to its “off” state while the subject is still sleeping.

FIG. 37is an isometric front view of the collar440ofFIGS. 26-36, of a battery-level indicator482, and of a remote-control device484, according to an embodiment.

The battery-level indicator482can be any suitable type of indicator, such as a Light-Emitting-Diode (LED) display, configured to change color, intensity, or both color and intensity, to indicate a charge state of one or more of the batteries110(FIGS. 8 and 45), which power the sleep-apnea-treatment system420. The indicator482can be located, for example, on the front side of the component compartment462, or at any other suitable location of the collar440. In response to the indicator482indicating that the one or more batteries110have low charge states, one can charge the battery, e.g., with an AC adapter, as described above in conjunction withFIG. 5.

The remote-control device484can be configured to control the operation of the sleep-apnea-treatment system420, can be any suitable device, such as a dedicated remote-control device or a smart phone, and can be configured to communicate with the sleep-apnea system according to any suitable wireless or wired protocol such as Bluetooth®, WiFi®, Zigbee®, Radio Frequency (RF), or infrared (IR). For example, the remote-control device484can be configured to allow one to adjust the settings (e.g., magnitude of the negative pressure, wake-up time) of the sleep-apnea-treatment system420, to enter data into, or to retrieve data from, the memory130(FIGS. 8 and 45) of the sleep-apnea system, and to turn “on” or “off” the sleep-apnea treatment system. The remote-control device484also can be configurable and reconfigurable by, e.g., firmware or software. For example, if the remote-control device484is a smart phone, then one may be able to download, into the smart phone's memory, a software application that allows one to use the smart phone to control the sleep-apnea-treatment system420. In addition to the remote-control device484, or as an alternative to the remote-control device, the collar440can include the input device98(FIGS. 8 and 45), which can be, for example, a keypad or a display screen, and which can be configured to allow one to control, to input data into the memory130of, or to retrieve data from the memory of, the sleep-apnea-treatment system420. Furthermore, the remote-control device484can be part of, or separate and distinct from, the sleep-apnea-treatment system420(e.g.,FIGS. 26-32).

FIG. 38is an isometric side view of the subject405wearing the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-32, according to an embodiment in which the system includes one or more sensors490, which are located other than on a rear side452of the collar440as are the one or more sensors456ofFIG. 31.

The one or more sensors490are mounted to an adjustable arm492, which is attached to, or integral with, the collar440, and which can be made from any suitable material such as metal or plastic. For example, the arm492can include a joint494about which one can rotate an upper section496of the arm in a plane parallel to a plane in which a lower section498of the arm lies. Furthermore, the arm492can include another joint500disposed between the collar440and the lower-arm section498and about which one can rotate or swivel the lower-arm section. Moreover, one or both of the upper-arm and lower-arm sections496and498can be extendible or retractable, e.g., by telescoping. In addition, the sleep-apnea system420can include one or more motors to change the position of the one or more sensors490under the control of the controller134(FIGS. 8 and 45). Furthermore, the arm492can be structurally and functionally configured in any other suitable manner. Moreover, although shown mounted to the end of the arm492, the one or more sensors490can be mounted to any other part of the arm.

The one or more sensors490can include any suitable types of sensors that are configured to sense respective physical quantities and to generate respective analog or digital electronic signals that represent respective parameters (e.g., magnitude, phase, frequency) of the corresponding quantities. For example, the one or more sensors490can include one or more gas sensors configured to sense one or more substances in the air exhaled by (e.g., the exhalant of) the subject405, or to sense a difference in levels of one or more substances in the ambient air and the levels of the same one or more substances in the subject's exhalant. Or, the one or more sensors490can include one or more sound sensors, such as microphones, configured to sense one or more sounds (e.g., snoring) made by the subject405. Alternatively, the one or more sensors490can include one or more cameras, or other vision sensors, configured to sense whether the subject405is awake or asleep by sensing whether the subject's eyes502are opened or closed. Furthermore, the one or more sensors490can include one or more accelerometers or gyroscopes (e.g., microelectromechanical (MEMS) accelerometers or gyroscopes) to sense motion of the subject405or to sense the force at which the subject exhales air.

FIG. 39is an isometric exploded view of the gasket assembly422and of the collar440of the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-32 and 38, according to an embodiment in which the sleep-apnea system includes one or more electrodes510located at any suitable position(s) of the collar, such as on the rear side452of the collar at collar ends512and514.

FIG. 40is a cutaway side view of a gasket516of the gasket assembly422ofFIGS. 26-34 and 39, according to an embodiment.

Referring toFIGS. 39-40, a front518of the gasket assembly422includes an engagement portion (e.g., a “lip”)520, and a rear522of the gasket assembly includes the gasket516.

The engagement portion520of the gasket assembly422is disposed about a perimeter524of the gasket assembly422and is configured to removably engage a rim526disposed about the perimeter442of the collar440. For example, the engagement portion520can engage the rim526by “snapping” onto the rim, and can disengage the rim by “snapping” off of the rim. Alternatively, the engagement portion520can attach to the rim526with an adhesive (not shown inFIGS. 39-40), or with pins (not shown inFIGS. 39-40) that are disposed on the engagement portion and that “snap” into and out of receptacles (not shown inFIGS. 39-40) disposed in the rim. Furthermore, the engagement portion520can be formed from any suitable material that is flexible and elastomeric enough to flex with the collar440and, e.g., to allow “snapping” of the engagement portion onto and off from the collar rim526.

The gasket522is configured to form an airtight seal with the neck400of the subject405(e.g.,FIG. 38) wearing the sleep-apnea-treatment system420ofFIGS. 26-32 and 38. The gasket522can be mounted to the front518of the gasket assembly422, e.g., by adhesive, such that the gasket is removable/replaceable independently of the front of the gasket assembly; or, the gasket can be permanently attached to, or integral with, the front of the gasket assembly. Furthermore, the gasket522can be formed from any material suitable for forming an airtight seal with the subject's neck400; examples of such material include foam, foam rubber, rubber, and a gel. Moreover, referring toFIG. 40, the gasket522can include channels528, which have openings530configured to be contiguous with skin532of the subject's neck400such that when a vacuum is pulled through the channels, the gasket is pulled or “sucked” against the skin to form a tighter seal than may be obtainable with only the strap assembly424(e.g.,FIG. 32). For example, the channels528can include openings (not shown inFIGS. 39-40) on an interior-facing side534of the gasket-assembly front516such that the vacuum pulled through the one or more outlet openings454(FIG. 31) to create a negative-pressure region between the collar440and a subject's neck400is also pulled through the channels528. Alternatively, the collar rim526, and also the gasket-assembly front516, can include one or more vacuum channels (not shown inFIGS. 39-40) that are configured to allow a pump that generates the negative-pressure region to communicate with the channels528independently of the negative-pressure region. In addition, one can enhance the seal formed by the gasket522by applying a sealant, such as a gel or foam, to the surface of the gasket that is configured to contact the skin before the subject405“puts on” the sleep-apnea system420. This sealant can also moisturize and otherwise soothe or heal the subject's skin to prevent marks, sores, or a rash in the area in which the gasket522contacts the skin. Furthermore, the gasket522can include one or more of the sealant-dispensing openings210(FIG. 15) through which a sealant-dispenser assembly124(FIGS. 8 and 45) can dispense a sealant from a sealant reservoir146(FIGS. 8 and 45) to form a seal, or to stop a leak in the seal, as described above in conjunction withFIGS. 8 and 15. Moreover, the seal formed by the gasket522can be enhanced by a replaceable and disposable self-adhesive sealing member (not shown inFIGS. 39-40) that has one side configured to adhere to the skin-facing surface of the gasket522, and has another side configured to contact the skin and having an adhesive or other substance to enhance the seal with the skin. One could replace such a sealing member periodically, e.g., daily prior to each use, and more often than one replaces the gasket522and gasket assembly422.

Referring again toFIG. 39, the one or more electrodes510(two electrodes510aand510bshown inFIG. 39) can function as sensors, as therapy-applying devices, or as both sensors and therapy-applying devices. For example, while functioning as sensors, the controller134(FIGS. 8 and 45), or other circuitry, of the sleep-apnea-treatment system420can be configured to measure a voltage across the electrodes510aand510b, and to measure respective currents into or out of the electrodes, where the voltage, currents, or both the voltage and currents (e.g., magnitude, phase of voltage or currents) can indicate a level of sleep apnea being experienced by the subject405(e.g.,FIG. 38), or can indicate a condition or parameter of the subject such as blood pressure, blood-sugar level, blood-oxygen level, and body or skin temperature. And while functioning as therapy-applying devices, the controller134, or other circuitry, of the sleep-apnea-treatment system420can be configured to apply a voltage across the electrodes510aand510b, and to apply respective currents into or out of the electrodes to treat the subject405(e.g., the controller/circuitry can be configured to control the magnitudes and phases of the voltage and currents). Examples of such treatments include reducing a level of sleep apnea, reducing high blood pressure, reducing high blood-sugar level, and increasing low blood-oxygen level. Examples of how the controller134or circuitry can effect such treatments include changing body or skin temperature, and relaxing, tensing, or “shocking” the muscles and other tissues, e.g., in the subject's neck or throat. Any data collected from the subject may be stored and/or shared with other devices (e.g., a physician, a database of other users, a mobile device, tablet, social media, etc.)

FIG. 41is an isometric exploded view of the gasket assembly422, the collar440, and a sleeve534of the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-32 and 38, according to an embodiment. The sleeve534can be configured for disposal between the collar440and the gasket assembly422, and can be held in place in any suitable manner. For example, one can install the sleeve534against, or adjacent to, the rear surface454of the collar440, and then secure the sleeve in place by “snapping” the gasket assembly422to the collar rim526as described above in conjunction withFIGS. 39-40. Or, one can secure the sleeve534to the collar440or gasket assembly422with an adhesive. Furthermore, the sleeve534can be made from any suitable material, such as a soft, breathable, moisture-wicking fabric, to make the sleep-apnea system420more comfortable to the subject405(e.g.,FIG. 38), as compared to the sleep-apnea system without the sleeve, while still allowing the sleep-apnea system to draw a vacuum through the sleeve to create a negative-pressure region between the sleeve and the subject's neck400(e.g.,FIG. 38). Moreover, some or all of the sleep-apnea-system components (e.g., pump, motor, controller, battery, temperature sensor, temperature adjuster) can be secured to, or disposed within one or more compartments formed in, the sleeve534. In addition, the sleeve534can be machine washable and replaceable; if there are components secured to or disposed within the sleeve, then these components can be discarded with a used sleeve and replaced with a new sleeve, or the components can be removed from the used sleeve and reinstalled with the new sleeve. Furthermore, the sleeve534can be configured to extend partially or fully around the subject's neck400.

FIG. 42is an isometric view of the sleep-apnea-treatment system420ofFIGS. 26-32 and 38, according to an embodiment in which the sleep-apnea system includes a rechargeable battery110(FIGS. 8 and 45).

FIG. 43is an isometric top view of an empty charging-and-storage case540for the sleep-apnea treatment system420ofFIG. 41, according to an embodiment.

FIG. 44is an isometric front view of the sleep-apnea-treatment system420ofFIG. 42inside of the charging-and-storage case540ofFIG. 43, according to an embodiment.

Referring toFIGS. 42-44, the sleep-apnea system420includes electrically conductive charging contacts542, which are configured to engage electrically conductive charging contacts544disposed in the case540while the sleep-apnea system is being stored in the case.

The charging-and-storage case540can be made from any suitable material, and can have any suitable configuration. For example, the charging case540can be made from a plastic and can have a rear-hinged clamshell configuration such as shown inFIGS. 43-44.

Furthermore, the charging-and-storage case540is configured to receive a power signal (e.g., an input voltage or an input current) from a power source (not shown inFIGS. 42-44) such as a standard alternating-current (AC) wall outlet (110 or 220 VAC), an AC adapter (e.g., a “wall wart”), a solar cell, and another battery, and can receive the power signal either via a wired connection (e.g., a power cord) or wirelessly (e.g., inductively or otherwise electromagnetically).

Either the sleep-apnea system420or the charging-and-storage case540includes battery-charging circuitry (not shown inFIGS. 42-44) that is configured to convert the power signal from the power source into a charging signal (e.g., a charging current or a charging voltage) suitable for charging the battery110(FIGS. 8 and 45) on board (e.g., in the compartment462ofFIG. 34) the sleep-apnea system420. If the sleep-apnea system420includes the battery-charging circuitry, then the case540provides to the battery-charging circuitry, via the charging contacts542and544, the power signal from the power source to which the case is coupled. But if the case540includes the battery-charging circuitry, then the case provides to the battery110, via the charging contacts542and544, the charging signal. In an embodiment, the case540includes the battery-charging circuitry to reduce the size and weight of the sleep-apnea system420.

Alternatively, the sleep-apnea system420and the charging-and-storage case540can omit the contacts542and544, and the case can be configured to provide the power signal, or the charging signal, to the sleep-apnea system in a wireless manner. For example, the case540can be configured to provide the power signal or charging signal to the sleep-apnea system420inductively, i.e., in a manner similar to the manner in which a card reader provides a power signal to circuitry on board a smart card.

FIG. 45is a block diagram of a component module550of the negative-pressure sleep-apnea-treatment system420ofFIGS. 26-32, 38, 42, and 44, according to an embodiment. For example, the component module550can be partially or fully disposed within the collar compartment462of the collar440(FIG. 34); if only partially disposed within the compartment, then the remaining portions of the component module can be disposed in other sections of the collar, the gasket assembly422, or outside of the collar and gasket assembly.

Unless stated otherwise, the structures and functions of the components of the component module550can be the same as, or similar to, the structures and functions of the corresponding components of the component module74ofFIG. 8; therefore, like components of the component module550are identified with the same reference numerals as corresponding components of the component module74.

And, unless stated otherwise, the sleep-apnea system420ofFIGS. 26-32, 38, 42, and 44, and the component module550and its components, can be configured to operate according to the flow diagram270ofFIG. 23.

In addition to the structure and functions of the power-switch assembly100described above in conjunction withFIG. 8, the power-switch assembly can include the switch480and other circuitry described above in conjunction withFIG. 36. Furthermore, in addition to be operated manually, the power-switch assembly100can be operated, e.g., to turn the sleep-apnea system420“on” (activate) and “off” (deactivate), by a remote-control device such as the remote-control device484(FIG. 37). Moreover, the power-switch assembly100can be operated to activate and deactivate the sleep-apnea system420while the sleep-apnea system is disposed in a base or case (e.g., the case540ofFIGS. 43-44), or while the sleep-apnea system is attached to a vacuum hose (not shown inFIG. 45), in which case the power-switch assembly can be configured to allow the subject405(e.g.,FIG. 38) to activate and deactivate a vacuum source disposed in a base unit to which the hose is attached. In addition, the power-switch assembly100can be configured to automatically deactivate the sleep-apnea system420when the subject405removes the sleep-apnea system from his/her body. For example, the sleep-apnea system420can include a sensor (e.g., accelerometer, gyroscope, temperatures sensor, infrared sensor) configured to sense when the subject405puts on, or takes off, the sleep-apnea system420.

In addition to the functions of the motor assembly116and the pump assembly118described above in conjunction withFIG. 8, controller134can be configured to activate the motor assembly, and, therefore, to drive the one or more pumps of the pump assembly, intermittently to save power as compared to activating the motor and driving the one or more pumps continuously. For example, the controller134can be configured to operate the motor assembly116and pump assembly118using hysteresis as follows to open the subject's airway14(FIG. 1). The controller134is configured to activate the motor assembly116to drive one or more pumps of the pump assembly118until the magnitude of negative pressure in one or more pressure regions equals or exceeds a magnitude of a first threshold. The controller134is configured then to deactivate the motor assembly116until the magnitude of the negative pressure falls to, or below, a magnitude of a second threshold that is less than the magnitude of the first threshold. In response to the magnitude of the negative pressure equaling or being less than, the magnitude of the second threshold, the controller134is configured to activate the motor assembly116to repeat the hysteresis cycle.

Furthermore, in addition to the components described above in conjunction with the component module74ofFIG. 8, the component module550includes at least a communication circuit552, a condition-and-other-sensor assembly554, and a therapy assembly556.

The communication circuit552is configured to allow the controller134to communicate with a remote device, such as a remote computer system or a remote device such as the remote-control device484(FIG. 37). For example, the communication circuit552can include circuitry, a connector, and an antenna that are configured to allow the controller134to communicate with a remote device over a wired Ethernet® connection, and over a wireless channel, such as a Bluetooth®, Wi-Fi®, Zigbee®, infrared, or radio-frequency (RF) channel. The controller134is configured, e.g., to receive instructions and settings from the remote device, to provide to the remote device status, usage, and other information regarding the sleep-apnea system420(FIGS. 26-32, 38, 42, and 44), and to provide to the remote device information regarding the subject405(e.g.,FIG. 38), who uses the sleep-apnea system. Examples of such instructions and settings include a maximum negative-pressure threshold for the one or more negative-pressure regions generated by the sleep-apnea system420, a wake-up time, and whether to dispense a sealant with the sealant-dispenser assembly124. Examples of status, usage, and other information include the charge level of the battery110, hours that the subject405has used the sleep-apnea system420, and a profile of detected apnea events (e.g., a profile of the degrees/magnitudes of apnea events, the number of apnea events per unit time, the average change in the degrees/magnitudes of apnea events, and the change in the number of apnea events per unit time), and whether it is time to replace one or more specified components of the sleep-apnea system. And examples of information regarding the subject405include a profile (e.g., magnitude, phase, change in magnitude, and change in phase) of physical conditions or parameters (e.g., blood pressure, blood-sugar level) of the subject over time. Furthermore, the communication circuit552can be configured to allow the controller134to upload this information to a database, such as a cloud database. Moreover, if the controller134is configured to operate by executing software instructions, or is otherwise software or firmware configurable, then the controller can be configured to download software and firmware via the communication circuit552.

Still referring toFIG. 45, the condition-and-other-sensor assembly554can include one or more sensors that are configured to sense one or more conditions of the subject405(e.g.,FIG. 45), or other conditions, for reasons other than detecting a level of sleep apnea being experienced by the subject, and for reasons other than detecting a level of negative pressure generated between the collar440(e.g.,FIG. 44) and the neck400(e.g.,FIG. 38) of the subject405. For example, the assembly554can include one or more sensors configured to detect conditions (e.g., blood pressure, blood-sugar level, body-movement level, sleep quality) that indicate a level of health or comfort of the subject405. Furthermore, the assembly554can include one or more sensors configured to detect conditions of the subject's usage (e.g., when the subject falls asleep, when the subject awakens, when the subject puts on and removes) of the sleep-apnea treatment system420, and conditions (e.g., ambient temperature, level of ambient light, level of ambient/background noise, level of pollution) of the environment in which the subject405is immersed while using the sleep-apnea system.

Following are descriptions of sensors that can be included in the apnea-degree sensor assembly128, in the condition-and-other-sensor assembly554, or in both of the sensor assemblies128and554. For example, each sensor assembly128and554can include a respective sensor of a same type (e.g., pulse oximetry), or the assemblies128and554effectively can share such a sensor, which the controller134can use, e.g., to determine a level of sleep apnea being experienced by the subject405(e.g.,FIG. 38) and to determine a condition of the subject for purposes other than determining a level of sleep apnea being experienced by the subject.

For example, one or both of the sensor assemblies128and554can include a conventional pulse-oximetry (pulse-ox) sensor, which is configured to generate a signal indicative of a level of oxygen in the subject's blood, and which also can be configured to generate a signal indicative of the subject's heart rate.

There are two types of pulse-ox sensor: a reflective type, and a transmissive type. Although only the reflective type of pulse-ox sensor is described in detail herein, the assemblies128and554can also include the transmissive type of pulse-ox sensor.

A reflective pulse-ox sensor transmits, into the skin of the subject405, two signals at respective near-infrared (IR) wavelengths, and a blood vessel of the subject redirects portions of the first and second signals back to the pulse-ox sensor. The amplitude of the received redirected portion of the first signal is independent of the amount of oxygen being carried by the hemoglobin in the blood flowing through the blood vessel; therefore, the first signal acts as a reference signal. In contrast, the amplitude of the received redirected portion of the second signal is proportional to the amount of oxygen being carried by the hemoglobin in the blood flowing through the blood vessel. Because both the first and second signals experience the same attenuation from the tissues through which they propagate, the difference in the amplitudes of the signals is proportional to the level of oxygen in the subject's blood.

The reflective pulse-ox sensor is configured to receive the redirected portions of the first and second signals, and circuitry in the sensor, or separate from the sensor (e.g., in the sensor assembly128, the sensor assembly554, the controller134, or elsewhere in the component module550), is configured to determine, in a conventional manner, a pulse-ox reading in response to the difference in the amplitudes of the received redirected portions of the first and second signals.

Circuitry in the sensor, or separate from the sensor, can also be configured to determine the subject's heart rate in response to the difference in the amplitudes of the received redirected portions of the first and second signals. Because there is always some oxygen in the blood of a living subject405, during a high-pressure (i.e., systolic) portion of the subject's cardiac cycle, the amplitude of the redirected portion of the second signal is higher because there is more blood, and, therefore, more total oxygen, in the portion of the blood vessel on which the two transmitted IR signals are incident; similarly, during a low-pressure (i.e., diastolic) portion of the cardiac cycle, the amplitude of the redirected portion of the second signal is lower because there is less blood, and, therefore, less total oxygen, in the portion of the blood vessel on which the two transmitted IR signals are incident. Therefore, passing a signal that represents the difference between the amplitudes of the first and second received redirected signals through a bandpass filter having a pass band of approximately 50 Hz to 300 Hz results in a filtered signal having a frequency that is approximately equal to the subject's heart rate.

If the pulse-ox sensor is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the pulse-ox sensor to determine a degree of sleep apnea being experienced by the subject405(e.g.,FIG. 38). While a subject's airway14(FIG. 1) is obstructed during an obstructive-sleep-apnea event, the level of oxygen reaching the subject's blood via his/her lungs is reduced, and his/her heart rate becomes elevated. Therefore, by detecting at least one of a decrease in blood oxygen level and an increase in heart rate, the controller134can determine that the subject is experiencing a sleep-apnea event, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat region407(FIGS. 24-25)) to alleviate the obstruction.

In some cases, the time between commencement of an airway obstruction and a measurable decrease in blood-oxygen level, or a measurable increase in heart rate, may be too long for blood-oxygen level or heart rate to be used as an indicator of sleep-apnea to which the controller134responds.

But even in these cases, a low blood-oxygen level or an elevated heart rate can be used as an indicator that the subject405is still recovering from a sleep-apnea event that the controller134detected via sensing of another marker.

And if the pulse-ox sensor is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the pulse-ox sensor to determine a health condition or other parameter of the subject405. For example, a low blood-oxygen level, or an elevated, depressed, or erratic heart rate, over an extended period of time, can indicate that the subject405has a health problem such as a chronic obstructive pulmonary disease (COPD), or a heart problem such as atrial fibrillation or another heart arrhythmia, congestive heart failure, or blood-vessel blockage. Therefore, in response to such information from the pulse-ox sensor, the controller134can be configured to warn the subject405, via the output device140or the communication circuit552, of the abnormal parameter and suggest that the subject see a doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal parameter and to inform the subject405, or the subject's doctor, via the output device140or the communication circuit552.

Still referring toFIG. 45, one or both of the sensor assemblies128and554can include an audio sensor, such as a piezoelectric microphone, which is configured to generate a signal indicative of a level of sound that it receives.

Circuitry in the audio sensor, or separate from the audio sensor, can be configured to filter, or otherwise to process, the signal generated by the audio sensor so that the controller134can glean information from the signal. For example, the circuitry can be configured to filter the sensor signal to yield a filtered signal having a frequency approximately equal to the subject's breathing rate. Or, the circuitry can be configured to analyze, spectrally, the sensor signal to yield breathing sounds made by the subject405(e.g.,FIG. 38), or to yield a breathing volume of the subject.

If the audio sensor is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the audio sensor to determine a degree of sleep apnea being experienced by the subject405. For example, in response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the breathing sounds (e.g., snoring) that the subject405makes can change, the subject's breathing rate can change, or the subject's breathing volume (i.e., the amount of air inhaled or exhaled) can change. As stated above, circuitry can be configured to process the signal generated by the audio sensor, and the controller134can be configured to determine, in response to the processed signal, whether a subject is experiencing a sleep-apnea event, and the level or degree of such an event. For example, the controller134can be configured to determine, in response to the processed signal, a breathing-sound profile of the subject405over time, and the look-up table (LUT)148can store representations of, and correlate, different breathing-sound profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined breathing-sound profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject405in response to the sensed breathing sounds, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat area407(FIGS. 24-25)). Similarly, the controller134can be configured to determine a breathing-rate or breathing-volume profile of the subject405, and the LUT148can store and correlate different breathing-rate or breathing-volume profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined breathing-rate or breathing-volume profile (or the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject in response to the sensed breathing rate or sensed breathing volume, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat area407(FIGS. 24-25)) to alleviate the obstruction.

If the audio sensor is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the audio sensor to determine a health condition or other parameter of the subject. For example, a low breathing rate, or a low breathing volume, over an extended period of time can indicate that the subject has a health problem such as a chronic obstructive pulmonary disease (COPD) or an airway obstruction that the sleep-apnea system420cannot alleviate. Therefore, in response to such information from the audio sensor, the controller134can be configured to warn the subject405, via the output device140or communication circuit552, of the abnormal parameter and suggest that the subject see a doctor. Or, the controller134even can be configured to diagnose the problem responsible for the abnormal parameter, and to provide the diagnosis to the subject405or the subject's doctor via the output device140or the communication circuitry552.

Furthermore, one or both of the sensor assemblies128and554can include a motion sensor, such as a MEMS accelerometer or gyroscope, which can be configured to generate a signal indicative of a level of motion that it experiences, e.g., due to movement of the subject405(e.g.,FIG. 38).

Circuitry in the motion sensor, or separate from the motion sensor, can be configured to filter, or otherwise to process, the signal generated by the motion sensor so that the controller134can glean information from the signal. For example, the motion sensor can be configured to sense the rising and falling of the subject's chest (not shown inFIG. 45) as he/she breathes, where the frequency of this rising and falling is the subject's breathing rate, and the amplitude of this rising and falling is proportional to the subject's breathing volume. Therefore, the circuitry can be configured to filter the sensor signal to yield a filtered signal having a frequency approximately equal to the subject's breathing rate. Or, the circuitry can spectrally analyze the sensor signal to yield a representation of other breathing movements (e.g., coughing or gasping) made by the subject405, or to yield a representation of the breathing volume of the subject. In addition, if the motion sensor is close enough to one of the subject's carotid arteries, then the circuitry can be configured to filter the sensor signal to yield a filtered signal having a frequency equal to the subject's heart/pulse rate.

If the motion sensor is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the motion sensor to determine a degree of sleep apnea being experienced by the subject405. In response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the breathing movements (e.g., vibrations from snoring, rising and falling of chest, coughing, gasping) that the subject405makes can change, the subject's breathing rate can change, the subject's breathing volume can change, and the subject's heart rate can change. As stated above, circuitry can be configured to process the signal generated by the motion sensor, and the controller134can be configured to determine, in response to the processed signal, whether the subject405is experiencing a sleep-apnea event, and the degree/level of such an event. For example, the controller134can be configured to determine, in response to the processed signal, a breathing-movement profile of the subject405, and the LUT148can store and correlate different breathing-movement profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined breathing-movement profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject405in response to the sensed breathing movements, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat region407(FIGS. 24-25)). Similarly, the controller134can be configured to determine a breathing-rate, breathing-volume, or heart-rate profile of the subject405, and the LUT148can store and correlate different breathing-rate, breathing-volume, or heart-rate profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined breathing-rate, breathing-volume, or heart-rate profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject in response to the sensed breathing rate, breathing volume, or heart rate, and can take appropriate action to reduce the degree of, or eliminate, the airway obstruction.

If the motion sensor is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the motion sensor to determine a health condition or other parameter of the subject. For example, excessive body movement over an extended period of time can indicate that the subject405is not sleeping comfortably or deeply enough, is sleepwalking, or has restless-leg syndrome. Therefore, in response to such information from the motion sensor, the controller134can be configured to warn the subject405or his/her doctor, via the output device140or the communication circuitry552, of the abnormal parameter, and to suggest that the subject see his/her doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal parameter, and to provide the diagnosis to the subject405or to the subject's doctor via the output device140or the communication circuitry552.

Moreover, one or both of the sensor assemblies128and554can include a stroke-volume sensor, such as micro-impulse radar transceiver, which can be configured to generate a signal indicative of a stroke volume, or a change in stroke volume, of the subject's heart (stroke volume is the volume of blood that the left ventricle pumps during a cardiac cycle).

Circuitry in the stroke-volume sensor, or separate from the stroke-volume sensor, can be configured to filter, or otherwise to process, the signal generated by the stroke-volume sensor so that the controller134can glean the stroke volume of the subject's heart from the signal. For example, the signal generated by the sensor can represent images of the left ventricle over time, and the circuitry can filter the signal such that the amplitude of the filtered signal is proportional to the stroke volume (the difference between the left ventricle at its largest volume and at its smallest volume).

If the stroke-volume sensor is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the stroke-volume sensor to determine a degree of sleep apnea being experienced by the subject405. In response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the stroke volume of the subject's heart may increase as the heart tries to provide more oxygen to the subject's tissues with blood that is less oxygenated than blood outside of an obstructive-sleep-apnea event. That is, the stroke volume increases to compensate for the lower level of oxygen in the subject's blood due to the airway obstruction. As stated above, circuitry can be configured to process the signal generated by the stroke-volume sensor, and the controller134can be configured to determine, in response to the processed signal, whether a subject is experiencing a sleep-apnea event, and the degree/level of such an event. For example, the controller134can be configured to determine, in response to the processed signal, a stroke-volume profile of the subject405, and the LUT148can store and correlate different stroke-volume profiles of the subject with respective degrees/levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined stroke-volume profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject405in response to the sensed stroke volume, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat region407(FIGS. 24-25)) to alleviate the obstruction.

In some cases, the time between commencement of an airway obstruction and a measurable increase in stroke volume is too long for stroke volume to be used as a sleep-apnea marker to which the controller134responds.

But even in these cases, the stroke volume can be used as an indicator that the subject405is still recovering from a sleep-apnea event that was detected via sensing of another sleep-apnea marker (e.g., breathing sound).

If the stroke-volume sensor is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the stroke-volume sensor to determine a health condition or other parameter of the subject405. For example, excessive or low stroke volume over an extended period of time while the subject405is sleeping can indicate that the subject is not sleeping comfortably or deeply enough, is sleepwalking, or has a heart problem such as congestive heart failure. Therefore, in response to such information from the stroke-volume sensor, the controller134can be configured to warn the subject405or his/her doctor, via the output device140or the communication circuitry552, of the abnormal stroke volume, and to suggest that the subject see a doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal stroke volume, and to provide the diagnosis to the subject or to the subject's doctor via the output device140or the communication circuitry552.

And because stroke volume occurs periodically, a stroke-volume sensor and its associated circuitry can also be configured to provide the heart rate of the subject405(e.g.,FIG. 38).

In addition, one or both of the assemblies128and554can include a conventional gas sensor (e.g., a spectral gas sensor), which can be configured to generate a signal indicative of a fraction or level (e.g., by mass, volume, or number of molecules), or a change in a fraction or level, of a substance in a subject's exhalant (i.e., the air exhaled by the subject405). Examples of such a substance include water vapor, carbon dioxide (CO2), oxygen (O2), and volatile organic compounds (VOCs). And if the substance sensed is CO2, then the gas sensor can include a non-dispersive infrared CO2module.

Circuitry in the gas sensor, or separate from the gas sensor, can be configured to filter, or otherwise to process, the signal generated by the gas sensor so that the controller134can glean a fraction or level, or a change in the fraction or level, of a substance exhaled by the subject as compared to the total of substances exhaled by the subject.

If the gas sensor is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the gas sensor to determine a degree of sleep apnea being experienced by the subject405. In response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the fraction or level of a substance in the subject's exhalant can increase (e.g., CO2) or decrease (e.g., O2). As stated above, circuitry can be configured to process the signal generated by the gas sensor, and the controller134can be configured to determine, in response to the processed signal, whether the subject405is experiencing a sleep-apnea event, and the degree/level of such an event. For example, the controller134can be configured to determine, in response to the processed signal, an exhaled-substance profile of the subject405, and the LUT148can store and correlate different exhaled-substance profiles of the subject405with respective degrees/levels of airway obstruction that the subject is experiencing. By retrieving from the LUT148the degree/level of airway obstruction corresponding to the determined exhaled-substance profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction that the subject405is experiencing in response to the sensed exhaled substance, and can take appropriate action (e.g., increase the magnitude of the negative pressure being applied to the subject's throat region406or throat region407(FIGS. 24-25)) to alleviate the obstruction.

If the gas sensor is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the gas sensor to determine a health condition or other parameter of the subject405. For example, exhaling an excessive fraction or level of CO2over an extended period of time while the subject405is sleeping can indicate that the subject is not sleeping comfortably or deeply enough, or has a lung problem. Therefore, in response to such information from the gas sensor, the controller134can be configured to warn the subject405or his/her doctor, via the output device140or the communication circuitry552, of the abnormal exhalant profile, and to suggest that the subject see a doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal exhalant profile, and to provide the diagnosis to the subject405or his/her doctor via the output device140or the communication circuitry552.

Still referring toFIG. 45, one or both of the assemblies128and554can include a conventional chemical sensor, which can be configured to generate a signal indicative of a fraction or level (e.g., by mass, volume, or number of molecules), or a change in a fraction or level, of a sensed substance (e.g., in a liquid or a gas phase) in, for example, the subject's sweat, exhalant, saliva, lipids, or tears. Examples of such a substance include hormones such as cortisol, alcohol, water vapor, carbon dioxide (CO2), oxygen (O2), and volatile organic compounds (VOCs).

Circuitry in the chemical sensor, or separate from the chemical sensor, can be configured to filter, or otherwise to process, the signal generated by the chemical sensor so that the controller134can glean a fraction or level, or a change in the fraction or level, of a substance excreted by the subject405as compared to the total of substances excreted by the subject.

If the chemical sensor is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the chemical sensor to determine a degree/level of sleep apnea that the subject405is experiencing. In response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the fraction or level of a substance that the subject405excretes can increase (e.g., cortisol) or decrease. As stated above, circuitry can be configured to process the signal generated by the chemical sensor, and the controller134can be configured to determine, in response to the processed signal, whether the subject405is experiencing a sleep-apnea event, and the degree/level of such an event. For example, the controller134can be configured to determine, in response to the processed signal, a sweat- or saliva-substance profile of the subject405, and the LUT148can store and correlate different sweat- and saliva-substance profiles of the subject with respective levels of airway obstruction being experienced by the subject405. By retrieving from the LUT148the level of airway obstruction corresponding to the determined sweat- and saliva-substance profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction that the subject405is experiencing in response to the sensed excreted substance, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subjects throat region406or throat region407(FIGS. 24-25)) to alleviate the obstruction.

If the chemical sensor is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the chemical sensor to determine a health condition or other parameter of the subject's wellbeing. For example, sweating out an excessive fraction or level of cortisol over an extended period of time while the subject405is sleeping can indicate that the subject is not sleeping comfortably or deeply enough; similarly sweating out an excessive fraction or level of alcohol over an extended period of time while the subject is sleeping can indicate that the subject is drunk, and, therefore, may have a drinking problem. Therefore, in response to such information from the chemical sensor, the controller134can be configured to warn the subject405or his/her doctor, via the output device140or the communication circuitry552, of the abnormal excretion profile, and to suggest that the subject see his/her doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal excretion profile, and to provide the diagnosis to the subject405or his/her doctor via the output device140or the communication circuitry552.

Furthermore, one or both of the sensor assemblies128and554can include an electroencephalogram (EEG) sensor assembly, which is configured to generate one or more signals that represent electrical activity in a brain of a subject405(e.g.,FIG. 38). The EEG sensor assembly can include one or more sensors that are attached to, or are part of, the collar440, or that are remote from the collar (an example of such a remote sensor is an epidermal electronic sensor, which can be printed, or otherwise attached or mounted, directly onto a subject's skin).

Circuitry in the EEG sensor assembly, or separate from the EEG sensor assembly, can be configured to filter, or otherwise to process, the one or more signals generated by the EEG sensor assembly so that the controller134can glean information from the one or more signals. For example, the circuitry can be configured to filter one or more of the one or more sensor signals to yield one or more filtered signals that represent a sleep state, or other condition, of the subject405. Or, the circuitry can be configured to analyze, spectrally, the one or more of the one or more sensor signals to yield the sleep state or other condition of the subject405.

If the EEG sensor assembly is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the EEG sensor assembly to determine a degree of sleep apnea being experienced by the subject405. For example, in response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the sleep state of the subject405can change, or the electrical activity in the subject's brain can otherwise change. As stated above, circuitry can be configured to process the one or more signals generated by the EEG sensor assembly, and the controller134can be configured to determine, in response to the processed one or more signals, whether a subject is experiencing a sleep-apnea event, and the level or degree of such an event. For example, the controller134can be configured to determine, in response to the one or more processed signals, a sleep-state profile or a brain-wave profile of the subject405over time, and the look-up table (LUT)148can store representations of, and correlate, different sleep-state and brain-wave profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined sleep-state or brain-wave profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject405in response to the sensed sleep state or brain electrical activity, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat area407(FIGS. 24-25)).

If the EEG sensor assembly is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the EEG sensor assembly to determine a health condition or other parameter of the subject. For example, a poor sleep-state profile (e.g., not entering one or more sleep states, staying in a sleep state for too short or too long a time) over an extended period of time can indicate that the subject has a health problem such as a chronic obstructive pulmonary disease (COPD), an airway obstruction that the sleep-apnea system420cannot alleviate, or a mental problem that is interfering with a subject's sleep. Therefore, in response to such information from the EEG sensor assembly, the controller134can be configured to warn the subject405, via the output device140or communication circuit552, of the abnormal parameter (e.g., poor sleep-state profile) and suggest that the subject see a doctor. Or, the controller134even can be configured to diagnose the problem (e.g., anxiety) responsible for the abnormal parameter, and to provide the diagnosis to the subject405or the subject's doctor via the output device140or the communication circuitry552.

Moreover, one or both of the sensor assemblies128and554can include an electrocardiogram (EKG) sensor assembly, which is configured to generate one or more signals that represent electrical activity in a heart of a subject405(e.g.,FIG. 38). The EKG sensor assembly can include one or more sensors that are attached to, or are part of, the collar440, or that are remote from the collar (an example of such a remote sensor is an epidermal electronic sensor, which can be printed, or otherwise attached or mounted, directly onto a subject's skin).

Circuitry in the EKG sensor assembly, or separate from the EKG sensor assembly, can be configured to filter, or otherwise to process, the one or more signals generated by the EKG sensor assembly so that the controller134can glean information from the one or more signals. For example, the circuitry can be configured to filter one or more of the one or more sensor signals to yield one or more filtered signals that represent a sleep state, or other condition or parameter, of the subject405. Or, the circuitry can be configured to analyze, spectrally, the one or more of the one or more sensor signals to yield the sleep state or other condition of the subject405.

If the EKG sensor assembly is included in the apnea-degree sensor assembly128, then the controller134can be configured to use the information provided by the EKG sensor assembly to determine a degree of sleep apnea being experienced by the subject405. For example, in response to the subject's airway14(FIG. 1) being obstructed during an obstructive-sleep-apnea event, the sleep state of the subject405can change, or the electrical activity in the subject's heart can otherwise change. As stated above, circuitry can be configured to process the one or more signals generated by the EKG sensor assembly, and the controller134can be configured to determine, in response to the processed one or more signals, whether a subject is experiencing a sleep-apnea event, and the level or degree of such an event. For example, the controller134can be configured to determine, in response to the one or more processed signals, a sleep-state profile or a heart-wave profile of the subject405over time, and the look-up table (LUT)148can store representations of, and correlate, different sleep-state and heart-wave profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined sleep-state or heart-wave profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject405in response to the sensed sleep state or heart electrical activity, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat area407(FIGS. 24-25)).

If the EKG sensor assembly is included in the condition-and-other-sensory assembly554, then the controller134can be configured to use the information provided by the EKG sensor assembly to determine a health condition or other parameter of the subject. For example, a poor sleep-state profile (e.g., not entering one or more sleep states, staying in a sleep state for too short or too long a time) over an extended period of time can indicate that the subject has a health problem such as a chronic obstructive pulmonary disease (COPD), an airway obstruction that the sleep-apnea system420cannot alleviate, heart disease, or another hear problem that is interfering with a subject's sleep. Therefore, in response to such information from the EKG sensor assembly, the controller134can be configured to warn the subject405, via the output device140or communication circuit552, of the abnormal parameter (e.g., poor sleep-state profile, poor heart-wave profile) and suggest that the subject see a doctor. Or, the controller134even can be configured to diagnose the problem (e.g., heart disease, atrial fibrillation) responsible for the abnormal parameter, and to provide the diagnosis to the subject405or the subject's doctor via the output device140or the communication circuitry552.

Furthermore, the controller134can be configured to determine a ballistocardiogram (BCG) from one or more of the subject's heart rate, variation in heart rate over time, change in stroke volume over time, and respiration rate, and can use the determined BCG to determine whether the subject405is experiencing a sleep-apnea event. For example, one or more of the above-described sensors in the apnea-degree sensor assembly128can sense the subject's heart rate, variation in heart rate over time, change in stroke volume over time, and respiration rate, and the sensors and their corresponding circuitry can generate signals representing these quantities. The controller134can be configured to determine, in response to the processed signal, a BCG profile of the subject405, and the LUT148can store and correlate different BCG profiles of the subject with respective levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined BCG profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction being experienced by the subject, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat region407(FIGS. 24-25)) to alleviate the obstruction.

Or, the controller134can be configured to use the determined BCG to determine a health condition or other parameter of the subject405. For example, an abnormal BCG can indicate that the subject405has a heart problem. Therefore, in response to an abnormal BCG, the controller134can be configured to warn the subject405or his/her doctor, via the output device140or the communication circuitry552, of the abnormal BCG, and to suggest that the subject see a doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal BCG, and to provide the diagnosis to the subject or his/her doctor via the output device140or the communication circuitry552.

Moreover, the controller134can be configured to determine a photoplethysmography (PPG) from information provided by a pulse-oximetry sensor, and to use the determined PPG to determine whether the subject405is experiencing a sleep-apnea event. The controller134can be configured to determine, in response to the processed signal from the pulse-oximetry sensor, a PPG profile of the subject405, and the LUT148can store and correlate different PPG profiles of the subject with respective degrees/levels of airway obstruction being experienced by the subject. By retrieving from the LUT148the level of airway obstruction corresponding to the determined PPG profile (or corresponding to the stored profile that most closely matches the determined profile), the controller134can determine the level of airway obstruction that the subject405is experiencing, and can take appropriate action (e.g., increasing the magnitude of the negative pressure being applied to the subject's throat region406or throat region407(FIGS. 24-25)) to alleviate the obstruction.

Or, the controller134can be configured to use the determined PPG to determine a health condition or other parameter of the subject405(e.g.,FIG. 38). For example, an abnormal PPG can indicate that the subject405has a lung or heart problem. Therefore, in response to an abnormal PPG, the controller134can be configured to warn the subject405or his/her doctor, via the output device140or the communication circuitry552, of the abnormal PPG, and to suggest that the subject see a doctor. Or, the controller140even can be configured to diagnose the problem responsible for the abnormal PPG, and to provide the diagnosis to the subject405or his/her doctor via the output device140or the communication circuitry552.

Still referring toFIG. 45, the therapy assembly556is configured to provide, under the control of the controller134, therapy to the subject405while he/she is wearing the negative-pressure sleep-apnea system420(FIGS. 26-32, 38, 42, and 44), according to an embodiment. For example, the therapy assembly556can include the electrodes510aand510b(FIG. 39), and can apply, via the electrodes, a current or voltage to open, or to maintain open, the subject's airway14(FIG. 1) by stimulating or “shocking” the subject405. The controller134can be configured to implement a feedback loop that adjusts the current or voltage applied via the electrodes510to open, and to maintain open, the subject's airway14. This loop can be in independent of, or combined with, a feedback loop that the controller134is configured to implement by adjusting a another parameter, e.g., the negative pressure within one or more of the pressure regions, to open, and to maintain open, the subject's airway14with the smallest magnitude of negative pressure possible. Where these feedback loops are independent, the controller134has at least two variables, pressure and temperature, that it can adjust to open, and maintain open, the subject's airway14. Furthermore, the therapy assembly556can include piezoelectric speakers and can be configured to generate, with the speakers, a sound, such as the sound of waves breaking onto a beach, that can soothe the subject405and can help the subject to sleep. Or, the therapy assembly556can be configured to sound an alarm with the speakers to awaken the subject405in response to the controller134detecting a sleep-apnea event that endures for a time that exceeds a safe-time threshold.

Still referring toFIG. 45, alternate embodiments of the component module550are contemplated. For example, alternate embodiments described above in conjunction withFIG. 8for the component module74may also be applicable to the component module550, and alternate embodiments described for the component module550may also be applicable to the component module74. Furthermore, the component module500may include components not disclosed herein, or may omit one or more of the components disclosed herein.

FIG. 46is an isometric view of a conventional thermoelectric couple (TEC)560of the auxiliary power source112of the component modules74and550(FIGS. 8 and 45), according to an embodiment. The TEC560is configured to harvest energy from the subject405(e.g.,FIG. 38) while the subject is wearing the negative-pressure sleep-apnea treatment system420(FIGS. 26-32, 38, 42, and 44). The power supply117of the component modules74and550can be configured to receive the energy harvested by the TEC560, and to convert the harvested energy into a power signal for powering one or more of the components of the component modules74and550and for charging the battery110.

The TEC560is configured to convert a temperature differential between a “hot” side562and a “cold” side564into a current through, and a voltage across, conductive terminals566and568. For example, the TEC560can be disposed in the sleep-apnea system420(FIGS. 26-32, 38, 42, and 44) such that the “hot” side562contacts a part (e.g., the neck400) of the subject's body, and the “cold” side564is exposed to the air. Because the normal body temperature of a human subject is approximately 98.6° F., and because a typical room temperature is approximately 68° F., the temperature differential across the “hot” and “cold” sides562and564is approximately 30° F. In response to such a temperature differential, one or more TECs560configured to have, in aggregate, a “hot” side562having an effective area of approximately 100 square millimeters (mm2), and a “cold” side564having an effective area of approximately 120 mm2, can generate approximately 5 milliwatts (mW) of power. The one or more TECs560can be disposed, for example, in the straps444and446(FIG. 32) of the sleep-apnea system420such that the “hot” side562of each TEC is adjacent to, or in contact with, the subject's neck400(e.g.,FIG. 38). Or, the one or more TECs560can be disposed along the inside surface452of the collar440(e.g.,FIG. 31), in the sleeve534(FIG. 41), or remote from the sleep-apnea system420(e.g., in an article of clothing such as a shirt or hat). If disposed remote from the sleep-apnea system420, then the one or more TECs560can transfer harvested power to the power supply117(FIGS. 8 and 45) via a wired or wireless connection.

Still referring toFIG. 46, further details of the TEC560, and of other energy-harvesting devices that the auxiliary power source112(FIGS. 8 and 45) can include, are disclosed in Bhatnagar et al.,Energy Harvesting for Assistive and Mobile Applications, Energy Science & Engineering, 3(3), pp. 153-173, (2015), which is incorporated herein by reference.

FIG. 47is an isometric view of a shape-adaptive triboelectric nanogenerator (saTENG) unit580, according to an embodiment.

FIG. 48is an isometric cutaway view of the saTENG unit580ofFIG. 47, according to an embodiment.

Referring toFIGS. 47-48, the saTENG unit580includes a conductive liquid electrode582disposed inside of a rubber layer or shell584. A conductor is inserted through an end of the shell584to provide a terminal or pin586for the electrode582. Examples of substances from which the electrode582can be formed include water and a solution of sodium chloride (NaCl).

FIG. 49is an isometric view of a saTENG power generator588, which includes the saTENG unit580ofFIGS. 47-48, according to an embodiment. The auxiliary power source112of the component modules74and550(FIGS. 8 and 45) includes the power generator588, which is configured to harvest energy from the subject405while he/she is wearing the negative-pressure sleep-apnea treatment system420(FIGS. 26-32, 38, 42, and 44). The power supply117(FIGS. 8 and 45) of the component modules74and550can be configured to receive the energy harvested by the power generator588, and to convert the harvested energy into a power signal for powering one or more of the components of the component modules, and for charging the battery110(FIGS. 8 and 45) of the component modules.

In addition to the saTENG unit580(FIGS. 47-48), the power generator588includes an electrode590having a nylon layer592and an aluminum layer594.

The power generator588is configured to convert motion and deformation (e.g., stretching and contracting) of the saTENG unit580relative to the electrode590into a current through, and a voltage across, conductive terminals596and598. For example, one or more power generators588can be disposed in the sleep-apnea system420such that movement of the subject's body (e.g., movement cause by breathing or tossing and turning) causes the respective saTENG unit580in each of the one or more power generators to move or deform relative to the respective electrode590. In response to such movement or deformation of the respective saTENG unit580in each of one or more power generators588, the power generators are configured to generate power to the power supply117(FIGS. 8 and 45) as described above. The one or more power generators588can be disposed, for example, in the straps444and446(FIG. 32) of the sleep-apnea system420. Or, the one or more power generators588can be disposed inside of, or can be otherwise secured to, the collar440(FIG. 31) or the sleeve534(FIG. 41), or can be located remote from the sleep-apnea system420, e.g., in an article of clothing such as a shirt or hat. If disposed remote from the sleep-apnea system420, then the one or more power generators588can be configured to transfer harvested power to the power supply117via a wired or wireless connection.

Referring again toFIGS. 47-49, further details of the saTENG unit580, of the power generator588, and of other energy-harvesting devices that the auxiliary power source112(FIGS. 8 and 45) can include, are disclosed in Yi et al.,A Highly Shape-Adaptive, Stretchable Design Based On Conductive Liquid For Energy Harvesting And Self-Powered Biomechanical Monitoring, Sci. Adv., pp. 1-10, 17 Jun. 2016, which is incorporated herein by reference.

FIG. 50is an isometric view of a saTENG power generator610, which includes the saTENG unit580ofFIGS. 47-48, according to another embodiment. The auxiliary power source112of the component modules74and550(FIGS. 8 and 45) includes the power generator610, which is configured to harvest energy from the subject405while he/she is wearing the negative-pressure sleep-apnea treatment system420(FIGS. 26-32, 38, 42, and 44). The power supply117(FIGS. 8 and 45) of the component modules74and550can be configured to receive the energy harvested by the power generator610, and to convert the harvested energy into a power signal for powering one or more of the components of the component modules and for charging the battery110(FIGS. 8 and 45) of the component modules.

In addition to the saTENG unit580ofFIGS. 47-48, the power generator610includes an aluminum electrode612.

FIG. 51is a charge diagram for the power generator610ofFIG. 50, the diagram showing how movement of the saTENG580relative to the electrode612displaces charge in electrodes582and612, according to an embodiment. As described below, it is in response to this displacement of charge that the power generator610generates a current and a voltage.

Referring toFIGS. 50-51, the operation of the power generator610is described, according to an embodiment.

The power generator610is configured to convert motion and deformation (e.g., stretching and contracting) of the saTENG unit580relative to the electrode612into a current through, and a voltage across, conductive terminals614and616by displacing charge in the electrodes582(FIG. 48) and612. For example, one or more power generators610can be disposed in the sleep-apnea system420such that movement of the subject's body (e.g., movement caused by breathing or tossing and turning) causes the respective saTENG unit580in each of the one or more power generators to move or deform relative to the respective electrode612. In response to such movement or deformation of the respective saTENG unit580in each of one or more power generators610, the power generators can generate power to the power supply117as described above. The one or more power generators610can be disposed, for example, in the straps444and446(FIG. 32) of the sleep-apnea system420. Or, the one or more power generators610can be disposed inside of, or can be otherwise secured to, the collar440(FIG. 31) or the sleeve534(FIG. 41), or can be located remote from the sleep-apnea system420, e.g., in an article of clothing such as a shirt or hat. If disposed remote from the sleep-apnea system420, then the one or more power generators610can transfer harvested power to the power supply117(FIGS. 8 and 45) via a wired or wireless connection.

Still referring toFIGS. 50-51, further details of the power generator610, and of other energy-harvesting devices that the auxiliary power source112(FIGS. 8 and 45) can include, are disclosed in Yi et al.,A Highly Shape-Adaptive, Stretchable Design Based On Conductive Liquid For Energy Harvesting And Self-Powered Biomechanical Monitoring, Sci. Adv., pp. 1-10, 17 Jun. 2016, which is incorporated herein by reference.

FIG. 52is an isometric transparent view of a TENG power generator620, according to another embodiment. The auxiliary power source112of the component modules74and550(FIGS. 8 and 45) includes the power generator620, which is configured to harvest energy from the subject405(e.g.,FIG. 38) while he/she is wearing the negative-pressure sleep-apnea treatment system420(FIGS. 26-32, 38, 42, and 44). The power supply117(FIGS. 8 and 45) of the component modules74and550can be configured to receive the energy harvested by the power generator620, and to convert the harvested energy into a power signal for powering one or more of the components of the component modules, and for charging the battery110(FIGS. 8 and 45) of the component modules.

The TENG power generator620includes a wrapper622, a TENG624disposed in the wrapper, and at least one supercapacitor, here two equal-sized supercapacitors,626and628, disposed in the wrapper and coupled to each other in electrical parallel to form, effectively, a single supercapacitor having a capacitance that is twice that of each of the supercapacitors626and628. The wrapper622is configured to be stretchable, and can be made from any suitable material such as silicone rubber.

FIG. 53is a cross section of the TENG624ofFIG. 52, according to an embodiment. The TENG624includes two electrodes630and632, a space634between the electrodes, and a portion636of the wrapper622disposed between the electrodes. The space634can be filled with any suitable material, such as air, and the electrodes630and632can be formed from any suitable material, such as a compound of carbon black (CB) and silicone rubber.

FIG. 54is a cross-sectional view of each of the supercapacitors626and628ofFIG. 52, according to an embodiment. Each supercapacitor626and628includes two electrodes638and640, a coating642on each of the electrodes, an electrolyte646disposed between the electrodes, and a wrinkled separator648disposed in the electrolyte. The electrodes638and640can be formed from any suitable material, such as the same material from which are formed the electrodes630and632of the TENG624ofFIG. 53. The coating642can be formed from any suitable material, such as a composite of an active material (e.g., soluble polypyrrole (PPy)) and a conducting additive (e.g., carbon black). The electrolyte646can be formed from any suitable material, such as a poly-vinyl-alcohol-(PVA)-phosphoric-acid-(H3PO4) gel. And the separator648, which prevents the electrodes638and640from short-circuiting together as the supercapacitors626and628are stretched or twisted, can be formed from any suitable material such as polyethylene.

Referring toFIGS. 52-54, the TENG power generator620is configured to generate power in response to the generator being deformed (e.g., stretched or twisted). In response to being deformed, the TENG624charges the supercapacitors626and628, which, like a battery, are configured to generate a voltage and a current with the stored charge. For example, one or more power generators620can be disposed in the sleep-apnea system420(FIGS. 26-32, 38, 42, and 44) such that movement of the subject's body (e.g., movement cause by breathing or tossing and turning) causes the respective TENG624in each of the one or more power generators to deform. In response to such deformation of the respective TENG624in each of one or more power generators620, the power generators can provide power to the power supply117(FIGS. 8 and 45) as described above. The one or more power generators620can be disposed, for example, in the straps444and446(FIG. 32) of the sleep-apnea system420, considering that the straps may be subject to stretching and twisting, particularly while a subject is putting on, or taking of, the sleep-apnea system420. Or, the one or more power generators620can be disposed inside of, or can be otherwise secured to, the collar440(FIG. 31) or the sleeve534(FIG. 41), or can be located remote from the sleep-apnea system420, e.g., in an article of clothing such as a shirt or hat. If disposed remote from the sleep-apnea system420, then the one or more power generators630can transfer harvested power to the power supply117(FIGS. 8 and 45) via a wired or wireless connection.

Still referring toFIGS. 52-54, further details of the power generator620, and of other energy-harvesting devices that the auxiliary power source112(FIGS. 8 and 45) can include, are disclosed in Yi et al.,Stretchable And Waterproof Self-charging Power System For Harvesting Energy From Diverse Deformation And Powering Wearable Electronics, American Chemical Society (ACS) Nano, 10, pp. 6519-6525, (2016), which is incorporated herein by reference.

FIG. 55is a block diagram of a system700, which includes the negative-pressure sleep-apnea-treatment system420(FIGS. 26-32, 38, 42, and 44), according to an embodiment. As described below, the system700can be configured to determine and to convey, to the subject450, lifestyle changes for reducing the frequency or severity of sleep-apnea events that the subject experiences, and can be configured to determine and to convey, to the subject, adjustments to the subject's usage of the sleep-apnea system420for improving the subject's wellbeing (e.g., health).

In addition to the sleep-apnea system420, the system700includes a client device702and computing circuitry704. The computing circuitry704and the sleep-apnea system420are configured to communicate with each other via a wired or wireless channel (e.g., a wired or wireless bus)706, the computing circuitry and the client device702are configured to communicate with each other via a wired or wireless channel708, and the sleep-apnea system and the client device are configured to communicate with each other via a wired or wireless channel710.

The client device702can include any device that is suitable for allowing the subject405(e.g.,FIG. 38), the sensors126and128of the component modules74and550(FIGS. 8 and 45), or the sensors554of the component module550to input data related to the subject's lifestyle and wellbeing. Examples of the client device702include a client computer such as a laptop computer, a tablet computer, or a smart phone, or one or more sensors that can sense conditions and other parameters of the subject405, such as blood pressure, mood, diet, degree of alertness, and whether the subject is awake or asleep.

And the computing circuitry704can include any circuitry that is suitable for determining, and conveying or implementing, changes to the subject's lifestyle to improve his/her sleep apnea, and changes to a subject's use of the sleep-apnea system420to improve his/her wellbeing. For example, the computing circuitry704can include specialized circuitry that is permanently configured to perform computations and tasks such as those described above and below. The computing circuitry704can also include circuitry, such as a microprocessor or microcontroller, that is configurable by software to perform computations and tasks such as those described above and below. Furthermore, the computing circuitry704can include circuitry, such as one or more field-programmable-gate arrays (FPGAs) or FPGA circuits, configurable by firmware to perform computations and tasks such as those described above and below. And the computing circuitry704can be local to the sleep-apnea system420and the client device702, or can be part of a larger network such as the internet or the cloud.

Still referring toFIG. 55, alternate embodiments of the system700are contemplated. For example, one or both of the client device702and the computing circuitry704can be onboard the sleep-apnea system420, and can be part of the component modules74and550(FIGS. 8 and 45) of the sleep-apnea system. Furthermore, the one or more sensors554(FIGS. 8 and 45) of the component module74can also act as, or be part of, the client device702, and can be configured to sense one or more conditions or other parameters of the subject405that are indicative of the subject's lifestyle and wellbeing. Moreover, the system700can include the sleep-apnea treatment system70(FIGS. 4-8) instead of, or in addition to, the sleep-apnea treatment system420.

FIG. 56is a flow diagram720of a procedure that the system700ofFIG. 55can be configured to implement for alleviating the subject's sleep apnea, according to an embodiment.

Referring toFIGS. 55-56, the procedure of the flow diagram720is described, according to an embodiment.

At a step722, the computing circuitry704receives, from the sleep-apnea system420, information regarding one or more sleep-apnea events experienced by the subject405(e.g.,FIG. 38) over a period of time. For example, the sleep-apnea system420can be configured to detect, with one or more sensors of the sensor assembly128(FIGS. 8 and 45), one or more sleep-apnea events, and to determine, with the controller134, one or more parameters of the one or more events. Examples of sleep-apnea events include airway obstructions and sleep-disturbances (e.g., a change in the subject's state of sleep, a change in the subject's duration of sleep, and other changes in the subject's sleep pattern) due to airway obstructions, and examples of parameters of sleep-apnea events include duration, frequency, and severity of the events (e.g., the percentage of the airway that is open or obstructed, the degree of change in the subject's sleep state, such as whether the subject woke up due to an event and how much the subject's sleep duration has changed from a benchmark duration). The sleep-apnea system420can be configured to store these determined parameters in the memory130(FIGS. 8 and 45), and to provide these stored parameters to the computing circuitry704automatically or in response to, e.g., a request from the computing circuitry.

Next, at a step724, the computing circuitry704receives, from the client device702, information regarding the subject's lifestyle. Examples of information regarding the subject's lifestyle include lifestyle parameters such as the subject's diet, meal times, snack times, exercise regimen including exercise frequency, exercise intensity, and exercise type, body weight, percentage of body fat, sleep schedule including number of hours of sleep per night, bed time, and out-of-bed time (the computing circuitry704may have already received this information from the sleep-apnea system420), level of stress, habits (e.g., smoking, drinking too much alcohol, and taking nutritional supplements), blood pressure, blood-sugar level, medications taken, medication schedule, and electronics use including number of hours per day of use in bed before sleep or between sleep periods (e.g., wake up, use electronic device, then go back to sleep). For example, the subject405, or another person, can enter this information via a keyboard of the client device702, or the client device can include one or more sensors to sense such lifestyle parameters. The client device702can be configured to store these lifestyle parameters in a memory (not shown inFIG. 56), and to provide these stored parameters to the computing circuitry704automatically or in response to, e.g., a request from the computing circuitry.

Then, at a step726, the computing circuitry704correlates the information received from the sleep-apnea system420regarding sleep-apnea events experienced by the subject405with the information received from the client device702regarding the subject's lifestyle. For example, the computing circuitry704can correlate the severity of airway obstructions to the subject's weight over a period of time, and can correlate the frequency of sleep-apnea events with a frequency or quantity at which the subject consumes a particular food or beverage, like coffee, over time. And in a further example, the computing circuitry704can correlate the severity of airway obstructions to the number of days per week that a subject exercises for more than 30 minutes.

Next, at a step728, the computing circuitry704generates one or more plots, charts, graphs, or other representations of the correlations generated at step726. For example, the computer circuitry704can generate a plot of the frequency of airway obstructions versus the average duration of the subject's exercise routines. These representations can be designed for display to the subject405or to another person (e.g., the subject's doctor) via a display device that, for example, is part of the client device702. Or, these representations can be a data structure in a memory of the computing circuitry704.

Then, at a step730, the computing circuitry704determines, in response to the correlation representations generated at the step728, recommendations of changes to the subject's lifestyle that may improve or eliminate the subject's sleep apnea. For example, if a correlation of the percentage of airway obstruction versus the subject's weight indicates that the average percentage of airway obstruction increases as the subject's weight increases, then the computing device704can generate a textual or audio message, for display/play via the client device702, stating that if the subject405loses a particular number of pounds, then he/she can reduce the average percentage of airway obstruction by a particular amount. Or, if the correlation of average frequency of airway obstructions per night versus the number of cups of coffee the subject405drinks per day indicates the average frequency of airway obstructions per night increases as the number of cups of coffee per day increases, then the computing device704can generate a textual or audio message, for display/play via the client device702, stating that if the subject405cuts back to no more than a particular number of cups of coffee per day, then he/she can reduce the average frequency of airway obstructions per night by a particular amount.

Next, at a step732, the computing circuitry704renders (e.g., displays or plays) the one or more recommendations determined at the step730via a media-rendering device, such as the client device702.

Still referring toFIG. 56, alternate embodiments of the procedure described in conjunction with the flow diagram720are contemplated. For example, the procedure can include one or more steps in addition to those described, or can omit one or more of the described steps722-732. Furthermore, instead of generating recommendations based on the correlation data, the computing circuitry704can provide the correlation data to a doctor or to another healthcare professional, who can develop recommendations in response to the correlation data, and who can make the developed recommendations to the subject405. Or, the computing circuitry704can provide the correlation data to the subject405, who can draw his/her own conclusions from the data and adjust his/her lifestyle accordingly.

FIG. 57is a flow diagram740of a procedure that the system700ofFIG. 55can be configured to implement for improving the subject's wellbeing, according to an embodiment.

Referring toFIGS. 55 and 57, the procedure of the flow diagram740is described, according to an embodiment.

At a step742, the computing circuitry704receives, from the sleep-apnea system420, information regarding the subject's use of the sleep-apnea system over a period of time. For example, the controller134(FIGS. 8 and 45) of the sleep-apnea system420can be configured to determine, in response to information sensed and provided by one or more sensors126and128of the component modules74and550(FIGS. 8 and 45), by one or more sensors554of the component module550, or by other components of the component modules, parameters of the subject's use of the sleep-apnea system. Examples of parameters of use of the sleep-apnea system420include the average number of hours per night, and the average number of nights per week, that the subject405wears the sleep-apnea system, and the settings of the sleep-apnea system (e.g., maximum negative pressure, temperature within the pressure chamber, whether the sealant-dispenser assembly124(FIGS. 8 and 45) is active, a set wakeup time, and what parameters are sensed (e.g., breathing sound, breathing rate) to detect an apnea event). The sleep-apnea system420can be configured to store these determined parameters in the memory130(FIGS. 8 and 45), and to provide these stored parameters to the computing circuitry704automatically or in response to, e.g., a request from the computing circuitry.

Next, at a step744, the computing circuitry704receives, from the client device702, information regarding the subject's wellbeing. Examples of information regarding the subject's wellbeing include the subject's mental state, emotional state, level of daytime fatigue (e.g., the number of times per day the subject naps or “nods off”), and health parameters such as the subject's weight, percentage of body fat, blood pressure, blood-sugar level, blood-oxygen level, and levels of other substances (e.g., vitamins, minerals, and hormones) in the subject's body. For example, the subject405, or another person, can enter this information via a keyboard of the client device702, or the client device can include one or more sensors to sense such wellbeing parameters. The client device702can be configured to store these wellbeing parameters in a memory (not shown inFIGS. 55 and 57), and to provide these stored parameters to the computing circuitry704automatically or in response to, e.g., a request from the computing circuitry.

Then, at a step746, the computing circuitry704correlates the information received from the sleep-apnea system420regarding the subject's use of the sleep-apnea system with the information received from the client device702regarding the subject's wellbeing. For example, the computing circuitry704can correlate the average number of hours per night that the subject405wears the sleep-apnea system420with the subject's blood pressure over a period of time, and can correlate the average number of nights per week that the subject wears the sleep-apnea system with the subject's reported level of daytime fatigue over a period of time.

Next, at a step748, the computing circuitry704generates one or more plots, charts, graphs, or other representations of the correlations generated at the step746. For example, the computer circuitry704can generate a plot of the average number of hours per night that the subject wears the sleep-apnea system420versus the subject's percentage of body fat. These representations can be designed for display to the subject405, or to another person, via a display device that, for example, is part of the client device702. Or, these representations can be a data structure in a memory of the computing circuitry704.

Then, at a step750, the computing circuitry704determines, in response to the correlation representations that it generated at the step748, recommendations of changes to the subject's use of the sleep-apnea system420that may improve the subject's wellbeing. For example, if a correlation of the average number of nights that the subject uses the sleep-apnea system420versus the subject's weight indicates that the subject's weight increases as the average number of nights of use decreases, then the computing device704can generate a textual or audio message, for display/play via the client device702, stating that if the subject405increases the number of days per week that he/she uses the sleep-apnea system420to a number that the computing device specifies, then he/she can lose a number of pounds within a range (e.g., 5-15 pounds) that the computing device specifies. Or, if the correlation of the average number of hours per night that the subject405uses the sleep-apnea system420versus the subject's blood pressure indicates that the subjects blood pressure increases as the average number of hours of use per night decreases, then the computing device704can generate a textual or audio message, for display/play via the client device702, stating that if the subject increases the number of hours per night that he/she uses the sleep-apnea system420to a number that the computing device specifies (e.g., increase by two hours, from five hours to seven hours), then he/she can reduce his/her systolic blood pressure by an amount within a range (e.g., 5-15 millimeters of Mercury (mm Hg)).

Next, at a step752, the computing circuitry704displays or otherwise renders the one or more recommendations determined at the step750via a media-rendering device, such as the client device702.

Still referring toFIG. 57, alternate embodiments of the procedure described in conjunction with the flow diagram740are contemplated. For example, the procedure can include one or more steps in addition to those described, or can omit one or more of the described steps742-752. Furthermore, instead of generating recommendations based on the correlation data, the computing circuitry704can provide the correlation data to a doctor or other healthcare professional, who can develop and make recommendations to the subject405in response to the correlation data. Or, the computing circuitry704can provide the correlation data to the subject405, who can draw his/her own conclusions from the data and adjust his/her usage of the sleep-apnea system420accordingly.

FIG. 58is an isometric view of the negative-pressure sleep-apnea-treatment system420, according to another embodiment.

FIG. 59is an isometric exploded view of the sleep-apnea-treatment system420ofFIG. 58, according to an embodiment.

Referring toFIGS. 58-59, the sleep-apnea system420includes a collar assembly760having a receptacle762, a strap assembly764configured to secure the sleep-apnea system to the subject's neck400(e.g.,FIG. 38), a gasket assembly765configured to make an airtight seal with the subject's neck, and a component module766attached to the strap assembly and configured to fit into the receptacle while the subject is wearing the sleep-apnea system. Other than having the receptacle762, the collar assembly760can be similar to the collar assembly440(e.g.,FIGS. 30-37), the strap assembly764can be made from a material that is similar to the material from which the strap assembly424(e.g.,FIGS. 30-32), is made, and the gasket assembly765can be similar to the gasket assembly422(FIGS. 27-28, 30-34, and 39-40). And other than being configured to fit into the receptacle762, the component module766can be structurally and functionally similar to the component module550(FIG. 45).

Still referring toFIGS. 58-59, alternate embodiments of the sleep-apnea system420are contemplated. For example, a remote-control device, such as the remote-control device484(FIG. 37), can be configured to program, to receive and to analyze the status of, and to otherwise control, the sleep-apnea system420. The remote-control device484can be part of, or separate from, the sleep-apnea system420.

FIG. 60is an isometric view of the negative-pressure sleep-apnea-treatment system420, according to yet another embodiment.

The sleep-apnea system420includes a wearable unit770, a base unit772, and an air hose774configured for pneumatically coupling the wearable unit to the base unit. The wearable unit770includes a collar assembly776having a hose connector778, a strap assembly (not shown inFIG. 60) configured to secure the wearable unit770around the subject's neck400(e.g.,FIG. 38), and a gasket assembly (not shown inFIG. 60) configured to form an airtight seal with the subject's neck. The base unit772includes at least a motor assembly and a pump assembly (not shown inFIG. 60), such as the motor assembly116and the pump assembly118ofFIG. 45, and is configured to generate a negative pressure within a pressure chamber (not shown inFIG. 60) between an inner surface of the collar assembly776and the subject's neck400by drawing a vacuum in the pressure chamber via the connector778, the hose774, and another hose connector (not shown inFIG. 60) located on the base unit. Other than having the hose connector778, the collar assembly776can be similar to the collar assembly440(e.g.,FIGS. 30-37), the strap assembly can be similar to the strap assembly424(e.g.,FIGS. 30-32), and the gasket assembly can be similar to the gasket assembly422(FIGS. 27-28, 30-34, and 39-40). In addition to the pump and motor assemblies116and118, the base unit772can include one or more other components of the component module550(FIG. 45), and can include a power supply (not shown inFIG. 60) that allows “plugging” the base unit into a wall outlet that provides 110 or 220 VAC. Moreover, the collar assembly776also can include one or more components of the component module550, such as components of the module that the base unit772lacks.

Still referring toFIG. 60, alternate embodiments of the sleep-apnea system420are contemplated. For example, a remote-control device, such as the remote-control device484(FIG. 37), can be configured to program, to receive and to analyze the status of, and to otherwise control the sleep-apnea system420. The remote-control device484can be part of, or separate from, the sleep-apnea system420.

FIG. 61is an isometric view of the negative-pressure sleep-apnea-treatment system420, according to still another embodiment.

The sleep-apnea system420includes a wearable unit790, and a hand-held unit792for pressurizing, with negative pressure, a pressure chamber (not shown inFIG. 61) adjacent to a region, e.g., the throat region406or throat region407(FIGS. 24-25), of the subject's throat. The wearable unit790includes a collar assembly794having a pneumatic connector796, a strap assembly (not shown inFIG. 61) configured to secure the wearable unit790around a subject's neck400(e.g.,FIG. 38), and a gasket assembly (not shown inFIG. 61) configured to form an airtight seal with the subject's neck. The hand-held unit792includes a pneumatic connector798and at least a motor assembly and a pump assembly (not shown inFIG. 60), such as the motor assembly116and the pump assembly118(FIG. 45), and is configured to generate a negative pressure within a pressure chamber between an inner surface of the collar assembly794and the subject's neck400by drawing a vacuum in the pressure chamber via the connectors796and798. The collar assembly794and the gasket assembly of the sleep-apnea system420are designed to hold the negative pressure in the pressure chamber for a period of time (e.g., one or more hours, or the entire time that the subject is sleeping). If the magnitude of the negative pressure decreases to or below a threshold pressure, then circuitry onboard the collar assembly794can sound an alarm to notify the subject405(e.g.,FIG. 38) that he/she should use the hand-held unit792to reestablish the proper pressure within the pressure chamber. Or, the collar assembly794can be configured to transmit to the hand-held unit792information sufficient for the hand-held unit to determine that the magnitude of the negative pressure has decreased to or below the threshold pressure; in response to this determination, the hand-held unit can sound the above-mentioned alarm. Other than having the pneumatic connector796, the collar assembly794can be similar to the collar assembly440(e.g.,FIGS. 30-37), the strap assembly can be similar to the strap assembly424(e.g.,FIGS. 30-32), and the gasket assembly can be similar to the gasket assembly422(FIGS. 27-28, 30-34, and 39-40). In addition to the pump and motor assemblies116and118, the hand-held unit792can include one or more other components of the component module550(FIG. 45), and can include a power supply (not shown inFIG. 60) that allows “plugging” the hand-held unit into a wall outlet that provides 110 or 220 VAC. Moreover, the collar assembly794also can include one or more components of the component module550, such as components of the module that the hand-held unit792lacks.

Still referring toFIG. 61, alternate embodiments of the sleep-apnea system420are contemplated. For example, a remote-control device800, which can be similar to the remote-control device484(FIG. 37), can be configured to program, to receive and to analyze the status of, and to otherwise control, the hand-held unit792of the sleep-apnea system420. The remote-control device800can be part of, or separate from, the sleep-apnea system420.

FIG. 62is an isometric view of the subject405wearing the negative-pressure sleep-apnea-treatment system420, according to another embodiment.

The sleep-apnea system420includes a wearable unit810, a garment unit812, and an air hose814configured for pneumatically coupling the wearable unit to the garment unit. The wearable unit810includes a collar assembly816having a hose connector818, a strap assembly819configured to secure the wearable unit810around the subject's neck400, and a gasket assembly (not shown inFIG. 62) configured to form an airtight seal with the subject's neck. The garment unit812includes a hose connector822and at least a motor assembly and a pump assembly (not shown inFIG. 62), such as the motor assembly116and the pump assembly118(FIG. 45), and is configured to generate a negative pressure within a pressure chamber (not shown inFIG. 62) between an inner surface of the collar assembly816and the subject's neck400by drawing a vacuum in the pressure chamber via the hose814and the connectors818and822. Other than having the hose connector818, the collar assembly816can be similar to the collar assembly440(e.g.,FIGS. 30-37), the strap assembly819can be similar to the strap assembly424(e.g.,FIGS. 30-32), and the gasket assembly can be similar to the gasket assembly422(FIGS. 27-28, 30-34, and 39-40). The garment unit812can be any wearable item, such as an undergarment, shirt, pants, arm band, or hat, and can be made from any suitable material. In addition to the pump and motor assemblies116and118, the garment unit812can include one or more other components of the component module550(FIG. 45), and can include a power supply (not shown inFIG. 60) that allows “plugging” the garment unit into a wall outlet that provides 110 or 220 VAC. For example, the garment unit812can include a module824, which can be similar to the module550, and can have one or more of the sensors126,128, and554(FIG. 45) disposed at suitable locations of the garment unit. Such one or more sensors126,128, and554can be located on the inner surface (the side facing the subject405when worn) of the garment, inside of the garment, or on the outer surface (the side facing away from the subject when worn) of the garment. Moreover, the collar assembly816also can include one or more components of the component module550, such as components of the module that the garment unit812lacks.

Still referring toFIG. 62, alternate embodiments of the sleep-apnea system420are contemplated. For example, a remote-control device, such as the remote-control device484(FIG. 37), can be configured to program, to receive and to analyze the status of, and to otherwise control the sleep-apnea system420. The remote-control device can be part of, or separate from, the sleep-apnea system420.

FIG. 63is an isometric view of a negative-pressure sleep-apnea-treatment system830, according to an embodiment.

The sleep-apnea system830includes multiple pressure-chamber units832(two units in this embodiment), an elastic coupler834disposed between, and coupling together, the pressure-chamber units, and a strap assembly (not shown inFIG. 63) configured for securing around the back of the subject's neck400to hold the pressure-chamber units in place against the neck and throat of the subject405. Each pressure-chamber unit832includes a gasket assembly838configured to form an airtight seal against the subject's neck400, at least a motor assembly and a pump assembly (not shown inFIG. 63), such as the motor assembly116and the pump assembly118(FIG. 45), and is configured to generate a negative pressure within a pressure chamber (not shown inFIG. 63) between an inner surface of the pressure-chamber unit832and the subject's throat by drawing a vacuum in the pressure chamber. For example, each unit832can include a component module (not shown inFIG. 63) such as the component module550(FIG. 45). Alternatively, one of the units832can contain at least one component of the module550, and the other pressure-chamber unit can include at least one other component of the module550, and the pressure-chamber units can communicate with each other electrically or pneumatically via one or more respective conduits (not shown inFIG. 63) disposed in or on the elastic coupler834. Other than having a different size and a different shape, each pressure-chamber unit832can be similar to the collar assembly440(e.g.,FIGS. 30-37), the strap assembly can be similar to the strap assembly424(e.g.,FIGS. 30-32), and the gasket assembly can be similar to the gasket assembly422(FIGS. 27-28, 30-34, and 39-40). And the elastic coupler834can be formed from any suitable material, such as the same material from which the strap assembly is formed.

Still referring toFIG. 63, alternate embodiments of the sleep-apnea system830are contemplated. For example, a remote-control device, such as the remote-control device484(FIG. 37), can be configured to program, to receive and to analyze the status of, and to otherwise control the sleep-apnea system830. The remote-control device can be part of, or separate from, the sleep-apnea system830.

From the foregoing it will be appreciated that, although specific embodiments have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the disclosure. Furthermore, it is contemplated that any feature disclosed in conjunction with an embodiment can be incorporated into any other embodiment. For example, any feature disclosed in conjunction with an embodiment of the sleep-apnea-treatment system70can be incorporated into any embodiment of the sleep-apnea-treatment systems420and830, and vice-versa. Moreover, where an alternative is disclosed for a particular embodiment, this alternative may also apply to other embodiments even if not specifically stated. For example, one or more of the above-described techniques can be implemented in a sleep-apnea-treatment system (e.g., a CPAP system) other than the sleep-apnea-treatment systems70,420, and830. In addition, one or more of the above-described techniques may be modified for implementation on a system (e.g., a CPAP system) that treats sleep apnea with positive pressure instead of negative pressure. Furthermore, it is contemplated that a system may treat sleep apnea with both positive and negative pressure using one or more of the above-described techniques. Moreover, “and” and “or” are to be interpreted as follows. A “or” B, and A “and” B, are to be interpreted as meaning A, B, or both A and B, unless otherwise indicated expressly or implicitly by, e.g., context.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art from the detailed description provided herein. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.