JP2020518298A - Treating sleep apnea with negative pressure, obtaining information related to sleep apnea event and sleep apnea treatment with a sleep apnea device, and sleep apnea event and Correlating sleep apnea treatment with subject lifestyle and well-being. - Google Patents

Abstract

One embodiment of a system for treating sleep apnea includes a collar, pump, motor, sensor, memory mechanism, and controller. The collar is configured to maintain a subject's airways open while the subject sleeps by applying a magnitude negative pressure to the subject's throat, and the pump applies a negative pressure. Configured to generate. The motor is configured to drive the pump and the sensor is configured to generate a sensing signal related to the degree to which the airway is open. The controller is then configured to change the magnitude of the negative pressure in response to the sensed signal. In addition, the controller can obtain information about the use and settings of the sleep apnea system and store it in memory, and the controller or another computing system can correlate this information with the wellbeing of the subject. , The use of sleep apnea system or changes in settings that can improve the well-being of the subject can be recommended.

Description

All subject matter of the priority application is incorporated herein by reference, unless such subject matter is contradictory to the present specification.

The following summary is merely exemplary and is in no way intended to be limiting. In addition to the exemplary aspects, embodiments, and features described above, further aspects, embodiments, and features will be apparent by reference to the drawings and the following detailed description.

A system for treating sleep apnea includes a collar, a pump, a motor, a sensor, a memory mechanism, and a controller. The collar is configured to keep the subject's airways open while the subject sleeps by applying a negative pressure of magnitude to the subject's throat, and the pump is under negative pressure. Is configured to generate. The motor is configured to drive the pump and the sensor is configured to generate a sensing signal related to the degree to which the airway is opened or closed. The controller is also configured to change the magnitude of the negative pressure in response to the sensed signal and store in memory information related to the sleep apnea event or sleep apnea treatment experienced by the subject. ..

For example, one or more of the pumps, motors, sensors, and controllers may allow the system to be self-contained, i.e., the entire system may be worn by the subject, e.g. It can be fixed to the collar so that it can be retained on it. Alternatively, the system can include a base unit that includes at least a pump and a motor, and can include an air hose that couples the base unit to the collar so that the pump can create a negative pressure through the hose.

In addition, the controller obtains information related to sleep apnea events (eg, average number of events per night, average frequency of events, average duration of each event, average level of airway obstruction that causes the event) and stores in memory. Can be stored and a controller or another computing system can correlate this information with the subject's lifestyle choices to improve the subject's sleep apnea symptoms (eg, average number of events per night). Lifestyle changes (eg, reducing body weight) that can reduce, reduce the frequency of events, reduce the average duration of each event, reduce the average level of airway obstruction that causes each event , Sleep for a long time, go to bed early, and do not drink caffeinated beverages within 2 hours before bed).

In addition, the controller may have information related to sleep disturbances that may or may not be associated with sleep apnea events (eg, subject motion, number of times bed was abandoned, number of sleep hours, apnea events). Other physiological characteristics such as blood pressure, body temperature, heart rate, etc. that are not directly associated with breathing disorders or snoring that do not lead to sleep apnea events) can be obtained and stored in memory.

Additionally, the controller may provide information related to sleep apnea system usage and settings (eg, the average number of nights the subject spends on the system per night, the average frequency of the subject using the device (days per week)). , The subject's bedtime and wake-up time, pressure settings, temperature settings) can be obtained and stored in memory, and the controller or another computing system can store this information in the subject's wellbeing (eg, Weight, blood pressure, blood sugar, mental status, emotional status, cardiovascular health, daytime sleepiness) or changes in the subject's wellbeing (eg, weight, blood pressure, blood sugar level, mental status, emotional status, cardiovascular health, Daytime sleepiness changes) and improve a subject's well-being (eg, losing weight, lowering blood pressure, lowering blood glucose levels, improving mental status, improving emotional status, Changes in the use or settings of sleep apnea systems that can improve cardiovascular health, improve a subject's daytime alertness) can be recommended.

FIG. 3 is a diagram of the airways of a human subject, as well as other biological tissues and structures near the airways. It is a figure of the subject who used a CPAP machine. FIG. 3 is a diagram of a subject's neck and throat region of the neck. FIG. 3 is a diagram of a subject wearing a system for treating sleep apnea, according to one embodiment. FIG. 3 is a diagram of a system for treating sleep apnea according to one embodiment. FIG. 6 is a diagram of a system for treating sleep apnea according to another embodiment. FIG. 8 is a diagram of a system for treating sleep apnea according to yet another embodiment. FIG. 8 is a block diagram of component modules of the sleep apnea system of FIGS. 4-7, according to one embodiment. FIG. 9 is a cross-sectional view of a portion of the apnea sensor assembly of FIG. 8 and a subject's neck and airway, according to one embodiment. FIG. 9 is a cross-sectional view of a portion of the apnea sensor assembly of FIG. 8 and a subject's neck and airway according to another embodiment. FIG. 9 is a cross-sectional view of a portion of the apnea sensor assembly of FIG. 8 and a subject's neck and airway according to yet another embodiment. FIG. 9 is a diagram of a portion of the apnea sensor assembly of FIG. 8 and a subject, according to yet another embodiment. 6 is a flow chart of a procedure for correlating a subject's airway openness to a condition associated with airway openness, according to one embodiment. FIG. 8 is a view of a sealing surface and a vacuum surface of the collar of FIGS. 4-7, according to one embodiment. FIG. 8 is a view of a sealing surface of the collar of FIGS. 4-7 according to another embodiment. FIG. 8 is a view of a portion of the collar of FIGS. 4-7, according to one embodiment. FIG. 17 is a view of the collar portion of FIG. 16 taken along the line AA of FIG. 16 according to one embodiment. FIG. 17 is a diagram of an end region of the collar portion of FIG. 16, according to one embodiment. FIG. 8 is a view of a portion of the collar of FIGS. 4-7 according to another embodiment. FIG. 20 is a view of the collar portion of FIG. 19 taken along the line AA of FIG. 19 according to one embodiment. FIG. 8 is a view of a portion of the collar of FIGS. 4-7 according to yet another embodiment. 22 is a view of the collar portion of FIG. 21 taken along the line AA of FIG. 21, according to one embodiment. 8 is a flow chart of operation of the sleep apnea therapy system of FIGS. 4-7, according to one embodiment. FIG. 6 is a front view of a subject's neck, cervical throat region, and region for applying negative pressure for treatment of sleep apnea of the throat, according to one embodiment. FIG. 25 is a side view of the neck, throat region, and negative impression pressure region of FIG. 24, according to one embodiment. FIG. 26 is a front view of a subject wearing a system designed to treat sleep apnea by applying negative pressure to the negative pressure application areas of FIGS. 24-25, according to one embodiment. FIG. 27 is a side view of a subject wearing the sleep apnea treatment system of FIG. 26, according to one embodiment. FIG. 27 is another side view of a subject wearing the sleep apnea treatment system of FIG. 26, according to one embodiment. FIG. 29 is a rear view of a subject wearing the sleep apnea treatment system of FIGS. 26-28, according to one embodiment. FIG. 30 is an isometric side view of the sleep apnea treatment system of FIGS. 26-29, according to one embodiment. FIG. 31 is an isometric rear view of the sleep apnea treatment system of FIGS. 26-30, according to one embodiment. FIG. 32 is an exploded view of the sleep apnea treatment system of FIGS. 26-31, according to one embodiment. FIG. 33 is an isometric front view of a collar assembly of the sleep apnea therapy system of FIGS. 26-32 having a perspective portion, according to one embodiment. FIG. 34 is an isometric side view of a collar assembly of the sleep apnea treatment system of FIGS. 26-33 having a perspective portion, according to one embodiment. FIG. 35 is an isometric perspective side view of the collar assembly of FIGS. 26-34, according to one embodiment. FIG. 36 is an isometric front view of the color assembly of FIGS. 26-35 including a haptic on/off switch, according to one embodiment. FIG. 36 is an isometric front view of the color assembly of FIGS. 26-35 with a light emitting diode (LED) battery level indicator and a device for remote control of the color assembly, according to one embodiment. FIG. 33 is an isometric side view of a subject wearing the sleep apnea therapy system of FIGS. 26-32, including an adjustable position sensor, according to one embodiment. FIG. 33 is an isometric exploded view of the collar assembly and gasket assembly of the sleep apnea treatment system of FIGS. 26-32, according to one embodiment. FIG. 30 is a cutaway side view of a gasket of the gasket assembly of FIG. 29, according to one embodiment. FIG. 33 is an isometric exploded view of the sleep apnea treatment system of FIGS. 26-32, including a replaceable sleeve, according to one embodiment. FIG. 33 is an isometric view of the sleep apnea therapy system of FIGS. 26-32 including battery charging contacts, according to one embodiment. FIG. 43 is an isometric top view of a battery charging storage case in an open position for the sleep apnea treatment system of FIG. 42, according to one embodiment. 43 is an isometric view of the sleep apnea treatment system of FIG. 42 disposed within the battery charging storage case of FIG. 43, according to one embodiment. FIG. 45 is a block diagram of component modules of the sleep apnea therapy system of FIGS. 26-32, 42, and 44, according to one embodiment. FIG. 46 is an isometric view of an energy-harvesting thermoelectric power source that the auxiliary power source of FIG. 45 may include, according to one embodiment. FIG. 47 is an isometric view of elements of an energy harvesting exercise power supply that the auxiliary power supply of FIG. 45 can include, according to one embodiment. FIG. 48 is an isometric view of a bisection of the device of FIG. 47, according to one embodiment. FIG. 49 is an isometric view of an energy harvesting exercise power supply including the elements of FIGS. 47-48, according to one embodiment. FIG. 49 is an isometric view of an energy harvesting exercise power supply including the elements of FIGS. 47-48, according to another embodiment. FIG. 51 is a diagram of an aspect of operation of the energy harvesting exercise power supply of FIG. 50, according to another embodiment. FIG. 47 is an isometric view of an energy harvesting twist-stretch power supply that the auxiliary power supply of FIG. 45 can include, according to one embodiment. FIG. 53 is a cutaway side view of a triboelectric nanogenerator (TENG) of the energy harvesting twist stretch power supply of FIG. 52, according to one embodiment. FIG. 53 is a cutaway side view of an energy storage component of the energy harvesting twist stretch exercise power supply of FIG. 52, according to one embodiment. Using the sleep apnea therapy system with data acquired by the sleep apnea therapy system of FIGS. 26-32, 42, and 44, the client, and the sleep apnea therapy system, according to one embodiment. FIG. 3 is a block diagram of a system including computer circuitry that can be correlated with data related to a subject. FIG. 56 is a flow diagram of an algorithm that can be executed by the system of FIG. 55 to determine changes in a subject's lifestyle that can improve a subject's sleep apnea, according to one embodiment. In accordance with one embodiment, an algorithm that can be executed by the system of FIG. 55 to determine changes associated with the use of a subject's sleep apnea therapy device that can improve a subject's well-being. It is a flow chart. FIG. 8 is an isometric view of a sleep apnea treatment system according to another embodiment. FIG. 8 is an isometric view of a sleep apnea treatment system according to another embodiment. FIG. 8 is an isometric view of a sleep apnea treatment system according to yet another embodiment. FIG. 8 is an isometric view of a sleep apnea treatment system according to yet another embodiment. FIG. 8 is an isometric view of a subject wearing a sleep apnea treatment system, according to another embodiment. FIG. 8 is an isometric view of a subject wearing a sleep apnea treatment system, according to yet another embodiment.

The following detailed description refers to the accompanying drawings, which form a part of the specification. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.

One or more embodiments are described with reference to the drawings, wherein like reference numerals can be used to refer to like elements. In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. However, it will be apparent 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 the description of one or more embodiments.

Sleep apnea is a disease characterized by an instance of abnormally low breathing during sleep or by an example of abnormal breathing pauses (eg, "apnea" or "apnea event"), such as: Apneas can occur at a frequency of about 5 to 30 times or more per hour, and each apnea can last from about 10 seconds to 1 minute or more.

To prevent a subject suffering from sleep apnea from suffocating during apnea, the body produces a short "burst" of adrenaline, which usually causes the subject to start breathing again. Sufficient, but not enough to fully awaken the subject.

Unfortunately, these bursts of adrenaline can cause the subject to face significant health problems. For example, such bursts of adrenaline can stress the subject's heart by increasing the subject's heart rate relatively quickly, so such bursts increase the subject's risk of a heart attack or stroke. Can be done. Moreover, these bursts of adrenaline disrupt the subject's sound sleep patterns, so that these bursts may be an underlying factor in health problems associated with sleep deprivation. Examples of such health problems associated with sleep deprivation include increased body fat (adipose tissue, arteriosclerosis, daytime fatigue, decreased cognitive function, decreased reaction time, and attention span). Includes decline.

Subjects suffering from sleep apnea are rarely aware that they have dyspnea during sleep or even after waking, so one or more symptoms may be associated with, for example, one or more of the health problems above. In the form of, the subject may be unaware of having sleep apnea for many years until the subject is symptomatic enough to require medical attention. However, by that time, the subject may have suffered severe injury (eg, a heart attack) or disability (eg, caused by a stroke), or death (eg, subject begins breathing after apnea). It is caused by the inability to do).

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

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

FIG. 1 is a cutaway view of a head and neck region 10 of a subject 12.

Referring to FIG. 1, obstructive sleep apnea indicates that the airway 14 of the subject 12 is collapsed, ie, blocked during sleep, for example, by the back of the tongue 16, the soft palate 18, or the uvula 20. Characterized, and thus, each case of blocked airways typically causes "apnea" as described above. Causes of blocked airways 14 during sleep may include decreased muscle tone, excessive relaxation, or excess tissue in the tongue 16, soft palate 18, or uvula 20.

If the body of the subject 12 produces a burst of adrenaline during a blocked-airway-induced apnea to restart the subject's breathing as described above, the adrenaline burst will cause the subject to: For example, by coughing, moving the neck 22, head 24, or jaw 26, or breathing deeper (stronger suction caused by deeper breathing may open the airway). Can open the occlusion.

Then, after subject 12 returns to a deeper sleep, the muscles of cervical 22 and jaw 26 relax and the subject's respiratory rate returns to a deeper sleep level, thus another apnea followed by an adrenaline burst. Cycle can begin.

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

Examples of invasive treatments include surgery to remove tissue from the body part (eg, tongue 16, soft palate 18, or uvula 20) that causes obstruction of the airways 14, and to “harden” the body part. Surgical procedures for implanting one or more members in the occluded body part (eg, implanting a plastic rod in the soft palate).

Unfortunately, potential problems with such invasive therapies include risks associated with surgical procedures, recovery time, irreversibility, and pain, which can result when the procedure is consumed during eating and drinking. Include the risk of post-recovery discomfort in the subject, as well as the risk that this procedure will ultimately prove unsuccessful in preventing the recurrence of airway obstruction that causes obstructive sleep apnea.

Examples of non-invasive treatments include subject 12 losing weight, using an oral appliance to maintain subject's jaws 26 in a slightly protruding position during sleep, below in connection with FIG. It includes using a Continuous Positive Airway Pressure (CPAP) machine as described.

Such non-invasive treatments are generally preferred over invasive treatments, for example because they have less risk and side effects than invasive treatments, but some non-invasive treatments such as weight loss and use of oral appliances. Treatment can be difficult or ineffective for some subjects with obstructive sleep apnea.

Unfortunately, however, CPAP machines have been shown to successfully treat obstructive sleep apnea in most subjects who would otherwise suffer from obstructive sleep apnea.

FIG. 2 is a diagram of a sleeping subject 12 using a CPAP machine 30 to prevent the development of obstructive sleep apnea.

The CPAP machine 30 includes a base unit 32, a hose 34, and a mask assembly 36.

The base unit 32 controls the air pressure in the hose 34, and thus in the airway 14 (FIG. 1) of the subject 12, while the subject is inhaling (inhaling) and exhaling (exhaling). ), configured to maintain a near constant level. If the airway pressure that the CPAP machine 30 maintains at a nearly constant level is different during exhalation and during inspiration, it is more properly called a BiPAP machine, but in general usage "CPAP" means during inspiration and It is used to indicate both machines that maintain airway pressure at the same positive level during exhalation and machines that maintain airway pressure at different positive levels during inspiration and expiration. The base unit 32 typically includes a power cord that plugs directly into a household power outlet (eg, 110/220 VAC) or can be coupled to an AC adapter.

The hose 34 is configured to couple the base unit 32 to the mask assembly 36, typically while the subject 12 is using the CPAP machine 30, the subject 12 places the base unit on a floor or nightstand. Long enough (eg, 6-10 feet) to allow placement in
The mask assembly 36 includes a fitting 38, a mask 40, and a strap 42. The connector 38 is configured to couple the mask 40 to the hose 34 and may be coupled to the mask with a swivel joint that allows the subject 12 some freedom of movement. The mask 40 is configured to form an airtight seal 44 around at least the nose of the subject 12 (although the mask can also form a seal around the subject's mouth as shown in FIG. 2) and air One or more openings that allow air to continue to flow from the base unit 32 through the hose 34 and the connector 38 into the mask 40 and through the one or more openings even during inspiration. (Not shown in FIG. 2). Without this constant airflow, the air inhaled by the subject is "stuck." The strap 42 then secures the mask 40 to the subject's 12 head 24 with sufficient tightness to form an airtight seal 44 between the mask and the subject's face.

Still referring to FIG. 2, as mentioned above, the CPAP machine 30 is an effective non-invasive treatment for obstructive sleep apnea, but the CPAP machine may still have some drawbacks. For example, the nature of the hose 34 that effectively connects the mask assembly 36 to the base unit 32 may deprive the subject 12 of full range of movement during sleep. As an example, when the subject 12 rolls to the left, the hose 34 may pull the base unit 32 and drop it from the nightstand. Alternatively, when the base unit is on the floor and the subject rolls to the left, the hose 34 becomes taught so that the mask 40 may be removed from the subject's face and the seal 44 may be broken. possible. Further, when the subject 12 sleeps sideways, the pillow may cause the mask 40 to come off the subject's face and break the seal 44. Moreover, the force with which the strap 42 must hold the mask 40 against the subject's 12 face to form a hermetic seal can cause discomfort to the subject. In addition, when the CPAP machine 30 is carried on an aircraft, for example, the subject 12 must at least separate the base unit 32 from other items when passing security, the dimensions of the base unit being Can be found to be inconvenient to move because it is difficult to carry in a briefcase or Boston bag.

FIG. 3 is a view of the subject's 12 neck 50 and jaw 52, and throat 54.

Referring to FIG. 3, non-invasively treat obstructive sleep apnea by applying a negative pressure (ie, suction or vacuum) to one or more areas of the neck 50 and/or jaw 52 of subject 12. can do. For example, applying a negative pressure to the underside 56 of the chin 52, ie, the area 58 (such as the hyoid muscle) of the throat 54 below the chin, while the subject 12 sleeps, the subject's airway 14 (see FIG. 1) Can help to position the subject's jaw, tongue 16 (FIG. 1), or one or more other biological structures of the subject, to keep the open and open .. In another example, applying negative pressure to one or more portions of the throat region 60 (below the throat region 58, above the sternum head 62 and clavicle 64, and between the sternocleidomastoid muscles 66) causes the subject to One or more biological structures of subject 12 may also be arranged to open and maintain the subject's airways 14 while sleeping. In yet another example, the anterior abdomen of the Digastricus 55 of the throat 54, the thyroid cartilage (ie, throat) 57, and the sternocleidomastoid muscle 66 while the subject 12 is sleeping. One or more biological structures of subject 12 may also be positioned to open and maintain open airways 14 of subject 12 when negative pressure is applied to the region in between. In yet another example, applying negative pressure to the area between the anterior abdomen of the flank 55 of the throat 54, the hyoid bone 59, and the sternocleidomastoid muscle 66 while the subject 12 is asleep may result in One or more biological structures of the subject 12 may also be arranged to open the airway 14 and maintain it open.

FIG. 4 is a diagram of a subject 12 using a negative pressure sleep apnea treatment system 70 configured to treat obstructive sleep apnea, according to one embodiment. As described below with respect to FIGS. 5-22, the system 70 is self-contained and maintains a negative pressure in one or more areas of the subject's neck 50, jaws 52, or throat 54. By doing so, the subject's airways 14 (FIG. 1) are configured to open and remain open during sleep. As used above and below, "self-contained" means that the system 70 is configured to treat obstructive sleep apnea alone. Compared to a CPAP machine such as the CPAP machine 30 of FIG. 2, the system 70 is not tethered to any other item or location, thus allowing the subject 12 more freedom of movement and It is worn around and not on the face, so it is more comfortable, has fewer parts, can be smaller, and can be folded, making it more suitable for movement.

The negative pressure sleep apnea therapy system 70 includes a collar assembly 72 and a component module 74 configured to be secured to the collar.

The collar assembly 72 includes a collar 76 and fasteners (not visible in FIG. 4), such as straps, snaps, buttons, or Velcro® strips, such that the system 70 applies negative pressure. The collar is configured to be secured to the subject's neck 50 such that the collar forms an airtight seal about one or more areas of the subject's neck, jaw 52, or throat 54 to be constructed. The collar 76 may be partially or fully flexible and may be formed from one or more suitable materials such as cloth, foam, metal, or plastic. The collar or fastener may be configured to allow adjustment of the internal dimensions of the collar assembly so that the assembly can accommodate subjects having varying neck circumferences, lengths, and shapes. The collar assembly 72 is described further below in connection with FIGS.

The module 74 is then configured to include one or more components of the system 70 other than the color assembly 72. For example, module 74 may include air pumps, motors, power supplies, pressure, airways, and other sensors, and controller circuits such as microprocessors or microcontrollers. Module 74 is described further below in connection with FIG.

With continued reference to FIG. 4, an alternative embodiment of the negative pressure sleep apnea treatment system 70 is contemplated. For example, instead of being flexible, the collar 76 includes two or more rigid portions that are hingedly attached to each other such that the rigid portions open to receive the subject's neck 50 and close to surround the neck. It may be configured to adhere. Further, not all system components except color assembly 72 may be located within module 74. For example, some or all of these other components can be secured outside collar 76 or outside the fastener, inside the collar or inside the fastener, or collar 76 or It can be placed inside the fastener. Further, the module 74 and the collar 76 can have any suitable shape other than that shown in FIG.

5 is a diagram of the negative pressure sleep apnea therapy system 70 of FIG. 4, according to one embodiment.

The collar 76 is a single flexible piece configured to completely surround the subject's neck 50 (FIG. 4) while the subject is wearing the system 70, and the Velcro® fastening. Tool 78 is adjustable to allow system 70 to accommodate various neck sizes and shapes.

The system 70 also includes an AC adapter/charger 90 configured to couple to a receptacle 92 of the component module 74, which AC adapter/charger 90 powers the system while the system is operating. It is configured to charge the system's battery (not shown in FIG. 5) to supply or while the system is operating or not operating. Alternatively, the receptacle 92 may be configured to couple to a power cord that is configured to couple to a standard power outlet (eg, 110 VAC, 220 VAC).

Further, the system 70 includes one or more sealing surfaces 94 each configured to form a hermetic seal with a respective opposing region of the subject's neck 50, the sealing surfaces 94 delimiting the system to a negative pressure. It includes one or more vacuum surfaces 96 configured to face the area of the subject's neck 50 (FIG. 4), jaw 52 (FIG. 4), or throat 54 (FIG. 4) to which pressure is applied. One or more sealing surfaces 94 and one or more vacuum surfaces 96 are described further below in connection with FIGS. 14-21.

In addition, the component module 74 includes an input/output device 98, a power switch assembly 100, and an exhaust assembly 102. The input/output device 98 is, for example, a touch screen and allows the subject 12 (FIG. 4) to program or otherwise control the system 70 to receive information from the system 70, such as status information and programming confirmation. To enable. For example, the I/O device allows the subject 12 to set the magnitude of the negative pressure or its maximum threshold, and the system 70 sets the wake-up time (eg, negative pressure) to wake the subject gently. It can be configured to allow the subject to set the wake-up time in anticipation that the size) can be adjusted. Alternatively, the input/output device 98 may include a separate input device (eg, keypad) and output device (eg, display, touch screen display). The power switch assembly 100 is displayed, for example, by any suitable assembly that allows the subject 12 (FIG. 4) to “turn on” or “off” the system 70 (eg, a toggle switch or a touch screen). Tactile slide switch). And, the vent assembly 102 allows the system 70 to provide one or more areas of negative pressure between the collar 76 and the subject's neck 50 (FIG. 4), chin 52 (FIG. 4), or throat 54 (FIG. 4). An air outlet is provided for inhaling air from between the collar and the neck, jaw, or throat to produce the.

FIG. 6 is a diagram of the negative pressure sleep apnea therapy system 70 of FIG. 4 according to yet another embodiment. The system 70 of FIG. 6 is configured so that the collar 76 only partially surrounds the subject's neck 50 (FIG. 4) when the system is worn, and the adjustable Velcro® fastener 78 of FIG. 5 is similar to the system 70 of FIG. 5, except that it is longer than the fastener 78 of FIG. 5 and compensates for the reduced length of the collar.

7 is a diagram of the negative pressure sleep apnea treatment system 70 of FIG. 4 according to yet another embodiment. The system 70 of FIG. 7 includes a portion 104 configured to position the collar 76 under the chin 52 (FIG. 4) of the subject 12 (FIG. 4), except that the system also includes a collar support 106. And is similar to the system 70 of FIGS. The collar 76 is configured to only partially surround the neck 50 (FIG. 4) of the subject 12 (FIG. 4) and is placed under the subject's chin 52 (FIG. 4) or chin 26 (FIG. 1). It includes a portion 104 adapted to be capable of applying pressure. Also, the collar support 106 is configured to fit on the shoulder (not shown in FIG. 7) of the subject 12 in place of or in addition to the fastener 78 of FIGS. 5 and 6. .. Support 106 can be made of any suitable material that is flexible, rigid, or semi-rigid and can be designed to give subject 12 freedom of movement during sleep. Also, although not shown in FIG. 7, the system 70 of FIG. 7 includes an AC adapter 90, an adapter receptacle 92, a sealing surface 94, and a vacuum surface 96, or one of any suitable alternatives thereof. It can include one or more.

With reference to FIGS. 4-7, alternative embodiments of sleep apnea treatment system 70 are contemplated. For example, the position of the component module 74 with respect to the collar assembly 72 may differ from that described. Further, the positions of the input/output device 98, the power switch 100, and the exhaust port 102 with respect to the component module 74 may differ from those described. Additionally, the collar 76 of FIGS. 4-6 may have a jaw or chin portion that performs the same function as the portion 104 of FIG. Moreover, system 70 may be modified in any suitable manner.

FIG. 8 is a block diagram of the component module 74 of FIGS. 4-7, according to one embodiment. In addition to the power receptacle 92, the input/output device 98, the power switch assembly 100, and the exhaust assembly 102, the component module 74 includes the following components: a power source such as a battery 110, an auxiliary power source 112, a power supply. ) 114, motor assembly 116, pump assembly 118, pressure regulator assembly 120, valve assembly 122, sealant dispenser assembly 124, pressure sensor assembly 126, apnea sensor assembly 128, memory 130, temperature control assembly 132, controller 134, And bus 136. Module 74 may also include a package (not shown in FIG. 8) that houses these components. For example, the package may be formed from epoxy resin, sealed to protect the contained components or prevent access to it, or for example for repair or replacement. May include structures that allow access to one or more of the contained components. In addition, the component module 74, in addition to the power receptacle 92, provides, for example, ventilation between the pressure regulator assembly 120, the valve assembly 122, and the collar 76 (FIGS. 4-7), between the dispenser assembly 124 and the collar. Other suitable receptacles or connectors that allow for flow of sealing material and signal communication between sensor assembly 126 and sensor assembly 128 may be included.

The power receptacle 92 is configured to receive a DC power signal, eg, from an AC adapter 90 (FIGS. 5-6), via the power switch assembly 100, or, eg, from a standard power outlet (eg, 110 VAC, 220 VAC). It is configured to receive an AC power signal.

The input/output device 98 is configured, for example, to receive data from the subject 12 (FIG. 4), a sleep technician, or a sleeping doctor and provide the data to the subject, technician, or doctor. For example, the device 98 may be a touch screen that allows data to be entered and displays the data. Alternatively, the device 98 may include a separate input device 138 such as a keypad or card reader and a separate output device 140 such as a display screen or card writer. Examples of data that can be input to the component module 74 via the device 98 include an instruction program for the controller 134, and system configuration parameters and system operating parameters such as pressure and temperature ranges and threshold levels. ..

Battery 110 is configured to power the components of component module 74 and to store energy to generally power negative pressure sleep apnea therapy system 70 (FIGS. 4-7). To be done. Battery 110 can be any suitable type of battery, such as a nickel-cadmium battery, a lithium-ion battery, or an alkaline battery, and produces any suitable output voltage (eg, in the range of 5-25 VDC). It can be one-time useable or rechargeable. Further, the battery 110 can include two or more batteries or battery cells electrically coupled in series, electrically parallel, or both electrically series and electrically parallel. Further, the battery 110 may provide an alarm (eg, an alarm signal) to, for example, the controller 134 or the input/output device 98 when the amount of charge or voltage the battery is accumulating drops below a low charge threshold, or , Another component, such as controller 134, can monitor the battery charge or voltage and generate such an alarm. Further, the component module 74 can include a receptacle for holding the battery 110.

The auxiliary power source 112 powers the components of the component module 74 to generate energy for generally powering the negative pressure sleep apnea therapy system 70 (FIGS. 4-7). Composed. For example, the auxiliary power source 112 may include a spring and a manual winding mechanism that may be rotated by the subject 12 (FIG. 4) to wind the spring to store energy in the wound spring. When is rewound, the spring is configured to drive a generator configured to generate a power signal, the generator also included in the auxiliary power source. Alternatively, the auxiliary power supply 112 can include an automatic winding mechanism that winds a spring in response to movement of the auxiliary power supply, such as when the subject 12 moves while wearing the system 70. The automatic winding mechanism may be similar to the conventional mechanism used to wind the spring of an automatic winding timepiece. Alternatively, the auxiliary power source 112 may include a mechanism for automatically driving the generator in response to movement of the auxiliary power source, such a mechanism being used to drive the generator of a self-powered watch. Can be similar to the conventional mechanism described. The auxiliary power supply 112 may be configured to directly supply the power signal generated by the generator to the power supply 114, or the generated power signal, which may be the battery 110, or part of the auxiliary power supply. It can be configured to charge another battery.

The power supply 114 receives power (via the power switch assembly 100) from one or more of the receptacle 92, the battery 110, and the auxiliary power supply 112, which power is supplied to the power supply itself, another configuration of the module 74. The elements and any other components of system 70 (FIGS. 4-7) are configured to be converted into one or more currents and voltages suitable for powering. For example, power supply 114 can be configured to sense a power signal at receptacle 92 and convert the sensed signal into one or more DC power signals having respective DC voltages. Further, the power supply 114 can be configured to charge the battery 110 (and any battery in the auxiliary power supply 112) while the power supply is receiving the power signal from the receptacle 92. If the power supply 114 does not sense the power signal at the receptacle 92, it converts the power signal from the auxiliary power supply 112 into one or more DC power signals to charge the battery 110 (and any battery in the auxiliary power supply 112). May be configured to use any excess power from the auxiliary power source (ie, a power level higher than that required to power the components of sleep apnea therapy system 70). it can. In addition, the power supply 114 does not sense the power signal at the receptacle 92, and if it senses that the power from the auxiliary power source 112 is insufficient to meet the power demand of the system 70, the power signal from the battery 110 is detected. It can be configured to convert to one or more DC power signals and use some power from the auxiliary power source to charge the battery. The power supply 114 can be or include any suitable type of power supply, eg, a DC-DC converter such as a buck converter, a boost converter, or a buck-boost converter.

The motor assembly 116 includes one or more motors configured to convert electrical energy in the form of a power signal from the power supply 114 into mechanical energy to drive one or more pumps of the pump assembly 118. Including. For example, the motor assembly 116 can include any suitable electric motor such as a DC motor, a brushless DC motor, a brushed AC synchronous motor, or an induction motor. Further, the motor assembly 116 is a motor controller for converting the power signal from the power supply 114 into one or more suitable signals for driving, commutating, and otherwise controlling one or more motors. Circuitry may be included. Further, the motor assembly 116 may cool the one or more motors, dampen or otherwise compensate for vibrations generated by the one or more motors, or generate sound generated by the one or more motors. Alternatively, the motor assembly may include one or more structures configured to not interfere with the subject 12 (FIG. 4) during sleep.

The pump assembly 118 is disposed within each pressure region (the pressure region) between the collar 76 (FIGS. 4-7) and the neck 50 (FIG. 4) of the subject 12 (FIG. 4) while being driven by the motor assembly 116. Is further described below in connection with FIGS. 14-21) and a main pump 142 configured to generate each negative pressure, and an auxiliary configured to operate independently of the motor assembly. And a pump 144. For example, pump assembly 118 may be mechanically coupled to motor assembly 116 using, for example, one or more rotating shafts and transmissions. The main pump 142 can be any suitable fluid pump or compressor such as an impeller pump or piston pump. Also, like the main pump 142, the auxiliary pump 144 may be any suitable fluid pump or compressor, such as an impeller pump or piston pump, but unlike the main pump, the auxiliary pump differs from the motor assembly 116. It is configured so that it can be driven independently. For example, the auxiliary pump 144 can include, and can be driven by, a manually or automatically wound spring mechanism, which can be similar to the spring mechanism described above in connection with the auxiliary power source 112. Alternatively, auxiliary pump 144 may include and may be drivable by an in-house power generation mechanism, which may be similar to the in-situ power generation mechanism described above in connection with auxiliary power source 112.
The pump assembly 118 engages the main pump 142 while the power supply 114 is supplying sufficient power to operate the motor assembly 116, and the power supply 118 supplies sufficient power to operate the motor assembly. Is configured to engage the auxiliary pump 144 alone or together with the main pump while not supplying. As a result, pump assembly 118 is configured to generate a negative pressure in the absence of power from supplier 114.

Air that the pump assembly 118 pumps from the pressure region between the collar 76 (FIGS. 4-7) and the subject's neck 50 (FIG. 4) to create each negative pressure is pumped through the exhaust outlet 102. Get out of.

Further, although described as including a single main pump 142 and a single auxiliary pump 144, pump assembly 118 can include multiple main pumps or multiple auxiliary pumps.

In addition, the pump assembly 118 includes one or more pumps that pump air into the pressure region to reduce the magnitude of the negative pressure in the pressure region faster than by simply shutting off the main pump 142 and the auxiliary pump 144. be able to. Alternatively, the motor assembly 116 or pump assembly 118 reversely drives one or more main pumps 142 and auxiliary pumps 144 to force air into the pressure region to more quickly reduce the magnitude of the negative pressure within the pressure region. Can be configured as follows.

The pressure regulator assembly 120 and the valve assembly 122 cooperate to each one of one or more pressure regions between the neck 50 (FIG. 4) and collar 76 (FIG. 4) of the subject 12 (FIG. 4). It is configured to provide a negative pressure and regulate one or more of these pressures. The valve assembly 122 includes one or more valves configured to direct one or more negative pressures respectively to one or more pressure regions between the collar 76 (FIGS. 4-7) and the neck 50 (FIG. 4). And the pressure regulator assembly 120 includes one or more pressure regulators coupled to the valves and configured to regulate one or more of these negative pressures to each pressure level. For example, the one or more valves may each be a one-way valve that allows air to flow from the collar 76 toward the pump assembly 118. Also, each of the one or more pressure adjustments exceeds any level of aspirated air required to maintain each of the one or more negative pressures at their respective levels, and any of the pressure adjustments drawn by pump assembly 118. It can be a mechanical open loop regulator that bypasses air. Alternatively, each pressure regulator can use feedback to the pump assembly 118 or motor assembly 116, either directly or via the controller 134, to regulate its respective pressure by controlling the pump power. Further, the one or more pressure regulators and the one or more valves can be part of one or both of the regulator assembly 120 and the valve assembly 122 or can be separate from these assemblies. And via a suitable network of couplings, and to the pressure region between collar 76 and neck 50. In addition, the pressure regulator of the regulator assembly 120 detects air leaks in the pressure region between the collar 76 and the neck 50, and seals the leak to the sealant dispenser 124, either directly or via the controller 134. It can be configured to command the sealing material to be dispensed in the vicinity of the air leak. Further, each of the one or more pressure regulators is configured to limit the magnitude of the negative pressure within the respective pressure region to a threshold pressure level determined to be approximately the maximum safe limit for subject 12. You can Further, the regulator assembly 120 and the valve assembly 122 are configured to rapidly release negative pressure from the subject's 12 neck 50 by rapidly increasing the pressure within the one or more pressure chambers. Some or all of the rapid repressurization assembly can be formed. This rapid re-pressurization can help prevent discomfort or injury to the subject 12, can be manually actuated by the subject (eg, by an emergency or panic button or voice command), or For example, it can be triggered by a sensor in response to detecting dyspnea abnormal heart activity or low blood oxygen levels. This rapid repressurization then shuts down one or more of the pumps of pump assembly 118, opens a valve (eg, an emergency valve), or between neck 50 and one or more sealing surfaces 94. May be broken to allow ambient air to enter one or more pressure zones, or to perform one or more similar actions.

The sealant dispenser assembly 124 includes a sealant reservoir 146 and is configured to dispense the sealant from the reservoir at or near one or more sealing surfaces 94 (FIGS. 5-6 and 14-15). To facilitate, strengthen, and/or repair a hermetic seal between the sealing surface and the neck 50 (FIG. 4) of the subject 12 (FIG. 4). For example, dispenser assembly 124 can include one or more sealant pumps that can be similar to one or both of pump 142 and pump 144 of pump assembly 118. In addition, the dispenser assembly 124 pushes the sealing material from the reservoir through the piston, such as to pressurize the reservoir 146, to exert a force on the reservoir (eg, to squeeze) to transport the sealing material from the reservoir. Or one or more pumps or other structures configured to perform one or more similar operations. Additionally, the dispenser assembly 124 may be coupled to the reservoir 146 and collar 76 via a suitable network of hoses, couplings, and injection nozzles, these components may be part of the dispenser assembly, Alternatively, it may be separate from the dispenser assembly.

The sealing material retained within the reservoir 146 may be any suitable substance, such as a liquid, gel, cream, or foam that forms a flexible or rigid seal and does not irritate the skin of the subject. Yes, examples of such gels include silicone-based gels. Further, the sealing material can be configured to form a second seal that is separate from the seal formed by the sealing surface 94 (FIGS. 5-6).

For example, if the pressure regulator of assembly 120 or the pressure sensor of assembly 126 senses a leak in one of the pressure regions (discussed below in connection with FIGS. 14-21), then the pressure regulator is direct. At or near the one or more sealing surfaces 94 (FIGS. 5-6 and 14-15) contacting the pressure area, at or near the dispenser assembly 124 via the controller 134. Can be ordered to dispense. For example, the pressure regulator may close each sealant-dispenser nozzle (e.g., figure 1) near one or more sealing surfaces 94 that contact the pressure area until the pressure regulator detects that the leak has slowed or stopped. 15 (described below in connection with 15) and may be configured to instruct the dispenser assembly 124 to continuously dispense the sealant. Controller 134, pressure regulator assembly 120, or another component or components of component module 74 may be configured to detect a leak in the pressure region by one or more of the following methods: pump assembly. Determining that the speed of the pump in 118 is above a threshold level, determining that the energy consumed or heat generated by the pump assembly 118 is above a threshold level, and the level of ventilation through the pump assembly is By determining that a flow or leak threshold has been exceeded, or by detecting a space between the sealing surface 94 and the portion of the subject's neck 50 (FIG. 4) that faces the sealing surface.

The pressure sensor assembly 126 includes a respective indicator of pressure (eg, in each of one or more pressure regions formed between the collar 76 (FIG. 4) and the neck 50 (FIG. 4) of the subject 12 (FIG. 4). , A feedback signal) and provide them to the controller 134. For example, the pressure sensor assembly 126 can include a respective pressure sensor (eg, piezoelectric vacuum sensor) within each pressure region or within an air hose coupled to each pressure region. In response to these pressure indicators, controller 134 controls pump assembly 118, pressure regulator assembly 120, or valve assembly 122 to control the pressure within each pressure region to its respective programmed or otherwise. Can be configured to maintain the level set at. Further, if the controller 134 determines that there is a leak in one of the pressure chambers, the controller controls the sealant dispenser assembly 124 to dispense the sealant as described above to seal the leak. Can be configured as. Further, if the controller 134 determines that the pressure in the pressure region has exceeded a threshold pressure level, such as a safe threshold pressure level, the controller keeps the pressure in the pressure region below the safe threshold pressure level. , The pressure regulator assembly 120, or the valve assembly 122 can be controlled. Further, in response to the one or more pressure indicators from pressure sensor assembly 126, controller 134 can perform a peristaltic procedure, as described below in connection with FIGS. 16-18. In other words, the pump assembly 118, the pressure regulator assembly 120, the valve assembly 122, the pressure sensor assembly 124, and the controller 134 each have one or more pressure zones within their programmed or otherwise set ranges. May form at least part of a feedback loop for maintaining a respective pressure within each of, or at least controller 134 may omit from this feedback loop. Further, pressure sensor assembly 126 can be configured to perform at least some of the functions of pressure regulator assembly 120, and thus can be configured to provide redundancy for these functions. Alternatively, the pressure sensor assembly 126 can be configured to perform some pressure related functions and the pressure regulator assembly 120 can be configured to perform other pressure related functions, eg, pressure regulation. The vessel assembly 120 can be configured such that the magnitude of pressure within any pressure region does not exceed a safe threshold pressure level, and the pressure sensor assembly 126 is configured to perform all other pressure related sensing functions. be able to.

Apnea sensor assembly 128 is configured to generate and provide to controller 134 an indication of the degree of sleep apnea that subject 12 (FIG. 4) is experiencing during sleep. For example, the apnea sensor assembly 128 can include one or more sensors configured to generate an indication of the degree to which the subject's airway 14 (FIG. 1) is open. In response to this indication, controller 134 controls pump assembly 118 or pressure regulator assembly 120 to reduce the degree of sleep apnea experienced by subject 12 in at least one pressure region. It is configured to change the pressure. For example, if the apnea sensor assembly 128 indicates that the subject's airway 14 is open to less than the target range, the controller 134 controls the pump assembly 118 or the pressure regulator assembly 120 to cause the at least one It is configured to change (eg, increase) the magnitude of negative pressure in the pressure region to increase the degree to which the subject's airways are open in order to bring the airway openness within the target range. Increasing the degree to which the airways are open can mean, for example, increasing the cross-sectional area of the airways at a location that is or will be occluded. In contrast, if the apnea sensor assembly 128 indicates that the airway 14 of the subject is open beyond the target range, the controller 134 controls the pump assembly 118 or the pressure regulator assembly 120. Configured to change (eg, decrease) the magnitude of the negative pressure within at least one pressure region to reduce the degree to which the subject's airway is open in order to bring the airway openness to a target range. It That is, the pump assembly 118, the pressure regulator assembly 120, the valve assembly 122, the apnea rate sensor assembly 128, and the controller 134 reduce the degree of apnea experienced by the subject 12 (eg, to zero). , Forms at least part of a feedback loop for maintaining the degree of openness of the subject's airway 14 within a programmed or otherwise set target range, or at least the controller 134 provides this feedback. It may be omitted from the loop. Apnea sensor assembly 128 is further described below in connection with FIGS.

The memory 130 can be any suitable type of volatile memory circuit (eg, DRAM, SRAM) or non-volatile memory circuit (eg, EPROM, EEPROM®, FLASH), as the controller 134 executes. And configured to store other software, firmware, and data for the system 70. For example, the memory 130 may store one or more safety threshold levels or other threshold levels for each pressure chamber, one or more apnea target ranges, and the negative pressure sleep apnea system 70 (FIGS. 7) may be configured to store one or more configuration or operating parameters. In addition, the memory 130 provides signal levels received from the apnea sensor assembly 128 to the extent of apnea (eg, when the subject's airway 14 (FIG. 1) is open), as described further below in connection with FIG. A look-up table (LUT) 148 that is configured to correlate the signal level from the apnea sensor assembly with the degree of sleep apnea. It may be configured to store the display of the curved line.

The temperature control assembly 132 includes one or more pressure regions between the collar 76 (FIGS. 4-7) and the subject's neck 50 (FIG. 4) for comfort of the subject 12 (FIG. 4), for example. Is configured to control the temperature of each of, or reduce, or eliminate, the degree of airway obstruction a subject experiences during a sleep apnea event. The assembly 132 is coupled to one or more heating elements (eg, resistive heating elements) and cooling elements (eg, thermoelectric cooling elements) strategically placed around the collar 76 (eg, inside or on the collar). And a heating element, a cooling element, and a temperature sensor, the heating element, the cooling element, and the temperature sensor may be configured to be coupled to one or more temperature sensors that are also strategically located. Or may be separate from the temperature control assembly. In response to an indication (eg, a temperature signal) from one such temperature sensor, the temperature control assembly 132 causes the temperature in the corresponding pressure region to fall within a programmed or otherwise set temperature range. Can be configured to adjust Alternatively, the assembly 132 may be configured to provide a respective indicator of the temperature in each pressure zone to the controller 134, which controls the heating and cooling elements to change the temperature in each pressure zone to the respective temperature. It can be configured to stay within range. In addition, the temperature control assembly 132 is coupled to valves strategically placed around the collar 76 to vent one or more pressure zones to ambient air to control the respective humidity or temperature level in each pressure chamber. It may help control, and these valves may form part of the temperature control assembly or valve assembly 122, or may be separate from these assemblies. Such valves are described further below in connection with FIGS. 14-22. Further, the controller 134 can be configured to regulate the temperature within one or more pressure zones to reduce the degree of sleep apnea experienced by the subject. For example, cooling the air or skin in one or more pressure zones can tension the airway muscles of the subject, thereby opening the subject's airways. The controller 134 may be configured to implement a feedback loop that regulates the temperature within the one or more pressure zones to open and maintain the subject's airways. The loop is configured to open and maintain an open airway in the subject with the lowest possible negative pressure, which the controller 134 implements by adjusting the negative pressure in one or more pressure zones. It can be independent of or combined with the feedback loop. When these feedback loops are independent, the controller 134 has at least two variables, pressure and temperature, that can be adjusted to open and maintain an open airway in the subject. The controller 134 and the temperature control assembly 132 can also be configured to allow the controller 134 to regulate the temperature in regions other than the pressure region to reduce the degree of sleep apnea experienced by the subject. For example, the controller 134 may be configured to regulate the temperature of one or more regions of the subject's neck outside the pressure region to reduce the degree of sleep apnea experienced by the subject. In one embodiment, the device may be in a low or “off” pump position unless or until a sleep apnea event is detected, at which point the device pump is “on” or higher. Power triggered. In one embodiment, the device may have a continuous setting regardless of any sensed sleep apnea event or sleep disorder.

Controller 134 may include a processor, microprocessor, microcontroller, or any other suitable instruction executing or non-instruction executing computing machine and computing circuitry, and controls the components of component module 74 as described above. Configured to generally control one or more other components of sleep apnea system 70 (FIGS. 4-7). Controller 134 may be configured to use the memory as a working memory when executing program instructions stored in memory 130, performing calculations, or otherwise making decisions.

For example, the controller 134 can be configured to operate the sleep apnea system 70 in a constant pressure mode. While in this mode, the controller 134 activates the motor assembly 116 and the pump assembly 118 and then indicates a pressure sensor that indicates that the magnitude of the pressure within the one or more pressure regions is greater than or equal to the respective first threshold value. Configured to deactivate the motor and pump assemblies in response to one or more pressure sensors of assembly 126. The controller 134 then causes the motor assembly to respond to the one or more pressure sensors of the pressure sensor assembly 126 indicating that the magnitude of the pressure in the one or more pressure zones is below a respective second threshold. 116 and pump assembly 118 can be activated and the cycle can be repeated as often as needed (each second threshold is lower than the corresponding first threshold to provide hysteresis). be able to). In response to the one or more sensors of the apnea sensor assembly 128 detecting that the subject 12 (FIG. 4) is experiencing an apnea event, eg, airway obstruction, the controller 134 causes the first to the first. The threshold, or the first and second thresholds, may be configured to increase to a level at which the apnea event is stopped, eg, the obstruction is removed from the airways. Alternatively, the controller 134 determines whether the negative pressure within the one or more pressure regions is between the first pressure threshold and the respective second pressure threshold regardless of whether the subject 12 experiences a sleep apnea event. It can be configured to remain contained in between.

Further, the controller 134 can be configured to operate the sleep apnea system 70 in an off until apnea detected mode until an apnea is detected. In this mode, controller 134 causes motor assembly 116 and motor assembly 116 and until the one or more sensors of apnea sensor assembly 128 indicate that subject 12 (FIG. 4) is experiencing a sleep apnea event. Configured to deactivate pump assembly 118. And in response to the one or more sensors detecting the sleep apnea event, controller 134 causes controller 128 to cause the one or more sensors of assembly 128 to no longer experience the sleep apnea event. Until then, the motor assembly 116 and the pump assembly 118 are configured to operate. The controller then deactivates motor assembly 116 and pump assembly 118 until one or more sensors in assembly 128 detect the next sleep apnea event. The controller 134 may also, regardless of whether the subject 12 is still experiencing an apnea event, the motor assembly 116 and the pump if the negative pressure in the one or more pressure regions is greater than or equal to the respective first maximum pressure threshold. The motor assembly 116 may be configured to deactivate the assembly 118 and is responsive to negative pressure in all pressure regions below a respective second maximum pressure threshold that is less than a corresponding first maximum pressure threshold. And may be configured to reactivate pump assembly 118.

Further, the controller 134 can be configured to operate the sleep apnea system 70 in a low-high mode. In this mode, the controller 134 causes the one or more sensors of the pressure sensor assembly 126 to have a first (higher) threshold value and a second (lower) threshold value for the negative pressure magnitude within the one or more pressure regions. ) Is configured to operate the motor assembly 116 and the pump assembly 118 until shown to fall within a threshold. Then, in response to the one or more sensors of the apnea sensor assembly 128 detecting that the subject 12 (FIG. 4) is experiencing a sleep apnea event, the controller 134 causes the pressure measure to increase. Until the one or more sensors of sensor assembly 126 indicate that the magnitude of the negative pressure in the one or more pressure regions is greater than or equal to a respective first pressure threshold that is greater than a respective second pressure threshold. , Motor assembly 116 and pump assembly 118 are configured to operate. The controller 134 is then responsive to the one or more sensors of the sleep apnea sensor assembly 128 detecting that the subject 12 is no longer experiencing a previously detected sleep apnea event. Until the one or more sensors of the pressure sensor assembly 126 indicate that the negative pressure in the one or more pressure regions is included between the corresponding first and second thresholds, respectively. And configured to deactivate pump assembly 118 or otherwise reduce their output. Controller 134 may repeat the above cycles in response to one or more sensors of apnea sensor assembly 128 detecting that subject 12 is experiencing another sleep apnea event. it can.
In addition, the controller 134 may respond to a set time (eg, 1/2 hour before the wake-up time programmed into the system 70 via the input device 88 or another set time) or in response to an increase in ambient light (eg, , As an indicator that it is morning), configured to change (eg, decrease) the magnitude of pressure in each of the one or more pressure regions to assist the subject 12 (FIG. 4) in waking. Or may be configured to change (eg, decrease) the magnitude of pressure in response to an indication from the apnea level sensor assembly 128 that the subject is awake. For example, controller 134 begins to change the respective pressure in each of the one or more pressure zones at a configurable start time and ends at a configurable stop time for a configurable duration during a configurable duration. It may be programmed or otherwise configured to control one or more pressures according to a profile. In this, the pressure profile may include varying one or more pressures linearly or otherwise monotonically over a configurable duration, the pressure profile being common to one or more pressure regions. Also, there may be multiple pressure profiles, each associated with a respective group of one or more pressure regions. As used herein, a "profile" is a plot or representation of a plot of an amount such as pressure over time. Also, an amount can have units of, for example, size, phase, concentration, change in size, change in phase, and change in concentration. Further, the “profile” may include parameters for use or function of the sleep apnea system 70 itself, or sleep characteristics of the subject 12 (FIG. 4), or identification of the subject, diet of the subject, And other parameters associated with the subject, such as the subject's exercise regime. Alternatively, instead of a configurable stop time, the controller 134 may individually stop one or more pressure changes when each of the one or more pressures exceeds a stop threshold, or one or more. Of one or more pressures above the stop threshold, at about the same time as one or more pressure changes may stop. Then, after the duration of this wakefulness procedure, if the controller 134 determines that the subject 12 (FIG. 4) is still asleep, the controller returns to treating the subject's sleep apnea in the manner described above. be able to. Further, although the wakefulness procedure is described in connection with system 70 that produces one or more negative pressures to treat sleep apnea, the wakefulness procedure may be one of the methods for treating sleep apnea. The above can be modified for systems such as CPAP systems that produce positive pressure. The controller 134 can also perform this treatment for reasons other than waking the subject 12.

Still referring to FIG. 8, alternative embodiments of component module 74 are contemplated. For example, module 74 can omit any one or more of the components described above, or can include one or more other components. Moreover, one or more of the functions described above may be performed by one or more components other than the one or more components in which the operation originates. Further, at least controller 134 may be implemented in software, firmware, hardware, or any combination or subcombination of software, firmware, and hardware.

9 is a cross-sectional view of a portion of the apnea sensor assembly 128 of FIG. 8 and the neck 50 (FIG. 4) and airway 14 (FIG. 1) of the subject 12 (FIG. 4), according to one embodiment. Although the neck is shown as having a circular cross section and the airways are shown as having a circular cross section, the neck and airways can each have other cross sections.

The sensor assembly 128 transmits an energy wave toward the neck 50 and the airway 14, receives a portion of the transmitted energy wave that is diverted (eg, reflected) by the area of the airway wall surface 162, and the energy wave. The controller 134 with information related to the received portion of the energy wave so that the controller can determine the degree to which the airway is open depending on the received portion of the An energy wave transceiver 160 configured to. Alternatively, the sensor assembly 128 can provide information so that the degree to which the airway 14 is collapsed can be determined or the controller 134 can determine the degree to which the airway is collapsed. For example, the sensor assembly 128 or controller 134 can use the received redirected portion of the energy wave to determine the dimension D of the airway 14, the value of D being the open (or collapsed) airway. It corresponds to the degree. That is, the larger the value of D, the higher the degree of opening of the airway 14 (the lower the degree of collapse of the airway), and the smaller the value of D, the lower the degree of opening of the airway (airway is The degree of collapse will be higher), but the following will only describe determining the degree to which the airways are open, but it is understood that the corresponding explanation is also applicable to determining the degree to which the airways are collapsed. Alternatively, the sensor assembly 128 or controller 134 uses the received redirected portion of the energy wave to determine more than one dimension of the airway 14 or acquire an image of the airway and acquire it. One or more airway dimensions can be determined from the image.

Transceiver 160 can be configured to transmit any suitable type of energy wave in which surface 162 of airway 14 is at least partially redirected. For example, the transceiver 160 can be configured to transmit acoustic ultrasonic waves, as used in conventional ultrasonic machines, or micro-impulse radar waves. Further, the transceiver 160 can be configured to transmit a continuous energy wave, a pulsed energy wave, or any other suitable type of energy wave.

Transceiver 160 may include multiple transmitters and multiple receivers to obtain an "image" of the entire cross-section of airway 14, or a small number that sensor assembly 128 sweeps to cover the entire cross-section of the airway. Or it may include one transmitter and a few or one receiver that the sensor assembly similarly sweeps, in which case the sensor assembly may sweep the transmitter or receiver mechanically but still electronically ( For example, it may be swept (as in beamforming with a phased array radar). If the transceiver 160 includes multiple transmitters or multiple receivers, these may be on or on the surface of the collar 76 (FIGS. 4-7) or in the component module 74 (FIGS. 4-8). It can be strategically placed in various positions. One example of a suitable transmitter and a suitable receiver includes a transducer, eg, a piezoelectric transducer, that can act as a transmitter or a receiver at different times.

The sensor assembly 128 or controller 134 may provide one of the energy waves in any suitable manner, such as, for example, a method in which an ultrasonic machine analyzes the received redirected portion of the transmitted sound waves that are redirected by the internal tissue of the subject. A time delay (eg, for the transmission time of the wave), a phase (eg, for the transmitted phase), a frequency spectrum (eg, for the frequency spectrum of the transmitted wave) of each of the one or more received redirecting portions, The airway by analyzing one or more of a waveform (eg, for the waveform of the transmitted wave), a power (eg, for the transmitted power), and an amplitude (eg, for the amplitude of the transmitted wave). 14 is configured to determine the dimension D.

10 is a cross-sectional view of a portion of the apnea sensor assembly 128 of FIG. 8 and the neck 50 (FIG. 4) and airway 14 (FIG. 1) of the subject 12 (FIG. 4), according to another embodiment. , And the airway is shown as having a circular cross-section, but the neck and airway may each have other cross-sections.

The sensor assembly 128 is adapted to receive energy wave transmitters 164 configured to transmit energy waves towards the airway 14 and one or more portions of the transmitted energy waves penetrating the neck 50 and airway 14. An energy receiver configured to determine the extent to which the airway is open in response to the received portion of the energy wave, or information related to the received portion of the energy wave to controller 134. And is configured to allow the controller to determine the degree to which the airway is open. For example, the sensor assembly 128 or controller 134 can use the received portion of the energy wave to determine the dimension D of the airway 14, 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 of opening of the airway 14, and the smaller the value of D, the lower the degree of opening of the airway. Alternatively, sensor assembly 128 or controller 134 may use the received portion of the energy wave to determine more than one dimension of airway 14.

The transmitter 164 may pass at least partially through a first portion of the neck 50 between the transmitter and the airway 14, an airway, and a second portion of the neck between the airway and the receiver 166. It can be configured to transmit any suitable type of energy wave. For example, the transmitter 164 may be configured to transmit x-ray waves, such as those used in conventional x-ray machines, or microimpulse radar waves. Further, the transmitter 134 may be configured to transmit a continuous energy wave, a pulsed energy wave, or any other suitable type of energy wave.

Transmitter 164 can include multiple transmitters and receiver 166 can include multiple receivers so that sensor assembly 128 can obtain an “image” of the entire cross-section of airway 14. Alternatively, the transmitter 164 may include a few or one transmitter that the sensor assembly 128 sweeps to cover the entire cross-section of the airway 14, and the receiver 166 may include the receiver that the sensor assembly similarly sweeps. May be included in a small number or one, in which case the sensor assembly may mechanically sweep the transmitter or receiver but electronically (eg, beamforming using a phased array radar). May be. If transmitter 164 includes multiple transmitters, or receiver 166 includes multiple receivers, these may be on the inside or surface of collar 76 (FIGS. 4-7) or on component module 74 ( It can be strategically placed at various locations within FIGS. 4-8).

The sensor assembly 128 or controller 134 may detect the one or more received portions of the energy wave in any suitable manner, such as, for example, by an x-ray machine analyzing the received portion of the transmitted x-ray wave. Each time delay (eg, relative to the transmission time of the wave), phase (eg, to the transmitted phase), frequency spectrum (eg, to the frequency spectrum of the transmitted wave), waveform (eg, waveform of the transmitted wave) ), power (eg, for transmitted power), and amplitude (eg, for amplitude of transmitted wave).

11 is a diagram of a portion of the apnea sensor assembly 128 of FIG. 8 and the subject 12 of FIG. 4 according to yet another embodiment.

The sensor assembly 128 is configured to receive one or more portions of one or more energy waves generated by the subject 12 and is responsive to the one or more energy wave portions received. 14 (FIGS. 9-10) to determine the extent to which the controller 14 is open, or to allow the controller to determine the extent to which the airway is open, information related to the one or more energy wave portions received by the controller 134. And an energy wave receiver 168 configured to provide the. For example, the sensor assembly 128 or the controller 134 can use the received one or more energy wave portions to determine the dimension D (FIGS. 9-10) of the airway 14, where the value of D is Corresponds to the open degree. That is, the larger the value of D, the higher the degree of opening of the airway 14, and the smaller the value of D, the lower the degree of opening of the airway. Alternatively, sensor assembly 128 or controller 134 may use the received one or more energy wave portions to determine two or more dimensions of airway 14.

Energy wave receiver 168 may be configured to receive any suitable type of energy wave produced by subject 12. For example, the receiver 168 may include sound waves, such as those generated when the subject 12 makes respiratory sounds (eg, breathing or snoring), eyes (even when the eyes are closed), or otherwise. Configured to receive disturbances in light waves, such as those generated when moving a body part of the body (eg, nose, mouth, jaw, or chin), or electromagnetic waves such as brain or heart waves (eg, electrocardiogram waves) Can be done.

The sensor assembly 128 may include a plurality of receivers 168 so that it can pick up energy waves emanating from anywhere around the subject's 12 head, neck, or other areas, Alternatively, the sensor assembly may include a few or one receiver that sweeps mechanically or electronically (eg, as in beamforming using phased array radar). If the sensor assembly 128 includes multiple receivers 168, these may be strategically located at various locations inside or on the surface of the collar 76 (FIG. 4) or within the component module 74 (FIGS. 4-8). May be located at. Further, one or more receivers 168 may be directed to an area of the subject other than the subject's neck (eg, head, thorax).

The sensor assembly 128 or controller 134 analyzes one or more of the phase, frequency spectrum, waveform, power, and amplitude of each of the one or more received energy wave portions in a conventional manner, and then this To determine the dimension D by correlating the results of the analysis with the extent to which the airway 14 (FIGS. 9-10) is open, using, for example, the look-up table 148 of FIG. 8 or a fitted curve. Composed. The procedure for creating and using such a correlation is described below in connection with FIG.

12 is a diagram of a portion of the apnea sensor assembly 128 of FIG. 8 and the subject 12 of FIG. 4 according to yet another embodiment.

The sensor assembly 128 includes a biological condition sensor 170 configured to sense one or more biological conditions of the subject 12 and is responsive to the one or more sensed biological conditions. The airway is open to determine the degree to which the person's airway 14 (FIGS. 9-10) is open, or by providing the controller 134 with information relating to one or more biological conditions sensed. The controller is configured to determine the degree. For example, the sensor assembly 128 or controller 134 may use the sensed one or more biological states to determine the dimension D of the airway 14 (FIGS. 9-10), where the value of D indicates that the airway is open. Corresponds to the extent That is, the larger the value of D, the higher the degree of opening of the airway 14, and the smaller the value of D, the lower the degree of opening of the airway. Alternatively, sensor assembly 128 or controller 134 may use the sensed one or more biological states to determine more than one dimension of airway 14.

Sensor 170 may be configured to sense any suitable type of biological condition in subject 12. Examples of such biological conditions include respiratory rate, heart rate, blood glucose level, blood oxygen level, blood adrenaline level, body temperature, body sweat level, body-cortisol level (from cortisol in the subject's sweat). ), body movement level (eg, the sensor can include an accelerometer), blood pressure, exhaled gas composition, and body part location (eg, chin position, degree of subject's mouth open, or subject) The extent that the nostrils have spread).
The sensor assembly 128 may include a plurality of biological condition sensors 170 such that one or more of the sensors may be collar 76 (FIGS. 7) inside or on the surface (removably or fixedly attached), at various locations within the component module 74 (FIGS. 4-8), or at various locations on or within the subject's body. Can be strategically placed and each such sensor, if on or in the body, can be connected to the component module 74 (FIGS. 4-8) by wire or other suitable connector. , Or can communicate wirelessly with the base portion of the sensor assembly 128. For example, the sensor assembly 128 can utilize one or more motion sensors configured to monitor the motion of the subject 12 during sleep. These one or more sensors may be mounted on or off the color assembly 72 (eg, one or more accelerometers) (eg, an accelerometer attached to the subject's limb or torso, or Remote imaging device (eg, low light or IR camera, or micro impulse radar). A sensor remote from the collar assembly 72 can deliver its measurements wirelessly or via one or more signal cables to a portion of the sensor assembly 128 mounted on the collar assembly. In response to the readings provided by such one or more sensors, controller 134 may cause excessive movement (eg, struggling or frequent posture changes) or lack of movement (eg, excessive movement) of subject 12. Rest) can be interpreted as an indicator that the subject is experiencing sleep apnea.

The sensor assembly 128 or controller 134 analyzes one or more parameters of each of the one or more sensed biological states in any suitable manner, and then the results of this analysis are analyzed, for example, in FIG. Look-up table 148, or a fitted curve stored in memory 130, to determine the dimension D by correlating with the degree to which the airway 14 (FIGS. 9-10) is open. The procedure for creating and using such a correlation is described below in connection with FIG.

With reference to FIGS. 8-12, alternative embodiments of the apnea sensor assembly 128 are contemplated. For example, sensor assembly 128 includes any combination or sub-combination of one or more of energy wave transceiver 160, energy wave transmitter 164, energy receivers 166 and 168, and biological state sensor 170, respectively. be able to.

FIG. 13 is a flow diagram 180 of a procedure for associating one or more biological states of a subject 12 (eg, FIG. 12) with a degree of sleep apnea that the subject is experiencing, according to one embodiment. Is. For example, the procedure can correlate one or more biological states to the extent to which the subject's airways 14 (eg, FIGS. 9-10) are open, and airway openness is experienced by the subject. It is related to the degree of sleep apnea. In the example described below in connection with the flow diagram 180, the biological condition that is correlated is the respiratory rate of the subject 12, but for the apnea sensor assembly 128 described above in connection with FIGS. It should be appreciated that any one or more other biological conditions sensed by any of the embodiments can be correlated in a similar manner. In addition, the psychiatrist or sleep technician may perform a correlation with the subject 12 in the sleep laboratory setting, and then, for example, a look-up table (LUT) 148 of the subject's sleep apnea therapy system 70 (Fig. 8) can be programmed with a correlation data structure, or the system's memory 130 (FIG. 8) can be programmed with a representation of a fitted curve relating biological status to the degree of sleep apnea. Alternatively, the subject's system 70 or laboratory version of the system may perform this procedure with or without the help of a sleep medicine specialist or subject 12.

At step 182, the sleep technician monitors the degree to which the airway 14 (FIGS. 9-10) of the subject 12 (FIG. 4) is open during sleep. For example, as described above in connection with FIG. 9, ultrasound may be used to monitor one or more dimensions D (FIGS. 9-10) of airway 14. The ultrasound waves and the resulting ultrasound images may be generated by one embodiment of the apnea treatment system 70 described above in connection with FIG. 9, or by an independent ultrasound machine.

At the same time, in step 184, the biological status of the subject 12 (FIG. 4) associated with the degree to which the subject's airways 14 (FIGS. 9-10) are open during sleep is monitored. For example, the volume or frequency spectrum of the subject's respiratory sounds (eg, breathing, snoring), or the subject's respiratory rate, as in this example, can be monitored.

Then, after performing steps 182 and 184 for an appropriate amount of time (eg, 2-8 hours while the subject is watching), at step 186, each of the one or more monitored biological conditions is airwayd. ((FIGS. 9-10)). For example, digitized observations of the subject's respiratory rate at corresponding sample times and digitized observations of the subject's airway 14 openness at the same corresponding sample times were obtained at each sample time. Each value of respiratory rate can be combined with the corresponding airway openness obtained at the same respective sample time. Further, in some cases, a predictive correlation can be derived. For example, it has been determined that a particular pattern of respiratory sounds often precedes airway closure during the period of time (eg, 2 minutes long) that precedes apnea-induced closure of the airway 14 of the subject 12. Good. Accordingly, such correlations are used to pre-emptively apply negative pressure to selected one or more regions of the subject's neck 50 to prevent the initiation of sleep apnea events just before they occur. Can be done.

Next, at step 188, respective data structures are generated that show the correlation between each of the biological states and airway openness.

For example, a data structure representing the correlation between the digitized value of respiratory rate and the corresponding digitized value of airway openness may be generated and stored in LUT 148 (FIG. 8). That is, each breath rate value can be associated with a corresponding address in the LUT 148, and at each address, the airway openness corresponding to the breath rate value associated with that address can be stored.

If the apnea sensor assembly 128 (FIGS. 8 and 12) provides a digitized value of a subject's respiratory rate, a respiratory value-to-address converter (such converter is part of the assembly 128). May be a part of any other component of the component module 74 or may be a separate component of the component module) and translates its value into the address of the LUT 148. .. The sensor assembly 128 or controller 134 then obtains the corresponding value of airway openness from the position of the LUT 148 at this address and uses this airway openness value to pump assembly 118 (FIG. 8), pressure regulator. The assembly 120 or valve assembly 122 is controlled to control the level of sleep apnea experienced by the subject 12. For example, if the airway openness value obtained from the LUT 148 is less than the programmed or otherwise set apnea level target range, the sensor assembly 128 or controller 134 sets the airway openness to the target range. In contrast, if the airway openness value obtained from the LUT exceeds the apnea level target range, the sensor assembly 128 or controller 134 may cause the airway openness to reach the target range. Can act to decrease towards or to maintain airway openness at current levels.

Alternatively, the digitized value of respiratory rate and the corresponding digitized value of airway openness can be fitted to a curve and a representation of this curve stored in memory 130 (FIG. 8).

When the apnea sensor assembly 128 (FIGS. 8 and 12) provides a digitized value of the subject's respiratory rate, the controller 134 uses a fitted curve representation to correlate this value to the airway openness. The airway openness value is used to control the pump assembly 118 (FIG. 8), the pressure regulator assembly 120, or the valve assembly 122 to determine the sleep apnea experienced by the subject 12. Control the level. For example, if the fitted curve is a straight line, an equation defining the line for the breathing value and the airway openness value is stored in memory 130 and used by controller 134 to correspond to the provided value of the breathing rate. Calculate the open airway. Thus, if the airway openness value obtained from the fit curve is below the programmed or otherwise set apnea level target range, the sensor assembly 128 or controller 134 will open the airway toward the target range. If the value of airway openness obtained from the fitted curve is above the apnea level target range, the sensor assembly 128 or controller 134 may move toward the target range. It can act to reduce openness or maintain airway openness at current levels.

Still referring to FIG. 13, an alternative embodiment of the procedure represented by flow diagram 180 is contemplated. For example, any one or more of the listed steps 182-188 may be omitted and one or more other steps may be added. Moreover, any of the steps listed may be performed manually, by a computing device, or by any other suitable device.

FIG. 14 is a plan view of an inner portion of the collar 76 of FIGS. 4-7, including two sealing surfaces 94 portions and a vacuum surface 96 portion, according to one embodiment. The “inner portion” is configured to face the neck 50 (FIG. 4) of the subject 12 (FIG. 4) while the subject is wearing the sleep apnea treatment system 70 (FIGS. 4-7). Means the portion of the collar 76 that has been marked.

Each sealing surface 94 is configured to contact each portion of the neck 50 (FIG. 4) of the subject 12 (FIG. 4) and form a respective hermetic seal with each contacted neck portion.

The vacuum surface 96 is then configured to form a negative pressure region 200 with the sealing surface 94, the contact portion of the neck 50, and the portion of the subject's neck that opposes the vacuum surface, which is also referred to as the pressure surface. The negative pressure region is also called a vacuum region, a pressure chamber, or a vacuum chamber. As described below in connection with FIGS. 16-22, the collar 76 can include a frame so that at least a portion of the vacuum surface 96 does not contact the subject's neck 50.

Each sealing surface 94 may be rigid, semi-rigid, or flexible and may be formed from any suitable sealing material such as plastic, rubber, foam, or silicone resin.

The vacuum surface 96 may also be rigid, semi-rigid, or flexible and may be formed from any suitable material such as plastic, rubber, foam, or silicone resin, and the set of one or more suction openings 202. , And a set of one or more discharge openings 204, wherein the suction openings and discharge openings may be arranged with respect to each other in any suitable pattern and may have any suitable size and shape. Further, nozzles, one-way valves, or other suitable components may be placed inside one or more of openings 202 and 204.

The one or more intake openings 202 allow air to pass from an outer portion of the collar 76 through one or more intake valves (discussed below in connection with FIGS. 16-22). Configured to allow entry into the negative pressure region 200 through the “outer portion” while the subject is wearing the sleep apnea treatment system 70 (FIGS. 4-7). 4 is a portion of a collar 76 configured to turn its back on the neck 50 (FIG. 4) of the person 12 (FIG. 4). Hoses and couplings in collar 76 may connect one or more intake openings 202 to one or more intake valves. Further, some or all of these hoses and couplings, one or more suction valves, and one or more suction openings 202 can be considered part of valve assembly 122 (FIG. 8).

The one or more exhaust openings 204 then allow air to pass from the negative pressure region 200 through the one or more exhaust openings through the valve assembly 122 (FIG. 8) and the pressure regulator assembly 120 (FIG. 8). It is configured to allow exit through pump assembly 118 (FIG. 8) and through exhaust valve 102 (FIGS. 4-8). Hoses and couplings in collar 76 can connect one or more drain openings 204 to valve assembly 122 and pressure regulator assembly 120 (FIG. 8). Additionally, some or all of these hoses and couplings, and one or more drain openings 204 can be considered part of valve assembly 122 (FIG. 8).

Allowing air to flow through the negative pressure region 200 may be more comfortable for the subject 12 (FIG. 4) than if the inhalation opening 202 were not present, which may be more than one inhalation opening. If there are no parts, the air in the pressure area may become hot and humid due to the subject's sweating, and otherwise “stagnate”. Although the negative pressure sleep apnea therapy system 70 (FIGS. 4-7) can include a temperature control assembly 132 (FIG. 8) to cool the air in the pressure region 200, the ventilation described above does. Can be reduced or eliminated, thus reducing the energy consumed by the system and reducing the cost of the system by omitting the cooling capacity from the temperature control assembly.
Still referring to FIG. 14, alternative embodiments of sealing surface 94 and vacuum surface 96 are contemplated. For example, although shown parallel to each other, the sealing surfaces 94 can be positioned relative to each other in any other suitable orientation. Additionally, the collar 76 may include less than or more than two sealing surfaces 94 and more than one vacuum surface 96. Additionally, the one or more sealing surfaces 94 can each include one or more drainage openings 204 to increase the strength of the seal each surface makes with the neck 50 (FIG. 4). Further, one or more portions of sealing surface 94 and one or more portions of vacuum surface 96 may be part of the same surface. Further, the portion of the vacuum surface 96 forming each pressure region 200 may be wholly or partially surrounded by one or more sealing surfaces 94 (if partially enclosed, a portion of the vacuum surface is a vacuum surface). By forming an airtight seal with the portion of the subject's neck 50 (FIG. 4) opposite the sealing portion of the seal of FIG. 4). Further, to form the pressure area 200, the hermetic seal formed by the one or more sealing surfaces 94 and the one or more vacuum surfaces 96 with respective portions of the subject's neck 50 (FIG. 4) is It may only partially extend around, which may, for example, allow the pump assembly 118 (FIG. 8) to draw in external air through the side of the pressure area where the hermetic seal is not formed, so that the suction opening. The need for 202 can be eliminated. Additionally, each of the one or more sealing surfaces 94 can include one or more draining openings 204, which seal surfaces use negative pressure to provide a seal against the skin of the subject. Allows to form. Each of the one or more sealing surfaces 94 can include an array of closely spaced, separate ejection openings 204, or can include a porous surface. The one or more sealing surface discharge openings 204 or pores may be coupled through a manifold or plenum to a pump (eg, belonging to pump assembly 118, pressure regulator assembly 120, or valve assembly 122), which pump comprises: Used to provide a negative pressure to adhere the sealing surface to the user's skin. The one or more underpressure levels forming the one or more seals can be different than the one or more underpressure levels in one or more pressure zones 200. Alternatively, the pressure level used to form the seal may be the same as the pressure level in the adjacent pressure region 200, for example, the manifold servicing the discharge openings/pores of the sealing surface 94 may be The discharge openings/pores can be connected to adjacent pressure zones, whereby a separate pump is not required.

FIG. 15 is a plan view of a portion of the sealing surface 94 according to one embodiment.

The portion of sealing surface 94 of FIG. 15 may be similar to the portion of sealing surface 94 of FIG. 14, except that the portion of the sealing surface of FIG. 15 includes one or more sealing material dispenser openings 210.

Each sealant dispenser opening 210 is configured to expel sealant from the sealant dispenser assembly 124 of FIG. 8, where the sealant is sealed to the sealing surface 94 as described above in connection with FIG. 12 (FIG. 4) configured to form a hermetic seal configured to form part of neck 50 (FIG. 4) or to repair a leak. For example, the sealant may repair leaks formed between the seal surface 94 and the subject's neck 50 (FIG. 4) around one or more locks of the subject's hair. Further, nozzles, one-way valves, or other suitable components may be placed within one or more openings 210. Additionally, the hoses and couplings in the collar 76 (FIG. 14) can connect one or more sealant dispenser openings 210 to the sealant dispenser device assembly 124 (FIG. 8), and the hose and couplings Some or all, and one or more sealant dispenser openings can be considered part of a sealant dispenser device assembly. Further, the one or more sealant dispenser openings 210 can have any suitable size and shape and can be arranged along the sealing surface 94 in any suitable spacing and in any suitable pattern. .. Further, the opening 210 can overlap the edge 212 of the sealing surface 94 such that a portion of the sealing material dispenser opening is formed in the sealing surface and another portion is formed in the adjacent vacuum surface 96 (FIG. 14). ). Alternatively, the opening 210 can be formed entirely in the vacuum surface 96, for example near the edge 212 of the sealing surface 94.

In operation of the sleep apnea system 70 (FIGS. 4-7), according to one embodiment, for example, if the controller 134 (FIG. 8) detects a leak in the pressure region 200 (FIG. 14), the controller may: , Sealing material dispenser assembly 124 (FIG. 8) through one or more sealing material dispenser openings 210 along a portion of the sealing surface 94 that forms or otherwise contacts the pressure area. , Sealing material can be dispensed from the reservoir 146 (FIG. 8). For example, the controller 134 may cause the sealant dispenser assembly 124 to dispense the sealant through one opening 210 in the sealing surface 94 until the controller detects that the leak is sealed.

Still referring to FIG. 15, alternative implementations are contemplated. For example, although only one sealing surface 94 is described, multiple sealing surfaces can include one or more sealant dispenser openings 210. Additionally, the sealant dispenser assembly 124 (FIG. 8) can be configured to selectively dispense the sealant at any one or more, but not all, of the sealant dispensing openings 210. Further, if the opening 210 includes a nozzle, the sealant dispenser assembly 124 can orient the nozzle in a selected direction before, during, or after dispensing the sealant.

16 is a view of a portion 220 of the collar 76 of FIGS. 4-7 and 14, according to one embodiment.

17 is a cross-sectional view of the central region of collar portion 220 of FIG. 16 and portion 222 of subject's neck 50 and airway 14 taken along line AA of FIG. 16 according to one embodiment.

FIG. 18 is a cross-sectional view of an end region of collar portion 220 of FIG. 16 and a portion 222 of subject's neck 50 and airway 14 according to one embodiment.

16-17, the collar 76 includes one or more segments 224 that the negative pressure sleep apnea therapy system 70 (FIGS. 4-7) wears by the subject 12 (FIG. 4). While being held, it is configured to be oriented substantially circumferentially around the subject's neck 50.

Each segment 224 is formed by a respective rigid or semi-rigid portion 226 of frame 228. Each frame portion 226 has a curved shape and can be made from any suitable material such as plastic, metal, or wire mesh.

Each frame portion 226 includes a respective portion of the vacuum surface 96 (eg, described above in connection with FIG. 14) and a respective outer cover 230 that may be made of any suitable material such as plastic or cloth. Parts and are attached. Any suitable attachment technique, such as gluing or tacking, may be used to attach the vacuum surface 96 and the outer cover 230 to the frame portion 226.

Each frame portion 226 is attached to an adjacent frame portion at its respective joint 232 by any suitable attachment technique such as welding, bonding, cementing, or gluing. Alternatively, the frame 228 may be made from a unitary piece such that the frame portions 226 are integrated together. Alternatively, joint 232 may be flexibly coupled together, for example using a hinge.

A respective sealing surface 94 (described above in connection with FIGS. 14-15) is located along each joint 232.

While the collar 76 is being worn by the subject, the sealing surface 94 engages each portion 234 of the subject's neck 50 to create a pressure region 200, one pressure region for each collar segment 224 in this example. To do.

Each collar segment 224 also includes a respective intake valve 238 that allows the pump assembly 118 (FIG. 8) to draw ambient air into the respective pressure region 200, as described above in connection with FIG.

For example, as described above in connection with FIGS. 8 and 14-15, any hoses or couplings that may be placed in the collar 76 have been omitted from FIGS. 16-18 for clarity. There is.

Referring to FIG. 18, the cross-section of the end region of the collar 76 is similar to the cross-section of the central region of the collar described above with respect to FIG. 17, except that a segment terminator 240 has been added.

Terminator 240 is configured to form a hermetic seal at the ends of collar segment 224 and may be made from any suitable rigid or semi-rigid material such as plastic, metal, or wire mesh.

The sealing surface 94 extends along the bottom of the terminator 240 and is configured to provide a hermetic seal with the portion 242 of the neck 50, with the curved top of the terminator along the seam 244 in any suitable hermetic manner. Attached to the vacuum surface 96.

Alternatively, the terminator 240 may be attached directly to the respective frame portion 226, or may be integrally formed with the frame portion, or may be integrally formed as an integral part of the frame 228.

16-18, in operation of sleep apnea therapy system 70 (FIGS. 4-7), pump assembly 118 (FIG. 8) draws air from negative pressure region 200, according to one embodiment. As a result, a negative pressure exists in the negative pressure region 200. The intake valve 238 allows air to enter the negative pressure region, but the force of the pump assembly overcomes this inflow to create a negative pressure in the negative pressure region. Further, the negative pressures in region 200 may be the same or different from each other.

Since the pressure on the outside of the collar 76 is greater than the pressure in the pressure area 200, the outside air effectively presses the frame 228, which in turn causes the sealing surface 94 against the neck portion 234 and neck portion 242. And press to form each hermetic seal. Alternatively, from another perspective, the frame 228 is effectively “sucked” against the neck 50 such that the sealing surface 94 is pressed against the respective neck portion 234 and neck portion 242. This effect can be used as a primary mechanism for attaching the collar assembly 72 to the neck 50 of the subject 12, and thus positively impacts the subject via straps or by completely surrounding the neck. Allows a color assembly that does not need to be installed. Such a collar assembly 72 is generally sufficient to hold the collar assembly against the subject's neck 50 in one or more pressure regions 200, but is too weak to visibly open the airway 14. A moderate “grasping” level of negative pressure, which is not possible, is available and the collar assembly provides one or more pressure zones as needed to keep the airway open or to keep it open. The magnitude of the negative pressure at can be increased to stop apnea or prevent apnea from occurring.

Further, because frame 228 and terminator 240 are rigid or semi-rigid, frame portion 226 and terminator hold vacuum surface 96 away from portion 246 of neck 50 covered by the frame portion. Thus, the negative pressure in the region 200 can cause the neck portion 246 to expand outwardly, thus providing the desired result of "pulling" and opening the airway 14 of the subject. If the frame portion 226 and the terminator 240 were not rigid or semi-rigid, the vacuum surface 96 would collapse against the neck portion 246, resulting in the subject's airway 14 being "pulled" open as intended. Not be

Still referring to FIGS. 16-18, in operation of the sleep apnea treatment system 70 (FIGS. 4-7), according to another embodiment, the system operates within the pressure region 200 to mimic peristalsis. The pressure of can be adjusted. For example, the system 70 may reduce or eliminate the possibility that the system will cause the portion 246 of the neck 50 to form edema (eg, a “hickey”) caused by prolonged continuous exposure to negative pressure. , The pressure can be adjusted so.

Peristalsis is a radially symmetric contraction and relaxation of the muscles that form the myotubes, the contractions propagating undulatingly down the myotubes in a forward-looking manner. An example of such a myotube in humans is the esophagus, whose muscles contract in a peristaltic manner to move food and beverages from the mouth to the stomach.

In one embodiment, the pressure regulator assembly 120 (FIG. 8) first increases the pressure in the pressure region 200 below the collar 76 (ie, reduces the magnitude of the negative pressure) during the middle and The pressure in the upper pressure area is kept unchanged. The amount and profile by which the pressure regulator assembly 120 increases the pressure in the lower pressure region 200, and the duration of this pressure increase, is formed between the adjacent sealing surface 94 and the neck portion 234 and neck portion 242. It may be suitable to reduce or eliminate the possibility of edema formation in the lower neck portion 246 without breaking the airtight seal.

The pressure regulator assembly 120 (FIG. 8) then causes the lower pressure region 200 to reach a level at which the controller 134 (FIG. 8) determines that it is suitable for treating the subject's sleep apnea. Reduce the pressure within (ie increase the magnitude of the negative pressure). The profile by which the pressure regulator assembly 120 lowers the pressure in the lower pressure region 200, and the duration of this pressure drop, will reduce or eliminate the likelihood of edema formation in the lower neck portion 246. Can be suitable.

The pressure regulator assembly 120 (FIG. 8) then raises the pressure in the intermediate pressure region 200 (ie, negative pressure) during or after reducing the pressure in the lower negative pressure region 200. The pressure magnitude is reduced), during which the pressure remains at least unchanged in the upper pressure zone. The amount and profile by which the pressure regulator assembly 120 increases the pressure in the intermediate pressure region 200, and the duration of this pressure increase, is formed between the adjacent sealing surface 94 and the neck portion 234 and neck portion 242. It may be suitable to reduce or eliminate the possibility of edema formation in the intermediate neck portion 246 without breaking the hermetic seal.

The pressure regulator assembly 120 (FIG. 8) then moves within the intermediate pressure region 200 until the controller 134 (FIG. 8) reaches a level that is determined to be suitable for treating the subject's sleep apnea. Decrease the pressure of (i.e. increase the magnitude of the negative pressure). The profile by which the pressure regulator assembly 120 reduces the pressure in the intermediate pressure region 200, and the duration of this pressure reduction, are suitable for reducing or eliminating the likelihood of edema formation in the intermediate neck portion 246. obtain.

The pressure regulator assembly 120 (FIG. 8) then increases the pressure in the upper pressure region 200 (ie, at negative pressure) during or after reducing the pressure in the intermediate pressure region 200. The size is reduced), during which the pressure, at least in the lower pressure area, remains unchanged. The amount and profile by which the pressure regulator assembly 120 increases the pressure in the upper pressure region 200, and the duration of this pressure increase, are formed between the adjacent sealing surface 94 and the neck portion 234 and neck portion 242. It may be suitable to reduce or eliminate the possibility of edema formation in the upper neck portion 246 without breaking the hermetic seal.

The pressure regulator assembly 120 (FIG. 8) then moves within the upper pressure region 200 until it reaches a level that the controller 134 (FIG. 8) determines is suitable for treating the subject's sleep apnea. Decrease the pressure of (i.e. increase the magnitude of the negative pressure). The profile by which the pressure regulator assembly 120 reduces pressure in the upper pressure region 200, and the duration of this pressure drop, may be suitable to reduce or eliminate the likelihood of edema formation in the upper neck portion 246. ..

To summarize the peristaltic procedure described above, the controller 134 causes the pressures in the lower, middle and upper pressure regions to cancel each other out in time, and thus topologically, and the controller propagates the collar 76 up and down. The pressures in the lower, middle and upper pressure zones are varied so as to effectively generate pressure "waves" that act.

The controller 134 (FIG. 8) may perform this peristaltic procedure periodically, at programmed or otherwise set intervals, or when a threshold size edema is present in an area of the subject's neck 50 (eg, It may be performed in response to a sensor of system 70 indicating that it has been formed in region 246) or may be formed soon. In addition, the controller 134 may cause the number of pressure areas that have been positively pressured at any one time such that the collar 76 is completely out of the subject's neck 50 (FIG. 4) or otherwise is the subject's sleep apnea. One or more pressure regions 200 can be at their respective positive pressures during each part of the peristaltic procedure, as long as they are small enough not to cause any problems in the treatment of. For example, controller 134 may be configured such that only one end pressure region (eg, upper or lower pressure region) 200 has a reduced amount of negative or positive pressure at any one time. obtain.

Still referring to FIGS. 16-18, alternative embodiments of collar 76, and generally system 70 (FIGS. 4-7), are contemplated. For example, the color segments 224 can have different sizes or shapes from each other and can have different sizes or shapes than those described. Further, there may be less or more than three segments 224. Further, the peristaltic movements can propagate from the top to the bottom of the collar 76, rather than from the bottom to the top, the directions of propagation can be alternated, and can be modified in any suitable manner.

19 is a view of a portion 250 of the collar 76 of FIGS. 4-7 and 14, according to another embodiment.

20 is a cross-sectional view of collar portion 250 of FIG. 19 and portion 222 of subject's neck 50 and airway 14 taken along line AA of FIG. 11, according to one embodiment.

With reference to FIGS. 19-20, the collar portion 250 includes the collar portion 220 of FIGS. 16-18 with the addition of one or more sealing surfaces 252, each of which separates from the terminator 240 and crosses the sealing surface 94. It may be similar, but with the addition of corresponding one or more pressure zone separators 254 supporting transverse sealing surfaces. The transverse sealing surface 252 can be similar to the sealing surface 94 and can be attached to the separator 254 in any suitable manner. Also, the separator 254 can be made from the same material as the frame portion 226 or the terminator 240, in a manner similar to that the terminator can be attached to the vacuum surface or the frame portion as described above in connection with FIG. It can be attached to the vacuum surface 96 or the frame portion. Alternatively, the separator 254 can be integrally formed with the frame portion 226 in a manner similar to that which allows the terminator 240 to be integrally formed with the frame portion 226, as described above in connection with FIG.

The transverse sealing surface 252 and the separator 254 form an additional pressure area 200 (FIGS. 16-18) by dividing the collar segment 224 into sections.

Further, when the sleep apnea therapy system 70 (FIGS. 4-7) adjusts the pressure within the pressure region 200 (FIGS. 16-18) to mimic peristalsis, the controller 134 (FIG. 8) causes the same color segment. The pressure in the pressure region belonging to 224 can be changed at the same time. Alternatively, the controller 134 may apply pressure in a manner similar to the peristaltic technique described above in connection with FIGS. 16-18, but circumferentially (ie, around the neck 50 rather than up and down the neck). It can be configured to regulate the pressure in region 200. Alternatively, the controller 134 system may be configured to regulate the pressure within the pressure zone 200 both transversely (ie, above and below the neck) and circumferentially.

Still referring to FIGS. 19-20, alternate embodiments of collar 76, and generally system 70 (FIGS. 4-7), are contemplated. For example, the same alternatives described above for collar 76 of FIGS. 16-18 can be applied to collar 76 of FIGS. 19-20.

21 is a view of a portion 260 of the collar 76 of FIGS. 4-7 and 14, according to yet another embodiment.

FIG. 22 is a cross-sectional view of collar portion 260 of FIG. 21 and portion 222 of subject's neck 50 and airway 14 taken along line AA of FIG. 21, according to one embodiment.

21-22, the collar portion 260 includes a collar segment 262 that is transverse to the subject 12 (FIG. 4) when the sleep apnea system 70 is worn (ie, above/below the neck 50). 16-18 except that the collar segment 224 (FIGS. 16-18) is configured to extend circumferentially (ie, around the neck). It is similar to the collar portion 220. Also, although not shown, collar portion 260 is similar to sealing surface 252 and separator 254 and seals substantially across sealing surface 92 and joint 264 (ie, in substantially the same direction as line AA in FIG. 21). It may be similar to collar portion 250 of FIGS. 19-20 in that it may include a face and a separator.

21-22, alternative embodiments of collar 76, and generally system 70 (FIGS. 4-7), are contemplated. For example, the same alternatives described above with respect to FIGS. 16-20 can be applied to collar 76 of FIGS. 21-22.

FIG. 23 is a flow diagram 270 of operational modes of the sleep apnea therapy system 70 (FIGS. 4-7), according to one embodiment.

The operation of the sleep apnea treatment system 70 (FIGS. 4-7) according to one embodiment is described with reference to FIGS. 4-8 and 14-22.

After the subject 12 turns on and activates the treatment system 70 (eg, via the power switch assembly 100), at step 272 of the flow diagram 270, the controller 134 directs the pump assembly 118 and the pressure regulator assembly 120 to each. The respective initial pressures, for example the respective negative pressures, are generated in the pressure region 200. That is, the pump assembly 118 is external to the collar 76 into the intake valve 238, through the intake opening 202 into one or more pressure regions 100, through the discharge opening 204, the valve assembly 122 and the pressure regulator. One or more negative pressures are created by drawing air through the assembly 120, into the pump assembly 118, and out through the exhaust valve 102. Alternatively, one or more of the inlet valve 238 and the inlet opening 202 are inert so that the pump assembly produces at least a portion of the one or more negative pressures without producing a respective continuous vent. It may be compounded or omitted.

Next, at step 274 of flow diagram 270, controller 134 is responsive to the one or more pressure indicators from pressure sensor assembly 126 to monitor one or more pressure regions 200 for air leaks.

At step 276, controller 134 determines if there is an air leak. If controller 134 determines that there are no leaks, the controller proceeds to step 280. However, if controller 134 determines that there is at least one leak, controller 134 proceeds to step 278.

At step 278, the controller 134 detects 1 by, for example, causing the sealant dispenser assembly 124 to dispense the sealant from the reservoir 146 through the one or more sealant dispenser openings 210 near each leak. Have each repair done on one or more leaks.

Next, in step 280, controller 134 monitors the degree of sleep apnea that subject 12 is experiencing via apnea sensor assembly 128. For example, controller 134 can monitor a subject's respiratory rate.

Next, in step 282, the controller 134 determines whether or not the degree of sleep apnea that the subject 12 is experiencing is within the target range. For example, the controller 134 can determine if the subject's respiratory rate is within a target range. If the controller 134 determines that the degree of sleep apnea is within the target range, then the controller proceeds to step 286. However, if the controller 134 determines that the degree of sleep apnea is outside the target range, then the controller proceeds to step 284.

At step 284, the controller 134 identifies one or more pressure regions 200 that the controller has determined to adjust, and identifies one or more identified pressure regions 200 to drive the degree of sleep apnea toward the target range. The pump assembly 118 or pressure regulator assembly 120 is controlled to regulate the pressure within the pressure region.

Next, in step 286, controller 134 monitors one or more comfort conditions in one or more comfort sectors of system 70 (FIGS. 4-7). For example, controller 134 can monitor the temperature or pressure within one or more pressure zones 200.

Next, at step 288, the controller 134 determines whether one or more comfort conditions in one or more comfort sectors are within each target range. For example, controller 134 can determine whether the temperature within each pressure region 200 is within its respective target range. If the controller 134 determines that each of the one or more comfort conditions is within its respective target range, then the controller proceeds to step 292. However, if the controller 134 determines that at least one of the one or more comfort conditions is outside its respective target range, then the controller proceeds to step 290.

In step 290, the controller 134 identifies one or more comfort sectors to be adjusted, and one of the identified one or more comfort sectors to promote one or more comfort conditions towards each target range. The temperature control assembly 132 is controlled to adjust one or more comfort parameters (eg, temperature). Additionally or alternatively, controller 134 may temporarily reduce the magnitude of pressure within one or more pressure regions 200 to reduce the likelihood of edema formation, or otherwise of the subject. The pump assembly 118 and pressure regulator assembly 120 may be controlled in a peristaltic manner to provide a "rest" from the higher magnitude pressure in each region 246 of the neck 50.

In step 292, controller 134 is the time for subject 12 to wake up or otherwise power off the system (eg, subject removes system 70 and powers system through power switch assembly 100). "Because it was turned off"). If it is not time to wake up subject 12, controller 134 returns to step 274. However, if it is time to wake up the subject 12, the controller 134 proceeds to step 294.

In step 294, the controller 134 executes a wakeup routine and then shuts down the system 70 (FIG. 4), or the controller skips wakeup routing and shuts down the system. As an example of a wake-up routine, controller 134 sounds an audible alarm at a specific time or in response to an increase in ambient light, by slowly decreasing the magnitude of the respective pressure in each pressure region 200, or It can be programmed to help wake the subject 12 by varying the respective pressures in one or more pressure zones according to an arrangement or pattern that gently awakens the subject.

After step 294, the operating mode described above ends and is repeated the next time the subject 12 activates the sleep apnea therapy system 70.

Further embodiments of the negative pressure sleep apnea therapy system are described below in connection with FIGS. 24-63. The sleep apnea treatment system 70 described above in connection with FIGS. 4-23 is any one of any of the embodiments of any sleep apnea treatment system described below in connection with FIGS. 24-63. The sleep apnea treatment system, which can be modified to include the features described above, and similarly described below in connection with FIGS. 24-63, respectively, is any embodiment of sleep apnea treatment 70. Can be modified to include any one or more features of Further, the embodiments of the sleep apnea therapy system described below with respect to FIGS. 24-63 include one or more of the embodiments of the sleep apnea therapy system 70 unless otherwise stated. Can be structurally and operationally similar.

24-25 illustrate a subject's 405 neck 400, throat 402, and chin for applying negative pressure to treat sleep apnea, such as obstructive sleep apnea, according to one embodiment. 404 is an isometric front view and an isometric side view of throat region 406 and throat region 407, respectively.

Referring to FIGS. 3 and 24-25, in one embodiment, the negative pressure application region 406 is targeted at the lower side by the subject's sternum head 62 and laterally by the subject's sternocleidomastoid muscle 66. It is bounded by the intersection 408 of the person's chin 404 and the subject's throat 402 (ie, the anterior abdomen of the two bellies 55 in FIG. 3). In another embodiment shown in FIGS. 24 to 25, the negative pressure application region 406 includes a lower side of the subject's throat 410 (thyroid cartilage 57 of FIG. 3) and a lateral side of the subject's sternocleidomastoid muscle 66. The upper side is bounded by the intersection 408 of the subject's chin 404 and the subject's throat 402.

Negative pressure application area 407 is typically smaller than area 406 and may be partially or completely within area 406 and may be rectangular or square around throat 410 of the subject. For example, the lateral borders of region 407 can be aligned with the respective corners of the subject's mouth, and the upper border of region 407 can be directly below the subject's chin 404. In one embodiment, the application of negative pressure is sufficient to move the subject's tongue and/or other soft palate tissue anteriorly, thereby reducing or eliminating airway obstruction. In one embodiment, the application of negative pressure is sufficient to move the subject's tongue and/or other soft palate tissue anteriorly, thereby reducing or eliminating snoring without airway obstruction.

As described above, the negative pressure (eg, suction) applied to region 406 or region 407 is sufficient to reduce or eliminate obstruction of the tissue that occludes the airway of the subject (airway 14 of FIG. 1). Can cause migration. Negative pressure can “pull out” tissue within region 406 or region 407 that is connected to occluded tissue or other tissue adjacent to the subject's airways to reduce or eliminate occlusion. A sufficient distance to "pull" the occluded tissue or other tissue adjacent to the subject's airways. Alternatively, the negative pressure can move the subject's jaw 412 sufficiently to reduce or eliminate the occlusion (eg, anterior, inferior, or both anterior and inferior). Alternatively, negative pressure may reduce or eliminate airway obstruction by both "pulling" tissue within region 406 or region 407 and moving jaw 412.

24-25, other embodiments of negative pressure application regions 406, 407 are contemplated. For example, each of the aforementioned boundaries of region 406 or region 407 can be modified by any distance within a distance range of, for example, ±25 millimeters (mm).

FIG. 26 is an isometric front view of a subject 405 wearing a negative pressure sleep apnea treatment system 420 according to one embodiment. System 420 is designed to apply a negative pressure to throat region 406, throat region 407, or both throat regions 406, 407 of the subject, as described above in connection with FIGS. In addition to the structural and operational features described below with respect to FIGS. 26-63, the system 420 is any embodiment of the sleep apnea therapy system 70 described above with respect to FIGS. 4-23. Can have any of the structural and operational characteristics of

The sleep apnea therapy system 420 can be self-contained so that it does not require a connection to an external device (eg, base station, power outlet) to operate, and thus can be a conventional CPAP machine, or , It may be more comfortable than other sleep apnea therapy systems that include a base station and an air hose coupled between the base station and the system. For example, a self-contained version of sleep apnea system 420 can include a battery (eg, battery 110) that can be recharged while subject 405 is not wearing/using the sleep apnea system. As a result, the sleep apnea system may have a physical connection (e.g., power cord, hose, and wired communication link) to another device or location while the subject is wearing or otherwise using the sleep apnea system. ) Is not required. However, the built-in version of sleep apnea system 420 can be configured to include a wireless communication link and a wireless power link.

27-28 are respective isometric side views of a subject 405 wearing the negative pressure sleep apnea treatment system 420 of FIG. 26, according to one embodiment. The sleep apnea system 420 includes a removable gasket assembly 422, which is configured to form an airtight seal around the perimeter of the sleep apnea system and includes a removable strap assembly 424, The strap assembly 424 is configured to secure the sleep apnea system around the subject's 405 neck 400. Alternatively, the strap assembly 424 can be configured to secure the sleep apnea system 420 to or around the head 425 of the subject 405.

FIG. 29 is an isometric view of a subject 405 wearing the negative pressure sleep apnea treatment system 420 of FIGS. 26-28, according to one embodiment. The strap assembly 424 can include a coupler 426 configured to connect the back ends of straps 428 and 430 of the strap assembly together at the back of the subject's neck 400. Coupler 426 is also configured to allow adjustment of the size of the neck loop formed by straps 428 and 430 of strap assembly 424. That is, the coupler 426 is used to ensure that the fit of the sleep apnea system 420 is not “tight” so as to cause discomfort to the subject 405, and where the gasket assembly 422 contacts the subject's neck 400. The loop size can be adjusted so that it is not "loose" to allow air leakage at. The ends of the coupler 426 and straps 428 and 430 may comprise Velcro® or any other suitable material or structure that allows the straps to be adjustably coupled together. Alternatively, the combiner 426 can be omitted from the sleep apnea system 420 and the strap ends, which can include Velcro®, can be directly coupled to each other.

30 is an isometric side view of the negative pressure sleep apnea therapy system 420 of FIGS. 26-29, according to one embodiment.

31 is an isometric rear view of the negative pressure sleep apnea therapy system 420 of FIGS. 26-30, according to one embodiment.

32 is an isometric exploded view of the negative pressure sleep apnea treatment system 420 of FIGS. 26-31, according to one embodiment.

Referring to FIGS. 30-32, in addition to gasket assembly 422 and strap assembly 424, negative pressure sleep apnea therapy system 420 includes a collar assembly (hereinafter “color”).

Gasket assembly 422 is configured to be removably attachable to collar 440, eg, by “snapping” around collar perimeter 442. In one embodiment of sleep apnea system 420, gasket assembly 422 is expected to wear, upgrade, or otherwise require more frequent repairs or replacements than collar 440, and thus gasket assembly The removable configuration allows the gasket assembly to be replaced independently of the collar.

The strap assembly 424 is also configured to be removably attachable to the collar 440, for example by attaching to the sides of the collar. Straps 428 and 430 of strap assembly 424 have respective front ends 444 and 446 configured to be removably attached to respective sides 448 and 450 of collar 440. For example, strap front end 444 and collar side 448, as well as strap front end 446 and collar side 450, may include Belcro® components of opposing construction. Further, the positions of the strap front ends 444 and 446 are adjustable relative to the collar sides 448 and 450 to allow for adjusting the size of the neck loop formed by the straps 428 and 430 of the strap assembly 424. Can be Further, in one embodiment of the sleep apnea system 420, it is expected that the strap assembly 424 will wear, upgrade, or otherwise require more frequent repairs or replacements than the collar 440, thus The removable configuration of the strap assembly allows the strap assembly to be replaced independently of the collar 440.

Referring to FIG. 31, a posterior side 452 of the collar 440 (the side configured to face the subject's neck 400 (eg, FIGS. 26-29) when the sleep apnea system 420 is worn). ) Or through, one or more discharge openings 454 (only one opening is shown in FIG. 31) and one or more sensors 456 (only one sensor in FIG. 31). (Shown) are arranged. For example, one or more exhaust openings 454 may be structurally and functionally similar to exhaust opening 204 of FIG. 14 and one or more sensors 456 may be structurally similar to the sensors of sensor assemblies 126, 128 of FIG. And can be functionally similar. As described above in connection with FIGS. 4-23 and described below, a pump (not shown in FIG. 31) draws air through one or more exhaust openings 454 to cause the collar to A negative pressure volume or region is created between the posterior side 452 of 440 and the throat region 406 or throat region 407 (FIGS. 24-25) of the subject.

The pulling of air through the one or more discharge openings 454 can also be referred to as pulling a vacuum through one or more discharge openings, or pulling into a partial vacuum, where the negative pressure volume or region is a vacuum. , Partial vacuum, or pressure region, and may be structurally and functionally similar to pressure region 200 described above in connection with FIG. 17, for example. Further, as described above in connection with FIGS. 4-24 and described below, one or more sensors 456 can be configured to sense and provide information or one or more physical parameters. From this information or one or more physical parameters, sleep apnea system 420 may adjust the magnitude of negative pressure or other parameters (eg, neck temperature) to adjust the subject's airways (eg, figure). Information can be derived that the sleep apnea system can use to open or maintain one airway 14). Further, the one or more sensors 456 are configured to sense and provide other information or one or more other physical parameters from which the sleep apnea system 420 can derive other information. You can For example, as described above in connection with FIG. 8 and as described below, one or more sensors 456 may be used to determine the physical or mental, emotional, health, or wellbeing condition or status of subject 405. It may be configured to sense and provide information related to (eg, FIGS. 26-29) or related to the use or setting of the subject's sleep apnea system 420. Further, the one or more discharge openings 454 and the one or more sensors 456 can have any suitable position, shape, and size, which position, shape, and size are shown in FIGS. 30-32. It can be different from the one.

30-32, the collar 440 can be custom manufactured to better fit the neck 400 of the subject 405 (eg, FIG. 29). For example, a physician or other person may use a conventional imaging device or a conventional scanner to generate a three-dimensional (3D) image or map of the subject's neck 400 (at least the front and sides of the subject's neck). be able to. The 3D image or map can then be converted into a print file having a format suitable for a 3D printer capable of "printing" the colors 440. Alternatively, the color 440 can be manufactured by CNC or other machine from a 3D image or map. Other components of sleep apnea system 420 (eg, gasket assembly 422, strap assembly 424) can be manufactured in a similar manner.

FIG. 33 is an isometric front view of the gasket assembly 422 and collar 440 of FIGS. 26-32, according to one embodiment.

34 is an isometric side view of the gasket assembly 422 and collar 440 of FIGS. 26-33, according to one embodiment.

FIG. 35 is an isometric side isometric view of collar 440 of FIGS. 26-34 having a perspective portion, according to one embodiment.

Referring to FIGS. 33-35, collar 440 includes a semi-rigid housing 460, formed in the front of the housing, and compartment 462 configured to hold one or more components of sleep apnea system 420. including.

Referring to FIG. 35, the collar housing 460 includes a rigid inner frame 464 disposed within a flexible, resilient overmold or package 466.

The frame 464 includes slats 468, either from plastic metal or with the collar 440 "collapsed" with respect to the neck between the collar's posterior surface 452 and the subject's 405 neck 400 (eg, FIGS. 26-29). No, it may be formed from any other material that has sufficient strength and rigidity to allow the negative pressure region to be formed. Although shown as oriented vertically, one or more of the slats 468 may be oriented horizontally or diagonally, and the vertical slats may be horizontal or diagonal cross slats (see FIG. 35). Are not shown). Further, the frame 464 can include optional strap attachments 470 and 472 for engaging the strap assembly 424 (eg, FIG. 32), where the attachments are associated with FIGS. The Velcro(R) strap attachments 444, 446, 448, 450 described above may then be replaced or otherwise eliminated. Although each strap attachment 470, 472 is shown to include two eyelets 474, 476, one or both strap attachments may include less than or more than two strap eyelets.

The overmold 466 is made of plastic metal or the collar 440 is between the posterior surface 452 of the collar and the throat region 406 or throat region 407 (eg, FIGS. 24-25) of the subject 405 (eg, FIGS. 27-28). The posterior surface has sufficient strength and rigidity to allow it to create an area of negative pressure without “collapse” against the throat, and the collar is the subject's neck 400 (eg, FIGS. 27-28). A) and may be formed from any other suitable material that also has sufficient flexibility and surface texture to allow it to conform to its shape. When collar 440 is configured to create an area of negative pressure between posterior surface 452 of collar and throat area 407, collar 440 creates an area of negative pressure between posterior surface of collar and throat area 406. It may be smaller than it is configured to, or for a given size, may have more room for components, such as components of component module 550.

To form the housing 460, the frame 464 can first be formed by conventional injection molding, and then the overmold 466 can be formed on the frame also by conventional injection molding.

Referring again to FIGS. 33-35, the compartment 462 can be formed as an integral compartment with the overmold 466 or can be formed as part of the frame 464 for added strength. Further, the compartment 462 may be at the rear of the collar 440 (side facing the subject 105) or at the front of the collar (side facing the subject) to allow repair or replacement of components within the compartment. And an access panel (not shown in FIGS. 33-35). Alternatively, compartment 462 does not include an access panel so that the components are sealed within the compartment and cannot be repaired or replaced without disassembling or destroying collar 440 (eg, by slitting overmold 466). May be. Examples of components that can be placed in compartment 462 include batteries, motors, pumps, valves, sensors, electronic circuits and electronic components, and mechanical assemblies and mechanical components (further details of such components). Examples are described above, for example, with respect to FIG. 8 and below with respect to, for example, FIG. 45).

FIG. 36 is an isometric front view of collar 440 of FIGS. 26-35 and on/off switch 480 for negative pressure sleep apnea therapy system 420, according to one embodiment. The switch 480 can be, for example, a tactile slide switch located in front of the component compartment 462. That is, by swiping your finger across the front of compartment 462, switch 480 is switched between its "on" and "off" states, just like switching the switch displayed on the screen of a smartphone. You can switch with. For example, the collar 440 includes a device such as a display screen or a capacitive sensor that is exposed through the front side of the compartment 462 or is located directly behind it, and the switch 480 is formed by the device. Or otherwise implemented. Switch 480, in its “on” state, connects the system components (eg, motors and other components in compartment 462, and sensor 456 of FIG. 31) to a power source such as a battery located in the compartment. Configured to activate the sleep apnea system 420, and in its "off" state to deactivate the sleep apnea system by disconnecting the components of the sleep apnea system from the power source. The switch 480 also makes it difficult or impossible for the subject 405 (eg, FIG. 29) to inadvertently switch the switch to the “off” state while the subject is asleep and wearing the sleep apnea system 420. Configured to be possible. For example, the switch 480 may cause the bedding to entangle with the switch and put the switch in its “off” state due to movement of the subject 405 (eg, movement while the subject rolls over or lies down). It can be configured to be difficult or impossible to switch. Further, although shown as located on the front side of compartment 462, switch 480 can be located in any other suitable position within or on collar 440. In addition, the switch 480 can be configured for control by a controller of the sleep apnea system 420 (eg, controller 134 of FIGS. 8 and 45). For example, the controller may automatically switch the switch 480 to the “off” state in response to detecting that the subject 405 has removed the sleep apnea system 420 from around the neck 400 and the subject is still The switch may be configured to automatically switch to the "on" state in response to detecting that the switch has switched to the "off" state while sleeping.

FIG. 37 is an isometric front view of collar 440, battery level indicator 482, and remote control 484 of FIGS. 26-36, according to one embodiment.

The battery level indicator 482 displays color, intensity, or both color and intensity to indicate the state of charge of one or more batteries 110 (FIGS. 8 and 45) that power the sleep apnea therapy system 420. It can be any suitable type of indicator, such as a light emitting diode (LED) display configured to vary. Indicator 482 may be located, for example, on the front side of component compartment 462 or in any other suitable location on collar 440. In response to the indicator 482 indicating that one or more batteries 110 are in a low state of charge, the batteries may be charged, for example, using an AC adapter, as described above in connection with FIG.

The remote controller 484 may be configured to control the operation of the sleep apnea therapy system 420 and may be a dedicated remote controller or any suitable device such as a smartphone, Bluetooth®, WiFi( It may be configured to communicate with the sleep apnea system according to any suitable wireless or wired protocol, such as ™, Zigbee®, Radio Frequency (RF), or Infrared (IR). For example, the remote control 484 may adjust the settings (eg, negative pressure magnitude, wake-up time) of the sleep apnea therapy system 420 to the sleep apnea system memory 130 (FIGS. 8 and 45). It may be configured to allow data to be entered or retrieved from it and the sleep apnea therapy system to be "on" or "off". The remote control 484 may also be configurable and reconfigurable, for example by firmware or software. For example, if remote control device 484 is a smartphone, it may be possible to download into the memory of the smartphone a software application that allows the smartphone to be used to control sleep apnea therapy system 420. In addition to or instead of remote control 484, collar 440 may include input device 98 (FIGS. 8 and 45), which may be, for example, a keypad or display screen. And configured to control the sleep apnea therapy system 420, enter data into the memory 130 of the sleep apnea therapy system 420, or retrieve data from the memory of the sleep apnea therapy system 420. obtain. Further, remote control 484 may be part of sleep apnea therapy system 420 (eg, FIGS. 26-32) or may be separate from sleep apnea therapy system 420. Good.

FIG. 38 illustrates the negative pressure sleep of FIGS. 26-32 according to one embodiment where the system includes one or more sensors 490 located other than the back side 452 of the collar 440 with one or more sensors 456 of FIG. 31. FIG. 10 is an isometric side view of a subject 405 wearing an hour apnea treatment system 420.

One or more sensors 490 are attached to adjustable arm 492, which is attached to collar 440 or is integral with collar 440 and may be made from any suitable material such as metal or plastic. For example, the arm 492 can include a joint 494 about which the upper portion 496 of the arm can be rotated in a plane parallel to the plane containing the lower portion 498 of the arm. In addition, the arm 492 can include another joint 500 disposed between the collar 440 and the lower arm section 498, about which the lower arm section can rotate or pivot. Further, one or both of the upper arm portion 496 and the lower arm portion 498 may be telescopically expandable, for example. In addition, sleep apnea system 420 can include one or more motors for changing the position of one or more sensors 490 under the control of controller 134 (FIGS. 8 and 45). Moreover, arm 492 may be structurally and functionally configured in any other suitable manner. Further, although shown mounted on the end of arm 493, one or more sensors 490 may be mounted on any other portion of the arm.

Any one or more sensors 490 configured to sense a respective physical quantity and generate a respective analog or digital electronic signal representative of a corresponding quantity of the respective parameter (eg magnitude, phase, frequency). Any suitable type of sensor can be included. For example, the one or more sensors 490 may sense one or more substances (eg, a subject's exhaled matter) in the air exhaled by the subject (eg, the subject's exhaled breath) 405, or the ambient. One or more gas sensors configured to sense a difference between the level of one or more substances in the air and the level of the same one or more substances in the subject's exhaled breath can be included. Alternatively, the one or more sensors 490 can include one or more sound sensors, such as microphones, configured to sense one or more sounds (eg, snoring) generated by the subject 405. .. Alternatively, the one or more sensors 490 are configured to sense whether the subject 405 is awake or sleeping by sensing whether the subject's eyes 502 are open or closed. It can include one or more cameras, or other visual sensors. Further, the one or more sensors 490 may include one or more accelerometers or gyroscopes (eg, microelectromechanical () for sensing movement of the subject 405, or for sensing the force the subject expels air. microelectromechanical (MEMS) accelerometer or gyroscope).

FIG. 39 is an illustration of a sleep apnea system according to one embodiment including one or more electrodes 510 disposed at any suitable location on the collar, such as on the posterior side 452 of the collar at collar ends 512, 514. FIG. 39 is an isometric exploded view of the gasket assembly 422 and collar 440 of the negative pressure sleep apnea therapy system 420 of FIGS. 26-32 and 38.

40 is a cross-sectional side view of the gasket 516 of the gasket assembly 422 of FIGS. 26-34 and 39, according to one embodiment.

With reference to FIGS. 39-40, the front portion 518 of the gasket assembly 422 includes an engagement portion (eg, “lip”) 520 and the rear portion 522 of the gasket assembly includes a gasket 516.

The engagement portion 520 of the gasket assembly 422 is disposed about the perimeter 524 of the gasket assembly 422 and is configured to removably engage a rim 526 disposed about the perimeter 442 of the collar 440. For example, the engagement portion 520 can engage the rim 526 by a "snap" fit on the rim and can disengage the rim by "snap" off the rim. Alternatively, the engagement portion 520 may be positioned with a glue (not shown in FIGS. 39-40) or on the engagement portion and positioned on the rim (shown in FIGS. 39-40). (Not shown) may be attached to the rim 526 using pins (not shown in FIGS. 39-40) that are “snapped” into/out of (not shown). Further, the engagement portion 520 is flexible and resilient enough to flex with the collar 440, for example, to allow the engagement portion to "snap" in/out of the collar rim 526. Can be formed from any suitable material.

The gasket 522 is configured to form an airtight seal with the neck 400 of the subject 405 (eg, FIG. 38) wearing the sleep apnea treatment system 420 of FIGS. 26-32 and 38. The gasket 522 may be attached to the front portion 518 of the gasket assembly 422 such that the gasket is removable/replaceable independently of the front portion of the gasket assembly, or the gasket is permanently attached or integral to the front portion of the gasket assembly. Can be attached by, for example, an adhesive. Further, the gasket 522 can be formed from any material suitable for forming a hermetic seal with the subject's neck 400, examples of such materials being foam, foam rubber, rubber, and gel. Is included. Still referring to FIG. 40, the gasket 522 can include a channel 528, the opening 530 of which the channel 528 has, when the vacuum is pulled through the channel, the gasket is pulled or "sucked" against the skin. And is configured to be continuous with the skin 532 of the subject's neck 400 so as to form a tighter seal than is obtained with the strap assembly 424 (eg, FIG. 32) alone. For example, the channel 528 may be such that a vacuum is drawn through the channel 528 through one or more discharge openings 454 (FIG. 31) to create a negative pressure region between the collar 440 and the subject's neck 400. , May include an opening (not shown in FIGS. 39-40) on the inward side 534 of the gasket assembly front 516. Alternatively, the collar rim 526, and also the gasket assembly front 516, are configured to allow a pump that creates a negative pressure region to communicate with the channel 528 independent of the negative pressure region. (Not shown in FIGS. 39-40). Further, before the subject 405 "wears" the sleep apnea system 420, the gasket 522 is applied by applying a sealing material, such as a gel or foam, to the surface of the gasket configured to contact the skin. The seal formed by can be enhanced. The sealant may also moisturize and otherwise soothe or heal the subject's skin to prevent scars, pain, or rashes in the areas where the gasket 522 contacts the skin. Additionally, the gasket 522 can include one or more sealant dispenser openings 210 (FIG. 15) through which the sealant dispenser assembly 124 (FIGS. 8 and 45) seals the sealant. The reservoir 146 (FIGS. 8 and 45) can be dispensed to form a seal or stop leakage at the seal, as described above in connection with FIGS. 8 and 15. Further, the seal formed by the gasket 522 is configured such that one side is configured to adhere to the skin-facing surface of the gasket 522 and the other side is configured to contact the skin to provide an adhesion to enhance the seal with the skin. It can be reinforced by a replaceable and disposable self-adhesive sealing member (not shown in Figures 39-40) with an agent or other substance. Such a seal member may be replaced, for example, on a routine basis, more often than before replacing gasket 522 and gasket assembly 422, before each use.

Referring again to FIG. 39, one or more electrodes 510 (two electrodes 510a, 510b shown in FIG. 39) can function as a sensor, a therapeutic application device, or both a sensor and therapeutic application device. For example, while functioning as a sensor, controller 134 (FIGS. 8 and 45) or other circuitry of sleep apnea therapy system 420 measures the voltage between electrodes 510a, 510b and to or from the electrodes. Can be configured to measure the respective currents of each of the subjects, where voltage, current, or both voltage and current (eg, voltage or current magnitude, phase current) can be measured by subject 405 (eg, FIG. 38) can indicate the level of sleep apnea that it is experiencing, or it can indicate a subject's condition or parameter such as blood pressure, blood glucose, blood oxygen level, and body or skin temperature. Also, while functioning as a therapeutic application device, controller 134 or other circuitry of sleep apnea therapy system 420 applies a voltage to electrodes 510a, 510b to treat subject 405, or to the electrodes. It can be configured to apply a respective current from the electrode layers (eg, the controller/circuit can be configured to control the magnitude and phase of the voltage and current). Examples of such treatments include reducing levels of sleep apnea, reducing hypertension, reducing high blood glucose levels, and increasing low blood oxygen levels. Examples of how the controller 134 or circuitry can affect such treatment include changing body or skin temperature, and muscle and other tissue, such as the subject's neck or throat. To relax, strain, or "shock". Any data collected from the subject may be stored and/or shared on other devices (eg, attending physicians, databases of other users, mobile devices, tablets, social media, etc.).

41 is an isometric exploded view of the gasket assembly 422, collar 440, and sleeve 534 of the negative pressure sleep apnea treatment system 420 of FIGS. 26-32 and 38, according to one embodiment. The sleeve 534 can be configured to be placed between the collar 440 and the gasket assembly 422 and can be held in place in any suitable manner. For example, by placing the sleeve 534 against or adjacent the rear surface 454 of the collar 440 and then “snapping” the gasket assembly 422 to the collar rim 526, as described above in connection with FIGS. 39-40. The sleeve can be fixed in place. Alternatively, sleeve 534 can be adhesively secured to collar 440 or gasket assembly 422. Further, the sleeve 534 makes the sleep apnea system 420 more comfortable for the subject 405 (eg, FIG. 38) as compared to a sleeveless sleep apnea system while the sleep apnea system is still sleeved. A vacuum through which to create a negative pressure area between the sleeve and the subject's neck 400 (eg, FIG. 38), any soft, breathable, moisture-wicking fabric or the like. It can be made of any suitable material. Additionally, some or all of the components of the sleep apnea system (eg, pumps, motors, controllers, batteries, temperature sensors, temperature regulators) are secured to or formed within sleeve 534. It can be placed in one or more compartments. Further, the sleeve 534 may be machine washable and replaceable, such that if there are components fixed or placed on the sleeve, those components are discarded with the used sleeve and replaced with a new sleeve. Or these components may be removed from the used sleeve and reinstalled with a new sleeve. Further, the sleeve 534 may be configured to extend partially or completely around the subject's neck 400.

42 is an isometric view of the sleep apnea therapy system 420 of FIGS. 26-32 and 38, according to one embodiment, where the sleep apnea system includes a rechargeable battery 110 (FIGS. 8 and 45). Is.

43 is an isometric top view of an empty filled storage case 540 for the sleep apnea treatment system 420 of FIG. 41, according to one embodiment.

44 is an isometric front view of the sleep apnea treatment system 420 of FIG. 42 inside the charging storage case 540 of FIG. 43, according to one embodiment.

With reference to FIGS. 42-44, the sleep apnea system 420 may engage conductive charging contacts 544 located within the case 540 while the sleep apnea system is stored within the case. Includes a configured conductive charging contact 542.

Charging storage case 540 can be made from any suitable material and can have any suitable configuration. For example, the charging case 540 can be made of plastic and have a rear hinged clamshell configuration as shown in FIGS. 43-44.

In addition, the charging storage case 540 may include standard alternating current (AC) wall outlets (110 VAC or 220 VAC), AC adapters (eg, “wall wart”), solar cells, and other batteries and the like. Configured to receive a power signal (eg, input voltage or current) from a power source (not shown in FIGS. 42-44), via a wired connection (eg, power cord), or wirelessly (eg, The power signal may be received inductively or otherwise electromagnetically.

Either the sleep apnea system 420 or the charging storage case 540 provides a power signal from a power source to the battery 110 (eg, in compartment 462 of FIG. 34) mounted on the sleep apnea system 420 (FIGS. 8 and 45) includes a battery charging circuit (not shown in FIGS. 42-44) configured to convert a charging signal (eg, charging current or charging voltage) suitable for charging. When sleep apnea system 420 includes a battery charging circuit, case 540 provides the battery charging circuit with a power signal from the power source to which the case is coupled via charging contacts 542 and 544. Otherwise, if case 540 includes a battery charging circuit, the case provides a charging signal to battery 110 via charging contacts 542,544. In one embodiment, case 540 includes a battery charging circuit to reduce the size and weight of sleep apnea system 420.

Alternatively, sleep apnea system 420 and charging storage case 540 may omit contacts 542 and 544, and the case may be configured to wirelessly provide a power or charging signal to the sleep apnea system. it can. For example, case 540 may provide a power or charge signal to sleep apnea system 420 inductively, ie, in a manner similar to how a card reader provides a power signal to a circuit mounted on a smart card. Can be configured.

45 is a block diagram of component modules 550 of the negative pressure sleep apnea treatment system 420 of FIGS. 26-32, 38, 42, and 44, according to one embodiment. For example, the component module 550 can be partially or completely located within the color compartment 462 (FIG. 34) of the collar 440, and if only partially located within the compartment, the remaining component module The portion can be located on another portion of the collar, the gasket assembly 422, or outside the collar and gasket assembly.

Unless otherwise stated, the structure and function of the components of the component module 550 may or may not be the same as the structure and function of the corresponding components of the component module 74 of FIG. As such, similar components of component module 550 are identified with the same reference numbers as corresponding components of component module 74.

Also, unless otherwise noted, the sleep apnea system 420 of FIGS. 26-32, 38, 42, and 44, and the component module 550 and its components are similar to the flow diagram 270 of FIG. Can be configured to operate according to.

In addition to the structure and function of power switch assembly 100 described above in connection with FIG. 8, power switch assembly may include switch 480 and other circuitry described above in connection with FIG. Further, in addition to being manually operated, the power switch assembly 100 may be “on” (activated) and “activated” by, for example, a sleep apnea system 420 via a remote control device, such as remote control device 484 (FIG. 37). It can be manipulated to be "off" (deactivated). In addition, the power switch assembly 100 may be used while the sleep apnea system is placed in the base or case (eg, case 540 of FIGS. 43-44) or the sleep apnea system has a vacuum hose (FIG. 45). While not attached) (in this case, the power switch assembly causes the subject 405 (eg, FIG. 38) to activate and deactivate the vacuum source located on the base unit to which the hose is attached. The sleep apnea system 420 can be operated to be activated and deactivated. Further, the power switch assembly 100 can be configured to automatically shut down the sleep apnea system 420 when the subject 405 removes the sleep apnea system from the body. For example, sleep apnea system 420 is a sensor configured to sense when subject 405 wears or removes sleep apnea system 420 (eg, accelerometer, gyroscope, temperature sensor, infrared sensor). Can be included.

In addition to the functions of motor assembly 116 and pump assembly 118 described above in connection with FIG. 8, controller 134 saves power as compared to continuously activating the motor to drive one or more pumps. For intermittent operation, the motor assembly may be activated, and as a result, configured to drive one or more pumps of the pump assembly. For example, the controller 134 may be configured to operate the motor assembly 116 and pump assembly 118 with hysteresis as follows to open the airway 14 (FIG. 1) of the subject. The controller 134 operates the motor assembly 116 until one of the pump assemblies 118 until the magnitude of the negative pressure in the one or more pressure regions equals or exceeds the magnitude of the first threshold. It is configured to drive the above pump. The controller 134 is then configured to deactivate the motor assembly 116 until the magnitude of negative pressure drops below or falls below a second threshold magnitude that is less than the first threshold magnitude. In response to the negative pressure magnitude being less than or equal to the second threshold, the controller 134 is configured to activate the motor assembly 116 to repeat the hysteresis cycle.

Further, in addition to the components described above in connection with the component module 74 of FIG. 8, the component module 550 includes at least a communication circuit 552, a status-other sensor assembly 554, and a treatment assembly 556.

Communications circuitry 552 is configured to allow controller 134 to communicate with a remote device, such as a remote computer system or remote device, such as remote controller 484 (FIG. 37). For example, the communication circuit 552 may be via a wired Ethernet connection and may be a Bluetooth, Wi-Fi, Zigbee, infrared, or radio frequency (RF) channel. Circuitry, connectors and antennas may be included that are configured to allow the controller 134 to communicate with remote devices over a wireless channel. The controller 134 receives commands and settings from, for example, a remote device and informs the remote device of the status, use, and other aspects of the sleep apnea system 420 (FIGS. 26-32, 38, 42, and 44). And information about the subject 405 (eg, FIG. 38) using the sleep apnea system to the remote device. Examples of such instructions and settings include whether the maximum aspiration threshold of one or more underpressure regions produced by sleep apnea system 420, the wake-up time, and whether the sealant is dispensed by sealant dispenser assembly 124. including. Examples of status, use, and other information include the charge level of the battery 110, the time that the subject 405 used the sleep apnea system 420, and the profile of detected apnea events (eg, of apnea events). Degree/magnitude profile, number of apnea events per unit time, mean change in degree/magnitude of apnea events, and change in number of apnea events per unit time), and sleep apnea system Included is whether it is time to replace one or more specified components. In addition, examples of the information regarding the subject 405 include a profile (eg, size, phase, change in size, and change in phase) of a physical condition or parameter (for example, blood pressure, blood sugar level) of the subject over time. Is included. Further, the communication circuit 552 can be configured to allow the controller 134 to upload this information to a database such as a cloud database. Further, if the controller 134 is configured to operate by executing software instructions or is software or firmware configurable, the controller is configured to download software and firmware via the communication circuit 552. Can be done.

Still referring to FIG. 45, the status-other sensor assembly 554 may be used for reasons other than detecting the level of sleep apnea that the subject is experiencing, and for the collar 440 (eg, FIG. 44) and the subject 405. One or more states of the subject 405 (eg, FIG. 45), or other states, for reasons other than detecting the level of negative pressure created between the subject's neck 400 (eg, FIG. 38). Can include one or more sensors configured to sense. For example, the assembly 554 may include one or more sensors configured to detect conditions indicative of the level of health or comfort of the subject 405 (eg, blood pressure, blood sugar levels, physical activity levels, sleep quality). .. In addition, the assembly 554 may be used by the subject of the sleep apnea therapy system 420 (eg, when the subject is sleeping, when the subject is awake, when the subject is on and off), and sleep apnea. One or more configured to detect environmental conditions (eg, ambient temperature, ambient light level, ambient/background noise level, contamination level) surrounding the subject 405 while using the system. A sensor can be included.

The following is a description of sensors that may be included in the apnea sensor assembly 128, the status-other sensor assembly 554, or both sensor assemblies 128,554. For example, each sensor assembly 128,554 can include a respective sensor of the same type (eg, pulse oximetry), or the assembly 128,554 can be experienced by, for example, a subject 405 (eg, FIG. 38). A controller 134 to determine the level of sleep apnea that is present, and to determine the subject's condition for purposes other than determining the level of sleep apnea being experienced by the subject. Such sensors that can be used can be effectively shared.

For example, one or both of the sensor assemblies 128, 554 can include a conventional pulse oximetry (pulse oxy) sensor, such that the pulse oxi sensor produces a signal indicative of the oxygen concentration in the blood of the subject. It may be configured and may also be configured to generate a signal indicative of the subject's heart rate.
There are two types of pulse oxysensors, a reflection type and a transmission type. Although only the reflective pulse oximeter is described in detail herein, the assemblies 128, 554 can also include a transmissive pulse ox sensor.

The reflected pulse oximeter sends two signals of near-infrared wavelengths subcutaneously to the subject 405, and in the subject's blood vessel, portions of the first and second signals are diverted back to the pulse oximeter. The amplitude of the received diverted portion of the first signal is independent of the amount of oxygen carried by hemoglobin in the blood flowing through the blood vessel, thus the first signal serves as a reference signal. .. In contrast, the amplitude of the received redirected portion of the second signal is proportional to the amount of oxygen carried by hemoglobin in the blood flowing through the blood vessel. The difference in amplitude of the signals is proportional to the oxygen concentration in the blood of the subject, as the first and second signals undergo the same attenuation from the tissues they pass through as they propagate.

The reflective pulse oxysensor is configured to receive the redirected portions of the first and second signals and may be within the sensor or separate from the sensor (eg, sensor assembly 128, sensor assembly 554, controller). 134, or elsewhere in component module 550) determines the pulse ox reading in a conventional manner in response to the difference in amplitude of the received redirected portions of the first and second signals. To be configured.

Circuitry within the sensor or separate from the sensor is configured to determine the heart rate of the subject in response to a difference in amplitude of the redirected portion where the first and second signals are received. Can also Since there is always some oxygen in the blood of a living subject 405, the portion of the blood vessel where two transmitted IR signals are incident during the high pressure phase (ie, systole) of the subject's cardiac cycle. Since there is more blood and thus more total oxygen, the amplitude of the diverted portion of the second signal is higher, as well as during the low pressure phase (ie, diastole) of the cardiac cycle. The diverted portion of the second signal has a lower amplitude because there is less blood in the portion of the blood vessel where the two transmitted IR signals are incident and therefore less total oxygen. Thus, when the signal representing the difference between the amplitudes of the first and second received diverted signals is passed through a bandpass filter having a passband of about 50 Hz to 300 Hz, it is approximately equal to the heart rate of the subject. A filtered signal having a frequency is obtained.

If a pulse oxysensor is included in the apnea sensor assembly 128, the controller 134 uses the information provided by the pulse ox sensor to determine the sleep apnea that the subject 405 (eg, FIG. 38) is experiencing. Can be configured to determine the degree of At the same time that the subject's airway 14 (FIG. 1) is occluded during an obstructive sleep apnea event, the level of oxygen reaching the subject's blood through the subject's lungs is reduced, Heart rate increases. Thus, by detecting at least one of a decrease in blood oxygen level and an increase in heart rate, the controller 134 can determine that the subject is experiencing a sleep apnea event and the occlusion. Appropriate measures (eg, increasing the amount of negative pressure applied to the throat area 406 or throat area 407 (FIGS. 24-25) of the subject) can be taken to mitigate the effect.

In some cases, the time between the onset of airway obstruction and the measurable decrease in blood oxygen level or the measurable increase in heart rate depends on the blood oxygen level or heart rate that controller 134 responds to during sleep apnea. May be too long to use as an indicator of.

However, even in these cases, low blood oxygen levels or elevated heart rate may occur while subject 405 is still recovering from a sleep apnea event detected by controller 134 via sensing another marker. It can be used as an index indicating that.

Also, if a pulse oxysensor is included in the status-other sensor assembly 554, the controller 134 is configured to use the information provided by the pulse oxysensor to determine the health status or other parameters of the subject 405. Can be done. For example, low blood oxygen levels over time, or elevated, decreased, or irregular heart rate may indicate that the subject 405 has a health problem, such as chronic obstructive pulmonary disease (COPD), or atrial. It may be indicated to have a cardiac problem such as fibrillation or another cardiac arrhythmia, congestive heart failure, or vascular occlusion. Therefore, in response to such information from the pulse oxysensor, the controller 134, via the output device 140 or the communication circuit 552, alerts the subject 405 of abnormal parameters and informs the subject to see a doctor. Can be configured to suggest. Alternatively, the controller 140 may be configured to diagnose the problem causing the abnormal parameter and notify the subject 405 or the subject's doctor via the output device 140 or the communication circuit 552.

Still referring to FIG. 45, one or both of the sensor assemblies 128, 554 may include an audio sensor such as a piezoelectric microphone configured to generate a signal indicative of the level of sound received.

Circuitry within the voice sensor or separate from the voice sensor is configured to filter or otherwise process the signal produced by the voice sensor so that the controller 134 can collect information from the signal. obtain. For example, the circuit may be configured to filter the sensor signal to produce a filtered signal having a frequency approximately equal to the respiratory rate of the subject. Alternatively, the circuit may be configured to spectrally analyze the sensor signal to produce a breathing sound made by the subject 405 (eg, FIG. 38) or to produce a breath volume of the subject. ..

If an audio sensor is included in the apnea sensor assembly 128, the controller 134 is configured to use the information provided by the audio sensor to determine the degree of sleep apnea that the subject 405 is experiencing. can do. For example, in response to an obstruction of the subject's airway 14 (FIG. 1) during an obstructive sleep apnea event, the breathing sound (eg, snoring) made by the subject 405 may change, The breathing rate of the subject can change, or the breathing volume of the subject (ie, the amount of inspiration or expiration) can change. As mentioned above, the circuit may be configured to process the signal produced by the audio sensor and the controller 134 is responsive to the processed signal to determine if the subject is experiencing a sleep apnea event. , And the level or degree of such event. For example, the controller 134 may be configured to determine the breath sound profile of the subject 405 over time in response to the processed signal, and the look-up table (LUT) 148 may be , Storing a representation of the subject's different breath sound profiles for each level of airway obstruction the subject is experiencing, and different breath sounds of the subject for each level of airway obstruction the subject is experiencing. Profiles can be associated. By retrieving the level of airway obstruction corresponding to the determined respiratory sound profile (or corresponding to the stored profile that best matches the determined profile) from the LUT 148, the controller 134 causes the sensed respiratory sound profile to In response to, the level of airway obstruction that the subject 405 is experiencing can be determined and appropriate measures (eg, applied to the subject's throat region 406 or throat region 407 (FIGS. 24-25)). (Increasing the magnitude of the negative pressure present) can be taken. Similarly, the controller 134 can be configured to determine a respiratory rate or volume profile of the subject 405, and the LUT 148 stores the different respiratory rate or volume profile of the subject, which the subject experiences. Can be correlated to each level of airway obstruction occurring. By retrieving from the LUT 148 the level of airway obstruction that corresponds to the determined respiratory rate or volume profile (or the stored profile that best matches the determined profile), the controller 134 causes the sensed respiratory rate or sense. In response to the tidal volume delivered, the level of airway obstruction the subject is experiencing can be determined and appropriate measures can be taken to reduce the obstruction (eg, the subject's throat region 406 or throat region 407( 24 to 25), the magnitude of the negative pressure applied can be increased).

If an audio sensor is included in the status-other sensor assembly 554, the controller 134 may be configured to use the information provided by the audio sensor to determine the health condition or other parameter of the subject. For example, low respiratory rate or low tidal volume over an extended period of time may indicate that the subject has a health problem, such as chronic obstructive pulmonary disease (COPD) or an airway obstruction that sleep apnea system 420 cannot alleviate. Thus, in response to such information from the voice sensor, the controller 134, via the output device 140 or the communication circuit 552, alerts the subject 405 of abnormal parameters and suggests that the subject see a doctor. Can be configured to. Alternatively, controller 134 may be configured to diagnose the problem causing the anomalous parameter and provide the diagnosis to subject 405 or the subject's physician via output device 140 or communication circuitry 552.

Further, one or both of sensor assemblies 128, 554 can include a motion sensor, such as a MEMS accelerometer or gyroscope, which motion sensor can, for example, result from motion of subject 405 (eg, FIG. 38). It may be configured to generate a signal that is indicative of the level of motion the sensor is experiencing.

Circuitry within the motion sensor or separate from the motion sensor is configured to filter or otherwise process the signal generated by the motion sensor so that the controller 134 can collect information from the signal. obtain. For example, the motion sensor may be configured to sense the rise and fall of the subject's chest as they breathe, the frequency of the rise and fall being the breathing rate of the subject, and the amplitude of the rise and fall being It is proportional to the breathing volume of the subject. Accordingly, the circuit may be configured to filter the sensor signal to produce a filtered signal having a frequency approximately equal to the respiratory rate of the subject. Alternatively, the circuit spectrally analyzes the sensor signal to produce an expression of other respiratory movements (eg, coughing or panting) performed by the subject 405, or to produce an expression of the subject's respiratory volume. Can be made. Further, if the motion sensor is sufficiently close to one of the subject's carotid arteries, the circuit is configured to filter the sensor signal to yield a filtered signal having a frequency equal to the subject's heartbeat/pulse rate. Can be done.

If a motion sensor is included in the apnea sensor assembly 128, the controller 134 is configured to use the information provided by the motion sensor to determine the degree of sleep apnea that the subject 405 is experiencing. Can be done. Respiratory movements performed by the subject 405 in response to the subject's airway 14 (FIG. 1) being occluded during an obstructive sleep apnea event (eg, snoring vibrations, chest rise and fall, cough, (Panting) may change, the respiratory rate of the subject may change, the respiratory rate of the subject may change, and the heart rate of the subject may change. As mentioned above, the circuit may be configured to process the signal produced by the motion sensor and the controller 134 is responsive to the processed signal to determine whether the subject 405 is experiencing a sleep apnea event. , And the degree/level of such events. For example, the controller 134 may be configured to determine a respiratory motion profile of the subject 405 in response to the processed signal, and the LUT 148 stores the different respiratory motion profile of the subject, which the subject experiences. Can be correlated to each level of airway obstruction present. By retrieving from the LUT 148 the level of airway obstruction that corresponds to the determined respiratory motion profile (or to the stored profile that best matches the determined profile), the controller 134 causes the controller 134 to detect the sensed respiratory motion. In response to determining the level of airway obstruction that the subject 405 is experiencing and applying appropriate measures (eg, to the subject's throat region 406 or throat region 407 (FIGS. 24-25)). (Increasing the magnitude of the negative pressure) can be taken. Similarly, controller 134 can be configured to determine a respiratory rate, respiratory volume, or heart rate profile of subject 405, and LUT 148 can be used to determine different respiratory rate, respiratory rate, or heart rate profiles of subject. Can be stored and correlated to each level of airway obstruction the subject is experiencing. The controller 134 by retrieving from the level LUT 148 of the airway obstruction that corresponds to the determined respiratory rate, volume, or heart rate profile (or to the stored profile that best matches the determined profile). Can determine the level of airway obstruction a subject is experiencing in response to sensed respiratory rate, volume, or heart rate, reducing the degree of airway obstruction, or reducing airway obstruction. Appropriate measures can be taken to eliminate it.

If a motion sensor is included in the condition-other sensor assembly 554, the controller 134 may be configured to use the information provided by the motion sensor to determine the subject's health condition or other parameter. For example, excessive physical movement over an extended period of time may indicate that the subject 405 is not sleeping comfortably or deeply enough, is asleep during sleep, or has restless legs syndrome. Accordingly, in response to such information from the motion sensor, the controller 134 alerts the subject 405 or the subject's doctor via the output device 140 or the communication circuit 552 of the abnormal parameter, and the subject sees the doctor. Can be configured to suggest that someone be asked. Alternatively, controller 140 may be configured to diagnose the problem causing the anomalous parameter and provide the diagnosis to subject 405 or the subject's physician via output device 140 or communication circuitry 552.

Further, one or both of the sensor assemblies 128, 554 may be configured as a micro-impulse radar transceiver that may be configured to generate a signal indicative of stroke volume or changes in stroke volume of the subject's heart. A stroke volume sensor may be included (stroke volume is the volume of blood that the left ventricle pumps during one cardiac cycle).

Circuitry within the stroke volume sensor or separate from the stroke volume sensor filters the signal produced by the stroke volume sensor so that the controller 134 can collect the stroke volume of the subject's heart from the signal. Alternatively, it may be configured to process in other ways. For example, the signal generated by the sensor may represent an image of the left ventricle over time, and the circuit may be such that the amplitude of the filtered signal is a stroke volume (left ventricle at maximum volume and left at minimum volume). The signal can be filtered to be proportional to the difference between the ventricles).

When a stroke volume sensor is included in the apnea sensor assembly 128, the controller 134 uses the information provided by the stroke volume sensor to determine the degree of sleep apnea that the subject 405 is experiencing. Can be configured to. In response to the subject's airway 14 (FIG. 1) being occluded during an obstructive sleep apnea event, the heart is blood that is less oxygenated than blood outside the obstructive sleep apnea event, The stroke volume of the subject's heart may increase as it seeks to provide more oxygen to the subject's tissue. That is, stroke volume is increased to compensate for the decrease in oxygen concentration in the blood of the subject due to airway obstruction. As mentioned above, the circuit may be configured to process the signal produced by the stroke volume sensor, and the controller 134 is responsive to the processed signal to cause the subject to experience a sleep apnea event. May be configured and to determine the extent/level of such an event. For example, the controller 134 can be configured to determine the stroke volume profile of the subject 405 in response to the processed signals, and the LUT 148 can determine the respective extent/of the airway obstruction that the subject is experiencing. Levels can be stored and correlated to different subject's stroke volume profiles. By searching the LUT 148 for the level of airway obstruction that corresponds to the determined stroke volume profile (or to the stored profile that best matches the determined profile), the controller 134 causes the controller 134 to sense the stroke volume. In response to the amount, the level of airway obstruction that the subject 405 is experiencing can be determined and appropriate measures to relieve the obstruction (eg, the subject's throat region 406 or throat region 407 (FIGS. 25) to increase the magnitude of the negative pressure applied).

In some cases, the time between the onset of airway obstruction and the measurable increase in stroke volume is too long for stroke volume to be used as a sleep apnea marker to which controller 134 responds. ..

However, even in these examples, the stroke volume is still recovering from a sleep apnea event detected by subject 405 via sensing another sleep apnea marker (eg, breath sounds). It can be used as an indicator that you are in the middle of being.

If a stroke volume sensor is included in the status-other sensor assembly 554, the controller 134 is configured to use the information provided by the stroke sensor to determine the health status or other parameters of the subject 405. Can be done. For example, excessive or low stroke volume over a long period of time while subject 405 sleeps may indicate that the subject is not sleeping comfortably or deeply enough, is asleep while walking, or is congestive. It can be shown to have a heart problem such as heart failure. Accordingly, in response to such information from the stroke volume sensor, the controller 134, via the output device 140 or the communication circuit 552, alerts the subject 405 or the subject's physician of abnormal stroke volume, It can be configured to suggest that the person consult a doctor. Alternatively, the controller 140 may be configured to diagnose a problem causing abnormal stroke volume and provide the diagnosis to the subject or the subject's physician via the output device 140 or the communication circuit 552.

And, as the stroke volume occurs periodically, the stroke volume sensor and associated circuitry can also be configured to provide the heart rate of the subject 405 (eg, FIG. 38).

In addition, one or both of the assemblies 128, 554 may include a conventional gas sensor (eg, a spectral gas sensor), which may detect substances in the subject's exhaled breath (ie, the air exhaled by the subject 405). It may be configured to generate a signal indicative of a rate or level (eg, by mass, volume, or number of molecules) or a signal indicative of a change in rate or level. Examples of such materials include water vapor, carbon dioxide (CO ₂ ), oxygen (O ₂ ), and volatile organic compounds (VOC). When the substance to be sensed is CO _2, the gas sensor may include a non-dispersive infrared CO ₂ module.

A circuit within the gas sensor or a circuit separate from the gas sensor allows the controller 134 to determine the percentage or level of a certain substance emitted by the subject, or a change in the percentage or level, as compared to the total amount of the substance emitted by the subject. The signal produced by the gas sensor may be configured to be filtered or otherwise processed so that it can be collected.

If a gas sensor is included in the apnea sensor assembly 128, the controller 134 may be configured to use the information provided by the gas sensor to determine the degree of sleep apnea being experienced by the subject 405. .. In response to an obstruction of the subject's airway 14 (FIG. 1) during an obstructive sleep apnea event, the percentage or concentration of a substance in the subject's exhaled breath may increase (eg, CO ₂ ) or decrease (eg For example, O ₂ ). As mentioned above, the circuit can be configured to process the signal generated by the gas sensor and the controller 134 is responsive to the processed signal to cause the subject 405 to experience a sleep apnea event. Can be configured to determine whether or not, and the extent/level of such events. For example, the controller 134 can be configured to determine the exhaled breath profile of the subject 405 in response to the processed signal, and the LUT 148 stores the different exhaled breath profile of the subject 405. Can be correlated to each degree/level of airway obstruction that the person is experiencing. The controller 134 is sensed by retrieving from the LUT 148 the degree/level of airway obstruction that corresponds to (or corresponds to the stored profile that best matches the determined profile) the determined exhaled substance profile. The level of airway obstruction that the subject 405 is experiencing in response to the exhaled substance can be determined and appropriate measures are taken to reduce the obstruction (eg, the subject's throat region 406 or throat region 407 (FIG. 24). ~25) to increase the magnitude of the negative pressure being applied).

If a gas sensor is included in the condition-other sensor assembly 554, the controller 134 may be configured to use the information provided by the gas sensor to determine the health condition or other parameter of the subject 405. For example, exhaling an excessive rate or level of CO ₂ over an extended period of time while the subject 405 sleeps may indicate that the subject is not sleeping comfortably or deeply enough, or has a lung disorder. Can be shown. Thus, in response to such information from the gas sensor, the controller 134 alerts the subject 405 or the subject's physician via the output device 140 or the communication circuit 552 of the abnormal breath profile, and the subject is informed of the physician. It may be configured to suggest to be seen. Alternatively, the controller 140 may be configured to diagnose a problem causing an abnormal breath profile and provide the diagnosis to the subject 405 or the subject's physician via the output device 140 or the communication circuit 552.

Still referring to FIG. 45, one or both of the assemblies 128, 554 can include a conventional chemical sensor, which senses, for example, in a subject's sweat, exhaled breath, saliva, lipids or tears. It may be configured to generate a signal indicative of a rate or level (eg, by mass, volume, or number of molecules) of a substance (eg, liquid or gas phase) to be treated or a signal indicative of a change in rate or level. Examples of such substances include hormones such as cortisol, alcohols, water vapor, carbon dioxide (CO ₂ ), oxygen (O ₂ ), and volatile organic compounds (VOC).

A circuit within the chemical sensor or a circuit separate from the chemical sensor allows the controller 134 to determine the percentage or level of a certain substance emitted by the subject 405, or a fraction or level, as compared to the total amount of the substance emitted by the subject. The signal generated by the chemical sensor may be configured to be filtered or otherwise processed so that the change in level may be collected.

If a chemical sensor is included in the apnea sensor assembly 128, the controller 134 may use the information provided by the chemical sensor to determine the degree/level of sleep apnea that the subject 405 is experiencing. Can be configured to. In response to an obstruction of a subject's airway 14 (FIG. 1) during an obstructive sleep apnea event, the percentage or level of substance excreted by subject 405 may increase (eg, cortisol) or decrease. obtain. As mentioned above, the circuit can be configured to process the signal generated by the chemical sensor and the controller 134 is responsive to the processed signal to cause the subject 405 to experience a sleep apnea event. Can be configured to determine whether or not, and the extent/level of such events. For example, the controller 134 can be configured to determine a sweat or salivary material profile of the subject 405 in response to the processed signal, and the LUT 148 can cause the different sweat and saliva substance profiles of the subject. Can be stored and correlated to each level of airway obstruction that subject 405 is experiencing. By retrieving from the LUT 148 the level of airway obstruction that corresponds to the determined sweat and salivary substance profile (or to the stored profile that best matches the determined profile), the controller 134 causes The level of airway obstruction that the subject 405 is experiencing in response to the expelled material that has been delivered can be determined and appropriate measures can be taken to reduce the obstruction (eg, the throat area 406 or throat area of the subject). 407 (increasing the magnitude of the negative pressure being applied to FIGS. 24-25).

If a chemical sensor is included in the status-other sensor assembly 554, the controller 134 may be configured to use the information provided by the chemical sensor to determine the well-being health or other parameter of the subject. .. For example, sweating and excreting an excessive rate or level of cortisol over a long period of time during sleep by subject 405 may indicate that the subject is not sleeping comfortably or deeply alike, and A subject's sweating and excretion of excessive proportions or levels of alcohol over an extended period of time during sleep may indicate that the subject is drinking and therefore may have a drinking problem. Thus, in response to such information from the chemical sensor, the controller 134 alerts the subject 405 or the subject's physician via the output device 140 or the communication circuit 552 of the abnormal emission profile, and the subject Can be configured to suggest to see your doctor. Alternatively, the controller 140 may be configured to diagnose a problem causing an abnormal excrement profile and provide the diagnosis to the subject 405 or the subject's physician via the output device 140 or the communication circuit 552.

Further, one or both of sensor assemblies 128 and 554 may include an electroencephalogram (EEG) sensor assembly, which is one or more signals representative of electrical activity in the brain of subject 405 (eg, FIG. 38). Is configured to generate. The EEG sensor assembly is attached to, or is part of, the collar 440 or is separate from the collar (examples of such remote sensors are printed or attached directly to or on the skin of the subject. Can include one or more sensors (which are electronic skin sensors that can be).

A circuit within the EEG sensor assembly or a circuit separate from the EEG sensor assembly filters one or more signals generated by the EEG sensor assembly such that the controller 134 can collect information from the one or more signals. Or it may be configured to process in other ways. For example, the circuit is configured to filter one or more of the one or more sensor signals to produce one or more filtered signals representative of a sleep state or other state of the subject 405. be able to. Alternatively, circuitry may be configured to spectrally analyze one or more of the one or more sensor signals to produce a sleep or other condition in subject 405.

When the EEG sensor assembly is included in the apnea sensor assembly 128, the controller 134 uses the information provided by the EEG sensor assembly to determine the degree of sleep apnea that the subject 405 is experiencing. Can be configured to. For example, a subject's 405 sleep state may change in response to an obstruction of the subject's airway 14 (FIG. 1) during an obstructive sleep apnea event, or in the subject's brain. Electrical activity can otherwise change. As mentioned above, the circuit can be configured to process one or more signals generated by the EEG sensor assembly, and the controller 134 is responsive to the processed one or more signals. It can be configured to determine if the person is experiencing a sleep apnea event and the level or degree of such event. For example, the controller 134 may be configured to determine a sleep state profile or an electroencephalogram profile of the subject 405 over time in response to the one or more processed signals, and the look-up table (LUT) 148 is the target. The person's different sleep state and electroencephalogram profiles can be stored and correlated to each level of airway obstruction the subject is experiencing. The controller 134 senses the level of airway obstruction corresponding to the determined sleep state or EEG profile (or corresponding to the stored profile that best matches the determined profile) by sensing from the LUT 148. Responsive to sleep conditions or electrical activity of the brain, the level of airway obstruction that the subject 405 is experiencing can be determined and appropriate measures (eg, the subject's throat region 406 or throat region 407( 24 to 25) can be taken) to increase the magnitude of the negative pressure applied.

If an electroencephalogram sensor assembly is included in the status-other sensor assembly 554, the controller 134 may be configured to use the information provided by the EEG sensor assembly to determine the subject's health status or other parameters. For example, a poor quality sleep state profile over a long period of time (eg, one or more sleep states not staying too short or too long) may indicate that the subject has chronic obstructive pulmonary disease (COPD), etc. Health problems, sleep apnea system 420 may have unrelieved airway obstruction, or a mental problem that interferes with the sleep of the subject. Accordingly, in response to such information from the EEG sensor assembly, the controller 134 alerts the subject 405 via the output device 140 or the communication circuit 552 of abnormal parameters (eg, poor sleep state profile), It may be configured to suggest that the subject seek medical attention. Alternatively, the controller 134 may be configured to diagnose a problem (eg, anxiety) that causes an abnormal parameter and provide the diagnosis to the subject 405 or the subject's physician via the output device 140 or the communication circuit 552.

Further, one or both of sensor assemblies 128, 554 may include an electrocardiogram (EKG) sensor assembly, where the EKG sensor assembly is one or more representative of electrical activity in the heart of subject 405 (eg, FIG. 38). It is configured to generate a signal. The EKG sensor assembly is attached to, or is part of, the collar 440 or separate from the collar (examples of such remote sensors can be printed or attached or attached directly onto the skin of the subject. One or more sensors (which are electronic skin sensors) can be included.

A circuit within the EKG sensor assembly or a circuit separate from the EKG sensor assembly filters one or more signals generated by the EKG sensor assembly such that the controller 134 can collect information from the one or more signals. Or it may be configured to process in other ways. For example, the circuit filters one or more of the one or more sensor signals to produce one or more filtered signals representative of the sleep state of the subject 405, or other conditions or other parameters. Can be configured as follows. Alternatively, circuitry may be configured to spectrally analyze one or more of the one or more sensor signals to produce a sleep or other condition in subject 405.

When the EKG sensor assembly is included in the apnea sensor assembly 128, the controller 134 uses the information provided by the EKG sensor assembly to determine the degree of sleep apnea that the subject 405 is experiencing. Can be configured to. For example, a subject's 405 sleep state may change in response to an obstruction of the subject's airway 14 (FIG. 1) during an obstructive sleep apnea event, or electrical activity in the subject's heartbeat. Other activities can change. As mentioned above, the circuitry may be configured to process one or more signals generated by the EKG sensor assembly, and the controller 134 may be responsive to the processed one or more signals to cause the subject to sleep. It may be configured to determine if it is experiencing an apnea event and the level or degree of such event. For example, the controller 134 may be configured to determine a sleep state profile or an electrocardiographic profile of the subject 405 over time in response to the one or more processed signals, and the look-up table (LUT) 148 may be a target. The person's different sleep state profiles and heart wave profiles can be stored and correlated to each level of airway obstruction the subject is experiencing. Controller 134 is sensed by retrieving from LUT 148 the level of airway obstruction that corresponds to the determined sleep state or heart wave profile (or to the stored profile that best matches the determined profile). In response to the sleep state or cardiac electrical activity, the level of airway obstruction that the subject 405 is experiencing can be determined and appropriate measures can be taken (eg, the subject's throat region 406 or throat region 407 (FIG. 24). ~25) to increase the magnitude of the negative pressure applied).

If the EKG sensor assembly is included in a status-other sensor assembly, the controller 134 may be configured to use the information provided by the EKG sensor assembly to determine the health status or other parameters of the subject. For example, a poor quality sleep state profile over a long period of time (eg, one or more sleep states not staying too short or too long) may result in a subject having chronic obstructive pulmonary disease (COPD). It may be indicated that the sleep apnea system 420 has an unrelieved airway obstruction, a heart disease, or another hearing problem that interferes with the sleep of the subject, such as a health problem. Thus, in response to such information from the EKG sensor assembly, the controller 134, via the output device 140 or the communication circuit 552, causes abnormal parameters (eg, poor sleep state profile, poor cardiac wave profile). May be configured to alert subject 405 and suggest that the subject see a doctor. Alternatively, the controller 134 may diagnose the problem causing the abnormal parameter (eg, heart disease, atrial fibrillation) and provide the diagnosis to the subject 405 or the subject's physician via the output device 140 or the communication circuit 552. Can be configured to.

In addition, the controller 134 produces a ballistocardiogram (BCG) from one or more of the subject's heart rate, heart rate variability over time, stroke volume change over time, and respiration rate. The determined BCG can be configured to determine and can be used to determine whether the subject 405 is experiencing a sleep apnea event. For example, one or more of the above-described sensors in the apnea sensor assembly 128 may sense a subject's heart rate, heart rate variability over time, stroke volume change over time, and respiration rate. And the sensor and corresponding circuitry can generate signals representative of these quantities. The controller 134 may be configured to determine the BCG profile of the subject 405 in response to the processed signals, and the LUT 148 stores the subject's different BCG profile and each of the airway obstructions the subject is experiencing. Can be correlated to the level of. By retrieving from the LUT 148 the level of airway obstruction that corresponds to the determined BCG profile (or that corresponds to the stored profile that best matches the determined profile), the controller 134 causes the subject to experience. The level of airway obstruction present can be determined and appropriate measures are taken to relieve the obstruction (eg, the magnitude of the negative pressure being applied to the subject's throat region 406 or throat region 407 (FIGS. 24-25). Can be taken).

Alternatively, the controller 134 may be configured to use the determined BCG to determine the health status or other parameters of the subject 405. For example, an abnormal BCG can indicate that subject 405 has a heart disorder. Therefore, in response to the abnormal BCG, the controller 134, via the output device 140 or the communication circuit 552, alerts the subject 405 or the subject's doctor of the abnormal BCG and informs the subject to see a doctor. It can be configured as suggested. Alternatively, the controller 140 may be configured to diagnose the problem causing the abnormal BCG and provide the diagnosis to the subject or the subject's physician via the output device 140 or the communication circuit 552.

In addition, the controller 134 determines a photoplethysmography (PPG) from the information provided by the pulse oximetry sensor and uses the determined PPG to determine whether the subject 405 is experiencing a sleep apnea event. May be configured to determine. The controller 134 may be configured to determine the PPG profile of the subject 405 in response to the processed signal from the pulse oximetry sensor, and the LUT 148 stores the subject's different PPG profile and experiences the subject. Can be correlated to each degree/level of airway obstruction. By retrieving from the LUT 148 the level of airway obstruction that corresponds to the determined PPG profile (or the stored profile that best matches the determined profile), the controller 134 causes the subject The level of airway obstruction that the 405 is experiencing can be determined and appropriate measures have been added to relieve the obstruction (eg, the subject's throat region 406 or throat region 407 (FIGS. 24-25). (Increasing the magnitude of the negative pressure) can be taken.

Alternatively, controller 134 may be configured to use the determined PPG to determine the health condition or other parameter of subject 405 (eg, FIG. 38). For example, an abnormal PPG can indicate that the subject 405 has a lung disorder or a heart disorder. Accordingly, in response to the abnormal PPG, the controller 134, via the output device 140 or the communication circuit 552, alerts the subject 405 or the subject's doctor of the abnormal PPG and informs the subject to see the doctor. It can be configured as suggested. Alternatively, the controller 140 may be configured to diagnose the problem causing the abnormal PPG and provide the diagnosis to the subject 405 or the subject's physician via the output device 140 or the communication circuit 552.

Still referring to FIG. 45, according to one embodiment, the treatment assembly 556 is under the control of the controller 134 and the negative pressure sleep apnea system 420 (FIGS. 26-32, 38, 42, and 44). Is configured to provide treatment to the subject 405 while wearing the. For example, the treatment assembly 556 can include electrodes 510a, 510b (FIG. 39) through which the subject's 405 can be stimulated or “shocked” to open the subject's airway 14 (FIG. 1), or Alternatively, current or voltage may be applied to maintain the open state. The controller 134 may be configured to implement a feedback loop that regulates the current or voltage applied through the electrode 510 to open and maintain the subject's airway 14 open. This loop opens another parameter (eg, negative pressure in one or more pressure zones) to keep the subject's airway 14 open and open with the minimum negative pressure possible by the controller 134. It may be independent of, or combined with, a feedback loop configured to be implemented by adjusting. When these feedbacks are independent, the controller has at least two variables that can be adjusted to maintain the subject's airway 14 open and open: pressure and temperature. Further, the treatment assembly 556 can include a piezoelectric speaker that can be used to soothe the subject 405 and help the subject to sleep, and generate sounds, such as surfing waves on the beach. Can be configured to. Alternatively, the treatment assembly 556 may use a speaker to sound an alarm to wake up the subject 405 in response to the controller 134 detecting a sleep apnea event that lasted above the safe time threshold. Can be configured.

Still referring to FIG. 45, an alternative embodiment of the component module 550 is contemplated. For example, the alternative embodiments described above in connection with FIG. 8 for component module 74 may be applied to component module 550, and the alternative embodiments described for component module 550 may be applied to component module 74. it can. Further, component module 500 may include components not disclosed herein, or one or more of the components disclosed herein may be omitted.

FIG. 46 is an isometric view of a conventional thermoelectric couple (TEC) 560 of the auxiliary power supply 112 of the component modules 74, 550 (FIGS. 8 and 45), according to one embodiment. The TEC 560 is removed from the subject 405 (eg, FIG. 38) while the subject is wearing the negative pressure sleep apnea treatment system 420 (FIGS. 26-32, 38, 42, and 44). It is configured to harvest energy from energy. The power supply 117 of the component module 74, 550 receives the energy harvested by the TEC 560 and powers the energy harvested to one or more of the components of the component module 74, 550. , And to convert the battery 110 into a power signal for charging.

The TEC 560 is configured to convert the temperature difference between the “hot” side 562 and the “cold” side 564 into a current through the conductive terminals 566, 568 and a voltage across the terminals. For example, the TEC 560 may have a sleep apnea system 420 (Fig. 4) such that the "hot" side 562 contacts a portion of the subject's body (eg, the neck 400) and the "cold" side 564 is exposed to air. 26-32, 38, 42, and 44). A human subject has a normal body temperature of about 98.6°F and a typical room temperature of about 68°F, so the temperature difference between the "hot" side 562 and the "cold" side 564 is about 30°. It is F. Responsive to such a temperature difference, collectively having a “hot” side 562 having an effective area of about 100 square millimeters (mm ² ) and a “cold” side 564 having an effective area of about 120 mm ^2. The configured one or more TECs 560 can generate about 5 milliwatts (mW) of power. One or more TECs 560 may be placed, for example, on straps 444, 446 (FIG. 32) of sleep apnea system 420 such that the “hot” side 562 of each TEC is on the subject's neck 400 (eg, FIG. 38). ) Adjacent to or contact. Alternatively, one or more TECs 560 may be disposed within sleeve 534 (FIG. 41) along inner surface 452 of collar 440 (eg, FIG. 31) or away from sleep apnea system 420 (eg, such as a shirt or hat). Can be placed (in clothing). When located remotely from the sleep apnea system 420, the one or more TECs 560 may transfer the harvested power to a power supply 117 (FIGS. 8 and 45) via a wired or wireless connection. You can

Still referring to FIG. 46, further details of the TEC 560, and other energy harvesting devices that may be included in the auxiliary power source 112 (FIGS. 8 and 45), can be found in Bhatnagar et al. Harvesting for Assistive and Mobile Applications)", Energy Science & Engineering, 3(3), pp. 153-173 (2015), which is incorporated herein by reference.

FIG. 47 is an isometric view of a shape adaptive triboelectric nanogenerator (saTENG) unit 580 according to one embodiment.

48 is an isometric cross-sectional view of the saTENG unit 580 of FIG. 47, according to one embodiment.

With reference to FIGS. 47-48, the saTENG unit 580 includes a conductive liquid electrode 582 disposed inside a rubber layer or shell 584. A conductor is inserted through the end of shell 584 to provide a terminal or pin 586 for electrode 582. Examples of materials that can form the electrode 582 include water and a solution of sodium chloride (NaCl).

FIG. 49 is an isometric view of a saTENG generator 588 including the saTENG unit 580 of FIGS. 47-48, according to one embodiment. The auxiliary power supply 112 of the component modules 74, 550 (FIGS. 8 and 45) can be used by the subject while wearing the negative pressure sleep apnea therapy system 420 (FIGS. 26-32, 38, 42, and 44). 405 includes a generator 588 configured to harvest energy. The power supply 117 (FIGS. 8 and 45) of the component modules 74, 550 receives energy harvested by the generator 588 and outputs the energy harvested to one of the components of the component module. It may be configured to provide power to the above and convert to a power signal for charging the component module battery 110 (FIGS. 8 and 45).

In addition to the saTENG unit 580 (FIGS. 47-48), the generator 588 includes an electrode 590 having a nylon layer 592 and an aluminum layer 594.

Generator 588 is configured to convert movement and deformation (eg, stretching and contracting) of saTENG unit 580 relative to electrode 590 into a current through conductive terminals 596 and 598 and a voltage across the terminals. For example, one or more generators 588 may be placed within the sleep apnea system 420 such that movement of the subject's body (eg, breathing or rolling and rolling-induced movements) causes one or more generators 588 to Each respective saTENG unit 580 may be allowed to move or deform with respect to each electrode 590. In response to such movement or deformation of each saTENG unit 580 in each of the one or more generators 588, the generators generate power to the power supply 117 (FIGS. 8 and 45) as described above. Is configured as follows. One or more generators 588 can be located, for example, in straps 444, 446 (FIG. 32) of sleep apnea system 420. Alternatively, one or more generators 588 may be located inside the collar 440 (FIG. 31) or sleeve 534 (FIG. 41), or otherwise secured to the collar or sleeve, or sleep apnea. It may be located remote from system 420 (eg, in clothing such as a shirt or hat). When located remotely from the sleep apnea system 420, the one or more generators 588 may be configured to transfer the energy harvested to the power supplier 117 via a wired or wireless connection.

Referring again to FIGS. 47-49, further details of the saTENG unit 580, the generator 588, and other energy harvesters that may be included in the auxiliary power source 112 (FIGS. 8 and 45) are provided by Yi et al. A Highly Shape Adaptive, Stretchable Design Based On Conductive Liquid For Energy Harvesting And Self Powered Biomechanical Monitoring”, June 17, 2016. Sci. Adv., pp. 1-10, and incorporated herein by reference.
FIG. 50 is an isometric view of a saTENG generator 610 including the saTENG unit 580 of FIGS. 47-48, according to another embodiment. The auxiliary power supply 112 of the component modules 74, 550 (FIGS. 8 and 45) is equipped with a negative pressure sleep apnea therapy system 420 (FIGS. 26-32, 38, 42, and 44). In between includes a generator 610 configured to harvest energy from the subject 405. The power supply 117 (FIGS. 8 and 45) of the component modules 74, 550 receives the energy energy harvested by the generator 610 and outputs the energy harvested to one or more of the components of the component module. Can be configured to provide power to and to convert a power signal to charge the component module battery 110 (FIGS. 8 and 45).

In addition to the saTENG unit 580 of FIGS. 47-48, the generator 610 includes an aluminum electrode 612.

FIG. 51 is a charge diagram of the generator 610 of FIG. 50 and illustrates how movement of saTENG 580 relative to electrode 612 displaces charge within electrodes 582 and 612, according to one embodiment. In response to this charge transfer, the generator 610 produces current and voltage, as described below.

The operation of the generator 610 according to the embodiment will be described with reference to FIGS. 50 to 51.

Generator 610 causes movement and deformation (eg, extension and contraction) of saTENG unit 580 relative to electrode 612 by displacing the charge within electrode 582 (FIG. 48) and electrode 612 through conductive terminals 614, 616. It is configured to convert a current and a voltage across the terminals. For example, one or more generators 610 may be placed in the sleep apnea system 420 such that movements of the subject's body (eg, breathing or rolling and rolling-induced movements) cause one or more generators to Each saTENG unit 580 in each may be moved or deformed with respect to each electrode 612. In response to such movement or deformation of each saTENG unit 580 in each of the one or more generators 610, the generator may generate power to the power supply 117 as described above. One or more generators 610 may be located, for example, on straps 444, 446 (FIG. 32) of sleep apnea system 420. Alternatively, one or more generators 610 may be located inside collar 440 (FIG. 31) or sleeve 534 (FIG. 41), or otherwise secured to the collar or sleeve, or sleepless. Remote from the breathing system 420, it may be placed on clothing, such as a shirt or hat. When located remotely from the sleep apnea system 420, the one or more generators 610 may deliver the stored energy to the power supply source 117 (FIGS. 8 and 45) via a wired or wireless connection. Can be transferred.

With further reference to FIGS. 50-51, further details of the generator 610 and other energy harvesters that may be included in the auxiliary power source 112 (FIGS. 8 and 45) are provided by Yi et al. A Highly Shape Adaptive, Stretchable Design Based On Conductive Liquid For Energy Harvesting And Self Powered Biomechanical Monitoring”, June 17, 2016, Sci. Adv., pp. 1-10, incorporated herein by reference.

FIG. 52 is an isometric perspective view of a TENG generator 620 according to another embodiment. The auxiliary power source 112 of the component modules 74, 550 (FIGS. 8 and 45) is equipped with a negative pressure sleep apnea therapy system 420 (FIGS. 26-32, 38, 42, and 44). In between includes a generator 620 configured to harvest energy from a subject 405 (eg, FIG. 38). The power supply 117 (FIGS. 8 and 45) of the component modules 74, 550 receives energy harvested by the generator 620 and outputs the energy harvested to one of the components of the component module. It may be configured to provide power to the above and convert to a power signal for charging the component module battery 110 (FIGS. 8 and 45).

The TENG generator 620 includes a package 622, a TENG 624 disposed within the package, and at least one supercapacitor (here, two equally sized supercapacitors 626,628), where the supercapacitors 626,628 are , Disposed within the package and electrically coupled together in parallel to effectively form a single supercapacitor having twice the capacitance of each of the supercapacitors 626,628. The wrapper 622 can be configured to be stretchable and can be made from any suitable material such as silicone rubber.

53 is a cross-sectional view of TENG 624 of FIG. 52, according to one embodiment. The TENG 624 includes two electrodes 630 and 632, a space 634 between the electrodes, and a portion 636 of the package 622 disposed between the electrodes. The space 634 can be filled with any suitable material such as air, and the electrodes 630, 632 can be formed from any suitable material such as carbon black (CB) and silicone rubber compounds.

54 is a cross-sectional view of supercapacitors 626 and 628 of FIG. 52, according to one embodiment. Each supercapacitor 626,628 includes two electrodes 638,640, a coating 642 on each electrode, an electrolyte 646 disposed between the electrodes, and a wrinkled separator 648 disposed within the electrolyte. Electrodes 638 and 640 can be formed from any suitable material, such as the same materials that form electrodes 630 and 632 of TENG 624 in FIG. The coating 642 can be formed of any suitable material, such as a mixture of an active material (eg, polypyrrole, PPy) and a conductive additive (eg, carbon black). The electrolyte 646 can be formed from any suitable material, such as polyvinyl alcohol (PVA) phosphoric acid (H ₃ PO ₄ ) gel. Also, the separator 648 prevents the electrodes 638, 640 from shorting together when the supercapacitors 626, 628 are stretched or twisted, and may be formed of any suitable material such as polyethylene.

52-54, the TENG generator 620 is configured to generate power in response to the generator being deformed (eg, stretched or twisted). In response to being deformed, TENG 624 charges supercapacitors 626 and 628, which, like batteries, are configured to generate voltage and current with stored charge. For example, one or more generators 620 may be placed within the sleep apnea system 420 (FIGS. 26-32, 38, 42, and 44) to move the subject's body movements (eg, breathing or The rolling and the movement caused by the rolling) may cause each TENG 624 in each of the one or more generators to deform. In response to such deformation of each TENG 624 in each of the one or more generators 620, the generators may provide power to the power supply 17 (FIGS. 8 and 45), as described above. One or more generators 620 may be used, especially considering that the straps may undergo stretching and twisting while the subject is wearing or not wearing the sleep apnea system 420. For example, it can be placed within straps 444, 446 (FIG. 32) of sleep apnea system 420. Alternatively, one or more generators 620 may be located inside collar 440 (FIG. 31) or sleeve 534 (FIG. 41), or otherwise secured, or separated from sleep and apnea system 420. Location, for example, a clothing item such as a shirt or hat. When located remotely from the sleep apnea system 420, one or more generators 630 may deliver the environmentally generated power to the power supply 117 (FIGS. 8 and 45) via a wired or wireless connection. Can be transferred.

52-54, further details of the generator 620 and other energy harvesters that may be included in the auxiliary power source 112 (FIGS. 8 and 45) are provided by Yi et al., “Energy harvesting from various variants.” And 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. 55 is a block diagram of a system 700 that includes a negative pressure sleep apnea therapy system 420 (FIGS. 26-32, 38, 42, and 44) according to one embodiment. As described below, the system 700 may be configured to determine and communicate to a subject 450 lifestyle changes to reduce the frequency or severity of sleep apnea events experienced by the subject. The subject may be configured to determine and communicate adjustments to the subject's use of the sleep apnea system 420 to improve the well-being (eg, health) of the subject.

In addition to sleep apnea system 420, system 700 includes client device 702 and computing circuitry 704. The computing circuit 704 and the sleep apnea system 420 are configured to communicate with each other via a wired or wireless channel (eg, wired or wireless bus) 706, and the computing circuit and the client device 702 have a wired or wireless channel 708. The sleep apnea system and the client device are configured to communicate with each other via a wired or wireless channel 710.

Client device 702 determines that subject 405 (eg, FIG. 38), sensor 126, 128 of component module 74, 550 (FIGS. 8 and 45), or sensor 554 of component module 550 is the subject's lifestyle and well. Any device suitable for allowing the input of data regarding being can be included. Examples of client device 702 include a client computer, such as a laptop computer, tablet computer, or smartphone, or a subject's 405 such as blood pressure, mood, diet, alertness, and whether the subject is awake or sleeping. Included are one or more sensors capable of sensing conditions and other parameters.

The computing circuitry 704 also uses the subject's sleep apnea system 420 to improve the subject's lifestyle changes to improve the subject's sleep apnea and the subject's wellbeing. Any circuit suitable for determining, communicating, or implementing a change in For example, computing circuitry 704 may include specialized circuitry that is permanently configured to perform the calculations and tasks described above and below. Computing circuitry 704 can also include circuitry such as a microprocessor or microcontroller that can be configured by software to perform calculations and tasks as described above and below. Additionally, computing circuitry 704 may include one or more field-programmable-gate arrays (FPGAs) that are configurable by firmware to perform calculations and tasks as described above and below. Alternatively, a circuit such as an FPGA circuit can be included. Also, computing circuitry 704 may be local to sleep apnea system 420 and client device 702, or it may be part of a larger network such as the Internet or the cloud.

Still referring to FIG. 55, an alternative embodiment of system 700 is contemplated. For example, one or both of client device 702 and computing circuitry 704 may be included in sleep apnea system 420 and are part of sleep apnea system component modules 74, 550 (FIGS. 8 and 45). possible. In addition, one or more sensors 554 (FIGS. 8 and 45) of component module 74 may also function as part of, or be part of, client device 702, which is indicative of the subject's lifestyle and well-being. The person 405 may be configured to sense one or more conditions or other parameters. Additionally, system 700 can include sleep apnea therapy system 70 (FIGS. 4-8) instead of or in addition to sleep apnea therapy system 420.

56 is a flow diagram 720 of procedures that the system 700 of FIG. 55 may be configured to implement to reduce sleep apnea in a subject, according to one embodiment.

55-56, the procedure of flow diagram 720 according to one embodiment is described.

In step 722, computing circuit 704 receives information from sleep apnea system 420 regarding one or more sleep apnea events that subject 405 (eg, FIG. 38) has experienced over a period of time. For example, sleep apnea system 420 may detect one or more sleep apnea events using one or more sensors of sensor assembly 128 (FIGS. 8 and 45) and one or more using controller 134. Can be configured to determine one or more parameters of the event. Examples of sleep apnea events include airway obstruction and sleep disorders resulting from airway obstruction (eg, changes in a subject's sleep status, changes in a subject's sleep duration, and other changes in a subject's sleep patterns. Examples of parameters for sleep apnea events include the duration, frequency, and severity of the event (eg, the rate at which the airway is open or obstructed, whether the subject was awakened by the event). The degree of change in the sleep state of the subject, such as whether or not the sleep duration of the subject has changed from the benchmark duration. Sleep apnea system 420 stores these determined parameters in memory 130 (FIGS. 8 and 45) and may store these stored parameters either automatically or in response to a request from a computing circuit, for example. And may be configured to provide to computing circuitry 704.

Next, in step 724, the computing circuit 704 receives from the client device 702 information about the subject's lifestyle. Examples of information about the lifestyle of the subject include the subject's diet, meal time, snack time, exercise frequency, exercise regimen including exercise intensity and type of exercise, weight, body fat percentage, number of sleep hours per night, Sleep schedules including bedtime and wake-up time (computing circuit 704 may have already received this information from sleep apnea system 420), stress levels, habits (eg, smoking, excessive drinking, and dietary supplements). Intake), blood pressure, blood sugar, medications, dosing schedules, and number of hours in bed before or during sleep (eg, after waking to use electronic devices and then returning to sleep) The use of electronics is mentioned. For example, the subject 405 or another person can enter this information via the keyboard of the client device 702, or the client device may have one or more sensors to sense such lifestyle parameters. Can be included. The client device 702 stores these lifestyle parameters in memory (not shown in FIG. 56) and stores these stored parameters automatically, or in response to a request from a computing circuit, for example. It may be configured to provide to computing circuitry 704.

Next, in step 726, the computing circuit 704 receives the information received from the sleep apnea system 420 regarding the sleep apnea event experienced by the subject 405 from the client device 702 regarding the lifestyle of the subject. Correlate with. For example, the computing circuitry 704 can correlate the severity of airway obstruction over a period of time with the subject's weight, and the frequency of sleep apnea events as the subject consumes a particular food or beverage such as coffee. Can be correlated to the frequency or amount of dosing. Also, in a further example, computing circuitry 704 can correlate the severity of airway obstruction with the number of days per week the subject exercises for more than 30 minutes.

Next, at step 728, the computing circuit 704 generates one or more plots, charts, graphs, or other representations of the correlations generated at step 726. For example, the computer circuitry 704 can generate a plot of airway obstruction frequency against the average duration of the subject's exercise routine. These representations may be designed to be displayed to subject 405 or another person (eg, the subject's physician) via a display device that is part of client device 702, for example. Alternatively, these representations may be data structures in memory of computing circuit 704.

Then, in step 730, the computing circuit 704, in response to the correlation representation generated in step 728, determines a recommendation for the subject's lifestyle change that may improve or eliminate the subject's sleep apnea. .. For example, if the correlation of the percentage of airway obstruction to the subject's weight indicates that the average percentage of airway obstruction increases as the subject's weight increases, the computing device 704 displays/displays via the client device 702. If the subject 405 loses a certain number of pounds for replay, the subject may generate a text or voice message stating that the average percentage of airway obstructions can be reduced by a certain amount. Or if the correlation between the average frequency of airway obstruction per night versus the number of coffee cups per day shows that the average frequency of airway obstruction per night increases as the number of coffee cups per day increases. , The computing device 704, if the subject 405 reduces the number of cups of coffee per day below a certain number of cups for display/playback via the client device 702, the subject will have airway obstruction per night. A text or voice message may be generated stating that the average frequency of the can be reduced by a certain amount.

Next, in step 732, the computing circuit 704 provides (eg, displays or plays) the one or more recommendations determined in step 730 via a media rendering device, such as the client device 702.

Still referring to FIG. 56, an alternative embodiment of the procedure described in connection with flow diagram 720 is contemplated. For example, a procedure can include one or more steps in addition to those described, or one or more of steps 722 to 732 described can be omitted. Further, instead of generating recommendations based on the correlation data, computing circuit 704 can provide the correlation data to a doctor or another medical professional, who can respond to the correlation data. Recommendations can be created and the created recommendations can be recommended to the subject 405. Alternatively, computing circuitry 704 can provide the correlation data to subject 405, who can draw his own conclusions from the data and adjust his lifestyle accordingly.

57 is a flow diagram 740 of a procedure that the system 700 of FIG. 55 may be configured to perform to improve well-being of a subject, according to one embodiment.

55 and 57, the procedure of flow diagram 740 according to one embodiment is described.

In step 742, the computing circuit 704 receives information from the sleep apnea system 420 regarding the subject's use of the sleep apnea system over a period of time. For example, the controller 134 (FIGS. 8 and 45) of the sleep apnea system 420 causes one or more of the component modules 550 by one or more sensors 126, 128 of the component modules 74, 550 (FIGS. 8 and 45). It may be configured to determine a parameter of use of the subject's sleep apnea system in response to information provided and sensed by one or more sensors 554 or by other components of the component module. Examples of use parameters for sleep apnea system 420 include average hours per night and average nights per week that subject 405 wears the sleep apnea system, and sleep apnea system Settings (eg, maximum negative pressure, temperature in pressure chamber, whether sealant dispenser assembly 124 (FIGS. 8 and 45) is active, set wake up time, and which parameters to detect apnea events. Sensed (eg breath sounds, breath rate). Sleep apnea system 420 stores these determined parameters in memory 130 (FIGS. 8 and 45) and may store these stored parameters either automatically or in response to a request from a computing circuit, for example. And may be configured to provide to computing circuitry 704.

Next, in step 744, the computing circuit 704 receives information from the client device 702 regarding the subject's well-being. Examples of information about a subject's well-being include the subject's mental state, emotional state, level of fatigue during the day (eg, the number of times the subject is napping or "hitting" per day), as well as the subject's well-being. Health parameters such as weight, body fat percentage, blood pressure, blood sugar, blood oxygen levels, and levels of other substances (eg, vitamins, minerals, and hormones) in the subject's body are included. For example, the subject 405 or another person can enter this information via the keyboard of the client device 702, or the client device includes one or more sensors to sense such health parameters. be able to. Client device 702 stores these well-being parameters in memory (not shown in FIGS. 55 and 57) and stores these stored parameters either automatically or in response to a request from a computing circuit, for example. And may be configured to provide computing circuit 704.

Then, in step 746, the computing circuitry 704 receives the information received from the sleep apnea system 420 regarding the subject's use of the sleep apnea system from the information received from the client device 702 regarding the subject's wellbeing. Correlate. For example, the computing circuitry 704 can correlate the average number of nights the subject 405 wears the sleep apnea system 420 with the subject's blood pressure over a period of time, and the subject sleeps. The average number of nights per week wearing the hour apnea system can be correlated with the subject's reported daytime fatigue level over a period of time.

Next, at step 748, computing circuit 704 generates one or more plots, charts, graphs, or other representations of the correlations generated at step 746. For example, the computer circuitry 704 may generate a plot of the average number of hours a subject wears the sleep apnea system 420 per night versus the subject's body fat percentage. These representations may be designed for display to subject 405 or another person, eg, via a display device that is part of client device 702. Alternatively, these representations may be data structures in memory of computing circuit 704.

Next, at step 750, the computing circuit 704 is responsive to the correlation representation generated at step 748 to improve the subject's well-being changes to the subject's use of the sleep apnea system 420. Determine recommendations. For example, if the correlation of the average number of nights the subject uses the sleep apnea system 420 to the subject's weight indicates that the subject's weight increases as the average number of nights used decreases, the computing device 704. If the subject 405 increases the number of days per week they use the sleep apnea system 420 to the number specified by the computing device, within the range specified by the computing device (eg, 5-15 pounds). A text or voice message may be generated for display/playback via the client device 702 indicating a potential weight loss. Alternatively, the correlation between the average number of hours per night that the subject 405 uses the sleep apnea system 420 versus the subject's blood pressure is such that the subject's blood pressure increases as the average number of hours used per night decreases. , The computing device 704 increases the number of hours the subject uses the sleep apnea system 420 per night to the number of hours specified by the computing device (eg, 2 hours from 5 hours to 7 hours). Display/playback via client device 702, indicating that the subject can decrease their systolic blood pressure by an amount within a range (eg, 5-15 millimeters of mercury (mmHg)) if increased by time). A text message or a voice message for can be generated.

Next, in step 752, the computing circuit 704 displays or otherwise provides, via a media rendering device, such as the client device 702, the one or more recommendations determined in step 750.

Still referring to FIG. 57, an alternative embodiment of the procedure described in connection with flow diagram 740 is contemplated. For example, a procedure can include one or more steps in addition to those described, or one or more of steps 742-752 described can be omitted. Further, instead of generating recommendations based on the correlation data, computing circuit 704 may provide the correlation data to a doctor or other medical professional, who may respond to the correlation data. Recommendations can be made to the subject 405. Alternatively, computing circuitry 704 can provide the correlation data to subject 405, who can draw his own conclusions from the data and adjust the use of sleep apnea system 420 accordingly. ..

58 is an isometric view of a negative pressure sleep apnea therapy system 420 according to another embodiment.

59 is an isometric exploded view of the sleep apnea treatment system 420 of FIG. 58, according to one embodiment.

58-59, a sleep apnea system 420 is configured to secure a collar assembly 760 having a receptacle 762 and a sleep apnea system to a subject's neck 400 (eg, FIG. 38). A strap assembly 764, a gasket assembly 765 configured to form an airtight seal with the subject's neck, and attached to the strap assembly to fit into the receptacle while the subject is wearing the sleep apnea system. A component module 766 configured to mate. Other than having a receptacle 762, the collar assembly 760 can be similar to the collar assembly 440 (eg, FIGS. 30-37) and the strap assembly 764 is made into the strap assembly 424 (eg, FIGS. 30-32). The gasket assembly 765 may be made of a material similar to the material and may be similar to the gasket assembly 422 (FIGS. 27-28, 30-34, and 39-40). Also, the component module 766 may be structurally and functionally similar to the component module 550 (FIG. 45) except that it is configured to mate with the receptacle 762.

With further reference to FIGS. 58-59, alternative embodiments of the sleep apnea system 420 are contemplated. For example, a remote controller, such as remote controller 484 (FIG. 37), controls sleep apnea system 420 to program, receive, analyze sleep apnea system 420 status, or otherwise. Can be configured to. Remote control 484 may be part of sleep apnea system 420 or may be separate from sleep apnea system 420.

FIG. 60 is an isometric view of a negative pressure sleep apnea therapy system 420 according to yet another embodiment.

The sleep apnea system 420 includes a mounting unit 770, a base unit 772, and an air hose 774 configured to pneumatically couple the mounting unit to the base unit. The mounting unit 770 includes a collar assembly 776 having a hose connector 778 and a strap assembly (not shown in FIG. 60) configured to secure the mounting unit 770 around the subject's neck 400 (eg, FIG. 38). ) And a gasket assembly (not shown in FIG. 60) configured to form a hermetic seal with the subject's neck. Base unit 772 includes at least one motor and pump assembly (not shown in FIG. 60), such as motor assembly 116 and pump assembly 118 of FIG. 45, connector 778, hose 774, and on the base unit. The vacuum chamber between the inner surface of the collar assembly and the subject's neck 400 (see FIG. 60) by drawing a vacuum into the pressure chamber through another hose connector (not shown in FIG. 60) located at Are not shown). Other than having a hose connector 778, the collar assembly 776 may be similar to the collar assembly 440 (eg, FIGS. 30-37) and the strap assembly is similar to the strap assembly 424 (eg, FIGS. 30-32). The gasket assembly may be similar to the gasket assembly 422 (FIGS. 27-28, 30-34, and 39-40). In addition to the pump assembly 118 and the motor assembly 116, the base unit 772 may include one or more other components of the component module 550 (FIG. 45), which allows the base unit to be plugged into a wall outlet that provides 110 VAC or 220 VAC. A power supply (not shown in FIG. 60) that allows “plugging” can be included. Additionally, the collar assembly 776 can also include one or more components of the component module 550, such as a component of a module that lacks the base unit 772.

Still referring to FIG. 60, an alternative embodiment of the sleep apnea system 420 is contemplated. For example, a remote controller, such as remote controller 484 (FIG. 37), controls sleep apnea system 420 to program, receive, analyze sleep apnea system 420 status, or otherwise. Can be configured to. Remote control 484 may be part of sleep apnea system 420 or may be separate from sleep apnea system 420.

61 is an isometric view of a negative pressure sleep apnea therapy system 420 according to yet another embodiment.

The sleep apnea system 420 applies negative pressure to the wearing unit 790 and a pressure chamber (not shown in FIG. 61) adjacent to the subject's throat region, eg, throat region 406 or throat region 407 (FIGS. 24-25). And a handheld unit 792 for hanging. The mounting unit 790 includes a collar assembly 794 having a pneumatic connector 796 and a strap assembly (not shown in FIG. 61) configured to secure the mounting unit 790 around the subject's neck 400 (eg, FIG. 38). ) And a gasket assembly (not shown in FIG. 61) configured to form a hermetic seal with the subject's neck. Handheld unit 792 includes a pneumatic connector 798 and at least one motor assembly and pump assembly (not shown in FIG. 60), such as motor assembly 116 and pump assembly 118 (FIG. 45), via connectors 796 and 798. Is configured to create a negative pressure in the pressure chamber between the interior surface of the collar assembly and the subject's neck 400 by drawing a vacuum in the pressure chamber. The collar assembly 794 and gasket assembly of the sleep apnea system 420 are designed to hold a negative pressure in the pressure chamber for a period of time (eg, one hour or more, or the entire time the subject sleeps). .. If the magnitude of the negative pressure is reduced below a threshold pressure, the circuitry mounted on the collar assembly 794 will cause the subject 405 (eg, FIG. 38) to handheld the subject to reestablish the proper pressure in the pressure chamber. An alarm can be sounded to notify that the unit 792 should be used. Alternatively, the collar assembly 794 may be configured to send to the handheld unit 792 sufficient information for the handheld unit to determine that the magnitude of the negative pressure has decreased below the threshold pressure, and in response to this determination, The handheld unit can sound the alarm described above. The collar assembly 794 may be similar to the collar assembly 440 (e.g., Figures 30-37) and the strap assembly may be similar to the strap assembly 424 (e.g., Figures 30-32), except having a pneumatic connector 796. And the gasket assembly may be similar to the gasket assembly 422 (FIGS. 27-28, 30-34, and 39-40). In addition to the pump assembly 118 and the motor assembly 116, the handheld unit 792 can include one or more other components of the component module 550 (FIG. 45), which allows the handheld unit to be plugged into a wall outlet that provides 110 VAC or 220 VAC. A power supply (not shown in FIG. 60) that allows “plugging” can be included. In addition, the collar assembly 794 can also include one or more components of the component module 550, such as those components of the module that the handheld unit 792 lacks.

Still referring to FIG. 61, an alternative embodiment of the sleep apnea system 420 is contemplated. For example, remote controller 800, which may be similar to remote controller 484 (FIG. 37), may program, receive, analyze, or otherwise sleep the status of handheld unit 792 of sleep apnea system 420. It may be configured to control the apnea system 420. Remote control device 800 may be part of sleep apnea system 420 or may be separate from sleep apnea system 420.

FIG. 62 is an isometric view of a subject 405 wearing a negative pressure sleep apnea treatment system 420 according to another embodiment.

Sleep apnea system 420 includes a mounting unit 810, a garment unit 812, and an air hose 814 configured to pneumatically couple the mounting unit to the garment unit. The mounting unit 810 includes a collar assembly 816 having a hose connector 818, a strap assembly 819 configured to secure the mounting unit 810 around the subject's neck 00, and to form a hermetic seal with the subject's neck. And a gasket assembly (not shown in FIG. 62) configured as described above. The garment unit 812 includes a hose connector 822 and at least one motor and pump assembly (not shown in FIG. 62), such as a motor assembly 116 and a pump assembly 118 (FIG. 45), a hose 814 and a connector 818. And 822 to create a vacuum in the pressure chamber (not shown in FIG. 62) between the inner surface of the collar assembly 816 and the subject's neck 400. To be done. Other than having a hose connector 818, the collar assembly 816 may be similar to the collar assembly 440 (eg, FIGS. 30-37) and the strap assembly 819 is similar to the strap assembly 424 (eg, FIGS. 30-32). The gasket assembly can be similar to the gasket assembly 422 (FIGS. 27-28, 30-34, and 39-40). Garment unit 812 can be any wearable item such as underwear, shirts, pants, armbands, or hats, and can be made from any suitable material. In addition to the pump assembly 118 and the motor assembly 116, the garment unit 812 can include one or more other components of the component module 550 (FIG. 45) to a wall outlet that provides 110 VAC or 220 VAC. A power supply (not shown in FIG. 60) may be included to allow the “plug in”. For example, the garment unit 812 can include a module 824 similar to the module 550 and can have one or more sensors 126, 128, 554 (FIG. 45) located at appropriate locations on the garment unit. Such one or more sensors 126, 128, 554 may be on the inside surface of the garment (the side that faces the subject 405 when worn), the inside of the garment, or the outside surface of the garment (the side that is turned toward the subject when worn). Can be placed. Additionally, the collar assembly 816 may also include one or more components of the component module 550, such as a component of a module that is missing from the garment unit 812.

Still referring to FIG. 62, an alternative embodiment of the sleep apnea system 420 is contemplated. For example, a remote controller, such as remote controller 484 (FIG. 37), controls sleep apnea system 420 to program, receive, analyze sleep apnea system 420 status, or otherwise. Can be configured to. The remote control may be part of sleep apnea system 420 or may be separate from sleep apnea system 420.

FIG. 63 is an isometric view of a negative pressure sleep apnea therapy system 830 according to one embodiment.

The sleep apnea system 830 includes a plurality of pressure chamber units 832 (two units in this embodiment), an elastic coupler 834 disposed between the pressure chamber units, and connecting them to each other, and a neck of the subject 405 and Strap assembly (not shown in FIG. 63) configured to secure around the back of the subject's neck 400 to hold the pressure chamber unit in place relative to the throat. Each pressure chamber unit 832 includes a gasket assembly 838 configured to form an airtight seal with the subject's neck 400 and at least one motor assembly and pump, such as motor assembly 116 and pump assembly 118 (FIG. 45). An assembly (not shown in FIG. 63 ), and by drawing a vacuum in the pressure chamber, the inside of the pressure chamber (not shown in FIG. 63) between the inner surface of the pressure chamber unit 832 and the throat of the subject. Is configured to generate a negative pressure at. For example, each unit 832 can include a component module (not shown in FIG. 63), such as component module 550 (FIG. 45). Alternatively, one of the units 832 can include at least one component of the module 550, the other pressure chamber unit can include at least one other component of the module 550, and the pressure chamber unit can be , Can be in electrical or pneumatic communication with one another via one or more conduits (not shown in FIG. 63) located in or on the elastic coupler 834. Other than having different sizes and different shapes, each pressure chamber unit 832 can be similar to the collar assembly 440 (eg, FIGS. 30-37) and the strap assembly can be a strap assembly 424 (eg, FIGS. 30-32). And the gasket assembly may be similar to gasket assembly 422 (FIGS. 27-28, 30-34, and 39-40). Also, the elastic coupler 834 can be formed from any suitable material, such as the same material from which the strap assembly is formed.

Still referring to FIG. 63, an alternative embodiment of the sleep apnea system 830 is contemplated. For example, a remote control device, such as remote control device 484 (FIG. 37), controls sleep apnea system 830 to program, receive, analyze the status of sleep apnea system 830, or otherwise. Can be configured to. The remote control may be part of the sleep apnea system 830 or may be separate from the sleep apnea system.

From the above, it will be appreciated that although particular embodiments are described herein for purposes of explanation, various modifications can be made without departing from the spirit and scope of the disclosure. Moreover, it is contemplated that any feature disclosed in connection with an embodiment may be incorporated into any other embodiment. For example, any of the features disclosed in connection with an embodiment of sleep apnea therapy system 70 may be incorporated into any embodiment of sleep apnea therapy system 420 and 830, and vice versa. .. Furthermore, if an alternative is disclosed for a particular embodiment, this alternative may be applicable to other embodiments even if not explicitly stated. For example, one or more of the techniques described above may be implemented in a sleep apnea therapy system other than sleep apnea therapy system 70, 420, 830 (eg, a CPAP system). Further, one or more of the techniques described above can be modified for implementation on a system (eg, CPAP system) for treating sleep apnea with positive pressure instead of negative pressure. Further, it is contemplated that the system may use one or more of the above techniques to treat sleep apnea with both positive and negative pressure. Also, "and" and "or" should be interpreted as follows. A "or" B, and A "and" B are taken to mean A, B, or both A and B, unless expressly or implicitly indicated otherwise (for example by context). Should be.

While various aspects and embodiments are 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, the true scope and spirit being indicated by the following claims.

Claims (32)

A collar configured to maintain the subject's airways open while the subject sleeps by applying a negative pressure having a magnitude to the subject's throat,
A pump configured to generate the negative pressure,
A motor configured to drive the pump,
A first sensor configured to generate a first sensing signal related to the degree to which the airway is open;
Memory and
Configured to change the magnitude of the negative pressure in response to the sensed signal and to store in the memory information associated with a sleep apnea event or sleep apnea treatment experienced by the subject. A system including a controller. The system of claim 1, wherein the pump, the motor, the first sensor, the memory, and the controller are fixed to the collar. A base unit including the pump and the motor;
The system of claim 1, further comprising a hose configured to couple the base unit to the collar. A base unit including the pump, the motor, the first sensor, the memory, and the controller;
The system of claim 1, further comprising a hose configured to couple the base unit to the collar. The controller is
Detecting an obstruction to the airway of the subject in response to the sensing signal,
The system of claim 1, wherein the controller is configured to store in the memory the time at which the controller detected an obstruction to the airway. The collar is adapted to apply the negative pressure above the subject's sternum head, below the subject's digastric anterior abdomen, and to the area of the throat between the subject's sternocleidomastoid muscles. The system according to claim 1, wherein the system is configured in. The controller is
Detecting an obstruction to the airway of the subject in response to the sensing signal,
Determining the duration of the obstruction to the airways detected by the controller,
The system of claim 1, configured to store the duration as information in the memory. Removable flexible, wherein one of the pump, the motor, the sensor, the controller, and a power source is fixed and configured to be positioned between the collar and the throat of the subject. The system of claim 1, further comprising a sleeve. The sensor includes a pulse oximetry sensor configured to generate the sensing signal related to the oxygen level in the blood of the subject,
The controller is
Determining a time profile of oxygen levels in the blood of the subject in response to the sensed signal;
The system of claim 1, wherein the system is configured to store the determined temporal profile of oxygen levels in the blood of the subject as information in the memory. The sensor includes a microphone configured to generate the sensed signal related to the level of sound produced by the subject;
The controller is
Determining a time profile of the level of sound produced by the subject in response to the sensed signal;
The system of claim 1, wherein the system is configured to store information in the memory of a determined temporal profile of the level of sound produced by the subject. The sensor includes an accelerometer configured to generate the sensing signal related to the level of movement of the subject,
The controller is
Determining a temporal profile of the level of motion of the subject in response to the sensed signal;
The system of claim 1, configured to store a temporal profile of the determined level of motion of the subject as information in the memory. The sensor includes an electrode, the electrode being configured to contact the subject's neck and generate the sensing signal associated with a current flowing in or out of one of the electrodes,
The controller is
Determining a time profile of current flowing in or out of one of the electrodes in response to the sensing signal;
The system of claim 1, wherein the system is configured to store information in the memory as a time profile of a determined current flowing in or out of one of the electrodes. The sensor includes electrodes, the electrodes being configured to contact the subject's neck and generate the sensing signal related to the voltage across the electrodes;
The controller is
Determining a time profile of the voltage across the electrodes in response to the sense signal,
The system of claim 1, configured to store the determined time profile of the voltage across the electrodes as information in the memory. Further comprising a heating-cooling assembly secured to the collar, coupled to a power source, and configured to heat and cool the neck region of the subject.
The system of claim 1, wherein the controller is configured to cause the heating-cooling assembly to change the temperature of the region of the subject's neck in response to the sensed signal. The system of claim 1, further comprising a power supply fixed to the collar and configured to supply power from a power supply to one of the motor, the sensor, and the controller. A tactile switch disposed adjacent to a side surface of the collar, the side surface configured to turn his back on the subject, the tactile switch having a tactile switch having an on state and an off state.
A power supply fixed to the collar,
Powering one of the motor, the sensor and the controller from a power source in response to the tactile switch having an on state;
The system of claim 1, further comprising a power supply configured to turn off power to one of the motor, the sensor, and the controller in response to the tactile switch having an off state. .. Negative pressure having a magnitude is applied to the subject's thoracic head, below the subject's digastric anterior abdomen, and between the subject's sternocleidomastoid muscles in the region of the subject's throat. Maintaining the subject's airways open while the subject sleeps by applying.
Determining the degree to which the airways are open;
Adjusting the magnitude of the negative pressure in response to the determined degree to which the airway is open;
Storing information about one of the maintaining, the determining, and adjusting. The step of determining the degree to which the airways are open comprises:
Transmitting electromagnetic energy towards the subject,
Receiving a portion of the transmitted electromagnetic energy diverted by the subject;
18. Responding to the received portion of the transmitted electromagnetic energy, determining the degree to which the airway is open. The step of determining the degree to which the airways are open comprises:
Determining the oxygen concentration in the blood of the subject,
18. The method of claim 17, comprising: determining the degree to which the airways are open in response to the determined oxygen concentration in the blood of the subject. The step of determining the degree to which the airways are open comprises:
Determining the level of sound produced by the subject;
18. The method of claim 17, comprising: responsive to the determined level of sound produced by the subject, determining the degree to which the airways are open. The step of determining the degree to which the airways are open comprises:
Determining a level of movement of the subject;
18. The method of claim 17, comprising responsive to the determined level of movement of the subject, determining the degree to which the airways are open. The step of determining the degree to which the airways are open comprises:
Determining a cross-sectional area of the airway of the subject;
18. The method of claim 17, comprising: responsive to a determined cross-sectional area of the airway of the subject, determining the degree to which the airway is open. The step of determining the degree to which the airways are open comprises:
Determining a stroke volume of the subject's heart;
18. The method of claim 17, comprising: responsive to a determined stroke volume of the heart of the subject, determining the degree to which the airways are open. The step of determining the degree to which the airways are open comprises:
Determining the level of substances in the air released by the subject during exhalation;
18. The method of claim 17, comprising responsive to a determined level of the substance, determining the degree to which the airways are open. The step of determining the degree to which the airways are open comprises:
Determining a parameter of current flowing into or out of the subject's neck,
18. The method of claim 17, comprising responsive to a determined parameter of the electrical current, determining a degree to which the airway is open. The step of determining the degree to which the airways are open comprises:
Determining a parameter of the voltage between the two regions of the subject's neck,
18. The method of claim 17, comprising responsive to the determined parameter of the voltage, determining a degree to which the airway is open. Using a computer system to receive parameters of sleep apnea device use by the subject from the sleep apnea therapy device;
Using the computer system to receive aspects of wellbeing of the subject;
Correlating the parameters of use of the sleep apnea device with the aspects of well-being using the computer system;
Using the computer system to determine recommendations for changing the parameter of use of the sleep apnea device to alter the aspect of the well-being;
Providing the recommendation to the subject using the computer system. Further comprising obtaining parameters of use of the sleep apnea device by the subject using the sleep apnea device,
The sleep apnea device,
A collar configured to maintain an open airway of the subject while the subject sleeps by applying a negative pressure having a magnitude to the subject's throat,
A pump configured to generate the negative pressure,
A motor configured to drive the pump,
A first sensor configured to generate a first sensing signal related to the degree to which the airway is open;
Memory and
A controller,
Changing the magnitude of the negative pressure in response to the sensing signal,
Detecting the use of the sleep apnea device,
Storing the parameters associated with the use of the sleep apnea device in the memory;
28. The method of claim 27, including a controller configured to provide the stored parameters to the computer system. 28. The method of claim 27, wherein the parameter of use of the sleep apnea device comprises an average number of hours per day the subject uses the sleep apnea device. 28. The method of claim 27, wherein the parameter of use of the sleep apnea device comprises the frequency with which the subject uses the sleep apnea device. 28. The method of claim 27, wherein the parameter of use of the sleep apnea device comprises a time of day during which the subject uses the sleep apnea device. The parameter of use of the sleep apnea device comprises a difference between the number of hours per day and the number of hours per day the subject uses the sleep apnea device. Item 27. The method according to Item 27.

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