CN110430854A

CN110430854A - It obtains with negative pressure treatment sleep apnea, and using sleep apnea equipment and sleep apnea event and the relevant information of sleep apnea and keeps sleep apnea event and sleep apnea therapy related with subject's life style and health

Info

Publication number: CN110430854A
Application number: CN201880017836.9A
Authority: CN
Inventors: 肯尼斯·G·卡尔代拉; 罗德里克·A·海德; 盖瑞·L·麦克奈特; 丹尼斯·J·里韦特; 凯瑟琳·谢拉丁; 迈克尔·A·史密斯; 洛厄尔·L·小伍德
Original assignee: Elwha LLC
Current assignee: Sommuni Co ltd; Invention Science Fund II LLC
Priority date: 2017-01-13
Filing date: 2018-01-12
Publication date: 2019-11-08
Also published as: SG11201906387VA; JP2020518298A; WO2018132646A1; EP3568116A1; EP3568116A4

Abstract

A kind of embodiment for treating the system of sleep apnea includes lantern ring, pump, motor, sensor, storage mechanism and controller.Lantern ring is configured to keep the airway open of subject and applying the negative pressure with amplitude to the throat of subject during sleep in subject, and pumps and be configured to generate the negative pressure.Motor is configured to drive the pump, and sensor is configured to generate sensing signal relevant to the degree of the airway open.And controller is configured in response to the amplitude that the sensing signal changes the negative pressure.Furthermore, controller, which can be obtained and be stored in memory, uses and is arranged relevant information to sleep apnea system, and controller or another computing system can be associated with the health of subject by the information, and can suggest changing the use or setting to the health that can improve subject of sleep apnea system.

Description

With negative pressure treatment sleep apnea, and using sleep apnea equipment obtain with Sleep apnea event and the relevant information of sleep apnea and make sleep-respiratory Suspending event and sleep apnea therapy are related to subject's life style and health

All themes of priority application are incorporated herein by reference, as long as the theme and not contradiction herein.

Summary of the invention

It is outlined below to be merely illustrative, it is not intended to be limited in any way.In addition to described above illustrative Except aspect, embodiment and feature, by reference to attached drawing and described in detail below, other aspects, embodiment and features general It becomes apparent.

A kind of system for treating sleep apnea includes lantern ring, pump, motor, sensor, storage mechanism and control Device processed.Lantern ring is configured to keep tested and applying the negative pressure with amplitude to the throat of subject during sleep in subject The airway open of person, and pump and be configured to generate the negative pressure.Motor is configured to drive the pump, and sensor is matched It is set to and generates sensing signal relevant to the degree of the airway open or obstruction.And controller is configured in response to institute The amplitude that sensing signal changes the negative pressure is stated, and the sleep apnea event or sleep that undergo with the subject are exhaled It inhales and suspends treatment-related information storage in the memory.

For example, one or more of pump, motor, sensor and controller can be fixed on lantern ring, so that system is Independent, i.e., whole system can be by subject wears, for example, by being maintained in the throat of subject with component.Alternatively, The system may include including at least pump and motor base unit, and may include base unit is coupled to lantern ring air it is soft Pipe, so that pump can generate negative pressure by hose.

In addition, controller can obtain and store in memory relevant to sleep apnea event information (for example, The par of event every night, the average frequency of event, the average duration of each event cause the airway obstruction of event Average level) and controller or other computing systems can be associated with the selection of the life style of subject by these information, And it can suggest changing lifestyles (for example, weight-reducing, sleeps to obtain the longer time, early sleep, not drink in two hours containing coffee before sleeping Coffee because beverage), the sleep apnea syndrome of subject can be improved (for example, the par of the event every night of reduction, subtracts The frequency of few event, reduces the average duration of each event, reduces the average water for leading to the airway obstruction of each event It is flat).

In addition, controller can obtain and store information relevant to sleep disturbance in memory, which can With (for example, the movement of subject, number of getting up, hourage of sleeping not will lead to apnea thing with sleep apnea event The disordered breathing of part or snoring, or other physiological characteristics with sleep apnea event without direct relation, such as blood pressure, body Temperature, heart rate etc.) it is related or uncorrelated.

In addition, controller, which can be obtained and be stored in memory, uses and is arranged (example with sleep apnea system Such as, subject uses the mean hours number of the system every night, and subject uses the average frequency (number of days weekly) of equipment, tested The bedtime of person and wakeup time, pressure setting, temperature setting) relevant information, and controller or other computing systems It can be by this information and the health status of subject (for example, weight, blood pressure, blood glucose, the state of mind, emotional state, angiocarpy are strong Health, daytime drowsiness) or subject's health status variation (in such as weight, blood pressure, blood glucose level, the state of mind, mood shape Variation in terms of state, cardiovascular health, daytime drowsiness) it is associated and suggests changing can improve to sleep apnea system The health of subject is (for example, losing weight, reducing blood pressure, reduce blood glucose level, improve the state of mind, improve emotional state, improve the heart Vascular health, improve subject daytime vigilance) use or setting.

Detailed description of the invention

Fig. 1 is the figure of the other biological tissue near the air flue and the air flue of human experimenter and structure.

Fig. 2 is the figure using the subject of CPAP machine.

Fig. 3 is the figure of the neck of subject He the throat region of the neck.

Fig. 4 is the view of the subject of the system according to the wearing of an embodiment for treating sleep apnea.

Fig. 5 is the view according to the system for treating sleep apnea of an embodiment.

Fig. 6 is the view according to the system for treating sleep apnea of another embodiment.

Fig. 7 is the view according to the system for treating sleep apnea of another embodiment.

Fig. 8 is the block diagram of the component models of the sleep apnea system according to an embodiment of Fig. 4-7.

Fig. 9 is a part of the apnea degree sensor component of Fig. 8 and the subject according to an embodiment The figure of the cross section of neck and air flue.

Figure 10 is a part of the apnea degree sensor component of Fig. 8 and the subject according to another embodiment Neck and air flue cross section figure.

Figure 11 is a part of the apnea degree sensor component of Fig. 8 and the subject according to another embodiment Neck and air flue cross section figure.

Figure 12 is a part of the apnea degree sensor component of Fig. 8 and the subject according to another embodiment Figure.

Figure 13 be according to embodiment for by the degree of the airway open of subject and with the degree phase of airway open The flow chart of the associated process of the state of pass.

Figure 14 is the figure of the sealing and vacuum surface according to the lantern ring of Fig. 4-7 of an embodiment.

Figure 15 is the figure according to the sealing surfaces of the lantern ring of Fig. 4-7 of another embodiment.

Figure 16 is the figure according to a part of the lantern ring of Fig. 4-7 of an embodiment.

Figure 17 is the view according to the collar portion of the line A-A interception in Figure 16 of an embodiment.

Figure 18 is the view according to the end regions of the collar portion of Figure 16 of an embodiment.

Figure 19 is the view according to a part of the lantern ring of another embodiment Fig. 4-7.

Figure 20 is the view of the collar portion intercepted according to the line A-A along Figure 19 of Figure 19 of an embodiment.

Figure 21 is the figure according to a part of the lantern ring of Fig. 4-7 of another embodiment.

Figure 22 is the view of the collar portion intercepted according to the line A-A along Figure 21 of Figure 21 of an embodiment.

Figure 23 is the flow chart according to the operation of the sleep apnea therapy system of Fig. 4-7 of an embodiment.

Figure 24 is according to the neck of the subject of an embodiment, the throat region of the neck and the throat for applying Negative pressure is to treat the front view in the region of sleep apnea.

Figure 25 is the side view according to the neck of Figure 24 of an embodiment, throat region and negative pressure applying zone.

Figure 26 is according to the front view of the subject of the wearable system of an embodiment, which is designed to by figure The negative pressure applying zone of 24-25 applies negative pressure to treat sleep apnea.

Figure 27-28 be according to an embodiment wearing Figure 26 sleep apnea therapy system subject it is corresponding Side view.

Figure 29 is the backsight according to the subject of the sleep apnea therapy system of wearing Figure 26-28 of an embodiment Figure.

Figure 30 is the isometric side view according to the sleep apnea therapy system of Figure 26-29 of an embodiment.

Figure 31 is the equidistant rearview according to the sleep apnea therapy system of Figure 26-30 of an embodiment.

Figure 32 is the exploded view according to the sleep apnea therapy system of Figure 26-31 of an embodiment.

Figure 33 is the equidistant forward sight according to the collar assemblies of the sleep apnea therapy system of an embodiment Figure 26-32 Figure.

Figure 34 is the set according to the sleep apnea therapy system with transparent part of Figure 26-33 of an embodiment The isometric side view of ring assemblies.

Figure 35 is the equidistant transparent side view according to the collar assemblies of Figure 26-34 of an embodiment.

Figure 36 be according to Figure 26-35 of an embodiment include tactile ON/OFF switch collar assemblies it is equidistant Front view.

It includes having light emitting diode (LED) battery level indicator that Figure 37, which is according to Figure 26-35 of an embodiment, The isometric front view of collar assemblies and the equipment for remotely controlling collar assemblies.

Figure 38 is controlled according to the sleep apnea including position tunable sensors of wearing Figure 26-32 of an embodiment The isometric side view of the subject for the treatment of system.

Figure 39 is the collar assemblies and washer sets according to the sleep apnea therapy system of Figure 26-32 of an embodiment The isometric exploded view of part.

Figure 40 is the sectional side view according to the washer of the gasket assembly of Figure 29 of an embodiment.

Figure 41 is the sleep apnea therapy system including replaceable lantern ring according to Figure 26-32 of an embodiment Isometric exploded view.

Figure 42 is the sleep apnea therapy system including Battery charging contacts according to Figure 26-32 of an embodiment Isometric view.

Figure 43 is according to the in an open position of the sleep apnea therapy system for Figure 42 of an embodiment The isometric top view of battery charging the storage box.

Figure 44 is that the sleep-respiratory of Figure 42 in the battery charging the storage box that Figure 43 is arranged according to an embodiment is temporary Stop the isometric view for the treatment of system.

Figure 45 is the component models according to the sleep apnea therapy system of Figure 26-32,42 and 44 of an embodiment Block diagram.

Figure 46 is the collection of energy thermoelectric power source that may include according to the supplemental power source of Figure 45 of an embodiment Isometric view.

Figure 47 is the collection of energy movement power source that may include according to the supplemental power source of Figure 45 of an embodiment The isometric view of element.

Figure 48 is the isometric view according to the bisection of the element of Figure 47 of an embodiment.

Figure 49 is the equidistant view that power source is moved according to the collection of energy of the element including Figure 47-48 of an embodiment Figure.

Figure 50 is the equidistant view that power source is moved according to the collection of energy of the element including Figure 47-48 of another embodiment Figure.

Figure 51 is the figure that the one aspect of operation of power source is moved according to the collection of energy of Figure 50 of another embodiment.

Figure 52 is that the collection of energy torsion that may include stretches power according to the supplemental power source of Figure 45 of an embodiment The isometric view in source.

Figure 53 is that the frictional electricity nanometer generating for stretching power source is reversed according to the collection of energy of Figure 52 of an embodiment The sectional side view of machine (TENG).

Figure 54 is that cuing open for the energy storage component for stretching power source is reversed according to the collection of energy of Figure 52 of an embodiment Depending on side view.

Figure 55 is according to the block diagram of the system of an embodiment, which includes that the sleep-respiratory of Figure 26-32,42 and 44 is temporary Stop treatment system, client and can control the data obtained by sleep apnea therapy system with using sleep apnea The associated computer circuits of the relevant data of the subject for the treatment of system.

Figure 56 is according to the flow chart of the algorithm that can be executed by the system of Figure 55 of an embodiment, and the algorithm is for determining The variation of the life style of the subject of the sleep apnea of subject can be improved.

Figure 57 is according to the flow chart of the algorithm that can be executed by the system of Figure 55 of an embodiment, and the algorithm is for true It is fixed related using sleep apnea therapy device to subject and the variation of subject's health can be improved.

Figure 58-59 is the isometric view according to the sleep apnea therapy system of another embodiment.

Figure 60 is the isometric view according to the sleep apnea therapy system of another embodiment.

Figure 61 is the isometric view according to the sleep apnea therapy system of another embodiment.

Figure 62 is the isometric view according to the subject of the wearing sleep apnea therapy system of another embodiment.

Figure 63 is the isometric view according to the subject of the wearing sleep apnea therapy system of another embodiment.

Specific embodiment

In the following detailed description, with reference to attached drawing, attached drawing forms a part of the invention.In the accompanying drawings, unless on Hereafter indicated otherwise, otherwise similar symbol usually identifies similar component.It is being described in detail, described in drawings and claims Illustrative embodiment be not meant to be restrictive.The spirit or scope for not departing from subject matter presented here the case where Under, it can use other embodiments, and other changes can be carried out.

One or more embodiments are described with reference to the drawings, wherein identical appended drawing reference can be used to indicate always Identical element.In the following description, for illustrative purposes, numerous specific details are set forth in order to provide to one or more The thorough understanding of embodiment.It will be apparent, however, that can practice without these specific details one or Multiple embodiments.In other instances, well known structure and equipment is shown in block diagram form, in order to describe one or more A embodiment.

Sleep apnea is a kind of disease during sleep, it is characterised in that the case where abnormal low breathing, Huo Zhe In breathing extremely pause (for example, " apnea " or " apnea ") the case where；For example, this apnea can be with About 5-30 times or more frequency occurs per hour, and apnea can continue about ten seconds to one minute or more every time More minutes.

The subject with sleep apnea suffocates during apnea in order to prevent, and body can generate of short duration kidney " outburst " of upper parathyrine, this outburst would generally make subject start again at his/her breathing, but be not enough to wake up completely he/ She.

Unfortunately, these adrenergic outbursts will lead to the serious health problem of subject's experience.For example, because this The adrenergic outburst of kind can oppress the heart of subject by increasing the heart rate of subject relatively quickly, this quick-fried Hair can increase the risk of subject's heart attack or apoplexy.Further, since these adrenergic outbursts can interrupt it is tested The deep sleep mode of person, these outbursts may be the basic reason for leading to health problem relevant to sleep insufficiency.It is this with The example for relevant health problem of having not enough sleep includes non-thin (adipose tissue) weight gain, artery sclerosis, daytime fatigue, cognition Function reduces, the reaction time is reduced and attention range is reduced.

Because the subject with sleep apnea seldom recognizes during sleep or even to breathe after waking up Difficulty, so subject may not recognize him/her with sleep apnea until one or more symptom (examples for many years Such as, the symptom of one of above-mentioned health problem or a variety of forms) show to have arrived in itself subject is made to seek medical care Degree.But till that time, subject may have been subjected to grievous injury (for example, heart attack), disabled (such as pass through apoplexy Cause), even dead (for example, causing since subject fails to start to breathe after apnea).

Therefore, suitably treatment sleep apnea can improve the health of subject in short-term and long-term, and at certain In a little situations, it might even be possible to prevent subject's premature death.

The most common sleep apnea type is obstructive sleep apnea.

Fig. 1 is the head of subject 12 and the cross-sectional view of neck area 10.

With reference to Fig. 1, obstructive sleep apnea is characterized in that the air flue 14 of subject 12 collapses, i.e., during sleep Blocked by such as back of tongue 16, soft palate 18 or uvula 20；Therefore, every kind of situation of obstructing airway usually causes institute as above " apnea " stated.The reason of obstructing airway 14 may include the muscle in tongue 16, soft palate 18 or uvula 20 during sleep Relaxation, overrelaxation or tissue are excessive.

It breaks out when the body of subject 12 generates adrenaline during the apnea that the air flue of obstruction induces with as above It is described start again at subject breathing when, adrenaline outburst can move his/her neck by making subject for example cough Portion 22, head 24 or chin 26, or deeper breathe to release (the stronger suction caused by deeper breathing of the obstruction of air flue 14 Power can force airway open).

Then, after subject 12 reenters deep sleep, the loosening all muscles of neck 22 and lower jaw 26, subject's is exhaled It inhales rate and returns to deeper sleep level, therefore, another circulation that apnea is followed by adrenaline outburst may Start.

Referring still to Fig. 1, it can be used for obstructive sleep apnea there are many treatment method.

The example of invasive treatment includes causing from physical feeling (for example, tongue 16, soft palate 18 or uvula 20) removal The operation of the tissue of obstructing airway 14 and by one or more components implantation blocking body position (for example, sticking plaster is implanted into In soft palate) with the operation of " reinforcement " physical feeling.

Unfortunately, the potential problems of this invasive treatment include risk, recovery time, irreversibility and with surgery hand The relevant pain of art will lead to uncomfortable after subject restores when he/her swallows or during he/her feeds including the operation Risk and the operation final certification cannot successfully prevent the airway obstruction for leading to obstructive sleep apnea from occurring again Risk.

The example of noninvasive laser therapy includes that subject 12 loses weight, and protects the jaw of subject 26 using during sleep The oral appliance in slightly prominent position is held, and uses continuous positive airway (CPAP) machine, combines Fig. 2 below Description.

Although this noninvasive laser therapy is typically superior to invasive treatment because for example they than it is invasive treatment have compared with Few risk and side effect, but for some subjects with obstructive sleep apnea, some noninvasive laser therapies, Such as weight-reducing and use oral appliance, it may be difficult to obtain, or invalid.

But fortunately, it has been found that CPAP machine can be treated successfully and most of can be exhaled originally with obstructive sleep Inhale the subject of pause.

Fig. 2 is the view using CPAP machine 30 to prevent the sleeping subject 12 of the generation of obstructive sleep apnea Figure.

CPAP machine 30 includes base unit 32, hose 34 and face shield assembly 36.

Base unit 32 is configured to when subject is to internal respiration (air-breathing) and in subject to external respiration (expiration) When the air pressure in hose 34 is kept to the level for being in constant, and therefore will be in the air flue 14 (Fig. 1) of subject 12 Interior air pressure keeps the level for being in constant.If CPAP machine 30 intake period by airway pressure be maintained at The level of its different approximately constant during expiration, then it is properly referred to as BiPAP machine, but usually used In, " CPAP " for indicates air-breathing and exhale during by airway pressure maintain identical just horizontal machine and air-breathing with Airway pressure is maintained to different just horizontal machines during expiration.Base unit 32 generally includes to be inserted directly into household power The power line of socket (for example, 110/220VAC), or can be coupled to AC adapter.

Hose 34 is configured to base unit 32 being coupled to face shield assembly 36, and is usually enough to long (for example, six to ten English Ruler) to allow subject 12 to be placed on base unit on floor or nightstand while subject 12 is using CPAP machine 30 On.

Face shield assembly 36 includes accessory 38, mask 40 and belt 42.Accessory 38 is configured to mask 40 being coupled to hose 34 On, and can be coupled on mask by rotary joint, rotary joint allows subject 12 to have some freedom of motion.Mask 40 be configured to be formed gas-tight seal 44 at least about the nose of subject 12 (but mask can also around the mouth of subject shape At sealing, as shown in Figure 2), and including one or more it is open (being not shown in Fig. 2), even if in intake period, the opening Allow air consistently to flow from base unit 32, by hose 34 and accessory 38, into mask 40, and passes through one or more Opening outflow；In the case where no this constant gas, the air sucked by subject may become " not flowing " ("stale").And mask 40 is fixed on the head 24 of subject 12 by belt 42, and tightness is enough in mask and tested Gas-tight seal 44 are formed between the face of person.

Still referring to Figure 2, although as described above, CPAP machine 30 effectively noninvasive laser therapy obstructive sleep respiratory is temporary Stop, but CPAP machine may still have the shortcomings that.For example, face shield assembly 36 effectively to be tied up to the hose on base unit 32 34 property can make subject 12 lose his/her overall range of motion during sleep.For example, subject 12 may be Do not make hose 34 from nightstand pull out base unit 32 in the case where without normal direction his/her left side roll；Alternatively, if pedestal list Member is on floor, then subject rolls to his/her left side and may cause hose 34 and be tauted, and therefore by mask 40 from tested The face of person is removed and destroys sealing element 44.In addition, mask 40 is removed and is destroyed from the face of subject in no pillow In the case where sealing element 44, subject 12 possibly can not sleep in his/her side.In addition, belt 42 must use by face Cover 40, which is maintained on subject's face 12, to be formed hermetically sealed power and subject may be made not feel good.In addition, CPAP machine 30 can prove that travelling inconvenience, because subject 12 must be when by safety check for example when carrying the machine aboard At least base unit 32 and other articles are separated, and the size of base unit may make it be difficult to carry in briefcase or mistake In night bag.

Fig. 3 is the figure of the neck 50 of subject 12 and the throat 54 of chin 52 and neck.

With reference to Fig. 3, one or more regions of neck 50 and/or chin 52 to subject 12 apply negative pressure and (aspirate Or vacuum) it can non-invasively treat obstructive sleep apnea.For example, subject 12 is during sleep, to chin 52 Downside 56 apply negative pressure, or apply negative pressure to the region 58 (such as mylohyoid) of the throat 54 below chin, can be with Help positions the chin, tongue 16 (Fig. 1) or one or more other biological structures of subject of subject, to open subject Air flue 14 (Fig. 1) and keep the air flue 14 of subject to open.In another example, when subject 12 during sleep, to larynx Portion region 60 (its below throat region 58, breastbone head 62 and the top of clavicle 64, and between nutator 66) One or more parts, which apply negative pressure, can also position one or more biological structures of subject 12, to open subject's Air flue 14 simultaneously keeps the air flue 14 of subject to open.In another example, when subject 12 during sleep, to digastric muscle 55 The region of throat 54 between preabdomen, thyroid cartilage (that is, Adam's apple) 57 and nutator 66, which applies negative pressure, to be positioned One or more biological structures of subject 12, so that the air flue 14 opened the air flue 14 of subject and keep subject is opened. In another example, subject 12 during sleep, between the preabdomen, hyoid bone 59 and nutator 66 of digastric muscle 55 The region of throat 54 apply negative pressure and can also position one or more biological structures of subject 12, to open subject's Air flue 14 simultaneously keeps the air flue 14 of subject to open.

Fig. 4 is somebody's turn to do according to the figure of the subject 12 using negative pressure sleep apnea therapy system 70 of an embodiment System is configured as treatment obstructive sleep apnea.Below with reference to as described in Fig. 5-22, system 70 is independent, and by It is configured to sleeping and to the application of subject's neck 50, chin 52 or one or more regions of throat 54 and maintenance negative pressure Period opens and stays open the air flue 14 (Fig. 1) of subject.As used above and below, " independent " means system 70 are configured as itself treatment obstructive sleep apnea.Compared with the CPAP machine of the CPAP machine 30 of such as Fig. 2, system 70, which can permit subject 12, more freely moves, can be more comfortable because it is not tied up on any other article or position, Because it is worn on neck rather than on the face, and can more suitable for travelling, because it can have less component, Can be smaller, and can fold.

Negative pressure sleep apnea therapy system 70 includes collar assemblies 72 and component models 74, and component models 74 are configured to Fixed on lantern ring.

Collar assemblies 72 include lantern ring 76 and fastener (invisible in Fig. 4), such as belt, snap-fastener, button orBand, be configured to by lantern ring be fixed to subject neck 50 so that lantern ring formed around subject's neck, One or more regions of chin 52 or throat 54 it is gas-tight seal, system 70 be configured to its apply negative pressure.Lantern ring 76 can be with Be it is partially or completely flexible, can be formed by one or more suitable materials (such as cloth, foam, metal or plastics), and And lantern ring or fastener can be configured to allow adjustment collar component 72 inside dimension, allow component be suitble to have it is various The subject of neck perimeter, length and shape.Collar assemblies 72 combine Fig. 5-7 to further describe below.

And module 74 is configured to include one or more components other than the collar assemblies 72 of system 70.Example Such as, module 74 may include air pump, motor, power supply source (power supply), pressure, air flue and other sensors, And controller circuitry, such as microprocessor or microcontroller.Module 74 is further described below with reference to Fig. 8.

Referring still to Fig. 4, it is contemplated that the alternate embodiment of negative pressure sleep apnea therapy system 70.For example, lantern ring 76 are not flexible, but may include two or more hinged rigid elements, so that these parts are configured to The neck 50 for opening and accommodating subject, is then closed and is attached at around neck.In addition, not other than collar assemblies 72 All system units may be located in module 74.For example, some or all of these other components can be fixed to The outside of lantern ring 76 or the outside of fastener can be fixed on the inside of lantern ring or the inside of fastener, or can be set The inside of lantern ring 76 or fastener.Moreover, module 74 and lantern ring 76 can have the shape shown in Fig. 4 in addition to any conjunction Suitable shape.

Fig. 5 is the view according to the negative pressure sleep apnea therapy system 70 of Fig. 4 of an embodiment.

Lantern ring 76 is single flexible part, is configured to surround the neck 50 of subject completely in subject wears' system 70 (Fig. 4), andFastener 78 is adjustable, so that system 70 can be suitble to various neck sizes and shape Shape.

System 70 further includes AC adapter/charger 90, is configured to couple to the jack 92 of component models 74, and is being It is system power supply or in the battery charging (being not shown in Fig. 5) that system operation or when not running are system when system operation.Substitution Ground, jack 92 can be configured to be coupled to power line, the power line be configured for being coupled to calibration power socket (for example, 110VAC 220VAC)。

In addition, system 70 includes one or more sealing surfaces 94, it is configured to the corresponding phase with subject's neck 50 Region is formed it is corresponding gas-tight seal, and including one or more vacuum surfaces 96, defined by sealing surfaces 94 and It is configured to the region for being applied negative pressure by system with the neck 50 (Fig. 4) of subject, chin 52 (Fig. 4) or throat 54 (Fig. 4) Relative positioning.One or more sealing surfaces 94 and one or more vacuum surfaces 96 combine Figure 14-21 further to retouch below It states.

In addition, component models 74 include input-output equipment 98, switching power devices 100 and air outlet slit component 102.It is defeated Entering output equipment 98 is, for example, touch screen (Fig. 4), which enables subject 12 to be programmed to system 70 or with other Mode control system 70, and receive such as status information from system 70 and program the information of confirmation etc.For example, input and output are set It is standby to be configured such that the amplitude or its max-thresholds of negative pressure is arranged in subject 12, and subject is enabled to set wake-up Time, system 70 can adjust setting (for example, amplitude of negative pressure) according to wakeup time gently to wake up subject.Substitution Ground, input-output equipment 98 may include individual input (for example, keyboard) and output (for example, display, touch screen are shown Device) equipment.Switching power devices 100 are, for example, any suitable component (for example, toggle switch or the tactile shown by touch screen Slide switch), allow subject 12 (Fig. 4) by 70 " on " of system or " shutdown ".And air outlet slit component 102 is system 70 air sucked between lantern ring 76 and the neck of subject 50 (Fig. 4), chin 52 (Fig. 4) or throat 54 (Fig. 4) provide Mouthful, to form one or more negative pressure regions between lantern ring and neck, chin or throat.

Fig. 6 is the view according to the negative pressure sleep apnea therapy system 70 of Fig. 4 of another embodiment.Fig. 6's is System is similar to the system 70 of Fig. 5, the difference is that lantern ring 76 is configured in subject wears' system only partially about him/her Neck 50 (Fig. 4) and Fig. 6 it is adjustableFastener 78 of the fastener 78 than Fig. 5 is long, is reduced with compensating Set ring length.

Fig. 7 is the view according to the negative pressure sleep apnea therapy system 70 of Fig. 4 of another embodiment.Fig. 7's is System 70 is similar to the system 70 of Fig. 5-6, unlike, lantern ring 76 includes being configured for being located under subject 12 (Fig. 4) Part 104 below bar 52 (Fig. 4), and the system further includes lantern ring supporting element 106.Lantern ring 76 is configured to only partially enclose Around the neck 50 (Fig. 4) of subject 12 (Fig. 4), and including part 104, it is configured to allow for (the figure of chin 52 in subject 4) or below lower jaw 26 (Fig. 1) apply negative pressure.And it can replace or be additional to the lantern ring branch of the fastener 78 of Fig. 5 and Fig. 6 Support member 106 is configured as cooperating above the shoulder of subject 12 and (being not shown in Fig. 7).Supporting element 106 can be by any suitable Flexibility, rigidity or semi-rigid material be made, and can have so that subject is in the design that can be move freely during sleep. Although not shown in FIG. 7, the system 70 of Fig. 7 may include: AC adapter 90, adapter jack 92,94 and of sealing surfaces One or more of vacuum surface 96 or its any suitable substitute.

With reference to Fig. 4-7, it is contemplated that the alternate embodiment of sleep apnea therapy system 70.For example, component models 74 Position relative to collar assemblies 72 can be unlike the described.In addition, input-output equipment 98, power switch 100 and sky It gas outlet 102 can be unlike the described relative to the position of component models 74.Moreover, the lantern ring 76 of Fig. 4-6 can have Chin or the lower jaw part of identical function are executed with the part 104 of Fig. 4.Furthermore, it is possible to which modification is in any suitable manner System 70.

Fig. 8 is the block diagram according to the component models 74 of Fig. 4-7 of an embodiment.In addition to power jack 92, input and output Except equipment 98, switching power devices 100 and air outlet slit component 102, component models 74 further include with lower component: power source (power source), such as battery 110, supplemental power source 112, power supply source (power supply) 114, motor sub-assembly 116, pump assembly 118, pressure regulator assembly 120, valve module 122, coating apparatus for sealant component 124, pressure sensor assembly 126, apnea degree sensor component 128, memory 130, temperature-controlling module 132, controller 134 and bus 136.Mould Block 74 can also include the packaging (being not shown in Fig. 8) for accommodating these components.For example, packaging can be formed by epoxy resin, and And it can be sealed to protect or prevent close to accommodated component, or may include allowing to approach one or more accommodated Structure of the component for example to be repaired or be replaced.In addition, other than power jack 92, component models 74 can also include Other suitable jacks or connector allow for example in pressure regulator assembly 120, valve module 122 and lantern ring 76 (Fig. 4-7) Between gas flowing, the sealant flowing between dispenser assembly 124 and lantern ring and is to and from sensor module 126 Signal with 128 transmits.

Power jack 92 is configured as receiving DC function from such as AC adapter 90 (Fig. 5-6) via switching power devices 100 Rate signal, or be configured as receiving AC power signal from such as calibration power socket (for example, 110VAC, 220VAC).

Input-output equipment 98 is configured as receiving from such as subject 12 (Fig. 4), sleep technical staff or sleep doctor Data, and data are provided to subject, technical staff or doctor.For example, equipment 98, which can be, to be allowed people's input data and shows The touch screen of registration evidence.Alternatively, equipment 98 may include individual input equipment 138, such as keyboard or card reader, Yi Jidan Only output equipment 140, such as display screen or card writer.Showing for the data of component models 74 can be input to via equipment 98 Example include program instruction and system configuration and system operating parameters for controller 134, such as pressure and temperature range with And threshold level.

Battery 110 is configured as storage energy, supplies power, and usually negative pressure for the component for component models 74 Sleep apnea therapy system 70 (Fig. 4-7) supplies power.Battery 110 can be the battery of any suitable type, such as nickel Cadmium cell, lithium ion battery or alkaline battery can produce any suitable output voltage (for example, in the range of 5-25VDC It is interior), and can be disposable or chargeable.In addition, battery 110 may include in the form of electrically coupled in series, electrically in parallel shape The more than one battery or battery unit that the form of formula or electrically coupled in series and electrically in parallel the two is coupled.In addition, working as battery When the electricity of storage or the size of voltage are reduced to power threshold or are lower than power threshold, battery 110 can be to such as controller 134 or input-output equipment 98 provide alarm (for example, alarm signal)；Alternatively, another component, such as controller 134, can be with It monitors battery capacity or voltage and generates such alarm.In addition, component models 74 may include for keeping inserting for battery 110 Hole.

Supplemental power source 112 is configured as generating energy, and to lead to for the component supply power for component models 74 Often power is supplied for negative pressure sleep apnea therapy system 70 (Fig. 4-7).For example, supplemental power source 112 may include spring And hand winding mechanism, subject 12 (Fig. 4) can rotate with wind spring, so as to the storage energy in wind spring；Spring It is configured as when it is unfolded, driven generator (is also included in supplemental power source), which is configured as generating power Signal.Alternatively, supplemental power source 112 may include automotive rolling mechanism, in response to the movement of supplemental power source, such as work as pendant The subject 12 for wearing system 70 when moving, wind spring；This automotive rolling mechanism can be similar to for wound on automatic Wind the traditional mechanism of the spring in table.Alternatively, supplemental power source 112 may include for the movement in response to supplemental power source And the mechanism of automatic driven generator；This mechanism can be similar to for driving the biography from the generator in supply power wrist-watch Unite mechanism.Supplemental power source 112, which can be configured as, is supplied directly to power supply source for the power signal generated by generator 114, or can be configured as using power signal generated to battery 110 or as the another of a part of supplemental power source The charging of one battery.

Power supply source 114 is configured as from jack 92 (via switching power devices 100), battery 110 and auxiliary power One or more reception power in source 112, and the power is converted into one or more electric currents and voltage, it is well-suited for it Itself, the power of any other component (Fig. 4-7) supply of the other component of module 74 and system 70.For example, power supply Source 114 can be configured as the power signal at sensing jack 92, and the sensing signal is converted to corresponding D/C voltage One or more DC power signals.It is received in power supply source from jack 92 in addition, power supply source 114 can be configured as It charges while power signal to battery 110 (and any battery in supplemental power source 112).Power supply source 114 can also To be arranged so that if it does not sense the power signal at jack 92, then it is by the power from supplemental power source 112 Signal is converted to one or more DC power signals, and using any extra power from supplemental power source (that is, higher than being Power level needed for the component supply power of sleep apnea therapy system 70), to (and the auxiliary power of battery 110 Any battery in source 112) charging.In addition, power supply source 114 can be configured so that if it does not sense jack 92 The power signal at place and it sense the underpower from supplemental power source 112 to meet the power demand of system 70, then Power signal from battery 110 is converted to one or more DC power signals by it, and uses appointing from supplemental power source What power charges the battery.Power supply source 114 can be or may include the power supply source of any suitable type, such as DC-DC converter, such as buck converter, boost converter or buck-boost converter.

Motor sub-assembly 116 includes one or more motors, and being configured to will be from the power signal shape in power supply source 114 The electric energy of formula is converted into the mechanical energy for driving one or more pumps of pump assembly 118.For example, motor sub-assembly 116 can wrap It includes any suitable electric motor, such as DC motor, brushless DC motor, has brush AC syncmotor or induction motor.In addition, motor Component 116 may include motor controller circuit, be used to be converted into being used to drive from the power signal in power supply source 114 Dynamic, rectification and the suitable signal of one or more for otherwise controlling one or more motors.In addition, motor sub-assembly 116 It may include one or more structures, be configured for cooling one or more motors, prevent or otherwise compensate by one The vibration that a or multiple motors generate, or the sound generated by one or more motors is eliminated, so that working as subject 12 During sleep, motor sub-assembly will not interfere he/her (Fig. 4).

Pump assembly 118 includes main pump 142, and main pump 142 is configured to while being driven by motor sub-assembly 116 in lantern ring 76 (pressure span combines Figure 14-below for each pressure span between the neck 50 (Fig. 4) of (Fig. 4-7) and subject 12 (Fig. 4) 21 further describe) in generate corresponding negative pressure, and including auxiliary pump 144, which is configured as independently of motor Component operation.For example, pump assembly 118 can be mechanically coupled to motor sub-assembly with for example one or more axis and transmission device 116.Main pump 142 can be any suitable fluid pump or compressor, such as impeller pump or piston pump.Also, with main pump 142 1 Sample, auxiliary pump 144 can be any suitable fluid pump or compressor, such as impeller pump or piston pump；But it is different from main pump, Auxiliary pump is configured to drive independently of motor sub-assembly 116.For example, auxiliary pump 144 may include that can be similar to above in conjunction with auxiliary The spring mechanism that power source 112 describes can manually or automatically coiling spring mechanism and can manually or automatically coiling bullet by this The driving of spring mechanism.Alternatively, auxiliary pump 144 may include self power generation mechanism and can be driven by the self generator mechanism, it should be certainly Generator mechanism can be similar to the self generator mechanism described above in conjunction with supplemental power source 112.

Pump assembly 118 is configured to engage master when power supply source 114 provides enough power to operate motor sub-assembly 116 Pump 142, and in power supply source do not provide enough power and engaged with to operate motor sub-assembly individually or together with main pump and is auxiliary Help pump 144.Therefore, pump assembly 118 is configured to generate in the case where the power not from power supply source 114 negative Pressure.

Pressure span of the pump assembly 118 between lantern ring 76 (Fig. 4-7) and subject's neck 50 (Fig. 4) is pumped to generate phase The air of negative pressure is answered to leave pump assembly via air outlet slit 102.

In addition, although depicted as including single main pump 142 and single auxiliary pump 144, but pump assembly 118 may include multiple masters Pump or multiple auxiliary pumps.

In addition, in order to reduce the amplitude of the negative pressure in pressure span than only by deactivating main pump 142 and auxiliary pump 144 Faster, pump assembly 118 may include the one or more pumps being pumped into air in pressure span for this reduction occurred.Alternatively, Motor sub-assembly 116 or pump assembly 118 can be configured to be driven in the reverse direction one or more of main pump 142 and auxiliary pump 144 to incite somebody to action Air is pumped into the amplitude for quickly reducing the negative pressure in pressure span in pressure span.

Pressure regulator assembly 120 and valve module 122 are configured to cooperate to the neck 50 (Fig. 4) of subject 12 (Fig. 4) Each of one or more pressure spans between lantern ring 76 (Fig. 4) provide corresponding negative pressure, and adjust this or Multiple pressure.Valve module 122 includes one or more valves, is configured to for one or more negative pressure to be directed to 76 (Fig. 4-of lantern ring 7) the corresponding pressure spans of one or more between neck 50 (Fig. 4), and pressure regulator assembly 120 include one or Multiple pressure regulators are coupled to valve and are configured to adjust the one or more negative pressure to corresponding stress level.Example Such as, one or more valves can be individually check valve, and air is allowed to flow from lantern ring 76 towards pump assembly 118.And one Or multiple pressure regulators can be individually mechanical open loop regulator.What the machinery open loop regulator made to be extracted out by pump assembly 118 More than suction needed for each of one or more negative pressure are maintained respective horizontal air level any air around Road.Alternatively, each pressure regulator can use anti-pump assembly 118 or motor sub-assembly 116 directly or by controller 134 Feedback, to adjust corresponding pressure by control pump power.In addition, one or more pressure regulators and one or more valves It can be by the network of suitable hose and coupler is coupled to each other and is coupled between lantern ring 76 and neck 50 pressure area Domain, hose and coupler can be a part of one or two of adjuster and valve module 120 and 122, or can be with These components separate.In addition, the pressure regulator of governor assembly 120 can be configured between detection lantern ring 76 and neck 50 Air leakage in pressure span, and divide near air-leak section directly or by 134 indicating sealing agent distributor 124 of controller With sealant, to attempt sealing leak.In addition, one or more of pressure regulator can be respectively configured to relevant pressure The amplitude of negative pressure in region is restricted to threshold pressure level, which has been confirmed as about subject's 12 Maximum safety margins.In addition, adjuster and valve module 120 and 122 can form part or all of quick repressurization component, The quick repressurization component is configured to rapidly remove by quickling increase the indoor pressure of one or more pressure to tested The neck 50 of person 12 applies negative pressure.This quick repressurization can be used for preventing the discomfort or injury of subject 12, and can be with By subject's (for example, passing through urgent or urgent button or voice command) activation manually, or can be by sensor in response to example Detect the cardiomotility of respiratory distress cacophonia or low blood oxygen level such as to trigger.And this quick repressurization may include stopping Only one or more of the pump of pump assembly 118 opens valve (for example, pop valve) or destroys neck 50 and one or more sealings Sealing between surface 94 is to allow surrounding air to enter one or more pressure spans, or takes one or more similar move Make.

Coating apparatus for sealant component 124 includes sealant reservoir 146, and is configured to distribute sealant from reservoir To on or near one or more sealing surfaces 94 (Fig. 5-6 and 14-15), for promoting, reinforcing and/or repairing sealing surfaces Gas-tight seal (Fig. 4) between the neck 50 (Fig. 4) of subject 12.For example, dispenser assembly 124 may include one or more Sealant pump, can be similar to one or two of pump 142 and 144 of pump assembly 118.In addition, dispenser assembly 124 can wrap One or more pumps or other structures are included, pressurizing reservoir 146 is configured as, (such as squeezes storage to reservoir applied force Device), by piston by sealant from reservoir release or take one or more similar actions, to convey from reservoir Sealant.In addition, dispenser assembly 124 can be coupled to storage via the network of suitable hose, coupler and injection nozzle Device 146 and lantern ring 76；These components can be a part of dispenser assembly or separate with dispenser assembly.

The sealant being maintained in reservoir 146 can be any suitable substance, such as liquid, gel, emulsifiable paste or bubble Foam forms flexible or rigid sealing element and does not stimulate the skin of subject；The example of this gel includes that siloxy group is solidifying Glue.In addition, second seal (Fig. 5-that sealant can be configured to be formed and be separated by the sealing element that sealing surfaces 94 are formed 6)。

For example, if the pressure regulator of component 120 or the pressure sensor of component 126 sense one in pressure span The leakage (describing below with reference to Figure 14-21) of a pressure span, then pressure regulator can be indicated directly or by controller 134 Dispenser assembly 124 is close in the one or more adjacent with pressure span with the sealant distribution that will remain in reservoir 146 It seals at or near surface 94 (Fig. 5-6 and 14-15).Lead to for example, pressure regulator can be configured as instruction dispenser assembly 124 It crosses and (is tied below for example, close in each sealant of the one or more sealing surfaces 94 adjacent with pressure span distribution nozzle Close Figure 15 description) sealant is continuously distributed, until pressure regulator detects that leakage has been slowed or stopped.Controller 134, Other one or more components of pressure regulator assembly 120 or component models 74 can be configured as with following a kind of or more Kind mode detects the leakage in pressure span: the speed for determining the pump in pump assembly 118 is more than threshold level, is determined by pump assembly The energy of 118 consumption or the heat of generation are more than threshold level, determine that by the flow level of pump assembly be more than flow or leakage Threshold value, or pass through the sky between detection sealing surfaces 94 part (Fig. 4) opposite with sealing surfaces with subject's neck 50 Between.

Pressure sensor assembly 126 is configured to generate (the figure of neck 50 in lantern ring 76 (Fig. 4) and subject 12 (Fig. 4) 4) the corresponding instruction (for example, feedback signal) of the pressure in each of one or more pressure spans formed between and to Controller 134 provides the corresponding instruction.For example, pressure sensor assembly 126 may include in each pressure span or Corresponding pressure sensor (for example, piezoelectricity vacuum transducer) in the air hose coupled with each pressure span.In response to this A little pressure instructions, controller 134 can be configured to control pump assembly 118, pressure regulator assembly 120 or valve module 122, will Pressure in each pressure span is maintained at level that is corresponding by programming horizontal or otherwise setting.In addition, if Controller 134 determines that one in pressure chamber has leakage, then controller can be configured to control coating apparatus for sealant component 124 To distribute sealant as described above to attempt sealing leak.In addition, if controller 134 has determined the pressure in pressure span More than threshold pressure level, such as secure threshold stress level, then controller can control pump assembly 118, pressure regulator group Part 120 or valve module 122 are to be maintained at secure threshold stress level for the pressure in pressure span or lower than secure threshold pressure It is horizontal.In addition, indicating that controller 134 can be implemented compacted in response to one or more pressure from pressure sensor assembly 126 Dynamic process, below with reference to as described in Figure 16-18.In other words, pump assembly 118, pressure regulator assembly 120, valve module 122, Pressure sensor assembly 124 and controller 134 form at least part of feedback loop, for keeping one or more pressure Corresponding pressure in each of region is in corresponding programmed range or in the range of otherwise setting；Substitution Ground can at least omit controller 134 from the feedback loop.In addition, pressure sensor assembly 126 can be configured to execute pressure At least some of the function of draught control mechanism component 120, and therefore could be configured as these functions and redundancy is provided.Substitution Ground, pressure sensor assembly 126 can be configured to execute some functions relevant to pressure, and pressure regulator assembly 120 It can be configured to execute other pressure correlation functions；For example, pressure regulator assembly 120 can be configured to prevent any pressure area Pressure magnitude in domain is more than secure threshold stress level, and pressure sensor assembly 126 can be configured to execute it is all its The relevant sensing function of his pressure.

Apnea degree sensor component 128 is configurable to generate subject 12 (Fig. 4) in his/her institute during sleep The instruction of the sleep apnea degree of experience simultaneously provides the instruction to controller 134.For example, apnea degree sensor group Part 128 may include one or more sensors, be configured to generate the instruction of the degree of air flue 14 (Fig. 1) opening of subject. In response to the instruction, controller 134 is configured to control pump assembly 118 or pressure regulator assembly 120 so as to tested to reduce The mode for the sleep apnea degree that person 12 is undergoing changes the pressure at least one pressure span.For example, if exhaling It inhales the degree that pause degree sensor component 128 indicates that the air flue 14 of subject is opened and is lower than target zone, then controller 134 is matched Control pump assembly 118 or pressure regulator assembly 120 are set to the negative pressure in change (for example, increase) at least one pressure span Amplitude, so as to increase subject airway open degree to make great efforts to drive airway open degree in target zone, The degree of the middle airway open for increasing subject, which may mean that, for example increases being blocked at it or being hindered originally for air flue Cross-sectional area at the position of plug.On the contrary, if apnea degree sensor component 128 indicates that the air flue 14 of subject is opened Degree be higher than target zone, then controller 134 be configured to control pump assembly 118 or pressure regulator assembly 120 with change The amplitude of negative pressure in (for example, reduce) at least one pressure span, so as to reduce subject airway open degree to exert Power drives airway open degree into target zone.That is, pump assembly 118, pressure regulator assembly 120, valve module 122, apnea degree sensor component 128 and controller 134 form at least part of feedback loop, with for maintain by In the target zone that the opening degree of the respiratory tract 14 of examination person is set in target zone by programming or otherwise, so as to Reduce the apnea degree (for example, to zero) that subject 12 undergoes；Alternatively, control can be at least omitted from the feedback loop Device 134 processed.Apnea degree sensor component 128 is further described below with reference to Fig. 9-13.

Memory 130 can be any suitable type volatibility (for example, DRAM, SRAM) or non-volatile (for example, EPROM, EEPROM, FLASH) memory circuit, be configured as storage configuration controller 134 execution program instruction, and by It is configured to other software, firmware and data that storage is used for system 70.It is used for for example, memory 130 can be configured as storage The one or more security threshold levels or other threshold levels of each pressure chamber store one or more apnea degree mesh Mark range, and one or more configurations or operating parameter (Fig. 4-7) of the storage for negative pressure sleep apnea system 70.This Outside, memory 130 can be configured as including look-up table (LUT) 148, and being configured as will be from apnea degree sensor group 128 received signal level of part is associated with apnea degree (for example, degree that the air flue 14 (Fig. 1) of subject is opened), As further described below with reference to Figure 13；Memory can be additionally configured to the expression of storage curve, which will come from and exhale The signal level for inhaling pause degree sensor component is associated with sleep apnea degree.

Temperature-controlling module 132 is configured to control one between lantern ring 76 (Fig. 4-7) and subject's neck 50 (Fig. 4) Or the relevant temperature of multiple pressure spans, for example, so that subject 12 (Fig. 4) comfortably, or reduce subject it is temporary in sleep-respiratory Stop the degree for the airway obstruction undergone during event or eliminates the air flue resistance that subject undergoes during sleep apnea event Plug.Component 132 can be configured as to be coupled to and strategically be placed on around lantern ring 76 (for example, inside or table in lantern ring 76 On face) one or more heating elements (for example, stratie) and cooling element (for example, thermoelectric cooling element), and And can be configured to be coupled to is also the one or more temperature sensors so strategically placed；It is the heating element, cold But element and temperature sensor may include that or can separate with temperature-controlling module in temperature-controlling module.In response to Instruction (for example, temperature signal) from such temperature sensor, temperature-controlling module 132 can be configured to will be corresponding Temperature in pressure span adjust to it is by programming or otherwise set within the temperature range of.Alternatively, component 132 can be with Be configured to provide the relevant temperature instruction of each pressure span to controller 134, controller 134 can be configured to control heating and Cooling element with the temperature in each pressure span is maintained to corresponding temperature within the scope of.In addition, temperature-controlling module 132 can It is to be coupled to the valve being strategically placed on around lantern ring 76, one or more pressure spans are open towards surrounding air, To help to control the indoor corresponding humidity of each pressure or temperature levels；These valves can be with formation temperature control assembly or valve module 122 a part, or can be separated with these components.This valve is further described below with reference to Figure 14-22.In addition, control Device 134 processed can be configured to adjust the temperature in one or more pressure spans, temporary with the sleep-respiratory for reducing subject's experience The degree stopped.For example, the air or skin in cooling one or more pressure span can make the airway muscle of subject nervous, This can open the air flue of subject in turn.Controller 134 can be configured to realize that feedback loop, the feedback loop adjust one Or the temperature in multiple pressure spans is to open the air flue of subject and keep its opening.The circuit can independently of feedback loop or With combinations of feedback loops, controller 134 is configured as that the feedback loop is accomplished by the following way: adjusting one or more pressure Negative pressure in region is opened with the negative pressure of minimum amplitude as far as possible and stays open the air flue of subject.In these feedback loops It is in independent situation, controller 134 has at least two variables, i.e. pressure and temperature, it is adjustable to open subject Air flue and keep the airway open of subject.Controller 134 and temperature-controlling module 132 can also be configured such that controller The temperature in the 134 adjustable regions in addition to pressure span, to reduce the degree of the sleep apnea of subject's experience.Example Such as, controller 134 can be configured as the temperature in one or more regions outside the pressurized zone for adjusting subject's neck, to subtract The degree of the sleep apnea of few subject's experience.In one embodiment, which can be at low or " shutdown " pump position, Unless or until detecting sleep apnea event, equipment pump is triggered at this time with " on " or higher power.In an embodiment party In case, regardless of any sleep apnea event sensed or sleep disturbance, which may have continuously being arranged.

Controller 134 may include processor, microprocessor, microcontroller or any other suitable instruction execution or non- Instruction execution computing machine and counting circuit, are configured as the component of control unit module 74 as described above, and also usually may be used To be configured to control one or more other components of sleep apnea system 70 (Fig. 4-7).Controller 134 can be matched It is set to and executes the program instruction of storage in memory 130, and will be deposited when executing and calculating or be otherwise determined Reservoir is used as working storage.

For example, controller 134, which can be configured as, operates sleep apnea system 70 with constant pressure mode.In the mould In formula, controller 134 is configured to starter motor component 116 and pump assembly 118, then in response to pressure sensor assembly 126 One or more pressure sensors indicate the pressure magnitude in one or more pressure spans at or greater than corresponding first threshold It is worth and deactivates motor sub-assembly and pump assembly.Next, one or more pressure sensors in response to pressure sensor assembly 126 refer to Show that the pressure magnitude in one or more pressure spans is equal to or less than corresponding second threshold, controller 134 can enable horse Up to component 116 and pump assembly 118, and per that can repeat the circulation when needed, (each second threshold can be lower than corresponding First threshold is to provide lag).In response to apnea degree sensor component 128 one or more sensors detect by Examination person 12 (Fig. 4) is undergoing apnea, such as airway obstruction, and controller 134, which can be configured as, increases by the first threshold Value or the first and second threshold values reach the level for preventing apnea, for example, removing obturator from air flue.Substitution Ground, controller 134 can be configured to for the negative pressure in one or more pressure spans to be maintained at first pressure threshold value and corresponding Between second pressure threshold value (including first pressure threshold value and corresponding second pressure threshold value), whether undergone but regardless of subject 12 Sleep apnea event.

In addition, controller 134 can be configured as in shutdown until apnea detection mode operates sleep apnea System 70.In this mode, controller 134 is configured as deactivating motor sub-assembly 116 and pump assembly 118, until apnea journey One or more sensors instruction subject 12 (Fig. 4) of degree sensor module 128 is undergoing sleep apnea event.So Afterwards, detect that sleep apnea event, controller 134 are configured as enabling motor sub-assembly in response to one or more sensors 116 and pump assembly 118, until the one or more sensors instruction subject of component 128 no longer undergoes sleep apnea thing Part.Next, controller deactivates motor sub-assembly 116 and pump assembly 118, until the one or more sensors of component 128 detect To next sleep apnea event.If controller 134 may be configured to the negative pressure in one or more pressure spans More than or equal to corresponding first maximum pressure threshold value, then motor sub-assembly 116 and pump assembly 118 are deactivated, but regardless of subject 12 Whether it is still experience apnea, and can be configured as and be less than or wait in response to the negative pressure in all pressure spans 116 He of motor sub-assembly is reactivated in the corresponding second maximum pressure threshold value smaller than corresponding first maximum pressure threshold value Pump assembly 118.

In addition, controller 134, which can be configured as, operates sleep apnea system 70 with low-high mode.In the mode In, controller 134 is configured to enable motor sub-assembly 116 and pump assembly 118, until the one of degree of pressure sensor module 126 A or multiple sensors indicate the amplitude of the negative pressure in one or more pressure spans be the first (higher) threshold value and second (compared with It is low) between threshold value, including the first (higher) threshold value and second (lower) threshold value.Then, in response to apnea degree sensor The one or more sensors of component 128 detect that subject 12 (Fig. 4) is undergoing sleep apnea event, controller 134 are configured as enabling motor sub-assembly 116 and pump assembly 118 until the one or more of degree of pressure sensor module 126 passes Sensor indicates that the amplitude of the negative pressure in one or more pressure spans is greater than or equal to corresponding first pressure threshold value, first pressure Force threshold is higher than corresponding second pressure threshold value.Next, one or more in response to sleep apnea sensor module 128 A sensor detects that subject 12 no longer undergoes the sleep apnea event being previously detected, and controller 134 is configured as Motor sub-assembly 116 and pump assembly 118 are deactivated, or otherwise reduces their output, until pressure sensor assembly 126 One or more sensors indicate each comfortable corresponding first threshold of the negative pressure in one or more pressure spans and the second threshold It include corresponding first threshold and second threshold between value.One or more in response to apnea degree sensor component 128 A sensor detects that subject 12 is undergoing another sleep apnea event, and controller 134 can repeat above-mentioned follow Ring.

In addition, controller 134 may be configured to the time in setting (for example, having passed through input equipment 88 in a people The time of 1/2 hour before being programmed into the wakeup time in system 70 or another setting) or in response to environment light Increase in each pressure span that (for example, instruction as morning) changes in (for example, reduction) one or more pressure spans Pressure amplitude, with help subject 12 (Fig. 4) revive or in response to from apnea levelness sensor component 128 The instruction that subject is reviving changes (for example, reduction) pressure size.For example, controller 134 can be programmed or with other Mode configures, to start to change the phase in each pressure span in one or more pressure spans at the beginning of can set Pressure is answered, and is controlled according to the pressure characteristic of the duration set terminated in the dwell time that can be set set One or more pressure, wherein pressure characteristic may include within the duration that can be set linearly or otherwise monotonously Change one or more pressure, and wherein pressure characteristic can be common, Huo Zheqi for one or more pressure spans In may exist multiple pressure characteristics, each pressure characteristic with one or more the respective sets of pressure span it is associated.As herein Used, " characteristic " is quantity (such as pressure) expression of the curve graph or curve graph of variation over time.And quantity can To have the unit of such as amplitude, phase, concentration, amplitude variation, phase change and concentration variation.In addition, " characteristic " can wrap It includes for the use of sleep apnea system 70 itself or the parameter of function, or may include sleeping for subject 12 (Fig. 4) Dormancy feature, or other parameters relevant to subject, such as the identity characteristic of subject, the diet of subject and subject Workout scheme.Alternatively, instead of the dwell time that can be set, controller 134 can be in each of one or more pressure Individually stop changing one or more pressure when more than outage threshold, or can be in any one in one or more pressure Stop changing one or more pressure in the about the same time when a pressure is more than outage threshold.Also, if in the wake-up Controller 134 determines that subject 12 (Fig. 4) is still within sleep state after the duration of process, then controller can return The sleep apnea of subject is treated in the above described manner.

In addition, system 70 generates one or more for treating sleep although describing the wakeup process in conjunction with system 70 The negative pressure of apnea, but the wakeup process can modify for system (such as CPAP system), to generate one kind Or a variety of positive pressures are to treat sleep apnea.In addition, controller 134 can be for the original in addition to waking up subject 12 Because realizing the process.

Referring still to Fig. 8, it is contemplated that the alternate embodiment of component models 74.For example, module 74 can be omitted above-mentioned component Any one or more of, or may include one or more other components.In addition, one or more of above-mentioned function It can be executed by one or more components other than operating affiliated one or more components.In addition, at least controller 134 can use the sub-portfolio of software, firmware, the combination of hardware or software, firmware and hardware or any software, firmware and hardware It realizes.

Fig. 9 is a part according to the apnea degree sensor component 128 of Fig. 8 of an embodiment, subject 12 The figure of the cross section of the neck 50 (Fig. 4) and air flue 14 (Fig. 1) of (Fig. 4)；Although neck be shown as with circular cross section and Air flue is shown as with circular cross section, but neck and air flue can respectively have other corresponding cross sections.

Sensor module 128 includes energy wave transmitter receiver 160, is configured as passing towards neck 50 and air flue 14 Defeated energy wave, to receive the part for the transmission energy wave for redirecting (for example, reflection) by the region on the surface 162 of the wall of air flue, And in response to the part of received energy wave determine the degree of airway open, or provide and received to controller 134 The relevant information in energy wave part, so that controller 134 can determine the degree of airway open.Alternatively, sensor module 128 can determine the degree that air flue 14 collapses, or provide information, and controller 134 is allowed to determine the degree of Airway Collapse. For example, sensor module 128 or controller 134 can be used the redirection part of received energy wave determine air flue 14 Dimension D, wherein the value of D corresponds to the degree of airway open (or collapsing).That is, the value of D is bigger, what air flue 14 was opened Degree is higher (degree of Airway Collapse is lower), and the value of D is smaller, and the degree of airway open is lower, and (degree of Airway Collapse is got over It is high)-hereinafter, the degree for determining airway open is only described, it should be understood that corresponding description can also be used for determining Airway Collapse Degree.Alternatively, sensor module 128 or controller 134 can be used the redirection part of received energy wave determine The more than one size of air flue 14, or obtain the image of air flue and one or more air flue rulers are determined according to the image of acquisition It is very little.

Transmitter receiver 160 can be configured to any conjunction that the surface 162 of transmission air flue 14 at least partly redirects The energy wave of suitable type.For example, transmitter receiver 160 can be configured as transmitting acoustics ultrasonic wave, such as in conventional Ultrasound Acoustics ultrasonic wave or micro-impulse radar wave used in wave machine.Connect in addition, transmitter receiver 160 can be configured to transmitting The energy wave of continuous energy wave, pulse energy wave or any other suitable type.

Transmitter receiver 160 may include multiple transmitters and receiver, to obtain the entire cross section of air flue 14 " image ", or may include a less or transmitter for the scanning of sensor module 128 to cover the cross section of entire air flue, with And the less or receiver that sensor module scans in a similar manner, wherein sensor module can be mechanically or electronically (for example, wave beam such as to use phased-array radar to be formed) scanning transmitter or receiver.If transmitter receiver 160 includes Multiple transmitters or receiver, then these can be strategically located on lantern ring 76 (Fig. 4-7) inside or surface or in portion The different location of (Fig. 4-8) in part module 74.The example of suitable transmitter and suitable receiver includes energy converter, such as is pressed Electric transducer once can be used as receiver at another time as transmitter.

Sensor module 128 or controller 134 are configured to one by analysing energy wave in any suitable manner Or multiple received time delay (for example, time relative to wave transmission), phase (examples for redirecting each of part Such as, relative to the phase of transmission), frequency spectrum (for example, frequency spectrum relative to transmitted wave), waveform is (for example, the wave relative to transmitted wave Shape), one or more of power (for example, power relative to transmitting) and amplitude (for example, amplitude relative to transmitted wave) Determine the dimension D of air flue 14, it is described in any suitable manner for example, the sound wave sent with ultrasound machine analysis connects The mode of the redirection part of receipts, redirection part are redirected by the interior tissue of subject.

Figure 10 is according to a part of the apnea degree sensor component 128 of Fig. 8 of another embodiment and tested The figure of the cross section of the neck 50 (Fig. 4) and air flue 14 (Fig. 1) of person 12 (Fig. 4)；Although neck is shown as with circular cross section And air flue is shown as with circular cross section, but neck and air flue can respectively have other corresponding cross sections.

Sensor module 128 includes energy wave launcher 164 and energy wave receiver 166, and energy wave launcher 164 is matched It is set to air flue 14 and transmits energy wave, energy wave receiver 166, which is configured as receiving, penetrates being emitted for neck 50 and air flue 14 Energy wave one or more parts and be configured to respond to received energy wave part determine the journey of airway open Degree, or by the relevant information in the part of received energy wave be supplied to controller 134, allow controller to determine gas The degree that road is opened.For example, sensor module 128 or controller 134 can be used the part of received energy wave determine The dimension D of air flue 14, wherein the value of D corresponds to the degree of airway open.That is, the value of D is bigger, the journey that air flue 14 is opened Degree is higher, and the value of D is smaller, and the degree of airway open is lower.Alternatively, sensor module 128 or controller 134 can be used The part of received energy wave determine the more than one size of air flue 14.

Transmitter 164 can be configured to transmit the energy wave of any suitable type, can be at least partially through neck 50 first part between transmitter and air flue 14 passes through air flue, and across the air flue of neck and receiver 166 Second part.For example, transmitter 164 can be configured to transmitting X-ray wave (such as used in typical X-ray machine) or scarcely perceptible pulse Rush radar wave.In addition, transmitter 134 can be configured to transmitting Continuous Energy wave, pulse energy wave or any other suitable type Energy wave.

Transmitter 164 may include multiple transmitters, and receiver 166 may include multiple receivers, so that sensor group Part 128 can get " image " of the entire cross section of air flue 14.Or transmitter 164 may include what sensor module 128 scanned A less or transmitter is to cover the entire cross section of air flue 14, and receiver 166 may include sensor module with similar The less or receiver that mode scans, wherein sensor module is mechanically or electronically (for example, such as to use phased array The wave beam that radar is formed) scan transmitter or receiver.If transmitter 164 includes that multiple transmitters or receiver 166 wrap Multiple receivers are included, then these can be strategically located on lantern ring 76 (Fig. 4-7) inside or surface or in component models Different location in 74 (Fig. 4-8).

Sensor module 128 or controller 134 are configured to being connect by analysing energy wave in any suitable manner The time delays (for example, time relative to wave transmission) of each of one or more parts of receipts, phase are (for example, phase For the phase of transmission), frequency spectrum (for example, frequency spectrum relative to transmitted wave), waveform (for example, waveform relative to transmitted wave), One or more of power (for example, relative to transmitting, power) and amplitude (for example, amplitude relative to transmitted wave) determine Dimension D, it is described in any suitable manner for example, with x-ray equipment analysis by the x-ray wave of transmission received part Mode.

Figure 11 is a part and Fig. 4 according to the apnea degree sensor component 128 of Fig. 8 of another embodiment The figure of subject 12.

Sensor module 128 includes energy wave receiver 168, be configured as receiving one generated by subject 12 or One or more parts of multiple energy waves, and be configured to determine that the air flue 14 of subject in response to institute it is received one or Multiple energy wave parts and the degree (Fig. 9-10) opened, or provided and the received one or more energy of institute to controller 134 The relevant information in wave part is measured, controller is allowed to determine the degree of airway open.For example, sensor module 128 or control Device 134 can be used received one or more energy wave parts determine the dimension D (Fig. 9-10) of air flue 14, wherein D Value corresponds to the degree of airway open.That is, the value of D is bigger, the degree that air flue 14 is opened is higher, and the value of D is smaller, The degree of airway open is lower.Alternatively, the received one or more of institute can be used in sensor module 128 or controller 134 Energy wave part determines the more than one size of air flue 14.

Energy wave receiver 168 can be configured as the energy wave for receiving any suitable type that subject 12 generates.Example Such as, receiver 168 can be configured as reception sound wave, such as when subject 12 issues breathing (for example, breathing or snoring sound) When the sound wave that generates, the interference in light wave, for example, when subject (even if when the eyes are occluded) it is mobile he eyes or another The interference in light wave generated when physical feeling (for example, nose, mouth, chin or lower jaw) or electromagnetic wave, such as E.E.G or the heart Dirty wave (for example, electrocardiagraphic wave).

Sensor module 128 may include multiple receivers 168, so as to pick up the head zone from subject 12, neck The energy wave issued from anywhere in around portion region or other regions, or may include sensor module mechanically or electrically A less or receiver of (for example, wave beam such as to be formed with phased-array radar) scanning.If sensor module 128 includes Multiple receivers 168, then these receivers can be strategically located in that lantern ring 76 (Fig. 4) is internal or surface on or component models At different location in 74 (Fig. 4-8).In addition, one or more receivers 168 can be directed toward subject's neck of subject with Outer region (for example, head, chest).

Sensor module 128 or controller 134 are configured as the received energy wave part by analyzing in a usual manner One or more of each of one or more of phase, frequency spectrum, waveform, power and amplitude and then use Such as Fig. 8 look-up table 148 or matched curve by the result of the analysis it is associated with the degree that air flue 14 (Fig. 9-10) is opened come Determine dimension D.Exploitation is described below with reference to Figure 13 and using the process of this correlation.

Figure 12 is a part and Fig. 4 according to the apnea degree sensor component 128 of Fig. 8 of another embodiment The figure of subject 12.

Sensor module 128 includes biological condition sensor 170, is configured as the one or more of sensing subject 12 Biological condition, and it is configured to determine that biological condition of the air flue 14 (Fig. 9-10) in response to one or more sensing of subject The degree of opening, or information relevant to one or more biological conditions of sensing is provided to controller 134, so that controller It can determine the degree of airway open.For example, sensed one or more can be used in sensor module 128 or controller 134 A biological condition determines the dimension D (Fig. 9-10) of air flue 14, and wherein the value of D corresponds to the degree of airway open.That is, The value of D is bigger, and the degree that air flue 14 is opened is higher, and the value of D is smaller, and the degree of airway open is lower.Alternatively, sensor One or more biological conditions for being sensed can be used to determine the more than one of air flue 14 in component 128 or controller 134 Size.

Sensor 170 can be configured as the biological condition of any suitable type of sensing subject 12.This biology shape The example of condition includes that respiratory rate, heart rate, blood glucose level, blood oxygen level, blood Adrenaline Level, body temperature, body perspire water Flat, body cortisol levels (cortisol in subject's sweat), body kinematics level (such as sensor may include adding Speedometer), blood pressure, expiration gas ingredient and body part position (for example, chin portion, the degree that subject oral cavity is opened, or The degree that subject nostril is opened).

Sensor module 128 may include multiple biological condition sensors 170, so as to sense multiple lifes of subject 12 Object situation, and one or more sensors can be strategically located in the inside or (removably or fixed of lantern ring 76 (Fig. 4-7) Ground is attached to) on surface, in component models 74 (Fig. 4-8) or even on the body of subject or in the body of subject Various positions, in this case, each such sensor can be with conducting wire or other suitable connector families in component In module 74 (Fig. 4-8), or can wirelessly it be connected to the base portion of sensor module 128.For example, sensor module 128 can To be configured as the movement of monitoring sleep subject 12 using one or more motion sensors.The one or more sensing Device can be on collar assemblies 72 (for example, one or more accelerometers), or can be far from collar assemblies (for example, attached It is connected to the limbs of subject or the accelerometer of trunk or long-range imager, for example, low light or IR camera or micropulse thunder Up to).Its measured value can be transmitted to a part of sensor module 128 by the sensor far from collar assemblies 72, the part without Line or be located on collar assemblies (on-board the collar assembly) by one or more signal cables.It rings The reading that Ying Yu is provided by such a or multiple sensors, controller 134 can explain the overexercise (example of subject 12 Such as, jolt or frequent postural change) or lack movement (for example, excessively static) as subject's experience sleep apnea It indicates.

Sensor module 128 or controller 134 are configured to by analyzing one or more institutes in any suitable manner One or more parameters of each of the biological condition of sensing, and then using the look-up table 148 of such as Fig. 8 or deposit Storage matched curve in memory 130 is determined the result of the analysis is associated with the degree that air flue 14 (Fig. 9-10) is opened Dimension D.Below with reference to Figure 13 description for develop and using this correlation process.

Referring to Fig. 8-12, it is contemplated to the alternate embodiment of apnea degree sensor component 128.For example, sensor Component 128 may include energy wave transmitter receiver 160, energy wave launcher 164, energy wave receiver 166 and 168 and life Any combination or sub-portfolio of one or more of each of object condition sensor 170.

Figure 13 be according to an embodiment for by one or more biological conditions (for example, Figure 12) of subject 12 with The flow chart 180 of the associated process of the degree for the sleep apnea that subject is undergoing.For example, the process can be by one A or multiple biological conditions are associated with the degree that the air flue 14 (for example, Fig. 9-10) of subject is opened, the airway open journey It spends associated with the degree for the sleep apnea that subject is undergoing.Below in the example in conjunction with the description of flow chart 180, Associated biomolecule situation is the respiratory rate of subject 12, it should be understood that by the apnea degree described above in conjunction with Fig. 8-12 Any one or more other biological situations of any embodiment sensing of sensor module 128 can be in a similar way It is associated.In addition, sleep doctor or sleep technical staff can carry out this phase to subject 12 in sleep laboratory setting Guan Xing, and then, for example, using correlation-data structure to the look-up table of subject's sleep apnea therapy system 70 (LUT) 148 (Fig. 8) are programmed, or are utilized biological condition matched curve associated with sleep apnea degree Expression is programmed the memory 130 (Fig. 8) of system.Alternatively, the system 70 of subject or the laboratory version of system can To execute the process with the help of being with or without sleep medicine professional or subject 12.

In step 182, a people, such as sleep technical staff, the air flue of monitoring subject subject 12 (Fig. 4) during sleep The degree that 14 (Fig. 9-10) are opened.For example, can as described in above in association with Fig. 9, be monitored using ultrasound one of air flue 14 or Multiple dimension Ds (Fig. 9-10).Ultrasonic wave and obtained ultrasound image can be treated by the apnea described above in conjunction with Fig. 9 The embodiment of system 70 generates, or can be generated by independent ultrasound machine.

Simultaneously in step 184, one or more biological conditions of subject 12 (Fig. 4) are also monitored, are slept with subject When subject the degree opened of air flue 14 (Fig. 9-10) it is related.For example, can monitor subject's Breathiness (for example, breathing, Snoring) volume or frequency spectrum, or as in this example, monitor the respiratory rate of subject.

Then, continue one suitable time (for example, small in the 2-8 of subject during sleep in execution step 182 and 184 When) after, in step 186, by beating for each of one or more biological conditions monitored and air flue 14 (Fig. 9-10) It is associated to open degree.For example, can will be digitized in the observed value of the respiratory rate of the subject in corresponding sampling time, it will be The observed value of the opening degree of the experimenter's air flue 14 in identical corresponding sampling time digitizes, and will be in the corresponding sampling time Each value of the respiratory rate of acquisition is matched with the corresponding airway open degree obtained in the identical corresponding sampling time.This Outside, in some cases, the correlation of prediction can be exported.For example, it may be determined that in the air flue 14 of induction closure subject 12 Apnea before a period of time (for example, two minutes long) during, the AD HOC of Breathiness usually air flue be closed Before.Therefore, this correlation can be used for preemptively being applied to negative pressure the selected one or more of subject's neck 50 Region, to prevent its breaking-out before sleep apnea event occurs.

Next, generating corresponding data structure in step 188, each biological condition and airway open degree are indicated Between correlation.

For example, can be generated indicates that the digital value of respiratory rate is related to the respective digital value of airway open degree The data structure of property, and the data structure is stored in LUT 148 (Fig. 8).That is, can be by each of respiratory rate Value is associated with the appropriate address of LUT 148, and at each address, and storage corresponds to breathing speed associated with the address The airway open degree of the value of rate.

When apnea degree sensor component 128 (Fig. 8 and 12) provides the digital value of subject's respiratory rate, exhale Inhale rate value to address translator (this converter can be a part of component 128, can be component models 74 it is any its A part of his component, or can be the separate part of component models) value is converted to the address of LUT 148.And it passes The position of the LUT 148 of sensor component 128 or controller 134 from the address obtains the corresponding value of airway open degree, and Pump assembly 118 (Fig. 8), pressure regulator assembly 120 or valve module 122 are controlled using the value of the airway open degree, so as to Control the level of the sleep apnea experienced of subject 12.For example, if the airway open degree that is obtained from LUT 148 Value is lower than apnea horizontal target range that is programming or otherwise setting, then sensor module 128 or controller 134 can be used for increasing airway open degree towards target zone；On the contrary, if the value of the airway open degree obtained from LUT Higher than apnea horizontal target range, then sensor module 128 or controller 134 can be used for reducing gas towards target zone Road opening degree or maintenance air passage opening degree are horizontal at present at it.

Alternatively, the respective digital value of the digital value of respiratory rate and air flue opening degree can be fitted to song Line, and in memory 130 (Fig. 8) by the expression of curve storage.

When apnea degree sensor component 128 (Fig. 8 and 12) provides the digital value of subject's respiratory rate, control The value is converted to the respective value of airway open degree using the expression of matched curve by device 134 processed, and uses the airway open The value of degree controls pump assembly 118 (Fig. 8), pressure regulator assembly 120 or valve module 122, to control subject 12 The level of sleep apnea experienced.For example, will be beaten according to respiratory rate value and air flue if matched curve is straight line The mathematic(al) representation for opening degree value definition wires stores in memory 130, and controller 134 is counted using the mathematic(al) representation Calculate airway open degree corresponding with provided respiratory rate value.Therefore, if the airway open obtained from matched curve The value of degree lower than programming or the apnea horizontal target range that otherwise sets, then sensor module 128 or Controller 134 can be used for increasing towards target zone the airway open degree；On the contrary, if the air flue obtained from matched curve The value of opening degree is higher than apnea horizontal target range, then sensor module 128 or controller 134 can be used for towards mesh Marking range reduces airway open degree, or airway open degree is maintained at its current level.

Referring still to Figure 13, it is contemplated that by the alternate embodiment for the process that flow chart 180 indicates.Such as, it is convenient to omit Any one or more of described step 182-188, and other one or more steps can be added.In addition, any institute Stating step can manually perform by computing device or by any other suitable device.

Figure 14 is according to the plan view of the interior section of the lantern ring 76 of Fig. 4-7 of an embodiment, including two sealings The a part on surface 94 and a part of vacuum surface 96." interior section " is a part of finger sleeve ring 76, be configured to by Neck 50 (Fig. 4) towards subject 12 (Fig. 4) when examination person wears sleep apnea therapy system 70.

Sealing surfaces 94 be individually configured to contact subject 12 neck 50 (Fig. 4) corresponding portion (Fig. 4), and with phase The neck contacted answered forms corresponding gas-tight seal.

And vacuum surface 96 be configured to sealing surfaces 94, the contact portion of neck 50 and subject's neck with it is true The opposite part in empty surface is formed together negative pressure region 200, and vacuum surface is referred to as pressure surface, and negative pressure region It is properly termed as vacuum area, pressure chamber or vacuum chamber.Below with reference to as described in Figure 16-22, lantern ring 76 may include frame, so that very At least part on empty surface 96 does not contact the neck 50 of subject.

Each sealing surfaces 94 can be rigid, is semirigid or flexible, and can be by any suitable sealing Material is formed, such as is formed by plastics, rubber, foam or silicone resin.

Vacuum surface 96 is also possible to rigid, semirigid or flexible, (such as can be moulded by any suitable material Material, rubber, foam or silicone resin) it is formed, and including groups of one or more entrance openings 202 and one or more groups of A exit opening 204；The entrance and exit can be positioned relative to each other with any suitable mode, and be can have and appointed What right dimensions and shapes.In addition, nozzle, check valve or other suitable components may be provided at one in opening 202 and 204 In a or multiple.

One or more entrance openings 202 be configured so that air can be flowed through from the exterior section of lantern ring 76 one or Multiple inlet valves (describing below with reference to Figure 16-22), by one or more entrance openings, and enter negative pressure region 200, " exterior section " is a part of finger sleeve ring 76, which is configured to wear sleep apnea therapy system in subject 12 Away from the neck 50 (Fig. 4) of subject 12 when 70 (Fig. 4-7).Hose and coupler in lantern ring 76 can be by one or more entrances Opening 202 is coupled to one or more inlet valves.In addition, these hoses and coupler, one or more inlet valves and one Or some or all of multiple entrance openings 202 are considered a part (Fig. 8) of valve module 122.

And one or more exit openings 204 be configured so that air can be flowed through from negative pressure region 200 one or Multiple exit openings, by valve module 122 (Fig. 8) and pressure regulator assembly 120 (Fig. 8), pass through pump assembly 118 (Fig. 8), simultaneously It is flowed out by outlet valve 102 (Fig. 4-8).Hose and coupler in lantern ring 76 can couple one or more exit openings 204 To valve and pressure regulator assembly 120 and 122 (Fig. 8).In addition, these hoses and coupler and one or more exit openings Some or all of 204 are considered a part (Fig. 8) of valve module 122.

Allow air flow through negative pressure region 200 for subject 12 (Fig. 4) may than in the presence of no entrance opening 202 more Comfortably, because of none or multiple entrance openings, the air in pressure span may become hot or due to subject perspire and Humidity, and " not flowing " may be become.Even if negative pressure sleep apnea therapy system 70 (Fig. 4-7) may include temperature control Component 132 (Fig. 8) processed can also be reduced or eliminated with the cooling air in pressure span 200, said flow to this cooling Needs, therefore the energy of system consumption can be reduced, and the cooling energy by omitting temperature-controlling module can be made it possible to Power reduces the cost of system.

Referring still to Figure 14, it is contemplated that the alternate embodiment of sealing surfaces 94 and vacuum surface 96.For example, although showing To be arranged parallel to each other, but sealing surfaces 94 can be arranged relative to one another with any other suitable orientation.In addition, lantern ring 76 may include the sealing surfaces 94 and more than one vacuum surface 96 fewer of more than two.In addition, one or more close Envelope surface 94 can respectively increase the strong of the sealing that each surface and neck 50 are formed including one or more exit openings 204 It spends (Fig. 4).In addition, one or more parts of sealing surfaces 94 and one or more parts of vacuum surface 96 can be it is same The a part on surface.In addition, the part of the corresponding pressure span 200 of formation of vacuum surface 96 can be completely or partially by one (if be partly surrounded, a part of of vacuum surface can be by with subject's for a or multiple encirclements of sealing surfaces 94 The part (Fig. 4) opposite with the hermetic unit of vacuum surface of neck 50 formed it is gas-tight seal and formed sealing around pressure The rest part in region).In addition, one or more sealing surfaces 94 and one or more vacuum surfaces 96 and subject's neck 50 The gas-tight seal portion to form pressure span 200 that the corresponding portion of (Fig. 4) is formed can prolong only partially about pressure span It stretches；For example, this can eliminate the needs to entrance opening 202, because pump assembly 118 (Fig. 8) can not having by pressure span Have to form the side in gas-tight seal portion sucking outside air.In addition, one or more sealing surfaces 94 can respectively include one or Multiple exit openings 204, this makes each sealing surfaces that negative pressure is able to use to form sealing against subjects skin.One Or multiple sealing surfaces 94 can respectively include the array of the isolated exit opening 204 of tight spacing, or may include porous table Face.Exit opening 204 or hole in one or more sealing surfaces can be coupled to by manifold or plenum chamber pump (for example, its Belong to pump assembly 118, pressure regulator assembly 120 or valve module 122), it is used to provide negative pressure, so that sealing surfaces be made to adhere to On a user's skin.The one or more pressure-reduction levels for forming one or more sealings can be with one or more pressure One or more pressure-reduction levels in region 200 are different.Alternatively, it is used to form the stress level of sealing and in adjacent pressure Stress level in power region 200 can be identical；For example, exit opening/hole manifold of maintenance sealing surfaces 94 can be with Exit opening/hole is connected to adjacent pressure span, without individually pumping.

Figure 15 is the plan view according to a part of the sealing surfaces 94 of an embodiment.

The part of the sealing surfaces 94 of Figure 15 is similar to the part of the sealing surfaces 94 of Figure 14, unlike, Figure 15's is close The a part for sealing surface includes one or more sealant distribution openings 210.

Each sealant distribution opening 210 is configured to spray sealant from the sealant dispersed components thereof 124 of Fig. 8, wherein Sealant is configured as strengthening or repairing the leakage in gas-tight seal portion, and sealing surfaces 94 are configured to the neck 50 with subject 12 The a part (Fig. 4) of (Fig. 4) forms the gas-tight seal portion, above in conjunction with as described in Figure 14.For example, sealant can repair by Shape around the lock of (Fig. 4) between sealing surfaces 94 and the neck 50 of subject or more thread hairs in examination person's hair At leakage.In addition, nozzle, check valve or other suitable components may be provided in one or more openings 210.In addition, set Hose and coupler in ring 76 (Figure 14) can distribute one or more sealants to opening 210 and be coupled to coating apparatus for sealant group Part 124 (Fig. 8)；Some or all of these hoses and coupler and one or more sealant distribution openings can be recognized For a part for being coating apparatus for sealant component.In addition, one or more sealants distribution openings 210 can have it is any suitable Size and shape, and can along sealing surfaces 94 at any suitable spacing with any suitable Pattern localization.In addition, Opening 210 can be Chong Die with the edge 212 of sealing surfaces 94, so that a part of sealant distribution opening is formed in sealing surfaces In, and another part is formed in adjacent vacuum surface 96 (Figure 14).Alternatively, opening 210 may be formed entirely in vacuum meter In face 96, for example, close to the edge 212 of sealing surfaces 94.

In the operation according to the sleep apnea system 70 (Fig. 4-7) of an embodiment, if such as controller 134 (Fig. 8) detects the leakage in pressure span 200 (Figure 14), then controller can make the edge coating apparatus for sealant component 124 (Fig. 8) Sealing surfaces 94 a part via one or more sealants distribution opening 210 from reservoir 146 (Fig. 8) distribute seal Agent, a part of sealing surfaces 94 form pressure span or otherwise form the boundary of pressure span.For example, controller 134 can make coating apparatus for sealant component 124 distribute sealant from an opening 210 in sealing surfaces 94 each time, until Controller detects that leakage is sealed.

Referring still to Figure 15, it is contemplated that alternate embodiment.Although for example, only describe a sealing surfaces 94, Multiple sealing surfaces may include one or more sealant distribution openings 210.In addition, coating apparatus for sealant component 124 (Fig. 8) It can be configured to selectively distribute from sealant distribution opening one or more of 210 but be not all of at any time close Seal agent.In addition, if opening 210 include nozzle, then coating apparatus for sealant component 124 can before distributing sealant, simultaneously Or position nozzle along preferential direction.

Figure 16 is the view according to a part 220 of the lantern ring 76 of Fig. 4-7 and 14 of an embodiment.

Figure 17 is the collar portion 220 and subject's neck intercepted according to the line A-A along Figure 16 of Figure 16 of an embodiment The cross-sectional view of the intermediate region of the part 222 and air flue 14 in portion 50.

Figure 18 is according to the collar portion 220 of Figure 16 of an embodiment and the part 222 of subject's neck 50 and air flue The cross-sectional view of 14 end regions.

With reference to Figure 16-17, lantern ring 76 includes one or more sections 224, is exhaled when subject 12 (Fig. 4) wears negative pressure sleep When inhaling pause treatment system 70 (Fig. 4-7), section 224 is configured fixed about on the circumferential direction around subject's neck 50 Position.

Each section 224 is formed by the corresponding rigidity or semirigid portion 226 of frame 228.Each frame part 226 has There is curved shape, and can be made of any suitable material, such as is made of plastics, metal or gauze.

Each frame part 226 is attached with the corresponding portion of vacuum surface 96 (above in conjunction with such as Figure 14 description), and The corresponding portion of outer cover 230, outer cover 230 can be made of any suitable material (for example, plastics or cloth). Any suitable attachment technology (such as bonding or glued) can be used, vacuum surface 96 and outer cover 230 are attached to frame On frame part 226.

Each frame part 226 is attached to by any suitable attachment technology (such as welding, combination, bonding or gluing) Adjacent frame part at corresponding connector 232.Alternatively, frame 228 can be made of a component, so that frame part 226 It is integral with one another.Alternatively, connector 232 for example can with hinge flex be coupled.

Corresponding sealing surfaces 94 (combining Figure 14-15 to describe above) are arranged along each connector 232.

When lantern ring 76 is worn by subject 12 (Fig. 4), sealing surfaces 94 engage the corresponding portion of the neck 50 of subject 234, to form pressure span 200, in this example, each collar segments 224 have a pressure span.

Each collar segments 224 further include corresponding inlet valve 238, make pump assembly 118 (Fig. 8) can be by outside air Corresponding pressure span 200 is sucked, as described in above in association with Figure 14.

For clarity, times being arranged in the lantern ring 76 as described in above in association with Fig. 8 and 14-15 is omitted in Figure 16-18 What hose and coupler.

With reference to Figure 18, the cross section of the end regions of lantern ring 76 is similar to the middle area of the as above lantern ring in conjunction with described in Figure 17 The cross section in domain still increases section terminator 240.

Terminator 240 is configured to form gas-tight seal portion in the end of collar segments 224, and can be by any suitable Rigidity or semi-rigid material be made, such as be made of plastics, metal or silk screen.

Sealing surfaces 94 extend along the bottom of terminator 240, and are configured to be formed with the part 242 of neck 50 airtight Sealing, and the curved top portion of terminator is connected to vacuum surface 96 along seam 244 with any suitable air tight manner.

Alternatively, terminator 240 can be directly attached to corresponding frame part 226, or can be with frame part one Body is formed or the component part of frame 228 as a whole.

Referring to Figure 16-18, in the operation according to the sleep apnea therapy system 70 (Fig. 4-7) of an embodiment, Pump assembly 118 (Fig. 8) is configured to be present in negative pressure in negative pressure region 200 and extracting air out from these regions；But Inlet valve 238 enables air to flow into negative pressure region, but the power of pump assembly overcomes the air-flow to produce in negative pressure region Raw negative pressure.In addition, the negative pressure in region 200 can be the same or different from each other.

Because the pressure outside lantern ring 76 is greater than the pressure in pressure span 200, outside air is effectively pressed against frame Sealing surfaces 94 are pressed against on neck 234 and 242 corresponding gas-tight seal to be formed by frame 228, frame 228 again.Alternatively, from another On the one hand it sees, frame 228 effectively " is sucked " on neck 50, so that sealing surfaces 94 are compressed against corresponding 234 He of neck On 242.This effect may be used as the principal organ of the neck 50 for collar assemblies 72 to be connected to subject 12, therefore, Collar assemblies can be made not need through belt or by reliably connecting entirely around neck with subject.Such lantern ring Component 72 can generally utilize the negative pressure of " grasping " level of appropriateness in one or more pressure spans 200, the level Negative pressure is enough on the neck 50 that collar assemblies are held against to subject, but too weak and cannot significantly open his/her Air flue 14；And the amplitude that collar assemblies can according to need the negative pressure in the one or more pressure spans of increase is tested to open The air flue 14 of person, or airway open is kept, to prevent apnea, or prevent apnea.

In addition, because frame 228 and terminator 240 is rigid or semirigid, frame part 226 and terminator Keep vacuum surface 96 far from the part 246 of the neck 50 covered by frame part.Therefore, the negative pressure in region 200 can make Neck 246 extends to the outside, to generate the expected result that " pulling " opens experimenter's air flue 14.If frame part 226 and end Device 240 is connect not to be rigid or semirigid, then, vacuum surface 96 will be collapsed against neck 246, so that the air flue of subject 14 will not open in " drawing " as expected.

Referring still to Figure 16-18, in the operation of sleep apnea therapy system 70 (Fig. 4-7), according to another implementation Scheme, system can adjust the pressure in pressure span 200 in a manner of imitating and wriggle.For example, system 70 can be adjusted so Pressure will lead to the formation of a part 246 of neck 50 as being continuously exposed to water caused by negative pressure for a long time to reduce or eliminate system The chance of swollen (for example, " pimple (hickey) ").

Wriggling is the contraction of the radial symmetric to form muscular tube and of flaccid muscles, the contraction in the way of direct motion with it is wavy to It propagates muscular tube lower end.An example of this muscular tube is esophagus in human body, muscle shunk in a manner of wriggling with by food and Beverage is moved to stomach from oral cavity.

In one embodiment, pressure regulator assembly 120 (Fig. 8) increases the base pressure region 200 of lantern ring 76 first Interior pressure (that is, the amplitude for reducing negative pressure), while keeping intermediate and top pressure region pressure constant.Pressure regulator group The amount and characteristic (profile) of pressure in the increase of part 120 base pressure region 200 and the duration of the pressure increase can Suitable for do not destroy formed between adjacent sealing surfaces 94 and neck 234 and 242 it is gas-tight seal in the case where reduce or Eliminate the chance that oedema is formed in bottom neck 246.

Next, pressure regulator assembly 120 (Fig. 8) reduces the pressure in base pressure region 200 (that is, increasing negative pressure Amplitude), until its reach controller 134 (Fig. 8) determine level be suitable for treat subject sleep apnea.Pressure tune Save the characteristic (profile) of the pressure in the reduction of device assembly 120 base pressure region 200 and the duration of the pressure reduction It may be adapted to reduce or eliminate the chance that oedema is formed in bottom neck 246.

Then, while reducing the pressure in bottom negative pressure region 200 or later, pressure regulator assembly 120 (Fig. 8) Increase the pressure (that is, the amplitude for reducing negative pressure) in intermediate pressure region 200, while keeping the pressure at least top pressure region Power is constant.Pressure regulator assembly 120 increase intermediate pressure region 200 in pressure amount and characteristic (profile) and should The duration of pressure increase may be adapted to do not destroying the gas formed between adjacent sealing surfaces 94 and neck 234 and 242 The chance that oedema is formed in intermediate neck 246 is reduced or eliminated in the case where sealing.

Next, pressure regulator assembly 120 (Fig. 8) reduces the pressure in intermediate pressure region 200 (that is, increasing negative pressure Amplitude), until its reach controller 134 (Fig. 8) determine level be suitable for treat subject sleep apnea.Pressure tune Save the characteristic (profile) of the pressure in the reduction of device assembly 120 intermediate pressure region 200 and the duration of the pressure reduction It may be adapted to reduce or eliminate the chance that oedema is formed in intermediate neck 246.

Then, while reducing the pressure in intermediate negative pressure region 200 or later, pressure regulator assembly 120 (Fig. 8) Increase the pressure (that is, the amplitude for reducing negative pressure) in top pressure region 200, while keeping the pressure at least base pressure region Power is constant.Pressure regulator assembly 120 increase top pressure region 200 in pressure amount and characteristic (profile) and should The duration of pressure increase may be adapted to do not destroying the gas formed between adjacent sealing surfaces 94 and neck 234 and 242 The chance that oedema is formed in top neck 246 is reduced or eliminated in the case where sealing.

Next, pressure regulator assembly 120 (Fig. 8) reduces the pressure in top pressure region 200 (that is, increasing negative pressure Amplitude), until its reach controller 134 (Fig. 8) determine level be suitable for treat subject sleep apnea.Pressure tune Save the characteristic (profile) of the pressure in the reduction of device assembly 120 top pressure region 200 and the duration of the pressure reduction It may be adapted to reduce or eliminate the chance that oedema is formed in top neck 246.

Above-mentioned wriggling process is summarized, controller 134 changes the pressure in bottom, centre and top pressure region, so that this A little pressure are offset from one another in time, and are therefore offset from one another in phase, so that controller is made effectively to generate pressure " wave ", It is propagated upward or downward along lantern ring 76.

Controller 134 (Fig. 8) can with programming or otherwise execute to the gap periods that are arranged the wriggling Journey, or can indicate to have been formed in the region (for example, region 246) of subject's neck 50 in response to the sensor of system 70 Or the oedema of threshold size can be quickly formed to execute the wriggling process.In addition, controller 134 can make pressure span 200 One or more of during the various pieces of wriggling process have corresponding normal pressure, as long as having in any one time The quantity of the pressure span of normal pressure is sufficiently small, so as not to which lantern ring 76 can be made to completely disengage the neck 50 (Fig. 4) of subject, also not The problem of will lead to the treatment aspect of subject's sleep apnea.For example, controller 134 may be configured so that any Pressure against the ends region (for example, top or base pressure region) 200 of one time no more than one has reduced negative pressure Or normal pressure.

Referring still to Figure 16-18, the alternate embodiment of lantern ring 76 and system 70 (Fig. 4-7) is generally considered.For example, Collar segments 224 can have different size or shapes each other, and can have different from described size or shape Size or shape.Furthermore, it is possible to there is the section 224 fewer of more than three.In addition, peristaltic action can be from the top of lantern ring 76 Portion is to bottom rather than propagates from bottom to top, can replace the direction of propagation, and can change in any suitable manner.

Figure 19 is the view according to a part 250 of the lantern ring 76 of Fig. 4-7 and 14 of another embodiment.

Figure 20 is according to the collar portion 250 of Figure 19 of an embodiment be along Figure 11 line A-A intercept and subject The part 222 of neck 50 and the cross-sectional view of air flue 14

Referring to Figure 19-20, collar portion 250 is similar to the collar portion 220 of Figure 16-18, unlike, increase one Or multiple sealing surfaces 252, each sealing surfaces 252 far from terminator 240, and add corresponding transverse to sealing surfaces 94 One or more pressure span separators 254 can be similar to terminator 240 and support transverse sealing surface.Transverse sealing Surface 252 can be similar to sealing surfaces 94, and can be attached to separator 254 in any suitable manner.And it separates Device 254 can be made of material identical with frame part 226 or terminator 240, and can be with as above in conjunction with described in Figure 18 Terminal organ be attached to the mode that vacuum surface 96 or frame part can be similar by the way of and be attached to vacuum meter to connection Face 96 or frame part.Alternatively, separator 254 can with terminator 240 as above in conjunction with Figure 18 and frame section Divide 226 integrally formed modes that can be similar by the way of and frame part 226 integrally formed.

Transverse sealing surface 252 and separator 254 form other pressure and collar segments 224 are divided into multiple portions Power region 200 (Figure 16-18).

In addition, if sleep apnea therapy system 70 (Fig. 4-7) adjusts pressure span 200 in a manner of imitating and wriggle Pressure in (Figure 16-18), then controller 134 (Fig. 8) can be arranged to change simultaneously the pressure for belonging to same collar segments 224 Pressure in power region.Alternatively, controller 134 can be configured to be similar to the wriggling skill described above in conjunction with Figure 16-18 Art but on circumferential direction (that is, around neck 50 side upward rather than on the direction above or below neck) side Formula adjusts the pressure in pressure span 200.Alternatively, 134 system of controller can be configured to transverse direction (that is, along neck to It is upper or downwards) and both circumferential directions on pressure in adjusting pressure span 200.

Referring still to Figure 19-20, it is contemplated that consider the alternate embodiment of common lantern ring 76 and system 70 (Fig. 4-7).Example Such as, the identical alternative solution of the lantern ring 76 of Figure 16-18 discussed above is applicable to the lantern ring 76 of Figure 19-20.

Figure 21 is the view according to a part 260 of the lantern ring 76 of another embodiment Fig. 4-7 and 14.

Figure 22 is the collar portion 260 and subject's neck of the Figure 21 intercepted according to the line A-A along Figure 21 of an embodiment The part 222 in portion 50 and the cross-sectional view of air flue 14.

1-22 referring to fig. 2, collar portion 260 are similar to the collar portion 220 of Figure 16-18, unlike, collar segments 262 be configured to subject 12 (Fig. 4) wear sleep apnea system 70 when in transverse direction (that is, along neck 50 upwards/to Under) extend, it is different from collar segments 224 (Figure 16-18), is configured to circumferentially (that is, around neck) extend.Collar portion Points 260 although it is not shown, the collar portion 250 of Figure 19-20 can be similar to because it may include sealing surfaces and point From device, the sealing surfaces and separator are similar to sealing surfaces 252 and separator 254 and are substantially transverse to (that is, with Figure 21 Line A-A direction substantially common direction) sealing surfaces 92 and connector 264.

1-22 still referring to Figure 2, it is contemplated to the alternate embodiment of common lantern ring 76 and system 70 (Fig. 4-7).For example, The lantern ring 76 of Figure 21-22 is applicable to above in conjunction with Figure 16-20 identical alternative solution discussed.

Figure 23 is the flow chart according to the operation mode of the sleep apnea therapy system 70 (Fig. 4-7) of an embodiment 270。

- 8 and 14-22 referring to fig. 4 describes the sleep apnea therapy system 70 (Fig. 4-7) according to an embodiment Operation.

After subject 12 puts on simultaneously (for example, by switching power devices 100) activation therapeutic system 70, in flow chart 270 step 272, controller 134 make pump assembly 118 and pressure regulator assembly 120 generate phase in each pressure span 200 The initial pressure answered, such as corresponding negative pressure.That is, pump assembly 118 generates one or more negative pressure in the following manner: Air outside lantern ring 76 is sucked in intake valve 238, by entrance opening 202, into one or more pressure spans 100, by exit opening 204, by valve and pressure regulator assembly 120 and 122, into pump assembly 118, and pass through outlet Valve 102 is discharged.Alternatively, one or more of inlet valve 238 and entrance opening 202 can be deactivated or be omitted, so that pump group Part generates at least some of one or more negative pressure, without generating corresponding continuous flow.

Next, controller 134 is in response to one from pressure sensor assembly 126 in the step 274 of flow chart 270 A or multiple pressure instructions monitor the air leakage of one or more pressure spans 200.

In step 276, controller 134 determines whether there is any air leakage.If the determination of controller 134 is not let out Leakage, then controller proceeds to step 280.But if controller 134 determines that controller proceeds to there are at least one leakage Step 278.

In step 278, controller 134 causes the reparation of each one or more leakages detected, for example, close by making It seals agent dispenser assembly 124 and distributes opening 210 from reservoir 146 via one or more sealants near corresponding leakage Sealant is distributed to repair.

Then, in step 280, controller 134 is monitoring subject 12 by apnea degree sensor component 128 The sleep apnea degree of experience.For example, controller 134 can monitor the respiratory rate of subject.

Next, whether the sleep apnea degree that the determining subject 12 of controller 134 is undergoing in step 282 In target zone.For example, whether controller 134 can determine the respiratory rate of subject in target zone.If control Device 134 determines sleep apnea degree in target zone, then controller proceeds to step 286.But if controller 134 Sleep apnea degree is determined except target zone, then controller proceeds to step 284.

In step 284,134 identification controller of controller has determined that the one or more pressure spans 200 to be adjusted, and controls Pump assembly 118 processed or pressure regulator assembly 120 are to adjust the pressure in the one or more pressure spans identified, with effort Sleep apnea degree is driven to target zone.

Then, in step 286, controller 134 monitors one or more of comfortable section of one or more of system 70 Internal consistency of general comfort (Fig. 4-7).For example, controller 134 can monitor the temperature or pressure in one or more pressure spans 200.

Next, controller 134 determines the comfortable shape in one or more of one or more comfortable sections in step 288 Whether condition is in corresponding target zone.For example, controller 134 can determine the temperature in each pressure span 200 whether In corresponding target zone.If controller 134 determines each of one or more internal consistency of general comfort all in its corresponding mesh It marks in range, then controller proceeds to step 292.But if controller 134 determines in one or more internal consistency of general comfort extremely Lack one outside its respective target zone, controller enters step 290.

In step 290, controller 134 identifies the comfortable section of one or more to be adjusted, and controls temperature-controlling module 132 to adjust one or more comfort quantities (for example, temperature) in the comfortable section of identified one or more, with effort One or more internal consistency of general comfort are driven to its respective target zone.In addition, alternatively, controller 134 can be with compacted Dynamic mode controls pump assembly 118 and pressure regulator assembly 120, temporarily to reduce in one or more pressure spans 200 The amplitude of pressure formed with reducing oedema, or make the corresponding region 246 and higher magnitude of subject's neck 50 in other ways Pressure " shutdown ".

In step 292, controller 134 determines whether the revival of subject 12 or otherwise makes the time of system cut-off (for example, because subject removal system 70 and via switching power devices " closing " system 100).If not wake-up The time of subject 12, then controller 134 returns to step 274.But if it is the time for waking up subject 12, then controller 134 proceed to step 294.

In step 294, controller 134 realizes wakeup routine, then deactivation system 70 (Fig. 4), alternatively, alternatively, control Device skips wakeup routine and deactivation system.As the example of wakeup routine, controller 134 can be programmed at the appointed time or Person helps to wake up subject 12 in the following manner in response to increased environment light: making a sound alarm and is reduced slowly The amplitude of relevant pressure in each pressure span 200, or by being changed according to the sequence or mode of gently wake-up subject Become the relevant pressure in one or more pressure spans.

After step 294, aforesaid operations mode terminates, and controls in 12 activated sleep apnea of subject next time It is repeated when treatment system 70.

The other embodiments of negative pressure sleep apnea therapy system are described below in conjunction with Figure 24-63.Above in conjunction with The sleep apnea therapy system 70 that Fig. 4-23 is described can be modified to include any sleep described below with reference to Figure 24-63 Any one or more features of any embodiment of apnea treatment system；Similarly, it is described below with reference to Figure 24-63 Sleep apnea therapy system can respectively modify to include any embodiment of sleep apnea therapy system 70 Any one or more features.In addition, unless otherwise stated, the sleep apnea described below with reference to Figure 24-63 The embodiment for the treatment of system can structurally and operationally aspect be configured to one of sleep apnea therapy system 70 or Multiple embodiments are identical.

Figure 24-25 be respectively according to the neck 400 of the subject 405 of an embodiment, throat 402 and lower jaw 404 and The isometric front view and isometric side view of throat region 406 and 407, throat region 406 and 407 are slept for applying negative pressure with treating Dormancy apnea, such as obstructive sleep apnea.

Referring to Fig. 3 and 24-25, in one embodiment, negative pressure applying zone 406 is in bottom by the breastbone head 62 of subject It defines, is defined in side by the nutator 66 of subject, and at top by the lower jaw 404 of subject and the larynx of subject It defines at the interface 408 (the preceding abdomen of the digastric muscle 55 i.e. in Fig. 3) in portion 402.The another embodiment shown in Figure 24-25 In, negative pressure applying zone 406 is defined in bottom by the Adam's apple 410 (thyroid cartilage 57 in Fig. 3) of subject, in side by tested The nutator 66 of person defines, and at top by 408 boundary of interface of the lower jaw 404 of subject and the throat 402 of subject It is fixed.

Negative pressure applying zone 407 is usually less than region 406, can be partially or completely in region 406, and can be and enclose Around the rectangular or square of the Adam's apple 410 of subject.For example, the lateral boundaries in region 407 can be with each angle of the mouth of subject Alignment, and the coboundary in region 407 can be located exactly at 404 lower section of lower jaw of subject.In one embodiment, negative pressure is applied It fills up to move forward the tongue of subject and/or other soft-palatal tissues, to reduce or eliminate airway obstruction.In an embodiment party In case, negative pressure applies the tongue for being enough to make subject and/or other soft-palatal tissues move forward, thus reduce or eliminate snoring and There is no airway obstruction.

As described above, being applied to the negative pressure (for example, suction) in region 406 or region 407 can cause to hinder experimenter's air flue The tissue movement of (air flue 14 of Fig. 1) is enough to reduce or remove obstruction.Negative pressure " can pull out " in region 406 or region 407 Tissue, the tissue " can pull " clogging tissue or neighbour by being connected to its hetero-organization of clogging tissue or neighbouring experimenter's air flue Its hetero-organization of the air flue of nearly subject reduces to enough distances or removes obstruction.Alternatively, negative pressure can make subject Chin 412 it is sufficiently mobile (for example, forward, downwards or forward and downwards), to reduce or remove obstruction.Alternatively, negative pressure can be with Airway obstruction is reduced or removed by the tissue in " pull-out " region 406 or 407 and by keeping chin 412 mobile.

4-25 referring to fig. 2, it is contemplated that other embodiments of negative pressure applying zone 406 and 407.For example, region 406 or area Each of the above-mentioned boundary in domain 407 can change any distance in distance range, and such as ± 25 millimeters of distance range (mm)。

Figure 26 be according to the subject 405 of the wearing negative pressure sleep apnea therapy system 420 of an embodiment etc. Away from front view.System 420 is designed to the throat region 406 to subject, throat region 407 or throat region 406 and 407 liang Person applies negative pressure, above in association with as described in Figure 24-25.Other than the structurally and operationally feature described below with reference to Figure 26-63, System 420 can also have appointing for any embodiment above in conjunction with Fig. 4-23 sleep apnea therapy system 70 described How structurally and operationally feature.

Sleep apnea therapy system 420 can be it is independent so that it does not need to be connected to external equipment (for example, Base station, power jack) it operates, it therefore, can be than including such as base station and the air hose being coupled between base station and system Traditional CPAP machine or other sleep apnea therapy systems it is more comfortable.For example, sleep apnea system 420 Standalone version may include being rechargeable battery when subject 405 does not wear/be not used sleep apnea system (for example, electricity Pond 110), when so that sleep apnea system using sleep apnea system as subject wears or otherwise, no It needs (for example, without power line, without hose, and there is no wire communication chain with the physical connection of another equipment or position Road).But the standalone version of sleep apnea system 420 can be configured as including wireless communication link and wireless power chain Road.

Figure 27-28 be according to an embodiment wearing Figure 26 negative pressure sleep apnea therapy system 420 it is tested The corresponding isometric side view of person 405.Sleep apnea system 420 includes dismountable gasket assembly 422, is configured as enclosing It is formed around the periphery of sleep apnea system gas-tight seal, and including dismountable band component 424, is configured as fixing Neck 400 of the sleep apnea system to subject 405.Alternatively, band component 424 can be configured as sleep-respiratory Break-Up System 420 is fixed to head 425 or the surrounding of subject 405.

Figure 29 be according to an embodiment wearing Figure 26-28 negative pressure sleep apnea therapy system 420 it is tested The equidistant Reading View of person 405.Band component 424 may include coupler 426, and coupler 426 is configured in subject's neck 400 The rear end of band 428 and 430 with component is coupled by rear portion.Coupler 426 is configured to allow to adjust by band component 424 Band 428 and 430 formed neck ring size.That is, coupler 426 can be used to adjust ring size, so that sleep The cooperation of apnea system 420 will not so " tight ", and will not such " pine " so that it causes subject 405 uncomfortable So that it allows that air occurs when gasket assembly 422 contacts the neck 400 of subject to leak.428 He of coupler 426 and band 430 end may includeOr any other suitable material or structure, allow that band is adjustably coupled in one It rises.Alternatively, coupler 426 can be omitted from sleep apnea system 420, and can will (it can wrap with end It includes) directly coupled to each other.

Figure 30 is the equidistant side view according to the negative pressure sleep apnea therapy system 420 of Figure 26-29 of an embodiment Figure.

Figure 31 is the equidistant backsight according to the negative pressure sleep apnea therapy system 420 of Figure 26-30 of an embodiment Figure.

Figure 32 is the equidistant decomposition according to the negative pressure sleep apnea therapy system 420 of Figure 26-31 of an embodiment Figure.

Referring to Figure 30-32, other than gasket assembly 422 and with component 424, negative pressure sleep apnea therapy system 420 further include collar assemblies (hereinafter referred to as " lantern ring ") 440.

Gasket assembly 422 is configured to be removably attached on lantern ring 440, for example, arriving the periphery of lantern ring by " buckle " It is realized on 442.In an embodiment of sleep apnea system 420, it is contemplated that gasket assembly 422 will wear, upgrading or Person will otherwise need more frequently to repair or replace than lantern ring 440；Therefore, gasket assembly is configured to detachably can be with Allow to replace gasket assembly independently of lantern ring.

Band component 424 is also configured to be detachably attached on lantern ring 440, such as the side by being attached to lantern ring is come real It is existing.Band 428 and 430 with component 424 has corresponding front end 444 and 446, and front end 444 and 446 is configured to removably be attached To the respective side portion 448 and 450 of lantern ring 440.For example, may include opposed configuration with front end 444 and lantern ring side 448Part, band front end 446 and lantern ring side 450 can also be such.In addition, the position with front end 444 and 446 can be opposite It is adjustable in lantern ring side 448 and 450, so that being adjustable the size of the neck ring formed by the band 428 and 430 with component 424. In addition, in an embodiment of sleep apnea system 420, it is contemplated that band component 424 will wear, upgrading or will be with its other party Formula needs more frequently to repair or replace than lantern ring 440；Therefore, it will be allowed at detachable independently of lantern ring with component Configuration 440 replacement band components.

With reference to Figure 31, lantern ring 440 include rear side 452 (be configured as when sleep apnea system 420 is worn towards The side (for example, Figure 26-Figure 29) of the neck 400 of subject), on the side or one or more outlets are set across the side and are opened 454 (opening is only shown in Figure 31) of mouth and one or more sensors 456 (sensor is only shown in Figure 31).Example Such as, one or more exit openings 454 are structurally and functionally similar to the exit opening 204 of Figure 14, and one or more A sensor 456 can be structurally and functionally similar to the sensor of the sensor module 126 and 128 of Fig. 8.As tied above It closes described in Fig. 4-23, and as described below, pump (being not shown in Figure 31) passes through one or more exit openings 454 and aspirates sky Gas, it is negative to be generated between the rear side 452 of lantern ring 440 and the throat region 406 of subject or throat region 407 (Figure 24-25) The volume of pressure or region.

Aspirating air by one or more exit openings 454 can also be referred to as true by one or more outlet extractions Sky or extraction section vacuum, and the volume of negative pressure or region can be referred to as vacuum, partial vacuum or pressure span, and And it can structurally and functionally be similar to the pressure span 200 described above in conjunction with such as Figure 17.Further as tied above It closes described in Fig. 4-24, and as described below, one or more sensors 456 can be configured as sensing and provide information, or One or more physical parameters are sensed and provide, sleep apnea system 420 can be slept from the physical parameter derived information Dormancy apnea system can be used for adjusting the amplitude of negative pressure, or adjust other parameters (for example, jugular temperature), to open or keep Open the air flue (for example, air flue 14 of Fig. 1) of subject.In addition, one or more sensors 456 can be configured as sensing and Other information, or sensing and the one or more physical parameters of offer are provided, sleep apnea system 420 can be from the object It manages parameter and exports other information.For example, one or more sensors 456 can be matched such as above in conjunction with Fig. 8 and as described below Be set to sensing and provide relevant to the body of subject 405, spirit, mood, health status or health status information (for example, Figure 26-29), or information relevant to use or setting of the subject to sleep apnea system 420.In addition, one or more A exit opening 454 and one or more sensors 456 can have any suitable position, shape and size.These positions, shape Shape and size can be different from shown in Figure 30-32.

Referring still to Figure 30-32, lantern ring 440 can be customized, be better suited for subject 405 neck 400 (for example, Figure 29).For example, doctor or other people traditional image capture device or traditional scanner can be used to generate subject's neck Three-dimensional (3D) image or map in portion 400 (at least front and side of subject's neck).It then can be by 3D rendering or ground Figure is converted to the mimeograph documents with the format for being suitable for 3D printer, and 3D printer " can print " lantern ring 440.Or it can be with Lantern ring 440 is manufactured according to 3D rendering or map by CNC or other machines.Other component (the example of sleep apnea system 420 Such as, gasket assembly 422, band component 424) it can manufacture in a similar way.

Figure 33 is the isometric front view of the gasket assembly 422 and lantern ring 440 according to Figure 26-32 of an embodiment.

Figure 34 is the isometric side view of Figure 26-33 gasket assembly 422 and lantern ring 440 according to an embodiment.

Figure 35 is equidistantly regarded according to the equidistant side of the lantern ring 440 with transparent part of Figure 26-34 of an embodiment Figure.

Referring to Figure 33-35, lantern ring 440 includes semi-rigid shell 460, and including compartment 462, compartment 462 is formed in shell The front of body and it is configured to one or more components for keeping sleep apnea system 420.

With reference to Figure 35, lantern ring shell 460 includes that flexible, elastic overmold is arranged in or packs rigid in 466 In property inner frame 464.

Frame 464 includes lath 468, and can be formed by plastic-metal or any other materials, the plastic-metal Or the strength and stiffness of any other materials are enough to allow lantern ring 440 in the rear surface 452 of lantern ring and the neck of subject 405 (for example, Figure 26-29) forms negative pressure region between 400, without rear surface " collapsing " on neck.While shown as vertical It is positioned on direction, but one or more of lath 468 can position in horizontal dimensions or diagonal line dimension, and vertical Lath can be coupled and (be not shown in Figure 35) by horizontally or diagonally line cross battens.In addition, frame 464 may include For the optional band attachment part 470 and 472 of bonding ribbon component 424 (for example, Figure 32), wherein the attachment part can be replaced Change above combination Figure 30-Figure 32 descriptionBand attachment part 444,446,448 and 450 otherwise makes it It is unnecessary.Although each band attachment part 470 and 472 is shown as including two eyelets 474 and 476, with attachment Point one or two of may include eyelet less than two or more.

Overmold 466 can be formed by plastic-metal or any other suitable material, and strength and stiffness are enough Allow lantern ring 440 in the rear surface 452 of lantern ring and the throat region 406 of subject 405 (for example, Figure 27-28) or throat region Form negative pressure region between 407 (Figure 24-25), without rear surface " collapsing " in throat, but have enough flexibilities and Surface texture to allow lantern ring to be cosily bonded the neck of subject 405, and meet subject's neck 400 shape (for example, Figure 27-28).If being configured as forming negative pressure between the rear surface 452 and throat region 406 of lantern ring compared to lantern ring 440 Region, if lantern ring 440 is configured to form negative pressure region, lantern ring between the rear surface 452 and throat region 407 of lantern ring 440 can be smaller, or for intended size, can have component etc of more spaces for such as component models 550 Component.

In order to form shell 460, frame 464 can be formed by traditional injection moulding first, then can also passed through Traditional injection moulding forms overmold 466 on frame.

Referring again to Figure 33-35, compartment 462 can be formed as the compartment integral with overmold 466, or can be with Be formed as a part of frame 464 to increase intensity.In addition, compartment 462 may include the rear portion in lantern ring 440 (towards tested The side of person 105) in enter panel (being not shown in Figure 33-35), or in the front of lantern ring 440 (away from subject Side) enter panel (being not shown in Figure 33-35), with allow repair or replace every indoor component.Alternatively, compartment 462 can not include entering panel, so that component is sealed in compartment, and not (for example, passing through cutting overmold 466) it removes or cannot repair or replace in the case where destroying lantern ring 440.And it can be the component being arranged in compartment 462 Example includes battery, motor, pump, valve, sensor, electronic circuit and electronic component and mechanical component and mechanical part (these Other examples of component are described above in conjunction with such as Fig. 8 and below in conjunction with such as Figure 45).

Figure 36 is according to the lantern ring 440 of Figure 26-35 of an embodiment and for negative pressure sleep apnea therapy system The isometric front view of 420 ON/OFF switch 480.Switch 480 can be haptic type slide switch, for example, positioned at component every The front side of room 462.That is, can by the front side of compartment 462 with finger sliding will switch 480 in its " on " and Switch between " shutdown " state, is very similar to the mode of the switch shown on switching smart phone screen.For example, lantern ring 440 May include display screen, capacitance sensor or by the front side exposure of compartment 462 or be located at the subsequent other equipment in the front side, Wherein switch 480 is formed by the equipment or is otherwise realized.Switch 480 is configured as passing through under its " on " state The component (for example, sensor 456 of other component and Figure 31 in motor and compartment 462) of system is connected to setting to exist Carry out activated sleep apnea system 420 every indoor power source (such as battery)；And under its " shutdown " state, quilt is switched It is configured to deactivate sleep apnea system by turning off the component of sleep apnea system and power source.Switch 480 It is also configured such that when subject sleeps and wears sleep apnea system 420, subject 405 (for example, Figure 29) It is difficult to it is not possible that switching is unintentionally arrived its " shutdown " state.It is used on bed for example, switch 480 may be configured so that Product are difficult or impossible to the movement due to subject 405 and wind with switch and switching is arrived its " shutdown " state (example Such as, subject is rolled to him/her and sleeps on all fours, or the movement when he/her sleeps on all fours).In addition, while shown as compartment 462 is located at Front side, but any other suitable position in lantern ring 440 or on lantern ring 440 can be set in switch 480.In addition, opening Closing 480 can be configured to be controlled by the controller (for example, controller 134 of Fig. 8 and 45) of sleep apnea system 420.Example Such as, controller can be configured as in response to detecting that subject 405 is temporary from his/her 400 surrounding of neck removal sleep-respiratory Stop system 420 and switch 480 is automatically switched to its " shutdown " state, and in response to still being detected during sleep in subject Its " shutdown " state is arrived to switching, switch is automatically switched to its " on " state.

Figure 37 is set according to the lantern ring 440 and battery level indicator 482 and long-range control of Figure 26-36 of an embodiment Standby 484 isometric front view.

Battery level indicator 482 can be the indicator of any suitable type, such as light emitting diode (LED) display Device is configured as changing color, intensity or both color and intensity, to be designated as the power supply of sleep apnea therapy system 420 One or more of battery 110 (Fig. 8 and 45) charged state.Indicator 482 can be located at such as component compartment 462 Front side, or any other suitable position positioned at lantern ring 440.Indicate that one or more battery 110 has in response to indicator 482 There is low state of charge, for example, can be charged the battery with AC adapter as above in conjunction with described in Fig. 5.

Remote control equipment 484 can be configured as the operation of control sleep apnea therapy system 420, can be any conjunction Suitable equipment, such as specialized remote control device or smart phone, and can be configured as according to it is any suitable wirelessly or non-wirelessly Agreement (such as Radio frequency (RF) is infrared (IR)) it is controlled with sleep apnea Treatment system 420 communicates.For example, remote control equipment 484, which can be configured as, allows to adjust setting for sleep apnea therapy system 420 Set (for example, amplitude of negative pressure, wakeup time), enter data into sleep apnea system memory 130 (Fig. 8 and 45) or Data are retrieved from the memory 130 (Fig. 8 and 45) of sleep apnea system, and open " on " or " shutdown " sleep-respiratory Suspend treatment system.Remote control equipment 484 can also be configured and be reconfigured for example, by firmware or software.For example, if Remote control equipment 484 is smart phone, then can be by the memory of software application downloads to smart phone, the software application Program allows to control sleep apnea therapy system 420 using smart phone.Other than remote control equipment 484 or conduct The substitute of remote control equipment, lantern ring 440 may include input equipment 98 (Fig. 8 and 45), can be such as keyboard or display screen Curtain, and can be configured as allow control sleep apnea therapy system 420, enter data into sleep apnea and control Data are retrieved in the memory 130 for the treatment of system 420 or from the memory of sleep apnea therapy system 420.In addition, remote control Equipment 484 can be used as a part of sleep apnea therapy system 420, or with sleep apnea therapy system 420 It separates and different (for example, Figure 26-32).

Figure 38 be according to an embodiment wearing Figure 26-32 negative pressure sleep apnea therapy system 420 it is tested The isometric side view of person 405, wherein system includes one or more sensors 490, they be located at lantern ring 440 rear side 452 it Outside, as the one or more sensors of Figure 31 456.

One or more sensors 490 are installed in adjustable arm 492, adjustable arm 492 be attached to lantern ring 440 or with set Ring 440 is integral, and can be made of any suitable material, such as be made of metal or plastics.For example, arm 492 can wrap Connector 494 is included, it can be around the connector 494 on the top of the plane internal rotation arm of the plane where the lower part 498 for being parallel to arm 496.In addition, arm 492 may include another connector 500 being arranged between lantern ring 440 and lower arm part 498, and can be with Turn lower arm part around connector rotation or ring.In addition, one or two of upper and lower arms part 496 and 498 can be It is tensile or telescopic, such as realized by stretching.In addition, sleep apnea system 420 may include one or more A motor, to change the position (Fig. 8 and 45) of one or more sensors 490 under the control of controller 134.In addition, arm 492 It can structurally and functionally be configured in any other suitable manner.In addition, one or more sensors 490 although It is shown mounted to the end of arm 492, but any other part of arm can be installed to.

One or more sensors 490 may include the sensor of any suitable type, and it is corresponding to be configured as sensing Physical quantity and corresponding simulation or the digital and electronic letter for generating the relevant parameter (for example, amplitude, phase, frequency) for indicating corresponding amount Number.For example, one or more sensors 490 may include one or more gas sensors, sensing is configured as by tested The level of one of one of air or many kinds of substance that person 405 breathes out, or sensing surrounding air or many kinds of substance and Subject breathes out the difference in object between the level of identical one or more substances.Alternatively, one or more sensors 490 can To include one or more sound transducers, such as microphone, it is configured as sensing one or more generated by subject 405 A sound (for example, snoring).Alternatively, one or more sensors 490 may include being configured as by sensing subject Eyes 502 are opened or are closed to sense the one or more more polyphasers or its that subject 405 wakes or falls asleep His visual sensor.In addition, one or more sensors 490 may include one or more accelerometers or gyroscope (for example, micro- Electromechanical (MEMS) accelerometer or gyroscope) to sense the movement of subject 405 or sense the power of subject's exhalation air.

Figure 39 is the washer sets according to the negative pressure sleep apnea therapy system 420 of embodiment Figure 26-32 and 38 The isometric exploded view of part 422 and lantern ring 440, wherein sleep apnea system includes at any suitable position of lantern ring On one or more electrodes 510, such as the rear side 452 of the lantern ring at collar end 512 and 514.

Figure 40 is the sectional side view according to the washer 516 of the gasket assembly 422 of Figure 26-34 and 39 of an embodiment.

Referring to Figure 39-40, the front 518 of gasket assembly 422 includes bonding part (for example, " lip ") 520, and washer The rear portion 522 of component includes washer 516.

The bonding part 520 of gasket assembly 422 is arranged around the periphery 524 of gasket assembly 422, and is configured to detachable Ground engages around the edge 526 that the periphery 442 of lantern ring 440 is arranged.For example, bonding part 520 can arrive edge by " buckle " Joint edge 526 on 526, and edge can be detached from and turning off from edge " buckle ".Alternatively, bonding part 520 It (can be not shown) and pass through in Figure 39-40 on the engagement portion with adhesive (being not shown in Figure 39-40) or with setting The pin that " buckle " enters and leaves the jack (being not shown in Figure 39-40) being arranged in edge is attached on edge 526.In addition, Bonding part 520 can be formed by any suitable material, the material have it is enough flexible and it is elastic with lantern ring 440 together Bending, and for example bonding part is allowed to be connected on collar rim 526 and be detached from from collar rim 526 by " buckle ".

Washer 522 is configured to the subject's 405 for the sleep apnea therapy system 420 for wearing Figure 26-32 and 38 Neck 400 (for example, Figure 38) forms gas-tight seal.Before washer 522 for example can be installed to gasket assembly 422 by adhesive Portion 518, so that washer can be independently of front removal/replacement of gasket assembly；Alternatively, washer can be permanently attached to washer sets The front of part is integral with the front of gasket assembly.In addition, washer 522 can be airtight by being suitable for being formed with subject's neck 400 Any material of sealing is formed；The example of this material includes foam, foam rubber, rubber and gel.In addition, referring to fig. 40, Washer 522 may include channel 528, and channel 528 has opening 530, and opening 530 is configured to the skin 532 with subject's neck 400 It is adjacent so that when vacuum is pulled through channel, washer be pulled or " absorption " to skin on to be formed than only with can with component 424 The closer sealing (for example, Figure 32) of the sealing of acquisition.For example, channel 528 may include in the inward-facing of gasket assembly front 516 Opening (being not shown in Figure 39-40) on side 534, so that being pulled through one or more exit openings 454 (Figure 31) in lantern ring The vacuum that negative pressure region is generated between 440 and subject's neck 400 is also pulled through channel 528.Alternatively, collar rim 526 with And gasket assembly front 516 may include one or more vacuum passages (Figure 39-40 is not shown), be configured so as to generate negative pressure The pump in region can be connected to independently of negative pressure region with channel 528.Furthermore it is possible to by the way that sealant (such as gel or foam) is applied The surface of washer is added to enhance the sealing formed by washer 522, the surface structure of washer is slept at subject 405 " putting on " Skin is contacted before apnea system 420.The sealant can also soak and otherwise releive or heal subject's Skin, to prevent washer 522 from contacting trace, ulcer or fash in the region of skin.In addition, washer 522 may include one or Multiple sealant distribution 210 (Figure 15) of opening, coating apparatus for sealant component 124 (Fig. 8 and 45) can be distributed by sealant and be open 210 distribution carry out the sealant (Fig. 8 and 45) of self-sealing substance reservoir 146 to form sealing, or prevent the leakage in sealing, such as Above in conjunction with described in Fig. 8 and 15.In addition, can be close by replaceable and disposable self-adhesion by the sealing that washer 522 is formed Envelope component (is not shown) Lai Zengqiang in Figure 39-40, the side of the containment member be configured to adhere to washer 522 towards skin On surface, and the other side is configured to contact skin and has adhesive or other substances to enhance the sealing with skin.It can determine Phase (such as before each is used daily) this containment member of replacement, and the more frequency than replacement washer 522 and gasket assembly 422 It replaces numerously.

Referring again to Figure 39, one or more electrodes 510 (two electrodes 510a and 510b shown in Figure 39) can be used Make sensor, is used as treatment use equipment, or be used as sensor and treatment use equipment.For example, when used as sensors, sleep The controller 134 (Fig. 8 and 45) of apnea treatment system 420 or other circuits can be configured as measuring electrode 510a and The voltage at the both ends 510b, and measurement flows in or out the electric current of electrode respectively, wherein voltage, current or voltage and electric current (example Such as, the amplitude of voltage or electric current, phase) both can indicate that subject 405 (for example, Figure 38) is undergoing sleep-respiratory it is temporary Cut off the water flat, or can indicate the situation or parameter of subject, such as blood pressure, blood glucose level, blood oxygen level and body or skin Temperature.And when being used as treatment use equipment, the controller 134 or other circuits of sleep apnea therapy system 420 can To be configured as applying voltage at the both ends electrode 510a and 510b, and apply the corresponding electricity of disengaging electrode 510a and 510b Stream, for treating subject 405 (for example, controller/circuit can be configured as the amplitude and phase of control voltage and current Position).The example of such treatment includes reducing the level of sleep apnea, reduces hypertension, reduces elevated blood glucose levels and increase Low blood oxygen level.The example that controller 134 or circuit influence the mode of this treatment includes change body or skin temperature, and Loosen, tense or " vibration " muscle and its hetero-organization, such as muscle and its hetero-organization in the neck or throat of subject.From Any data that subject collects can store and/or with other equipment (for example, doctor, the database of other users, movement are set It is standby, tablet computer, social media etc.) it shares together.

Figure 41 is the washer according to the negative pressure sleep apnea therapy system 420 of Figure 26-32 and 38 of an embodiment The isometric exploded view of component 422, lantern ring 440 and casing 534.Casing 534 is configured in lantern ring 440 and gasket assembly It is handled, and can be held in place between 422 in any suitable manner.For example, casing 534 can be installed Rear surface 454 in the rear surface 454 of lantern ring 440 or adjacent to lantern ring 440, then by arriving gasket assembly 422 " buckle " Casing is secured in position by collar rim 526, as above in conjunction with described in Figure 39-40.Alternatively, casing 534 can be consolidated with adhesive Determine onto lantern ring 440 or gasket assembly 422.In addition, casing 534 can be made of any suitable material, such as by soft, saturating Gas, moisture absorbing and sweat releasing fabric be made, to make sleep apnea system compared with the sleep apnea system of not casing 420 is more comfortable for subject 405 (for example, Figure 38), while it is true to still allow for sleep apnea system to extract out by casing Sky is to generate negative pressure region (for example, Figure 38) between casing and the neck of subject 400.In addition, sleep apnea system Some or all of component (for example, pump, motor, controller, battery, temperature sensor, thermoregulator) can fix On the one or more compartments formed into casing 534 or set within it.In addition, lantern ring 534 can be it is machine-washable and can Replacement；If there is component is fixed on casing or is arranged in casing, then these components can be lost together with used casing It abandons and is replaced with new casing or component can take out from used casing and be reinstalled with new casing.In addition, casing 534 can be configured as the extension of neck 400 partially or wholly around subject.

Figure 42 be according to the isometric view of the sleep apnea therapy system 420 of Figure 26-32 and 38 of an embodiment, Wherein sleep apnea system includes rechargeable battery 110 (Fig. 8 and 45).

Figure 43 is the empty charging according to the sleep apnea therapy system 420 for Figure 41 of an embodiment and deposits The isometric top view of storage box 540.

Figure 44 is temporary according to the sleep-respiratory of Figure 42 of the inside of the charging and the storage box 540 in Figure 43 of an embodiment Stop the isometric front view for the treatment of system 420.

2-44 referring to fig. 4, sleep apnea system 420 include conductive charging contact 542, are configured in sleep-respiratory The conductive charging contact 544 being arranged in box 540 is engaged when Break-Up System stores in box 540.

Charging and the storage box 540 can be made of any suitable material, and can have any suitable configuration.Example Such as, charging box 540 can be made of plastics, and can have rear hinged clamshell structure shown in such as Figure 43-44.

In addition, charging and the storage box 540 are configured as receiving power signal from power source (being not shown in Figure 42-44), and And power letter can be received by wired connection (such as power line) or wireless (for example, inductively or otherwise electromagnetically) Number (for example, input voltage or input current), power source such as standard electric alternating current (AC) wall socket (110 or 220VAC), AC Adapter (such as " wall wart "), solar battery and another battery.

Sleep apnea system 420 or charging and the storage box 540 include that battery charger (does not show in Figure 42-44 Out), it is configured as being converted to the electric power signal from power source into charging signals (for example, charging current or charging voltage), It is suitable for be loaded in sleep apnea system 420 (for example, in compartment 462 of Figure 34) battery 110 (Fig. 8 and Figure 45) charge.If sleep apnea system 420 includes battery charger, box 540 passes through charging contact 542 The power signal from the power source coupled with box is provided to battery charger with 544.But as compartmentalized box for holding assorted fruits and candies 540 is filled including battery Circuit, then box provides charging signals to battery 110 by charging contact 542 and 544.In one embodiment, box 540 includes Battery charger, to reduce the size and weight of sleep apnea system 420.

Alternatively, sleep apnea system 420 and charging and the storage box 540 can be omitted contact 542 and 544, and Box, which can be configured as, wirelessly provides power signal or charging signals to sleep apnea system.For example, box 540 can To be configured as inductively providing power signal or charging signals to sleep apnea system 420, that is, to be similar to card reader It is provided to the mode for the mode for loading circuit circuit with power signal on smart cards.

Figure 45 is the negative pressure sleep apnea therapy system 420 according to Figure 26-32,38,42 and 44 of an embodiment Component models 550 block diagram.For example, the lantern ring compartment of lantern ring 440 can be partially or even wholly arranged in component models 550 In 462 (Figure 34)；If be only partially arranged in compartment, the rest part of component models may be provided at other portions of lantern ring Divide, in gasket assembly 422 or in the outside of lantern ring and gasket assembly.

Unless otherwise stated, the structure and function of the component of component models 550 can be with the component models 74 of Fig. 8 The structure and function of corresponding component is same or like；Therefore, the like of component models 550 is with the corresponding portion of component models 74 The identical appended drawing reference mark of the appended drawing reference of part.

Also, unless otherwise stated, the sleep apnea system 420 and component of Figure 26-32,38,42 and 44 The flow chart 270 that module 550 and its component can be configured as according to fig. 23 operates.

Other than the structure and function of the switching power devices 100 described above in conjunction with Fig. 8, the switching power devices are also It may include switch 480 and other circuits above in conjunction with Figure 36 description.In addition, other than manual operation, it can be with operating work Rate switch block 100, such as operated by the remote control equipment device of such as remote control equipment 484 (Figure 37) etc with sleep-respiratory is temporary Stop system 420 is changed into " on " (enabling) and " shutdown " (deactivated).Furthermore, it is possible to which operation power switch block 100 is to sleep It is enabled while dormancy apnea system is arranged in pedestal or box (for example, box 540 of Figure 43-44) and deactivated sleep-respiratory is temporary Stop system 420, or enable and deactivate while sleep apnea system is attached to vacuum hose (being not shown in Figure 45) Sleep apnea system 420, in this case, switching power devices can be configured to allow subject 405 (for example, figure 38) enable and deactivate the vacuum source being arranged in base unit attached by hose.In addition, switching power devices 100 can be by It is configured to deactivate sleep apnea system automatically when subject 405 removes sleep apnea system from his/her body 420.For example, sleep apnea system 420 may include sensor (for example, accelerometer, gyroscope, temperature sensor, red Outer sensor), it is configured as when sensing subject 405 puts on or take off sleep apnea system 420.

Other than the function of the motor sub-assembly 116 and pump assembly 118 that describe above in conjunction with Fig. 8, controller 134 can be with It is configured to intermittently enable motor sub-assembly and therefore drives one or more pumps of pump assembly to enable motor and driving with continuous One or more pump is compared to saving power.For example, controller 134 can be configured to operate motor sub-assembly using lag as follows 116 and pump assembly 118, to open the air flue 14 (Fig. 1) of subject.Controller 134 is configured to enable motor sub-assembly 116 to drive One or more pumps of pump assembly 118, until the negative pressure amplitude in one or more pressure spans equals or exceeds first threshold Amplitude.Then, controller 134 is configured as deactivating motor sub-assembly 116, until the amplitude of negative pressure falls below the second threshold The amplitude of value, the amplitude of the second threshold are less than the amplitude of first threshold.It is equal to or less than the second threshold in response to the amplitude of negative pressure The amplitude of value, controller 134 are configured as enabling motor sub-assembly 116 to repeat hysteresis cycle.

In addition, other assemblies, portion can also be used other than the component described above in conjunction with the component models 74 of Fig. 8 Part module 550 also includes at least telecommunication circuit 552, situation and other sensors component 554 and curative component 556.

Telecommunication circuit 552 is configured as allowing controller 134 and remote equipment (such as remote computer system) or long-range Equipment (such as remote control equipment 484) (Figure 37) communication.For example, telecommunication circuit 552 may include circuit, connector and day Line is configured as allowing controller 134 by wiredConnection and by wireless channel (such as Infrared or radio frequency (RF) channel) it is communicated with remote equipment.Controller 134 It is configured as example receiving instruction and setting from remote equipment, provide to remote equipment about the (figure of sleep apnea system 420 26-32,38,42 and state, use and other information 44), and provide to remote equipment about using sleep apnea The information of the subject 405 (for example, Figure 38) of system.The example of this instruction and setting includes by sleep apnea system 420 generate the peak suction threshold values of one or more negative pressure regions, wakeup time and whether use sealant-distributor group Part 124 distributes sealant.The example of state, use and other information include the charge level of battery 110, subject 405 Using the hourage of sleep apnea system 420 and the characteristic of the apnea detected (for example, apnea Degree/amplitude characteristic of event, quantity, the degree/amplitude of apnea of apnea per unit time Mean change and apnea per unit time quantity variation) and whether be replacement sleep-respiratory it is temporary When the component that the one or more of stop system is specified.And the example of the information about subject 405 includes subject's The characteristic of physical condition or parameter (for example, blood pressure, blood glucose level) changed over time is (for example, amplitude, phase, amplitude change And phase change).Allow controller 134 that the information is uploaded to database, example in addition, telecommunication circuit 552 can be configured as Such as cloud database.In addition, if controller 134 is configured as operating by executing software instruction, or in other situation Under be that software or firmware are configurable, then controller, which can be configured as, downloads software and firmware via telecommunication circuit 552.

Referring still to Figure 45, situation and other sensors component 554 may include one or more sensors, be configured For the one or more situations or other situations for sensing subject 405 (for example, Figure 45), reason is not that detection is passed through by subject The level for the sleep apnea gone through, and its reason is not the lantern ring 440 (for example, Figure 44) and neck detected in subject 405 The pressure-reduction level generated between portion 400 (for example, Figure 38).For example, component 554 may include one or more sensors, configuration At the health of detection instruction subject 405 or the situation of level of comfort (for example, blood pressure, blood glucose level, body kinematics are horizontal, sleep Dormancy quality).In addition, component 554 may include one or more sensors, detection is configured as (for example, when subject falls asleep When, when subject's revival, when subject puts on and removes) use of the subject to sleep apnea therapy system 420 Situation and subject 405 environment locating while using sleep apnea system situation (for example, environment temperature, The level of environment light, environment/background noise level, level of pollution).

It is that may include below in apnea degree sensor component 128, situation and other sensors component 554 In or sensor in the two of sensor module 128 and 554 description.For example, each sensor module 128 and 554 can be with Respective sensor (for example, pulse oximetry) or component 128 and 554 including same type can effectively share The sensor can be used in such sensor, controller 134, for example, to determine that subject 405 (for example, Figure 38) is passing through The level for the sleep apnea gone through, and determine the situation of subject with the sleep for being undergoing in addition to determining subject Purpose except the level of apnea.

For example, one or two of sensor module 128 and 554 may include traditional pulse oximetry (pulse- Oxygen) sensor, it is configured as generating the signal for indicating the oxygen level in subject's blood, and it also can be configured as production The raw signal for indicating heart rate.

There are two types of pulse-lambda sensors of type: reflection-type and transmission-type.Although reflection-type arteries and veins is only described in detail here It fights-lambda sensor, but component 128 and 554 also may include Transmittance type pulse-lambda sensor.

Reflectance pulse-lambda sensor will be transferred to subject 405 in two signals under corresponding near-infrared (IR) wavelength Skin in, and the part of the first and second signals is redirected back to pulse-lambda sensor by the blood vessel of subject.It is received The first signal redirection part amplitude in the blood for flowing through blood vessel hemoglobin carrying the amount of oxygen it is unrelated；Cause This, the first signal is used as reference signal.On the contrary, the amplitude of the redirection part of received second signal with flow through the blood of blood vessel The amount for the oxygen that hemoglobin carries in liquid is proportional.Because the first and second signals all undergo the tissue propagated through from them Identical decaying, so the level of the difference of signal amplitude and the oxygen in subject's blood is proportional.

Reflectance pulse-lambda sensor is configured as receiving in redirection part and the sensor of the first and second signals Circuit or separated with sensor circuit (for example, in sensor module 128, in sensor module 554, controller 134 In or in component models 550 elsewhere) be configured in response to received first and second signal redirection portion The amplitude difference divided determines pulse-oxygen reading in a usual manner.

Circuit in sensor or the circuit separated with sensor also can be configured as in response to institute received first and The amplitude difference of the redirection part of second signal determines the heart rate of subject.Because in the blood of subject 405 living It is constantly present oxygen, thus, during high pressure (i.e. systole phase) part of subject's cardiac cycle, the redirection portion of second signal Point amplitude it is higher because blood is more and therefore, always oxygen is more in the vasculature part for IR signal incidence that two emit； Similarly, during the low pressure of cardiac cycle (that is, diastole) part, the amplitude of the redirection part of second signal is lower, because For in blood part blood it is less, and therefore, always oxygen is less in the vasculature part for IR signal incidence that two emit.Cause This, by the bandpass filter transmitting of the passband with about 50Hz to 300Hz indicate received redirection first and the The signal of difference between the amplitude of binary signal causes the signal of filtering to have frequency approximately equal with the heart rate of subject.

If pulse-lambda sensor is included in apnea degree sensor component 128, controller 134 can be by The information that pulse-lambda sensor provides is configured so as to determine sleep apnea degree (example that subject 405 is undergoing Such as, Figure 38).When the air flue 14 (Fig. 1) of subject is blocked during obstructive sleep apnea event, pass through him/her Lung reach the oxygen level of subject's blood and reduce, and his/her heart rate is got higher.Therefore, it is reduced by detection blood oxygen level With heart rate increase at least one of, controller 134 can determine that subject is undergoing sleep apnea event, and can To take movement appropriate (for example, increasing the throat region 406 or throat region 407 (Figure 24-25) that are applied to subject The amplitude of negative pressure) to mitigate obstruction.

In some cases, airway obstruction starts between the measurable reduction of blood oxygen level or the measurable increase of heart rate Time may be too long for blood oxygen level or heart rate, and cannot act as the sleep apnea index of the response of controller 134.

Even if in these cases, low blood oxygen level or raised heart rate also are used as subject 405 still from control Device 134 is by sensing the index restored in the sleep apnea event that another label detects.

And if pulse-lambda sensor is included in situation and other sensory packages 554, controller 134 can be by The information that pulse-lambda sensor provides is configured so as to determine the health status or other parameters of subject.For example, extending Period in, it is strong that low blood oxygen level or raised, reduce or unstable heart rate can indicate that subject 405 has Kang Wenti, such as chronic obstructive pulmonary disease (COPD) or cardiac problems, such as auricular fibrillation or other arrhythmia cordis, the congested heart Force failure or angiemphraxis.Accordingly, in response to from this information of pulse-lambda sensor, controller 134 be can be configured as Anomaly parameter is alerted to subject 405 via output device 140 or telecommunication circuit 552 and suggests that subject sees the doctor.Alternatively, Controller 140 even can be configured as the problem of diagnosis leads to anomaly parameter and via output equipment 140 or telecommunication circuit 552 notify the doctor of subject 405 or subject.

Referring still to Figure 45, one or two of sensor module 128 and 554 may include audio sensor, such as Piezoelectric microphones are configured as generating the signal for indicating its received sound levels.

Circuit in audio sensor or the circuit separated with audio sensor can be configured as filtering or with its other party The signal that formula processing is generated by audio sensor, allows controller 134 to collect information from signal.For example, circuit can be with Filtered sensor signal is configured as to generate the filtering signal with the frequency for being approximately equal to subject's respiratory rate.Alternatively, Circuit, which can be configured as, carries out spectrum analysis to sensor signal to obtain being exhaled by subject 405 (for example, Figure 38) generation Sound absorption, or obtain the breathing volume of subject.

If audio sensor is included in apnea degree sensor component 128, controller 134 can be configured For the degree for using the information provided by audio sensor to determine sleep apnea that subject 405 is undergoing.For example, Response air flue 14 (Fig. 1) of subject during obstructive sleep apnea event is blocked, the breathing that subject 405 issues Sound (for example, snoring) can change, and the respiratory rate of subject can change or the respiratory capacity of subject is (that is, sucking or exhaling Air capacity out) it can change.As described above, circuit can be configured as the signal that processing is generated by audio sensor, and Controller 134, which can be configured as, determines whether subject is undergoing sleep apnea thing in response to handled signal The level or degree of part and this event.For example, controller 134 can be configured as the signal in response to processing, at any time The Breathiness characteristic for determining subject 405 is elapsed, and look-up table (LUT) 148 can store the different breathings of subject The expression of sound property and the corresponding air flue resistance for being undergoing the different Breathiness characteristic of subject with subject Fill in horizontal relevance.By corresponding to identified Breathiness characteristic (or corresponding to most closely matching institute from the retrieval of LUT 148 The characteristic of determining characteristic stored) airway obstruction level, controller 134 can be in response to the Breathiness that senses It determines the level for the airway obstruction that subject 405 is undergoing, and movement appropriate can be taken (to be applied to for example, increasing The amplitude of the negative pressure of subject's throat region 406 or throat region 407 (Figure 24-25)).Similarly, controller 134 can configure At the respiratory rate or breathing flow characteristic for determining subject 405, and LUT 148 can store the different respiratory rates of subject Or the airway obstruction for breathing flow characteristic and being undergoing the different respiratory rates of subject or breathing flow characteristic and subject Horizontal relevance.By from LUT 148 retrieval correspond to identified respiratory rate or breathing flow characteristic (or correspond to it is closest Ground match determined by characteristic the characteristic stored) airway obstruction it is horizontal, controller 134 can be exhaled in response to what is sensed Suction rate or the respiratory capacity sensed determine the level for the airway obstruction that subject is undergoing, and can take appropriate dynamic Make (for example, increasing the amplitude for being applied to the throat region 406 of subject or the negative pressure of throat region 407 (Figure 24-25)) with slow Unblock.

If audio sensor is included in situation and other sensory packages 554, controller 134, which can be configured as, to be made The health status or other parameters of subject are determined with the information provided by audio sensor.For example, in the extended period The health that interior low respiratory rate or low respiratory capacity can indicate that there is subject sleep apnea system 420 can not alleviate is asked Topic, such as chronic obstructive pulmonary disease (COPD) or airway obstruction.Accordingly, in response to this information from audio sensor, control Device 134 processed, which can be configured as, to be alerted anomaly parameter to subject 405 via output equipment 140 or telecommunication circuit 552 and builds View subject sees the doctor.Alternatively, controller 134 even can be configured as the problem of diagnosis leads to anomaly parameter, and via Output equipment 140 or telecommunication circuit 552 provide diagnosis to the doctor of subject 405 or subject.

In addition, one or two of sensor module 128 and 554 may include motion sensor, such as MEMS accelerates Degree meter or gyroscope, can be configured as generate indicate its sports level being undergoing signal, the movement for example due to The movement of subject 405 (for example, Figure 38) and cause.

Circuit in motion sensor or the circuit separated with motion sensor can be configured as filtering or with its other party The signal that formula processing is generated by motion sensor, allows controller 134 to collect information from signal.For example, motion-sensing Device can be configured as the fluctuating (being not shown in Figure 45) that subject's chest is sensed when he/her breathes, wherein the frequency of the fluctuating Rate is the respiratory rate of subject, and the amplitude of this fluctuating is directly proportional to the respiratory capacity of subject.Therefore, circuit can be by Filtered sensor signal is configured to generate the filtering signal with the frequency for being approximately equal to subject's respiratory rate.Alternatively, electric Road can carry out spectrum analysis to sensor signal, to generate other respiratory movements made by subject 405 (for example, cough Or breathe) expression, or generate subject respiratory capacity expression.In addition, if motion sensor sufficiently closes to subject Arteria carotis in one, then circuit can be configured as filtered sensor signal with generate have equal to subject the heart The filtering signal of the frequency of dirty/pulse frequency.

If motion sensor is included in apnea degree sensor component 128, controller 134 can be configured For the degree for using the information provided by motion sensor to determine sleep apnea that subject 405 is undergoing.Response The air flue 14 (Fig. 1) of subject is blocked during obstructive sleep apnea event, the respiratory movement that subject 405 makes (for example, coming from snoring, chest rise, cough, snorting vibration) can change, and the respiratory rate of subject can change, by The respiratory capacity of examination person can change, and the heart rate of subject can change.As described above, circuit can be configured as processing by The signal that motion sensor generates, and controller 134 can be configured as and determine subject 405 in response to handled signal Whether degree/the level of sleep apnea event and this event is undergoing.For example, controller 134 can be configured For the signal in response to processing, the respiratory movement characteristic of subject 405 is determined, and LUT 148 can store subject not Same respiratory movement characteristic and the corresponding air flue for being undergoing the different respiratory movement characteristic of subject with subject Blocking level association.By corresponding to identified respiratory movement characteristic (or corresponding to most closely matching from the retrieval of LUT 148 The characteristic of identified characteristic stored) airway obstruction level, controller 134 can transport in response to the breathing that senses The dynamic level for determining airway obstruction that subject 405 is undergoing, can take movement appropriate (for example, increase be applied to by The amplitude of the negative pressure of examination person's throat region 406 or throat region 407 (Figure 24-25)).Similarly, controller 134 can be configured to Determine the respiratory rate, respiratory capacity or heart rate characteristic of subject 405, and LUT 148 can store not sharing a common fate for subject Rate, respiratory capacity or heart rate characteristic and the different respiratory rates of subject or breathing flow characteristic and subject are undergoing The horizontal relevance of airway obstruction.It is (or right by corresponding to identified respiratory rate, respiratory capacity or heart rate from the retrieval of LUT 148 Ying Yu most closely match determined by characteristic the characteristic stored) airway obstruction it is horizontal, controller 134 can be in response to The respiratory rate, respiratory capacity or the heart rate that sense determine the level for the airway obstruction that subject is undergoing, and can take Movement appropriate is to reduce the degree of airway obstruction or eliminate airway obstruction.

If motion sensor is included in situation and other sensory packages 554, controller 134, which can be configured as, to be made The health status or other parameters of subject are determined with the information provided by motion sensor.For example, in the extended period Interior excessive body kinematics can indicate subject 405 without cosily or depth sleep, be sleep-walking or there is uneasy leg Syndrome.Accordingly, in response to this information from motion sensor, controller 134 be can be configured as via output equipment 140 or telecommunication circuit 552 alert anomaly parameter to subject 405 or his/her doctor and suggest that subject sees that his/her is cured It is raw.Alternatively, controller 134 even can be configured as the problem of diagnosis leads to anomaly parameter, and via output equipment 140 or Telecommunication circuit 552 provides diagnosis to the doctor of subject 405 or subject.

In addition, one or both of sensor module 128 and 554 may include stroke output sensor, such as scarcely perceptible pulse It fights radar transceiver, can be configured to the letter of the stroke output for generating the heart for indicating subject or stroke output variation Number (stroke output is the blood volume that left ventricle pumps out in cardiac cycle).

Circuit in stroke output sensor or the circuit separated with stroke output sensor can be configured as Filter or otherwise handle the signal generated by stroke output sensor, allow controller 134 from signal collection by The stroke output of the heart of examination person.For example, the signal that sensor generates can indicate the image that left ventricle changes over time, and And circuit can be with trap signal, so that the amplitude of filtering signal is proportional to stroke output, (left ventricle is in its maximum and most Difference between a small amount of).

If stroke output sensor is included in apnea degree sensor component 128, controller 134 can be with The information that is there is provided by stroke output sensor is configured with to determine sleep apnea that subject 405 is undergoing Degree.Response air flue 14 (Fig. 1) of subject during obstructive sleep apnea event is blocked, subject's heart Stroke output may attempt do not have obstructive sleep to exhale to the oxygenation degree ratio of the wherein blood of subject with heart The low more oxygen of tissue offer of oxygenation degree of the blood of suspending event are provided and are increased.That is, output of often fighting Amount increases the oxygen for being compensated the reduced levels as caused by airway obstruction in subject's blood.As described above, circuit can be by It is configured to handle the signal generated by stroke output sensor, and controller 134 can be configured as in response to handled Signal determine whether subject is undergoing degree/level of sleep apnea event and this event.For example, control Device 134 processed can be configured as the signal in response to processing, determine the stroke output characteristic of subject 405, and LUT 148 Can store the different stroke output characteristics of subject and by the different stroke output characteristic of subject with it is tested Corresponding airway obstruction degree/horizontal relevance that person is undergoing.It is defeated by often fighting corresponding to determined by from the retrieval of LUT 148 The level of the airway obstruction of flow characteristic (or corresponding to the characteristic stored for most closely matching identified characteristic) out, control Device 134 can determine the level for the airway obstruction that subject is undergoing in response to the stroke output sensed, can take Movement appropriate is (for example, increase the width for being applied to the negative pressure of subject's throat region 406 or throat region 407 (Figure 24-25) Value) to slow down obstruction.

In some cases, the time between the beginning and the increase of measurable stroke output of airway obstruction is too long, So that stroke output cannot act as the corresponding sleep apnea of controller 134 label.

Even if in these cases, stroke output also is used as subject 405 still from another by sensing The index restored in the sleep apnea event that sleep apnea label (for example, breathing) detects.

If stroke output sensor is included in situation and other sensory packages 554, controller 134 can be matched It is set to using the information provided by stroke output sensor and determines the health status or other parameters of subject 405.For example, When subject 405 during sleep, excessive or low stroke output can indicate that subject does not have within the extended period Have cosily or depth sleep, be sleep-walking or the cardiac problems with such as congestive heart failure etc.Therefore, it responds In this information from stroke output sensor, controller 134 be can be configured as via output equipment 140 or communication electricity Road 552 alerts abnormal stroke output to subject 405 or his/her doctor and suggests that subject sees the doctor.Alternatively, control Device 140 even can be configured as the problem of diagnosis leads to abnormal stroke output, and via output equipment 140 or communication electricity Road 552 provides diagnosis to the doctor of subject or subject.

And because stroke output periodically occurs, stroke output sensor and its correlation can also be configured Circuit is to provide the heart rate of (for example, Figure 38) of subject 405.

In addition, one or both of component 128 and 554 may include traditional gas sensor (for example, spectroscopic gas Sensor), it can be configured as and generate the substance in the exhalation object for indicating subject (i.e. the air of the exhalation of subject 405) The signal of the variation of (for example, quality, volume or molecular number) ratio or level or ratio or level.The example packet of this substance Include vapor, carbon dioxide (CO₂), oxygen (O₂) and volatile organic compounds (VOC).If the substance sensed is CO₂, So gas sensor may include nondispersive infrared CO₂Module.

Circuit in gas sensor or the circuit separated with gas sensor can be configured as filtering or with its other party The signal that formula processing is generated by gas sensor, collects controller 134 compared with the substance total amount of subject's exhalation Subject exhalation substance ratio or level or ratio or level variation.

If gas sensor is included in apnea degree sensor component 128, controller 134 can be configured For the degree for using the information provided by gas sensor to determine sleep apnea that subject 405 is undergoing.Response The air flue 14 (Fig. 1) of subject is blocked during obstructive sleep apnea event, and subject breathes out the substance in object Ratio or level can increase (for example, CO₂) or reduce (for example, O₂).As described above, circuit can be configured as processing by gas The signal that body sensor generates, and controller 134 can be configured as and determine that subject 405 is in response to handled signal No degree/the level for being undergoing sleep apnea event and this event.For example, controller 134 can be configured as In response to the signal of processing, the characteristic of the substance of the exhalation of subject 405 is determined, and LUT 148 can store subject 405 Different exhalation substance characteristic and the characteristic of the substance of the different exhalation of subject is undergoing with subject Corresponding airway obstruction degree/horizontal relevance.By the characteristic for corresponding to the substance of identified exhalation from the retrieval of LUT 148 Degree/level of the airway obstruction of (or corresponding to the characteristic stored for most closely matching identified characteristic), controller 134 can determine the level for the airway obstruction that subject 405 is undergoing in response to the substance of the exhalation sensed, and can be with Take movement appropriate (for example, increasing the negative pressure for being applied to subject's throat region 406 or throat region 407 (Figure 24-25) Amplitude) to slow down obstruction.

If gas sensor is included in situation and other sensory packages 554, controller 134, which can be configured as, to be made The health status or other parameters of subject 405 are determined with the information provided by gas sensor.For example, working as subject 405 During sleep, the CO of extra proportion or level is breathed out within the extended period₂Subject can be indicated without cosily Or depth sleep, or have lung's problem.Accordingly, in response to this information from gas sensor, controller 134 can To be configured as alerting abnormal exhalation object to subject 405 or his/her doctor via output equipment 140 or telecommunication circuit 552 Characteristic and suggest that subject sees the doctor.Alternatively, controller 140, which even can be configured as diagnosis, leads to abnormal exhalation object characteristic The problem of, and diagnosis is provided to subject 405 or his/her doctor via output equipment 140 or telecommunication circuit 552.

Referring still to Figure 45, one or both of component 128 and 554 may include traditional chemical sensor, can To be configured as generating the substance sensed indicated in the sweat in such as subject, expiration, saliva, lipid or tears The signal of (for example, quality, volume or molecular number) ratio or level or the ratio or level.The example of this substance includes such as Hormone, alcohol, vapor, the carbon dioxide (CO of cortisol etc₂), oxygen (O₂) and volatile organic compounds (VOC).

Circuit in chemical sensor or the circuit separated with chemical sensor can be configured as filtering or with its other party The signal that formula processing is generated by chemical sensor, allows controller 134 to collect the substance total amount phase being discharged with subject 405 The variation of the ratio or level or ratio or level of the substance of subject's discharge of ratio.

If chemical sensor is included in apnea degree sensor component 128, controller 134 can be configured For the degree/level for using the information provided by chemical sensor to determine sleep apnea that subject 405 is undergoing. In response to during obstructive sleep apnea event the air flue 14 (Fig. 1) of subject be blocked, subject 405 be discharged object The ratio or level of matter can increase (for example, cortisol) or reduce.As described above, circuit can be configured as processing by chemistry The signal that sensor generates, and controller 134 can be configured as in response to whether handled signal determines subject 405 It is undergoing degree/level of sleep apnea event and this event.For example, controller 134 can be configured as sound In the signal of processing, should determine the sweat of subject 405 or the characteristic of saliva substance, and LUT 148 can store it is tested The different sweat of person or the characteristic of saliva substance and by the characteristic of the different sweat of subject or saliva substance with Corresponding airway obstruction degree/horizontal relevance that subject 405 is undergoing.It is determined by corresponding to from the retrieval of LUT 148 Sweat or saliva substance characteristic (or corresponding to most closely match determined by characteristic the characteristic stored) gas The level of road obstruction, controller 134 can determine the air flue that subject 405 is undergoing in response to the substance of the discharge sensed The level of obstruction, and movement appropriate can be taken (to be applied to subject's throat region 406 or throat region for example, increasing The amplitude of the negative pressure of 407 (Figure 24-25)) to slow down obstruction.

If chemical sensor is included in situation and other sensory packages 554, controller 134, which can be configured as, to be made The other parameters of health status or the health of subject are determined with the information provided by chemical sensor.For example, working as subject 405 during sleep, within the extended period by the cortisol of perspire discharge extra proportion or level can indicate by Examination person without cosily or depth sleep；Similarly, when subject had been discharged by perspiring in a long time during sleep The alcohol of amount ratio or level may indicate that subject is drunk, and therefore may have drinking problem.Accordingly, in response to next From this information of chemical sensor, controller 134 can be configured as via output equipment 140 or telecommunication circuit 552 to by Examination person 405 or his/her doctor alert abnormal emissions characteristics and suggest that subject sees his/her doctor.Alternatively, controller 140 even can be configured as the problem of diagnosis leads to abnormal emissions characteristics, and via output equipment 140 or telecommunication circuit 552 provide diagnosis to subject 405 or his/her doctor.

In addition, one or two of sensor module 128 and 554 may include electroencephalogram (EEG) sensor module, It is configurable to generate one or more signals of the electrical activity in the brain for indicating subject 405 (for example, Figure 38).EEG sensing Device assembly may include one or more sensors, be attached on lantern ring 440 either a part or separate of lantern ring 440 (example of this distance sensor is the epidermis electronic sensor that can be printed to lantern ring, or otherwise directly adheres to or pacify On the skin of subject).

Circuit in EEG sensor module or the circuit separated with EEG sensor module can be configured as filtering or with One or more signals that other modes processing is generated by EEG sensor module, allow controller 134 from this or more A signal collection information.For example, circuit can be configured as filtering one or more of one or more sensors signal with Generate one or more filtering signals of the sleep state or other situations that indicate subject 405.Alternatively, circuit can be configured For spectrum analyses are carried out to one or more in one or more sensors signal with obtain the sleep state of subject 405 or Other situations.

If EEG sensor module is included in apnea degree sensor component 128, controller 134 can be by The information provided by EEG sensor module is configured so as to determine the journey of sleep apnea that subject 405 is undergoing Degree.For example, in response to during obstructive sleep apnea event the air flue 14 (Fig. 1) of subject be blocked, subject 405 Sleep state can change or the brain of subject in electrical activity can change in other ways.As described above, circuit It can be configured as one or more signals that processing is generated by EEG sensor module, and controller 134 can be configured as Determine whether subject is undergoing sleep apnea event and this thing in response to handled one or more signals The level or degree of part.For example, controller 134 can be configured as in response to handled one or more signals, determine by The sleep state characteristic or E.E.G characteristic that examination person 405 changes over time, and look-up table (LUT) 148 can store subject's The expression of different sleep states and E.E.G characteristic and undergo the different sleep states of subject and E.E.G characteristic with subject Corresponding airway obstruction level it is associated.By corresponding to identified sleep state and E.E.G characteristic from the retrieval of LUT 148 The level of the airway obstruction of (or corresponding to the characteristic stored for most closely matching identified characteristic), controller 134 can To determine the level of airway obstruction that subject 405 is undergoing in response to the sleep state sensed or electrical activity of brain, and Movement appropriate can be taken (for example, increasing the throat region 406 or throat region 407 (Figure 24-25) for being applied to subject The amplitude of negative pressure).

If EEG sensor module is included in situation and other sensory packages 554, controller 134 can be configured The health status or other parameters of subject are determined at the information provided by EEG sensor module is used.For example, extended Poor sleep state characteristic is not (for example, enter one or more sleep states, within short time or long time in period Keep sleep state) it can indicate that subject has health problem, such as chronic obstructive pulmonary disease (COPD), sleep apnea system The psychic problems of airway obstruction or interference subject's sleep that system 420 can not be alleviated.Accordingly, in response to from EEG sensor group This information of part, controller 134, which can be configured as, to be alerted via output equipment 140 or telecommunication circuit 552 to subject 405 Anomaly parameter (for example, sleep state characteristic of difference) simultaneously suggests that subject goes to see the doctor.Alternatively, controller 134 even can be by Be configured to diagnosis the problem of leading to anomaly parameter (for example, anxiety), and via output equipment 140 or telecommunication circuit 552 to by The doctor of examination person 405 or subject provide diagnosis.

In addition, one or two of sensor module 128 and 554 may include electrocardiogram (EKG) sensor module, It is configurable to generate one or more signals of the electrical activity in the heart for indicating subject 405 (for example, Figure 38).EKG sensing Device assembly may include one or more sensors, be attached on lantern ring 440 either a part or separate of lantern ring 440 (example of this distance sensor is the epidermis electronic sensor that can be printed to lantern ring, or otherwise directly adheres to or pacify On the skin of subject).

Circuit in EKG sensor module or the circuit separated with EKG sensor module can be configured as filtering or with One or more signals that other modes processing is generated by EKG sensor module, allow controller 134 from this or more A signal collection information.For example, circuit can be configured as filtering one or more of one or more sensors signal with Generate one or more filtering signals of the sleep state or other situations or parameter that indicate subject 405.Alternatively, circuit can be with It is configured as to one or more progress spectrum analyses in one or more sensors signal to obtain the sleep of subject 405 State or other situations.

If EKG sensor module is included in apnea degree sensor component 128, controller 134 can be by The information provided by EKG sensor module is configured so as to determine the journey of sleep apnea that subject 405 is undergoing Degree.For example, in response to during obstructive sleep apnea event the air flue 14 (Fig. 1) of subject be blocked, subject 405 Sleep state can change or the heart of subject in electrical activity can change in other ways.As described above, circuit It can be configured as one or more signals that processing is generated by EKG sensor module, and controller 134 can be configured as Determine whether subject is undergoing sleep apnea event and this thing in response to handled one or more signals The level or degree of part.For example, controller 134 can be configured as in response to handled one or more signals, determine by The sleep state characteristic or cardiac wave characteristic that examination person 405 changes over time, and look-up table (LUT) 148 can store subject's The expression of different sleep states and cardiac wave characteristic and undergo the different sleep states of subject and cardiac wave characteristic with subject Corresponding airway obstruction level it is associated.By corresponding to identified sleep state and cardiac wave characteristic from the retrieval of LUT 148 The level of the airway obstruction of (or corresponding to the characteristic stored for most closely matching identified characteristic), controller 134 can To determine the level of airway obstruction that subject 405 is undergoing in response to the sleep state sensed or electrocardio-activity, and Movement appropriate can be taken (for example, increasing the throat region 406 or throat region 407 (Figure 24-25) for being applied to subject The amplitude of negative pressure).

If EKG sensor module is included in situation and other sensory packages 554, controller 134 can be configured The health status or other parameters of subject are determined at the information provided by EKG sensor module is used.For example, extended Poor sleep state characteristic is not (for example, enter one or more sleep states, within short time or long time in period Keep sleep state) it can indicate that subject has health problem, such as chronic obstructive pulmonary disease (COPD), sleep apnea system The other hearing problem of airway obstruction, heart disease or interference subject's sleep that system 420 can not be alleviated.Accordingly, in response to next From this information of EKG sensor module, controller 134 can be configured as via output equipment 140 or telecommunication circuit 552 to Subject 405 alerts anomaly parameter (for example, cardiac wave characteristic of the sleep state characteristic of difference, difference) and suggests that subject goes to see doctor It is raw.Alternatively, controller 134 even can be configured as the problem of diagnosis leads to anomaly parameter (for example, heart disease, atrial fibrillation It is dynamic), and diagnosis is provided to the doctor of subject 405 or subject via output equipment 140 or telecommunication circuit 552.

In addition, controller 134 may be configured to the variation over time of the heart rate according to subject, heart rate, often fight One or more of output quantity variation over time and respiratory rate determine ballistocardiogram (BCG), and can Determine whether subject 405 is undergoing sleep apnea event to use identified BCG.For example, apnea journey Heart rate, the heart rate that one or more of the sensor in degree sensor module 128 can sense subject push away at any time The variation over time of the variation of shifting, stroke output and respiratory rate, and sensor and its corresponding circuit can produce Represent the signal of this tittle.Controller 134, which can be configured as, determines that the BCG of subject 405 is special in response to handled signal Property, and LUT 148 can store subject different BCG characteristics and by the different BCG characteristic of subject with it is tested The corresponding airway obstruction level that person is undergoing is associated.By corresponding to identified BCG characteristic from the retrieval of LUT 148 The level of the airway obstruction of (or corresponding to the characteristic stored for most closely matching identified characteristic), controller 134 can To determine the level of airway obstruction that subject is undergoing, and can take movement appropriate (for example, increase be applied to by The amplitude of the negative pressure of the throat region 406 or throat region 407 (Figure 24-25) of examination person) to slow down obstruction.

Alternatively, controller 134 can be configured as using identified BCG the health status for determining subject 405 or Other parameters.For example, exception BCG can indicate that subject 405 has cardiac problems.Accordingly, in response to abnormal BCG, controller 134 can be configured as via output equipment 140 or telecommunication circuit 552 alerted to subject 405 or his/her doctor it is abnormal BCG, and suggest that subject goes to see the doctor.Alternatively, controller 140, which even can be configured as diagnosis, leads to asking for abnormal BCG Topic, and diagnosis is provided to subject or his/her doctor via output equipment 140 or telecommunication circuit 552.

In addition, controller 134, which can be configured as, determines photocapacitance according to the information that pulse-oximetry sensors provide Product pulse tracing art (PPG), and determine whether subject 405 is undergoing sleep apnea using identified PPG Event.Controller 134 can be configured as in response to the processing signal from pulse-oximetry sensors, determine subject 405 PPG characteristic, and LUT 148 can store the different PPG characteristics of subject and the different BCG by subject Characteristic is associated with corresponding airway obstruction degree/level that subject is undergoing.By corresponding to institute from the retrieval of LUT 148 The water of the airway obstruction of determining PPG characteristic (or corresponding to the characteristic stored for most closely matching identified characteristic) Flat, controller 134 can determine the level for the airway obstruction that subject 405 is undergoing, and can take movement appropriate (for example, increasing the amplitude for being applied to the throat region 406 of subject or the negative pressure of throat region 407 (Figure 24-25)) is to slow down Obstruction.

Alternatively, controller 134, which can be configured as using identified PPG, determines subject's 405 (for example, Figure 38) Health status or other parameters.For example, exception PPG can indicate that subject 405 has lung's problem or cardiac problems.Therefore, In response to abnormal PPG, controller 134 can be configured as via output equipment 140 or telecommunication circuit 552 to subject 405 or His/her doctor alerts exception PPG, and suggests that subject goes to see the doctor.Alternatively, controller 140 even can be configured as Diagnosis the problem of leading to abnormal PPG, and via output equipment 140 or telecommunication circuit 552 to subject 405 or his/her doctor It is raw that diagnosis is provided.

Referring still to Figure 45, according to an embodiment, curative component 556, which is configured to wear negative pressure in subject 405, sleeps Dormancy apnea system 420 (Figure 26-32,38,42 and 44) when, provide treatment to him/her under the control of controller 134.Example Such as, curative component 556 may include electrode 510a and 510b (Figure 39), and can apply current or voltage via electrode with logical Stimulation oversaturation or " vibration " subject 405 open or are maintained open the air flue 14 (Fig. 1) of subject.Controller 134 can be configured To realize feedback loop, it is tested to open and stay open which adjusts the current or voltage applied via electrode 510 The air flue 14 of person.The circuit can be the feedback loop for being configured to be accomplished by the following way independently of controller 134 or With the combinations of feedback loops: adjusting another parameter (for example, negative pressure in one or more pressure spans) and come with as far as possible most The negative pressure of small magnitude is opened and stays open the air flue 14 of subject.In the case where these feedback loops are independent situation, controller 134 have at least two variables, i.e. pressure and temperature, the adjustable air flue 14 to open and stay open subject.This Outside, curative component 556 may include piezoelectric speaker and can be configured to generate sound by loudspeaker, such as wave bumps against The sound being crushed on seabeach, can console subject 405 and subject can be helped to sleep.Alternatively, curative component 556 can Be configured to respond to controller 134 detect be continued above the time of safety time threshold value sleep apnea event and Loudspeaker is sounded an alarm to wake up subject 405.

Referring still to Figure 45, it is contemplated that the alternate embodiment of component models 550.For example, above in conjunction with the portion of Fig. 8 description The alternate embodiment of part module 74 is readily applicable to component models 550, and the substitution of the component models 550 described is implemented Scheme is readily applicable to component models 74.In addition, component models 500 may include undocumented component herein, or can be with One or more components disclosed herein are omitted.

Figure 46 is the tradition heat according to the supplemental power source 112 of the component models 74 and 550 (Fig. 8 and 45) of an embodiment The isometric view of galvanic couple (TEC) 560.TEC560 is configured to wearing negative pressure sleep apnea therapy in subject 405 System 420 (Figure 26-32,38,42 and 44) when from subject 405 (for example, Figure 38) obtain energy.Component models 74 and 550 Power supply source 117 can be configured as the energy for receiving and being collected by TEC 560, and acquired energy is converted to and is used for One or more components for component models 74 and 550 are powered and the power signal for charging to battery 110.

TEC 560 is configured as being converted to the temperature difference between " heat " side 562 and " cold " side 564 by conductive terminal 566 With 568 electric current and the voltage of leap conductive terminal 566 and 568.For example, TEC 560 can be arranged in sleep apnea System 420 (Figure 26-32,38,42 and 44) in make " heat " side 562 contact subject's body a part (for example, neck 400), and " cold " side 564 exposes in air.Since the normal body temperature of human body is about 98.6 °F, and due to typical room About 68 °F of temperature, therefore the temperature difference between " heat " side 562 and " cold " side 564 is about 30 °F.In response to such temperature difference, construction At generally have effective area be about 100 square millimeters of (mm²) " heat " side 562, and have about 120 squares of effective area One or more TEC560 of " cold " side 564 of millimeter can produce the power of about 5 milliwatts (mW).One or more TEC560 can To be arranged in the band 444 and 446 (Figure 32) of such as sleep apnea system 420 so that " heat " side 562 of each TEC with The neck 400 (for example, Figure 38) of subject is adjacent or contacts.Alternatively, one or more TEC560 can be along the inner surface of lantern ring 440 452 (for example, Figure 31) are arranged in casing 534 (Figure 41), or far from sleep apnea system 420 (for example, in dress It is interior, in shirt or cap).If be arranged far from sleep apnea system 420, one or more TEC560 can be via It is wired or wireless to connect acquired power transmission to power supply source 117 (Fig. 8 and 45).

Referring still to Figure 46, TEC560 and other energy gathering devices that supplemental power source 112 (Fig. 8 and 45) may include Further details in Bhatnagar et al., Energy Harvesting for Assistive and Mobile Applications, Energy Science&Engineering, 3 (3), pp.153-173 obtain disclosure in (2015), lead to It crosses and is incorporated herein by reference.

Figure 47 be according to form adaptive frictional electricity nano generator (saTENG) unit 580 of an embodiment etc. Away from view.

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

7-48 referring to fig. 4, saTENG unit 580 includes the conducting liquid electrode being arranged in inside rubber layer or shell 584 582.One end that conductor passes through shell 584 is inserted into, to provide terminal or pin 586 for electrode 582.Electrode 582 can be formed The example of substance includes water and sodium chloride (NaCl) solution.

Figure 49 is the isometric view according to the saTENG generator 588 of an embodiment comprising the saTENG of Figure 47-48 Unit 580.The supplemental power source 112 of component models 74 and 550 (Fig. 8 and 45) includes generator 588, is configured in subject 405 wear negative pressure sleep apnea therapy systems 420 (Figure 26-32,38,42 and 44) when from him/her obtain energy.Component mould The power supply source 117 (Fig. 8 and 45) of block 74 and 550 can be configured to receive the energy collected by generator 588, and will collect Energy be converted into for for component models one or more components power supply and be component models battery 110 (Fig. 8 and 45) power signal to charge.

Other than saTENG unit 580 (Figure 47-48), generator 588 further includes with nylon layer 592 and aluminium layer 594 Electrode 590.

Generator 588 be configured as by saTENG unit 580 relative to electrode 590 movement and deformation (for example, stretching, extension and Shrink) it is converted into the electric current by conductive terminal 596 and 598 and the voltage across conductive terminal 596 and 598.For example, one Or multiple generators 588 may be provided in sleep apnea system 420, so that the movement of subject's body is (for example, by exhaling Inhale or toss about and rotation caused by movement) make corresponding saTENG unit in each of one or more generators 580 move and deform relative to corresponding electrode 590.In response to corresponding in each of one or more generators 588 This movement or deformation of saTENG unit 580, generator configuration lead to 117 (Fig. 8 of power supply source as described above at generation With power 45).The band 444 and 446 in such as sleep apnea system 420 can be set in one or more generators 588 In (Figure 32).Alternatively, one or more generators 588 can be set in lantern ring 440 (Figure 31) or casing 534 (Figure 41) inside, Perhaps it can be otherwise fixedly secured on lantern ring 440 (Figure 31) or casing 534 (Figure 41) or to may be located remotely from sleep-respiratory temporary Stop system 420, for example, in the clothes of such as shirt or cap etc.If be arranged far from sleep apnea system 420, Then one or more generators 588 can be configured to connect via wired or wireless by the power transmission of collection to power supply source 117。

Referring again to Figure 47-49, saTENG unit 580, generator 588 that supplemental power source 112 (Fig. 8 and 45) may include And the further details of other energy extracting devices are in Yi et al., A Highly Shape-Adaptive, Stretchable Design Based On Conductive Liquid For Energy Harvesting And Self- It is described in Powered Biomechanical Monitoring, Sci.Adv., pp.1-10,17June 2016, by drawing With being incorporated herein.

Figure 50 is the isometric view according to the saTENG generator 610 of another embodiment comprising Figure 47's -48 SaTENG unit 580.The supplemental power source 112 of component models 74 and 550 (Fig. 8 and 45) includes generator 610, is configured to Subject 405 wear negative pressure sleep apnea therapy system 420 (Figure 26-32,38,42 and 44) when from him/her obtain energy. The power supply source 117 (Fig. 8 and 45) of component models 74 and 550 can be configured to receive the energy collected by generator 610, and The energy of collection is converted into the battery 110 for being used for one or more components power supply for component models and being component models The power signal of (Fig. 8 and 45) charging.

Other than the saTENG unit 580 of Figure 47-48, generator 610 further includes aluminium electrode 612.

Figure 51 is according to the charging figure of the generator 610 of Figure 50 of an embodiment, and the figure shows 580 phases of saTENG The figure for how making the charge in electrode 582 and 612 mobile the movement of electrode 612.As described below, in response to this of charge Displacement, generator 610 generate electric current and voltage.

Referring to Figure 50-51, the operation of generator 610 is described according to embodiment.

Generator 610 be configured as by saTENG unit 580 relative to electrode 612 movement and deformation (for example, stretching, extension and Shrink) by make charge electrode 582 (Figure 48) and 612 move be converted into flowing through the electric current of conductive terminal 614 and 616 and Across the voltage of conductive terminal 614 and 616.For example, one or more generators 610 may be provided at sleep apnea system In 420, so that the movement (for example, passing through movement caused by breathing or tossing and rotation) of subject's body makes one or more Corresponding saTENG unit 580 in each of generator is moved and is deformed relative to corresponding electrode 612.In response to one This movement of corresponding saTENG unit 580 in each of a or multiple generators 610 or deformation, generator can produce Lead to the power in power supply source 117 as described above.One or more generators 610 can be set temporary in such as sleep-respiratory In the band 444 and 446 (Figure 32) of stop system 420.Alternatively, one or more generators 610 can be set at lantern ring 440 (Figure 31) Or casing 534 (Figure 41) is internal, or can be otherwise fixedly secured on lantern ring 440 (Figure 31) or casing 534 (Figure 41), or Person may be located remotely from sleep apnea system 420, for example, in the clothes of such as shirt or cap etc.If far from sleep Apnea system 420 is arranged, then one or more generators 610 can be configured to will acquire via wired or wireless connect Power transmission is to power supply source 117 (Fig. 8 and 45).

Referring still to Figure 50-51, the generator 610 and other energy that supplemental power source 112 (Fig. 8 and 45) may include are obtained Take the further details of equipment in Yi et al., A Highly Shape-Adaptive, Stretchable Design Based On Conductive Liquid For Energy Harvesting And Self-Powered It is described in Biomechanical Monitoring, Sci.Adv., pp.1-10,17June 2016, is incorporated by reference into this Text.

Figure 52 is the isometric transparent view according to the TENG generator 612 of another embodiment.(the Fig. 8 of component models 74 and 550 Include generator 620 with supplemental power source 112 45), is configured to wear negative pressure sleep apnea therapy in subject 405 System 420 (Figure 26-32,38,42 and 44) when from him/her obtain energy (such as Figure 38).The power of component models 74 and 550 supplies It answers source 117 (Fig. 8 and 45) to can be configured to receive the energy collected by generator 620, and the energy of collection is converted into being used for For component models one or more components power supply and be component models battery 110 (Fig. 8 and 45) charging power signal.

TENG generator 620 includes packing material 622, and the TENG624 in packing material and at least one super electricity is arranged in Container is the supercapacitor 626 and 628 of two equivalent sizes here, is arranged in packing material and each other electrically in parallel It couples to be effectively formed twice of single supercapacitor of the capacitor that capacitor is each supercapacitor 626 and 628.Packaging Object 622 is configured as stretchable, and can be made of any suitable material of such as silicon rubber etc.

Figure 53 is the cross section according to the TENG 624 of Figure 52 of an embodiment.TENG 624 includes two electrodes 630 With 632, a part 636 of the setting in space 634 and packing material 622 between electrode between the electrodes.Space 634 can be with Filled with any suitable material, such as air, and electrode 630 and 632 can be formed by any suitable material, such as by The compound of carbon black (CB) and silicon rubber is made.

Figure 54 is the cross-sectional view according to each of the supercapacitor 626 and 628 of Figure 52 of an embodiment.Often A supercapacitor 626 and 628 includes two electrodes 638 and 640, and the coating 642 on each electrode is arranged between the electrodes Electrolyte 646, and the fold separator 648 of setting in the electrolyte.Electrode 638 and 640 can be by any suitable material It is formed, such as is formed by material identical with the material of electrode 630 and 632 of TENG 624 of Figure 53 is formed.Coating 642 can be by Any suitable material is formed, such as by active material (for example, Soluble Polypyrrole (PPy)) and conductive additive (such as charcoal It is black) composite material formed.Electrolyte 646 can be formed by any suitable material, such as by polyvinyl alcohol (PVA) phosphoric acid (H₃PO₄) gel-forming.Also, when supercapacitor 626 and 628 is stretched or distorts, prevent the short circuit of electrode 638 and 640 from existing Separator 648 together can be formed by any suitable material (such as polyethylene).

Referring to Figure 52-54, TENG generator 620 is configured to generator deformation (for example, stretch or distort) and produces Raw power.In response to deformation, TENG 624 charges to supercapacitor 626 and 628, supercapacitor 626 and 628 and battery one Sample is configured as generating voltage and current using stored charge.For example, one or more generators 620 can be set and sleep Dormancy apnea system 420 (Figure 26-32,38,42 and 44) in so that subject's body movement (for example, by breathing or roll over Movement caused by turning and rotating) the corresponding TENG 624 in each of one or more generators is deformed.Response This deformation of corresponding TENG 624 in each of one or more generators 620, generator can be to as described above Power supply source 117 (Fig. 8 and 45) provide power.In view of band may be stretched and be distorted, especially when subject wears When wearing or take off sleep apnea system 420, one or more generators 620 be can be set in such as sleep apnea In the band 444 and 446 (Figure 32) of system 420.Alternatively, one or more generators 620 can be set in lantern ring 440 (Figure 31) or Casing 534 (Figure 41) is internal, can perhaps be otherwise fixedly secured on lantern ring 440 (Figure 31) or casing 534 (Figure 41) or It may be located remotely from sleep apnea system 420, for example, in the clothes of such as shirt or cap etc.If exhaled far from sleep It inhales Break-Up System 420 to be arranged, then one or more generators 630 can be via the wired or wireless power transmission that connects and will acquire To power supply source 117 (Fig. 8 and 45).

Referring still to Figure 52-54, the generator 620 and other energy that supplemental power source 112 (Fig. 8 and 45) may include are obtained Take the further details of equipment in Yi et al., Stretchable And Waterproof Self-charging Power System For Harvesting Energy From Diverse Deformation And Powering Wearable Electronics, American Chemical Society (ACS) Nano, 10, pp.6519-6525, description in (2016), It is incorporated herein by reference.

Figure 55 is according to the block diagram of the system 700 of an embodiment, and system 700 includes negative pressure sleep apnea therapy system System 420 (Figure 26-32,38,42 and 44).As described below, system 700, which can be configured as, determines and conveys life to subject 450 The change of mode living to reduce the frequency or seriousness of the sleep apnea event of subject's experience, and can be configured For the health for determining and conveying subject to improve subject to the adjustment of sleep apnea system 420 used to subject (for example, health status).

Other than sleep apnea system 420, system 700 further includes client device 702 and counting circuit 704. Counting circuit 704 and sleep apnea system 420 are configured as via wired or wireless channel (for example, wired or wireless total Line) it 706 communicates with one another, counting circuit and client device 702 are configured as communicating with one another via wired or wireless channel 708, And sleep apnea system and client device are configured as communicating with one another via wired or wireless channel 710.

Client device 702 may include being adapted to allow subject 405 (for example, Figure 38), component models 74 and 550 The life style of the input of the sensor 554 of the sensor 126 and 128 of (Fig. 8 and 45) or component models 550 and subject and Any equipment of the relevant data of health.The example of client device 702 include such as laptop computer, tablet computer or The client computer of smart phone or the situation and other parameters (such as blood pressure, mood, drink that subject 405 can be sensed Food, vigilance degree and subject wake or fall asleep) one or more sensors.

And counting circuit 704 may include be adapted to determine that, convey or realize the living-pattern preservation of subject with Improve the change used of any circuit and subject of his/her sleep apnea to sleep apnea system 420 To improve any circuit of his/her health.For example, counting circuit 704 may include special circuit, the special circuit is permanent Ground is configured to execute all calculating and task as described above and below.Counting circuit 704 can also include circuit, such as micro- place Device or microcontroller are managed, calculating and task, all calculating and task as described above and below can be executed by software configuration. In addition, counting circuit 704 may include circuit, such as one or more field programmable gate arrays (FPGA) or FPGA circuitry, It can be executed calculating and task, all calculating and task as described above and below by firmware configuration.And counting circuit 704 Sleep apnea system 420 and client device 702 can be it is local, or can be such as internet or cloud it A part of the larger network of class.

Referring still to Figure 55, the alternate embodiment of system 700 is considered.For example, client device 702 and counting circuit One or two of 704 can be in sleep apnea system 420, and can be the component of sleep apnea system A part of module 74 and 550 (Fig. 8 and 45).In addition, the one or more sensors 554 (Fig. 8 and 45) of component models 74 are also A part of the either client device 702 of client device 702 can be served as, and can be configured as sensing to indicate tested The one or more situations or other parameters of the subject of the life style and health of person 405.In addition, system 700 may include Instead of the sleep apnea therapy system 70 (Fig. 4-8) of sleep apnea therapy system 420, or in addition to including that sleep is exhaled Inhaling except pause treatment system 420 further includes sleep apnea therapy system 70.

Figure 56 be can be configured as according to the system 700 of Figure 55 of an embodiment realization for mitigating subject's The flow chart 720 of the process of sleep apnea.

Referring to Figure 55-56, the process of flow chart 720 is described according to embodiment.

In step 722, counting circuit 704 is received about subject 405 from sleep apnea system 420 (for example, figure 38) information of the one or more sleep apnea events undergone whithin a period of time.For example, sleep apnea system 420 can be configured as the one or more sleeps of one or more sensors detection using sensor module 128 (Fig. 8 and 45) Apnea, and utilize one or more parameters of the determining one or more events of controller 134.Sleep apnea The example of event include airway obstruction and the sleep disturbance as caused by airway obstruction (for example, the dormant variation of subject, The variation of subject's sleep time and other variations of subject's sleep pattern), and sleep apnea event The example of parameter include duration of event, frequency and severity (for example, open or the percentage of the air flue of obstruction, by The dormant variation degree of examination person, such as whether subject wakes up because of event and the sleep time of subject Variation degree relative to reference duration).Sleep apnea system 420 can be configured as the parameter for determining these Storage in memory 130 (Fig. 8 and 45), and is automatically, or in response to such as request from counting circuit and deposits these The parameter of storage is supplied to counting circuit 704.

Next, counting circuit 704 receives the life style about subject from client device 702 in step 724 Information.The example of information about subject's life style includes lifestyle parameter, for example, subject diet, when having meal Between, the snacks time, motion scheme (including motion frequency, exercise intensity and type of sports), weight, body fat percentage, sleep when Between table (including hourage of sleeping every night, in bed time and the time of leaving the bed, (counting circuit 704 may be from sleep apnea System 420 receives the information)), stress level, habit (for example, smoking, drink beyond one's capacity and take nutritional supplement), blood Pressure, blood glucose level, the drug taken, drug protocol and electronic product use (including before sleep or during sleep between (example Such as, wake up, using electronic equipment, be then followed by and sleep) hourage that uses in bed daily).For example, subject 405 or another Individual can input the information via the keyboard of client device 702 or client device may include one or more biographies Sensor is to sense such lifestyle parameter.Client device 702, which can be configured as, stores these lifestyle parameters In memory (being not shown in Figure 56), and it is automatically, or in response to such as request from counting circuit and stores these Parameter be supplied to counting circuit 704.

Then, in step 726, counting circuit 704 will be received about subject 405 from sleep apnea system 420 The information of sleep apnea event experienced and the letter from the received life style about subject of client device 702 Manner of breathing association.For example, counting circuit 704 can be related to the weight of subject by the seriousness of airway obstruction whithin a period of time Connection, and the frequency of sleep apnea event and subject can be consumed into specific food or beverage over time The frequency or quantity of (such as coffee) are associated.And in another example, counting circuit 704 can be by the seriousness of airway obstruction It is associated with the number of days that subject motion weekly is more than 30 minutes.

Next, in step 728, counting circuit 704 generate the correlation generated in step 726 it is one or more scheme, Chart, curve graph or other expressions.For example, airway obstruction frequency and subject's degree of physical exercise can be generated in computer circuits 704 Average duration relational graph.These expressions can be designed to be shown to subject 405 or another via display equipment One people (for example, doctor of subject), which is, for example, a part of client device 702.Alternatively, these are indicated It can be the data structure in the memory of counting circuit 704.

Then, in step 730, counting circuit 704 is indicated in response to the correlation generated in step 728, is determined and is suggested changing The life style for becoming subject, can improve or eliminate the sleep apnea of subject.For example, if the hundred of airway obstruction The correlation of ratio and the weight of subject is divided to show that the average percent of airway obstruction increases with the weight gain of subject, Then calculating equipment 704 can be generated text or audio message, be used to show or play via client device 702, statement If the specific poundage of 405 weight loss of subject, the average percent of airway obstruction can be reduced specific quantity by him/her. Alternatively, if the correlation of the quantity for the coffee cup that the average frequency of airway obstruction is drunk with daily beverage 405 every night shows often The average frequency of the airway obstruction in evening increases with the increase of the cup number of daily coffee, then calculating equipment 704 can give birth to It at text or audio message, is used for via 702 display/play of client device, if the coffee that statement subject 405 is daily Cup number, which is cut down, is no more than specific quantity, then the average frequency of airway obstruction every night can be reduced specific amount by he/her.

Next, in step 732, counting circuit 704 is in via the media presentation devices of such as client device 702 etc Existing (for example, display or broadcasting) is suggested in the one or more that step 730 determines.

Referring still to Figure 56, it is contemplated that in conjunction with the alternate embodiment for the process that flow chart 720 describes.For example, the process It can also include one or more steps other than including those described steps, or can be omitted described step One or more of 722-732.Suggest in addition, replacing generating based on correlation data, counting circuit 704 can provide correlation Data are to doctor or another health care professionals, they can be with response correlation data R & D Suggestions, and they can be with Developed suggestion is proposed to subject 405.Alternatively, counting circuit 704 can provide related data to subject 405, it can To obtain his/her conclusion from data and correspondingly adjust his/her life style.

Figure 57 be can be configured as according to the system 700 of Figure 55 of an embodiment realization to improve subject's The flow chart 740 of the process of health.

With reference to Figure 55 and 57, the process of flow chart 740 is described according to an embodiment.

In step 742, counting circuit 704 is received about subject whithin a period of time from sleep apnea system 420 Use the information of sleep apnea system.For example, the controller 134 (Fig. 8 and 45) of sleep apnea system 420 can be by Be configured in response to by component models 74 and 550 (Fig. 8 and Figure 45) one or more sensors 126 and 128, by component mould The one or more sensors 554 of block 550, or the information that senses and provide by the other components of component models determine by Examination person uses the use parameter of sleep apnea system.The example using parameter of sleep apnea system 420 include by Examination person 405 wears the mean hours number of sleep apnea system every night and wears weekly the average night of sleep apnea system Several and sleep apnea system setting is (for example, peak suction, the indoor temperature of pressure, coating apparatus for sealant component 124 (Fig. 8 and 45) whether effectively, the wakeup time of setting, and sense what parameter (for example, breathing, respiratory rate) with Detect apnea).Sleep apnea system 420, which can be configured as, is stored in memory for these parameters determined In 130 (Fig. 8 and 45), and it is automatically, or in response to such as request from counting circuit and these parameters stored is provided To counting circuit 704.

Next, counting circuit 704 receives the information about subject's health from client device 702 in step 744. The example of information about subject's health include the state of mind of subject, emotional state, in the daytime degree of fatigue (for example, by Examination person takes a nap daily or the number of " dozing off ") and health parameters, such as the weight of subject, the percentage of body fat, blood The content of other substances (such as vitamin, minerals and hormone) in pressure, blood glucose level, blood oxygen level and subject's body.For example, Subject 405 or another person, which can input the information or client device via the keyboard of client device 702, can wrap One or more sensors are included to sense such health parameters.Client device 702 can be configured as these health ginsengs Number is stored in memory (being not shown in Figure 55 and 57), and is automatically, or in response to request for example from counting circuit These parameters stored are supplied to counting circuit 704.

Then, in step 746, counting circuit 704 will from sleep apnea system 420 it is received about subject to sleeping The information of dormancy apnea system used is related to from the received information of health about subject of client device 702 Connection.For example, subject 405 whithin a period of time can be worn the flat of sleep apnea system 420 by counting circuit 704 every night Equal hourage is associated with the blood pressure of subject, and subject can will wear weekly sleep apnea whithin a period of time The average night number of system is associated with the daytime fatigue level of subjects reported.

Next, counting circuit 704 generates the one or more of the correlation generated at step 746 in step 748 Figure, chart, figure or other expressions.For example, subject can be generated in computer circuits 704 wears sleep apnea system every night The relational graph of the percentage of the mean hours number and subject's body fat of system 420.These expression can be designed to via Display equipment is shown to subject 405 or is shown to another person, which is, for example, one of client device 702 Point.Alternatively, these expressions can be the data structure in the memory of counting circuit 704.

Then, in step 750, the correlation that counting circuit 704 generates at step 748 in response to it indicates that determination is built View changes use of the subject to sleep apnea system 420, can improve the health of subject.For example, if tested Person using the average night number of sleep apnea system 420 and the correlation of subject's weight show the weight of subject with It averagely reduces and increases using night number, then computing device 704 can be generated for via 702 display/play of client device Text or audio message, if statement main body 405 increases to him/her weekly using the number of days of sleep apnea system 420 The specified quantity of equipment is calculated, then the weight poundage that he/her loses can calculate the specified range (for example, 5-15 pounds) of equipment It is interior.Alternatively, if subject 405 is every night using the phase of the mean hours number and subject's blood pressure of sleep apnea system 420 Closing property shows that subject's blood pressure is increased with averagely being reduced every night using hourage, then calculating equipment 704 can be generated use In text or audio message via 702 display/play of client device, if statement subject is by him/her every night using sleeping The hourage of dormancy apnea system 420, which increases to, calculates the specified quantity of equipment (for example, increasing by two hours, from increasing in five hours It is added to seven hours), then his/her systolic pressure can be reduced a certain range of amount (for example, 5-15 millimeters of mercury by he/her (mm Hg))。

Next, counting circuit 704 is aobvious via the media presentation devices of such as client device 702 etc in step 752 Show or be otherwise presented on one or more suggestions that step 750 determines.

Referring still to Figure 57, the alternate embodiment for the process for combining flow chart 740 to describe is considered.For example, the process is removed It include except those described steps can also include one or more steps, or can be omitted described step One or more of 742-752.Suggest in addition, replacing generating based on correlation data, counting circuit 704 can provide correlation To doctor or other health care professionals, they can mention data with response correlation data tapping proposal and to subject 405 Suggest out.Alternatively, counting circuit 704 can provide related data to subject 405, subject 405 can obtain from data His/her conclusion simultaneously correspondingly adjusts his/her use to sleep apnea system 420.

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

Figure 59 is the isometric exploded view according to the sleep apnea therapy system 420 of Figure 58 of an embodiment.

Referring to Figure 58-59, sleep apnea system 420 includes the collar assemblies 760 with jack 762, be configured to by Sleep apnea system is fixed to the band component 764 of the neck 400 (for example, Figure 38) of subject, is configured to subject's Neck forms hermetically sealed gasket assembly 765, and band component is attached in subject wears' sleep apnea system And it is configured to be assembled to the component models 766 in jack.Other than with jack 762, collar assemblies 760 can be similar to set Ring assemblies 440 (for example, Figure 30-37), with component 764 can by with manufacture the material class with component 424 (for example, Figure 30-32) As material be made, and gasket assembly 765 can be similar to gasket assembly 422 (Figure 27-28,30-34 and 39-40).And Other than being configured as being assembled in jack 762, component models 766 can structurally and functionally be similar to component models 550 (Figure 45).

Referring still to Figure 58-59, the alternate embodiment of sleep apnea system 420 is considered.For example, such as remote control is set The remote control equipment of standby 484 (Figure 37) etc can be configured as programming, the shape of reception and analysis sleep apnea system 420 State, and otherwise control sleep apnea system 420.Remote control equipment 484 can be sleep apnea system 420 A part is separated with sleep apnea system 420.

Figure 60 is the isometric view according to the negative pressure sleep apnea therapy system 420 of another embodiment.

Sleep apnea system 420 includes wearable unit 770, base unit 772 and air hose 774, and air is soft Pipe 774 is configured for wearable unit is pneumatically coupled to base unit.Wearable unit 770 includes having hose connection The collar assemblies 776 of device 778 are configured as being fixed on wearable unit 770 around subject's neck 400 (for example, Figure 38) Band component (being not shown in Figure 60), and be configured as forming hermetically sealed gasket assembly with the neck of subject and (not exist It is shown in Figure 60).Base unit 772 includes at least motor sub-assembly and pump assembly (being not shown in Figure 60), such as the motor of Figure 45 Component 116 and pump assembly 118, and the pressure being configured as between the inner surface and subject's neck 400 of collar assemblies 776 By via connector 778, hose 774 and another hose coupling on base unit in room (being not shown in Figure 60) (being not shown in Figure 60) extracts vacuum out in pressure chamber and generates negative pressure.Other than with hose coupling 778, collar assemblies 776 can be similar to collar assemblies 440 (for example, Figure 30-37), and band component can be similar to band component 424 (for example, Figure 30- 32), and gasket assembly can be similar to gasket assembly 422 (Figure 27-28,30-34 and 39-40).Base unit 772 is in addition to packet It includes except pump and motor sub-assembly 116 and 118, can also include one or more other components (Figure 45) of component models 550, and It and may include allowing the power supply source of the offer 110 of base unit " insertion " wall socket or 220VAC (in Figure 60 not It shows).In addition, collar assemblies 776 may also include one or more components of component models 550, such as the base unit of module 772 components lacked.

Referring still to Figure 60, the alternate embodiment of sleep apnea system 420 is considered.For example, such as remote control equipment The remote control equipment of 484 (Figure 37) etc can be configured as the state of programming, reception and analysis sleep apnea system 420, And otherwise control sleep apnea system 420.Remote control equipment 484 can be the one of sleep apnea system 420 Part is separated with sleep apnea system 420.

Figure 61 is the isometric view according to the negative pressure sleep apnea therapy system 420 of another embodiment.

Sleep apnea system 420 includes wearable unit 790 and handheld unit 792, and handheld unit 792 is for utilizing Negative pressure gives pressure chamber's (figure in the region (such as throat region 406 or throat region 407 (Figure 24-25)) of neighbouring subject throat It is not shown in 61) pressurization.Wearable unit 790 includes the collar assemblies 794 with pneumatic connector 796, be configured to can Wearable unit 790 is fixed on band component (being not shown in Figure 61) around subject's neck 400 (such as Figure 38) and is constructed Hermetically sealed gasket assembly (being not shown in Figure 61) is formed at the neck with subject.Handheld unit 792 includes being pneumatically connected Device 798 and at least motor sub-assembly and pump assembly (being not shown in Figure 60), such as motor sub-assembly 116 and pump assembly 118 (Figure 45), and And it is configured as in the pressure chamber between the inner surface and subject's neck 400 of collar assemblies 794 by via connector 796 With 798 in pressure chamber extract out vacuum and generate negative pressure.The collar assemblies 794 and gasket assembly of sleep apnea system 420 It is designed to keep negative pressure to continue for some time (for example, one or more hour or subject's sleep is whole in pressure chamber A time).If the amplitude of negative pressure decreases to or below threshold pressure, the circuit on collar assemblies 794 can be sounded an alarm To notify subject 405 (for example, Figure 38), he/her should use handheld unit 792 to re-establish pressure appropriate in pressure chamber Power.Alternatively, collar assemblies 794, which can be configured to transmit to handheld unit 792, has been enough the amplitude for making handheld unit determine negative pressure Decrease to or below the information of threshold pressure；In response to the determination, handheld unit can issue above-mentioned alarm.It is pneumatic in addition to having Except connector 796, collar assemblies 794 can be similar to collar assemblies 440 (for example, Figure 30-37), and band component can be similar to Band component 424 (for example, Figure 30-32), and gasket assembly can be similar to gasket assembly 422 (Figure 27-28,30-34 and 39- 40).Handheld unit 792 other than including pump and motor sub-assembly 116 and 118, can also include one of component models 550 or Multiple other components (Figure 45), and may include allowing the offer 110 of handheld unit " insertion " wall socket or 220VAC Power source (being not shown in Figure 60).In addition, collar assemblies 794 may also include one or more components of component models 550, example The component lacked such as the handheld unit 792 of module.

Referring still to Figure 61, the alternate embodiment of sleep apnea system 420 is considered.For example, can be similar to distant The remote control equipment 800 of control equipment 484 (Figure 37) can be configured as programming, reception and analysis sleep apnea system 420 State, and otherwise control the handheld unit 792 of sleep apnea system 420.Remote control equipment 800 can be sleep and exhale It inhales a part of Break-Up System 420 or is separated with sleep apnea system 420.

Figure 62 is the isometric view according to the wearing negative pressure sleep apnea therapy system 420 of another embodiment.

Sleep apnea system 420 includes wearable unit 810, apparatus 812 and air hose 814, and air is soft Pipe 814 is configured for wearable unit is pneumatically coupled to apparatus.Wearable unit 810 includes having hose connection The collar assemblies 816 of device 818 are configured as wearable unit 810 being fixed on the band component 819 around subject's neck 400, And it is configured as forming hermetically sealed gasket assembly (being not shown in Figure 62) with the neck of subject.Apparatus 812 is wrapped Include hose coupling 822 and at least one motor sub-assembly and pump assembly (being not shown in Figure 62), such as motor sub-assembly 116 and pump group Part 118 (Figure 45), and the pressure chamber (Figure 62 being configured as between the inner surface and subject's neck 400 of collar assemblies 816 In be not shown) in generate negative pressure and extracting vacuum out in pressure chamber via hose 814 and connector 818 and 822.In addition to tool Have outside hose coupling 818, collar assemblies 816 can be similar to collar assemblies 440 (for example, Figure 30-37), and band component 819 can class It is similar to band component 424 (for example, Figure 30-32), gasket assembly can be similar to gasket assembly 422 (Figure 27-28,30-34 and 39- 40).Apparatus 812 can be any wearable article, such as underwear, shirt, trousers, armband or cap, and can be by Any suitable material is made.Apparatus 812 can also include component other than including pump and motor sub-assembly 116 and 118 One or more other components of module 550 (Figure 45), and may include allow by apparatus " insertion " provide 110 or The power supply source (being not shown in Figure 60) of the wall socket of 220VAC.For example, apparatus 812 may include module 824, mould Block 824 can be similar to module 550, and can have the sensor 126,128 being arranged at the suitable position of apparatus One or more of with 554 (Figure 45).Such a or multiple sensors 126,128 and 554 can be located at the interior of clothes Surface (side towards subject 405 when wearing), the inside in clothes or the outer surface in clothes are (away from tested when wearing The side of person) on.In addition, collar assemblies 816 may also include one or more components of component models 550, such as the clothes of module The component that dress unit 812 lacks.

Referring still to Figure 62, the alternate embodiment of sleep apnea system 420 is considered.For example, such as remote control equipment The remote control equipment of 484 (Figure 37) etc can be configured as the state of programming, reception and analysis sleep apnea system 420, And otherwise control sleep apnea system 420.Remote control equipment can be a part of sleep apnea system 420 Or it is separated with sleep apnea system 420.

Figure 63 is the isometric view according to the negative pressure sleep apnea therapy system 830 of an embodiment.

Sleep apnea system 830 includes multiple pressure chamber units 832 (being in this embodiment two units), sets It sets between pressure chamber unit and by elastic coupling 834 that pressure chamber unit is coupled and is configured to fix In the rearward portion of subject's neck 400 pressure chamber unit is maintained at suitable position against the neck of subject 405 and throat Band component (being not shown in Figure 63) set.Each pressure chamber unit 832 includes being configured to form gas against subject's neck 400 Gasket assembly 838, at least one motor sub-assembly and the pump assembly (being not shown in Figure 63) of sealing, such as 116 He of motor sub-assembly Pump assembly 118 (Figure 45), and the pressure chamber being provided between the inner surface of pressure chamber unit 832 and subject throat Negative pressure is generated and extracting vacuum out under pressure chamber in (being not shown in Figure 63).For example, each unit 832 may include component Module (is not shown) in Figure 63, such as component models 550 (Figure 45).Alternatively, one in unit 832 may include module 550 at least one component, and another pressure chamber unit may include at least one other component of module 550, and Pressure chamber unit can by be arranged in elastic coupling 834 or on the corresponding conduits of one or more (do not show in Figure 63 It electrically or is pneumatically connected to each other out).Other than having different sizes with different shapes, each pressure chamber unit 832 can be similar to collar assemblies 440 (for example, Figure 30-37), and band component can be similar to band component 424 (for example, Figure 30- 32), and gasket assembly can be similar to gasket assembly 422 (Figure 27-28,30-34 and 39-40).And elastic coupling 834 can be formed by any suitable material, such as be formed by material identical with the material with component is formed.

Referring still to Figure 63, the alternate embodiment of sleep apnea system 830 is considered.For example, such as remote control equipment The remote control equipment of 484 (Figure 37) etc can be configured as the state of programming, reception and analysis sleep apnea system 830, And otherwise control sleep apnea system 830.Remote control equipment can be a part of sleep apnea system 830 Or it is separated with sleep apnea system 830.

According to foregoing teachings, it should be appreciated that although specific embodiment is described herein for illustrative purposes, It is that various modifications can be carried out without departing from the spirit and scope of the disclosure.Additionally, it is contemplated that in conjunction with embodiment public affairs Any feature opened can be incorporated into any other embodiment.For example, in conjunction with the reality of sleep apnea therapy system 70 Applying any feature disclosed in scheme can be incorporated into any embodiment of sleep apnea therapy system 420 and 830, instead .In addition, in the case where disclosing alternative solution for specific embodiment, even if not illustrating, the substitution Scheme also can be applied to other embodiments.For example, one or more of above-mentioned technology can be different from sleep-respiratory Suspend in the sleep apnea therapy system (for example, CPAP system) for the treatment of system 70,420 and 830 and implements.Furthermore, it is possible to Modify one of above-mentioned technology or it is a variety of with positive pressure rather than the system of negative pressure treatment sleep apnea (for example, CPAP system) on implement.Additionally, it is contemplated that one or more above-mentioned technologies can be used to sleep using the treatment of both positive pressure and negative pressure for system Dormancy apnea.In addition, "and" and "or" should be explained as follows.A "or" B and A "and" B, which should be interpreted that, means A, B or A and B two Person, unless expressly stated otherwise, or for example, by context cues.

Although various aspects and embodiment have been disclosed herein, according to detailed description provided herein, other Aspect and embodiment will be apparent those skilled in the art.Various aspects and embodiment disclosed herein are For purposes of illustration rather than restrictive, real scope and spirit are indicated by appended claims.

Claims

1. a kind of system comprising:

Lantern ring is configured to protect and applying the negative pressure with amplitude to the throat of the subject during sleep in subject Hold the airway open of the subject；

Pump, is configured to generate the negative pressure；

Motor is configured to drive the pump；

First sensor is configured to generate the first sensing signal relevant to the degree of the airway open；With

Memory；And

Controller is configured to

Change the amplitude of the negative pressure in response to the sensing signal, and

The relevant information of the sleep apnea event or sleep apnea therapy that undergo to the subject is stored in institute It states in memory.

2. system according to claim 1, wherein the pump, the motor, the first sensor, the memory and The controller is fixed on the lantern ring.

3. system according to claim 1, further include:

Base unit comprising the pump and the motor；With

Hose is configured as the base unit being coupled on the lantern ring.

4. system according to claim 1, further include:

Base unit comprising the pump, the motor, the first sensor, the memory and the controller；With

Hose is configured as the base unit being coupled on the lantern ring.

5. system according to claim 1, wherein the controller is configured that

The obstruction of the air flue of the subject is detected in response to the sensing signal；And

The controller is detected that the time of the obstruction of the air flue stores in the memory as the information.

6. system according to claim 1, wherein the lantern ring is configured to the negative pressure being applied to the subject The throat above breastbone head, below the preabdomen of the digastric muscle of the subject and the chest of subject lock Region between papillary muscle.

7. system according to claim 1, wherein the controller is configured to

The obstruction of the air flue of the subject is detected in response to the sensing signal；

Determine the duration of the obstruction for the air flue that the controller detects；And

It is stored the duration as information in the memory.

8. system according to claim 1 further includes dismountable flexible sleeve, the pump, the motor, the biography One in sensor, the controller and power source is fixed on dismountable flexible sleeve, and described dismountable Flexible sleeve is configured as being arranged between described sleeve pipe and the throat of the subject.

9. system according to claim 1, in which:

The sensor includes pulse-oximetry sensors, is configured as generating the oxygen water in the blood with the subject Put down the relevant sensing signal；And

The controller is configured as:

In response to the sensing signal, the time response of oxygen level in the blood of the subject is determined；And

The identified time response of oxygen level in the blood of the subject is stored in the memory as the information In.

10. system according to claim 1, in which:

The sensor includes microphone, and the microphone is configurable to generate and the sound levels phase that is generated by the subject The sensing signal closed；And

The controller is configured to respond to the sensing signal, determines the time of the sound levels generated by the subject Characteristic, and

It is stored in using the identified time response of the sound levels generated by the subject as the information described In memory.

11. system according to claim 1, in which:

The sensor includes accelerometer, which is configurable to generate relevant to the sports level of the subject described Sensing signal；And

The controller is configured to

In response to the sensing signal, the time response of the sports level of the subject is determined, and

It is stored the identified time response of the sports level of the subject as the information in the memory.

12. system according to claim 1, in which:

The sensor includes electrode, and the electrode is configured as contacting the neck of the subject and generates and flow into or flow The relevant sensing signal of one electric current in the electrode out；And

The controller is configured to

In response to the sensing signal, the time response for flowing in or out one electric current in the electrode is determined, and

The identified time response of one electric current flowed in or out in the electrode is stored in institute as the information It states in memory.

13. system according to claim 1, in which:

The sensor includes electrode, the electrode be configured as contacting the neck of the subject and generate in the electrode The relevant sensing signal of the voltage at both ends；And

The controller is configured to

In response to the sensing signal, the time response in the voltage at the electrode both ends is determined, and

It is stored in the identified time response of the voltage at the electrode both ends in the memory as information.

14. system according to claim 1, further include:

Cooling component is heated, is fixed on the lantern ring, is coupled on the power source, and is configured to heating and cooling institute State the region of the neck of subject；And

Wherein the controller is configured to that the heating cooling component is made to change the subject in response to the sensing signal The neck the region temperature.

15. system according to claim 1 further includes power supply source, the power supply source is fixed to the set Ring and be configured to one the power from power source is supplied in the motor, the sensor and the controller.

16. system according to claim 1, further include:

Tact switch is arranged close to the side of the lantern ring, which is configured to away from the subject, and the tactile is opened Closing has on and off；With

Power supply source is fixed on the lantern ring and is configured to

There is the on-state in response to the tact switch, the power from power source is supplied to the motor, described One in sensor and the controller；And

There is the off state in response to the tact switch, not into the motor, the sensor and the controller An offer power.

17. a kind of method comprising:

In subject during sleep by the throat in the subject above the breastbone head of the subject, the subject Digastric muscle preabdomen below and region between the nutator of the subject apply the negative pressure with amplitude To keep the airway open of the subject；

Determine the degree of the airway open；

The amplitude of the negative pressure is adjusted in response to the degree of the identified airway open；And

It stores and one of the holding, the determination and the adjustment relevant information.

18. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Emit electromagnetic energy to the subject；

Receive the part of the electromagnetic energy emitted redirected by the subject；And

In response to the electromagnetic energy that is emitted received part and determine the degree of the airway open.

19. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the oxygen level in the blood of the subject；And

In response to identified oxygen level in the blood of the subject, the degree of the airway open is determined.

20. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the sound levels of subject's manufacture；And

The degree of the airway open is determined in response to the sound levels of identified subject's manufacture.

21. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the sports level of the subject；And

The degree of the airway open is determined in response to the sports level of the identified subject.

22. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the cross-sectional area of the air flue of the subject；And

The degree of the airway open is determined in response to the cross-sectional area of the air flue of the identified subject.

23. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the stroke output of the heart of the subject；And

The degree of the airway open is determined in response to the stroke output of the heart of the identified subject.

24. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the level of the substance during expiration in the air of subject's discharge；And

The degree of the airway open is determined in response to the level of the identified substance.

25. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the parameter for flowing in or out the electric current of neck of the subject；And

The degree of the airway open is determined in response to the parameter of the identified electric current.

26. according to the method for claim 17, wherein determining that the degree of the airway open includes:

Determine the parameter in the voltage at the both ends in two regions of the neck of the subject；And

The degree of the airway open is determined in response to the parameter of the identified voltage.

27. a kind of method comprising:

It is received using computer system from sleep apnea therapy equipment and the sleep apnea equipment is used by subject Use parameter；

Using the computer system receive the subject health for the use of；

Using the computer system by the side using parameter and the health of the sleep apnea equipment Face is associated；

Determine the suggestion using parameter for changing the sleep apnea equipment, using the computer system to change The aspect of the health；And

The suggestion is provided to the subject using the computer system.

28. according to the method for claim 27, further include: obtained using the sleep apnea equipment described tested Person uses the use parameter of the sleep apnea equipment, and the sleep apnea equipment includes:

Lantern ring is configured in the subject during sleep by applying the negative pressure with amplitude to the throat of the subject And keep the airway open of the subject；

Pump, is configured to generate the negative pressure；

Motor is configured to drive the pump；

First sensor is configured to generate the first sensing signal relevant to the degree of the airway open；

Memory；And

Controller is configured to

Change the amplitude of the negative pressure in response to the sensing signal, to detect the use of the sleep apnea equipment,

By to the sleep apnea equipment using the relevant parameter storage in the memory, and

The parameter stored is supplied to the computer system.

29. according to the method for claim 27, wherein the use parameter of the sleep apnea equipment includes institute State the mean hours number that subject uses the sleep apnea equipment daily.

30. according to the method for claim 27, wherein the use parameter of the sleep apnea equipment includes institute State the frequency that subject uses the sleep apnea equipment.

31. according to the method for claim 27, wherein the use parameter of the sleep apnea equipment includes institute State the period that the sleep apnea equipment is used in subject one day.

32. according to the method for claim 27, wherein the use parameter of the sleep apnea equipment includes institute It states and uses the sleep apnea using the hourage of the sleep apnea equipment and per another day subject's every day Difference between the hourage of equipment.