CN102625720B - For including the mthods, systems and devices with the invasive ventilation of non-tight vented interface of free space nozzle characteristics - Google Patents

Abstract

A kind of system supported for providing ventilation, including nasal interface, the nasal interface be designed to the nose of connection patient and allow patient directly breathing environment air and be not passed through nasal interface.Nozzle can be connected with nasal interface at a distance with nose.Nozzle can connect to gas transport circuit and gas transmission sources.Nozzle can be delivered gas in nasal passage and generating negative pressure region near the nozzle and generating barotropic field in nose entrance.The combination of gas from gas transport source and the air of the entrainment of the gas by leaving nozzle can provide ventilation and support.

Description

For including that there is the noninvasive of non-tight vented interface of free space nozzle characteristics to lead to The mthods, systems and devices of gas

Cross reference to related applications

This application claims on September 3rd, the 2009 U.S. Provisional Patent Application No.61/239,728 submitted, in October, 2009 The U.S. Provisional Patent Application No.61/255,760 that submits for 28th, the U.S. Provisional Patent Application submitted on January 12nd, 2010 The priority of No.61/294,363 and 2010 year 19 days 2 months U.S. Provisional Patent Application No.61/306,370 submitted；In it Hold through whole reference comprising herein.The U.S. Non-provisional Patent application No.12/ that the application also requires on April 2nd, 2010 to submit 753,846, on April 2nd, 2010 submits PCT Patent Application No.PCT/US2010/029871, on April 2nd, 2010 submit The PCT Patent Application No.PCT/US2010/ that U.S. Non-provisional Patent application No.12/753,851, on April 2nd, 2010 submit 029873, on April 2nd, 2010 submits U.S. Non-provisional Patent application No.12/753,853, the beauty submitted on April 2nd, 2010 The PCT Patent Application No.PCT/US2010/ that state non-provisional No.12/753,854, on April 2nd, 2010 submit 029874, what the U.S. Non-provisional Patent application No.12/753,856 and on April 2nd, 2010 that on April 2nd, 2010 submits were submitted The priority of PCT Patent Application No.PCT/US2010/029875；Its content is by whole reference comprising herein.This application passes through Reference includes on September 3rd, 2010 entitled " METHODS, SYSTEMS AND DEVICES the FOR NON-INVASIVE submitted VENTILATION INCLUDING A NON-SEALING VENTILATION INTERFACE WITH AN ENTRAINMENT The U.S. Non-provisional Patent application No.______ of PORT AND/OR PRESSURE FEATURE " and submission on September 3rd, 2010 Entitled " METHODS, SYSTEMS AND DEVICES FOR NON-INVAS IVE VENTILATION INCLUDING A NON-SEALING VENTILATION INTERFACE WITH AN ENTRAINMENT PORT AND/OR PRESSURE The PCT Patent Application No.______ of FEATURE ".

Technical field

The present invention relates to the people's for breathed and ventilated imbalance such as respiratory insufficiency and sleep apnea Ventilation therapy field.More particularly it relates to utilize the method and apparatus using the noninvasive nose ventilation patient interface of non-tight Open airway pressure is provided.

Background of invention

For transmission machine ventilation support or positive airway pressure and the nose minimally outstanding that patient will not be interfered Cover and aerating system, which exist, to be needed.There are a series of Comprehensive Clinicals of ventilation therapies for needing would benefit from this cover and system It disease such as respiratory insufficiency, air flue or dyssomnias, congestive heart failure, neuromuscular disease and a series of will be benefited The case where for example chronic, acute, urgent, heavy casualties and popularity.

Using the device of patient will not be interfered to be conducive to oxygen therapy.However, oxygen therapy is used for compared with therapy of ventilating The clinical syndrome of remote less serious form.For example, in order to transmit mixing for air and oxygen into cover by carrying air secretly Object is closed, has developed some nose cup oxygen therapy systems, however these are not ventilation therapy or the breathing by careful consideration It supports, because they do not facilitate work of breathing mechanically.In recent years, referred to as high flow capacity oxygen therapy has been applied (HFOT) variant of oxygen therapy.In this case, oxygen gas flow rate increases above standard long-term oxygen therapy (LTOT), example Such as high 15LPM.Because of high flow rate, oxygen must be humidified to prevent the air flue for making patient dry.It is reported that, HFOT can be omited Edge down the absolute Pleural pressure of patient during low autonomous respiration, therefore has slight influence to work of breathing.Because they are consumed A large amount of oxygen, become them and inactive system and interfere patient, therefore these systems are invalid.

In the presence of to patient provide mechanical ventilation (MV) and mechanically facilitate work of breathing Breathing Suppotion and ventilation therapy. MV therapy is inserted into patient Lai Lian by using the tracheal catheter or sealing surface or nose cup or sealing nasal cannula of flange or non-flanging It is connected to patient.Although helping to support work of breathing, the patient interface for MV is outstanding and/or wound for user Property, and MV is not easy to mobility or number of storage tanks produced per day, therefore hamper patient and for many potential users For be a disadvantage.In the presence of the invasive ventilation (NIV) for making patient ventilating without being intubated using face or nose cup, it is being permitted It is an advantage in more situations.However, patient cannot use their epithelium healing because interface can on nose and/or mouth shape At outside seal, and this external system be not it is movable, a combination thereof can not carry out number of storage tanks produced per day.

In order to treat obstructive sleep apnea (OSA), gold standard ventilation therapy is duration positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), it is the variant of NIV, and wherein patient is exhaled by the air outlet portion in cover It gas and returns in big gas transport pipe fitting, rather than passes through expiration circuit as in MV.By ventilator by being sealed in The duration positive pressure that nose or nose cup on the face or mask apply to patient can prevent Upper airway obstruction.Although effectively, The therapy has the patient compliance of difference, because patient interface is outstanding for patient, and because patient is gentle by covering Body transmission circuit breathes artificially.

In short, existing therapy and the prior art have the disadvantage that they are not provided in a manner of it will not interfere patient Breathing Suppotion or air flue are supported and (1) is noninvasive, and be it is non-outstanding, it allows for mobility and daily life in this way Activity, (2) allow the feeling that normally breathes from ambient enviroment, and (3) provide and are being easy to portable system or can be by In the system that patient easily carries or wears.

Summary of the invention

The present invention can be used noninvasive open airway pressure (NIOV) and fully will not cover or seal patient's Non-tight nose cup interface in the free space of mouth or nose with nozzle provides ventilation to patient.

The embodiment of the present invention may include a kind of system supported for providing ventilation, which includes gas transport Source: gas transport circuit；Nasal interface, be designed to be connected to the nose of patient and allow patient directly breathing environment air and Need not flow through nasal interface；In the nozzle being connected at a distance with nasal interface with nose, wherein nozzle is connected to gas Transmit the gentle body transmission sources in circuit；And wherein nozzle can be by generating negative pressure region and in nose entrance near the nozzle It nearby generates barotropic field to deliver gas in nasal passage, wherein the gas from gas transport source and the gas by leaving nozzle The combination of the air of body entrainment provides ventilation and supports.

The embodiment of the present invention may include a kind of method supported for providing ventilation, this method comprises: providing nose circle Face, the nasal interface allow patient to pass through nasal interface breathing environment air；There is provided in free space with nose at a distance of a spacing The nozzle connected from the proximal end in nasal interface；Nozzle and gas transport circuit and gas transmission sources is in fluid communication, wherein spraying Mouth can deliver gas in nasal interface to generate negative pressure region near the nozzle and generate just in nose entrance Intermediate pressure section, and the combination offer ventilation support of the gas wherein from gas transport source and the air by nozzle clamp band.

The some embodiments of system and method also may include can be at some places outside nose and far from life at the point At barotropic field.The far-end on boundary and the boundary in nostril margins can be generated in barotropic field.Barotropic field can give birth to At any in nasal airway and far from the point.Nasal interface system may include manifold, and wherein manifold includes nozzle. Manifold can be designed to be disposed away from nozzle at one distance of nostril entrance, and can be designed to nozzle relative to nostril The angled placement of the center line of air flue.The embodiment of the present invention may include one or more sensors, one of them or Multiple sensors include far from nozzle towards nose extend and terminate at the sense channel in barotropic field and/or one of them Or multiple sensors include the sense channel for being directed away from nozzle extension.Sense channel extends in nose.Sense channel It can be extended to from nostril entrance from internal substantially +/- 5 millimeters.The embodiment of the present invention can each nostril include two or more Multiinjector.Nozzle can be oval gas transport nozzle orifice.Nozzle may include multiple being arranged with round or oval pattern The array of gas transport nozzle.The embodiment of the present invention may include jet pump trunnion, which includes flow path. Jet pump trunnion can be connected with manifold, and nozzle can be connected by jet pump trunnion with jet pump trunnion flow path. Manifold may include the entrainment port being connected to jet pump trunnion flow path.Nozzle can slope inwardly.Nozzle can be with big The angle of 1-20 degree is caused to slope inwardly.It is wide that nozzle can generate oval gas transport airflow inside nasal airway.Nozzle can To be rotatably adjustable.Nozzle may include at least one left nozzle and at least one right nozzle, and wherein at least one is left Spacing between nozzle and at least one right nozzle is adjustable.At least one left nozzle and at least one right nozzle can be It is rotatably adjustable.Spacing between nostril entrance and nozzle can be adjustable.Nasal interface can be in different sizes It obtains, is generated in the distance of injector spacing, nozzle spin orientation and nozzle to nostril entrance different.Negative pressure region can be from spray Mouth extends to the position for closing on nose entrance.Negative pressure can be less than environmental pressure.Negative pressure can be about -5 to -28cmH₂O.Just Intermediate pressure section can extend to nose entrance from the position of nozzle distal end.Positive pressure can be greater than environmental pressure.Positive pressure can be about 0.01-0.50psi.The combination of gas from gas transport source and the air of the entrainment of the gas by leaving nozzle can be nose Internal laminar flow.Nozzle can be placed on outside nose entrance at about 0-1.5 inches.Gas can be with by the transmission of nozzle The breathing pattern of patient is synchronous.Gas from gas transport source can be controlled by wearable ventilator.Ventilation is supported can be with Including reducing work of breathing to treat respiratory insufficiency.Ventilation supports to may include that raising airway pressure is temporary to treat sleep-respiratory Stop.Nasal interface may include for system to be connected to the bridge of the nose and at least one gas transport nozzle is directed at nose entrance Connector.Connector may include lug with the boundary alignment relative to nostril margins.The angle of the adjustable nozzle of connector To be directed at the center line of nasal airway.

The embodiment of the present invention may include a kind of system supported for providing ventilation, which includes: gas transport Source；Gas transport circuit；Nasal interface, be designed to be connected to the nose of patient and allow patient directly breathing environment air and Need not flow through nasal interface；In the nozzle being connected at a distance with nasal interface with nose, wherein nozzle is connected to gas Transmit the gentle body transmission sources in circuit；Jet pump trunnion includes the flow path across jet pump trunnion, wherein jet pump trunnion with Manifold is connected, and nozzle is connected by jet pump trunnion with jet pump trunnion flow path；Road is flowed with jet pump trunnion The entrainment port of diameter connection, wherein nozzle can be by generating negative pressuren zone near the nozzle inside jet pump trunnion flow path Domain and far from nozzle jet pump trunnion flow path inside generate barotropic field and deliver gas in nasal passage, In the combination of gas from gas transport source and the air by carrying entrainment port secretly ventilation be provided support.System and method Some embodiments may include ventilation supports to include reducing work of breathing to treat respiratory insufficiency.Ventilation is supported to may include mentioning High airway pressure is to treat sleep apnea.

By considering following detailed description, drawings and claims, additional feature, advantage and the embodiment of the present invention are just It is elucidated with or obviously.In addition, it should be understood that foregoing summary and following detailed description are exemplary and are expected to mention Range for further explanation without limiting the claimed invention.

Detailed description of the invention

Attached drawing show the preferred embodiment of the present invention and with principle used to explain the present invention together is described in detail, In, attached drawing be included to provide it is of the invention further understand, and attached drawing includes in this specification and to constitute the specification A part.

Fig. 1 shows the conventional oxygen transmission casing of the prior art for implementing oxygen therapy.

Fig. 2 shows traditional invasive ventilation of the prior art using nose cup and using CPAP or BiPAP ventilating mode.

Fig. 3, which is shown using the embodiment of the present invention, receives the unimpeded patient that work of breathing is supported when walking about.

Fig. 4 is the schematic diagram for showing exemplary system of the invention.

Fig. 5 shows that wherein open non-tight nose vent hood is configured to be placed in the underthe nose of user and can be from The middle line of face bidirectionally extends to the exemplary embodiment of the side of nose.

Fig. 6 is the perspective view of the nose cup component of Fig. 5.

Fig. 7 shows the schematic elevation view of one embodiment of nose cup of the invention.

Fig. 8 shows forward sight-top view-side view of the nose cup of Fig. 5.

Fig. 9 shows the hidden line view of the nose cup of Fig. 8, it is shown that gas flow paths and respiratory pressure detect path.

Figure 10 shows the top view of the nose cup of Fig. 5.

Figure 11 shows the hidden line view of the nose cup of Figure 10, it is shown that gas flow paths and respiratory pressure detect path.

Figure 12 shows backsight-top view of the nose cup of Fig. 5.

Figure 13 shows the hidden line view of the nose cup of Figure 12, it is shown that gas flow paths and respiratory pressure detect path.

Figure 14 shows the pattern generated by the airflow exits from gas transport nozzle.

Figure 15 shows the pattern generated by the airflow exits from gas transport nozzle.

Figure 16 shows one embodiment of nose cup shown in Fig. 5 with oval gas transport nozzle.

Figure 17 shows nose cup shown in Fig. 5 with the multiple gas transport nozzles arranged with anatomically functional mode One embodiment.

Figure 18 shows the hidden line view of the cover view of one embodiment of nose cup, it is shown that gas flow paths and breathing Pressure detecting path, wherein gas transport nozzle is tilted inward towards middle line.

Figure 19 shows one embodiment of cover shown in Fig. 5, and the cover has at cover manifold bottom portion with venturi The jet pump trunnion of entrance.

Figure 20 shows the cover worn by user and has venturi with the top of the manifold near trunnion bottom The jet pump trunnion of entrance.

Figure 21 shows an alternate embodiment of nose cup, and wherein gas transport nozzle is set by the nose part with adjutage In underthe nose.

Figure 22 shows the pressure detecting of the nose cup of Figure 21 and gas transmission airflow mode in nasal airway.

Figure 23 shows the shade assembly of nose cup shown in Figure 21.

Figure 24 shows an alternative embodiment of nose cup shown in Figure 21, and wherein gas transport nozzle is by the nose zero that extends Part is placed in underthe nose.

Figure 25 shows nose cup shown in Figure 21 with the nose part and fairshaped upright arm and horizontal arm that minimize One embodiment.

Figure 26 shows one embodiment of nose cup shown in Figure 21, and wherein gas transport nozzle is set by head tool and bracket In underthe nose.

Figure 27 graphically shows that the present invention can be how when the present invention is applied for lung disease or neuromuscular disease Advantageously influence the work of breathing of patient.

Figure 28 graphically shows lung volume in x-axis and shows lung pressure graphically on the y axis to show and tradition Ventilation is compared to such as how NIOV realizes lung volume on lung simulator platform model.

Figure 29 graphically shows the lung volume realized compared with oxygen therapy using lung simulator platform model with NIOV.

Figure 30 A graphically shows the square wave gas transport pressure according to one embodiment.

Figure 30 B graphically shows the volume delivery of Figure 30 A.

Figure 30 C graphically shows the lung pressure of the generation of Figure 30 A.

Figure 30 D graphically shows the sinusoidal waveform gas transport pressure according to one embodiment.

Figure 30 E graphically shows the volume delivery of Figure 30 D.

Figure 30 F graphically shows the lung pressure of the generation of Figure 30 D.

Figure 30 G is graphically shown to be passed according to the square wave gas for a part of expiratory phase of one embodiment Defeated pressure.

Figure 30 H graphically shows the volume delivery of Figure 30 G.

Figure 30 I graphically shows the lung pressure of the generation of Figure 30 G.

Figure 30 J graphically shows the more waveforms gas transport pressure according to one embodiment.

Figure 30 K graphically shows the volume delivery of Figure 30 J.

Figure 30 L graphically shows the lung pressure of the generation of Figure 30 J.

Figure 31 A graphically shows the rising waveform gas transport pressure according to one embodiment.

Figure 31 B graphically shows the volume delivery of Figure 31 A.

Figure 31 C graphically shows the lung pressure of the generation of Figure 31 A.

Figure 31 D graphically shows the falling waveform gas transport pressure according to one embodiment.

Figure 31 E graphically shows the volume delivery of Figure 31 D.

Figure 31 F graphically shows the lung pressure of the generation of Figure 31 D.

Figure 31 G graphically shows the two-stage wave amplitude waveform gas for a part of expiratory phase according to one embodiment Transmit pressure.

Figure 31 H graphically shows the volume delivery of Figure 31 G.

Figure 31 I graphically shows the lung pressure of the generation of Figure 31 G.

Figure 31 J graphically shows the waveform gas transport pressure according to one embodiment.

Figure 31 K graphically shows the volume delivery of Figure 31 J.

Figure 31 L graphically shows the lung pressure of the generation of Figure 31 J.

Figure 32 graphically shows timing and the wave of the adjustable air-flow wave amplitude transmission of respiratory rate according to one embodiment Width.

Specific embodiment

Fig. 1 shows the conventional oxygen transmission casing 101 of the prior art for implementing oxygen therapy.On casing 101 Extension 105 is configured to enter nostril 103.The proximal end (not shown) of casing 101 be connected to once detecting inspiratory effort Continuous flow oxygen is transmitted to the nose of user under 1-6LPM or transmits the oxygen transmission device of an oxygen.The system of Fig. 1 It will not mechanically support the work of breathing of patient, but and wait until the OSA of severe form in being not believed to can be effectively prevented.Fig. 1 Casing be also used for another oxygen transmission therapy i.e. high flow capacity oxygen therapy (HFOT), wherein be greater than 15LPM moist oxygen The nose of user is transmitted to continuous flow velocity.The high flow capacity as needed for HFOT, system are that non-portable and oxygen must It must be moist.

Fig. 2 shows the Breathing Suppotion therapy of the prior art for invasive ventilation (NIV), and the therapy is with double horizontal air flues Positive pressure (BiPAP) ventilating mode uses nose cup 201.NIV is used to make patient respiration, or can be used for helping the breathing of patient, The autonomous respiration of patient makes great efforts triggering ventilator to transmit the mechanical ventilation (MV) based on pressure or volume in this case.Back and forth It can transmit and remove from ventilating return 203 and nose cup 201 in all volumes of pulmonary delivery.

System similar with Fig. 2 can be used for OSA, wherein cover is sealed on the face, such ventilation gas is just mentioned by ventilator For and a part of exhaled gas just pass through gas vent 205 and breathe out.NIV, duration positive airway pressure (CPAP) and BiPAP are recognized To be to the clinically effective mode of autonomous respiration patient and therapy.However, these modes and therapy are not easy to daily life Movable (ADL).For example, ventilator cannot be carried by patient, patient cannot be natural due to seal closure and freely in respiratory chamber Air, and the epithelium healing of patient cannot act on normally and naturally, because it is sealed by outer cup, and furthermore Gas transport pipe fitting is excessively huge and cannot practically support mobility and ADL.

The embodiment of the present invention is described now with reference to remaining figure.Breathing Suppotion or air flue support are not hampered with patient What the ways and means hindered provided.Noninvasive, non-tight and the system and method not hindered can permit mobility and daily life Activity.System and method allow the feeling from ambient enviroment eupnea.System and method offer can be by patient easily It is carrying or wear, easily portable system and the gas transport pipe fitting of patient will not be interfered.

System and method may include gas transport source, gas transport circuit and allow by nasal interface breathing environment air Nasal interface.It can have remote gas flow path aperture across the gas flow paths of nasal interface.Nozzle can be with distal end The proximal end of the nasal interface of gas flow paths aperture at a distance is connected.In certain embodiments, at least part is pressed from both sides Port can be between nozzle and distal end flow openings.Nozzle can deliver gas in nasal interface at entrainment port Gas flow paths in generate negative pressure region.Nasal interface and nozzle can generate between entrainment port and the distal end of nasal interface Barotropic field.Gas from gas transport source and the air by carrying entrainment port secretly can increase airway pressure.

Fig. 3 show in activity using one embodiment of the present of invention provide mechanical ventilation support or work of breathing support Patient 301.It is motionless when receiving ventilation and supporting that traditional ventilator needs patient, or traditional ventilator is carried using wheelchair Required huge and heavy equipment.Traditional ventilator also needs the seal closure and macropore gas transport pipe fitting of obstruction property.Disease People can also wear ventilator module 307, it can be it is extra small, being capable of the offer when the present invention is used for respiratory insufficiency Mobility.Ventilator can be connected to air and/or oxygen supply 311 by pipe fitting or other facilities 309.Ventilator module 307 can To include display 313 and/or input unit.

The present invention may include the non-tight nose cup patient interface that ventilator is connected to aperture gas transport pipe fitting.Nose cup It can be uniquely non-tight, such patient can directly pass through cover sucking and exhalation environment when receiving ventilation and supporting Air, wherein there is negligible dead volume in cover.Cover may include unique venturi system, which can make to lead to Mechanism of qi transmits the gas of relatively small amount to realize relatively advanced ventilation support or airway pressure.Venturi cover is more fully described In Fig. 6-31.

Each embodiment of nasal interface 303 is described in detail in following disclosure.Compared with standard enclosure, nasal interface 303 can Minimally to protrude, such patient normally can feel and take action when receiving treatment.For example, using nasal interface and Therapy, patient can speak, swallow, have a meal or drink water and feel that they seem normally to breathe.With standard ventilator pipe fitting It compares, required gas transport pipe fitting can be very small, this is easier that patient is allowed to go about with system, and hides and treat Equipment needed for method and pipe fitting.The venturi system of the lung or airway pressure for the treatment of grade is realized using low-level gas volume It is relatively small that efficiency allows gas to supply, and can also realize the mobility of patient and/or the miniaturization of aeration equipment.Nasal interface can Be designed to be connected to the nose of patient and allow patient directly breathing environment air without flowing through nasal interface.

Although Fig. 3 shows that patient is used for mobility using the present invention, the present invention also can be applied to sleep-respiratory Obstacle.In latter, it is an advantage of the invention that cover and pipe fitting are less than the sleep apnea therapy cover and pipe fitting of standard. In addition, patient can have the feeling of more directly breathing environment air, this makes patient be easier to tolerate the therapy, rather than logical Machine breathing is crossed, this is feeling when using the sleep apnea air-breather of standard.

Fig. 4 is the block diagram of description exemplary system of the invention.The exemplary system of Fig. 4, which can be, to be had as shown in Figure 3 Portable gas source wearable ventilator, or can be another ventilator and/or gas source.It schematically shows Ventilator and patient interface feature system-related.Fig. 4 shows noninvasive open nasal interface 400.It will be described herein Noninvasive open nasal interface described in each embodiment, for example, in Fig. 5-8B (curved nose cup), Fig. 9-15 (flexible joint) and In Figure 16-25 and 29-31 (ergonomics configuration).

Ventilator module 401 may include several other function accessories or be connected to several other function accessories.In Fig. 3 Ventilator and the intemal anatomical structure of patient shown in Fig. 4 with illustrating format.It would generally include nasal airway pipe pressure Sensor 429.It may include transmitter 403 to transmit to remote location about patient, the therapy of patient and ventilator performance Information for checking, analyzing, remote intervention, two-way communication and filing.For example, can comply with monitoring and evaluating patient therapy The utilization of property or therapy.Important information can be trending, such as the respiratory rate of patient, I: E ratio, oxygen use, activity Rank or depth of respiration.And information can be sent to ventilator 433, for example, sending program instruction for defeated for ventilator Setting titration option is out to meet disease human needs or instruct as patient sends.Patient can also pass through ventilator and transmitter 403 send information or problem to remote clinician.

Source of oxygen 407 and/or compressed air source 409 are typically included in the outside of ventilator module 401.However, certain In embodiment, if the therapy is used for motionless use and for example stays at home, source of oxygen 407 and/or compressed air source 409 can Inside ventilator module 401.It may include mixer 411 to control the O of the fractional transmission in gas transport circuit 413₂。 The titration that pulse oximeter 415 can be used for ventilator module 401 is set to meet the physiological requirements of patient, such as is arranged just True oxygen mixer setting or the output of ventilator volume.Other than the compressed supply of oxygen and air, ventilator module 401 It may include internal or external air and oxygen generating system 417 such as compressor, pump or air blower to generate compressed air, oxygen Gas generator and/or pump are to generate charge oxygen and/or compressed gas accumulator.Source of oxygen is also possible to liquid oxygen or liquid Body oxygen generating system.It may include that extension of the internal or external humidifier 405 for therapy uses, or is used for dry climate In.

Because the therapy is frequently used for helping ADL and for promoting activity, it is possible in ventilator module 401 Portion or outside include that pedometer 419 and/or wrist move flowmeter sensor 421.Optional sensor may include CO₂Sensor 425, And/or external respiration sensors unit 437.There may also be CO₂Signal piping 439 and/or airway pressure signal piping 441. It may include one or more of the other external sensor.For example, other external sensors may include external respiration sensors or Respiratory effort sensor 427, such as breathing muscle make great efforts sensor, chest impedance sensor 435 or other types of sensor Such as tracheae or other microphones or vibrating sensor 443 or acoustics or ultrasonic sensor.One or more external sensors It may be used as the redundant sensor of nasal airflow or nose pressure sensor 429, or supplement from nasal airflow or nose pressure sensor 429 The information of acquisition, or replace nasal airflow or nose pressure sensor 429.Also oral airflow respiration transducer can be used, such as Nasal airflow or nose pressure sensor 429 can be oral airflow sensor.

It can include drug delivery module 431 inside or outside ventilator module 401.Because in face of the medicine being currently atomized Object transmits the challenge of inhalator, and drug delivery module 431 can be used for that drug granule is pushed and deposited to the depth of respiratory system Place is without the use of carrier propellant.Because the patient using the therapy usually requires prescription drug, this is convenient and efficient Application drug mode.

When the therapy is used for Breathing Suppotion, user can have two options: (1) wearing or carry ventilator module 401, such user can walk about or enjoy number of storage tanks produced per day, or (2) fixed use, if patient's plan is motionless Or without the ability walked about.For the latter, transmission circuit, such gas optionally are provided with 25-100 feet of length Body source and ventilator module 401 can patient family it is motionless, and patient still can wear interface and receive to control Family when treatment at them moves back and forth.Or gas source can be hose connection that is motionless, and using 25-100 feet To ventilator module 401, such patient can be worn or carried by ventilator and activity in the range of hose.

Ventilator module 401 may include one or more processors 445 and one or more memories 447 to analyze letter It ceases and exports therapy.

Ventilation gas 449 can be left under the speed of entrained ambient air 451, in this way if patient automatically breathes, The combination of ventilation gas 449, the surrounding air 451 of entrainment and the air automatically sucked is just transmitted to the gas of patient under power Road such as nasal cavity 455, Oropharynx airway 457, tracheae 459, lung 461 and other to generate the effective effect in clinical ground on lung and air flue Fruit.Patient can pass through nose or mouth expiration 463.Further include various air flues, for example, nasal airway 473, nasal airway 475, Oral cavity air flue 481, epithelium healing 477 and downtake 479.

When utilizing the present invention, although having received mechanical support by interface, patient can be by their upper gas It road and is normally breathed by their nose.During expiration, the gas of exhalation does not enter gas transport circuit preferably But leave nose or mouth is directly entered surrounding air, or pass through or enter surrounding air across or around nasal interface 400.? In use process in such as breathing process, patient can close their mouth to help machinery is supported guiding downtake and is passed through Oral cavity 465, the root of tongue 467, palate 469 and oesophagus 471 are crossed, or mouth guard or chin strap can be used, if necessary If.Patient can be exhaled when using the therapy by their mouth.

Fig. 5-26 describes the embodiment of the open air flue nose cup of non-tight in free space with nozzle.It describes System and method for making patient ventilating in a manner of it will not interfere user, which breathe interface using permission user The nose ventilation patient interface and system of neighbouring surrounding air.Gas transport nozzle can with nose at a distance with Nasal interface is connected.Nozzle can be connected to gas transport circuit and ventilator, and transmit the gas before nasal interface to nose.Nose Interface and nozzle can generate negative pressure region near the nozzle and generate barotropic field in nose entrance.From ventilation The combination of transmitted of the air of the gas and entrainment of machine is to patient to support work of breathing.

Fig. 5 describes one embodiment of the present of invention, it is shown that has features designed to 503 lower section of nose for being placed in user The ventilating nasal shade assembly 500 of nose cup 501, without sealing or preventing surrounding air to flow freely into and flow out nose 503.Nose cup 501 may include manifold 505.Nose cup 501 also may include the one or more respiratory pressures detection placed close to nostril entrance Port 507 or sensor.Nose cup 501 may include one or more gas transports that a distance is spaced with nose entrance 503 Nozzle 509.One or more gas transport nozzles 509 can import ventilation gas in nasal airway, and environment is empty Gas is entrained in nasal airway.

Gas transport pipe fitting 511 and pressure detecting pipe fitting 515 from ventilator as shown in Figure 4 can be in manifolds 505 Proximal end be connected on manifold 505.Gas transport pipe fitting 511 and pressure detecting pipe fitting 515 can be far from manifold 505 and Around bilaterally the route of ear 513 of user.

Fig. 6 shows the isometric view of nose cup component 500, the nose cup 501 of the far-end including nose cup component 500, in gas The far-end of body transmission pipe fitting 511 and pressure detecting pipe fitting 515 is connected to gas transport pipe fitting 511 and the pressure inspection of manifold 505 Test tube part 515 connects gas transport pipe fitting with the proximal end of each arm of pressure detecting pipe fitting 515 in gas transport pipe fitting 511 511 with the Y-connector 601 of pressure detecting pipe fitting 515, and extend to from Y-connector 601 group of ventilator connector 605 The gas transport and pressure detecting pipe fitting 603 of conjunction.

In certain embodiments, the rotary joint 517 and/or pressure detecting between gas transport pipe fitting 511 and manifold 503 Rotary joint 519 between pipe 515 and manifold 503 may include pawl configuration.These pawls configuration connector 517,519 can be used The nasal airway of patient is directed at the angle of regulating gas delivery nozzle 507 in the angle for adjusting manifold 503.Alternatively, gas Transmission pipe fitting 511 and pressure detecting pipe fitting 515 can be connected to manifold 503 with different spin orientations equally to make gas transport The nasal airway of the alignment patient of nozzle 507.

Fig. 7 describes the elevated cross section diagram of nose cup 701, it is shown that an exemplary side of nose cup 701, for example (,) it is left Side.Fig. 7 shows nasal airway 703, nostril wall 705, nostril entrance 707, gas transport nozzle 713, passes through gas transport spray The airflow channel 711 of mouth 713, the manifold 709 in conjunction with gas transport nozzle 713, respiratory pressure detection casing 715 and gas transport The distance between nozzle 713 and nostril entrance 707 717.The circular distal tip of gas transport nozzle 713 can be used for helping by Leave the reduction of the sound of the gas generation of gas transport nozzle 713.

Fig. 7 shows specific nozzle tip to show that nozzle tip can be flaring or circular subtract for sound Gently.Flaring is a kind of option.

Distance from nozzle to nose:

Gas transport nozzle 713 is desirably integrated into manifold 709, and manifold 709 can shape, size is arranged and design It is placed at the ideal position of 707 lower section of nostril entrance at by gas transport nozzle 713.Gas transport nozzle 713 and nostril entrance 707 distance can be selected to optimize the function of the venturi generated by gas transport nozzle 713 and nostril.Best-of-breed functionality It can be described as generating that maximum pressure and gas transport be still comfortable for user and tolerable in nasal airway 703.

In general, the positive pressure gas flow of layering should be formed before air-flow reaches nostril depths.The positive pressure gas flow can by from It opens inside the air-flow cone that the gas of gas transport nozzle 713 defines and the region deviding of distal end.Region outside the cone is Mechanical ventilation is generated by venturi and supports negative pressure, its entrained ambient air enters nose and nasal passage, therefore generates mechanical ventilation Energy needed for supporting.When the cone and the inner wall in nostril intersect, the distal side of intersection point is positive pressure.

Alternatively, position and other operating parameters and plant bulk, the cone based on gas transport nozzle 713 exist It can be more wider than nostril entrance when reaching nostril.In the case, positive pressure appears in outside nostril and distally extending.And And alternatively, which can be in nostril wall intersection by certain distance inside nostril, so that negative pressure region be allowed to occur At nostril entrance and slightly inside, but then transit to the positive pressure of intersection point distal end.Because cross-sectional geometry is non-equal It is even, such as be not perfectly round, so just being deposited in cone and nostril circumference and the air-flow cone intersection point of nostril wall In changeability.As will be described later like that, the specific embodiment of nose cup can solve the nuance, thus may be implemented More evenly with predictable performance.

In the example of figure 7, nostril entrance 707 can serve as jet stream pump intake and nasal passage can serve as jet pump Trunnion.Intuitively, it may be desirable to which best-of-breed functionality, which will order, is placed in gas transport nozzle 713 at nostril entrance 707 or nostril It is slightly internal；However, pass through empirical test it has been determined that in average adult user, it is real for gas transport nozzle 713 Now the optimum position of best venturi function is placed in gas transport nozzle 713 from 707 substantially 0.950 inches of nostril entrance Place.

The position of respiratory pressure detection port:

To keep the embodiment of the present invention effective, need to measure and monitor the breathing of patient with suitably synchronized ventilation machine gas The autonomous respiration mode of transmission control system and patient, if clinically wishing.Therefore, although gas transport nozzle 713 are ideally disposed away from a certain distance from the nostril entrance 707 of user, but respiratory pressure detection casing 715, breathing pressure Power detection port or other sensors may need to be placed in nostril entrance 707 nearby, at nostril entrance 707 or inside.For example, pressure The distal end of power detection casing 715 can be placed in the slightly internal region within which for generating positive pressure via venturi system of nose In.

It is beneficial that having multiple positions for measuring pressure.For example, a position can be used for detecting and measure disease The autonomous respiration pressure of people, and another position is used to measure the pressure generated by aerating system.For example, respiratory pressure detects Port can be placed in the slightly internal of nostril entrance 707, and ventilation gas pressure sensor can be placed in nostril entrance 707 703 inside deeper inside of outside or nasal airway.

The position of pressure detecting port such as respiratory pressure detection casing 715 can be selected to keep precision and fidelity optimal Change.For example, respiratory pressure detection port such as respiratory pressure detection casing 715 can be arranged to it and be located at nasal airway 703 Interior side is nearby or at the rear of nasal airway 703.Also multiple respiratory pressure detections position can be used.For example, in nostril Detection port at the inside rear of air flue 703 can be used for accurately measuring pressure of inspiration(Pi), and before nasal airway 703 The detection port just located can be used for accurately measuring breath pressure.

In addition to nasal airway breath pressure sensor, other sensor types or position can be used.For example, microphone Or ultrasonic sensor can be used for detecting respiration phase when the neck for being placed in user is to detect the movement of gas air in tube. Other sensors and sensor position can be used.

In addition to measuring venting pressure by the pressure detecting port outside nose, in nostril inlet or nasal airway Portion, venting pressure can be obtained by other device and method.For example, being hindered by the crucial interrelated patient parameters of measurement such as air flue Power and breathing path compliance and these parameters are related to the transmission pressure based on gas transport pressure, gas transport circuit In gas transport pressure can be interrelated with the transmission respiratory ventilation pressure that is transmitted to patient by aerating system.

Fig. 8 shows top view-side view of the alternate embodiment of Fig. 5, it is shown that gas transport nozzle 809 and pressure detecting Casing 803.Gas transport nozzle 809 may include a pair of outlet 801 for being used for right and left gas transport nozzle 809.It is as follows Described, double outlets 801 can improve the function and user's tolerance of device.

Fig. 9 shows 805 manifold hidden line view of nose cup 800 shown in Fig. 8 and manifold, including close from the first of manifold 805 End 903 extends to and the pressure detecting lumen 901 by each pressure detecting casing 803 and the second proximal end from manifold 805 907 extend to and by the gas transport lumen 905 of each outlet 801.Figure 10 shows the top of nose cup 800 shown in Fig. 8 View, and Figure 11 shows the hidden line view of nose cup 800 shown in Fig. 8.Before Figure 12 shows nose cup 800 shown in Fig. 8 Depending on-top view, and Figure 13 shows the hidden line view of nose cup 800 shown in Figure 12.

The critical size and value of ventilation nose cup are shown in Table 1.The parameter that ventilation nose cup and system provide is shown in Table 2.It is logical Additional exemplary dimensions, value and the material of gas nose cup are shown in Table 3.

Jet pattern:

In in some cases, due to the changeability found in the nostril of patient and nose air duct geometry, lead to Gas gas may not form desired laminar flow by the transmission of a left side and a right gas transport nozzle to patient.Therefore, In certain embodiments of the present invention, the left and right gas transport of cover can be executed by multiple nozzles.

For example, as shown in Figure 8, a pair of left and a pair of right gas vent 801 may be embodied in manifold 805, so by The pattern of the gas generation of outlet 801 is left just to approach the pattern expansion of the cross-sectional area of nasal airway, and therefore just In the positive pressure gas flow for generating layering.It is shown in Figure 14 and 15 by the pattern 1401 that the airflow exits from outlet 801 generate.It should Air-flow and head type exterior feature are unfolded and keep airflow exterior feature flat, this can optimize discharge characteristic, and have minimum dry convenient for generating Disturb the positive pressure gas flow with the layering of resistance.Also other embodiments can be used.For example, oval gas transport as shown in Figure 16 The gas transport nozzle array 1701 of nozzle orifice 1601 or single gas transport nozzle 1703, such as with as shown in Figure 17 Round or oval pattern arrangement.Arbitrary jet pattern can be used.

In addition to gas delivery nozzle pattern, the gas flow paths axis or jet patterns that generated by left and right nozzle it Between the angle for including can be it is not parallel.For example, as shown in Figure 18, orifice gas flow path 1801 and leaving axis It can slope inwardly, such as inside with the angle of substantially 0.5-20 degree, and preferably inside with the angle of substantially 2-6 degree.It should The vent gas for entering nasal airway can be directed at nasal airway by angle, this can optimize discharge characteristic, and convenient for generating The positive pressure gas flow of layering with least interference and resistance.

Figure 14 and 15 describes the gas flow paths pattern into nose.As an example, make in this specification With double left and double right gas transport jet patterns.As can be seen, it is generated in nasal airway by twin-jet nozzle configuration Combined flow pattern can by the air-flow of transmission and velocity profile exterior feature on the appropriate cross section in nasal airway path equably Distribution.This positive pressure that can improve before gas is moved to nasal airway depths is formed, and improves laminar flow, and reduce stimulation to make The turbulent flow of user.For example, high-speed flow can impact the neuroceptor on nasal passage inside if airflow exterior feature is more concentrated, this It can be intolerable to user.In test, the airflow exterior feature more concentrated is found that user can be stimulated, and more dispersed Airflow exterior feature is found to be endurable.The spacing of nozzle, angle, rotation position and/or orientation can be it is adjustable, or Cover can obtain in different sizes, just match the size of user's nose anatomical structure by the flow pattern that nozzle generates in this way And shape.For example, nozzle location can be rotated to rotate by the rotation of the oval pattern generated to nozzle when using twin-jet nozzle Indexing is set, and such oval pattern is just matched with the oval orientation of the nasal airway of user.

Nose cup with jet pump trunnion:

In addition, cover may include jet pump throat section 1901 as shown in Figure 19 and 20.Figure 19 has in manifold 1907 Bottom upper opening entrainment port 1905.Figure 20 shows identical throat section 1901, but in throat section 1901 There is entrainment port 1905 on the top of the manifold of base position.In Figure 19, surrounding air can be carried secretly through manifold 1907 Bottom.In Figure 20, surrounding air can carry the top by manifold 1907 secretly.

Minimum by being reduced to influence of the patient's anatomy for performance, jet pump throat section 1901 can be used In the consistent performance for generating aerating system between different people.Jet pump throat section 1901 can be used for inhibit by from Open the sound of the high-speed gas generation of gas transport nozzle 1903 and entrained ambient air.Jet pump throat section 1901 or May include as shown in Figure 20 can in the entrainment port 1905 of the base position of jet pump throat section 1901 or manifold 1907 To include serving as the through-hole 1909 for carrying hole secretly as shown in figure 19, which extends through manifold from the bottom of manifold 1907 1907 thickness to manifold 1907 top and be connected to gas transport nozzle 1903.The throat section of cover shown in Figure 19 1901 can be used for reducing the sound generated by venturi and similarly the embodiment can be used for sleep apnea and answer With wherein the smallest sound is crucial performance requirement.Port 1905 is carried secretly in Figure 19 to be shown as in the bottom of manifold 1907, But it can be on the side of jet pump throat section 1901 for example near nozzle 1903.Gas transport lumen 1911 can be with Including in any proximal end of manifold 1907.

Nozzle in Figure 19 can be any type of nozzle.In Figure 19, can have as manifold a part and Trunnion option outside nose.

Other cover formative factors:

Figure 21 describes the alternate embodiment of nose cup 2101, and wherein gas transport nozzle 2103 is by using horizontally extending 2105 are placed in the correct position of underthe nose, wherein horizontally extending 2105 be connected to from be designed to place and be fixed to nose On the vertical adjutage 2107 that nose part 2109 on sub- front extends downwardly.Nose part 2109 can be fixed in several ways Onto nose, such as by using being connected to nose cup 2101 so that nose part 2109 is fixed to 2115 He of gas delivery tube on the face Pressure detecting pipe 2111.Nose part 2109 can also be fixed on nose otherwise, such as pass through strapping, bonding Agent, frictional fit or combinations thereof.

The vertical adjustable position being in gas transport nozzle 2103 with user's suitable distance of adjutage 2107, and And horizontally extending 2105 can be rotatably adjustable to gas transport nozzle 2103 angle for being properly aligned with nasal airway.Gas Spacing between body delivery nozzle 2103 is adjustable, such as passes through the linear regulation in horizontal arm.

Respiratory pressure detection port (not shown) can be upwardly extended from nose part 2109 with whip hand in nose entrance Locate, near or within.Nose part 2109 can include for being placed in the shelf 2113 against nostril margins in its bottom end.Breathing Pressure detecting pipe 2111 can connect to the side of nose part 2109, be the right side of user in Figure 21, and gas transport Pipe 2115 can connect to opposite side.

Nose cup 2101 also may include additional detection function, such as CO₂It gas sample port (not shown) and extends to The pipeline of capnometer (not shown), it can be by being integrated into gas transport pipe fitting or pressure detecting for accessory channel In pipe fitting and necessary channel (requsite) is integrated into cover nose part and/or adjutage and is included.Nose part 2109 The gas transmitted from gas transport nozzle 2103 can also be prevented to be oriented to eye when nose cup 2101 is not suitably suitble to user Eyeball.

Nose cup 2101 also may include additional detection function such as CO₂Gas sample port (not shown) and carbon dioxide The pipeline of detection meter (not shown).Nose part 2109 can also be prevented when nose cup 2101 is not suitably suitble to user from gas The gas that body delivery nozzle 2103 transmits is oriented to eyes.

The angle of the interior side of the bridge of the nose can be used to make the therapy match patient in the embodiment of the invention.In experimental period Between, it is determined that optimum performance is when gas transport nozzle 2103 is aligned to be parallel to the bridge of the nose so that the nozzle of ventilation gas is directed at nose It is realized when hole.The gas transport nozzle 2103 of nose cup 2101 can be aligned to be parallel to nose part 2109, in this way by by nose Part 2109 is placed on the bridge of the nose, and gas transport nozzle 2103 can be parallel to the bridge of the nose.

If there is some misalignment, performance will be reduced.Nose is preferably suitably open by gas transport nozzle 2103 Alignment nostril axis is maintained within 10 degree.Similarly, when patient is moved to the left or right their nose (such as by overstate The mobile chin of the mode opened) when, nose cup 2101 can follow nose, it is ensured that gas transport nozzle 2103 is still aligned in nose Therefore heart line is simultaneously directed at nostril.In Figure 22, gas transport pattern 2205 may include two intersection circles to generate effective ovum Shape pattern, such as generated by twin-jet nozzle, such as solved before this for the layering cross section of formation air-flow and positive pressure in nasal airway As releasing.

Figure 22 shows how the bottom view of nose 2201 and the nose cup 2101 of Figure 21 are directed at nose 2201.Respiratory pressure inspection Location sets 2203 and gas transmission patterns 2205 overlap nose 2201 and as it is two big it is oval shown in nasal airway 2207 On bottom view picture.Gas transport pattern 2205 and nose air pressure detection position 2203 are indicated by big and small circle respectively.In this example Middle pattern 2205 is generated by two gas transport nozzles for left and right nostril, this is suitable for other than the cover of Figure 22 Other cover embodiments of the invention.

It is correct in the breathing path in nostril to help achieve port is detected that nose air pressure detection port can be protrusion Position.Gas delivery port may be positioned so that gas transport path has the clean path for leading to nasal airway.Can have two Adjusting feature in the nose cup 2201 and/or nose cup of a or more size, the detection gentle body transmission region in port in this way will be with Nasal airway canal path is appropriately aligned.Previous figure depict detection position must neighbouring nostril entrance, can it is internal, with Entrance is coplanar or slightly in outside, but is no more than 5 millimeters far from entrance, and gas transport nozzle tip is located at and nostril entrance one At section distance, for example away from 10-25 millimeters.The configuration can permit nose cup 2201 and be examined using jet pump geometry without sacrificing Precision is surveyed, such ventilator is just suitably synchronous with patient.Moreover, airflow exterior feature can become more before the nostril for entering patient Add turbulent jet that is organized, rather than entering nostril, the latter will be very uncomfortable for patient and be difficult to endure 's.

Figure 23 shows the isometric view of patient circuit's component 2301 of nose cup 2201 shown in Figure 21.Show that connection is exhaled The Y-connector 2303 of suction pressure power detection pipe 2111 and gas delivery tube 2115, and show in the proximal end of patient circuit Combined pipe fitting 2305 and ventilator connector 2307.

Figure 24 and 25 describes the aesthetic fairshaped version of nose cup shown in Figure 21.Nose part 2401,2501 Feature is adjustable to optimize comfort and make to be reduced to the protrusion of user minimum.In Figure 24, gas transport spray Mouth 2403 can be placed in underthe nose by the extension 2405 of nose part 2401 itself, and be prolonging vertically by cover in Figure 21 Semi-girder.In Figure 25, nose part 2501 can be the band on the top of the bridge of the nose and gas transport nozzle 2503 can pass through It is placed using fairshaped vertical arm 2505 and fairshaped horizontal arm 2507.

Figure 26 shows a kind of pattern of cover shown in Figure 21, and wherein gas transport nozzle 2601 is used with adjutage 2605 head tool 2603 is placed in the proper position of underthe nose.Head tool 2603 and adjutage 2605 can be adjusted to incite somebody to action Gas transport nozzle 2601 and respiratory pressure detection port (not shown) are placed in correct position.

Following table only lists example values and is not construed as the limitation disclosure.

Table 1: nose cup example key size and value

Table 2: parameter is supported in the ventilation of example part

Table 3: additional exemplary dimensions, value and material

(1) square, round, decline, rising, sinusoidal, oscillation.

* listed size is exemplary and is used for the adult of average-size；Children's size is small by 20%, newborn's ruler It is very little small by 50%.

Listed diameter is effective diameter (mean cross sectional size).

Figure 27 describes the mechanism of action of the invention, and when the present invention is used for lung disease or neuromuscular disease application When, how the present invention can advantageously influence the work of breathing of patient.The lung volume of patient can be illustrated as the function of lung pressure with curve, The cartographic represenation of area function of curvilinear inner is usually indicated with every liter of joule (J/L), and can be for normal normal adults 0.3-0.6J/L.For breathing damaged patients, 4-10 times of more function are needed during rest or are needed more during effort More function overcome static and dynamic inflation excessive to overcome the disease state of tissue, such as in the situation of COPD, or in fiber High airway resistance is overcome in the case where change or ARDS.

In shown curve graph, the area in pressure axis lower curve is air-breathing WOB, and by pressure axis top curve The area of region deviding is expiration WOB.Arrow shows the progress of single breathing over time, to VT since RV, Then RV is returned from VT.RV1 and VT1 is the remaining volume and tidal volume (TV) without using the therapy.Line 3201 indicates autonomous respiration It ventilates without noninvasive open nose.Line 3203 indicates autonomous respiration and has noninvasive open nose ventilation, has used air-breathing expansion Increase and end-expiratory positive pressure (PEEP) therapy.RV2 and VT2 is the remaining volume and tidal volume (TV) using the therapy.As can see As, RV increases with the therapy, because in this example, expiratory gas flow is provided as a part of this therapy, this can increase Big remnants volume.Importantly, VT increases with this therapy and is increased even more than RV, this indicates more volumes due to this Therapy and enter and leave lung.The increase of tidal volume (TV) is considered clinically effective, however open ventilation, it is noninvasive and Realize technically there is challenge in minimum level system outstanding.As shown in the graph, when the present invention is opens (ON) The air-breathing WOB of patient can be that the air-breathing WOB of patient when closing (OFF) is small by about 25% than the present invention.Moreover, air-breathing lung pressure increases (negative value is smaller) and tidal volume (TV) increase greatly, and optionally, if providing the therapy during expiration, breath pressure can increase Greatly.Although remaining volume can increase because of gas is provided during ventilator in this example expiration phase in the example shown, But ventilation parameters can titrate not influence remaining volume, and because patient tempers their lung flesh when receiving the therapy Ability, the lung mechanism of patient may remold in the situation of COPD, actually result in the value that remaining volume is reduced to more normal. In shown curve graph, the waveform with the therapy takes inspiration trigger time early stage to the output of ventilator expiratory phase therapy, And volume output is transmitted in the inspiratory duration of patient.However, alternatively, the difference that can adjust WOB curve can be executed Transmitted waveform it is synchronous with transmission.For example, ventilator expiratory phase therapy can the later transmission in the inhalation cycle of people, and pass It is defeated to be completed at the end of air-breathing, and transmitted using square or rising waveform profile.In this case, using the therapy WOB curve will tilt upwards to the right side of curve, and such air-breathing just terminates and be transitioned into exhale at the point above lung pressure zero axle Gas.

Figure 28 is graphically shown to be held on lung simulator platform model using the lung that NIOV is realized compared with traditional ventilation Amount.In all waveforms, simulation patient automatically breathes under the identical inspiratory effort for the tidal volume (TV) for causing 245ml, and Clinical target is that the tidal volume (TV) of patient is increased to 380ml from 245ml (see 3301) (see 3303).In the graph from a left side to In right first waveform, the breathing 3305 of patient be do not assist and therefore patient receives the tidal volume (TV) of 245ml.Next In a waveform, the simulation patient with identical effort is assisted with traditional closed system ventilator, such as exhaling using sealing The pneumatic duct of suction hood or flange.Ventilator output 3309 is set as a rank to realize desired " auxiliary " tide of 380ml Gas amount.Ventilator is set as 420ml to realize the target, because passing in the gas for being transmitted to lung by ventilator with by ventilator Defeated then and not up to lung and wasting has differences between the gas in environment 3307.In third waveform, Small leak is led Enter in traditional ventilator system, such as in the case where cutting off ventilator to patient as completion.In order to realize 380ml's Desired " auxiliary " tidal volume (TV), ventilator are significantly necessarily placed at 705ml.In second and third waveform, it can also see It arrives, is derived from ventilator by all volumes that the lung of patient receives, and it must be in these legacy systems.In the 4th waveform, Patient's auxiliary is with NIOV, and it is seen that the output of NIOV ventilator only has to be arranged in the phase for realizing 380ml at 90ml " auxiliary " rank hoped.In this case, ventilator, and the phase in 380ml are more only come from 380ml tidal volume (TV) When the surrounding air 3311 that part is sucked from entrainment and independently, therefore make NIOV system more efficiently, comfortably than other systems And health.

Figure 29 graphically shows the NIOV compared with oxygen therapy using lung simulator platform model.First wave on the left side In shape, patient is not assisted and in -0.8cmH₂It is breathed under the effort of O, generates the sucking tidal volume (TV) 3401 of 248ml.? In two waveforms and third waveform, patient respectively via nasal cannula receive oxygen continuous flow 3403 and Pulsating Flow 3405, and for Lung pressure and tidal volume (TV) are no or have insignificant effect.In the 4th waveform, NIOV 3407 is used, this shows lung Pressure is dramatically increased with tidal volume (TV), therefore indicates that NIOV facilitates previously mentioned work of breathing, although NIOV is open gas Road system.

It is respective that Figure 30 A-30L shows that exemplary air gas transport type exterior feature of the invention presses lung volume and lung with them Influence.

Figure 30 A, 30D, 30G and 30J are shown by the exemplary pressure and/or flow waveform of ventilator transmission.Figure 30 A is retouched The square wave 3501 during complete inhalation cycle is stated；Figure 30 D describes raising and lowering waveform 3503；Figure 30 G is retouched The square wave 3507 of first part's transmission of the autonomous inspiratory duration for patient is stated；Figure 30 J, which shows to have, to be inhaled The multistage wave amplitude waveform 3509 of the first wave amplitude 3511 and the second wave amplitude 3513 in expiration phase transmission that are transmitted during the gas stage, Wherein the second wave amplitude 3513 for example be used to transmit end-expiratory positive pressure (PEEP), this is effective in some clinical applications.Its Its waveform is also included in the present invention, such as declines the trapezoidal or trapezoidal square wave of rising.Enter gas transport pipe fitting from ventilator Pressure and flow velocity export usually in the range of 5-40psi and 6-30lpm.

Figure 30 B, 30E, 30H and 30K describe the lung volume transmitted by the therapy, including ventilator output 3515 and entrainment Volume 3517.

Figure 30 C, 30F, 30I and 30L show the lung pressure for not using the therapy indicated by dotted line 3519, and use is by solid line The lung pressure of the generation of 3521 therapies indicated, display is positive pressure of inspiration(Pi) for entire expiratory phase in Figure 30 C, in Figure 30 F It is positive pressure of inspiration(Pi) with a part in 30I for expiratory phase, and therapy extends in expiration 3523, and in Figure 30 L Show the negative pressure of inspiration(Pi) of raising.

Figure 31 A-31L describes additional exemplary air gas transport type exterior feature of the invention with them to lung volume and lung The respective influence of pressure.

Figure 31 A describes rising waveform 3601.Figure 31 D describes falling waveform 3603.Figure 31 G describes more waveforms 3605, it has lower wave amplitude in the first part of expiratory phase, such as to transmit earlier to lung in respiration phase Required oxygen molecule, and the wave amplitude with higher in the second part of expiratory phase, such as to transmit the machinery of therapy Support section is to help work of breathing.Figure 31 J describes waveform 3607, it can more efficiently using gas supply and it is raw At almost the same venturi, entrainment and therapeutic effect.

Figure 31 B, 31E, 31H and 31K describe the lung volume transmitted by the therapy, including ventilator output 3609 and entrainment Volume 3611.

Figure 31 C, 31F, 31I and 31L show the lung pressure for not using the therapy indicated by dotted line 3613, and use is by reality The lung pressure of the generation for the therapy that line 3615 indicates.

The lung pressure generated by the therapy can be controlled by the combination of the following factor: gas transport circuit pressure, jet pump are set Meter and configuration, the lung compliance of patient and airway resistance, the respiratory effort of patient, ventilator output phase for patient air-breathing rank The timing and ventilator output waveform of section.However, in general, there is the gas of the 30psi of the 100ml of square wave to pass for transmission Defeated circuit pressure and when the expiratory phase of patient starts transmit 500msec can increase lung pressure 5-15cmH₂O.Also, usually Transmit the gas transport circuit pressure with the 30psi of 250ml of trapezoidal waveform and during most of expiratory phase of patient Transmission 700msec can make lung pressure increase 10-25cmH₂O.Oxygen, air, oxygen-sky can be by the gas that ventilator transmits Gas mixture or treatment gas such as helium.In main function mechanism of the invention, the lung pressure and lung volume of patient increases, this Allow patient oneself with them without by fatigue and dyspneic limitation.In another main function machine of the invention In reason, the pressure and volume that patient's response is provided by therapy are supported to reduce their respiratory effort, therefore will not lead from the therapy The variation of total lung volume is caused, but reduced work of breathing can be generated.In another main embodiment of the invention, can occur The combination of above-mentioned two mechanism of action.

Figure 32 is the figure of the timing and air stream transportation according to one embodiment.The wave amplitude of air stream transportation speed 3701 uses Respiratory rate is adjusted to influence airway pressure 3703.Respiratory rate is faster, and wave amplitude is higher.Unless being changed by user, otherwise hold Product transmission can maintain under constant speed between quiet state and application state.However, can be by the quantity of power of system transmission It is higher during application state, because flow velocity is faster, more gases will be carried secretly, this can generate more power during expiratory phase With higher lung pressure.In addition, the transmission time of the air-flow of transmission can be adjusted to the percentage of respiratory cycle by user.Example Such as, if the respiratory cycle is 3 seconds, 25% transmission time is set the transmission flow pulse width equal to 0.75 second.Transport stream Amount pulse width will change with respiratory rate；However, it can continue as the 25% of the respiratory cycle (unless being changed by user Become).Setting can be arranged in the range of the 15% to 70% of such as respiratory cycle.Setting can be independent of volume settings. For example, one 25% pair 40% of setting still can transmit identical set volume, and can be only with biography different in flow rate Defeated set volume.Algorithm for adjusting the transmission flow burst length can for example check that preceding 3 to 5 breathings are worked as with determination What the preceding respiratory cycle is, and can have correction coefficient to exclude abnormal breathing.

Although preceding description is directed toward the preferred embodiment of the present invention, it should be understood that other variants and modifications are for this The technical staff in field will be apparent, and can make without departing from the spirit or scope of the present invention.In addition, in conjunction with The feature of one embodiment of the present of invention description can be used together with other embodiments, even if not expressing above.

Claims (30)

1. a kind of system supported for providing ventilation, the system include:

Gas transport source；

Gas transport pipe fitting；

Non-tight nasal interface, be designed to be connected to the nasal airway of patient and allow patient directly breathing environment air without Need to flow through non-tight nasal interface, wherein non-tight nasal interface includes manifold；And

It is connected at a distance with the manifold in free space in the nostril entrance with the nasal airway from patient Nozzle, wherein the manifold is configured to be located in the nozzle on one position to generate venturi by the nozzle and nostril Function, wherein nozzle is connected to the gentle body transmission sources of gas transport pipe fitting；

Wherein nozzle can be formed air-flow cone by the gas being discharged from the nozzle, and the air-flow cone is in a crosspoint and disease The inner wall of people's nasal airway intersects, patient's nasal airway inner region of the distal end in region and the crosspoint inside air-flow cone Define barotropic field, wherein form the positive pressure gas flow of layering, the region deviding negative pressure region outside the cone, the negative pressure region by The venturi generates and entrained ambient air enters patient's nasal airway,

The combination for the air that the gas of gas wherein from gas transport source and the nasal airway into patient is carried secretly provides logical Gas is supported.

2. the system as claimed in claim 1, which is characterized in that further include one or more sensors.

3. system as claimed in claim 2, which is characterized in that one or more sensors include far from nozzle towards patient's Nasal airway extends and terminates at the sense channel in barotropic field.

4. system as claimed in claim 2, which is characterized in that one or more sensors include the detection extended far from nozzle Channel.

5. system as claimed in claim 4, which is characterized in that sense channel extends in the nasal airway of patient.

6. system as claimed in claim 4, which is characterized in that sense channel extends to internal +/- 5 millimeters from nostril entrance Place.

7. the system as claimed in claim 1, which is characterized in that further include two or more sprays of the nasal airway of each patient Mouth.

8. the system as claimed in claim 1, which is characterized in that nozzle is oval gas transport nozzle orifice.

9. the system as claimed in claim 1, which is characterized in that nozzle includes with multiple gases of round or oval pattern arrangement The array of delivery nozzle.

10. the system as claimed in claim 1, which is characterized in that further include jet pump trunnion, which includes flowing Path.

11. system as claimed in claim 10, which is characterized in that jet pump trunnion is connected with manifold, and nozzle is by penetrating Stream pump trunnion is connected with jet pump trunnion flow path.

12. system as claimed in claim 11, which is characterized in that manifold includes the folder being connected to jet pump trunnion flow path Port.

13. the system as claimed in claim 1, which is characterized in that nozzle slopes inwardly.

14. system as claimed in claim 13, which is characterized in that nozzle is sloped inwardly with the angle of 1-20 degree.

15. the system as claimed in claim 1, which is characterized in that nozzle generates oval gas transport gas inside nasal airway Flow pattern is wide.

16. system as claimed in claim 15, which is characterized in that nozzle forms oval gas transport nozzle orifice, the ovum Shape gas transport nozzle orifice is rotatably adjustable, with rotate the oval gas transport nozzle orifice with nasal airway Oval orientation matching.

17. the system as claimed in claim 1, which is characterized in that nozzle includes at least one left nozzle and at least one right spray Mouth, the spacing between wherein at least one left nozzle and at least one right nozzle are adjustable.

18. system as claimed in claim 17, which is characterized in that at least one left nozzle and at least one right nozzle are can to revolve Turn adjustable.

19. the system as claimed in claim 1, which is characterized in that the spacing between nostril entrance and nozzle is adjustable.

20. the system as claimed in claim 1, which is characterized in that non-tight nasal interface can obtain in different sizes, spray There is difference into the distance of nostril entrance in mouth spacing, nozzle spin orientation and nozzle.

21. the system as claimed in claim 1, which is characterized in that negative pressure region extends to the position for closing on nostril entrance from nozzle It sets.

22. the system as claimed in claim 1, which is characterized in that the negative pressure of negative pressure region is less than environmental pressure.

23. the system as claimed in claim 22, which is characterized in that the negative pressure of negative pressure region is -5 to -28cmH₂O。

24. the system as claimed in claim 1, which is characterized in that the positive pressure of barotropic field is greater than environmental pressure.

25. system as claimed in claim 24, which is characterized in that the positive pressure of barotropic field is 0.01-0.50psi.

26. the system as claimed in claim 1, which is characterized in that nozzle is placed in outside nose entrance at 0-1.5 inches.

27. the system as claimed in claim 1, which is characterized in that gas is same by the transmission of nozzle and the breathing pattern of patient Step.

28. the system as claimed in claim 1, which is characterized in that the gas from gas transport source is by wearable ventilation Machine control.

29. the system as claimed in claim 1, which is characterized in that ventilation supports to include reducing work of breathing to treat breathing function It is incomplete.

30. the system as claimed in claim 1, which is characterized in that ventilation supports to include improving airway pressure to exhale to treat sleep Inhale pause.