WO2015002662A1 - Procédé et système pour réguler la respiration - Google Patents

Procédé et système pour réguler la respiration Download PDF

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Publication number
WO2015002662A1
WO2015002662A1 PCT/US2013/057815 US2013057815W WO2015002662A1 WO 2015002662 A1 WO2015002662 A1 WO 2015002662A1 US 2013057815 W US2013057815 W US 2013057815W WO 2015002662 A1 WO2015002662 A1 WO 2015002662A1
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WIPO (PCT)
Prior art keywords
patient
volume
orifice
respiratory
breathing
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Application number
PCT/US2013/057815
Other languages
English (en)
Inventor
Robert W. Daly
Original Assignee
The Periodic Breathing Foundation, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/933,255 external-priority patent/US9884159B2/en
Application filed by The Periodic Breathing Foundation, Llc filed Critical The Periodic Breathing Foundation, Llc
Publication of WO2015002662A1 publication Critical patent/WO2015002662A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0045—Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A61M16/026—Control means therefor including calculation means, e.g. using a processor specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875—Connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0808—Condensation traps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0866—Passive resistors therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A61M16/203—Proportional
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0042—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the expiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/02—Equipment for testing the apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)

Definitions

  • the present invention relates generally to a method and system for the treatment of breathing disorders.
  • the present invention relates to systems and methods for controlling breathing of a patient by maintaining specific levels of carbon dioxide (“CO 2 ”) dissolved in the patient's arterial blood.
  • CO 2 carbon dioxide
  • SDB Sleep-disordered breathing
  • OSA obstructive sleep apnea
  • MSA mixed sleep apnea
  • CSA central sleep apnea
  • CSR Cheyne-Stokes respiration
  • An apparatus for controlling flow of CO2 to a patient during breathing includes a CO2 mixing device coupled to the patient interface device.
  • the CO2 mixing device is configured to be coupled to the pressurized gas device.
  • the CO2 mixing device includes multiple ventilation orifices interchangeably connected with multiple dead spaces, wherein the multiple ventilation orifices control supply of CO2 to the patient and volume of CO2 in the multiple dead spaces.
  • a method for controlling flow of CO 2 to a patient during breathing is carried out as follows.
  • the patient interface device is coupled to a CO 2 mixing device, which is coupled to air supply device; and the CO 2 mixing device includes multiple ventilation orifices interchangeably connected with multiple dead spaces, wherein the multiple ventilation orifices control supply of CO 2 to the patient and volume of CO 2 in the multiple dead spaces.
  • the method includes measuring airflow through each of the multiple ventilation orifices; detecting a content of CO 2 in the measured airflow; adjusting airflow through each of the multiple ventilation orifices based on the detecting of the concentration of CO 2 ; and adjusting sizes of the multiple dead spaces based on the detection of the concentration of CO 2 and the adjusting of the airflow through each of the multiple ventilation orifices.
  • FIG. 1 B is another illustration showing an exemplary system for controlling breathing of a patient, according to the present invention.
  • FIG. 12 is a series of tracings showing heart rate and blood oxygen saturation through the night, according the present invention.
  • a sensitive and finely tuned system detects blood CO2 levels via a number of sensors, or chemoreceptors, located within the vasculature and the brain of the patient. Nerve signaling from these sensors is processed by respiratory control centers in the brain, which in turn send appropriate breathing pattern commands to the respiratory muscles including those of the diaphragm, chest and breathing airway.
  • the goal of the system is to match the excretion of CO2 with the production of CO2 by varying the rate of respiration (both the depth and frequency of breathing). In healthy individuals, this system is accurate and steady. It is able to respond quickly to changes in CO2 production and maintain blood CO2 levels within a narrow range. Like many homeostatic mechanisms in the body, control of blood gases is accomplished by a closed-loop negative feedback control system.
  • the peripheral chemoreceptor is located within the carotid artery and directly samples arterial blood for oxygen and CO2 content.
  • the chemoreceptor is sensing the concentration of H+ ions in the blood, which is a proxy for CO2 content in the arterial blood over a short period of time.
  • the sensing becomes disordered and sends signals to the respiratory centers in the brain that tends to overestimate changes in blood gases, specifically, CO2.
  • the cause of the disordered sensing is unknown, it is common in various diseases, e.g., heart failure. It is difficult to correct the above disordered sensing using current medical technology. Further, problems with blood circulation prolong the time delay in reporting changes in blood gases, which adds to the problem of instability in the patient's respiratory control loop.
  • the system and method capable of controlling breathing of a patient by maintaining certain levels of CO2 in the patient's blood, while maintaining or improving blood oxygenation, described herein provide a solution to these problems.
  • the present invention also provides a way to substantially eliminate "dead space gain". This issue is present in some conventional breathing systems.
  • FIG. 13-15 illustrate that during normal breathing the dead space gains of both proximal single dead space design and distal single dead space design are quite high.
  • Single proximal dead space systems interpose a single dead space volume between a sealed patient interface and a single orifice configured to be large enough to permit flow through the orifice sufficient to wash out all exhaled gases that exceed the volume of the single dead space.
  • Such devices are then further connected to an air supply device via a typical respiratory conduit.
  • Single distal dead space systems are configured with a single orifice substantially on or near the patient interface and with a single conduit comprising the entire dead space acting as a coupling to the air supply device.
  • the single orifice is configured to permit a certain maximum amount of a gas to be excreted from the device and to cause substantial re- breathing of any additional exhaled gas.
  • High dead space gain is signified by a steep positive slope of the function in the shaded zone.
  • the shaded zone represents a range of normal breathing while using the device.
  • the system provides an interaction between multiple discreet dead space volumes and multiple ventilation orifices of either fixed (precisely-defined) or variable size, where the volumes and orifices can be organized in a specific pattern.
  • a ventilatory assist device such as a Continuous Positive Airway Pressure ("CPAP") machine, which is set to a predetermined pressure.
  • CPAP Continuous Positive Airway Pressure
  • a ventilatory assist device is not used and the same effect is achieved using a simple device into which the patient breathes.
  • a respiratory conduit which is placed between a patient interface device (e.g., a sealed CPAP mask) and the CPAP machine (or any other air supply device), has a cylindrical shape. Ventilation orifices are placed in line with the conduit to provide outflow of CO2 that is exhaled by the patient.
  • the lengths of conduit lying between each ventilation orifice represent a distinct dead space or quasi-dead space volume.
  • the pattern depends on the volume of each one of patient's breaths or tidal volume (V T ) and the frequency of breathing, or respiration rate.
  • V T tidal volume
  • Each breath consists of an expiratory interval and an inspiratory interval. Once the expiratory interval is over, inspiration commences and most or all of the remaining CO2 in the conduit is re-breathed by the patient.
  • the curve describing a relationship between the rate of ventilation and the rate of CO2 excretion has an arbitrary number of inflection points defining line or curve segments (See, FIG. 3), each with a different slope and length.
  • FIGS. 1A and 1 B illustrate an exemplary system 100 for controlling breathing of a patient 101 .
  • the system 100 includes a respiratory conduit or a mixing device 120 configured to be coupled to mask and headgear assembly 102 and to a pressurized air supply device or CPAP device 130.
  • the mask and headgear assembly 102 includes multiple straps 103 and a mask 104.
  • the multiple straps 103 secure the mask 104 to the face of patient 101 so that there is a substantially sealed connection between the mask and the patient's breathing airway (e.g., nose or mouth).
  • the sealed interface or connection prevents uncontrolled leakage of air or gases from openings that may occur between the patient's face and the mask.
  • FIG. 1 A the system 100 includes a respiratory conduit or a mixing device 120 configured to be coupled to mask and headgear assembly 102 and to a pressurized air supply device or CPAP device 130.
  • the mask and headgear assembly 102 includes multiple straps 103 and a mask 104.
  • one or a plurality of straps 103 are placed over upper and lower portions of the patient's head.
  • a pressurized and/or non pressurized gaseous substance (including air, gas, etc.) generating device e.g., the CPAP device 130, can be used with the therapeutic breathing system.
  • the mask 104 is a sealed orofacial non-invasive ventilation mask.
  • the mask 104 can be a Mirage NV Full Face Mask with adjustable VELCRO® strap headgear, as manufactured by ResMed Corp., Poway, CA.
  • a full-face mask can be used to cover both the nose and the mouth. This design eliminates mouth leak, permitting therapy for patients who breathe through the mouth and/or the nose.
  • other types of masks can be used, such as a nasal mask, an oral mask, an orofacial mask, a nasal prong device, an intraoral device, an endotracheal tube, or any other device.
  • Luer fitting that includes an orifice 136 and that attaches to one of the existing Luer ports on the mask 104.
  • the orifice 136 can be drilled, punctured, or created by any other methods.
  • the mask valve 105, through orifice 136 allows escape of gas (e.g., CO2) exhaled by the patient.
  • the mask 104 does not include the mask valve 105.
  • a first valve 108 is placed on the mixing device 120, substantially adjacent to the mask 104.
  • the orifice 136 has a fixed size. This design allows a certain volume of air to escape from the mask valve 105 per unit of time.
  • the orifice 136 has a variable size, which can be altered depending on the amount of air intended to be allowed to escape from the mask valve 105.
  • the orifice 136 permits air flow of 0.5-6 liters per minute, when the mask is pressurized by the CPAP machine 130 at a specific pressure. This pressure can be equal to the patient's CPAP pressure prescription.
  • the mixing device 120 includes a first valve 108, a first volume 1 1 1 1 , a second valve 1 12, a second volume 1 13, a third valve 1 14, and a connector volume 1 15.
  • the first valve 108 includes an orifice 131 .
  • the second valve 1 12 includes an orifice 133.
  • the third valve 1 14 includes an orifice 135.
  • the mask valve 105 can be the first valve 108.
  • the mask valve 105 can be included or absent from the mask 104.
  • the first valve 108 can be placed on the mask 104 instead of the fitting 139.
  • a fitting 139 incorporates the first valve 108.
  • the fitting incorporates the first valve 108.
  • [39] 139 is coupled to the mask 104 and the first volume 1 1 1 1 .
  • the second valve 1 12 is coupled to the first volume 1 1 1 and the second volume 1 13.
  • the third valve 1 14 is coupled to the second volume 1 13 and connector volume 1 15.
  • the connector volume 1 15 is coupled to the pressurized air/gas generating device 130.
  • the fitting 139 further includes fittings 122 and 124 through which it is coupled to the mask 104 and first volume 1 1 1 , respectively.
  • the fittings 122, 124 can be standard type fittings having 22 mm outside diameter ("o.d.”).
  • the first volume 1 1 1 can be a standard 22 mm inside diameter ("i.d.") respiratory hose.
  • fittings 122, 124 can be of a swivel type to permit rotation of the fitting 139 to accommodate various positions and orientations of the mixing device 120 and provide substantially leak proof connection.
  • fitting 139 can be a straight fitting or a bent fitting, for example a fitting with two 22mm o.d. ends and a 90-degree bend.
  • the first valve 108 provides an air flow of 0.5 to 6 liters per minute when the system 100 is pressurized by the CPAP machine 130 at a given pressure equal to the patient's CPAP pressure prescription.
  • the first volume 1 1 1 can be a standard 22 mm i.d. respiratory hose and can have an internal volume of 100-400 ml depending on the desired increase in the patients' arterial CO2.
  • the hose can be a conventional hose with rubber cuffs as used with CPAP machines; it can be a corrugated disposable respiratory hose, or it can be any other hose appropriate for connecting mask 104 to a fitting 126.
  • the second valve 1 12 includes a straight connector incorporating the orifice 133 that can have a fixed size.
  • the orifice 133 has a variable size.
  • This connector can be plastic and have 22 mm o.d. ends suitable for connection to the first volume 1 1 1 and second volume 1 13.
  • the orifice 133 location in the connector is such that it is not obstructed by lying on a surface (e.g., a bed).
  • a groove in the fitting containing the second valve 1 12 can be created to prevent any obstructions.
  • the orifice 133 permits airflow of 3-8 liters per minute when it is pressurized by the CPAP machine 130 at a given pressure equal to the patient's CPAP pressure prescription.
  • the second volume 1 13 is substantially identical in type to the first volume 1 1 1 .
  • the third valve 1 14 incorporates the orifice I35, which can be variable or fixed.
  • the third valve 1 14 can be a straight connector, as shown in FIG. 1A.
  • the connector can be plastic and have 22 mm o.d. ends suitable for connection to the first volume 1 13 and connector volume 1 15.
  • the orifice 135 location in the mixing device 120 is such that it is not obstructed by lying on a surface (e.g., a bed).
  • a groove in the fitting containing the third valve 1 14 can be created to prevent any obstructions.
  • the orifice 135 permits airflow of 15-30 liters per minute when it is pressurized by the CPAP machine 130 at a given pressure that is equal to the patient's CPAP pressure prescription.
  • the connector volume 1 15 can be substantially identical in type to the first volume 1 1 1 and second volume 1 13.
  • the length of the connector volume 1 15 can be set to accommodate placement of the CPAP machine 130 in relation to the patient 101 .
  • Each one of the orifices 131 (or alternatively 136), 133, and 135 is configured to allow escape of air at a specific rate when the pressurized air supply device 130 is operated at a specific pressure. Depending on the concentration of gas in the airflowing through each of the orifices, the gas will be escaping through each orifice at a specific rate.
  • the orifices can be fixed, variable, or a combination of fixed and variable sized orifices can be used. As can be understood by one having ordinary skill in the art, varying locations and/or numbers of fixed and variable orifices can be used as desired.
  • variable orifices This allows a predetermined amount of air and gas (depending on the concentration of the gas in such air) to escape from the orifices in case of fixed orifices' sizes or a variable amount of gas to escape from the orifices in case of variable orifices' sizes. Further, in case of variable orifices, their sizes can be manually or dynamically controlled. When orifice sizes are manually controlled, a patient, a clinician, or someone else can control the size of the orifice and, thus, the amount of gas allowed to escape from the orifice.
  • orifice sizes When orifice sizes are automatically controlled, their sizes can be adjusted automatically based on an amount of gas exhaled by the patient, amount of gas escaping from each specific orifice, amount of gas contained in the volume connectors 1 1 1 and 1 13, patient physical parameters (such as blood pressure, body mass, age, etc.) and/or other factors.
  • the sizes of orifices 131 , 133, 135 and three volumes 1 1 1 , 1 13, 1 15 can be preliminary determined using an algorithm based on patient's estimated high and low Vco2 (rate of production of CO2 in ml per minute) as directly measured during sleep.
  • the patient's estimated high and low V C o2 can be derived from patient's body mass or any other physiological or demographic variable or combination of variable.
  • the sizes of volumes and orifices are adjusted during a polysomnographic study in a clinic, hospital, laboratory, or any other facility that is equipped with CO2 monitoring equipment. Based on the adjustment, a final combination of orifices and volumes is determined. This combination establishes a first respiratory plateau (See, FIG.
  • V C o2 at or below a value of V C o2 equal to the minimum estimated CO2 production per minute expected to occur during sleep and a second respiratory plateau (See, FIG. 3, segment 310) at or above a value of V C o2 equal to the maximum estimated CO2 production per minute expected to occur during sleep.
  • the respiratory conduit 120 is rotatably coupled to the mask 104 and the CPAP device 130. This arrangement allows the conduit 120 to rotate if the patient turns during sleep. As can be understood by one of ordinary skill in the art, the rotatable connection can be sealed to prevent any leaks during operation of system 100.
  • the conduit 120 includes an anti-asphyxiation valve 1 18 and any number of auxiliary valves 1 16 that can assist a patient during breathing.
  • the anti-asphyxiation valve 1 18 and the auxiliary valve 1 16 are placed in the fitting 139.
  • the auxiliary valve 1 16 when opened, provides a flow of air through the mixing device 120 sufficient to provide substantial washout of the exhaled CO 2 from the mixing device 120.
  • the patient 101 can operate the auxiliary valve 1 16 in order to provide CO 2 washout until patient 101 is resting comfortably.
  • the auxiliary valve 1 16 can be closed manually by the patient 101 or automatically after a certain period of time elapsed.
  • the anti-asphyxiation valve 1 18 opens when the operating pressure of the
  • CPAP machine 130 falls below a predefined value (i.e., CPAP machine 130 fails to provide adequate pressure).
  • CPAP machine 130 fails to provide adequate pressure.
  • the anti-asphyxiation valve 1 18 opens and allows the patient 101 to breathe ambient air through the valve 1 18.
  • the valve 1 18 prevents asphyxiation of the patient in the event of failure of the CPAP machine 130.
  • the mixing device 120 includes a water condensation collection device that collects moisture from the patient's breaths. This prevents undesirable accumulation of moisture within the mixing device 120.
  • Orifice 135 22 liters per minute
  • FIG. 2A illustrates an exemplary setup 200 for a polysomnographic and/or titration study of a patient.
  • the setup 200 includes a CO2 monitor 204, a computing device 206, variable area flow meters 202 (a, b, c) having needle valve controls, a CPAP machine 212, a switchable manifold 208, tubing 210 (a, b, c), a conduit 218, and an orofacial mask 214.
  • the mask 214 is similar to 104 shown in FIGS. 1A and 1 B.
  • the conduit 218 is similar to the CPAP machine 130. Also, the conduit 218 is similar to the mixing device 120. The conduit 218 connects mask 214 and CPAP machine 212. The conduit 218 is also connected to tubing 210 (a, b, c). The conduit 218 includes a first volume 21 1 , a second volume 213, and a connector volume 215, which are similar to the volumes 1 1 1 , 1 13, and 1 15, respectively.
  • the tubing 210a connects orifice 131 (not shown in FIG. 2A) a flow meter 202a.
  • the tubing 210b connects orifice 133 (not shown in FIG. 2A) to a flow meter 202b.
  • the tubing 210c connects orifice 135 (not shown in FIG.
  • the tubing 210 (a, b, c) can be 3/8 inch i.d. Tygon tubing.
  • the tubing 210 (a, b, c) can be glued, cemented, or otherwise securely fastened to the orifices 131 , 133, 135 and flow meters 202 (a, b, c), respectively.
  • the conduit 218 is configured to vary volumes 213 and 215 using movable pistons or cylinders (shown in FIG. 2C) located inside the volumes 213 and 215.
  • the cylinders can be sealed using o-ring clamps (shown in FIG. 2C).
  • FIG. 2C illustrates a portion of the conduit 218 having a cylinder/piston 236 placed in the conduit's interior 234.
  • the cylinder/piston 236 is able to move back and forth as shown by the bi-directional arrow A.
  • the movement increases or decreases dead space volume 232.
  • the cylinder/piston 236 is secured by an O-ring clamp 238.
  • This cylinder/piston 236 arrangement can be placed in either or all volumes 21 1 , 213, and 215.
  • the volumes can also include graduation scales (not shown in FIGS. 2A, 2C) to adjust the dead space volume 232 to a specific value.
  • the output sides of the flow meters 202 are coupled to switchable manifold 208, which allows measurement of CO2 content in the air flowing from anyone of or a combination of the variable flow meters 202 (a, b, c) by the monitor 204.
  • the monitor 204 is connected to the computing device 206, which collects the data. The data is used to adjust the rates of airflow through each of the flow meters 202 and the sizes of the volumes, as described with respect to FIGS. 1A, 1 B and 3-9.
  • the mixing device 120 includes a first orifice 131 connected and in fluid communication with a first control tube 161 and terminating in a first variable flow control valve 162, a first volume 1 1 1 that includes the collective interior volume of a gain chamber 163, a second orifice 133 connected and in fluid communication with a second control tube 164 and terminating in a second variable flow control valve 165.
  • a controller 166 is provided that houses the variable flow control valves 162, 165, the computer interface 206, and the CO2 monitor 204.
  • a means for establishing airflow through the mixing device 120 is shown as a pressurized air supply device 130 or CPAP. Alternately, rather than introducing pressure to the mixing device 120, airflow through the mixing device 120 may be established by providing a vacuum pump that is connected to the outlet ends of the variable flow control valves 162, 165.
  • the second control tube 164 may preferably have its inlet located centrally on the interior of the gain chamber 163. Further the inlet of the second control tube 164 may be a length of perforated tubing such that the gasses entering the second control tube inlet are an accurate representation of the gasses within the gain chamber 163 itself.
  • the orifices 131 and 133 are configured to allow a specific, measured rate of escaping gases based on the rates of the supply air flow (either via pressure or vacuum) and the predicted metabolic rate of the patient.
  • the flow of gasses out of the orifices 131 and 133, via control tubes 161 and 164 as controlled by control valves 162 and 165 may be set for example at an outflow of 4 l/min.
  • the outflowing gasses are monitored at the CO 2 detector 204 such that the CO 2 output is preferably maintained at 1 % of the mixed gas output. More preferably, the process variable in terms of percentage CO2 output is monitored via the second control tube at the gain chamber 163. Should the CO2 output vary beyond a predetermined range, the controller 166 adjusts the flow at control valve 162 to either increase or decrease the outflow of gasses until the CO2 output returns to the set range.
  • variable orifices their sizes can be manually or dynamically controlled.
  • a patient, a clinician, or someone else can control the size of the orifice and, thus, the amount of gas allowed to escape from the orifice.
  • orifice sizes are automatically controlled, their sizes can be adjusted automatically based on an amount of gas exhaled by the patient, amount of gas escaping from each specific orifice, patient physical parameters (such as blood pressure, body mass, age, etc.) and/or other factors.
  • the initial outflow allowed by control valves 162, 165 and the combined volume of the tubing 1 1 1 and the gain chamber 163 can be preliminary determined using an algorithm based on patient's estimated high and low V C o2 (rate of production of CO2 in ml per minute) as directly measured during sleep.
  • the patient's estimated high and low V C o2 can be derived from patient's body mass or any other physiological or demographic variable or combination of variable.
  • the sizes of volumes and orifices are adjusted during a polysomnographic study in a clinic, hospital, laboratory, or any other facility that is equipped with CO2 monitoring equipment. Based on the adjustment, a final combination of flow control setting and volume is determined. This combination establishes a first respiratory plateau (See, FIG.
  • Vco2 at or below a value of Vco2 equal to the minimum estimated CO2 production per minute expected to occur during sleep and a second respiratory plateau (See, FIG. 3, segment 310) at or above a value of Vco2 equal to the maximum estimated CO2 production per minute expected to occur during sleep.
  • a nightly CO2 excretory profile of a patient during sleep is determined. This profile is determined by measuring a total amount of CO2 production by the patient during a diagnostic overnight polysomnographic study. Such profile contains information about high, low and mean levels of CO2 production during sleep.
  • the collected data Prior to a trial fitting of the device (See, FIGS. 1A-2) on a patient, the collected data along with other patient physiological data and desired therapeutic results are used to generate a simulation model, which provides a best estimate of a configuration of volumes and orifices to be used during treatment.
  • the device is fitted on the patient, an initial CPAP pressure is selected and an actual CO2 flow through each of the orifices is measured at the predetermined air flow rate.
  • the orifice sizes are adjusted (either manually or automatically) so that the CO2 flow through or escape from each orifice equals a desired value depending on an intended relationship to the patient's CO2 excretory profile.
  • the volumes' sizes are also adjusted (whether manually or automatically). This depends on whether patient's mean amount of arterial CO2 diverges from the desired level.
  • the adjustment of sizes can be done by physically substituting volume hoses of known size.
  • a cylinder/piston arrangement shown in FIG. 2C) can be inserted into each of the volumes to manually or automatically decrease or increase the interior spaces of the volumes based on the obtained data and desired values. In the event that it is necessary to change the starting CPAP pressure, the procedure of measuring and adjusting can be repeated to return to a specific desired result.
  • the device and therapeutic system is tailored to each individual patient. Initially, the patient is referred to an appropriate sleep diagnostic facility. In the facility, a clinician orders an evaluation of a patient for possible respiratory instability. Certain modifications and enhancements are optionally made to the usual overnight polysomnographic study, described above. These modifications can include additions of end-tidal CO2 monitoring and calibrated nasal pressure measurement. Alternatively, instead of nasal pressure, another highly accurate means of determining airflow through the patient's nose and mouth can be utilized, including wearing a respiratory mask with an attached flow sensor. The capnography 600 waveform (See, FIG. 6) and flow signals are recorded throughout the night and stored in the polysomnographic recording system.
  • a patient's minute CO2 volume (Vco2) versus time i.e., a rate of CO2 excretion during sleep
  • Vco2 minute CO2 volume
  • the patient's CO2 excretion profile is determined using a number of commercially available analytic packages, such as DASYIab, manufactured by National Instruments Corporation of Austin, Texas.
  • the interpreting clinician inspects the evolution of V C o2 duhng the course of the night and determines the predicted low, mean, and high V C o2 targets for which the device should be configured.
  • the clinician also inspects the end-tidal CO2 waveform itself to evaluate the evolution of arterial CO2 and to determine to what degree the patient will require overall CO2 support in order to reach a target mean arterial CO2 level during the night.
  • the clinician then again refers the patient for a titration study using the present invention.
  • the polysomnographic technician will obtain certain demographic and physical information about the patient in order to establish a starting configuration. For example, age, sex, body mass, arterial CO2 level, estimated CPAP prescription, and actual and target end-tidal CO2 values are collected. This information is then used to make an estimate of a probable optimal configuration of orifices and volumes. Patient's age, sex and body mass are used to derive a probable low, mean, and high value for sleeping V C o2 based on at least studies of multiple patients. Then, Vco2 values are used to set target flow rates for the orifices and determine the size of the orifices based on flow rates through each orifice under pressure. The size of the first dead space volume 1 1 1 is estimated based on the desired target end-tidal CO2. Finally, a minimum size for the third orifice 1 15 is estimated. This permits a washout of any overflow CO2.
  • the patient can be provided with a home-use device that is similar to the system 100 shown in FIG. 1 .
  • the patient can be scheduled for treatment at a clinic using the system of present invention.
  • the device is capable of the following exemplary functions
  • valves can be operated manually or automatically
  • variable volume devices can be incorporated, which permit altering the dead space volumes without changing hoses; the variable volume devices can be nested cylinders sealed with O-rings that can slide in and out); and
  • FIGS. 8 and 9 illustrate exemplary methods 800 and 900, respectively, of controlling breathing of a patient in accordance with the above discussion and using the systems shown in FIGS. 1A-2C.
  • method 800 begins with step 802.
  • step 802 the amount of CO2 generated by the patient is determined (high, low and mean values of CO2 production per minute by the patient are measured).
  • step 803 the end-tidal CO2 tracing for the night is inspected to determine the magnitude of a desired increase in the mean arterial CO2 during therapy.
  • step 804 the optimum CPAP pressure likely to treat any existing obstructive apnea is determined.
  • steps 805 and 806 a preliminary configuration of the system 100 is determined using the data gathered in steps 802-804.
  • a computer simulation of the performance of the system under various assumptions can be used.
  • empirically determined values for the orifices and volumes that are a function of the data gathered in steps 802 and 804 in addition to patient's physiological and/or demographic data can be used.
  • step 806 a rate of flow and concentration of gas at each of the multiple controllable openings is measured.
  • step 807 patient's arterial CO2 level is measured.
  • steps 808-809 the sizes of the orifices, volumes, and optionally CPAP pressure are adjusted. Steps 808-809 can be repeated until a specific configuration of orifices, volumes and CP AP pressure is reached.
  • step 902 airflow through each of the ventilation orifices is measured.
  • step 904 the content of CO2 in the airflow, measured in step 902, is determined.
  • step 906 the airflow is adjusted through each of the multiple ventilation orifices based on the detecting, performed in step 904.
  • step 908 the sizes of the dead space volumes are adjusted also based on the detecting of step 904 as well as the adjustment of the multiple ventilation orifices performed in step 906.
  • FIG. 3 illustrates a relationship 300 between the various dead space volumes and orifices which permits an extensive modeling of the rate of excretion of CO 2 (V C o 2 ) by the patient with respect to various rates of ventilation (V E ).
  • the present invention includes two dead space volumes 1 1 1 and 1 13 and three ventilation orifices 131 ,133,135 that cause various changes in the slope of FIG. 3.
  • curve 302 represents a nightly CO 2 excretion profile of a patient which is overlaid on the plot to illustrate the range of likely CO 2 excretion rates by the patient.
  • the horizontal axis of the plot represents time in minutes and the vertical axis represents a rate of production of CO 2 by a patient per minute, as measure in milliliters per minute (ml/min).
  • the horizontal axis represents patient's rate of ventilation (V E ), measured in ml/min
  • the vertical axis represents the rate of excretion of CO 2 (V C o 2 ) by the patient in ml/min when the present invention's system is used.
  • V E patient's rate of ventilation
  • V C o 2 rate of excretion of CO 2
  • VC02 (VE-V D )* (FAC02-FIC02) (1 )
  • V D is equal to the sum of the physiological and artificially added volumes of dead space multiplied by the respiratory frequency
  • V E is equal to the total volume of air inspired and expired during each breath multiplied by the respiratory frequency
  • FA C o2 is the partial pressure of dissolved CO2 in arterial blood divided by an ambient air pressure
  • FI C o2 is a fractional concentration of CO2 in the air inspired by the patient.
  • the function described in equation (1 ) is represented by a straight line that intersects a horizontal axis above zero.
  • the curve 320 describes a relationship between V E and Vco2 according to the present invention, and includes the following segments: hypoventilatory traverse segment 304, first respiratory plateau segment 306, eucapnic traverse segment 308, second respiratory plateau segment 310, and hyperventilatory traverse segment 312.
  • Each segment has a specific slope and length defined by the number and size of dead space volumes and orifices placed in the respiratory conduit as well as volume of CO2 flowing through the dead space volumes and orifices.
  • the number of segments varies with the number of dead space volumes and orifices in the conduit.
  • the hypoventilatory traverse segment 304 is caused by the placement of the first orifice in the respiratory conduit.
  • the slope of the segment illustrates a normal relationship between breathing and CO2 excretion described in equation (1 ) until a saturation point is reached.
  • the saturation point that corresponds to a maximum rate of CO2 flow through the first orifice is represented as the junction of the segment 304 and segment 306.
  • V C o2 CO2 excretion while the patient is hypoventilating.
  • V C o2 the relationship between V E and V C o2 is substantially unchanged from the normal physiological relationship.
  • One of the destabilizing elements in unstable respiratory syndromes is the rapid accumulation of blood CO2 during epochs of hypoventilation. Due to the inherent time delay in executing the control loop, overshoot is inevitable when this happens and the accumulation will quickly result in blood CO2 levels that are substantially above normal.
  • the system described herein substantially minimizes any CO2 build-up and provides sufficient ventilation to expel all exhaled CO2 during hypoventilation immediately through the orifices.
  • the size of the first orifice together with the configuration of the other orifices and dead space volumes as well as patient's respiratory parameters determines the value at which the relationship between V C o2 and V E begins to depart from normal values.
  • the first orifice is sufficiently large to place this first inflection point in the curve 320 at or just below the minimum expected sleeping V C o2 (See, FIG. 3).
  • the first respiratory plateau segment 306 represents the effect of placing a first dead space volume in the respiratory conduit. Once the first orifice reaches the saturation point, it does not matter how much the patient increases ventilation until such increase overcomes the first dead space volume by pushing expired CO2 beyond the first dead space volume and past the second orifice. Hence, increases in ventilation do not result in any additional CO2 excretion until this point is reached.
  • the rate of ventilation at which the first dead space is overcome and CO2 can flow from the second orifice is defined at the junction of the segment 306 and segment 308.
  • This respiratory plateau includes a zone where increased respiration above the first inflection point in the curve results in virtually no increase in V C o2- This segment has a slope substantially near zero.
  • the existence of this respiratory plateau is due to the fact that the first dead space volume is larger than the volume of gas that can be expelled through first orifice during the duration of a typical breath. The remaining volume of CO2 is re-inhaled. Any additional CO2 volume within the first dead space volume does not result in increased levels of excreted CO2.
  • the onset of an unstable respiratory cycle often commences with a progressive narrowing of the airway, resulting in decreasing V E .
  • the instability may further develop if decreases in V E are accompanied by proportional decreases in V C o2- This gives rise to a build-up of CO2 in the blood sufficiently rapid to cause "overshoot" before the brain can respond to the build-up.
  • the existence of the first respiratory plateau serves to maintain CO2 excretion at a steady level in the face of substantial decreases in V E , thus, avoiding a rapid CO2 build-up and preventing substantial "overshoot" as the brain has time to respond to the decrease in ventilation.
  • the first respiratory plateau prevents the increase in CO2 excretion from increasing proportionally to the increase in ventilation. In a similar fashion, this places an obstacle in front of excessive CO2 blow-off that poses the possibility of "undershoot.”
  • the first respiratory plateau segment 306 also permits the clinician to specify a mean arterial level of CO2 for the patient during sleep. Since affected patients are typically at least slightly hypocapnic (i.e., having lower than normal CO2 in arterial blood), it is desirable to reset their sleeping CO2 levels to a value that is closer to normal.
  • the length of the first respiratory plateau segment 306 determines blood CO2 during therapy. Further, since the segment 306 is generated as a result of existence of the first dead space volume in the mixing device, increasing the size of the first dead space volume will raise blood CO2 levels. The amount by which any such increase in volume will raise blood CO2 levels can be calculated based on the patient's collected data.
  • the eucapnic traverse segment 308 represents placement of a second orifice or gain chamber in the respiratory conduit. Until this orifice is saturated (i.e., the point at which the concentration of CO2 in the air flowing from the orifice reaches a maximum), increases in the rate of ventilation (V E ) result in increases in the rate of CO2 excretion (Vco2)- The saturation point of the second orifice is defined at the junction of the segment 308 and 310.
  • segment 308 represents the relationship between V E and V C o2 in the range of expected sleeping V C o2 .
  • Segment 308 is a straight line having a slope that is substantially less than that of the hypoventilatory traverse segment 304. The slope of this relationship as it passes through the actual rate of CO2 production by the patient at a given time establishes the conditions for respiratory stability. The slope is a variable in the relationship describing a closed-loop gain in the respiratory control feedback loop. Since the gain in the control becomes excessive in unstable respiratory syndromes, reducing the slope of the segment 308 in an immediate vicinity of a point where CO2 production and excretion match (i.e., eucapnia) stabilizes respiration.
  • the slope of the eucapnic traverse segment 308 is governed by multiple variables, such as the first and second dead space volumes and sizes of the first and second ventilator orifices.
  • the slope of segment 308 becomes shallower when larger dead space volumes are used and where the saturation points of the first and second orifices are closer together.
  • the range of V C o2 traversed is also determined by the size of the second orifice 133.
  • the measurement of patient's sleeping V C o2 permits setting the first respiratory plateau segment 306 at the highest appropriate V C o2 level and making the length of the eucapnic traverse segment 308 as short as possible. This achieves a shallow slope of the segment 308.
  • the second respiratory plateau segment 310 is similar to the first respiratory plateau segment 306, however, segment 310 represents placement of a second dead space volume in the respiratory conduit. The effects produced are similar to those discussed above with respect to segment 306.
  • the saturation point of the second dead space volume is defined at the junction of the segment 310 and 312.
  • the second respiratory plateau segment 310 is disposed above the highest expected sleeping value of V C o2 and functions in a manner similar to that of the first respiratory plateau segment 306. It is also a line segment with a nearly zero slope and constitutes a zone where changes in V E result in little or no change in V C o2.
  • the length of the second respiratory plateau segment 310 is determined by the volume of the second dead space. It inhibits CO2 excretion during hyperventilation, as sharp increases in ventilation result in little or no increase in V C o2.
  • the first and second respiratory plateaus segments 306, 310 provide a powerful
  • V C o2 can vary outside of the zone determined by the two plateaus 306,310, it will do so in response to a very strong stimulus, e.g., a need to excrete CO2 rapidly after a prolonged obstructive apnea.
  • the hyperventilatory traverse segment 312 represents placement of an
  • escape valve or a third orifice in the respiratory conduit.
  • the third orifice is larger than the other two orifices. This allows escape of CO2 after saturation of the first and second orifices and dead space volumes.
  • other configurations of orifices and dead space volumes are possible, thus, resulting in a different graphical representation.
  • the hyperventilatory traverse segment 312 serves as a safety precaution in the event that it will be necessary to excrete CO2 at a higher than expected rate, e.g., after a lengthy obstructive breathing event. Such excretion generates vigorous breathing at rates that are twice or more the normal rate of ventilation required to achieve such V C o2 levels. Without the hyperventilatory traverse there is a risk of developing at least temporary respiratory acidosis under some circumstances.
  • the hyperventilatory traverse is created by the third orifice 135, which can be larger than orifices 131 and 133.
  • the size of the orifice 135 is determined by the ability of the CPAP machine 130 to maintain pressure at maximum flow rates likely to be encountered during treatment. In an embodiment, the orifice 135 is made as large as possible without overtaxing the CPAP machine.
  • FIG. 6 illustrates a tracing 600 the concentration of CO2 in the air flowing out of all of the orifices of the system together over the course of eight breaths.
  • this tracing the system is correctly adjusted and a characteristic "hip" 612 develops in the waveform.
  • the existence of this hip is due to the elimination of all exhaled CO2 from the second dead space at a point in the breathing cycle and thus a cessation of all CO2 flow through the second orifice. Since significant CO2 remains in the first dead space and in fact the first orifice remains saturated for a further period of time, the flow of CO2 remains briefly at the level of the hip until the first dead space is fully exhausted.
  • the lack of a hip is an indication that the first orifice is too large and the emergence of a second hip is an indication that the first and second orifices taken together are too small.
  • the system may be tunable with reference to the morphology of this waveform.
  • FIGS. 10-1 1 illustrate tracings of a heart rate (respective upper portions of the figures) and blood oxygen saturation levels (respective lower portions of the figures) for a patient during a night.
  • the segments of the heart rate tracings containing dense spikes indicate disturbed or fragmented sleep due to frequent arousals originating from a respiratory anomaly.
  • the segments of the heart rate tracings not containing frequent spikes indicate restful or consolidated sleep.
  • FIGS. 10 and 1 1 illustrate that the affected patient actually gets very few and short periods of consolidated sleep during the night using conventional methods and systems for controlling breathing.
  • FIG. 12 illustrates tracings of heart rate and blood oxygen saturation using the systems and methods discussed in FIGS. 1 A-9.
  • the device substantially resolved the frequent arousals, permitting long periods of restful, consolidated sleep. This results in an improvement of symptoms and is indicated by the existence of far fewer spikes in the heart rate tracings, as well as a virtually fixed oxygen tracing.
  • the system described herein has increased the patient's blood oxygen saturation to a level nearly the same as that in FIG. 10, where three liters per minute of supplemental oxygen were being given.
  • the oxygen levels indicated in FIG. 12 were achieved using only the system and no supplemental oxygen.
  • the present invention allows for 2-2.5% improvement in oxyhemoglobin saturation in a patient as compared to free breathing of ambient air. Since the oxyhemoglobin saturation curve is flat at its high end, this represents an important increase in available oxygen at the perfused tissues. Further, the present invention potentially obviates a need for supplemental oxygen in a number of medical settings. Also, by increasing oxygenation the present invention may reduce the sensitivity of the peripheral chemoreceptor, which causes most periodic breathing syndromes.
  • the present invention forces an increase in the depth of breathing and, thus, the overall rate of ventilation, since the first orifice is configured to saturate at a level that is insufficient to permit excretion of all CO2 being produced by the patient.
  • the patient breathes deeply enough to push CO2 through the first dead space volume, so that CO2 exits the device through at least the second orifice or at the gain chamber.
  • the exhaled gas in various dead space volumes has been replaced with air and, thus, the concentration of oxygen in the inspired air is only slightly lower than that in the ambient air. Taking the two things together, the increase in breathing more than offsets the slight decline in oxygen content of inspired air (F102) to produce greater oxygen transport in the lungs.
  • F102 inspired air
  • the present invention as described with respect to FIGS. 1 A-12, can be used in the following areas:

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Abstract

La présente invention concerne un procédé et un système qui permettent de réguler la respiration d'un patient. Un système qui permet de réguler la respiration d'un patient comprend un conduit respiratoire. Le conduit respiratoire est configuré pour être couplé à un dispositif d'interface patient et pour être couplé à un dispositif de génération d'air mis sous pression. Le conduit respiratoire comprend au moins deux dispositifs de régulation d'écoulement d'air, positionnés entre le dispositif d'interface patient et le dispositif de génération d'air mis sous pression qui coopèrent pour réguler étroitement les niveaux de CO2 dans la circulation sanguine du patient au moyen de la régulation de la respiration du patient.
PCT/US2013/057815 2013-07-02 2013-09-03 Procédé et système pour réguler la respiration WO2015002662A1 (fr)

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US13/933,255 US9884159B2 (en) 2006-04-17 2013-07-02 Method and system for controlling breathing
US14/013,774 US9878114B2 (en) 2006-04-17 2013-08-29 Method and system for controlling breathing
US14/013,774 2013-08-29

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4619269A (en) * 1983-06-29 1986-10-28 Utah Medical Products, Inc. Apparatus and method for monitoring respiratory gas
WO2000022985A1 (fr) * 1998-10-22 2000-04-27 Children's Hospital, Inc. Appareil permettant la ventilation controlee d'un patient
US20060201505A1 (en) * 1999-02-04 2006-09-14 Remmers John E Ventilatory Stabilization Technology
US20070255160A1 (en) * 2006-04-17 2007-11-01 Daly Robert W Method and system for controlling breathing
US20110146681A1 (en) * 2009-12-21 2011-06-23 Nellcor Puritan Bennett Llc Adaptive Flow Sensor Model

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4619269A (en) * 1983-06-29 1986-10-28 Utah Medical Products, Inc. Apparatus and method for monitoring respiratory gas
WO2000022985A1 (fr) * 1998-10-22 2000-04-27 Children's Hospital, Inc. Appareil permettant la ventilation controlee d'un patient
US20060201505A1 (en) * 1999-02-04 2006-09-14 Remmers John E Ventilatory Stabilization Technology
US20070255160A1 (en) * 2006-04-17 2007-11-01 Daly Robert W Method and system for controlling breathing
US20110146681A1 (en) * 2009-12-21 2011-06-23 Nellcor Puritan Bennett Llc Adaptive Flow Sensor Model

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