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WO2006130369A2 - Procede et systeme d'assistance respiratoire non invasive - Google Patents

Procede et systeme d'assistance respiratoire non invasive Download PDF

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Publication number
WO2006130369A2
WO2006130369A2 PCT/US2006/019557 US2006019557W WO2006130369A2 WO 2006130369 A2 WO2006130369 A2 WO 2006130369A2 US 2006019557 W US2006019557 W US 2006019557W WO 2006130369 A2 WO2006130369 A2 WO 2006130369A2
Authority
WO
WIPO (PCT)
Prior art keywords
air
flow
patient
combined
compressed air
Prior art date
Application number
PCT/US2006/019557
Other languages
English (en)
Other versions
WO2006130369A3 (fr
Inventor
Blaine E Beck
Charles James Corris
Andre J Lovas
Joe C Hurst
Burt Jennings
Paul J Scheinberg
Original Assignee
Ventendo Products Corporation, Inc.
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
Application filed by Ventendo Products Corporation, Inc. filed Critical Ventendo Products Corporation, Inc.
Publication of WO2006130369A2 publication Critical patent/WO2006130369A2/fr
Publication of WO2006130369A3 publication Critical patent/WO2006130369A3/fr

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Classifications

    • 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. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • 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. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0063—Compressors
    • 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. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • A61M16/122—Preparation of respiratory gases or vapours by mixing different gases with dilution
    • A61M16/125—Diluting primary gas with ambient air
    • A61M16/127—Diluting primary gas with ambient air by Venturi effect, i.e. entrainment mixers
    • 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. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • 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. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • 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. ventilators; 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
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/11—Laminar flow

Definitions

  • respirators also known as ventilators
  • Conventional mechanical ventilators currently in widespread use for patients in need thereof are intended to deliver a volume of oxygen enriched air into the trachio-bronchial tree, to inflate the alveoli of the lungs, where they participate in gas exchange or respiration.
  • Various modalities have been developed to generate the correct volume and oxygen concentration at the correct pressure, to optimize gas exchange and minimize patient trauma, for a given set of patient circumstances involving chronic obstructive pulmonary disease (COPD).
  • COPD chronic obstructive pulmonary disease
  • the patient ventilation procedure involves an endotracheal intubation, in which a tube is inserted in the patient's airway, in order to deliver ventilation support to the patient's lungs. Since endotracheal intubation in life support ventilators is both invasive and potentially traumatic, the procedure is usually limited to treatment in intensive care units of hospitals. It is considered unwise to assist marginally ventilating patients by intubation at home or in post ICU hospital COPD beds because of the need for close observation of intubated patients.
  • Bi-Level PAP bi-level positive airway pressure
  • the respirator system and method of the present invention uses a remote source of pressurized air and avoids the use of successive rotor-driven compressor stages.
  • the invention instead uses a special air amplification means which includes a primary source of laminar (non-turbulent), low pressure compressed air, in combination with an adjustable, passive amplifier which includes a venturi chamber through which such laminar air flows.
  • the amplifier is arranged to admit the compressed air upstream of the venturi chamber, through a precisely controllable variable annular opening provided to control the flow of such primary compressed air into and through the venturi chamber.
  • the venturi chamber utilizes the suction effect of the primary laminar flow of compressed air to entrain and induce ambient air to flow into and through the venturi chamber as required by the patient.
  • the primary flow of compressed air through the venturi chamber is laminar and the induced ambient air is therefore also laminar (i.e., non-turbulent) with an extremely low level of noise. This greatly benefits the patient and makes possible for the first time a very precise regulation of the volume of airflow, and the pressure thereof, to the patient. Furthermore, the resultant laminar flow is produced with the highest degree of efficiency and controllability and with the minimal expenditure of power.
  • the ventilator system of the invention has various ventilatory modes, among which is a variable pressure support mode that is especially suitable for the non-invasive aid to marginally breathing COPD patients. It provides for a variable pressure support during the inspiratory cycle, to augment the patient's spontaneous breathing, so as to achieve sufficient tidal volume to avoid tachypnea, or insufficient, rapid, shallow breathing. Tachypnea is the result of the patient's spontaneous breathing not being adequate to sufficiently evacuate the lungs to prevent the build-up of CO 2 gas in the lungs. Since the amount of pressure support required to achieve optimal tidal volume will vary with each patient's spontaneous efforts, the system of the invention has a regulated feedback loop using special flow sensors.
  • the flow sensors monitor the average tidal volume of all the spontaneous breathing during the preceding minute. This enables continual adjustment, based on a "rolling minute ventilation" protocol. It is therefore possible for COPD patients with respiratory insufficiency to avoid the progression to respiratory failure with the use of the new ventilator system and method.
  • the new system and method are especially valuable while the patient is sleeping, when hypoventilation is most likely to occur.
  • the ventilator of the invention can "reset” or lower SaCO 2 , or lower blood saturation of CO 2 gas, even when the patient is not using the ventilator.
  • the respirator system of the invention uses an air amplifier which has the ability to transform compressed air from a moderate pressure (6 to 10 psia), low volume (10 to 15 Ipm) air source into a high volume, low pressure output (20 to 200 lpm at 1 psia).
  • the air supply is free of contamination as well as the usual high turbulence and noise.
  • the specific air amplification means disclosed herein comprises a pair of telescopically inter-related tubular elements defining a flow path for air.
  • the downstream tubular element defines a venturi chamber and has output and input ends.
  • a controlled flow of compressed (primary) air into the throat of the venturi causes ambient air to be drawn into the input side of the amplifier in considerably larger volumes than the volume of the higher pressure primary air.
  • the combined airflow is substantially laminar and non-turbulent, and is easily controllable as to pressure and total volume of flow, within the limits desired for the intended purposes.
  • a digitally controlled stepper motor serves to adjustably position the telescoping elements of the amplifier in real time, such that the flow of air to the patient can be made to correspond in an ideal manner to the breathing rhythms and/or requirements of the patient.
  • both the volume and the pressure of air supplied to the patient are measured on a continuing basis and the results thereof utilized by way of continuous feedback controls.
  • the amplifier can be correspondingly adjusted to reduce the amount of air supplied to the patient as well as the pressure thereof.
  • the process inputs are supplied to a digital microcontroller element, which can be externally controlled by medical staff.
  • the control system may be adjusted to impose a timed breathing cycle on a patient who is having difficulty in maintaining a suitable rhythm of inhale and exhale actions.
  • a pass code is required for operating modes and changing the mode parameters.
  • Fig. 1 is a schematic diagram illustrating the functional procedures involved in the system and method of the invention.
  • Fig. 2 is a simplified elevational view, partly in section, of a controllable air amplifier unit incorporated in the system of the invention.
  • Fig. 3 is a cross sectional view illustrating the telescoping elements of the air amplifier unit adjusted to a position for minimum airflow through the amplifier unit.
  • Fig. 4 is a cross sectional view similar to Fig. 3, showing the telescoping elements adjusted to a position for maximum air flow through the amplifier unit.
  • Fig. 5 is a fragmentary, cross sectional view as taken generally on line 5-5 of Fig. 2, illustrating a drive cam arrangement for adjusting the telescoping elements of the air amplifier unit.
  • Fig. 6 is a simplified flow diagram illustrating control steps involved in operating the system of the invention in a spontaneous breathing mode, in which the control of the system follows the spontaneous breathing activity of the patient.
  • Fig. 7 is a simplified flow diagram illustrating a modified form of control for the system of the invention, in which a controlled tidal volume can be imposed upon the patient, where the patient's spontaneous activity is deemed to be insufficient to prevent CO 2 build-up.
  • the amplifier unit which is generally designated by the reference numeral 10, includes a pair of close fitting, telescopically adjustable tubular elements 11 , 12 forming respectively upstream and downstream elements of the amplifier.
  • the upstream element 11 is formed with a cylindrical body 14, which closely receives the downstream element 12, while allowing for limited telescopic adjustment of the two elements, as will be further described.
  • downstream portion 12 of the air amplifier is formed with a gradually converging passage 15 at its upstream end, which merges with a throat portion 16.
  • the downstream portion 17 of the flow passage gradually diverges from the throat 16.
  • the flow passage 16-17 through the downstream element thus forms a venturi chamber, as will be understood.
  • the tubular element 12 At its upstream extremity, the tubular element 12 is formed with an annular end surface of arcuate cross sectional configuration, as indicated at 18. Immediately adjacent to the annular surface 18, on the downstream side thereof, is an outwardly facing annular groove 19.
  • the upstream amplifier element 11 telescopically overlaps with the downstream element 12 and is formed with an inlet opening 20 in the side wall 14 thereof.
  • the inlet opening 20 communicates with the annular recess 19 in any of the telescopically adjustable positions of the elements 11 , 12 within their operative limits.
  • Slightly pressurized air e.g., 6 to 10 psig
  • the upstream tubular element 11 thereof is formed with an annular arcuate recess 21 facing in a generally downstream direction and directly opposing the annular arcuate surface 18 of the downstream element to define an air gap G.
  • Air at elevated pressure which flows into the annular recess 19 is able to flow through the gap G defined by the arcuate surfaces 18, 21 and is injected into the upstream end of the amplifier element 12.
  • the radially innermost portions of the arcuately recessed surface 21 extend around far enough to project somewhat in a downstream direction.
  • the air discharged through the gap G flows in a downstream direction toward the throat 16 of the venturi chamber.
  • the effect of this flow of somewhat pressurized air is to reduce the pressure in the upstream end 15 of the venturi chamber and induce the flow of ambient air through an inlet opening 22 defined by the upstream element 11.
  • the upstream amplifier element 11 can be telescopically adjusted relative to the downstream element 12.
  • an O-ring or similar sealing element 23 is provided adjacent the downstream end of the amplifier element 11 , held in place by a sealing ring 24, so that the compressed air delivered to the inlet opening 20 is discharged exclusively through the annular air gap G.
  • the combined airflow through the amplifier unit 10 compressed air combined with entrained ambient air
  • the flow of pressurized air is correspondingly reduced and less ambient is induced to flow through the amplifier.
  • a typical range of adjustment of flow of the pressurized air e.g., 6 to 10 psig
  • the amplified flow is smooth, laminar and non-turbulent and is accompanied by a minimum noise in comparison to known systems.
  • Figs. 2 and 5 of the drawing illustrate an advantageous form of precision control for the telescopically adjustable amplifier 10 of Figs. 3 and 4.
  • the reference numeral 30 designates a housing of a rotary stepper motor whose shaft 31 (Fig. 5) extends vertically upward from the housing.
  • a fixed, L-shaped bracket 32 is secured by its base 33 to the motor housing and has an opening in a vertical portion 34 thereof for receiving the downstream end of the amplifier element 12.
  • a flange 35, formed on the outer portion of the amplifier element 12 seats against the bracket portion 34 and is suitably fixed thereto.
  • a coil spring 36 extends between the sealing ring 24 and the flange 35, urging the upstream amplifier element 11 in a direction (upstream) tending to enlarge the air gap G between the arcuate surfaces 18, 21.
  • a movable L-shaped bracket 38 has a horizontal portion 39 (Fig. 5) which is slideably guided in the fixed bracket portion 33 for limited sliding movement in an axial direction relative to the air amplifier unit 10.
  • a vertical portion 40 of the bracket 38 is provided with an opening for the reception of the upstream end 41 of the amplifier element 11 , as shown in Fig. 2.
  • the lower or base portion 39 of the movable bracket is formed with a transversely elongated opening 42 therein which receives a cam 43 mounted eccentrically on the stepper motor shaft 31.
  • the spring 36 tends to urge the telescoping amplifier elements 11 , 12 in a separating direction, they are confined against such movement by the brackets 32, 38.
  • the width of the air gap between the arcuate surfaces 18, 21 can be controllably varied in the operating limits of the mechanism.
  • the cam 43 has an eccentricity of approximately 0.030 inch, such that a full excursion of the movable bracket 38 of 0.060 inch can be achieved in 180 degree rotation of the cam 43.
  • a suitable stepper motor for the purposes of this invention is arranged to rotate in increments of 1.8 degrees per step, to achieve a full 180 degrees of rotation in one hundred steps.
  • the full adjustment of the amplifier air gap, from 0 to 0.060 can be divided into increments of one hundred, providing a highly precise control of airflow through the amplifier unit, for delivery to the patient.
  • the unique ability to control the flow of air to the patient enables respiratory assistance to be effectively tailored to specific needs of the patient and, where appropriate, to be modified and adjusted on a continuing basis during periods of respiratory assistance.
  • the system of the invention includes a primary source 50 of pressurized air, typically at a pressure in the range of 6 - 10 psig.
  • the specific source of the pressurized air is not significant, as long as it is clean, filtered, free of oil, etc., and non-turbulent.
  • the compressed air source may comprise a fractional hosepower rotary compressor. From the primary source 50, the pressurized air is delivered to an accumulator 51 which retains the air in a quiescent state, for delivery to the inlet opening 20 per demand, through a suitable flow connection 52.
  • the main body of air passing through the amplifier unit 10 is simply filtered, ambient air which is provided to the opening 22 at the upstream end 41 of the amplifier element 11.
  • the discharge airflow from the amplifier, indicated at 54 in Fig. 1 flows through a suitable delivery hose 55 (Fig. 2) where both the pressure and velocity of flow are detected by a pressure sensor and flow sensor 56, 57 respectively.
  • the outputs of the pressure and flow sensors are directed to a microcontroller 58 as feedback data.
  • the controlled air is delivered to the patient, typically using an appropriate mask (not shown) that accommodates the comfortable delivery of the air as well as enabling the patient to exhale through the mask.
  • One of the outputs of the microcontroller, indicated at 59 in Fig. 1 , is directed to a motor control 60, which drives the stepper motor 30 and its cam 31 to vary the air gap G in the amplifier unit 10.
  • the air gap can be varied from approximately zero to approximately 0.60 inch in one hundred individual steps.
  • the position of the stepper motor is at all times fed back to the microprocessor through a position sensor 61.
  • the operating mode of the system is under the control of an operator by way of a bank 62 of panel switches connected to the microcontroller 58.
  • control of the unit may be done remotely through an external serial interface 63.
  • a suitable display panel 64 is associated with the microcontroller to display the operating mode and relevant parameters.
  • the system and method of the invention desirably has multiple operating modes, which include the following: (1) Continuous Mode, (2) Timed Mode, (3) Spontaneous Mode, (4) Spontaneous/Timed Mode, (5) Volume Pressure Regulated Support.
  • Continuous Mode the ventilator system supplies air continuously at a constant pressure during both inspiratory and expiratory cycles of the patient.
  • the pressure of air to be delivered to the patient is set by adjustment of the microcontroller, and feedback from the pressure sensor element 56 causes the stepper motor to be adjusted as appropriate to maintain the desired pressure in the flow tube 55.
  • the ventilator provides respiratory support at a prescribed rate of breaths per minute on a preset pressure basis.
  • the stepper motor is repetitively cycled according to the prescribed breaths per minute to be delivered, cycling the pressure according to a prescribed cycle of increasing and decreasing pressures to achieve a desired cycle of inhalation and exhalation by the patient.
  • the pressure delivered to the patient is measured by the pressure sensor element 56 at a rapid rate (e.g., in cycles of around 6 ms).
  • These pressure measurements are repetitively fed to the microcontroller, which determines the response of the stepper motor to vary the air gap of the air amplifier unit 10 and increase or decrease the air gap G accordingly, in order to maintain pressures at prescribed levels.
  • the ventilator system auto-synchronizes to the patient's own cycle of breathing while imposing prescribed levels for inspiration positive airway pressure (IPAP) and expiration positive airway pressure (EPAP).
  • IPAP inspiration positive airway pressure
  • EPAP expiration positive airway pressure
  • the control procedures for the spontaneous mode are illustrated in Fig. 6.
  • the airflow pressures at the pressure sensor 56 are measured every 0.1 second and compared with the IPAP pressure setting entered by the operator. If the pressure is insufficient, the stepper motor is adjusted to increase the air gap G and increase the rate of airflow to the patient.
  • the feedback cycle is repeated rapidly until the delivered pressure agrees with the preset IPAP pressure levels.
  • the control then passes to a hysteresis time delay unit, imposing a delay of about 0.3 seconds after which the flow rate of the delivered air is measured at the sensor 57.
  • a suitable threshold value for the rate of change of flow may be on the order of 2.45 lpm change in the 6.125 ms interval. If the rate of change equals or exceeds that value, the end of a cycle is indicated and the state of the respirator system is changed from IPAP to EPAP (if ending an inspiratory cycle) or from EPAP to IPAP (if ending an expiratory cycle).
  • Typical pressure setpoints for the IPAP and EPAP portions of the breathing cycle might be 25 - 35 cm H 2 O (IPAP) and 5 cm H 2 O (EPAP).
  • the Spontaneous/Timed Mode functions in the same manner as described with respect to the Spontaneous Mode, except that, if a breath does not occur spontaneously within a prescribed period of time, an override is effected and the system causes the patient to breaths by momentarily increasing the pressure delivered to the patient.
  • the system operates basically in a form of the Spontaneous Mode, in which the system tends to augment the natural breathing rhythms of the patient, as previously described.
  • the VPRS Mode includes provisions for monitoring the tidal volume of air supplied to the patient.
  • the maintenance of an adequate tidal volume of air delivered to the patient can be very significant in order to prevent the build-up of CO 2 in the patient's blood.
  • Inadequate tidal volume, where resulting in build-up of CO2 can result in respiratory acidosis and, in severe cases, respiratory failure.
  • Fig. 7 is an illustrative flow diagram of the control sequences for carrying the VPRS Mode.
  • the system is set to a predetermined pressure setpoint, and the pressure of the air flowing to the patient is measured repetitively by the pressure sensor 56.
  • the rate of airflow to the patient is measured in the flow sensor 57 and the pressure and flow rate values are integrated to establish a volume rate.
  • the control system will loop back.
  • the system will test for the rate of change of the airflow. If it does not exceed a predetermined threshold, the system will again loop back. If the threshold is exceeded, the system will change the state from IPAP to EPAP or vice verse, and then the control will loop back.
  • the tidal volume is calculated on the basis of a rolling minute average. In this respect, all of the measurements over the previous minute are combined and averaged. If the rolling minute average is below a desired, preset target level, the pressure setpoint is increased and the system recycles until the air flowing to the patient reaches the increased setpoint, as determined by the pressure sensor 56. If the rolling minute average exceeds the desired target level, the pressure setpoint is reduced. In this respect, it is understood that, when the measured pressure at the pressure sensor 56 is either below or above a desired setpoint, the stepper motor 30 is incrementally actuated to open or close the gap G of the air amplifier, to increase or decrease airflow to the patient until the desired setpoints are achieved.
  • the tidal volume is calculated multiple times each second, the individual measurements are accumulated over a period of time, preferably one minute, and the system makes corrections only in response to the average tidal volume over that period of time. Accordingly, momentary changes in the breathing action of the patient will not trigger an immediate response.
  • the system and method of the invention are capable of continuous, and where desired, substantially instantaneous response to patient activities.
  • the system of the invention can simply augment the spontaneous actions of the patient.
  • the system may override the patient's activities, where they are insufficient to maintain adequate circumstances, such as sufficient tidal volume, adequate breathing rate, etc.
  • the entire system of the invention is greatly simplified in relation to conventional systems.
  • the air amplifier mechanism enables precise and instantaneous control over airflow conditions by means of telescopic adjustment of the amplifier components, using a simple stepper motor-operated mechanism providing for high speed adjustments in very small increments, and thus providing virtually infinite control over the airflow conditions within the maximum and minimum limits of the system.
  • the supply of compressed air for driving the air amplifier can be obtained from any suitable source, such as a low power rotary compressor, and can be remote in appropriate circumstances.
  • the compressed air is delivered to the air amplifier unit via an accumulator such that the flow of the compressed air to the amplifier is non-turbulent.
  • Airflow exiting the amplifier includes not only the injected compressed air, but a much greater volume of ambient air which is induced to flow through the amplifier by reason of discharge of the compressed air into the venturi chamber of the amplifier.
  • the ability to control the flow of the compressed air into the venturi chamber on a virtually instantaneous basis allows the system to be able to respond closely to patient requirements as well as to inputs by an attending physician, for example.
  • the system of the invention enables bi-level positive airway pressure ventilators to be provided which are non-invasive, which are very quiet, and which enable accurate and varied controls to be applied using a simplified and economical control system.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

La présente invention concerne un procédé et un appareil permettant de fournir de l'air régulé avec précision à un patient nécessitant une assistance respiratoire. On utilise un amplificateur de débit d'air de type venturi; une commande numérique incrémentielle d'un vide d'air fournissant de l'air comprimé à l'amplificateur. L'air comprimé induit et entraîne de l'air ambiant en quantités importantes, ce qui fournit au patient un flux fortement amplifié d'air non turbulent. Les flux combinés sont soumis à des mesures rapides et répétitives de pression et de conditions d'écoulement, ces mesures servant de données de rétroaction permettant de gérer au plus près le fonctionnement du système. Dans divers modes de réalisation, le procédé et le système de l'invention fournissent une assistance à la respiration spontanée du patient, qui peut être contournée par des moyens de synchronisation, si le patient n'arrive pas à respirer naturellement pendant trop longtemps. Le système assure étalement une mesure du volume respiratoire du patient, garantissant qu'un volume suffisant d'air est inhalé et exhalé par le patient pour éliminer l'excédant de CO2 des poumons du patient. L'amplification passive de l'air offre un fonctionnement particulièrement silencieux, ce qui permet un meilleur sommeil du patient. Ce système qui n'est pas seulement efficace, est également exceptionnellement économique à installer et mettre en oeuvre.
PCT/US2006/019557 2005-05-31 2006-05-22 Procede et systeme d'assistance respiratoire non invasive WO2006130369A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14071605A 2005-05-31 2005-05-31
US11/140,716 2005-05-31

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WO2006130369A2 true WO2006130369A2 (fr) 2006-12-07
WO2006130369A3 WO2006130369A3 (fr) 2007-11-22

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012020228A1 (fr) * 2010-08-13 2012-02-16 Linde Aktiengesellschaft Dispositif de surveillance de la concentration gazeuse
WO2015132682A1 (fr) * 2014-03-04 2015-09-11 Koninklijke Philips N.V. Système et procédé pour renforcer la pression enrichie en gaz de mélange
US20180192915A1 (en) * 2017-01-12 2018-07-12 Oridion Medical 1987 Ltd. Prong-free cannula device for co2 sampling and o2 delivery
WO2019204877A1 (fr) * 2018-04-27 2019-10-31 Gasapps Australia Pty Ltd Système d'alimentation en gaz

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US4527557A (en) * 1984-11-01 1985-07-09 Bear Medical Systems, Inc. Medical ventilator system

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012020228A1 (fr) * 2010-08-13 2012-02-16 Linde Aktiengesellschaft Dispositif de surveillance de la concentration gazeuse
US8584693B2 (en) 2010-08-13 2013-11-19 Linde Aktiengesellschaft Device for monitoring gas concentration and method using the device
WO2015132682A1 (fr) * 2014-03-04 2015-09-11 Koninklijke Philips N.V. Système et procédé pour renforcer la pression enrichie en gaz de mélange
US11278698B2 (en) 2014-03-04 2022-03-22 Koninklijke Philips N.V. Blending gas enriched pressure support system and method
US20180192915A1 (en) * 2017-01-12 2018-07-12 Oridion Medical 1987 Ltd. Prong-free cannula device for co2 sampling and o2 delivery
WO2018132717A1 (fr) * 2017-01-12 2018-07-19 Oridion Medical 1987 Ltd. Dispositif de canule sans broche pour échantillonnage de co2 et administration de o2
US10932692B2 (en) 2017-01-12 2021-03-02 Oridion Medical 1987 Ltd. Prong-free cannula device for CO2 sampling and O2 delivery
WO2019204877A1 (fr) * 2018-04-27 2019-10-31 Gasapps Australia Pty Ltd Système d'alimentation en gaz

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