WO2014193847A1 - Masque respiratoire destiné à ventiler un patient - Google Patents

Masque respiratoire destiné à ventiler un patient Download PDF

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Publication number
WO2014193847A1
WO2014193847A1 PCT/US2014/039605 US2014039605W WO2014193847A1 WO 2014193847 A1 WO2014193847 A1 WO 2014193847A1 US 2014039605 W US2014039605 W US 2014039605W WO 2014193847 A1 WO2014193847 A1 WO 2014193847A1
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WO
WIPO (PCT)
Prior art keywords
gas
cavity
inspiratory
expiratory
limb
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PCT/US2014/039605
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English (en)
Inventor
Heikki Antti Mikael Haveri
Original Assignee
General Electric Company
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Publication of WO2014193847A1 publication Critical patent/WO2014193847A1/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
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • 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
    • A61M16/0833—T- or Y-type connectors, e.g. Y-piece
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/3504—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light for analysing gases, e.g. multi-gas analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/497—Physical analysis of biological material of gaseous biological material, e.g. breath
    • 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
    • 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
    • A61B5/087—Measuring breath flow
    • 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
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • 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
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • 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
    • A61M2016/0027—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. 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
    • A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • 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
    • A61M2205/3306—Optical measuring means
    • 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
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • 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
    • 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
    • A61M2240/00—Specially adapted for neonatal use

Definitions

  • This disclosure relates generally to a breathing mask for ventilating a patient.
  • Tidal volume is an amount of an air inspired or taken into the lungs in a single breath.
  • TV is also dependent on the sex, size, height, age and a health etc. of a patient. In general TV also decreases as the size of the patient decreases. In an average healthy adult, TV is about 400-600 ml whereas in an average healthy neonate, that measures 3.5-4 kg and is 50 cm tall, TV is approximately 25-50 ml. On the other hand, in an average premature neonate that measures only 500 grams TV is only about 2-3.5 ml. TV of a smaller patient's is very difficult to measure, but it can be approximated to 4-7 ml/kg, applying a general rule of thumb for approximating the TV of the human lung. In practice the TV of the patient suffering pulmonary system deficiency is normally less than the approximation gives.
  • Patients can be mechanically ventilated invasively or non-invasively.
  • invasive ventilation an endotracheal tube is placed into a trachea so that it goes through oral or nasal cavity and larynx.
  • tracheostomy endotracheal tube goes straight into trachea through neck.
  • the other end of the endotracheal tube is connected to a breathing circuit Y-piece through a connector.
  • Continuous Positive Airway Pressure is a one type of non-invasive positive pressure ventilation used to maintain an elevated baseline respiratory system pressure during spontaneous breathing. Neonates or infants are preferential nose breathers until 5 months of age, which easily facilitates the application of nasal CPAP for a variety of clinical conditions including respiratory distress syndrome, apnea of prematurity and in other conditions that require positive pressure. This is accomplished by inserting nasopharyngeal tubes, affixing nasal prongs, or fitting a nasal mask to the patient.
  • Continuous flow CPAP systems use a preset flow of gas to maintain CPAP through nasal prongs.
  • CPAP delivered is dependent upon the flow rate and the resistance created by the exhalation valve that is housed in the breathing circuit.
  • ventilator-driven CPAP represents a continuous flow system. Because of the presence of an exhalation valve, patients must exhale against a fixed resistance, thus resulting in a higher induced work of breathing.
  • Variable flow CPAP technology incorporates a flow driver that delivers fresh gas through a breathing circuit to a dual injector generator with a specially designed valve, mask or nasal prongs. Gas enters at the point of the interface on inspiration and shunts flow away through an expiratory gas channel as the patient desires on exhalation. CPAP levels are stabilized and maintained by a change in the flow rate at the generator with little variability, unless there is a leak at the patient's interface.
  • Bi-level CPAP known by different acronyms such as SiPAPTM or biphasic CPAP or nasal ⁇
  • SiPAPTM is another type of CPAP that allows spontaneous breathing at two levels of CPAP.
  • a sigh level of CPAP is reached for a preset defined interval of time (set as inspiratory time) and a low level, the baseline CPAP is maintained continuously. The number of sighs is determined and preset by the caregiver. The difference created by these two levels of pressure is minimal, however; it may be associated with small changes in volume and associated increases in functional residual capacity (FRC), which can be integral to recruitment.
  • FRC functional residual capacity
  • the goal of this bi-level CPAP is to achieve some higher level of alveolar recruitment and prevent alveolar collapse.
  • Synchronized non-invasive positive pressure ventilation is another method to deliver positive pressure breaths through nasal prongs or a mask.
  • gas flow issues from a flow driver used in variable flow CPAP or through a mechanical ventilator.
  • SNIPPV has been shown to decrease work of breathing in infants with respiratory distress syndrome compared to nasal CPAP alone.
  • Synchronization to the breathing cycle can be done various ways. It is common to measure the breathing circuit pressure and/or flow during the breathing cycle from the breathing circuit at the ventilator. In this case the distance between the patient and the ventilator is longer, which may induce disturbances to the measurement and decreases the sensitivity, as well as to the synchronization. This is due to for example air compression or breathing circuit tubing compliance, which relates to the elasticity of the tubing.
  • Some ventilators support a flow measurement where a flow sensor is attached closer to the patient usually between the breathing circuit and the accessory attached to the patient. This type of measurement usually functions more accurately, but adds the dead space or the volume that causes rebreathing of gases, the number of connections, which may leak and cause turbulences into the flow path, which in turn increase the dead space and decrease the measurement accuracy.
  • a diaphragm or chest movement with additional sensors to support ventilator synchronization.
  • the movement can be measured with piezoelectric or resistive, strain gauge or similar based sensors externally from the chest by attaching the sensor on the skin or even internally from for example through a stomach with a catheter that comprises a measurement sensor.
  • An electrical signal from the sensor(s) is then transmitted into the ventilator where it is used to synchronize for example the pressure support, thus to detect patient's sigh to deliver higher pressure within inspiration and lower pressure during expiration.
  • External and internal measurements are very sensitive to any other movements as well and thus cause false triggers to start inspiration, even during the expiration. Inspiration during the actual expiration stresses the patient considerably.
  • the internal measurements are also cumbersome to place for the user and inconvenient for the patient.
  • Figure 1 shows a cross sectional view of a commercially available nasal prong.
  • the pressurized inspiratory air flows through a tiny tube 100 and is injected from the nozzle 101 towards the patient's nasal cavities through a nose piece 102. If the nasal cavities are open the air flows into the patient, but otherwise the air flows out from the device through the cavity 103, similarly during expiration the air flows through the cavity 103 out from the patient and the device.
  • the device also comprises a cavity or cavities 104 to transmit pressure inside the cavity 103 extending towards the nose piece 102 into the host device through a tubing (not shown in figure 1) to measure the pressure with a pressure sensor inside the host.
  • the problem in this design is that the injected air generates turbulences that generate noise and disturbances in to the pressure signal being measured through the cavity 104.
  • the level of noise is so high that the signal cannot be used to trigger the inspiratory phase or expiratory phase reliably and cannot be used.
  • the anatomical dead volume is almost impossible to reduce, but it is proportional to the size and the physical condition of the patient.
  • the mechanical dead volume depends on a breathing circuit design, an inner diameter of a tubing, connectors and additional accessories, such as sidestream and mainstream gas analyzers connected to patient's respiratory system. Obviously the mechanical dead volume is more critical for smaller patients with smaller TV or patients suffering barotraumas etc., which also decrease TV.
  • the tendency is to connect sick patients with breathing deficiency into the noninvasive ventilation to support the patient's own breathing efforts rather than connecting the patient to more inconvenient intubated ventilation.
  • the synchronization is important so that the patient's breathing efforts are not resisted, for example delivering inspiratory gas during the expiration that prevents the air to flow out from the patient's lungs, so that the patient's lungs would not be worn out, but rather to speed up the recovery.
  • the synchronization, especially to small patient's breathing or breathing efforts is difficult since the tidal volumes, or the movement caused by the lungs, are so small and difficult to detect with existing techniques.
  • the existing devices do not detect the start of inspiration correctly and the ventilation is usually insufficient or even harmful to certain functions of the lungs.
  • patients in poor shape are usually intubated and connected to more demanding form of ventilation in physical sense, which increase the recovery time.
  • a breathing mask for ventilating a patient includes an inspiratory limb providing inspiratory gas for the patient, and an expiratory limb providing expiratory gas from the patient.
  • the breathing mask also includes at least two respiratory cavities delivering inspiratory gas from the inspiratory limb towards the patient and expiratory gas from the patient towards the expiratory limb, and a first cavity configured to convey both an inspiratory and expiratory gas, the first cavity having a first connection point for the inspiratory limb and the expiratory limb, and a second connection point for the at least two respiratory cavities, the first cavity extending between the first and second connection points.
  • the breathing mask also includes at least one measurement component in operational contact with at least one of the inspiratory and expiratory gas of the first cavity, the at least one measurement component being configured to enable signal acquisition of at least one of a pressure, gas flow, gas compound quantity and gas compound quality.
  • the at least one measurement component is configured to locate between the first connection point, where the inspiratory limb and the expiratory limb branch from the first cavity, and the second connection point, where the at least two respiratory cavities are configured to branch from the first cavity, but outside the first connection point and the second connection point.
  • a breathing mask for ventilating a patient includes an inspiratory limb providing inspiratory gas for the patient, and an expiratory limb providing expiratory gas from the patient.
  • the breathing mask also includes at least two respiratory cavities delivering inspiratory gas from the inspiratory limb towards the patient and expiratory gas from the patient towards the expiratory limb, and a first cavity configured to convey both an inspiratory and expiratory gas, the first cavity having a first connection point for the inspiratory limb and the expiratory limb, and a second connection point for the at least two respiratory cavities, the first cavity extending between the first and second connection points.
  • the breathing mask also includes at least one measurement component in operational contact with at least one of the inspiratory and expiratory gas of the first cavity, the at least one measurement component being configured to enable signal acquisition of at least one of a pressure, gas flow, gas compound quantity and gas compound quality.
  • the at least one measurement component is configured to locate between the first connection point, where the inspiratory limb and the expiratory limb branch from the first cavity, and the second connection point, where the at least two respiratory cavities are configured to branch from the first cavity, but outside the first connection point and the second connection point.
  • a cross sectional inner area of the first cavity is substantially similar with cross sectional inner area of at least one of the inspiratory limb and the expiratory limb deviating less than ⁇ 10% from each other.
  • a breathing mask for ventilating a patient includes an inspiratory limb providing inspiratory gas for the patient, and an expiratory limb providing expiratory gas from the patient.
  • the breathing mask also includes at least two respiratory cavities delivering inspiratory gas from the inspiratory limb towards the patient and expiratory gas from the patient towards the expiratory limb, and a first cavity configured to convey both an inspiratory and expiratory gas, the first cavity having a first connection point for the inspiratory limb and the expiratory limb, and a second connection point for the at least two respiratory cavities, the first cavity extending between the first and second connection points.
  • the breathing mask also includes at least one measurement component in operational contact with at least one of the inspiratory and expiratory gas of the first cavity, the at least one measurement component being configured to enable signal acquisition of at least one of a pressure, gas flow, gas compound quantity and gas compound quality.
  • the at least one measurement component is configured to locate between the first connection point, where the inspiratory limb and the expiratory limb branch from the first cavity, and the second connection point, where the at least two respiratory cavities are configured to branch from the first cavity, but outside the first connection point and the second connection point.
  • a longitudinal axis of the first cavity and a longitudinal axis of at least one of the inspiratory limb and the expiratory limb is configured to form an angle a which is between 90° and 160° degrees.
  • Figure 1 shows a cross-sectional schematic side view of a prior art nasal prong
  • Figure 2 shows a schematic view of a breathing circuit incorporating a breathing mask with a gas sensor in accordance with an embodiment
  • Figure 3 shows a perspective, schematic view of the breathing mask and the gas sensor in Figure 2 coupled together;
  • Figure 4 shows a perspective, schematic view of the breathing mask and the gas sensor in Figure 3 when detached from each other;
  • Figure 5 shows a cross-sectional schematic side view of the sensor in Figure 4.
  • Figures 6 - 8 show different detailed, schematic views of inspiratory and expiratory gases flowing through the breathing mask of Figure 4 in different phases of the respiratory cycle;
  • Figure 9 shows a cross sectional, schematic view of the breathing mask of Figure 4 seen from above.
  • FIG. 2 shows a breathing circuit 1 comprising a sensor 2, such as a mainstream sensor, connectable to a breathing mask 3, such as a nasal prong, for ventilating a patient, which breathing mask further connects to a host device 4, which may be a ventilator in this particular embodiment, through an inspiratory tube 5 that allows inspiratory gas, such as fresh gas, to flow through the sensor 2 and breathing mask 3 into the patient's lungs and an expiratory tube 8 that allows expiratory gas to flow out from the patient's lungs through the breathing mask 3, through the sensor 2, and expiratory tube 8 and a connection 9, between the host device 4 and the sensor 2, that allows the host device, which is the ventilator in this embodiment, to be synchronized with patient's respiratory cycle.
  • the breathing mask comprises the sensor 2 detachable from the breathing mask.
  • the breathing mask 3 for neonates, infants and possibly for pediatrics covering only nostrils without the mouth is attachable around or against nostrils. Naturally the breathing mask could also cover the mouth, but in this specific embodiment it is not necessarily needed.
  • the breathing mask is attached against patient's nostrils and may be kept in place with a flexible string 12 attached to a cap 13 or similar.
  • the sensor 2 which is advantageously detachable from the breathing mask 3, can be connected electrically or pneumatically to the host device 4 through the connection 9, such as a cable, and connector 10.
  • the host device can transfer electric power through the connector 10 and the connection 9 into the sensor 2 to operate the sensor.
  • the sensor can also be wireless in which case it comprises a battery (not shown in figures) to operate the sensor.
  • the sensor 2 can transmit the measurement or signal data and receive control data through radio frequency transceiver (not shown in figures) or similar between the connector 10 or between a module 11 that may also comprise a radio frequency transceiver or similar to receive and transmit the data.
  • the connector 10 or module 11 may comprise a processing unit 14, such as a central processing unit (CPU), or it can be located into the sensor 2 to operate the sensor and to make one of qualitative and quantitative analysis of at least one of the inspiratory and expiratory gas property, such as at least one of the breathing gas flow, the pressure and gas compound analysis based on the signals received from the sensor 2.
  • the gas compound analysis may include at least one of gas compound quantitative analysis and gas compound qualitative analysis.
  • the at least one of the inspiratory and expiratory gas properties calculated by the processing unit can be transferred from the sensor 2 to the host device 4 to show the information for the care giver or user on a display 15 or similar.
  • FIG 3 and 4 shows two, more detailed, schematic views of one embodiment of the breathing mask 3 such as nasal prong.
  • the sensor 2 is connected advantageously detachably into the breathing mask 3 and in Figure 4 the sensor is removed from the breathing mask.
  • This breathing mask 3 comprises a first cavity 20 , such as a first conduit, and an inspiratory limb 6 and an expiratory limb 7 both connecting into the first cavity 20 through a first connection point 21.
  • the first cavity 20 further connects through a second connection point 37 into respiratory cavities 22 of the breathing mask, such as respiratory conduits, which finally extend into respiratory ports 25.
  • Respiratory ports 25 are made of a soft and elastic material, covering at least one of the respiratory passages of the patient, entering the patients nostrils, when the nasal prong is placed on the patients face, connecting the first cavity 20, the respiratory cavities 22 and the respiratory ports 25 to form a continuous flow path with the nasal cavities of the patient to allow inspiratory air to flow from the inspiratory limb 6 into the patients lungs and through the expiratory limb 7 out from the patients lungs.
  • the breathing mask 3 also comprises a gas sampling cell 26 between the first connection point 21 and the second connection point 37 dividing the first cavity 20 into two parts to convey both the inspiratory gas from the inspiratory limb 6 to the respiratory ports 25 and the expiratory gas from the respiratory port 25 to the expiratory limb 7.
  • the gas sampling cell 26 advantageously integrated into the breathing mask 3 or typically integrated into the first cavity 20 of the breathing mask and the first cavity 20 are thus advantageously in direct flow communication with each other.
  • the first cavity 20 or the sampling cell 26, which is part of the first cavity comprises at least one measurement component 30, 49 in operational contact with at least one of the inspiratory and expiratory gas for enabling a signal acquisition of at least one respiratory gas property, such as gas flow rate, pressure or one of qualitative and quantitative gas analysis.
  • the at least one respiratory gas property may be at least one of the inspiratory and expiratory gas property.
  • a respiratory passage piece 24 in Figure 3 places against the patient's nostrils so that respiratory ports 25 enter the both nostrils to distribute inspiratory gas from the inspiratory limb 6 and expiratory gas to the expiratory limb 7 to prevent the inspiratory or expiratory gas from leaking.
  • the respiratory cavities 22 extend through the respiratory passage piece 24.
  • the insphatory gas is delivered through the inspiratory limb 6 towards the patient's nostrils, first into the first cavity 20 common for inspiratory and expiratory gas and through the gas sampling cell 26 between the first cavity 20 and then to nostrils through the second cavities 22 into the respiratory ports 25 of the nasal respiratory passage piece 24.
  • Expiratory gas from patient's lungs flows the same path, but into the opposite direction, first through the respiratory ports 25 of the nasal respiratory passage piece 24, then the respiratory cavities 22 and sampling cell 26 between the first cavity 20 out from the breathing mask 3 through the expiratory limb 7.
  • the first cavity or the sampling cell 26 of the first cavity may comprise the measurement component 30, such as a flow sensor 31 or a pressure sensor 34, 35, for measuring at least one gas property.
  • the flow sensor 31 may be a thermistor based flow sensor or similar that senses the speed of the flow and the direction of the flow, such as a small chip comprising a heater element in the middle and sensing elements on both sides of the heater element that are all positioned in line with the direction of the breathing gas flow.
  • the flow measurement may also be based on measuring the pressure difference over a flow restrictor positioned into the breathing gas flow path between the two pressure sensors 34 and 35, from which the flow speed and the flow direction can be calculated.
  • the flow sensor 31 between the pressure sensors 34 and 35 would be replaced with a flow restrictor.
  • the use of the pressure sensors gives an advantage of measuring the breathing gas pressure at the same time with the flow, but the technology and the implementation may be more expensive and may not be preferred to a low cost, disposable device. It is also possible to measure the breathing gas pressure only with one of the pressure sensors 34 or 35, but then the speed and the direction of breathing gas flow remains unknown, which is a disadvantage if spirometry or gas exchange information for patient's energy expenditure or metabolism is needed. Thus it is advantageous to have both the flow sensor 31 and at least one of the pressure sensors 34 or 35.
  • the flow sensor 31 and/or at least one of the pressure sensors 34 and 35 which connect with the first cavity 20 or the sampling cell 26 and thus the inspiratory and expiratory breathing gases, are used for acquiring a signal indicative of a flow and/or the pressure of the breathing gas to determine the flow and or the pressure during the breathing cycle in the embodiments in Figures 2 and 3, which information is used by the host device 4 to synchronize the start of delivery of inspiratory air with the start of patient's inspiration.
  • the sensor 2 shown in Figure 5, which connects with the breathing mask 3, comprises of a radiation source 40, such as an infrared radiation source, at least one detector 41, such as a thermal detector, and an electronics board 45, which may also include the processing unit 14.
  • the radiation source, the detector and the electronics board may be attached to the body 46, but typically they are inside the body 46.
  • the radiation emitted by the radiation source 40 is directed towards the at least one detector 41 placed inside a thermal mass 42 of the sensor 2 on the other side of a sensor cavity 43.
  • the detector and the radiation source may locate on opposite sides of the sensor cavity 43.
  • the first cavity 20 or the gas sampling cell 26 of the first cavity may comprise the at least one measurement component 30, 49 for enabling a signal acquisition of at least one of the inspiratory and expiratory gas properties such as the flow or the pressure or gas compound quantitative or quality analysis.
  • the measurement component 49 may be a gas compound analysis element 50, such as an optical element, which is able to transmit radiation or guide radiation emitted by the radiation source 40 to the at least one detector 41.
  • the optical element can be for example a light guide for oxygen measurement or window.
  • the sensor 2 connects with the breathing mask 3 so that the sensor cavity 43 of the sensor 2 may slide on the first cavity or the sampling cell 26 of the breathing mask 3 so that the first surface 44 of the cavity 43 in the sensor 2 is towards the second surface 51 of the sampling cell 26.
  • the sensor 2 locks between wings 52 in the breathing mask 3 and the optical element, such as the optical window, on both sides of the sampling cell 26 are aligned with the radiation source 40 and the at least one detector 41 in body 46 of the sensor. Now the radiation from the radiation source 40 can traverse through the optical windows and through the breathing gas flowing crosswise through the sampling cell 26.
  • Different gases flowing through the first cavity or the sampling cell 26 absorb infrared radiation at certain wavelengths that can be measured with the at least one detector 41.
  • the detector transforms the received radiation into a signal, such as voltage(s), which is proportional to the concentration of at least one measured gas.
  • the signal is further processed in the electronics board 45 and transmitted to the host device 4, the connector 10 or the module 11.
  • the gas analysis element 50 may also be an electro-chemical or electromagnetic element, especially in case the measurement of gas compound, such gas component as oxygen, is based on chemical properties or paramagnetic properties of a gas.
  • the first cavity 20, respiratory cavities 22 and respiratory ports 25 are for inspiratory or expiratory gases as shown in Figure 4 depending on a phase of the breathing cycle.
  • Chest or stomach movement measurements are very sensitive to other body movements as well and generate falls triggering.
  • Flow or pressure measurements at the ventilator suffer from the large air volumes and elasticity of ventilator tubing that damp the flow and/or pressure signal.
  • the existing nasal prongs are designed so that they generate high flow turbulences close to the nasal cavities, the place where the pressure measurement may also be located, destroying the measurements sensitiveness as the measurement signal is buried under the noise generated by the turbulence.
  • FIG. 6 The embodiments shown in previous Figures 2, 3 and 4, but also in more detailed in Figures 6, 7, 8 and 9 show the breathing mask 3, which is designed to minimize or even eliminate the flow turbulences thus making the gas flow laminar or substantially laminar through the first cavity 20 and sampling cell 26, if such is included, and very suitable for measuring at least one gas property in the breathing gas, such as the breathing gas flow, pressure or the concentration of the gas with one of the measurement components 30, 49 such as a flow sensor 31, a pressure sensor 34, 35 located in connection with the first cavity 20 and the gas compound analysis element 50.
  • Figures 6, 7 and 8 show different detailed, schematic views of inspiratory and expiratory gases flowing through the breathing mask 3 in different phases of the respiratory cycle.
  • the patient's nasal cavities are closed and there is no gas flow into the patient or into the first cavity 20, but the gas flows straight from the inspiratory limb 6 to the expiratory limb 7.
  • the measurement components 30 and 49 should be outside the first connection point 21 and the second connection point 37, typically at a predetermined distance from the first connection point 21 at the first end of the first cavity and the second connection point 37 at the second end of the first cavity, but between these first and second connection points.
  • the angle a between the longitudinal axis of inspiratory limb 6 and the first cavity 20 as wells as the angle ⁇ between the longitudinal axes of inspiratory limb 6 and the expiratory limb 7 is significant when trying to reach laminar or substantially laminar flow in the first cavity 20 and/or the gas sampling cell 26 between the first cavity 20 having the measurement components 30, 49 for enabling a signal acquisition of at least one of the inspiratory and expiratory gas property.
  • some turbulences may still exist close to the first connection point 21 after choosing optimal parameters for the angles a and ⁇ the length of the first cavity 20 can be made longer to make the flow laminar at least in the middle of the first cavity 20 parallel with its longitudinal axis, which is the optimal place for the
  • the middle of the first cavity parallel with the longitudinal axis is an optimal place for the flow sensor 31 to acquire a signal indicative of the breathing gas flow and/or for at least one of pressure sensors 34 and 35 to acquire the signal indicative of the pressure of the breathing gas.
  • these components are very sensitive detecting any change in the gas property when the patient's nasal cavities are opened to allow breathing gas to flow into the lungs or out from the lungs.
  • the inspiratory gas flows through the breathing mask 3 into the patient's lungs after the patient's sigh is detected or the nasal cavities are opened, in other words an effort to breathe in is detected, when the air flow is allowed from the inspiratory limb thiough the first connection point 21 into the first cavity 20 and through the respiratory cavities 22 in nasal respiratory passage piece 24 and respiratory ports 25 into the patient's lungs.
  • the air flow is directed mainly through the inspiratory limb, through the first cavity 20 and the respiratory passage piece 24 into the patient's lungs as the expiratory valve at the ventilator of the host device 4 is closed or partially closed to prevent the gas to flow through the expiratory limb 7, to increase the breathing gas pressure inside the circuit and to force the gas to flow into the lungs.
  • the optimum contact angle between the longitudinal axis of the first cavity 20 and the inspiratory limb 6, described with an angle a would be 180° degrees.
  • turbulences close to the first connection point 21, depending on the gas flow speed, which depends on the diameter of the cavity and the volume of gas delivered.
  • the turbulences are made laminar at the location of the gas property measurements, which increases the sensitivity and the accuracy of the measurements.
  • the inspiratory flow is stopped when for example the breathing circuit pressure or the flow reach their pre-adjusted maximum values as the patient's lungs start to fill up or the nasal cavities are closed for example for the time when the patient swallows or coughs.
  • FIG. 8 the expiratory gas flows out from the patient's lungs during the expiration through the breathing mask 3 and expiratory limb 7 into the expiratory tube 8.
  • the ventilator's expiration valve (not shown in figures) is opened to release the pressure in the breathing circuit to allow exhaled gas to flow out with a minimal flow resistance, however ensuring that the positive end expiratory pressure remains at a minimal level to keep the lungs open and preventing alveoli in the lungs to collapse.
  • the flow path from the nasal cavities towards the expiratory limb 7 is continuous and straightforward avoiding turbulences in the first cavity 20 and more specifically at the place of one of the flow sensor 31, at least one of the pressure sensors 34, 35 and the gas compound analysis element 50 in the middle of the first cavity 20 parallel with the longitudinal axis making it as an optimal place for the measurements.
  • the optimum contact angle between the longitudinal axis of the first cavity 20 and the expiratory limb 7, described with a sum of the angles a + ⁇ , would be 180° degrees.
  • the distance as well as the diameter of the cavities between the respiratory ports 25 and at least one of the flow sensor 31, at least one of the pressure sensors 34, 35 and the gas compound analysis element 50 should be optimal to make the gas flow laminar during the expiration phase, at the place of those components 31, 34, 35 and 50, as the breathing gas flows from the respiratory ports 25, through the respiratory cavities 22 and the first cavity 20 towards the expiratory limb 7.
  • the distance between the first connection point 21 and at least one of the flow sensor 31, at least one of the pressure sensors 34, 35 and the gas compound analysis element 50, as well as the distance between the respiratory ports 25 and those components 31, 34, 35 and 50 should be minimal to minimize the dead space causing rebreathing of gases.
  • the diameter of the first cavity 20, the respiratory cavities 22 and the respiratory ports 25 should be minimized to reduce the dead space, but on the other hand they have a minimum diameter comparable to the size of the patient's nasal cavities to minimize the flow resistance of the breathing gas.
  • the angle a between the inspiratory limb 6 and the first cavity 20 is close to 180° degrees it increases the rebreathing of gases as the expiratory gas tends to flow back to the inspiratory limb in the case there is no flush flow through the inspiratory limb 6.
  • Figure 9 shows a cross sectional, schematic view of the breathing mask 3 of Figure 4 seen from above through the second surface 51, which is from the direction of the flow sensor 31 and/or at least one of the pressure sensors 34, 35 towards the first cavity 20. It is advantageous if the angle a between the longitudinal axis of the first cavity 20 and the longitudinal axis of one of the inspiratory limb 6 and the expiratory limb 7deviates from 180°. Thus angle a can be between 90° and 160° degrees, whereas the angle ⁇ between the longitudinal axis of the inspiratory limb 6 and the longitudinal axis of the expiratory limb is between 45° and 180° degrees depending on the angle a.
  • the angle a is between 90° and 135° degrees, whereas the angle ⁇ is between 90° and 135° degrees similarly.
  • the best performance may be achieved if the angle a is close to 135° degrees deviating less than ⁇ 10% from that number of degrees, whereas the angle ⁇ is close to 90° degrees deviating less than ⁇ 10% from that number of degrees.
  • Both the angle a and ⁇ are calculated from the part of the inspiratory and expiratory limb ends which are joining to the first connection point 21, because the opposite end of these Umbs can be directed in a different way, which is not so relevant considering the laminar flow inside the first cavity 20.
  • angle a 180° degrees or even between 160° - 180° degrees and angle ⁇ 0° degrees or even less than 20° degrees since the design would have disadvantages such as turbulences disturbing the measurements located into the first cavity 20 like in the existing technologies or in the designs where the inspiratory and expiratory tubes are coaxial.
  • each respiratory cavity 22 it is desirable to have a contact angle between the longitudinal axes of each respiratory cavity 22 and the first cavity 20 more than 90° degrees or preferably more than 135° degrees to minimize the turbulences near the second connection point 37.
  • the best performance in minimizing the turbulences is achieved with the contact angle more than 150° degrees.
  • the straight cavity would be best in minimizing the turbulences, but it is not possible arrangement with two respiratory ports 22.
  • the average distance Dl shown in Figure 9 between the first connection point 21 and the place of at least one of the flow sensor 31, at least one of the pressure sensors 34, 35 and the gas compound analysis element 50, used to measure at least one of the gas properties, should be increased proportionally to the magnitude of turbulences near the first connection point 21 to get the flow laminar at that place.
  • the average distance D2 between the second connection point 37, the intersection of the respiratory cavities 22 inside the respiratory passage piece 24 and the first cavity 20, and the place of at least one of the flow sensor 31 at least one of the pressure sensors 34, 35 and the gas compound analysis element 50 along the first cavity 20 should be determined so that the flow in the middle of the first cavity 20 parallel with the longitudinal axis at that place is laminar.
  • the distances Dl and D2 are proportional to the maximum flow speed of the breathing gas, which speed is inversely proportional to the inner diameter dl of the first cavity 20, the inner diameter d4 of the respiratory cavities 22, the inner diameter d2 of the expiratory limb 7 and the inner diameter of d3 of the inspiratory limb 6 as well as the angles a and ⁇ .
  • the flow speed remains fairly similar dependent on the size of a patient and the size of a breathing mask in other words the diameter of the cavities.
  • the distances Dl and D2 can be expressed relative to the diameter dl of the first cavity 20, where the cross sectional inner area of the first cavity 20, should have substantially similar cross sectional inner areas with the pair of second cavities 22 and the pair of respiratory ports 25, which may also be dependent on the angles a and ⁇ .
  • substantially similar can be understood to mean the cross sectional inner areas deviating less than ⁇ 10% from each other.
  • ratios Dl/dl and D2/dl may be advantageous to have the ratios Dl/dl and D2/dl more than 1. It is more advantageous if the ratios Dl/dl and D2/dl are more than 1.5. The best performance may be achieved if the ratios Dl/dl and D2/dl are more than 2.
  • the inner diameter or more closely the inner cross sectional area of all cavities including respiratory ports 25 inside the breathing mask 3 should advantageously be as close to the cross sectional area of the nasal cavities of the patient as possible and there should not be any step like changes or sharp corners in the flow path to minimize turbulences and to keep the gas flow laminar as well as the flow speed constant.
  • the turbulences in the flow path disturb the gas exchange and increase the rebreathing of gases, but turbulences also degrade the measurement of gas properties and for example the turbulences generate noise in to the breathing gas flow measurement, which is especially harmful at lower gas flow rates where the patient's sighs also appear.
  • the inner diameter of the cavities together with the length of the cavities also describe the overall dead volume of the breatliing mask 3 causing rebreathing of gases.
  • the breathing gas flow speed in the first cavity 20 can be adjusted by adjusting the diameter of the first cavity, which is the optimal place for the components 31, 34, 35 and 50 used for measuring one of the gas properties.
  • Some of the gas flow measurement techniques are more accurate at smaller flow rates and the accuracy degreases at higher flow rates whereas some are more accurate at higher flow rates and the accuracy decreases at lower flow rates.
  • the maximum dynamic range for example for a thermistor based gas flow measurement technique, where one thermistor is heated up to transmit the heat into the breathing gas and two additional thermistors located symmetrically on both sides of the heated thermistor sense the heat transferred within the gas flow, which amount of heat is proportional to the gas flow speed may be between 0-50 m/s.
  • the dynamic range of a more accurate gas flow measurement for breathing gas measurement purposes may be only 0-28 m/s, but the most useful range only less than 14 1/min.
  • the speed of gas is inversely proportional to the cross sectional area of the tube where the gas flows. For example for a 3 kg infant, whose tidal volume is 20 ml, respiration rate (R ) about 60 respiration/minute and the I:E ratio about 1 :2, the average gas flow speed during inspiration in a standard endotracheal tube, which inner diameter is 3 mm is approximately 4 m/s. The maximum speed would be higher, but still within the accuracy range of the thermistor based gas flow measurement as in the example above.
  • the average flow speed of gas during inspiration in a standard endotracheal tube which inner diameter is 4 mm may be approximately 14 m/s and the maximum flow speed exceeds that. This is close to the most useful dynamic range of a thermistor based flow speed measurement technology.
  • the diameter of the cross sectional area can be increased when the flow speed decreases. Using the above example by increasing the diameter from 4 to 4.5 mm the average flow speed drops down to approximately 11 m/s. The dead volume increases at the same time, but for example for a 15 mm long tube the increase is approximately 0.05 ml.
  • the breathing masks 3 can be reusable or disposable and they can be made of plastic, silicon, a combination of those or any other similar materials.
  • the used materials and the construction of disposable accessory need to be recyclable and low cost to enable reasonable and efficient disposability.
  • Some parts of the breathing mask can be reusable and include disposable parts that are changed more often, like the respiratory passage piece 24, which is made of very elastic material to fit patient's nostrils without causing harm, but which can be changed more often to reduce contamination or blockage risk due secretions.
  • the passage piece 24 can also have different sizes to correspond better the size of a patient it is connected to.
  • the breathing mask 3 can have less sizes, for example one for a group of neonates and one for a group of pediatrics, but within each group the final fitting to correspond the particular face and size of each patient is done by choosing the correct respiratory passage piece 24.
  • the breathing masks 3 comprising at least one of the measurement component 30 and the measurement component 49 for measuring at least one gas property outside the first connection point 21 and the second connection point 37 of the first cavity 20, which first cavity is extending between these connection points, but which measurement components locate between these connection points, has several advantages compared to well-known masks. First of all it enables accurate, real time, non-invasive breathing gas property measurement of neonatal patients that do not exist at the moment.
  • the dead volume can be remarkably minimized, which is especially important for neonatal and pediatrics.
  • the dead volume may be decreased more than 5 ml with pediatrics.
  • the overall dead volume for neonates may be less than 3 ml, but may be even less than 1 ml depending on the features integrated into the mask, such as pressure cavity to detect breathing cycle.
  • the integration of the breathing mask and measurement components used for measuring at least one gas property enables very tubular flow path design for breathing gases that enables laminar flow of gases from the patient through the analyzer, in other words turbulences mixing the inspiratory and expiratory air are minimized to enable accurate analyzing of inspiratory air and expiratory air separately. This is very important in getting gas concentration measurement values that correlate with the blood gas concentration values, even when the respiration rate (RR) is increased. Any breathing gas analyzes would otherwise be useless.

Abstract

L'invention concerne un masque respiratoire (3) destiné à ventiler un patient. Le masque respiratoire comprend un élément d'inspiration (6) fournissant du gaz d'inspiration et un élément d'expiration (7) fournissant du gaz d'expiration. Le masque respiratoire comprend également au moins deux cavités respiratoires (22) fournissant du gaz d'inspiration et du gaz d'expiration, et une première cavité (20) pour transporter à la fois du gaz d'inspiration et du gaz d'expiration, la première cavité comportant un premier point de raccordement (21) pour l'élément d'inspiration et l'élément d'expiration, et un second point de raccordement (37) pour lesdites cavités respiratoires. En outre, le masque respiratoire comprend au moins un élément de mesure (30; 49) permettant l'acquisition des signaux d'une pression, d'un débit de gaz, d'une quantité de composés gazeux et/ou d'une qualité de composé gazeux. Ledit élément de mesure se trouve entre le premier point de raccordement et le second point de raccordement, mais en dehors du premier point de raccordement et du second point de raccordement.
PCT/US2014/039605 2013-05-29 2014-05-27 Masque respiratoire destiné à ventiler un patient WO2014193847A1 (fr)

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CN109069063A (zh) * 2016-06-14 2018-12-21 日本光电工业株式会社 气体传感器套件和气体供给单元
CN111801048A (zh) * 2018-02-20 2020-10-20 明尼苏达大学董事会 呼吸取样面罩和系统
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WO2023010172A1 (fr) * 2021-08-05 2023-02-09 Colin Dunlop Pièce raccord pour un circuit respiratoire anesthésique
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CN116369898A (zh) * 2023-06-06 2023-07-04 青岛市第五人民医院 一种用于危重症的呼吸数据提醒系统
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