WO2021240529A1 - Ventilation splitter device and system and method for ventilation - Google Patents

Ventilation splitter device and system and method for ventilation Download PDF

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Publication number
WO2021240529A1
WO2021240529A1 PCT/IL2021/050633 IL2021050633W WO2021240529A1 WO 2021240529 A1 WO2021240529 A1 WO 2021240529A1 IL 2021050633 W IL2021050633 W IL 2021050633W WO 2021240529 A1 WO2021240529 A1 WO 2021240529A1
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Prior art keywords
multiplicity
patient
flow
valves
pressure
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PCT/IL2021/050633
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French (fr)
Inventor
Yuval GUR
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Eon Computerized Solutions Ltd.
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Publication of WO2021240529A1 publication Critical patent/WO2021240529A1/en

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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
    • A61M16/021—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
    • 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
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • 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
    • A61M16/12—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. 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A61M16/209—Relief 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
    • A61M2016/0027—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
    • A61M2016/0039—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
    • 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
    • A61M2202/0208—Oxygen
    • 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
    • A61M2205/11—General characteristics of the apparatus with means for preventing cross-contamination when used for multiple patients
    • 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
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • 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
    • A61M2205/3592—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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2205/84—General characteristics of the apparatus for treating several patients simultaneously

Definitions

  • the present disclosure relates to the field of medical ventilators, in particular ventilation of multiplicity of patients utilizing a single ventilator.
  • a ventilator When a disease caused the lungs to fail or operate ineffectively such that the body's oxygen levels to drop, a ventilator is used to takes over or assist the body's breathing process. During ventilation, the patient is given time to fight off the infection and recover.
  • Ventilators are designed to push air, with the option for increased levels of oxygen, into the lungs.
  • Positive-pressure ventilators operate by increasing the patient's airway pressure, typically, through an endotracheal or tracheostomy tube or a mask. The positive pressure allows air to flow, at a predetermined flow rate and for a predetermined period of time, into the airway. Then, the airway pressure drops and the air is passively exhaled from the lungs.
  • a ventilation parameter for example, the delivered volume measured by the ventilator
  • the ventilator will detect abnormally high pressure and an alarm will be issued and/or the ventilator will automatically limit the delivered volume.
  • the compliance of one of the patients decreases the airflow will be re-directed to the other patient with the higher compliance without any alarm being triggered and the physician will not know that both patients are getting inadequate ventilation.
  • SCCM Society of Critical Care Medicine
  • AARC American Association for Respiratory Care
  • ASA American Society of Anesthesiologists
  • ACN Anesthesia Patient Safety Foundation
  • AACN American Association of Critical-Care Nurses
  • CHEST American College of Chest Physicians
  • the ventilator monitors the average pressures and volumes.
  • the present disclosure provides, in accordance with some embodiments, a device, system and method, which advantageously enables ventilation of multiplicity of patients using the same ventilator, yet ensuring that some of the key ventilation parameters are maintained independently for each ventilated patient depending on his/her condition, e.g., lung capacity, resistance, and compliance, changes in their condition, which may occur during the ventilation period.
  • some of the key ventilation parameters that are controlled independently for each ventilation patient are independent ventilation volume, independent monitoring and independent alarming for each of the patients. It is noted, however that some of the ventilation parameters, such as the timing of the breaths, inspiratory time (Ti) and positive end-expiratory pressure (PEEP), are the same for all ventilated patients.
  • the ventilation splitter unit is constructed such that one patient's condition does not affect other patients, thus the risk of hypoventilation/hyperventilation is mitigated or even prevented. This may be of utmost importance in situations of shortage of ventilators such as in case of pandemics, as experienced during the resent COVID-19 pandemic.
  • the tubing and valve setup pf the ventilation splitter unit is constructed such that contamination (air enriched with CO2, bacteria, fungi, viral infection etc.) from one of the ventilated patients will not reach the other ventilated patients.
  • the tubing, valves and sensors configuration of the ventilation splitter unit disclosed herein which is controlled by a designated CPU, in accordance with some embodiments, allow delivering the correct volumes to each ventilated patient and avoid a situation where volumes go to the patient having the most compliant lungs.
  • the CPU of the ventilation splitter unit facilitates alarm monitoring of each patient, independently.
  • the tubing and valves setup of the ventilation splitter unit which is controlled by the designated CPU as disclosed herein in accordance with some embodiments, further allow stopping ventilation for only one of the ventilated patients (for example, in case of cardiac arrest), without altering breath delivery dynamics to the other ventilated patients.
  • multi-patient ventilation utilizing a single ventilator and the ventilation splitter unit can be conducted without additional external monitoring.
  • a ventilation splitter assembly for ventilation of multiplicity of patients using a single ventilator, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is positioned between the ventilator and the first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves is positioned between the ventilator and the second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient, and each additional valves of the multiplicity of valves is positioned between the ventilator and the patient and determines the flow, pressure and/or volume to an additional patient; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the first valve and wherein a second flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the second valve
  • a system for ventilation of multiplicity of patients using a single ventilator comprising: a single ventilator configured to output flow at a predetermined rate and/or pressure; and a ventilation splitter assembly configured to split the flow between the multiplicity of patients, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is on an air path between the ventilator and a first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves is on an air path between the ventilator and a second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient and each additional valve of the multiplicity of valves is on an air path between the ventilator and the corresponding patient, said additional valve is configured to determine a the flow, pressure and/or volume to the corresponding patient; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow
  • the ventilation splitter assembly may further include multiplicity of pressure sensors, wherein a first pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the first patient's airway and wherein a second pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the second patient's airway and wherein any additional pressure sensors of the multiplicity of pressure sensors are configured to provide a signal indicative of the pressure of the corresponding patient's airway, and wherein the controller is further configured to utilize the pressure measured by the pressure sensors to adjust any of the multiplicity of valves.
  • the ventilation splitter assembly may further include multiplicity of one-way valves, wherein a first one-way valve of the multiplicity of one-way valves is positioned in the inspiratory path to the first patient and is configured to prevent backflow from the first patient towards the ventilator and other air paths of other patients, and wherein a second one-way valve of the multiplicity of one-way valves is positioned in the inspiratory path to the second patient and is configured to prevent backflow from the second patient towards the ventilator and other air paths of other patients, wherein any additional one-way valve of the multiplicity of one-way valves corresponding to a respective patient of the multiplicity of patients, is positioned in the inspiratory path of the respective patient and configured to prevent backflow from the respective patient towards the ventilator and other air paths and their respective patients.
  • the ventilation splitter assembly may further include multiplicity of one-way valves, wherein a first one-way valve of the multiplicity of one-way valves is positioned in the expiratory air path of the first patient and configured to prevent cross contamination between patients and wherein a second one-way valve of the multiplicity of one way valves is positioned in the expiratory air path of the second patient and configured to prevent cross contamination between patients, wherein any additional one-way valve of the multiplicity of one-way valves corresponding to the respective patient of the multiplicity of patients, is positioned in the expiratory air path of the respective patient and configured to prevent cross contamination between patients.
  • the ventilation splitter assembly may further include multiplicity of relief valves, wherein a first relief valve corresponding to the first patient of the multiplicity of patients, positioned in the inspiratory air path of the first patient and configured to release hyper-pressure if created in the first patient's airway, and wherein a second relief valve corresponding to the second patient of the multiplicity of patients, positioned in the inspiratory air path of the second patient and configured to release hyper-pressure if created in the second patient's airway, and wherein any additional relief valve of the multiplicity of relief valves corresponding to a respective patient of the multiplicity of patients, positioned in the inspiratory air path of the respective patient and configured to release hyper-pressure if created in the respective patient's airway, and wherein the controller is further configured to independently operate each relief valve of the multiplicity of relief valves.
  • the ventilation splitter assembly may further include multiplicity of flow sensors, wherein a first flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the first patient and the first one-way valve or between the first one-way valve and the ventilator, and wherein a second flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the second patient and the second one-way valve or between the second one-way valve and the ventilator, and wherein any additional flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the respective patient and the corresponding respective one-way valve or between the corresponding respective one-way valve and the ventilator, and wherein the controller is further configured to obtain signals provided from each of said expiratory path flow sensors.
  • the ventilation splitter assembly may further include a user interface (Ul).
  • Ul user interface
  • the ventilation splitter assembly may further include a communication interfaces configured to control one or more ventilator operation parameters, or to allow control over one or more parameters in the system.
  • the CPU of the ventilation splitter assembly may further be configured to activate an alarm upon detecting/calculating volume and/or pressure values being below or above predetermined values.
  • the CPU ventilation splitter assembly may further be configured to activate an alarm upon detection of patient disconnection.
  • a method for ventilation of multiplicity of patients using a single ventilator and a ventilation splitter assembly includes: providing a system including a single ventilator and a ventilation splitter assembly fluidly connected to the ventilator and, said ventilation splitter assembly including: multiplicity of valves, wherein a first valve of the multiplicity of valves is on an air path between the ventilator and a first patient, and wherein a second valve of the multiplicity of valves is on an air path between the ventilator and a second patient, such that each valve of the multiplicity of valves is on an air path between the ventilator and a respective patient; multiplicity of flow sensors each corresponding to the respective valve of the multiplicity of valves; and a controller; outputting air flow at a predetermined rate and/or pressure utilizing the single ventilator to the ventilation splitter assembly; splitting the flow between the multiplicity of patients utilizing the ventilation splitter assembly; determining a first flow, pressure and/or volume to the first patient of the multiplicity of utilizing the first
  • the ventilation splitter assembly may further include multiplicity of pressure sensors
  • the method may further include: providing a signal indicative of the pressure of the first patient's airway utilizing the first pressure sensor of the multiplicity of pressure sensors, providing a signal indicative of the pressure of the second patient's airway utilizing the second pressure sensor of the multiplicity of pressure sensors; providing a signal indicative of the pressure of any additional patient's airway utilizing the corresponding pressure sensor of the multiplicity of pressure sensors; and adjusting any of the multiplicity of valves utilizing the controller.
  • the ventilation splitter assembly may further include multiplicity of one-way valves corresponding to the multiplicity of patients, each positioned in the inspiratory path to the respective patient and configured to prevent backflow from the patient towards the ventilator and other air paths and their respective patients.
  • the ventilation splitter assembly may further include multiplicity of one-way valves corresponding to the multiplicity of patients, positioned in the expiratory path from the patients and configured to prevent cross contamination between patients.
  • the ventilation splitter assembly may further include multiplicity of flow sensors positioned in the expiratory path between the multiplicity of patients and the multiplicity of corresponding one-way valves or between the multiplicity of one-way valves and the ventilator and wherein the method may further includes obtaining signals provided from said multiplicity of expiratory path flow sensors.
  • the ventilation splitter assembly may further include multiplicity of relief valves corresponding to the multiplicity of patients, positioned in the inspiratory path to each patient and configured to release hyper-pressure if created in a patient's airway, and wherein the method may further include operating the multiplicity of relief valves utilizing the controller.
  • the method may further include controlling one or more ventilator operation parameters of the single ventilator.
  • the method may further include activating an alarm upon detecting/calculating volume and/or pressure values being below or above predetermined values.
  • the method may further include activating an alarm upon detection of patient disconnection.
  • the alarm may be indicated by the controller by audible and/or visual means for example, but not limited to by the user interface, speaker, large LED light etc.
  • the ventilation splitter assembly system since to the ventilation splitter assembly system can obtain/calculate the flow/volume/pressure for each ventilated patient, it may also detect other parameters, such as but not limited to, occluded airways, leak in the circuit and other calculated parameters (such as parameters typically obtained/calculated by the ventilator itself and may now be obtained/calculated by the ventilation splitter assembly system, in accordance with some embodiments).
  • Certain embodiments of the present disclosure may include some, all, or none of the above advantages.
  • One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein.
  • specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages.
  • FIG. la schematically illustrates a typical pneumatic ventilation system
  • FIG. lb schematically illustrates a typical ventilation system utilizing a blower
  • FIG. 2 schematically illustrates a device/system for ventilating multiple patients utilizing a single ventilation machine, according to some embodiments.
  • FIG. la schematically illustrates a typical pneumatic ventilation system 10, configured to push air, with the option for increased levels of oxygen, into a single patient's lungs.
  • ventilation systems such as ventilation system 10
  • high- pressure oxygen and high-pressure air are provided to a mixer 12 via respective oxygen valve 14 and air valve 16.
  • the mixture of air and oxygen then pushed via a one-way valve 18 to the airway of a single patient 20, at a predetermined flow rate or a variable flow rate when targeting a pressure and in some cases for a predetermined period of time, detected by a flow sensor 22 located at the inspiratory path (between mixer 12 and one-way valve 18).
  • a pressure sensor 24 is positioned between one-way valve 18 and patient 20 and is configured to provide indication of the airway pressure delivered to the patient 20.
  • the exhaled air from patient 20 flows out the environment through one way exhalation valve 26.
  • the exhaled flow is detected by a flow sensor 28 located at the expiratory path (between patient 20 and exhalation valve 26).
  • FIG. lb schematically illustrates a typical ventilation system 10' utilizing a blower 13.
  • a blower such as blower 13
  • ambient air is provided into a mixer 12 ' together with high-pressure oxygen via oxygen valve 14 ' .
  • a valve 15 can be positioned between blower 13 and the flow sensor 22 ' .
  • the mixture of air and oxygen flows via a one-way valve 18 ' to the airway of a single patient 20 ' , at a predetermined flow rate or a variable flow rate when targeting a pressure and in some cases for a predetermined period of time, detected by flow sensor 22 ' .
  • a pressure sensor 24 ' is positioned between one way valve 18 ' and patient 20 ' and is configured to provide indication of the airway pressure delivered to the patient 20 ' .
  • the exhaled air from patient 20 ' flows out the environment through one way exhalation valve 26 ' .
  • the exhaled flow is detected by a flow sensor 28 ' located at the expiratory path (between patient 20 ' and exhalation valve 26 ' ).
  • Ventilation systems such as ventilation systems 10 and 10 ' cannot be used for ventilating more than a single patient, at least for the reasons disclosed herein above.
  • ventilation splitter assembly which advantageously enables ventilation of multiplicity of patients using the same ventilator (such as, but not limited to, a pneumatic ventilator or a blower- based ventilator) yet ensuring that some of the key ventilation parameters are maintained independently for each ventilated patient depending on his/her condition and needs.
  • FIG. 2 schematically illustrates a multiple-patient ventilating system 100 for ventilating multiple patients utilizing a single ventilator 110, according to some embodiments.
  • System 100 includes ventilator 110, which may be a common ventilator currently on the market.
  • System 100 further includes a CPU 200, which is configured to control the air/0 2 flow provided to the patient independently.
  • the air flow control to the patients is facilitated using multiple valves, such as valves 101, 102, 103...
  • Each of these valves is configured to adjust the flow to a single patient, namely, patient 1, patient 2, patient 3... respectively.
  • These valves appear herein as one per patient but, according to some embodiments, the valves may also be connected in various other combinations, such as a valve that splits the flow between its outputs.
  • the flow of air/0 2 to the valves is supplied by external ventilator 110.
  • the external flow might also be supplied by other devices that are configured to supply the flow and pressure required.
  • the number of inputs from which flow and pressure can be supplied (110) to the system 100 and outputs from which flow and pressure can be supplied to the patients (patient 1,2%) may vary.
  • each of the valves controls the flow to each patient independently and is controlled by CPU 200.
  • the flow from each valve passes through corresponding flow sensors (such as flow sensors 301, 302, 303..., n-1), which is read by CPU 200 to enable correct control of the flow.
  • CPU 200 may also receive signals from corresponding optional outlet pressure sensors (such as outlet pressure sensors 901, 902, 903..., respectively) which are configured to measure the respective patient's pressure, enabling CPU 200 to adjust valves 101, 102, 103...
  • the flow sensors may be in various locations on the air path, for example before or after the valves or in other locations on the air path.
  • one-way valves (such as one-way valves 401, 402, 403..., respectively) may be added to ensure that air does not flow back from the patients into the system and to ensure that there is no cross contamination between patients.
  • one-way valves may be added to ensure that the pressure does not equalize between patients' lungs and to ensure no cross contamination.
  • the location of the optional one-way valves 401, 402, 403...and 801, 802, 803... may change.
  • one way valves 401, 402, 403...and 801, 802, 803... may be added or removed.
  • additional flow sensors such as flow sensors 851, 852, 853ituated may be placed between each patient and one way valves 801, 802, 803..., respectively, or additionally/alternatively between one-way valves 801, 802, 803...and ventilator 110. These flow sensors enable measurement of exhaled gas flow from each respective patient to which they are connected. Such measurements also enable detection of leaks and/or more measurements per patient.
  • multiple-patient ventilating system 100 may optionally include corresponding optional relief valves (such as outlet relief valves 701, 702, 703..., respectively), which are configured to be controlled by CPU 200 enable immediate release of pressure from the patients' lungs in cases such as occlusion.
  • optional relief valves such as outlet relief valves 701, 702, 703..., respectively
  • the software may evaluate the condition of the patient, alarm on patient disconnection, occlusion and other such conditions.
  • a user interface (Ul) 500 may optionally be added to enable setting the required parameters, alarms and other required functions, for example, flow and pressure, volume and pressure limits, for each patient, individually.
  • the Ul 500 may optionally display measurements, alarms or other data, for example low/high volume alarm, low/high pressure alarm, for each patient individually.
  • An optional communication interfaces 600 will allow the above to be controlled from ventilator 110 or from a PC or any other type of remote unit, such as remote unit 120. It is noted that the term "user interface" as disclosed herein may include a display, touchscreen, keys, LED indicators, buzzer, speaker or any other type of user interface means or combination of means.
  • multiple-patient ventilating system 100 may also be configured to control and/or read other devices connected to it through the communication interfaces 600, such as command ventilator 110 to change the provided flow and/or pressure and/or volume (or other devices as required).
  • the communication interface may be serial, USB, LAN, WiFi or any other required means or a combination of these.
  • ventilator and “ventilation machine” may be used interchangeably.
  • controller and “CPU” may be used interchangeably.
  • unit and “assembly” may be used interchangeably.
  • the single ventilation machine available is configured to provide a volume of 600 mL (milliliters).
  • the ventilation splitter assembly provided herein, according to some embodiments, can be set to direct the flows so that 400 mL (utilizing a first valve) is provided to the adult patient and 200 mL (utilizing a second valve) to the child.
  • the single ventilation machine available is configured to provide a Volume of 800 mL.
  • the ventilation splitter assembly provided herein can direct the flows so that 400 mL (utilizing a first valve) is provided to the first patient and 400 mL (utilizing a second valve) is provided to the second patient. At some point, the lung infection of the first patient deteriorates causing an increased resistance of the first patient's lungs.
  • the flow splitter will still provide 400 mL to each patient as it controls the valve by measuring the actual delivered flow in a closed loop method and therefore is unaffected by the change in lung resistance or compliance of any patient connected thus preventing hyperventilation of the second patient and hypoventilation of the first patient.
  • multiple may refer to two or more, such as 2, 3, 4, 5 or more.

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Abstract

There is provided herein a ventilation splitter assembly, a system and a method of use thereof for ventilation of multiplicity of patients using a single ventilator. The ventilation splitter assembly includes: multiplicity of valves, wherein a first valve of the multiplicity of valves is positioned between the ventilator and a first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves is positioned between the ventilator and a second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient, such that a flow, pressure and/or volume are determined for each patient of the multiplicity of patients, independently, utilizing respective valves of the multiplicity of valves; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow passes through the first valve and wherein a second flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow passes through the second valve such that a signal indicative to a flow that passes through each respective valve of the multiplicity of valves is provided; and a controller configured to control the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, therefore to mitigate/prevent a risk of hyperventilation/hypoventilation one or more of the patients.

Description

VENTILATION SPUTTER DEVICE AND SYSTEM AND METHOD FOR VENTILATION
TECHNOLOGICAL FIELD
The present disclosure relates to the field of medical ventilators, in particular ventilation of multiplicity of patients utilizing a single ventilator.
BACKGROUND
When a disease caused the lungs to fail or operate ineffectively such that the body's oxygen levels to drop, a ventilator is used to takes over or assist the body's breathing process. During ventilation, the patient is given time to fight off the infection and recover.
Ventilators are designed to push air, with the option for increased levels of oxygen, into the lungs. Positive-pressure ventilators operate by increasing the patient's airway pressure, typically, through an endotracheal or tracheostomy tube or a mask. The positive pressure allows air to flow, at a predetermined flow rate and for a predetermined period of time, into the airway. Then, the airway pressure drops and the air is passively exhaled from the lungs.
In times of medical emergencies or scarce funding, lack in ventilators, such as in case of COVID-19 pandemic, may cause loss of lives.
Attempts to utilize a single ventilator for multiple patient, for example by using a T- connector to split the delivered flow from the ventilator have been made. However, certain problems were encountered. The airway resistance and compliances differ between patients and even vary in the same patient as the disease deteriorates or improves. As a result, the patient having, at a certain point, a higher compliance may receive a volume of air which is too large and may cause lung injury. On the other hand, the patient with lower compliance may receive a volume of air which is too low.
Moreover, modern ventilators enable measuring various ventilation parameters of the patient connected thereto, such as the volume of air provided, airway pressure, airway resistance, lung compliance etc. However, if multiplicity of patients are connected to a single ventilator, a ventilation parameter, for example, the delivered volume measured by the ventilator, will be for the two patients together and there is no way to know what volume is delivered to either patient. A problem related to such measurement can be understood by the following example: in case of single patient ventilation, when the compliance of the lungs decreases (e.g., due to deterioration of their disease) the ventilator will detect abnormally high pressure and an alarm will be issued and/or the ventilator will automatically limit the delivered volume. In case of multi-patient ventilation, however, if the compliance of one of the patients decreases the airflow will be re-directed to the other patient with the higher compliance without any alarm being triggered and the physician will not know that both patients are getting inadequate ventilation.
In a statement released by The Society of Critical Care Medicine (SCCM), American Association for Respiratory Care (AARC), American Society of Anesthesiologists (ASA), Anesthesia Patient Safety Foundation (ASPF), American Association of Critical-Care Nurses (AACN), and American College of Chest Physicians (CHEST), the aforementioned organizations state that sharing of a single ventilator with multiple patients cannot be done safely with existing equipment. Some of their reasoning is as follows:
1. Volumes would go to the most compliant lung segments.
2. Alarm monitoring and management would not be feasible.
3. In the case of a cardiac arrest, ventilation to all patients would need to be stopped to allow the change to bag ventilation without aerosolizing the virus and exposing healthcare workers. This circumstance also would alter breath delivery dynamics to the other patients.
4. Additional external monitoring would be required. The ventilator monitors the average pressures and volumes.
5. Even if all patients connected to a single ventilator have the same clinical features at initiation, they could deteriorate and recover at different rates, and distribution of gas to each patient would be unequal and unmonitored. The sickest patient would get the smallest tidal volume and the improving patient would get the largest tidal volume. 6. The greatest risks occur with sudden deterioration of a single patient (e.g., pneumothorax, kinked endotracheal tube), with the balance of ventilation distributed to the other patients.
There is therefore an urgent need for solutions that enable utilizing a single ventilation machine for more than one patient, while ensuring independent ventilation of each patient and maintaining the appropriate ventilation parameters of each patient.
SUMMARY
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, devices and methods which are meant to be exemplary and illustrative, not limiting in scope.
The present disclosure provides, in accordance with some embodiments, a device, system and method, which advantageously enables ventilation of multiplicity of patients using the same ventilator, yet ensuring that some of the key ventilation parameters are maintained independently for each ventilated patient depending on his/her condition, e.g., lung capacity, resistance, and compliance, changes in their condition, which may occur during the ventilation period. According to some embodiments, among the key ventilation parameters that are controlled independently for each ventilation patient are independent ventilation volume, independent monitoring and independent alarming for each of the patients. It is noted, however that some of the ventilation parameters, such as the timing of the breaths, inspiratory time (Ti) and positive end-expiratory pressure (PEEP), are the same for all ventilated patients.
Advantageously, in accordance with some embodiments, the ventilation splitter unit is constructed such that one patient's condition does not affect other patients, thus the risk of hypoventilation/hyperventilation is mitigated or even prevented. This may be of utmost importance in situations of shortage of ventilators such as in case of pandemics, as experienced during the resent COVID-19 pandemic. Advantageously, in accordance with some embodiments, the tubing and valve setup pf the ventilation splitter unit is constructed such that contamination (air enriched with CO2, bacteria, fungi, viral infection etc.) from one of the ventilated patients will not reach the other ventilated patients.
Advantageously, the tubing, valves and sensors configuration of the ventilation splitter unit disclosed herein, which is controlled by a designated CPU, in accordance with some embodiments, allow delivering the correct volumes to each ventilated patient and avoid a situation where volumes go to the patient having the most compliant lungs.
Advantageously, the CPU of the ventilation splitter unit, disclosed herein in accordance with some embodiments, facilitates alarm monitoring of each patient, independently.
Advantageously, the tubing and valves setup of the ventilation splitter unit, which is controlled by the designated CPU as disclosed herein in accordance with some embodiments, further allow stopping ventilation for only one of the ventilated patients (for example, in case of cardiac arrest), without altering breath delivery dynamics to the other ventilated patients.
Advantageously, multi-patient ventilation utilizing a single ventilator and the ventilation splitter unit, as disclosed herein in accordance with some embodiments, can be conducted without additional external monitoring.
According to some embodiments, there is provided herein a ventilation splitter assembly for ventilation of multiplicity of patients using a single ventilator, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is positioned between the ventilator and the first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves is positioned between the ventilator and the second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient, and each additional valves of the multiplicity of valves is positioned between the ventilator and the patient and determines the flow, pressure and/or volume to an additional patient; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the first valve and wherein a second flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the second valve and any additional flow sensor of the multiplicity of flow sensors for each valve of the multiplicity of valves is configured to provide a signal indicative of the flow that passes through the corresponding valve; and a controller configured to control the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, by controlling the flow, pressure and/or volume output from each of said multiplicity of valves, independently, wherein said controller is further configured to obtain the signals provided from said multiplicity of flow sensors and to adjust at least one of the multiplicity of valves, such as to change the ratio between the multiplicity of valves and therefore to mitigate/prevent a risk of hyperventilation/hypoventilation one or more of the patients.
According to some embodiments, there is provided herein a system for ventilation of multiplicity of patients using a single ventilator, the system comprising: a single ventilator configured to output flow at a predetermined rate and/or pressure; and a ventilation splitter assembly configured to split the flow between the multiplicity of patients, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is on an air path between the ventilator and a first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves is on an air path between the ventilator and a second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient and each additional valve of the multiplicity of valves is on an air path between the ventilator and the corresponding patient, said additional valve is configured to determine a the flow, pressure and/or volume to the corresponding patient; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the first valve and wherein a second flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the second valve and wherein additional flow sensors of the multiplicity of flow sensors are configured to provide a signal indicative of the flow that passes through the corresponding valve; and a controller configured to control the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, by controlling the flow, pressure and/or volume output from each of said multiplicity of valves, independently, wherein said controller is further configured to obtain the signals provided from said multiplicity of flow sensors and to adjust at least one of the multiplicity of valves, such as to change the ratio between the multiplicity of valves and therefore to mitigate/prevent a risk of hyperventilation/hypoventilation one or more of the patients.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of pressure sensors, wherein a first pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the first patient's airway and wherein a second pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the second patient's airway and wherein any additional pressure sensors of the multiplicity of pressure sensors are configured to provide a signal indicative of the pressure of the corresponding patient's airway, and wherein the controller is further configured to utilize the pressure measured by the pressure sensors to adjust any of the multiplicity of valves.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of one-way valves, wherein a first one-way valve of the multiplicity of one-way valves is positioned in the inspiratory path to the first patient and is configured to prevent backflow from the first patient towards the ventilator and other air paths of other patients, and wherein a second one-way valve of the multiplicity of one-way valves is positioned in the inspiratory path to the second patient and is configured to prevent backflow from the second patient towards the ventilator and other air paths of other patients, wherein any additional one-way valve of the multiplicity of one-way valves corresponding to a respective patient of the multiplicity of patients, is positioned in the inspiratory path of the respective patient and configured to prevent backflow from the respective patient towards the ventilator and other air paths and their respective patients.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of one-way valves, wherein a first one-way valve of the multiplicity of one-way valves is positioned in the expiratory air path of the first patient and configured to prevent cross contamination between patients and wherein a second one-way valve of the multiplicity of one way valves is positioned in the expiratory air path of the second patient and configured to prevent cross contamination between patients, wherein any additional one-way valve of the multiplicity of one-way valves corresponding to the respective patient of the multiplicity of patients, is positioned in the expiratory air path of the respective patient and configured to prevent cross contamination between patients.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of relief valves, wherein a first relief valve corresponding to the first patient of the multiplicity of patients, positioned in the inspiratory air path of the first patient and configured to release hyper-pressure if created in the first patient's airway, and wherein a second relief valve corresponding to the second patient of the multiplicity of patients, positioned in the inspiratory air path of the second patient and configured to release hyper-pressure if created in the second patient's airway, and wherein any additional relief valve of the multiplicity of relief valves corresponding to a respective patient of the multiplicity of patients, positioned in the inspiratory air path of the respective patient and configured to release hyper-pressure if created in the respective patient's airway, and wherein the controller is further configured to independently operate each relief valve of the multiplicity of relief valves.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of flow sensors, wherein a first flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the first patient and the first one-way valve or between the first one-way valve and the ventilator, and wherein a second flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the second patient and the second one-way valve or between the second one-way valve and the ventilator, and wherein any additional flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the respective patient and the corresponding respective one-way valve or between the corresponding respective one-way valve and the ventilator, and wherein the controller is further configured to obtain signals provided from each of said expiratory path flow sensors.
According to some embodiments, the ventilation splitter assembly may further include a user interface (Ul).
According to some embodiments, the ventilation splitter assembly may further include a communication interfaces configured to control one or more ventilator operation parameters, or to allow control over one or more parameters in the system.
According to some embodiments, the CPU of the ventilation splitter assembly may further be configured to activate an alarm upon detecting/calculating volume and/or pressure values being below or above predetermined values.
According to some embodiments, the CPU ventilation splitter assembly may further be configured to activate an alarm upon detection of patient disconnection.
According to some embodiments, there is provided herein a method for ventilation of multiplicity of patients using a single ventilator and a ventilation splitter assembly, the method includes: providing a system including a single ventilator and a ventilation splitter assembly fluidly connected to the ventilator and, said ventilation splitter assembly including: multiplicity of valves, wherein a first valve of the multiplicity of valves is on an air path between the ventilator and a first patient, and wherein a second valve of the multiplicity of valves is on an air path between the ventilator and a second patient, such that each valve of the multiplicity of valves is on an air path between the ventilator and a respective patient; multiplicity of flow sensors each corresponding to the respective valve of the multiplicity of valves; and a controller; outputting air flow at a predetermined rate and/or pressure utilizing the single ventilator to the ventilation splitter assembly; splitting the flow between the multiplicity of patients utilizing the ventilation splitter assembly; determining a first flow, pressure and/or volume to the first patient of the multiplicity of utilizing the first valve of the multiplicity of valves; determining a second flow, pressure and/or volume to the second patient of the multiplicity of patients utilizing the second valve of the multiplicity of valves, such that a flow, pressure and/or volume is determined for each patient of the multiplicity of patients, independently, utilizing respective valve of the multiplicity of valves; providing a signal indicative of the flow that passes through the first valve, utilizing the first flow sensor of the multiplicity of flow sensors; providing a signal indicative of the flow that passes through the second valve, utilizing the second flow sensor of the multiplicity of flow sensors, such that a signal indicative to a flow that passes through each respective valve of the multiplicity of valves is provided; and utilizing the controller: controlling the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, by controlling the flow, pressure and/or volume output from each of the multiplicity of valves, independently; and obtaining the signals provided from the multiplicity of flow sensors and adjusting at least one of the multiplicity of valves, such as to change the ratio between the multiplicity of valves and thereby to mitigating/preventing a risk of hyperventilation/hypoventilation one or more of the patients.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of pressure sensors, and the method may further include: providing a signal indicative of the pressure of the first patient's airway utilizing the first pressure sensor of the multiplicity of pressure sensors, providing a signal indicative of the pressure of the second patient's airway utilizing the second pressure sensor of the multiplicity of pressure sensors; providing a signal indicative of the pressure of any additional patient's airway utilizing the corresponding pressure sensor of the multiplicity of pressure sensors; and adjusting any of the multiplicity of valves utilizing the controller.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of one-way valves corresponding to the multiplicity of patients, each positioned in the inspiratory path to the respective patient and configured to prevent backflow from the patient towards the ventilator and other air paths and their respective patients.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of one-way valves corresponding to the multiplicity of patients, positioned in the expiratory path from the patients and configured to prevent cross contamination between patients.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of flow sensors positioned in the expiratory path between the multiplicity of patients and the multiplicity of corresponding one-way valves or between the multiplicity of one-way valves and the ventilator and wherein the method may further includes obtaining signals provided from said multiplicity of expiratory path flow sensors.
According to some embodiments, the ventilation splitter assembly may further include multiplicity of relief valves corresponding to the multiplicity of patients, positioned in the inspiratory path to each patient and configured to release hyper-pressure if created in a patient's airway, and wherein the method may further include operating the multiplicity of relief valves utilizing the controller.
According to some embodiments, the method may further include controlling one or more ventilator operation parameters of the single ventilator.
According to some embodiments, the method may further include activating an alarm upon detecting/calculating volume and/or pressure values being below or above predetermined values.
According to some embodiments, the method may further include activating an alarm upon detection of patient disconnection.
According to some embodiments, the alarm may be indicated by the controller by audible and/or visual means for example, but not limited to by the user interface, speaker, large LED light etc. According to some embodiments, since to the ventilation splitter assembly system can obtain/calculate the flow/volume/pressure for each ventilated patient, it may also detect other parameters, such as but not limited to, occluded airways, leak in the circuit and other calculated parameters (such as parameters typically obtained/calculated by the ventilator itself and may now be obtained/calculated by the ventilation splitter assembly system, in accordance with some embodiments).
Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages.
BRIEF DESCRIPTION OF THE FIGURES
Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the disclosure may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show details of an embodiment in more detail than is necessary for a fundamental understanding of the teachings of the disclosure.
FIG. la schematically illustrates a typical pneumatic ventilation system;
FIG. lb schematically illustrates a typical ventilation system utilizing a blower; and
FIG. 2 schematically illustrates a device/system for ventilating multiple patients utilizing a single ventilation machine, according to some embodiments.
While certain embodiments of the invention have been illustrated and described, it will be clear that the invention is not limited to the embodiments described herein. Numerous modifications, changes, variations, substitutions and equivalents will be apparent to those skilled in the art without departing from the spirit and scope of the present invention as described by the claims, which follow.
DETAILED DESCRIPTION
In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.
Reference is now made to FIG. la, which schematically illustrates a typical pneumatic ventilation system 10, configured to push air, with the option for increased levels of oxygen, into a single patient's lungs. In currently used ventilation systems such as ventilation system 10, high- pressure oxygen and high-pressure air are provided to a mixer 12 via respective oxygen valve 14 and air valve 16. The mixture of air and oxygen then pushed via a one-way valve 18 to the airway of a single patient 20, at a predetermined flow rate or a variable flow rate when targeting a pressure and in some cases for a predetermined period of time, detected by a flow sensor 22 located at the inspiratory path (between mixer 12 and one-way valve 18). A pressure sensor 24 is positioned between one-way valve 18 and patient 20 and is configured to provide indication of the airway pressure delivered to the patient 20. The exhaled air from patient 20 flows out the environment through one way exhalation valve 26. The exhaled flow is detected by a flow sensor 28 located at the expiratory path (between patient 20 and exhalation valve 26).
Reference is now made to FIG. lb, which schematically illustrates a typical ventilation system 10' utilizing a blower 13. When a blower, such as blower 13 is used, ambient air is provided into a mixer 12' together with high-pressure oxygen via oxygen valve 14'. Optionally, a valve 15 can be positioned between blower 13 and the flow sensor 22'. The mixture of air and oxygen flows via a one-way valve 18' to the airway of a single patient 20', at a predetermined flow rate or a variable flow rate when targeting a pressure and in some cases for a predetermined period of time, detected by flow sensor 22'. A pressure sensor 24' is positioned between one way valve 18' and patient 20' and is configured to provide indication of the airway pressure delivered to the patient 20'. The exhaled air from patient 20' flows out the environment through one way exhalation valve 26'. The exhaled flow is detected by a flow sensor 28' located at the expiratory path (between patient 20' and exhalation valve 26').
Ventilation systems, such as ventilation systems 10 and 10' cannot be used for ventilating more than a single patient, at least for the reasons disclosed herein above. There is thus provided herein ventilation splitter assembly, which advantageously enables ventilation of multiplicity of patients using the same ventilator (such as, but not limited to, a pneumatic ventilator or a blower- based ventilator) yet ensuring that some of the key ventilation parameters are maintained independently for each ventilated patient depending on his/her condition and needs.
Reference is now made to FIG. 2, which schematically illustrates a multiple-patient ventilating system 100 for ventilating multiple patients utilizing a single ventilator 110, according to some embodiments.
System 100 includes ventilator 110, which may be a common ventilator currently on the market. System 100 further includes a CPU 200, which is configured to control the air/02 flow provided to the patient independently. The air flow control to the patients is facilitated using multiple valves, such as valves 101, 102, 103... Each of these valves is configured to adjust the flow to a single patient, namely, patient 1, patient 2, patient 3... respectively. These valves appear herein as one per patient but, according to some embodiments, the valves may also be connected in various other combinations, such as a valve that splits the flow between its outputs.
The flow of air/02 to the valves (such as such as valves 101, 102, 103...) is supplied by external ventilator 110. It is noted that, according to additional or alternative embodiments, the external flow might also be supplied by other devices that are configured to supply the flow and pressure required. According to some embodiments, the number of inputs from which flow and pressure can be supplied (110) to the system 100 and outputs from which flow and pressure can be supplied to the patients (patient 1,2...) may vary.
Based on the settings entered into the CPU 200, which include the required volume and/or pressure as well as volume and/or pressure alarm limits for each patient (and additional possible settings and functions), each of the valves (such as valves 101, 102, 103...n) controls the flow to each patient independently and is controlled by CPU 200. The flow from each valve passes through corresponding flow sensors (such as flow sensors 301, 302, 303..., n-1), which is read by CPU 200 to enable correct control of the flow. CPU 200 may also receive signals from corresponding optional outlet pressure sensors (such as outlet pressure sensors 901, 902, 903..., respectively) which are configured to measure the respective patient's pressure, enabling CPU 200 to adjust valves 101, 102, 103... for immediate correction of the flow and/or pressure, alarm on high or low pressure, patient disconnection and other situations that can be detected by flow and pressure analysis. This can enable not only detecting the hazardous situation of disconnection but also enable disconnecting a patient on purpose without affecting the other patients. According to some embodiments, the flow sensors may be in various locations on the air path, for example before or after the valves or in other locations on the air path.
Optionally, one-way valves (such as one-way valves 401, 402, 403..., respectively) may be added to ensure that air does not flow back from the patients into the system and to ensure that there is no cross contamination between patients.
Optionally, one-way valves (such as one-way valves 801, 802, 803..., respectively) may be added to ensure that the pressure does not equalize between patients' lungs and to ensure no cross contamination. According to some embodiments, the location of the optional one-way valves 401, 402, 403...and 801, 802, 803... may change. According to some embodiments, one way valves 401, 402, 403...and 801, 802, 803... may be added or removed. Optionally, additional flow sensors (such as flow sensors 851, 852, 853...) may be placed between each patient and one way valves 801, 802, 803..., respectively, or additionally/alternatively between one-way valves 801, 802, 803...and ventilator 110. These flow sensors enable measurement of exhaled gas flow from each respective patient to which they are connected. Such measurements also enable detection of leaks and/or more measurements per patient.
According to some embodiments, multiple-patient ventilating system 100 may optionally include corresponding optional relief valves (such as outlet relief valves 701, 702, 703..., respectively), which are configured to be controlled by CPU 200 enable immediate release of pressure from the patients' lungs in cases such as occlusion.
According to some embodiments, the software may evaluate the condition of the patient, alarm on patient disconnection, occlusion and other such conditions.
A user interface (Ul) 500 may optionally be added to enable setting the required parameters, alarms and other required functions, for example, flow and pressure, volume and pressure limits, for each patient, individually. The Ul 500 may optionally display measurements, alarms or other data, for example low/high volume alarm, low/high pressure alarm, for each patient individually. An optional communication interfaces 600 will allow the above to be controlled from ventilator 110 or from a PC or any other type of remote unit, such as remote unit 120. It is noted that the term "user interface" as disclosed herein may include a display, touchscreen, keys, LED indicators, buzzer, speaker or any other type of user interface means or combination of means.
According to some embodiments, multiple-patient ventilating system 100 may also be configured to control and/or read other devices connected to it through the communication interfaces 600, such as command ventilator 110 to change the provided flow and/or pressure and/or volume (or other devices as required).
According to some embodiments, the communication interface may be serial, USB, LAN, WiFi or any other required means or a combination of these.
The terms "ventilator" and "ventilation machine" may be used interchangeably.
The terms "controller" and "CPU" may be used interchangeably. The terms "unit" and "assembly" may be used interchangeably.
Examples:
Example 1:
Two patients, an adult and a child, are in a need of ventilation. The single ventilation machine available is configured to provide a volume of 600 mL (milliliters). The ventilation splitter assembly provided herein, according to some embodiments, can be set to direct the flows so that 400 mL (utilizing a first valve) is provided to the adult patient and 200 mL (utilizing a second valve) to the child.
Example 2:
Two adult patients suffering from a severe lung infection (e.g., caused by COVID-19) are in a need of ventilation. The single ventilation machine available is configured to provide a Volume of 800 mL. The ventilation splitter assembly provided herein, according to some embodiments, can direct the flows so that 400 mL (utilizing a first valve) is provided to the first patient and 400 mL (utilizing a second valve) is provided to the second patient. At some point, the lung infection of the first patient deteriorates causing an increased resistance of the first patient's lungs. The flow splitter will still provide 400 mL to each patient as it controls the valve by measuring the actual delivered flow in a closed loop method and therefore is unaffected by the change in lung resistance or compliance of any patient connected thus preventing hyperventilation of the second patient and hypoventilation of the first patient.
The term "multiplicity" as used herein may refer to two or more, such as 2, 3, 4, 5 or more.

Claims

CLAIMS What we claim is:
1. A ventilation splitter assembly for ventilation of multiplicity of patients using a single ventilator, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is positioned between the ventilator and a first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves is positioned between the ventilator and a second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient such that a flow, pressure and/or volume is determined for each patient of the multiplicity of patients, independently, utilizing a respective valve of the multiplicity of valves; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow passes through the first valve and wherein a second flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow passes through the second valve, such that a signal indicative to a flow that passes through each respective valve of the multiplicity of valves is provided; and a controller configured to control the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, by controlling the flow, pressure and/or volume output from each of said multiplicity of valves, independently, wherein said controller is further configured to obtain the signals provided from said multiplicity of flow sensors and to adjust at least one of the multiplicity of valves, such as to change the ratio between the multiplicity of valves and therefore to mitigate/prevent a risk of hyperventilation/hypoventilation one or more of the patients.
2. The ventilation splitter assembly of claim 1, further comprising multiplicity of pressure sensors, wherein a first pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the first patient's airway and wherein a second pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the second patient's airway, such that each pressure sensor of the multiplicity of pressure sensors is configured to provide a signal indicative of the pressure of the corresponding patient's airway and wherein the controller is further configured to adjust any of the multiplicity of valves.
3. The ventilation splitter assembly of any one of claims 1-2, further comprising multiplicity of one-way valves, wherein a first one-way valve of the multiplicity of one-way valves is positioned in the inspiratory path to the first patient and is configured to prevent backflow from the first patient towards the ventilator and other air paths of other patients, and wherein a second one-way valve of the multiplicity of one-way valves is positioned in the inspiratory path to the second patient and is configured to prevent backflow from the second patient towards the ventilator and other air paths of other patients, wherein any additional one-way valve of the multiplicity of one-way valves corresponding to a respective patient of the multiplicity of patients, is positioned in the inspiratory path of the respective patient and configured to prevent backflow from the respective patient towards the ventilator and other air paths and their respective patients.
4. The ventilation splitter assembly of any one of claims 1-3, further comprising multiplicity of one-way valves, wherein a first one-way valve of the multiplicity of one-way valves is positioned in the expiratory air path of the first patient and configured to prevent cross contamination between patients and wherein a second one-way valve of the multiplicity of one-way valves is positioned in the expiratory air path of the second patient and configured to prevent cross contamination between patients, wherein any additional one-way valve of the multiplicity of one-way valves corresponding to the respective patient of the multiplicity of patients, is positioned in the expiratory air path of the respective patient and configured to prevent cross contamination between patients.
5. The ventilation splitter assembly of any one of claims 1-4, further comprising multiplicity of flow sensors, wherein a first flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the first patient and the first one-way valve or between the first one-way valve and the ventilator, and wherein a second flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the second patient and the second one-way valve or between the second one-way valve and the ventilator, and wherein any additional flow sensor of the multiplicity of flow sensors is positioned in the expiratory path between the respective patient and the corresponding respective one-way valve or between the corresponding respective one-way valve and the ventilator, and wherein the controller is further configured to obtain signals provided from each of said expiratory path flow sensors.
6. The ventilation splitter assembly of any one of claims 1-5, further comprising multiplicity of relief valves, wherein a first relief valve corresponding to the first patient of the multiplicity of patients, positioned in the inspiratory air path of the first patient and configured to release hyper-pressure if created in the first patient's airway, and wherein a second relief valve corresponding to the second patient of the multiplicity of patients, positioned in the inspiratory air path of the second patient and configured to release hyper-pressure if created in the second patient's airway, and wherein any additional relief valve of the multiplicity of relief valves corresponding to a respective patient of the multiplicity of patients, positioned in the inspiratory air path of the respective patient and configured to release hyper-pressure if created in the respective patient's airway, and wherein the controller is further configured to independently operate each relief valve of the multiplicity of relief valves.
7. The ventilation splitter assembly of any one of claims 1-6, further comprising a user interface (Ul).
8. The ventilation splitter assembly of any one of claims 1-7, further comprising a communication interfaces configured to control one or more ventilator operation parameters, or to allow control over one or more parameters in the system.
9. The ventilation splitter assembly of any one of claims 1-8, wherein the controller is further configured to activate an alarm upon detecting/calculating volume and/or pressure values being below or above predetermined values.
10. The ventilation splitter assembly of any one of claims 1-9, wherein the controller is further configured to activate an alarm upon detection of patient disconnection.
11. A system for ventilation of multiplicity of patients using a single ventilator, the system comprising: a single ventilator configured to output flow at a predetermined rate and/or pressure; and a ventilation splitter assembly fluidly connected to the ventilator and configured to split the flow between the multiplicity of patients, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is on an air path between the ventilator and a first patient, said first valve is configured to determine a first flow, pressure and/or volume to the first patient, and wherein a second valve of the multiplicity of valves valve is on an air path between the ventilator and a second patient, said second valve is configured to determine a second flow, pressure and/or volume to the second patient, such that a flow, pressure and/or volume is determined for each patient of the multiplicity of patients, independently, utilizing a respective valve of the multiplicity of valves; multiplicity of flow sensors corresponding to the multiplicity of valves, wherein a first flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the first valve and wherein a second flow sensor of the multiplicity of flow sensors is configured to provide a signal indicative of the flow that passes through the second valve, such that a signal indicative to a flow that passes through each respective valve of the multiplicity of valves is provided; and a controller configured to control the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, by controlling the flow, pressure and/or volume output from each of said multiplicity of valves, independently, wherein said controller is further configured to obtain the signals provided from said multiplicity of flow sensors and to adjust at least one of the multiplicity of valves, such as to change the ratio between the multiplicity of valves and therefore to mitigate/prevent a risk of hyperventilation/hypoventilation one or more of the patients.
12. A method for ventilation of multiplicity of patients using a single ventilator and a ventilation splitter assembly, the method comprising: providing a system comprising: a single ventilator; and a ventilation splitter assembly fluidly connected to the ventilator and, said ventilation splitter assembly comprises: multiplicity of valves, wherein a first valve of the multiplicity of valves is on an air path between the ventilator and a first patient, and wherein a second valve of the multiplicity of valves is on an air path between the ventilator and a second patient, such that each valve of the multiplicity of valves is on an air path between the ventilator and a respective patient; multiplicity of flow sensors each corresponding to the respective valve of the multiplicity of valves; and a controller; outputting air flow at a predetermined rate and/or pressure utilizing the single ventilator to the ventilation splitter assembly; splitting the flow between the multiplicity of patients utilizing the ventilation splitter assembly; determining a first flow, pressure and/or volume to the first patient of the multiplicity of utilizing the first valve of the multiplicity of valves; determining a second flow, pressure and/or volume to the second patient of the multiplicity of patients utilizing the second valve of the multiplicity of valves, such that a flow, pressure and/or volume is determined for each patient of the multiplicity of patients, independently, utilizing respective valve of the multiplicity of valves; providing a signal indicative of the flow that passes through the first valve, utilizing the first flow sensor of the multiplicity of flow sensors; providing a signal indicative of the flow that passes through the second valve, utilizing the second flow sensor of the multiplicity of flow sensors, such that a signal indicative to a flow that passes through each respective valve of the multiplicity of valves is provided; and utilizing the controller: controlling the flow, pressure and/or volume provided to each one of the multiplicity of patients, independently, by controlling the flow, pressure and/or volume output from each of the multiplicity of valves, independently; and obtaining the signals provided from the multiplicity of flow sensors and adjusting at least one of the multiplicity of valves, such as to change the ratio between the multiplicity of valves and thereby to mitigating/preventing a risk of hyperventilation/hypoventilation one or more of the patients.
13. The method of claim 12, wherein the ventilation splitter assembly further comprises multiplicity of pressure sensors, and the method further comprises: providing a signal indicative of the pressure of the first patient's airway utilizing the first pressure sensor of the multiplicity of pressure sensors, providing a signal indicative of the pressure of the second patient's airway utilizing the second pressure sensor of the multiplicity of pressure sensors; providing a signal indicative of the pressure of any additional patient's airway utilizing the corresponding pressure sensor of the multiplicity of pressure sensors; and adjusting any of the multiplicity of valves utilizing the controller.
14. The method of any one of claims 12-13, wherein the ventilation splitter assembly further comprises multiplicity of one-way valves corresponding to the multiplicity of patients, each positioned in the inspiratory path to the respective patient and configured to prevent backflow from the patient towards the ventilator and other air paths and their respective patients.
15. The method of any one of claims 12-14, wherein the ventilation splitter assembly further comprises multiplicity of one-way valves corresponding to the multiplicity of patients, positioned in the expiratory path from the patients and configured to prevent cross contamination between patients.
16. The method of any one of claims 12-15, wherein the ventilation splitter assembly further comprises multiplicity of flow sensors positioned in the expiratory path between the multiplicity of patients and the multiplicity of corresponding one-way valves or between the multiplicity of one-way valves and the ventilator, and wherein the method further comprises obtaining signals provided from said multiplicity of expiratory path flow sensors.
17. The method of any one of claims 12-16, wherein the ventilation splitter assembly further comprises multiplicity of relief valves corresponding to the multiplicity of patients, positioned in the inspiratory path to each patient and configured to release hyper pressure if created in a patient's airway, and wherein the method further comprises operating the multiplicity of relief valves utilizing the controller.
18. The method of any one of claims 12-17, further comprising controlling one or more ventilator operation parameters of the single ventilator.
19. The method of any one of claims 12-18, further comprising activating an alarm upon detecting/calculating volume and/or pressure values being below or above predetermined values.
20. The method of any one of claims 12-19, further comprising activating an alarm upon detection of patient disconnection.
PCT/IL2021/050633 2020-05-27 2021-05-27 Ventilation splitter device and system and method for ventilation WO2021240529A1 (en)

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