WO2019232491A1 - Pressure safety device for bag valve mask - Google Patents

Pressure safety device for bag valve mask Download PDF

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Publication number
WO2019232491A1
WO2019232491A1 PCT/US2019/035075 US2019035075W WO2019232491A1 WO 2019232491 A1 WO2019232491 A1 WO 2019232491A1 US 2019035075 W US2019035075 W US 2019035075W WO 2019232491 A1 WO2019232491 A1 WO 2019232491A1
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WO
WIPO (PCT)
Prior art keywords
flow
bag
mask
valve
reduction valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2019/035075
Other languages
English (en)
French (fr)
Inventor
Iordache F. TIRDEA
Nadia ALAM
Amrita BHOWMICK
Liuyi MENG
Ananya Gupta
Haris SHEKHANI
Prathamesh P. PRABHUDESAI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Safebvm Corp
Original Assignee
Safebvm Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Safebvm Corp filed Critical Safebvm Corp
Priority to KR1020207037790A priority Critical patent/KR102907731B1/ko
Priority to JP2021516860A priority patent/JP7464998B2/ja
Priority to CA3101837A priority patent/CA3101837A1/en
Priority to EP24170308.1A priority patent/EP4420704A3/en
Priority to CN201980050694.0A priority patent/CN112533657B/zh
Priority to EP19810067.9A priority patent/EP3801717B1/en
Priority to AU2019276585A priority patent/AU2019276585C1/en
Publication of WO2019232491A1 publication Critical patent/WO2019232491A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0084—Pumps therefor self-reinflatable by elasticity, e.g. resuscitation squeeze bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; 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. ventilators; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory 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. ventilators; 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. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0078—Breathing bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0866—Passive resistors therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—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. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8281—Mechanical spring operated
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • A62B18/10—Valves

Definitions

  • the present invention relates generally to medical devices and methods. More particularly, the present invention relates to the field of breathing gas delivery using manual resuscitators.
  • Bag valve mask resuscitators have long used to manually ventilate patients who cannot breathe on their own, such as those in cardiac arrest, suffering respiratory distress, under anesthesia, and the like.
  • Conventional BVM’s have a compression bag that is manually compressed by a user to pressurize and deliver a breathing gas to a patient through a breathing mask held over the patient’s mouth and nose.
  • U.S. Pat. No. 5,557,049 discloses a disposable manometer as an accessory to the BVM to indicate pressure of gas being delivered to the patient.
  • U.S. Pat. No. 5,722,394 shows a BVM having a high pressure exhaust valve.
  • U.S. Pat. No. 5,537,998 discloses a spring-loaded piston which sense and exhausts excess air pressure.
  • U.S. Pat. No 4,898,166 discloses a resuscitation bag control apparatus
  • U.S. Pat. No. 6,792,947 discloses a BVM having flow control.
  • U.S. Pat. No. 2015/0096559A1 discloses feedback sensors for a BVM.
  • the present invention is useful in optimizing airflow to patients during manual ventilation with a bag valve mask (BVM ) resuscitator to maintain adequate ventilation and lung perfusion while minimizing air entry into the stomach.
  • BVM bag valve mask
  • the present invention controls inspiratory pressure to the patient by blocking airflow from the compression bag of the BVM when an optimum out flow pressure is exceeded.
  • stiffening of the bag caused by back pressure provides“tactile feedback” to the user as a teaching or reinforcement toll for proper manual ventilation technique.
  • the present invention thus enhances the safety while performing manual ventilation using a BVM resuscitator and can minimize complications in concurrent procedures, such as gastric insufflation, aspiration, aspiration pneumonia, Acute Respiratory Distress Syndrome (ARDS), cardiopulmonary compromise.
  • the present invention can also reduce human errors and variability, improving quality of patient care, and reduce the cost of care delivery to the health system.
  • the invention may be used with any positive pressure air delivery device, impedance threshold accessory device, air filter and/or resuscitation outlet device, such as a mask, endotracheal tube, laryngeal mask airway, oral mask and the like.
  • the invention may also be used for air delivery to any entity other than a patient like a lung simulation system, animal, cadaver, training equipment and the like.
  • the present invention provides a pressure safety device for use with a bag valve mask (BVM).
  • BVM bag valve mask
  • the BVM typically includes a bag assembly having a bag connector for detachably mating to a mask connector on a patient mask.
  • the bag assembly will also typically have at least a compression bag which allows a user to manually compress the compression bag to deliver a volume or bolus of air or other breathing gas to a patient via the mask.
  • the BVM may include various other components typical of conventional manual gas resuscitators.
  • the pressure safety device of the present invention will include a housing and an automatic flow reduction valve.
  • the housing will typically have a bag port, a mask fitting, and an interior with passageways configured to define a flow path from the bag port to the mask fitting.
  • the bag port will usually be configured to detachably connect to the bag connector on the BVM, and the mask fitting will typically be configured to detachably connect to the mask connector on the BVM.
  • the automatic flow reduction valve is located on or along the flow path in the housing and will be configured to impede flow when a pressure or flow rate of a breathing gas through the automatic flow reduction valve or a pressure on a bag connector side of the automatic flow reduction valve exceeds a maximum threshold value.
  • the automatic flow reduction valve may be configured to impede flow when a maximum threshold pressure value comprises a pressure in the range 5 mmHg to 20 mmHg, usually in a range from 9 mmHg to 15 mmHg.
  • the automatic flow reduction valve may be configured to impede flow when a maximum threshold flow value comprises a peak flow rate in the range 30 Z/min to 70 Z/min, typically from 35 H min to 50 Z/min.
  • the automatic flow reduction valves of the present invention will typically have any one of a number of conventional mechanical designs such as umbrella valves, spring-piston valves, and the like.
  • the automatic flow reduction valves of the present invention could incorporate electronic components includes, pressure sensors, flow sensors, microprocessor controllers, powered valves, and the in order to block or inhibit flow through the BVM in accordance with the principles of the present invention described herein.
  • the automatic flow reduction valve may in some instances be configured to fully block flow and/or to partially block flow in other instances by“partially blocked flow,” it is meant that the flow rate will be reduced by at least 50% of an unrestricted value, typically at least 60% of the unrestricted value, often at least 75% of the unrestricted value, and many times at least 90% or more of the unrestricted value.
  • the automatic flow reduction valve maybe adjustable so that it can be set to fully block flow or to partially block flow depending on the desired use.
  • the spring of a spring-piston type valve could have a variable set point or variable loading adjustment to allow the pressure or flow rate set point at which the valve closes to be changed. It will be appreciated that when the automatic flow reduction valve does not fully block flow, there will be a residual flow path remaining for breathing gas to be delivered to the patient at a reduced pressure and/or flow rate.
  • the pressure safety device of the present invention may further comprise a one-way valve placed in or along the flow path from the bag port to the mask fitting, where the one-way valve will be oriented to block or divert an exhalation flow which enters the housing from the BVM mask through the mask fitting.
  • the housing will be configured to have fenestrations or other openings oriented to release the diverted or blocked exhalation flow from the one-way valve to an exterior of the housing. Changes in a flow resistance provided by the fenestration can be used to build or otherwise control pressure inside lung (PEEP).
  • the present invention provides methods for modifying, typically reversibly, a bag valve mask (BVM) which includes a bag assembly and a bag connector as described above.
  • the methods for modifying the BVM according the present invention comprise providing a pressure safety device (PSD) having a bag port in a mask fitting, and connecting the bag port and the mask fitting of the PSD to the bag connector and the mask connector of the BVM, respectively.
  • PSD pressure safety device
  • the PSD will be configured to impede breathing gas flow from the BVM to patient when a pressure or flow rate of the breathing gas entering the bag port of PSD exceeds a maximum threshold value.
  • the present invention provides a bag valve mask (BVM) assembly which includes a manifold, a compression bag attached to deliver a breathing gas to the manifold, and a breathing mask attached to receive the breathing gas from the manifold.
  • BVM bag valve mask
  • an automatic flow reduction valve is located on flow path in the manifold between the compression valve and the breathing mask.
  • the automatic flow reduction valve is configured to impede flow a flow rate or a pressure on the compression bag side of the automatic flow reduction valve exceeds a maximum threshold value.
  • the automatic flow reduction valve may be configured to impede flow when a maximum threshold pressure value comprises a pressure in the range 5 mmHg to 20 mmHg, usually in a range from 9 mmHg to 15 mmHg.
  • the automatic flow reduction valve may be configured to impede flow when a maximum threshold flow value comprises a peak flow rate in the range 30 Z/min to 70 Z/min, typically from 35 Z/min to 50 Z/min.
  • a method for delivering a breathing gas to a patient comprises placing a breathing mask over the patient’s mouth and nose. A compression bag is then compressed to deliver the breathing gas to the breathing mask and to the patient. A flow of breathing gas delivered to the breathing mask is impeded if a pressure or flow rate from the breathing gas bag exceeds maximum value.
  • impeding the flow of the breathing gas to the mask comprises placing an automatic flow reduction valve in a flow path between the
  • the automatic flow reduction valve will be configured to impede the breathing gas flow when a flow rate or pressure from the compression bag exceeds a maximum threshold value.
  • the automatic flow reduction valve may be incorporated directly into the structure of the BVM or, alternatively, may be provided as a separate PSD as described above. Specific characteristics of the automatic flow reduction valve may be generally the same as previously described in the devices and methods of the present set forth above.
  • PSD can be removed from the BVM when treating certain conditions where there is an obstructive or restrictive condition requiring the use of high pressure to deliver adequate volumes during manual ventilation.
  • the PSD it will be possible to have the PSD incorporated as an integrated component in the manifold or other structure of the BVM with an override mechanism to allow high pressure ventilation ungovemed by the PSD component.
  • the PSD of the present invention is configured to be hand-held, light weight, portable, durable, and cost-efficient to meet the criteria for adoption in an Emergency Medical Services (EMS) space.
  • EMS Emergency Medical Services
  • the pressure threshold for the flow blocking valve is relative to the patient’s intrathoracic pressure, resulting in personalization of the threshold to optimize airflow to the lung while preventing gastric insufflation.
  • FIGs. 1 A and 1B illustrate a conventional bag valve mask (BVM) apparatus having a pressure safety device of the present invention incorporated therein.
  • BVM bag valve mask
  • FIG. 2 is an exploded view of a first embodiment of a pressure safety device of the present invention having an umbrella valve as the automatic flow reduction valve.
  • Figs. 3 A and 3B are cross-sectional views of the pressure safety device of Fig. 2 with the umbrella valve shown in an open configuration in Fig. 3 A and in a closed configuration in Fig. 3B.
  • Fig. 4 is an exploded view of an alternative embodiment of a pressure safety device constructed in accordance with the principles of the present invention and having a spring-loaded valve as the automatic flow reduction valve.
  • FIG. 5 is cross-sectional view of the pressure safety device of Fig. 4 is showing a seal plate of the spring-loaded valve in an open configuration (full line) and a closed configuration (broken line).
  • Fig. 6 is a detailed view of the seal plate of the spring-loaded valve.
  • Fig. 7A and 7B illustrate fenestrations in a housing of the pressure safety device for the release of exhalation gases from the patient blocked by a one-way valve in the pressure safety device.
  • FIG. 1A and 1B show a pressure safety device (PSD) 10 constructed in accordance with the principles of the present invention in its intended position within a standard bag valve mask (BVM) assembly 50.
  • the BVM 50 includes a compression bag 52, a reservoir bag 54 connected to the compression bag by a reservoir valve 56, a positive end expiratory pressure (PEEP) valve 58, and a pop-off valve 60.
  • the compression bag 52, PEEP valve 58 and pop-off valve 60 are all connected to a manifold 62 having a connector port 64 for removably receiving a breathing mask 70.
  • the breathing mask 70 typically has an air cushion 72 on one surface for placing over a patient’s mouth and nose when in use and a connector fitting 74 for detachably mating to the connector port 64 of the manifold 62.
  • the connector port 64 on the manifold 62 will be a male connector
  • the connector fitting 74 on the breathing mask 70 will be a female fitting, but the present invention can be adapted to work with any pair of detachable connectors, including screw connectors, bayonet connectors, latched connectors, and the like.
  • the BVM 50 is entirely conventional, and will be ready for use once the connector port 64 of the manifold 62 has been inserted directly into the connector fitting 74 of the breathing mask 70.
  • the breathing mask 70 will be disposable and kept in a sterile pack before use.
  • the PSD of the present invention is intended for use with a standard BVM such as BVM 50 just described. While the PSD can be constructed in various ways, the main components will include an“automatic flow reduction valve,” such as a blocking valve, to prevent excess flow and/or pressure from being delivered to the breathing mast 70.
  • the PSD 10 may also include a one-way valve that prevents patient exhalation from returning to the BVM, typically redirecting the exhalation flow outwardly through openings in the PSD.
  • The“automatic flow reduction valve” or“AFRD” of the present invention can take any one of a variety of forms.
  • the AFRD can be any type of pressure-response or flow- responsive valve which is capable of being located along an inhalation flow path to the patient and reducing or stopping a flow of breathing gas from the compression bag to the patient whenever the flow or pressure exceeds a maximum threshold value.
  • a conventional bag valve mask assembly comprises a compression bag 52, a reservoir bag 54, reservoir valve 56, a PEEP valve 58, a pop- off valve 60, and an oxygen tube 61.
  • the compression bag 52, pop-off valve 60 and PEEP valve 58 are all connected to a manifold 62 having a connector port 64 on a lower end thereof.
  • the compression bag 52 is constructed to deliver breathing gas from the oxygen tube 61 through the manifold 62 and out the connector port 64.
  • a breathing mask 70 having an air cushion 72 on its lower surface and a connector fitting 74 on an upper surface will be connected directly to the manifold 62.
  • the connector port 64 is typically a male fitting which fits in a female connector fitting 74 so that breathing gas from the manifold flows directly into the breathing mask 70.
  • the BVM may then be used by placing the air cushion 72 over a patient’s nose and mouth and manually squeezing the compression bag 52 to deliver breathing gas to the patient.
  • a pressure safety device can as provided for insertion between the connector port 64 of the BVM 50 and the connector fitting 74 of the breathing mask 70.
  • the pressure safety device may take a variety of specific forms, but will be designed and configured to limit over pressurization and/or overflow of breathing gas from the compression bag 52 to the patient.
  • a PSD 10 comprises a housing 12 having a bag port 14 and base 16.
  • An umbrella valve 18 is provided as an automatic flow reduction valve and includes a deformable seal 20, typically in the form of a conical seal capable of everting to block or reduce flow as described below.
  • the umbrella valve 18 is mounted on a support plate 26 having a plurality of flow openings or passages 28 formed therethrough.
  • a dagger-type anchor 22 is mounted in a hole 32 in the support plate 26 to properly position the deformable seal 20 so that a conical periphery of the seal is deflected upwardly away from the support plate 26when the seal is in an unstressed, undeformed configuration.
  • the support plate 26 is mounted in a one-way valve fitting 34 having a duckbill valve 36 aligned to receive breathing gas outflow from the flow openings 28 in the support plate 26.
  • the duckbill valve is oriented so that breathing gas flowing from the bag port 14 which flows through the open umbrella valve 18 will open the duckbill and freely flow therethrough.
  • the PSD 10 further comprises a bottom plate 38 having a polarity of fenestrations 40 formed in in an annular ring about its periphery.
  • the fenestrations 40 may be any sort of passage which allows a an exhalation gas stream which is blocked by the duckbill valve 36 to flow downwardly and outwardly away from the housing 12 through the fenestrations.
  • a mask fitting 44 is formed at the bottom of the bottom plate to provide for connection to the breathing mask 70, as illustrated in Figs. 1 A and 1B.
  • FIG. 3 A and 3B the PSD 10 is shown with the conical periphery of the deformable seal 20 of the umbrella valve 18 in its open, upwardly disposed configuration.
  • air flow 46 entering the bag port 14 travels beneath the deformable seal 20 and through the flow openings 28 in the support plate 26, as shown by flow path arrows 48.
  • a second PSD embodiment 80 having a spring-loaded valve as the automatic flow reduction valve is illustrated.
  • the housing 14, one-way valve 34, and bottom plate 38 of PSD 80 may all be identical to those described previously with respect to PSD 10.
  • the automatic flow relief valve will be a spring-loaded valve 86 having a support plate 88 with guide posts 90.
  • a seal plate 94 having guide slots 102 is slidably received over the guide posts 90, and a spring 92 is place between the guide posts and has a lower end received on a support surface 99 of the support plate 88 and an upper end received in a recess 100 formed in a lower surface of the seal plate 94.
  • the spring 92 while in an unconstrained configuration holds the seal plate 94 well above the flow openings 95 in the support plate 88 so that a breathing gas may flow from the compression bag 52 may flow in through the bag port 14 and out through the mask fitting 44.
  • the seal plate 94 will be moved downwardly to the position shown in broken line in Fig. 5 to close the openings 95 and inhibit or fully block the flow of breathing gas.
  • a decrease in the fenestration 40 size and/or number will increase resistance against expiration and increase the PEEP.
  • High PEEP helps to maintain the airway open during conditions like chronic obstructive pulmonary disease (COPD) where the airway has a tendency to collapse after expiration.
  • COPD chronic obstructive pulmonary disease
  • a standard BVM incorporating the PSD of the present invention may be used as follows. With one hand, a user holds the mask 70 placing the air cushions 72 over the nose and the mouth of the patient to obtain a tight seal and prevent leakage of air. The user’s other hand
  • the AFRD18 or 86 of the PSD 10 will reduce or stop breathing gas flow to the patient to reduce the risk of injury.
  • the devices and methods of the present invention can be used in combination with other rusticator features, such as a cadence indicator as described in ET.S. Pat. No. 10,098,809 and ET.S. Pat. Publ. No 2003/0192547, the complete disclosures of which are herein incorporated by reference.
  • the devices and methods of the present invention can also be used in combination with devices for managing intrathoracic pressure, such as an impedance threshold device (ITD) as described in in ET.S. Pat. Nos. 6,604,523; 6,986,349; 7,195,012; and 7,204,251, the complete disclosures of which are herein incorporated by reference.
  • ITD impedance threshold device
  • the devices and methods of the present invention can be used in combination electronic sensors, within or external to the device to record pressure, volume, frequency of manual ventilation, delivery pressures, and the like.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Critical Care (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/US2019/035075 2018-06-01 2019-05-31 Pressure safety device for bag valve mask Ceased WO2019232491A1 (en)

Priority Applications (7)

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KR1020207037790A KR102907731B1 (ko) 2018-06-01 2019-05-31 백 밸브 마스크용 압력 안전 디바이스
JP2021516860A JP7464998B2 (ja) 2018-06-01 2019-05-31 バッグバルブマスクのための圧力安全デバイス
CA3101837A CA3101837A1 (en) 2018-06-01 2019-05-31 Pressure safety device for bag valve mask
EP24170308.1A EP4420704A3 (en) 2018-06-01 2019-05-31 Pressure safety device for bag valve mask
CN201980050694.0A CN112533657B (zh) 2018-06-01 2019-05-31 用于袋阀式面罩的压力安全装置
EP19810067.9A EP3801717B1 (en) 2018-06-01 2019-05-31 Pressure safety device for bag valve mask
AU2019276585A AU2019276585C1 (en) 2018-06-01 2019-05-31 Pressure safety device for bag valve mask

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US201862679301P 2018-06-01 2018-06-01
US62/679,301 2018-06-01

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US12017008B2 (en) 2018-06-01 2024-06-25 Safebvm Corp Pressure safety device for bag valve mask

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EP3801717B1 (en) 2024-05-22
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KR20210034553A (ko) 2021-03-30
JP7464998B2 (ja) 2024-04-10
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US20230226306A1 (en) 2023-07-20
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US12017008B2 (en) 2024-06-25
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US20240350764A1 (en) 2024-10-24
KR102907731B1 (ko) 2026-01-02

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