Patent Application
20220193352
The present invention relates to improvements to resuscitators. In particular although not solely the invention relates to resuscitators for neonatal resuscitation in the Delivery Room (DR), to ensure precise, safe and repeatable tidal volume delivery to new-born patients with rapidly changing lung compliance, thereby mitigating lung and brain injury due to excessive volume delivery by current pressure-driven neonatal resuscitators' as the new-born's lung compliance increases during their transition to extrauterine life.
Resuscitators that can supply pressurised air or oxygen to a patient are well-known. There are currently 3 types; Flow-inflating Bag (FIB), now very rarely used, Self-Inflating Bag (SIB) and T-Piece types. These are all manually-operated and therefore deliver variable performance. The performance is often left wanting for both inexperienced and experienced users, even for patients that have no resuscitation complications. These performance limitations may be amplified by complications of certain patients or situations, but even in general use prior art resuscitators have a risk of overinflating a patient's lungs by delivering a volume of air that is greater than their lungs can accommodate without injury (volutrauma), as prior art resuscitators provide no feedback to the operator as to volume delivered to the patient. Such can have serious and life-threatening adverse effects on the patient.
There is also a risk the pressure of the air or oxygen delivered may be greater than their lungs can accommodate without injury (barotrauma). In certain patients, their airway passage may be unknowingly blocked prior to resuscitation, or may become blocked during resuscitation. The pressure created by prior art devices may become undesirably high and further increased pressure may cause sudden dislodgement of the blockage with potentially serious consequences for the patient. Common manually operable prior art resuscitators cannot accurately control volume or airway pressures to which the lungs of the patient are being subjected. Using a Self -Inflating Bag (SIB) resuscitator, squeezing the ‘Bag’ the operator may feel a resistance when they are applying a force to the device to deliver air or oxygen. The operator may increase the force to overcome the resistance or blockage. Similarly, using a T-Piece resuscitator, the operator failing to see chest rise may increase the pressure to overcome the resistance or blockage. However, when the resistance or blockage clears there is a risk of over-pressurising or overfilling the lungs, thereby causing volutrauma, barotrauma or both.
Hence in known devices there is the risk that an operator may displace too great a volume of air into the patient and therefore overinflate the patient's lungs. There is also the risk of applying a pressure that is too great for the patient's lungs. For example, when the airway passage is blocked, existing resuscitators do not signal that the operator should stop with a view to then removing the blockage. Certain patients present even further challenges making known resuscitators unsuitable or dangerous to use. In particular for new born babies. “Ten million newborns worldwide each year need resuscitation assistance. More than one million babies die annually from complications of birth asphyxia”Thomas E Wiswell MD. ‘Neonatal Resuscitation’ Respiratory Care March 2003, 48 (3) 288-295 http://rc.rcjournal.com/content/48/3/288.
When used to resuscitate new-borns Flow-inflating Bag (FIB), Self-Inflating Bag (SIB) and T-Piece type resuscitators fail to address a unique feature of the new-born's transition to life outside the womb, namely that of rapid lung compliance change. Those new-borns that require resuscitation, are predominantly premature new-borns because the lungs are among the last organs to develop.
“Preterm birth, defined as birth prior to 37 completed weeks of gestation, affects 7-12% of births worldwide”
Howson C P, Kinney M V, Lawn J E editors. March of Dimes, PMNCH, Save the Children, WHO. ‘Born Too Soon: The Global Action Report on Preterm Birth. Geneva: World Health Organization (2012)’.
https://www.who.int/pmnch/media/news/2012/201204 borntoosoon-report.pdf
“In 2020, preterm birth affected 1 of every 10 infants born in the United States”.
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm
The failure of current resuscitators to safely control volume delivered to new-borns has the potential for lung and brain injury, significant life-long physiological consequences and death.
“Despite major improvements in the care and outcome of extremely preterm infants over the last few decades, Bronchopulmonary Dysplasia (BPD) remains a challenging disease to treat and presents several challenges to clinicians. Its effects can be seen not only in the lungs of these infants but also in many other organ systems. BPD is a risk factor for the development of Cerebral Palsy (CP), with a significant increase in rates of CP in patients with severe BPD.”
Bronchopulmonary Dysplasia is defined as “a chronic lung condition that is caused by tissue damage to the lungs, is marked by inflammation, exudate, scarring, fibrosis, and emphysema, and usually occurs in immature infants who have received mechanical ventilation Gild supplemental oxygen as treatment for respiratory distress syndrome”
https://www.merriam-webster.com/medical/bronchopulmonary%20dysplasia
“Reducing the rate of BPD and identifying new specific targeted therapies for established BPD remains one of the biggest challenges for neonatologists and paediatric pulmonologists.” Frances Flanagan and Anita Bhandari. ‘Bronchopulmonary Dysplasia and Cerebral Palsy’. Springer Nature Switzerland AG 2019 Cerebral Palsy.
https://doi.org/10.1007/978-3-319-50592-3 67-1
“Several animal studies reported that high VT delivery during PPV causes lung and brain injury. However, when VT is controlled little or no lung injury occurs. Delivery room studies have reported large variation in VT delivery with high tidal volumes as large as 30 ml/kg.” (Current best practice is 4-6 mL/Kg)
Georg M Schmoelzer MD, PhD, Colin J. Morley, Omar C. O. F. Kamlin, ‘Enhanced monitoring during neonatal resuscitation, Seminars in Perinatology’
https://doi.org/10.1053/j.semperi.2019.08.006
At birth a new-born's lungs have to transition from being fluid-filled to air-filled. This transition entails a rapid increase in lung compliance which, in keeping with the laws of Physics, results in rapidly increased volume delivery. Boyle's law states “the volume of a gas at constant temperature varies inversely with the pressure exerted on it”.
https://www.merriam-webster.com/dictionary/Boyle%27s%20law
Accordingly as the new-born's lung compliance increases, pressure reduces, resulting in a rapid and potentially injurious /deadly escalation in delivered volume. By way of illustration see
The main reason why prior art Neonatal Resuscitators have been shown to deliver excessive volume is because they were developed in the mid to late 1900s when the collective thinking was that controlling pressure was of primary importance for ‘safe’ resuscitation. This has long-since been debunked and replaced by recognition of the primary need to control volume.
“Initially, barotrauma was seen as being of major importance . . . however, increasing evidence has suggested that excessive volume, leading to over-expansion (volutrauma) and inadequate volume, leading to under-expansion/collapse, are more important aetiologically.” A Grover, Neonatal Unit, Leicester Royal Infirmary, Leicester, UK, D Field Department of Health Sciences, University of Leicester, Leicester, UK. ‘Volume-targeted ventilation in the neonate: time to change?’ 2006.
https://pubmed.ncbi.nlm.nih.gov/17768158/
“When Tidal Volume was controlled so as to avoid lung over-distension, little or no injury occurred” Georg M. Schmölzer, MD, Arjan B. Te Pas, MD, Peter G. Davis, MD, Colin J. Morley, MD. ‘Reducing Lung Injury during Neonatal Resuscitation of Preterm Infants.’ Journal of pediatrics 153(6):741-5 August 2008.
https://www.jpeds.com/article/S0022-3476(08)00689-6/fulltext
“This study highlights the critical role that the initial respiratory support has on the development of brain inflammation and injury, and the requirement for better monitoring of delivered tidal volumes to preterm infants in the delivery room.” Graeme R. Polglase, *Suzanne L. Miller, Samantha K. Barton, Ana Baburamani, Flora Y. Wong, James D. S. Aridas, Andrew W. Gill, Timothy J. M. Moss, Mary Tolcos Martin Kluckow and Stuart B. Hooper ‘Initiation of Resuscitation with High Tidal Volumes Causes Cerebral Hemodynamic Disturbance, Brain Inflammation and Injury in Preterm Lambs’ 2012. US National Library of Medicine, National Institutes of Health, U.S. Department of Health & Human Services
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3382197/
“One could ask if there is harm in using a volume targeted strategy in the delivery room? I think we would be hard pressed to say that keeping the volumes under 6 mL/kg is a bad idea.”
“The challenge as I see it now is whether we rig up devices to accomplish this or do the large medical equipment providers develop an all-in-one system to accomplish this? I think the time has come to do so and will be first in line to try it out if there is a possibility to do a trial.” Michael Narvey, MD, FAAP, RCPSC Pediatrics, Committee Chair at Canadian Pediatric Society: Fetus & Newborn Committee ‘All Things Neonatal’ Jun. 5, 2019 http://allthingsneonatal.com/2019/06/
Peer-reviewed published studies by leading researchers confirming the need for volume-controlled neonatal resuscitation in the Delivery Room (DR).
“This study highlights the critical role that the initial respiratory support has on the development of brain inflammation and injury, and the requirement for better monitoring of delivered tidal volumes to preterm infants in the delivery room.” Graeme R. Polglase, *Suzanne L. Miller, Samantha K. Barton, Ana Baburamani, Flora Y. Wong, James D. S. Aridas, Andrew W. Gill, Timothy J. M. Moss, Mary Tolcos Martin Kluckow and Stuart B. Hooper. ‘Initiation of Resuscitation with High Tidal Volumes Causes Cerebral Hemodynamic Disturbance, Brain Inflammation and Injury in Preterm Lambs’
US National Library of MedicineNational Institutes of Health, U.S. Department of Health & Human Services
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3382197/
The problem remains that all prior art resuscitators are pressure-driven and consequently as the new-borns lung compliance increases Physics dictates that delivered volume must also increase.
This is unbeknown to the operator because no prior art devices provide any operator feedback as to volume.
It would therefore be an advantage to provide improvements to resuscitators that address or go at least some way towards addressing at least some of the abovementioned disadvantages and provide the public and healthcare industry with an automated, easier-to-use, safer choice.
Accordingly in a first aspect the present invention consists in an electrically operable resuscitator for resuscitation of a patient who is not autonomously breathing and/or has never breathed air, the resuscitator comprising:
(i) a cylinder/piston assembly comprising:
(ii) a patient interface in ducted fluid connection with said cylinder/piston assembly to receive gas in and from said cylinder, via said at least one gas outlet, to deliver the gas to the patient for their resuscitation,
(iii) an accurate positional control motor operatively connected to the piston to cause the piston to displace in said cylinder, and
(iv) a controller configured for controlling the motor to control the position and displacement of the piston in the cylinder to cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to control (A) tidal volume (Vt), (B) respiratory rate (RR), of gas delivered to the patient.
Preferably the controller is configured for controlling the motor to control the position and displacement of the piston in the cylinder to cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to control each of the (A) tidal volume (Vt), (B) respiratory rate (RR), and (C) Inspiratory time, of gas delivered to the patient.
Preferably the controller is configured for controlling the motor to control the position and displacement of the piston in the cylinder to cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to control and in real time allow variation of the (A) tidal volume (Vt), (B) respiratory rate (RR), of gas delivered to the patient.
Preferably a sensor at the patient interface and where the motor can cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to allow (A) respiratory rate and (B) tidal volume to be controlled irrespective of (i) peak inspiratory pressure (PIP) at the patient interface (ii) respiratory rate (RR) and (iii) inspiratory: expiratory ratio (I.E. Ratio) at the patient interface and (iv) Peak End Expiratory Pressure (PEEP) sensed by the sensor at the patient interface.
Preferably the stroke length of the piston in the cylinder is adjustable.
Preferably the piston has a fixed bottom-dead centre within the cylinder that is proximal the gas outlet and a top-dead-centre withing he cylinder that is more distal the gas outlet, the top-dead-centre able to be adjusted by said controller based on the weight of the patient to thereby adjust the tidal volume of gas delivered to the patient during resuscitation.
Preferably the resuscitator further comprising a sensor at the patient interface and where the motor can cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to allow the tidal volume to be controlled and/or varied in response to gas pressure at the patient interface.
Preferably the stroke length of the piston in the cylinder is adjustable.
Preferably the piston has a fixed bottom-dead centre within the cylinder that is proximal the gas outlet and a top-dead-centre withing he cylinder that is more distal the gas outlet, the top-dead-centre able to be adjusted by said controller based on the weight of the patient to thereby adjust the tidal volume of gas delivered to the patient during resuscitation.
In a second aspect the present invention may be said to be a resuscitator for resuscitation of a patient who is not autonomously breathing and/or has never breathed air before, the resuscitator comprising:
(i) a piston/cylinder assembly including
(ii) a positionally controllable motor, operatively connected to said piston to move said piston in said cylinder, and
(iii) a controller configured for controlling the motor to control the position and displacement of the piston in the cylinder to provide a tidal volume of the gas for delivery to a patient at a pressure sufficient to inflate the lungs of the patient;
wherein the piston/cylinder assembly is engaged or engageable in ducted fluid connection with a patient interface for receiving gas via said at least one gas outlet and delivering said gas to said patient,
wherein intermediate of the patient interface and the at least one outlet of the cylinder and in said ducted fluid connection therewith is a gas flow controller the gas flow controller includes a one way valve that allows gas to be displaced from the outlet of the cylinder towards the patient interface and prevents gas from flowing through the one way valve in the opposite direction, and
wherein one of the ducted fluid connection and the patient interface includes a pressure relief valve to allow pressure reduction of gas in said patient interface to occur.
Preferably said patient interface is a face mask, endotracheal tube or nasal mask.
Preferably said valved exhaust port assumes a closed condition when the piston is moving in a direction to displace gas towards the patient interface and assumes an open condition when the piston is moving in the opposite direction to allow gas due to exhalation of or by the patient to pass through the exhaust port.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted on or to or in operative association with an actuator to actively control the movement of the valve relative to the opening.
In a further aspect the present invention may be said to be a method of using the resuscitator as herein described for the purposes of resuscitating a patient such as a neonatal baby who's lung compliance is unknow and subject to rapid change during resuscitation, the method comprising:
Preferably the invention may be said to be a resuscitator as herein defined that is volume-controlled with operator pre-sets for volume, (Vt) Peak Inspiratory Pressure (PIP), Respirator Rate (RR), Inspiratory-Expiratory (I:E) Ratio and Peak End Expiratory Pressure (PEEP) wherein PEEP is to avoid lung collapse between breaths (Atelectasis).
Accordingly in a further aspect the present invention consists in an electrically operable resuscitation device comprising:
(a) a piston/cylinder arrangement including
a rigid cylinder including at least one gas inlet and at least one gas outlet,
a piston to travel in said cylinder, and
at least one valve, the or each valve configured for allowing gas to be drawn into said cylinder through said at least one gas inlet during at least one of a first stroke direction and/or a second stroke direction of said piston in said cylinder, and for allowing gas to be displaced through said at least one gas outlet during an opposite of at least one of the first stroke direction and/or second stroke direction of said piston in said cylinder,
(b) accurate positional control motor preferably selected from a stepper motor and feedback motor or a stepper motor with feedback and linear motor, operatively connected to said piston to move said piston in said cylinder with accurate velocity control,
(c) a patient interface in ducted fluid connection with said piston/cylinder assembly to receive gas via said at least one gas outlet and to deliver said gas to said patient.
Preferably said patient interface is a face mask, endotracheal tube or naso-mask.
Preferably said motor is a linear stepper motor that may also have feedback.
Preferably said motor is a servo motor that may also have feedback.
Preferably said motor is a linear stepper motor and is directly connected to said piston.
Preferably the motor is directly connected with said piston.
Preferably said piston includes a connection rod with which said motor is in operative connection.
Preferably said piston is or includes one part (eg an iron bar and rare earth magnet assembly) of the two moving part linear motor.
Preferably the motor and cylinder are connected together (and are preferably engaged to each other).
Preferably intermediate of the patient interface and the at least one outlet of the cylinder and in said ducted fluid connection therewith is a gas flow controller.
Preferably the gas flow controller includes a one way valve that allows gas to be displaced from the outlet of the cylinder towards the patient interface and prevents gas from flowing through the one way valve in the opposite direction.
Preferably the gas flow controller includes a valved exhaust port via which gas can exhaust to relieve pressure at the patient interface.
Preferably said valved exhaust port assumes a closed condition when the piston is moving in a direction to displace gas towards the patient interface and assumes an open condition when the piston is moving in the opposite direction to allow gas due to exhalation of or by the patient to pass through the exhaust port.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted on or to or in operative association with an actuator to actively control the movement of the valve relative the opening.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted for movement relative the opening in a passive manner under the influence of pressure differential in the gas from controller and/or between the gas flow controller and ambient gas pressure.
Preferably said valved exhaust port is moved to a closed condition when gas is to be displaced into said patient and to an open condition to allow gas due to exhalation of or by the patient to pass through the exhaust port.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted on or to or in operative association with an actuator to actively control the movement of the valve relative to the opening.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted for movement relative the opening in a passive manner under the influence of pressure differential in the gas from controller and/or between the gas flow controller and ambient gas pressure.
Preferably when the valved exhaust port is in the open condition, said motor stops or reduces the velocity of the piston.
Preferably a controller is coupled to said motor to control the velocity, and position of the piston to thereby control the respiratory rate and position/volume displacement of gas delivered to the patient.
Preferably said controller is coupled to said actuator to move said actuator preferably in a manner in synchronicity with control of said motor.
Preferably a source of electricity is connected to said motor.
Preferably said source of electricity is connected to said motor via said controller.
Preferably via an interface, the controller can be instructed to operate the device in a suitable manner.
Preferably the interface allows for patient-related information to be entered into the controller, the information including a patient's weight.
Preferably the delivered volume is controlled in accord with current best practice, currently 4-6 mL/kg of the patient's weight.
Preferably the controller receives data from other parts of the device, including at least one of gas pressure at the patient interface and tidal volume flow rate, respiratory rate (RR) and inspiratory: expiratory ratio (I.E. Ratio) at the patient interface.
Preferably the controller receives data from other parts of the device, including each of gas pressure at the patient interface and tidal volume flow rate, respiratory rate (RR) and inspiratory: expiratory ratio (I.E. Ratio) at the patient interface.
Preferably a display is provided to display operating conditions of said device.
Preferably the operating conditions displayed may include Tidal Volume (Vt), Maximum (safe) Pressure (Pmax) Piston oscillation/Respiratory Rate (RR), I:E Ratio, battery power and duration of operation.
Preferably the operating conditions may also be recorded for subsequent reference.
Preferably fluid connection between said outlet of said cylinder and the patient interface is defined in part by a flexible conduit.
Preferably fluid connection between said outlet of said cylinder and the patient interface is defined in part by a flexible conduit and said flow controller is located more proximate to said patient interface than said cylinder.
Preferably the ducted fluid connection and/or the patient interface includes a pressure relief valve to allow pressure reduction of gas in said patient interface.
Preferably the pressure relief valve becomes operative to relieve pressure when the pressure in said patient interface reaches a certain threshold.
Preferably said piston/cylinder assembly includes an inlet volute.
Preferably the inlet volute includes an opening to allow pressure relief of said inlet volute to occur.
Preferably said inlet volute includes a one way valve to allow pressure relief to occur into the inlet volute.
Preferably the said inlet volute includes a pressure relief valve to allow pressure relief to occur out of said inlet volute.
Preferably said inlet of said cylinder is in fluid connection with a supplementary gas supply to allow gas from said supplementary gas supply to pass into said cylinder for subsequent delivery to the patient. More preferably, the gas is oxygen.
Preferably said cylinder is split into two zones by said piston, a first zone being on one side of said piston and a second zone being on the other side of said piston and wherein said gas inlet(s) are provided to allow gas into the first zone and said gas outlet(s) are provided to allow gas out of said second zone, wherein a one way valve is provided to allow gas to transfer from said first zone to said second zone and that restricts flow in the opposite direction.
Preferably the one way valve is carried by the piston to operate on a passage through the piston.
Preferably gas in said first zone, is or becomes pressurised sufficiently to, upon the movement of the piston in its first stroke direction, allow some of the gas to displace through the one way valve into the second zone.
Preferably the one way valve is a passive one way valve that moves between an open and closed condition dependent on pressure differential across the one way valve.
Preferably a one way valve (inlet one way valve) may be provided to allow gas to be drawn into the first zone upon the movement of the piston in its second stroke direction and that restricts flow of gas in the opposite direction through said inlet one way valve upon the movement of the piston in the first stroke direction.
Preferably the inlet one way valve is a passive one way valve that moves between an open and closed condition dependent on pressure differential across the inlet one way valve.
Preferably one or each of the one way valves mentioned are valves under active control to be in the open and closed conditions in correspondence with the direction of movement of the piston.
Preferably the cylinder and piston stroke length are of a size to allow a sufficient volume of gas to be displaced from said cylinder through said gas outlet(s) during said second direction of movement of the piston to deliver a desired volume and flow rate of gas for a single inhalation to a neonatal patient for resuscitation purposes.
Preferably said cylinder is split into two zones by said piston, a first zone being on one side of said piston and a second zone being on the other side of said piston, and wherein the piston/cylinder assembly is a double acting piston/cylinder arrangement that includes:
(b) a first one way valve to
i) allow gas to enter into the first zone via a said gas inlet (herein after “first gas inlet”) of said cylinder during movement of the piston in its second direction of movement, and
ii) restrict gas flow in the opposite direction through said first gas inlet during movement of the piston in the first direction of movement
(c) a second one way valve to
i) allow gas to exit the first zone via a said gas outlet (herein after “first gas outlet”) of said cylinder during movement of the piston in its first direction of movement, and
ii) restrict gas flow in the opposite direction through said first gas outlet during movement of the piston in the second direction of movement
(d) a third one way valve to
i) allow gas to enter into the second zone via a said gas inlet (herein after “second gas inlet”) of said cylinder during movement of the piston in its first direction of movement, and
ii) restrict gas flow in the opposite direction through said second gas inlet during movement of the piston in the second direction of movement
(e) a fourth one way valve to
i) allow gas to exit the second zone via a said gas outlet (herein after “second gas outlet”) of said cylinder during movement of the piston in its second direction of movement, and
ii) restrict gas flow in the opposite direction through said second gas outlet during movement of the piston in the first direction of movement
(f) a manifold or ducting to duct gas from said first and second outlets to said patient interface.
Preferably each of at least one of the first to fourth one way valves are either actively controlling or passive in moving between their open and closed conditions.
Preferably the cylinder and piston stroke length are of a size, and the motor is able to move and be controlled, to allow a sufficient volume of gas to be displaced from said cylinder through said gas outlet(s) during single, or multiple oscillations of the piston to deliver a desired volume and flow rate of gas for a single inhalation to a patient for resuscitation purposes.
Preferably the piston/cylinder arrangement is a double acting piston/cylinder arrangement and the motor is of a sufficient speed to, in multiple stokes of the piston, deliver a single tidal volume of gas for a single inhalation to a patient for ventilation and/or resuscitation purposes.
Preferably the device is portable.
Preferably at least one of the piston/cylinder arrangement and patient interface and motor are portable and preferably unitary and preferably able to be held in one hand by a user.
Preferably at least one of the controller and power supply and display are also portable and preferably unitary and preferably able to be held in one hand by a user.
Preferably communication to and from the controller may be wireless.
In a second aspect the present invention consists in a resuscitator to deliver gas to a patient to be resuscitated that includes a positive displacement piston/cylinder arrangement that is operated by a linear motor.
Preferably the piston/cylinder arrangement is of a kind to allow intermittent displacement of gas to a patient during operation of the piston/cylinder arrangement and the operation of piston by the linear motor is controlled to displace gas to the patient of a patient-appropriate, safe volume to facilitate resuscitation.
Preferably the control of the linear motor is such as to allow a variation in the volume of gas delivered in accord with each patient's individual requirement.
Preferably the piston/cylinder arrangement is a positive displacement piston/cylinder arrangement (preferably a piston/cylinder assembly).
Preferably the linear motor actuates the piston for single or multiple oscillations to deliver a single tidal volume of gas to suit the patient.
In a further aspect the present invention consists in a gas flow controller for a resuscitator that includes a piston/cylinder assembly to deliver gas to a patient and a patient interface, the controller interposed between said piston/cylinder assembly and interface and including a one way valve that allows gas to be displaced from the piston/cylinder arrangement towards the patient interface and prevents gas from flowing through the one way valve in the opposite direction.
Preferably the gas flow controller includes a valved exhaust port via which gas can exhaust to relieve pressure at the patient interface.
Preferably said valved exhaust port assumes a closed condition when the piston/cylinder arrangement is operating in a mode to displace gas towards the patient interface and assumes an open condition during exhalation of or by the patient to pass allow exhaled gas to pass through the exhaust port.
Preferably, said valved exhaust port assumes an open condition when the device is in a non-operative or non-operational mode. More preferably, the valved exhaust port assumes an open condition when the piston/cylinder assembly is in a non-operative or non-operational mode.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted on or to or in operative association with an actuator to actively control the movement of the valve relative the opening.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve is mounted for movement relative the opening in a passive manner under the influence of pressure differential in the gas from controller and/or between the gas flow controller and ambient gas pressure.
Preferably said valved exhaust port is moved to a closed condition when gas is to be displaced into said patient and to an open condition to allow gas due to exhalation of or by the patient to pass through the exhaust port.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted on or to or in operative association with an actuator to actively control the movement of the valve relative the opening.
Preferably said valved exhaust port includes at least one opening closable by a valve, said valve mounted for movement relative the opening in a passive manner under the influence of pressure differential in the gas from controller and/or between the gas flow controller and ambient gas pressure.
In a further aspect the present invention consists in a resuscitator device that operates to define an inhalation period during which a gas is displaced from the device to the patient and an exhalation period where no gas is displaced from the device to the patient and any gas received from the patient is exhausted from the device, wherein the device utilises an accurate positional control motor (eg a linear motor or rotary stepper motor) that controls a piston/cylinder arrangement, the motor being controlled to operate the piston/cylinder arrangement during the inhalation period and the motor being controlled to stop the piston/cylinder arrangement during the exhalation period.
Preferably the piston/cylinder arrangement undertakes a plurality of oscillations during any one inhalation period.
Preferably the piston/cylinder arrangement undertakes no more than one oscillation during any one inhalation period.
Preferably the motor is able to control the position of the piston in the cylinder prior to resuscitation so that the piston is caused to move from a pre-determined position in the cylinder upon the initiation of movement of the piston in the cylinder for the purposes of resuscitation.
Preferably the position of the piston in the cylinder is able to be set by the motor, prior to resuscitation so that the piston can subsequently be caused to move from the set position in the cylinder.
Preferably the position of the piston in the cylinder is able to be set by the motor, prior to resuscitation so that the piston can subsequently be caused to move from the set position in the cylinder, upon the initiation of movement of the piston in the cylinder for the purposes of resuscitation.
In a further aspect the present invention may be said to be a volume-controlled neonatal resuscitator with operator pre-sets for volume, (Vt) Peak Inspiratory Pressure (PIP), Respiration Rate (RR), Inspiratory-Expiratory (I:E) Ratio and Peak End Expiratory Pressure (PEEP) to avoid lung collapse between breaths (Atelectasis).
In a further aspect the present invention may be said to be resuscitator as herein defined that is volume-controlled with operator pre-sets for volume, (Vt) Peak Inspiratory Pressure (PIP), Respirator Rate (RR), Inspiratory-Expiratory (I:E) Ratio and Peak End Expiratory Pressure (PEEP) to avoid lung collapse between breaths (Atelectasis).
Preferably the controller is configured for controlling the motor to control the position and displacement of the piston in the cylinder to cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to control and/or vary at least one of (A) tidal volume (Vt), (B) respiratory rate/RR, (C) Peak Inspiratory Pressure (PIP) and (D) Inspiratory time and (E) the I:E ratio.
Preferably the motor can cause gas in said cylinder to be delivered via said at least one gas outlet through said patient interface to said patient in a manner to allow (A) respiratory rate and (B) tidal volume to be controlled and varied, irrespective of Peak Inspiratory Pressure (PIP), Inspiratory-Expiratory (I:E) Ratio and Peak End Expiratory Pressure (PEEP).
In a further aspect the present invention consists in a resuscitator as herein before described and as herein described with reference to the accompanying drawings.
In a further aspect the present invention consists in a resuscitator as herein described with reference to the accompanying drawings.
This invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features, and where specific integers are mentioned herein which have known equivalents in the art to which this invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.
As used herein the term “and/or” means “and” or “or”, or both. As used herein “(s)” following a noun means the plural and/or singular forms of the noun.
The term “comprising” as used in this specification means “consisting at least in part of”. When interpreting statements in this specification which include that term, the features, prefaced by that term in each statement, all need to be present but other features can also be present. Related terms such as “comprise” and “comprised” are to be interpreted in the same manner.
It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range (for example, 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of rational numbers within that range (for example, 2 to 8, 1.5 to 5.5 and 3.1 to 4.7).
A preferred form of the present invention will now be described with reference to the accompanying drawings in which,
Eliminating human operation of a resuscitator for delivering air and oxygen to a patient is advantageous. By eliminating the operator the risk of delivering too great a volume of air into the patient and overinflating the patient's lungs, causing volutrauma, is significantly reduced. By eliminating the human operator, the risk of delivering too great a pressure of air into the patient and therefore over pressurising the patient's lungs, causing barotrauma, is significantly reduced. Several examples of resuscitators according to the present invention will now be described that can aid in reducing these operator risks.
With reference to
The resuscitator body 2 consists of a piston/cylinder assembly unit 6, a flow control unit 7 and a patient interface 8.
Broadly speaking the piston/cylinder assembly unit 6 includes a piston/cylinder assembly that will deliver air to the flow control unit 7. The flow control unit 7 will control the flow of gas between the patient interface and the flow control unit 7 in conjunction with or without the piston/cylinder assembly unit 6 depending on the status of operation of the resuscitator 1.
In the most preferred form, the piston/cylinder assembly unit 6 and flow control unit 7 are part of the same body as for example shown in
In the examples shown in the accompanying drawings, the interface is preferably a face mask. However, alternatively, the interface may be a, naso-mask, nasopharyngeal airway, or endotracheal tube that extends into the patient's airway.
The piston/cylinder assembly 6 consists of a piston 10 that locates in a cylinder 11 to displace gas through an outlet opening 12 of the cylinder and to the flow control unit 7. The piston and cylinder are a complementary shape and make sure that a sufficiently tight seal exists between the piston and cylinder for the purposes of positively displacing gas through the outlet opening 12.
The cylinder 11 may be cylindrical in cross-section or may be any other shape in cross-section.
The piston is actuated via its connection rod 14, by a motor 13. In the most preferred form the motor is an actuator preferably a linear motor. In an alternative form the actuator may be a servomotor, stepper motor or similar device. The connection rod 14 may be the reactor to operate in conjunction with the motor 13 for the purposes of displacing the piston 10 in the cylinder 11 in an oscillating manner. Alternatively the connection rod 14 may carry a reactor plate or surface in conjunction with the motor 13. In the figures, the connection rod 14 is acted upon directly by the motor 13. The reactor plate may also be incorporated as part of the piston to be integral therewith. No connection rod may then be provided. Alternative mechanisms may be employed where such action is indirect via a linkage mechanism. Such linkage may include a rotor and crank and connection rod.
In the most preferred form, the motor 13 is a linear motor or any other motor that has accurate and rapid positional control capabilities. The controller 3 via a connection 15 with the motor 13 will operate the motor in a manner so that the desired flow rate, volume and pressures are being delivered through the outlet opening 12.
As is herein after described there is a benefit in being able to control the start position of the piston upon initiation of the resuscitation process and the use of a position controllable electric motor enables this to be achieved. The start position of the piston, prior to initiating resuscitation, can be set based on a patient's weight (current best practice 4-6 mL/kg). The start position of the piston is effectively it's “top-dead-centre” and this is adjusted based on patient weight so as to adjust the tidal volume to be delivered. This information can be programmed into the controller via the operator pre-set to then move the piston to the desired set start position. The piston moves from a starting position towards the delivery (proximal) end of the resuscitator. The distance the piston travels, i.e. the stroke of the piston, determines the tidal volume delivered (Vt=πr2S), whereby the tidal volume target is derived from the patient's weight and where S is the piston stroke length Before the piston moves from the start position, a reference position (i.e. zero position) is first be established. This is done because at start-up, the piston may be located anywhere in the cylinder, for example due to movement of the device when not in use. Setting the zero position can be achieved in two ways:
In an open loop control system, the zero position is not known and hence must first be determined. For this, the piston moves until it stops at the most proximal end of the resuscitator (the end closest to the patient interface and effectively the piston's “bottom-dead-centre”), and records this as the zero position. From there, the piston withdraws to the starting position. The zero position is established at the power start-up and is maintained until power off.
In a closed loop system with absolute position sensing the zero position is known and the piston directly moves to the start position.
The process of establishing the zero position and the movement to the start position of the piston is activated immediately the ‘on’ button/power interface is selected and may take approximately 2 seconds or less. This is done prior to/without the resuscitator being connected to the patient. Once this process is complete, resuscitation can commence. The flow control unit 7 consists of an inlet that may coincide with or define the outlet opening 12 of the piston/cylinder assembly unit. The flow control unit includes an outlet 20 and a passage extending between the inlet and outlet. The passage allows the transmission of gas being displaced from the piston/cylinder assembly unit 6 to the outlet 20. The outlet 20, preferably via a conduit 9, allows the delivery of this gas to the patient interface 8.
Intermediate of the inlet and outlet of the flow control unit is a one-way valve 21. The one-way valve allows for gas to travel from the inlet towards the outlet via the passage but prevents flow of gas from the outlet to the inlet.
The valve 21 may be mounted in a fixed manner to the housing 22 of the flow control unit 7 or alternatively and as shown in
In a preferred form the movable mount 23 forms part of a voice coil actuator 24 that can displace the movable mount 23 between two positions. The first position is as shown in
In the second position of the mount as shown in
As a consequence of a pressure differential between the patient side and piston/cylinder assembly side of the one-way valve 21, the one-way valve 21 will assume a closed position as shown in
In the exhalation operating phase of the resuscitator, the piston is withdrawn by the motor 13 preferably back to a predetermined start position. The piston retracts once it has travelled its full desired stroke during the inhalation operating phase and has delivered the required tidal volume or has timed out while holding the maximum airway pressure during the inhalation period. Control of the position or movement of the voice coil actuator 24 can occur by the controller 3 and is preferably synchronised with movement of the piston.
In a “PEEP” mode (positive end expiratory pressure) parameters can be pre-set by using the controller or the display panel PEEP so that pressure is controlled by the voice coil actuator. The voice coil actuator 24 will exert a closing force to the exhalation valve equal to the predetermined PEEP pressure. The PEEP pressure is measured by the airway pressure sensor 31. The controller 3 will activate the voice coil actuator 24 when the expiratory airway pressure has reached the predetermined level.
In operation of the resuscitator shown in
The controller 3 instructs the motor 13 to move the piston 10 a predetermined distance at a predetermined velocity. The controller can control and adjust and vary the operation of the resuscitator including for example controlling one or more of:
A. Tidal volume,
B. Respiratory rate,
C. Inspiratory time (this may be determined by the I/E ratio and the speed of the motor), and/or
D. Shape of the flow of the delivery of gas from the cylinder to the patient via the patient interface.
Controlling, setting, varying or adjusting the shape of the flow allows, in one delivery of a tidal volume, a change over time of the rate of that delivery to occur. This is achieved by changing the speed of the piston during the delivery of one tidal volume, able to be repeated for each tidal volume delivery.
Feedback from the airway pressure sensor 31 and a flow and tidal volume sensor 36 can provide further control. These sensors may vary normal operation of the piston 10 and/or voice coil actuator 24 from conditions of operation predetermined by an operator and instructed to the device via the display panel 4 and/or controller 3. The stroke length and position of the piston 10 may in addition be monitored by a sensor (a piston position sensor) of or associated with the motor 13 and/or piston 10. The operation of the resuscitator will control the breath rate and inhalation/exhalation ratio. This can be pre-set by using the controller and/or display panel and may be controlled at least in part by a timer of the controller. Patient dependent parameters may also control operation. For example, input information into the controller 3 may include a patient's weight. There is a direct relationship between a patient's weight and ideal delivered volume. Current international best practice advocates a safe volume of 4-6 mL/kg.
In a situation where the airway pressure sensor 31 senses that the maximum predetermined airway pressure has been reached, the controller 3 can instruct the motor 13 to slow or stop. This can result in a maintaining of the maximum predetermined airway pressure for the duration of the inhalation time period. In the event of an overpressure or system failure, a safety valve 37 may be actuated to open and relieve pressure on the patient airway. The safety valve 37 may be a passive valve that has predetermined operating conditions. Alternatively it may be a safety valve connected with the controller 3 and controlled by the controller for operation. Alternative to the safety valve 37, the airway pressure sensor 31 and/or flow and tidal volume sensor 36 may communicate with the controller 3 to direct movement of the voice coil actuator in instances where undesirable conditions are being sensed to thereby relieve pressure and/or flow by exhausting gas through the opening 29.
The table below illustrates the operational controls (A,B,C) of the resuscitator and the resulting performance parameters that they relate to, where applicable.
This first form of resuscitator described as well as the form yet to be described allows for data from the airway pressure sensor 31, the piston position sensor, the flow and tidal volume sensor 36 and from a timer to be used to record operating data and performance. A graphical display on the display panel 4 can also be generated. The graphical display can be used by the operator to monitor performance and determine if leakage, blockage or further adjustments are required to the resuscitator. The graph and/or related data can be stored to assist in the setup of other life support systems and for clinical analysis/training. Such statistical information may offer significant benefits to future situations.
The electrical connection 15 will ensure that the controller 3 can appropriately control the linear motor to thereby control the position and movement of the piston.
As is herein described there is a benefit in being able to control the start position of the piston upon initiation of the resuscitation process and the use of a position controllable electric motor enables this to be achieved.
The cylinder 11 has an inlet volute 16 that includes a primary inlet 17. It is through the primary inlet that ambient air may be drawing into the inlet volute as the piston displaces inside the cylinder towards the outlet opening 12. This direction of travel is shown in
The resuscitator may (for example shown in
In C-pap mode operational conditions can be specified and pre-set by using the controller and/or display panel. Where the delivery rate and pressure to the supplementary gas reservoir 40 is set at an appropriate flow level, the ventilator can operate in the C-pap mode. The motor 13 will stop operation and the flow from the supplementary gas reservoir 40 will pass through the one-way valve 18 through the one-way valve 21 to the patient interface 8. The airway pressure sensor 31 will determine the patient's airway pressure. When the predetermined C-pap pressure has been reached the voice coil actuator 24 will exert a closing force to the exhalation valve to the predetermined C-pap pressure.
With reference to
The resuscitator of
An alternative configuration of resuscitator may be utilised where size can be smaller. This resuscitator is shown for example in
This alternative form of resuscitator also includes a piston/cylinder assembly unit 106. The piston/cylinder assembly unit 106 varies to the piston/cylinder assembly unit 6 described with reference to
The cylinder includes two openings capable of being in communication with the inlet volute 116. A first opening 160 is provided on the extension side of the piston 110. A second opening 161 is provided on the retraction side of the piston 110. The opening 160 is closable by a one-way valve 162. The opening 161 is closable by a one-way valve 163. The one-way valve 162 is able to assume an opening condition during the retraction stroke of the piston and is in a closed condition during the extension stroke of the piston. The one-way valve 163 is able to assume an open position during the extension stroke of the piston and is in a closed condition when the piston is retracting. On the extension side of the piston 110 is an outlet opening 164 of the cylinder 111. The outlet opening is closable by a one-way valve 165. The one-way valve 165 is in a closed condition during the retraction stroke of the piston and is able to assume an open condition during the extension stroke of the piston. The one-way valve 165 hence essentially works in an opposite mode to the one-way valve 162 to the cylinder. The outlet opening 164 is able to create a fluid connection of that part of the cylinder on the compression side of the piston with an outlet volute 166. The outlet volute 166 includes an outlet opening 112 through which gas displaced by the piston can pass to the flow control unit 7. The outlet volute 166 is separated from the inlet volute 116. The housing of the piston/cylinder assembly unit 106 may include both the inlet volute 116 and outlet volute 166 and partitions 167 and the cylinder 111 may separate the volutes. On the retraction side of the piston 110 the cylinder includes an opening 168 to the outlet volute 166. The opening 168 includes a one-way valve 169. The one-way valve is positioned so that during the retraction stroke of the piston, gas can displace on the retraction side of the cylinder through the one-way valve 169 into the outlet volute 166. The one-way valve 169 will assume a closed condition during the extension stroke of the piston 110.
In operation during the extension stroke of the piston as shown in
With reference to
The number of oscillations of the piston can be predetermined and controlled to deliver a safe, patient-appropriate volume. The number of oscillations or singular distance travelled by the piston determines the tidal volume delivered to the patient. An operator may interact with the control unit and/or display to set parameters of operation of the resuscitator. Like the resuscitator described with reference to
The airway pressure may be monitored by a pressure sensor. When the pressure sensor senses that the maximum predetermined airway pressure has been reached the controller then instructs the linear motor to stop or slow to maintain but not exceed the maximum predetermined airway pressure for the duration of the inhalation period. Alternatively the controller may instruct the linear motor to stop to reduce pressure. In the event of any over pressure or system failure a safety valve like that described with reference to
The voice coil actuator may be preloaded so that the exhaust port tends to an open biased condition allowing external air to enter the patient airway.
The resuscitator of
With reference to the resuscitators in
With reference to
An alternative form of a sensor is one that has no inertial mass delay characteristics. An alternative form of sensor that may be used may be a gas flow meter that measure flow thermally. An example of such a flow meter is one manufactured by Sensirion.com such as their digital gas flow sensor ASF1400/ASF/1430. It may be one that is made in accordance to that described in U.S. Pat. No. 6,813,944. Such a flow sensor has a high response rate, given that it has unlike the sensor of
The invention may offer the advantages of being portable, hand held (including being able to be held by one hand in order to hold the patient interface in the appropriate condition) and self-contained by virtue of including its own power source (such as an internal battery pack).
The device may have programmable profiles fixed and/or customised to suit patients, clinicians and operators requirements.
A heart rate monitoring and pulse oximetry facility may also be incorporated with the device, wherein heart rate and blood oxygen and can be accounted for in the control of the device and be displayed by the device.
The display can assist the operator in evaluating resuscitation of the patient. The performance, operating parameters and status of the features of the device are able to be recorded. This can assist in statistical analysis and to gather information for set-up of other devices.
The patient as herein defined may a mammal such a person or animal.
The resuscitator's use, purpose and application is well suited for initiating the first breaths of a new born's life in the delivery room. This is in sharp contrast to a ventilator that is designed to maintain ventilation of a patient who has previously breathed and whose lung compliance has been established.
A resuscitator is defined as ‘An apparatus used to restore respiration’ https://www.merriam-webster.com/dictionary/resuscitator whereas a ventilator is defined as ‘a device for maintaining artificial respiration’ https://www.merriam-webster.com/dictionary/ventilator. The differentiation between Resuscitation and Ventilation is of particular significance for the following reasons:
1. The resuscitation of a New-Born provides a unique challenge as they have not previously ‘breathed’ air, only fluid. Within this context the role of the resuscitator becomes to ‘initiate respiration’ rather than ‘restore respiration’ under conditions unique to the New-born transitioning to life outside the womb.
2. The transition to extrauterine life and the requirement to breathe air entails rapid change from fluid-filled to air-filled lungs and an associated rapid change in lung compliance. Prior art Neonatal Resuscitators have been shown in multiple published studies as having the potential to deliver excessive volume and inflict lung and brain injury (Volutrauma). This can lead to life-long respiratory and neurological insufficiencies and healthcare dependency termed Bronchopulmonary Dysplasia/BPD at significant quality-of-life, social and financial cost to survivors and their families.
Unknown and/or rapidly changing lung compliance in some resuscitation patients, highlights the particular importance of delivering reliable and accurate tidal volumes throughout rapid changes in lung compliance and the benefit of a specific predetermined start position of the piston to achieve an accurate, patient-specific, safe volume.
The present invention enables safe, Volume-Controlled Neonatal Resuscitation with Operator Pre-Sets for the Patient's weight/Safe Volume, (Vt) based on current best practice 4-6 mL/Kg, Maximum Pressure (Pmax), Respiratory Rate (RR), Inspiratory-Expiratory (I:E) Ratio and Peak End Expiratory Pressure (PEEP) to avoid lung collapse between breaths (Atelectasis). Operator pre-sets direct a micro-controller which controls the movement of the piston within the piston/cylinder assembly. The distance the piston moves determines volume (V=πr2h), the frequency with which the piston moves determines respiratory rate (RR).
Control of these functional parameters together with sensors monitoring Volume, Pressure and Flow combine to ensure continuous real-time Operator feedback and maximise alveolar recruitment, whilst avoiding excessive volume delivery, lung over-extension, volutrauma and associated lung and brain injury, known as Bronchopulmonary Dysplasia (BPD).
As a new-born's lung compliance is not known, will not be known and will change during the resuscitation the resuscitator of the present invention may be used in the delivery room by a healthcare professional operator to initiate respiration, mitigate over-inflation, volutrauma, lung and brain injury before admission to the Neonatal Intensive Care Unit (NICU). It is quite distinct from ventilators used in the Neonatal Intensive Care Unit, the primary purpose of which is sustaining respiration by providing closed-loop, automatic and unsupervised care, often with anaesthetic support.
| Number | Date | Country | Kind |
|---|---|---|---|
| 555581 | May 2007 | NZ | national |
This application is a continuation-in-part of U.S. application Ser. No. 15/926,393, filed on Mar. 20, 2018, which is a continuation of U.S. application Ser. No. 14/741,848, filed on Jun. 17, 2015, which was a continuation of U.S. application Ser. No. 12/602,292, filed on Feb. 26, 2010, which was the National Stage of International Application No. PCT/NZ2008/000128, filed on May 30, 2008, the entireties of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14741848 | Jun 2015 | US |
| Child | 15926393 | US | |
| Parent | 12602292 | Feb 2010 | US |
| Child | 14741848 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15926393 | Mar 2018 | US |
| Child | 17691216 | US |
