The present disclosure generally relates to ventilators and, more particularly, to ventilator devices and methods of using such devices for co-venting multiple patients.
The use of a single ventilator among a plurality of patients has been implemented to provide ventilation for patients when the demand for ventilation exceeds the supply of ventilator machines. Current solutions include inserting a simple splitter in inspiratory ventilation tubing from a central location, with individual tubing segments going to each patient. However, this technique has an inherent problem; the air flow delivery to the patients is only equivalent when the patients' lung compliance and lung size are the same. This is often not the case. In situations where patients have differing lung compliance and size, patients with more compliant lungs receive more air. Other current solutions use valves to regulate air flow to multiple patients, but such valves are not adjustable in real-time, making it difficult to keep the patients properly ventilated as their conditions change. New methods and devices are needed for ventilating multiple patients in a manner such that air flow can be adjusted in real-time to account for patient differences and provide sufficient air to the patients as they breathe from a single ventilator over time.
The present disclosure provides ventilator devices, systems, and methods for co-ventilation of multiple patients. In one aspect, a ventilator device for co-ventilation of multiple patients is provided. In one embodiment, the ventilator device may include an air tube splitter having an inlet, a plurality of outlets, and a plurality of branches, with each of the branches extending to a respective one of the outlets. The ventilator device also may include a plurality of valves coupled to the branches, a plurality of actuators coupled to the valves, and a controller in operable communication with the actuators. Each of the valves may be configured to be adjusted to regulate air flow through a respective one of the branches. Each of the actuators may be configured to adjust a respective one of the valves. The controller may be configured to receive a set of inspiratory pressure settings or tidal volume settings for the patients, and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings.
In some embodiments, the plurality of outlets may consist of two outlets, the plurality of branches may consist of two branches, the plurality of valves may consist of two valves, and the plurality of actuators may consist of two actuators. In some embodiments, the plurality of outlets may include three or more outlets, the plurality of branches may include three or more branches, the plurality of valves may include three or more valves, and the plurality of actuators may include three or more actuators. In some embodiments, the plurality of branches may include a first branch and a second branch disposed adjacent to one another and defining an angle therebetween. In some embodiments, the angle may be fixed. In some embodiments, the angle may be between 15 degrees and 180 degrees. In some embodiments, the angle may be adjustable. In some embodiments, the angle may be adjustable between 15 degrees and 180 degrees. In some embodiments, the air tube splitter may include an adjustable connection disposed between the first branch and the second branch and configured to allow adjustment of the angle. In some embodiments, the adjustable connection may include a hinge.
In some embodiments, each of the valves may be configured to be adjusted between an open position and a closed position. In some embodiments, the controller may be further configured to control the actuators to alternately adjust the valves between the open position and the closed position based at least in part on a predetermined inspiratory to expiratory ratio pattern. In some embodiments, the controller may be further configured to control the actuators to alternately adjust the valves between the open position and the closed position based at least in part on a predetermined inspiratory to expiratory ratio. In some embodiments, the predetermined inspiratory to expiratory ratio may be 1:1, 1:1.5, 1:2, 1:3, 1:4, or 1:5. In some embodiments, each of the valves may be further configured to be adjusted to a plurality of partially open positions between the open position and the closed position. In some embodiments, the controller may be further configured to control the actuators to adjust the valves such that: a first valve and a second valve of the plurality of valves are in the closed position for a first time period; the first valve is in the open position or a partially open position while the second valve is in the closed position for a second time period following the first time period; the second valve is in the open position or a partially open position while the first valve is in the closed position for a third time period following the second time period; and the first valve and the second valve are in the closed position for a fourth time period following the third time period. In some embodiments, each of the valves may include a ball valve. In some embodiments, each of the valves may include a pinch valve.
In some embodiments, the ventilator device also may include a plurality of first connectors coupled to the branches and the valves, with each of the first connectors connecting a respective one of the valves to a respective one of the branches. In some embodiments, the ventilator device also may include a plurality of second connectors coupled to the valves, with each of the second connectors being configured to connect a ventilation tubing line to a respective one of the valves. In some embodiments, the air tube splitter, the first connectors, the valves, and the second connectors may be separately formed and connected to one another. In some embodiments, the air tube splitter, the first connectors, portions of the valves, and the second connectors may be integrally formed with one another. In some embodiments, each of the actuators may include a motor. In some embodiments, each of the actuators may include a servo motor.
In some embodiments, the ventilator device also may include a plurality of flow sensors coupled to the branches downstream from the valves and in operable communication with the controller, with each of the flow sensors being configured to detect a flow rate of air flow downstream from a respective one of the valves, and with the controller being further configured to receive flow rate signals indicative of flow rates detected by the flow sensors, and independently control the actuators to adjust the valves based at least in part on the flow rate signals. In some embodiments, the ventilator device also may include a plurality of pressure sensors coupled to the branches downstream from the valves and in operable communication with the controller, with each of the pressure sensors being configured to detect a pressure of air flow downstream from a respective one of the valves, and with the controller being further configured to receive pressure signals indicative of pressures detected by the pressure sensors, and independently control the actuators to adjust the valves based at least in part on the pressure signals. In some embodiments, the ventilator device also may include a plurality of carbon dioxide sensors coupled to the branches downstream from the valves and in operable communication with the controller, with each of the carbon dioxide sensors being configured to detect a carbon dioxide concentration of air flow downstream from a respective one of the valves, and with the controller being further configured to receive carbon dioxide concentration signals indicative of carbon dioxide concentrations detected by the carbon dioxide sensors, and independently control the actuators to adjust the valves based at least in part on the carbon dioxide concentration signals. In some embodiments, the ventilator device also may include a plurality of oxygen sensors coupled to the branches downstream from the valves and in operable communication with the controller, with each of the oxygen sensors being configured to detect an oxygen concentration of air flow downstream from a respective one of the valves, and with the controller being further configured to receive oxygen concentration signals indicative of oxygen concentrations detected by the oxygen sensors, and independently control the actuators to adjust the valves based at least in part on the oxygen concentration signals.
In some embodiments, the ventilator device also may include a user interface in operable communication with the controller, with the user interface being configured to allow a user to input and adjust the set of inspiratory pressure settings or tidal volume settings for the patients. In some embodiments, the user interface may be further configured to allow the user to input and adjust an inspiratory to expiratory ratio for the patients. In some embodiments, the user interface may include a display screen, a rotary encoder, and a knob coupled to the rotary encoder. In some embodiments, the user interface may include a graphical user interface. In some embodiments, the graphical user interface may be configured to display independent patient data for each of the patients. In some embodiments, the user interface may include a touchscreen display. In some embodiments, the ventilator device also may include an enclosure, with the valves, the actuators, the controller, and at least part of the air tube splitter being disposed within the enclosure.
In some embodiments, the ventilator device also may include a ventilator coupled to the inlet of the air tube splitter by a ventilation tubing line and configured to deliver air to the inlet of the air tube splitter. In some embodiments, the controller may be in operable communication with the ventilator and configured to control an air output of the ventilator. In some embodiments, the ventilator may be configured to deliver air to the inlet of the air tube splitter at a flow rate that is at least double a single patient tidal volume requirement. In some embodiments, the ventilator may be configured to deliver air to the inlet of the air tube splitter at a respiratory rate that is at least double a single patient respiratory rate requirement. In some embodiments, the ventilator device also may include a continuous positive airway pressure device coupled to the inlet of the air tube splitter by a ventilation tubing line and configured to deliver air to the inlet of the air tube splitter. In some embodiments, the ventilator device also may include an oxygen tank coupled to the inlet of the air tube splitter by a ventilation tubing line and configured to deliver air to the inlet of the air tube splitter. In some embodiments, the oxygen tank may be configured to deliver air to the inlet of the air tube splitter at a flow rate that is at least double a single patient respiratory rate requirement.
In another aspect, a ventilator system for co-ventilation of multiple patients is provided. In one embodiment, the ventilator system may include a first ventilation device and a second ventilation device each including an air tube splitter having an inlet, a plurality of outlets, and a plurality of branches, with each of the branches extending to a respective one of the outlets. The first ventilator device and the second ventilator device each also may include a plurality of valves coupled to the branches, a plurality of actuators coupled to the valves, and a controller in operable communication with the actuators. Each of the valves may be configured to be adjusted to regulate air flow through a respective one of the branches. Each of the actuators may be configured to adjust a respective one of the valves. The controller may be configured to receive a set of inspiratory pressure settings or tidal volume settings for the patients, and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings. The ventilator system also may include an upstream air tube splitter having an inlet and a plurality of outlets. The inlet of the air tube splitter of the first ventilation device may be fluidically coupled to one of the outlets of the upstream air tube splitter, and the inlet of the air tube splitter of the second ventilation device may be fluidically coupled to another of the outlets of the upstream air tube splitter.
In still another aspect, a method for co-ventilation of multiple patients is provided. In one embodiment, the method may include delivering air from a ventilator to a ventilator device. The ventilator device may include an air tube splitter having an inlet, a plurality of outlets, and a plurality of branches, with each of the branches extending to a respective one of the outlets. The ventilator device also may include a plurality of valves coupled to the branches, a plurality of actuators coupled to the valves, and a controller in operable communication with the actuators. Each of the valves may be configured to be adjusted to regulate air flow through a respective one of the branches. Each of the actuators may be configured to adjust a respective one of the valves. The method also may include receiving, via the controller, a set of inspiratory pressure settings or tidal volume settings for the patients, and independently controlling, via the controller, the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings.
In yet another aspect, a method for co-ventilation of a first patient and a second patient is provided. In one embodiment, the method may include delivering air from a ventilator to a ventilator device, delivering air from the ventilator device to the first patient for a first time period while no air is delivered from the ventilator device to the second patient, and delivering air from the ventilator device to the second patient for a second time period while no air is delivered from the ventilator device to the first patient.
In another aspect, a method for co-ventilation of a first patient and a second patient is provided. In one embodiment, the method may include delivering air from a ventilator to a ventilator device, delivering air from the ventilator device to the first patient at a first pressure for a first time period while no air is delivered from the ventilator device to the second patient, and delivering air from the ventilator device to the second patient at a second pressure for a second time period while no air is delivered from the ventilator device to the first patient, with the second pressure being different from the first pressure.
In still another aspect, a method for co-ventilation of a first patient and a second patient is provided. In one embodiment, the method may include delivering air from a ventilator to a ventilator device, delivering a first volume of air from the ventilator device to the first patient over a first time period while no air is delivered from the ventilator device to the second patient, and delivering a second volume of air from the ventilator device to the second patient over a second time period while no air is delivered from the ventilator device to the first patient, with the second volume of air being different from the first volume of air.
These and other aspects and improvements of the present disclosure will become apparent to one of ordinary skill in the art upon review of the following detailed description when taken in conjunction with the several drawings and the appended claims.
The detailed description is set forth with reference to the accompanying drawings. The drawings are provided for purposes of illustration only and merely depict example embodiments of the disclosure. The drawings are provided to facilitate understanding of the disclosure and shall not be deemed to limit the breadth, scope, or applicability of the disclosure. The use of the same reference numerals indicates similar, but not necessarily the same or identical components. Different reference numerals may be used to identify similar components. Various embodiments may utilize elements or components other than those illustrated in the drawings, and some elements and/or components may not be present in various embodiments. The use of singular terminology to describe a component or element may, depending on the context, encompass a plural number of such components or elements and vice versa.
In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, and/or components have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.
Ventilator devices disclosed herein integrate with a medical ventilator to split one airflow into two or more streams with customized pressures, which are then delivered to two or more individual patients, allowing safe co-ventilation of patients of different sizes and different lung compliances, with real-time monitoring and adjustment capability. As described herein, the ventilator device can turn off airflow to a specific patient in a synchronized manner to allow temporal ventilator splitting as a method to allow multiple patients to safely share ventilation. In this manner, the ventilator device may be used to increase the number of patients able to be safely ventilated in situations where ventilator demand exceeds supply, such as during the COVID-19 pandemic, chemical warfare, environmental disasters, mass shootings, or other locoregional disturbances that may cause increased demand. The ventilator device also may help developing countries or areas with limited ventilator resources, where the cost of full ventilators is prohibitive. The ventilator device also may be useful for the military. particularly in remote areas, where appropriate ventilator supply may be limited or logistically difficult because of travel needs.
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In some embodiments, the valves 130 may be coupled to the branches 126 of the air tube splitter 120 by the first connectors 132. As shown, the first connectors 132 may be coupled to the branches 126 and the valves 130, with each of the first connectors 132 connecting a respective one of the valves 130 to a respective one of the branches 126. In some embodiments, the second connectors 134 may be coupled to the valves 130 for connecting respective ventilation tubing lines extending between the ventilator device 100 and the patients being ventilated. As shown, the second connectors 134 may be coupled to the valves 130, with each of the second connectors 134 being configured to connect a ventilation tubing line to a respective one of the valves 130. In some embodiments, as shown, the second connectors 134 may define the outlets 114 of the overall ventilator circuit 110. According to the illustrated example, the air tube splitter 120, the valves 130, the first connectors 132, and the second connectors 134 may be separately formed and coupled to one another, as shown, to form the ventilator circuit 110 of the ventilator device 100. In some embodiments, the air tube splitter 120, portions of the valves 130, the first connectors 132, and the second connectors 134 may be integrally formed with one another as a single component. By integrally forming these components, the introduction of undesired resistances or contaminants to the ventilator circuit 110 may be minimized. Other configurations of the ventilator circuit 110 may be used in other embodiments.
The actuators 140 may be coupled to the valves 130 and configured to adjust the positions of the respective valves 130 to regulate air flow through the ventilator circuit 100 in a desired manner for ventilating the patients connected to the ventilator device 100. In particular, each of the actuators 140 may be configured to adjust a respective one of the valves 130 between the open position, closed position, and partially open positions of the valve 130. According to the illustrated example, the plurality of actuators 140 may consist of two actuators 140. In some embodiments, the plurality of actuators 140 may include three, four, or more actuators 140, with the number of the actuators 140 corresponding to the number of the valves 130. Any number of the actuators 140 suitable for adjusting the valves 130 to regulate air flow through the ventilator circuit 100 for a plurality of patients may be used in different embodiments, with the number of the actuators 140 generally corresponding to the number of patients intended to be co-ventilated using the ventilator device 100. As described below, the actuators 140 may be controlled by the controller 150 to adjust the valves 130 in a desired manner. In some embodiments, each of the actuators 140 may be a motor, such as a servo motor, as shown. In other embodiments, each of the actuators 140 may be a solenoid valve or any other type of actuation device suitable for adjusting the valves 130 between the open position, closed position, and partially open positions. In some embodiments, as shown, the actuators 140 may be movably coupled to the valves 130 such that movement of a portion of one of the actuators 140 causes a mating portion of the respective valve 130 to move to adjust the position of the valve 130. For example, rotation of a portion of one of the actuators 140 may cause a mating portion of the respective valve 130 to rotate to adjust the position of the valve 130. Various other types of movable couplings between the actuators 140 and the valves 130 may be used in other embodiments. In some embodiments, as shown, the actuators 140 may be removably coupled to the valves 130, for example, to facilitate disassembly of the ventilator device 100 for maintenance or cleaning purposes.
The controller 150 may be in operable communication with the actuators 140 as well as other electronic components of the ventilator device 100. As shown in
In some embodiments, the controller 150 may be configured to receive a predetermined inspiratory to expiratory ratio for the patients being treated using the ventilator device 100 and to independently control the actuators 140 to adjust the valves 130 based at least in part on the predetermined inspiratory to expiratory ratio for the patients. In some embodiments, the controller 150 may be configured to receive a predetermined inspiratory to expiratory ratio of the ventilator 190 being used with the ventilator device 100 and to independently control the actuators 140 to adjust the valves 130 based at least in part on the predetermined inspiratory to expiratory ratio of the ventilator. As described below; the predetermined inspiratory to expiratory ratio for the patients and the predetermined inspiratory to expiratory ratio of the ventilator may be input by a user, such as a clinician, via the user interface 160 and provided to the controller 150.
In some embodiments, the controller 150 may employ temporal multiplexing in independently controlling the actuators 140 to adjust the valves 130 for providing ventilation to a plurality of patients. As described further below, the valves 130 may be alternately adjusted such that only one of the valves 130 is in the open position or a partially open position while a remainder of the valves 130 are in the closed position, and thus air is delivered from the ventilator device 100 to only one of the patients at a time. For example, during operation of the illustrated ventilator device 100 having two valves 130, the first valve 130 may be adjusted to the open position or a partially open position to deliver air to a first patient while the second valve 130 is in the closed position for a first time period, and then the second valve 130 may be adjusted to the open position or a partially open position to deliver air to a second patient while the first valve 130 is in the closed position for a subsequent second time period. Further, for other time periods during which the ventilator 190 is not delivering air to the ventilator device 100, both of the valves 130 may be maintained in the closed position, such that no air is delivered from the ventilator device 100 to the patients during those time periods. According to the temporal multiplexing approach, the controller 150 may determine the timing and duration of the time periods during which one of the valves 130 is in the open position or a partially open position and the time periods during which both of the valves 130 are maintained in the closed position based at least in part on the predetermined inspiratory to expiratory ratio for the patients. In various embodiments, the predetermined inspiratory to expiratory ratio for the patients may be 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:5, or any other ratio suitable for providing ventilation to the plurality of patients being ventilated using the ventilator device 100. It will be appreciated that the predetermined inspiratory to expiratory ratio for the patients selected by a clinician may be influenced by the range of inspiratory to expiratory ratios at which the ventilator 190 being used with the ventilator device 100 is capable of operating. In some embodiments, the controller 150 may be an Arduino microcontroller. In other embodiments, the controller 150 may be a Raspberry Pi controller, which may use Python programming language. In still other embodiments, the controller 150 may be any processor capable of independently controlling the actuators 140 to adjust the valves 130 for providing ventilation to a plurality of patients. The controller 150 may be programmed to receive one or more settings and/or one or more operating parameters, as described herein, and to control the actuators 140 to adjust the valves based at least in part on the one or more settings and/or one or more operating parameters.
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In some embodiments, the sensors 180 of the ventilator device 100 may include a plurality of flow sensors 184, as shown in
In some embodiments, the sensors 180 of the ventilator device 100 may include a plurality of oxygen sensors 186, as shown in
In some embodiments, the sensors 180 of the ventilator device 100 may include a plurality of carbon dioxide sensors 188, as shown in
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The electronic components of the ventilator device 100, including the actuators 140, the controller 150, the user interface 160, and the sensors 180, may be powered by an external power source. For example, the ventilator device 100 may be connected to mains power for providing power to the electronic components. In some embodiments, the ventilator device 100 may include an internal power source, such as one or more batteries or other power storage devices, as a backup to the external power source. In this manner, the internal power source may allow for temporary use of the ventilator device 100 while external power is not available, for example, during intermittent power outages. Because the ventilator device 100 is intended for use in emergency situations, the internal power source may be particularly beneficial for patient safety, enabling continuous operation of the ventilator device 100.
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The ventilator device 100 may be configured to operate in different modes for controlling ventilation of a plurality of patients. In some embodiments, the ventilator device 100 may be configured to operate in a pressure control ventilation mode, according to which the controller 150 controls the actuators 140 to adjust the valves 130 to regulate the pressure of air delivered to the respective patients based on settings input by the clinician for the different patients. Specifically, the clinician may use the user interface 160 to input a set of inspiratory pressure settings for the patients, including a particular inspiratory pressure setting for each of the respective patients, as well as an inspiratory pressure setting of the ventilator 190 (i.e., the pressure of air delivered from the ventilator 190 to the ventilator device 100). The controller 150 may receive the set of inspiratory pressure settings for the patients and the inspiratory pressure setting of the ventilator 190 from the user interface 160 and may independently control the actuators 140 to adjust the valves 130 based at least in part on the set of inspiratory pressure settings for the patients and the inspiratory pressure setting of the ventilator 190. In particular, the controller 150 may control the actuators 140 to adjust the valves 130 such that the respective resistances provided by the valves 130 correspond to the respective inspiratory pressure settings for the patients. The resistance provided by each of the valves 130 may induce a pressure drop from the pressure of air being delivered from the ventilator 190 to the ventilator device 100 to a lower pressure for the respective patient, thereby allowing for safe delivery of appropriate pressures and volumes for each of the patients. In this manner, each of the patients may receive customized breaths, despite the patients having different ventilation requirements. During operation of the ventilator device 100, the resistance being provided by a particular one of the valves 130 may be changed by the clinician adjusting the inspiratory pressure setting for the respective patient via the user interface 160. In this manner, the ventilator device 100 may provide dynamic control of the pressures of air being delivered to the patients, allowing the ventilator device 100 to adapt to changing ventilation needs of each patient as that patient's condition worsens or improves, without impacting the ventilator device's ability to provide adequate ventilation to the remaining patients. As discussed above, the clinician also may use the user interface 160 to input an inspiratory to expiratory ratio for the patients and an inspiratory to expiratory ratio of the ventilator 190, which the controller 150 may use to split airflow temporally to the different patients being ventilated using the ventilator device 100.
In some embodiments, the controller 150 may control the actuators 140 to adjust the valves 130 based at least in part on a predetermined pressure drop calibration curve for the valves 130.
As discussed above, in some embodiments, the ventilator device 100 may include pressure sensors 182 in operable communication with the controller 150, with each of the pressure sensors 182 being configured to detect a pressure of air flow downstream of a respective one of the valves 130. The controller 150 may be configured to receive pressure signals indicative of pressures detected by the pressure sensors 182 and to independently control the actuators 140 to adjust the valves 130 based at least in part on the pressure signals. In this manner, one of the pressure sensors 182 may be used to detect the pressure of air being delivered to one of the patients during that patient's inspiratory phase, and the controller 150 may control the respective actuator 140 to adjust the respective valve 130 based on a difference between the pressure detected by the pressure sensor 182 and the inspiratory pressure setting for the patient. For example, if the detected pressure is greater than the patient's inspiratory pressure setting, the controller 150 may control the actuator 140 to adjust the valve 130 to a partially open position closer to the closed position. Conversely, if the detected pressure is less than the patient's inspiratory pressure setting, the controller 150 may control the actuator 140) to adjust the valve 130 to a partially open position closer to the open position. In this manner, the controller 150 and the respective pressure sensor 182 may implement a near real-time feedback loop for controlling the pressure of air being delivered to the respective patient.
In some embodiments, the controller 150 may use a pre-determined pressure drop calibration curve, as discussed above, along with the pressure signals received from the pressure sensors 182 in controlling the actuators 140 to adjust the valves 130. Specifically, the controller 150 may implement code for using the detected pressure data to override the pre-determined pressure drop calibration curve to ensure accuracy of the ventilation provided to the respective patients. In this manner, the controller 150 may implement a near real-time feedback loop for controlling the pressure of air being delivered to the respective patients. As discussed above, the pressure sensors 182 may be coupled to the branches 126 of the air tube splitter 120 downstream from the valves 130 and in operable communication with the controller 150, with each of the pressure sensors 182 being configured to detect a pressure of air flow downstream from a respective one of the valves 130. The controller 150 may be configured to receive pressure signals indicative of pressures detected by the pressure sensors 182 and to independently control the actuators 140 to adjust the valves 130 based at least in part on the pressure signals. In this manner, the controller 150 may be configured to determine a pressure of air being delivered to a particular patient and to control the respective actuator 140 to adjust the respective valve 130, as needed, in accordance with a predetermined inspiratory pressure setting for the patient, as input by the clinician. In an example scenario, the inspiratory pressure setting for a patient may be set at 21 cmH2O, while the pressure sensor 182 corresponding to the patient may detect that the pressure of air delivered to the patient is only 19.2 cmH2O (e.g., due to a leak in the circuit or variation in the consistency of breaths delivered by the ventilator 190). In this scenario, based on the detected pressure, the controller 150 may control the respective actuator 140 to adjust the respective valve 130 to a position that more accurately corresponds to the inspiratory pressure setting for a patient (i.e., adjusting the valve 130 to a position closer to the fully open position). In some embodiments, the controller 150 may use an adjustment algorithm that receives the current position of the valve 130 and the detected pressure as inputs and that provides an output of a new position to which the valve 130 is to be moved. In some embodiments, the controller 150 may rely solely on the pressure signals received from the pressure sensors 182 in controlling the actuators 140 to adjust the valves 130, eliminating the need for a pressure drop calibration curve. In some embodiments, the controller 150 may rely solely on a pressure drop calibration curve in controlling the actuators 140 to adjust the valves 130, for example, when the ventilator device does not include the pressure sensors 182. Still other approaches for operating the ventilator device 100 in the pressure control ventilation mode may be used in other embodiments.
In some embodiments, the controller 150 may be configured to use data from any of the sensors 180 or any combination of the sensors 180 in implementing a near real-time feedback loop for controlling one or more characteristics of air being delivered to the respective patients. For example, the controller 150 may use pressure data, flow rate data, tidal volume data, or lung compliance data, or any combination of such data, in implementing a near real-time feedback loop for controlling one or more characteristics of air being delivered to the respective patients. In some embodiments, the controller 150 may use data for non-airflow related parameters, such as blood oxygen levels, end tidal CO2 concentration, blood pressure, heart rate, or other physiological measurements in implementing a near real-time feedback loop for controlling one or more characteristics of air being delivered to the respective patients. In implementing any of these types of feedback loops, the controller 150 may use one or more algorithms that receive the corresponding data as an input and that provide an output corresponding to a particular position of the respective valve 130 for a particular patient such that the patient receives air having the desired characteristics.
In some embodiments, the controller 150 may be configured to perform an internal calibration using data from one or more of the sensors 180. For example, the internal calibration may be performed with test lungs in a simulated scenario of co-ventilation. The controller 150 may receive the settings of the ventilator 190, input by a user via the user interface 160, and the corresponding data signals from the sensors 180 obtained during ventilation of the test lungs with the valves 130 in various positions. The controller 150 may use the detected data to generate a new calibration curve that the controller 150 then uses for controlling the actuators 140 to adjust the valves 130 during subsequent operation of the ventilator device 100 for co-ventilation of multiple patients. Such internal calibration may be particularly useful in providing compatibility of the ventilator device 100 with many different types of ventilators 190.
As discussed above, in some embodiments, the controller 150 may employ temporal multiplexing in independently controlling the actuators 140 to adjust the valves 130 for providing ventilation to a plurality of patients. Specifically, the valves 130 may be alternately adjusted such that only one of the valves 130 is in the open position or a partially open position while a remainder of the valves 130 are in the closed position, and thus air is delivered from the ventilator device 100 to only one of the patients at a time. The temporal multiplexing approach may be implemented based on the inspiratory to expiratory ratio of the ventilator 190 and the inspiratory to expiratory ratio for the patients being ventilated using the ventilator device 100. The respiratory rates of patients consist of an inspiratory time (I-time) and an expiratory time (E-time). During the inspiratory time for a particular patient, which may be one second in duration, the ventilator device 100 may deliver air to the patient at a set pressure or volume. During the expiratory time for a particular patient, which may be of a variable duration depending on the number of patients being co-ventilated using the ventilator device 100, the patient may exhale passively while no air is being delivered from the ventilator device 100 to the patient. The time multiplexing approach takes advantage of this resting time to deliver another personalized breath to a second patient. To accomplish this, the ventilation rate of the ventilator 190 may be doubled. In this manner, the ventilator device 100 may facilitate the distribution and customization of each breath to each patient in an alternating pattern.
In some embodiments, the ventilator device 100 may be configured to operate in a volume control ventilation mode, according to which the controller 150 controls the actuators 140 to adjust the valves 130 to regulate the volume of air delivered to the respective patients based on settings input by the clinician for the different patients. Specifically, the clinician may use the user interface 160 to input a set of tidal volume settings for the patients, including a particular tidal volume setting for each of the respective patients, as well as a tidal volume setting of the ventilator 190 (i.e., the volume of air delivered from the ventilator 190 to the ventilator device 100 during a single inspiratory phase of the ventilator). The controller 150 may receive the set of tidal volume settings for the patients and the tidal volume setting of the ventilator 190 from the user interface 160 and may independently control the actuators 140) to adjust the valves 130 based at least in part on the set of tidal volume settings for the patients and the tidal volume setting of the ventilator 190. In particular, the controller 150 may control the actuators 140 to adjust the valves 130 such that the volumes of air that flow through the respective valves 130 correspond to the respective tidal volume settings for the respective patients. In this manner, each of the patients may receive customized breaths, despite the patients having different ventilation requirements. During operation of the ventilator device 100, the volume of air being provided by a particular one of the valves 130 may be changed by the clinician adjusting the tidal volume setting for the respective patient via the user interface 160. In this manner, the ventilator device 100 may provide dynamic control of the volumes of air being delivered to the patients, allowing the ventilator device 100 to adapt to changing ventilation needs of each patient as that patient's condition worsens or improves, without impacting the ventilator device's ability to provide adequate ventilation to the remaining patients.
As discussed above, in some embodiments, the ventilator device 100 may include flow sensors 184 in operable communication with the controller 150, with each of the flow sensors 184 being configured to detect a flow rate of air flow downstream of a respective one of the valves 130. The controller 150 may be configured to receive flow rate signals indicative of flow rates detected by the flow sensors 184 and to independently control the actuators 140 to adjust the valves 130 based at least in part on the flow rate signals. In this manner, one of the flow sensors 184 may be used to detect the flow rate of air being delivered to one of the patients during that patient's inspiratory phase, and the controller 150 may control the respective actuator 140 to adjust the respective valve 130 based on the flow rate detected by the flow sensor 184 and the tidal volume setting for the patient. For example, the controller may use the flow rate detected by the flow sensor 184 to calculate the volume of air delivered to the patient and then control the respective actuator 140 to adjust the respective valve 130 to the closed position when the calculated volume of air is equal to the patient's tidal volume setting. In this manner, the controller and the respective flow sensor 184 may implement a near real-time feedback loop for controlling the volume of air being delivered to the respective patient. Still other approaches for operating the ventilator device 100 in the volume control ventilation mode may be used in other embodiments.
According to one example of the ventilator device 100 operating in the volume control ventilation mode for co-ventilation of two patients, the tidal volume setting of the ventilator 190 may be 600 mL, the tidal volume setting for the first patient may be 400 mL. and the tidal volume for the second patient may be 200 mL. The inspiratory phase of the ventilator 190 may include two stages, a first stage corresponding to the inspiratory phase of the first patient and a second stage corresponding to the inspiratory phase of the second patient. During the first stage, the first valve 130 (i.e., the valve 130 corresponding to the first patient) of the ventilator device 100 may be in the open position or a partially opened position while the second valve 130 (i.e., the valve 130 corresponding to the second patient) is in the closed position, such that a tidal volume of 400 mL of air is delivered from the ventilator device 100 to the first patient, while no air is delivered from the ventilator device 100 to the second patient. During the second stage, the second valve 130 may be in the open position or a partially opened position while the first valve 130 is in the closed position, such that a tidal volume of 200 mL of air is delivered from the ventilator device 100 to the first patient, while no air is delivered from the ventilator device 100 to the second patient. During the expiratory phase of the ventilator 190, both of the valves 130 may be in the closed position, such that no air is delivered from the ventilator device 100 to either of the patients. According to various example uses, the ventilator device 100 may be operated in the volume control ventilation mode to facilitate temporally split breaths with different and similar pressures and tidal volumes to allow for co-ventilation of multiple patients, independent of their lung compliance.
In some embodiments, the ventilator 190 may be operated in a continuous positive airway pressure (CPAP) mode, such that the ventilator 190 provides continuous airflow output at a predetermined pressure, and the ventilator device 100 may be used to distribute portions of the airflow to a plurality of patients. By receiving a continuous flow of air from the ventilator 190, the ventilator device 100 may provide co-ventilation for an increased number of patients.
In some embodiments, the time-multiplexing approach and the electromechanical control of the actuators 140 of the ventilator device 100 may be combined with the ventilator 190 being operated in a CPAP mode to ventilate multiple patients with different I:E ratios for the patients. When operating in the CPAP mode, the ventilator 190 may be constantly sensing and waiting for a decrease in pressure in the ventilation circuit to deliver air and raise the pressure back up to the set point. By individually controlling the actuators 140 to adjust the valves 130 between the open position and the closed position, each patient's branch may be opened in rhythm to a separate I:E ratio, and the ventilator 190 may produce variable flow rates to deliver air as appropriate for each of the patients. This approach may not allow for ventilation at different times for every breath, but resistances still may be induced to personalize the inspiratory pressure of the air delivered to each patient. Inspiratory times can be adjusted to allow variable inspiratory times and even reverse I:E ratios (i.e., where the inspiratory time is longer than the expiratory time, e.g., a I:E ratio of 1.5:1). In one example in which the ventilator device 100 is used to provide ventilation to two patients, a I:E ratio of 1:3 may be used for a first patient, and a I:E ratio of 1:1 may be used for a second patient. One implementation of this example is provided in Table 1, showing positions of the valves 130 for the respective patients at different times of a cycle. In another example in which the ventilator device 100 is used to provide ventilation to two patients, a I:E ratio of 1:3 may be used for a first patient, and a I:E ratio of 1.5:1 may be used for a second patient. One implementation of this example is provided in Table 2, showing positions of the valves 130 for the respective patients at different times of a cycle.
In some embodiments, multiple of the ventilator devices 100 may be used with a single ventilator 190 for co-ventilation of a plurality of patients. For example,
In some embodiments, the ventilator device 100 may be used with a source of pressurized air other than a ventilator for ventilating a plurality of patients. For example,
In some embodiments, the ventilator device 100 may be used with a source of pressurized air and a source of oxygen in ventilating a plurality of patients, with the ventilator device 100 being configured to control a fraction of inspired oxygen (FiO2) for each of the patients. For example,
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In some embodiments, the valves 330 may be coupled to the branches 326 of the air tube splitter 320 by the first connectors 332. As shown, the first connectors 332 may be coupled to the branches 326 and the valves 230, with each of the first connectors 232 connecting a respective one of the valves 330 to a respective one of the branches 326. In some embodiments, the second connectors 334 may be coupled to the valves 330 for connecting respective ventilation tubing lines extending between the ventilator device 300 and the patients being ventilated. As shown, the second connectors 334 may be coupled to the valves 330, with each of the second connectors 334 being configured to connect a ventilation tubing line to a respective one of the valves 330. In some embodiments, as shown, the second connectors 334 may define the outlets 314 of the overall ventilator circuit 310.
The actuators 340 may be coupled to the valves 330 and configured to adjust the positions of the respective valves 330 to regulate air flow through the ventilator circuit 300 in a desired manner for ventilating the patients connected to the ventilator device 300. In particular, each of the actuators 340) may be configured to adjust a respective one of the valves 330 between the open position, closed position, and partially open positions of the valve 330. The actuators 340 may be controlled by the controller 350 to adjust the valves 330 in a desired manner. In some embodiments, each of the actuators 340) may be a motor, such as a servo motor, as shown, although other types of actuation devices may be used in other embodiments.
The controller 350 may be in operable communication with the actuators 340 as well as other electronic components of the ventilator device 300. As shown, the controller 350 may be in operable communication with the actuators 340 and the user interface 360. In some embodiments, the controller 350 may be in operable communication with one or more sensors of the ventilator device 300, which may be similar to the sensors 180 discussed above. The controller 350 may be configured to control operation of the actuators 340 to adjust the valves 330 based at least in part on one or more settings and/or one or more operating parameters of the ventilator device 300. In some embodiments, the controller 350 may be configured to receive one or more settings for the patients being treated using the ventilator device 300 and to independently control the actuators 340 to adjust the valves 330 based at least in part on the settings. According to various embodiments, the controller 350 may be configured to interact with and control the other components of the ventilator device 300 in a manner similar to the controller 150 described above with respect to the ventilator device 100. In other words, the controller 350 may provide the same functionality as the controller 150 described above.
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The electronic components of the ventilator device 300, including the actuators 340, the controller 350, the user interface 360, and the sensors 380, may be powered by an external power source. For example, the ventilator device 300 may be connected to mains power for providing power to the electronic components. In some embodiments, as shown, the ventilator device 300 also may include an internal power source, such as one or more batteries or other power storage devices, as a backup to the external power source. In this manner, the internal power source may allow for temporary use of the ventilator device 300 while external power is not available, for example, during intermittent power outages. Because the ventilator device 300 is intended for use in emergency situations, the internal power source may be particularly beneficial for patient safety, enabling continuous operation of the ventilator device 300.
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The ventilator devices 100, 300 described herein may be used in various types of environments for safely co-ventilating various types of patients, as needed, when ventilator demand exceeds availability. In some instances, the ventilator devices 100, 300 may be used in the event of pandemics, such as the COVID-19 pandemic, chemical warfare, environmental disasters, mass shootings, or other locoregional disturbances that may cause increased demand. The ventilator devices 100, 300 may be beneficial in developing countries or areas with limited ventilator resources. The ventilator devices 100, 300 also may be useful for the military, particularly in remote areas, where appropriate ventilator supply may be limited or logistically difficult because of travel needs. In various instances, the ventilator devices 100, 300 may be used for multiple adult or pediatric patients in hospitals or other types of healthcare facilities. In some instances, the ventilator devices 100, 300 may be used in neonatal applications, to provide ventilation to multiple infants. The ventilator devices 100, 300 also may be used for co-ventilation of multiple animals. Comparative medicine and veterinary practices often use ventilators for pre-clinical studies or life-saving procedures. Use of the ventilator devices 100, 300 employing the time-multiplexing approach for animal surgeries or life support may increase the quality of life for the animals.
The ventilator devices 100, 300 often may be used in hospitals or other types of healthcare facilities having ventilators. In some instances, the ventilator devices 100, 300 may be moved from one location to another in such facilities and then supported by existing structure in the area of the patients being treated. For example, the ventilator devices 100, 300 may be temporarily mounted to or otherwise supported by a ventilator with which the devices 100, 300 are being used, for example, via a hook or other type of fastener provided with the devices 100, 300. In some instances, the ventilator devices 100, 300 may be permanently or temporarily mounted on a wall in a hospital or other healthcare facility. In hospitals, air and oxygen gas lines often are embedded into the walls of the hospital. In such instances, the ventilator devices 100, 300 may be mounted to the same walls, mediating the gas lines to patients and providing the ability to safely ventilate multiple patients in a time multiplexed manner to increase hospital capacity. In some instances, the ventilator devices 100, 300 may be provided within emergency vehicles, such as ambulances. Emergency vehicles often require the ability to mechanically ventilate a patient. During mass casualty events, an ambulance carrying a single patient can cause delays to others who need similar life-saving procedures, and thus embedding the ventilator devices 100, 300 into emergency vehicles may increase the number of patients that can be safely transported to a hospital for further care. As will be appreciated, the ventilator devices 100, 300 may be used in various types of environments other than traditional healthcare facilities.
In some embodiments, the functionality of the ventilator devices 100, 300 described above may be incorporated into a ventilator. In other words, instead a ventilator being used along with one of the ventilator devices 100, 300, a ventilator itself may be configured to provide the functionality of the ventilator devices 100, 300 to allow safe co-ventilation of multiple patients.
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In some embodiments, the ventilator 400 may have only a single inspiratory port 402 but may include a valve assembly for controlling the flow of air from the inspiratory port 402 to multiple patients.
A number of example embodiments are provided herein. However, it is understood that various modifications can be made without departing from the spirit and scope of the disclosure herein. As used in the specification, and in the appended claims, the singular forms “a.” “an,” “the” include plural referents unless the context clearly dictates otherwise. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. Although the terms “comprising” and “including” have been used herein to describe various implementations, the terms “consisting essentially of” and “consisting of” can be used in place of “comprising” and “including” to provide for more specific implementations and are also disclosed.
Disclosed are materials, systems, devices, methods, compositions, and components that can be used for, can be used in conjunction with, can be used in preparation for, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed, while specific reference of each various individual and collective combinations and permutations of these components may not be explicitly disclosed, each is specifically contemplated and described herein. For example, if a device is disclosed and discussed each and every combination and permutation of the device, and the modifications that are possible are specifically contemplated unless specifically indicated to the contrary. Likewise, any subset or combination of these is also specifically contemplated and disclosed. This concept applies to all aspects of this disclosure including. but not limited to, steps in methods using the disclosed systems or devices. Thus, if there are a variety of additional steps that can be performed, it is understood that each of these additional steps can be performed with any specific method steps or combination of method steps of the disclosed methods, and that each such combination or subset of combinations is specifically contemplated and should be considered disclosed.
Although embodiments have been described in language specific to structural features and/or methodological acts, it is to be understood that the disclosure is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as illustrative forms of implementing the embodiments. Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments could include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63/320,453, filed on Mar. 16, 2022, and titled “Time or Tidal Volume Splitting Ventilator and methods of Use,” and U.S. Provisional Patent Application No. 63/176,039, filed on Apr. 16, 2021, and titled “Time or Tidal Volume Splitting Ventilator and methods of Use,” the disclosures of which are expressly incorporated herein by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/025218 | 4/18/2022 | WO |
Number | Date | Country | |
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63176039 | Apr 2021 | US | |
63320453 | Mar 2022 | US |