WO2018065448A1

WO2018065448A1 - An apparatus and method for harvesting energy during bag valve mask ventilation

Info

Publication number: WO2018065448A1
Application number: PCT/EP2017/075157
Authority: WO
Inventors: Kiran Hamilton J. DELLIMORE; Calina Ciuhu
Original assignee: Koninklijke Philips N.V.
Priority date: 2016-10-05
Filing date: 2017-10-04
Publication date: 2018-04-12

Abstract

There are provided methods, systems and apparatus (10) for powering a bag valve mask (BVM, 100) feedback device by harvesting (150) and storing (180) the energy used by an operator to compress and decompress the inflatable bag during the ventilation process. The BVM feedback device further comprises a means to advantageously utilize the produced and stored energy to power acquisition of pressure and flow rate data (400), transmission (500) of the acquired data to a wireless receiver (600), such as a cell phone or similar portable communications device, and for recording and/or immediate provision of feedback to the operator based on the acquired data.

Description

AN APPARATUS AND METHOD FOR HARVESTING ENERGY DURING BAG

VALVE MASK VENTILATION

FIELD OF THE INVENTION

The present disclosure is directed generally to bag valve mask ventilation system. More particularly, but not exclusively, various methods and apparatus disclosed herein relate to systems and methods for harvesting energy during bag valve mask ventilation to power feedback and guidance systems for a user.

BACKGROUND OF THE INVENTION

Manual bag valve mask ventilation ("BMV") is a critical and essential emergency medical procedure used to provide positive pressure ventilation to patients who are experiencing respiratory arrest or failure caused by any one of a myriad medical conditions. BMV is typically performed using a device called a bag valve mask ("BVM") that typically comprises a self-inflating bag, a one-way valve, and a mask shaped to cover the patient's mouth and nose. BMV is employed in many medical response situations to patients who aren't breathing properly (respiratory failure) or patients who are not breathing at all (respiratory arrest). BMV is performed in field settings by firefighters, paramedics, and medics, in clinics by medical personnel, and in hospitals for emergency response as well as during surgical operations. Bag valve masks are standard equipment in ambulances and hospital crash carts, and are in widespread use.

In operation, BVM use require the bag to be manually compressed, thereby forcing air (or any gas such as oxygen) through the valve and through the patient's airway through the trachea and into the lungs. By periodically compressing the bag an emergency responder may resuscitate a patient or at least force them to breathe until further medical measures can be taken. Manually operated BVMs are typically compressed at a frequency of 10-20 compressions per minute (cpm) depending on the size and age of the patient. Adults usually require a bag compression every 5-6 seconds while children and infants require a bag compression every 3 seconds.

The mask portion of the apparatus must be sealed around the patients' mouth and nose so that all the air being forced through the one-way valve enters the patients' lungs. Typically, the mask must be held in place by a user to create the air seal. Accordingly, the user must compress and release the bag with one hand while holding the mask in place with the other hand. This technique, (termed a "CE" technique for the proper hand position) can often be cumbersome for a person to perform over any extended period of time and thus a tandem approach is often employed, with one user holding the mask to the patients' face to maintain a good seal around the perimeter of the mask, while a second user focuses on compressing and filling the bag properly and at the proper time intervals.

One drawback of manual bag valve masks is the lack of feedback provided to the responder regarding the frequency and pressure of air being supplied to the patient. One response to this problem is the use of an add-on apparatus to a BVM called an Augmented Infant Resuscitator ("AIR"). AIR devices were developed to aid primarily in infant resuscitation in low-resource settings. The AIR device provides an apparatus to monitor air pressure and flow rate through the mask as it is being operated, thereby providing an operator with data to determine if they are compressing the bag frequently enough and with enough power to optimize aid to the patient. Typically, AIR systems provide an operator with one or more LED indicators to guide resuscitation efforts. AIR devices can also monitor air leakage and aid in determining if there is airway blockage or restrictions hindering the resuscitation. AIR devices are particularly useful in infant resuscitation where the pulmonary systems are less developed and more sensitive. The operator feedback permits a responder to provide optimal airway management and support during BVM operation thereby maximizing the probability of a positive outcome for a patient.

However, as described in US 2014/0275820 Al AIR devices require an electrical power source to operate the sensors necessary to monitor pressure and airflow rate, as well as power visual and/or audible indicators to the operator to provide feedback during use. Most AIR devices are necessarily battery powered, and therefore are suitable for use in portable and emergency settings such as ambulances or military medical field use. Of course the main disadvantage of battery powered systems is their tendency to fail during use due to discharged (i.e., dead) batteries, particularly when the BVM is subjected to temperature extremes and frequent temperature fluctuations encountered in out-of-hospital settings.

SUMMARY OF THE INVENTION

The present disclosure is related to methods, systems and apparatus for powering a BVM feedback device by harvesting and storing the energy used by an operator to compress and decompress the inflatable bag during the ventilation process. The power produced and stored by the system described herein is then advantageously used to power an AIR device or similar feedback apparatus that provides pressure and flow rate data to the operator of the BVM during use. Furthermore, the invention provides a source of power to the BVM that is sufficient to enable the wireless transmission of all data collected by the BVM device to a wireless receiver, such as a cell phone or similar portable communications device, which can then be recorded and/or immediately used to provide feedback to the operator.

In various embodiments, the invention described herein includes a bag valve mask (BVM) having an inflatable self-filling bag that is in fluid communication with a one way valve, which is in turn in fluid communication with a mask capable of being placed over the nose and mouth of a patient in respiratory distress. The invention may further include at least one of a pressure sensor for determining air pressure in the bag and/or mask and/or a flow rate sensor to determine the volume of gas or air being supplied through valve and mask to the patient and/or a carbon dioxide sensor for measuring the C0₂ concentration of the patient's exhaled breath.

In various other embodiments of the invention, the apparatus for harvesting energy includes a light, or a plurality thereof, to provide visual feedback to a user regarding proper pressure and/or airflow through the BVM to the patient. In other aspects of the invention a speaker or buzzer may be included to provide an audible indicator to an operator that may be indicative of proper or improper device usage. The invention further includes a source of electrical power storage, such as a battery to supply electrical power to the lights and/or speaker in alternative embodiments.

In some embodiments of the invention, an electrical generator is provided to convert a portion of the motion of the bag compression into electrical energy and supply the electrical energy to a conventional storage battery. A linear alternator may be employed as an electrical generator without departing from the scope of the invention, the alternator converting a portion of linear motion of the inflatable bag into electrical energy. In other aspects of the invention a piezoelectric material or a rotary alternator may be used as an electrical generator to convert the bag motion into usable electrical power without departing from the scope of the invention.

In various embodiments of the invention a processor or controller having concomitant data memory forms a part of the invention, the processor having a plurality of inputs for receiving signals and outputs for supplying signals to components of the invention. According to one aspect of the invention the processor accepts data from the flow and pressure sensors, stores the data for further use, analyzes the data based upon predetermined criteria and activates outputs to the lights and/or speaker of the instant invention to provide feedback to a user regarding the operation of the BVM device.

In further embodiments of the invention, a wireless transmitter is operably coupled to the processor to provide transmission of data being gathered and stored by the processor to other wireless capable devices, such as smartphones, tablet computers, or other wireless enabled devices. In some aspects of the invention the processor may provide a wired data output that may be operably coupled to the input of another device for storage, viewing, or further processing.

In various alternative embodiments of the invention a user interface operably coupled to the controller may be provided to enable a user to interact with the BVM device to provide physical characteristics of the patient and otherwise configure the operation of the BVM device to produce a desired feedback system or a desired data output. A user interface may encompass any known user interface such as a touch sensitive display, or a simple LCD or LED display and a pushbutton(s).

In various embodiments of the invention the speaker may provide an audible metronomic pulse to the user to assist in timing the compressions of the bag. The

metronomic pulse in various aspects of the invention may be customized to provide a predetermined periodic pulse based upon physical characteristics of the patient supplied through the user interface.

In further alternative embodiments of the invention a real time clock may be provided either separately or integrally with the processor to permit time stamping of data acquired during operation of the system disclosed herein.

Generally, in one aspect, the invention is a system for capturing energy from the compression and de-compression of a BBVM that utilizes a linear alternator disposed within the compressible bag to produce an electrical power output that may then be stored in an electrical (power) storage system and/or utilized to operate a processor and concomitant inputs and outputs as well as pressure and flow sensors to monitor the ventilation of a patient.

As used herein for purposes of this disclosure the term "bag valve mask" or "BVM" should be understood to include, but not be limited to, any manual resuscitator, mechanical ventilator or ambu-bag that incorporates a self-inflating bag, a one-way valve or shutter valve, and a mask for providing a seal around a patients' mouth and nose. BVMs may include attached and/or detachable supplemental oxygen tanks and fittings to secure the bag and valve to an endotracheal tube or laryngeal mask airway. Furthermore, the various sized masks may be employed to fit patients of differing sizes.

As used herein for purposes of the present disclosure, the term "wireless transmitter" is used herein to generally describe apparatus and systems relating to the wireless transmission of a signal. Any of a wide variety of wireless transmission devices and communications protocols may be employed in the system of the invention, including analog and digital transmission systems. Exemplary but non-limiting wireless transmitters that may form a part of the invention include radio transmitters, cellular transmitters, LTE and LTE advanced systems, ZigBee TM, Wi-Fi, and Bluetooth transmitters. Additionally, a plurality of wireless network and transmission systems may be employed without departing from the scope of the invention, including but not limited to wireless personal area networks, local area networks, mesh networks, metropolitan area and global area networks.

The term "processor" or alternatively "controller" is used herein generally to describe various apparatus relating to the operation of one or more light sources. A controller can be implemented in numerous ways (e.g., such as with dedicated hardware) to perform various functions discussed herein. A "processor" is one example of a controller which employs one or more microprocessors that may be programmed using software (e.g., microcode) to perform various functions discussed herein. A controller may be implemented with or without employing a processor, and also may be implemented as a combination of dedicated hardware to perform some functions and a processor (e.g., one or more

programmed microprocessors and associated circuitry) to perform other functions. Examples of controller components that may be employed in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field-programmable gate arrays (FPGAs).

In various implementations, a processor or controller may be associated with one or more storage media (generically referred to herein as "memory," e.g., volatile and non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM, floppy disks, compact disks, optical disks, magnetic tape, etc.). In some implementations, the storage media may be encoded with one or more programs that, when executed on one or more processors and/or controllers, perform at least some of the functions discussed herein.

Various storage media may be fixed within a processor or controller or may be transportable, such that the one or more programs stored thereon can be loaded into a processor or controller so as to implement various aspects of the present disclosure discussed herein. The terms "program" or "computer program" are used herein in a generic sense to refer to any type of computer code (e.g., software or microcode) that can be employed to program one or more processors or controllers.

The term "user interface" as used herein refers to an interface between a user or operator and one or more devices that enables interaction between the user and the device(s). Examples of user interfaces that may be employed in various implementations of the present disclosure include, but are not limited to, switches, potentiometers, buttons, dials, sliders, a mouse, keyboard, keypad, various types of game controllers (e.g., joysticks), track balls, display screens, various types of graphical user interfaces (GUIs), touch screens, microphones and other types of sensors that may receive some form of human-generated stimulus and generate a signal in response thereto.

It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the disclosure, wherein:

Fig. 1 schematically illustrates various components that may be used to implement techniques described herein, in accordance with various embodiments;

Fig. 2 depicts a bag valve mask in accordance with various embodiments of the invention;

Fig. 3 is a graphical representation of an exemplary energy storage calculation in accordance with various embodiments of the invention; and

Fig. 4 depicts a system of energy recovery in accordance with various embodiments of the invention. DETAILED DESCRIPTION OF EMBODIMENTS

Bag- Valve-Mask (BVM) systems are in widespread use in the medical community for providing a device and method for a user to assist a patient in respiratory distress or arrest. Known feedback systems to guide operators, such as Augmented Infant Resuscitator (AIR) systems are available in many BVM embodiments. However, these known AIR systems typically rely on battery power to operate properly, and as such are susceptible to failure at critical moments, since BVM systems are almost always in use when a patient is in medical distress. Accordingly, there is a need for a BVM system that harvests energy used in compressing an inflatable bag of a BVM, storying that energy, and utilizing the stored energy to power a user feedback device to aid in proper BVM operation.

Referring now to Figs. 1 and 2, and in accordance with one embodiment of the invention, a system 10 for BVM resuscitation includes a BVM apparatus 100 that has a self- inflating compressible bag 1 10 in fluid communication with a one-way valve 120, which is in turn in fluid communication with a mask 130 through a patient feedback device 200. Patient feedback device 200 may be, for example, an AIR device that provides operator guidance in BVM operation and for the purposes of this specification the two terms will be used synonymously, although feedback devices 200 are not limited to AIR type systems.

Furthermore, one-way valve 120 may comprise any known in the art one way flow valve suitable for use in a gas system, without departing from the scope of the invention.

In various embodiments AIR device 200 may include a passage 210 therein in fluid communication with both one-way valve 120 and mask 130 that includes a gas pressure sensor 220 for measuring the pressure of air (or any other gas) forced through passage 210 by compression of bag 1 10. For purposes of this specification the terms "air" and "gas" may be used interchangeably to denote any gas supplied to a patient through a BVM to aid in ventilation. Passage 210 may also include a flow sensor 230 for measuring the volume of gas traveling there through. Both the pressure and flow sensor may include signal outputs 222, 232 respectively, that are representative of the air pressure and flow rate through passage 210, as will be discussed further herein below. In alternative but non-limiting embodiments a carbon dioxide sensor may also be included to monitor the C0₂ content of the patient's breath. In an alternative embodiment, at least one pressure sensor and at least one flow sensor may be realized as one device having a data output representative of the pressure of the gas supplied from said inflatable bag and having a data output representative of the volume of the gas supplied from the inflatable bag. In some embodiments of the invention AIR device 200 may include a user interface 250 that may comprise a plurality of visual indicators, such as lights or LED's, or a low power display such as a liquid crystal display or an e-ink display, wherein the visual indicators are indicative of patient characteristics related to the ventilation process. In exemplary but non-limiting embodiments, user interface 250 may provide a user with an indication of correct or incorrect bag compression pressure for the patient, correct or incorrect air flow rate for the patient, and proper or improper compression frequency. In an exemplary but non-limiting embodiment user interface 250 may be provided with an indication that a sudden change in air pressure has occurred, thus indicating a potential lung injury in the patient.

In some embodiments of the invention user interface may also include an audible alarm or indication (provided by a small speaker) of proper or improper operation of BVM system 10 based upon the patient characteristics being monitored. Furthermore, user interface 250 may include a button, a plurality of buttons, a keypad, or a touch sensitive pad to enable a user to configure system 10 for use. For example, user interface 250 may be used to rapidly enter a patients' age or size such that the processor can provide predetermined ventilation parameters to configure the proper pressure and frequency of ventilation for a specific patient. Additionally, user interface 250 may be used to select an option to initiate data acquisition or data storage or transmission, as will be discussed further herein.

In various embodiments, system 10 may include a processor 300, for example a microcontroller having a plurality of electrical signal inputs 302 and outputs 304 that may be operatively coupled to various components of system 10 described herein. Processor 300 may include concomitant data storage memory, both RAM and ROM, and further may also be operatively coupled to additional storage memory 400 for storing and using data acquired during operation of BVM system 10. Memory 400 can include a number of memories including a main random access memory (RAM) for storage of instructions and data during processor 300 operation and a read only memory (ROM) n which fixed instructions may be stored.

In some embodiments of the invention processor 300 may be operatively coupled to AIR device 200 and user interface 250 to provide outputs 304 indicative of proper (or improper) system 10 operation as a visual and/or audible feedback for a user during patient ventilation. Processor inputs 302 may be operatively coupled to the outputs 222, 232 of flow and pressure sensors 220, 230 respectively, to acquire and store patient characteristic data as BVM 1 10 is operated. Processor outputs 304 may be supplied to, for example, power LED indicators, or provide selected messages on a user interface, or provide an audible signal to prompt a user during patient ventilation, as will be discussed in detail below.

Self-inflating bag 1 10, in various embodiment of the invention, includes a linear alternator 150 that is disposed in or proximate to bag 1 10 such that it is displaced upon compression and/or decompression of bag 1 10. Linear alternator 150, in certain

embodiments, typically includes a magnet that oscillates or otherwise moves back and forth inside an electrical coil, which thereby induces an electrical current in the coil, thereby providing a source of electrical power. Linear alternator 150 comprises an electrical power output 152 generated by its motion, which is in turn generated by the compression and decompression of the bag as patient ventilation is being performed. Power output 152 is operatively (systemelectrically) coupled to an electrical storage system 180, which can be one of many varieties of electrical storage systems including, but not limited to batteries and super capacitors.

Accordingly, in various embodiments of the invention power output 152 and/or the electrical storage system 180 may be coupled to AIR device 200, user interface 250 and processor 300 to provide electrical power for the operation thereof. Excess energy produced by the compression of bag 1 10 and operation of linear alternator 150 is then advantageously stored in storage system 180 for use in operating system 10 as required, even when compression of the bag is not being performed. The stored or produced by electrical generator (in this embodiment the linear alternator 150) power can be also used to enable an operation of the pressure and flow sensors.

As can be seen from the foregoing, in various aspects of the invention system 10 acts to harvest and store mechanical energy generated from the compression of the inflatable bag 1 10 during patient ventilation, and then to discharge this energy in the acquisition, and recording or storage of ventilation quality data (i.e., pressure and flow rate), as well as providing instantaneous feedback through user interface 250 to a responder through audio and/or visual indicators.

Furthermore, and as shown in Fig. 1, in various aspects of the invention the storing and or/sharing of the recorded ventilation data with other external devices 600 such as a smart phone, tablet or computer may be accomplished via a wireless transmitter 500.

Wireless transmitter 500 may comprise any one of a variety of wireless data transmission systems, including but not limited to NFC transmission, Bluetooth low energy transmission, and low-power Wi-Fi data transmission. Additionally, the transmission of stored data from system 10 to external device 600 may take place automatically, for example at predetermined intervals, or alternatively upon an user-initiated prompt via user interface 250.

In operation, and in accordance with various embodiments, system 10 is advantageously employed by compression of the inflatable bag 1 10 during patient ventilation. The kinetic energy of the compression/decompression motion is converted into electrical energy through the linear alternator 150. The induced electrical energy is then used to power the processor 300 to automatically acquire data from the pressure 220 and flow 230 sensors during patient ventilation. Processor 300 may then further monitor and process the acquired pressure and flow rate data to determine patient ventilation quality characteristics, including but not limited to, ventilation rate, leakage from mask 130 which is indicated by low sensor 230 pressure airway blockage, and air pressure. This ventilation characteristics data is then used by processor 300 to assess the quality of ventilation delivered by the operator which is then used to provide feedback (via user interface 250 and guidance to improve or maintain the quality of ventilation. For example, a ventilation rate that is too high may prompt an output 304 from processor 300 that provides a red LED indicator on interface 250, and/or an audible alarm indicating excessive ventilation rate. Similarly, a ventilation rate that is in the proper range may provide a green LED indicator, and/or a positive audible indication that the ventilation rate for that patient is acceptable.

In various embodiments of the invention excess electrical energy that is not consumed by operation of processor 300, user interface 250, and data acquisition sensors 220, 230 is stored in electrical storage system 180 for later use. In many patients, and following known resuscitation guidelines ventilation is typically delivered at a frequency of 10-20 breaths per minute (bpm) depending on whether an adult or infant is being

resuscitated, with a goal of delivering a target volume of gas such as air or air supplemented with oxygen. Typical target air volumes for an adult male are 400-800 ml.

Accordingly, based on known measured values for BMV usage the power and energy generated by compression and decompression of the inflatable self-filling bag 1 10 during ventilation may be calculated. Based upon an average compression force, per hand, of F = 100-200 N (based on squeezing force estimated from a squeeze flash light which produces 1.6 W at a squeezing rate of 1.5 Hz with a displacement of 0.01 m) and application of this force over a distance, d = 2.5-5.0 cm at a ventilation rate of /= 10-20 bpm (0.167— 0.333 Hz) the following power output is obtained: P = f*F*(2*d) = (0.167-0.333)

Hz*(2* 100-200) N*(2xl .25-2.5xl0^"2 m) = ± 0.84- 6.6 W where P = power output,/ = chest compression rate, F = compression force and d = sternal displacement during compression. The total energy, E_totai, harvested per minute is therefore:

Etotai = *60s = ± 50.4 - 396.0 J

As can be seen from the foregoing, the present invention provides a system capable of storing abundant excess energy generated in the operation of commonly used BVM systems. This energy is then used to provide power to user interface 250, processor 300 and data memory 400. Additionally, the patient characteristic data provided by pressure 220 and flow 230 sensors may be used to provide feedback to the user and be stored for further use by medical professionals or other users.

In various aspects of the invention, the stored ventilation characteristic data may then be transmitted via wireless transmitter 500, to a nearby mobile device or to cloud storage or an alternative data storage system. Wireless transmission systems utilizing Bluetooth, low power Wi-Fi transmission, or NFC wireless transmission may be used without departing from the scope of the invention, although a wide variety of wireless data transmission systems may be employed. Advantageously, low-power wireless transmission systems can be used in some embodiments of the invention. For example, the power requirement for low-power Wi-Fi or ZigBee™ transmission may be estimated at 36 mJ per 24 bytes of data, while for Bluetooth low energy transmission it is 0.147 mJ per 24 bytes. For an NFC transmitter the transmission energy is harvested from an external NFC reader (e.g., a data interrogator in a device such as a smartphone or handheld reader) such that no energy is used by the system 10 for data transfer in this embodiment of the invention.

Accordingly, any remaining energy generated by linear alternator 150 is then stored in electrical storage system 180 for later use by system 10 as required.

Referring now to Fig. 3 there is depicted a graph showing the energy generated and used by the system 10 of the present invention over time as inflatable bag 1 10 is periodically compressed during ventilation. The energy generated by operation of the BVM 100 produced in accordance with some embodiments of the invention can be calculated as follows:

Net energy generated = Energy harvested during ventilation - ([Energy consumed during data acquisition and processing^ energy used in feedback (user interface) + data storage + data transmission]^ energy losses) Assuming a very conservative figure of 50% energy loss through system 10, and furthermore based on the following assumptions: processor 300, pressure and flow sensors 22, 230 each consume no more than 0.1 W during data acquisition; user interface utilizes LED lamps that consume 0.1 W; an audio speaker consumes 0.5 W; data storage and transmission require 0.1 W each, the minimum energy generated by operation of system 10 can be calculated as follows:

Energy consumed during data acquisition and processing = (0.1 W*3) *(40s)

= 12J

Energy consumed during data storage = 0.1 W*40s = 4J

Energy consumed during feedback^1' = 0.7W*10s = 7 J

Energy consumed during data transmission = 0.1 W*ls = 0.1J Energy losses = 0.5* 25.2 -396.0 J = 25.2 - 198.0 J

} Based on Nyquist sampling theorem the minimum sampling rate, f, must be at least twice the highest frequency, f, contained in the bag compression signal (i. e., 2*0.333 = 0.6667 Hz). Data acquisition therefore requires at maximum 40s of sampling, as does data storage.

f Feedback to the operator is provided every 6s, i. e., based on the target ventilation rate of 10-20 bpm, which implies one breath is delivered at minimum every 3-6s.

Net energy generated = ± 50.4J - (12 J + 4J + 7J + 0.1J ± 25.2 J) = ±2.1J* Furthermore, and in accordance with some embodiments of the invention, where NFC is employed for data transmission even less energy is used in system 10 operation since the energy required for data transmission is instead harvested from an external NFC reader or interrogator. Additionally, power usage is further reduced in some embodiments of the invention wherein data transmission is accomplished at predetermined intervals during system 10 usage, such that the data is not transmitted continuously during ventilation. Finally, it should be noted that compression forces of up to 250-300 N are feasible during operation of bag 1 10, thereby providing a system 10 capable of harvesting larger amounts of energy than those calculated herein above.

In some alternative embodiments of the invention, system 10 operates without an energy storage system by enabling the BVM device 100 to be powered on an "event- based" basis, in other words, powered during a compression of inflatable bag 100. In these embodiments an integrated user interface 250 may be eliminated from BVM 100. Further, in these embodiments the power consuming elements of the system 10 for capturing energy from operation of the bag valve mask can be powered directly by the electrical generator (by coupling these elements to the electrical power output of the generator). These elements include: processor, wireless transmitter, user interface and flow and pressure sensors.

Therefore either of this elements such as processor can be powered by coupling either to the electrical power output of the electrical generator or to the electrical storage system.

Additionally, a piezo-ceramic material such as a ceramic lead zirconate titanate, (PZT) may be positioned within or proximate to bag 100 as an alternative to linear alternator 150, such that it is continuously flexed during compression of the bag, whereby it generates a concomitant electrical current. This generated electrical energy is then immediately discharged to provide power to system 10 via a sound-acoustic modulator or an transmitter 500 to wirelessly transmit the measured ventilation characteristic data (pressure and flow rate) to a remote user interface 250 such as a smart phone, smart watch, or similar handheld device which operates, in this embodiment, as a user interface 250.

Additionally, and in accordance with some embodiments, the system 10 complexity can be further reduced by configuring the remote user interface 250 to automatically prioritize the data from the system 10 when it is being operated such that no user input or action is required in order to initiate the ventilation feedback and guidance remote user interface 250.

Referring now to Fig. 4 and in accordance with various embodiments of the invention the energy that is harvested through operation of system 10 can be re-used cyclically to supply system 10 with energy. In operation of BVM 100 systems, due to the importance of proper sealing of mask 130 around the mouth and nose of a patient, BVM 100 ventilation is often performed by two operators or users. While one user is periodically compressing bag 100, a second user is holding mask 130 in place over a patient's mouth and nose, to ensure a good seal and limit leakage of gas around mask 130. However, where only one user is available he or she has to simultaneously compress bag 1 10 while maintain a good seal around mask 130. In these situations, the user is required to maintain a substantial prolonged cyclical physical effort.

In some non-limiting embodiments and as best seen in Fig. 4, to facilitate ease of use for one-user operation, BVM 1 10 may include a second bag 1 12 that is elastically coupled to bag 1 12 such that the energy supplied from a first bag 1 10 decompression is utilized to compress the air or gas in the second bag 1 12, thereby charging second bag 1 12 with the energy of decompression of first bag 1 10. In other words, the energy produced by the decompression of the first bag is mechanically coupled to compress the second bag, and vice-versa. Of course the user assists in supplying energy to this system through systematic compression of the first bag, and then the second bag, to ventilate the patient.

In some further non-limiting embodiments of the invention, processor 300 may provide a time stamp to each sample of pressure and flow data acquired and recorded so that a user or remote observer can monitor the patient's ventilation progress, or further analyze the patient characteristic data after the ventilation procedure is completed.

While various inventive embodiments have been described and illustrated in this specification, those of ordinary skill in the art may discern a variety of other systems or structures for performing the functions and/or obtaining the results and advantages described herein. Each of these variations and modifications is deemed to be within the scope of the inventive embodiments described herein. One of ordinary skill in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary of the invention, and that the actual parameters, dimensions, materials, and configurations will depend upon the specific application or applications of the invention. Furthermore, those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive

embodiments described herein. Accordingly, it is understood that the foregoing

embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described in this specification. Any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one."

The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and/or" should be construed in the same fashion, i.e., "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and/or B", when used in conjunction with open-ended language such as "comprising" can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating items in a list, "or" or "and/or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e. "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of." "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

As used herein in the specification and in the claims, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently "at least one of A and/or B") can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc. It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

In the claims, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of and "consisting essentially of shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 21 1 1.03. It should be understood that certain expressions and reference signs used in the claims pursuant to Rule 6.2(b) of the Patent Cooperation Treaty ("PCT") do not limit the scope.

Claims

CLAIMS:

1. A system for capturing energy from operation of a bag valve mask for ventilating a human patient comprising:

a bag valve mask (130) having a compressible bag (110) for supplying air, a one way valve (120) in fluid communication with the compressible bag, and a mask in fluid communication with said one way valve for introducing said air into said patient's airway;

an electrical generator disposed in said compressible bag, said electrical generator positioned to be activated by the compression and de-compression of said bag during ventilation, said generator having an electrical power output;

a processor (300) having a plurality of inputs and outputs;

at least one pressure sensor (220) having a data output representative of the pressure of said gas supplied from said inflatable bag, said output operatively coupled to an input of said processor;

at least one flow sensor (230 ) having a data output representative of the volume of said gas supplied from said inflatable bag, said output coupled to an input of said processor.

2. The system for capturing energy of claim 1 further comprising an electrical storage (180) electrically coupled to the electrical power output (152) for storing the power supplied by said generator.

3. The system for capturing energy of claim 1 or 2 further comprising a user interface (250) having a visual indication of a plurality of patient ventilation characteristics.

4. The system for capturing energy of either of the preceding claims, wherein the electrical generator is either one of linear alternator or rotary alternator.

5. The system for capturing energy of claim 1 or 2 further comprising a wireless transmitter coupled to the processor (300) and being arranged to be powered by the electrical generator, said wireless transmitter providing said flow sensor and pressure sensor data outputs to a remote device.

6. The system for capturing energy of claim 3 wherein said patient ventilation characteristics include at least either on of ventilation frequency, ventilation pressure, and airflow volume.

7. The system for capturing energy of claim 3 wherein said user interface comprises either on of plurality of LEDs, low-power liquid crystal display and speaker to provide audible feedback to said user.

8. The system for capturing energy of claim 1 wherein said processor is arranged to store to data memory pressure and flow sensor data outputs at predetermined intervals during operation of said system.

9. The system for capturing energy of claim 5 wherein said wireless transmitter is arranged to transmit flow sensor and pressure sensor data at periodic intervals.

10. The system for capturing energy of claim 9 wherein said wireless transmitter comprises a Bluetooth transmitter.

1 1. The system for capturing energy of claim 9 wherein said wireless transmitter comprises a low power Wi-Fi transmitter.

12. The system for capturing energy of claim 5, wherein the electrical generator is a piezo-ceramic material member disposed in said compressible bag and positioned to be displaced by the compression and de-compression of said bag during ventilation, wherein the wireless transmitter is powered by said piezo-ceramic material member when said bag is being compressed.

13. A method for capturing energy from operation of a bag valve mask having a compressible bag for supplying air, a one way valve in fluid communication with the compressible bag, and a mask in fluid communication with said one way valve for introducing said air into said patient's airway for ventilating a human patient comprising the steps of:

providing an electrical generator preferably a linear alternator disposed in said compressible bag, said generator positioned to be activated by the compression and decompression of said bag during ventilation, said alternator having an electrical power output;

providing a processor having a plurality of inputs and outputs; providing at least one pressure sensor having a data output representative of the pressure of said gas supplied from said inflatable bag, said output operatively coupled to an input of said processor;

providing at least one flow sensor having a data output representative of the volume of said gas supplied from said inflatable bag, said output coupled to an input of said processor.

14. The method for capturing energy from operation of a bag valve mask as in claim 13 further comprising:

providing an electrical storage system electrically coupled to said generator output for storing the power supplied by said generator.

15. The method for capturing energy from operation of a bag valve mask as in claim 13 or 14 further comprising

providing a user interface having a visual indication of a plurality of patient ventilation characteristics

16. The method for capturing energy from operation of a bag valve mask as in claim 15 comprising the steps of:

providing a visual indicator of ventilation frequency;

providing a visual indicator of ventilation pressure; and

providing a visual indicator of ventilation flow rate.

17. A method of capturing energy from operation of a bag valve mask as in claim 15 comprising the steps of:

storing said pressure sensor data output and said flow sensor data output at periodic intervals in a data memory; and

providing a wireless transmitter to transmit said pressure sensor data output and said flow sensor data output at periodic intervals to a remote device.