The present invention is directed to a portable life support apparatus and particularly to a respiratory support apparatus adapted to be easily mounted to a stretcher.
When transporting a patient on a stretcher, such as a NATO litter, a large metal bracket called a SMEED is sometimes mounted to the side frame members of the stretcher. The SMEED extends over the patient and serves as a mounting bracket for receiving a plurality of life support devices that function independently of one another. There are several problems associated with the use of the SMEED however. One problem is that the SMEED obstructs access to the patient. Additionally, the SMEED is heavy and cumbersome to use. Loading the SMEED with a variety of different respiratory support and monitoring devices is inefficient from the standpoint of space consumption and weight (the SMEED itself weighs 22 pounds) and does not provide equal optimal access to each of those devices. Accordingly, there is a great need for a portable emergency support device that overcomes the weight, size, positioning, and other portability disadvantages of the SMEED, allows for easy loading of various respiratory support devices in proximity to a subject during the course of emergency transport.
In one aspect, the invention is directed to a respiratory support apparatus comprising an oxygen generating device including an ambient air inlet, for generating oxygen from ambient air, at least one gas reservoir, a conduit system for handling gas generated by the oxygen generating device and expired gas exhaled by a patient, wherein the conduit system comprises at least one conduit, operatively associated with a one-way valve, that is fluidly connected between a patient airway interface and the gas reservoir for directing expired gas towards the gas reservoir and at least one conduit, operatively associated with a one-way valve, that is fluidly connected between the gas reservoir and the patient airway interface, for directing reservoir gas towards the patient airway interface. A device according to this aspect of the invention is particularly advantageous for portable applications where size of the oxygen generator and its power consumption are of particular importance.
In one aspect, the invention is directed to a portable combination ventilator and oxygen generator which integrates the functions of producing oxygen and those pertaining to ventilatory support. The inventors have found that controlling oxygen levels supplied to the patient can be accomplished efficiently with superior oxygen generation, conservation and controls and that a patient can be efficiently ventilated in a variety of different types in emergency settings with vastly enhanced oxygen concentrations relative to ambient air in a single portable, weight and size efficient apparatus.
The inventors have determined that a useful arrangement of the gas delivery system is one in which expired gas is collected and re-breathed by the patient, as this potentiates more efficient oxygen output, conserves oxygen already available, and allows the volume and oxygen content of the oxygen generating device to be suited to both ventilate a patient and to be portable i.e. to be of suitable size, weight and power consumption for rapid deployment for a duration suitable in emergency settings. In one respect, since expired gas has a higher concentration of oxygen than ambient air the inventors have found that reuse of oxygen expired by the patient from a previous breath would make generating oxygen feasible within a combination portable unit. Therefore one aspect of the invention provides a portable oxygen generation device that is capable of exploiting both ambient air and expired gas to provide the patients oxygen consumption requirements; the foregoing irrespective of whether the patient is breathing spontaneously or is incapable of breathing spontaneously and is being fully ventilated by an apparatus according to an aspect of the invention.
Accordingly in one aspect the invention is directed to portable respiratory support device comprising a ventilator and an oxygen generating device. In a further embodiment the portable respiratory support device further comprises and an oxygen conservation system adapted to utilize both ambient air and air exhaled by the patient to produce the oxygen requirements of the patient. Optionally, the oxygen conservation system comprises a conduit fluidly connected between the patient airway interface (e.g. a mask) and the ventilator for receiving gas exhaled by the patient and a carbon dioxide scrubber fluidly connected therebetween. Optionally, the oxygen generation device is an oxygen concentrator. The oxygen concentrator may be of the type that is set to operate on a pressure swing adsorption or a pressure/vacuum swing cycle. In another embodiment, the portable respiratory support device further comprises a controller that regulates the oxygen output of the oxygen concentrator based on a sensor system that measures the volume of flow and oxygen gas concentration proximal to the patient inspiratory port.
An embodiment of the invention enables a combined ventilator/oxygen generating device with an output 1.2 L of 90% oxygen or its equivalent. This output has been determined to be adequate to ventilate a patient with 6 litres of 90% oxygen as opposed using an alternative that supplies the entire 6 L of 90% oxygen. For example, for a 2 hour emergency transport mission, the combined weight of the oxygen generator (and scrubber to remove carbon dioxide from the expired gas) suitable for carrying out aspects of the invention herein may be, for example, no greater than 12 pounds (with battery added 15 lbs—with a combined volume of less than 0.27 cu ft, add 1-2 lbs for housing components) and may obviate the need to carry 5 or 6 bottles of oxygen which occupy a much greater volume and weigh far more.
In one embodiment of the invention, the portable life support is adapted to operate in a mode that provides more pleasant ventilation support to a patient capable of breathing spontaneously. Accordingly, optionally, an embodiment of the invention further comprises a by-pass system for by-passing the scrubber. In this connection, the term “by-pass system” or “scrubber-by-pass” is used broadly to refer to any system in which the scrubber is not interposed or in fluid communication between the patient and a gas reservoir on either the inspiratory or expiratory side. It will be appreciated that this can be accomplished with two and three position valves and additional conduits. Optionally, to reduce the size of the apparatus this by-pass system comprises a substitute portion of the breathing circuit, the use of which entails removal of a scrubber unit. Optionally the by-pass system comprises a removable cartridge containing the scrubber and a substitute cartridge comprising a re-breathing circuit, optionally a sequential gas delivery circuit (SGD) which fresh gas is breathed in first and expired gas is available to supply the remainder of the patient's minute ventilation (separate masks can be purchased (Hi-Ox SR) to operate such an SGD with a scrubber unit, where desired). Optionally, the portable life support apparatus is capable of producing fresh gas flow containing approximately an equivalent of 40% patient oxygen sufficient to make up the effective alveolar ventilation of the patient, for example 5 to 8 litres of fresh gas containing 40% oxygen. Accordingly, in one embodiment the oxygen generator is capable producing approximately 2.0 to 2.2 L of 90% oxygen (for example, 2.2 L of 90% oxygen combined with 5.8 litres of ambient air yields 8 litres of 40% oxygen. In another embodiment, the portable life support apparatus is adapted to operate at reduced pressure, for example the atmospheric pressure corresponding to the altitude at which emergency transport helicopters fly for military emergency patient transport. Optionally, to make up 1.2 L an approximate oxygen generator output of equivalent to 1.8 liters of 90% oxygen is required, and an oxygen generator output of equivalent to 3.0 L of 90% oxygen is required in scrubber by-pass mode to effectively make up 2.2 litres of 90% oxygen.
In a further aspect the invention is directed a portable life support apparatus in the form of a portable respiratory support apparatus comprising a ventilator, an oxygen generator and an oxygen conservation system that is capable of exploiting both ambient air and expired gas as oxygen sources with higher oxygen content than ambient air, wherein the oxygen generator and ventilator are arranged (substantially end to end) to provide a longitudinal profile that can thus be compactly secured to a stretcher or other similar emergency transport vehicle. Optionally, the oxygen conservation system is positioned in end to end arrangement with other components. Optionally, the ventilator is positioned between the oxygen generating component and the oxygen conservation system component. Optionally, the oxygen conservation system component comprises at least one of two or more alternative modules (at least a scrubber module which is optionally configured to direct expired gas to the ventilator and optionally a scrubber by-pass which is optionally configured to direct expired gas to an expired gas holding chamber, optionally in the form of an elongated tube and ultimately to atmosphere), for example, in the form of cartridges that have a matching profile to that of the housing the remainder of the apparatus. The apparatus optionally includes a portable power source in the form of rechargeable battery housing unit. Optionally, the portable power source is adapted to minimize the total length of the apparatus and has the same profile as the remainder of the apparatus to make efficient use of profile of the apparatus. Optionally, the placement of the portable power source is at the end of unit opposite end the oxygen conservation system ie. adjacent the oxygen generation device. Optionally, the apparatus further comprises a system for suctioning a patient's airway. In one embodiment the oxygen generator uses a vacuum pump as part of a pressure swing adsorption system to concentrate oxygen from ambient air and negative pressure generated by this pump can be switched (for example with a two or three position valve) between fluid connection to one or more concentrator sieve beds and a suction port, thereby trimming the weight of the combined apparatus relative to separate devices an additional ten to twelve pounds (the weight of a typical standalone suctioning device typically mounted onto a SMEED for patients that may be in need of this form of respiratory support).
In another aspect of the invention, the portable life support apparatus includes a patient monitoring system. The patient monitoring system may display one or more respiratory parameters and optionally displays one or more non-respiratory parameters optionally including ECG, heart rate, continuous or intermittent non-invasive blood pressure, and temperature. The respiratory parameters may be selected from O2 saturation, expired CO2 concentration, system CO2 concentration (particularly immediately upstream of the scrubber) inspired O2 concentration, airway pressure (particularly, to measure pressure proximal to the patient inspiratory port), respiratory rate, and tidal volume. Optionally, the display also displays one or more device parameters including available battery power and operation mode.
Optionally, the patient monitoring system includes a display that is rotatable between a plurality of viewing positions about a display axis that is parallel to the longitudinal axis of the portable life support apparatus. Optionally, display is shaped to a have a compact longitudinal orientation that complements that of the body of the portable life support apparatus. Optionally, the display axis is positioned between the top and bottom of the display to maximize the rotational range of usable reading orientations of the display. Accordingly, in another aspect, the invention is directed to a portable life support apparatus that integrates in a longitudinally arranged profile within a single apparatus a plurality of respiratory support devices selected from the group comprising an oxygen generator, a ventilator, an oxygen conservation system, an airway suctioning system, and further comprises a patient monitoring system including a display rotatable between a plurality of positions (reading orientation positions) about an axis that is parallel to the longitudinal axis of the portable life support apparatus.
In another aspect, the portable life support apparatus includes a positioning system comprising a clamp assembly adapted to support the apparatus in a horizontal plane parallel to a patient support surface of a portable patient transport apparatus, for example a stretcher. Optionally, the apparatus is supportable proximal to and below the plane of the patient support surface to facilitate access to the patient (first or patient treatment position), as well as above the plane of the patient support surface of the patient transport vehicle (second or patient transport position). Optionally, the positioning system makes the apparatus displaceable between first and second support positions without detachment from the portable patient transport apparatus. Optionally in the second or in a third position the apparatus is partially displaced towards the center of the patient support surface (i.e. at least partially overlying the side support bar of the stretcher or other such vehicle, implicitly to a degree that does not significantly encroach on the side of patient's body). Optionally, depending on the support and loading system accorded to the portable patient transport apparatus within the carrier transport (helicopter, ambulance, humvee or other automotive vehicle), the transport position may also be below the stretcher displaced partially underneath the stretcher.
Accordingly, in another aspect, the invention is directed to a portable life support system comprising a positioning system and a plurality of respiratory support devices integrated in a longitudinal profile into a single apparatus including a patient monitoring system and at least one device selected from the group comprising an oxygen generator, a ventilator and a patient airway suctioning system, the patient monitoring system including a display rotatable between a plurality of viewing positions about an axis that is parallel to the longitudinal axis of the apparatus, the positioning system including a clamp assembly adapted to support the apparatus in a horizontal plane parallel to a patient support surface of a portable patient transport apparatus.
The present invention will now be described by way of example only with reference to the attached drawings, in which:
a is an exploded perspective view of some of the components shown in
a is an exploded perspective view of some of the components shown in
a is a perspective view of the life support system shown in
a is a plan view of the end support shown in
a and 22b are perspective views of a patient transport apparatus connector and a strap, which are part of the positioning system shown in
c is a sectional side view of the patient transport apparatus connector and strap shown in
a and 23b are perspective and sectional side views respectively of the patient transport apparatus connector and strap shown in
a and 24b are perspective and sectional side views respectively of the patient transport apparatus connector and strap shown in
a is a side view of a life support device connector shown in
b is a side view of the life support device connector shown in
a is an end view of a channel in the housing of the life support device shown in
b is a plan view of a channel in the housing of the life support device shown in
a is a perspective view from inside a channel on the housing of the life support device shown in
b is a perspective view from inside a channel on the housing of the life support device shown in
The following terms are defined as set forth below:
The term “conditioned gas” is used to refer to a gas, optionally conditioned ambient air, having at least one of the following properties: it has a higher content of oxygen than available ambient air, it is less humid than available ambient air, it has a lower nitrogen gas content relative to available ambient air, it comprises exhaled air of a subject that has been scrubbed of carbon dioxide. In a preferred embodiment, the conditioned gas is a gas that has a higher content of oxygen as a result of having been generated by re-breathing circuit and/or an oxygen concentrator and will optionally have been dehumidified and/or scrubbed).
The term “conduit” or “conduit segment” is used broadly to refer to a fluidly intact (pneumatically efficient, and optionally, though not necessarily sealably intact) gas pathway and includes without limitation, tubes and channels of any type that conduct air from place to place.
The term “configure”, “configured” and variations thereof, when used with reference to the capability of an oxygen generating device to generate oxygen, refers to design criteria, that impact on portability including at least one of size, weight, and power consumption of the device in watts/liter of oxygen generated. The term “output controller” used in relation to a controller that controls the oxygen generating device means a controller that controls at least one of: (a) the flow rate of oxygenated gas leaving the oxygen generating device; (b) the concentration of oxygenated gas leaving the oxygen generating device; and (c) the on-off status of the device whereby it can be turned on and off without detrimentally affecting the operation of the apparatus as a whole. This allow the oxygen generating device to be run intermittently to control oxygen concentration and/or power consumption, optionally based on feedback from a sensor that detects the oxygen concentration of gas in the circuit.
The term “conditioned gas outlet” refers to an apparatus outlet or juncture least proximal to the patient that has substantially the final gas composition available for the beginning of the next upcoming patient inspiratory cycle(s). The term “inspiratory gas” is the gas having this composition.
The term “towards” when used describe gas flow in a conduit segment (particularly when in operative association with a one way valve) is used to describe unidirectional flow. It will be appreciated that the location of valves including one way valves and points of attachment of conduit segments may often be dictated by convenience or certain advantages which are not necessarily critical to the operation of the structure in which they are incorporated. Accordingly, precise structural linkages may not be material to the operation even if specified in a drawing or descriptions of preferred embodiments of the invention and equivalent arrangements will apparent to persons skilled in art. The term “operative association” and related terms are meant to signify that the precise method of association or location can be variably selected without inventive skill and do not materially affect the operation of some embodiments of the invention. It will also be appreciated that portions of the gas circuit may be left outside the body of the apparatus, particularly disposable, relatively inexpensive, commonly replacable and technologically trivial parts, and connected by the user via a port designated for such connection, in effect making the port equivalent to those portions of the gas circuit, if added after and secondary to the essential features of the apparatus. Persons skilled in the art of working with respiratory apparatus are attuned to assembly of these types of circuit elements and will readily perceive an assembly of parts as the essential apparatus. Examples follow. A scrubber may be introduced into the circuit outside the core apparatus and may be so introduced advantageously on the inspiratory side of the circuit but without very significant effect also on the expiratory side of the circuit. Oxygenated gas leaving the oxygen concentrator may be introduced into the conduit system or directly into the ventilator reservoir.
The term “ventilator” includes pressure based ventilators that provide pressure to the airway of the subject to a certain preset level (e.g. 25 cm H2O) or range, and volume based ventilators that control the tidal volume and frequency of the inspiratory flow to the patient. Ventilators of these types could be used for ventilatory assistance of a type that does not require rigorous pressure, volume, frequency controls. A variety of types of ventilatory assistance are known to those skilled in the art including CPAP, BiPAP, pressure controlled, volume controlled, pressure support ventilation, airway pressure release ventilation, inspiratory pause, inspiratory flow profile, proportional assist ventilation, neurally activated ventilatory assistance, assist control ventilation etc. The term “ventilator device” is used broadly to refer to a ventilator and may depending on the context implicitly exclude the gas reservoir component of such a device.
The term “oxygenated” means air having an oxygen content higher than ambient air, optionally having a concentration of at least 40% oxygen.
The term “portable life support apparatus” (or interchangeably “portable life support device”) as used herein, generally is used to refer to the apparatus as whole the name contemplating but not implying monitoring functions that are not limited to respiratory parameters. However, this term may be used interchangeably with “portable respiratory support apparatus” and “respiratory support apparatus”, among others, in which the primary functions of respiratory support are highlighted in name.
The term “substantially in series” with reference to longitudinal configuration of an apparatus or system according to an embodiment of the invention is not meant to necessarily imply that each component, of each sub-assembly—namely oxygen generator, ventilator mechanism, scrubber unit, battery housing is in a distinct compartment with each compartment arranged in series but rather that the most space consuming part of each sub-assembly is arranged in series in a longitudinal configuration.
The term “re-breathing circuit” means any circuit in which exhaled air is captured and remains available for re-breathing during a portion of an inspiratory phase of breathing. The re-breathing circuit may be optionally a sequential gas delivery (“SGD”) circuit. The term sequential gas delivery circuit means a system which includes controls, (for example, valves) that are set to open sequentially, for ensuring that in the first part of an inspiratory cycle the patient receives a gas of a first composition and in the second part of the inspiratory cycle, the patient receives a second different composition (for example the first gas may be oxygen and the second gas may be gas exhaled from a previous inspiratory cycle). The term “a sequential gas delivery valve” means a one way valve set to open to source of expired gas which opens at a higher pressure than a valve set to open to a source of fresh gas and which is typically positioned in parallel to an expiratory valve which allow expired gas to leave to ambient air. A “sequential gas delivery control system”, optionally a valve system, refers to at least two valves that open sequentially to fresh gas and expired gas sources, typically valves that open at different pressures, one at a lower pressure connected to an inspiratory gas source, and one at a higher pressure connected to an expired gas source.
The term “fresh gas” generally means gas entering the patient's breathing circuit that does not contain appreciable amounts of carbon dioxide, and is usually air or oxygen enriched air, although other components may be present as well, such as anesthetic agents or the like.
The term “inspiratory relief valve” means a valve that allows gas, usually ambient air, into a portion of the conduit assembly that is available to the patient to breathe on during an inspiratory cycle in which inspiratory gas, usually in the form of a conditioned gas, is temporarily depleted.
The term “patient airway interface” means a patient interface such as a mask, nasal tube, endotracheal tube, or tracheotomy tube that is fluidly connected to a patient airway.
The term “independently movable” is understood to mean having some degree of independent movement, for example, rotational independence about at least one axis.
The term “reading orientation” means the preferred orientation in which a line of data, normally readable in a horizontal orientation (in the case of many languages) from left to right (or right to left), for example a number, is presented horizontally and therefore is most easily readable. By contrast, a “reading position” is any screen position in which substantially all of the data is normally viewable by a user, though not necessarily in a reading orientation.
The top and bottom with reference to the display refer to the borders of the display parallel to its reading orientation.
The term “intermediate” with reference to a rotational position refers to a position roughly in the middle of its rotational extremes.
The term “vertical” with reference to a display position means that the screen axis is roughly parallel to the ground and the display is a plane roughly perpendicular to the ground.
The term “airway” includes, without limitation, the mouth, trachea, and nose.
The term “processing” with reference to machine intelligence means any handling, merging, sorting or computing of machine readable information using digital or analog circuitry in a way that it is compatible with visual presentation on a screen.
The term “reading” is meant to include scanning with a view to interpretation of any visually depicted subject matter (not just letters and numbers), including without limitation, graphs, symbols, heart monitor output, brain waves etc. Optionally the device is considered positionable for reading when the device is anywhere within arms length of the user, so that the user can use the user interface on the display.
The term “plane” is used broadly to include a curvilinear profile that is substantially planar.
The term “preferred position” means a position with reference to the position of the portable life support device about an axis generally parallel to the axis of rotation of the display that permits use of at least half and preferably substantially more of the range of motion of the display.
The term “device positioning interface”, alternately called the “device interface” when referencing the positioning system, is used broadly to refer to any interface that serves as a point of attachment of the support structure of the positioning system including, without limitation, a flat metallic surface for engaging a magnet.
The term “holding” with reference to a way of keeping the screen from rotating is understood in its broadest sense to provide resistance to rotation. For example, the apparatus may include a spring-loaded detent that interacts with a plurality of grooves defined by annularly located toothed portion of the screen housing, so that rotation of the screen in one direction or the other successively engages the intermittent grooves defined by those teeth to define a series of intermittently spaced screen positions.
As detailed below, and shown in the drawings (
As detailed below, according to one embodiment of the invention, the portable life support system is a portable respiratory support apparatus that provides treatment in the form of ventilation and oxygen supply and may be used in many emergency and medical transport applications, particularly by the military—for example, in the field or in transit between forward field surgical units and more permanent treatment units (Echelon 3 units); as well as in the civilian market for emergency transport by ambulance and helicopter. This unit optionally includes a facility to suction the airway of a subject.
In one aspect, the portable life support system serves to monitor the outcome of respiratory treatment parameters and also serves to monitor non-treatment parameters of importance to attending medical personnel such as the patient's ECG, heart rate, temperature and blood pressure. Device parameters may also be displayed most notably available battery power and operation modes. Respiratory treatment parameters measured and displayed by the life support system are detailed below. In a general aspect, the portable life support system of the invention contemplates that other forms of treatment and/or monitoring could be provided, measured and/or displayed.
The term “treatment” is used broadly to refer to ministrations of any kind, including without limitation provision of respiratory gases, drugs, stimuli, signals etc.
A preferred embodiment of the invention will now be described, and relates to a portable respiratory support apparatus and measurement of respiratory physiological parameters for display.
The portable respiratory system optionally comprises six main components collectively termed Mobile Oxygen, Ventilation and External Suction system (portable life support apparatus 1102) Referring to
A “conditioning section” 8 (
a ventilator 1;
a patient airway suction system including a suction port 70, which is used with conventional accessories to clear the patient's airway;
a patient monitoring system, in the form of a display 600, which monitors and displays a patient's vital statistics and optionally device parameters, for example remaining battery power, tidal volume (in ventilatory mode);
the breathing circuit, which may optionally be a circle circuit, a non-rebreathing circuit, or a partial rebreathing circuit, which controls delivery of gas to the patient and which may optionally operate in either a ventilated or spontaneously breathing mode, and
a power system 1500, which may for example optionally be comprised of rechargeable batteries, or removable, rechargeable batteries, or removable hot swappable batteries, and which may optionally include an AC power supply, or which may optionally including a connector for connecting to an AC power supply.
In one aspect of the invention the oxygen content of the system is controlled independently of the minute ventilation of the patient, that is, without reference to the patient's minute ventilation and the operation of the ventilator. Accordingly, the inventors have discerned that integrating emergency ventilation and oxygen supply functions is simplified and energy efficient according to the invention. In one aspect of the invention, the oxygen supply is controlled in response to the patient's minute oxygen consumption. This may be done by measurement of oxygen concentration in the system, for example with an oxygen sensor, and turning the oxygen supply on only when the oxygen concentration drops below a set value, and turning the supply off when it reaches a set concentration.
For example, when the oxygen concentration reaches 85%, a controller operatively connected to sensor can shut the concentrator off. When the oxygen concentration is sensed to fall to 80%, for example, the oxygen concentrator can be turned on again. This minimizes the amount of oxygen that needs to be produced by the system and hence provides for a more energy efficient and lightweight system.
Importantly, at least some embodiments of the invention overcome dismissive perspectives attributable to presumed design constraints on using an oxygen concentrator in place of oxygen tanks, in emergency transport settings, in terms of power consumption, required size and output of O2. Importantly, at least some embodiments of the invention contemplate that these constraints can efficiently be obviated in important part by re-circulating a patient's expired gas in a circle circuit, or partially reusing a patient's exhaled gas in a partial rebreathing circuit, for example a SGD circuit. In particular, since ambient air traditionally conditioned in concentrators contains 21% O2 and exhaled gas of patients receiving, for example, 40% O2, contains approximately 33-35% O2, it has been determined according to an embodiment of the invention to be efficient as well as otherwise advantageous, to use an O2 concentrator in conjunction with a circle or re-breathing circuit and scrubber, to supply oxygen to patients requiring ventilation during emergency transport. Some embodiments of the invention also contemplates that patients not requiring ventilation can also be efficiently supplied with oxygen generated by an oxygen concentrator by providing a reservoir for collecting the patient's exhaled gas and optionally allowing the patient to use exhaled gas at the end of an inspiratory cycle.
As generally shown in
Litter support stanchions in military helicopters have at least three levels at which litter support hooks or shelf like supports are located so that at least three litters may be occupied and supported one on top of the other during emergency transport from a small surgical field unit (for example a unit that may have only one surgical table, one pre-op area and one post-surgical monitoring area nearest the combat zone—sometimes known as a Forward Resuscitative Surgical Site (FRSS) or Echelon 2 facility) to the next more permanent or Echelon 3 medical facility. The longitudinal profile best enables the portable life support apparatus to be suspended parallel to the litter, off its side, or above it with minimal interference to access to the patient to whom the unit is allocated or any patient above or beneath.
The portable life support apparatus can be supported in at least two positions longitudinally displaced from another with individual positioning structures that do not need to support the entire weight of the apparatus and are hence simpler, more versatile, lighter and less bulky.
The screen displaying vital statistics may be compactly oriented in a longitudinal orientation parallel of the orientation of the life support apparatus. In this orientation, the display may be adapted to rotate into a variety of planes about an axis parallel to the axis of the apparatus so that it can be rotated into a reading position that accommodates upper, intermediate and lower litter positions.
According to one embodiment of the invention, the portable life support apparatus treats both spontaneously breathing patients and ventilated patients and may be operated differently in “spontaneous” mode versus “ventilation” mode, as described below.
Referring to
Furthermore, as shown in
As shown in
In both ventilated and spontaneous modes, ambient air enters the portable life support system, through the hydrocarbon filter 14 drawn by the pump 16 and through “conditioning” section generally identified as 8 (oxygenation and optionally dehumidification) of the conduit assembly, as described hereafter. The pump/vacuum 16 (optionally combined) pumps ambient air via conduit section 17 through the inner tubes 82 (shown in
It is generally understood that there are a variety of ways of attenuating the oxygen concentration, in either ventilated or spontaneous mode, depending on the fresh gas flow and oxygen concentration requirements of the patient. These include shutting the concentrator off for a period, blending the oxygenated air with ambient air or changing the oxygen concentration settings (for example, with a controller that controls parameters affecting the performance of the concentrator such as working pressures and length of the cycles).
In a circle circuit, the O2 concentration and rate of the fresh gas flow (“FGF”) are set so as to provide at least the oxygen consumption of the patient, which may be only 200-300 ml of O2 per minute, at a concentration determined by the needs of the patient. If the FGF has a concentration of 85%, then only 350 ml/minute of FGF is required. However in practice it is common to provide a higher rate FGF, for example, at least 1 L/min to flush out trace gases from the system. By way of example, assume the concentrator is capable of providing 2 L/min of 85% O2, and only 40% O2 is required for a particular patient with an oxygen consumption of 300 ml/min. The minimum FGF for this patient would be 500 ml/min of 40%. If 1 L/min of FGF is required to flush out the system, the 40% concentration may be generated by running the concentrator produce 85% intermittently (for example, the concentrator would be run with a 15% duty cycle to produce 0.3 LPM of 85%) and blending with 0.7 LPM ambient air to achieve 1 LPM at 40% oxygen concentration. Alternatively, the concentrator working pressures may be adjusted to produce 1 L/min of 40% oxygen without blending with ambient air.
As shown in
In one embodiment of the invention, the inspiratory reservoir 36 takes the form of a bellows that is acted on by blower 44 (receiving air through conduit section 48) to exert positive inspiratory pressure to ventilate the patient. The bellows 36 contains an expiratory valve 66, for example a positional valve (see
In an alternative embodiment, the inspiratory reservoir 36 could comprise some other suitable vessel, such as a bag, instead of a bellows.
Conduit 38 leads to the patient via inspiratory hose 39, optionally an extendable hose, through a Y-piece 34 that connects (in ventilatory mode) to a patient's endotracheal tube (not shown) through a filter 47 via an elbow connector 49.
On the expiratory side, in ventilatory mode, Y-piece 34 is connected to expiratory conduit sections 42, 41 and 40, and through one-way valve 46 (set to open easily—e.g. 0.5 cm of H2O) to the bellows 36.
By contrast, in spontaneous breathing mode, cartridge 12 receives expired air through patient expiratory conduit section 54 which leads to a one-way valve 50 (set to open easily—e.g. 0.5 cm of H2O) to atmosphere and sequential rebreathing valve 52 (e.g. set to open at 2.5 cm of H2O) which may be planned to open during a planned re-breathing part of the inspiratory cycle and is generally triggered to open during the latter portion of inspiration when the patient's breathing rate exceeds the rate of fresh gas flow.
As described above, expiratory reservoir in the form of optionally extendable expiratory hose 54 one way valve 50 provides a point of venting expired air to atmosphere at a distance from the patient mask, so that much of the 8 litres of 40% oxygen typically generated for a spontaneously breathing patient in need of oxygen, is not otherwise immediately lost to atmosphere via an expiratory vent in the mask. Expiratory hose 54 optionally contains at least 200 ml of volume.
The ventilator cartridge contains a CO2 scrubbing material (e.g. soda lime). Inasmuch as portability may often entail size limitations and hence possibly longitudinal space limitations that reduce the path length through which expired gas can travel for scrubbing (reducing the amount of CO2 that can be removed by the scrubber), a scrubber design containing a helical scrubber material chamber/airflow pathway, as particularly shown in
As described above, ambient air enters the circuit through a hydrocarbon filter 14 and is optionally pumped by pump 16 (having a common motor 18 with vacuum 20) directly into the core of moisture removal device 22 which is generally configured like a shell and tube heat exchanger, as shown in
In one embodiment, as shown in
As shown in
De-humidifiers of the type sold under the name Perma Pure® e.g. FC series handling flow rates of up to 80 slpm, for example 75 slpm, can be used in the present context for gas-gas dehumidification. Optional adaptations of off-the-shelf Perma Pure specifications (e.g. FC-125), include increased Nafion® membrane thickness (e.g. to 0.030 in.) to handle larger pressure differentials between ambient and counter flow gases, and increasing tube number (e.g. to 400 tubes). Parameters impacting on dehumidification include the differences in humidity and pressure between the gas inside and outside the tubes. The combined effect of changes in humidity and pressure differences across the tubes can be routinely approximated using published data and can be readily empirically determined. In one embodiment of the invention, the pressure differential in the tubes is approximately 36 psi.
According to one embodiment of the invention, the oxygen concentrator is of the type that operates on a pressure swing adsorption or a pressure/vacuum swing cycle as described by way of background in U.S. Pat. No. 6,478,850 (the '850 patent), the contents of which are hereby incorporated by reference. As described in the '850 patent, the concentrated oxygen is released to the breathing circuit following which some is used to prime the second sieve bed. The sieve bed is then vacuumed to release the nitrogen and purged. This occurs in repeating cycles, with each sieve bed alternately being pressurized, releasing oxygen to the breathing circuit, then being purged. As shown in
According to one embodiment of the invention, the portable life support system comprises a volume controlled ventilator that provides control of respiratory rate, tidal (breath) volume, and delivered oxygen concentration. As shown in more detail in
As shown in
To vary the delivered oxygen concentration ambient air is pulled through the hydrocarbon filter by the air mixing pump and delivered to the patient expiratory tube 40 or to the bellows 36. This air fills the bellows and is mixed with concentrated product to deliver desired oxygen concentrations (for example, 40% and 85%).
During ventilation, the blower produces the pressure that forces the bellows to collapse delivering whatever gas blend is in the circuit to the patient through the scrubber, at the desired tidal volumes and respiratory rates. Correct estimation of the tidal volume requires adjustment for the concentrator generated enriched oxygen flow, that is not simply measured by displacement of the bellows. The blower 44 draws air through the inlet filter 33 and delivers it to the sealed chamber housing the bellows 36.
As shown in
1. inspired O2 concentrations of 21% to 93%—For increased ease of use, 3 presets may be settable by the user of 21%, 40%, and 85%. Tidal volumes may be settable between 400 ml and 1 litre (e.g in increments of 100 ml), which are useful for adult ventilation.
2. Breath Frequency: between 8 and 20 per minute
3. PEEP: 0-25 cm H2O optionally with settings incremented in 5 cm H2O
4. Inspiratory: Expiratory ratio between 1:1 AND 1:2—this is typically adjusted automatically based on tidal volume, breath frequency, and blower flow rate.
5. End Inspiratory or end expiratory Pause with pressure hold.
If the system reaches the maximum airway pressure limit set on the ventilator control, the blower stops blowing and switches into constant PEEP mode as described below.
The system is able provide intermittent tracheal suction. A suction kit consisting of a wand, hoses, and suction bucket with optional filter may be attached to the suction port. Activating suction mode energizes valve V6 which then connects the vacuum head of the pump 16 to the suction port 70. The vacuumed air is then vented through the outlet filter 30. Suction is preferably at approximately 100 mm Hg but may be higher or lower is dictated by the patient's requirements. A suction relief valve (not shown) may be optionally provided in parallel to the suction path and leads to ambient air to ensure the suction does not exceed the maximum desired vacuum level.
As shown in detail in
In spontaneous breathing mode the concentrator works exactly the same as in ventilated mode. The oxygen produced by the concentrator is fed to the inspiratory limb 37 of the breathing circuit. In ventilated mode, the ventilator and concentrator controls preferably communicate so that oxygen is not released from the concentrator to the breathing circuit during the last portion of inspiration, as this volume would not be accounted for in the tidal volume measurement, as determined for example by the bellows position sensor.
As described above with reference to
In spontaneous breathing mode, it is helpful for ease of use to provide a concentration of 40% O2, since most adults require less than 8 LPM of FGF, and providing this concentration requires a concentrator capable of producing 2.2 LPM of 90% O2 which can be made relatively small (<10 lbs.).
The patient can breathe at any frequency and with any tidal volume in spontaneous mode.
The system can be optionally used in a monitoring mode whereby the ventilator and concentrator are not operative and only patient monitoring is active. The patient may be breathing spontaneously on the circuit with the air pump 27 providing FGF to the circuit.
The spontaneous breathing circuit consists of the bellows 36, the one-way valve 45 from the bellows to the inspiratory limb of the spontaneous cartridge, the cartridge (which contains the optional filter 55), an inspiratory hose 54 with a Y-piece 51 connected to a plastic oxygen mask 53 (without holes to prevent dilution), an expiratory hose 54a, a one-way expiration valve 50 in the cartridge, and a sequential rebreathing valve 52 in parallel to the one-way expiration valve 50.
In spontaneous breathing mode the system does not generally provide assisted ventilation, although it may in some instances. During inhalation gas in the inspiratory limb and bellows is pulled through the optional filter 55 in the cartridge and through the patient inspiratory tube 54 to the mask 53. The patient exhales through the expiratory tube and out to ambient through the one-way exhalation valve 50. The sequential rebreathing valve 52 triggers when the patient's continues to inspire once the bellows 36 is empty, which occurs in general when his breathing rate exceeds the rate of FGF into the circuit.
According to one embodiment of the invention, the portable respiratory device operates with battery, DC or AC power.
Optionally, the device may house up to two batteries, preferably lithium polymer due to energy density, mounted internally and accessible at the end of the device. Optionally, the device operates on a battery for approximately 1.25 hours (2.5 hours per set). While operating from AC, the device may optionally trickle charge internal batteries.
Reference is made to
The cartridge 10 includes an inspiratory inlet 215 (
Referring to
The internal structure 207 includes an internal divider 220 that is generally midway between the first and second end plates 210 and 230. The plates 210, 220 and 230 are all generally perpendicular to the longitudinal axis of the scrubber 199 and of the portable life support apparatus 1102.
The internal structure 207 further includes wall structures 240 and 250 that cooperate with the plate 220 and with the housing 205 to urge the air along the aforementioned generally helical flow path. The interior wall structures 240 and 250 are better shown in
Scrubber material 217 is present through the inspiratory air flow path through the housing 205. Only a small portion of the total quantity of scrubber material 217 in the scrubber 199 is shown in
Pass-through conduit 41 (also shown in
The scrubber housing 205 and internal structure 207 are easily disassemblable for easy replacement of the scrubber material 217 and easy reassembly, as illustrated in the exploded view in FIGS. 11,12.
Referring to
As shown in
Persons skilled in the art will appreciate that a dedicated control board may be allocated for machine intelligence related to ventilator controls (tidal volume, airway pressure and BPM), concentrator control (oxygen concentration %, rate of operation), display controls etc.
As shown in
The display 600 may be part of a display assembly 601 that also includes a housing 603 which may be polymeric. The display assembly 601 may also include a filter suitable to screen output frequency to make the display night vision goggle compatible. The display 600 may utilize membrane switch keys above and below the screen, as exemplified above.
The housing 603 permits rotation of the display 600 about a display axis 605 for viewing over a range of angles by a user and can be flipped more than 180° to accommodate various mounting positions of the life support device 1002 in relation to the user.
As shown in
Either or both axial ends of the display housing 603 (
Reference is made to
The patient transport apparatus connector 800 connects to a patient transport apparatus 806, such as, for example, a stretcher and more particularly a NATO litter 808. The patient transport apparatus connector 800 may connect to the patient transport apparatus 806 in any suitable way for supporting the weight of the life support system 1100 (see
The patient transport apparatus connector 800 may mount releasably to the patient transport apparatus 806, and more particularly to the frame member 810. The patient transport apparatus connector 800 may include a clamp assembly 812 that is configured to clamp onto the frame member 810. The clamp assembly 812 includes a first clamp member 814 and a second clamp member 816, which cooperate with each other to clamp onto the frame member 810 (
In the embodiment shown in
It will further be understood that the clamp assembly 812 (
The first and second clamp members 814 and 816 may be pivotally connected to each other about a pivot axis 817. For example, a shaft 818 may extend through both clamp members 814 and 816, and may permit one or both of the clamp members 814 and 816 to rotate thereon.
The patient transport apparatus connector 800 is movable between an open position, shown in
The patient transport apparatus connector 800 further includes an actuation arm 824 that is used to urge the clamp members 814 and 816 towards each other. The actuation arm 824 is pivotally connected to the first clamp member 814 about a pivot axis 825. A shaft 826 passes through apertures in both the first and second clamp members 814 and 816 and the actuation arm 824. The aperture in the first clamp member 814 is shown at 828 (
Referring to
A biasing member 834 (
Movement of the actuation arm 824 from the position shown in
The actuation arm 824 further includes a first strap-locking surface 838 which can cooperate with a second strap-locking surface 840 that may be present, for example, on the shaft 818 (see
When the actuation arm 824 is in the position shown in
When the actuation arm is in the position shown in
When the actuation arm is in the position shown in
When the actuation arm 824 is in the position shown in
The retaining member 844 may have any suitable structure for releasably holding the actuation arm 824 in place in the position shown in
The arm 845 may be pivotally movable about a pivot axis 850. A shaft 852 may extend through the first clamp member 814 and the retaining member 844 along the pivot axis 850 to support such pivoting movement.
A biasing member 854 may be provided to bias the retaining member 844 to move in a direction towards hooking an object. The biasing member 854 may, for example, be a torsional spring 856 about the shaft 852.
During movement from the position shown in
When the actuation arm 824 is held in the position shown in
Alternatively, a user could continue moving the actuation arm 824 past the position shown in
The retaining member 858 may have any suitable structure for releasably holding the actuation arm 824 in place in the position shown in
The arm 859 may be pivotally movable about a pivot axis 864. A shaft 866 may extend through the first clamp member 814 and the retaining member 858 along the pivot axis 864 to support such pivoting movement.
A biasing member 868 may be provided to bias the retaining member 858 to move in a direction towards hooking an object. The biasing member 868 may, for example, be a torsional spring 869 about the shaft 866.
During movement from the position shown in
Other structures may alternatively be employed to hold the actuation arm 824 at the positions shown in
When the actuation arm 824 is held in the position shown in
It will be understood that the patient transport apparatus connector 800 could alternatively be configured so that the actuation arm 824 drives the second clamp member 816 towards the first clamp member 814.
Reference is made to
As shown in
Referring to
To lock the life support device connector 804 on the exterior 1103, the body 878 is positioned to rest on a pair of adjacent overhang elements 876, so that the head portion 886 is aligned with a cutout 874 in the channel 870, as shown in
Such a connector is sold by ANCRA (40340-27—Single Stud Track Fitting, and may be used with track 40467-33-144, which is the basis for the shape of the channel 870). Other suitable connectors may instead be used.
In the embodiment shown in
Referring to
Referring to
The portable life support apparatus 1102 could, for example, be positioned on the patient transport apparatus 806 optionally with the air of an extra strap 897 (
By shortening the straps 802, the portable life support apparatus 1102 can be brought into relative close proximity to the patient transport apparatus connector 800, which reduces the magnitude of any swinging that might take place during use. It is possible that the straps 802 can be shortened sufficiently to bring the portable life support apparatus 1102 into contact with the patient transport apparatus connector 800, which can effectively create a generally rigid connection between the portable life support apparatus 1102 and the patient transport apparatus 806.
Referring to
Referring to
The portable life support apparatus 1102 may include several control boards (eg. five control boards) in the life support apparatus, in addition to any boards that control patient monitors. The control boards are described as follows:
User Interface and main bus control—manages display screen and user buttons, communicates with other boards to manage traffic. It sends signals to other boards as to what to do and gets reports back, displays these on screen, handles alarm conditions and warning lights.
Main Power—controls battery vs wall power, switching between batteries when discharged, monitoring power etc., including measuring battery temperature for overheating
O2 Controller—controls the oxygen concentrator. Controls MiniOx sensor for measuring O2 in the bellows as well as sieve pressure sensors used for controlling concentrator valves. Controls the valves on the concentrator. It has a motor controller for controlling the concentrator pump motor. It coordinates with the ventilator control to ensure it does not provide oxygen enriched air to the circuit at the end of inspiration, because at that point it's impossible to correct the delivered volume for this amount.
Ventilator Control—controls the blower motor to provide the required volume and breath frequency, as well as PEEP. This also contains and airway pressure sensor and the bellows position sensor. It also contains a differential pressure sensor which can be used for a flow sensor to measure flow at the patient's mouth to measure what actually got delivered, as opposed the measuring bellows displacement. Differential pressure divided by the known circuit resistance gives flow). This board controls the mixing pump and measures delivered volume using an estimate of O2 enriched air volume from the concentrator.
Sensor Control Board—controls all of the off the shelf patient monitoring devices, some of which have their own boards. Contains/controls the patient CO2 and O2 sensors and their sampling pump, pressure sensor for measuring pressure in the sampling line (since this affects the reading of the CO2 and O2 sensors and is preferably corrected for, and it also detects occlusion of the sampling line), contains a barometric pressure sensor for altitude corrections for the sensors. Additionally, knowing the altitude enables “tuning” the concentrator to work at different working pressures based on the altitude (i.e. the set of working pressures that optimizes the concentrator at sea level may not be the same set that optimizes at 8,000 ft.). This board also measures temperature in the housing as well.
Patient Monitors—CO2 and O2 as above (continuous waveform, calculates inspired and end-tidal from waveform), O2 saturation and plethysmography (from pulse ox), heart rate (from either pulse ox or ECG or blood pressure cuff), non-invasive blood pressure (NIBP, both acoustic noise cancelling and oscillometric), ECG 3 lead, temperature, airway pressure (see above).
Some of the alarm conditions include:
Patient parameter out of present range, (eg. O2, CO2, SpO2, HR, BP, T, Airway pressure), system error (occlusion, leak, O2 low, CO2 high, battery low, valve failure, pump failure, ventilator failure and patient monitor failure).
The device 1102 may further have sufficient controls to operate in selected failsafe modes. For example, the device 1102 may be configured to operate if there is an O2 failure, in a ‘limpalong’ mode whereby the concentrator is not capable of producing O2 at 85% concentration. It may also ventilate using ambient air. In the event of a ventilator failure, an Ambu bag may be interposed in the breathing circuit for manual ventilation, using the oxygen concentrator and/or mixing pump as its supply.
The device 1102 includes optional alarm lights 1150 which may be visible along nearly 180 degrees of viewing angle. The lights may be red to indicate an urgent problem, yellow to indicate a problem that does not require urgent attention, green to indicate that everything is operating within selected ranges and infra-red when operating in stealth mode.
The device 1102 may be mounted along the edge of a stretcher or other patient transport device using the positioning system facing either direction, so that preferably the patient connections and tubes are closest to the head. The screen may be rotated and its contents flipped to make reading easier.
While the above description constitutes the preferred embodiments, it will be appreciated that the present invention is susceptible to modification and change without departing from the fair meaning of the accompanying claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/CA07/01998 | 11/7/2007 | WO | 00 | 2/21/2012 |
Number | Date | Country | |
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60863920 | Nov 2006 | US |