Method and system for gas delivery including gas conserver

A pneumatic oxygen conserver delivering a constant minute flow volume rate to a nasal mask, face mask, or nasal cannula is rendered lightweight by using tubing connected between the conserver and an oxygen source as a reservoir of oxygen for delivery to the nasal mask, face mask, or nasal cannula.

BACKGROUND

Field of the Invention

The present invention relates to the use of gas conservers in gas delivery systems, more particularly, in gas delivery systems for inhalation of medical oxygen or emergency oxygen.

Related Art

Gas conservers are used to provide controlled amounts of gas for inhalation by persons. Two examples of conservers include those for delivering oxygen for patient oxygen therapy and oxygen for airplane crew and/or passengers in low oxygen or low pressure environments aboard aircraft.

Oxygen conservers in the home healthcare market have for many years improved the usable duration of supply vessels (cylinders, tanks, containers, etc.) over continuous flow devices (regulators, flowmeters, liquid oxygen dewars, etc.) while still adequately satisfying the clinical needs of the oxygen patient. These systems typically only provide oxygen to the user during the inhalation portion of a breath, optimally in the first half of the user's inhalation.

Initially most devices were electronic using batteries as a power source. Later, pneumatic device using the pressure in the supply vessel as a power source became the preferred systems due to no need for batteries, smaller size and ease of use. Both types afforded the oxygen patient to ambulate for longer periods of time and/or require less frequent oxygen supply refills.

Weight reduction in aerospace is a constant goal to reduce fuel consumption, increase range and improve safety. Current systems for on-board oxygen provide continuous flow oxygen which limits supply duration, requires the maximum size supply vessel storage space will allow regardless if used which in most flights they are not and can limit aircraft range.

Some home healthcare demand systems have been tried in commercial aviation market with limited acceptance and success. Most were not durable enough for the rigors of the commercial aviation market or provided inadequate interface with the aircraft storage system.

Therefore it is an object of the invention to provide a method and apparatus for regulating gas flow with a conserver that does not experience the problems exhibited by conventional gas flow regulation methods and apparatuses.

SUMMARY

There is disclosed a pneumatic oxygen conserving system for delivering oxygen for inhalation, comprising tubing that is adapted and configured to receive gas from a source of gas, a conserver in downstream flow communication with said tubing, and a wearable gas distribution device comprising a face mask, a nasal mask, or nasal cannula in downstream flow communication with said conserver that is adapted and configured to deliver oxygen to a person for inhalation thereof, the conserver comprising a main body into which is formed: a vent orifice that opens out of the main body; a slave chamber divided into upper and lower regions by a slave diaphragm; a sensing chamber divided into upper and lower regions by a sensing diaphragm; an inhalation sensing passageway that opens into the main body in upstream flow communication with the sensing chamber lower region; slave chamber inlet passage fluidly communicating between the main body inlet and the slave chamber upper region; a slave chamber outlet passage in flow communication between the slave chamber upper region and the mask or nasal cannula; a timing gas inlet passage in upstream fluid communication with the slave chamber lower region; and a timing gas outlet passage fluidly communicating between the slave chamber lower region, the sensing chamber upper region, and the vent orifice, wherein:

an inhalation gas flow path is comprised of said slave chamber inlet passage, said slave chamber upper region, and said slave chamber outlet passage;

a timing gas flow path is comprised of said timing gas inlet passage, said slave chamber lower region, said timing gas outlet passage, and said vent orifice;

the slave diaphragm is biased to a closed position in which it occludes flow communication between the slave chamber inlet and outlet passages and a flow of oxygen through the inhalation gas flow path is prevented;

the slave diaphragm is moved from its closed position to its open position when a difference in pressure, Pslave upper−Pslave lower, between the slave chamber upper and lower regions, respectively, exceeds a predetermined differential pressure Pslave break;

the sensing diaphragm is biased in a closed position in which it occludes flow communication between timing gas inlet and outlet passages and prevents a flow of oxygen through the timing gas flow path;

the sensing diaphragm is moved from its closed position to its open position when a difference in pressure, Psensing upper−Psensing lower, between the secondary slave chamber upper and lower regions, respectively, exceeds a predetermined differential pressure Psensing break; and

the conserver is adapted and configured such that:when the sensing and slave diaphragms are in their closed positions, inhalation of a person wearing the mask or nasal cannula will cause Psensing upper−Psensing lowerto exceed Psensing breakand move the sensing diaphragm to its open position, oxygen flows out of the vent orifice via the main body inlet and the timing gas inlet and outlet passages, and an oxygen flow out of the inhalation gas outlet passage is delayed by a time period ΔT1;at the expiration of ΔT1, a decrease in pressure in the timing gas flow path causes Pslave upper−Pslave lowerto exceed Pslave breakand the slave diaphragm is moved to its open position and oxygen flows through the inhalation gas flow path while the sensing diaphragms remains in its open position for a time period ΔT2;at the expiration of ΔT2, Psensing upper−Psensing lowerdrops below Psensing breakand the sensing diaphragm is moved to its closed position and oxygen is prevented from flowing through the timing gas flow path while oxygen continues to flow through the inhalation gas flow path for a time period ΔT3;at the expiration of ΔT3, an increase in pressure in the timing gas flow path causes Pslave upper−Pslave lowerto drop below Pslave breakand the slave diaphragm is moved to its closed position and flows of oxygen are prevented through the timing and inhalation gas flow pathways; andduring ΔT2and ΔT3, a bolus of oxygen delivered by the conserver to the mask or nasal cannula is drawn from a reservoir in the tubing.

There is also disclosed an oxygen delivery system comprising an oxygen source, a pressure regulator, and aforementioned pneumatic oxygen conserving system. The pressure regulator is adapted and configured to regulate a pressure of the oxygen source to a lower pressure for delivery into the tubing. The tubing includes an orifice choking a flow of oxygen therethrough that separates the tubing into upstream and downstream portions. The one or both of the inhalation gas inlet and outlet passages includes an orifice choking a flow of oxygen therethrough. The downstream portion of tubing is sized and the orifice(s) of the inhalation gas inlet and outlet passages are dimensioned so as to achieve a predetermined minute volume flow rate of oxygen to the wearable gas distribution device.

There is also disclosed a method of using the aforementioned oxygen delivery system comprising the following steps. The aforementioned oxygen delivery system is provided. The oxygen distribution device is caused to be worn by a person

The pneumatic oxygen conserving system, the oxygen delivery system, and/or the method of using the oxygen delivery system may include one or more of the following aspects:the conserver further comprises a main body inlet in fluid communication between the tubing and the inhalation and timing gas flow paths so as to receive a flow of oxygen via the tubing and the main body inlet.the conserver further comprises a main body inlet in fluid communication between the tubing and the inhalation gas flow path and the timing gas inlet passage is in downstream flow communication with the tubing so as to receive a flow of oxygen via the tubing but not from the main body inlet.the wearable gas distribution device is a face mask or nasal mask comprising an inspiratory valve and an expiratory valve, the conserver is integrated into the face mask or nasal mask, the inhalation gas inlet passage is in fluid communication with a downstream end of the tubing, and the inhalation gas outlet passage opens out into an interior of the face mask or nasal mask.the wearable gas distribution device is a nasal cannula and the conserver is disposed in-line with the tubing.the conserver is made of a plastic material.an altitude adjustment device is disposed downstream of the tubing orifice in-line with the tubing that is adapted and configured to increase or decrease a minute volume flow rate delivered by the conserver when a decrease or increase in ambient pressure caused by an increase or decrease in altitude, respectively.the altitude adjustment device comprises a housing having an inlet, an outlet, at least one vent holes on an end thereof that opens out to an exterior of the housing and the ambient atmosphere, and an altitude adjustment diaphragm dividing an interior of the housing into first and second regions, the first region being in flow communication with the housing inlet and outlet, the second region being in flow communication with each of the one or more vent holes, the altitude adjustment diaphragm being biased with a spring into a rest position, a decrease in ambient pressure caused by an increase in altitude causing the diaphragm to move against the biasing of the spring, decrease the volume of the second region, and increase the volume of the first region and consequently increase the volume of the tubing downstream portion.the altitude adjustment device comprises a section of the tubing having a flexibility that is greater than remaining sections of the tubing so that a decrease in ambient pressure caused by an increase in altitude causing the section of the tubing comprising the altitude adjustment device to expand outward and increase the volume of the tubing downstream portionthe oxygen distribution device is a mask and the person is a passenger or crew member of an aircraft.the person is a patient receiving oxygen therapy.no other chamber is formed in the main body that is in fluid communication with the inhalation gas flow path.no electricity is used to initiate a flow of timing gas through the timing gas flow path, initiate a flow of gas through the inhalation gas flow path, move the slave diaphragm to its open closed position, and/or move the sensing diaphragm to its open or closed position.

DESCRIPTION OF PREFERRED EMBODIMENTS

Together with an oxygen source, tubing, and a wearable gas distribution device (a face mask, nasal mask, or nasal cannula), the inventive gas conserver is used to supply a gas to a person only upon their inhalation. The gas is delivered in a bolus very quickly upon detection of the start of inhalation. For use in oxygen therapy, the conserver is adapted and configured for use with cryogenic oxygen systems, oxygen generators, institution wall oxygen gas outlets, portable oxygen systems, and remotely piped oxygen systems. For use aboard aircraft, the conserver is adapted and configured for use with oxygen generators (such as chemical or ceramic oxygen generators or pressure swing adsorption systems) or compressed gas cylinders containing oxygen.

A source of oxygen feeds oxygen at a regulated pressure to the tubing. The term “oxygen” should be construed to include both industrially pure oxygen and also oxygen-rich air.

The tubing includes an orifice in an upstream portion thereof. The portion of the tubing downstream of the orifice and upstream of the conservoir serves as a reservoir for the bolus of oxygen metered out by the conserver. Because this reservoir (i.e., the tubing) is not integrated into the conserver, the conserver may be made with a lower weight and smaller size. In one aspect of the invention, the minute volume flow rate delivered by the conserver may be easily adjusted by adjusting the tubing reservoir volume. Indeed, the inventive device uses the tubing downstream of the orifice as a primary reservoir chamber to accumulate and hold the bolus of oxygen for delivery to the wearer of the mask or nasal cannula until the conserver is triggered by the wearer's inspiratory breath. Along with the conserver's pneumatic timing mechanism, the inside diameter and length of the tube reservoir and the regulated pressure of oxygen supplied by the source determines the maximum volume of the bolus deliverable by the conserver. The pneumatic timing is designed to allow the maximum bolus volume to exit the tube (primary reservoir chamber).

The inventive gas conserver comprises a main body that includes a timing gas flow path and an inhalation gas (oxygen) flow path formed therein. The purpose of the timing gas flow path is to pneumatically open and close the inhalation gas flow path. More particularly, the conserver is adapted and configured such that, after an amount of time ΔT1after the flow of oxygen is triggered through the timing gas flow path, a flow of oxygen through an inhalation gas flow path to the mask or nasal cannula is initiated. After passage of an amount of time ΔT2after the flow of oxygen through the inhalation gas flow path is triggered, the flow of oxygen through the timing gas flow path is prevented, but the flow through the inhalation gas flow path continues. After passage of an amount of time ΔT3after the flow of oxygen through the timing gas flow path is triggered, the flow of oxygen along the inhalation gas flow path is prevented. After passage of an amount of time ΔT4after the flow of oxygen through the inhalation gas flow path is prevented, the pressure in the tubing reservoir reaches the regulated pressure provided by the oxygen source. After passage of ΔT3, the cycle of oxygen delivery may be repeated when the person wearing the mask or nasal cannula draws another breath but, if the breath is drawn before expiration of ΔT4, the size of the bolus of oxygen delivered will be prorated according to the partial portion of ΔT4that has passed.

As best illustrated inFIG. 1, oxygen from a source of oxygen is received into tubing5via tubing inlet3and tubing orifice1. The volume enclosed by the tubing5downstream of tubing orifice1and upstream of the conserver defines a reservoir of oxygen. Formed within the conserver are a slave chamber19and a sensing chamber31. A slave diaphragm25divides the slave chamber19into an upper region23and a lower region21. Similarly, a sensing diaphragm37divides the sensing chamber31into an upper region35and a lower region33.

The tubing5supplies oxygen to the lower region21of the slave chamber19via a slave chamber inlet passage7in which is formed a slave chamber inlet orifice15. Alternatively, the tubing5supplies oxygen to the lower region21of the slave chamber19via an optional slave chamber inlet passage17. In this alternative case, the tubing5is provided with two lumens, one of which supplies oxygen to the lower region21of the slave chamber19and the other which supplies oxygen to the upper region23of the slave chamber19via the inhalation gas flow path inlet9. Otherwise, the tubing5has just one lumen supplying oxygen to both the slave chamber inlet passage7(including a slave chamber inlet orifice15) and inhalation gas flow path inlet passage9(including an inhalation gas flow path inlet orifice11).

A flow of oxygen, as the timing gas, exits the lower region21of the slave chamber19via a slave chamber outlet orifice29disposed in a slave chamber outlet passage27. When in its closed position, the sensing diaphragm37(in its closed position) occludes the slave outlet orifice29and prevents the timing gas from flowing out of orifice29. When a person wearing a mask39inhales, the vacuum induced in passages41,51and the lower region33of the sensing chamber31is sufficient to overcome the biasing of the sensing diaphragm37to its closed position by spring53and the sensing diaphragm37is moved to its open position and no longer occludes orifice29. As such, the timing gas flows out of the upper region35of the sensing chamber and is vented out of the conserver via a sensing chamber outlet passage43having a sensing chamber outlet orifice45disposed therein. Consistent with the foregoing, one of ordinary skill in the art will recognize that the timing gas flow path includes slave chamber inlet passage7(alternatively optional slave chamber inlet passage17), slave chamber inlet orifice15, lower region21of slave chamber19, slave chamber outlet passage27, slave chamber outlet orifice29, upper region35of sensing chamber31, sensing chamber outlet passage43and sensing chamber outlet orifice45.

When in its closed position, the slave diaphragm25prevents a flow of oxygen, as the inhalation gas, out of the tube chamber5via outlet orifice11into the upper region23of slave chamber19. When in its open position, the inhalation gas flows out of the upper region23, into passage47and to an interior of the mask39via orifice49. WhileFIG. 1illustrates a single passage51fluidly communicating with passages41,47in parallel, passage51is optional. In this alternative, both passage41and passage47separately fluidly communicate with an interior of the mask or nasal cannula39(hereinafter “mask”). Consistent with the foregoing, the skilled artisan will recognize that the inhalation gas flow path includes inhalation gas flow path inlet passage9, inhalation gas flow path inlet orifice11, upper region23of slave chamber19, passage47, orifice49, passage51, and mask39.

In operation, when a person wearing the mask39inhales, the pressure difference across the sensing diaphragm37increases because a slight vacuum is induced in the lower region33of the sensing chamber31. This increased pressure difference (Psensing upper−Psensing lower) is sufficient to overcome biasing of the sensing diaphragm37into its closed position by spring53. Those of ordinary skill in the art will recognize that the biasing (Psensing break) is a function of the configuration and material of construction of the sensing diaphragm37and of the bias applied by the spring53. As a result, the timing gas (oxygen) is allowed to flow out of the slave chamber outlet passage27, through the upper region35of the sensing chamber31. The timing gas is thenceforth vented outside the conserver via sensing chamber outlet passage43and sensing chamber outlet orifice45.

The initiation of the flow of timing gas through the timing gas flow path starts a timer whose expiration (after passage of predetermined time ΔT1) initiates the flow of inhalation gas (oxygen) through the inhalation gas flow path. After passage of ΔT1, a decrease in pressure in the lower region21of the slave chamber19increases the pressure differential (Pslave upper−Pslave lower) across the slave diaphragm25(i.e., pressure in upper region23versus pressure in lower region21). This pressure differential increases because the flow of timing gas out of the conserver via the sensing chamber outlet passage43is relatively uninhibited while the flow of oxygen through the slave chamber inlet orifice15is inhibited due to its relatively small hydraulic diameter. As ΔT1expires, this increasing pressure differential exceeds the biasing of the slave diaphragm25towards its closed position. Those of ordinary skill in the art will understand that, due to the configuration and material of construction of the slave diaphragm25, the biasing of the slave diaphragm towards its closed position can be characterized by a predetermined pressure differential (Pslave break). Thus, as ΔT1expires, the slave diaphragm25is caused to move to its open position.

When the slave diaphragm25moves to its open position, the flow of inhalation gas (oxygen) through the inhalation gas flow path is initiated and time ΔT2begins. During this time, the decrease in pressure in the upper region35of the sensing chamber31decreases a pressure differential across the sensing diaphragm37(Psensing upper−Psensing lower). As ΔT2expires, this decreasing pressure differential decreases to a point where it is longer sufficient to counter the biasing force from spring53. As a result, the sensing diaphragm37moves back to its closed position and the sensing diaphragm37occludes the slave chamber outlet passage27.

When the sensing diaphragm37moves to its closed position, time ΔT3beings, the flow of inhalation gas through the inhalation gas flow path continues, and the flow of timing gas through the timing gas flow path is prevented. During this time, the pressure in the lower region21of the slave chamber19start to increase. This causes the pressure differential (Pslave upper−Pslave lower) across the slave diaphragm25(i.e., pressure in upper region23versus pressure in lower region21) to decrease. As ΔT3expires, this pressure differential is no longer sufficient to counter the biasing force of the slave diaphragm25and the slave diaphragm25moves to its closed position. This of course prevents the flow of inhalation gas through the inhalation gas flow path and delivery of the bolus of oxygen is completed

At any time after expiration of ΔT3, the cycle of initiation of the timing gas flow, the initiation of the inhalation gas flow, the prevention of the timing gas flow, and the prevention of the inhalation gas flow may be repeated when the person wearing the mask39draws another breath. If a breath is drawn at the expiration of ΔT4or at some point in time after expiration of ΔT4, the full bolus of oxygen intended to be delivered by the conserver will be delivered to the wearer. On the other hand, if a breath is drawn before passage of ΔT4, although the pressure in the tubing reservoir may not have reached the regulated pressure provided by the oxygen source, a bolus of oxygen will still be delivered to the wearer. Nevertheless, this bolus will be smaller in comparison to the bolus delivered when a breath is drawn at or after expiration of ΔT4because it is prorated against the portion of ΔT4that passes before the breath is drawn.

As seen from the foregoing discussion, the conserver allows delivery of bolus of oxygen on demand by the wearer while at the same time preventing the delivery of more than a maximum minute volume flow rate of oxygen to the wearer. The minute volume rate delivered by the conserver may be expressed as:

where ΔX is the variable amount of time that passes after the flow of oxygen is prevented through the inhalation gas flow path and before a breath is subsequently drawn. Hence, ΔX depends upon when the wearer draws a breath. Imagine if the wearer draws breath precisely when the reservoir pressure reaches the regulated pressure, ΔX=ΔT4and the intended full bolus of oxygen is delivered. If the wearer instead draws breath after the reservoir pressure reaches the regulated pressure, ΔX>ΔT4and the same intended full bolus of oxygen is again delivered but over a longer period of time. If the wearer instead draws a breath before the reservoir pressure reaches the regulated pressure, ΔX<ΔT4and less than the intended full bolus is delivered because the reservoir pressure has not been “reset”. While these boluses are delivered to such a wearer more frequently in comparison to a wearer who waits until at least ΔT4passes and the denominator in the above equation is smaller, such boluses are also smaller because they are prorated according to the amount of time that passes before ΔT4expires.

Therefore, one can see that the wearer receives a same minute volume rate, regardless of how frequently breaths are drawn, so long as the wearer does not draw a breath before the reservoir pressure is reset. A constant minute volume rate is advantageous because it satisfies not only persons drawing breaths at a moderate rate but also persons taking smaller, more frequent breaths. The conserver also prevents the wastage of oxygen in the event that the wearer draws breaths less frequently than the sum of ΔT1+ΔT2+ΔT3+A T4.

Particular embodiments of the inventive device will now be described with reference toFIGS. 2-22.

As best shown inFIG. 2, the oxygen delivery system includes tubing T, a conserver C, and an optional flow indicator F. In this instance, the conserver C delivers oxygen to a nasal mask M.

As best illustrated inFIG. 3and in a different embodiment, the oxygen delivery system includes tubing T and a flow indicator F used in conjunction with a mask M. In contrast to the system ofFIG. 2, however, the conserver C is integrated directly into the mask.

As best shown inFIG. 4and in yet another embodiment, the oxygen delivery system includes tubing T, a conserver C, and a flow indicator F. In this instance, instead of feeding oxygen to a mask, it is fed to nasal cannula.

As best illustrated inFIG. 5, the integrated mask M includes an inspiratory valve VIthrough which the mask wearer may draw in air and an expiratory valve VEthrough which the mask wearer's exhalations may be vented from the mask M.

As best shown inFIGS. 6-11and in the embodiment where the conserver is not integrated into a mask, the conserver includes an upper housing4and a lower housing8sandwiching a middle housing6. At least the conserver housings4,6may be secured to one another with a plurality of screws S. One of ordinary skill in the art will recognize, however, that the invention is not limited to such a technique. Ultrasonic welding and/or an adhesive may be used instead. The upper housing4includes a main body inlet2and the lower housing8includes a main body outlet10.

With reference toFIGS. 8-9, disposed in between the upper and middle housings4,6are o-rings12,14and a slave diaphragm18. A slave chamber inlet orifice16is inserted into any one of a plurality of cavities formed in the middle housing6that are adapted and configured to receive the orifice16in threaded connection or pressed interference fit. The o-ring14or similar seal serves to provide a gas-tight seal at the interface of the upper and middle conserver housings4,6adjacent an upstream end of the orifice16. The hollow passage of the orifice16is sized to provide a desired length of time during which the timing gas is allowed to flow through the timing gas flow path. A larger orifice16will allow a faster flow of the timing gas into the conserver and thus decrease ΔT2and ΔT3. As a result, the volume of the bolus of gas released form the primary chamber tube5will be decreased. A smaller orifice16will of course have the opposite effect. Optionally, the conserver may be provided with a set of multiple o-rings or seals14and orifices16where the hollow passage of each orifice16has a different hydraulic diameter and each orifice16is received by an associated different cavity. In this manner, the conserver may be designed to deliver a variety of minute volume flow rates where the middle housing6need only be rotated in order to change the minute volume flow rate. Instead of, or in addition to, a set of multiple o-rings, seals14, and orifices16, one out of a variety of minute volume flow rates may be selected by providing a set of tubing inlet orifices having different hydraulic diameters.

Disposed in between the middle and lower housings6,8is the sensing diaphragm24. The sensing diaphragm24has dual functions. A thickened, peripheral portion28provides the function of an o-ring for providing a gas-tight seal between the conserver middle and lower housings6,8. A raised middle portion32serves to prevent a flow of timing gas through the timing gas flow path by occluding the slave chamber outlet orifice68. An intermediate portion30connects the peripheral and middle portions28,32. A spring36provides the desired biasing of the sensing diaphragm24towards its closed position in which it occludes the slave chamber outlet orifice68. The biasing force of the spring36may be adjusted by rotating screw cap38. Screw cap38is threadedly received, in the manner of a nut and bolt, in a correspondingly sized cavity formed in the lower housing8to form a gas-tight seal and may be used to adjust the biasing force of the screw36.

With reference toFIGS. 10-11, when the wearer of the mask or nasal cannula draws a breath, a slight vacuum induced in a lower region70of the sensing chamber (via main body outlet10and inhalation sensing passageway72) causes the differential pressure across the sensing diaphragm24(Psensing upper−Psensing lower) to exceed the bias provided by spring36and move the sensing diaphragm24to its open position in which the middle portion32no longer occludes the slave chamber outlet orifice68. As a result of the discontinuation of occlusion, oxygen through the timing gas flow path is no longer prevented and time period ΔT1begins.

With respect to the timing gas flow path, oxygen received from the tubing by main body inlet2is fed into an upstream end of a slave chamber inlet passage58. When the sensing diaphragm is in its open position, the flow continues, in order, through timing gas inlet orifice16, downstream end of slave chamber inlet passage62, passage64, a lower region60of the slave chamber, slave chamber outlet orifice68, an upper region72of the sensing chamber, and is vented outside the conserver via vent orifice74. This flow of the timing gas continues through time periods ΔT1and ΔT2. During time period ΔT1, the pressure within the timing gas flow path (including the lower region60of the slave chamber) decreases. At the expiration of time period ΔT1, Pslave upper−Pslave lowerexceeds Pslave breakand the slave diaphragm18is moved to its open position and time period ΔT2begins.

With respect to the inhalation gas pathway, during time period ΔT1, an abutment66formed on a surface of an upper region54of the slave chamber is in contact with the slave diaphragm18and prevents a flow of oxygen through the upper region54. During time periods ΔT1and ΔT2, oxygen is received from the tubing via inhalation gas inlet passage52. The flow continues through an upper region54of the slave chamber and enters passages20,76,26. Together, passages20,76,26comprise an inhalation gas outlet passage. Because the slave diaphragm18has been moved to its open position, the abutment66no longer prevents a flow of oxygen through the upper region. During ΔT1, the pressure in the timing gas flow path decreases, however pressure increases in the upper region72of the sensing chamber.

At the expiration of ΔT1, the pressure in upper region72of the sensing chamber has decreased to a point where Psensing upper−Psensing lowerno longer exceeds the biasing force of spring36and the sensing diaphragm is moved to its closed position. As such, a flow of oxygen from the slave chamber outlet orifice68to the upper region72of the sensing chamber is prevented. Consequently, a flow through the timing gas flow path is prevented and the pressure thereof (including in the lower region60of the slave chamber) begins to build during time period ΔT3.

At the expiration of ΔT3, because of the building pressure in the lower region60, Pslave upper−Pslave lowergoes under Pslave break, the slave diaphragm18is moved to its closed position, and contact between abutment66and slave diaphragm18prevents a flow of oxygen through the upper region54of the slave chamber. After passage of ΔT3, if the wearer of the mask or nasal cannula draws a breath, the cycle repeats with initiation of a flow of oxygen through the timing gas flow path and time period ΔT1. During ΔT4, the pressure in the tubing reservoir and the timing and inhalation gas flow paths builds back up to the regulated pressure provided by the oxygen source. Before ΔT4expires, any breath drawn by the wearer will result in the delivery of a bolus of oxygen that is prorated according to the degree of completion of ΔT4.

The conserver of the embodiment ofFIGS. 12-17is the same as that ofFIGS. 6-11with a few differences. The lower housing8is no longer provided with a main body outlet10. This means that the slave chamber outlet passage made up of passages20,76,26and the inhalation gas sensing passageway emerge from the main body itself. This particular embodiment is useful when the conserver is integrated into a mask and thus does not need to be connected to any portion of tubing leading to the mask or nasal cannula.

With regard to the description ofFIGS. 6-17above, we note that, instead of the main body having a main body inlet, oxygen may be received by passages52,58directly from the tubing.

In the context of an aeronautical vehicle based system, the invention may also include a device (i.e., an altitude adjustment device). In the case of cabin depressurization, as altitude is increased the ambient air pressure available for breathing in by the wearer via the inspiratory valve of the mask is decreased. Without adjusting for altitude, a conserver whose minute volume flow rate of oxygen is constant will fail to deliver enough oxygen to the wearer to compensate for the decreased amount of oxygen available from the subambient air. If such a constant minute volume flow rate conserver is sized so as to allow a minimum rate at very high altitudes, the conserver will deliver more than the needed rate at relatively lower altitudes and thus waste oxygen and unnecessarily increase the size and thus weight of the source of oxygen.

The altitude adjustment device of the invention acts to increase the minute volume flow rate of oxygen delivered by the conserver during an increase in altitude and decrease the minute volume flow rate of oxygen delivered by the conserver during a decrease in altitude. Any altitude adjustment known in the field of emergency oxygen supplies for aeronautical vehicles may be used in the invention.

The embodiments ofFIGS. 18 and 19are the same as those ofFIGS. 2 and 3, except that an altitude adjustment device A is disposed in-line with the tubing T downstream of any inlet orifice of the tubing T.

Proposed below are two altitude adjustment devices that adjust the minute volume flow rate of oxygen delivered by the conserver by mechanical means instead of with an electromechanical device.

According to the first type of device, and as best shown inFIGS. 20-22, the altitude adjustment device A1acts to increase a volume of the tubing reservoir downstream of the tubing inlet orifice during an altitude increase and decrease a volume of the reservoir during an altitude decrease. The altitude adjustment device A1includes an upper housing UH secured to a lower housing LH in gas-tight fashion. Upstream and downstream ends of the device A1are connected in gas-tight fashion to upstream and downstream portions of the tubing T via fittings. The interior of the device A1is divided into upper and lower cavities UC, LC by a diaphragm D. The diaphragm is biased towards the upper cavity UC by a spring. While the upper cavity UC is in fluid communication with the fittings, the lower cavity LC is not. The lower cavity LC is also not gas-tight in that a plurality of apertures are formed in the lower housing so that the pressure is equalized between the lower cavity LC and the ambient atmosphere outside the device. During an increase in altitude, the ambient pressure decreases while the pressure inside the upper cavity UC remains the same. As a result, the diaphragm D moves downwardly to expand the volume of the upper cavity UC. In this manner, the volume of the tubing reservoir is increased so as to increase the minute volume flow rate delivered by the conserver. Conversely, during a decrease in altitude, the ambient pressure increases while the pressure inside the upper cavity UC remains the same. As a result, the diaphragm moves upwardly to decrease the volume of the upper cavity UC. In this manner, the volume of the tubing reservoir is decreased so as to decrease the minute flow volume rate delivered by the conserver.

According to the second type of device, and as best shown inFIG. 23, the altitude adjustment device A2acts to increase the amount of oxygen passed through the tubing inlet orifice during an altitude increase and decrease that amount during an altitude decrease. The altitude adjustment device A2is secured to the tubing T adjacent a tubing inlet orifice80. A interior of the altitude adjustment device A2enclosed by a housing83is divided by a rigid wall84and a flexible diaphragm85into an upper region86, a middle region87, and a lower region88. The lower region is pressure-equalized to ambient by way of opening89. The middle region87is gas-tight and filled with a gas at atmospheric pressure. The upper region86is also gas-tight (but for fluid communication with tubing T) and pressure-equalized with the pressure in the tubing T.

AlthoughFIG. 23depicts the altitude adjustment device A2in its open position, a spring90has a biasing force designed to push a rod91upward so as to occlude a valve seat92when the altitude adjustment device A2is at ground level so as to prevent oxygen from an upstream portion81of tubing T from flowing through the altitude adjustment device inlet94and into upper region86.

During an increase in altitude, the pressure difference across the diaphragm85increases because, while the middle region87is gas-tight and filled with a gas at atmospheric pressure, the lower region88is at subambient due to the pressure equalization afforded by opening89. The biasing force of the spring90is set so that, above a predetermined altitude, the pressure difference across the diaphragm85is sufficient to slightly compress the spring90and lower the rod91. As a result, the valve seat92is no longer occluded by the rod91and oxygen is allowed to flow from an upstream portion81of the tubing T to a downstream portion82of tubing T via inlet94, secondary orifice93, upper region86, and altitude adjustment device outlet95. As the gap between the open end of the inlet94and the opposing face of the rod91increases, the resistance to oxygen flow decreases. The presence of the secondary orifice93prevents the oxygen from bypassing the orifice80. In this manner, a greater amount of oxygen is allowed to flow into the tubing reservoir downstream of inlet80. The minute volume flow rate of oxygen delivered by the conserver is increased, during ΔT2and ΔT3, the pressure in the upper region of the slave chamber will decrease more slowly in comparison to the case where a flow of oxygen is not permitted past orifice93. Because the pressure decreases more slowly, a greater amount of oxygen flows through the inhalation gas pathway of the conserver.

As an alternative to the two above-described altitude adjustment devices A1, A2shown inFIGS. 20-23, other mechanical structures adapted and configured to perform the same function may be used. For example, a portion of the tubing may be made of a material having a relatively lower hardness (thus having an inherently greater flexibility) than other portions of the tubing) that expands during an increase in altitude and contracts during a decrease in altitude. As one more example, instead of a spring-biased diaphragm, a stand-alone rolling diaphragm or a piston may be used.

While the inventive system may be used for anything requiring a controlled flow of gas delivered in boluses in a cyclical fashion, the inventive gas demand device is typically used by either a patient in gas therapy, such as oxygen therapy with oxygen, oxygen-enriched gas, or compressed air, or by the crew or passengers of an aircraft during low oxygen and/or pressure conditions.

Whether used by a patient for gas therapy or by aircraft crew in low oxygen and/or low pressure environments, in comparison to conventional gas demand devices, the inventive device has several advantages.

The inventive device reduces the required size and/or weight of an oxygen supply vessel (such as a compressed gas cylinder) and/or increases the time of use in between successive refilling or replacement of the vessel. Decreased size and/or weight are important in the gas therapy context for patients who may experience, muscular weakness, lack of muscle tone, and/or lack of stamina. Decreased size and/or weight will also ordinarily result in decreased costs for the manufacturer, insurer, and/or patient. In contrast to the demand device disclosed in U.S. patent application Ser. No. 15/255,858, filed Sep. 2, 2016, there is no need to provide a primary chamber (comparable to the tubing reservoir of the instant invention) within the main body. Because the tubing reservoir serves the function of the primary chamber of the device of the '858 application, the volume encompassed by the main body of the instant invention need not be increased to accommodate the volume of such a primary chamber. Because the volume of the main body of the instant invention need not be so large, the material of construction of the main body need not be so heavy.

Decreased size and/or weight are also important in the aerospace context. Aerospace oxygen systems are typically only used in the rare occurrence of a cabin depressurization in the worst case or to provide first aid to an ill passenger. Regardless, every flight must care enough oxygen supply to meet the worst case scenario. Consequently, the weight of these systems on board consumes fuel, reduces payload and range and increases operating costs. Current systems for on-board oxygen provide continuous flow oxygen. Continuous flow limits the duration of time during which the oxygen is supplied. Continuous flow also requires the maximum size supply vessel that the storage space. When an aircraft is used with a same continuous flow system on both short-distance and long-distance flights, the oxygen requirements for the long-distance flight will control. Thus, long-distance flights with a bulkier and/or heavier continuous flow system that decreases fuel consumption. While short-distance flights may utilize a less bulky and/or less heavy continuous flow system, such a system will limit the range of the aircraft on a subsequent flight unless the system is swapped out with a more bulky and/or heavier continuous flow system. By using the inventive gas demand device, the weight can be reduced. Therefore, the aircraft range and/or payload may be increased and fuel consumption decreased. Indeed, in comparison to some conventional systems, the inventive device can reduce the amount of oxygen required on the typical aircraft by as much as 75%. The weight reduction achievable by the inventive device can also improve safety and maintenance costs as well enabling the use of compressed gas cylinders rather than chemical oxygen generators.

The conserver has also been designed to be made of fewer components and lightweight materials, such as plastic and typically high density polyethylene. This simplifies the conserver resulting in better reliability and ease of manufacture. It will also reduce the conserver's weight which will save fuel when utilized in aerospace. This lighter weight can also help maintain a good mask seal on the wearer's face. If a conserver is too heavy (such as conventional conservers), it can pull the mask down and create a leak between the user's face and the mask, thereby causing the inhalation sensing feature of the conserver to fail and not be triggered by the wearer's inspiratory breath. Many conventional devices are electrically powered with a battery and may suffer from power failures, voltage errors and are generally heavier due to the weight of the battery. In contrast, the inventive device functions pneumatically and does not require any electrical power or batteries.

The conserver is designed to be sensitive enough to trigger at a negative pressure less than the cracking pressure of the masks inspiratory valve but less sensitive then similar devices that could cause false triggering if used on a mask. However the design when used with a nasal cannula has good sensitivity due to its close proximity to the user's end of the cannula as opposed to most systems where the conserver is integrated into a regulator on an oxygen cylinder and distant from the user, often 7 feet.

Many conventional devices include features which are freely movable within the device and which may be impacted by the relative position of the device by the force of gravity. For example, some conventional devices may include a ball-type check valve intended to reduce the amount of back pressure created when a pulse of oxygen exits the device and prematurely forces a diaphragm closed. This type of valve is a positional valve that only functions properly when the device is in an orientation where gravity keeps the check valve ball away from its seat. Should the device be inverted the check valve ball will fall to its seat and occlude the passage to the diaphragm, the device may not function since the check valve ball can remain to occluded if the inspiration from the user is not great enough to lift the ball from its seat. The amount of negative pressure (<−1.00 cm H2O) typically created by the user at an outlet of such device would most likely not be enough to lift the check valve ball off its seat. In contrast, operation of the inventive device does not depend upon how it is positioned or oriented. In other words, the main diaphragm will not be prematurely closed and operation will not change if the position of the inventive device is changed.

The inventive design is small and easy to use and can be configured and adapted to several modalities such as compressed gas high pressure cylinders, cryogenic oxygen systems, oxygen generators, institution wall oxygen gas outlets, portable oxygen systems and remotely piped oxygen systems.

While some conventional home healthcare gas demand systems have been tried in the commercial aviation market with limited acceptance and success, most were not durable enough for the rigors of the commercial aviation market or provide inadequate interface with the aircraft storage system. The inventive device has been designed with the commercial aviation market in mind in order to overcome the problems experienced by many conventional systems as well as for the healthcare market so as to improve upon current gas demand systems for the healthcare market.

Conventional continuous flow compressed gas systems have a limited use time (for inhalation by the user) that is based upon the volume and pressure of the gas cylinder. Put quite simply, the use time is determined by dividing the mass of gas in the cylinder by the flow rate. In contrast, for the same mass of gas in the gas cylinder, the inventive device extends the use time (for inhalation by the user) because it does not use a continuous flow.

Many conventional gas demand devices tend to be complicated, do not control the volume of gas delivered over time, and do not provide the desired pulse bolus flow curve (i.e., a relatively high peak flow for a short duration) that is best for the person using the device. On the other hand, the inventive device provides the desired bolus flow curve.

Some conventional devices deliver multiple pulses in rapid succession creating a saw tooth gas flow pattern that is depend on constant inhalation and does not control the flow over time. In contrast, the inventive device supplies a bolus of gas upon user demand (i.e., inhalation by the user). Thus, it does not deliver another bolus of gas unless it is demanded by the user.

In comparison to many conventional devices, the inventive device exhibits increased reliability, performance, and ease of use, and a decreased rate of failure caused by uncontrolled user interfaces and real world user conditions.

Most conventional devices depend upon either a back pressure from the gas delivery line or back pressure at an outlet of the device in order to close a main diaphragm and reset its pneumatic circuit. The dependence of a back pressure for closing the main diaphragm is because the last orifice upstream of the outlet is located downstream of a fluidic passage to the diaphragm in question. This particular arrangement will result in a varying back pressure upon the diaphragm; consequently, cause an inconsistent volume per minute delivery.

In contrast, the internal features of the tubing and conserver work together create a timing circuit that is independent of any back pressure exerted onto the sense diaphragm. The sense diaphragm of the inventive conserver resets itself based upon the pneumatic timing circuit and the bias of the spring. Upon movement of the sensing diaphragm to its open position, a “secondary slave chamber” in the upper region of the sensing chamber is created. This secondary slave chamber adds to the timing circuit to ensure the main diaphragm followed by the slave diaphragm does not close before the tubing reservoir volume and pressure is depleted. This is important to ensure any back pressure on the sense diaphragm does not affect the timing and the minute volume is consistent across typical range of breath rates.

An ongoing challenge for most conventional pneumatic demand devices is the ability to be sensitive enough for the person with slow shallow breaths to trigger the device without the device being over sensitive to variations in the gas inlet pressure resulting in the device to self-cycle (auto-pulse). Overly complicated designs exacerbate this sensitivity problem since they magnify the amplitude of any pressure deviations from the specified regulated pressure.

In contrast, the design of the pneumatic circuit of the inventive conserver is simplified, so the amplification of pressure-sensitivity experienced by many conventional devices is significantly dampened in the inventive device. The simplified design of the pneumatic circuit also increases the ease of manufacturing, reduces component count and improves performance. To put a finer point on this assertion, the geometry of the components that make the slave chamber and sensing chamber and the orifices formed in the main body of the conserver are designed to reduce the quantity of components and the cost of the components for manufacturing the device. For example, the device of U.S. Pat. No. 7,089,938 may use as many as 22 components making up the pneumatic circuit while the inventive device may use as few as 15 components.

LegendsAfirst altitude adjustment deviceCconserverDdiaphragm for first altitude adjustment deviceFflow indicatorLClower cavityLHlower housing of altitude adjustment deviceMmaskSscrewTtubingUCupper cavityUHupper housing of altitude adjustment deviceVEexpiratory valveVIinspiratory valve1tubing orifice2main body inlet3tubing inlet4upper conserver housing5tubing downstream of tubing orifice6middle conserver housing7slave chamber inlet passage8lower conserver housing9inhalation gas flow path inlet passage10main body outlet11inhalation gas flow path inlet orifice12o-ring14o-ring15slave chamber inlet orifice16slave chamber inlet orifice17optional slave chamber inlet passage18slave diaphragm19slave chamber20Inhalation gas passage21lower region of slave diaphragm22plug23upper region of slave diaphragm24sense diaphragm25slave diaphragm26inhalation gas passage27slave chamber outlet passage28peripheral portion of sensing diaphragm29slave chamber outlet orifice30middle portion of sense diaphragm31sense chamber32raised portion of sense diaphragm33lower region of sense chamber35upper region of sense chamber36spring37sense diaphragm38screw cap30mask41inhalation sense Passage43sense chamber outlet passage45upper region of sense chamber outlet orifice47inhalation gas passage51inhalation gas and sense passage52inhalation gas inlet passage53spring58upstream end of slave chamber inlet orifice60lower region of the slave chamber62downstream end of slave chamber inlet orifice64passage66inhalation gas flow path inlet orifice68slave chamber outlet orifice70lower region of sensing chamber72inhalation sense passageway74upper region of sense chamber outlet orifice76inhilation gas passage