Low-flow oxygen therapy humidifier and method
11071842 · 2021-07-27
Assignee
Inventors
- Craig Sunada (Manasquan, NJ, US)
- Wanchai Lim (Lakewood, NJ, US)
- Nate Inkrote (Lakewood, NJ, US)
- Steven Lepke (Wakefield, MA, US)
- Vincent Lambert (Lakewood, NJ, US)
- Eric Hyman (Lakewood, NJ, US)
- Wayne S. Breyer (Middletown, NJ, US)
Cpc classification
A61M16/1005
HUMAN NECESSITIES
A61M2205/8262
HUMAN NECESSITIES
A61M2205/7536
HUMAN NECESSITIES
A61M16/142
HUMAN NECESSITIES
International classification
A61M16/14
HUMAN NECESSITIES
Abstract
A system for humidifying oxygen for low-flow oxygen therapy includes a volume-adaptable water reservoir that contains, in addition to water, a water-vapor-permeable membrane.
Claims
1. A humidification system for use with low-flow oxygen therapy, the humidification system comprising: a reservoir, wherein the reservoir receives a volume of liquid water, and further wherein a liquid capacity of the reservoir is alterable such that instantaneous liquid capacity of the reservoir is substantially equal to an instantaneous volume of liquid water in the reservoir; and a tube comprising a water-vapor-permeable (WVP) membrane, wherein a major portion of the tube is contained in the reservoir.
2. The humidification system of claim 1 wherein the WVP membrane comprises a perfluorosulfonic acid polymer.
3. The humidification system of claim 1 wherein the reservoir comprises two spaced-apart liquid-water-impermeable membranes, wherein a first one of the two membranes comprises a greater surface area than a second one of the two membranes.
4. The humidification system of claim 1 wherein the reservoir comprises a pouch.
5. The humidification system of claim 1 wherein the reservoir comprises a tube comprising a soft, pliable material.
6. The humidification system of claim 1 wherein the reservoir comprises a vent.
7. The humidification system of claim 1 and further comprising means for applying positive pressure to the reservoir.
8. The humidification system of claim 1 and further comprising one or more restraints that immobilize the tube within the reservoir.
9. The humidification system of claim 1 and further comprising a heater for heating the liquid water in the reservoir.
10. The humidification system of claim 1 and further comprising an oxygen outlet line coupled to an end of the tube.
11. The humidification system of claim 10 and further comprising a heating element for heating the oxygen outlet line.
12. The humidification system of claim 1 wherein the reservoir and the tube are contained in housing, wherein the housing, reservoir, and tube collectively define a cartridge.
13. The humidification system of claim 12 and further comprising a receiver, wherein the receiver includes a heater, and wherein the receiver and the cartridge are physically adapted to couple to one another, and when coupled, the heater aligns with and is in sufficient proximity to the reservoir to heat the water therein.
14. The humidification system of claim 13 wherein the housing of the cartridge includes an opening, wherein the opening is located so that the heater abuts a portion of the reservoir when the receiver and the cartridge are coupled to one another.
15. The humidification system of claim 14 wherein the housing further comprises a cover that detachably couples to the housing at the opening.
16. The humidification system of claim 13 wherein at least a portion of the housing comprises a high-thermal-conductivity material, wherein the portion is located between the reservoir and the heater when the receiver and the cartridge are coupled to one another.
17. The humidification system of claim 13 wherein the receiver includes a user interface by which a user adjusts the temperature of the reservoir.
18. The humidification system of claim 1 wherein the reservoir comprises a fill port for filling the reservoir with water.
19. The humidification system of claim 18 further comprising a pump for pumping the water into the reservoir through the fill port.
20. The humidification system of claim 19 and further comprising a source of water for filling the reservoir, wherein the reservoir is fluidically coupled to the source of water via the pump.
21. The humidification system of claim 20 wherein the water reservoir further comprises a return port, wherein, in conjunction with a return line, the return port fluidically couples the reservoir to the source of water.
22. The humidification system of claim 18 further comprising a sterile water bag, wherein the sterile water bag is fluidically coupled to the fill port to provide a continuous supply of water to the reservoir.
23. The humidification system of claim 13 wherein receiver includes a power inlet port.
24. The humidification system of claim 9 further comprising a power source.
25. The humidification system of claim 12 wherein the cartridge includes an identifier, wherein the identifier is electronically read.
26. The humidification system of claim 12, wherein the housing has a length of about 13 centimeters and a width of about 10 centimeters.
27. The humidification system of claim 17 wherein the user interface is operable to control the temperature of the reservoir to at least one of 28° C., 32° C., and 36° C.
28. The humidification system of claim 9 wherein the heater is physically adapted to enable resistance heating thereof.
29. A humidification system for use with low-flow oxygen therapy, the humidification system comprising: a housing; a water reservoir contained in the housing, wherein the water reservoir is refillable, and further wherein a volume of the reservoir adapts to an amount of liquid water contained therein; a tube comprising a water-vapor-permeable (WVP) membrane, wherein a major portion of the tube is contained in the water reservoir, wherein the housing, the water reservoir, and the tube collectively define a cartridge; a receiver, the receiver including a heating element, and wherein the cartridge and the receiver are structured for detachable coupling with one another, wherein, when coupled, the heating element transfers heat to the reservoir.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
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(27) In some embodiments, based on the manner in which humidification system 100 operates, the dew point of the humidified oxygen is the temperature of the water used for humidification. In some embodiments of humidification system 100, the water used for humidifying the oxygen is heated, typically to a temperature in the range of about 28 to about 37° C. As a consequence, in such embodiments, humidification system 100 provides humidified oxygen 94 having a dew point in the range of about 28 to about 37° C. In some other embodiments, the water used for humidifying oxygen is not heated. Since evaporation of liquid (in this case, water) releases heat (i.e., latent energy), such unheated water cools to a temperature that is less than that of its surroundings.
(28) After humidification, humidified oxygen 94 is conveyed to the patient. To that end, humidification system 100 is fluidically coupled to standard nasal cannula 98, as is widely available in the marketplace. In some embodiments, humidification system 100 includes an oxygen outlet line, which couples to nasal cannula 98. In some alternative embodiments, a proprietary cannula is used, which serves the function of both the oxygen outlet line and the nasal cannula.
(29) There is usually at least a meter of cannula between humidification system 100 and the patient. If the water that humidifies the oxygen is not heated, then rain-out (condensation) will not occur in the cannula. This is because the dew point of humidified oxygen 94 (based on the aforementioned cooling phenomena) will be lower than the ambient temperature and, hence, lower than the temperature in the cannula. However, if the water is heated during the humidification process, then the dew point of humidified oxygen 94 will be greater than the ambient temperature. Consequently, as humidified oxygen 94 passes through the cannula, it will cool below its dew point and rain-out will occur.
(30) To prevent rain-out, in some embodiments, the temperature of the humidified oxygen is increased above its dew point temperature (i.e., above 28-37° C.) via a source of heat. In some embodiments, the heating occurs in the oxygen outlet line (in such cases, the oxygen outlet line is commonly referred to as a “heated line”). In some embodiments, the temperature of humidified oxygen 96 is increased to a temperature in the range of about 37 to about 40° C.
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(32) During operation, reservoir 202 contains liquid water 204, which is either distilled or de-ionized. Liquid water 204 is the source for the humidity—water vapor—that is added to oxygen 92 coming from the oxygen supply.
(33) As described later in this specification, reservoir 202 can be embodied in a variety of ways. For example, in some embodiments, the reservoir is in the form of a sealed “bag” or “pouch” filled with water. In some embodiments, the pouch of water is “single use,” such that when the amount of water in reservoir drops below a threshold amount, the pouch is exchanged for another that is full of water. In some other embodiments, the pouch includes a re-sealable water fill port by which the pouch is refilled as liquid water evaporates. After a period of time, the refillable pouch is replaced to ensure consistent performance.
(34) In some additional embodiments, reservoir 202 is in the form of a tube. In yet some further embodiments, the reservoir is embodied by a frame, having a central opening (the frame has an annular or ring shape, etc.), wherein water impermeable membranes seal each of the two major sides of the frame, thereby creating a void therebetween. In some embodiments, the void is filled with water via a re-sealable water fill port.
(35) In the illustrative embodiments, WVP membrane 206 is in the form of a tube, which is situated either in whole or in major part, in reservoir 202. One end of the WVP tube is in fluidic communication with oxygen source 90, receiving dry oxygen therefrom, and the other end of the WVP tube is in fluidic communication with nasal cannula 98, providing humidified oxygen thereto. Oxygen flows through the inside of WVP membrane 206; the exterior of WVP membrane is exposed to water 204 that is within reservoir 202. Water vapor, sourced from liquid water 204, passes through WVP membrane 206 into the flowing oxygen, thereby humidifying it. Importantly, liquid water does not pass through the WVP membrane.
(36) In some embodiments, WVP membrane 206 comprises a perfluorosulfonic acid (PFSA) polymer. Such polymers have a poly(tetrafluoroethylene) backbone with perfluoroether pendant side chains terminated by sulfonic acid groups. A preferred PFSA membrane for use in conjunction with the present invention is Nafion™, which is generated by the free-radical initiated copolymerization of a perfluorinated vinyl ether sulfonyl fluoride co-monomer with tetrafluoroethylene:
(37) ##STR00001##
Nafion™ is highly selectively and exceedingly permeable to water vapor, yet does not allow oxygen and other gasses to pass through the membrane. Nafion™ is available from Perma Pure LLC of Lakewood, N.J.
(38) Assuming a sufficient amount of Nafion™ is present (the sufficiency of which primarily being a function of the oxygen flow rate), the dew point of the humidified oxygen is equal to the temperature of the water at the surface of the Nafion™. At the prevailing oxygen flow rates (i.e., 0.5 to about 0.6 LPM), at least about 30 centimeters (cm) of TT-110 Nafion™ (http://permapure.com/products/nafion-tubing/) is sufficient to achieve the aforementioned humidification performance.
(39) In some embodiments, WVP membrane 206 comprises a porous membrane that is permeable to water vapor but relatively impermeable to liquid water. Such WVP membranes include olefin-fiber membranes such as Tyvek, porous PTFE membranes such as Gore-tex and polysulfone hollow-fiber membranes. When using a porous membrane, additional design considerations are required to prevent water breakthrough. These considerations can include controlling the water pressure, increasing membrane thickness or various hydroscopic coatings or surface modifications. Porous membranes are typically permeable to oxygen and other gases, and careful management of the pressure differential from the inside to the outside of the tubing is required to prevent excessive transfer of oxygen through the tubing walls. For guidance, see, for example, U.S. Pat. No. 7,708,013, wherein a plurality of hollow-fiber membranes are used to humidify oxygen.
(40) In some embodiments, WVP membrane 206 comprises a solid wall pervaporation membrane that selectively permeates water. Such materials include, for example, cellulose acetate, polyvinyl alcohol, polyimides and polyamides. The disadvantage of these membranes compared with Nafion™ include the need for significantly more surface area to achieve the same humidification levels, and poorer control over the final humidification level. Nafion™ can equalize the outlet dew point with the water temperature, while due to permeation resistance in the walls of other pervaporation membranes, the outlet dew point might not reach the same level. In addition, the bacteriostatic nature of Nafion™ prevents bacteria growth, while many of these materials can actively promote bacteria growth.
(41) Liquid-water contact (as opposed to water vapor) with WVP membrane 206 results in best humidification performance. To that end, in some embodiments, reservoir 202 includes physical adaptations to ensure that, as water leaves the reservoir (i.e., from evaporation and transport of the vapor across WVP membrane 206), the reservoir “collapses,” adapting its volume to the amount of liquid water remaining in the reservoir. This, in addition to any other physical adaptations, ensures that as long as a threshold amount of liquid water is present in reservoir 202, WVP membrane 206 remains in at least partial contact with liquid water 204. In some embodiments, the aforementioned threshold or minimal amount of liquid water is an amount sufficient to keep at least about ⅓ of the exterior surface area of WVP membrane 206 in contact with liquid water.
(42) The ability of reservoir 202 to adapt its volume to the amount of liquid water is implemented by one or more features. One such feature is the presence of vent, which vents any air that enters the reservoir. Another such feature is the manner in which the reservoir is formed. In particular, in embodiments in which the reservoir comprises membranes attached to a frame, the upper membrane is vacuum formed into a shape that results in minimal space in the reservoir, similar to the shape shown in
(43) In some embodiments, another structural adaptation the enables reservoir 202 to adapt its volume to the amount of liquid water present is an arrangement that applies a constant positive pressure to reservoir 202 (see, e.g.,
(44) In some embodiments, the same and, in some embodiments, one or more additional structural adaptations ensure that, as long as the aforementioned threshold amount of liquid water is present in reservoir 202, contact between WVP membrane 206 and liquid water 204 is maintained regardless of the orientation of reservoir 202 (e.g., horizontal, vertical, etc.). In some embodiments, an additional structural adaptation for this purpose comprises restraints that immobilize WVP membrane 206 and maintain it in a predetermined location within the reservoir.
(45) Heating element 208, which is an optional element of humidification system 100, heats water 204 in reservoir 202. The heating element can take any form suitable for the form factor of reservoir 202. The heating element can be, for example and without limitation, a flat plate, a flexible tape/web of metal or wires, cartridge heater, or other conventional heating devices. The heat supplied by heating element 208 controls the level of humidification and the dew point of the oxygen. More particularly, heating the water in reservoir 202 as well as the oxygen flowing through WVP membrane 206 increases the level of humidification and, hence, the dew point of the flowing oxygen. In some embodiments, heating element 208 is resistively heated by electrical current, as may be sourced from an external source of power (e.g., AC power, as appropriately converted to DC and reduced in voltage, a battery, etc.), or via a power supply that is included in humidification system 100 (e.g., rechargeable or non-rechargeable battery, super capacitor, etc.).
(46) Oxygen outlet line 210, which is an optional element of humidification system 100, receives humidified oxygen from WVP membrane 206. In some embodiments, oxygen outlet line 210 conveys the humidified oxygen to nasal cannula 98.
(47) In some embodiments, particularly those in which water 204 in the reservoir is heated, oxygen outlet line 210 is heated as well via a heating element (not depicted in
(48) If a standard nasal cannula is used in conjunction with oxygen outlet line 210, an excess length of cannula may be present (i.e., beyond the meter or so required to traverse the distance between the outlet of oxygen outlet line 210 and the patient's nose). In embodiments in which oxygen outlet line 210 is heated, such excess length of cannula should be treated to prevent heat loss and condensation. In some embodiments, the cannula is insulated to minimize heat loss, such as can be accomplished by a “cozy” that wraps around the cannula. In some other embodiments, the nasal cannula itself is heated, such as by incorporating a heating element in/on the cannula or in the cozy.
(49) In some embodiments, heating element 208 for water 204 in reservoir 202 also functions as the heat source for the humidified oxygen in oxygen outlet line 210. In some other embodiments, separate heat sources (which may be the same type or different) are used for heating the water and heating the humidified oxygen in oxygen outlet line 210.
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(54) In particular, web/tape 308 of heating wires embodies heating element 208 (
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(56) In the embodiment depicted in
(57) The form factor of humidification system 400 enables it to be readily carried by a patient. In some embodiments, the humidification system is received in a carry case (not depicted), which couples to a patient's belt, or otherwise is supported by a waist- or shoulder strap. The form factor of humidification system 400 (in particular housing 420) is characterized by a thin, flat profile. In the illustrative embodiment, the form factor is further characterized as being quadrilateral; a rectangular or square shape. However, in some other embodiments, the shape is circular, oblong, oval, or the like. As used herein and the appended claims, the term “cartridge” is used to refer to embodiments of humidification system 100 in which the reservoir 202 and WVP membrane 206 are in a structure (e.g., housing 420, etc.) having a form factor as described above. In some embodiments, housing 420 (or other related embodiments of the housing/enclosure) has a length in the range of about 7.5 to about 13 cm, a width in the range of about 7 to about 10 cm, and a thickness in the range of about 1.25 to 2.5 cm. In some embodiments, housing 420 comprises a rigid material, such as, without limitation, an injection-molded plastic, including polyurethane and polypropylene, among others. Hereinafter, the terms “humidification system 400” and “cartridge 400” are used interchangeably.
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(59) Cartridge 400′ includes the same main elements (and has the same form factor) as humidification system 400, including WVP membrane 206 and reservoir 202 and functions in substantially the same manner. However, in this embodiment, heat is supplied to reservoir 202; in particular, via heating plate 508 of receiver 530.
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(61) In some embodiments, cartridge 400′ is releasably secured to receiver 530, such as by latch 524. Heating plate 508 aligns with, and is in sufficient proximity to, reservoir 202 to be in thermal communication therewith when cartridge 400′ and receiver 530 are coupled to one another. And when so coupled, heating plate 508 heats water 204 in reservoir 202, thereby controlling the level of humidification and the dew point of the oxygen flowing through WVP 206.
(62) It will be appreciated that in the embodiment of humidification system 400 depicted in
(63) To this end, in some embodiments of cartridge 400′ depicted in
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(65) In yet some other embodiments, such as depicted in
(66) With continuing reference to
(67) In some alternative embodiments, heating element 314 may be spirally wound around conduit 312. Or, heating element 314 is a heating tape that is spirally wound around conduit 312. The spirally wound configuration is useful, for example, in situations in which relatively longer lengths of heating element 314 are required to achieve the requisite heating wattage. On the other hand, a benefit to the use of a longitudinal heating element is that the heat applied per unit length is constant. With a spirally wound configuration, variation in the spacing of spirals results in regions receiving relatively greater or lesser amounts of heat.
(68) In yet in some further embodiments, heating element 314 can be embedded in the wall of conduit 312 or disposed within the lumen of conduit 312. In some embodiments, heating element 314 comprises carbon fiber wire. Further description of heating element 314 and the manner in which it is interconnected to other elements of the humidification system is provided later in this specification in conjunction with
(69) Insulation 316 provides several benefits, including uniformly spreading the heat generated from heating element 314, significantly reducing the power required to heat the line (by minimizing heat loss), and it is comfortable against a user's skin.
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(71) The embodiment depicted in these figures, and with particular reference to
(72) A plurality of retainers 638 extend inwardly into region 636. In some embodiments, retainers 638 are coupled to frame 631. More particularly, in some embodiments, retainers 638 attach directly to frame 631; in some other embodiments, the retainers are attached to a fixture (not depicted) that attaches to frame 631. In some embodiments, the fixture has the same shape as the frame, and has dimensions suitable for overlying (or underlying) frame 631. Retainers 638 receive WVP membrane 206 and maintain it in a predefined position. As depicted in
(73) With continuing reference to
(74) As depicted most clearly in
(75) In the illustrative embodiment, “lower” impermeable membrane 652 remains flat (i.e., parallel to the bottom 632 of frame 631), whereas impermeable membrane 650 must be able to move towards or away from membrane 652. This enables the volume of reservoir 402 to expand or contract with changes in the amount of water 204 therein. In some embodiments, upper membrane 650 is vacuum formed to provide it with the requisite surface area to move. Since, in the illustrative embodiment, membranes 650 and 652 are formed from a resilient material having a limited ability to “stretch,” there is more of membrane 650 than there is of membrane 652 within open central region 636. This is seen most clearly in
(76) As depicted in
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(78) Returning to
(79) WVP membrane 206, embodied as a flexible tube, is coupled at one end to oxygen inlet port 422 and at its other end to oxygen outlet port 423. The oxygen inlet port 422 is also connected to an oxygen line (not depicted) that conveys oxygen from oxygen source 90 (
(80) Fill port 642 enables reservoir 402 to be filled/refilled with water. In some embodiments, fill port 642 is implemented as a Luer fitting, which receives a corresponding dispensing Luer fitting for dispensing water 204. In some embodiments, fill port 642 comprises a valve to prevent air or contaminants from entering when the corresponding dispensing Luer fitting is not present. A non-limiting example of such a valve is a needlefree swabable valve as is commercially available from Nordson Medical of Westlake, Ohio. In this regard, a large “syringe” or small accordion bottle filled with distilled or de-ionized water can be provided for use with such an embodiment of the humidification system. After the initial dose of water is introduced into reservoir 402 and humidifies the flowing oxygen, the syringe or bottle can be refilled with distilled/de-ionized water and engaged to the fill port 642 to refill reservoir 402.
(81) In some embodiments, fill port 642 can be used to extract air that might enter reservoir 402′, as well as to fill the reservoir with water. In such an embodiment, air is directed to fill Port 642 by appropriately orienting the reservoir. After filling the reservoir with water, the syringe or bottle can be used to extract air, as appropriate.
(82) In some embodiments, a pump (not depicted) is used in conjunction with fill port 642 to supply water to reservoir 402. In some of such embodiments, the pump is a manual pump, with each stroke providing a predetermined amount of water. To avoid over-pressurizing or over-filling reservoir 402, in some embodiments, a pressure relief valve is incorporated into the pump, wherein any additional pumps of water are redirected back to the water source (i.e., external water container). In some other embodiments, the pump is electrically driven and controlled. The pump control can be used to automatically shut-off when the pressure reaches a threshold value, or a bypass feature can be used.
(83) In yet some further embodiments, the pump can connect to two ports with two separate lines; a fill port with a fill line and a return port (not depicted) with a return line. The fill port (e.g., fill port 642, etc.) is used to supply water to reservoir 402. The return port is positioned such that in the normal fill orientation, the return port is located at the highest location in reservoir 402. This will place the return port in contact with any air that might be in the reservoir, and return that air to the fill container during the fill cycle. Once all air is purged, water will start flowing through the return path, which will then signal the user that it is time to stop pumping. This accomplishes the objective of removing air from the reservoir to keep the WVP membrane in contact with liquid water, and prevents over-filling or over-pressurizing the reservoir since excess water will simply return to the container that is the source of the water.
(84) In still some further embodiments, fill port 642 is fluidically coupled to a much larger (than reservoir 402) container of water, such as a sterile water bag to provide, thereby providing a much larger water capacity. In embodiments in which the WVP membrane comprises Nafion™, the pressure of the water has very little if any effect on performance. As such, a simple collapsible bag, positioned anywhere above reservoir 402, will continuously flow water into the reservoir as the liquid water therein evaporates and passes into the oxygen flowing through the WVP membrane. This arrangement is particularly advantageous in acute-care settings wherein oxygen therapy is applied continuously for long periods of time to an immobile patient.
(85) Additional elements depicted in
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(87) In the embodiment depicted in
(88) Valve 758 functions as a one-way check valve, moving “upward” (i.e., away from membrane 650′) under the influence of positive pressure (i.e., higher pressure in reservoir 402′). Valve 758 serves to prevent gas (or liquid) from entering the reservoir, and also functions to limit, to the extent possible, water-vapor loss through vent 756.
(89) In the illustrative embodiment, valve 758 is a mini umbrella valve, which has a convex diaphragm-shaped sealing disk that seals against negative pressure (i.e., lower pressure in reservoir 402′ than surrounding environment), but lifts and unseals against positive pressure (i.e., relatively higher pressure in reservoir 402′ than surrounding environment). Such a valve is available from miniValve Inc of Cleveland, Ohio, or others. In some other embodiments, a thin-film check valve that relies on surface-to-surface affinity to stick the valve sheet to membrane 650′ to prevent air from entering reservoir 402′ while enabling air to escape. Such a valve is commercially available from Dielectrics Industries of Chicopee, Mass. Valve 448 comprises, in some embodiments, the same material as membrane 340 (e.g., urethane, etc.).
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(91) In the embodiment depicted in
(92) In the illustrative embodiment, resilient elements 864 are springs. In some other embodiments, the resilient elements can be a resilient material, such as rubber, etc. In some embodiments, rather than having a plurality of discrete elements, a sheet of rubber or other resilient material is placed between pressure plate 862 and the inside surface of housing 420, 420′, 420″. In embodiments in which reservoir 202 includes a vent and/or fill port, accommodation must be made for such features, such as by providing suitably positioned and sized openings in pressure plate 862.
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(94) Reservoir 902 can be single use. When the water in the reservoir drops to a threshold amount (previously discussed), reservoir 902 is replaced with another reservoir 902 that is full of water. In some embodiments, arrangement 860 for applying positive pressure is used to promote collapse of reservoir 902 as water evaporates and passes into WVP membrane 206.
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(96) To readily replace and/or access reservoirs 902 and 902′, in some embodiments, housing 920 is used in conjunction with such reservoirs. Housing 920 includes removable cover 966, which provides access to the inside of the cartridge. In the illustrative embodiment, housing 920 is depicted as including opening 527 or thermally conductive insert 529, such as is used for some embodiments of the humidification system in which the reservoir is heated. In some other embodiments, such as when heating is not desired or not required, such opening or insert can be omitted (see, e.g., humidification system 400).
(97) In some embodiments in which reservoir 202 is in the form of a bag/pouch, such as reservoirs 902 and 902′, the bag/pouch is made from a single material, such as, for example, urethane or silicone.
(98) As previously mentioned, to ensure best performance, reservoir 202 should be discarded after a period of time. In some embodiments, such as at least some of those in which reservoir 202 is embodied as a bag or pouch (see, e.g.,
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(100) Base 1070 is dimensioned and arranged to receive/align cartridge 400′ (or other versions thereof) as depicted in
(101) As to alignment, boss 1090 (
(102) Heating plate 1008, which in some embodiments comprises aluminum, is resistively heated by current sourced from an external source of power (e.g., AC power, as appropriately converted to DC and reduced in voltage, a battery, etc.), as coupled through power input 1086, or from optional on-board power supply 1082 (e.g., rechargeable or non-rechargeable battery, super capacitor, etc.).
(103) Control panel 1074 includes user-operated controls for controlling the level of heating (i.e., humidification) as well as status indicators. In the embodiment depicted in
(104) In some embodiments, the heating levels provided by receiver 1030 are discrete; for example, heating plate 1008 can be controlled to a few different temperatures, such as 28° C., 32° C., and 36° C. In such embodiments, indicators, such as indicator lights 1080 (e.g., LEDs, etc.), may be used to indicate the level of heating (humidification) provided. For example, one light illuminated for low-level heating/humidification (e.g., 28° C.), two lights illuminated for a moderate level (e.g., 32° C.), and three lights illuminated for a high level (e.g., 36° C.).
(105) In some other embodiments, heating/humidification is analog; that is, infinitely controllable between a low and high value. In some embodiments, a temperature gauge is included on control panel 1074. As previously discussed, in some embodiments, oxygen outlet line 210 is heated, and, in some such embodiments, control panel 1074 includes a control device for controlling the temperature of that line.
(106) Electronics board 1088, which includes one or more processors, memory, etc., is suitably programmed to maintain temperature within safe operating ranges to prevent injury to the patient. In some embodiments, the electronics board, in conjunction with appropriate sensors, is capable of identifying and signaling power outages, flow restrictions, low oxygen flow, high or low temperatures or other faults. Oxygen flow sensors, for example, may be used to prevent oxygen deprivation, even in situations in which the humidifier itself is not at fault (e.g., the oxygen cylinder running out of oxygen, etc.). Resistance sensing on the heating elements can sense electrical shorts and prevent unsafe operation in case of a mechanical fault. Ambient temperature sensing can detect when the ambient temperatures are above 37° C. and shut down heating to prevent over humidification of the oxygen stream. Indicator lights 1080, for example, can be used to indicate such conditions, by “blinking” in a particular pattern.
(107) To the extent power is coupled between receiver 1030 and a cartridge (e.g., cartridge 400′), such as for heating outlet-oxygen line 210, electrical contacts 1092 can be used to do so. Additionally, the electrical contacts can be used to read an identifier associated with the cartridge. From this information, and information stored in memory on electronics board 1084 (e.g., usage, age, etc.), receiver 1030 can signal replacement of the cartridge and/or reservoir as appropriate, as well as providing additional information to the user and/or manufacturer.
(108) In some embodiments, particularly those in which there is relatively minimal coupling of power and signals between receiver 1030 and cartridge 400′, spring contacts 1088 can be used rather than optional contacts 1092.
(109) As previously noted, in some embodiments, heating element 314 comprises carbon fiber wire. Referring again to
(110) With continued reference to
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(112) Humidification system 1100 is very compact and is based on the cartridge form factor.
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(114) Definitions. The following definitions, in addition to those previously provided in context, are to be used to interpret terms used in this disclosure and the appended “about” or “substantially” means within +/−15% of a stated figure. “up”, “down”, “lower”, “upper”, “below”, “above” are used to reference positions depicted in drawings, and do not have any absolute meaning. That is, they reference a position based on a particular orientation of the humidification system (horizontal, vertical, etc.), as depicted in the Figures. However, one skilled in the art will be able to discern, in absolute terms, the position of such elements with respect to other elements, based on such descriptors. It is to be understood that the disclosure describes a few embodiments and that many variations of the invention can easily be devised by those skilled in the art after reading this disclosure and that the scope of the present invention is to be determined by the following claims.