Nasal cannula

Abstract

A nasal cannula (10) for use with a gas dispensing system (100) at ambient pressure with an ambient pressure tube (122). Nasal prongs (20A, 20B) extend from the nasal cannula body (12, 14). A gas receiving aperture (22) is fluidly connected to the interior volume of the nasal cannula body (12, 14) for receiving gas through the tube (122). A one-way exhalation valve (24) is carried by the nasal cannula body (12, 14). Gas provided by the tube (122) can be inhaled through the nasal prongs (20A, 20B), and exhaled breaths can be exhausted through the one-way exhalation valve (24). First and second FiO2 adjustment apertures (25A, 25B) are individually and selectively adjustable in size to provide a desired amount of air entrainment into the gas inhaled through the nasal prongs (20A, 20B). The nasal cannula bodies (12, 14) are formed from a first body member (12) of a resilient, flexible material assembled with a cavity that receives a second body member (14) of a rigid material.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 408,653, filed September 21, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates generally to the delivery of gases from a source to a recipient. More particularly, disclosed herein is a nasal cannula for use in a system for delivering oxygen at ambient pressure from a donor reservoir to a recipient. The nasal cannula operates to allow exhaled air to be exhaled through the nasal cannula and, in certain embodiments, provides direct and immediate control over the fraction of inspired oxygen (FiO2) inhaled through the nasal cannula. [Background technology]

[0003] Normally, the lungs absorb a sufficient supply of oxygen from the air during natural breathing. However, certain conditions can prevent a person from obtaining enough oxygen. As a result, oxygen therapy using an oxygen delivery device is necessary. Patients can receive oxygen therapy from an oxygen source through a tube placed in the patient's nose, through a face mask, or through a tube placed in the patient's tuleikia (windpipe). Oxygen therapy increases the amount of oxygen the lungs can receive and deliver to the blood. Oxygen therapy can be prescribed to patients when their blood oxygen levels become significantly low. Low blood oxygen can leave patients feeling short of breath, fatigued, or drowsy, and can be damaging to the patient's body. Oxygen therapy can be needed temporarily or long-term, such as for treatable respiratory conditions. Oxygen sources are often tanks of compressed oxygen gas or liquid.

[0004] Oxygen supplies can be critically needed for hospital patients and others. Meanwhile, in developing countries and while demand is increasing everywhere, oxygen shortages and excessive costs can significantly limit availability and endanger the health and safety of patients in need. For example, during the COVID-19 pandemic, demand for oxygen has left hospitals and other care facilities in dire need of the life-saving gas. A headline from AP Network News on June 24, 2020, sounded the alarm: "Scarce Medical Oxygen Worldwide Leaves Many Gasping for Life." A day later, Reuters noted, "WHO Warns of Oxygen Shortage as COVID Cases Set to Top 10 Mln," stating that the World Health Organization estimates that roughly one million new coronavirus cases are occurring worldwide each week, and the world is experiencing an average of 620,000 m² of oxygen a day. 3 The study estimates that approximately 88,000 large cylinders of oxygen will be needed for COVID-19 patients alone.

[0005] One way supplemental oxygen is delivered to a patient under prior art teachings is via a fluid connection, typically a tube, between a pressurized source of oxygen, such as an oxygen cylinder or tank, and an output interface, such as a nasal cannula or mask, to provide a high flow of oxygen to the patient. In such systems, oxygen flows continuously, whether the patient is breathing or not. As a result, oxygen flows continuously, even while the patient is exhaling and unable to inhale oxygen. Thus, a vast amount of oxygen is wasted. In fact, more than half of the oxygen delivered continuously is wasted or simply expelled to the environment. During exhalation, the entire delivered oxygen is wasted, and during inhalation, a portion of the delivered oxygen is wasted.

[0006] High-flow systems inherently provide an excess oxygen supply to ensure that the patient receives sufficient oxygen throughout the entire respiratory cycle. Concomitantly, it will be appreciated that the ability to conserve oxygen for one patient may be lifesaving for another, particularly in emergency situations such as during epidemics or pandemics associated with respiratory distress, when demand may critically exceed supply. In remote and economically challenged areas, replenishing oxygen supplies can be prohibitively costly or catastrophically impossible. The difficulty of providing sufficient oxygen while minimizing waste is widely understood.

[0007] In a typical nasal cannula configuration, one end of an oxygen delivery tube is connected to an oxygen source, while the other end of the tube splits into two branches that meet to form a loop. Two nasal prongs are positioned along the loop for insertion into the patient's nares. Oxygen flows continuously through the tube and exits through the nasal prongs into the patient's nares. During inspiration, the patient thus breathes oxygen through the prongs along with entrained room air. Room air is drawn in through the space between the nasal prongs and the patient's nostril walls. During expiration, the patient exhales through the space between the nasal prongs and the patient's nostril walls, while oxygen continues to exit into the patient's nares. Much of this oxygen is carried with the exhaled airflow into the surrounding room air.

[0008] In continuous flow systems, the fraction of inspired oxygen (FiO2) provided to the patient is sought to be controlled by increasing or decreasing the flow of oxygen through the oxygen delivery tube. Unfortunately, once the flow rate is set, it operates optimally only for the patient's breathing pattern at the time of calibration. Changes to this breathing pattern, such as due to physical exercise, or other changes in circumstances, will affect the FiO2, which in turn will affect the patient's saturation. For example, when a patient takes deep breaths or moves and breathes more frequently as a result of strenuous activity, the patient will inhale a greater volume into their lungs. Because the amount of oxygen provided is fixed but the amount of air is not, more air enters the mixture, becoming more diluted and decreasing the FiO2. Thus, the patient's blood oxygen concentration (SaO2) may decrease along with the decreased FiO2. Active readjustments from the patient or healthcare provider may be required. However, the patient may not have the necessary skills or knowledge to make such adjustments accurately, or the patient may simply be unaware or inattentive to do so. Additionally, medical personnel may be overwhelmed with making continuous adjustments to the oxygen flow, especially in non-medical settings.

[0009] In an attempt to counter the foregoing, pulsed oxygen delivery systems have been disclosed to attempt to conserve oxygen by sensing a patient's breathing cycle and delivering short streams, or pulses, of oxygen during inspiration. However, such systems rely on complex electrical circuitry and operation and may not adequately approximate a person's natural breathing. In pulsed oxygen delivery, oxygen is "pulsed" to the patient with a single bolus of oxygen administered during the inhalation phase.

[0010] Several important factors come into play in delivering consistent and effective supplemental oxygen to a patient. By way of non-limiting example, FiO2 is affected by oxygen purity, triggering mechanism, pulse dose, pulse duration, pulse flow curve, ventilation volume, and peak inspiratory flow. Known devices do not fully optimize all of these factors. Instead, each manufacturer is forced to make compromises among them.

[0011] Pulse oxygen delivery systems are configured to trigger pulse doses at specific, but non-standard, negative pressures in the inspiratory curve of the respiratory cycle. If the triggering pressure is too low, the pulse dose will be delivered too early in the inspiratory curve when the patient does not have enough negative pressure to inhale the entire amount of delivered oxygen. If the triggering pressure is too high, the pulse will be delivered too late in the inspiratory curve for optimal clinical use. With high sensitivity to negative pressure and the patient's respiratory cycle and volume, a pulse oxygen delivery system would require fairly complex engineering, hardware, and software to respond based on real-time biofeedback as the patient dynamically responds. To be fully responsive, the system needs to respond immediately or near-instantly to what may be called the "shadow effect" to meet the fluctuating demands of daily life, such as when a person transitions from sitting to standing, walking, talking, exercising, and other daily activities. Current systems do not do this satisfactorily. Additionally, it should be noted that current supplemental oxygen systems typically require the patient to remember to adjust flow rate and to do so based on best estimates of need based on varying activity levels or respiratory volume. These and other factors lead patients to use pulse oxygen systems that are vulnerable to desaturation, resulting in discomfort and health risks.

[0012] Recognizing the conflicting needs of conserving oxygen while being able to adequately provide oxygen on demand, the inventors developed an automated system for conserving gases and other substances, U.S. Patent Application Publication No. 17 / 068,718, filed October 12, 2020, which is incorporated herein by reference. The automated conserving system operates to provide adequate oxygen on demand while conserving against loss and waste, including during the respiratory phase of exhalation. The automated conserving system minimizes an individual patient's oxygen consumption while meeting patient demand and maximizing the effective supply of oxygen. In doing so, the automated conserving system enables better health outcomes in a cost-effective manner, even during a public health crisis.

[0013] In this system implementation, an expandable and compressible donor reservoir holds a volume of oxygen at ambient pressure. A supply conduit receives oxygen from an oxygen source, and an ambient pressure conduit delivers oxygen from the donor reservoir to the patient through the ambient pressure conduit. An inflation detection system detects when the donor reservoir has been inflated with oxygen to a predetermined inflation state, within a fully inflated state, and when the donor reservoir is below the predetermined state of inflation. When the donor reservoir is inflated to the predetermined inflation state, the valve system closes, preventing oxygen from the oxygen source from flowing into the donor reservoir. When the donor reservoir is below the predetermined inflation state, the valve system opens, allowing oxygen to flow from the oxygen source to automatically replenish the donor reservoir. In this way, oxygen can be continuously held in the reservoir and delivered to the patient on demand through a patient-contact delivery device, such as a nasal cannula or breathing mask, with minimal waste. By providing such an on-demand oxygen supply system at a given location, such as a high flow oxygen supply system, a significant reduction in oxygen demand and waste is realized.

[0014] However, the inventors further realize that delivering oxygen at ambient pressure in an on-demand configuration establishes unique requirements and opportunities for functioning at a practical patient interface, such as a nasal cannula. For example, if oxygen is naturally inhaled from a donor reservoir at ambient pressure through an ambient pressure conduit, it is desirable for the recipient to be able to freely exhale, including through the cannula. It is further desirable to prevent significant expulsion of breath by being returned to the ambient pressure conduit and, potentially, back into the donor reservoir, mixing with the oxygen held therein. The inventors further realize that it would be advantageous for such an on-demand system to be able to exercise direct and rapid control over the ratio of oxygen to entrained air inhaled through the nasal cannula during inspiration. [Prior art documents] [Patent documents]

[0015] [Patent Document 1] U.S. Patent Application Publication No. 17 / 068,718 Summary of the Invention [Problem to be solved by the invention]

[0016] In view of the foregoing, the inventors further explain their underlying objective of providing a nasal cannula that is particularly adapted for use with an oxygen dispensing and conserving system at ambient pressure.

[0017] Another object of an embodiment of the present invention is to provide a nasal cannula for an oxygen dispensing and conserving system at ambient pressure, which facilitates the provision of an adequate supply of oxygen when needed while minimizing or eliminating inefficient oxygen loss.

[0018] A more specific object of an embodiment of the present invention is to provide a nasal cannula for oxygen dispensing and conserving systems at ambient pressure that allows for direct expulsion of breath through the cannula.

[0019] A more specific object of an embodiment of the present invention is to provide a nasal cannula for an oxygen dispensing and conserving system at ambient pressure that operates to prevent breath from being exhaled into a connected ambient pressure conduit.

[0020] It is yet another object of the present invention in certain embodiments to provide a nasal cannula that allows direct and rapid control over the ratio of oxygen to entrained air inhaled through the nasal cannula.

[0021] These and other objects and advantages of the present invention will become apparent not only to those who examine this specification and drawings, but also to those who have had the opportunity to experience the nasal cannula and ambient pressure oxygen delivery and conserving system, which utilizes such cannulae in surgery. However, while several of the foregoing goals may be achieved in a single embodiment of the invention, and in fact may be preferred, it should be understood that not all embodiments seek or are required to achieve each and every possible advantage and feature. Nevertheless, all such embodiments should be considered within the scope of the present invention.

[0022] It should be appreciated that the foregoing has outlined broadly the more important objects and features of the present invention in order to better interpret the detailed description that follows, and to provide a better understanding of the inventors' contributions to the art. Before describing any particular embodiment or aspects thereof in detail, it should be made clear that the following structural details and illustrations of the inventive concept are merely illustrative of the many possible manifestations of the invention.

[0023] To further one or more of the foregoing objectives, a nasal cannula is taught herein for use with a gas dispensing system at ambient pressure, which includes an ambient pressure tube for cooperating in providing gas to an individual. In one embodiment, the nasal cannula is fabricated on a nasal cannula body with an internal volume. First and second nasal prongs extend from the nasal cannula body. The first and second nasal prongs are in fluid communication with the internal volume of the nasal cannula body. A gas receiving aperture is in fluid communication with the internal volume of the nasal cannula body for receiving gas from the tubing of the gas dispensing system, and a one-way exhalation valve is carried by the nasal cannula body and in fluid communication with the internal volume of the nasal cannula body. Under this configuration, gas provided by the tubing can be inhaled through the nasal prongs, and exhaled breath can be expelled through the one-way exhalation valve during exhalation.

[0024] In certain embodiments, the nasal cannula may further include an FiO2 adjustment aperture in the nasal cannula body that is in fluid communication with the interior volume of the nasal cannula body. The FiO2 adjustment aperture is selectively adjustable in size, such as by actuation of a movable cover. In this manner, the size of the FiO2 adjustment aperture may be adjusted to provide a desired amount of air entrainment in the gases inhaled through the first and second nasal prongs. More particularly, embodiments of nasal cannulas are disclosed in which the nasal cannula body has first and second FiO2 adjustment apertures that are individually and selectively adjustable in size.

[0025] According to implementations of the present invention, the nasal cannula body can be formed from a first body member combined with a second body member. The first body member can have a central portion defining a receiving cavity, and the second body member can be at least partially received within the receiving cavity of the first body member, such as through the first body member. For example, the receiving cavity in the first body member can be generally tubular, and the second body member can be generally correspondingly tubular. First and second straps can extend in opposite directions from the central portion of the first body member to facilitate retention of the nasal cannula on the wearer's head.

[0026] As disclosed herein, the first body member can be formed from a resilient, substantially flexible material, and the second body member can be formed from a substantially rigid material. In an embodiment of the invention, the second body member has an interior volume with an opening bounded by a platform, and the first body member has a nasal prong platform. The nasal prongs extend from the nasal prong platform on the first body member, and the nasal prong platform on the first body member establishes a sealing engagement with the platform on the second body member when the first and second body members are assembled. This sealing engagement is facilitated in part by the resilient, flexible nature of the first body member.

[0027] When the nasal cannula is formed from first and second body members, the gas receiving aperture can be disposed at a first end of the second body member, and the one-way exhalation valve can be characterized as a first one-way exhalation valve disposed at a second end of the second body member. In such embodiments, a second one-way exhalation valve, and optionally a third one-way exhalation valve, can be additionally disposed in the center of the second body member in general alignment with at least one of the first and second nasal prongs.

[0028] An embodiment of the present invention can alternatively be described as an ambient pressure gas dispensing system for providing gas to an individual at ambient pressure. The ambient pressure gas dispensing system includes a donor reservoir adapted to hold gas at substantially ambient pressure, which provides the gas to the individual through a nasal cannula and ambient pressure tubing interposed between the nasal cannula and the donor reservoir. A supply valve is disposed in fluid communication with the donor reservoir. The supply valve has an open state when gas is allowed to flow into the donor reservoir and a closed state when gas is disabled from flowing into the donor reservoir. An expansion detection system operates to detect when the donor reservoir has expanded to within a predetermined range relative to a fully expanded state. The expansion detection system can detect a first state when the donor reservoir has expanded to within the predetermined range relative to a fully expanded state and a second state when the donor reservoir is below the predetermined range relative to a fully expanded state. The inflation detection system operates to activate the supply valve to open when the donor reservoir is less than a predetermined range relative to a fully expanded state, allowing replacement gas to flow from a gas source, such as a pressurized tank. The environmental pressure tube has a first end and a second end. The first end of the environmental pressure tube is in fluid communication with the donor reservoir, and the second end of the environmental pressure tube is fluidly connected to the nasal cannula.

[0029] In a gas dispensing system at ambient pressure, the nasal cannula is similarly formed with a nasal cannula body having an internal volume. First and second nasal prongs extend from the nasal cannula body and are fluidly connected to the internal volume of the nasal cannula body. A gas receiving aperture is provided for receiving gas from a donor reservoir through an ambient pressure tube, and a one-way exhalation valve is carried by the nasal cannula body. The one-way exhalation valve is fluidly connected to the internal volume of the nasal cannula body, thereby allowing gas provided from the tube to be inhaled through the nasal prongs and allowing exhaled breath to be expelled through the one-way exhalation valve during exhalation. An FiO2 adjustment aperture can be disposed in the nasal cannula body so as to be fluidly connected to the internal volume of the nasal cannula body. The FiO2 adjustment aperture has a size that can be selectively adjusted. At the same time, the size of the FiO2 adjustment aperture can be adjusted to provide a desired amount of air entrainment into the gas inhaled through the first and second nasal prongs.

[0030] In accordance with the practice of the invention disclosed herein, a system for conserving oxygen delivered to a patient includes an expandable and compressible donor reservoir having an outer wall, an internal volume for holding an amount of oxygen, and at least one aperture for allowing oxygen to enter and leave the internal volume. The donor reservoir can include a shell of a flexible material, such as a foil shell. A supply conduit is adapted to receive oxygen from an oxygen source. The supply conduit has a first end for supplying oxygen to the donor reservoir and a second end for fluid connection to the oxygen source. An ambient pressure conduit is adapted to deliver oxygen from the donor reservoir along a fluid pathway to a recipient, such as through a nasal cannula or a breathing mask. The ambient pressure conduit has a first end in fluid communication with the donor reservoir, such as through a connector, to receive oxygen from the donor reservoir, and a second end for fluid connection to the recipient.

[0031] The inflation detection system is operable to detect a first state in which the donor reservoir is inflated with oxygen to a predetermined inflation state and a second state in which the donor reservoir is below the predetermined inflation state. Finally, a valve system is disposed between the oxygen source and the donor reservoir. The valve system operates in a closed state to prevent oxygen from flowing into the donor reservoir from the oxygen source when the donor reservoir is in the first state, and operates in an open state to allow oxygen to flow into the donor reservoir from the oxygen source when the donor reservoir is in the second state. Under this configuration, oxygen can be supplied to a recipient patient from the donor reservoir, such as through the patient's breathing mask. The donor reservoir can be automatically refilled to the predetermined inflation state.

[0032] In an implementation of this system, the valve system and the expansion detection system operate to maintain the amount of oxygen in the donor reservoir at substantially ambient pressure. For example, the donor reservoir can be considered to have a fully expanded state. The expansion detection system can operate to detect when the donor reservoir has expanded to within a predetermined range of the fully expanded state. The expansion detection system can detect a first state in which the donor reservoir has expanded to within the predetermined range of the fully expanded state, and can detect a second state in which the donor reservoir is below the predetermined range of the fully expanded state.

[0033] In certain embodiments, the expansion detection system comprises an electromechanical system. For example, the expansion detection system can include a switch disposed to be actuated by an outer wall of the donor reservoir when the donor reservoir is inflated with oxygen to a predetermined expansion state. The switch can be biased toward the donor reservoir by gravity, a resilient, compressible member, or other effective method. The switch can be considered to have an activated state, in which the switch is disposed at or beyond an inward position relative to the interior volume of the donor reservoir, and an inactivated state, in which the switch is actuated outward by the outer wall of the donor reservoir when the amount of oxygen in the donor reservoir reaches a predetermined expansion state. The valve system operates to prevent oxygen from flowing into the donor reservoir from the oxygen source when the switch is in the inactivated state and to allow oxygen to flow into the donor reservoir from the oxygen source when the switch is in the activated state.

[0034] In a detailed specification of the system, the switch includes a float switch. For example, the float switch can have a contact structure with an expandable and contractible collar relative to a central post. The collar can carry a magnet, and the central post can carry electrical contacts that are electrically contacted by the proximity of the magnet when the switch is in an actuated state.

[0035] According to an implementation of the system, the valve system can take the form of a solenoid valve in electrical communication with an expansion detection system. When the donor reservoir is in a first state, the solenoid valve can be induced by the expansion detection system to a closed state to prevent oxygen from flowing from the oxygen source into the donor reservoir. When the donor reservoir is in a second state, the solenoid valve can be induced by the expansion detection system to an open state to allow oxygen from the oxygen source to flow into the donor reservoir.

[0036] In certain embodiments, the donor reservoir is disposed within a housing. This housing may include the main housing of the system, a sub-housing within the main housing, or another type of housing. In other implementations, the donor reservoir may be disposed without a housing. When a housing is provided, the expansion detection system may include an electromechanical system with a switch. The switch is supported by the housing and is configured to be actuated by the outer wall of the donor reservoir when the donor reservoir is expanded with oxygen to a predetermined expansion state. In alternative implementations of the invention, the expansion detection system includes a non-contact detection system. For example, the expansion detection system may take the form of an optical detection system. In certain embodiments, all or a portion of the housing may be transparent, thereby allowing visual recognition of the expansion state of the donor reservoir, which may provide further assurance to the user that the system is in proper operation.

[0037] Embodiments of the system may further incorporate a one-way intake valve disposed along the fluid pathway from the donor reservoir to the recipient, which is operable to allow oxygen to flow from the donor reservoir, through the ambient pressure conduit, to the recipient, while preventing backflow of oxygen.

[0038] A recipient delivery device, such as a nasal cannula, the patient's breathing mask, or another recipient delivery device, is coupled to the second end of the ambient pressure conduit. The nasal cannula is configured to allow direct exhaustion of breath through the cannula and to prevent the exhausted breath from returning into the connected ambient pressure conduit. As taught herein, the nasal cannula allows direct and rapid control of the ratio of oxygen to entrained air inhaled through the nasal cannula during inspiration.

[0039] It should be appreciated that the foregoing has outlined broadly the more important objects and features of the present invention in order to better interpret the detailed description that follows, and to provide a better understanding of the inventors' contributions to the art. Before describing any particular embodiment or aspects thereof in detail, it should be made clear that the following structural details and illustrations of the inventive concept are merely illustrative of the many possible manifestations of the invention. [Brief explanation of the drawings]

[0040] [Figure 1] 1 is a schematic diagram of an oxygen dispensing and conserving system according to the present invention. [Figure 2] FIG. 2 is a front perspective view of a housing in an oxygen dispensing and conserving system taught herein. [Figure 3] FIG. 1 is a rear perspective view of a housing in an oxygen dispensing and conserving system. [Figure 4] 1 is a cross-sectional side view of an oxygen dispensing and conserving system according to the present invention. [Figure 5] FIG. 1 is a rear perspective view of the oxygen dispensing and conserving system with the top, bottom, and side walls of the housing removed. [Figure 6] FIG. 1 is a perspective view of a nasal cannula adapted for use with an oxygen dispensing and conserving system that allows direct and rapid control of the breath exhaled through the nasal cannula and the fraction of inspired oxygen (FiO2) inhaled through the nasal cannula. [Figure 7] FIG. 7 is an alternative perspective view of the nasal cannula of FIG. 6. [Figure 8] FIG. 7 is a bottom view of the nasal cannula of FIG. 6. [Figure 9] FIG. 10 is a perspective view of an alternative embodiment of the nasal cannula of the present invention. [Figure 10] FIG. 10 is an exploded view of the nasal cannula of FIG. [Figure 11] FIG. 10 is a bottom perspective view of the nasal cannula of FIG. [Figure 12] FIG. 10 is another side view of the nasal cannula of FIG. 9. [Figure 13]1 is a schematic diagram of the system in operation during a series of breathing cycles. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0041] The nasal cannula and ambient pressure oxygen dispensing and conserving system operating therewith are the subject of a wide variety of embodiments, but certain preferred embodiments of the broader invention are described below and illustrated in the accompanying drawings to ensure that those skilled in the art will understand the invention and be able to practice the invention disclosed herein, where appropriate.

[0042] To understand and appreciate the utility and operation of the nasal cannula 10 disclosed herein, reference will first be made to the oxygen dispensing and conserving system 100 it is designed to function with. Referring to the schematic diagram of FIG. 1 and to the oxygen dispensing and conserving system 100 in FIGS. 2-5, the oxygen dispensing and conserving system 100 provides a supply of oxygen at ambient pressure to a recipient on demand, in this case from a donor reservoir 104 through the nasal cannula 10. The donor reservoir 104 holds oxygen at ambient pressure, and oxygen is continuously and automatically supplied from an oxygen source 106, such as a tank of compressed oxygen gas or liquid oxygen.

[0043] Because the donor reservoir 104 holds oxygen at ambient pressure and is automatically replenished, a large and ample supply of oxygen is constantly available for the patient's inspiration. Because oxygen is drawn from the reservoir 104 solely through inspiration, oxygen loss during the patient's expiration is virtually eliminated. In this way, the oxygen supply is conserved without compromising its effectiveness for each individual recipient.

[0044] The donor reservoir 104 in this embodiment comprises an expandable and compressible shell, bladder, or other expandable and compressible body disposed within the housing 102. The housing 102 may be a primary housing or a secondary housing within a larger structure. However, the donor reservoir 104 need not necessarily be within the housing 102 within the scope of the present invention. The housing 102 in the illustrated embodiment defines a boundary surrounding the reservoir 104 such that, when the reservoir 104 is expanded, the shell of the reservoir 104 presses toward one or more of the boundaries defined by the housing 102. In this illustrated non-limiting example, the housing 102 has a bottom defining a lower boundary of the reservoir 104, a top defining an upper boundary of the reservoir 104, and a distal end defining a longitudinal boundary of the reservoir 104.

[0045] As shown in FIGS. 4 and 5 , the housing 102 in this example defines an elongated, generally cubic interior volume, and the reservoir 104 has a corresponding elongated, generally cubic shape. Other shapes and combinations of shapes are readily possible and within the scope of the present invention unless expressly excluded by the claims. In a specific implementation of the present invention, the lower wall portion of the shell of the reservoir 104 is adhered or secured to the housing 102 at one or more locations, such as by adhesive strips 148 as shown in FIG. 4 or by any other method. In this example, the reservoir 104 has four elongated side walls that are joined to form a rectangular cross-section when expanded. The first end wall is formed by and joined with four triangular portions extending from the first ends of the side walls. Similarly, the second end wall is formed by and joined with four triangular portions extending from the second ends of the side walls. The edges of the walls are sealingly joined to define a cubic reservoir 104. The reservoir 104 is thus sealed except for an inlet hole at a first end of the reservoir 104.

[0046] The shell of the reservoir 104 is formed of a flexible, substantially gas-impermeable material. One of ordinary skill in the art will recognize many such materials. Each is within the scope of the present invention unless expressly excluded by the claims. The shell of the reservoir 104 can be formed, for example, from a flexible polymeric material, with or without a lining layer. The material defining the reservoir 104 can be comprised of a foil formed from one or more layers of polymeric material with an aluminum lining. The reservoir 104 can have one or more flexible walls, rigid walls, compressible walls, collapsible walls, expandable walls, thin walls, or other combinations capable of retaining a volume of gas therein. Other configurations of the reservoir 104 are possible and within the scope of the present invention.

[0047] Preferably, as is possible with the lightweight, flexible foil construction of reservoir 104, once expanded, reservoir 104, whether due to its own structural integrity or otherwise, tends to substantially maintain its expanded shape and configuration even when vented to ambient pressure, such as through a fluid connection to a recipient. Fluid connection to the recipient can be achieved, for example, through ambient pressure tubing 122 and ultimately through a patient delivery device such as the nasal cannula 10 disclosed herein, through a breathing mask, or through another mechanism for delivering oxygen to the recipient. Because system 100 is designed to provide oxygen on demand during natural inspiration by the patient, ambient pressure tubing 122 has a large inner diameter to reduce any patient resistance to inspiration to nearly zero. As taught herein, once expanded, reservoir 104 in preferred embodiments does not collapse significantly on itself due to the weight of its walls. When filled with oxygen, reservoir 104 temporarily stores a compartmentalized amount of oxygen at ambient pressure, waiting to be drawn from by the recipient.

[0048] 1 , fluid connector 118, which may be considered a T-connector, has a first longitudinal port in fluid communication with donor reservoir 104, such as through a tubular connector 128 secured and sealed within an aperture in the neck of reservoir 104. Fluid connector 118 has a second longitudinal port, which is in fluid communication with ambient pressure tubing 122 and includes an output connector 116 in fluid communication with a recipient, such as through nasal cannula 10, a breathing mask, or another gas delivery mechanism, via tubing 122. Finally, fluid connector 118 has a third lateral port between the first and second openings, in this case in fluid communication with oxygen source 106, via flow-restricting connector 115. The first, second, and third ports are in fluid communication with each other within fluid connector 118. Fluid communication from source 106 to connector 118 may be through, for example, high pressure tubing 108 from oxygen source 106 to an oxygen connector 110 secured to housing 102, and through high pressure tubing 152 from oxygen connector 110 to supply valve 112. Pressure sensor 126 is interposed, such as by being fluidly sandwiched along high pressure tubing 152, to detect the gas pressure entering supply valve 112.

[0049] 4 and 5, ambient air can be selectively mixed with oxygen drawn from donor reservoir 104 by operation of a gas mixing device formed by fluid connector 118. It can be seen that one-way intake valve 124 is disposed within fluid connector 118 between a first port of connector 118 in communication with reservoir 104 and a second port of connector 118 in communication with output connector 116. Flow restricting connector 115 is disposed proximal to one-way intake valve 124 relative to donor reservoir 104, and air input connector 134 is disposed distal to one-way intake valve 124 relative to donor reservoir 104 and, therefore, distal to output connector 116 relative to one-way intake valve 124. Furthermore, one-way air input valve 136 is fitted to air input connector 134. Under this configuration, the donor reservoir 104 can be replenished with oxygen or possibly another gas through flow-restricting connector 115. Oxygen or other gases within the donor reservoir 104 can be withdrawn from the donor reservoir 104 during inspiration through output connector 116, and ambient air is selectively admixed through air input connector 134. During expiration, exhaled gas is prevented from entering the donor reservoir 104 by one-way inhalation valve 124.

[0050] Supply valve 112, in this example comprising an electromechanical solenoid valve 112, has an open state and a closed state. Valve 112 is fluidly interposed between pressurized oxygen source 106 and reservoir 104. When supply valve 112 is in the open state, oxygen can be transferred from oxygen source 106, through tubing 108, through valve 112, through connector 118, and into reservoir 104. When valve 112 is in the closed state, the passage of oxygen between oxygen source 106 and reservoir 104 is prevented.

[0051] A one-way intake valve 124 is fluidly sandwiched between the reservoir 104 and the recipient, such as by being fluidly connected directly to the second port of the fluid connector 118. A gas filter 120 is disposed along the flow path between the reservoir 104 and the cannula 10, such as by being fluidly sandwiched between the fluid connector 118 and the ambient pressure tubing 122, as in the example of FIG. 1. By fluidly connecting the fluid connector 118 through its first port to the neck of the reservoir 104, the one-way intake valve 124 operates to allow gas to flow from the donor reservoir 104, through the ambient pressure tubing 122, to the recipient, such as through the nasal cannula 10 or a breathing mask, but prevents gas from flowing back into the donor reservoir 104 from the recipient.

[0052] The amount of gas, in this example, oxygen, in the donor reservoir 104 is maintained at substantially ambient pressure. Ambient pressure can be defined as the pressure of the air surrounding the donor reservoir 104. Substantially ambient pressure can be understood to be equal to or within slightly different ranges of ambient pressure. For example, substantially ambient pressure can be interpreted as within 5% of ambient pressure. When the recipient is in the inspiratory phase of breathing, oxygen will be drawn from the donor reservoir 104 through the ambient pressure tube 122, thereby drawing from and tending to reduce the amount of oxygen in the donor reservoir 104. Due to the compressible nature of the donor reservoir 104, the reservoir 104 tends to contract. When contracting, the donor reservoir 104 is automatically refilled with oxygen, or possibly with another gas. In this embodiment, expansion of the donor reservoir 104 is initiated by an expansion detection system. The inflation detection system detects when the donor reservoir 104 is not fully inflated and actuates the supply valve 112 to an open state to inflate the donor reservoir 104 while avoiding pressurization of the reservoir 104 so that the oxygen in the reservoir 104 remains at substantially ambient pressure.

[0053] The expansion detection system has a first state in which supplemental oxygen is not supplied to the donor reservoir 104 and a second state in which supplemental oxygen is supplied to the donor reservoir 104. The first state can be a state in which the donor reservoir 104 is inflated with oxygen to a predetermined expansion state, and the second state can be a state in which the donor reservoir 104 is inflated with oxygen to less than the predetermined expansion state. The expansion detection system operates to detect when the donor reservoir 104 reaches the predetermined expansion state. The predetermined expansion state can be detected when the donor reservoir 104 reaches a predetermined size or other expansion state of any dimension or combination of dimensions. In embodiments of the present invention, the donor reservoir 104 can be considered to have a fully inflated state, and the expansion detection system detects when the donor reservoir 104 has expanded to the fully inflated state or to within a predetermined range of the fully inflated state. By way of example and not limitation, the expansion detection system can detect when the donor reservoir 104 is expanded with oxygen above a threshold expansion level, which may be below a fully expanded state.

[0054] Upon review of this disclosure, one skilled in the art will recognize multiple mechanisms that would operate as an inflation detection system to detect when the donor reservoir 104 has been inflated to a predetermined inflation state. Each such mechanism is within the scope of the present invention unless expressly limited by the claims. The inflation detection mechanism can include mechanical systems, electrical systems, electromagnetic systems, optical systems, electromechanical systems, sound-activated systems, motion sensors, optical sensors, and any other type of system effective for detecting when the donor reservoir 104 has been inflated to a predetermined inflation state. Note again that the predetermined inflation state can be reached while the oxygen in the donor reservoir 104 is at substantially ambient pressure.

[0055] In the embodiment of FIGS. 1-5, the expansion detection system takes the form of a non-contact system 156, which may be an optical detection system 156. The detection system 156 may be, for example, a laser detection system, a camera system, an infrared expansion detection system, or any other effective non-contact detection system 156. In certain embodiments, the non-contact detection system 156 may be formed using an optical emitter, such as a laser or other light emitter, held on one side of the reservoir 104 and an optical receiver held on the opposite side of the reservoir 104. Under such a configuration, the expansion state of the donor reservoir 104 may be sensed in a non-contact manner, such as when the donor reservoir 104 is expanded to a state that prevents light communication from the emitter to the receiver. The reservoir 104 may exhibit a predetermined reflectivity or other non-contact method.

[0056] In another embodiment, detection system 156 comprises one or more proximity sensors that operate to detect the proximity of a localized opposing surface of donor reservoir 104. For example, as shown in Figures 4 and 5, the series of proximity sensors forming inflation detection system 156 are carried relative to the interior of housing 102, in this example, relative to an electronics casing 155 secured within housing 102 above donor reservoir 104. Electronics casing 155 carries electronic control system 157, which has electronic circuitry with electronic memory-holding system software, one or more computer processors for processing the software, and other electronic circuitry and wiring necessary for operation of system 100.

[0057] In this manner, the expansion detection system 156 can detect the expansion state of the donor reservoir 104, possibly at multiple locations along the donor reservoir 104. The expansion detection system 156 can detect when the donor reservoir 104 has reached a predetermined expansion state. The predetermined state of expansion can be detected based on a sensed position of a wall of the donor reservoir 104, such as by detecting the proximity of the wall of the donor reservoir 104 to the expansion detection system 156, or based on a sensed expansion of the donor reservoir 104 obstructing optical communication between the light emitter and the light receiver.

[0058] Based on the inflation state of the donor reservoir 104, as detected by the inflation detection system 156, the flow switch 114 operates to actuate the valve 112 between an on state, which allows oxygen to flow from the oxygen source 106 to the donor reservoir 104, and an off state, which prevents this flow. More specifically, when the inflation detection system 156 detects that the donor reservoir 104 is below a predetermined state of inflation, based on inward contraction of the walls of the donor reservoir 104, the flow switch 114 actuates the valve 112 to the on state, allowing oxygen to flow from the oxygen source 106 to fill the donor reservoir 104. When the donor reservoir 104 reaches a predetermined state of expansion, based on the detected wall expansion of the donor reservoir 104, as also detected by the expansion detection system 156, the flow switch 114 actuates the valve 112 to the OFF state to prevent further flow of oxygen beyond the predetermined state of expansion, thereby preventing pressurization of the donor reservoir 104 and preventing oxygen or other gases from venting from the system 100. Thus, when the flow switch 114 is in an activated state, it may be considered to be in an ON state, and the donor reservoir 104 is detected to be below the predetermined state of expansion. When the flow switch 114 is in a deactivated state, it may be considered to be in an OFF state, and the donor reservoir 104 is detected to have reached the predetermined state of expansion, based on detection by the expansion detection system 156 of the expansion of the donor reservoir 104.

[0059] In another non-limiting embodiment, the expansion detection system comprises an electromechanical system for detecting when the donor reservoir 104 has filled to a predetermined expanded state. Such a detection system (not shown in this embodiment) can have a contact structure disposed to contact, be contacted by, be moved by, or be actuated by the donor reservoir 104 when the donor reservoir 104 reaches the expanded state. The location and structure of the contact structure can vary within the scope of the present invention. For example, the contact structure can be disposed from or through the distal end wall of the housing 102 and protrude into the interior volume of the housing 102, such that the contact structure can protrude toward and engage the distal end of the reservoir 104. In other embodiments, the contact structure is disposed to protrude from or through the top wall of the housing 102 into the interior volume of the housing 102 and engage an intermediate portion of the reservoir 104. The contact structure may be held by a support structure, for example, secured to the top wall or another upper portion of the housing 102.

[0060] The contact structure is positioned to be moved by the donor reservoir 104 as it expands toward the expanded state. The contact structure may be, for example, pushed, pivoted, rotated, or otherwise actuated by the donor reservoir 104, more particularly by the expansion of the donor reservoir 104. The contact structure may operate as, or as a component of, the flow switch 114, or by actuating the flow switch 114. When the contact structure is actuated by the expansion of the donor reservoir 104, the flow switch 114 operates to operate the valve 112 between an on state that allows oxygen to flow from the oxygen source 106 into the reservoir 104 to replenish and fill the reservoir 104, and an off state that prevents oxygen from flowing from the oxygen source 106 into the reservoir 104. The contact member is biased toward donor reservoir 104 by spring force under gravity, by resiliency, or by other biasing methods, or a combination thereof.

[0061] 1-5, donor reservoir 104 is disposed within housing 102. Additionally or alternatively, donor reservoir 104 can be disposed within a sub-housing, which in turn can be disposed within housing 102 or located independently. Furthermore, donor reservoir 104 can be disposed without a housing or enclosure, in which case contact structure and, optionally, flow switch 114 can be retained by a surrounding band, rigid arm, or other retaining structure for contacting or otherwise sensing or engaging donor reservoir 104. Contact structure and flow switch 114 can be retained together, optionally as a unit, or as separate locations.

[0062] When the oxygen content of the donor reservoir 104 is below a predetermined expansion state, thereby distorting or moving the outer wall inward, the contact structure is permitted to move inward toward the donor reservoir 104. The flow switch 114 is activated, which is considered to be in an on state, when the contact structure is fully moved, such as by expanding, pivoting, or other movement in an inward direction toward the interior volume of the donor reservoir 104. The flow switch 114 is deactivated, which is considered to be in an off state, when the contact structure is moved, such as by contracting, pivoting, or other movement in an outward direction away from the donor reservoir 104. The contact structure is moved outward to adjust the flow switch 114 to a deactivated state, which is in an off state, when the oxygen content of the donor reservoir 104 reaches a predetermined expansion state and the outer wall of the donor reservoir 104 is urged outward by the expansion of the donor reservoir 104. For example, if the contact structure is a push switch, expansion of donor reservoir 104 will force the outer wall or shell of donor reservoir 104 outward, depressing the contact structure and flow switch 114 into a deactivated state.

[0063] In an embodiment of oxygen dispensing and conserving system 100, supply valve 112 may comprise a solenoid valve, which is in electrical communication with flow switch 114, such as through electrical wiring in an electrical circuit. Illustratively, electrical control system 157, which may include electrical circuitry, electronic memory, wiring, system software maintained and operated by the electrical circuitry and electronic memory, and other electrical control and connection elements, cooperates with the inflation detection system to induce solenoid supply valve 112 to an open state, allowing oxygen to flow from source 106 when flow switch 114 is in an activated state. The electrical control system may receive power from a power source. The power source may be an alternating current source through power supply connection 130, a direct current source such as a battery power source, or other power source. The flow of power from the power source may be controlled by power switch 132. The solenoid valve 112 is induced to a closed state by the inflation detection system and the electrical control system to prevent oxygen from flowing from the source 106 into the reservoir 104 when the flow switch 114 is in a deactivated state. Each of the components referenced herein may be further combined or separated within the scope of the present invention.

[0064] Even when valve 112 is in an open state, the flow rate, flow pressure, or both the flow pressure and flow rate from source 106 to donor reservoir 104 is limited by flow-restricting connector 115. Flow-restricting connector 115 can limit the flow rate of oxygen from source 106 to donor reservoir 104 to a predetermined rate, such as less than 1 liter / minute or any other rate. Flow-restricting connector 115 can comprise a small-diameter tubing connector, such as a connector having an inner diameter of 0.02 mm or other dimensions that are reduced compared to other conduit connections in the fluid system. Thus, sudden pressure changes in donor reservoir 104 can be prevented by opening valve 112.

[0065] Referring to FIG. 13 , system 100 is shown in operation during a series of breathing cycles, providing an on-demand supply to a recipient, such as through a mask or cannula 10 disclosed herein, worn by a patient in need. In operation, system 100 operates by drawing oxygen at ambient pressure from donor reservoir 104, thereby tending to deflate reservoir 104. When reservoir 104 falls below a predetermined inflation state, oxygen is diverted, and reservoir 104 automatically fills to the predetermined inflation state. Thus, a continually replenishing amount of ambient pressure oxygen is available in reservoir 104, which is drawn through ambient pressure tube 122 during the natural inspiration phase of the breathing cycle. When the recipient is not engaged in inspiration, oxygen is not drawn from reservoir 104 and tends not to be released from reservoir 104. When the amount of oxygen in reservoir 104 falls below the predetermined inflation state, an inflation detection system detects this and triggers valve 112 to open. Oxygen flow is then enabled from the oxygen source 106, causing the donor reservoir 104 to fill with oxygen until a predetermined inflation state is reached. Once the predetermined inflation state is reached, the inflation detection system detects this and actuates the valve 112 to a closed state, preventing further delivery of oxygen from the source 106 to the donor reservoir 104 until another inspiratory phase of the breathing cycle draws an amount of oxygen from the reservoir 104. In this manner, the donor reservoir 104 is automatically oxygenated while automatically preventing oxygen pressurization within the reservoir 104. Supplemental oxygen is safely and efficiently delivered to the patient at ambient pressure in an on-demand volume displacement system, allowing oxygen transfer during the entire inspiratory phase of the breathing cycle while preventing wasteful release of oxygen to the atmosphere, including during the expiratory phase.

[0066] The donor reservoir 104 automatically receives supplemental oxygen from the pressurized source 106 through the high-pressure tubing 108 and through the supply valve 112. Automatically filling the reservoir 104 ensures that the donor reservoir 104 always has a supply of oxygen available for the next inspiratory phase of the breathing cycle, while the oxygen in the reservoir 104 does not exceed ambient pressure. When the donor reservoir 104 is visually exposed through a partially or fully transparent housing 102 or a viewing aperture or window in the housing 102, the observer is provided with visual confirmation of the inflation state of the donor reservoir 104. For example, as shown in FIG. 3 , the housing 102 of the depicted embodiment has a translucent rear wall portion 105, which allows the inflation state of the donor reservoir 104 to be confirmed. This may be a useful comfort in confirming proper operation, given the quiet operation of the oxygen dispensing and conserving system 100 at ambient pressure. Additionally, system 100 includes an electronic status indicator 125, as shown in FIG. 2, to confirm the inflation status of donor reservoir 104. Electronic status indicator 125 may comprise, for example, a series of lights or another visual electronic indicator of the fill level of donor reservoir 104. System 100 can therefore provide a consistent delivery of supplemental oxygen to the recipient because donor reservoir 104 and system 100 generally match the patient's physiological ventilation based on the storage and replenishment of ambient atmospheric oxygen in donor reservoir 104 and automatic termination of oxygen delivery when donor reservoir 104 reaches a predetermined inflation state.

[0067] Within the scope of the present invention, system 100 can measure, record, and analyze a patient's oxygen flow and breathing characteristics through the use of electrical control system 157 and, potentially, or alternatively, through data processing via remote data communication and wireless communication. As shown in FIG. 3, a data port 135, such as a USB port or other data port, allows wired communication to and from electrical control system 157 and overall system 100. Through wired or wireless communication using data port 135 or wireless communication protocols, system software can be updated and modified, system 100 can be programmed to meet specific requirements, and resulting data, such as data regarding system operation, user respiration, and other aspects, can be downloaded for use and analysis.

[0068] To facilitate such data acquisition and analysis, a volumetric flow meter may be connected to the oxygen source 106. Additionally or alternatively, one or more flow meters may be retained within the housing 102 along the path of gas flow through the system 100. For example, a flow meter may be disposed to meter oxygen passing through the valve 112. The valve 112 may incorporate a flow meter or may have a separate flow meter disposed therein. A flow meter may also or alternatively be disposed between the reservoir 104 and the ambient pressure tubing 122. By measuring the amount of oxygen delivered to the recipient by the system 100 over a given period of time, determinations, measurements, and analysis may be performed for each or multiple inhalation and exhalation cycles. For example, the amount of oxygen inhaled by the patient and, additionally or alternatively, the amount of oxygen remaining in the oxygen source 106 may be determined. Through software operating on or in communication with electronic memory and electrical systems, direct integration, wireless communication, or a combination thereof, the system 100 may collect, process, and analyze data based on use of the system 100.

[0069] While a tank of compressed gas is often shown and referred to herein as the oxygen source 106, other oxygen sources 106 are possible and within the scope of the present invention. By another non-limiting example, the system 100 can provide oxygen to a patient on demand using oxygen supplied by an oxygen concentrator. An oxygen concentrator takes oxygen and removes nitrogen from it, leaving an oxygen-enriched gas for patients requiring medical oxygen. The typical flow of this compressed oxygen is 1-5 liters / minute. High-end oxygen concentrators can deliver up to 50 liters / minute, but they require more electricity and more maintenance.

[0070] If the oxygen source 106 is an oxygen concentrator, the system 100 can be installed between the oxygen concentrator and the oxygen delivery device, so that as oxygen leaves the concentrator, it enters a large reservoir 104, where it remains at ambient pressure until the patient inhales. As the patient breathes and draws oxygen from the reservoir 104, the reservoir 104 begins to empty, and a supply valve 112 from the oxygen concentrator as the oxygen source 106 opens, refilling the reservoir 104 with compressed oxygen from the oxygen concentrator. When the patient exhales, there is no flow between the reservoir 104 and the patient. During the patient's exhalation phase, rather than wasting oxygen flowing from the concentrator, the flow is utilized to refill the reservoir 104. Once the reservoir 104 is filled, the supply valve 112 stops the flow of oxygen from the oxygen source 106. This cycle can be repeated with each breath. In this way, oxygen not taken in by the patient during inspiration is stored without loss.

[0071] Use of the oxygen dispensing and conserving system 100 allows the patient to naturally draw supplemental oxygen from the donor reservoir 104 through a breathing mask, through nasal cannula 10 as disclosed herein, or through another delivery device. Alternative recipient delivery devices may also include, for example, a laryngeal mask airway (LMA), an endotracheal tube, a tracheostomy, a ventilator, a CPAP machine connector, an ambu bag, or a delivery device for recreational oxygen delivery.

[0072] The on-demand supply of naturally inspired oxygen provided by the donor reservoir 104 using the present system 100 overcomes many of the drawbacks and limitations presented by prior art systems. For example, many prior art systems rely on the patient's peak inspiratory flow rate (PIFR) to achieve a prescribed inspired oxygen concentration. For example, using a nasal cannula at a low continuous flow rate can be helpful when the patient requires a low inspired oxygen concentration, but this practice limits the patient's oxygen to only that low inspired oxygen concentration. If the patient's oxygen demand were to increase significantly, the inspiratory effort to force more air into the lungs, which is governed by tidal volume, inspiration "speed," and respiratory rate, would cause the PIFR to exceed the flow rate at which oxygen or oxygen / air mixture is supplied by the delivery device. This means that during the PIFR, more or less room air entrainment occurs, causing the resulting FiO2 to vary unpredictably. On the other hand, while less dependent on PIFR, using a non-rebreathing face mask with very high oxygen rates (10-15 L / min) can provide reliable delivery of oxygen at the prescribed concentration, but a large amount of oxygen is wasted in the environment as oxygen continues to flow during exhalation.

[0073] In this manner, system 100 can passively allow the transfer of oxygen or another gas from reservoir 104 at ambient pressure by making the gas available to the recipient in a manner that meets the exact volume and amount required by the recipient. A pressure drop, such as by inhalation, is used to transfer volume from reservoir 104. No additional pressure, such as opening a pressure check valve, is required to initiate flow, which may be required when the chamber or reservoir contains oxygen at a pressure higher than ambient pressure.

[0074] As taught herein, oxygen from the donor reservoir 104 can be made available for inhalation by a recipient through a breathing mask, the nasal cannula 10 disclosed herein, or another delivery device. An embodiment of a nasal cannula 10 according to the present invention is depicted in FIGS. 6-8 , in which the nasal cannula 10 is formed using a first body member 12, which is assembled with a second body member 14. In this embodiment, the first body member 12 is formed from a resilient, relatively flexible material, such as, but not limited to, silicone rubber or thermoplastic polyurethane, while the second body member 14 is formed from a relatively rigid material, such as, but not limited to, a hard plastic. The first body member 12 has a central portion, which defines a receiving cavity, and is generally tubular. The second body member 14 may similarly be generally tubular and may be received and retained within the first body member 12 by passing a central portion of the second body member 14 through a receiving cavity in the first body member 12. The central portion of the first body member 12 has a nasal prong platform 30, and first and second nasal prongs 20A and 20B extend parallel from the nasal prong platform 30 for reception within the patient's nares.

[0075] First and second straps 16 extend in opposite directions from a central portion of first body member 12 to both sides, and buckles 18 are held at the distal ends of straps 16. Nasal cannula 10 can thereby be held against the wearer's head by straps 16 and buckles 18, possibly in combination with additional fastening mechanisms such as another strap passing around the neck or behind the head of the user, by cloth tape or any other fastening method that will be apparent to one of ordinary skill in the art after reviewing this disclosure.

[0076] Within the scope of the present invention, the first and second body members 12 and 14 may be interchangeable and replaceable with one another to suit the needs and preferences of a particular patient. For example, the first body member 12 may be provided with nasal prongs 20A and 20B of different sizes or spacings to mate with the second body member 14. By non-limiting example, the first body member 12 may be provided with nasal prongs 20A and 20B having outer diameters of 4 mm, 5 mm, 6 mm, and 7 mm to comfortably receive and engage the nares of different users.

[0077] When the body members 12, 14 are engaged with one another, the second body member 14 has an open interior volume with openings disposed to align with the nasal prongs 20A and 20B of the first body member 12. Additionally, a central portion of the first body member 12 is open, such as through openings, generally opposite the nasal prongs 20A and 20B. The second body member 14 has first and second FiO2 adjustment apertures 25A and 25B and first and second adjustment aperture covers 26A and 26B. The FiO2 adjustment apertures 25A and 25B are in fluid communication with the interior volume of the second body member 14 and are positioned to align with the openings of the first body member 12 opposite the nasal prongs 20A and 20B. The effective size of the opening to the interior volume of the second body member 14, and therefore the opening to the nasal prongs 20A and 20B of the first body member 12 provided by the FiO2 adjustment apertures 25A and 25B, is individually adjustable. For example, in the depicted embodiment, the size of the opening provided by the FiO2 adjustment apertures 25A and 25B is adjustable from closed to fully open, and anywhere in between, by sliding, rotating, or other actuation of the adjustable aperture covers 26A and 26B.

[0078] The second body member 14 has a gas receiving aperture 22 at its first end. The gas receiving aperture 22 fluidly engages with the ambient pressure tubing 122 of the oxygen dispensing and conserving system 100, such as by threading, engagement, or by using a connector interposed between the ambient pressure tubing 122 and the nasal cannula 10. For example, the second body member 14 in this embodiment has a threaded tubular portion for insertion into the distal end of the ambient pressure tubing 122 or its associated connector. The second body member 14 further includes a one-way exhalation valve 24 disposed at its second end, which is in fluid communication with the interior volume of the second body member 14. For example, the second body member 14 in this embodiment has a tubular portion at its second end with the one-way exhalation valve 24 held at the distal end of the tubular portion.

[0079] Under this configuration, the first and second body members 12 and 14 can be assembled with the nasal prongs 20A and 20B aligned with corresponding openings in the second body member 14, as shown, for example, in FIGS. 6-8. Due to the flexible nature of the first body member 12, a sealing engagement is efficiently created between the nasal prong platform 30 and the nasal prongs 20A and 20B projecting therefrom and the underside of the second body member 14, which may be flat. Additionally, the first and second FiO2 adjustment apertures 25A and 25B and the first and second adjustment aperture covers 26A and 26B are exposed and accessible to a user for selectively adjusting the intake air. A one-way exhalation valve 24 is disposed in fluid communication with the interior volume of the second body member 14 and, consequently, with the nasal prongs 20A and 20B.

[0080] Thus, in use with the oxygen dispensing and conserving system 100, the ambient pressure tube 122 can be connected, either directly or through a connector, to the gas-receiving aperture 22 of the nasal cannula 10. The nasal cannula 10 can be secured to the patient's head by receiving the nasal prongs 20A and 20B within the patient's nares, such as by using the strap 16 and buckle 18. Oxygen or any other gas retained by the donor reservoir 104 can then be easily inhaled through the nasal prongs 20A and 20B. The size of the opening provided by the FiO2 adjustment apertures 25A and 25B can be easily adjusted by manipulating the first and second adjustment aperture covers 26A and 26B to provide the desired amount of air entrainment in the inhaled oxygen or other gas. Furthermore, breath exhaled during exhalation can be directly expelled through the cannula 10 and through the one-way exhalation valve 24. Discharge of exhaled breath into the ambient pressure tube 122 and subsequent rebreathing of the exhaled breath is thus prevented.

[0081] An alternative embodiment of a nasal cannula 10 for use with an oxygen dispensing and conserving system 100 is shown in FIGS. 9-12. There, the nasal cannula 10 again includes a first body member 12, which is assembled with a second body member 14. The first body member 12 again is formed from a relatively flexible material, while the second body member 14 is formed from a relatively rigid material. The central portion again includes a nasal prong platform 30 from which the first and second nasal prongs 20A and 20B project. The first body member 12 again includes a central portion, which defines a receiving cavity. In this embodiment, the receiving cavity is formed with a resilient strap receiving structure 28 in combination with the nasal prong platform 30. The second body member 14 is also generally tubular, with a central portion of the second body member 14 extending through the receiving cavity and being received and retained within the receiving cavity by an elastic strap receiving structure 28 and a nasal prong platform 30.

[0082] First and second straps 16 again extend in opposite directions from a central portion of first body member 12 to either side, and buckles 18 are retained at the distal ends of straps 16. Nasal cannula 10 can then be retained against the wearer's head by straps 16 and buckles 18, again possibly in combination with additional fastening mechanisms such as head or neck straps, medical tape, or some other method, or combination thereof. First and second body members 12 and 14 are again interchangeably connected for removal and replacement of one or both components to suit the needs and preferences of a particular patient.

[0083] The second body member 14 has an open interior volume with an opening defined by a nasal prong platform 30 on the first body member 12 and a platform 32 disposed to mate with the nasal prongs 20A and 20B when the body members 12 and 14 are engaged with one another. The second body member 14 has first and second FiO2 adjustment apertures 25A and 25B that are in fluid communication with the interior volume of the second body member 14. The effective size of the opening provided by the FiO2 adjustment apertures 25A and 25B relative to the interior volume of the second body member 14 can be individually adjusted by sliding aperture covers 26A and 26B. Aperture covers 26A and 26B allow the size of the openings provided by FiO2 adjustment apertures 25A and 25B to be adjusted from closed to fully open, and any state in between, by sliding or otherwise adjusting aperture covers 26A and 26B.

[0084] Gas receiving aperture 22 is disposed at a first end of second body member 14 for fluidly engaging ambient pressure tubing 122 of oxygen dispensing and conserving system 100, either directly, such as by threadedly receiving the distal end of ambient pressure tubing 122, or by engaging using a connector disposed therebetween. First one-way exhalation valve 24A is disposed at a second end of second body member 14 in fluid communication with the interior volume of second body member 14. In this embodiment, second and third one-way exhalation valves 24B and 24C are centrally disposed along second body member 14 and in fluid communication with the interior volume of second body member 14 and nasal prongs 20A and 20B when first and second body members 12 and 14 are assembled. The second and third one-way exhalation valves 24B and 24C are disposed to be generally aligned with the nasal prongs 20A and 20B when the first and second body members 12 and 14 are assembled.

[0085] 9 and 11, with the nasal prongs 20A and 20B aligned with the corresponding openings in the second body member 14 and the platform 32 of the second body member 14 aligned with the nasal prong platform 30 on the first body member 12. Due to the flexible nature of the first body member 12, a sealing engagement is efficiently created between the nasal prong platform 30, and the nasal prongs 20A and 20B projecting therefrom, and the platform 32 of the second body member 14. Additionally, the first and second FiO2 adjustment apertures 25A and 25B are exposed and accessible for a user to selectively adjust by sliding or otherwise adjusting aperture covers 26A and 26B. One-way exhalation valves 24A, 24B, and 24C are disposed in fluid communication with the interior volume of second body member 14 and, through this interior volume, with nasal prongs 20A and 20B.

[0086] With the nasal cannula 10 thus assembled, the ambient pressure tubing 122 of the oxygen dispensing and conserving system 100 can be connected to the gas-receiving aperture 22 of the nasal cannula 10. The nasal cannula 10 can be held against the patient's head with the nasal prongs 20A and 20B received in the patient's nostrils. The patient can then freely inhale oxygen or any other gas held in the donor reservoir 104 through the nasal prongs 20A and 20B. Furthermore, the size of the openings provided by the FiO2 adjustment apertures 25A and 25B can be easily adjusted by simply sliding the aperture covers 26A and 26B to control the mixture of ambient air and inspired oxygen. Breaths exhaled by the patient can be exhausted through the one-way exhalation valves 24A, 24B, and 24C, thereby preventing them from escaping into the ambient pressure tubing 122.

[0087] As used herein, reference to a singular item should be understood to include a plural number of items, and vice versa, unless expressly stated otherwise or apparent from the context. Unless expressly stated otherwise or apparent from the context, grammatical conjunctions are intended to represent any and all disjunctive and conjunctive combinations of joined clauses, sentences, words, and the like. Thus, for example, the term "or" should generally be understood to mean "and / or." The recitation of ranges of values ​​herein is not intended to be limiting and, unless otherwise indicated herein, instead refers individually to any and all values ​​falling within the range, with each individual value within such range being incorporated herein as if individually recited herein. The terms "about," "approximately," and the like, when used in conjunction with numerical values, should be construed to indicate a variation that would be understood by one of ordinary skill in the art to operate to meet the intended purpose. Similarly, approximation terms such as "approximately" or "substantially," when used to refer to physical characteristics, should be understood to contemplate a range of variation that can be understood by those skilled in the art to operate to fulfill a corresponding use, function, or purpose. Any and all examples or exemplary terms "such as" provided herein are intended merely to better illustrate the embodiments and do not impose limitations on the scope of the embodiments. Terms in this specification should not be construed to indicate any undefined elements that are essential to implementing the embodiments. In this description, terms such as "first," "second," "top," "bottom," "upper," and "lower" are terms of convenience and should not be construed as limiting terms.

[0088] It will be appreciated that, given the specific details and embodiments of the present invention for a nasal cannula and an ambient pressure oxygen dispensing and conserving system operating in conjunction with the disclosed embodiments, those skilled in the art may make numerous modifications and additions thereto without departing from the spirit or scope of the present invention. This is particularly true when one keeps in mind that the presently preferred embodiments are merely examples of the broad invention disclosed herein. Thus, while keeping in mind the main features of the present invention, it will be apparent that embodiments incorporating those main features may be created, and that not all features included in the preferred embodiments may be incorporated.

[0089] Accordingly, the following claims are intended to define the scope of protection afforded this invention. The claims are intended to include equivalent structures without departing from the spirit and scope of the present invention. It should be further noted that the following claims may, at times, express or be construed to express certain elements as means for performing a particular function without reciting the structure or material. As a requirement of law, any such claims shall be construed to cover not only the corresponding structure and materials explicitly described herein, but also their legally recognizable equivalents.

Claims

1. A nasal cannula (10) for use with a gas dispensing system (100) with a tube (122) for providing gas to an individual, said nasal cannula (10) comprising: a nasal cannula body (12, 14) with an internal volume; first and second nasal prongs (20A, 20B) extending from the nasal cannula body (12, 14) and in fluid communication with an interior volume of the nasal cannula body (12, 14); a gas receiving aperture (22) in fluid communication with the interior volume of the nasal cannula body (12, 14) for receiving gas from the tube (122) of the gas dispensing system (100); and a one-way inhalation valve (24) carried by the nasal cannula body (12, 14) and in fluid communication with the interior volume of the nasal cannula body (12, 14); and The gas provided by the tube (122) can be inhaled through the nasal prongs (20A, 20B), so that during exhalation, exhaled breath can be expelled through the one-way exhalation valve (24); A nasal cannula (10) characterized by:

2. The nasal cannula (10) includes a FiO (FiO) filter in the nasal cannula body (12, 14) that is in fluid communication with the internal volume of the nasal cannula body (12, 14). ２ Further comprising an adjustment aperture (25A, 25B); ２ The adjustment apertures (25A, 25B) are selectively adjustable in size, thereby adjusting the FiO ２ 2. The nasal cannula (10) of claim 1, wherein the size of the adjustment apertures (25A, 25B) can be adjusted to provide a desired amount of air entrainment in the gases inhaled through the first and second nasal prongs (20A, 20B).

3. In the nasal cannula body (12, 14), first and second FiOs are fluidly connected to the interior volume of the nasal cannula body (12, 14). ２ The presence of adjustment apertures (25A, 25B) and the first and second FiO ２ The adjustment apertures (25A, 25B) are individually and selectively adjustable in size, thereby adjusting the FiO ２ 3. The nasal cannula (10) according to claim 2, wherein the size of the adjustment apertures (25A, 25B) can be individually adjusted to provide a desired amount of air entrainment in the gases inhaled through the first and second nasal prongs (20A, 20B).

4. The FiO ２ 3. The nasal cannula (10) according to claim 2, characterized in that the size of the adjustment apertures (25A, 25B) can be adjusted by manipulating the movable covers (26A, 26B).

5. 2. The nasal cannula (10) of claim 1, wherein the nasal cannula body (12, 14) is formed from a first body member (12) assembled with a second body member (14), the first body member (12) having a central portion that defines a receiving cavity, and the second body member (14) is at least partially received within the receiving cavity of the first body member (12).

6. 6. The nasal cannula (10) of claim 5, wherein the first body member (12) is formed from a resilient, substantially flexible material and the second body member (14) is formed from a substantially rigid material.

7. 6. The nasal cannula (10) of claim 5, further comprising first and second straps (16) extending in opposite directions from the central portion of the first body member (12) to opposite sides thereof.

8. 6. The nasal cannula (10) of claim 5, wherein the first body member (12) has a central strap portion (28) that defines a receiving cavity for receiving the second body member (14), and the second body member (14) passes through the receiving cavity.

9. 9. The nasal cannula (10) of claim 8, wherein the receiving cavity of the first body member (12) is generally tubular, and the second body member (14) is generally correspondingly tubular.

10. 6. The nasal cannula of claim 5, wherein the second body member has an internal volume with an opening bounded by a platform, the first body member has a nasal prong platform, the nasal prongs extend from the nasal prong platform on the first body member, and the nasal prong platform on the first body member establishes a sealing engagement with the platform on the second body member when the first and second body members are assembled.

11. 6. The nasal cannula (10) according to claim 5, wherein the gas receiving aperture (22) is disposed at a first end of the second body member (14), and the one-way exhalation valve (24) comprises a first one-way exhalation valve (24A) disposed at a second end of the second body member (14).

12. 12. The nasal cannula (10) according to claim 11, further comprising a second one-way exhalation valve (24B) generally aligned with at least one of the first and second nasal prongs (20A, 20B) and centrally disposed in the second body member (14).

13. A nasal cannula for use with a gas dispensing system (100) with a tube (122) for providing gas to an individual, said nasal cannula (10) comprising: a nasal cannula body (12, 14) with an internal volume; first and second nasal prongs (20A, 20B) extending from the nasal cannula body (12, 14) and in fluid communication with an interior volume of the nasal cannula body (12, 14); The FiO of the nasal cannula body (12, 14) is in fluid communication with the internal volume of the nasal cannula body (12, 14) and is selectively adjustable in size. ２ Adjustment apertures (25A, 25B), and a gas receiving aperture (22) in fluid communication with the interior volume of the nasal cannula body (12, 14) for receiving gas from the tube (122) of the gas dispensing system (100); and The gas provided by the tube (122) can be inhaled through the nasal prongs (20A, 20B), thereby ２ The size of the adjustment apertures (25A, 25B) can be adjusted to provide a desired amount of air mixing into the inhaled gas; A nasal cannula (10) characterized by:

14. 14. The nasal cannula (10) according to claim 13, further comprising a one-way exhalation valve (24) carried by the nasal cannula body (12, 14), the one-way exhalation valve (24) being in fluid communication with the internal volume of the nasal cannula body (12, 14), thereby allowing exhaled breath to be expelled through the one-way exhalation valve (24) during exhalation.

15. In the nasal cannula body (12, 14), first and second FiOs are fluidly connected to the interior volume of the nasal cannula body (12, 14). ２ The presence of adjustment apertures (25A, 25B) and the first and second FiO ２ The adjustment apertures (25A, 25B) are individually and selectively adjustable in size, thereby adjusting the FiO ２ 14. The nasal cannula (10) according to claim 13, wherein the size of the adjustment apertures (25A, 25B) can be individually adjusted to provide a desired amount of air entrainment in the gases inhaled through the first and second nasal prongs (20A, 20B).

16. The FiO ２ 14. The nasal cannula (10) according to claim 13, characterized in that the adjustment apertures (25A, 25B) are adjustable in size by manipulating the movable covers (26A, 26B).

17. 14. The nasal cannula (10) of claim 13, wherein the nasal cannula bodies (12, 14) are formed from a first body member (12) assembled with a second body member (14), the first body member (12) having a central portion that defines a receiving cavity, and the second body member (14) is at least partially received within the receiving cavity of the first body member (12).

18. 18. The nasal cannula (10) of claim 17, wherein the first body member (12) is formed from a resilient, substantially flexible material and the second body member (14) is formed from a substantially rigid material.

19. 18. The nasal cannula (10) of claim 17, further comprising first and second straps (16) extending in opposite directions from the central portion of the first body member (12) to opposite sides thereof.

20. 18. The nasal cannula (10) of claim 17, wherein the first body member (12) has a central portion defining a receiving cavity for receiving the second body member (14).

21. 18. The nasal cannula of claim 17, wherein the second body member has an internal volume with an opening bounded by a platform; the first body member has a nasal prong platform; the nasal prongs extend from the nasal prong platform on the first body member; and the nasal prong platform on the first body member establishes a sealing engagement with the platform on the second body member when the first and second body members are assembled.

22. 18. The nasal cannula (10) according to claim 17, characterized in that the gas receiving aperture (22) is disposed at a first end of the second body member (14), and the one-way exhalation valve (24) comprises a first one-way exhalation valve (24A) disposed at a second end of the second body member (14).

23. 23. The nasal cannula (10) of claim 22, further comprising a second one-way exhalation valve (24B) generally aligned with at least one of the first and second nasal prongs (20A, 20B) and centrally disposed in the second body member (14).

24. 1. An ambient pressure gas dispensing system (100) for providing ambient pressure gas to an individual, the ambient pressure gas dispensing system (100) comprising: a donor reservoir (104) adapted to hold gas at substantially ambient pressure and having a fully inflated state; a supply valve (112) fluidly associated with the donor reservoir (104), the supply valve (112) having an open state that allows gas to flow into the donor reservoir (104) and a closed state that disables gas from flowing into the donor reservoir (104); an expansion detection system (156) operative to detect expansion of the donor reservoir (104) to within a predetermined range of a fully expanded state, the expansion detection system (156) operative to detect a first state in which the donor reservoir (104) is expanded to within the predetermined range of a fully expanded state and a second state in which the donor reservoir (104) is expanded to less than the predetermined range of a fully expanded state, and to actuate the supply valve (112) to an open state when the donor reservoir (104) is expanded to less than the predetermined range of a fully expanded state; an ambient pressure tube (122) with a first end and a second end, the first end of the ambient pressure tube (122) in fluid communication with the donor reservoir (104); a nasal cannula (10) including a nasal cannula body (12, 14) with an interior volume; first and second nasal prongs (20A, 20B) extending from the nasal cannula body (12, 14) and in fluid communication with the interior volume of the nasal cannula body (12, 14); and first and second nasal prongs (20A, 20B) in fluid communication with the interior volume of the nasal cannula body (12, 14) for receiving gas from the donor reservoir (104) through the environmental pressure tube (122). a gas receiving aperture (22); and a one-way exhalation valve (24) carried by the nasal cannula body (12, 14), the one-way exhalation valve (24) fluidly communicating with an internal volume of the nasal cannula body (12, 14) so ​​that gas provided from the tube (122) can be inhaled through the nasal prongs (20A, 20B) and thereby expelled through breath exhaled during exhalation; A gas dispensing system (100) at ambient pressure, comprising:

25. The ambient pressure gas dispensing system (100) includes a FiO gas supply in the nasal cannula body (12, 14) in fluid communication with the interior volume of the nasal cannula body (12, 14). ２ Further comprising an adjustment aperture (25A, 25B); ２ The adjustment apertures (25A, 25B) are selectively adjustable in size, thereby adjusting the FiO ２ and wherein the size of the adjustable apertures (25A, 25B) can be adjusted to provide a desired amount of air entrainment in the gas inhaled through the first and second nasal prongs (20A, 20B).

26. 26. The gas dispensing system (100) at ambient pressure of claim 25, wherein the nasal cannula bodies (12, 14) are formed from a first body member (12) assembled with a second body member (14), the first body member (12) having a central portion that defines a receiving cavity, and the second body member (14) is at least partially received within the receiving cavity of the first body member (12).

27. 27. The gas dispensing system (100) at ambient pressure as described in claim 26, wherein the first body member (12) of the nasal cannula bodies (12, 14) is formed from a resilient, substantially flexible material, and the second body member (14) of the nasal cannula bodies (12, 14) is formed from a substantially rigid material.

28. 27. The gas dispensing system at ambient pressure of claim 26, wherein the second body member has an internal volume with an opening bounded by a platform; the first body member has a nasal prong platform; the nasal prongs extend from the nasal prong platform on the first body member; and the nasal prong platform on the first body member establishes a sealing engagement with the platform on the second body member when the first and second body members are assembled.

29. 27. The gas dispensing system (100) at ambient pressure as described in claim 26, characterized in that the gas receiving aperture (22) is disposed at a first end of the second body member (14), and the one-way exhalation valve (24) comprises a first one-way exhalation valve (24A) disposed at a second end of the second body member (14).

30. 30. The ambient pressure gas dispensing system (100) of claim 29, further comprising a second one-way exhalation valve (24B) generally aligned with at least one of the first and second nasal prongs (20A, 20B) and centrally disposed in the second body member (14).

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