Augmentation of oxygen delivery through inline reservoir oxygen supplementation equipment

Abstract

A device for supplying a high dosage of oxygen to a patient is provided. The device allows a patient to breathe oxygen directly from an expandable-collapsible reservoir that collects oxygen supplied by continuous flow. The system has an oxygen supply line connected to a fenestrated adaptor that allows oxygen to fill the reservoir while also continuing to flow within tubing. The reservoir expands as oxygen accumulates. A second fenestrated adaptor allows oxygen to be simultaneously drawn from the reservoir and the supply tubing. The second adaptor is connected to large bore oxygen tubing leading to a large bore nasal cannula.

Description

AUGMENTATION OF OXYGEN DELIVERY THROUGH INLINE RESERVOIR OXYGEN SUPPLEMENTATION EQUIPMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 705,829, filed October 10, 2024, and U.S. Provisional Application Serial No. 63 / 808,902, filed May 20, 2025, the contents of which are hereby incorporated by reference in their entirety.TECHNICAL FIELD

[0002] The present invention relates to oxygen delivery devices.BACKGROUND OF THE INVENTION

[0003] As chronic hypoxic respiratory failure progresses, supplemental oxygen requirements can exceed the capacity to deliver the gas using practical, portable equipment, limiting mobility and participation in physical therapy and cardiopulmonary rehabilitation. During the COVID pandemic, many hospitals struggled to keep up with demand for oxygen. These challenges highlight the need to develop more efficient and effective means to deliver supplemental oxygen in the inpatient and outpatient settings.

[0004] Supplemental oxygen is prescribed in flow rates measured in liters per minute (LPM). Chronic hypoxic respiratory failure associated with certain conditions such as chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF) are typically treated with 2 to 6 LPM, while people with other conditions such as interstitial lung diseases (ILD) and advanced pulmonary hypertension (PH) may require up to 8 to 10 LPM, which can exceed the maximum capacity of many home oxygen concentrators. When oxygen needs reach 11- 15L / min, such as in end stage ILD patients awaiting transplant, higher oxygen flow rates can be achieved by combining the outflow of two large oxygen concentrators. Patients with resting hypoxia often have a high oxygen requirement with activity, which can preclude participation in physical therapy, and cardiopulmonary rehabilitation. In the inpatient setting, high oxygen requirements typically necessitate a higher level of care associated with higher cost and resource constraints, and can complicate discharge planning for end stage respiratory failure patients who are denied access to hospice or skilled nursing facilities.

[0005] The current system by which oxygen is delivered is inherently flawed in that humans do not breathe a continuous stream of air. The time each patient spends taking an inhaled breath is variable, but it is typically 1 / 3 to 1 / 2 of the time spent exhaling, and as a result, 66-75% of the oxygen delivered via continuous supply is directed to the ambient atmosphere instead of the patient’s lungs. The volume of air that a patient breathes in one minute is between 5 and 8 liters for healthy adults at rest and can increase as much as 30 fold with exertion in healthy adults.

[0006] Pulsed delivery systems can sense a patient’s inspiration and then deliver oxygen, but these systems are expensive, and limited in terms of how much oxygen they can supply. Additionally, there are reservoir devices such as the Oxymizer or mustache style expanded capacity nasal cannulas that are commercially available, but these typically only have a reservoir capacity of 30-60 ml, which is less than a tenth of the typical tidal volume of 350-600 ml. Therefore, a need still exists for an improved system for providing higher volumes of oxygen to a patient in a cost-effective manner.SUMMARY OF THE INVENTION

[0007] Certain exemplary aspects of the invention are set forth below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms the invention might take and that these aspects are not intended to limit the scope of the invention.

[0008] In a first embodiment of the invention, an apparatus for delivering oxygen-containing gas to a patient’s airway is provided. The apparatus includes an oxygen supply that is removably connected to an oxygen supply tubing line. It also includes a first fenestrated adapter that is removably connected to the oxygen supply tubing line. Further, an in-line tubing line is connected to the first fenestrated adapter. The apparatus also includes a flexible reservoir that is connected to the first fenestrated adapter. The flexible reservoir expands as oxygen accumulates in the flexible reservoir. A second fenestrated adapter that is connected to the inline tubing line and flexible reservoir is also included. Further, a large bore oxygen tubing that is removably connected to the second fenestrated adapter is included. Finally, the apparatus includes a large bore nasal cannula that is removably connected to the large bore oxygen tubing. The first fenestrated adapter allows oxygen to fill the flexible reservoir while oxygen also continues to flow through the in-line tubing line; and further. Also, the second fenestrated adapter allows a patient to simultaneously draw oxygen from the flexible reservoir and oxygen flowing through the in-line tubing line.

[0009] In one embodiment, the in-line tubing line is located inside the flexible reservoir. In another embodiment, the apparatus also includes a nasal occlusion device connected to the large bore nasal cannula where the occlusion device inhibits ambient air from entering the patient’s nasal passages. In one embodiment, the nasal occlusion device is connected to a tieable headstrap system. In another embodiment, the large bore nasal cannula is coaxially fixed to a respiratory baffle. In one embodiment, the flexible reservoir has a volume capacity of at least about 500 milliliters. In another embodiment, the flexible reservoir has a volume capacity of at least about 800 milliliters. In one embodiment, the flexible reservoir comprises plastic sheeting. In another embodiment, a method to deliver oxygen-containing gas to a patient’s airway is provided. The method involves connecting the patient to the apparatus described above by placing the nasal cannula in the patient’s nares and activating the oxygen supply.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The objects and advantages of the disclosed invention will be further appreciated in light of the following detailed descriptions and drawings in which:

[0011] FIG. l is a photograph of an embodiment a device according to the present invention.

[0012] FIG. 2 is a photograph of a large bore nasal cannula with an occlusion device that inhibits ambient air from entering the nasal passages.

[0013] FIG. 3 is a photograph of a large bore nasal cannula with an occlusion device as placed on a user.

[0014] FIG. 4 is a graph showing an example plot of simultaneous exhaled carbon dioxide and oxygen concentration readings.

[0015] FIG. 5 is a graph showing a plot of exhaled oxygen concentration comparing the IROSE device with a nasal cannula, as well as a commercially available nasal reservoir device (Oxymizer) in a single individual.

[0016] FIG. 6 is a schematic of the basic design of the IROSE device.

[0017] FIG. 7A is a zoomed in photo of a representative IROSE proximal adapter. Fenestrations allow oxygen rich gas to easily pass from the reservoir to the patient upon inhalation.

[0018] FIG. 7B is a photo of the distal IROSE adapter. Arrows point to fenestrations in the device which allow ambient air to be drawn in when the subject minute ventilation exceeds oxygen supply rate.

[0019] FIG. 7C is a photo of the plastic sheeting which jackets the oxygen tubing to create the reservoir.

[0020] FIG. 8 is a series of graphs showing a comparison of the performance of different tested devices.DEFINITIONS

[0021] As used herein, the term “fenestration” means an opening provided through a surface of a structure from the interior of the structure to the exterior of the structure and may have a variety of geometries, including circular, semi-circular, oval, oblong, as well as other geometries. The term “fenestrated” means the structure has a plurality of fenestrations.DETAILED DESCRIPTION OF THE INVENTION

[0022] One or more specific embodiments of the present invention will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0023] The present invention involves a novel device for supplying oxygen to a patient. Herein, the device may be referred to as “The Inline Reservoir Oxygen Supplementation Equipment” or “IROSE.” This design provides a solution to the problem of delivering high dose oxygen by allowing a patient to breathe oxygen directly from an expandable-collapsible reservoir that collects oxygen supplied by continuous flow. FIG. 1 is a photograph of an embodiment a device according to the present invention, referred to as the “in-line reservoir oxygen supplementation equipment system.” The system has an oxygen supply line 1 and a fenestrated adaptor 2 that allows oxygen to fill the reservoir while also continuing to flow within tubing. The system also has a flexible reservoir 3 that expands as oxygen accumulates. A fenestrated adaptor 4 allows oxygen to be simultaneously drawn from the reservoir and the supply tubing. Large bore oxygen tubing 5 connects to a large bore nasal cannula 6, shown without an occlusion device.

[0024] In one embodiment, the reservoir is located coaxially with the oxygen supply line to minimize its weight and profile. In another embodiment, the reservoir interfaces with a large bore nasal cannula which is equipped with a baffle (FIG. 2 and FIG. 3) designed to minimize entrainment of ambient air into the nasal passages. This system allows the user to draw high volumes of oxygen rich gas from the reservoir using their own inspiratory effort. A large bore nasal cannula with an occlusion device inhibits ambient air from entering the nasal passages. Such an occlusion device allows the user to draw high concentration oxygen from the IROSE reservoir, increasing the user’s oxygen delivery.

[0025] FIG. 6 shows a schematic of one embodiment of the basic design of the IROSE device 10. A continuous oxygen supply 20 flows through an inlet adapter 30. The inlet adapter 30 is fenestrated, allowing a portion of the oxygen supply to flow through an in-line supply line 70 and the other portion of the oxygen supply to fill an expandable-collapsible reservoir 40. The double arrows in the figure indicate that the reservoir 40 is expandable and collapsible. An outlet adapter 50 is fenestrated, allowing for a patient to inhale from the reservoir 40 in addition to the inline supply line 70 through the nasal cannula 60. In another embodiment, a face mask can be used instead of a nasal cannula. In one embodiment, at least 20 percent of the oxygen entering inlet adapter is diverted into the expandable-collapsible reservoir. In another embodiment, at least 30 percent of the oxygen entering inlet adapter is diverted into the expandable-collapsible reservoir.

[0026] In one embodiment, the expandable-collapsible reservoir has a volume capacity of at least about 500 milliliters. In another embodiment, the expandable-collapsible reservoir has a volume capacity of at least about 600 milliliters. In another embodiment, the expandable- collapsible reservoir has a volume capacity of at least about 800 milliliters.

[0027] As shown by the data presented herein, there is a strong signal that the IROSE system, which includes both the in-line reservoir as well as a nasal cannula equipped with a baffle, could have significant advantage over existing circuits in terms of effectiveness of oxygen utilization and cost reduction. The efficiency benefits are evident at all levels of oxygen supply, and limited data suggests that the efficiency benefit could be as much as 80% over currently available products.

[0028] The IROSE device is novel in that it is a high-capacity expandable reservoir for use in maximizing efficiency of oxygen delivery. It offers an affordable, efficient, and more effective alternative to current devices for oxygen delivery and has the potential to improve mobility and quality of life for patients with chronic respiratory failure. No existing reservoir devices exist that utilize an in-line concept, a larger reservoir approaching a physiologic tidal volume, or anasal dampener. The present invention allows significant efficiency benefits over devices that are commercially available, and have the potential to significantly affect patient care.

[0029] The present invention has the potential to increase the efficiency of oxygen delivery in various settings and end-user applications, with ramifications that can drastically affect the oxygen market. A variety of market segments may be affected by the device of the present invention. For example, it can be used for low flow oxygen. COPD and CHF patients using 2- 4L with activity currently have to carry around portable concentrators or oxygen tanks, which are heavy, cumbersome, and can add to their work of breathing. Increasing efficiency of delivered oxygen may allow them to use smaller tanks and be able to ambulate easily. The device of the present invention can also be used for high flow oxygen. ILD and PH patients who use 6-15 LPM of oxygen currently do so by using bulky, stationary concentrators in their homes, sometimes connecting them in parallel in order to increase their delivered flow. This technology has the potential to allow them to avoid the excess cost of large concentrators.

[0030] The present device is also useful for exercise and physical therapy. Both minute ventilation and oxygen consumption increase with activity and patients with chronic hypoxic respiratory failure often have increased oxygen requirements with activity. The addition of this technology may allow these patients to better participate in physical therapy and rehabilitation, with potentially improved outcomes. This device can impact inpatient settings. In other countries, as highlighted during the recent pandemic, hospitals were known to run out of oxygen. Delivery of higher concentration oxygen at higher efficiency may allow conservation and improved care in those markets. In addition, the device can be used for palliative care. It is not uncommon for patients with end stage respiratory failure to be unable to wean from inpatient supplemental oxygen, and as a result they are unable to discharge home with hospice. Our device may allow them to do so.

[0031] The device of the present invention employs a reservoir that is continuously filled with oxygen. It provides higher oxygen concentrations with lower oxygen flow rates. The use of a reservoir reduces the volume of gas that is wasted during the exhalation phase of respiration when using conventional delivery systems such as nasal cannula. Although currently available pulsed oxygen concentrators or flow regulators can also reduce waste, they are expensive and only available for lower supplemental oxygen needs. Preliminary data collected on IROSE to date demonstrates proof of concept and a significant efficiency benefit.EXAMPLESExample 1

[0032] Preliminary testing of an IROSE prototype in one healthy subject was conducted, including measurement of exhaled oxygen and carbon dioxide concentrations at various continuous oxygen flow rates. The prototype was fabricated using parts printed on a 3D printer, plastic sheeting, and commercially available oxygen circuit equipment. Exhaled oxygen concentration (as confirmed by simultaneous exhaled carbon dioxide concentration peaks) were measured and averaged over several respiratory cycles after a steady state was achieved. Exhaled oxygen concentration is used as a non-invasive proxy for inhaled oxygen concentration, and given a single healthy subject at rest, it is appropriate to use this measurement to compare oxygen delivery devices. Measurements were taken using an O2Cap Oxygen Analyzer (Oxigraf Inc, USA) with continuous sampling at 7.5 hz via a tube placed to continuous suction at a fixed distance from the user’s mouth. Results were compared with the use of regular nasal cannula and Oxymizer at similar levels of oxygen flow (FIG. 4 and FIG. 5). FIG. 4 shows an example plot of simultaneous exhaled carbon dioxide and oxygen concentration readings. The dashed vertical line shows an example sampling point where CO2 concentration (blue) is at a maximum, suggesting an exhaled breath. The corresponding oxygen concentration (orange) is then recorded and averaged with other steady state data. Exhaled gas sampling was performed because it is non-invasive and functionally represents the trends of oxygen delivery. FIG. 5 is a plot of exhaled oxygen concentration comparing the IROSE device with a nasal cannula, as well as a commercially available nasal reservoir device (Oxymizer) in a single individual. A comparison of exhaled O2 for various devices at different oxygen supply flow rates. The “nasal pillows” curve incorporates a commercially available CPAP style mask that is impractical for patients to wear in an ambulatory setting, but shows the capability of the technology when the nasal cannula baffle is 100% effective at restricting ambient air from entering the nasal passages.Example 2

[0033] IROSE was compared with a conventional nasal cannula (NC), a high-flow nasal cannula (HFNC), and an Oximizer® in 10 subjects during restful breathing. Since SpO? would not change with supplemental O2 in healthy subjects, we used exhaled oxygen (feO2) to measure the changes in fiO2. FeO2 and feCO2 at various continuous oxygen flow rates of 0, 3, 6, and 9LPM were measured.

[0034] Measurements were obtained using an ChCap Oxygen Analyzer (Oxigraf Inc, USA) with continuous sampling at 7.5Hz via a tube placed to continuous suction at a fixed distance from the user’s mouth. The sequence of devices was randomized for each participant with adequate washout time in-between each test. FeO? (as confirmed by simultaneous feCCh peaks) were averaged over 5 breaths after a steady state was achieved.

[0035] Ten healthy subjects completed the study. No differences were observed in exhaled CO2 (feCO?). IROSE was comfortable to use. Results of feO2 changes are shown in Table 1 and Figures 4, 5 and 8.Table 1P values are in comparison with iROSE (500cc) device.

[0036] Every document cited herein, including any cross-referenced or related patent or application, is hereby incorporated herein by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any other reference or references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.

[0037] While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

What is claimed is:

1. An apparatus for delivering oxygen-containing gas to a patient’s airway, said apparatus comprising: a. an oxygen supply that is removably connected to an oxygen supply tubing line; b. a first fenestrated adapter that is removably connected to the oxygen supply tubing line; c. an in-line tubing line that is connected to the first fenestrated adapter; d. a flexible reservoir that is connected to the first fenestrated adapter, wherein the flexible reservoir expands as oxygen accumulates in the flexible reservoir; e. a second fenestrated adapter that is connected to the in-line tubing line and flexible reservoir; f. large bore oxygen tubing that is removably connected to the second fenestrated adapter; and g. a large bore nasal cannula that is removably connected to the large bore oxygen tubing; wherein the first fenestrated adapter allows oxygen to fill the flexible reservoir while oxygen also continues to flow through the in-line tubing line; and further, wherein the second fenestrated adapter allows a patient to simultaneously draw oxygen from the flexible reservoir and oxygen flowing through the in-line tubing line.

2. The apparatus of claim 1 wherein the in-line tubing line is located inside the flexible reservoir.

3. The apparatus of claim 1 further comprising a nasal occlusion device connected to the large bore nasal cannula wherein the occlusion device inhibits ambient air from entering the patient’s nasal passages.

4. The apparatus of claim 3 wherein the nasal occlusion device is connected to a tieable headstrap system.

5. The apparatus of claim 1 wherein the large bore nasal cannula is coaxially fixed to a respiratory baffle.

6. The apparatus of claim 1 wherein the flexible reservoir has a volume capacity of at least about 500 milliliters.

7. The apparatus of claim 1 wherein the flexible reservoir has a volume capacity of at least about 800 milliliters.

8. The apparatus of claim 1 wherein the flexible reservoir comprises plastic sheeting.

9. A method to deliver oxy gen-containing gas to a patient’s airway comprising connecting the patient to the apparatus of claim 1 by placing the nasal cannula in the patient’s nares and activating the oxygen supply.

Images