The invention concerns a device for controlling the flow of gas such as oxygen from a gas source to a patient through gas delivery devices such as nasal cannula, nasal pillows and masks.
Oxygen therapy involves the prescribed administration of oxygen and/or a flow rate for oxygen to be delivered for effective breathing via a nasal cannula having prongs resting in the nose, via a face mask, or via a tube placed in the trachea of a patient.
Home oxygen therapy has been shown to decrease mortality and improve quality of life for patients with Chronic Obstructive Pulmonary Diseases (COPD) and hypoxemia. Home oxygen therapy is prescribed to those who have been lifelong smokers, and some who are actively smoking. For home use, oxygen concentrators are used to pull oxygen from the surrounding air, never requiring a refill, but its use is dictated by a prescribed flow rate for each patient.
For portable use, oxygen is considered a medicine stored as a gas or liquid in special tanks. Lightweight concentrators are also available, eliminating the need for a special tank.
Because oxygen accelerates combustion and is a known fire hazard, COPD patients who smoke and use oxygen therapy in their homes or other enclosed spaces risk having a fire-related incident.
The prongs of a cannula are intended to direct oxygen into the nose. However, a significant amount of oxygen exits the nose and constantly leaks out and bathes the lower face. An oxygen-enriched environment facilitates ignition and combustion of any material. The buildup of oxygen in an enclosed space is often caused by non-compliant behavior, such as removing one's cannula without turning off the machine. Additionally, patients suffering from hypoxemia due to, for example, congestive heart failure and COPD are at risk when nasal cannula are not used properly. For example, a relatively large proportion of COPD patients using continuous supplemental oxygen suffer nasal cannula dislodgment during sleep on a weekly basis. Nasal cannula dislodgement predisposes COPD patients to exacerbations that may require emergency room treatment. There is clearly an opportunity to increase the safety of oxygen therapy by reducing the potential for fire-related incidents as well as correcting dislodgement of nasal cannula and thereby mitigating concomitant complications.
The invention concerns a device for controlling flow of gas from a gas source to a patient. In an example embodiment the device comprises a nasal cannula providing fluid communication between the gas source and the patient. The nasal cannula includes two prongs adapted to fit within nostrils of the patient. A first and a second portion of the nasal cannula are in fluid communication with the prongs. The first and second portions are adapted to fit respectively between a first and a second ear and head of the patient. A first sensor is positioned on the first portion of the nasal cannula. The first sensor is adapted to sense a degree of curvature of the first portion of the nasal cannula and generate first signals indicative thereof. An actuator is engaged with the nasal cannula between the gas source and the first and second portions of the nasal cannula. The actuator has a first configuration permitting flow of gas from the gas source through the nasal cannula to the first and second portions of the nasal cannula, and a second configuration preventing flow of gas from the gas source through the nasal cannula to the first and second portions of the nasal cannula. A controller is in communication with the first sensor and the actuator. The controller is adapted to receive the first signals from the first sensor and adjust the actuator between the first and second configurations. The controller adjusts the actuator to the first configuration when the first sensor senses the degree of curvature greater than a threshold value, and the controller adjusts the actuator to the second configuration when the first sensor senses the degree of curvature less than the threshold value.
The invention further encompasses a device for controlling flow of gas from a gas source to a patient. An example device comprises a tube providing fluid communication between the gas source and the patient. An adapter is in fluid communication with the tube. The adapter is engagable with a mouth and/or nose of the patient. A band extends from the adapter and is positionable surrounding a head of the patient for attaching the adapter thereto. A first sensor is positioned on the band. The first sensor is adapted to sense a degree of curvature of the band and generate first signals indicative thereof. An actuator is engaged with the tube between the gas source and the adapter. The actuator has a first configuration permitting flow of gas from the gas source through the tube to the adapter, and a second configuration preventing flow of gas from the gas source through the tube to the adapter. A controller is in communication with the first sensor and the actuator. The controller is adapted to receive the first signals from the first sensor and adjust the actuator between the first and second configurations. The controller adjusts the actuator to the first configuration when the first sensor senses the degree of curvature greater than a threshold value. The controller adjusts the actuator to the second configuration when the first sensor senses the degree of curvature less than the threshold value.
By way of example, the controller may be adapted to generate an alarm signal when the first sensor senses the degree of curvature less than the threshold value.
In an example embodiment, the first sensor may comprise a resistive flexible sensor having an electrical resistance which changes in response to a change in curvature of the first sensor. For example, the electrical resistance may increase with an increase in curvature of the first sensor.
An example embodiment may further comprise a second sensor positioned on the second portion of the nasal cannula. The second sensor is adapted to sense a degree of curvature of the second portion of the nasal cannula and generate second signals indicative thereof. The controller is in communication with the second sensor. The controller is adapted to receive both the first and second signals respectively from the first and second sensors and adjust the actuator between the first and second configurations. The controller adjusts the actuator to the first configuration when at least one of the first and second sensors sense the degree of curvature greater than a threshold value. The controller adjusts the actuator to the second configuration when both the first and second sensors sense the degree of curvature less than the threshold value.
In an example embodiment the second sensor may comprise a resistive flexible sensor having an electrical resistance which changes in response to a change in curvature of the second sensor. By way of example, the electrical resistance of the second sensor may increase with an increase in curvature of the second sensor.
In an example embodiment the actuator comprises a servo motor having a rotatable shaft and a head mounted on the shaft. The head has at least two fingers extending therefrom. The fingers are in spaced apart relation and define a slot therebetween. The nasal cannula or the tube are received within the slot. The head is rotatable between the first configuration wherein the nasal cannula or the tube extend through the slot without deformation thereby permitting flow of the gas therethrough, and the second configuration, wherein the fingers impinge on the nasal cannula or the tube so as to form a kink therein thereby preventing flow of the gas therethrough.
By way of example the controller may comprise a microprocessor. A wireless communication system may be used to provide communication between the controller and the first sensor and the actuator. Also by way of example, a first electrical conductor may connect the controller to the first sensor and a second electrical conductor may connect the controller to the actuator.
An example device according to the invention may further comprise a power supply electrically connected to the first sensor, the actuator and the controller for providing electrical power thereto. By way of example the power supply may comprise a battery.
In an example embodiment the adapter comprises a mask or nasal pillows.
The invention also includes a method of controlling flow of a gas in response to non-compliant behavior of a patient with respect to a nasal cannula. In an example embodiment the method comprises:
An example method may further comprise:
Another example method of controlling flow of a gas in response to non-compliant behavior of a patient with respect to an adapter in fluid communication with a source of the gas, the adapter being engagable with a mouth and/or nose of the patient, a band extending from the adapter and positionable surrounding a head of the patient for attaching the adapter thereto, comprises:
In an example embodiment the curvature is measured by an electrical resistance of a sensor. The electrical resistance is proportional to a curvature of the sensor. In an example embodiment the electrical resistance increases with an increase of the curvature of the sensor.
The example device 10 is shown in
A first sensor 36 is positioned on the first portion 26 of the nasal cannula 20 also between the first ear 30 and the head 32. The first sensor 36 is adapted to sense a degree of curvature of the first portion 26 of the nasal cannula 20 and generate first signals indicative thereof. An actuator 38, positioned within a housing 40 through which the nasal cannula 20 passes, engages the nasal cannula 20 between the gas source 12 and the first and second portions 26 and 28 of the nasal cannula 20. As described in detail below, the actuator 38 has a first configuration permitting flow of gas from the gas source 12 through the nasal cannula 20 to the first and second portions 26, 28 of the nasal cannula 20, and a second configuration preventing flow of gas from the gas source 12 through the nasal cannula 20 to the first and second portions 26, 28 of the nasal cannula 20. A controller 42, also contained within housing 40, is in communication with the first sensor 36 and the actuator 38. Communication between the controller 42, the actuator 38 and the first sensor 36 may be via a wireless system, such as Bluetooth technology, or hard wired and comprising a first electrical conductor 44 connecting the controller 42 to the first sensor 36 and a second electrical conductor 46 connecting the controller 42 to the actuator 38 as shown in
Controller 42 is adapted to receive the first signals from the first sensor 36 indicative of the curvature of the first portion 26 of the nasal cannula 20 and adjust the actuator 38 between the first and second configurations. In this example embodiment, the controller 42 adjusts the actuator 38 to the first configuration (permitting gas flow) when the first sensor 36 senses a degree of curvature of the first portion 26 of the nasal cannula 20 greater than a threshold value. Curvature above the threshold value indicates that the patient 14 is wearing the nasal cannula 20 properly, as evidenced by the first portion 26 of the nasal cannula 20 curving around the first ear 30. Oxygen or other medical gases are thus being properly consumed. The controller 42 adjusts the actuator 38 to the second configuration (preventing gas flow) when the first sensor 36 senses a degree of curvature of the first portion 26 of the nasal cannula 20 less than the threshold value. Curvature less than the threshold value indicates a straightening of the first portion 26 of the nasal cannula 20, a result of the prongs 22 no longer being within the nostrils 24, as would occur, for example if the patient 14 removed the prongs and placed them on the forehead (see
As shown in
It is thought advantageous for device 10 to comprise a second sensor 48 positioned on the second portion 28 of the nasal cannula 20 worn behind the second ear 34 as shown in
As shown in
One or more bands 78 extend from the adapter 68 and are positionable surrounding the head 32 of the patient 14 for attaching the adapter. A first sensor 36, as described above, is positioned on the band or bands 78. Again, the first sensor is adapted to sense a degree of curvature of the band 78 and generate first signals indicative thereof. An actuator 38 (not shown) within housing 40 as described above is engaged with the tube 66 between the gas source and the adapter 68. Again, the actuator 38 has a first configuration permitting flow of gas from the gas source through the tube 66 to the adapter 68, and a second configuration preventing flow of gas from the gas source through the tube 66 to the adapter 68 (see
The invention further encompasses methods for controlling gas flow in response to non-compliant behavior of a patient. In one example, drawn to a patient using a device comprising nasal cannula in fluid communication with a source of the gas, the method comprises:
This example method may further comprise:
Another example method is directed to controlling flow of a gas in response to non-compliant behavior of a patient using a device comprising an adapter (such as a mask) in fluid communication with a source of the gas. The adapter is engagable with a mouth and/or nose of the patient, and a band extends from the adapter and is positionable surrounding a head of the patient for attaching the adapter thereto. An example of such a method comprises:
In either example method described above, the curvature of the nasal cannula or the band may be measured by an electrical resistance of a sensor wherein the electrical resistance is proportional to a curvature of the sensor. In an example embodiment, the electrical resistance of the sensor may increase with an increase of the curvature of the sensor. The sensor is mounted on the cannula, tube or band and thus the curvature of the sensor is the same or proportional to the curvature of the cannula tube or band.
Devices as claimed and described herein are expected to prevent injury to patients and damage to property by signaling (via an alarm) a dangerous condition and/or stopping the flow of oxygen within the device, thus preventing unintentional, excessive oxygen concentration levels that serve as an accelerant for sources of ignition. The devices according to the invention are expected to mitigate the risk and danger associated with non-compliance during oxygen therapy sessions through a self-correcting and user independent product. Since non-compliant behavior may be defined as the removal of one's cannula while the gas source is still providing oxygen, resulting in a buildup of oxygen levels in an enclosed space, devices herein are expected to achieve greater patient safety by preventing the deleterious effects of patient non-compliance.
Devices according to the invention can be added on to existing cannulas to sense the removal of the cannula. Oxygen is always flowing if systems and components herein are worn correctly, whereas non-compliant behavior triggers an existing alarm within oxygen concentrators, alerting users to either: 1) shut off the machine, or 2) put the cannula back on. In addition, devices as described and claimed herein can be paired to a select an oxygen source either directly or indirectly, such as via a smartphone, iPad, computer station, or the like.
It is advantageous if the various components of the devices described herein, as appropriate, are formed of non-toxic materials operationally safe components, and single use (disposable) components. Devices according to the invention are furthermore well adapted for use with both stationary and portable gas sources. The devices according to the invention may be used with a wide range of patients such as a neonate, infant, a child, an adolescent or an adult. Patients may be treated at home, or when confined to a medical facility or nursing home. Devices according to the invention are furthermore compact and lightweight, allowing for their use by ambulatory patients. The devices are adaptable for continuous or intermittent use.
Devices as claimed and described herein are expected to serve clinical needs for respiratory therapists, pulmonologists, nursing homes/care centers, durable medical equipment (DME) companies/staff, first responders (EMT, Firefighters, Police), insurance companies, hospitals and the like.
Additionally, the devices can be configured to selectively connect with existing FireSafe devices or other similar safety systems in a home, hospital, or nursing facility. To this end, wired or wireless signals can be generated and sent to FireSafe devices to indicate an alarm has been detected or the flow of oxygen has been obstructed.
A number of advantages are expected to be achieved by the devices described and claimed herein, including: lower oxygen (and other medical gas) use and waste; prevention of oxygen level build up without an alarm; allow for corrective measures when nasal cannula are dislodged during sleep; reduced fire risk; increased patient safety; increased safety for family, caregivers, neighbors, and pets. The devices described and claimed herein can be configured to work with existing home oxygen concentrators to trigger alarms and auto shut-off functions.
All of the embodiments of the claimed invention described herein are provided expressly by way of example only. Innumerable variations and modifications may be made to the example embodiments described herein without departing from the concept of this disclosure. Additionally, the scope of this disclosure is intended to encompass any and all modifications and combinations of all elements, features, and aspects described in the specification and claims, and shown in the drawings. Any and all such modifications and combinations are intended to be within the scope of this disclosure.
This application is based upon and claims benefit of priority to U.S. Provisional Application No. 63/289,053, filed Dec. 13, 2021, which application is hereby incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/052526 | 12/12/2022 | WO |
Number | Date | Country | |
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63289053 | Dec 2021 | US |