# US 12,214,139 B2 · Pulsating positive airway pressure devices and methods of use

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- Number: US 12,214,139 B2
- Document ID: US12214139B2
- Status: Granted
- Kind: B2
- Application number: 17/287,575
- Filed: 2019-11-01
- Published: 2021-12-23
- Granted: 2025-02-04
- Earliest claimed: 2018-11-02
- Assignees: University of Cincinnati
- Applicants: University of Cincinnati
- Inventors: Liran Oren; Ephraim Gutmark; Mehmet Tomac
- Web page: https://patentgrep.com/patent/US12214139B2

## CPC

- A61M 16/0006: {with means for creating vibrations in patients' airways}
- A61M 16/202: {electrically actuated}
- A61M 16/0009: {with sub-atmospheric pressure, e.g. during expiration}
- A61M 16/0057: {Pumps therefor}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0875: {Connecting tubes}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/42: Reducing noise
- A61M 2206/16: Rotating swirling helical flow, e.g. by tangential inflows
- A61M 2206/20: having means for promoting or enhancing the flow, actively or passively
- A61M 2230/40: Respiratory characteristics
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Methods and systems for delivery of pulsated air to a user using a device including a flow generator to generate a continuous air flow, a first actuator comprising a pulsated flow delivery mechanism configured to generate a pulsated air flow from the continuous air flow based on a pre-determined duty cycle to vary a frequency of the pulsated air flow, a user interface configured to generate and deliver vortices of pulsated air to the user at the frequency of the pulsated air flow, and a set of tubing to couple the flow generator, the first actuator, and the user interface.

## Claims

### Claim 1

A device for delivery of pulsated air to a user, the device comprising:
a flow generator to generate a continuous air flow;
at least one actuator comprising a pulsated flow delivery mechanism having one or more valves and configured to generate a pulsated air flow from the continuous air flow based on a pre-determined duty cycle to vary a frequency of the pulsated air flow;
a user interface configured to generate and deliver vortices of pulsated air to the user at the frequency of the pulsated air flow; and
a set of tubing to couple the flow generator, the at least one actuator, and the user interface;
wherein the continuous air flow is received by the pulsated flow delivery mechanism at a percentage associated with a first duty cycle value of the pre-determined duty cycle, and the continuous air flow is blocked from reception at a percentage associated with a second duty cycle value of the pre-determined duty cycle, and wherein a decrease in the first duty cycle value relative to a base first duty cycle value causes the strength of the vortices generated to increase relative to the strength of the vortices generated with the base first duty cycle value, and an increase in the first duty cycle value relative to the base first duty cycle value causes the strength of the vortices to decrease relative to the strength of the vortices generated with the base first duty cycle value.

### Claim 2 (depends on 1)

The device of claim 1, wherein the user interface is disposed at a downstream position and comprises a distal portion of the set of tubing, and the distal portion of the set of tubing is configured to convert the pulsated air flow into the vortices of pulsated air upon release to atmosphere.

### Claim 3 (depends on 2)

The device of claim 2, wherein the vortices of pulsated air comprise ring-shaped forms of air.

### Claim 4 (depends on 1)

The device of claim 1, wherein a proximal portion of the set of tubing is communicatively coupled to the flow generator at an upstream position.

### Claim 5 (depends on 1)

The device of claim 1, wherein the pre-determined duty cycle comprises a 50/50 duty cycle, a 30/70 duty cycle, or a 20/80 duty cycle, such that the first duty cycle value is 50, 30, or 20, and the second duty cycle value is respectively 50, 70, or 80.

### Claim 6 (depends on 1)

The device of claim 1, wherein the pulsated flow delivery mechanism comprises one or more ports of a solenoid valve configured to switch between open and closed positions.

### Claim 7 (depends on 1)

The device of claim 1, wherein the pulsated flow delivery mechanism comprises a rotary valve configured to include an aperture as an open port and a solid surface as a closed port such that the rotary valve is configured to switch between open and closed positions through valve rotation between the open port and the closed port.

### Claim 8 (depends on 1)

The device of claim 1, wherein the at least one actuator comprises a solenoid valve and the pulsated flow delivery mechanism is configured to switch the solenoid valve between (i) an on position during an on portion of the pre-determined duty cycle to receive the continuous air flow and convert to the pulsated air flow and (ii) an off position during an off portion of the pre-determined duty cycle to block the continuous air flow.

### Claim 9 (depends on 8)

The device of claim 8, wherein the at least one actuator comprises a second solenoid valve communicatively coupled to a vacuum source and disposed downstream of the solenoid valve toward the user interface, the second solenoid valve configured to close when the solenoid valve is in the on position and configured to open when the solenoid valve is in the off position to generate negative pressure.

### Claim 10

A system for delivery of pulsated air to a user, the system comprising:
a device comprising a flow generator at an upstream position, at least one actuator comprising a pulsated flow delivery mechanism having one or more valves, a user interface at a downstream position, and a set of tubing;
a processor communicatively coupled to the device; and
a non-transitory computer-readable memory storing instructions that, when executed by the processor, cause the processor to:
generate a continuous air flow via the flow generator for receipt at the at least one actuator;
generate via the pulsated flow delivery mechanism a pulsated air flow from the continuous air flow based on a pre-determined duty cycle to vary a frequency of the pulsated air flow; and
generate and deliver vortices of pulsated air to the user at the frequency of the pulsated air flow through a distal portion of the set of tubing coupled to the user interface at the downstream position disposed downstream of the pulsated flow delivery mechanism;
wherein the continuous air flow is received by the pulsated flow delivery mechanism at a percentage associated with a first duty cycle value of the pre-determined duty cycle, and the continuous air flow is blocked from reception at a percentage associated with a second duty cycle value of the pre-determined duty cycle, and wherein a decrease in the first duty cycle value relative to a base first duty cycle value causes the strength of the vortices generated to increase relative to the strength of the vortices generated with the base first duty cycle value, and an increase in the first duty cycle value relative to the base first duty cycle value causes the strength of the vortices to decrease relative to the strength of the vortices generated with the base first duty cycle value.

### Claim 11 (depends on 10)

The system of claim 10, further comprising instructions to:
monitor breathing pressure of the user via one or more pressure sensors communicatively coupled to the device;
apply the vortices of pulsating air to the user in coordination with negative breathing pressure of the user as sensed by the one or more pressure sensors.

### Claim 12 (depends on 11)

The system of claim 11, wherein the distal portion of the set of tubing is configured to convert the pulsated air flow into the vortices of pulsated air upon release to atmosphere.

### Claim 13 (depends on 12)

The system of claim 12, wherein the vortices of pulsated air comprise ring-shaped forms of air.

### Claim 14

A method for delivery of pulsated air to a user, the method comprising:
generating vortices of pulsated air at a variable frequency based on a pre-determined duty cycle utilizing a device comprising a flow generator at an upstream position, at least one actuator comprising a pulsated flow delivery mechanism having one or more valves and configured to generate a pulsated air flow from a continuous airflow generated by the flow generator at a percentage associated with a first duty cycle value of the pre-determined duty cycle and the continuous air flow is blocked from reception at a percentage associated with a second duty cycle value of the pre-determined duty cycle, wherein the pulsated air flow is generated at the variable frequency based on the pre-determined duty cycle, a user interface at a downstream position, and a set of tubing to couple the flow generator, the at least one actuator, and the user interface;
monitoring breathing pressure of the user via one or more pressure sensors communicatively coupled to the device; and
delivering the vortices of pulsating air to the user in coordination with a negative breathing pressure of the user as sensed by the one or more pressure sensors, wherein a decrease in the first duty cycle value relative to a base first duty cycle value causes the strength of the vortices generated to increase relative to the strength of the vortices generated with the base first duty cycle value, and an increase in the first duty cycle value relative to the base first duty cycle value causes the strength of the vortices to decrease relative to the strength of the vortices generated with the base first duty cycle value.

### Claim 15 (depends on 14)

The method of claim 14, wherein generating vortices of pulsated air at the variable frequency based on the pre-determined duty cycle comprises:
generating a continuous air flow via the flow generator for receipt at the at least one actuator;
generating via the pulsated flow delivery mechanism the pulsated air flow from the continuous air flow at the variable frequency based on the pre-determined duty cycle; and
generating and delivering vortices of pulsated air to the user at the variable frequency of the pulsated air flow through a distal portion of the set of tubing coupled to the user interface at the downstream position disposed downstream of the pulsated flow delivery mechanism.

### Claim 16 (depends on 15)

The system of claim 15, wherein the distal portion of the set of tubing is configured to convert the pulsated air flow into the vortices of pulsated air upon release to atmosphere.

### Claim 17 (depends on 16)

The system of claim 16, wherein the vortices of pulsated air comprise ring-shaped forms of air.
