# US 11,439,869 B2 · Positive expiratory pressure device

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- Number: US 11,439,869 B2
- Document ID: US11439869B2
- Status: Granted
- Kind: B2
- Application number: 15/983,741
- Filed: 2018-05-18
- Published: 2019-01-03
- Granted: 2022-09-13
- Earliest claimed: 2017-05-19
- Assignees: Trudell Medical International
- Applicants: Trudell Medical International
- Inventors: Stephen Costella; Martin P. Foley; Alanna Kirchner; Robert Morton; Jason Collins; Jerry Grychowski
- Web page: https://patentgrep.com/patent/US11439869B2

## CPC

- A63B 23/18: for improving respiratory function
- A61M 16/0006: {with means for creating vibrations in patients' airways}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0816: {Joints or connectors}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A63B 71/0622: {Visual, audio or audio-visual systems for entertaining, instructing or motivating the user}
- A61M 16/049: {Mouthpieces}
- A61M 16/0627: {with sealing means on a part of the body other than the face, e.g. helmets, hoods or domes}
- A61M 16/0666: {Nasal cannulas or tubing (devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02)}
- A61M 16/0688: {by means of an adhesive}
- A61M 16/1045: {Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas}
- A61M 2016/0018: {electrical}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0033: {electrical}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/0272: Electro-active or magneto-active materials
- A61M 2205/3303: Using a biosensor
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2210/0637: Teeth
- A61M 2230/202: partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/42: Rate
- A61M 2230/50: Temperature
- A63B 2220/17: Counting, e.g. counting periodical movements, revolutions or cycles, or including further data processing to determine distances or speed
- A63B 2220/20: Distances or displacements
- A63B 2225/50: Wireless data transmission, e.g. by radio transmitters or telemetry
- A63B 2230/06: heartbeat rate only
- A63B 2230/20: blood composition characteristics
- A63B 2230/436: partial O2 value
- A63B 2230/50: temperature
- A63B 2230/75: calorie expenditure
- A63B: APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT (apparatus for passive exercising, massage A61H)
- 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

A positive exhalation pressure device increases the pressure gradient in the airways, thereby increasing oxygen saturation levels and decreasing the severity of hypoxia. Various embodiments of the device may be inserted into the nasal and/or oral cavities, or configured as mask devices covering the nasal and/or oral cavities. In some embodiments, the resistance of the device may be varied.

## Claims

### Claim 1

A positive expiratory pressure device comprising:
a mask comprising a body shaped to cover the user's mouth and nose and defining an interior space,
wherein the mask is configured with a first port that communicates directly between an ambient environment surrounding an exterior of the body and the interior space,
wherein the at least one first port is configured with an inhalation valve and wherein the first port defines an inhalation path communicating with the body, and
a second exhalation port sized to produce an exhalation pressure between 1-15 cmH2O, wherein the second exhalation port has an unobstructed orifice with a non-variable and minimal cross-sectional area that communicates directly between the interior space and the ambient environment,
wherein the positive expiratory pressure device is free of any exhalation valves; and
a neck tube coupled to the mask and extending downwardly therefrom.

### Claim 2 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the neck tube is releasably coupled to the mask.

### Claim 3 (depends on 2)

The positive expiratory pressure device of claim 2 wherein the neck tube is releasably coupled to the mask with a magnet.

### Claim 4 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the neck tube does not cover the first inhalation port or the second exhalation port.

### Claim 5 (depends on 4)

The positive expiratory pressure device of claim 4 wherein the mask comprises fabric catches for aligning one or more openings in the neck tube with the first inhalation port and the second exhalation port on the mask.

### Claim 6 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the neck tube comprises an elastic member configured to engage the user.

### Claim 7 (depends on 6)

The positive expiratory pressure device of claim 6 further comprising a drawstring mechanism for adjusting the elastic member.

### Claim 8 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the neck tube is the only feature for securing the mask to the user.

### Claim 9 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the body defines a dead space external to the user.

### Claim 10 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the unobstructed orifice is configured as a single orifice having an area of between 3.142 mm2 and 78.540 mm2.

### Claim 11 (depends on 1)

The positive expiratory pressure device of claim 1 comprising an electronic module coupled to the mask, the electronic module comprising at least one sensor capable of measuring one or more body functions and/or parameters, and a control unit operable to determine at least one threshold based on data collected from the at least one sensor.

### Claim 12 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the neck tube is open along a portion or an entirety of a length thereof.

### Claim 13 (depends on 12)

The positive expiratory pressure device of claim 12 further comprising a fastener closing the open neck tube.

### Claim 14 (depends on 1)

The positive expiratory pressure device of claim 1 wherein the neck tube has a continuous periphery defining a tubular structure with openings at each end of the tubular structure.

### Claim 15

A method of using a positive expiratory pressure device comprising:
positioning a body of a mask to cover a user's mouth and nose, wherein the mask is configured with a first port configured with an inhalation valve and communicating directly with an ambient environment surrounding an exterior of the body, and a second exhalation port comprising an unobstructed orifice with a non-variable and minimal cross-sectional area;
positioning a neck tube around a neck of the user, wherein the neck tube is coupled to the mask and holds the mask on the user;
inhaling only from an ambient environment through the first port and thereby opening the inhalation valve;
exhaling through the unobstructed orifice of the second exhalation port directly to the ambient environment from an interior of the body and creating an exhalation pressure between 1-15 cmH2O; and
wherein the positive expiratory pressure device is free of any exhalation valves.

### Claim 16 (depends on 15)

The method of claim 15 further comprising decoupling the mask from the neck tube.

### Claim 17 (depends on 16)

The method of claim 16 wherein said decoupling comprises releasing a magnetic force between the mask and neck tube.

### Claim 18 (depends on 15)

The method of claim 15 further comprising positioning the neck tube on the user without the mask being positioned on the user.

### Claim 19 (depends on 15)

The method of claim 15 wherein the neck tube does not cover the first inhalation port or the second exhalation port.

### Claim 20 (depends on 15)

The method of claim 15 wherein the unobstructed orifice is configured as a single orifice having an area of between 3.142 mm2 and 78.540 mm2.

### Claim 21 (depends on 15)

The method of claim 15 wherein the neck tube has a continuous periphery defining a tubular structure with openings at each end of the tubular structure, and wherein positioning the neck tube around the neck of the user comprises passing the user's head through the tubular structure.

### Claim 22 (depends on 15)

The method of claim 15 wherein the neck tube is open along a portion or an entirety of a length thereof, and wherein positioning the neck tube around the neck of the user comprises wrapping the open neck tube around the neck of the user.

### Claim 23 (depends on 22)

The method of claim 22 further comprising securing the open neck tube around the neck of the user with a fastener.