# US 11,298,492 B2 · Ventilation mask

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- Number: US 11,298,492 B2
- Document ID: US11298492B2
- Status: Granted
- Kind: B2
- Application number: 16/333,215
- Filed: 2017-08-22
- Published: 2019-07-25
- Granted: 2022-04-12
- Earliest claimed: 2016-09-14
- Assignees: Revolutionary Medical Device, Inc.
- Applicants: Revolutionary Medical Devices, Inc.
- Inventors: Michael J. Pedro; Thomas M. Reilly; Ryan G. Redford; David M. Kane
- Web page: https://patentgrep.com/patent/US11298492B2

## CPC

- A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure}
- A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices
- A61M 16/085: {Gas sampling}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/6803: {Head-worn items, e.g. helmets, masks, headphones or goggles}
- A61M 16/01: specially adapted for anaesthetising {(A61M16/104, A61M16/18 take precedence)}
- A61M 16/12: by mixing different gases
- A61M 2202/0208: Oxygen
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2230/432: partial CO2 pressure (P-CO2)
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A nasal mask has exhalation scoop fixed adjacent a lower portion of mask, adapted to overlie an upper lip of a patient when the mask is worn. The mask includes ports for sampling flow of CO2 expelled from the mouth and nose of the patient to the end-tidal CO2 port, and a pressure-based flow resistor for balancing flow of CO2 expelled from the mouth and the nose of the patient.

## Claims

### Claim 1

A nasal mask having an interior forming a nasal chamber, an end-tidal CO2 port, and an exhalation scoop fixed adjacent a lower portion of the nasal mask and adapted to overlie an upper lip of a patient when the mask is worn, the exhalation scoop formed of a material that is flexible relative to a material of the nasal mask such that the exhalation scoop is adapted to be pressed away from a mouth of the patient or folded back on itself to permit access to the mouth of the patient, and the end-tidal CO2 port comprising a first opening located behind the exhalation scoop to overlie the upper lip of the patient for sampling exhaled CO2 expelled from the mouth of the patient, and a second opening located in the nasal chamber to underlie a nare of the patient for sampling exhaled CO2 expelled from a nose of the patient.

### Claim 2 (depends on 1)

The nasal mask of claim 1, wherein said end-tidal CO2 port comprises an interface configured to connect with an interface connector.

### Claim 3 (depends on 1)

The nasal mask of claim 1, further comprising a ventilation port configured to connect with any of an anesthesia machine, a ventilation machine, and/or a hyperinflation bag.

### Claim 4 (depends on 1)

The nasal mask of claim 1, further comprising an oxygen port configured to connect with an oxygen source for supplying oxygen to an interior of the nasal mask.

### Claim 5 (depends on 1)

The nasal mask of claim 1, wherein the material of the exhalation scoop is formed of a material having a Shore OO Durometer Hardness of 0020 to 0050.

### Claim 6 (depends on 1)

The nasal mask of claim 1, wherein the material of the exhalation scoop is formed of a material having a Shore A Hardness selected from 2-10 or 3-7.

### Claim 7 (depends on 1)

The nasal mask of claim 1, wherein said second opening comprises a pressure-based flow resistor configured to maintain substantially constant sampling flow of CO2 expelled from the mouth and nose of the patient to the end-tidal CO2 port.

### Claim 8 (depends on 7)

The nasal mask of claim 7, wherein the pressure-based flow resistor comprises a manifold having two or more holes which communicate between a nasal chamber of the nasal mask and the end tidal CO2 port.

### Claim 9 (depends on 1)

The nasal mask of claim 1, wherein said exhalation scoop includes an opening permitting access to the mouth of the patient when the mask is worn, and a flexible flap arranged on an inside surface of the scoop for closing off the opening of the exhalation scoop.

### Claim 10 (depends on 9)

The nasal mask of claim 9, wherein the opening of the exhalation scoop comprises an aperture or one or more slits.

### Claim 11

A method for ventilating a patient, comprising:
providing a nasal mask having an interior forming a nasal chamber, an end-tidal CO2 port, a ventilation port, and an exhalation scoop fixed adjacent a lower portion of the nasal mask and adapted to overlie an upper lip of the patient when the mask is worn, the exhalation scoop formed of a material that is flexible relative to a material of the nasal mask,
connecting the ventilation port to any of an anesthesia machine, a ventilation machine, and/or a hyperinflation bag,
moving the exhalation scoop away from a mouth of the patient to provide access to the patient's mouth, and
monitoring end-tidal CO2 by sampling exhaled CO2 expelled from the mouth of the patient into a first opening of the end-tidal CO2 port located behind the exhalation scoop to overlie the upper lip of the patient, and expelled from a nare of the patient into a second opening of the end-tidal CO2 port located in the nasal chamber to underlie the nare of the patient.

### Claim 12 (depends on 11)

The method of claim 11, further comprising maintaining substantially constant sampling flow of CO2 expelled from the mouth and nose of the patient to an end-tidal CO2 port by a pressure-based flow resistor of said second opening.

### Claim 13 (depends on 12)

The method of claim 12, wherein the pressure-based flow resistor maintains constant flow by varying resistance as a function of differential pressure, between the first opening and the second opening, QBC, as defined by (PB−PC)1/2RBC, wherein QBC is a volumetric nasal exhalation flow through the second opening, PB is the pressure at the second opening, PC is the pressure at node C, and RBC is the resistance from Node B to Node C.

### Claim 14 (depends on 11)

The method of claim 11, further comprising folding the scoop back on itself to provide access to the mouth of the patient.

### Claim 15 (depends on 11)

The method of claim 11, further comprising connecting an oxygen port of said nasal mask to an oxygen source for supplying oxygen to the nasal chamber of the nasal mask.

### Claim 16 (depends on 11)

The method of claim 11, further comprising connecting the end-tidal CO2 port of the nasal mask to a gas sampling device.

### Claim 17 (depends on 11)

The method of claim 11, further comprising accessing the mouth of the patient through an opening of the exhalation scoop by moving a flexible flap arranged on an inside surface of the scoop for closing off the opening of the exhalation scoop.
