# US 11,027,086 B2 · Oro-nasal inhalation plethysmography mask exposure system

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- Number: US 11,027,086 B2
- Document ID: US11027086B2
- Status: Granted
- Kind: B2
- Application number: 16/076,094
- Filed: 2017-02-07
- Published: 2020-01-23
- Granted: 2021-06-08
- Earliest claimed: 2016-02-07
- Assignees: The Government of the United States, as represented by the Secretary of the Army
- Applicants: The Government of the United States, as Represented by the Secretary of the Army
- Inventors: Larry E. Bowen
- Web page: https://patentgrep.com/patent/US11027086B2

## CPC

- A61M 16/06: Respiratory or anaesthetic masks
- A61B 5/091: Measuring volume of inspired or expired gases, e.g. to determine lung capacity
- A61B 5/4821: {Determining level or depth of anaesthesia (based on movements A61B5/1106)}
- A61D 7/00: Devices or methods for introducing solid, liquid or gaseous remedies or other materials into or onto the bodies of animals (for reproduction or fertilisation A61D19/00)
- A61D 7/04: Devices for anaesthetising animals by gases or vapours; Inhaling devices
- A61M 16/085: {Gas sampling}
- A61M 15/00: Inhalators {(drug delivery in endotracheal tubes A61M16/04)}
- A61M 2250/00: Specially adapted for animals
- 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)
- A61D: VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS

## Abstract

In at least one embodiment, a system includes an inhalation source; a plenum in fluid communication with the inhalation source; at least one challenge plethysmography mask in fluid communication with the plenum, for each challenge plethysmography mask including a mask having a cavity to receive at least a nose of a test animal, a delivery conduit in fluid communication with the plenum and the cavity of the mask, at least one exhaust conduit in fluid communication with the cavity of the mask and the plenum, and a pressure sensor attached to the mask to measure pressure within the cavity of the mask; at least one processor in electrical communication with the at least one pressure sensor, the processor configured to process an output signal of the pressure sensor into respiratory data for each test animal during an exposure study; and an exhaust system in fluid communication with the plenum.

## Claims

### Claim 1

A system comprising:
an inhalation source;
a plenum in fluid communication with said inhalation source;
at least one challenge plethysmography mask in fluid communication with said plenum, each challenge plethysmography mask including
a mask having a cavity in which to receive at least a nose of a test animal,
a delivery conduit in fluid communication with said plenum and the cavity of said mask,
at least one exhaust conduit in fluid communication between the cavity of said mask and said plenum, and
a pressure sensor attached to said mask to measure pressure within the cavity of said mask;
at least one sampling mask in fluid communication with said plenum, each sampling mask including
a cavity,
a sealing wall covering an open side of said sampling mask, and
a sampling conduit passing through said sealing wall and placing a sampling end at a point inside the cavity of said sampling mask and an attachment end external to said sampling mask;
at least one processor in electrical communication with said at least one pressure sensor, said processor configured to process an output signal of said pressure sensor into respiratory data for each test animal during an exposure study; and
an exhaust system in fluid communication with said plenum.

### Claim 2 (depends on 1)

The system according to claim 1, further comprising at least one sampling mask system including:
said at least one sampling mask;
an aerosol diluter/APS in fluid communication with said at least one sampling mask and in electrical communication with said at least one processor; and
wherein said at least one sampling mask system is in fluid communication with said plenum and in electrical communication with said at least one processor.

### Claim 3 (depends on 2)

The system according to claim 2, wherein said at least one sampling mask system includes
a concentration sampling mask in fluid communication with said plenum;
an aerosol sampler in fluid communication with said concentration sampling mask;
at least one filter in fluid communication with said aerosol sampler and said exhaust system.

### Claim 4 (depends on 2)

The system according to claim 2, wherein said at least one sampling mask includes
a delivery conduit in fluid communication with said plenum and the cavity of said sampling mask, and
a pair of exhaust conduits in fluid communication between the cavity of said sampling mask and said plenum, said exhaust conduits are located on opposing surfaces of said sampling mask.

### Claim 5 (depends on 1)

The system according to claim 1, wherein said inhalation source includes
a compressed gas source;
a gas flow controller in fluid communication with said compressed gas source; and
a nebulizer in fluid communication with said gas flow controller and said plenum.

### Claim 6 (depends on 5)

The system according to claim 5, wherein
said inhalation source further includes a second gas flow controller in fluid communication with said compressed gas source; and
a radial mixer in fluid communication with said nebulizer, said second gas flow controller and said nebulizer such that the gas flows from said nebulizer and said second gas flow controller are mixed together prior to discharge towards said plenum.

### Claim 7 (depends on 1)

The system according to claim 1, wherein said inhalation source further includes a diffusion dryer in fluid communication with said plenum such that the gas flow from said inhalation source passes through it prior to entry into said plenum.

### Claim 8 (depends on 1)

The system according to claim 1, wherein said exhaust system includes
at least one filter in fluid communication with said plenum;
an exhaust gas flow controller in fluid communication with said plenum such that said exhaust gas flow controller regulates the flow rate exiting said plenum; and
a vacuum in fluid communication with said exhaust gas flow controller to draw the exiting gas flow from said plenum.

### Claim 9 (depends on 1)

The system according to claim 1, wherein said exhaust system includes an exhaust sink having a reservoir to at least one of kill organic inhalants and neutralize organic inhalants.

### Claim 10 (depends on 1)

The system according to claim 1, wherein each challenge plethysmography mask having two exhaust conduits attached on opposing surfaces of said mask.

### Claim 11 (depends on 10)

The system according to claim 10, wherein said two exhaust conduits from a Y-shaped conduit such that said stem of the Y is in fluid communication with said plenum.

### Claim 12 (depends on 1)

The system according to claim 1, wherein said at least one challenge plethysmography mask includes a dental dam over at least a portion of an open side of said mask and partially enclosing the cavity of said mask.

### Claim 13

A sampling mask for use in an exposure system, said sampling mask comprising:
a mask having an open ended cavity,
a sealing wall covering the cavity of said mask,
a sampling conduit passing through said sealing wall and placing a sampling end at a point inside the cavity and an attachment end external to said sampling mask,
a delivery conduit connectable to a plenum and in fluid communication with the cavity of said mask,
at least one exhaust conduit in fluid communication with the cavity of said mask and connectable to the plenum, and
a pressure sensor attached to said mask to measure pressure within the cavity of said mask.

### Claim 14

A method for performing an exposure study of at least one test animal using an exposure system, the method comprising:
placing a snout of one test animal into a challenge plethysmography mask having a delivery conduit connecting the mask to a plenum, at least one exhaust conduit connecting the mask to the plenum, and a pressure sensor on the mask to measure a pressure within a cavity of the mask;
creating an environment within the plenum having material provided by an inhalation source where the material is being used in the exposure study;
passing the environment through the delivery conduit to the mask; passing the environment in the mask including expiration from the test animal through the at least one exhaust conduit back to the plenum;
sending a pressure signal from the pressure sensor to a processor;
sampling characteristics of the environment present in the plenum, wherein the sampling is taken from a cavity of a sampling mask having a delivery conduit connecting the sampling mask to the plenum, two exhaust conduits connecting the sampling mask to the plenum, a sealing wall over an open face of the sampling mask, and a sampling conduit passing through the sealing wall and through which the sampling is taken; and
calculating, with the processor connected to the pressure sensor, a dosage received by the test animal based on respiration data obtained from the pressure signal provided by the pressure sensor and environment characteristics.

### Claim 15 (depends on 14)

The method according to claim 14, wherein sampling characteristics includes sampling a concentration of a material being used in the exposure study.

### Claim 16 (depends on 14)

The method according to claim 14, wherein calculating the dosage includes
calculating the respiratory frequency for the test animal based on the pressure signal from the pressure sensor,
calculating a minute volume based on the respiratory frequency and a tidal volume,
correlating the characterization data for the environment with the respiratory information, and
determining the dosage received by the test animal.

### Claim 17 (depends on 14)

The method according to claim 14, wherein the characterization data includes particle size for the material.

### Claim 18 (depends on 14)

The method according to claim 14, further comprising:
creating the environment using a nebulizer attached to a compressed gas source; and
pulling the environment from the plenum using a vacuum.

### Claim 19 (depends on 1)

The system according to claim 1, wherein said plenum includes
a housing having a cavity in fluid communication with said inhalation source and said exhaust system; and
a plurality of connection ports in fluid communication with and configured to attach to any of said delivery conduit and said exhaust conduit to establish fluid communication from said plenum cavity to said connected delivery conduit or exhaust conduit.
