# US 12,007,386 B2 · Respiratory simulation system including an anatomical model of the human nasal cavity configured for in vitro inhalation studies and associated methods

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- Number: US 12,007,386 B2
- Document ID: US12007386B2
- Status: Granted
- Kind: B2
- Application number: 16/680,851
- Filed: 2019-11-12
- Published: 2020-05-14
- Granted: 2024-06-11
- Earliest claimed: 2018-11-13
- Assignees: Miami University and Government of the United States (Air Force)
- Applicants: Government of the United States (Air Force)
- Inventors: Lei L. Kerr; Saber M. Hussain; Andrew Yerich
- Web page: https://patentgrep.com/patent/US12007386B2

## CPC

- G01N 33/5082: {Supracellular entities, e.g. tissue, organisms}
- B29C 33/3835: {Designing moulds, e.g. using CAD-CAM}
- B29C 33/3842: {Manufacturing moulds, e.g. shaping the mould surface by machining}
- B29C 33/3857: {by making impressions of one or more parts of models, e.g. shaped articles and including possible subsequent assembly of the parts}
- B29C 33/405: {Elastomers, e.g. rubber (B29C33/50 takes precedence)}
- B29C 39/02: for making articles of definite length, i.e. discrete articles
- B29C 64/386: Data acquisition or data processing for additive manufacturing
- B33Y 10/00: Processes of additive manufacturing
- B33Y 50/00: Data acquisition or data processing for additive manufacturing
- B33Y 80/00: Products made by additive manufacturing
- C12M 23/16: {Microfluidic devices; Capillary tubes (integrated microfluidic structures B01L3/5027; microreactors B01J19/0093)}
- C12M 29/04: {Filters; Permeable or porous membranes or plates, e.g. dialysis}
- C12N 5/062: {Sensory transducers, e.g. photoreceptors; Sensory neurons, e.g. for hearing, taste, smell, pH, touch, temperature, pain}
- C12N 5/0688: {Cells from the lungs or the respiratory tract}
- G09B 23/288: {for artificial respiration or heart massage}
- G09B 23/30: Anatomical models {(G09B23/281 - G09B23/288 take precedence)}
- G09B 23/303: {specially adapted to simulate circulation of bodily fluids}
- G09B 23/34: with removable parts
- B29L 2031/40: Test specimens {; Models, e.g. model cars (mannequins B29L2031/7028); Probes}
- B29L 2031/7532: {Artificial members, protheses}
- C12N 2513/00: 3D culture
- C12N 2533/00: Supports or coatings for cell culture, characterised by material
- C12N 2533/90: Substrates of biological origin, e.g. extracellular matrix, decellularised tissue
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

The anatomical model of a nasal cavity, such as a human nasal cavity, for in-vitro inhalation studies such as toxicological screening, intranasal drug delivery studies, and neurophysiological studies. The model includes a model body including separable upper and lower model portions together defining the nasal cavity and including fluidic channels therein that define an olfactory region of the upper model portion, and a nasal passage defined in the lower model portion. A biocompatible porous membrane is positioned between the upper and lower model portions, and the biocompatible membrane is configured for culturing olfactory epithelium cells thereon. An artificial mucous layer coats a surface of the nasal cavity and is configured to collect particles passing through the nasal cavity.

## Claims

### Claim 1

An anatomical model of a nasal cavity, the model comprising:
(a) a model body constructed of non-living material, the model body including upper and lower model portions configured to be affixed together to define the nasal cavity and including fluidic channels therein that define an olfactory region of the upper model portion and define a nasal passage of the lower model portion; and
(b) a biocompatible porous membrane positioned between the upper and lower model portions when the upper and lower model portions are affixed together, the biocompatible porous membrane disposed adjacent the fluidic channels that define the olfactory region, wherein the membrane is configured for
(i) culturing olfactory epithelium cells thereon and
(ii) receiving particles that flow into the nasal cavity of the model body toward the fluidic channels that define the olfactory region;
wherein the upper and lower model portions are configured to be separated and spaced from one another to enable access to the biocompatible membrane between the upper and lower model portions.

### Claim 2 (depends on 1)

The anatomical model according to claim 1, further comprising an artificial mucous layer coating a surface of the nasal cavity and configured to collect particles passing through the nasal cavity.

### Claim 3 (depends on 2)

The anatomical model according to claim 2, wherein the nasal cavity is configured to mimic the shape of a human nasal cavity.

### Claim 4 (depends on 2)

The anatomical model according to claim 2, wherein the artificial mucous layer is configured to be removed after separation of the upper and lower model portions.

### Claim 5 (depends on 1)

The anatomical model according to claim 1, wherein the upper and lower model portions comprise a silicone material.

### Claim 6 (depends on 1)

The anatomical model according to claim 1, wherein the biocompatible porous membrane includes artificial pores defining the permeability of the biocompatible porous membrane.

### Claim 7 (depends on 1)

The anatomical model according to claim 1, further comprising a microfluidic system defining the fluidic channels and configured for the growth of olfactory neuron and epithelium cells.

### Claim 8 (depends on 1)

The anatomical model according to claim 1, further comprising a biomaterial framework defining the fluidic channels and configured for the growth of olfactory neuron and epithelium cells.

### Claim 9 (depends on 1)

The anatomical model according to claim 1, further comprising a breathing system coupled to the model body and configured to simulate a breathing pattern with air entering and exiting via the nasal passage.

### Claim 10

An anatomical model of a nasal cavity, the model comprising:
(a) a model body constructed of silicone and including upper and lower model portions configured to be affixed together to define the nasal cavity and including fluidic channels therein that define an olfactory region of the upper model portion and define a nasal passage of the lower model portion; and
(b) a biocompatible porous membrane positioned between the upper and lower model portions when the upper and lower model portions are affixed together, the biocompatible membrane configured for culturing olfactory epithelium cells thereon;
wherein the upper and lower model portions are configured to separate to enable removal of the biocompatible membrane for analysis.