# US 12,215,305 B2 · Tissue-processing container for automated processing of tissue, methods of use thereof, and systems comprising the same

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,215,305 B2
- Document ID: US12215305B2
- Status: Granted
- Kind: B2
- Application number: 18/441,108
- Filed: 2024-02-14
- Published: 2024-06-06
- Granted: 2025-02-04
- Earliest claimed: 2019-09-17
- Assignees: Axogen Corporation
- Applicants: Axogen Corporation
- Inventors: Daniel Barousse; Gerhard Andrew Foelsche
- Web page: https://patentgrep.com/patent/US12215305B2

## CPC

- A61B 50/30: Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40)
- C12M 21/08: {for producing artificial tissue or for ex-vivo cultivation of tissue (prostheses A61F2/00, grafts A61L27/00)}
- C12M 23/44: {Multiple separable units; Modules}
- C12M 25/10: {Hollow fibers or tubes (hollow fiber modules in general B01D63/02)}
- C12M 29/10: {Perfusion}
- C12M 45/02: {by mechanical forces; Stirring; Trituration; Comminuting (crushing, pulverizing, disintegrating in general B02C)}
- C12M 45/09: {by enzymatic treatment}
- C12M 47/04: {Cell isolation or sorting (purging biological preparations of unwanted cells C12N5/0081, determining the presence or kind of microorganism C12Q1/04)}
- A61B 2050/3007: {Stackable casings}
- B65D 21/00: Nestable, stackable or joinable containers; Containers of variable capacity
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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}
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

Tissue-processing containers are disclosed for facilitating multistep processing of tissue. Also disclosed are systems incorporating the tissue-processing containers that include shakers, incubators, controllers, and pumps. Multistep methods are disclosed for processing tissues using the tissue-processing containers. The tissue-processing containers are specially designed to achieve efficiencies in automated tissue processing, exposure of tissues to processing media, and multistep tissue processing protocols. The described tissue-processing containers comprise a cup-like cavity comprising a middle hole covered by a mesh screen, troughs for separate processing steps, and are stackable in a substantially airtight and substantially watertight manner. Tissues for processing using the described tissue-processing containers include nerve tissue. Also described herein is a transport housing for the transport of stacks of tissue-processing containers, and which may directly incubate those containers, or which may be placed inside a separate incubator for incubating the containers.

## Claims

### Claim 1

A container system comprising:
a cup having;
an open end;
a closed end;
a periphery defined by an outer wall;
an inner wall located radially inward of the outer wall, wherein a height of the inner wall is less than a height of the outer wall;
a floor defining the closed end of the cup;
a hole located in substantially a middle of the floor, wherein the hole is located radially inward of the inner wall so that the inner wall surrounds the hole and the outer wall surrounds the inner wall;
at least two troughs located on an inner surface of the floor of the cup, wherein the at least two troughs are defined by two or more trough walls projecting from the floor towards the open end of the cup, and wherein the two or more trough walls each have a height that is less than the height of the inner wall;
a first mesh screen extending across the hole; and
a second mesh screen extending along an outer surface of the closed end of the cup.

### Claim 2 (depends on 1)

The container system of claim 1, wherein the cup further has a first gasket configured to fixedly seal the first mesh screen across the hole, and a second gasket configured to seal the second mesh screen to the closed end of the cup.

### Claim 3 (depends on 2)

The container system of claim 2, wherein an end of the outer wall closest to the floor of the cup defines a first diameter, and wherein an end of the inner wall of the cup, closest to the floor of the cup, defines a second diameter, smaller than the first diameter, and wherein the hole defines a third diameter, smaller than the second diameter.

### Claim 4 (depends on 3)

The container system of claim 3, wherein the floor of the cup is sloped radially outwards from the second diameter to the first diameter so that the floor adjacent the first diameter is located further from the open end of the cup than the floor adjacent the second diameter.

### Claim 5 (depends on 1)

The container system of claim 1, wherein the cup further has a lid configured to removably cover the open end of the cup.

### Claim 6 (depends on 1)

The container system of claim 1, wherein substantially the middle of the floor of the cup is the middle of the floor of the cup.

### Claim 7 (depends on 1)

The container system according to claim 1, wherein a gauge of the first mesh screen and/or the second mesh screen is about 300×300 threads per inch to about 500×500 threads per inch.

### Claim 8 (depends on 7)

The container system according to claim 7, wherein the gauge of the first mesh screen and/or the second mesh screen is about 325×325 threads per inch.

### Claim 9 (depends on 1)

The container system according to claim 1, wherein the first mesh screen and/or the second mesh screen comprises openings of less than about 0.0017 inches.

### Claim 10 (depends on 1)

The container system according to claim 1, wherein the two or more trough walls are separate from one or both of the inner wall or the outer wall.

### Claim 11

The container system according to acclaim 1, wherein the floor of the cup is sloped, so that the hole in the floor of the cup is higher than an outside edge of the floor of the cup when the inner side of the floor is facing upward.

### Claim 12 (depends on 1)

The container system according to claim 1, comprising a plurality of cups.

### Claim 13 (depends on 12)

The container system according to claim 12, wherein the plurality of cups are arranged in one or more stacks.

### Claim 14 (depends on 13)

The container system according to claim 13, further comprising a housing, including a cover, configured to encase the one or more stacks of the plurality of cups.

### Claim 15 (depends on 13)

The container system according to claim 13, further comprising a stabilizer shroud for each stack, of the one or more stacks.

### Claim 16 (depends on 13)

The container system according to claim 13, further comprising an air regulator to control the flow of gas, and a humidity control to control one or more predetermined humidity levels of tissue during tissue processing in the plurality of cups.

### Claim 17 (depends on 13)

The container system according to claim 13, further comprising one or more of:
an incubator configured to control at least a temperature of tissue and tissue-processing media within the plurality of cups;
a shaker configured to tilt and/or oscillate the plurality of cups;
a camera configured to assess a fill level of the tissue-processing media within the plurality of cups; and
one or more pumps connected to the container system via one or more hoses, and configured to supply the tissue-processing media to the plurality of cups, wherein the one or more pumps are configured to create pressure within the one or more hoses to achieve ingress of the tissue processing media into and egress of the tissue processing media out of the plurality of cups via a nozzle.

### Claim 18 (depends on 17)

The container system according to claim 17, further comprising a controller, provided with a user interface, a programmable memory, and a computing chip, and being configured to execute a software program that controls one or more of the incubator, the shaker, the camera, and the one or more pumps.
