# US 9,750,482 B2 · Sample collection device

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- Number: US 9,750,482 B2
- Document ID: US9750482B2
- Status: Granted
- Kind: B2
- Application number: 14/939,671
- Filed: 2015-11-12
- Published: 2016-06-02
- Granted: 2017-09-05
- Earliest claimed: 2011-08-16
- Assignees: Exact Sciences Corporation
- Applicants: Exact Sciences Corporation
- Inventors: Graham P. Lidgard; Michael J. Domanico; Keith Fourrier; James P. Light, II; Scott Castanon; Keith Kopitzke
- Web page: https://patentgrep.com/patent/US9750482B2

## CPC

- A61B 10/0038: {Devices for taking faeces samples; Faecal examination devices (anal receptacles A61F5/451)}
- G01N 1/38: Diluting, dispersing or mixing samples
- B01L 3/50825: {Closing or opening means, corks, bungs}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

Provided herein is technology relating to collecting and preparing samples. For example, the technology relates particularly, but not exclusively, to devices, systems, and kits that allow a subject to collect and prepare a sample for analysis.

## Claims

### Claim 1

A device for collecting and preserving a sample, the device comprising:
a) a body comprising a sample collection chamber bounded on a distal end by a penetrable seal and bounded on a proximal end by a septum comprising an aperture, said penetrable seal being penetrable by a pipette tip or needle;
b) a flexible sampling rod comprising a proximal portion and a distal portion, said sampling rod adapted to fit through and seal said aperture when said distal portion is in said sample collection chamber, wherein said distal portion comprises:
i) an asymmetrical beveled tip at a distal end, said beveled tip having an apex at the circumference of the flexible sampling rod and configured to bend the flexible sampling rod away from collisions and/or to deflect collisions with an inserted pipette tip or needle; and
ii) a plurality of metering ridges; and
c) a solution in said sample collection chamber for preserving a suspended sample.

### Claim 2 (depends on 1)

The device of claim 1 wherein said solution comprises Tris buffer, bovine serum albumen, polysorbate 20, sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin.

### Claim 3 (depends on 1)

The device of claim 1 comprising a plurality of stacked coaxial frusta cones to form said plurality of metering ridges.

### Claim 4 (depends on 1)

The device of claim 1 wherein a cap is attached to said proximal end of said sampling rod, wherein said cap is configured to engage a proximal end of said body.

### Claim 5 (depends on 4)

The device of claim 4 wherein said cap and said proximal end of said body have mated threads for securing said cap to said body.

### Claim 6 (depends on 1)

The device of claim 1 wherein said aperture has a radius, and wherein said distal portion of said sampling rod has a radius approximately the same as said radius of said aperture and said proximal portion of said sampling rod has a radius larger than said radius of said aperture.

### Claim 7 (depends on 6)

The device of claim 6 wherein a junction between said distal portion of said sampling rod and said proximal portion of said sampling rod forms a stopper that seals said aperture when said distal portion of said sampling rod is fully inserted through said aperture.

### Claim 8 (depends on 7)

The device of claim 7 wherein said aperture when sealed is configured to hold 30 psi when the device is internally pressurized with air.

### Claim 9 (depends on 1)

The device of claim 1 wherein said sampling rod and said aperture are configured such that insertion of said sampling rod through the aperture removes excess sample from said distal portion of said sampling rod and leaves a metered sample in said metering ridges.

### Claim 10 (depends on 1)

The device of claim 1 wherein said penetrable seal is made from a foil.

### Claim 11 (depends on 1)

The device of claim 1 wherein said penetrable seal is configured to hold a pressure of 30 psi when said device is internally pressurized with air.

### Claim 12 (depends on 10)

The device of claim 10 wherein said foil has a thickness of approximately 0.001 inches.

### Claim 13 (depends on 1)

The device of claim 1 wherein said penetrable seal comprises a foil layer and a polyester layer.

### Claim 14 (depends on 13)

The device of claim 13 wherein said foil layer is 0.001 inch thick and said polyester layer is 0.005 inch thick.

### Claim 15 (depends on 1)

The device of claim 1 wherein said body further comprises a recessed sealing surface, wherein said penetrable seal is affixed to said sealing surface.

### Claim 16 (depends on 15)

The device of claim 15, wherein said recessed sealing surface is recessed 0.125 inches with respect to a distal end of said body.

### Claim 17 (depends on 1)

The device of claim 1 further comprising a protective cap adapted to fit on a distal end of said body, wherein said cap covers said penetrable seal.

### Claim 18 (depends on 1)

The device of claim 1 wherein said penetrable seal is made from a material selected from the group consisting of paper, rubber, wax, and plastic.

### Claim 19 (depends on 1)

The device of claim 1, wherein said body is made from a material selected from the group consisting of polypropylene, polyethylene, polystyrene, and polytetrafluoroethylene.

### Claim 20 (depends on 1)

The device of claim 1 wherein said sample collection chamber has a volume of approximately 1-5 milliliters.

### Claim 21 (depends on 1)

The device of claim 1 wherein said at least one metering ridge retains a sample of approximately 20 milligrams of a fecal sample.

### Claim 22 (depends on 1)

The device of claim 1 wherein when said sampling rod is fully inserted through said aperture in said septum, at least one metering ridge remains in contact with said solution regardless of the orientation of the device.

### Claim 23 (depends on 1)

The device of claim 1 wherein said solution has a volume of approximately 2 milliliters.

### Claim 24 (depends on 1)

The device of claim 1, wherein said solution is a fecal sample solution comprising approximately 20 mM Tris (pH 7.4), 10% bovine serum albumen, 0.10% Tween-20, 0.095% sodium azide, 140 mM sodium chloride, 10 mM EDTA, and 15 μg/ml gentamicin.

### Claim 25

A system for collecting a sample, the system comprising:
a) a sample collection chamber holding a solution comprising components for preserving a suspended sample;
b) a penetrable seal for sealing said chamber on an end, and configured to allow access to said chamber by penetrating said penetrable seal with a pipette tip or needle;
b) a flexible sampling rod for contacting a sample and acquiring a portion of said sample, said flexible sampling rod comprising an asymmetrical beveled tip having an apex at the circumference of the flexible sampling rod and configured to bend the flexible sampling rod away from collisions and/or to deflect collisions with an inserted pipette tip or needle
c) a plurality of metering ridges for providing into said chamber a defined volume of said acquired portion of the sample.

### Claim 26 (depends on 25)

The system of claim 25, wherein said solution comprises Tris buffer, bovine serum albumen, polysorbate 20, sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin.

### Claim 27 (depends on 26)

The system of claim 26, wherein said solution is a fecal sample solution that comprises approximately 20 mM Tris (pH 7.4), 10% bovine serum albumen, 0.10% polysorbate 20, 0.095% sodium azide, 140 mM sodium chloride, 10 mM ethylenediaminetetraacetic acid, and 15 μg/ml gentamicin.

### Claim 28 (depends on 1)

A kit for collecting a sample, the kit comprising:
a) the device of claim 1; and
b) an instruction for use.

### Claim 29 (depends on 28)

The kit of claim 28 further comprising a package in which to mail said device containing a collected sample.