# US 12,005,438 B2 · Sample collection apparatus and uses thereof

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- Number: US 12,005,438 B2
- Document ID: US12005438B2
- Status: Granted
- Kind: B2
- Application number: 17/474,185
- Filed: 2021-09-14
- Published: 2022-03-17
- Granted: 2024-06-11
- Earliest claimed: 2020-09-15
- Assignees: Norgen Biotek Corp.
- Applicants: Norgen Biotek Corp.
- Inventors: Yousef Haj-Ahmad
- Web page: https://patentgrep.com/patent/US12005438B2

## CPC

- A61B 10/0096: {Casings for storing test samples (A61B10/0038, A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/10; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30)}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- A61B 10/0038: {Devices for taking faeces samples; Faecal examination devices (anal receptacles A61F5/451)}
- A61B 10/0045: {Devices for taking samples of body liquids}
- A61B 10/0051: {for taking saliva or sputum samples (devices for receiving spittle A61J9/00)}
- B01L 2200/025: Align devices or objects to ensure defined positions relative to each other
- B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details
- B01L 2200/0689: Sealing
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/042: Caps; Plugs
- B01L 2300/044: pierceable, e.g. films, membranes
- B01L 2300/046: Function or devices integrated in the closure
- B01L 2300/0672: Integrated piercing tool
- B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

An apparatus for collecting and combining a sample, and in particular, a biological sample, with a reagent, and uses thereof. The apparatus comprises a sample collection container and a complementary sealing cap. A sealed reagent reservoir containing a reagent, such as a preservative reagent, is provided in a lower portion of the collection container. A piercing insert is nested within the collection container, above the seal of the reagent reservoir. Following the collection of the sample into the collection container, the action of sealing the collection container with the cap causes the piercing insert to engage with and disrupt the seal on the reagent reservoir, thereby exposing the collected sample to the reagent.

## Claims

### Claim 1

An apparatus for collecting and combining a sample with a reagent, the apparatus comprising:
a container comprising an upper portion defining an opening for receiving the sample a closed, lower portion comprising a cavity for containing the sample and a reservoir containing a reagent, the reservoir comprising a pierceable membrane;
a cap, the cap and upper portion of the container each comprising complementary threads configured to removably engage the cap with the container to form a seal, the cap further comprising first engagement means, wherein the first engagements means comprises a first plurality of teeth; and
an insert configured to nest within the container, the insert comprising an upper portion defining an upper opening, the upper portion of the insert comprising second engagement means complementary to the first engagement means, wherein the second engagement means comprises a second plurality of teeth and wherein the first plurality of teeth are configured to engage with the second plurality of teeth; and
a lower portion defining a lower opening, the lower portion comprising one or more piercing elements; the insert being open and configured to permit the sample to flow unobstructed through the insert;
the insert being movable from a first position to a second position within the container, wherein when the insert is in the first position, the one or more piercing elements are located above the pierceable membrane; and
wherein when said apparatus is sealed by twisting the cap onto the container and engaging the complementary threads, the first plurality of teeth of the first engagement means engage with the second plurality of teeth of the second engagement means causing the insert to rotate and move downward within the container from the first position to the second position, whereby the one or more piercing elements disrupt the pierceable membrane to allow fluid communication between the cavity and the reservoir.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the cap comprises a top portion and a skirt, the complementary threads comprise internal threads on the skirt configured to engage with external threads provided on the upper portion of the container to removably engage the container with the cap when the internal threads are screwed onto the external threads.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the first engagement means extend from an underside portion of the cap into an interior of the cap.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the lower portion of the insert comprises a plurality of piercing elements and a lower peripheral edge of the insert comprises a serrated edge.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the insert further comprises an annular groove defined on an exterior surface of the insert, and the container comprises a peripheral retaining lip extending from an interior surface of the upper portion of the container, wherein the retaining lip is configured to be received within the annular groove of the insert.

### Claim 6 (depends on 1)

The apparatus of claim 1, further comprising a funnel configured to be placed over or be received within the upper portion of the container, wherein the funnel has an upper open end for receiving a sample and a lower open end in fluid communication with the container.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the container is a tube.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the tube comprises a false bottom extending from the lower portion of the tube.

### Claim 9 (depends on 1)

The apparatus of claim 1, wherein the reagent is a preservative reagent.

### Claim 10 (depends on 9)

The apparatus of claim 9, wherein the preservative reagent is a DNA preservative reagent and/or an RNA preservative reagent.

### Claim 11 (depends on 1)

The apparatus of claim 1, wherein the reservoir comprises a capsule, the capsule comprising a cavity for containing a reagent and an opening which is sealed with the pierceable membrane, and wherein the capsule is configured to be received in the lower portion of the container.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein the capsule comprises a skirt extending from a peripheral edge of the capsule and the container comprises a first peripheral retaining lip extending from an interior surface of the lower portion of container, wherein the skirt of the capsule is configured to abut the first peripheral retaining lip.

### Claim 13 (depends on 12)

The apparatus of claim 12, wherein the capsule further comprises an annular groove defined on an exterior surface of the capsule, and the container comprises a second peripheral retaining lip extending from an interior surface of the lower portion of the container, wherein the second peripheral retaining lip is configured to be received within the annular groove of the capsule.

### Claim 14 (depends on 1)

A method for collecting and combining a sample with a reagent, the method comprising:
providing the apparatus of claim 1;
adding a sample into the container; and
closing said container by removably engaging the cap with the container, whereby said insert is moved downward within the container from the first position to the second position, disrupting the pierceable membrane to expose the sample to the reagent.

### Claim 15 (depends on 14)

The method of claim 14, wherein the sample is a biological sample.

### Claim 16 (depends on 15)

The method of claim 15, wherein the biological sample is a liquid biological sample, which is a blood, plasma, serum, urine, fecal matter, tears, sweat, saliva, breast milk, amniotic fluid, seminal fluid, cerebral spinal fluid, or colostrum sample.

### Claim 17 (depends on 15)

The method of claim 15, wherein the biological sample is a solid biological sample, which is a tissue sample or a stool sample.

### Claim 18 (depends on 14)

The method of claim 14, wherein the pierceable membrane of the reservoir is substantially removed from the reservoir by the one or more piercing elements.

### Claim 19 (depends on 18)

The method of claim 18, wherein the reagent is a preservative reagent.

### Claim 20 (depends on 19)

The method of claim 19, wherein the preservative reagent is a DNA preservative reagent and/or an RNA preservative reagent.

### Claim 21 (depends on 1)

A kit for collecting and combining a sample with a reagent, the kit comprising: the apparatus of claim 1; and instructions for the use thereof.

### Claim 22 (depends on 21)

The kit of claim 21, wherein the reagent is a DNA preservative reagent and/or an RNA preservative reagent and wherein the kit further comprises a funnel for collecting a saliva sample.

### Claim 23 (depends on 21)

The kit of claim 21, wherein the reagent is a DNA preservative reagent and/or an RNA preservative reagent and wherein the kit further comprises a stool sample collecting device, wherein the stool collecting device is a spoon or a spatula.