# US 11,026,611 B2 · Rotatable disk-shaped fluid sample collection device

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- Number: US 11,026,611 B2
- Document ID: US11026611B2
- Status: Granted
- Kind: B2
- Application number: 15/686,241
- Filed: 2017-08-25
- Published: 2017-12-07
- Granted: 2021-06-08
- Earliest claimed: 2013-03-15
- Assignees: Ortho-Clinical Diagnostics, Inc.
- Applicants: Ortho-Clinical Diagnostics, Inc.
- Inventors: Kory A. Gunnerson; Raymond F. Jakubowicz; Andrew M. Kirsch; James Ellis Robinson; Daniel P. Salotto; David A. Tomasso; Zhong Ding; William Franklin Gottermeier; Aaron Michael Swick
- Web page: https://patentgrep.com/patent/US11026611B2

## CPC

- A61B 5/150343: {Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045)}
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/1468: using chemical or electrochemical methods, e.g. by polarographic means
- A61B 5/150213: {Venting means}
- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- A61B 10/007: {for taking urine samples (measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006)}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)}
- B01L 2200/025: Align devices or objects to ensure defined positions relative to each other
- B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles
- B01L 2300/0681: Filter
- B01L 2300/087: Multiple sequential chambers
- B01L 2300/161: Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
- B01L 2400/0406: capillary forces
- B01L 2400/0487: fluid pressure, pneumatics
- B01L 2400/0644: rotary valves
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- 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)

## Abstract

A sample collection device for a fluid includes: a substantially disk-shaped body having a periphery; a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

## Claims

### Claim 1

A sample collection device for a fluid sample, the device comprising:
a substantially disk-shaped body having a periphery, the body being made from a two part construction comprising a top piece and a bottom piece, the top piece being a hydrophilic tape;
a capillary channel extending through the body, bounded by the periphery, and including a portion that is at least semi-circular, the capillary channel having a first end and a second end, the first end being formed at the periphery of the disk-shaped body, wherein the first end is adapted to draw the fluid sample into the capillary channel by capillary action;
a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel;
an opening in the hydrophilic tape, the opening in fluid communication with the sample collection well to enable at least one of: (i) the fluid sample to be added to the sample collection well via the opening, or (ii) air pressure to be applied via the opening to move the fluid sample in a direction away from the sample collection well towards the first end of the capillary channel; and
an axis of rotation extending through the center of the disk-shaped body and which is substantially perpendicular to a major surface of the disk-shaped body, and wherein the at least semi-circular portion of the capillary channel includes a straight portion extending radially inward from the first end of the capillary channel and ending at the second end of the capillary channel whereby the semi-circular portion substantially surrounds the axis of rotation extending through the center of the disk-shaped body.

### Claim 2 (depends on 1)

The sample collection device as claimed in claim 1, wherein the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk-shaped body is rotated to a first position.

### Claim 3 (depends on 2)

The sample collection device as claimed in claim 2, wherein the air vent is located in the vicinity of and in fluid communication with the second end of the capillary channel when the disk-shaped body is rotated to the first position.

### Claim 4 (depends on 1)

The sample collection device as claimed in claim 1, wherein an opening of the first end is located on a side surface of the bottom piece of the disk-shaped body and the sample collection well is located on a top surface of the bottom piece of the disk-shaped body.

### Claim 5 (depends on 1)

The sample collection device as claimed in claim 1, wherein the capillary channel is non-linear.

### Claim 6 (depends on 5)

The sample collection device as claimed in claim 5, wherein the capillary channel has a semi-circular shape.

### Claim 7 (depends on 6)

The sample collection device as claimed in claim 6, wherein the capillary channel has a staff shape including a straight portion extending from the first end of the channel and a staff shaped portion extending to the second end.

### Claim 8 (depends on 1)

The sample collection device as claimed in claim 1, wherein the first end of the capillary channel is hydrophilic.

### Claim 9 (depends on 8)

The sample collection device as claimed in claim 8, wherein the first end of the capillary channel is provided with a hydrophilic coating.

### Claim 10

A working element comprising:
a sample collection device comprising: a substantially disk-shaped body having a periphery, the body being made from a two part construction comprising a top piece and a bottom piece, the top piece being a hydrophilic tape; a capillary channel extending through the body, bounded by the periphery, and including a portion that is at least semi-circular, the capillary channel having a first end and a second end, the first end being formed at the periphery of the disk-shaped body, wherein the first end is adapted to draw the fluid sample into the capillary channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; an opening in the hydrophilic tape, the opening in fluid communication with the sample collection well to enable at least one of: (i) the fluid sample to be added to the sample collection well via the opening, or (ii) air pressure to be applied via the opening to move the fluid sample in a direction away from the sample collection well towards the first end of the capillary channel; and an axis of rotation extending through the center of the disk-shaped body and which is substantially perpendicular to a major surface of the disk-shaped body, and wherein the at least semi-circular portion of the capillary channel includes a straight portion extending radially inward from the first end of the capillary channel and ending at the second end of the capillary channel whereby the semi-circular portion substantially surrounds the axis of rotation extending through the center of the disk-shaped body; and
a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk-shaped body is rotated to a first position, and containing a sample manipulation device, wherein the sample collection device is rotatably positioned within the cartridge housing and at least a portion of a side and a top surface of the disk-shaped body are exposed for application of sample.

### Claim 11 (depends on 10)

The working element as claimed in claim 10, wherein the air vent is located in the vicinity of and in fluid communication with the second end of the capillary channel when the disk-shaped body is rotated to the first position.

### Claim 12 (depends on 10)

The working element as claimed in claim 10, wherein the sample manipulation device includes a pre-manipulation portion.

### Claim 13 (depends on 10)

The working element as claimed in claim 10, wherein the sample manipulation device is an analytical chamber having an analytical reagent thereon.

### Claim 14 (depends on 13)

The working element as claimed in claim 13, wherein the analytical chamber is a lateral flow assay device.

### Claim 15 (depends on 10)

The working element as claimed in claim 10, wherein the sample collection device is located at a first end of the cartridge housing and the portion of the side and top surface are exposed at the first end of the cartridge housing.

### Claim 16 (depends on 15)

The working element as claimed in claim 15, wherein the sample collection device protrudes from the first end of the cartridge housing.

### Claim 17 (depends on 15)

A working element as claimed in claim 15, wherein the sample collection device is fully contained within the cartridge housing and a portion of the cartridge housing is recessed from the first end to form a notch exposing the side and top surface of the disk-shaped body.

### Claim 18 (depends on 15)

A working element as claimed in claim 15, wherein when the sample collection device is rotated about the axis of rotation to a second position, the first end of the capillary channel is exposed at the first end of the cartridge housing.

### Claim 19 (depends on 15)

A working element as claimed in claim 15, wherein when the sample collection device is rotated about the axis of rotation to a third position, the second end of the capillary channel is exposed at the first end of the cartridge housing.

### Claim 20 (depends on 10)

A working element as claimed in claim 10, wherein when the disk-shaped body is rotated about the axis of rotation to the first position, the first end of the capillary channel is in communication with the sample manipulation device.

### Claim 21 (depends on 20)

A working element as claimed in claim 20, wherein the air vent is adapted to be connected to a source of air pressure to force sample from the capillary channel through the first end of the capillary channel and into the sample manipulation device.

### Claim 22 (depends on 1)

The sample collection device as claimed in claim 1, wherein the second end is rotatable from a contained position below the top piece to a dispense position where the second end is aligned with a vent or port.

### Claim 23 (depends on 1)

The sample collection device as claimed in claim 1, wherein the portion that is at least semi-circular reduces the distance between the first end and the second end.
