Biological fluid collection device and biological fluid collection and testing system

Patent metadata

Field	Value
Publication number	US-9380972-B2
Application number	US-201414251682-A
Country	US
Kind code	B2
Filing date	Apr 14, 2014
Priority date	Apr 15, 2013
Publication date	Jul 5, 2016
Grant date	Jul 5, 2016

Abstract

A blood collection device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood collection device separates a plasma portion from a cellular portion. After separation, the blood collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood collection device of the present disclosure also provides a closed collection and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The blood collection device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood collection device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

First claim

What is claimed is:

1. A biological fluid collection device, comprising:
a housing having an inlet port, a transfer port, and a flow channel, the inlet port and the transfer port in fluid communication via the flow channel, the housing further defining a reservoir adjacent the transfer port and in fluid communication with the flow channel;
a puncturing element disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing and provides fluid communication with the flow channel;
a separation member disposed within the flow channel between the inlet port and the reservoir; and
a wicking element disposed within the flow channel between the inlet port and the separation member, wherein the wicking element comprises a sample stabilizer disposed therewith.

2. The biological fluid collection device of claim 1 , wherein the inlet port is adapted to receive a multi-component blood sample.

3. The biological fluid collection device of claim 2 , wherein the separation member is adapted to trap a first component of the multi-component blood sample and allow a second component of the multi-component blood sample to pass therethrough.

4. The biological fluid collection device of claim 2 , wherein the separation member is adapted to trap a cellular component of the multi-component blood sample and allow a plasma component of the multi-component blood sample to pass through the filter and into the reservoir.

5. The biological fluid collection device of claim 1 , wherein the wicking element surrounds at least a portion of the puncturing element.

6. The biological fluid collection device of claim 1 , wherein the housing includes an actuation mechanism in communication with the puncturing element.

7. The biological fluid collection device of claim 1 , wherein the transfer port includes a septum transitionable between a closed position and an open position.

8. The biological fluid collection device of claim 1 , wherein the separation member is one of a lateral flow filter and a tangential flow filter.

9. The biological fluid collection device of claim 1 , wherein the separation member comprises a sample stabilizer disposed therewith.

10. A biological fluid collection and testing system, comprising:
a biological fluid collection device adapted to receive a multi-component blood sample, the biological fluid collection device comprising:
a housing having an inlet port, a transfer port, and a flow channel, the inlet port and the transfer port in fluid communication via the flow channel, the housing further defining a reservoir adjacent the transfer port and in fluid communication with the flow channel,
a puncturing element disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing and provides fluid communication with the flow channel,
a separation member disposed within the flow channel between the inlet port and the reservoir, and
a wicking element disposed within the flow channel between the inlet port and the separation member, wherein the wicking element comprises a sample stabilizer disposed therewith; and

a blood testing device having a receiving port adapted to engage the transfer port of the biological fluid collection device for closed transfer of at least a portion of a component of the multi-component blood sample from the reservoir of the biological fluid collection device to the blood testing device.

11. The biological fluid collection and testing system of claim 10 , wherein the transfer port includes a septum transitionable between a closed position and an open position.

12. The biological fluid collection and testing system of claim 10 , wherein the housing includes an actuation mechanism in communication with the puncturing element.

13. The biological fluid collection and testing system of claim 10 , wherein the separation member is one of a lateral flow filter and a tangential flow filter.

14. The biological fluid collection and testing system of claim 10 , wherein the separation member comprises a sample stabilizer disposed therewith.

15. The biological fluid collection and testing system of claim 10 , wherein the blood testing device is a point-of-care testing device.

Assignees

• Becton Dickinson Co

Inventors

• Fletcher Gary D
• Rothenberg Ashley Rachel
• Gelfand Craig A
• Marchiarullo Daniel J
• Wilkinson Bradley M

Classifications

• A61B5/15144

  comprising driving means, e.g. a spring, for retracting the piercing unit into the housing · CPC title

• A61B5/150213 Primary

  Venting means · CPC title

• G01N33/491

  by separating the blood components (G01N15/05 takes precedence) · CPC title

• A61B5/150343

  Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045) · CPC title

• A61B5/150442

  Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin · CPC title