Biological fluid transfer device and biological fluid sampling system

Patent metadata

Field	Value
Publication number	US-10342471-B2
Application number	US-201414251681-A
Country	US
Kind code	B2
Filing date	Apr 14, 2014
Priority date	Apr 15, 2013
Publication date	Jul 9, 2019
Grant date	Jul 9, 2019

Abstract

A biological fluid sampling transfer device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid sampling transfer device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid sampling transfer 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 transfer device adapted to receive a multi-component blood sample, the biological fluid transfer device comprising:
a housing having an inlet port and a transfer port, the inlet port and the transfer port in fluid communication, wherein the transfer port includes a bellows and a septum transitionable between a closed position and an open position, wherein compression of the bellows actuates the septum from the closed position to the open position;
a mixing channel in fluid communication with the inlet port and the transfer port and shaped to promote mixing of the multi-component blood sample;
a porous blood separation element disposed in the mixing channel between the inlet port and the transfer port, the blood separation element adapted to restrain a first component of the multi-component blood sample and allow a second component of the multi-component blood sample to pass therethrough; and
a sample stabilizer, including an anticoagulant and/or a substance configured to preserve a specific element within the multi-component blood sample, disposed within the mixing channel and/or on the porous blood separation element.

2. The biological fluid transfer device of claim 1 , wherein the first component is a cellular portion of the multi-component blood sample and the second component is a plasma portion of the multi-component blood sample.

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

4. The biological fluid transfer device of claim 1 , wherein the inlet port is adapted to receive the multi-component blood sample via connection to a capillary device.

5. The biological fluid transfer device of claim 1 , wherein the inlet port is adapted to receive the multi-component blood sample via connection to a needle device.

6. The biological fluid transfer device of claim 1 , wherein the inlet port is adapted to receive the multi-component blood sample via connection to an intravenous line.

7. The biological fluid transfer device of claim 1 , further comprising a wicking membrane adapted to cause the multi-component blood sample to flow into the biological fluid transfer device.

8. The biological fluid transfer device of claim 1 , wherein the mixing channel comprises a sample stabilizer and the biological fluid transfer device is a plasma preparation cartridge.

9. A biological fluid sampling system, comprising:
a biological fluid transfer device adapted to receive a multi-component blood sample, the biological fluid transfer device comprising:
a housing having an inlet port and a transfer port, the inlet port and the transfer port in fluid communication, wherein the transfer port includes a bellows and a septum transitionable between a closed position and an open position, wherein compression of the bellows actuates the septum from the closed position to the open position;
a mixing channel in fluid communication with the inlet port and the transfer port and shaped to promote mixing of the blood sample;
a porous membrane disposed in the mixing channel between the inlet port and the transfer port, the membrane adapted to restrain a first component of the multi-component blood sample and allow a second component of the multi-component blood sample to pass therethrough; and
a sample stabilizer, including an anticoagulant and/or a substance configured to preserve a specific element within the multi-component blood sample, disposed within the mixing channel between the porous membrane and the inlet port;

a first interface removably connectable to the biological fluid transfer device, the first interface adapted for connection to a first biological fluid collection device;
a second interface removably connectable to the biological fluid transfer device, the second interface adapted for connection to a second biological fluid collection device; and
a packaging member having a compartment sized and adapted to receive the biological fluid transfer device, the first interface, and the second interface therein.

10. The biological fluid sampling system of claim 9 , wherein the first component is a cellular portion of the multi-component blood sample and the second component is a plasma portion of the multi-component blood sample.

11. The biological fluid sampling system of claim 9 , wherein with the first interface connected to the biological fluid transfer device, the inlet port is adapted to receive the multi-component blood sample via a blood collection set.

12. The biological fluid sampling system of claim 9 , wherein with the first interface connected to the biological fluid transfer device, the inlet port is adapted to receive the multi-component blood sample via an intravenous line.

13. The biological fluid sampling system of claim 9 , wherein with the second interface connected to the biological fluid transfer device, the inlet port is adapted to receive the multi-component blood sample via a capillary device.

14. The biological fluid sampling system of claim 9 , wherein the inlet port is adapted to receive the multi-component blood sample via connection to a needle device.

15. The biological fluid sampling system of claim 9 , wherein the biological fluid transfer device further comprises a wicking membrane adapted to cause the multi-component blood sample to flow into the biological fluid transfer device.

16. The biological fluid sampling system of claim 9 , wherein the mixing channel comprises a sample stabilizer and the biological fluid transfer device is a plasma preparation cartridge.

17. The biological fluid sampling system of claim 9 , wherein the first interface comprises a spinlock interface.

18. The biological fluid sampling system of claim 9 , wherein the second interface comprises a capillary interface.

19. The biological fluid sampling system of claim 9 , wherein the packaging member comprises a blister package.

20. A biological fluid separation and testing system for a multi-component blood sample, the biological fluid separation and testing system comprising:
a biological fluid sampling transfer device adapted to receive the multi-component blood sample, the biological fluid sampling transfer device comprising:
a housing having an inlet port and a transfer port, the inlet port and the transfer port in fluid communication, wherein the transfer port includes a bellows and a septum transitionable between a closed position and an open position, wherein compression of the bellows actuates the septum from the closed position to the open position;
a mixing channel in fluid communication with the inlet port and the transfer port and shaped to promote mixing of the blood sample;
a porous membrane disposed between the inlet port and the transfer port, the membrane adapted to restrain a first component of the multi-component blood sample and allow a second component of the multi-component blood sample to pass therethrough; and
a sample stabilizer, including an anticoagulant and/or a substance configured to preserve a specific element within the multi-component blood sample, disposed within the mixing channel and/or on the porous membrane; and

a blood testing device having a receiving port adapted to receive the transfer port of the biological fluid sampling transfer device for closed transfer of at least a portion of the second component from the biological fluid sampling transfer device to the blood testing device.

21. The biological

Assignees

• Becton Dickinson Co

Inventors

• Wilkinson Bradley M
• Marchiarullo Daniel J
• Fletcher Gary D

Classifications

• B04B7/08

  Rotary bowls (centrifugal casting machines B22D) · CPC title

• A61B5/150351

  Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel · CPC title

• A61B5/150221

  Valves · CPC title

• A61B5/15198

  purely manually retracted · CPC title

• G01N1/34

  Purifying; Cleaning {(processes or apparatus for extracting or separating nucleic acids from biological samples C12N15/1003)} · CPC title