Biological fluid sampling transfer device and biological fluid separation and testing system

Patent metadata

Field	Value
Publication number	US-9380973-B2
Application number	US-201414251720-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 biological fluid sampling transfer device that is adapted to receive and separate a multi-component blood sample is disclosed. After separation, the biological fluid sampling transfer device is able to transfer a plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device of the present disclosure 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 an anticoagulant. 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 sampling transfer device adapted to receive a multi-component blood sample, the biological fluid sampling transfer device comprising:
a housing having an inlet port and an outlet port, the inlet port and the outlet port in fluid communication;
a filter disposed between the inlet port and the outlet port, the filter restrains at least a first part of the multi-component blood sample, and allows at least a second part of the multi-component blood sample to pass therethrough;
a compression element disposed between the inlet port and the outlet port, the compression element spaced from the filter; and
a holding element movable within the housing between a first position, in which the holding element receives the second part of the multi-component blood sample from the filter, and a second position, in which the compression element contacts a portion of the holding element to direct the second part of the multi-component blood sample from the holding element to the outlet port.

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

3. The biological fluid sampling transfer device of claim 1 , wherein the compression element provides a force to the holding element to expel the second part of the multi-component blood sample therefrom.

4. The biological fluid sampling transfer device of claim 1 , wherein the compression element comprises a pair of rollers that squeeze the second part of the multi-component blood sample from the holding element.

5. The biological fluid sampling transfer device of claim 1 , wherein the filter comprises a lateral flow membrane.

6. The biological fluid sampling transfer device of claim 1 , further comprising a sample stabilizer disposed between the filter and the inlet port.

7. The biological fluid sampling transfer device of claim 1 , wherein the holding element comprises a wicking membrane.

8. The biological fluid sampling transfer device of claim 1 , further comprising a vent element disposed within the housing, the vent element in communication with the inlet port.

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

10. The biological fluid sampling transfer device of claim 1 , wherein the outlet port is connectable to a point-of-care testing device for closed transfer of a portion of the second part of the multi-component blood sample from the biological fluid sampling transfer device to the point-of-care testing device via the outlet port.

11. 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 an outlet port, the inlet port and the outlet port in fluid communication;
a filter disposed between the inlet port and the outlet port, the filter restrains at least a first part of the multi-component blood sample, and allows at least a second part of the multi-component blood sample to pass therethrough;
a compression element disposed between the inlet port and the outlet port, the compression element spaced from the filter; and
a holding element movable within the housing between a first position, in which the holding element receives the second part of the multi-component blood sample from the filter, and a second position, in which the compression element contacts a portion of the holding element to direct the second part of the multi-component blood sample from the holding element to the outlet port; and

a blood testing device having a receiving port engageable with the outlet port of the housing of the biological fluid sampling transfer device for closed transfer of a portion of the second part of the multi-component blood sample from the biological fluid sampling transfer device to the blood testing device via the outlet port.

12. The biological fluid separation and testing system of claim 11 , wherein the first part of the multi-component blood sample is a cellular component and the second part of the multi-component blood sample is a plasma component.

13. The biological fluid separation and testing system of claim 11 , wherein the blood testing device comprises a point-of-care testing device.

14. The biological fluid separation and testing system of claim 11 , wherein the compression element provides a force to the holding element to expel the second part of the multi-component blood sample therefrom.

15. The biological fluid separation and testing system of claim 11 , wherein the compression element comprises a pair of rollers that squeeze the second part of the multi-component blood sample from the holding element.

16. The biological fluid separation and testing system of claim 11 , wherein the filter comprises a lateral flow membrane.

17. The biological fluid separation and testing system of claim 11 , further comprising a sample stabilizer disposed between the filter and the inlet port.

18. The biological fluid separation and testing system of claim 11 , wherein the holding element comprises a wicking membrane.

19. The biological fluid separation and testing system of claim 11 , further comprising a vent element disposed within the housing, the vent element in communication with the inlet port.

20. The biological fluid separation and testing system of claim 11 , wherein the outlet port includes a septum transitionable between a closed position and an open position.

21. The biological fluid separation and testing system of claim 11 , wherein the filter comprises a fibrous membrane.

Assignees

• Becton Dickinson Co

Inventors

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

Classifications

• G01N1/34

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

• A61B5/150022

  for capillary blood or interstitial fluid · CPC title

• A61B5/150435

  Specific design of proximal end · CPC title

• B01L2400/0478

  pistons · CPC title

• A61B5/15101

  Details · CPC title