Biological fluid collection device and biological fluid separation and testing system

• US 9,597,028 B2
• Filed: 04/14/2014
• Issued: 03/21/2017
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Marchiarullo, Daniel J., Rothenberg, Ashley Rachel, Wilkinson, Bradley M.
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US14/251,705
• Publication Number:
  US 20140308165A1
• Time in Patent Office: 1,072 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150778 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15101 Details
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15198 purely manually retracted
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 : Regulation parameters
• CPC Class Codes: B01L 2200/0631 : Purification arrangements, e.g. solid phase extraction [SPE]
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0681 : Filter
• CPC Class Codes: B01L 2400/0478 : pistons
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5021 : Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04
• CPC Class Codes: B04B 7/08 : Rotary bowls centrifugal casting machines B22D
• CPC Class Codes: G01N 1/28 : Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Qmounting specimens on microscopic slides G02B21/34; means for supporting the objects or the materials to be analysed in electron microscopes H01J37/20 ; laboratory gas handling apparatus B01L5/00
• CPC Class Codes: G01N 1/34 : Purifying; Cleaning processes or apparatus for extracting or separating nucleic acids from biological samples C12N15/1003
• CPC Class Codes: G01N 1/4005 : by transferring a selected component through a membrane
• CPC Class Codes: G01N 1/4077 : by other techniques involving separation of suspended solids
• CPC Class Codes: G01N 2001/4016 : being a selective membrane, e.g. dialysis or osmosis
• CPC Class Codes: G01N 2001/4088 : filtration
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence

Abstract

A biological fluid collection device that is adapted to receive a multi-component blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to separate the plasma portion from the cellular portion. After separation, the biological fluid collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid collection 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 an anticoagulant. The biological fluid collection device is engageable with a testing device for closed transfer of a portion of the plasma portion from the biological fluid collection device to the testing device. The testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

Claims

1. A biological fluid collection device for a multi-component blood sample, comprising:

a housing having an inlet port, an outlet port, a first flow channel defined within the housing and in fluid communication with the inlet port, and a second flow channel defined within the housing and in fluid communication with the outlet port;

a valve disposed between the first flow channel and the second flow channel and transitionable between a closed position and an open position, wherein with the valve in the closed position, the first flow channel is in fluid isolation from the second flow channel, and wherein with the valve in the open position, the first flow channel is in fluid communication with the second flow channel; and

an actuation member in communication with the inlet port and transitionable from an initial position in which a portion of the actuation member is disposed within the housing in a first position, to an activated position in which the same portion of the actuation member is displaced from the first position within the housing, the actuation member being provided on an opposing end of the housing from the inlet port,

wherein the second flow channel comprises a collection chamber having a separation member disposed therein and a blood component chamber in communication with the separation member.

2. The biological fluid collection device of claim 1, wherein the inlet port receives the multi-component blood sample.

3. The biological fluid collection device of claim 2, wherein the multi-component blood sample comprises a cellular portion and a plasma portion.

4. The biological fluid collection device of claim 3, wherein the separation member allows the plasma portion to pass through the separation member and into the blood component chamber.

5. The biological fluid collection device of claim 1, wherein the separation member is a lateral flow filter.

6. The biological fluid collection device of claim 2, wherein, with the actuation member in the activated position, the multi-component blood sample is drawn into the first flow channel of the housing through the inlet port.

7. The biological fluid collection device of claim 6, wherein the actuation member comprises a plunger.

8. The biological fluid collection device of claim 2, further comprising a drive element in communication with the inlet port, the drive element adapted to assist the flow of the multi-component blood sample within the inlet port.

9. The biological fluid collection device of claim 8, wherein the drive element comprises an acoustic driver.

10. The biological fluid collection device of claim 1, wherein the first flow channel comprises a sample stabilizer.

11. The biological fluid collection device of claim 1, wherein the first flow channel includes at least one agitation member.

12. The biological fluid collection device of claim 1, wherein the first flow channel includes at least one agitation flute therein and wherein the at least one agitation flute has at least one sample stabilizer coated thereon.

13. The biological fluid collection device of claim 1, wherein the first flow channel comprises a sample stabilizer, and wherein the inlet port receives the multi-component blood sample and the valve is transitionable from the closed position to the open position subsequent to mixing of the multi-component blood sample within the first flow channel.

14. The biological fluid collection device of claim 1, wherein the outlet port is in communication with the blood component chamber.

15. The biological fluid collection device of claim 1, wherein the inlet port receives the multi-component blood sample having a cellular portion and a plasma portion, and wherein the outlet port is connectable to a point-of-care testing device for closed transfer of at least a portion of the plasma portion from the blood component chamber to the point-of-care testing device.

16. The biological fluid collection device of claim 1, wherein the valve comprises a rotatable stop-cock.

17. The biological fluid collection device of claim 1, wherein the actuation member is integral to the biological fluid collection device.

18. The biological fluid collection device of claim 1, wherein the housing includes a first end, a second end, and a side portion, the first end opposite the second end,

wherein the inlet port extends from the first end,

wherein the actuation member extends from the second end, and

wherein the outlet port extends from the side portion in a direction substantially perpendicular to the first end and the second end.

19. A multi-component biological fluid sample separation and testing system, comprising:

a biological fluid collection and separation device comprising;

a housing having an inlet port, an outlet port, a first flow channel defined within the housing and in fluid communication with the inlet port, and a second flow channel defined within the housing and in fluid communication with the outlet port, the inlet port receives a multi-component blood sample;

a valve disposed between the first flow channel and the second flow channel and transitionable between a closed position and an open position, wherein with the valve in the closed position, the first flow channel is in fluid isolation from the second flow channel, and wherein with the valve in the open position, the first flow channel is in fluid communication with the second flow channel; and

an actuation member in communication with the inlet port and transitionable from an initial position in which a portion of the actuation member is disposed within the housing in a first position, to an activated position in which the same portion of the actuation member is displaced from the first position within the housing, the actuation member being provided on an opposing end of the housing from the inlet port,

wherein the second flow channel comprises a collection chamber having a separation member disposed therein and a blood component chamber in communication with the separation member; and

a testing device having a receiving port connectable to the outlet port of the biological fluid collection and separation device for closed transfer of a portion of the multi-component blood sample from the blood component chamber to the testing device.

20. The multi-component biological fluid sample separation and testing system of claim 19, wherein the testing device comprises a point-of-care testing device.

21. The multi-component biological fluid sample separation and testing system of claim 19, wherein the multi-component blood sample includes a cellular portion and a plasma portion.

22. The multi-component biological fluid sample separation and testing system of claim 21, wherein the separation member allows the plasma portion to pass through the separation member and into the blood component chamber.

23. The multi-component biological fluid sample separation and testing system of claim 19, wherein the separation member is a lateral flow filter.

24. The multi-component biological fluid sample separation and testing system of claim 19, wherein the first flow channel includes at least one sample stabilizer.

25. The multi-component biological fluid sample separation and testing system of claim 19, wherein the first flow channel includes at least one agitation member located therein.

26. The multi-component biological fluid sample separation and testing system of claim 19, wherein the actuation member is integral to the biological fluid collection and separation device.

27. The multi-component biological fluid sample separation and testing system of claim 19, wherein the housing includes a first end, a second end, and a side portion, the first end opposite the second end,

wherein the inlet port extends from the first end,

wherein the actuation member extends from the second end, and

wherein the outlet port extends from the side portion in a direction substantially perpendicular to the first end and the second end.