Biological fluid collection device and biological fluid separation and testing system

• US 10,080,516 B2
• Filed: 04/14/2014
• Issued: 09/25/2018
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ellis, Robert G., Wilkinson, Bradley M.
• Primary Examiner(s): Le, Son
• Assistant Examiner(s): Eyassu, Marrit
• Application Number:
  US14/251,686
• Publication Number:
  US 20140305196A1
• Time in Patent Office: 1,625 Days
• Field of Search: 73 6456, 21032172
• 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: A61M 1/36 : Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• 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 blood sample having a cellular portion and a plasma portion is disclosed. After collection of the blood sample, the plasma portion is separated 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 a sample stabilizer. The biological fluid collection device is engageable with a biological fluid testing device for closed transfer of a portion of the plasma portion from the biological fluid collection device to the biological fluid testing device. The biological fluid testing device is adapted to receive the plasma portion to analyze the blood sample.

Claims

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

a housing defining a first chamber having a first chamber inlet and a first chamber outlet, a second chamber having a second chamber inlet and a second chamber outlet, and including a separation member disposed between the first chamber outlet and the second chamber inlet, wherein the first chamber outlet is in communication with the second chamber inlet via the separation member, wherein the first chamber receives the multi-component blood sample;

an actuator member comprising a plunger rod and a piston including a valve,

wherein at least a portion of the piston is located within the housing and movement of the actuator member in a first direction draws a component of the multi-component blood sample from the first chamber through the separation member to the second chamber,

wherein the valve transitions between a closed position in which the second chamber is fully sealed and an open position in which the second chamber is open.

2. The biological fluid collection device of claim 1, wherein the separation member allows the component to pass through the separation member to the second chamber.

3. The biological fluid collection device of claim 2, wherein the component is a plasma component.

4. The biological fluid collection device of claim 1, further comprising a septum engaged with the housing to seal the first chamber inlet of the first chamber.

5. The biological fluid collection device of claim 1, wherein the valve engages a receiving port of a testing device for closed transfer of at least a portion of the component from the second chamber to the testing device.

6. The biological fluid collection device of claim 5, wherein the component is a plasma component.

7. The biological fluid collection device of claim 5, wherein the valve transitions from the closed position to the open position via engagement with the receiving port of the testing device.

8. The biological fluid collection device of claim 5, wherein the testing device comprises a point-of-care testing device.

9. The biological fluid collection device of claim 1, wherein the valve is a spring-loaded dispensing valve.

10. The biological fluid collection device of claim 1, wherein the actuator member is disposable at least partially within a tubular member and wherein at least a portion of the actuator member is removably engaged with the housing.

11. The biological fluid collection device of claim 10, wherein the tubular member and at least a portion of the actuator member are removable from the housing after passage of at least a portion of the component from the first chamber into the second chamber.

12. The biological fluid collection device of claim 11, wherein the component is a plasma component.

13. The biological fluid collection device of claim 11, wherein transition of the valve from the closed position to the open position occurs after the tubular member and at least a portion of the actuator member are removed from the housing.

14. The biological fluid collection device of claim 1, wherein the housing includes a sample stabilizer.

15. A biological fluid sample separation and testing system for a multi-component blood sample, comprising:

a biological fluid collection and separation device comprising;

a housing defining a first chamber having a first chamber inlet and a first chamber outlet, a second chamber having a second chamber inlet and a second chamber outlet, and including a separation member disposed between the first chamber outlet and the second chamber inlet, wherein the first chamber is in communication with the second chamber inlet via the separation member, wherein the first chamber receives the multi-component blood sample; and

an actuator member comprising a plunger rod and a piston including a valve,

wherein at least a portion of the piston is located within the housing and movement of the actuator member in a first direction draws a component of the multi-component blood sample from the first chamber through the separation member to the second chamber,

wherein the valve transitions between a closed position in which the second chamber is fully sealed, and an open position in which the second chamber is open; and

a testing device having a receiving port adapted to engage the valve of the biological fluid collection and separation device, wherein the valve transitions from the closed position to the open position when the receiving port is engaged with the valve.

16. The biological fluid sample separation and testing system of claim 15, wherein the housing includes a tubular member removably engaged therewith and transition of the valve from the closed position to the open position occurs after the tubular member is removed from the housing.

17. The biological fluid sample separation and testing system of claim 15, wherein the separation member allows a component of the multi-component blood sample to pass through the separation member to the second chamber.

18. The biological fluid sample separation and testing system of claim 17, wherein the component is a plasma component.

19. The biological fluid sample separation and testing system of claim 15, further comprising a septum engaged with the housing to seal the first chamber inlet of the first chamber.

20. The biological fluid sample separation and testing system of claim 15, wherein the valve is engageable with the receiving port of the testing device for closed transfer of at least a portion of a component of the multi-component blood sample from the second chamber to the testing device.

21. The biological fluid sample separation and testing system of claim 20, wherein the component is a plasma component.

22. The biological fluid sample separation and testing system of claim 15, wherein the valve is a spring-loaded dispensing valve.

23. The biological fluid sample separation and testing system of claim 15, wherein the housing includes a tubular member which is removable from the housing after passage of at least a portion of a component of the multi-component blood sample from the first chamber into the second chamber.

24. The biological fluid sample separation and testing system of claim 23, wherein the component is a plasma component.

25. The biological fluid sample separation and testing system of claim 18, wherein actuation of the actuator member in a first direction draws a component of the multi-component blood sample from the first chamber through the separation member to the second chamber.

26. The biological fluid sample separation and testing system of claim 25, wherein the component is a plasma component.