Biological fluid transfer device and biological fluid sampling system

• US 10,342,471 B2
• Filed: 04/14/2014
• Issued: 07/09/2019
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Wilkinson, Bradley M., Marchiarullo, Daniel J., Fletcher, Gary D.
• Primary Examiner(s): Jarrett, Lore R
• Application Number:
  US14/251,681
• Publication Number:
  US 20140308164A1
• Time in Patent Office: 1,912 Days
• 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 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.

Claims

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 fluid separation and testing system of claim 20, 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.