Biological fluid separation device and biological fluid separation and testing system

• US 10,154,808 B2
• Filed: 04/14/2014
• Issued: 12/18/2018
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Fletcher, Gary D., Marchiarullo, Daniel J., Crawford, Jamieson W.
• Primary Examiner(s): West, Paul
• Assistant Examiner(s): Shabman, Mark A
• Application Number:
  US14/251,714
• Publication Number:
  US 20140305197A1
• Time in Patent Office: 1,709 Days
• Field of Search: 73 6456
• 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 blood separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood separation device is able to separate a plasma portion from a cellular portion. After separation, the blood separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood separation 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 blood separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood separation 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 separation device adapted to receive a multi-component blood sample, the biological fluid separation device comprising:

a housing having an inlet port, a flow channel, and an outlet port having a valve, the inlet port and the outlet port in fluid communication via the flow channel, wherein the valve comprises a deformable wall member defining an interior space and transitionable between an extended position and a compressed position and a barrier disposed within the interior space of the deformable wall member, the barrier is reversibly transitionable between a closed position and an open position, and the barrier is transitioned from the closed position to the open position as the deformable wall member is transitioned from the extended position to the compressed position;

a separation member disposed within the flow channel between the inlet port and the outlet port;

a first reservoir defined within the flow channel between the inlet port and the separation member; and

a second reservoir defined within the flow channel between the separation member and the outlet port, wherein the separation member is adapted to trap a first portion of the multi-component blood sample within the first reservoir and to allow a second portion of the multi-component blood sample to pass through the separation member and into the second reservoir.

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

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

4. The biological fluid separation device of claim 1, wherein the separation member comprises a tangential flow filter.

5. The biological fluid separation device of claim 4, wherein the tangential flow filter utilizes a cross-flow filtration to separate the first portion from the second portion.

6. The biological fluid separation device of claim 4, further comprising an acoustic focus element disposed within the housing.

7. The biological fluid separation device of claim 1, wherein the outlet port is adapted for connection to a point-of-care testing device for closed transfer of at least a portion of the second portion from the second reservoir to the point-of-care testing device via the outlet port.

8. The biological fluid separation device of claim 1, further comprising a one-way valve disposed within the flow channel.

9. The biological fluid separation device of claim 8, further comprising a pump in fluid communication with the flow channel for advancing the multi-component blood sample received within the flow channel through the one-way valve.

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

a biological fluid separation device adapted to receive the blood sample, the biological fluid separation device comprising;

a housing having an inlet port, a flow channel, and an outlet port having a valve, the inlet port and the outlet port in fluid communication via the flow channel, wherein the valve comprises a deformable wall member defining an interior space and transitionable between an extended position and a compressed position and a barrier disposed within the interior space of the deformable wall member, the barrier is reversibly transitionable between a closed position and an open position, and the barrier is transitioned from the closed position to the open position as the deformable wall member is transitioned from the extended position to the compressed position;

a separation member disposed within the flow channel between the inlet port and the outlet port;

a first reservoir defined within the flow channel between the inlet port and the separation member; and

a second reservoir defined within the flow channel between the separation member and the outlet port, wherein the separation member is adapted to trap a first portion of the multi-component blood sample within the first reservoir and allow a second portion of the multi-component blood sample to pass through the separation member and into the second reservoir; and

a blood testing device having a receiving port engageable with the outlet port of the blood separation device for closed transfer of at least a portion of the second portion from the second reservoir to the blood testing device via the outlet port.

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

12. The biological fluid separation system of claim 10, wherein the blood testing device comprises a point-of-care testing device.

13. The biological fluid separation system of claim 10, wherein the separation member comprises a tangential flow filter.

14. The biological fluid separation system of claim 13, wherein the tangential flow filter utilizes a cross-flow filtration to separate the second portion from the first portion.

15. The biological fluid separation system of claim 10, further comprising an acoustic focus element disposed within the housing.

16. The biological fluid separation system of claim 10, wherein the inlet port is adapted to receive the blood sample via connection to a biological fluid collection device.

17. The biological fluid separation system of claim 10, further comprising a one-way valve disposed within the flow channel.

18. The biological fluid separation system of claim 17, further comprising a pump in fluid communication with the flow channel for advancing the blood sample received within the flow channel through the one-way valve.