Biological fluid separation device and biological fluid separation and testing system

• US 9,833,182 B2
• Filed: 04/14/2014
• Issued: 12/05/2017
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Marchiarullo, Daniel J., Wilkinson, Bradley M.
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US14/251,699
• Publication Number:
  US 20140308179A1
• Time in Patent Office: 1,331 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 1/3406 : Physical characteristics of the filtrate, e.g. urea
• 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 separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation 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 separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid 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 cartridge, comprising:

a housing having a single inlet port and a flow channel defined within the housing in fluid communication with the single inlet port, the flow channel having a spiral shape;

a first collection chamber defined within the housing in fluid communication with the flow channel and including a first outlet port having a valve;

a second collection chamber defined within the housing in fluid communication with the flow channel and including a second outlet port, the second collection chamber isolated from the first collection chamber, and the second outlet port spaced apart from the first outlet port; and

an inlet channel in fluid communication with the single inlet port and the flow channel, wherein at least one of the inlet channel and the flow channel contains a sample stabilizer therein,

wherein the valve comprises a deformable wall member and a septum, and wherein the septum covers the first outlet port.

2. The biological fluid separation cartridge of claim 1, wherein the biological fluid separation cartridge receives a multi-component blood sample.

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

4. The biological fluid separation cartridge of claim 3, wherein the flow channel comprises a separation element that separates the cellular portion and the plasma portion of the multi-component blood sample.

5. The biological fluid separation cartridge of claim 4, wherein the separation element comprises a plurality of posts.

6. The biological fluid separation cartridge of claim 2, wherein the single inlet port includes a connecting portion that engages a blood collection device and the single inlet port receives the multi-component blood sample via connection to the blood collection device.

7. The biological fluid separation cartridge of claim 3, wherein the first collection chamber receives at least a portion of the plasma portion therein and the second collection chamber receives at least a portion of the cellular portion.

8. The biological fluid separation cartridge of claim 7, further comprising a one-way mechanism for preventing the cellular portion from entering the first collection chamber.

9. The biological fluid separation cartridge of claim 3, wherein the first outlet port is adapted for connection to a point-of-care testing device for closed transfer of a portion of the plasma portion from the first collection chamber to the point-of-care testing device.

10. The biological fluid separation cartridge of claim 9, further comprising a connection portion that engages a drive device, wherein with the drive device connected to the biological fluid separation cartridge, the drive device causes flow of the plasma portion from the first collection chamber to the point-of-care testing device.

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 separation cartridge adapted to receive the multi-component blood sample, the biological fluid separation cartridge comprising;

a housing having a single inlet port and a flow channel defined within the housing in fluid communication with the single inlet port, the flow channel have a spiral shape;

a first collection chamber defined within the housing in fluid communication with the flow channel and including a first outlet port having a valve;

a second collection chamber defined within the housing in fluid communication with the flow channel and including a second outlet port, the second collection chamber isolated from the first collection chamber, and the second outlet port spaced apart from the first outlet port; and

an inlet channel in fluid communication with the single inlet port and the flow channel, wherein at least one of the inlet channel and the flow channel contains a sample stabilizer therein,

wherein the valve comprises a deformable wall member and a septum, and wherein the septum covers the first outlet port; and

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

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

13. The biological fluid separation and testing system of claim 12, further comprising a connection portion that engages a drive device, wherein with the drive device connected to the biological fluid separation cartridge, the drive device causes flow of the plasma portion from the first collection chamber to the blood testing device.

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