Biological fluid collection device and biological fluid separation and testing system

• US 9,517,026 B2
• Filed: 04/14/2014
• Issued: 12/13/2016
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Gelfand, Craig A., Rothenberg, Ashley Rachel, Wilkinson, Bradley M., Marchiarullo, Daniel J.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/251,676
• Publication Number:
  US 20140309555A1
• Time in Patent Office: 974 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 1/3406 : 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 2200/027 : for microfluidic devices
• CPC Class Codes: B01L 2200/0621 : Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0631 : Purification arrangements, e.g. solid phase extraction [SPE]
• CPC Class Codes: B01L 2200/0684 : Venting, avoiding backpressure, avoid gas bubbles
• 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 2300/0627 : Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 : Filter
• CPC Class Codes: B01L 2300/0803 : Disc shape
• CPC Class Codes: B01L 2300/0864 : comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0877 : Flow chambers
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0409 : centrifugal forces
• CPC Class Codes: B01L 2400/0478 : pistons
• CPC Class Codes: B01L 2400/0688 : surface tension valves, capillary stop, capillary break
• 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: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• 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 collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

Claims

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

a biological fluid collection device, comprising;

a lancet housing having an inlet port and an interior defining a first flow channel in fluid communication with the inlet port and a second flow channel in fluid communication with the first flow channel, wherein at least a portion of the second flow channel is diverted from the first flow channel;

a puncturing element moveable between a pre-actuated position wherein the puncturing element is retained within the interior of the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing and provides fluid communication with the first flow channel; and

a transfer cartridge having a reservoir, wherein the second flow channel is in fluid communication with the reservoir of the transfer cartridge; and

a biological fluid separation device, comprising;

a rotatable body having a center of rotation and an outer periphery, the rotatable body having a body inlet adapted to receive the multi-component blood sample;

a separation chamber defined within the rotatable body and in fluid communication with the body inlet and having a chamber outlet spaced apart from the body inlet, the separation chamber adapted to receive the multi-component blood sample therein; and

a blood component chamber defined within the rotatable body and in fluid communication with the chamber outlet, wherein when the separation chamber contains the multi-component blood sample and a rotational force is applied to the rotatable body, a blood component of the multi-component blood sample passes from the separation chamber into the blood component chamber and a second component of the multi-component blood sample is retained within the separation chamber,

wherein the blood component chamber is disposed adjacent the center of rotation and the separation chamber is disposed adjacent the outer periphery of the rotatable body, and

wherein the body inlet is engagable with the reservoir of the transfer cartridge for transferring the multi-component blood sample from the reservoir of the transfer cartridge to the biological fluid separation device.

2. The biological fluid separation and testing system of claim 1, wherein a portion of the rotatable body is threadably engageable with a portion of the transfer cartridge for aligning the body inlet in fluid communication with the reservoir.

3. The biological fluid separation and testing system of claim 1, wherein the first flow channel is dimensioned to receive the first blood provided to the flow channel.

4. The biological fluid separation and testing system of claim 1, wherein the transfer cartridge is removably engageable with a portion of the housing and subsequently engageable with a portion of the rotatable body.

5. The biological fluid separation and testing system of claim 1, wherein at least one of the first flow channel and the second flow channel includes a vent to atmosphere.

6. The biological fluid separation and testing system of claim 1, further comprising a diagnostic chamber in fluid communication with the blood component chamber.

7. The biological fluid separation and testing system of claim 1, wherein the blood component is a plasma component of the multi-component blood sample and the second component is a cellular component of the multi-component blood sample.

8. The biological fluid separation and testing system of claim 1, wherein the blood component chamber receives the blood component of the multi-component blood sample upon the rotatable body being rotated by a processing instrument.

9. The biological fluid separation and testing system of claim 1, further comprising a diagnostic chamber in fluid communication with the blood component and including a detection zone readable by a processing instrument.