Biological Fluid Collection Device and Biological Fluid Separation System

• US 20140309096A1
• Filed: 04/14/2014
• Published: 10/16/2014
• Est. Priority Date: 04/15/2013
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Wilkinson, Bradley M., Gelfand, Craig A.
• Application Number:
  US14/251,697
• Publication Number:
  US 20140309096A1
• Time in Patent Office: Days
• US Class Current: 494/43
• 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 1/36 : 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 system for a blood sample is disclosed. The biological fluid separation system includes a biological fluid collection device adapted to receive a blood sample and a centrifuge. The centrifuge is adapted to receive the biological fluid collection device such that with the biological fluid collection device received within the centrifuge and a rotational force applied to the biological fluid collection device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The biological fluid collection device is only receivable within the centrifuge in one orientation.

Claims

1. A biological fluid collection device, comprising:

a housing having an inlet port and a serpentine flow channel in fluid communication with the inlet port; and

a puncturing element disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing and establishes flow communication with the serpentine flow channel.

2. The biological fluid collection device of claim 1, wherein with the puncturing element in the puncturing position, the biological fluid collection device is adapted to generate a vacuum in communication with the inlet port.

3. The biological fluid collection device of claim 1, further comprising a second flow channel in fluid communication with the serpentine flow channel, the second flow channel oriented in a plane that is offset from a plane defining a flow axis of the serpentine flow channel.

4. The biological fluid collection device of claim 1, wherein the biological fluid collection device is adapted to receive a multi-component blood sample having a cellular portion and a plasma portion.

5. The biological fluid collection device of claim 4, wherein when a rotational force is applied to the biological fluid collection device, the plasma portion is separated from the cellular portion through the serpentine flow channel.

6. The biological fluid collection device of claim 4, further comprising an indicator element transitionable between an initial setting and a complete setting, wherein the indicator element automatically transitions to the complete setting when collection of the blood sample is complete.

7. The biological fluid collection device of claim 1, wherein the puncturing element comprises a micro-needle array.

8. The biological fluid collection device of claim 1, wherein the housing includes a push button, wherein actuation of the push button moves the puncturing element from the pre-actuated position to the puncturing position.

9. The biological fluid collection device of claim 1, wherein at least a portion of the serpentine flow channel comprises a sample stabilizer.

10. The biological fluid collection device of claim 1, wherein the housing includes an electric contact for engagement with a corresponding electric contact of a centrifuge.

11. A biological fluid separation system for a blood sample having a cellular portion and a plasma portion, comprising:

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

a housing having an inlet port and a flow channel in fluid communication with the inlet port;

a puncturing element disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing and establishes flow communication with the flow channel; and

an electric contact disposed on an exterior portion of the housing.

12. The biological fluid separation system of claim 11, further comprising a centrifuge having a receiving port adapted to receive the biological fluid collection device, wherein the electric contact of the biological fluid collection device is engaged with a corresponding portion of the centrifuge.

13. The biological fluid separation system of claim 11, wherein the flow channel is a serpentine flow channel.

14. The biological fluid separation system of claim 11, wherein the biological fluid collection device is only receivable within the centrifuge in one orientation.

15. The biological fluid separation system of claim 11, wherein with the biological fluid collection device received within the centrifuge and a rotational force applied to the biological fluid collection device, the plasma portion of the blood sample is separated from the cellular portion through the flow channel.