Biological fluid collection device and biological fluid collection and testing system

• US 9,380,972 B2
• Filed: 04/14/2014
• Issued: 07/05/2016
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Fletcher, Gary D., Rothenberg, Ashley Rachel, Gelfand, Craig A., Marchiarullo, Daniel J., Wilkinson, Bradley M.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/251,682
• Publication Number:
  US 20140309556A1
• Time in Patent Office: 813 Days
• Field of Search: 600/576, 600/573, 604/190, 604/256, 604/905, 604/164.11, 210/335, 210/257.2, 210/321.62, 210/321.65, 530/390.5, 530/414, 530/417, 530/427, 251/149.1, 251/149.6, 422/44
• 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 1/36 : 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 collection device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood collection device separates a plasma portion from a cellular portion. After separation, the blood collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood collection device of the present disclosure also provides a closed collection 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 collection device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood collection 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 collection device, comprising:

a housing having an inlet port, a transfer port, and a flow channel, the inlet port and the transfer port in fluid communication via the flow channel, the housing further defining a reservoir adjacent the transfer port and in fluid communication with the flow channel;

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 provides fluid communication with the flow channel;

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

a wicking element disposed within the flow channel between the inlet port and the separation member, wherein the wicking element comprises a sample stabilizer disposed therewith.

2. The biological fluid collection device of claim 1, wherein the inlet port is adapted to receive a multi-component blood sample.

3. The biological fluid collection device of claim 2, wherein the separation member is adapted to trap a first component of the multi-component blood sample and allow a second component of the multi-component blood sample to pass therethrough.

4. The biological fluid collection device of claim 2, wherein the separation member is adapted to trap a cellular component of the multi-component blood sample and allow a plasma component of the multi-component blood sample to pass through the filter and into the reservoir.

5. The biological fluid collection device of claim 1, wherein the wicking element surrounds at least a portion of the puncturing element.

6. The biological fluid collection device of claim 1, wherein the housing includes an actuation mechanism in communication with the puncturing element.

7. The biological fluid collection device of claim 1, wherein the transfer port includes a septum transitionable between a closed position and an open position.

8. The biological fluid collection device of claim 1, wherein the separation member is one of a lateral flow filter and a tangential flow filter.

9. The biological fluid collection device of claim 1, wherein the separation member comprises a sample stabilizer disposed therewith.

10. A biological fluid collection and testing system, comprising:

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

a housing having an inlet port, a transfer port, and a flow channel, the inlet port and the transfer port in fluid communication via the flow channel, the housing further defining a reservoir adjacent the transfer port and in fluid communication with the flow channel,

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 provides fluid communication with the flow channel,

a separation member disposed within the flow channel between the inlet port and the reservoir, and

a wicking element disposed within the flow channel between the inlet port and the separation member, wherein the wicking element comprises a sample stabilizer disposed therewith; and

a blood testing device having a receiving port adapted to engage the transfer port of the biological fluid collection device for closed transfer of at least a portion of a component of the multi-component blood sample from the reservoir of the biological fluid collection device to the blood testing device.

11. The biological fluid collection and testing system of claim 10, wherein the transfer port includes a septum transitionable between a closed position and an open position.

12. The biological fluid collection and testing system of claim 10, wherein the housing includes an actuation mechanism in communication with the puncturing element.

13. The biological fluid collection and testing system of claim 10, wherein the separation member is one of a lateral flow filter and a tangential flow filter.

14. The biological fluid collection and testing system of claim 10, wherein the separation member comprises a sample stabilizer disposed therewith.

15. The biological fluid collection and testing system of claim 10, wherein the blood testing device is a point-of-care testing device.