Biological fluid sampling transfer device and biological fluid separation and testing system

• US 9,549,700 B2
• Filed: 04/14/2014
• Issued: 01/24/2017
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Fletcher, Gary D., Gelfand, Craig A., Marchiarullo, Daniel J., Newby, C. Mark, Rothenberg, Ashley Rachel
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/251,693
• Publication Number:
  US 20140309557A1
• Time in Patent Office: 1,016 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 1/36 : 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 2300/0672 : Integrated piercing tool
• 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 and testing system for a blood sample is disclosed. The blood separation and testing system includes a blood sampling transfer device adapted to receive a blood sample, a blood separation device, and a blood testing device. The blood separation device is adapted to receive a portion of the blood sampling transfer device such that with the blood sampling transfer device received within the blood separation device and a rotational force applied to the blood sampling transfer device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The blood testing device is adapted to receive a portion of the blood sampling transfer device to analyze the plasma portion of the blood sample and obtain test results.

Claims

1. A biological fluid sampling transfer device, comprising:

a housing having a resiliently deformable upper portion, a lower portion removably connectable to the upper portion, the lower portion having an inlet port, an outlet port, and a flow channel, the inlet port and the outlet port in fluid communication via the flow channel, the upper portion transitionable between an undeformed position and a deformed position; and

a puncturing element, a portion of which is 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 lower portion of the housing,

wherein, when the lower portion of the housing is removed from the upper portion of the housing, the inlet port and the flow channel in the lower portion are sealed and the puncturing element is contained within the upper portion of the housing.

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

3. The biological fluid sampling transfer device of claim 2, wherein the multi-component blood sample comprises a first cellular component and a second plasma component.

4. The biological fluid sampling transfer device of claim 2, wherein the flow channel is adapted to receive the blood sample via the inlet port.

5. The biological fluid sampling transfer device of claim 1, wherein actuation of the upper portion from the undeformed position to the deformed position moves the puncturing element from a pre-actuated position to a puncturing position.

6. The biological fluid sampling transfer device of claim 5, wherein after the puncturing element moves to the puncturing position, the upper portion returns to its undeformed position and returns the puncturing element to the pre-actuated position.

7. The biological fluid sampling transfer device of claim 6, wherein with the blood sample received within the flow channel, the lower portion is removable from the upper portion.

8. The biological fluid sampling transfer device of claim 1, further comprising an adhesive disposed on an outside surface of the lower portion.

9. The biological fluid sampling transfer device of claim 1, further comprising a check valve in the upper portion.

10. A biological fluid sampling transfer device adapted to receive a multi-component blood sample, the biological fluid sampling transfer device comprising:

a housing having a resiliently deformable upper portion, a lower portion removably connectable to the upper portion, the lower portion having an inlet port, an outlet port, and a flow channel, the inlet port and the outlet port in fluid communication via the flow channel, the flow channel adapted to receive the blood sample via the inlet port, the upper portion transitionable between an undeformed position and a deformed position; and

a puncturing element, a portion of which is 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 lower portion of the housing,

wherein actuation of the upper portion from the undeformed position to the deformed position moves the puncturing element from the pre-actuated position to the puncturing position,

wherein after the puncturing element moves to the puncturing position, the upper portion returns to the undeformed position and the puncturing element returns to the pre-actuated position, and

wherein, when the lower portion of the housing is removed from the upper portion of the housing, the inlet port and the flow channel in the lower portion are sealed and the puncturing element is contained within the upper portion of the housing.

11. The biological fluid sampling transfer device of claim 10, wherein with the blood sample received within the flow channel, the lower portion is removable from the upper portion.

12. The biological fluid sampling transfer device of claim 10, further comprising an adhesive disposed on an outside surface of the lower portion.

13. The biological fluid sampling transfer device of claim 10, further comprising a check valve in the upper portion.