Blood Sampling Transfer Device and Blood Separation and Testing System

• US 20140308166A1
• Filed: 04/14/2014
• Published: 10/16/2014
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Fletcher, Gary D., Wilkinson, Bradley M., Newby, C. Mark
• Granted Patent: US 10,194,851 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• 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: A61M 2205/3331 : Pressure; Flow
• 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 sampling transfer device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. The blood sampling transfer device is able to separate the plasma portion from the cellular portion. After separation, the blood sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood sampling transfer device also provides a closed sampling 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 sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood sampling transfer 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 blood sampling transfer device adapted to receive a blood sample having a cellular portion and a plasma portion, the blood sampling transfer device comprising:

a first component having an actuation member; and

a second component removably connected to the first component, the second component comprising;

an inlet port,

a flow channel,

an outlet port, the inlet port and the outlet port in fluid communication via the flow channel,

a filter disposed within the flow channel between the inlet port and the outlet port,

a first chamber defined between the inlet port and the filter, and

a transfer chamber defined between the filter and the outlet port;

wherein the inlet port is adapted to receive the blood sample upon actuation of the actuation member, and wherein the filter is adapted to trap the cellular portion in the first chamber and allow the plasma portion to pass through the filter and into the transfer chamber.

2. The blood sampling transfer device of claim 1, wherein the first component is a reusable component.

3. The blood sampling transfer device of claim 1, wherein the second component is a disposable component.

4. The blood sampling transfer device of claim 1, wherein the filter comprises a tangential flow filter.

5. The blood sampling transfer device of claim 4, wherein the tangential flow filter utilizes a cross-flow filtration to separate the plasma portion from the cellular portion.

6. The blood sampling transfer device of claim 4, further comprising an acoustic focus element that oscillates the blood sample over the tangential flow filter.

7. The blood sampling transfer device of claim 1, wherein the inlet port is adapted to receive the blood sample via connection to a blood collection device.

8. The blood sampling transfer device of claim 1, wherein the 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 transfer chamber to the point-of-care testing device.

9. The blood sampling transfer device of claim 8, wherein with the outlet port connected to the point-of-care testing device for closed transfer, the plasma portion is transferred from the transfer chamber to the point-of-care testing device upon actuation of the actuation member.

10. A blood separation and testing system for a blood sample having a cellular portion and a plasma portion, the blood separation and testing system comprising:

a blood sampling transfer device adapted to receive the blood sample, the blood sampling transfer device comprising;

a first component having an actuation member, and

a second component removably connected to the first component, the second component comprising;

an inlet port,

a flow channel,

an outlet port, the inlet port and the outlet port in fluid communication via the flow channel,

a filter disposed within the flow channel between the inlet port and the outlet port,

a first chamber defined between the inlet port and the filter, and

a transfer chamber defined between the filter and the outlet port, wherein the inlet port is adapted to receive the blood sample upon actuation of the actuation member, and wherein the filter is adapted to trap the cellular portion in the first chamber and allow the plasma portion to pass through the filter and into the transfer chamber; and

a blood testing device having a receiving port adapted to receive the outlet port of the blood sampling transfer device for closed transfer of a portion of the plasma portion from the transfer chamber to the blood testing device.

11. The blood separation and testing system of claim 10, wherein with the outlet port connected to the blood testing device for closed transfer, the plasma portion is transferred from the transfer chamber to the blood testing device upon actuation of the actuation member.

12. The blood separation and testing system of claim 10, wherein the blood testing device comprises a point-of-care testing device.

13. The blood separation and testing system of claim 10, wherein the first component is a reusable component.

14. The blood separation and testing system of claim 10, wherein the second component is a disposable component.

15. The blood separation and testing system of claim 10, wherein the filter comprises a tangential flow filter.

16. The blood separation and testing system of claim 15, wherein the tangential flow filter utilizes a cross-flow filtration to separate the plasma portion from the cellular portion.

17. The blood separation and testing system of claim 15, further comprising an acoustic focus element that oscillates the blood sample over the tangential flow filter.

18. The blood separation and testing system of claim 10, wherein the inlet port is adapted to receive the blood sample via connection to a blood collection device.

19. A blood sampling transfer system adapted to receive a blood sample, the blood sampling transfer system comprising:

a reusable component having an actuation member;

a first disposable component removably connectable to the reusable component, the first disposable component having a first inlet port, wherein the first inlet port is adapted to receive the blood sample upon actuation of the actuation member; and

a second disposable component removably connectable to the reusable component, the second disposable component having a second inlet port, wherein the second inlet port is adapted to receive the blood sample upon actuation of the actuation member.

20. A blood sampling transfer system adapted to receive a blood sample having a cellular portion and a plasma portion, the blood sampling transfer system comprising:

a reusable component having an actuation member;

a first disposable component removably connectable to the reusable component, the first disposable component having a first inlet port, a first flow channel, a first outlet port, the first inlet port and the first outlet port in fluid communication via the first flow channel, a first filter disposed within the first flow channel between the first inlet port and the first outlet port, a first chamber between the first inlet port and the first filter, and a first transfer chamber between the first filter and the first outlet port, wherein the first inlet port is adapted to receive the blood sample upon actuation of the actuation member, and wherein the first filter is adapted to trap the cellular portion in the first chamber and allow the plasma portion to pass through the first filter and into the first transfer chamber; and

a second disposable component removably connectable to the reusable component, the second disposable component having a second inlet port, a second flow channel, a second outlet port, the second inlet port and the second outlet port in fluid communication via the second flow channel, a second filter disposed within the second flow channel between the second inlet port and the second outlet port, a second chamber between the second inlet port and the second filter, and a second transfer chamber between the second filter and the second outlet port, wherein the second inlet port is adapted to receive the blood sample upon actuation of the actuation member, and wherein the second filter is adapted to trap the cellular portion in the second chamber and allow the plasma portion to pass through the second filter and into the second transfer chamber.