Blood Sampling Transfer Device

• US 20140305823A1
• 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: Gelfand, Craig A., Fletcher, Gary D., Wilkinson, Bradley M.
• Granted Patent: US 10,925,530 B2
• Time in Patent Office: Days
• US Class Current: 206/363
• 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 sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer.

Claims

1. A blood sampling transfer device, comprising:

a lancing tape having a flow channel; and

a transfer cartridge removably connected to the lancing tape, the transfer cartridge having a reservoir,

wherein with the transfer cartridge connected to the lancing tape, the reservoir is in fluid communication with the flow channel, and

wherein with the transfer cartridge disconnected from the lancing tape, the reservoir is sealed.

2. The blood sampling transfer device of claim 1, wherein the lancing tape includes a target for a lancet device.

3. The blood sampling transfer device of claim 2, wherein the target of the lancing tape is aligned with the flow channel.

4. The blood sampling transfer device of claim 2, wherein the target of the lancing tape is a circular graphic indicator.

5. The blood sampling transfer device of claim 1, wherein the transfer cartridge includes a transfer cartridge flow channel in fluid communication with the reservoir.

6. The blood sampling transfer device of claim 5, wherein the transfer cartridge flow channel comprises a sample stabilizer.

7. The blood sampling transfer device of claim 5, wherein the transfer cartridge includes a dispensing bulb in fluid communication with the transfer cartridge flow channel, the transfer cartridge flow channel disposed between the dispensing bulb and the reservoir.

8. The blood sampling transfer device of claim 1, further comprising a frangible portion between the transfer cartridge and the lancing tape, wherein the transfer cartridge is removably connected to the lancing tape via the frangible portion.

9. A blood sampling system, comprising:

a lancet device having a puncturing element; and

a blood sampling transfer device, comprising;

a lancing tape having a flow channel and a target aligned with the flow channel, the target for the puncturing element of the lancet device; and

a transfer cartridge removably connected to the lancing tape, the transfer cartridge having a reservoir,

wherein with the transfer cartridge connected to the lancing tape, the reservoir is in fluid communication with the flow channel, and

wherein with the transfer cartridge disconnected from the lancing tape, the reservoir is sealed.

10. The blood sampling system of claim 9, wherein the target of the lancing tape is a circular graphic indicator.

11. The blood sampling system of claim 9, wherein the transfer cartridge includes a transfer cartridge flow channel in fluid communication with the reservoir.

12. The blood sampling system of claim 11, wherein the transfer cartridge flow channel comprises a sample stabilizer.

13. The blood sampling system of claim 11, wherein the transfer cartridge includes a dispensing bulb in fluid communication with the transfer cartridge flow channel, the transfer cartridge flow channel disposed between the dispensing bulb and the reservoir.

14. The blood sampling system of claim 9, further comprising a frangible portion between the transfer cartridge and the lancing tape, wherein the transfer cartridge is removably connected to the lancing tape via the frangible portion.

15. A blood sampling system, comprising:

a lancet device having a puncturing element;

a blood sampling transfer device, comprising;

a lancing tape having a flow channel and a target aligned with the flow channel, the target for the puncturing element of the lancet device; and

a transfer cartridge removably connected to the lancing tape, the transfer cartridge having a reservoir,

wherein with the transfer cartridge connected to the lancing tape, the reservoir is in fluid communication with the flow channel, and

wherein with the transfer cartridge disconnected from the lancing tape, the reservoir is sealed; and

a packaging member having a compartment sized and adapted to receive the lancet device and the blood sampling transfer device therein.

16. The blood sampling system of claim 15, wherein the packaging member comprises a blister package.

17. The blood sampling system of claim 15, wherein the lancing tape includes an adhesive on an inferior surface of the lancing tape.

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

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

a lancing tape having a flow channel; and

a transfer cartridge removably connected to the lancing tape, the transfer cartridge having a reservoir,

wherein with the transfer cartridge connected to the lancing tape, the reservoir is in fluid communication with the flow channel, and

wherein with the transfer cartridge disconnected from the lancing tape, the reservoir is sealed; and

a centrifuge having a receiving port adapted to receive the transfer cartridge, wherein with the transfer cartridge received within the centrifuge and a rotational force applied to the transfer cartridge, the plasma portion of the blood sample is separated from the cellular portion through the reservoir.

19. The blood separation system of claim 18, wherein the lancing tape includes an adhesive on an inferior surface of the lancing tape.