Medical device for collection of a biological sample

• US 10,238,325 B2
• Filed: 04/14/2014
• Issued: 03/26/2019
• Est. Priority Date: 04/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Burkholz, Jonathan Karl, Davis, Bryan Garret
• Primary Examiner(s): Dougherty, Sean P
• Application Number:
  US14/251,672
• Publication Number:
  US 20140309551A1
• Time in Patent Office: 1,807 Days
• 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 biological fluid sampling device for collecting a blood sample from a separate vascular access device and for ejecting a portion of the collected sample to a point-of-care testing device for analysis is provided. The biological fluid sampling device includes a body enclosing a reservoir. The reservoir has an internal volume sufficient to contain enough blood for use in a diagnostic test. The sampling device further includes: an access lumen extending from a distal end of the body for establishing fluid communication between a separate vascular access device and the reservoir; an outflow lumen also in fluid communication with the reservoir; and a removable vented cap attached to the outflow lumen including a gas permeable vent in gaseous communication between the reservoir and ambient air. In addition, several sample and transfer devices are provided for obtaining a sample from a subject and transferring the sample to a point-of-care testing device.

Claims

1. A biological fluid sampling device engageable with a separate vascular access device, comprising:

a housing enclosing a biological fluid reservoir, the reservoir defining an interior;

an access lumen extending from a portion of the housing and establishing fluid communication between the separate vascular access device and the interior of the reservoir;

an outflow lumen extending from a portion of the housing, the outflow lumen having a first end provided in fluid communication with the interior of the reservoir and a second end; and

a vented cap removably disposed over the second end of the outflow lumen such that the vented cap is separable from the outflow lumen, the vented cap comprising;

a gas permeable vent in gaseous communication between the interior of the reservoir and an ambient environment; and

a channel in fluid communication with the outflow lumen and positioned between the vent and the reservoir.

2. The biological fluid sampling device of claim 1, further comprising a luer lock at least partially surrounding the access lumen.

3. The biological fluid sampling device of claim 1, wherein the vented cap comprises a luer lock for insertion in the outflow lumen.

4. The biological fluid sampling device of claim 3, wherein the vented cap comprises a fastener for removably connecting a portion of the cap to a portion of the housing.

5. The biological fluid sampling device of claim 1, wherein the interior of the reservoir is configured for receiving a fluid sample therein.

6. The biological fluid sampling device of claim 5, wherein the housing comprises a compressible portion, wherein compression of the compressible portion expels the fluid sample from the interior of the reservoir through the access lumen.

7. The biological fluid sampling device of claim 1, wherein the access lumen is disposed at a distal end of the housing and the outflow lumen is disposed at a proximal end of the housing.

8. The biological fluid sampling device of claim 1, wherein the reservoir contains a sample stabilizer.

9. The biological fluid sampling device of claim 8, wherein the housing has a visual identifier which corresponds to a specific sample stabilizer.

10. The biological fluid sampling device of claim 9, wherein the visual identifier is a specific color.

11. The biological fluid sampling device of claim 1, wherein the vent comprises at least one of a porous plug, a permeable membrane, and small vent holes.

12. A biological fluid sampling and collection assembly comprising:

a biological fluid sampling device comprising;

a housing enclosing a biological fluid reservoir, the reservoir defining an interior;

an access lumen extending from a portion of the housing and establishing fluid communication between a separate vascular access device and the interior of the reservoir; and

an outflow lumen extending from a portion of the housing, the outflow lumen having a first end provided in fluid communication with the interior of the reservoir and a second end, wherein the outflow lumen is generally disposed on an opposite end of the housing from the access lumen; and

a sample collection device comprising;

an adapter for accessing an interior of a sample container and for establishing fluid communication between the biological fluid reservoir and an interior of the sample container, thereby allowing fluid communication between the interior of the reservoir and the interior of the sample container; and

a flow restrictor engaged with the adapter, the flow restrictor transitionable from an open position, in which fluid communication is permitted between the biological fluid reservoir and the interior of the sample container, to a closed position, in which the biological fluid reservoir is in fluid isolation from the interior of the sample container.

13. The biological fluid sampling and collection assembly of claim 12, wherein the biological fluid reservoir contains a fluid and, wherein when the flow restrictor is in the open position, the fluid passes from the biological fluid reservoir to the interior of the sample container.

14. The biological fluid sampling and collection assembly of claim 12, wherein the flow restrictor is in the open position when the sample container is engaged with the adapter, and wherein the flow restrictor is in the closed position when the sample container is removed from the adapter.

15. The biological fluid sampling and collection assembly of claim 12, further comprising a vented cap removably disposed over the second end of the outflow lumen such that the vented cap is separable from the outflow lumen, the vented cap comprising:

a gas permeable vent in gaseous communication between the interior of the reservoir and an ambient environment; and

a channel in fluid communication with the outflow lumen and positioned between the vent and the reservoir.

16. The biological fluid sampling and collection assembly of claim 12, wherein the sample container is a vacuum evacuated container.

17. The biological fluid sampling and collection assembly of claim 12, further comprising the separate vascular access device in fluid communication with the access lumen.

18. The biological fluid sampling and collection assembly of claim 17, further comprising an adapter connected between the separate vascular access device and the biological fluid sampling device.

19. The biological fluid sampling and collection assembly of claim 18, wherein the adapter comprises:

a housing;

a main lumen enclosed within the housing having a main outflow port;

a side port including a side lumen extending from and in fluid communication with the main lumen; and

a valve transitionable from a first position in which fluid flow is permitted through the main lumen and fluid flow is prevented through the side lumen, to a second position in which fluid flow through both the main lumen and side lumen is permitted.

20. The biological fluid sampling and collection assembly of claim 19, wherein the valve is transitioned from the first position to the second position by insertion of a tubular member into the side lumen through the side port.