Biological fluid sampling device

• US 9,408,568 B2
• Filed: 04/14/2014
• Issued: 08/09/2016
• 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.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/251,727
• Publication Number:
  US 20140309558A1
• Time in Patent Office: 848 Days
• Field of Search: 600/573, 600/576, 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 biological fluid sampling device adapted to receive a blood sample and includes a housing having a reservoir disposed therein and a first cavity in fluid communication with the reservoir is disclosed. The biological fluid sampling device includes a first test element removably receivable within the first cavity and a lancet having a puncturing element. Additionally, the housing may include a second cavity in fluid communication with the reservoir and a second test element removably receivable within the second cavity. With the blood sample received within the reservoir of the biological fluid sampling device, the first test element and the second test element are adapted to receive a portion of the blood sample. In this manner, the biological fluid sampling device allows for a blood sample to be collected on a plurality of test elements simultaneously. In one embodiment, the biological fluid sampling device contains a sample stabilizer.

Claims

1. A biological fluid sampling device, comprising:

a housing having an inlet port, a reservoir disposed within the housing and in fluid communication with the inlet port, and a first cavity in fluid communication with the reservoir;

a first test element removably receivable within the first cavity, wherein the first test element is a test strip; 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 housing.

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

3. The biological fluid sampling device of claim 2, wherein the housing includes an upper portion and a lower portion, the inlet port provided within the lower portion.

4. The biological fluid sampling device of claim 3, further comprising an adhesive disposed on a bottom surface of the lower portion.

5. The biological fluid sampling device of claim 3, wherein the reservoir is adapted to receive the blood sample via the inlet port.

6. The biological fluid sampling device of claim 3, wherein the upper portion is a resiliently deformable member and the upper portion is transitionable between an undeformed position and a deformed position.

7. The biological fluid sampling device of claim 6, wherein the puncturing element is configured to move from the pre-actuated position to the puncturing position upon actuation of the upper portion from the undeformed position to the deformed position,

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

wherein with the blood sample received within the reservoir, the first test element is adapted to receive a portion of the blood sample.

8. The biological fluid sampling device of claim 1, wherein the housing further comprises a second cavity in fluid communication with the reservoir, and wherein a second test element is removably receivable within the second cavity.

9. The biological fluid sampling device of claim 3, further comprising a check valve in the upper portion.

10. The biological fluid sampling device of claim 1, wherein a first portion of the housing includes a first sample stabilizer.

11. The biological fluid sampling device of claim 10, wherein a second portion of the housing includes a second sample stabilizer.

12. A biological fluid sampling device, comprising:

a housing having an inlet port, a reservoir disposed within the housing and in fluid communication with the inlet port, a first cavity in fluid communication with the reservoir, and a second cavity in fluid communication with the reservoir;

a first test element removably receivable within the first cavity;

a second test element removably receivable within the second cavity; 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 housing.

13. A biological fluid sampling device adapted to receive a blood sample, the biological fluid sampling device comprising:

a housing having a resiliently deformable upper portion, a lower portion, an inlet port within the lower portion, a reservoir disposed within the housing and in fluid communication with the inlet port, the reservoir adapted to receive the blood sample via the inlet port, and a first cavity in fluid communication with the reservoir, the upper portion transitionable between an undeformed position and a deformed position;

a first test element removably receivable within the first cavity; 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 housing,

wherein the puncturing element is configured to move from the pre-actuated position to the puncturing position upon actuation of the upper portion from the undeformed position to the deformed position,

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

wherein with the blood sample received within the reservoir, the first test element is adapted to receive a portion of the blood sample.

14. The biological fluid sampling device of claim 13, further comprising an adhesive disposed on an outside surface of the lower portion.

15. The biological fluid sampling device of claim 13, wherein the housing further comprises a second cavity in fluid communication with the reservoir, and wherein a second test element is removably receivable within the second cavity.

16. The biological fluid sampling device of claim 15, wherein with the blood sample received within the reservoir, the first test element is adapted to receive a first portion of the blood sample and the second test element is adapted to receive a second portion of the blood sample.

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

18. A biological fluid testing system for a blood sample, the biological fluid testing system comprising:

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

a housing having a resiliently deformable upper portion, a lower portion, an inlet port at the lower portion, a reservoir disposed within the housing and in fluid communication with the inlet port, the reservoir adapted to receive the blood sample via the inlet port, and a first cavity in fluid communication with the reservoir, the upper portion transitionable between an undeformed position and a deformed position;

a first test element removably receivable within the first cavity; 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 housing,

wherein the puncturing element is configured to move from the re-actuated position to the puncturing position upon actuation of the upper portion from the undeformed position to the deformed position,

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

wherein with the blood sample received within the reservoir, the first test element is adapted to receive a portion of the blood sample; and

a blood testing device adapted to receive the first test element for closed transfer of the blood sample from the first test element to the blood testing device.

19. The biological fluid testing system of claim 18, wherein the blood testing device comprises a point-of-care testing device.

20. The biological fluid testing system of claim 18, wherein the housing further comprises a second cavity in fluid communication with the reservoir, and wherein a second test element is removably receivable within the second cavity.

21. The biological fluid testing system of claim 20, wherein with the blood sample received within the reservoir, the first test element is adapted to receive a portion of the blood sample and the second test element is adapted to receive a portion of the blood sample.