Systems and methods for sample collection

• US 9,066,698 B2
• Filed: 10/11/2011
• Issued: 06/30/2015
• Est. Priority Date: 10/11/2010
• Status: Active Grant

• Current Assignee: Bioanalytical Systems, Inc.
• Original Assignee: Bioanalytical Systems, Inc.
• Inventors: Peters, Scott R., Hampsch, James M.
• Primary Examiner(s): HIXSON, CHRISTOPHER
• Application Number:
  US13/270,889
• Publication Number:
  US 20120088309A1
• Time in Patent Office: 1,358 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: B01L 2200/021 Adjust spacings in an array of wells, pipettes or holders, format transfer between arrays of different size or geometry
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 3/021 Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
• CPC Class Codes: B01L 3/0237 Details of electronic control, e.g. relating to user interface
• CPC Class Codes: B01L 3/0289 Apparatus for withdrawing or distributing predetermined quantities of fluid B01L3/02 takes precedence; sample taking G01N1/00; sample taking within automatic analysers G01N35/00; volume measuring in general G01F
• CPC Class Codes: B01L 3/0293 for liquids
• CPC Class Codes: B01L 3/0296 from piercable tubing, e.g. in extracorporeal blood sampling
• CPC Class Codes: G01N 1/14 Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: G01N 35/1004 : Cleaning sample transfer devices
• CPC Class Codes: G01N 35/1016 : Control of the volume dispensed or introduced
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

A tube assembly, system and method for biological sample collection. In one embodiment, the tube assembly of the present disclosure includes a first tube, a second tube, a mechanism for securing the first and second tubes. The securing mechanism orients the first ends of the first and second tubes in a manner such that the first end of the second tube extends beyond the first end of the first tube to create an interstitial space between the outer diameter of the first tube and the inner diameter of the second tube.

Claims

1. A system for sample collection, the system comprising:

a tube assembly comprising;

a first tube having first and second ends, the first end of the first tube having an outer diameter and having a first tube opening therein;

a second tube having a first end and a second end, the first end of the second tube having a second tube opening therein and the second end of the second tube having a third tube opening therein, the second tube opening having an inner diameter greater than the outer diameter of the first end of the first tube;

a securing mechanism operable to secure the first tube and the second tube such that the first end of the second tube extends beyond the first end of the first tube, with the first end of the first tube inside the first end of the second tube creating an interstitial space about the first tube at the first end of the second tube; and

a seal, wherein when the seal is disposed against the first end of the second tube to form a barrier, wherein a biological sample can pass from the first end of the first tube by way of the interstitial space into the third tube opening of the second end of the second tube;

a sample source fluidly coupled to the second end of the first tube; and

a collection vessel comprising a collection medium, wherein the collection medium is capable of binding biological samples, and wherein the collection vessel is positioned to receive a fluid from the tube assembly.

2. The system of claim 1, further comprising a controller coupled to the collection vessel and the tube assembly, the controller operable to change the time of receipt of the fluid or the quantity of the fluid received.

3. The system of claim 1, wherein the collection medium comprises a nitrocellulose material.

4. The system of claim 1, wherein when the seal is disposed against the first end of the second tube to form a barrier, wherein a biological sample can pass from the second end of the second tube by way of the interstitial space into the first tube opening of the first end of the first tube.

5. The system of claim 1, wherein the securing mechanism comprises a threaded hub.

6. The system of claim 5, wherein the threaded hub is sized and shaped to form a cavity for receipt of a portion of the first tube and the second tube.

7. The system of claim 6, wherein the securing mechanism further comprises an adhesive within the cavity of the threaded hub to fixedly secure the first tube and second tube.

8. The system of claim 5, wherein the first end of the second tube extends a fixed distance beyond the first end of the first tube, the distance selected from the group consisting of about 0.3 mm to about 1.6 mm, about 0.5 mm to about 1.3 mm, about 0.6 mm to about 1.0 mm, and about 0.8 mm.

15. The system of claim 1, wherein the seal comprises an elastomeric seal material.

9. A method of sample collection, the method comprising the steps of:

introducing a biological sample into a tube assembly of a system of sample collection from a sample source, the system comprising;

the tube assembly comprising;

a first tube having first and second ends, the first end of the first tube having an outer diameter and having a first tube opening therein;

a second tube having a first end and a second end, the first end of the second tube having a second tube opening therein and the second end of the second tube having a third tube opening therein, the second tube opening having an inner diameter greater than the outer diameter of the first end of the first tube;

a securing mechanism operable to secure the first tube and the second tube such that the first end of the second tube extends beyond the first end of the first tube, with the first end of the first tube inside the first end of the second tube creating an interstitial space about the first tube at the first end of the second tube;

a seal, wherein when the seal is disposed against the first end of the second tube to form a barrier, wherein a biological sample can pass from the first end of the first tube by way of the interstitial space into the third tube opening of the second end of the second tube;

the sample source fluidly coupled to the second end of the first tube; and

a collection vessel comprising a collection medium, wherein the collection medium is capable of binding biological samples, and wherein the collection vessel is positioned to receive a fluid from the tube assembly; and

depositing the biological sample from the tube assembly on the collection media;

wherein the biological sample deposited on the collection media is undiluted.

10. The method of claim 9, wherein the collection medium comprises a nitrocellulose material.

11. The method of claim 9, wherein the securing mechanism comprises a threaded hub.

12. The method of claim 11, wherein the threaded hub is sized and shaped to form a cavity for receipt of a portion of the first tube and the second tube.

13. The method of claim 11, wherein the securing mechanism further comprises an adhesive within the cavity of the threaded hub to fixedly secure the first tube and second tube.

14. The method of claim 9, wherein the first end of the second tube extends a fixed distance beyond the first end of the first tube, the distance selected from the group consisting of about 0.3 mm to about 1.6 mm, about 0.5 mm to about 1.3 mm, about 0.6 mm to about 1.0 mm, and about 0.8 mm.