Apparatus and method for collecting blood samples

• US 6,155,991 A
• Filed: 07/01/1999
• Issued: 12/05/2000
• Est. Priority Date: 07/01/1999
• Status: Expired due to Fees

• Current Assignee: VIA Christi Research, Inc.
• Original Assignee: VIA Christi Research, Inc.
• Inventors: Boettger, Conrad H., Carrithers, Joe A., Beat, Thomas R.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/345,486
• Time in Patent Office: 523 Days
• Field of Search: 600/573, 600/576, 600/577, 600/579
• US Class Current: 600/573
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150038 for blood from umbilical cord
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

Abstract

A small volume blood collection apparatus and method. A capillary tube has an end cap on each end thereof. Each end cap has a passage formed therethrough, a plug for selectively closing the passage and a flexible arm extending between the plug and a base portion of the end cap. A Luer surface is defined on each end cap.

Claims

1. A blood sample collection apparatus comprising:

an elongated capillary tube having an open proximal end and an open distal end;

a first end cap including a base portion having an inner end and an outer end and a passage extending between said inner end and said outer end, a plug configured to selectively close said passage and a Luer surface defined on an outer portion thereof, said inner end of said base portion being coupled to said proximal end of said capillary tube; and

a second end cap coupled to said distal end of said capillary tube.

2. An apparatus as recited in claim 1, wherein said second end cap comprises a base portion having an inner end, an outer end and a passage extending between said inner end and said outer end, and a plug configured to selectively close said passage of said second end cap, said inner end of said second end cap being coupled to said distal end of said capillary tube.

3. An apparatus as recited in claim 2, wherein said plug of said first end cap and said plug of said second end cap are stoppers, said first end cap further comprises a flexible arm extending between said stopper of said first end cap and said base portion of said first end cap, said second end cap further comprises a flexible arm extending between said stopper of said first end cap and said base portion of said second end cap.

4. An apparatus as recited in claim 2, wherein said plug of said second end cap comprises a hydrophobic filter disposed in said passage of said base portion of said second end cap.

5. An apparatus as recited in claim 4, further comprising a visual indicator formed on said second end cap to indicate that said second end cap includes said hydrophobic filter.

6. An apparatus as recited in claim 2 wherein an outer portion of said second end cap has a Luer surface defined thereon.

7. An apparatus as recited in claim 2, further comprising a needle assembly including a hub and a needle coupled to said hub, said hub defining a mating Luer surface and being configured to mate with said Luer surface defined on said first end cap.

8. A blood sample collection method comprising the steps of:

coupling a needle assembly having a needle to a first end cap on an open proximal end of an elongated capillary tube, the first end cap including a base portion having an inner end and an outer end and a passage extending between the inner end and the outer end, a first plug configured to selectively close the passage, and a Luer surface defined thereon, the inner end being coupled to the proximal end of the capillary tube, said coupling step including disposing a hub of the needle assembly over the Luer surface with the plug not closing the passage of the base portion of the first end cap;

placing an end of the needle in communication with a blood supply;

drawing blood through the needle and the passage into the capillary tube;

closing the distal end of the capillary tube with a second end cap;

removing the needle assembly from the capillary tube; and

closing the passage of the first end cap with the plug.

9. A method as recited in claim 8 wherein said placing step comprises inserting the end of the needle into a blood vessel.

10. A method as recited in claim 8, wherein said placing step comprises inserting the end of the needle into a blood line.

11. A method as recited in claim 8, wherein said step of closing the distal end comprises placing a second plug in an opening of a passage formed through the second end cap, the second plug being attached to a base portion of the second end cap by a second flexible arm, and wherein said step of closing the passage of the first end cap comprises placing the first plug in an opening of the passage of the first end cap, the first plug being attached to the base portion of the first end cap by a first flexible arm.

12. A method as recited in claim 11, further comprising the steps of:

removing one of the first end cap and the second end cap from one of the proximal end and the distal end of the capillary tube;

inserting one of the proximal end and the distal end of the capillary tube into a female port of a test instrument; and

analyzing the blood with the test instrument.

13. A method as recited in claim 11, further comprising the steps of:

opening the passage of one of the first end cap and the second end cap;

inserting a probe of a test instrument into the passage of the one of the first end cap and the second end cap; and

analyzing the blood with the test instrument.

14. A blood sample collection method comprising the steps of:

coupling a needle assembly having a needle to a first end cap on an open proximal end of an elongated capillary tube, the first end cap including a base portion having an inner end and an outer end and a passage extending between the inner end and the outer end, a first plug configured to selectively close the passage, and a Luer surface defined thereon, the inner end being coupled to the proximal end of the capillary tube, said coupling step including disposing a hub of the needle assembly over the Luer surface with the plug not closing the passage of the base portion of the first end cap;

placing an end of the needle in communication with a blood supply;

drawing blood through the needle and the passage into the capillary tube;

removing the needle assembly from the capillary tube; and

closing the passage of the first end cap with the plug and the distal end of the capillary tube with a second end cap.

15. A method as recited in claim 14, wherein said closing step comprises closing the passage with the first end cap prior to closing the distal end of the capillary tube with the second end cap.

16. A method as recited in claim 14, wherein said closing step comprises closing the passage with the first end cap subsequent to closing the distal end of the capillary tube with the second end cape.

17. A method as recited in claim 14 wherein said placing step comprises inserting the end of the needle into a blood vessel.

18. A method as recited in claim 14, wherein said placing step comprises inserting the end of the needle into a blood line.

19. A method as recited in claim 14, wherein said step of closing comprises closing the distal end by placing a second plug in an opening of a passage formed through the second end cap, the second plug being attached to a base portion of the second end cap by a second flexible arm, said step of closing further comprises closing the passage of the first end cap by placing the first plug in an opening of the passage of the first end cap, the first plug being attached to the base portion of the first end cap by a first flexible arm.

20. A method as recited in claim 14, further comprising the steps of:

removing one of the first end cap and the second end cap from one of the proximal end and the distal end of the capillary tube;

inserting one of the proximal end and the distal end of the capillary tube into a female port of a test instrument; and

analyzing the blood with the test instrument.

21. A method as recited in claim 14 further comprising the steps of:

opening the passage of one of the first end cap and the second end cap;

inserting a probe of a test instrument into the capillary tube through the passage of the one of the first end cap and the second end cap; and

analyzing the blood with the test instrument.

22. An end cap for closing an end of a capillary tube configured to retain a blood sample, said end cap comprising:

a base portion adapted to receive the end of the capillary tube, said base portion having a passage defined therethrough;

a plug configured to selectively close said passage; and

a Luer surface defined on an outer portion of said base portion.

23. An end cap as recited in claim 22 wherein said plug comprises a stopper, said end cap further comprising a flexible arm extending between said stopper and said base portion.

24. An end cap as recited in claim 22 wherein said plug comprises a hydrophobic filter disposed in said passage.

25. An end cap for closing an end of a capillary tube configured to retain a blood sample, said end cap comprising:

a base portion having a passage defined therethrough;

a plug configured to selectively close said passage; and

a Luer surface defined on an outer portion of said base portion;

wherein said plug comprises a stopper, said end cap further comprising a flexible arm extending between said stopper and said base portion.

26. An end cap for closing an end of a capillary tube configured to retain a blood sample, said end cap comprising:

a base portion having a passage defined therethrough;

a plug configured to selectively close said passage; and

a Luer surface defined on an outer portion of said base portion;

wherein said plug comprises a hydrophobic filter disposed in said passage.