SAMPLE CONTAINER WITH PHYSICAL FILL-LINE INDICATOR

• US 20080125673A1
• Filed: 09/07/2007
• Published: 05/29/2008
• Est. Priority Date: 09/08/2006
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cook, Rick, Iskra, Michael, Carano, Donald J., Newby, C. Mark
• Granted Patent: US 9,409,176 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0854 Double walls
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: Y10T 29/49879 Spaced wall tube or receptacle
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material

Abstract

A collection container for collecting biological fluid specimens having an integral fill-line indicator which corresponds to a desired specimen volume is disclosed. The integral fill-line indicator may comprise a ridge that is raised from the surface of the collection container. The integral fill-line indicator may also be altered by surface modification to impart a distinct visual appearance and/or texture. The collection container may have a single or a plurality of integral fill-line indicators which correspond to a desired specimen volume range. A method of manufacturing a collection container having an integral fill-line indicator is also disclosed.

Claims

1. A specimen collection container assembly comprising:

a first tubular member having a first opening, a first closed bottom, and a first sidewall extending circumferentially between said first opening and said first closed bottom, said first tubular member capable of receiving a specimen sample therein;

a second tubular member having a second opening, a second closed bottom, and a second sidewall extending circumferentially between said second opening and said second closed bottom, said first tubular member being disposed within said second tubular member; and

a fill-line indicator positioned on at least one of said first and second sidewall, said fill-line indicator corresponding to at least a minimum expected fill volume of the collection container.

2. The container assembly of claim 1 wherein said first sidewall member has an inner and outer surface and said fill-line indicator is positioned on said inner surface of said first sidewall member.

3. The container assembly of claim 1 wherein said first sidewall member has an inner and outer surface and said fill-line indicator is positioned on said outer surface of said first sidewall member.

4. The container assembly of claim 1 wherein said second sidewall member has an inner and outer surface and said fill-line indicator is positioned on said inner surface of said second sidewall member.

5. The container assembly of claim 1 wherein said fill-line indicator is disposed on a surface of at least one of said first and second sidewall or the fill-line indicator is a textured surface capable of diffusing light and is formed integrally with one of said first and second sidewall.

6. The container assembly of claim 1 wherein the fill-line indicator comprises a single wide band extending at least partially circumferentially about a portion of at least one of said first and second sidewall, said single band having a first predetermined width defined by an upper boundary and a lower boundary, said upper boundary defining a maximum expected fill volume, said lower boundary defining a minimum expected fill volume.

7. The container assembly of claim 1 wherein the fill-line indicator comprises an upper line and a lower line extending at least partially circumferentially about a portion of at least one of said first and second sidewall and spaced a predetermined distance from each other, said upper line defining a maximum expected fill volume and said lower line defining a minimum expected fill volume.

8. The container assembly of claim 1 wherein the fill-line indicator comprises a line extending at least partially circumferentially about a portion of one of said first and second sidewall, said single line having a second predetermined width corresponding to a minimum volume of the expected fill volume of said collection container.

9. The container assembly of claim 1 wherein said first tubular member is formed from a moisture barrier material and said second tubular member is formed from a vapor barrier material.

10. The container assembly of claim 9 wherein said first tubular member comprises polypropylene and said second tubular member comprises polyethylene terephthalate.

11. The container assembly of claim 1 wherein the first tubular member defines an internal volume and the container assembly further includes a pierceable closure wherein the pressure of the internal volume is reduced with respect to atmosphere.

12. The container assembly of claim 11 wherein the fill-line indicator is positioned on at least one of said first and second sidewall so as to indicate at least a minimum expected fill volume of the specimen sample according to the reduced pressure of the internal volume of said container.

13. The container assembly of claim 11 wherein the fill-line indicator is positioned on at least one of said first and second sidewall so as to indicate at least a minimum expected fill volume of the specimen sample in combination with a pre-filled reagent located within said container in accordance with the reduced pressure of the internal volume of said container.

14. A biological specimen collection container assembly comprising:

a first tubular member having a first opening, a first closed bottom, and a first sidewall extending circumferentially between said first opening and said first closed bottom, said first tubular member capable of receiving a specimen sample therein;

a second tubular member having a second opening, a second closed bottom, and a second sidewall extending circumferentially between said second opening and said second closed bottom, said second sidewall having an inner and outer surface and a fill-line indicator integral with an inner surface of said second sidewall, said fill-line indicator corresponding to at least a minimum expected fill volume of the collection container, said first tubular member disposed within said second tubular member.

15. The container assembly of claim 14 wherein the fill-line indicator comprises a line extending at least partially circumferentially about a portion of said inner surface of said second sidewall, said line having a second predetermined width corresponding to a minimum volume of the expected fill volume of said collection container.

16. The container assembly of claim 14 wherein said fill-line indicator is a textured surface capable of diffusing light and is formed integrally with said inner surface of said second sidewall.

17. The container assembly of claim 14 wherein said minimum expected fill volume corresponds with one of a biological specimen sample to be received within said container or a biological specimen sample and a reagent present within the container.

18. The container assembly of claim 14 wherein the first tubular member defines an internal volume and the container assembly further includes a pierceable closure wherein the pressure of the internal volume is reduced with respect to atmosphere.

19. A method of making a specimen collection container comprising:

molding a first tubular member having a first opening, a first closed bottom, and a first sidewall extending circumferentially between said first opening and said first closed bottom, said first tubular member having a predetermined volume for receiving a specimen sample therein;

molding a second tubular member having a second opening, a second closed bottom, and a second sidewall extending circumferentially between said second opening and said second closed bottom;

providing a fill-line indicator on at least one of said first and second sidewall, said fill-line indicator corresponding to at least a minimum expected fill volume of the collection container; and

positioning said first tubular member within said second tubular member.

20. The method of claim 19 wherein at least said second tubular member is formed by an injection molding process including a core member and said fill-line indicator is formed on an inner surface of said second sidewall portion by providing a roughened surface at least partially circumventing a perimeter of said core member.

21. The method of claim 19 wherein the fill-line indicator comprises a single wide band extending at least partially circumferentially about a portion of one of said first and second sidewall, said band having a first predetermined width defined by an upper boundary and a lower boundary, said upper boundary defining a maximum expected fill volume, said lower boundary defining a minimum expected fill volume.

22. The method of claim 19 wherein the fill-line indicator comprises an upper and lower line extending at least partially circumferentially about a portion of one of said first and second sidewall and spaced a predetermined distance from each other, said upper fill-line defining a maximum expected fill volume and said lower line defining a minimum expected fill volume.

23. The method of claim 19 wherein the fill-line indicator comprises a line extending at least partially circumferentially about a portion of one of said first and second sidewall, said line having a first predetermined width corresponding to a minimum expected volume of the expected fill volume of said collection container.

24. A specimen collection container assembly comprising:

a tubular member having a first end, a second end, and a sidewall extending circumferentially between said first end and said second end, said tubular member capable of receiving a specimen sample therein; and

a fill-line indicator positioned on an inner surface of said sidewall, said fill-line indicator corresponding to at least a minimum expected fill volume of the collection container.

25. A method of making a specimen collection container comprising:

molding a tubular member having a first end, second, and a sidewall extending circumferentially between said opening and said closed bottom, said tubular member having a predetermined volume for receiving a specimen sample therein;

providing a fill-line indicator on an inner surface of said sidewall, said fill-line indicator corresponding to at least a minimum expected fill volume of the collection container.