Sample container with physical fill-line indicator

Patent metadata

Field	Value
Publication number	US-9409176-B2
Application number	US-85196507-A
Country	US
Kind code	B2
Filing date	Sep 7, 2007
Priority date	Sep 8, 2006
Publication date	Aug 9, 2016
Grant date	Aug 9, 2016

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.

First claim

The invention claimed is:

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 non-removably engaged with said second tubular member; and
a fill-line indicator integrally formed with an inner surface of 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,
wherein said fill-line indicator is integrally formed with said inner surface of said second sidewall, wherein the first tubular member defines an internal volume, wherein the fill-line indicator corresponds to at least a minimum expected fill volume of the internal volume defined by the first tubular member, wherein said fill-line indicator comprises a roughened surface that defines an array of peaks and valleys, and wherein the remainder of the inner surface of the second sidewall comprises a highly polished transparent surface, and wherein said fill-line indicator provides an enlarging effect to the specimen sample when a meniscus of a fluid level of the specimen sample is at the fill-line indicator, providing an apparent indication of reaching such level of containment.

2. The container assembly of claim 1 wherein said fill-line indicator is a textured surface capable of diffusing light.

3. 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 said 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.

4. 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 said 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.

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

6. 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.

7. The container assembly of claim 6 wherein said first tubular member comprises polypropylene and said second tubular member comprises polyethylene terephthalate.

8. The container assembly of claim 1 wherein the container assembly further includes a pierceable closure wherein the pressure of the internal volume is reduced with respect to atmosphere.

9. The container assembly of claim 8 wherein the fill-line indicator is positioned on said 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.

10. The container assembly of claim 8 wherein the fill-line indicator is positioned 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.

11. 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 integrally formed with an inner surface of said second sidewall, said fill-line indicator corresponding to at least a minimum expected fill volume of the collection, said first tubular member non-removably engaged with said second tubular member,
wherein the first tubular member defines an internal volume, wherein the fill-line indicator corresponds to at least a minimum expected fill volume of the internal volume defined by the first tubular member, wherein said fill-line indicator comprises a roughened surface that defines an array of peaks and valleys, and wherein the remainder of the inner surface of the second sidewall comprises a highly polished transparent surface, and wherein said fill-line indicator provides an enlarging effect to the specimen sample when a meniscus of a fluid level of the specimen sample is at the fill-line indicator, providing an apparent indication of reaching such level of containment.

12. The container assembly of claim 11 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.

13. The container assembly of claim 11 wherein said fill-line indicator is a textured surface capable of diffusing light.

14. The container assembly of claim 11 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.

15. The container assembly of claim 11 wherein the container assembly further includes a pierceable closure wherein the pressure of the internal volume is reduced with respect to atmosphere.

16. 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 integrally formed with an inner surface of 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
non-removably engaging said first tubular member with said second tubular member,
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 by providing a roughened surface at least partially circumventing a perimeter of said core member, wherein said fill-line indicator comprises a roughened surface that defines an array of peaks and valleys, and wherein the remainder

Assignees

• Carano Donald J
• Cook Rick
• Iskra Michael
• Newby C Mark
• Becton Dickinson Co

Inventors

• Carano Donald J
• Cook Rick
• Iskra Michael
• Newby C Mark

Classifications

• B01L2300/02

  Identification, exchange or storage of information · CPC title

• B01L2300/0854

  Double walls · CPC title

• B01L3/5082 Primary

  Test tubes per se · CPC title

• B01L2200/12

  Specific details about manufacturing devices · CPC title

• A61B5/150755

  Blood sample preparation for further analysis, e.g. by separating blood components or by mixing · CPC title