Density phase separation device

Patent metadata

Field	Value
Publication number	US-9452427-B2
Application number	US-201213687292-A
Country	US
Kind code	B2
Filing date	Nov 28, 2012
Priority date	Jul 21, 2008
Publication date	Sep 27, 2016
Grant date	Sep 27, 2016

Abstract

A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.

First claim

The invention claimed is:

1. A mechanical separator for separating a fluid sample into first and second phases within a tube, the mechanical separator comprising:
a float comprising a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float;
a ballast longitudinally movable with respect to the float; and
a bellows extending between a portion of the float and a portion of the ballast, the bellows adapted for deformation upon longitudinal movement of the float and the ballast, the bellows isolated from the pierceable head, wherein both the pierceable head and the bellows comprise a thermoplastic elastomer.

2. The mechanical separator of claim 1 , wherein the float has a first density, and the ballast has a second density greater than the first density of the float.

3. The mechanical separator of claim 1 , wherein the pierceable head is structured to resist deformation upon application of a puncture tip therethrough.

4. The mechanical separator of claim 1 , wherein the pierceable head further comprises a rim portion for engagement with a closure.

5. The mechanical separator of claim 4 , wherein the rim portion of the pierceable head defines at least one notch.

6. The mechanical separator of claim 1 , wherein the pierceable head is received at least partially within an upper recess of the float.

7. The mechanical separator of claim 1 , wherein the bellows are circumferentially disposed about at least a portion of the float.

8. The mechanical separator of claim 1 , wherein the pierceable head and the bellows are isolated by a portion of the float.

9. The mechanical separator of claim 8 , wherein the pierceable head and the bellows are isolated by a neck portion of the float.

10. The mechanical separator of claim 1 , wherein the bellows comprises an interior wall defining a restraining surface, and the float comprises a shoulder for engaging the restraining surface.

11. The mechanical separator of claim 1 , wherein the ballast defines an interlock recess for accommodating a portion of the bellows for attachment thereto.

12. The mechanical separator of claim 1 , wherein the ballast comprises an exterior surface and defines an annular shoulder circumferentially disposed within the exterior surface.

13. The mechanical separator of claim 1 , wherein the float comprises polypropylene and the ballast comprises polyethylene terephthalate.

14. A mechanical separator comprising:
a first sub-assembly comprising a float having a pierceable head enclosing a first end thereof, the float having a first density; and
a second sub-assembly comprising a ballast and a bellows, the ballast having a second density greater than the first density of the float,
wherein the first sub-assembly and the second sub-assembly are attached through the bellows such that the ballast is longitudinally movable with respect to the float upon deformation of the bellows, the bellows of the second sub-assembly being isolated from the pierceable head of the first sub-assembly.

15. A method of assembling a mechanical separator, comprising the steps of:
providing a first sub-assembly, the first sub-assembly comprising a float with a neck and a pierceable head attached to the neck, the float having a first density;
providing a second sub-assembly, the second sub-assembly comprising a ballast having a second density greater than the first density of the float, the second sub-assembly further comprising a bellows extending from the ballast and including an interior restraining surface; and
joining the first sub-assembly with the second sub-assembly such that the neck of the float is in mechanical interface with the interior restraining surface of the bellows, wherein the pierceable head of the float is isolated from the bellows.

16. The method of claim 15 , wherein the joining step comprises inserting and guiding the float through an interior of the bellows until the neck of the float is in mechanical interface with the interior restraining surface of the bellows.

17. The method of claim 15 , wherein the ballast comprises an exterior surface and defines an annular shoulder circumferentially disposed thereabout, the annular shoulder structured for receipt of a mechanical assembler therein.

18. The method of claim 15 , wherein the float comprises polypropylene, the pierceable head comprises thermoplastic elastomer, the bellows comprises thermoplastic elastomer, and the ballast comprises polyethylene terephthalate.

19. A mechanical separator for separating a fluid sample into first and second phases within a tube, the mechanical separator comprising:
a float comprising a passageway extending between an upwardly oriented, pierceable closed end of the float and a downwardly oriented open end thereof;
a ballast longitudinally movable with respect to the float; and
a bellows extending between a portion of the float and a portion of the ballast, the bellows adapted for deformation upon longitudinal movement of the float and the ballast, the bellows isolated from the upwardly oriented, pierceable closed end of the float, wherein both the upwardly oriented, pierceable closed end of the float and the bellows comprise a thermoplastic elastomer,
wherein at least a portion of the float is positioned within a channel defined by an interior surface of the bellows.

20. A separation assembly for enabling separation of a fluid sample into first and second phases, comprising:
a tube, having an open end, a second end, and a sidewall extending therebetween;
a closure adapted for sealing engagement with the open end of the tube, the closure defining a recess; and
a mechanical separator releasably engaged within the recess, the mechanical separator comprising:
a float comprising a passageway extending between an upwardly oriented, pierceable closed end of the float and a downwardly oriented open end thereof;
a ballast longitudinally movable with respect to the float; and
a bellows extending between a portion of the float and a portion of the ballast, the bellows adapted for deformation upon longitudinal movement of the float and the ballast, the bellows isolated from the upwardly oriented, pierceable closed end of the float, wherein both the upwardly oriented, pierceable closed end of the float and the bellows comprise a thermoplastic elastomer,
wherein at least a portion of the float is positioned within a channel defined by an interior surface of the bellows.

21. The separation assembly of claim 20 , adapted to introduce a fluid sample into the tube and around the mechanical separator without passing through the mechanical separator.

Assignees

• Becton Dickinson Co

Inventors

• Felix Shenika E
• Crawford Jamieson W
• Battles Christopher A
• Gram Jes Tougaard

Classifications

• Y10T29/49826

  Assembling or joining · CPC title

• B04B7/08

  Rotary bowls (centrifugal casting machines B22D) · CPC title

• B01L2300/044

  pierceable, e.g. films, membranes · CPC title

• B01L2300/0858

  Side walls · CPC title

• B01L2300/048

  enabling gas exchange, e.g. vents · CPC title