Isolation tube woth and endcap

Inventors

Ronsick, Christopher S. • Wilson, Mark S. • Walsh, John D.

Assignees

Biomerieux Inc

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Publication Number

US-12070745-B2

Patent

Publication Date

2024-08-27

Expiration Date


Abstract

A separation container for extracting a portion of a sample for use or testing and method for preparing samples for downstream use or testing are provided. The separation container may include a body defining an internal chamber. The body may define an opening, and the body may be configured to receive the sample within the internal chamber. The separation container may further include a seal disposed across the opening, such that the seal may be configured to seal the opening of the body, and a plunger movably disposed at least partially inside the internal chamber. The plunger may be configured to be actuated to open the seal and express the portion of the sample.

Core Innovation

The invention relates to a microbial sample isolation separation container and associated centrifugation assemblies in which a body defines an internal chamber configured to receive a sample and defines an opening at a first end of the body. A seal is attached to the body and disposed across the opening to seal the opening at the first end, and an end cap is configured to be removably disposed at the first end so that the seal is positioned between the body and the end cap. The end cap defines an internal cavity, an end cap opening, and a support surface, and the seal is supported by the end cap during centrifugation.

The container and end cap include flange features in which the body defines an axis and a body flange with a flange surface facing parallel to the axis, and the end cap defines an end cap flange within the internal cavity configured to engage the body flange. The separation container may also include a coupling member defining a coupling member opening, with the coupling member disposed around a portion of the body such that the seal and a second portion of the body extend through the coupling member opening. These structural relationships position and retain the seal between the body and the end cap during centrifugation.

The described embodiments further address seal control during recovery of microbial pellets, including a removably supported end-cap interface that provides a support surface in a centrifuge cup interface and can couple to a downstream sample collecting vessel. The end-cap geometry is described as including one or more projecting ribs extending into an interior cavity of the end cap, as part of the removable end-cap configuration.

Claims Coverage

The independent claims cover a separation-container assembly with four inventive features: a body defining an internal chamber and an opening at a first end, a seal across the opening, an end cap removably received at the first end with flange and cavity/support-surface features, and additional coupling-member or projecting-rib refinements.

Removably disposed end cap positioning a seal across a first-end opening

A separation container having a body defining an internal chamber and an opening at a first end; a seal attached to the body and disposed across the opening to seal the opening; and an end cap configured to be removably disposed at the first end such that the seal is positioned between the body and the end cap.

Flange engagement with an end cap defining an internal cavity and a support surface

The body defines an axis extending from the first end to a second end; the body defines a body flange with a flange surface facing parallel to the axis; the end cap defines an internal cavity; and the end cap defines an end cap flange within the internal cavity configured to engage the body flange, wherein the end cap further includes an end cap opening and a support surface.

Coupling member with an opening for seal and second body portion extension

A separation container that further includes a coupling member defining a coupling member opening therethrough, wherein the coupling member is disposed around a portion of the body and wherein the seal and a second portion of the body extend through the coupling member opening, with the separation container configured to receive an end cap at the first end such that the seal is positioned between the body and the end cap.

End cap projecting ribs extending into an interior cavity

An assembly with an end cap configured to be removably disposed at the first end to receive the first end of the body such that the seal is positioned between the body and the end cap, wherein the end cap further comprises one or more projecting ribs extending into an interior cavity of the end cap.

The independent claims collectively define a microbial separation-container assembly that positions and retains a seal across a first-end opening using a removably disposed end cap, including flange engagement and internal-cavity support-surface features. Additional independent coverage introduces a coupling member through which the seal and a second body portion extend, and specifies an end cap with projecting ribs extending into an interior cavity.

Stated Advantages

Improve manufacturability.

Prevent contamination.

Reduce user handling.

No leakage.

Consistent pellet transfer.

Improved safety/ease of use.

Documented Applications

Downstream use of recovered viable/non-viable microorganisms pellets for culture.

Downstream use of recovered viable/non-viable microorganisms pellets for antibiotic susceptibility testing.

Downstream use of recovered viable/non-viable microorganisms pellets for MALDI-TOF.

Downstream use of recovered viable/non-viable microorganisms pellets for other assays.

Larger-volume sample processing, including viable recoveries for downstream MALDI-TOF and VITEK AST antibiotic susceptibility testing (AST).

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