Reagent component dispensing caps for reagent containers used in automated clinical analyzers

• US 10,456,787 B2
• Filed: 08/11/2016
• Issued: 10/29/2019
• Est. Priority Date: 08/11/2016
• Status: Active Grant

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Inventors: Blankenstein, Gert, Zeng, Hansong
• Primary Examiner(s): Whatley, Benjamin R
• Application Number:
  US15/234,111
• Publication Number:
  US 20180043363A1
• Time in Patent Office: 1,174 Days
• Field of Search: 422550
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/523 with means for closing or opening
• CPC Class Codes: B65D 39/08 Threaded or like closure members secured by rotation; Bushes therefor
• CPC Class Codes: B65D 51/2807 the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
• CPC Class Codes: B65D 51/2835 ruptured by a sharp element, e.g. a cutter or a piercer
• CPC Class Codes: B65D 51/2864 the element being a plug or like element closing a passage between the auxiliary container and the main container
• CPC Class Codes: B65D 51/2892 the element, e.g. a valve, opening an aperture of the auxiliary container B65D51/2864, B65D51/2878 take precedence
• CPC Class Codes: B65D 81/3211 coaxially and provided with means facilitating admixture
• CPC Class Codes: G01N 35/1002 Reagent dispensers

Abstract

Described is an automated reagent dispensing cap and methods of use in an automated clinical analyzer for introducing one or more reagent components housed in the reagent dispensing cap into a container enclosing another reagent component with which it is combined to achieve a reagent useful for diagnostic testing.

Claims

1. A device for storing reagent components in an automated clinical analyzer, comprising:

a container lid, said container lid comprising,

a cylindrical wall about a longitudinal central axis, the cylindrical wall defining a lumen,

a first opening to the lumen at a first end of the cylindrical wall,

a second opening to the lumen at a second end of the cylindrical wall

a portion of the lumen defining a reagent chamber 62 configured to store one or more reagents,

wherein the cylindrical wall further comprises internal threads 30 extending from the first end 20 to the second end 22 of the cylindrical wall;

a cylindrical member 40 positioned within the lumen and confined between and shorter than the distance between the first and second ends, said cylindrical member 40 comprising external threads 50 configured to operatively engage the internal threads 30 of said cylindrical wall and thereby to move the cylindrical member along the central longitudinal axis within the lumen, and wherein said engagement between the internal threads 30 and said external threads 50 form a gas-tight seal between the first opening of the lumen and the reagent chamber 62;

a breakable seal 60 positioned at the second end 22 of cylindrical wall extending across the second opening of the lumen, wherein the reagent chamber 62 is bounded by the cylindrical wall, the cylindrical member 40 and the breakable seal 60; and

an attachment structure 75 joined to the second end of the cylindrical wall, the attachment structure 75 including an engagement portion shaped for receiving a mating engagement portion of a container 72 at an opening of the container 72 and retaining the cylindrical wall and the breakable seal 60 in a fixed position against the container 72 such that the breakable seal 60 seals the opening of the container 72.

2. The device of claim 1, wherein said attachment structure 75 is selected from the group consisting of threads, snap-lock, mating rings, receiving grooves, a friction-fit mechanism, Luer lock, and one or more tabs.

3. The device of claim 1, further comprising;

a cap 100 positioned at the first end 20 of the cylindrical wall, the cap 100 enclosing the cylindrical member and sealing the first opening of the lumen.

4. The device of claim 3, wherein said cap 10 is configured to reversibly attach to the container 72.

5. The device of claim 1, further comprising;

the container 72 coupled to the container lid via the attachment structure 75.

6. The device of claim 5, further comprising:

a first reagent stored in the reagent chamber of the container lid; and

a second reagent separately stored in the container, wherein the first reagent and the second reagent are separated from each other by the breakable seal 60.

7. The device of claim 6, wherein the first reagent is capable of breaking the breakable seal and mixing with the second reagent in response to displacement of the cylindrical member along the longitudinal axis toward the breakable seal.

8. The device of claim 1, further comprising a piercing probe extending from the cylindrical member toward the breakable seal, the piercing probe including a pointed tip configured for piercing the breakable seal in response to displacement of the cylindrical member along the longitudinal axis toward the breakable seal.