Method for transferring a substance to or from a closed system

• US 20050079633A1
• Filed: 09/29/2004
• Published: 04/14/2005
• Est. Priority Date: 03/09/2001
• Status: Active Grant

• Current Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Original Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Inventors: Kacian, Daniel L., Carter, Nick M., Kennedy, Mark R.
• Granted Patent: US 7,294,308 B2
• Time in Patent Office: Days
• US Class Current: 436/180
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: B01L 3/565 Seals in general F16L
• CPC Class Codes: B65D 41/0414 formed by a plug, collar, flange, rib or the like contacting the internal surface of a container neck
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: B65D 51/1616 by means of a filter
• CPC Class Codes: B65G 2203/044 Optical
• CPC Class Codes: H01L 21/67784 using air tracks
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

The present invention relates to a cap which can form an essentially leak-proof seal with an open-ended vessel capable of receiving and holding fluid specimens or other materials for analysis. To minimize potentially contaminating contact between a fluid sample present in the vessel and humans or the environment, the present invention features a cap having a frangible seal which is penetrable by a plastic pipette tip or other fluid transfer device. The cap further includes filtering means for limiting dissemination of an aerosol or bubbles once the frangible seal has been pierced. The filtering means is positioned between the frangible seal and retaining means. The retaining means is positioned on the cap above the filtering means and may be used to contain the filtering means within the cap. The retaining means may be comprised of a material which is penetrable by a fluid transfer device.

Claims

1. A method for removing a fluid substance from a closed system comprising a penetrable cap in sealing engagement with an open end of a fluid-holding vessel, the method comprising the steps of:

a) entering an interior space defined by the cap and vessel of the system, wherein the step of entering the interior space of the system comprises;

i) penetrating a first frangible seal affixed to the cap with a fluid transfer device such that air passageways are formed between the fluid transfer device and the first frangible seal; and

ii) penetrating a second frangible seal affixed to the cap and axially aligned below the first frangible seal with the fluid transfer device such that air passageways are formed between the fluid transfer device and the second frangible seal, thereby permitting air to be vented from the interior space of the system;

b) drawing at least a portion of the fluid substance contained in the vessel into the fluid transfer device; and

c) removing the fluid transfer device from the system.

2. The method of claim 1 further comprising the step of passing the fluid transfer device through a filter contained within the cap and interposed between the first and second frangible seals.

3. The method of claim 2, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, a GORE-TEX ®

fabric, and a fabric containing a LYCRA®

fiber.

4. The method of claim 3, wherein the filter comprises a pile fabric.

5. The method of claim 1, wherein each of the first and second frangible seals comprises a foil.

6. The method of claim 5 further comprising the step of passing the fluid transfer device through a filter contained within the cap and interposed between the first and second frangible seals.

7. The method of claim 6, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, a GORE-TEX®

fabric, and a fabric containing a LYCRA®

fiber.

8. The method of claim 7, wherein the filter comprises a pile fabric.

9. The method of claim 2, wherein the fluid transfer device is a plastic pipette tip.

10. The method of claim 9, wherein step a) requires an insertion force of less than about 8 pounds force and step c) requires a withdrawal force of less than about 4 pounds force.

11. The method of claim 9, wherein step a) requires an insertion force of less than about 6.5 pounds force and step c) requires a withdrawal force of less than about 3 pounds force.

12. The method of claim 9, wherein step a) requires an insertion force of less than about 5 pounds force and step c) requires a withdrawal force of less than about 2 pounds force.

13. The method of claim 9, wherein step a) requires an insertion force of less than about 4.5 pounds force and step c) requires a withdrawal force of less than about 1 pound force.

14. The method of claim 1 further comprising the step of exposing at least a portion of the fluid substance removed from the system in step c) to nucleic acid amplification reagents and conditions.

15. The method of claim 1, wherein steps a) - c) are performed by an automated instrument.

24. The method of claim 13, wherein the substance is a fluid substance.

25. The method of claim 24, wherein the fluid substance is a reagent for performing a diagnostic assay.

26. The method of claim 13, wherein steps a) - c) are performed by an automated instrument.

16. A method for depositing a substance in a closed system comprising a penetrable cap in sealing engagement with an open end of a substance-holding vessel, the method comprising the steps of:

a) entering an interior space defined by the cap and vessel of the system, wherein the step of entering the interior space of the system comprises;

i) penetrating a first frangible seal affixed to the cap with a substance transfer device; and

ii) penetrating a second frangible seal affixed to the cap and axially aligned below the first frangible seal with the substance transfer device;

b) depositing one or more substances in the vessel; and

c) removing the substance transfer device from the system.

17. The method of claim 16 further comprising the step of passing the substance transfer device through a filter contained within the cap and interposed between the first and second frangible seals.

18. The method of claim 17, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, a GORE-TEX®

fabric, and a fabric containing a LYCRA®

fiber.

19. The method of claim 18, wherein the filter comprises a pile fabric.

20. The method of claim 16, wherein each of the first and second frangible seals comprises a foil.

21. The method of claim 20 further comprising the step of passing the substance transfer device through a filter contained within the cap and interposed between the first and second frangible seals.

22. The method of claim 21, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, a GORE-TEX®

fabric, and a fabric containing a LYCRA®

fiber.

23. The method of claim 22, wherein the filter comprises a pile fabric.