Sealed collection device having striated cap Number:7,435,389 from the United States Patent and Trademark Office (PTO) owispatent A cap comprising a generally conical wall positioned beneath an opening in the cap and having a plurality of striations formed therein to facilitate penetration of the cap by a fluid transfer device.<H collection, striated, Sealed, collecti, 7435389.html, Patent, pto, 7435389

Title: Sealed collection device having striated cap

Abstract: A cap comprising a generally conical wall positioned beneath an opening in the cap and having a plurality of striations formed therein to facilitate penetration of the cap by a fluid transfer device.

Patent Number: 7,435,389 Issued on 10/14/2008 to Anderson, et al.

Inventors: Anderson; Bruce W. (Rancho Cucamonga, CA), Carter; Nick M. (Mooresville, NC), Iheme; Mordi I. (San Diego, CA), Johnson; Shirley J. (Mountain View, CA), Kacian; Daniel L. (San Diego, CA), Light, II; James P. (San Diego, CA), Tseo; Gus G. (San Diego, CA)
Assignee: Gen-Probe Incorporated (San Diego, CA)

Appl. No.: 10/758,304

Filed: January 14, 2004

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
09704210	Nov., 2000	6716396
09675641	Sep., 2000
09570124	May., 2000
60134265	May., 1999

Current U.S. Class: 422/100

Current International Class: B01L 3/02 (20060101)

Field of Search: 422/100

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Primary Examiner: Griffin; Walter D.
Assistant Examiner: Ramdhanie; Bobby
Attorney, Agent or Firm: Cappellari; Charles B.

Parent Case Text

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 09/704,210, filed Nov. 1, 2000, now U.S. Pat. No. 6,716,396, the contents of which are hereby incorporated by reference herein, which is a continuation-in-part of application Ser. No. 09/675,641, filed Sep. 29, 2000, now abandoned, which is a continuation-in-part of application Ser. No. 09/570,124, filed May 12, 2000, now abandoned, which claims the benefit of U.S. Provisional Application No. 60/134,265, filed May 14, 1999.

Claims

What we claim is:

1. A sealed collection device comprising a plastic cap frictionally fitted onto an open end of a fluid-holding vessel, said cap comprising: an opening defined by a top wall; and a downwardly tapered inner wall positioned beneath the opening and structurally interrelated to the top wall, the inner wall including a plurality of radially extending striations formed therein, wherein each of the striations has a thickness.

2. The cap of claim 1, wherein the cap is in threaded engagement with the vessel.

3. The cap of claim 1, wherein the inner wall depends from the top wall.

4. The cap of claim 1 further comprising a lower annular wall joining the top wall to the inner wall.

5. The cap of claim 1 further comprising an upper annular wall extending upwardly from the top wall.

6. The cap of claim 5 further comprising an absorbent wick contained within the cap.

7. The cap of claim 6, wherein the wick is positioned substantially above the top wall.

8. The cap of claim 6, wherein the wick is a pile fabric.

9. The cap of claim 6 further comprising a seal affixed to a top surface of the upper annular wall.

10. The cap of claim 6, wherein the combined force needed to penetrate the wick and the inner wall with a plastic pipette tip is less than about 10 pounds force.

11. The cap of claim 6, wherein the combined force needed to penetrate the wick and the inner wall with a plastic pipette tip is less than about 7 pounds force.

12. The cap of claim 6, wherein the combined force needed to penetrate the wick and the inner wall with a plastic pipette tip is less than about 4.5 pounds force.

13. The cap of claim 1, wherein the inner wall is conically shaped and has an angle of from about 25.degree. to about 65.degree. relative to the longitudinal axis of the cap.

14. The cap of claim 1, wherein the inner wall has a rounded bottom.

15. The cap of claim 1, wherein the thickness ratio between non-striated and striated portions of the inner wall is in the range of about 10:1 to about 1.25:1.

16. The cap of claim 1, wherein the average thickness of striated portions of the inner wall is between about 0.002 inches and about 0.008 inches, and wherein the average thickness of non-striated portions of the inner wall is between about 0.01 inches and about 0.02 inches.

17. The cap of claim 1, wherein the striations are formed in an inner surface, an outer surface or both the inner and outer surfaces of the inner wall.

18. The cap of claim 17, wherein the inner wall has between 3 and 12 of the striations.

19. The cap of claim 1, wherein each of the striations comprises a radially extending groove in the inner wall.

20. The cap of claim 1 further comprising one or more radially extending ribs formed on an inner surface of the inner wall, each rib being positioned between a pair of adjacent striations.

21. The cap of claim 1, wherein an inner surface of the inner wall is at least partially coated with a lubricant.

22. The cap of claim 1, wherein the force needed to penetrate the inner wall with a plastic pipette tip is less than about 8 pounds force.

23. The cap of claim 1, wherein the force needed to penetrate the inner wall with a plastic pipette tip is less than about 6 pounds force.

24. The cap of claim 1, wherein the force needed to penetrate the inner wall with a plastic pipette tip is less than about 4 pounds force.

Description

FIELD OF THE INVENTION

The present invention relates to caps for use in combination with fluid-holding vessels, such as those designed to receive and retain biological specimens for clinical analysis and patient monitoring or diagnosis. In particular, the present invention relates to a cap which is penetrable by a fluid transfer device used to transfer fluids to or from a fluid-holding vessel, where the vessel and cap remain physically and sealably associated during a fluid transfer.

The present invention further relates to fluid transfer devices which can be used to penetrate the caps of the present invention. In particular, these fluid transfer devices are adapted to include ribs which are expected to improve the strength characteristics of the fluid transfer devices and which may aid in creating passageways for venting displaced air from within a collection device. In addition to or in lieu of these ribs, fluid transfer devices of the present invention may include grooves on their outer surfaces for creating passageways to vent air displaced from the interior of a penetrated collection device. By providing means for venting air from within a collection device, fluid transfer devices of the present invention are expected to exhibit improved volume accuracy during fluid transfers (e.g., pipetting).

BACKGROUND OF THE INVENTION

Collection devices are a type of cap and vessel combination commonly used for receiving and storing biological specimens for delivery to clinical laboratories, where the specimens may be analyzed to determine the existence or state of a particular condition or the presence of a particular infectious agent. Types of biological specimens commonly collected and delivered to clinical laboratories for analysis include blood, urine, sputum, saliva, pus, mucous and cerebrospinal fluid. Since these specimen-types may contain pathogenic organisms, it is important to ensure that collection devices are constructed to be essentially leak-proof during transport from the site of collection to the site of analysis. This feature of collection devices is particularly critical in those cases where the clinical laboratory and the collection facility are remote from one another.

To prevent leakage, collection device caps are typically designed to be screwed, snapped or otherwise frictionally fitted onto the vessel component, thereby forming an essentially leak-proof seal between the cap and the vessel. In addition to preventing leakage of the specimen, an essentially leak-proof seal formed between the cap and the vessel of a collection device will also ameliorate exposure of the specimen to potentially contaminating influences from the surrounding environment. This aspect of a leak-proof seal is important for preventing the introduction of contaminants that could alter the qualitative or quantitative results of an assay.

While a leak-proof seal should prevent specimen seepage during transport, the physical removal of the cap from the vessel prior to specimen analysis presents another opportunity for contamination. When removing the cap, specimen which may have collected on the under-side of the cap during transport could come into contact with a practitioner, possibly exposing the practitioner to harmful pathogens present in the fluid sample. And if the specimen is proteinaceous or mucoid in nature, or if the transport medium contains detergents or surfactants, then a film or bubbles which may have formed around the mouth of the vessel during transport can burst when the cap is removed from the vessel, thereby disseminating specimen into the environment. It is also possible that specimen residue from one collection device, which may have transferred to the gloved hand of a practitioner, will come into contact with specimen from another collection device through routine or careless removal of the caps. Another risk is the potential for creating a contaminating aerosol when the cap and the vessel are physically separated from one another, possibly leading to false positives or exaggerated results in other specimens being simultaneously or subsequently assayed in the same general work area through cross-contamination.

Concerns with cross-contamination are especially acute when the assay being performed involves nucleic acid detection and includes an amplification procedure. There are many procedures in use for amplifying nucleic acids, including the polymerase chain reaction (PCR), (see, e.g., Mullis, "Process for Amplifying, Detecting, and/or Cloning Nucleic Acid Sequences," U.S. Pat. No. 4,683,195), transcription-mediated amplification (TMA), (see, e.g., Kacian et al., "Nucleic Acid Sequence Amplification Methods," U.S. Pat. No. 5,399,491), ligase chain reaction (LCR), (see, e.g., Birkenmeyer, "Amplification of Target Nucleic Acids Using Gap Filling Ligase Chain Reaction," U.S. Pat. No. 5,427,930), strand displacement amplification (SDA), (see, e.g., Walker, "Strand Displacement Amplification," U.S. Pat. No. 5,455,166), and loop-mediated isothermal amplification (see, e.g., Notomi et al., "Process for Synthesizing Nucleic Acid," U.S. Pat. No. 6,410,278). A review of several amplification procedures currently in use, including PCR and TMA, is provided in HELEN H. LEE ET AL., NUCLEIC ACID AMPLIFICATION TECHNOLOGIES (1997).

Since amplification is intended to enhance assay sensitivity by increasing the quantity of targeted nucleic acid sequences present in a specimen, transferring even a minute amount of pathogen-bearing specimen from another container, or target nucleic acid from a positive control sample, to an otherwise negative specimen could result in a false-positive result. To minimize the potential for creating contaminating specimen aerosols, and to limit direct contact between specimens and humans or the environment, it is desirable to have a collection device cap which can be penetrated by a fluid transfer device (e.g., pipette tip) while the cap remains physically and sealably associated with the vessel. And, to prevent damage to the fluid transfer device which could effect its ability to predictably and reliably dispense or draw fluids, the cap design should limit the forces necessary for the fluid transfer device to penetrate the cap. Ideally, the collection device could be used in both manual and automated formats and would be suited for use with pipette tips made of a plastic material.

In addition, when a sealed collection device is penetrated, the volume of space occupied by a fluid transfer device will displace an equivalent volume of air from within the collection device. Therefore, it would be desirable to have a fluid transfer device with means for permitting air to be released from a collection device at a controlled rate as the fluid transfer device penetrates a surface of the collection device (e.g., associated cap). Without such means, a pressurized movement of air from the collection device into the surrounding environment could promote the formation and release of potentially harmful or contaminating aerosols, or bubbles in those instances where proteins or surfactants are present in the fluid sample. Therefore, a fluid transfer device which facilitates a controlled release of air from a penetrated collection device is needed to prevent or minimize the release of fluid sample in the form of aerosols or bubbles.

SUMMARY OF THE INVENTION

The present invention addresses potential contamination problems associated with conventional collection devices by providing an integrally molded cap which includes an annular flange adapted to grip an inner or outer side wall surface of a vessel at an open end of the vessel, an annular top wall which is substantially perpendicular to the annular flange, an aperture defined by the inner circumference of the annular top wall, and a conical inner wall which tapers inwardly from the aperture to an apex located substantially at the longitud