Penetrable cap

• US 20020127147A1
• Filed: 03/08/2002
• Published: 09/12/2002
• 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 6,893,612 B2
• Time in Patent Office: Days
• US Class Current: 422/100
• 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 penetrable cap comprising:

a closed side wall having an inner surface, an outer surface, a top surface and a bottom surface;

attachment means for fixing the cap to an open-ended vessel in sealing engagement;

a ledge extending radially inwardly from the inner surface of the side wall of the cap and having a top surface, a bottom surface and an end surface, the end surface of the ledge defining an aperture sized to receive a fluid transfer device, wherein the inner surface of the side wall of the cap and the top surface of the ledge define a bore;

a frangible seal for preventing the passage of a fluid from an interior space of the vessel defined by the side wall and a bottom wall of the vessel into the bore, the seal being affixed to the top or bottom surface of the ledge;

filtering means for impeding or preventing the release of an aerosol or bubbles from the interior space of the vessel into the atmosphere, the filtering means being positioned substantially within the bore; and

retaining means for containing the filtering means within the bore.

2. The cap of claim 1, wherein the side wall, the flange and the ledge of the cap are comprised of a molded plastic and form a unitary piece.

3. The cap of claim 2, wherein the side wall of the cap is generally cylindrical.

4. The cap of claim 3, wherein the outer surface of the cap includes serrations to facilitate manual gripping of the cap.

5. The cap of claim 1, wherein the seal is affixed to the top surface of the ledge.

6. The cap of claim 1, wherein the seal comprises a foil.

7. A collection device comprising the cap of claim 1.

8. The collection device of claim 7 in packaged combination with at least one of a transport medium and a specimen retrieval device.

9. A method for removing a fluid substance from a collection device, the method comprising the steps of:

a) penetrating the cap of claim 7 with a fluid transfer device such that air passageways are formed between the fluid transfer device and the seal, thereby permitting air to be vented from the interior space of the vessel;

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

c) removing the fluid transfer device from the collection device.

10. The method of claim 9, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 8 pounds force.

11. The method of claim 9, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 6.5 pounds force.

12. The method of claim 9, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 5 pounds force.

13. The method of claim 9, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 4.5 pounds force.

14. The method of claim 9 further comprising the step of exposing at least a portion of the fluid substance removed from the collection device in step c) to nucleic acid amplification reagents and conditions.

16. The cap of claim 15, wherein the side wall, the flange, the ledge and the skirt of the cap are comprised of a molded plastic and form a unitary piece.

17. The cap of claim 16, wherein the side wall and the skirt of the cap are generally cylindrical.

18. The cap of claim 17, wherein the outer surface of the cap includes serrations to facilitate manual gripping of the cap.

19. The cap of claim 15, wherein the seal is affixed to the top surface of the ledge.

20. The cap of claim 15, wherein the seal comprises a foil.

21. A collection device comprising the cap of claim 15.

22. The collection device of claim 21 in packaged combination with at least one of a transport medium and a specimen retrieval device.

23. A method for removing a fluid substance from a collection device, the method comprising the steps of:

a) penetrating the cap of claim 21 with a fluid transfer device such that air passageways are formed between the fluid transfer device and the seal, thereby permitting air to be vented from the interior space of the vessel;

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

c) removing the fluid transfer device from the collection device.

24. The method of claim 23, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 8 pounds force.

25. The method of claim 23, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 6.5 pounds force.

26. The method of claim 23, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 5 pounds force.

27. The method of claim 23, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the cap with the pipette tip in step a) is less than about 4.5 pounds force.

28. The method of claim 23 further comprising the step of exposing at least a portion of the fluid substance removed from the collection device in step c) to nucleic acid amplification reagents and conditions.

30. The cap of claim 29, wherein the side wall, the flange, the ledge and the skirt of the cap are comprised of a molded plastic and form a unitary piece.

31. The cap of claim 30, wherein the side wall and the skirt of the cap are generally cylindrical.

32. The cap of claim 31, wherein the outer surface of the cap includes serrations to facilitate manual gripping of the cap.

33. The cap of claim 29, wherein the skirt has an outer surface which includes a seal bead which is in frictional contact with an inner surface of the side wall of the vessel when the cap is fitted onto the open end of the vessel.

34. The cap of claim 29, wherein the first seal is affixed to the top surface of the ledge.

35. The cap of claim 29, wherein each of the first and second seals comprises a foil.

36. The cap of claim 29, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, Gore-Tex®

and Lycra®

.

37. The cap of claim 36, wherein the filter comprises a pile fabric.

39. The cap of claim 38, wherein the side wall, the flange, the ledge and the skirt of the cap are comprised of a molded plastic and form a unitary piece.

40. The cap of claim 39, wherein the side wall and the skirt of the cap are generally cylindrical.

41. The cap of claim 40, wherein the outer surface of the cap includes serrations to facilitate manual gripping of the cap.

42. The cap of claim 38, wherein the skirt has an outer surface which includes a seal bead which is in frictional contact with an inner surface of the side wall of the vessel when the cap is fitted onto the open end of the vessel.

43. The cap of claim 38, wherein the seal is affixed to the top surface of the ledge.

44. The cap of claim 38, wherein the seal comprises a foil.

45. The cap of claim 38, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, Gore-Tex®

and Lycra®

.

46. The cap of claim 45, wherein the filter comprises a pile fabric.

48. The cap of claim 47, wherein the disc is comprised of a plastic, and wherein the side wall, the flange, the ledge and the skirt of the cap are comprised of a molded plastic and form a unitary piece.

49. The cap of claim 48, wherein the side wall and the skirt of the cap are generally cylindrical.

50. The cap of claim 49, wherein the outer surface of the cap includes serrations to facilitate manual gripping of the cap.

51. The cap of claim 47, wherein the skirt has an outer surface which includes a seal bead which is in frictional contact with an inner surface of the side wall of the vessel when the cap is fitted onto the open end of the vessel.

52. The cap of claim 47, wherein the top surface of the side wall of the cap includes a shelf sized to receive the disc in a frictional fit.

53. The cap of claim 47 further comprising a second seal affixed to a top surface or a bottom of the disc and which covers the hole formed in the disc.

54. The cap of claim 53, wherein the second seal is affixed to the top surface of the disc and includes a tab for removal.

55. The cap of claim 53, wherein the second seal comprises a frangible foil.

56. The cap of claim 47, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, Gore-Tex®

and Lycra®

.

57. The cap of claim 56, wherein the filter comprises a pile fabric.

59. The cap of claim 58, wherein each of the first and second seals comprises a foil.

60. The cap of claim 59, wherein the filter comprises a pile fabric.

15. A penetrable cap comprising:

a closed side wall having an inner surface, an outer surface, a top surface and a bottom surface;

attachment means for fixing the cap to an open-ended vessel in sealing engagement;

a ledge extending radially inwardly from the inner surface of the side wall of the cap and having a top surface, a bottom surface and an end surface, the end surface of the ledge defining an aperture sized to receive a fluid transfer device, wherein the inner surface of the side wall of the cap and the top surface of the ledge define a first bore;

a skirt depending from the bottom surface of the ledge, the skirt having an inner surface, an outer surface and a bottom surface, wherein the inner surface of the skirt defines a second bore having a diameter or width smaller than that of the first bore;

a frangible seal for preventing the passage of a fluid from an interior space of the vessel defined by the side wall and a bottom wall of the vessel into the first bore, the seal being affixed to the top surface of the ledge or to the bottom surface of the skirt;

filtering means for impeding or preventing the release of an aerosol or bubbles from the interior space of the vessel into the atmosphere, the filtering means being positioned substantially within the first bore; and

retaining means for containing the filtering means within the first bore.

29. A penetrable cap comprising:

a closed side wall having an inner surface, an outer surface, a top surface and a bottom surface;

attachment means for fixing the cap to an open-ended vessel in sealing engagement;

a ledge extending radially inwardly from the inner surface of the side wall of the cap and having a top surface, a bottom surface and an end surface, the end surface of the ledge defining an aperture sized to receive a fluid transfer device, wherein the inner surface of the side wall of the cap and the top surface of the ledge define a first bore;

a skirt depending from the bottom surface of the ledge, the skirt having an inner surface, an outer surface and a bottom surface, wherein the inner surface of the skirt defines a second bore having a diameter or width smaller than that of the first bore;

a first frangible seal for preventing the passage of a fluid from an interior space of the vessel defined by the side wall and a bottom wall of the vessel into the first bore, the seal being affixed to the top surface of the ledge or to the bottom surface of the skirt;

a filter for impeding or preventing the release of an aerosol or bubbles from the interior space of the vessel into the atmosphere, the filter being positioned substantially within the first bore; and

a second frangible seal for retaining the filter within the first bore.

38. A penetrable cap comprising:

a closed side wall having an inner surface, an outer surface, a top surface and a bottom surface;

attachment means for fixing the cap to an open-ended vessel in sealing engagement;

a ledge extending radially inwardly from the inner surface of the side wall of the cap and having a top surface, a bottom surface and an end surface, the end surface of the ledge defining an aperture sized to receive a fluid transfer device, wherein the inner surface of the side wall of the cap and the top surface of the ledge define a first bore;

a skirt depending from the bottom surface of the ledge, the skirt having an inner surface, an outer surface and a bottom surface, wherein the inner surface of the skirt defines a second bore having a diameter or width smaller than that of the first bore;

a frangible seal for preventing the passage of a fluid from an interior space of the vessel defined by the side wall and a bottom wall of the vessel into the first bore, the seal being affixed to the top surface of the ledge or to the bottom surface of the skirt;

a filter for impeding the release of an aerosol or bubbles from the interior space of the vessel into the atmosphere, the filter being positioned substantially within the first bore; and

a foil ring affixed to the top surface of the side wall of the cap, wherein the ring has a centrally located hole which is sized to receive the fluid transfer device and which is substantially axially aligned with the first and second bores.

47. A penetrable cap comprising:

a closed side wall having an inner surface, an outer surface, a top surface and a bottom surface;

attachment means for fixing the cap to an open-ended vessel in sealing engagement;

a ledge extending radially inwardly from the inner surface of the side wall of the cap and having a top surface, a bottom surface and an end surface, the end surface of the ledge defining an aperture sized to receive a fluid transfer device, wherein the inner surface of the side wall of the cap and the top surface of the ledge define a first bore;

a skirt depending from the bottom surface of the ledge, the skirt having an inner surface, an outer surface and a bottom surface, wherein the inner surface of the skirt defines a second bore having a diameter or width smaller than that of the first bore;

a first frangible seal for preventing the passage of a fluid from an interior space of the vessel defined by the side wall and a bottom wall of the vessel into the first bore, the seal being affixed to the top surface of the ledge or to the bottom surface of the skirt;

a filter for impeding or preventing the release of an aerosol or bubbles from the interior space of the vessel into the atmosphere, the filter being positioned substantially within the first bore; and

a disc affixed to the top surface of the side wall of the cap, wherein the disc has a hole formed therein which is sized to receive the fluid transfer device and which is substantially axially aligned with the first and second bores.

58. A penetrable cap comprising:

a generally cylindrical side wall having an inner surface, an outer surface, a top surface and a bottom surface;

a flange depending from the bottom surface of the side wall of the cap and having an inner surface adapted to grip an outer surface of a generally cylindrical side wall of an open-ended vessel;

a ledge extending radially inwardly from the inner surface of the side wall of the cap and having a top surface, a bottom surface and an annular end surface, the end surface of the ledge defining an aperture sized to receive a fluid transfer device, wherein the inner surface of the side wall of the cap and the top surface of the ledge define a first bore;

a generally cylindrical skirt depending from the bottom surface of the ledge, the skirt having an inner surface, an outer surface and a bottom surface,

wherein the inner surface of the skirt defines a second bore having a diameter smaller than that of the first bore,

wherein the skirt has an outer surface which includes an annular seal bead which is in frictional contact with an inner surface of the side wall of the vessel when the cap is fitted onto the open end of the vessel, and

wherein the side wall, the flange, the ledge and the skirt of the cap are comprised of a molded plastic and form a unitary piece;

a first frangible seal for preventing the passage of a fluid from an interior space of the vessel defined by the side wall and a bottom wall of the vessel into the first bore, the seal being affixed to the top surface of the ledge;

a filter for impeding or preventing the release of an aerosol or bubbles from the interior space of the vessel into the atmosphere, the filter being positioned substantially within the first bore; and

a second frangible seal for retaining the filter within the first bore.

61. A method for removing a fluid substance contained in a closed system comprising a cap and a fluid-holding vessel, the method comprising the steps of:

a) 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 seal;

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

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

d) removing the fluid transfer device from the system.

62. The method of claim 61, wherein each of the first and second seals comprises a foil.

63. The method of claim 61 further comprising the step of passing the fluid transfer device through a filter contained within the cap and interposed between the first and second seals.

64. The method of claim 63, wherein the filter comprises a material selected from the group consisting of a pile fabric, a sponge, a foam, a felt, a sliver knit, GoreTex®

and Lycra®

.

65. The method of claim 64, wherein the filter comprises a pile fabric.

66. The method of claim 61, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the first and second seals is less than about 8 pounds force.

67. The method of claim 61, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the first and second seals is less than about 6.5 pounds force.

68. The method of claim 61, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the first and second seals is less than about 5 pounds force.

69. The method of claim 61, wherein the fluid transfer device is a plastic pipette tip for use with an air displacement pipette, and wherein the total force required to penetrate the first and second seals is less than about 4.5 pounds force.

70. The method of claim 61 further comprising the step of exposing at least a portion of the fluid substance removed from the collection device in step d) to nucleic acid amplification reagents and conditions.

71. The method of claim 61, wherein the penetrating steps are performed by an automated instrument.

72. A method for depositing a substance in a closed system comprising a cap and an open-ended vessel, the method comprising the steps of:

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

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

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

d) removing the substance transfer device from the system.

73. The method of claim 72 further comprising the step of passing the substance transfer device through a filter contained within the cap and interposed between the first and second seals.

74. The method of claim 72, wherein at least one of the substances deposited in the vessel is a fluid.

75. The method of claim 74, wherein the fluid is a reagent for performing a diagnostic assay.