Penetrable cap

• US 6,893,612 B2
• Filed: 03/08/2002
• Issued: 05/17/2005
• Est. Priority Date: 03/09/2001
• Status: Expired due to Term

• Current Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Original Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Inventors: Kacian, Daniel L., Carter, Nick M., Kennedy, Mark R.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US10/093,511
• Publication Number:
  US 20020127147A1
• Time in Patent Office: 1,166 Days
• Field of Search: 422/99, 422/100, 422/101, 422/102, 422/916, 436/174, 436/177, 436/180, 435/6, 215247-250, 215/258, 215/232, 738/647.4
• US Class Current: 422/570
• 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

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 cap has a frangible seal which is penetrable by a plastic pipette tip or other fluid transfer device. The cap further includes a filter for limiting dissemination of an aerosol or bubbles once the frangible seal has been pierced. The filter is positioned between the frangible seal and a retainer. The retainer is positioned on the cap above the filter and may be used to contain the filter within the cap. The material of the retainer may be penetrable by a fluid transfer device.

Claims

1. A penetrable cap comprising:

closed side wall;

a ledge extending radially inwardly from the side wall of the cap and having an end surface which defines an opening sized to receive a fluid transfer device therethrough;

a frangible seal for providing a fluid barrier, the frangible seal being affixed to a surface of the ledge and covering the opening; and

a filter for impeding or preventing the passage an aerosol or bubbles through the cap, the filter being positioned above the frangible seal and contained substantially within the cap.

2. The cap of claim 1, wherein the cap is adapted for joining the cap to an open-ended vessel.

3. The cap of claim 1 further comprising a retainer for containing the filter within the cap.

4. The cap of claim 3, wherein the retainer is selected from the group consisting of a second frangible seal affixed to a top surface of the side wall, a foil ring affixed to the top surface of the side wall and defining an opening which is sized to receive the fluid transfer device therethrough, and a disc affixed to the top surface of the side wall and having a hole formed therein which is sized to receive the fluid transfer device therethrough.

5. The cap of claim 3, wherein the side wall includes attachment means for fixing the cap on m open-ended vessel in sealing engagement.

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

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

8. The cap of claim 1, wherein the filter comprises a synthetic material.

9. The cap of claim 8, wherein the filter comprises a pile fabric.

10. The cap of claim 1, wherein the filter is bound to the cap with an adhesive.

11. The cap of claim 1, wherein the side wall has a generally cylindrical shape.

12. The cap of claim 1, wherein the side wall and the ledge are formed of a unitary piece of molded plastic.

13. The cap of claim 1 further comprising a skirt depending from the ledge and circumscribing the opening.

14. The cap of claim 13, wherein the skirt includes an outer seal bead which is in frictional contact with an inner surface of a closed side wall of a vessel having an open end when the open end of the vessel is in sealing engagement with the cap.

15. The cap of claim 13, wherein the side wall, the ledge and the skirt are formed of a unitary piece of molded plastic.

16. The cap of claim 1, wherein the fluid transfer device is a plastic pipette tip.

17. The cap of claim 1 in packaged combination with an open-ended vessel dimensioned to hold fluid substances.

18. The cap and vessel of claim 17 in further packaged combination with at least one of a transport medium and a specimen retrieval device.

19. A system comprising the cap of claim 1 sealing engagement with an open-ended vessel dimensioned to hold fluid substances.

20. A method for removing a fluid substance from the system of claim 19, the method comprising the steps of:

a) penetrating the cap of the system with a fluid transfer device such that air passageways are formed between the fluid transfer device and the frangible seal, thereby permitting air to be vented from the system;

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

c) removing the fluid transfer device from the system.

21. The method of claim 20, wherein the fluid transfer device is a pipette tip.

22. The method of claim 21, 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.

23. The method of claim 21, 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.

24. The method of claim 21, 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.

25. The method of claim 21, 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.

26. The method of claim 20 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.

27. A penetrable cap comprising:

a generally cylindrical side wall;

a generally cylindrical skirt inside of and structurally interrelated to die side wall, the skirt defining an opening dimensioned to receive a fluid transfer device therethrough;

a frangible seal for providing a fluid barrier, the frangible seal being affixed to the cap and covering the opening in the skirt; and

a filter fix impeding or preventing the passage of an aerosol or bubbles through the cap, the filter being positioned above the frangible seal and contained substantially within the cap.

28. The cap of claim 27, wherein the cap is adapted for joining the cap to an open-ended vessel.

29. The cap of claim 27 further comprising a retainer for containing the filter within the cap.

30. The cap of claim 29, wherein the retainer is selected from the group consisting of a second frangible seal affixed to a top surface of the side wall, a foil ring affixed to the top surface of the side wall and defining an opening which is sized to receive the fluid transfer device therethrough, and a disc affixed to the top surface of the side wall and having a hole formed therein which is sized to receive the fluid transfer device therethrough.

31. The cap of claim 29, wherein the side wall includes attachment means for fixing the cap on an open-ended vessel in sealing engagement.

32. The cap of claim 27, wherein the frangible seal is affixed to the cap above the skirt.

33. The cap of claim 27, wherein the frangible seal is affixed to an annular bottom surface of the skirt.

34. The cap of claim 27, wherein the frangible seal comprises a foil.

35. The cap of claim 27, wherein the filter comprises a synthetic material.

36. The cap of claim 35, wherein the filter comprises a pile fabric.

37. The cap of claim 27, wherein the filter is bound to the cap with an adhesive.

38. The cap of claim 27, wherein the skirt includes an annular, outer seal bead which is in frictional contact with an inner surface of a closed side wall of a vessel having an open end when the open end of the vessel is in sealing engagement with the cap.

39. The cap of claim 27, wherein the side wall and the skirt are formed of a unitary piece of molded plastic.

40. The cap of claim 27, wherein the fluid transfer device is a plastic pipette tip.

41. The cap of claim 27 in packaged combination with an open-ended vessel dimensioned to hold fluid substances.

42. The cap and vessel of claim 41 in further packaged combination with at least one of a transport medium and a specimen retrieval device.

43. A system comprising the cap of claim 27 in sealing engagement with an open-ended vessel dimensioned to bold fluid substances.

44. A method for removing a fluid substance from the system of claim 43, the method comprising the steps of:

a) penetrating the cap of the system with a fluid transfer device such that air passageways are formed between the fluid transfer device and the frangible seal, thereby permitting air to be vented from the system;

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

c) removing the fluid transfer device from the system.

45. The method of claim 44, wherein the fluid transfer device is a pipette tip.

46. The method of claim 45, 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.

47. The method of claim 45, 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.

48. The method of claim 45, 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.

49. The method of claim 45, 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.

50. The method of claim 44 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.

51. A penetrable cap comprising:

a closed side wall;

a ledge extending radially inwardly from the side wall and having an end surface which defines an opening, wherein the side wall above the ledge defines a first bore;

a skirt depending from the ledge and circumscribing the opening, wherein the skirt defines a second bore having a diameter or width smaller than that of the first bore, wherein the second bore is sized to receive a fluid transfer device therethrough;

a first frangible seal for providing a fluid barrier, the first frangible seal being affixed to a top surface of the ledge or to a bottom surface of the skirt;

a filter for impeding or preventing the passage of an aerosol or bubbles through the cap, the filter being positioned above the first frangible seal and contained substantially within the first bore; and

a retainer for containing the filter within the cap.

52. The cap of claim 51, wherein the cap is adapted for joining the cap to an open-ended vessel.

53. The cap of claim 51, wherein the retainer is selected from the group consisting of a second frangible seal affixed to atop surface of the side wall, a foil ring affixed to the top surface of the side wall and defining an opening which is sized to receive the fluid transfer device therethrough, and a disc affixed to the top surface of the side wall and having a hole formed therein which is sized to receive the fluid transfer device therethrough.

54. The cap of claim 53, wherein the side wall includes attachment means for fixing the cap on an open-ended vessel in sealing engagement.

55. The cap of claim 53, wherein the retainer is the second frangible seal.

56. The cap of claim 55, wherein each of the first and second frangible seals comprises a foil.

57. The cap of claim 55, wherein the side wall and the skirt each have a generally cylindrical shape.

58. The cap of claim 53, wherein the retainer is the foil ring.

59. The cap of claim 58, wherein the first frangible seal comprises a foil.

60. The cap of claim 58, wherein the side wall and the skirt each have a generally cylindrical shape.

61. The cap of claim 58, wherein the opening defined by the foil ring and the opening defined by the ledge are substantially axially aligned.

62. The cap of claim 53, wherein the retainer is the disc.

63. The cap of claim 62, wherein the disc is a plastic.

64. The cap of claim 62, wherein the top surface of the side wall includes a shelf sized to receive the disc in a frictional fit.

65. The cap of claim 64 further comprising a second seal affixed to atop or bottom surface of the disc and which covers the hole formed in the disc.

66. The cap of claim 65, wherein the second seal is affixed to the top surface of the disc and includes a tab for removal.

69. The cap of claim 62, wherein the side wall and the skirt each have a generally cylindrical shape.

70. The cap of claim 62, wherein the hole formed in the disc and the opening defined by the ledge are substantially axially aligned.

71. The cap of claim 51, wherein the first frangible seal is affixed to the top surface of the ledge.

72. The cap of claim 51, wherein the first frangible seal comprises a foil.

73. The cap of claim 51, wherein the filter comprises a synthetic material.

74. The cap of claim 73, wherein the filter comprises a pile fabric.

75. The cap of claim 51, wherein the filter is bound to the cap with an adhesive.

76. The cap of claim 51, wherein the skirt includes an outer seal bead which is in frictional contact with an inner surface of a closed side wall of a vessel having an open end when the open end of the vessel is in sealing engagement with the cap.

77. The cap of claim 51, wherein the side wall, the ledge and the skirt are formed of a unitary piece of molded plastic.

78. The cap of claim 51, wherein the fluid transfer device is a plastic pipette tip.

79. The cap of claim 51 in packaged combination with an open-ended vessel dimensioned to hold fluid substances.

80. The cap and vessel of claim 79 in further packaged combination with at least one of a transport medium and a specimen retrieval device.

81. A system comprising the cap of claim 51 in sealing engagement with an open-ended vessel dimensioned to hold fluid substances.

82. A method for removing a fluid substance from the system of claim 81, the method comprising the steps of:

a) penetrating the cap of the system with a fluid transfer device such that air passageways are formed between the fluid transfer device and the first frangible seal, thereby permitting air to be vented from the system;

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

c) removing the fluid transfer device from the system.

83. The method of claim 82, wherein the fluid transfer device is a pipette tip.

84. The method of claim 83, 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.

85. The method of claim 83, 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.

86. The method of claim 83, 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.

87. The method of claim 83, 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.

88. The method of claim 82 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.

67. The cap of claim 67, wherein the second seal is a frangible seal.

68. The cap of claim 67, wherein each of the first and second frangible seals comprises a foil.