Granted Patent B2

US 9,989,177 · App. 13/874,839 · Granted Jun 5, 2018

Abstract

Claims (133)

1. A connector, comprising:

a first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;

a second connector portion adapted to engage the first connector portion and including (1) a valve, having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough, and (2) a septum axially overlying the flexible valve member;

wherein at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port;

wherein the closure is configured such that, in the first position, the closure hermetically seals with respect to ambient atmosphere all surfaces of the first connector portion that said fluid contacts when the first and second connector portions are in the connected position, thereby allowing aseptic passage of said fluid over said surfaces through the first connector portion when the first and second connector portions are in the connected position.

2. A connector as defined in claim 1 , wherein in the first position, the closure forms a substantially fluid-tight seal between the at least one port and the ambient atmosphere.

3. A connector as defined in claim 1 , wherein the closure is normally biased in the direction from the second position toward the first position to normally close the at least one port.

4. A connector as defined in claim 1 , wherein the flexible valve member is normally biased in the direction from the open position toward the closed position, to normally sealingly close the valve from the passage of fluid therethrough.

5. A connector as defined in claim 1 , wherein the first connector portion further includes a biasing member that normally biases the closure in the direction from the second position to the first position.

6. A connector as defined in claim 5 , wherein the biasing member includes a sealing member for sealingly engaging the hollow shaft of the filling member.

7. A connector as defined in claim 6 , wherein the sealing member is integrally formed with the biasing member.

8. A connector as defined in claim 6 , wherein the sealing member comprises an O-ring.

9. A connector as defined in claim 5 , wherein the biasing member comprises an elastic spring.

10. A connector as defined in claim 9 , wherein the elastic spring is approximately dome shaped.

11. A connector as defined in claim 10 , wherein the approximately dome shaped spring is over-molded to the closure.

12. A connector as defined in claim 10 , wherein the first connector portion further includes a venting valve.

13. A connector as defined in claim 12 , wherein the venting valve is configured to vent in air from the ambient atmosphere into a chamber defined by the dome shaped spring biasing member, when the at least one of the closure and the shaft is moved from the second position to the first position.

14. A connector as defined in claim 12 , wherein the venting valve is integrally formed with the approximately dome shaped spring biasing member.

15. A connector as defined in claim 1 , wherein the flexible valve member comprises an integral spring that normally biases the flexible valve member in the direction from the open position toward the closed position, to normally sealingly close the valve from the passage of fluid therethrough.

16. A connector as defined in claim 15 , wherein the integral spring is an elastic spring.

17. A connector as defined in claim 15 , wherein the spring is approximately dome shaped.

18. A connector as defined in claim 1 , wherein the septum axially overlying the flexible valve member is adapted to receive at least a portion of the filling member.

19. A connector as defined in claim 1 , wherein the septum defines a thickness within the range of a thickness equivalent to ½ the diameter of the filling member to a thickness equivalent to double the diameter of the filling member.

20. A connector as defined in claim 1 , wherein the septum defines a durometer within the range of 20 Shore A to 50 Shore A.

21. A connector as defined in claim 20 , wherein the septum defines a durometer within the range of 25 Shore A to 45 Shore A.

22. A connector as defined in claim 1 , wherein at least a portion of the closure is engageable with the septum of the second connector portion to prevent further movement of the closure relative to the second connector portion, whereby subsequent movement of the first connector portion moves the shaft from the first position to the second position.

23. A connector as defined in claim 1 , wherein movement of one of the first connector portion and the second connector portion relative to the other of the first connector portion and the second connector portion from the disconnected position to the connected position achieves at least approximately a 3 log reduction in bio-burden.

24. A connector as defined in claim 1 , wherein at least one of the closure and the shaft is movable from the second position to the first position, and the valve is movable from the open position to the closed position during or upon disengaging the filling member from the valve.

25. A connector as defined in claim 1 , wherein the closure includes a shutter extending annularly about the shaft.

26. A connector as defined in claim 25 , wherein the shutter is adapted to at least partially penetrate the septum during said movement between the disconnected position and the connected position.

27. A connector as defined in claim 26 , wherein the closure is adapted to be interposed between the at least one filling port and the septum during said movement between the disconnected position and the connected position.

28. A connector as defined in claim 1 , wherein the filling member comprises a cannula or a probe.

29. A connector as defined in claim 28 , wherein the tip is a blunt tip.

30. A connector as defined in claim 29 , wherein the tip is substantially curvilinear.

31. A connector as defined in claim 1 , further comprising a fitting adjacent an end of the shaft opposite the tip and engageable in fluid communication with a filling line for introducing fluid from the filling line through the connector.

32. The connector as defined in claim 1 , wherein the flexible valve member defines a concave recess or socket, said concave recess or socket configured to, when the first and second connector portions are in the connected position, sealingly receive any external portion of the filling member exposed to the ambient atmosphere in the first position, thereby sealing said ambient-exposed external portion within the concave recess or socket and preventing flow of fluid in the connected position across all surfaces of said ambient-exposed external portion that were exposed to the ambient atmosphere in the first position.

33. The connector as defined in claim 32 , wherein said ambient-exposed external portion includes an annular protrusion, the annular protrusion being sealed by the concave recess or socket.

34. The connector as defined in claim 32 , wherein the septum defines a septum passageway substantially axially overlying and aligned with said concave recess or socket.

35. The connector as defined in claim 34 , wherein a shape of the recess or socket corresponds with a shape of said filling member tip.

36. A connector as defined in claim 32 , wherein, during said movement between the disconnected position and the connected position, one or more of the closure is adapted to at least partially penetrate the septum or the closure is adapted to be interposed between the at least one filling port, and the tip engages with the concave recess or socket in the connected position.

37. A connector as defined in claim 1 , wherein the septum defines a septum passageway therein, said septum passageway adapted receive the filling member.

38. A connector as defined in claim 37 , wherein the flexible valve member defines an axially extending concave recess or socket and the septum passageway substantially aligns therewith, allowing the filling member to pass through the septum and engage with the concave recess or socket.

39. A connector as defined in claim 38 , wherein the concave recess or socket and the septum passageway are of substantially a same diameter.

40. A connector as defined in claim 1 , wherein the closure is adapted to at least partially penetrate the septum during said movement between the disconnected position and the connected position.

41. A connector, comprising:

first means for providing fluid to a second means for engaging the first means and for receiving fluid from the first means;

the first means comprising

third means for providing a conduit for the passage of fluid therethrough;

fourth means for engaging a valve and formed at one end of the third means;

fifth means for passage of fluid from the third means therethrough and in fluid communication with the third means; and

sixth means for closing the third means;

wherein at least one of the third means and the sixth means is movable between

(i) a first position wherein the sixth means closes the fifth means; and

(ii) a second position opening the fifth means;

the second means comprising

seventh means for engaging at least a portion the third means when the first means and the second means approach a connected position with each other, said seventh means axially overlying an eighth means for engaging the third means prior to the third means engaging the eighth means when the first means and the second means are in the connected position with each other;

wherein the eighth means is moveable between

(i) a closed position, wherein the eighth means prevents the flow of fluid therethrough; and

(ii) an open position, wherein the eighth means allows the flow of fluid therethrough;

wherein at least one of the first means and the second means is moveable relative to each other between

(i) a disconnected position wherein the at least one of the third means and the sixth means is in the first position and the eighth means is in the closed position; and

(ii) a connected position wherein the third means has engaged and moved the eighth means from the closed position to the open position and the at least one of the third means and the sixth means is in the second position opening the fifth means;

wherein the sixth means is configured such that, in the first position, the sixth means hermetically seals with respect to ambient atmosphere all surfaces of the first means that said fluid contacts when the first means and the second means are in the connected position, thereby allowing aseptic passage of said fluid over said surfaces through the first means when the first means and the second means are in the connected position.

42. A connector as defined in claim 41 , wherein the first means is a first connector portion, the second means is a second connector portion, the third means is a filling member, the fourth means is a tip of the filling member, the fifth means is at least one port, the sixth means is a closure, and the seventh means is a septum, and the eighth means is a valve.

43. A method, comprising:

engaging a first connector portion with a second connector portion,

the first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;

wherein the second connector portion is adapted to engage the first connector portion and includes (1) a valve having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough, and (2) a septum axially overlying the flexible valve member;

at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port; and

in the first position, the closure hermetically seals with respect to ambient atmosphere all surfaces of the first connector portion that said fluid contacts when the first and second connector portions are in the connected position, thereby allowing aseptic passage of said fluid over said surfaces through the first connector portion when the first and second connector portions are in the connected position;

moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position;

engaging the valve with the filling member;

moving the valve from the closed position to the open position;

moving at least one of the closure and the shaft from the first position closing the at least one port to the second position opening the at least one port; and

introducing fluid from the shaft through the at least one port and the valve, thereby aseptically passing fluid through the first connector portion.

44. A method as defined in claim 43 , wherein the step of moving at least one of the closure and the shaft from the first position to the second position occurs with the step of moving the valve from the closed position to the open position.

45. A method as defined in claim 43 , further comprising substantially sealing the at least one filling port from ambient atmosphere in the closed position.

46. A method as defined in claim 43 , further comprising the step of sterilizing the first connector portion and the second connector portion.

47. A method as defined in claim 43 , further comprising the step of aligning the first connector portion with the second connector portion.

48. A method as defined in claim 43 , wherein the step of moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position comprises both axial and rotational movement.

49. A method as defined in claim 43 , wherein the septum axially overlying the flexible valve member is adapted to receive at least a portion of the filling member and the step of moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position further comprises moving the filling member through the septum and wiping contaminants from the filling member with the septum.

50. A method as defined in claim 49 , wherein the wiping step comprises wiping contaminants from the tip of the filling member with the septum.

51. A method as defined in claim 49 , wherein the septum defines a durometer within the range of 20 Shore A to 50 Shore A.

52. A method as defined in claim 51 , wherein the septum defines a durometer within the range of 25 Shore A to 45 Shore A.

53. A method as defined in claim 51 , wherein the septum defines a thickness with the range of a thickness equivalent to ½ the diameter of the filling member to a thickness equivalent to double the diameter of the filling member.

54. A method as defined in claim 49 , wherein the wiping step achieves at least approximately a 3 log reduction in bio-burden of the filling member.

55. A method as defined in claim 43 , further comprising the following steps:

disengaging the filling member from the valve;

before or during the disengaging step, moving at least one of the closure and the shaft from the second position to the first position, and moving the valve from the open position to the closed position;

moving the at least one of the first connector portion and the second connector portion relative to each other from the connected position to the disconnected position; and

separating the first connector portion and the second connector portion.

56. A method as defined in claim 55 ,

wherein during said step of moving from the disconnected position toward the connected position, substantially preventing any contact between the at least one filling port and the septum.

57. A method as defined in claim 55 ,

wherein the method further comprises interposing the closure between the at least one filling port and septum during said step of moving from the disconnected position toward the connected position and substantially preventing any contact between the at least one filling port and septum.

58. A method as defined in claim 55 , further comprising performing the engaging, introducing and disengaging steps in a non-sterile environment or an environment defining a SAL of log 3 or less; introducing a sterile fluid through the first and second connector portions; and maintaining the sterility of the filled fluid throughout the engaging, introducing and disengaging steps.

59. A method as defined in claim 43 , further comprising aseptically passing fluid through the second connector portion.

60. A connector, comprising:

a first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port; and

a second connector portion adapted to engage the first connector portion and including a valve, having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough;

wherein at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port;

wherein the second connector portion further comprises a septum axially overlying the flexible valve member of the valve and adapted to receive and engage with at least a portion of the filling member.

61. A connector as defined in claim 60 , wherein movement of one of the first connector portion and the second connector portion relative to the other of the first connector portion and the second connector portion from the disconnected position to the connected position achieves at least approximately a 3 log reduction in bio-burden.

62. A connector, comprising:

a first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable relative to each other between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port; and

a second connector portion adapted to engage the first connector portion and including a valve, having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough;

wherein at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port; and

wherein the second connector portion is configured such that movement of the at least one of the first and second connector portions relative to each other in a direction from the disconnected position toward the connected position wipes contaminants from the filling member.

63. A connector as defined in claim 62 , wherein such wiping of the filling member achieves at least approximately a 3 log reduction in bio-burden.

64. A method, comprising:

engaging a first connector portion with a second connector portion,

the first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;

wherein the second connector portion is adapted to engage the first connector portion and includes a valve having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough, wherein the second connector further comprises a septum axially overlying the flexible valve member of the valve and adapted to receive at least a portion of the filling member;

and at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port;

moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position;

engaging the valve with the filling member;

moving the valve from the closed position to the open position;

moving at least one of the closure and the shaft from the first position closing the at least one port to the second position opening the at least one port; and

introducing fluid from the shaft through the at least one port and the valve.

65. A method as defined in claim 64 , wherein the step of moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position achieves at least approximately a 3 log reduction in bio-burden.

66. A method comprising:

engaging a first connector portion with a second connector portion,

the first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure;

wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;

wherein the second connector portion is adapted to engage the first connector portion and includes a valve having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough; and

at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port;

moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position;

wiping contaminants from the filling member during said moving step;

engaging the valve with the filling member;

moving the valve from the closed position to the open position;

moving at least one of the closure and the shaft from the first position closing the at least one port to the second position opening the at least one port; and

introducing fluid from the shaft through the at least one port and the valve.

67. A method as defined in claim 66 , wherein the wiping step achieves at least approximately a 3 log reduction in bio-burden of the filling member.

Assignments (6)