Container with valve assembly for filling and dispensing substances, and apparatus and method for filling

• US 7,077,176 B2
• Filed: 04/28/2004
• Issued: 07/18/2006
• Est. Priority Date: 04/28/2003
• Status: Active Grant

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel
• Primary Examiner(s): Douglas, Steven O.
• Application Number:
  US10/833,371
• Publication Number:
  US 20050178462A1
• Time in Patent Office: 811 Days
• Field of Search: 141346-352, 141/301, 141/302, 251/149.1, 251/149.6, 251/149.7
• US Class Current: 141/301
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/1431 Permanent type, e.g. welded or glued
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/1481 with connection retaining means, e.g. thread or snap-fit
• CPC Class Codes: A61J 1/1487 with friction fit, e.g. connecting tubes directly to a protruding port
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2041 having removable plugs
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: B65D 47/248 the valve being opened or closed by imparting a motion to the valve stem B65D47/244, B65D47/245 take precedence

Abstract

A vial has a body defining a chamber for receiving a substance therein; and a valve assembly coupled in fluid communication with the chamber and defining (i) an open position permitting at least one of (a) passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and (ii) a closed position forming a fluid-tight seal between the chamber and exterior of the container. A filling member engages a flexible valve member of the valve assembly to move the valve member between the closed and open positions to fill and seal the vial, respectively. A syringe is connectable to the vial. The valve assembly opens upon connecting the syringe to the vial to allow the substance within the vial to be withdrawn from the vial and into the syringe by actuating a plunger of the syringe, and the valve assembly closes upon disconnecting the vial and syringe to hermetically seal and store the substance remaining in the syringe for later use.

Claims

1. A system comprising:

a container and valve assembly, including;

a body defining a chamber for receiving a substance therein; and

a valve assembly coupled in fluid communication with the chamber and defining (i) an open position permitting at least one of (a) passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and

(ii) a closed position forming a fluid-tight seal between the chamber and exterior of the container, the valve assembly comprising a flexible valve member defining a spring that is approximately dome-shaped when the valve assembly is in the closed position; and

a filling assembly including a filling member engageable with the valve assembly and coupled in fluid communication with a substance source for introducing the substance through the valve assembly and into the chamber, and wherein at least one of the valve assembly and the filling member is movable relative to the other to move the valve assembly between the closed and open positions and introduce the substance from the filling member therethrough and into the chamber.

2. A system as defined in claim 1, wherein the valve assembly permits in its open position both passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and passage of the substance out of the chamber for dispensing the substance therefrom.

3. A system as defined in claim 1, wherein the valve assembly further includes a valve seat, and the flexible valve member is movable between an open position spaced away from the valve seat and a closed position engaging the valve seat.

4. A system as defined in claim 3, wherein the container includes a cap coupled to the body and defining the valve seat.

5. A system as defined in claim 1, wherein the container further includes a mounting surface connectable to a syringe for connecting the syringe in fluid communication with the valve assembly.

6. A system as defined in claim 5, wherein the valve assembly includes a flexible valve member movable between the closed and open positions upon connecting the syringe to the mounting surface.

7. A system as defined in claim 6, wherein the valve member is received within the mounting surface and movable relative to the mounting surface between the open and closed positions.

8. A system as defined in claim 3, wherein the flexible valve member defines a sealing surface engageable with the valve seat for forming a fluid-tight seal therebetween, and wherein the spring stores energy therein upon moving the valve member from the closed to the open position, and that applies stored energy to in turn move the valve member from the open to the closed position.

9. A system as defined in claim 8, wherein the spring defines an annular surface extending about a periphery of the sealing surface.

10. A system as defined in claim 9, wherein the spring is curvilinear shaped.

11. A system as defined in claim 8, wherein the flexible valve member further defines a substantially cylindrically shaped portion connected to the spring at a nonrectangular angle.

12. A system as defined in claim 8, wherein the flexible valve member defines at least one aperture therein for permitting the flow of substance therethrough.

13. A system as defined in claim 4, wherein the container further includes a sealing member seated between the cap and the body and forming a fluid-tight seal therebetween.

14. A system as defined in claim 13, wherein the sealing member is formed by a peripheral portion of the flexible valve member.

15. A system as defined in claim 14, wherein the valve member is engageable with the filling member and movable between the closed and open positions upon movement of at least one of the valve member and filling member relative to the other.

16. A system as defined in claim 15, wherein the flexible valve member defines at least one aperture therethrough for permitting the flow of substance therethrough in the open position.

17. A system as defined in claim 16, wherein the spring normally biases the flexible valve member into the closed position.

18. A system as defined in claim 17, wherein the spring is formed by an annular portion of the flexible valve member.

19. A system as defined in claim 1, further comprising a syringe, wherein the container is a multiple dose vial including a mounting surface for connecting the vial to the syringe, the valve assembly is movable into the open position upon connecting the vial to the syringe to permit the withdrawal of substance from the chamber through the valve assembly and into the syringe, and the valve assembly is movable into the closed position upon removing the vial from the syringe to seal within the chamber any substance remaining within the vial.

20. A system as defined in claim 19, wherein the syringe includes a syringe mounting surface engageable with the vial mounting surface for releasably mounting the vial to the syringe and connecting the chamber of the vial in fluid communication with a chamber of the syringe.

21. A system as defined in claim 19, further comprising a sterile non-preserved substance contained within the chamber of the vial.

22. A system as defined in claim 4, wherein the cap is secured to the body by at least one of a snap-fit connection for snapping the cap to the body and a welded connection wherein the cap is welded to the body.

23. A system as defined in claim 1, wherein the valve assembly includes an integral elastomeric spring that is deformed upon moving the valve assembly from the closed to the open position, and that applies both axial and transversal forces to move the valve assembly from the open to the closed position.

24. A method of filling a container, wherein the container includes a body defining a chamber for receiving a substance therein;

a valve assembly coupled in fluid communication with the chamber and defining (i) an open position permitting at least one of (a) passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and

(ii) a closed position forming a fluid-tight seal between the chamber and exterior of the container, the valve assembly comprising a flexible valve member defining a spring that is approximately dome-shaped when the valve assembly is in the closed position;

wherein the method comprises the following steps;

sterilizing the sealed empty container;

filling the sterilized empty container with substance by moving at least one of the valve assembly and a filling member into engagement with the other;

moving the valve assembly into the open position upon engaging the filling member;

introducing substance from the filling member through the open valve assembly and into the chamber of the container; and

moving at least one of the valve assembly and filling member relative to the other to disengage the valve assembly and filling member and, in turn, move the valve assembly into the closed position to seal the substance within the chamber.

25. A method as defined in claim 24, wherein the step of sterilizing the empty container includes irradiating the sealed empty container.

26. A method as defined in claim 25, wherein the step of irradiating the sealed empty container includes subjecting the container to at least one of gamma, e-beam and laser radiation.

27. A method as defined in claim 24, further comprising the step of withdrawing substance from the container by connecting a syringe to the container, moving a plunger of the syringe and, in turn, withdrawing substance from the chamber of the container and into the syringe, and disconnecting the syringe and container.

28. A method as defined in claim 27, further comprising the steps of moving the valve assembly from the closed to the open position upon connecting the syringe to the container, withdrawing the substance through die open valve assembly by moving the plunger of the syringe, and moving the valve assembly from the open to the closed position upon disconnecting the syringe and container to seal the remaining substance within the container.

29. A method as defined in claim 26, further comprising the steps of:

following introduction of the substance from the filling member through the open valve assembly and into the chamber of the container, and with the valve member in an open position, evacuating at least the chamber;

lyophilizing the substance within the chamber; and

moving the valve member from the open to the closed position to seal the lyophilized substance within the chamber.

30. A method as defined in claim 29, further comprising the step of connecting the container to a syringe, moving the valve member from the closed to the open position, injected a diluent from the syringe into the chamber, and mixing the lyophilized substance with the diluent within the chamber.

31. A container and valve assembly that is fillable in a filling assembly including a filling member coupled in fluid communication with a substance source for introducing the substance into the container, the container and valve assembly comprising:

a body defining a chamber for receiving a substance therein; and

a valve assembly engageable with the filling member for introducing the substance through the valve assembly and into the chamber, the valve assembly being coupled in fluid communication with the chamber and defining (i) an open position permitting at least one of (a) passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and

(ii) a closed position forming a fluid-tight seal between the chamber and exterior of the container, the valve assembly comprising a flexible valve member defining a spring that is approximately dome-shaped when the valve assembly is in the closed position, wherein at least one of the valve assembly and the filling member is movable relative to the other to move the valve assembly between the closed and open positions and introduce the substance from the filling member therethrough and into the chamber.

32. A container and valve assembly as defined in claim 31, wherein the valve assembly further includes a valve seat, and the flexible valve member is movable between an open position spaced away from the valve seat and a closed position engaging the valve seat.

33. A container and valve assembly as defined in claim 32, wherein the container includes a cap coupled to the body and defining the valve seat.

34. A container and valve assembly as defined in claim 32, wherein the container further includes a mounting surface connectable to a syringe for connecting the syringe in fluid communication with the valve assembly.

35. A container and valve assembly as defined in claim 34, wherein the flexible valve member is movable between the closed and open positions upon connecting the syringe to the mounting surface.

36. A container and valve assembly as defined in claim 35, wherein the valve member is received within the mounting surface and movable relative to the mounting surface between the open and closed positions.

37. A container and valve assembly as defined in claim 32, wherein the flexible valve member defines a sealing surface engageable with the valve seat for forming a fluid-tight seal therebetween, and wherein the spring stores energy therein upon moving the valve member from the closed to the open position, and that applies stored energy to in turn move the valve member from the open to the closed position.

38. A container and valve assembly as defined in claim 37, wherein the spring defines an annular surface extending about a periphery of the sealing surface.

39. A container and valve assembly as defined in claim 38, wherein the spring is curvilinear shaped.

40. A container and valve assembly as defined in claim 37, wherein the flexible valve member further defines a substantially cylindrically shaped portion connected to the spring at a nonrectangular angle.

41. A container and valve assembly as defined in claim 37, wherein the flexible valve member defines at least one aperture therein for permitting the flow of the substance therethrough.

42. A container that is fillable in a filling assembly including a filling member coupled in fluid communication with a substance source for introducing the substance into the container, the container comprising:

a body defining a chamber for receiving a substance therein; and

first means engageable with the filling member and coupled in fluid communication with the chamber for introducing the substance from the filling member therethrough and into the chamber, and defining (i) an open position for permitting at least one of (a) passage of the substance through the first means and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and

(ii) a closed position for forming a fluid-tight seal between the chamber and exterior of the container, the first means defining a spring that is approximately dome-shaped when the first means is in the closed position, wherein at least one of the first means and the filling member is movable relative to the other to move the first means between the closed and open positions and introduce the substance from the filling member therethrough and into the chamber.

43. A container as defined in claim 42, wherein the first means is a flexible valve member and a valve seat, and the flexible valve member is movable between an open position spaced away from the valve seat and a closed position engaging the valve seat.

44. A container as defined in claim 42, further including second means for connecting the container to a syringe with the first means coupled in fluid communication with an interior chamber of the syringe.

45. A container as defined in claim 44, wherein the first means includes a flexible valve member movable between the closed and open positions upon connecting the syringe to the second means.

46. A container as defined in claim 45, wherein the second means is a mounting surface on the container.

47. A container as defined in claim 46, wherein the first means is received within the mounting surface and movable relative to the mounting surface between the open and closed positions.

48. A container as defined in claim 43, wherein the flexible valve member defines a sealing surface engageable with the valve seat for forming a fluid-tight seal therebetween, and wherein the spring stores energy therein upon moving the valve member from the closed to the open position, and that applies stored energy to in turn move the valve member from the open to the closed position.

49. A container as defined in claim 48, wherein the spring defines an annular surface extending about a periphery of the sealing surface.

50. A container as defined in claim 49, wherein the flexible valve member further defines a substantially cylindrically shaped portion connected to the spring at a nonrectangular angle.