Multi-Dose Vial and Method

• US 20130180618A1
• Filed: 01/17/2013
• Published: 07/18/2013
• Est. Priority Date: 01/17/2012
• Status: Active Grant

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Dr Py Institute LLC
• Inventors: Py, Daniel
• Granted Patent: US 9,801,787 B2
• Time in Patent Office: Days
• US Class Current: 141/2
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A vial for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices. The vial has a body, a variable-volume storage chamber within the body for storing multiple doses of the substance therein, and a one-way valve connectable in fluid communication with a syringe or other delivery device. The one-way valve is moveable relative to the body between first and second positions (i) one of which permits the valve to open so that substance from the variable-volume storage chamber can flow therethrough and into the syringe or other delivery device connected in fluid communication therewith, and (ii) one of which prevents the valve from opening.

Claims

1. A device for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices, comprising:

a body;

a storage chamber within the body for storing multiple doses of the substance therein; and

a one-way valve connectable in fluid communication with a syringe or other delivery device and moveable between first and second positions, and having a closed position preventing substance from passing therethrough and an open position permitting substance to pass therethrough;

wherein, in the first position the one-way valve is prevented from opening into the open position and substance from the storage chamber cannot pass therethrough, and in the second position the one-way valve is permitted to open into the open position so that the one-way valve permits substance from the storage chamber to flow therethrough and into the syringe or other delivery device connected in fluid communication therewith.

2. A device as defined in claim 1, wherein the one-way valve is configured to substantially prevent any fluid flow in a substantially opposite direction, from the syringe or other delivery device, therethrough, and into the storage chamber.

3. A device as defined in claim 1, wherein the storage chamber comprises a variable-volume storage chamber.

4. A device as defined in claim 1, wherein the one-way valve includes an elastic valve member defining a normally closed, valve seam that substantially prevents the passage of fluid therethrough when a pressure differential across the valve is less than a valve opening pressure, and allows the passage of fluid therethrough when a pressure differential across the valve exceeds the valve opening pressure.

5. A device as defined in claim 4, wherein the one-way valve includes a valve seat, and the elastic valve member engages the valve seat and forms the valve seam therebetween.

6. A device as defined in claim 5, wherein at least one of (i) the elastic valve member defines a progressively decreasing wall thickness in a direction from an inlet toward an outlet of the valve seam, and (ii) the valve seat defines a progressively increasing width or diameter in a direction from an inlet toward an outlet of the valve seam.

7. A device as defined in claim 1, wherein the one-way valve includes a valve member and a valve seat, and the valve member is movable relative to the valve seat when the pressure differential across the one-way valve exceeds a valve opening pressure.

8. A device as defined in claim 1, wherein the device includes a penetrable and resealable portion that is penetrable by a needle, filling or injection member for filling the storage chamber with substance to be dispensed, and is resealable to hermetically seal a resulting penetration aperture in the portion.

9. A device as defined in claim 8, wherein the penetrable and resealable portion is resealable by at least one of a liquid sealant and the application of radiation or energy thereto.

10. A device as defined in claim 1, further comprising a connector located downstream of an outlet of the one-way valve, wherein the connector is adapted to connect thereto the syringe or other delivery device.

11. A device as defined in claim 10, wherein the connector is a Luer connector.

12. A device as defined in claim 1, wherein the one-way valve is normally biased in a direction from the second position toward the first position.

13. A device as defined in claim 12, further including a spring that normally biases the one-way valve in a direction from the second position toward the first position.

14. A device as defined in claim 13, wherein the spring is approximately dome shaped.

15. A device as defined in claim 1, wherein (i) in the first position, the one-way valve is engaged with a surface of the device that substantially prevents the one-way valve from opening into the open position, and (ii) in the second position, the one-way valve is sufficiently disengaged from the surface of the device to permit the valve to open into the open position.

16. A device as defined in claim 15, wherein the one-way valve includes a valve seat and a valve member normally engaging the valve seat to define the closed position, the valve member being movable relative to the valve seat when a pressure differential across the one-way valve exceeds a valve opening pressure thereof, and in the first position, the surface of the device substantially prevents movement of the valve member relative to the valve seat, and in the second position, the valve member is sufficiently disengaged from the surface to permit movement of the valve member relative to the valve seat.

17. A device as defined in claim 16, wherein the surface of the device engageable with the valve member extends substantially annularly about the valve member.

18. A device as defined in claim 16, further comprising a connector located downstream of an outlet of the one-way valve, wherein the connector is adapted to connect thereto the syringe or other delivery device, and connection of the syringe or other delivery device causes the valve to move in a direction from the first position to the second position.

19. A device as defined in claim 18, wherein the connector defines the surface of the device engageable with the valve member in the first position.

20. A device as defined in claim 18, wherein the valve seat is configured so that the syringe or other delivery device engages the valve seat when connected to the device and moves the valve in a direction from the first position toward the second position.

21. A device as defined in claim 18, wherein the connector is a Luer connector.

22. A device as defined in claim 21, wherein the connector is one of a male and female Luer connector adapted to connect to a respectively corresponding female or male Luer connector of the syringe or other delivery device.

23. A device as defined in claim 22, wherein the Luer connector is either a threaded or slip fit Luer connector.

24. A device as defined in claim 1, wherein the storage chamber is hermetically sealed with respect to ambient atmosphere, is sterile, and includes therein sterile or aseptic substance.

25. A device as defined in claim 24, wherein the storage chamber is one of (i) empty and sterile, and (ii) sterile and includes therein sterile or aseptic substance.

26. A device as defined in claim 25, wherein the substance is at least one of a medicament, pharmaceutical, vaccine, liquid nutrition product and supplement.

27. A device as defined in claim 2, wherein the body is a flexible and collapsible body and defines the variable-volume storage chamber therein.

28. A device as defined in claim 2, wherein the body is substantially rigid and the variable-volume storage chamber is defined by a flexible bladder received within the rigid body.

29. A device as defined in claim 28, wherein the flexible bladder is a pouch and defines the variable-volume storage chamber therein.

30. A device as defined in claim 1, further including a closure connected to the body and hermetically sealing the storage chamber with respect to ambient atmosphere.

31. A device as defined in claim 30, wherein the closure includes the one-way valve.

32. A device as defined in claim 31, wherein the closure further includes a connector adapted to connect thereto the syringe or other delivery device, and the one-way valve is received within the connector.

33. A device as defined in claim 32, wherein in the first position the one-way valve engages at least one of the closure and the connector to prevent the one-way valve from opening into the open position, and in the second position the one-way valve is sufficiently disengaged from the at least one of the closure and the connector to permit the valve to open into the open position.

34. A device as defined in claim 33, wherein the one-way valve is normally biased in a direction from the second position toward the first position.

35. A device as defined in claim 34, further including a spring that normally biases the one-way valve in the direction from the second position toward the first position.

36. A device as defined in claim 35, wherein the spring is substantially dome shaped.

37. A device as defined in claim 30, wherein the closure includes a penetrable and resealable portion that is penetrable by a needle, filling or injection member for filling the variable-volume storage chamber with substance, and is resealable to hermetically seal a resulting penetration aperture in the portion.

38. A device as defined in claim 37, wherein the closure includes a base, and a relatively flexible assembly mounted to the base and forming at least one of the penetrable and resealable portion and the one-way valve.

39. A device as defined in claim 38, wherein the flexible assembly forms the penetrable and resealable portion, a valve member, and an elastic spring that both allows the valve member to move between the first and the second positions and biases the valve member in the direction from the second position toward the first position.

40. A device as defined in claim 39, wherein the flexible assembly is located between the closure base and the body and forms a fluid-tight seal therebetween.

41. A device as defined in claim 38, wherein the variable-volume storage chamber is defined by a pouch formed integral with the closure base and projecting therefrom.

42. A device as defined in claim 41, wherein the pouch is blow molded from a preform defined at least in part by the closure.

49. A device as defined in claim 1, wherein the body includes a sliding seal received therein and spaced relative to the one-way valve, wherein the storage chamber is a variable-volume storage chamber defined within the body between the sliding seal and the one-way valve.

50. A device as defined in claim 49, wherein the sliding seal includes a penetrable and resealable portion that is penetrable by a needle, filling, or injection member for filling the variable-volume storage chamber with substance, and resealable to hermetically seal a resulting penetration aperture in the portion.

51. A device as defined in claim 52, wherein the penetrable and resealable portion is resealable by at least one of a liquid sealant and the application of radiation or energy thereto.

52. A device as defined in claim 1, further comprising a base closure sealingly enclosing the body at an opposite side of the body from the one-way valve, and a flexible bladder integrally formed with the base closure and projecting therefrom toward the one-way valve, wherein the storage chamber is a variable-volume storage chamber defined between the flexible bladder and the body.

53. A device as defined in claim 52, wherein the flexible bladder is configured to collapse when the variable-volume storage chamber is filled and expand when substance is dispensed from the variable-volume storage chamber.

54. A device as defined in claim 52, wherein the flexible bladder is blow molded from a preform defined at least in part by the base closure.

55. A device as defined in claim 52, wherein the base closure further includes a penetrable and resealable portion that is penetrable by a needle, filling or injection member for filling the variable-volume storage chamber with substance, and resealable to hermetically seal a resulting penetration aperture in the portion.

56. A device as defined in claim 55, wherein the penetrable and resealable portion is resealable by at least one of a liquid sealant and the application of radiation or energy thereto.

43. A device for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices, comprising:

first means for storing therein multiple doses of the substance;

second means for coupling in fluid communication with a syringe or other delivery device and for moving between first and second positions, and for preventing substance from passing through the second means in a closed position and for permitting substance to pass through the second means in an open position;

and third means for preventing the second means from opening into the open position in the first position, and for permitting the second means to open into the open position in the second position.

44. A device as defined in claim 43, further including fourth means for penetrating with a needle, filling or injection member and for sterile or aseptic filling the substance into the first means.

45. A device as defined in claim 44, wherein the fourth means comprises a penetrable and resealable portion.

46. A device as defined in claim 43, further comprising fifth means for connecting thereto the syringe or other delivery device.

47. A device as defined in claim 46, further comprising sixth means for biasing the second means in a direction from the first position toward the second position.

48. A device as defined in claim 47, wherein the first means is a storage chamber, the second means is a one-way valve, the fifth means is a connector, the sixth means is a spring, and the third means is a surface of at least one of a body of the device and the connector that is engageable with the one-way valve in the first position.

57. A method comprising the following steps:

i. storing multiple doses of a substance to be dispensed in a storage chamber and sealing the stored multiple doses with respect to ambient atmosphere;

ii. connecting a syringe or other delivery device in fluid communication with a one-way valve in fluid communication with the storage chamber;

iii. dispensing a dose of substance from the storage chamber through the one-way valve and into the syringe or other delivery device;

iv. substantially preventing ambient fluid from passing through the one-way valve and into the storage chamber during step iii; and

v. repeating steps ii through iv with the same multiple dose device.

58. A method as defined in claim 57, wherein step (iii) includes creating at least a partial vacuum in the syringe or other delivery device and creating a pressure differential across the one-way valve that exceeds a valve opening pressure thereof.

61. A method as defined in claim 57, further comprising maintaining the substance in the storage chamber hermetically sealed with respect to ambient atmosphere throughout at least steps (i) through (iv).

62. A method as defined in claim 61, further comprising maintaining the substance in the storage chamber sterile or aseptic at least throughout steps (i) through (iv).

59. A method as defined in claim 59, further including during or after step (ii), moving the one-way valve from (i) a first position where the one-way valve is prevented from opening into an open position wherein substance may pass therethrough, to (ii) a second position where the one-way valve is permitted to open into the open position and substance may pass therethrough.

60. A method as defined in claim 59, wherein the moving step includes engaging the one-way valve with the syringe or other delivery device.