Container with valve assembly, and apparatus and method for filling

• US 20070084524A1
• Filed: 07/17/2006
• Published: 04/19/2007
• Est. Priority Date: 04/28/2003
• Status: Active Grant

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Maej, LLC
• Inventors: Py, Daniel
• Granted Patent: US 7,568,509 B2
• Time in Patent Office: Days
• 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 is connectable in fluid communication with the valve assembly to fill the chamber therethrough.

Claims

1-50. -50. (canceled)

51. A device 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 device, the device comprising:

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

a valve assembly connectable in fluid communication between the filling member and the chamber for introducing the substance through the valve assembly and into the chamber, wherein the valve assembly includes an axially-extending valve seat, and a flexible valve member overlying the valve seat, the flexible valve member and the valve seat form a normally closed interface defining a fluid-tight seal therebetween, and the flexible valve member is flexible outwardly relative to the valve seat in response to the introduction of substance at sufficient pressure from the filling member into the interface between the valve member and the valve seat to open the valve assembly and allow passage of the substance therethrough and into the chamber.

52. A device as defined in claim 51, wherein the valve assembly defines an annular, axially-extending interface between the valve member and the valve seat.

53. A device as defined in claim 51, wherein the valve seat is relatively rigid in comparison to the valve member, and the valve member is relatively flexible in comparison to the valve seat.

54. A device as defined in claim 53, wherein the relatively flexible valve member extends about a periphery of the relatively rigid valve seat.

55. A device as defined in claim 51, wherein the valve member forms an interference fit with the valve seat at the interface of the valve member and the valve seat to thereby form the fluid-tight seal therebetween.

56. A device as defined in claim 51, wherein the valve member defines a progressively decreasing wall thickness in an axial direction toward the chamber.

57. A device as defined in claim 51, wherein the flexible valve member extends annularly about the valve seat and forms a normally closed annular seam at the interface of the valve member and the valve seat for allowing the passage of substance at sufficient pressure therethrough.

58. A device as defined in claim 51, wherein the valve assembly includes a body defining an inlet port connectable in fluid communication with the filling member, and a plurality of inlet apertures in fluid communication between the inlet port and the interface of the valve member and the valve seat.

59. A device as defined in claim 51, in combination with the filling member, wherein the filling member defines a tubular conduit for the passage of the substance therethrough, and is movable into engagement with the valve assembly for introducing the substance from the tubular conduit through the valve assembly and into the chamber.

60. A device as defined in claim 51, wherein the axially-extending valve seat and flexible valve cover form an inlet valve for introducing the substance through the inlet valve and into the chamber, and the valve assembly further includes an outlet valve that is normally closed and forms a fluid-tight seal between the chamber and ambient atmosphere.

61. A device as defined in claim 60, wherein the outlet valve includes a valve member and a valve seat, the valve member engages the valve seat in the normally closed position defining a fluid-tight seal therebetween, and the valve member is movable relative to the valve seat to allow the passage of fluid from the chamber between the valve member and valve seat.

62. A device 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 device, the device comprising:

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

first means connectable in fluid communication between the filling member and the chamber for introducing the substance through the first means and into the chamber, wherein the first means includes second means extending axially within the first means and cooperating with third means for forming a normally closed interface between the second and third means defining a fluid-tight seal, and third means cooperating with the second means for forming the normally closed interface defining the fluid-tight seal, and for flexing outwardly relative to the second means in response to the introduction of substance at sufficient pressure from the filling member into the interface between the second and third means to allow passage of the substance through the interface and into the chamber.

63. A device as defined in claim 62, wherein the first means further includes fourth means for cooperating with fifth means for forming a normally closed interface between the fourth and fifth means and defining a fluid-tight seal between the chamber and ambient atmosphere, and fifth means cooperating with the fourth means for forming the normally closed interface defining the fluid-tight seal, and for moving relative to the fourth means to allow the passage of fluid from the chamber between the fourth and fifth means.

64. A device as defined in claim 63, wherein the first means is a valve assembly, the second means is a valve seat, the third means is a valve member, the fourth means is a valve seat, and the fifth means is a valve member.

65. A method of filling a device with a substance, wherein the device includes a body defining a chamber for receiving the substance therein, and a valve assembly including an axially-extending valve seat, and a flexible valve member overlying the valve seat and forming a normally closed interface defining a fluid-tight seal between the valve member and the valve seat, wherein the method comprises the following steps:

providing a device having a sealed, empty sterile chamber;

filling the sterile empty chamber with the substance by moving at least one of the valve assembly and a filling member into fluid communication with the other;

introducing the substance from the filling member at sufficient pressure into the interface between the valve member and the valve seat to flex the valve member outwardly relative to the valve seat and, in turn, flow through the interface between the valve member and the valve seat and into the chamber;

terminating the flow of the substance from the filling member into the interface between the valve member and the valve seat, allowing the flexible valve member to form the normally closed interface defining the fluid-tight seal between the valve member and the valve seat, and in turn sealing the substance with the chamber; and

moving at least one of the valve assembly and the filling member relative to the other to disconnect the valve assembly and the filling member from fluid communication with each other.

66. A method as defined in claim 65, further comprising the step of sterilizing the sealed, empty device.

67. A method as defined in claim 66, wherein the sterilizing step includes irradiating the sealed empty device.

68. A method as defined in claim 67, wherein the step of irradiating the sealed empty device includes subjecting the device to at least one of gamma, e-beam and laser radiation.

69. A method as defined in claim 65, further comprising the step of providing a device having a valve assembly wherein the axially-extending valve seat and flexible valve cover form an inlet valve for introducing the substance through the inlet valve and into the chamber, and the valve assembly her includes an outlet valve that is normally closed and forms a fluid-tight seal between the chamber and ambient atmosphere;

and dispensing substance from the chamber through the outlet valve.

70. A method as defined in claim 69, wherein the dispensing step includes dispensing multiple doses of the substance from the chamber through the outlet valve, and maintaining the substance remaining within the chamber after each dose sterile and sealed within the chamber with respect to the ambient atmosphere.