阅读说明：本技术 用于封闭流体输送系统的药瓶适配器组件 (Vial adapter assembly for enclosing a fluid delivery system ) 是由 齐夫·纳夫塔洛维茨 于 2019-01-02 设计创作，主要内容包括：一种药瓶适配器组件,适于与包含药物的药瓶和注射器适配器一起使用,药瓶适配器组件又可与具有活塞的注射器连接,活塞适于在用于将流体吸入到注射器中的第一方向和用于将流体从注射器中排出的第二方向上选择性地移动,药瓶适配器组件包括：药瓶连接件,用于与包含药物的药瓶不可移除地连接；注射器适配器连接件,用于与注射器适配器连接；具有可变体积的压力平衡室,其在使用期间与外部环境密封；液体通路,当注射器适配器连接到注射器适配器连接件且注射器连接到注射器适配器且药瓶连接件连接到包含药物的药瓶时在包含药物的药瓶的内部和注射器的内部之间进行连通；以及排放通路,当药瓶连接件连接到包含药物的药瓶时在包含药物的药瓶的内部和压力平衡室的内部之间进行连通,其中,压力平衡室和排放通路相互构造为使得,当注射器适配器连接到注射器适配器连接件且注射器连接到注射器适配器且药瓶连接件连接到包含药物的药瓶时,变得位于压力平衡室内的基本上所有任何药物都经由排放通路从该压力平衡室中移除并通过注射器的活塞在第一方向上的位移而返回到药瓶的内部。(A vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn being connectable with a syringe having a piston adapted for selective movement in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly comprising: a vial connector for non-removably connecting with a vial containing a drug; a syringe adapter connector for connection with a syringe adapter; a pressure balancing chamber having a variable volume that is sealed from an external environment during use; a liquid passage communicating between an inside of the medicine containing vial and an inside of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the medicine vial connector is connected to the medicine vial containing the medicine; and a discharge passageway communicating between an interior of the drug-containing vial and an interior of the pressure balance chamber when the vial connector is connected to the drug-containing vial, wherein the pressure balance chamber and the discharge passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the drug-containing vial, substantially all of any drug that becomes located within the pressure balance chamber is removed from the pressure balance chamber via the discharge passageway and returned to the interior of the drug vial by displacement of the piston of the syringe in the first direction.)

1. A vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn connectable with a syringe having a piston adapted for selective movement in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly comprising:

a vial connector for non-removably connecting with the vial containing the drug;

a syringe adapter connector for connecting with the syringe adapter;

a pressure balancing chamber of varying volume that is sealed from an external environment during use;

a liquid passage communicating between an interior of the vial containing the drug and an interior of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug; and

a discharge passage communicating between the interior of the vial containing the drug and the interior of the pressure equalizing chamber when the vial connector is connected to the vial containing the drug,

wherein the pressure balance chamber and the vent passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug, substantially all of the drug that becomes located within the pressure balance chamber is removed from the pressure balance chamber via the vent passageway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction.

2. The vial adapter assembly of claim 1, further comprising a deformable membrane contained within a volume enclosed between the vial connector and the syringe adapter connector and fixedly attached therebetween.

3. The vial adapter assembly of claim 1, wherein the pressure equalization chamber is disposed between the syringe adapter connector and the deformable membrane.

4. The vial adapter assembly of any one of claims 1-3, further comprising a needle element extending longitudinally along the longitudinal axis.

5. The vial adapter assembly of any one of claims 1-4, further comprising a septum element disposed within a portion of the syringe adapter connector and configured to be penetrated by a needle of a medical implement adapted to engage the vial adapter assembly.

6. The vial adapter assembly of any one of claims 1-5, wherein the vial connector further comprises a plurality of circumferentially arranged snaps adapted for secure engagement with the vial.

7. The vial adapter assembly of any one of claims 1-6, wherein the vial connector further comprises a sheath having an upper portion and a pointed portion.

8. The vial adapter assembly of claim 7, wherein a longitudinal hole is formed through the sheath, and wherein the hole has a "water-drop" shape including a wide portion and a narrow portion.

9. The vial adapter assembly of claim 8, wherein a recess extends radially outward from the wide portion of the bore and is oppositely directed relative to the narrow portion of the bore.

10. The vial adapter assembly of claim 8, wherein an opening is formed in the spike portion and adapted to communicate with the bore, the opening being oriented in the same direction as the recess.

11. The vial adapter assembly of claim 2, wherein the deformable membrane is a deformable sheet having a predetermined shape and is adapted to change its shape in response to pressure applied thereto.

12. The vial adapter assembly of claim 10, wherein the needle element has a cylindrical portion and a sharp tip, and an interior volume of the needle element defines the liquid pathway.

13. The vial adapter assembly of claim 12, wherein the needle element has a tab extending radially outward from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid passageway.

14. The vial adapter assembly of claim 13, wherein the opening is disposed adjacent the sharp distal tip of the needle element and oriented in the same direction as the tab.

15. The vial adapter assembly of any one of claims 1-14, wherein a liquid drug collection and drain well is formed in the syringe adapter connector, the liquid drug collection and drain well having a tapered wall surface and a flat surface.

16. The vial adapter assembly of any one of claims 2-15, wherein the pressure equalization chamber is formed between the deformable membrane and the syringe adapter connector.

17. The vial adapter assembly of claim 16, wherein the deformable membrane is configured to change its shape in response to pressure exerted thereon, thereby changing the volume of the pressure-equalizing chamber.

18. The vial adapter assembly of claim 8, wherein the needle element is inserted into the wide portion of the bore, thereby forming the vent passageway extending through the narrow portion of the bore.

19. The vial adapter assembly of any one of claims 1-18, wherein the discharge passageway at least partially surrounds the liquid passageway.

20. The vial adapter assembly of claim 13, wherein the tab is disposed within a portion of the sheath and adapted to orient the needle element such that the opening of the needle element and the opening of the spike portion face in the same direction.

21. The vial adapter assembly of claim 13, wherein the tip of the needle element protrudes axially longitudinally from the spike portion and forms a sharp tip with the spike portion, the sharp tip adapted to penetrate a septum of the vial containing the drug.

22. The vial adapter assembly of any one of claims 1-21, wherein increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure balance chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

23. A method of transferring medication from a vial containing medication to a syringe having a piston adapted to be selectively moved in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe via a syringe adapter, the method comprising:

non-removably connecting a vial adapter assembly to the vial containing a drug and to the syringe via the syringe adapter;

displacing the piston in the first direction, thereby drawing a first amount of the drug into the syringe;

then displacing the piston in the second direction, thereby expelling at least a portion of the first amount of the drug into a pressure equalization chamber of the vial adapter assembly having a varying volume; and then

Displacing the piston in the first direction to expel substantially all of the at least a portion of the first amount of the drug from the pressure equalizing chamber of the vial adapter assembly into the vial.

24. The method of delivering a medication of claim 23, wherein the vial adapter assembly comprises: a vial connector for non-removably connecting with the vial containing the drug; a syringe adapter connector for connecting with the syringe adapter; a pressure balance chamber of varying volume that is sealed from an external environment during use.

25. The method of delivering a medication of claim 24, wherein when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the medication, a fluid pathway communicates between an interior of the vial containing the medication and an interior of the syringe; and a vent passageway communicates between the interior of the vial containing the drug and the interior of the pressure equalizing chamber when the vial connector is connected to the vial containing the drug.

26. A method of delivering a medication as recited in claim 24, wherein a liquid medication collection and drain well is formed in the syringe adapter connector, the liquid medication collection and drain well having a tapered wall surface and a flat surface.

27. A method of delivering medication as recited in claim 24, wherein the deformable membrane is fixedly retained between the vial connector and the syringe adapter connector, and the deformable membrane is configured to change its shape in response to pressure exerted thereon, thereby changing the volume of the pressure balance chamber.

28. A method of delivering a drug as in claim 24, wherein increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure-equalizing chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

29. A vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn connectable with a syringe having a piston adapted for selective movement in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly comprising:

a vial connector for non-removably connecting with the vial containing the drug;

a syringe adapter connector for connecting with the syringe adapter;

a pressure balancing chamber of varying volume that is sealed from an external environment during use;

a liquid passage communicating between an interior of the vial containing the drug and an interior of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug; and

a discharge passage communicating between the interior of the vial containing the drug and the interior of the pressure equalizing chamber when the vial connector is connected to the vial containing the drug, and

wherein the pressure equalization chamber is configured with a liquid drug collection and drain well in direct communication with the drain passage.

30. The vial adapter assembly of claim 29, wherein:

the vial adapter assembly is substantially axially symmetric about a longitudinal axis;

the liquid passage extends generally along the longitudinal axis;

the drain passage at least partially surrounds the liquid passage; and is

The liquid drug collection and discharge well is substantially centered along the longitudinal axis.

31. The vial adapter assembly of claim 29, wherein the pressure balance chamber and the vent passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug, substantially all of any of the drug that becomes located within the pressure balance chamber is removed from the pressure balance chamber via the vent passageway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction.

32. The vial adapter assembly of any one of claims 29-31, further comprising a deformable membrane contained within a volume enclosed between the vial connector and the syringe adapter connector and fixedly attached therebetween.

33. The vial adapter assembly of claim 32, wherein the pressure equalization chamber is disposed between the syringe adapter connector and the deformable membrane.

34. The vial adapter assembly of any one of claims 29-33, further comprising a needle element extending longitudinally along the longitudinal axis.

35. The vial adapter assembly according to any one of claims 29-34, further comprising a septum element disposed within a portion of the syringe adapter connector and configured to be penetrated by a needle of a medical implement adapted to engage the vial adapter assembly.

36. The vial adapter assembly of any one of claims 29-35, wherein the vial connector further comprises a plurality of circumferentially arranged snaps adapted for secure engagement with the vial.

37. The vial adapter assembly of any one of claims 29-36, wherein the vial connector further comprises a sheath having an upper portion and a pointed portion.

38. The vial adapter assembly of claim 37, wherein a longitudinal bore is formed through the sheath, and wherein the bore has a "drop" shape including a wide portion and a narrow portion.

39. The vial adapter assembly of claim 38, wherein a recess extends radially outward from the wide portion of the bore and is oppositely directed relative to the narrow portion of the bore.

40. The vial adapter assembly of claim 38, wherein an opening is formed in the spike portion and adapted to communicate with the bore, the opening being oriented in the same direction as the recess.

41. The vial adapter assembly of claim 32, wherein the deformable membrane is a deformable sheet having a predetermined shape and is adapted to change its shape in response to pressure applied thereto.

42. The vial adapter assembly according to any one of claims 34-41, wherein the needle element has a cylindrical portion and a sharp tip, and an interior volume of the needle element defines the liquid pathway.

43. The vial adapter assembly according to claim 42, wherein the needle element has a tab extending radially outward from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid passage.

44. The vial adapter assembly of claim 43, wherein the opening is disposed adjacent the sharp distal tip of the needle element and oriented in the same direction as the tab.

45. The vial adapter assembly of any one of claims 29-44, wherein the liquid drug collection and drain well has a tapered wall surface and a planar surface.

46. The vial adapter assembly of any one of claims 32-45, wherein the pressure equalization chamber is formed between the deformable membrane and the syringe adapter connector.

47. The vial adapter assembly according to any one of claims 32-46, wherein the deformable membrane is configured to change its shape in response to pressure exerted thereon, thereby changing the volume of the pressure equalizing chamber.

48. The vial adapter assembly of claim 38, wherein the needle element is inserted into the wide portion of the bore thereby forming the vent passageway extending through the narrow portion of the bore.

49. The vial adapter assembly of claim 43, wherein the tab is disposed within a portion of the sheath and adapted to orient the needle element such that the opening of the needle element and the opening of the spike portion face in the same direction.

50. The vial adapter assembly of claim 43, wherein the tip of the needle element protrudes axially longitudinally from the spike portion and forms a sharp tip with the spike portion, the sharp tip adapted to penetrate a septum of the vial containing the drug.

51. The vial adapter assembly of any one of claims 29-50, wherein increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure balance chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

52. A vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn connectable with a syringe having a piston adapted for selective movement in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly comprising:

a vial connector for non-removably connecting with the vial containing the drug;

a syringe adapter connector for connecting with the syringe adapter;

a pressure balancing chamber of varying volume that is sealed from an external environment during use;

a liquid passage communicating between an interior of the vial containing the drug and an interior of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug; and

a discharge passage communicating between the interior of the vial containing the drug and the interior of the pressure equalizing chamber when the vial connector is connected to the vial containing the drug, and

wherein:

the vial adapter assembly is substantially axially symmetric about a longitudinal axis; the liquid passage extends generally along the longitudinal axis; and is

The drain passage at least partially surrounds the liquid passage.

53. The vial adapter assembly of claim 52, wherein the pressure equalization chamber is configured with a liquid drug collection and drain well in direct communication with the drain passage.

54. The vial adapter assembly of claim 53, wherein the liquid drug collection and discharge well is generally centered along the longitudinal axis.

55. The vial adapter assembly of any one of claims 52-54, wherein the pressure equalization chamber and the vent passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug, substantially all of the drug that becomes located within the pressure equalization chamber is removed from the pressure equalization chamber via the vent passageway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction.

56. The vial adapter assembly of any one of claims 52-55, further comprising a deformable membrane contained within a volume enclosed between the vial connector and the syringe adapter connector and fixedly attached therebetween.

57. The vial adapter assembly of claim 56, wherein the pressure equalization chamber is disposed between the syringe adapter connector and the deformable membrane.

58. The vial adapter assembly of any one of claims 52-57, further comprising a needle element extending longitudinally along the longitudinal axis.

59. The vial adapter assembly according to any one of claims 52-58, further comprising a septum element disposed within a portion of the syringe adapter connector and configured to be penetrated by a needle of a medical implement adapted to engage the vial adapter assembly.

60. The vial adapter assembly of any one of claims 52-59, wherein the vial connector further comprises a plurality of circumferentially arranged snaps adapted for secure engagement with the vial.

61. The vial adapter assembly of any one of claims 52-60, wherein the vial connector further comprises a sheath having an upper portion and a pointed portion.

62. The vial adapter assembly of claim 61, wherein a longitudinal hole is formed through the sheath, and wherein the hole has a "water-drop" shape including a wide portion and a narrow portion.

63. The vial adapter assembly of claim 62, wherein a recess extends radially outward from the wide portion of the bore and is oppositely directed relative to the narrow portion of the bore.

64. The vial adapter assembly of claim 62, wherein an opening is formed in the spike portion and adapted to communicate with the bore, the opening being oriented in the same direction as the recess.

65. The vial adapter assembly of claim 56, wherein the deformable membrane is a deformable sheet having a predetermined shape and is adapted to change its shape in response to pressure applied thereto.

66. The vial adapter assembly according to any one of claims 58-65, wherein the needle element has a cylindrical portion and a sharp tip, and an interior volume of the needle element defines the liquid pathway.

67. The vial adapter assembly according to claim 66, wherein the needle element has a tab extending radially outward from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid passage.

68. The vial adapter assembly of claim 67, wherein the opening is disposed adjacent the sharp distal tip of the needle element and oriented in the same direction as the tab.

69. The vial adapter assembly of claim 53, wherein the liquid drug collection and discharge well has a tapered wall surface and a flat surface.

70. The vial adapter assembly of any one of claims 56-69, wherein the pressure equalization chamber is formed between the deformable membrane and the syringe adapter connector.

71. The vial adapter assembly of any one of claims 56-70, wherein the deformable membrane is configured to change its shape in response to pressure exerted thereon, thereby changing the volume of the pressure equalization chamber.

72. The vial adapter assembly of claim 62, wherein the needle element is inserted into the wide portion of the bore thereby forming the vent passageway extending through the narrow portion of the bore.

73. The vial adapter assembly of claim 68, wherein the fin is disposed within a portion of the sheath and adapted to orient the needle element such that the opening of the needle element and the opening of the spike portion face in the same direction.

74. The vial adapter assembly according to any one of claims 61-74, wherein the tip of the needle element axially projects longitudinally from the spike portion and forms a sharp tip therewith, the sharp tip being adapted to penetrate a septum of the vial containing the drug.

75. The vial adapter assembly of any one of claims 52-74, wherein increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure equalizing chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

Technical Field

The present disclosure relates generally to closed fluid delivery systems, and more particularly, to a vial (visual) adapter assembly that enables fluid to be delivered between two containers while maintaining a closed system.

Background

Various types of vial adapter assemblies for enclosing fluid delivery systems are known in the art.

Hazardous drugs are known to be frequently used in the treatment of certain medical conditions, however, the use of such hazardous drugs presents a danger to health care providers. Therefore, there is a need for a system that allows safe handling of hazardous drugs while reducing exposure of health care providers and while allowing the use of the entire amount of drug contained in the system.

Summary of the invention

The present invention seeks to provide an improved vial adapter assembly for enclosing a fluid delivery system and method of use thereof.

There is thus provided in accordance with an embodiment of the present invention, a vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn being connectable to a syringe having a piston adapted to be selectively moved in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly including: a vial connector for non-removably connecting with a vial containing a drug; a syringe adapter connector for connecting with a syringe adapter; a pressure balancing chamber having a variable volume that is sealed from an external environment during use; a liquid passage communicating between an inside of the medicine containing vial and an inside of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the medicine vial connector is connected to the medicine vial containing the medicine; and a discharge passageway communicating between an interior of the drug-containing vial and an interior of the pressure balance chamber when the vial connector is connected to the drug-containing vial, wherein the pressure balance chamber and the discharge passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the drug-containing vial, substantially all of any drug that becomes located within the pressure balance chamber is removed from the pressure balance chamber via the discharge passageway and returned to the interior of the drug vial by displacement of the piston of the syringe in the first direction.

Preferably, the vial adapter assembly further comprises a deformable membrane contained within the volume enclosed between the vial connector and the syringe adapter connector and fixedly attached therebetween.

More preferably, a pressure equalization chamber is disposed between the syringe adapter connector and the deformable membrane. Still more preferably, the vial adapter assembly further comprises a needle element extending longitudinally along the longitudinal axis. Still more preferably, the vial adapter assembly further comprises a septum element disposed within a portion of the syringe adapter connector and configured to be penetrated by a needle of a medical implement adapted to engage the vial adapter assembly. Still more preferably, the vial adapter assembly further comprises a plurality of circumferentially arranged snaps adapted to fixedly engage with the vial. More preferably, the vial adapter assembly further comprises a sheath having an upper portion and a spike portion.

According to one embodiment of the invention, a longitudinal hole is formed through the sheath, and wherein the hole has a "drop" shape comprising a wide portion and a narrow portion.

Preferably, the recess extends radially outwardly from the wide portion of the bore and is oppositely directed relative to the narrow portion of the bore. More preferably, an opening is formed in the tip portion and adapted to communicate with the bore, the opening being oriented in the same direction as the recess. Still more preferably, the deformable membrane is a deformable sheet having a predetermined shape and adapted to change its shape in response to pressure applied thereto. It is also preferred that the needle element has a cylindrical portion and a sharp tip, and that its interior volume defines the liquid passage. Still more preferably, the needle element has a tab extending radially outwardly from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid passageway.

According to one embodiment of the invention, the opening is disposed adjacent the sharp distal end of the needle element and is oriented in the same direction as the fin.

Preferably, a liquid drug collection and discharge well is formed in the syringe adapter connector, the liquid drug collection and discharge well having a tapered wall surface and a flat surface. More preferably, a pressure equalization chamber is formed between the deformable membrane and the syringe adapter connector. Still more preferably, the deformable membrane is configured to change its shape in response to pressure applied thereto, thereby changing the volume of the pressure-equalizing chamber. Still more preferably, the needle element is inserted into the wide portion of the bore, thereby forming a discharge passage extending through the narrow portion of the bore. Still more preferably, the drain passage at least partially surrounds the liquid passage.

According to one embodiment of the invention, a fin is provided within a portion of the sheath and adapted to orient the needle element such that the opening of the needle element and the opening of the tip portion face in the same direction.

Preferably, the tip of the needle element projects axially longitudinally from the spike portion and forms therewith a sharp tip adapted to penetrate a septum of a drug-containing vial. More preferably, increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure balance chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

According to one embodiment of the present invention, a method of transferring medication from a vial containing the medication to a syringe having a piston adapted to be selectively moved in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe via a syringe adapter, the method comprising: non-removably connecting a vial adapter assembly to a vial containing a drug and to a syringe via a syringe adapter; displacing a piston in a first direction to draw a first amount of medication into a syringe; then displacing the piston in a second direction, thereby expelling at least a portion of the first amount of the drug into a pressure equalization chamber of the vial adapter assembly having a variable volume; and then displacing the piston in a first direction to expel substantially all of at least a portion of the first quantity of the drug from the pressure equalizing chamber of the vial adapter assembly into the vial.

Preferably, the vial adapter assembly comprises: a vial connector for non-removably connecting with a vial containing a drug; a syringe adapter connector for connecting with a syringe adapter; a pressure balance chamber having a variable volume that is sealed from an external environment during use. More preferably, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to the vial containing the drug, the liquid pathway communicates between the interior of the vial containing the drug and the interior of the syringe; and the discharge passageway communicates between the interior of the vial containing the drug and the interior of the pressure equalization chamber when the vial connector is connected to the vial containing the drug. Still more preferably, a liquid drug collection and drainage well is formed in the syringe adaptor connector, the liquid drug collection and drainage well having a tapered wall surface and a flat surface. Still more preferably, a deformable membrane is fixedly retained between the vial connector and the syringe adapter connector and is configured to change its shape in response to pressure applied thereto, thereby changing the volume of the pressure balance chamber. More preferably, increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure balance chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

According to one embodiment of the present invention, a vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn connectable with a syringe having a piston adapted to be selectively moved in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly comprising: a vial connector for non-removably connecting with a vial containing a drug; a syringe adapter connector for connecting with a syringe adapter; a pressure balancing chamber having a variable volume that is sealed from an external environment during use; a liquid passage communicating between an inside of the medicine containing vial and an inside of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the medicine vial connector is connected to the medicine vial containing the liquid medicine; and a discharge passageway communicating between an interior of the drug vial containing the drug and an interior of the pressure balance chamber when the drug vial connector is connected to the drug vial containing the drug, and wherein the pressure balance chamber is configured to have a liquid drug collection and discharge well in direct communication with the discharge passageway.

Preferably, the vial adapter assembly is substantially axially symmetric about the longitudinal axis; the liquid passage extends generally along a longitudinal axis; the drain passage at least partially surrounds the liquid passage; and the liquid drug collection and discharge well is substantially centered along the longitudinal axis. More preferably, the pressure balance chamber and the vent passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to a vial containing a drug, substantially all of the drug that becomes located within the pressure balance chamber is removed from the pressure balance chamber via the vent passageway and returned to the vial interior by displacement of the piston of the syringe in the first direction. Still more preferably, the vial adapter assembly further comprises a deformable membrane contained within the volume enclosed between the vial connector and the syringe adapter connector and fixedly attached therebetween. Still more preferably, a pressure equalization chamber is disposed between the syringe adapter connector and the deformable membrane.

According to one embodiment of the present invention, the vial adapter assembly further comprises a needle element extending longitudinally along the longitudinal axis.

Preferably, the vial adapter assembly further comprises a septum element disposed within a portion of the syringe adapter connector and configured to be penetrated by a needle of a medical implement adapted to engage the vial adapter assembly. More preferably, the vial connector further comprises a plurality of circumferentially arranged snaps adapted to fixedly engage the vial. Still more preferably, the vial connector further comprises a sheath having an upper portion and a pointed portion. Still more preferably, a longitudinal hole is formed through the sheath, and wherein the hole has a "drop" shape including a wide portion and a narrow portion.

According to one embodiment of the invention, the recess extends radially outwardly from the wide portion of the hole and is oppositely directed with respect to the narrow portion of the hole.

Preferably, an opening is formed in the tip portion and adapted to communicate with the bore, the opening being oriented in the same direction as the recess. More preferably, the deformable membrane is a deformable sheet having a predetermined shape and adapted to change its shape in response to pressure applied thereto. Still more preferably, the needle element has a cylindrical portion and a sharp tip, and its internal volume defines the liquid passage. Still more preferably, the needle element has a tab extending radially outwardly from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid passageway.

According to one embodiment of the invention, the opening is disposed adjacent the sharp distal end of the needle element and is oriented in the same direction as the fin.

Preferably, the liquid drug collection and discharge well has a tapered wall surface and a flat surface. More preferably, a pressure equalization chamber is formed between the deformable membrane and the syringe adapter connector. Still more preferably, the deformable membrane is configured to change its shape in response to pressure applied thereto, thereby changing the volume of the pressure-equalizing chamber. Still more preferably, the needle element is inserted into the wide portion of the bore, thereby forming a discharge passage extending through the narrow portion of the bore.

According to one embodiment of the invention, a fin is provided within a portion of the sheath and adapted to orient the needle element such that the opening of the needle element and the opening of the tip portion face in the same direction.

Preferably, the tip of the needle element projects axially longitudinally from the spike portion and forms therewith a sharp tip adapted to penetrate a septum of a drug-containing vial. More preferably, increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure balance chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.

According to one embodiment of the present invention, a vial adapter assembly adapted for use with a vial containing a drug and a syringe adapter, the vial adapter assembly in turn connectable with a syringe having a piston adapted to be selectively moved in a first direction for drawing fluid into the syringe and a second direction for expelling fluid from the syringe, the vial adapter assembly comprising: a vial connector for non-removably connecting with a vial containing a drug; a syringe adapter connector for connecting with a syringe adapter; a pressure balancing chamber having a variable volume that is sealed from an external environment during use; a liquid passage communicating between an inside of the medicine containing vial and an inside of the syringe when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the medicine vial connector is connected to the medicine vial containing the medicine; and a discharge passage communicating between an interior of the medicine-containing medicine bottle and an interior of the pressure equalizing chamber when the medicine bottle connector is connected to the medicine-containing medicine bottle, and wherein: the vial adapter assembly is substantially axially symmetric about the longitudinal axis; the liquid passage extends generally along a longitudinal axis; and the drain passage at least partially surrounds the liquid passage.

Preferably, the pressure equalization chamber is configured to have a liquid drug collection and drain well in direct communication with the drain passageway. More preferably, the liquid drug collection and drain well is substantially centered along the longitudinal axis. Still more preferably, the pressure balance chamber and the vent passageway are mutually configured such that, when the syringe adapter is connected to the syringe adapter connector and the syringe is connected to the syringe adapter and the vial connector is connected to a vial containing a drug, substantially all of the drug that becomes located within the pressure balance chamber is removed from the pressure balance chamber via the vent passageway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction. Still more preferably, the vial adapter assembly further comprises a deformable membrane contained within the volume enclosed between the vial connector and the syringe adapter connector and fixedly attached therebetween.

According to one embodiment of the invention, a pressure equalization chamber is disposed between the syringe adapter connector and the deformable membrane.

Preferably, the vial adapter assembly further comprises a needle element extending longitudinally along the longitudinal axis. More preferably, the vial adapter assembly further comprises a septum element disposed within a portion of the syringe adapter connector and configured to be penetrated by a needle of a medical implement adapted to engage the vial adapter assembly. Still more preferably, the vial connector further comprises a plurality of circumferentially arranged snaps adapted to fixedly engage the vial.

According to one embodiment of the invention, the vial connector further comprises a sheath having an upper portion and a pointed portion.

Preferably, a longitudinal hole is formed through the sheath, and wherein the hole has a "drop" shape including a wide portion and a narrow portion. More preferably, the recess extends radially outwardly from the wide portion of the bore and is oppositely directed relative to the narrow portion of the bore. Still more preferably, an opening is formed in the tip portion and adapted to communicate with the bore, the opening being oriented in the same direction as the recess. Still more preferably, the deformable membrane is a deformable sheet having a predetermined shape and adapted to change its shape in response to pressure applied thereto.

According to one embodiment of the invention, the needle element has a cylindrical portion and a sharp tip, and its inner volume defines the liquid passage.

Preferably, the needle element has a tab extending radially outwardly from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the fluid passageway. More preferably, the opening is disposed adjacent the sharp distal end of the needle element and is oriented in the same direction as the fin. Still more preferably, the liquid drug collection and drain well has a tapered wall surface and a flat surface. Still more preferably, a pressure equalization chamber is formed between the deformable membrane and the syringe adapter connector.

According to one embodiment of the invention, the deformable membrane is configured to change its shape in response to a pressure exerted thereon, thereby changing the volume of the pressure-equalizing chamber.

Preferably, the needle element is inserted into the wide portion of the bore, thereby forming a discharge passage extending through the narrow portion of the bore. More preferably, the tab is provided in a portion of the sheath and is adapted to orient the needle element such that the opening of the needle element and the opening of the tip portion face in the same direction. Still more preferably, the tip of the needle element projects axially longitudinally from the spike portion and forms therewith a sharp tip adapted to penetrate a septum of a drug-containing vial. Still more preferably, increasing the pressure within the vial causes fluid to be transferred from the vial into the pressure balance chamber; and reducing the pressure within the vial causes fluid to be transferred from the pressure balance chamber into the vial.