Multiple use universal connector

• US 6,287,289 B1
• Filed: 01/20/2000
• Issued: 09/11/2001
• Est. Priority Date: 01/20/1998
• Status: Expired due to Fees

• Current Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Original Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Inventors: Niedospial, John J. Jr.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/488,370
• Time in Patent Office: 600 Days
• Field of Search: 604/403, 604/408, 604/411, 604/415, 604/905, 215/247, 215/249, 206/828
• US Class Current: 604/408
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/201 having one piercing end
• 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 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: Y10S 206/828 Medicinal content

Abstract

Multiple use universal connector designed for use in various containers having a fluid port for accessing to the content of the container or for transferring fluid into the container. The multiple use universal connector incorporates a diaphragm capable of being penetrated repeatedly by an access means such as a luer connector or a syringe having a sharp or blunt cannula for fluid communication between the content of the container and the access means. The multiple use universal connector re-seals itself after being penetrated and the access means removed therefrom.

Claims

1. A multiple use universal connector flexible medical container assembly comprising:

a) first and second polymeric sheets superimposed and sealed together at their periphery defining an interior reservoir, said container having a top portion, a mid portion and a bottom portion;

said bottom portion terminates in a first angle and a second angle of from about 5°

to about 45°

each from the center thereof and relative to a horizontal plane crossing the center of said bottom portion;

b) an access member integral with said container located at the center of said bottom portion;

c) at least one oval shaped reinforcing means positioned in said mid portion of the interior reservoir;

d) a multiple use universal connector sealed into said access member, said multiple use universal connector comprising;

(1) a connector body of tube-like configuration having a distal end and a proximal end, wherein said distal end is designed to be slideably inserted into the fluid port of a container and said proximal end is designed to seal the content of the container by a diaphragm and a removable cap;

(2) an elastomeric diaphragm of M-shaped configuration, capable of flexing under pressure, sealing said proximal end of said connector body, and being capable of re-sealing itself after being pierced by an external access means; and

(3) a removable cap threaded onto the proximal end of said connector body to protect said diaphragm from environmental forces and maintain said diaphragm in aseptic condition prior to removal of said cap for accessing the fluid content of the container or transferring fluid to said container by an access or transfer means.

2. The multiple use universal connector flexible medical container assembly of claim 1 wherein said connector body further comprises:

(1) a first cap-locking ring on the proximal end of said connector body which serves as a male thread to receive said removable cap; and

(3) a second cap-locking ring, spaced from said first cap-locking ring towards the distal end of said connector body, which serves as stopping means for the removable cap when the removable cap is threaded onto the connector body.

3. The multiple use universal connector flexible medical container assembly of claim 1 wherein said diaphragm has a thickness of from about 1 mm to about 20 mm and a durometer of from about 25 to about 80 Shore A.

4. The multiple use universal connector flexible medical container assembly of claim 1 wherein said diaphragm is of an elastomeric material selected from the group consisting of:

natural rubber;

acrylate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers;

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers;

butyl rubber;

polyisobutene;

synthetic polyisoprene rubber;

silicone rubbers;

styrene-butadiene rubbers;

tetrafluoroethylene propylene copolymers; and

thermoplastic-copolyesters.

5. The multiple use universal connector flexible medical container assembly of claim 1 wherein said M-shaped diaphragm comprises:

a leg portion and a cup-shaped portion.

6. The multiple use universal connector flexible medical container assembly of claim 5 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose an obtuse angle between them.

7. The multiple use universal connector flexible medical container assembly of claim 5 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

8. The multiple use universal connector flexible medical container assembly of claim 7 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

9. The multiple use universal connector flexible medical container assembly of claim 5 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose a semi-circular surface between them.

10. The multiple use universal connector flexible medical container assembly of claim 9 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

11. The multiple use universal connector flexible medical container assembly of claim 10 wherein said unpenetrated portion has a thickness of from about 0.001 mm to about 2.0 mm.

12. The multiple use universal connector flexible medical container assembly of claim 1 wherein said diaphragm reseals itself after puncture by a fluid access means.

13. The multiple use universal connector flexible medical container assembly of claim 1 wherein said access or transfer means comprises a luer connector or a syringe having a sharp or blunt needle cannula.

14. The multiple use universal connector flexible medical container assembly of claim 1 wherein said medical fluid is a therapeutic liquid.

15. The multiple use universal connector flexible medical container assembly of claim 1 wherein said medical fluid is a diagnostic media.

16. The multiple use universal connector flexible medical container assembly of claim 1 wherein said medical fluid is a nutritional liquid.

17. The multiple use universal connector flexible medical container assembly of claim 1 wherein said reinforcing means is an oval shaped elongated disc containing at least one rib therein.

18. The multiple use universal connector flexible medical container assembly of claim 1 wherein said polymeric sheets sealed together at their periphery are of rectangular configuration.

19. The multiple use universal connector flexible medical container assembly of claim 1 wherein said container further comprises at its top portion a heat welded periphery having a hole therein for suspending said container during the delivery process.

20. The multiple use universal connector flexible medical container assembly of claim 1 wherein said first and second polymeric sheets are made of polyvinyl chloride sandwiched between two layers of polyethylene or polyvinylacetate.

21. The multiple use universal connector unitary, flexible medical container assembly of claim 1 wherein said first and second polymeric sheets are made of polyvinyl chloride.

22. The multiple use universal connector unitary, flexible medical container assembly of claim 1 wherein said first and second polymeric sheets are made of a polyethylene layer sandwiched between polyester outer layers sealed together by a propylene copolymer.

23. The multiple use universal connector unitary, flexible medical container assembly of claim 1 wherein said first and second polymeric sheets are made of polycyclohexanedimethylcyclohexane dicarboxylate.

24. The multiple use universal connector unitary, flexible medical container assembly of claim 1 wherein said first and second polymeric sheets are made of ethyl vinyl acetate.

25. A multiple use universal connector unitary, flexible medical container assembly comprising:

a) first and second flexible polymeric sheets having a generally rectangular or square configuration superimposed and sealed together at their periphery to form a pouch defining an interior, said pouch having a top and bottom portion, wherein said first and second sheets are non-coplanar to each other forming a concavo-convex shape;

said bottom portion terminates in a first angle and a second angle of from about 5°

to 45°

from the center of said bottom portion and relative to a horizontal plane crossing the center of said bottom portion to direct and facilitate the flow of content contained in the pouch towards an access port;

b) at least one access member integral with said pouch located at the center of the bottom portion of said pouch for allowing filling of pouch with a fluid and access thereto for its delivery, said access member comprising;

at least one access port located below the bottom portion of said pouch where said first angle and said second angle meet; and

c) a multiple use universal connector sealed into said access port;

said multiple use universal connector comprising;

(1) a connector body of tube-like configuration the distal end of which is designed to be slideably insertable into the fluid exit port, and the proximal end of which is designed to seal the content of the container by an elastomeric membrane and also to receive a removable cap;

(2) an elastomeric diaphragm of M-shaped configuration, capable of flexing under pressure, sealing said proximal end of said connector body, and being capable of re-sealing itself after being pierced by an external access means; and

(3) a removable cap threaded onto the proximal end of said connector body to protect said diaphragm from environmental forces and maintain said diaphragm in aseptic condition prior to removal of said cap for accessing the fluid content of the container or transferring fluid to said container by an access or transfer means.

26. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said connector body further comprises:

(1) a first cap-locking ring on the proximal end of said connector body which serves as a male thread to receive said removable cap; and

(2) a second cap-locking ring, spaced from said first cap-locking ring towards the distal end of said connector body, which serves as stopping means for the removable cap when the removable cap is threaded onto the connector body.

27. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said diaphragm has a thickness of from about 5 mm to about 20 mm and a durometer of from about 25 to about 80 Shore A.

28. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said wherein said diaphragm is of an elastomeric material selected from the group consisting of:

natural rubber;

acrylate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers;

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers;

butyl rubber;

polyisobutene;

synthetic polyisoprene rubber;

silicone rubbers;

styrene-butadiene rubbers;

tetrafluoroethylene propylene copolymers; and

thermoplastic-copolyesters.

29. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said M-shaped diaphragm comprises:

a leg portion and a cup-shaped portion.

30. The multiple use universal connector unitary, flexible medical container assembly of claim 29 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose an obtuse angle between them.

31. The multiple use universal connector unitary, flexible medical container assembly of claim 30 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

32. The multiple use universal connector unitary, flexible medical container assembly of claim 31 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

33. The multiple use universal connector unitary, flexible medical container assembly of claim 29 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose a semi-circular surface between them.

34. The multiple use universal connector unitary, flexible medical container assembly of claim 33 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

35. The multiple use universal connector unitary, flexible medical container assembly of claim 34 wherein said unpenetrated portion has a thickness of from about 0.001 mm to about 2.0 mm.

36. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said diaphragm reseals itself after puncture by a fluid access means.

37. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said access or transfer means comprises a luer connector or a syringe having a sharp or blunt needle cannula.

38. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said medical fluid is a therapeutic liquid.

39. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said medical fluid is a diagnostic media.

40. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said medical fluid is a nutritional liquid.

41. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said first and second polymeric sheets are made of polyvinyl chloride.

42. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said first and second polymeric sheets are made of a polyethylene layer sandwiched between polyester outer layers sealed together by a propylene copolymer.

43. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said first and second polymeric sheets are made of polycyclohexanedimethylcyclohexane dicarboxylate.

44. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said first and second polymeric sheets are made of ethyl vinyl acetate.

45. The multiple use universal connector unitary, flexible medical container assembly of claim 25 wherein said first and second polymeric sheets are made of transparent, UV rays absorbent material selected from the group consisting of:

copolyester elastomers, ethylene methocrylate, ethylene vinyl acetate, ethylene vinyl alcohol, low density polyethylene, nylon/polypropylene, polyester, polyolefin, polypropylene, polyethylene and polyvinylchloride containing a UV blocking or UV absorbing agent.

46. A multiple use universal connector unitary, flexible medical container assembly comprising:

a) first and second polymeric sheets having a generally hexagonal or octagonal configuration superimposed and sealed together at their periphery to form a pouch defining an interior forming a concavo-convex shape, said pouch having a top portion at an angle of the hexagonal or octagonal configuration and a bottom portion at another angle of the hexagonal or octagonal configuration, said top and bottom angles being on opposite sides of each other at the longest distance within the confines of the hexagonal or octagonal configuration, wherein said first and second sheets are non-coplanar to each other; and

b) an access member integral with said pouch located at the center of the bottom portion of said pouch allowing filling of the pouch with a fluid and access thereto for its delivery, said access member comprising;

an access port located in said access member; and

c) a multiple use universal connector sealed into said access member;

said multiple use universal connector comprising;

(1) a connector body of tube-like configuration the distal end of which is designed to be slideably insertable into the fluid exit port, and the proximal end of which is designed to seal the content of the container by an elastomeric membrane and also to receive a removable cap;

(2) an elastomeric diaphragm of M-shaped configuration, capable of flexing under pressure, sealing said proximal end of said connector body, and being capable of re-sealing itself after being pierced by an external access means; and

(3) a removable cap threaded onto the proximal end of said connector body to protect said diaphragm from environmental forces and maintain said diaphragm in aseptic condition prior to removal of said cap for accessing the fluid content of the container or transferring fluid to said container by an access or a transfer means.

47. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said connector body further comprises:

(1) a first cap-locking ring on the proximal end of said connector body which serves as a male thread to receive said removable cap; and

(3) a second cap-locking ring, spaced from said first cap-locking ring towards the distal end of said connector body, which serves as stopping means for the removable cap when the removable cap is threaded onto the connector body.

48. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said diaphragm has a thickness of from about 5 mm to about 20 mm and a durometer of from abut 25 to about 80 Shore A.

49. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said diaphragm is of an elastomeric material selected from the group consisting of:

natural rubber;

acrylate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers;

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers;

butyl rubber;

polyisobutene;

synthetic polyisoprene rubber;

silicone rubbers;

styrene-butadiene rubbers;

tetrafluoroethylene propylene copolymers; and

thermoplastic-copolyesters.

50. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said M-shaped diaphragm comprises:

a leg portion and a cup-shaped portion.

51. The multiple use universal connector unitary, flexible container assembly of claim 50 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose an obtuse angle between them.

52. The multiple use universal connector unitary, flexible container assembly of claim 51 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetration said bottom surface.

53. The multiple use universal connector unitary, flexible container assembly of claim 52 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

54. The multiple use universal connector unitary, flexible container assembly of claim 50 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose a semi-circular surface between them.

55. The multiple use universal connector unitary, flexible container assembly of claim 54 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

56. The multiple use universal connector unitary, flexible container assembly of claim 55 wherein said unpenetrated portion has a thickness of from about 0.001 mm to about 2.0 mm.

57. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said diaphragm reseals itself after puncture by a fluid access means.

58. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said access or transfer means comprises a luer connector or a syringe having a sharp or blunt needle cannula.

59. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said medical fluid is a therapeutic liquid.

60. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said medical fluid is a diagnostic media.

61. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said medical fluid is a nutritional liquid.

62. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said first and second polymeric sheets are made of polyvinyl chloride.

63. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein wherein said first and said second polymeric sheets are made of a polyethylene layer sandwiched between polyester outer layers sealed together by a propylene copolymer.

64. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said first and said second polymeric sheets are made of polycyclohexanedimethylcyclohexane dicarboxylate.

65. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said first and said second polymeric sheets are made of ethyl vinyl acetate.

66. The multiple use universal connector unitary, flexible container assembly of claim 46 wherein said first and said second polymeric sheets are made of a transparent, UV rays absorbent material selected from the group consisting of:

copolyester elastomers, ethylene methacrylate, ethylene vinyl acetate, ethylene vinyl alcohol, low density polyethylene, nylon/polyproplene, polyeste, polyolefin, polypropylene, polyehtylene and polyvinylchloride, containing a UV blocking or UV absorbing agent.

67. A multiple use universal connector unitary, flexible container assembly comprising:

a) first and second collapsibly thin polymeric sheets having a generally parabolic side configuration superimposed and sealed together at their periphery to form

1) an interior reservoir of a concavo-convex shape;

2) a non-collapsible top portion;

3) a non-collapsible bottom portion, and

4) parabolic side portions;

b) an access member;

wherein said top portion comprises;

a center area where the polymeric sheets sealed together form a hole for suspending the bag during delivery of its content;

two symmetrically positioned rectangular areas extending outwardly from the center of the bag and sealed at their periphery to render said top portion less flexible than the polymeric sheets which form the interior reservoir;

said bottom portion comprises;

two symmetrically positioned rectangular areas extending outwardly from the center of the bag and sealed at their periphery to render said bottom portion less flexible than the polymeric sheets which form the interior reservoir, said interior reservoir at its bottom portion terminates in a first angle and a second angle of from about 5°

to about 45°

each from the center thereof and relative to a horizontal plane crossing the center of said bottom portion;

said parabolic side portions are designed to flex inwardly when the medical bag is filled with a parenteral solution;

said access member located in the center of the bottom portion where said first angle and said second angle meet;

c) a multiple use universal connector sealed into said access member;

said multiple use universal connector comprising;

(1) a connector body of tube-like configuration having a distal end and a proximal end, wherein said distal end is designed to be slideably inserted into the fluid port of a container and said proximal end is designed to seal the content of the container by a diaphragm and a removable cap;

(2) an elastomeric diaphragm of M-shaped configuration, capable of flexing under pressure, sealing said proximal end of said connector body, and being capable of re-sealing itself after being pierced by an external access means; and

(3) a removable cap threaded onto the proximal end of said connector body to protect said diaphragm from environmental forces and maintain said diaphragm in aseptic condition prior to removal of said cap for accessing the fluid content of the container or transferring fluid to said container by an access or transfer means.

68. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said connector body further comprises:

(1) a first cap-locking ring on the proximal end of said connector body which serves as a male thread to receive said removable cap; and

(2) a second cap-locking ring, spaced from said first cap-locking ring towards the distal end of said connector body, which serves as stopping means for the removable cap when the removable cap is threaded onto the connector body.

69. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said diaphragm has a thickness of from about 5 mm to about 20 mm and a durometer of from about 25 to about 80 Shore A.

70. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said diaphragm is of an elastomeric material selected from the group consisting of:

natural rubber;

acrylate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers;

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers;

butyl rubber;

polyisobutene;

synthetic polyisoprene rubber;

silicone rubbers;

styrene-butadiene rubbers;

tetrafluoroethylene propylene copolymers; and

thermoplastic-copolyesters.

71. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said M-shaped diaphragm comprises:

a leg portion and a cup-shaped portion.

72. The multiple use universal connector unitary, flexible container assembly of claim 71 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose a semi-circular surface between them.

73. The multiple use universal connector unitary, flexible container assembly of claim 72 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

74. The multiple use universal connector unitary, flexible container assembly of claim 73 wherein said unpenetrated portion has a thickness of from about 0.001 mm to about 2.0 mm.

75. The multiple use universal connector unitary, flexible container assembly of claim 71 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose an obtuse angle between them.

76. The multiple use universal connector unitary, flexible container assembly of claim 75 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

77. The multiple use universal connector unitary, flexible container assembly of claim 76 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

78. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said diaphragm reseals itself after puncture by a fluid access means.

79. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said access or transfer means comprises a luer connector or a syringe having a sharp or blunt needle cannula.

80. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said medical fluid is a therapeutic liquid.

81. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said medical fluid is diagnostic media.

82. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said medical fluid is nutritional liquid.

83. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said first and second polymeric sheets are made of polyvinyl chloride.

84. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said first and second polymeric sheets are made of a polyethylene layer sandwiched between polyester outer layers sealed together by a propylene copolymer.

85. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said first and said second polymeric sheets are made of polycyclohexanedimethylcyclohexane dicarboxylate.

86. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said first and said second polymeric sheets are made of ethyl vinyl acetate.

87. The multiple use universal connector unitary, flexible container assembly of claim 67 wherein said first and said second polymeric sheets are made of transparent, UV rays absorbent material selected from the group consisting of:

copolyester elastomers, ethylene methacrylate, ethylene vinyl acetate, ethylene vinyl alcohol, low density polyethylene, nylon/polyproplene, polyeste, polyolefin, polypropylene, polyehtylene and polyvinylchloride, containing a UV blocking or UV absorbing agent.

88. A multiple use universal connector unitary, flexible container assembly comprising:

a) first and second polymeric sheet having a generally oval or elliptical configuration superimposed and sealed together at their periphery to form a pouch defining an interior reservoir forming a concavo-convex shape, said pouch having a top portion and a bottom portion, wherein said first and second sheets are noncoplanar to each other;

b) an access member integral with said pouch located at the center of the bottom portion of said pouch, said access member comprising;

an access port located in said access port;

c) a multiple use universal connector sealed into said access port;

said multiple use universal connector comprising;

(1) a connector body of tube-like configuration having a distal end and a proximal end, wherein said distal end is designed to be slideably inserted into the fluid port of a container and said proximal end is designed to seal the content of the container by a diaphragm and a removable cap;

(2) an elastomeric diaphragm of M-shaped configuration, capable of flexing under pressure, sealing said proximal end of said connector body, and being capable of re-sealing itself after being pierced by an external access means; and

(3) a removable cap threaded onto the proximal end of said connector body to protect said diaphragm from environmental forces and maintain said diaphragm in aseptic condition prior to removal of said cap for accessing the fluid content of the container or transferring fluid to said container by an access or transfer means.

89. The multiple use universal connector unitary, flexible container assembly of claim 88 wherein said connector body further comprises:

(1) a first cap-locking ring on the proximal end of said connector body which serves as a male thread to receive said removable cap; and

(3) a second cap-locking ring, spaced from said first cap-locking ring towards the distal end of said connector body, which serves as stopping means for the removable cap when the removable cap is threaded onto the connector body.

90. The multiple use universal connector unitary, flexible container assembly of claim 88 wherein said diaphragm has a thickness of from about 5 mm to about 20 mm and a durometer of from about 25 to about 80 Shore A.

91. The multiple use universal connector unitary, flexible container assembly of claim 88 wherein said diaphragm is of an elastomeric material selected from the group consisting of:

natural rubber;

acrylate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers;

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers;

butyl rubber;

polyisobutene;

synthetic polyisoprene rubber;

silicone rubbers;

styrene-butadiene rubbers;

tetrafluoroethylene propylene copolymers; and

thermoplastic-copolyesters.

92. The multiple use universal connector unitary, flexible container assembly of claim 88 wherein said M-shape diaphragm comprises:

a leg portion and a cup-shaped portion.

93. The multiple use universal connector unitary, flexible container assembly of claim 92 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose an obtuse angle between them.

94. The multiple use universal connector unitary, flexible container assembly of claim 93 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

95. The multiple use universal connector unitary, flexible container assembly of claim 94 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

96. The multiple use universal connector unitary, flexible container assembly of claim 92 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose a semi-circular surface between them.

97. The multiple use universal connector unitary, flexible container assembly of claim 96 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

98. The multiple use universal connector unitary, flexible container assembly of claim 97 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

99. The multiple use universal connector flexible medical container assembly comprising of claim 88 wherein said diaphragm reseals itself after puncture by a fluid access means.

100. The multiple use universal connector unitary, flexible medical container assembly of claim 88 wherein said access or transfer means comprises a luer connector or a syringe having a sharp or blunt needle cannula.

101. The multiple use universal connector unitary, flexible medical container assembly of claim 88 wherein said medical fluid is therapeutic liquid.

102. The multiple use universal connector unitary, flexible medical container assembly of claim 88 wherein said medical fluid is a diagnostic media.

103. The multiple use universal connector unitary, flexible medical container assembly of claim 88 wherein said medical fluid is a nutritional liquid.

104. The multiple use universal connector unitary, flexible medical container assembly of claim 88 wherein said first and second polymeric sheets are made of polyvinyl chloride.

105. The multiple use universal connector flexible medical container assembly of claim 88 wherein said first and second polymeric sheets are made of polyethylene layer sandwiched between polyester outer layers sealed together by a propylene copolymer.

106. The multiple use universal connector flexible medical container assembly of claim 88 wherein said first and second polymeric sheets are made of polycyclohexanedimethylcyclohexane dicarboxylate.

107. The multiple use universal connector flexible medical container assembly of claim 88 wherein said first and second polymeric sheets are made of ethyl vinyl acetate.

108. The multiple use universal connector flexible medical container assembly of claim 88 wherein said first and said second polymeric sheets are made of a transparent, UV rays absorbent material selected from the group consisting of:

copolyester elastomers, ethylene methacrylate, ethylene vinyl acetate, ethylene vinyl alcohol, low density polyethylene, nylon/polyproplene, polyeste, polyolefin, polypropylene, polyehtylene and polyvinylchloride, containing a UV blocking or UV absorbing agent.

109. A multiple use universal connector unitary, flexible container assembly comprising:

a) first and second polymeric sheet having a generally spherical configuration superimposed and sealed together at their periphery to form a pouch defining an interior, said pouch having a top portion and a bottom portion, wherein said first and second sheets are non-coplanar to each other forming a concavo-convex shape; and

b) an access member integral with said pouch located at the center of the bottom portion of said pouch for allowing filling of the container with a parenteral solution and access thereto for its delivery, said access member comprising;

an access port located in said access member;

c) a multiple use universal connector sealed into said access port;

said multiple use universal connector comprising;

(1) a connector body of tube-like configuration having a distal end and a proximal end, wherein said distal end is designed to be slideably inserted into the fluid port of a container and said proximal end is designed to seal the content of the container by a diaphragm and a removable cap;

(2) an elastomeric diaphragm of M-shaped configuration, capable of flexing under pressure, sealing said proximal end of said connector body, and being capable of re-sealing itself after being pierced by an external access means; and

(3) a removable cap threaded onto the proximal end of said connector body to protect said diaphragm from environmental forces and maintain said diaphragm in aseptic condition prior to removal of said cap for accessing the fluid content of the container or transferring fluid to said container by an access or transfer means.

110. The multiple use universal connector unitary, flexible container assembly of claim 109 wherein said connector body further comprising:

(1) a first cap-locking ring on the proximal end of said connector body which serves as a male thread to receive said removable cap; and

(2) a second cap-locking ring, spaced from said first cap-locking ring towards the distal end of said connector body, which serves as stopping means for the removable cap when the removable cap is threaded onto the connector body.

111. The multiple use universal connector flexible medical container assembly of claim 109 wherein said diaphragm has a thickness of from about 1 mm to about 20 mm and a durometer of from about 25 to about 80 Shore A.

112. The multiple use universal connector flexible medical container assembly of claim 109 wherein said diaphragm is of an elastomeric material selected from the group consisting of:

natural rubber

acetate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers,

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers;

butyl rubbers;

polyisobutene;

synthetic polyisoprene rubber;

tetrafluoroethylene porpylene copolymers; and

thermoplastic-copolyesters.

113. The multiple use universal connector flexible medical container assembly of claim 109 wherein said M-shaped diaphragm comprises:

a leg portion and a cup-shaped portion.

114. The multiple use universal connector flexible medical container assembly of claim 113 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose an obtuse angle between them.

115. The multiple use universal connector flexible medical container assembly of claim 114 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

116. The multiple use universal connector flexible medical container assembly of claim 115 wherein said unpenetrated portion has a thickness of from about 0.001 to about 2.0 mm.

117. The multiple use universal connector flexible medical container assembly of claim 113 wherein said cup-shaped portion comprises:

a horizontal bottom portion and a side portion which enclose a semi-circular surface between them.

118. The multiple use universal connector flexible medical container assembly of claim 117 wherein said horizontal bottom portion comprises a slit extending from the top surface thereof toward the bottom surface thereof without penetrating said bottom surface.

119. The multiple use universal connector flexible medical container assembly of claim 118 wherein said unpenetrated portion has a thickness of from about 0.001 mm to about 2.0 mm.

120. The multiple use universal connector flexible medical container assembly of claim 109 wherein said diaphragm reseals itself after puncture by a fluid access means.

121. The multiple use universal connector flexible medical container assembly of claim 109 wherein said access or transfer means comprises a luer connector or a syringe having a sharp or blunt needle cannula.

122. The multiple use universal connector flexible medical container assembly of claim 109 wherein said medical fluid is therapeutic liquid.

123. The multiple use universal connector flexible medical container assembly of claim 109 wherein said medical fluid is a diagnostic media.

124. The multiple use universal connector flexible medical container assembly of claim 109 wherein said medical fluid is a nutritional liquid.

125. The multiple use universal connector flexible medical container assembly of claim 109 wherein said first and second polymeric sheets are made of polyvinyl chloride.

126. The multiple use universal connector flexible medical container assembly of claim 109 wherein said first and second polymeric sheets are made of polyethylene layer sandwiched between polyester outer layers sealed together by a propylene copolymer.

127. The multiple use universal connector flexible medical container assembly of claim 109 wherein said first and second polymeric sheets are made of polycyclohexanedimethylcyclohexane dicarboxylate.

128. The multiple use universal connector flexible medical container assembly of claim 109 wherein said first and second polymeric sheets are made of ethyl vinyl acetate.

129. The multiple use universal connector flexible medical container assembly of claim 109 wherein said first and second polymeric sheets are made of transparent, UV rays absorbent material selected from the group consisting of:

copolyester elastomers, ethylene methacrylate, ethylene vinyl acetate, ethylene vinyl alcohol, low density polyethylene, nylon/polyproplene, polyeste polyolefin, polypropylene, polyehtylene and polyvinylchloride, containing a UV blocking or UV absorbing agent.