Medical fluid delivery system

• US 6,468,261 B1
• Filed: 07/14/1999
• Issued: 10/22/2002
• Est. Priority Date: 07/14/1999
• Status: Expired due to Term

• Current Assignee: Liebel Flarsheim Co LLC (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Incorporated (Mallinckrodt plc)
• Inventors: Fago, Frank M., Small, James R., Wagner, Gary S., Smith, Mitchell A., Tyson, Joseph B.
• Primary Examiner(s): Hayes, Michael J
• Application Number:
  US09/353,217
• Time in Patent Office: 1,196 Days
• Field of Search: 604/80, 604/87-89, 604/246, 604/256, 604/257, 604/258, 604/403, 604/405, 604/411, 604/412, 604/414, 604/415, 604/523, 604/413, 604/533-539, 604/201, 604/905, 215/247-9, 222/80-83
• US Class Current: 604/535
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2039/167 with energizing means, e.g. light, vibration, electricity
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: A61M 39/165 Shrouds or protectors for aseptically enclosing the connector
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A system to provide a specified volume of a medical fluid from a bulk source to a dose and/or delivery container for injection into a patient. The fluid path between the bulk container and the delivery container is physically separated at a connecting site before fluid is injected from the delivery container into the patient. The bulk container may be a bag or bottle, and the delivery container may be a syringe or bag. A bag delivery container may be contained in a pressurizeable chamber and fluid may be delivered by providing pressure to a membrane in the chamber contacting a wall of the bag. The system may be automated.

Claims

1. A connector for a bulk container, the connector providing a controlled flow of a fluid from an access site of the bulk container to a filling port of a dose container, comprising:

a body including a wall that defines a chamber, a fluid interconnect having an inlet port, a connecting site positioned within the chamber, and a flow channel extending through said wall between said inlet port and said connecting site, said fluid interconnect configured to engage the access site of the bulk container to establish a flow of the fluid from the bulk container into said inlet port, said wall having an opening dimensioned and configured to receive the filling port of the dose container, said connecting site having a septum partitioning said flow channel from said chamber, said septum configured to permit fluid to flow from said connecting site when engaged by the filling port of the dose container; and

a controlled-access device operable to open and close said opening in said wall, said device having an open condition that permits the filling port of the dose container to access said chamber through said opening for forming a fluid connection with said septum of said connecting site and a closed condition in which said controlled-access device and said chamber protect said connecting site against contact when not engaged by the filling port.

2. The connector of claim 1 wherein said controlled-access device is a door opening inwardly into said chamber, said door providing the closed condition when not engaged by the filling port of the dose container.

3. The connector of claim 1 further comprising an air channel to provide air at an atmospheric pressure to the bulk container to urge fluid from the bulk container into said inlet port.

4. The connector of claim 3 wherein said air channel includes a filter operable to filter the air flowing through said air channel.

5. The connector of claim 1 wherein said fluid interconnect is an engaging projection that extends outwardly from said wall and a length of said flow channel is enclosed within said engaging projection.

6. The connector of claim 1 wherein said connecting site includes a receiving projection that extends inwardly from said wall into said chamber, said receiving portion supporting said septum within said chamber.

7. The connector of claim 6 wherein said receiving projection is configured and dimensioned to be removeably engaged by the filling port.

8. The connector of claim 1 wherein said body further comprises a resilient side wall extending outwardly from said wall, said resilient side wall having an engagement structure operable to engage a complementary engagement structure provided on the exterior of the access site of the bulk container in a snap-fit.

9. The connector of claim 1 wherein said body further comprises an internally-threaded side wall extending outwardly from said wall, said internally-threaded side wall having a plurality of internal threads configured to engage mating threads provided on the exterior of the access site of the bulk container in a threading fit.

10. The connector of claim 1 wherein said body further comprises an expandable side wall extending outwardly from said wall, said expandable side wall operable to deform to engage the exterior of the access site of the bulk container in a compressive fit.

11. The connector of claim 1 further comprising a sterilant conduit penetrating said wall, said sterilant conduit operable to selectively supply a sterilant to said chamber for sterilizing said connecting site.

12. The connector of claim 11 wherein said sterilant is selected from the group consisting of purified air, radiation, a chemical sterilant and combinations thereof.

13. A fluid connector pair for transferring a fluid from an access site of a bulk container to a dose container, comprising:

a first fluid connector attachable in fluid communication with the dose container, the first fluid connector including a filling port and a shield that partially surrounds the filling port, the shield preventing contact with said filling port except when being used to transfer fluid; and

a second fluid connector including;

a body including a wall that defines a chamber, a fluid interconnect having an inlet port, a connecting site, and a flow channel extending through said wall between said inlet port and said connecting site, said fluid interconnect configured to engage the access site of the bulk container to establish a flow of the fluid from the bulk container into said inlet port, said wall having an opening dimensioned and configured to receive said filling port, said connecting site having an exterior surface positioned within said chamber and a septum partitioning said flow channel from said chamber, said septum configured to permit fluid to flow from said connecting site when engaged by said filling port; and

a controlled-access device operable to open and close said opening in said wall, said device having an open condition that permits said filling port to access said chamber through said opening for forming a fluid connection with said septum of said connecting site and a closed condition in which said controlled-access device and said chamber protect said connecting site against contact when not engaged by the filling port.

14. The connector of claim 13 further comprising an air channel to provide air at an atmospheric pressure to the bulk container to urge fluid from the bulk container into said inlet port.

15. The connector of claim 14 wherein said air channel includes a filter operable to filter the air flowing through said air channel.

16. The connector of claim 13 wherein connecting site includes a receiving projection that extends inwardly from said wall into said chamber, said receiving portion supporting said septum within said chamber.

17. The connector of claim 16 wherein said receiving projection is configured and dimensioned to be removeably engaged by said shield.

18. The connector of claim 13 further comprising a sterilant conduit penetrating said wall, said sterilant conduit operable to selectively supply a sterilant to said chamber for sterilizing said connecting site.

19. The connector of claim 18 wherein said sterilant is selected from the group consisting of purified air, radiation, a chemical sterilant and combinations thereof.

20. The connector of claim 13 wherein said controlled-access device is a door opening inwardly into said chamber, said door providing the closed condition when not engaged by said filling port.