Dye management system including an administration set with an in-line burette

• US 5,334,170 A
• Filed: 07/14/1993
• Issued: 08/02/1994
• Est. Priority Date: 07/14/1993
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories
• Inventors: Moroski, Mark T.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Wilkens, Frank
• Application Number:
  US08/091,543
• Time in Patent Office: 384 Days
• Field of Search: 604/80-83, 604/247, 604/250, 604/257, 604/258, 604/262, 604/403, 604/407, 137/606
• US Class Current: 604/80
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1412 Burettes, measuring cylinders for laboratory use B01L3/02

Abstract

An apparatus wherein the primary dye container is connected to a secondary dye container with sufficient safeguards, including at least one-way check valve and at least one stopcock between the primary dye container and the secondary dye container, to assure a sterile barrier between the primary and secondary dye sources so that less than the total amount of sterile contrast media can be transferred from the primary dye container in an amount sufficient to perform a cardiac catheterization procedure.

Claims

1. A fluid management system comprising:

a primary fluid container;

a secondary fluid container;

a sterile fluid disposed in said primary fluid container for transfer to said secondary fluid container;

a fluid flow input line connecting said primary and secondary fluid containers;

a fluid flow control member provided in the fluid flow input line between said primary and secondary fluid containers to interrupt fluid flow from said primary to said secondary fluid container;

a one way fluid flow control device disposed in the fluid flow input line between the primary fluid container and the fluid flow control member to prevent fluid return from the secondary fluid container to the primary fluid container thereby providing a sterile barrier for the primary fluid container;

at least one external fluid flow control member provided on the fluid flow input line for controlling fluid flow through the one-way fluid flow control from the primary fluid container to the secondary fluid container and operable to terminate fluid flow;

a disconnect member in the fluid input line engageable with the one way fluid flow control device thereby enabling the disconnection of the primary fluid container from the secondary fluid container without loss of fluid; and

a sterile cap engaging the disconnect to preserve the sterile barrier for the primary fluid container thus to permit the use of the single container of fluid held in the primary fluid container in a second procedure with another secondary fluid container, thus to minimize waste and to maintain sterility in the primary fluid container.

2. A fluid management system of claim 1 wherein the external fluid flow control means includes an adjustable fluid flow clamp interposed between the primary fluid container and the one-way fluid flow control device and a slide clamp interposed between the one-way fluid flow control device and the secondary fluid container.

3. The fluid management system as claimed in claim 2 wherein the one-way flow control device comprises a one-way check valve disposed in the fluid flow input line and a fixed tubing section rigidly mounted to the distal end of the one-way check valve, the rigidly mounted tubing section receiving the slide clamp mounted thereon to close flow from the one-way check valve to the secondary fluid container.

4. A fluid management system as claimed in claim 3 wherein a vented spike is provided at the proximal end of the fluid flow input line, the vented spike engaging the primary fluid container to open a fluid flow path between the primary and secondary fluid container.

5. A fluid management system as claimed in claim 4 wherein the fluid flow control member comprises a stop cock and a removable tubing section having locking members at opposite ends, a proximal end of the removable tubing section connected to the distal end of the rigidly mounted tubing section and a distal end connected to a proximal end of the stop cock, the distal end of the stop cock connected to the fluid input of the secondary fluid container.

6. A fluid management system as claimed in claim 5 wherein the secondary fluid container is a metered burette, the burette having metering indicia thereon to control and measure the amount of fluid delivered from the primary fluid container to the secondary fluid container.

7. The fluid management system of claim 6 wherein the metered burette of the secondary fluid container is an in-line burette which includes a top wall, a bottom wall and a metered cylinder therebetween, with a fluid input in the top wall and a fluid output in the bottom wall, the fluid output including a fluid infusion line extending from the bottom wall of the burette to the patient.

8. A fluid management system as claimed in claim 7 in which the fluid input in the top wall of the in-line burette comprises a flexible tubing section passing through the top wall and bonded thereto at a distal end thereof and having a locking connection to the stop cock of the fluid flow input line at a proximal end thereof.

9. A fluid management system as claimed in claim 8 wherein a vent-to-air member is provided in the top wall of the burette, the vent-to-air member including a rigid connector on the top wall of the burette, a flexible tubing section extending from said rigid mounting member, an outer filter element, and a slide clamp engaging the flexible tubing section of said vent-to-air member, to selectively open and close said vent-to-air member.

10. A fluid management system as claimed in claim 9 wherein the fluid output of the in-line burette comprises a rigid connector passing through and rigidly joined to the bottom wall of the burette, a section of flexible tubing extending from the fluid output of the burette to the patient, and a locking member provided at the proximal end of the flexible tubing section, the rigid connector engaging the locking member to secure the flexible tubing section to the rigid connector of the fluid output of the in-line burette.

11. A fluid management system as claimed in claim 10 wherein the fluid output from the burette to the patient includes a multi-port manifold comprising multiple interconnected ports, including a fluid input port, a syringe port and a catheter port, with a throughput line interconnected between the respective ports, the flexible tubing extending from the fluid output of the burette and connected at a distal end thereof to the fluid input port, a syringe engagable with the syringe port of the manifold, and a catheter connected to the catheter port whereby fluid can be drawn into the syringe from the fluid output of the burette and thereafter fluid is expelled from the syringe to the catheter port along the fluid throughput line of the manifold and into the catheter connected to the patient.

12. A fluid management system comprising multiple primary fluid containers;

a secondary fluid container;

a sterile fluid disposed in said primary fluid containers for transfer to said secondary fluid container;

respective primary fluid input lines connecting each of said primary fluid containers to the secondary fluid container;

a fluid flow control member provided in each of the primary fluid input lines between a respective primary fluid container and said secondary fluid container to interrupt fluid flow from said primary to said secondary fluid container;

a connector connecting each of said primary fluid input lines to a secondary fluid container input line, to direct flow from each of the primary fluid containers to a single secondary fluid input line;

a one-way fluid flow control device disposed in the secondary fluid flow input line between the primary fluid containers and the secondary fluid container to prevent fluid return from the secondary fluid container to the primary fluid containers;

at least one external fluid flow control member provided on the single secondary fluid input line for controlling fluid flow from the primary fluid containers to the secondary fluid container;

a disconnect member in the secondary fluid flow input line;

a fluid flow control member engageable with the disconnect member in the secondary fluid flow input line, the one-way fluid flow control device providing a sterile barrier for the primary fluid containers, the external fluid flow control member operable to terminate fluid flow to enable the disconnection of the secondary fluid container from the primary fluid containers without loss of fluid; and

a sterile cap engaging the disconnect member to preserve the sterile barrier for the primary fluid containers, thus to permit the use of the single source of medical fluid in said primary fluid containers in a second procedure with another secondary fluid container, thus to minimize waste while maintaining sterility in the primary fluid containers.

13. A fluid management system as claimed in claim 12 wherein the primary fluid flow input line connected to each of the primary fluid containers includes a vented spike at a proximal end thereof to engage the primary fluid containers and to initiate flow between a respective primary fluid container and the secondary fluid container;

a fluid flow control member comprising a stop cock mounted distally of the vented spike in each primary fluid flow input line;

a multiple input/single output connector disposed distally of the stop cock, and receiving at each input a respective primary fluid flow input line;

a secondary fluid line attached to the single output of the connector;

a one-way fluid flow control device comprising a one-way check valve fixedly mounted in the fluid line between the connector and the secondary fluid container, the proximal end of the one-way check valve receiving a flexible tubing section fixedly mounted thereon, said flexible secondary fluid flow input line carrying at its proximal end a connector; and

a sterile cap overlying the connector to, following disconnection, preserve a sterile barrier.

14. A fluid management system as claimed in claim 13 wherein an external fluid flow control clamp engages the flexible tubing section at a location intermediate the fluid output of the burette and the patient, to control fluid flow therebetween.

15. A fluid management system as claimed in claim 14 wherein the secondary fluid container is a metered burette, the burette having metering indicia thereon to control and measure the amount of fluid delivered from each of the primary fluid containers to the secondary fluid container.

16. A fluid management system as claimed in claim 15 wherein the metered burette of the secondary fluid container is an in-line burette which includes an upper wall, a bottom wall and a metered cylinder therebetween, with a fluid input in the top wall and a fluid output in the bottom wall, the fluid output including a fluid infusion line extending from the bottom wall of the burette to the patient.

17. A method of transferring a sterile fluid from a primary fluid container to a secondary fluid container in a fluid management system comprising at least one primary fluid container, a secondary fluid container, a sterile fluid disposed in said primary fluid container for transfer to said secondary fluid container, and a fluid input line connecting said primary and secondary fluid containers and maintaining a sterile barrier within said primary container before, and during and after fluid transfer, including disconnection of said secondary container therefrom, the method comprising:

disposing a fluid flow control member in the fluid flow input line between said primary and secondary fluid containers to interrupt fluid flow from said primary to said secondary fluid container;

disposing a one-way fluid flow control device in the fluid flow input line between the primary fluid container and the secondary fluid container to prevent fluid return from the secondary fluid container to the primary fluid container and to provide a sterile barrier for said primary container;

enabling the disconnection of the primary fluid container from the secondary fluid container; and

capping the fluid input line connected to the primary fluid container to maintain the sterile barrier for the primary fluid container to permit the use of the sterile fluid in the primary fluid container in a second procedure with another secondary fluid container, thus to minimize waste and to maintain sterility in the primary fluid container.