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The Shepherd Laboratories, Inc., Dye Stop and Save-Quick Fill® Contrast Administration Set is intended to administer contrast agent to a patient while isolating the patient's bodily fluids from the contrast bottle to allow reuse of the contrast bottle on subsequent patients, and to exclude air from entering the tubing connecting the contrast bottle to the control syringe. The Dye Stop and Save-Quick Fill® device is indicated as a means to administer contrast agents to a patient and to isolate a patient's bodily fluids from the contrast agent bottle to allow the use of the remaining contrast agent in the bottle on subsequent patients. It is also indicated to provide a simple means of initiation of rapid fill flow, and to exclude air from entering the tubing connecting the contrast agent chamber with a control syringe.

The Dye Stop and Save-Quick Fill®, Contrast Agent Administration Set consists of two major components which perform the task of administering the contrast agent. The first is a Spike Assembly that is used to communicate the contrast agent out of the contrast agent bottle. The second is a Deformable Chamber and Tubing Set which blocks the contrast agent from retrograde flow, provides flow initiation means via the deformable chamber, displays volume flow indications in the chamber, and provides a chamber outlet float valve which prevents air from entering the tubing line to the patient. The Dye Stop and Save-Quick Fill® device, therefore, is designed to administer contrast agents to a patient like other such devices but also: - Isolates a patient's bodily fluids from a contrast agent bottle to allow the use of the remaining contrast agent in the bottle on subsequent patients. - Provides a simple means of initiation of rapid fill flow. - Excludes air from entering the tubing connecting the contrast agent chamber with the control syringe. The Dye Stop and Save-Quick Fill® device incorporates a vented spike that is used to penetrate the stopper of the contrast agent bottle. A disconnect point is included just downstream of the spike. This disconnect point is provided with an automatic shut off valve which prevents contrast from leaking out of the disconnect when it is separated. A sterility protection cap is provided to close the end of the disconnect to prevent contamination. Downstream of the disconnect point are two one-way valves. These two valves are mounted in series and provide added security. These valves prevent a patients' bodily fluids from traveling backwards and entering the contrast agent bottle. Downstream of the two one-way valves is a deformable burette chamber. At the top of the burette chamber is a high-pressure check valve. When the burette chamber is squeezed, the high-pressure check valve will open allowing air within the burette chamber to vent to the atmosphere. When the squeezed burette chamber is released a partial vacuum is created within the burette chamber. This partial vacuum causes the aforementioned differential pressure to occur, drawing contrast agent from the bottle into the burette chamber in a quick fill mode. Contained in the bottom of the burette chamber is a floating check valve that acts to prevent air from escaping from the bottom of the burette chamber when fluid flow ceases and the burette empties. A section of tubing then connects the burette chamber to a manifold/control syringe assembly.