Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
2001-03-08
2004-02-03
Basichas, Alfred (Department: 3743)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S414000, C604S088000
Reexamination Certificate
active
06685692
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a drug delivery system. More particularly, the invention relates to a drug delivery system that stores a drug or other beneficial agent and subsequently delivers the drug to a reservoir containing a component and allows the drug and component mixture to flow from the reservoir through the drug delivery device to an administration set or other device to be delivered to a patient.
BACKGROUND OF THE INVENTION
Medicaments or drugs have been stored and delivered using several types of systems. In the past, many drug delivery devices were attached to a standard IV bag wherein the beneficial agent would mix with the diluent and then flow through an outlet port to an administration set. A common method of mixing a beneficial agent with a diluent is by adding the beneficial agent with a syringe through an additive port in a partial-fill diluent container. The beneficial agent and diluent was mixed by inverting the container, the resulting mixture delivered to the administration set through an outlet port in the diluent container.
Another example of a prior drug delivery device is disclosed in U.S. Pat. No. 4,614,267 to Larkin. Larkin discloses a drug delivery system comprising a stopper vial that attaches to a flexible container. In the Larkin system, the stopper is removed from the vial and the beneficial agent flows into the flexible container and then out an outlet port of the container to the patient.
An additional drug delivery device is described in U.S. Pat. No. 5,484,406 to Wong et al. Wong discloses a drug delivery device consisting of a drug container that is attached to a container including a diluent. The drug container is spiked providing fluid communication between the drug container and the diluent container. The drug and diluent are mixed in the diluent container, with the mixture flowing out a port of the diluent container to the patient In contrast, the present drug delivery device may be described as a flow through system with the drug and diluent flowing through the device to the administration set.
SUMMARY OF THE INVENTION
The present invention is a drug delivery system that provides a drug chamber for liquid, powder, or lyophilized drugs to be held in a stable formulation until it is administered to the patient. In addition to serving as the storage container for the beneficial agent, the present drug delivery system is also the vehicle for injecting the beneficial agent into a fluid reservoir to be administered to a patient. The present drug delivery device may be described as a flow through system with the drug and diluent flowing through the device to the administration set. In the present flow through system a beneficial agent is delivered to an external reservoir and mixed with a diluent before administering the beneficial agent and diluent mixture to a patient. An advantage of the present drug delivery system is that this system is compatible with standard IV containers (rigid or flexible) and standard administration sets.
Another advantage of the present flow-through drug delivery system is the elimination of non-delivered drug sitting in the drug delivery device. The present drug delivery system delivers the drug to a reservoir including a fluid, wherein the drug and fluid are mixed. After the drug and diluent are mixed, the mixture flows through the delivery system to the administration set, eliminating the disadvantage of drug dripping back into a delivery system without flowing to the administration set.
A further advantage of the present system is that the system provides both visual and audible evidence that the drug delivery system is activated. When the system is activated a stopper will make a popping noise as the stopper is released and the stopper plug will be located in the fluid reservoir. In addition, an automatic lock on the delivery system is triggered only after the entire drug is delivered to an external environment of the drug delivery system. Thus, the location of the plug in the reservoir, as well as the location of the base of the delivery device in a locked position, will allow the person administering the beneficial agent, and anyone checking the system later, to confirm that the drug has been delivered to the patient.
The present drug delivery system provides a totally contained and enclosed system for the beneficial agent. This contained system prevents unwanted exposure of the beneficial agent to the person administering the beneficial agent to the patient.
Moreover, the present drug delivery system reduces drug wastage by providing a device that may be connected to a standard IV bag without activation and delivery. If the present drug delivery system is connected to a standard IV without activation the beneficial agent need not be delivered immediately and may be available for use at a later time.
Furthermore, the present drug delivery system does not require needles to administer the drug to a standard IV system. A needleless system prevents the risk of transmission of various pathogens due to an inadvertent needle stick.
Additional advantages of the invention will be realized and attained by the apparatus and method particularly pointed out in the written description and claims hereof, as well as from the appended drawings. It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
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Abbott Laboratories
Basichas Alfred
Vrioni Beth A.
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