Intravenous drug access system

Abstract

An intravenous drug access system. In one embodiment of the invention, the drug access system includes an IV bag having an inlet port and outlet port, whereby the inlet port is a female luer integral therewith. The integral female luer fitting may be fitted with a sealed end cap comprising a male luer insert with a closed end. An alternative embodiment of the present invention comprises a discrete pre-molded connector made with one spike at one end and a female luer fitting at the opposing end. The spike is used to penetrate a standard IV bag through a conventional inlet port.

Description

PRIORITY INFORMATION [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 832,906, filed Apr. 27, 2004, which is a continuation of U.S. patent application Ser. No. 09 / 487,105, filed Jan. 19, 2000, which is a continuation of U.S. patent application Ser. No. 09 / 161,942, filed Sep. 28, 1998. The entirety of each of these applications is hereby incorporated by reference and made part of the specification hereof.FIELD OF THE INVENTION [0002] The invention relates to the field of fluid transfer devices and, more specifically, to a novel intravenous drug access system. BACKGROUND OF THE INVENTION [0003] The manipulation of fluids for administration to a patient in hospital and medical settings involves the use of drug access systems that typically include a sealed inflatable container, commonly referred to as an intravenous (IV) bag. The IV bag is used to store a primary liquid such as plasma, blood, saline, or other types of medicinal solutions. When fluids are...

AI Technical Summary

Benefits of technology

[0014] The present invention is an intravenous drug access system. In one embodiment of the invention, the drug access system includes an IV bag having an inlet (injection) port and an outlet port, whereby the inlet port is a female luer fitting integral with the IV bag. With a female luer fitting integral with the IV bag, any number of one-way valves or needleless syringes may be connected to the female luer fitting to facilitate and control the flow of fluid into or out of the IV bag. With a one-way valve connected to the female luer, the IV bag of the present drug access system may be filled with primary fluid and shipped to the end user for later introduction of a secondary fluid. In this embodiment, breakaway parts and / or push-away plugs are advantageously eliminated.

[0015] Where it is desired that the IV bag be filled and shipped without a one-way valve already attached thereto, the integral female luer fitting may be enclosed with a sealed end cap comprising a male luer insert with a closed end. Upon receipt by the end user, the IV bag may be turned upside down to isolate the inlet port away from the contents of the IV bag so that the end cap may be removed and replaced by any valve or connector chosen by the end user. In a variation of this embodiment, the female luer fitting may include a thin membrane stretched across the opening of the female luer fitting to prevent the flow of fluid therethrough. It is contemplated that the membrane be readily penetrable by the application of a male luer fitting of a valve by the end user when desired. With this latter variation, no end cap is required and the IV bag need not be turned upside down to connect the valve thereto.

[0016] The advantage of an integral female luer with an IV bag is that it eliminates the need for a costly conventional dual-spiked connector. However, if a user would prefer to receive IV bags that have conventional inlet ports, an alternative embodiment of the present invention comprises a discrete pre-fabricated connector made with one spike at one end and a female luer fitting at the opposing end. The spike is used to penetrate the IV bag through the conventional inlet port, as with the prior art connectors. Instead of having a second spike, however, an integral female luer is provided that permits connection to a one-way valve or needleless syringe, or any other connector having a male luer fitting. In one variation of this second embodiment, the improved connector includes a protective flange that surrounds, at least in part, the spike to prevent the spike from inadvertently coming into contact with other objects and becoming contaminated when the connector is not in use. In addition, the flange prevents the spike from piercing the skin of a healthcare worker.

[0017] There are additional advantages to this second embodiment. In the molding process of the prior art connectors, there were high rejection rates, as explained above. With a connector having a female luer fitting at one end, instead of a second spike, the core pin may be more effectively secured, reducing the likelihood of the core pin floating during the molding process. This results in a reduction in the cost of manufacture, when compared to the molding of prior art connectors. Unlike the prior art connectors, the spike contemplated in the second embodiment of the present invention need not be a closed tip spike. In other words, the spike can be open-ended, permitting immediate backflow of the primary fluid in the IV bag into the interior conduit of the inventive connector. In that instance, the female luer fitting at the other end may be provided with an end cap or thin membrane, as described above, to prevent the fluid from leaking. Upon the connection of a one-way valve or a needleless syringe, fluid flow may be established between a secondary fluid source and the IV bag.

Problems solved by technology

As a discrete pre-fabricated component, such a dual-spiked connector does not permit fluid flow therethrough because at least one spike includes a closed, break-away tip.

Disadvantageously, the break-away tip floats in the IV bag during the administration of the primary and secondary fluids to the patient through the outlet port.

Should the break-away tip become lodged in the outlet port of the IV bag, the flow of the primary and secondary fluids to the patient may be stopped or dramatically reduced, endangering the health of a patient.

Moreover, because the mixed solution in the IV bag is visible to the patient, the existence of the floating foreign object (spike tip) in the fluid may be psychologically troubling to the patient.

The use of a push-away plug also presents problems.

For example, it has been proven difficult, if not costly, to manufacture a conduit plug that reliably performs as designed.

If the conduit plug is made too small, the plug does not exert sufficient frictional force against the interior walls of the internal conduit.

Under those circumstances, the ambient pressure from the primary fluid itself may dislodge the primary plug prematurely, causing leakage of fluid intended for a patient.

Alternatively, if the conduit plug is too large, the compressive force that is necessary to dislodge the plug is too great.

Under those circumstances, the force applied externally to the IV bag may adversely compromise the structural integrity of the bag, again causing life sustaining fluid to leak.

With either of the above connectors, an inherent problem exists in that once fluid flow is established, it cannot be stopped.

Moreover, the configuration of the connectors is such that a fluid-control valve cannot be readily attached to the exposed spike end of the connector.

Another problem with the connectors identified above is that manufacturing costs are high.

Due to the extremely high temperatures used in the molding process, there is a tendency of the core pin to float within the liquified housing material during the molding process, creating non-uniform wall thickness, which is unacceptable.

Thus, the rejection rate is high, driving up the costs of manufacture.

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