Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-04-03
2001-04-24
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S284000, C604S905000, C604S533000
Reexamination Certificate
active
06221065
ABSTRACT:
BACKGROUND OF THE INVENTION
The present application relates to “Y”-adapters for use with liquid flow and administrative apparatus for medical purposes. In particular, the present application relates to a self-priming needle-free “Y”-adapter for use with intravenous delivery systems.
An intravenous (“IV”) delivery system, such as a low volume drug infuser, is commonly used to administer fluids such as saline solution or blood plasma to a patient. One end of the IV set tubing is connected to the fluid to be administered to the patient. The other end of the IV set tubing is connected to a needle which is inserted into the vein of the patient. The IV delivery system ordinarily includes a flow control device which regulates the rate of flow of the fluid being administered. The IV delivery system may also include other devices such as drip chambers, filters, or air eliminators.
The IV delivery system may also include an adapter or connector through which additional fluid medications can be administered to the patient, thereby reducing or eliminating the need to administer separate injections to the patient. The adapter is typically “Y”-shaped having three ends. Two of the ends of the “Y”-adapter are connected to the IV set tubing to permit unobstructed flow of the IV fluid through the adapter. The third end of the “Y”-adapter typically comprises a septum through which a hypodermic needle can be passed to inject the fluid medication into the adapter. The fluid medication mixes with, and is consequently transported to the patient by, the IV fluid.
In recent years, there has been an effort to reduce the use of hypodermic needles to avoid needle-stick accidents. These are not only painful, but could cause serious disease or complications in the needle-stick victim if the needle is contaminated. Thus, it is therefore desirable to provide an IV tubing adapter which utilizes a needle-free access port in lieu of a septum. Several types of needle-free access devices are described in U.S. Pat. No. 5,360,413. However, prior attempts to incorporate a needle-free access port into a typical “Y”-adapter have been unsuccessful. For example, the interior configuration of such devices often results in trapped air within the device when the device is initially connected to the IV set tubing. This trapped air may inhibit the flow of fluids through the device. The trapped air may also inadvertently enter the flow path of the IV fluid, subsequently entering the blood stream of the patient. The introduction of air bubbles into the blood stream may pose serious medical complications for the patient. It is therefore desirable to provide a needle-free “Y”-adapter which is self-priming.
SUMMARY OF THE INVENTION
In preferred aspects, the present invention comprises a needle-free “Y”-adapter for use with intravenous delivery systems. The “Y”-adapter comprises a “Y”-shaped housing having an inlet passageway, an outlet passageway, and an injection access passageway. Each of the three passageways has an interior end and an exterior end. The interior ends of the passageways are in fluid communication and intersect with each other. In addition, the injection access passageway comprises a non-circular cross-section near its interior end.
An inlet port is located at the exterior end of the inlet passageway. An outlet port is located at the exterior end of the outlet passageway. An injection access port is located at the exterior end of the injection access passageway. A needle-free access device is also located in the injection access passageway adjacent to the injection access port.
The non-circular cross-section of the interior end of the injection access passageway assists in priming the “Y”-adapter. In the preferred embodiment, the portion of the injection access passageway adjacent to the inlet and outlet passageways has an elliptical cross-section. This configuration reduces the possibility that air will be trapped inside the “Y”-adapter housing when the “Y”-adapter is initially connected to the IV set tubing.
These and other advantages, as well as the invention itself, will become apparent in the details of construction and operation as more fully described and claimed below. Moreover, it should be appreciated that several aspects of the invention can be used with other types of medical devices and devices for intravenous delivery systems.
REFERENCES:
patent: 5201725 (1993-04-01), Kling
patent: 5356375 (1994-10-01), Higley
patent: 5618268 (1997-04-01), Raines et al.
patent: 5676346 (1997-10-01), Leinsing
patent: 5782816 (1998-07-01), Werschmidt et al.
patent: 0 684 050 (1995-11-01), None
Brinks Hofer Gilson & Lione
Filtertek Inc.
Maynard Jennifer
Seidel Richard K.
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