Needleless access device

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S905000

Reexamination Certificate

active

06228069

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates to a needleless access device for use with liquid flow and administrative apparatus for medical purposes.
The use of hypodermic needles to inject or withdraw fluids in medical applications has been standard practice for a number of years. Even where a patient already has an IV tubing set connected to a vein, hypodermic needles are frequently used to inject fluids into the IV tubing. Often a “Y connector” with a septum is provided in the tubing set for this very purpose. The needle is used to puncture the septum to administer the drug or other fluid, and the septum then sufficiently seals the opening to prevent airborne bacteria from entering the system. Septums are also common on drug vials, where the needle is inserted to withdraw a quantity of the drug.
The widespread use of hypodermic needles leads to numerous needle-stick accidents. These are not only painful, but if the needle is contaminated, could cause serious disease or complications in the needle-stick victim.
To prevent such accidents, needleless access devices have been designed. These devices typically include a cap having an inlet opening and a body with an outlet opening. In some instances, the devices are provided with a piston that, in its normally closed position, seals the inlet opening of the device to prevent bacterial contamination and maintain sterility.
U.S. Pat. No. 5,439,451 discloses a Capless Medical Backcheck Valve for allowing liquid flow into an IV line. The backcheck valve includes a flexible elastomeric piston that has a flexible tubular wall. The use of such a flexible piston in a needleless access device tends to increase the interior hold-up volume within the device. Further, the flexible tubular wall may tend to impede fluid flow. In addition, the material required to make a flexible piston may require lubricants to function properly.
In some instances, blood and possibly other fluids may enter a needleless device through the outlet after the device has been used to administer fluid into IV tubing. This phenomenon is commonly referred to as reflux.
There is thus a desire for a needleless medical system, where a fluid can be injected or aspirated with minimal reflux, while minimizing hold-up volume, allowing unimpeded fluid flow and requiring no additional lubricants to function properly.
SUMMARY OF THE INVENTION
A needleless access device has been invented which avoids reflux while minimizing hold-up volume, allows unimpeded fluid flow and requires no additional lubricants to function properly. The device comprises a housing having a fluid pathway and an inner chamber; a biased plunger disposed within the inner chamber and movable between a first position and a second position; a main seal sealing the inner chamber from the fluid pathway; and a vent between the inner chamber and the outside of the housing to allow air to pass out of and into the inner chamber when the plunger is moved between the first and second positions.


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