Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-08-19
2003-04-22
Bennett, Henry (Department: 3743)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S174000
Reexamination Certificate
active
06551284
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to catheters and, more particularly, to an improved intravascular catheter having a hub which may be easily secured to the skin while maintaining universal precautions.
2. Description of the Related Art
When a vascular catheter is placed, for example for intravenous administration of fluids, a combined catheter and needle is used to create the vascular puncture after which the needle is removed and the hub of the remaining catheter attached to a source of infusion liquid. It is necessary to stabilize the catheter in relation to the blood vessel to prevent movement of the catheter to preclude catheter withdrawal, undesirable additional blood vessel punctures and the like. The catheter hub is typically stabilized by taping the hub and associated tube fittings to the patient's skin in the area adjacent the vessel puncture.
Universal precautions, i.e., the use of gloves, while placing intravascular catheters has made the process of securing these catheters complicated. Indeed, in general, it is difficult to apply sticky tape to the skin while wearing gloves. In addition, the extra movement needed to reach for and to apply such tape risks the loss of the unsecured catheter. This is particularly true where the catheter has been placed in a child. As a result, it is not uncommon for universal precautions to be broken, i.e., gloves taken off, so that the catheter can be secured, but without skin protection, or for tape to be applied, as best as possible, many times with the loss of the proper position of the catheter.
There have been prior attempts to address the foregoing problem of stabilization of an inserted needle or catheter immediately following vein puncture. This has typically been accomplished by providing an adhesive surface on the undersurface of wings provided on the catheter hub. Such intravenous needle assemblies are shown, for example, in U.S. Pat. Nos. 4,324,236 and 4,627,842. A difficulty encountered with such prior art products, however, is that the protective covering on the adhesive must be removed before the needle is inserted into the vein so that it may be thereafter adhered to the skin surface. Providing an adhesive surface that is exposed before vein puncture, however, risks premature adhesion to the skin and/or adhesion to the medial care provider's gloves.
SUMMARY OF THE INVENTION
The catheter structure provided in accordance with the invention was designed to provide an easy way to secure the catheter hub to the skin while maintaining universal precautions and avoiding premature adhesion to the skin surface. In the presently preferred embodiment, the invention is applied to a vascular catheter.
In accordance with the invention, an adhesive layer is provided on the underside of a catheter hub. A protective covering is applied over the adhesive layer to preclude adhesion of the catheter hub to the medical practitioner's gloves or premature adhesion to the patient's skin. This protective cover is maintained on the adhesive until the catheter has been placed, e.g., in a blood vessel. Once the catheter has been properly positioned, the protective covering is removed. This is accomplished in a presently preferred embodiment by gripping a pull tab, which preferably projects proximally, away form the inserted catheter tip. The pull tab is thus available to be pulled to peel back the protective cover by folding the cover back over itself and pulling it proximally from the inserted catheter tip to reveal the sticky surface of the skin. The catheter hub is pressed firmly to the skin in order to create an effective adherence. If deemed necessary or desirable, additional tape or securing devices may be applied to the adhered catheter hub.
In one embodiment, the exposed surface of the protective covering has a thin layer of absorbent material so that, as the protective cover is everted to expose the adhesive surface, it defines a splash-absorbent plate to protect the patient's skin from being soiled with blood, particularly when the introducer needle is removed.
In accordance with a further alternate embodiment of the invention, when the protective cover is everted and peeled back to expose the adhesive surface, the peel back action does not entirely remove the protective cover from the hub. Instead, an additional and potentially greater force must be applied to fully remove the cover from the catheter hub. This alternative may be advantageously employed to ensure that the protective cover remains in position to catch any spillage, particularly upon introducer needle removal.
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Gentry Carol M.
Greenberg Robert S.
Bennett Henry
Easy-Stik, LLC
Nixon & Vanderhye PC
Patel Nihir
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