Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-10-09
2002-04-23
Sykes, Angela D. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C602S042000, C128SDIG008
Reexamination Certificate
active
06375639
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a stabilizing device for catheters, and in particular, to intravenous catheters. The stabilizing device of the present invention includes a main body having an opening or window adjacent a needle insertion site and either a plurality of straps to attach the device to a patient's body or being of a wide band encircling the limb or appendage. Smaller narrow portions (loops) attached to, or extend from the main body of the device to secure the IV catheter tubing. The present invention eliminates the need for applying tape directly to the patient's skin.
BACKGROUND OF THE INVENTION
Many of the patients that enter a hospital are given an intravenous (IV) catheter for venous access as well as for the administration of fluids, medications, and parenteral nutrition. In the past, it has been common practice to apply tape directly to securely attach the catheter hub and tubing to the patient. However, certain patients have severe allergy to tape/adhesives. Furthermore, elderly, newborn and burn patients have frail or damaged skin that is not conducive to the use of tape to anchor an IV. In some instances, skin is actually removed when the tape is removed.
Previously, some designs have been proposed to alleviate the problem of direct taping. One such design utilizes a stabilizing sleeve having an outer fabric layer with a gauze inner layer that wraps around a patient's appendage and holds the IV needle and tube against the patient's appendage. The sleeve utilizes VELCRO adjacent a seam to removably fasten the sleeve to the appendage. Disadvantages to this are the potential for a tourniquet effect and the inability to view the area proximal to the IV site, not to mention the difficulty and cost in manufacturing it.
Another previously proposed design utilizes bands that wrap around a patient's appendage adjacent the insertion site of an IV catheter. Ends of the bands attach to each other using hook and loop type fasteners. Catheter tubing is anchored against the bands by using adhesive tape. Thus, the adhesive tape is applied to the bands and not the patient's skin. Some of the disadvantages to this design include: high cost manufacturing, increased risk of a tourniquet effect, inability to observe the sites proximal and distal to the IV catheter insertion site.
Yet another stabilizer design includes a base unit that is placed against the patient's body and includes wing straps having medical adhesive on one side which wrap around and attach to the base unit to secure the device to the patient. A low profile one-piece tub mount is centrally located in the base unit for grasping a tube.
However, none of the prior art of stabilizing devices have an opening or window to allow viewing of the area proximate the needle insertion site. In addition, the area proximal and distal to the insertion site is covered, therefore, prohibiting surveillance for IV infiltration. In addition, the prior designs lack the use of a disposable, resilient, surgical grade material that is self-adherent but non-adhesive to a patient's skin or hair. Also, the prior art lacks protection from a tourniquet effect because the materials are non-expansible.
SUMMARY OF THE INVENTION
The present invention is directed to a stabilizing device for securing a catheter to a patient's body at a catheter insertion site, the stabilizer device includes a main body for positioning over at least a portion of the catheter insertion site. An opening of sufficient size is formed in the main body for permitting passage of a catheter. Optionally, the opening is sized to permit viewing of an area f a patient's body distal the catheter insertion site. A slit is further formed in the main body and connected to the opening to allow the main body to be positioned around a previously installed catheter without requiring catheter removal. At least one attachment member is connected to the main body for securely attaching the stabilizing device to a patient. Optionally, but preferably, the main body is generally flexible for adapting to contours of a patient's body near the catheter insertion site. Therefore, the present invention reduces the amount of time for securing an IV catheter. Additionally, an existing catheter does not need to be removed when using the present invention, which reduces health risks and increases patient comfort.
Further, the present invention includes a stabilizing device for securing a catheter to a patient's body at a catheter insertion site, the stabilizer device including a main body for positioning over at least a portion of the catheter insertion site. An opening of sufficient size is formed in the main body for permitting passage of a catheter and at least one attachment member is connected to the main body for securely attaching the stabilizing device to a patient. Also, the main body and the at least one attachment member are formed from a self-adherent material that is non-adhesive. An example of a self-adherent material is one supplied by 3M Corporation under the trademark COBAN, which is disposable, resilient, extensible and surgical grade. Accordingly, the present invention is cost-effective and does not adhere to the patient's body.
Still further, the present invention includes a stabilizing device for securing a catheter to a patient's body at a catheter insertion site, the stabilizer device having a main body for positioning over at least a portion of the catheter insertion site. The main body includes a front strip connected to a rear strip by a pair of spaced apart side strips. An opening of sufficient size is formed in the main body for permitting passage of a catheter and at least one attachment member is connected to the main body for securely attaching the stabilizing device to a patient. Also, a slit is provided in the main body and connected to the opening to allow the main body to be positioned around a previously installed catheter without requiring catheter removal. At least one tubing fastener is selectively attachable to the main body for supporting a catheter tube. Moreover, each of the main body, the at least one attachment member, and the at least one tubing fastener are formed from a self-adherent material that is non-adhesive. In a preferred embodiment, the main body and the attachment member are formed integrally from one piece of self-adherent material. Optionally, the tubing fastener can be formed integrally with the main body and the attachment member.
Additionally, the present invention includes a stabilizing device for securing a catheter having a main body provided with an opening that allows passage of a catheter through it (or through a cut-out portion of a window). The main body further includes a front portion connected to a rear portion by a pair of side portions. At least one of the side portions has a slit to allow the opening to be placed around a previously installed catheter. Straps are connected to the side portions. At least one of the side portions extend outwardly away from the main body. These straps are used to attach the main body to a patient's appendage at a catheter needle insertion site. Loops, in the form of a partial figure eight shape, surround the catheter tubing and attach the tubing to the front and rear portions of the main body.
The present invention allows healthcare personnel to view the areas of a patient's body that are both proximal and distal to the needle insertion site to detect signs of complications such as IV catheter infiltration or phlebitis. The opening or window permits viewing of an area distal the needle insertion site, while the main body is configured to permit viewing of an area proximal the insertion site, for example, an area immediately above the front strip. Another feature of the present invention is the use of non-adhesive, disposable, self-adherent, surgical grade material for the entire device. Thus, the loops holding the tubing are pressed against the main body to attach the catheter in place.
Duplessie Renee F.
Miller David S.
Bianco Patricia
Rader & Fishman & Grauer, PLLC
Sykes Angela D.
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