Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover
Reexamination Certificate
2003-04-24
2004-10-26
Lewis, Kim M. (Department: 3743)
Surgery: splint, brace, or bandage
Bandage structure
Skin laceration or wound cover
C602S054000, C602S057000, C604S174000, C604S179000, C604S180000
Reexamination Certificate
active
06809230
ABSTRACT:
TECHNICAL FIELD
The subject invention relates generally to a medical device used in intravenous procedures. The device is particularly useful in providing convenient, self-contained, physical, viral and bacteriological protection to a venipuncture site.
BACKGROUND OF THE INVENTION
The need to protect intravenous infusion sites has long been recognized. Such sites should be disturbed as little as possible both to maximize patient comfort and to minimize the risk of infection or contamination. Venipuncture sites on patients are generally covered with gauze, tape or sealer, and, when a shower or bath is taken, bags or plastic are secured over the site with tape or other adhesives. Catheters secured at such intravenous sites by methods known in the art are often easily dislodged as well as being open to infection due to exposure to water and airborne contaminants. Furthermore, it is necessary to replace existing PRN (pro re nata, or, as needed) adapters as frequently as every 3 days pursuant to hospital protocols. Such adapters may be applied to a catheter when continuous IV fluids are not in use to allow flushing and meds to be given intravenously. Some adapters are even available which permit a needleless system to be used. Thus, the venipuncture cover of the present invention may be used with any system. When PRN adapters are used, dressings around intravenous sites must be taped, often repeatedly, causing great patient discomfort and increasing the risk of dislodging the catheter and allowing infection. Intravenous sites on the back of a hand are sometimes covered with gloves for protection in showers or baths, but the difficulties in waterproofing the glove opening at the wrist also increases the risk of infection from waterborne or airborne contaminants.
Devices for shielding venipuncture sites and for immobilizing cannulae post insertion are generally known in the art. Some of these devices include transparent portions for observing their status and functioning. Others include hinged mechanisms to facilitate direct access to the venipuncture site ostensibly without irritating the patient's skin by the removal and replacement of adhesive tape. Still others use complicated multilayered structures to prevent and detect exposure to moisture There are even additional, separate devices which are designed to be used in conjunction with venipuncture shields just to protect those sites while the patient showers or bathes. However, despite their improvements, many of these devices are clumsy to use, unnecessarily bulky, expensive or require chemical additives or coatings to function properly.
Therefore, there remains a need for a simple, self-contained, inexpensive, nonbulky venipuncture cover device that substantially eliminates patient discomfort when needles are changed, is transparent to permit monitoring, eliminates the need for the additional application of tape, provides an extended wearing period without the need for replacement and does not require the use of additional mechanisms or safety measures when a patient wishes to bathe or shower.
SUMMARY OF THE INVENTION
This invention relates to a venipuncture cover for catheters at intravenous sites of patients undergoing medical treatment. The cover is made in one piece from a flat, transparent, flexible, nonbiocompatible material and has two primary parts. The first part is a main body which may have a generally rectangular shape and includes a tab on one side thereof. An adhesive is placed around the periphery of the interior surface of the main body, except for the tab, which is then covered by a protective, removable sheet. The second part is an arm which is foldably connected to the end of a side of the main body opposing the side on which the tab of the main body is located. The arm terminates in a tab. The width of the arm and the width of the main body are substantially the same. Both the interior and exterior surfaces of the arm, except for the arm's tab, are coated with an adhesive and are covered by protective, removable sheets. After removal of the protective sheets, the exterior surface of the arm is adhesively affixed to the skin of a patient behind and beneath the catheter in proximity to the intravenous site. A waterproof, contamination barrier is provided by the cover after the protective sheets are removed from the interior surfaces of the main body and the arm and those two surfaces are adhesively sealed to each other along one side of the main body while the other three sides of the main body are similarly sealed to the skin of the patient.
It is a primary objective of this invention to provide a self-contained cover for a venipuncture site which provides protection from bacteria, moisture, infection, and airborne or waterborne contaminants.
An additional objective of this invention is to provide a cover for a venipuncture site which permits easy removal after intravenous treatment is completed.
Another objective of this invention is to provide a cover for a venipuncture site which enables a patient or user to complete normal personal hygiene functions without risk of disturbance and the necessity to add further protective material to the cover.
It is a further objective of this invention to provide a cover for a venipuncture site which is substantially transparent thereby enabling medical personnel to visually examine the puncture site without removing the cover and to monitor that site for leakage, swelling, irritation and infection.
It is yet another objective of this invention to provide a cover for a venipuncture site which is clear and flexible.
It is still another objective of this invention to provide a cover for a venipuncture site which is a one-part device and can thus be more easily and inexpensively manufactured, packaged and transported.
Yet an additional objective of this invention is to provide a cover for a venipuncture site which permits the patient or user to be more functionally independent than other such covers known in the art.
It is another objective of this invention to provide a venipuncture cover which optionally allows easy, painless periodic changing of the PRN adapter.
Another objective of this invention is to provide a venipuncture cover which can remain in place for up to at least three days or in conformance with any hospital protocols in use.
A further objective of this invention is to provide nurses and others charged with establishing venipuncture sites with the option of securing either the PRN adapter or the cannula to the cover and the skin when setting up such sites.
Yet another objective of this invention is to provide a venipuncture cover which is flexible enough to easily conform to the contours of any anatomical position where it is placed while being adhesively retained in that position.
Yet a further objective of this invention is to provide is to extend the comfortable and safe period during which a venipuncture cover may remain in place without being replaced.
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Carr Patricia
Hancock Betty
Lewis Kim M.
Rosden Peter E.
Woods Rogers PLC
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