Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2000-09-25
2001-07-31
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128SDIG006, C128SDIG008, C604S179000, C604S180000
Reexamination Certificate
active
06267115
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to protective device for a portion of a limb. Further, the present invention relates to protective device for maintaining a clean area around a portion of a limb and preventing water and other contaminants from reaching the clean area. In particular, the present invention provides a device for protecting an intravenous site of a patient from water and other contaminants during intravenous infusion and water immersion of the limb.
Intravenous (“IV”) infusion is an effective route for quick administration of water, electrolytes, medications, and nutrients for a patient. The fluid directly passes through a tube connected to a catheter, then enters into the extracellular fluid in the vein. The veins in and around the cubital fossa are commonly used for venipuncture; other veins include those in the forearm and the radial area of the wrist and the hand, femoral and saphenous veins in the thigh, the foot veins, and scalp veins in infants and in the aged. An insertion of a catheter through a slit in the vein is used when veins are hard to find and long-term fluid therapy is anticipated.
The IV site must be kept dry and free from contaminants. When a patient has to bathe during IV infusion, he has to position himself to avoid contact of the affected area with water and other contaminants, and is generally limited to incomplete sponge baths causing great inconvenience and awkwardness. Patients have even tried to wrap the area with plastic tape or trash bag to prevent water intrusion. This practice is time-consuming, and the effect is unsatisfactory. Worse, the patient may have the wound or site contaminated and subject to infection.
BACKGROUND
Devices are known in the art for protecting a limb. However, no device has been invented for effective protection of a patient's intravenous site against water and other contaminants during intravenous infusion. Further, no protective device has been invented for an intravenous site which also allows the free movement of the affected limb so that the patient can help himself in the absence of a nurse.
Most of protective devices known in the art use a waterproof sleeve sealed at one end and opened at the other end for placement over a leg or an arm to protect the leg or the arm from contacting with water or other contaminants. The protective devices known in the art use elastic band and/or straps to secure the opening end of the protective sleeve onto the limb. However, the elastic band and straps are usually not tight enough to secure the entire protective sleeve onto the limb due to the huge volume of the sleeve. Very often there are openings between the protective sleeve and the limb, through which water and other contaminants leak into the sleeve. Moreover, such a protective sleeve is not flexible enough for a person's needs. The hand or foot is entirely covered in the protective sleeve and therefore unavailable for use. Such a device is inconvenient and unnecessary for the person wearing it.
Further, the protective devices of the prior art do not effectively prevent water and other contaminants from contacting an intravenous site when the person undergoing intravenous infusion must bathe. An intravenous site is where a catheter enters a vein for intravenous infusion; at the same time, the catheter is connected to a tube which is in turn connected to a liquid reservoir. During the intravenous infusion, if the patient desires to take a shower, or soak in water, or simply be outdoors during wet weather, the intravenous site is not well protected against water and contaminants. Leakage occurs at the site through the tube connecting to the catheter which enters the vein.
U.S. Pat. No. 5,720,713 teaches a protective sleeve for an intravenous site. The tube connected to the catheter enters the sleeve through a passage in a water impermeable flexible band inside the sleeve. The tube is localized by a flap and a seal. A strap secures the sleeve to the limb by wrapping around it. The protective sleeve has disadvantages. For instance, the sleeve covers the entire distal end of the limb, which is inconvenient and unnecessary. The entire sleeve solely depends on the strap to prevent it from sliding, and can easily become loose or dislocated because of the huge volume of the sleeve. In addition, there may not be enough security for the tube passing the band by the seal and flap. Additionally, this type of device is not very flexible since there is only one localized passage for the tube through the band.
U.S. Pat. No. 5,415,642 teaches a protective shield for protecting an indwelling percutaneous catheter. However, the shield is not designed for use during IV infusion and there is no tube passage through the entire structure. Besides, an adhesive is used to adhere the shield onto the skin. The structure makes it impossible for any fluid passing through a tube and a catheter at the same time.
U.S. Pat. No. 5,592,953 teaches protective sleeves for a medicinal site which are open at both ends. The sleeves are sealed with adjustable elastic sections with elastic drawstrings which circumscribe a cushioning resilient layer. There are no passages for a tube connected to a catheter for IV infusion.
U.S. Pat. No. 5,643,183 teaches a waterproof cover made of transparent polyethylene for a limb. The cover does not allow for passage of a tube; it is hermetically sealed at the distal end. The cover uses a hook and loop fastener to affixing the cover on the extremity through the folding and gathering of the sleeve, which is not effective for waterproof purposes at the proximate end.
U.S. Pat. No. 5,063,919 teaches a waterproof member which protects casts, splints, or other appliances or surgical dressings from water damage. The waterproof member uses a combination of a securing member and straps to secure the member and provides a waterproof seal between the waterproof member and the wearer. However, the waterproof member does not concern protection of an IV site; there is no passage for the tube; and the member is sealed at one end.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a method and a protective device for protecting a portion of a limb against water and other contaminants when a person wearing the device takes a shower, soaks in a whirlpool or swims, participates in hydrotherapy, or is outdoors during wet weather. More particularly, the present invention is directed to a method and protective device for protecting an intravenous (IV) site having a tube connected thereto during intravenous infusion.
The protective method and device of the present invention includes providing a waterproof flexible covering or wrap that wraps one or more times around a portion of a limb where an intravenous site and a catheter entering a vein are located. A tube that connects to the catheter passes through a portion of the device covering the site by way of an opening or slit in the wrap. The tube may be secured at the innermost position of the opening by a flexible flap or by a closure of the opening. Once the tube is secured, the tube is further confined to the surface of the wrap by a second flap located on the outer surface of the first layer of the wrap. The wrap is then wrapped around the portion of the limb to cover the first layer of the wrap where the tube passes through and is secured. The inner surface of the second layer of the wrap is tightly and removably adhered or secured to the outer surface of the first layer of the wrap by an attaching or adhering means such as Velcro closure stripes or adhesives positioned on one or both surfaces. These adhering or securing portions may be positioned along the outer edges of said inner and outer surfaces.
The present invention comprises a method of protecting an intravenous catheter and infusion site from water and other contaminants by providing a water proof protective wrap having a through slit from one edge of the width of said wrap said slit intersecting an opening in an interior portion of said wrap and traversing the thickness of said wrap w
Brown Michael A.
Schmidt Richard D.
Venable
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