Surgery – Body protecting or restraining devices for patients or infants
Reexamination Certificate
2000-06-30
2003-03-04
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
C128S877000, C128S878000, C128S879000
Reexamination Certificate
active
06526981
ABSTRACT:
FIELD OF INVENTION
The present invention relates to a guard for protecting sites on the body, including a fabric connector that holds the guard in place without applying adhesive to a patient's body.
BACKGROUND OF INVENTION
Parenteral administration of therapy is a common and often life-saving medical technique. Perhaps its most common form is intravenous (IV) infusion, a high volume, high risk, high cost therapy that affects virtually all patient populations in all healthcare settings. In this procedure, a needle breaks a patient's skin and enters a vein, and additional equipment delivers therapeutic infusates such as antibiotics, hydration fluids, hyperalimentation, pain management drugs, chemotherapy drugs, indigestible drugs, or blood products into the body. Similar equipment may drain harmful fluids away from the body, such as fluids accumulating around infected wounds or emptying into colostomy bags. Patients may receive IV or other parenteral therapy for a few hours, a few months, or even years.
On the human body, there are a number of possible venipuncture sites. The scalp, upper extremity and lower extremity contain many peripheral venipuncture sites, while central venipuncture sites may access the vena cava.
The major superficial veins of the scalp are the frontal, superficial temporal, posterior auricular, supraorbital, occipital and posterior facial. In the upper extremity, venipuncture sites include the cephalic, median basilic and median antecubital veins, as well as the dorsal venous arch. The saphenous veins, the median marginal veins and the veins of the dorsal arch of the lower extremities are also used.
Central venipuncture sites include the external jugular, the internal jugular or the subdlavian vein. The inferior vena cava is entered through the femoral vein. Central access to the superior vena cava is commonly achieved through peripherally inserted central catheters known as PICC lines, which may take the place of multiple repeated peripheral IVs.
The selection of an IV site depends on a host of considerations including the age of the patient, condition of the patient, what kind of fluid is to be infused, rate at
The simplest way to stabilize the joint between the hub and the supply line and to prevent the needle and catheter from being displaced is with adhesive tape (after application of a transparent dressing that maintains sterility). The supply line tubing is taped to the patient over the transparent dressing and “looped,” or directed, back to its source. This loop needs to be secure to prevent mechanical catheter manipulation, so that the needle or catheter is less likely to become dislodged if the tubing is accidentally bumped or pulled. If the venipuncture site is adjacent ajoint, the joint is often immobilized.
If the IV equipment is taped but otherwise unguarded, the catheter may still be accidentally dislodged or, in the case of adult patients with impaired senses or involuntary movement and pediatric patients, pulled out by the patient or one of his a caregivers or visitors. A taped but otherwise uncovered infusion site may frighten pediatric patients and be a stressor even to adults, particularly if they are very old or sick.
In addition to tape, devices have been proposed for guarding the needle or catheter at the infusion site and for protecting the joint between the needle or catheter and the supply line. Many of these devices are specially designed for use at a particular infusion site and are big, expensive and mechanically complicated. For example, there are devices with domes over the infusion site and with means for immobilizing the elbow joint for intravenous infusion adjacent the joint of an adult. There are other special purpose devices for protecting the infusion site on a child's scalp and so forth.
The applicants' U.S. Pat. Nos. 5,167,240 and Des. 335,926 teach a hollow member to cover puncture sites made by IV needles (the “I.V. HOUSE”®). Through principles of blow dispersion and absorption, the I.V. HOUSE helps protect sites such as injection sites which are a catheter length away from the infusion sites, as well as venipunctures and their accompanying IV needles and catheters from being bumped or pulled. The I.V. HOUSE is used in the health care industry on adult and pediatric patients.
Hollow members are usually secured in place by adhesives such as tape. However, the use of adhesives is problematic for many patients. Patients may have which the fluid is to be infused and so forth. In general, if the patient is an adult, the best venipuncture sites, in order of preference, are the lower arm and hand, the upper arm, and the antecubital fossa. If the patient is an infant, a scalp vein may be used because it is accessible and when other peripheral attempts have failed.
Needles and catheters of various sorts are used for IV infusions. In the past, the same needle used to puncture the vein was also used for infusing the fluid. Present practice, however, is to infuse the fluid through a catheter that is planted with a needle which is then withdrawn. Currently there are two major types of catheters—namely, over-the-needle catheters and through-the-needle catheters. A third type, steel butterfly needles, formerly used in treating children, have been superseded by over-the-needle catheters.
Old fashioned needles and modern catheters terminate in a hub for connection to a fluid supply line by means of a separable tapered part. The friction joint between the hub and the supply line sometimes becomes detached even with a threaded locking connector such as a luer lock. When this happens, fluid is lost and the patient may be seriously affected beyond the value of the fluid lost. Needles and catheters are also subject to inadvertent displacement whereby the needle or catheter is withdrawn from the vein or perforates the vein's opposite wall causing the infused fluid to infiltrate and swell the surrounding tissue. This thwarts infusion therapy and causes other problems. Displacement of the needle or catheter is particularly likely when the venipuncture infusion site is adjacent a joint.
Agencies such as the Center for Disease Control require that catheters be changed every 48 hours if an institution has an incidence of phlebitis greater than 5%, and every 72 hours if the incidence of phlebitis is less than 5%. However, such agencies seek to extend catheter dwell time to 96 hours. Prolonging the lifespan of peripheral catheters benefits patients by decreasing the number of IV starts, decreasing infection due to fewer needlesticks, decreasing the incidence of thrombus, decreasing the cost of IV start supplies, decreasing nursing time and physiologic cost to the patient, and in some cases, fewer interruptions in nutritional therapy. Also, increasing the dwell time can salvage more veins for use at a later date. external or subsurface conditions adjacent a site that may be irritated or exacerbated by the adhesive's chemicals, by the tape's nonporous nature, or by the mechanical pulling needed to remove the tape. Some patients are immunocompromised or sensitive or allergic to the adhesive, or become so during the course of treatment. The skin of geriatric and pediatric patients, especially neonates, tends to be sensitive even when healthy. Other patients have unhealthy skin, such as patients suffering from diseases of or affecting the skin including but not limited to Stevens-Johnson syndrome, skin cancer, acne, allergic rashes or general dermatitis, and may also be harmed by the use of adhesives. The sensitivity of patients' skin with bums, for example from fire, the sun, contact with chemicals or chemotherapy treatments, presents enormous difficulties in protecting IV puncture sites and other surface or subsurface problems. Many patients have varying concentrations of hair on their skin, making tape painful to remove unless the site is shaved. Patients with these or other skin conditions may suffer mild to severe itching, rashes, blisters, open sores, sloughing of the skin, even scars, among other thin
Rozier Betty M.
Vallino Lisa M.
Brown Michael A.
I.V. House, Inc.
Mahoney Joseph A.
Mayer Brown Rowe & Maw
Rebman Christine M.
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