Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
2003-03-25
2004-07-20
Lewis, Kim M. (Department: 3743)
Surgery: splint, brace, or bandage
Bandage structure
C604S174000, C604S179000
Reexamination Certificate
active
06765122
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates, generally, to medical appliances. More particularly, it relates to a skin guard that protects the skin of a patient who receives nutrients through a gastrostomy tube.
2. Description of the Prior Art
The provision of nutritious foods to a patient through a feeding tube placed in the nose, small intestine, or stomach is known as enteral nutrition. A nasogastric or nasoenteral tube is a feeding tube placed in the nose. A jejunostomy or percutaneous endoscopic jejunostomy tube is a feeding tube placed into the small intestine. A feeding tube that extends through the skin into the stomach is called a gastrostomy or percutaneous endoscopic gastrostomy.
A feeding tube may be needed for numerous reasons. For example, a burn injury or other trauma to the head may keep a patient from swallowing comfortably. Further conditions that may require tube feedings include severe cerebral palsy, traum a caused by surgery, or acid reflux disease.
Advantages of a gastrostomy over a nasogastric tube include a greater ability to provide food and calories and less chance of the feeding tube coming out. Moreover, a feeding tube is easier to replace than a nasogastric tube. A gastrostomy site is also less conspicuous than a nasogastric site. However, a gastrostomy is more likely to malfunction or leak. It is also more likely to cause infection or irritation of the patient's skin.
In a gastrostomy procedure, an opening or stoma is formed in the patient's abdomen and a feeding tube is installed with a first end protruding through the stoma and a second end in communication with the stomach. Gastrostomy tubes are typically used for patients who require enteral nutrition for more than thirty days. When the tube is first placed in the patient's stomach it is secured with stitches that extend through the skin and around the tube. This helps the tube stay in place until the gastrostomy tract is healed; healing takes about three weeks. After the initial healing, a natural tract develops between the stomach and skin. During this time, gauze is placed around the tube to absorb any drainage from the site. Gauze, however, binds to the skin and as a result the patient experiences pain with each replacement of gauze.
After the gastrostomy tract is healed, the feeding tube remains securely in the patient's stomach. A detent means in the form of a raised annular protuberance or bumper is positioned at an inner end of the tube inside the stomach. An inflated balloon may also be attached to the feeding tube inside the stomach to hold said feeding tube in place. A flange provided in the form of a plastic piece circumscribes the tube outside the patient's body. This configuration keeps the feeding tube from sliding in and out of the opening. The flange is formed integrally with the tube or is securely attached thereto so that there is no relative movement between the tube and the flange. The tube is able to move in and out of the patient's stomach just slightly. The flange fits snugly against the skin, but it does not bear thereagainst, i.e., it does not apply pressure thereto.
The site of the gastrostomy is susceptible to infection and leakage, particularly during the initial stages of healing. Gastric fluids may leak through the space between the outside of the tube and the stoma. Gauze is typically used to provide a dressing; it is attached to the skin with adhesive tape. Both the gauze and the tape become stuck to the skin so that changing the gauze is painful to the patient.
Hydrophilic foam dressings have developed that are effective in the treatment of highly exuding wounds such as skin graft donor sites, venous leg ulcers, and pressure ulcers. Foam dressings for a gastrostomy patient promote a sterile environment while absorbing excess fluids to prevent the skin from becoming too moist. Hydrophilic foam dressing allows a patient to maintain longer intervals between dressing changes.
Although hydrophilic dressings have been shown to form an effective bacterial barrier on the skin of a gastrostomy patient, these dressings are typically adhered to the skin with tape or other similar adhesive. Upon removal of the dressing, the dressing may adhere to the skin and cause discomfort to the patient. Disturbance of the site of the stoma can also introduce bacteria into the wound.
The hydrophilic devices and other medical appliances that have been developed to absorb bodily fluids exuding around a protruding tube are not available to the general public. They are medical-appliances used in hospitals by medical personnel. As is typical with hospital medical appliances, the devices of the prior art are used once and discarded. Thus, it would be desirable if a less wasteful alternative could be found.
U.S. Pat. No. 4,699,616 to Nowak et al. discloses a catheter retention device. It includes a core formed of thermoplastic foam for cushioning purposes but not for absorptive purposes. Accordingly, a material that presents a barrier to liquid covers the foam core.
Another cannula-anchoring device formed of non-absorptive materials is disclosed in U.S. Pat. No. 5,364,367 to Banks.
Gisselberg et al., in U.S. Pat. No. 5,569,207, disclose a dressing applied around a catheter. The dressing includes a lip that extends into an exit site so that part of the dressing extends a short distance into the subcutaneous tissue along the catheter tract in the patient. The edges of the dressing may be secured to the skin of the patient by using a gauze tape or other type of adhesive material. In the alternative, the dressing is secured to the catheter and both items are moved into their final positions together. The side of the dressing away from the patient's skin is formed of a liquid-impermeable barrier. Thus, the dressing is not reversible.
It would also be desirable if a less wasteful alternative could be used in a home environment.
When a patient is sent home, the caregiver is simply instructed to keep gauze on the wound and to change the gauze frequently. Accordingly, a suitable device that could be used in a non-hospital environment is highly desirable.
In summary, the needed improvements include a device that does not adhere to the patient's skin upon removal of the dressing, that can easily be used in a home environment with a gastrostomy feeding tube to absorb gastric fluids, and which is inexpensive and re-useable.
However, in view of the prior art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how the identified needs could be fulfilled.
SUMMARY OF INVENTION
The long-standing but heretofore unfulfilled need for a feeding tube skin guard that can be used at home in a non-hospital environment, which can be replaced painlessly, and which can be re-washed and re-used, is now provided in the form of a new, useful and non-obvious device.
The novel device for absorbing liquids and protecting a patient's skin when a feeding tube is in use includes a disc-shaped member having a flexible and resilient construction. A central opening having a diameter about equal to a diameter of the feeding tube is formed in the disc-shaped member and is adapted to receive the feeding tube. A radial cut is formed in the disc-shaped member, extending from the central opening to an outer peripheral edge of the disc-shaped member.
A first releasable fastening means is mounted to a first side of the disc-shaped member near the radial cut and near the peripheral edge. The first releasable fastening means is also disposed on a first side of the radial cut.
A second releasable fastening means is mounted to a second side of the disc-shaped member near the radial cut and near the peripheral edge. The second releasable fastening means is also disposed on a second side of the radial cut.
The disc-shaped member has a top wall, a bottom wall, and a hydrophilic core of predetermined thickness disposed in sandwiched relation between the top and bottom walls.
The top and bo
Lewis Kim M.
Smith Ronald E.
Smith & Hopen , P.A.
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