Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-07-18
2003-04-08
Denion, Thomas (Department: 3748)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S179000, C604S181000, C128SDIG008
Reexamination Certificate
active
06544232
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a belt for holding a cystostomy catheter device stable against a user, thereby virtually preventing any trauma to an exit site from which the catheter device extends out of the user's body and is intended for use in cytostome applications where the patient is recovering from kidney of bladder related surgery and the fluid is collected via a catheter inserted into the urethra in the pubic area and temporarily held into place by stitches, staples or the like. The present invention eliminates or is an alternative means of holding the tubing into place without the use of an adhesive used as a conventional means to hold the tubes into place. Replacing the adhesive eliminates serious problems some patients have due to an allergic reaction to the adhesive or latex materials. In addition to supporting the catheter tubes, the belt cushions, covers, and protects the apparatus connecting to the catheter and includes a manifold assembly with quick connections, a two-way valve and sample ports.
2. Description of the Related Art
In cystostomy, the peritoneal catheter is inserted through the abdomen in the pubic area to drain fluid from the bladder. The catheter is a soft plastic tube surgically placed in the patient's lower abdomen. Although the present invention may also be utilized to support a dialysis catheter, the instant invention incorporates design features providing advantages which are not necessary for dialysis catheter holding devices.
Dialysis is a way of cleaning the blood when a person's kidneys can no longer perform their function. Dialysis substitutes for the kidneys by removing the body's wastes, which include excess salt and water. A peritoneal catheter is placed in the patient's abdomen and used in dialysis for filtering the blood across a lining of the patient's abdominal cavity as set forth and described in U.S. Pat. No. 5,496,282, and hereby incorporated by reference. The lining is called the peritoneum and serves as a natural filtering membrane. In peritoneal dialysis, wastes are removed by means of a sterile cleansing fluid which is washed in and out of the abdomen in cycles. The cleansing fluid enters the abdomen through the catheter. Wastes from the blood pass through the peritoneal membrane into the cleansing fluid. Later, when the filtering process is completed, the fluid leaves the body through the catheter. Another name for peritoneal dialysis is “Continuous Ambulatory Peritoneal Dialysis” (CAPD). The process of CAPD does not require the patient to use a dialysis machine, and may be performed at home, at the work place or anywhere where a calm and semi-sterile environment can be temporarily established. Because dialysis is usually, if not always accomplished while the patient is immobile, the belt or other means of holding a dialysis catheter is designed to hold the catheter immobile in the region where the catheter is inserted into the abdominal cavity. Support for holding the auxiliary tubing and providing the patient with a means of easily moving about is typically not a high priority, nor should it be.
However, the instant invention provides a peritoneal dialysis device for supporting a cystostomy catheter used for bladder dysfunction cases wherein a tube extends from the bladder through the peritoneal cavity wall. Patients on peritoneal cystostomy are constantly inconvenienced by the long plastic tube, generally about two feet in length, exiting from their lower abdomen. The exit site in the abdomen is easily irritated by the tube being tugged and moved as the person moves. Usually the cystostomy catheter is temporary and the patient is encouraged to move about during the day sometimes for weeks or months until the recovery period is complete and the bladder functions normally. Of course, in some cases the catheter is worn indefinitely. Injuries due to movement of the catheter where it enters the abdomen or is secured by stitches, staples, or the like, occur daily and cause problems ranging from simple pain and discomfort to severe infections and peritonitis.
The problem area is in supporting the catheter tubing. Tape is a good temporary solution but, over time, tends to really irritate the skin. Some patients have even required medical treatment because skin breakdown was so severe. Securing the catheter apparatus by merely taping a section of the catheter apparatus directly to the patient's body is unsatisfactory because frequent removal of the tape, as in the continuous ambulatory peritoneal dialysis treatment method, 4-6 times daily, can result in physical discomfort; the tape is not re-usable; the tape secures only a portion of the catheter apparatus, leaving the majority of the apparatus exposed; some people are allergic to the tape adhesive; and the taping method is aesthetically undesirable because it inhibits the pursuit of a normal, active lifestyle, including physical intimacy.
SUMMARY OF THE INVENTION
The present invention provides a catheter support belt for stabilizing an implanted peritoneal cystostomy catheter exiting from the abdomen of a user and having a two-way valve at one end. The belt includes a band of fabric designed to encircle the patient, at least two fasteners incorporating means of attachment such as with hook and loop features, and a receptacle. The front portion of the belt includes a plurality of spaced apart wide loops or bands, preferably three, sewn on to the front of the belt to hold the distal end of the catheter, the valve, and a catheter bag attachment fitting. A first vertical flap having a slit forming a hole therein extends from the upper edge of the front portion of the belt, and folds downwardly covering the front portion of the belt, the loops and the distal end of the catheter, the valve, a sample port, and the catheter bay attachment fitting. A pair of second short side flaps extend outwardly from the edges of the first vertical flap. Means for attachment such as one of more hooks sewn into or connected to the underside of the short flaps cooperatively engage mating hook loops sewn or otherwise fastened to the outer surface of the front of the belt. Cooperatively engaging the short flap hooks with the belt hook loops holds the flap in position over the apparatus forming a protective support pouch and providing a smooth surface and appearance. Means for holding such as hooks extend from the distal end of the belt for cooperatively engaging a plurality of hook loops fastened to the exterior surface of the belt for adjustably holding the ends of the belt together. The support pouch is used to securely hold the valve end of the catheter, bag line attachment fitting, valve, and sample port against the belt body. The receptacle generally consists of a plastic bag or pouch which may be hung from a support member such as the bed frame or could be carried by the user and supported by a conventional belt, shoulder strap, handle, or supported by other structures in close proximity to the user.
The principle object of the present invention is to provide a more convenient, comfortable and desirable device for use securing surgically-implanted peritoneal catheters for cystostomy in a durable, re-usable adjustable belt pack and provide a means for taking samples from the manifold assembly held therein by simply opening of closing valves and providing a sample port. Moreover, the belt enables the wearer to move and actively pursue a normal life style while wearing the belt.
The invention solves such problems by having a plurality of button holes in the belt throughout its length which cooperate with a button fastening system on the pouch to permit a wide range of adjustment of the belt.
REFERENCES:
patent: 4662873 (1987-05-01), Lash et al.
patent: 4738661 (1988-04-01), Marut
patent: 4763648 (1988-08-01), Wyatt
patent: 5087251 (1992-02-01), Heyman et al.
patent: 5188608 (1993-02-01), Fritts
patent: 5304145 (1994-04-01), Blair
patent: 5403285 (1995-04-01), Roberts
patent: 5425719 (1995-06-01),
Carrithers David W.
Carrithers Law Office
Denion Thomas
Tran Binh
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