Apparatus and method to stabilize a peritoneal dialysis catheter

A belt for stabilizing an implanted peritoneal dialysis catheter exiting from the abdomen of a user and having a valve at one end. The belt includes a body of elasticized fabric designed to encircle the patient, two fasteners with hook and pile features, and a receptacle. In addition, a relatively small adhesive-backed member, having adhesive on its inner surface and having a pile member on its outer surface, surrounds a portion of the catheter tubing at a point near where the tubing exits the user. One of the two fasteners secures and stabilizes the tubing to the belt body by pressing against the pile outer surface of the adhesive-backed member and subsequently is secured to itself. The second fastener is used to further secure the tubing against the belt body at a distance from the one fastener. The receptacle, or envelope, integral to the belt body, is used to securely hold the valve end of the catheter against the belt body. The method of using the present invention is also described.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The present invention relates generally to belt-like articles of clothing, 
and more particularly to a stretchable and adjustable belt which holds a 
peritoneal dialysis 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. 
2. Description of the Related Art 
Dialysis is a way of cleaning the blood when a person's kidneys can no 
longer perform their function. Not long ago, total kidney failure meant 
death. Today, there are almost 200,000 people with end-stage kidney 
disease in the United States alone. They are being kept alive because of 
treatments such as dialysis and kidney transplant. Dialysis substitutes 
for the kidneys by removing the body's wastes, which include excess salt 
and water. Dialysis also helps control blood pressure. Two basic methods 
of dialysis exist: hemodialysis and peritoneal dialysis. In the 
hemodialysis method, blood is pumped out of the body to an artificial 
kidney machine which contains a special membrane to filter the blood and 
remove wastes. The cleansed blood is then returned to the body by tubes 
that connect the patient to the machine. The hemodialysis procedure takes 
approximately four hours and must be performed three times a week. 
Although hemodialysis is effective at removing wastes from the blood, 
patients are traumatized by the procedure. They often feel exhausted for a 
day or more afterwards, at which point it's time to repeat the procedure. 
Peritoneal dialysis is the other method of dialysis. In this method, the 
wastes are filtered out of the blood across a lining of the patient's 
abdominal cavity. 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. A soft plastic tube called a catheter is surgically 
placed in the patient's lower abdomen. 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. Out of the 600,000 patients worldwide who are being treated 
with dialysis, a significant number, approximately 100,000, use CAPD. 
Patients can personally perform the procedure by placing approximately two 
liters of cleansing fluid in their abdominal cavity and later draining it. 
The procedure begins by attaching a solution container and a drain bag 
(two flexible plastic bags) to the catheter in the patient's abdomen 
through a connecting length of tubing. Raising the solution container to 
shoulder level causes the force of gravity to pull the solution into the 
abdominal cavity. While the person goes about everyday activities, wastes 
and excess water pass from the patient's blood stream through the network 
of tiny blood vessels in the peritoneal membrane and into the solution. 
When the CAPD is completed, an empty plastic drain bag is lowered to a 
surface below the abdomen. Then the solution, which now contains wastes, 
drains by gravity from the abdominal cavity back into the bag. The used 
containers are then thrown away. This process usually is performed four 
times during any 24-hour period while the patient is awake. Each exchange 
takes about 30 minutes to complete. 
Compared to hemodialysis, CAPD offers several advantages. With the 
continuous dialysis, the patient does not have large fluid gains which may 
reduce stress on the heart and blood vessels. Fewer dietary restrictions 
are required and a need for certain medications is decreased. No long 
interruptions in daily activities occur and patients find work and travel 
arrangements much easier to perform. However, there are some difficulties 
with peritoneal dialysis. For example, patients on peritoneal dialysis 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. These injuries occur daily and cause problems ranging from 
simple pain and discomfort to severe infections and peritonitis. If not 
treated promptly peritonitis can lead to death. 
The problem area is in supporting the catheter tubing. Unfortunately, to 
date, there has been no satisfactory way to support this tube that has 
been commercially available. 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. Burnnet 
(Systenet.TM.) is used on many users who cannot tolerate tape but that 
also can be uncomfortable and expensive for long-term use. 
When a catheter is poorly supported it becomes a nuisance and an annoyance. 
More importantly, when a catheter is dangling it is more prone to 
traumatic injury. This can lead to exit site complications and infection 
which may require medical intervention. In extreme cases the trauma has 
caused the need for catheter replacement, a full fledged surgical 
procedure. 
In an attempt to overcome these difficulties mentioned above, and to help 
eliminate serious medical risk, inventors have tried to design devices to 
restrain the tubing from movement. Kaplan U.S. Pat. No. 4,096,863 
discloses a band and various straps for anchoring a catheter to the body. 
Unfortunately, Kaplan's device is unnecessarily complicated, and is 
cumbersome to wear under street clothing. In addition, a rigid clip 
applied to the belt-like device interferes with comfort, restful sleeping 
and needlessly adds additional time to each 30 minute dialysis procedure. 
In each procedure, the Kaplan device must be totally unfastened before the 
catheter transfer set valve can be used. Kovacs, in U.S. Pat. No.4,445,894 
illustrates a band strapped to the body utilizing two opposing Velcro 
TM.TM.-like fasteners to restrain the catheter. While Kovacs has devised a 
simpler solution to Kaplan's method, it is not optimized because the 
catheter easily slides back and forth when used for peritoneal dialysis, 
causing trauma to the exit site. Endo's U.S. Pat. No. 4,955,867 teaches a 
belt-like device incorporating a pouch to hold the valve end of the 
catheter. However, serious trauma to the exit site results because the 
approximately two foot length of tubing remains unsecured. Therefore, the 
dangling tubing is tugged and moved by the wearer, stressing the exit 
site. Furthermore, the pouch is fastened on top of the belt material 
making Endo's device unnecessarily thick. To applicants' knowledge, the 
Endo device product has not been produced and is not commercially 
available, presumably because of the aforementioned problems. Finally, 
U.S. Pat. Nos. 4,976,700 and 5,098,399 teach a catheter and tubing 
immobilizer. However, this invention is inadequate for several reasons. 
While it immobilizes the tubing at the exit site, it leaves the valve end 
dangling and unprotected. It is for one-time use only, must be disposed of 
after use, and causes irritation and allergic reaction on the user's skin 
because of the adhesive tape backing that is used to secure the device to 
the skin. 
Therefore, with all the above noted problems, there; is still an urgent and 
continuing need for an improved apparatus and method to stabilize a 
peritoneal dialysis catheter, without causing trauma to the user at the 
exit site. 
SUMMARY OF THE INVENTION 
The above-mentioned difficulties and problems of the prior art are overcome 
by the present invention. Briefly stated, the present invention provides 
novel improvements to a belt for stabilizing a peritoneal dialysis 
catheter device against a user. In summary, the present invention 
represents a soft, adjustable, elasticized belt which provides easy and 
quick access to a peritoneal catheter device allowing multiple and 
trauma-free daily dialysis fluid exchanges. Additionally, the present 
invention is a simple device which is comfortably worn 24 hours a day, and 
is used virtually always without having to disrobe. 
More specifically, the present invention includes a belt body which 
encircles a user without slipping, an adhesive-backed fabric band attached 
to the tubing of the catheter device, a first fastener attaches over the 
adhesive-backed band to firmly stabilize the tubing to the belt body near 
where the tubing exits the user, a second fastener to further stabilize 
the tubing against the belt body, and a pocket for securely holding the 
valve end of the catheter device against the belt body. 
One of the advantages of the adhesive-backed band is in providing stability 
during draining and filling, preventing stress and tugging on the tubing, 
thereby ensuring additional protection of the exit site. More 
specifically, the medical advantage of the belt is that it keeps the 
catheter tubing immobile at the exit site, where the tube exits the 
peritoneum, and protects the exit tunnel from trauma, including 
inadvertent dangling of the catheter device. These advantages reduce the 
chance of pain, exit site infections, and potentially serious peritoneal 
complications. 
Having two fasteners, instead of one which other prior art devices have 
used, provides a doubly firm grip on the catheter tubing. The belt body is 
advantageously assembled from two pieces and, by overlapping these parts 
in the manufacture of the device, the two parts form a smooth pocket or 
envelope. The valve end is stored and protected in the envelope. 
For dialysis patients with sensitive skin, protection from frequent use of 
tape adhesives and allergic reactions is achieved by eliminating the need 
of having to tape the peritoneal catheter or any part of the tubing to the 
skin. 
Additional advantages of the preferred embodiment include the belt being 
manufactured from a woven and elastic material, thereby providing slight 
compression to abdominal bloat while it still remains expandable and 
adjustable to allow for bloat. The belt promotes more natural activity by 
allowing a full range of motion which improves patient strength and 
general health. Additionally, the belt is adaptable for use during most 
sporting activities, at night while asleep, and while bathing. It fits 
compactly under all normal clothing, is machine washable, durable and 
reusable. Wearing the belt will avoid user discomfort and complications, 
thereby reducing the need for medical attention and the related costs. 
The method for using the present invention begins with placing the belt 
around one's waist. Next the belt body is positioned so that the first 
fastener is located approximately above the exit site. After a short loop 
is made in the tubing, it is placed parallel to the belt and atop the 
first fastener. Then the adhesive-backed band is secured around the tubing 
in the vicinity of the first fastener. A flap in the first fastener is 
then placed over the tubing and squeezed together, thereby securing the 
tubing firmly adjacent to the belt body. Next the valve end of the 
catheter is inserted into the pocket. Lastly, a second flap on the second 
fastener is secured over the tubing in a similar fashion as the first 
fastener. These, and other, features and advantages of the present 
invention are set forth more completely in the accompanying drawings and 
the following description.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
Referring initially to FIG. 1, a schematic representation view illustrates 
a peritoneal dialysis procedure known as a Continuous Ambulatory 
Peritoneal Dialysis (CAPD) exchange. In a CAPD, waste fluid (10) is 
drained from a person's peritoneal cavity (12) through an implanted 
catheter apparatus (14), such as manufactured by the Baxter Healthcare 
Corporation. The CAPD process is well understood in the field of dialysis. 
Nevertheless, it is helpful to briefly describe each of the components of 
the catheter apparatus (14) prior to the subsequent discussion and 
description of the present invention. 
Beginning from the abdominal cavity (12), catheter tubing (16), at a 
proximal end (18) of the catheter apparatus (14), extends from the 
peritoneal cavity (12) out of a person's body (20) through an exit site 
(22) in the outer surface (24) of the abdomen (26). The next portion of 
the catheter tubing (16) is designated as transfer set tubing (28). A 
connector (29) joins the catheter tubing (16) to the transfer set tubing 
(28). The transfer set tubing (28) is fixedly connected to a transfer set 
valve (30) at a distal end (32) of the catheter apparatus (14). The 
transfer set valve (30) is used to either 1) allow fresh peritoneal fluids 
(34) from a fill bag (36) to enter the abdominal cavity (12) through the 
catheter tubing (16), or 2) to allow peritoneal waste fluid (10), which 
now includes body wastes, to flow out of the abdominal cavity (12) into an 
expandable drain bag (38). Filling the peritoneal cavity (12) with fresh 
peritoneal fluid (34) from a flexible fill bag (36) is accomplished by 
first elevating the fill bag (36) above the peritoneal cavity (12). Then 
gravity is used to allow the fluid (34) to flow. The fresh fluid (34) 
flows from the fill bag (36) into the peritoneal cavity (12) when a clamp 
(not shown) is released from the fill bag tubing (42). The draining 
process of the used peritoneal fluid begins by connecting the transfer 
valve (30) to drain bag tubing (44). Next, the drain bag (38) is placed 
below the level of the peritoneal cavity (12) to allow the force of 
gravity to drain the waste fluid (10) out of the peritoneal cavity (12). 
The waste fluid (10) begins flowing when another clamp (not shown) is 
released from the drain bag tubing (44). 
Referring next to FIG. 2, a perspective representation view shows a portion 
of the representative catheter apparatus (14) being stabilized by a 
preferred embodiment of a belt apparatus (46). The belt (46) includes a 
belt body (48), an adhesive-backed band (50) semi-permanently attached to 
the tubing (16) of the catheter (14), a first fastener (52) attached over 
the adhesive-backed band (50) holding the catheter apparatus (14), a 
second fastener (54) to hold the catheter (14) against the belt body (48) 
at a point spaced from the first fastener (52), and a receptacle (56) 
spaced from the first (52) and second fasteners (54) for securely holding 
the transfer set valve (30) against the belt body (48). Together, the 
first fastener (52), the second fastener (54) and the receptacle (56) at 
the distal end (32) of the catheter apparatus (14) are radially spaced 
along the belt body (48) to hold the catheter apparatus (14) substantially 
parallel to the belt body (48). 
The belt body (48) is preferably fabricated from elasticized fabric adapted 
to encircle a user without slipping from the user's abdomen (26). 
Furthermore, the belt body (48) has soft, flexible, expandable and 
stretchable properties, with a first end (58) and a second end (60). The 
belt body (48) is also adjustable using hook (62) and pile (64) closures. 
Such hook and pile features on material are typically incorporated in the 
product known as Velcro.TM.. The hook (62) and pile (64) closures are 
placed at opposing end surfaces of the belt body (48) to accommodate a 
catheter (14) exiting on either the right or the left side of the user's 
body (20). To secure the belt body (48) around a user, the user merely 
presses the two hook and pile closures (62,64) against each other at a 
comfortable circumference, thereby achieving closure, of the belt body 
(48). The width of the belt body (48) is preferably about two inches. 
Experimentation has shown that a two inch width provides an optimized 
comfort width and prevents rolling of the fabric against the body (20) as 
normal daily activities occur. The belt body (48) may be of various 
lengths, depending on the circumference of the abdomen of different users. 
Preferably, the lengths could be about 20-30 inches, 26-36 inches, 30-40 
inches, 34-44 inches and 40-50 inches. These lengths generally correspond 
to child, small, medium, large, and extra large sizes. 
The first and second fasteners (52, 54) are formed into clamping devices 
which may be fabricated from one of numerous materials. Just some of these 
materials are plastic, rubber, metal and fabric. The first fastener (52) 
has a first flap (72) adapted to fold over the catheter tubing (16) of the 
catheter apparatus (14). The first fastener (52) is in secure contact with 
the pile outer surface (70) of the cylindrical adhesive-backed band (50). 
Subsequently, the first fastener attaches securely upon itself, thereby 
firmly stabilizing the catheter tubing (16) against the belt body (48). It 
is a key advantage of the present invention for the tubing (16) of the 
catheter (14) to be secured to the belt body (48) at a point proximate to 
where the tubing (16) of the catheter (14) exits the user. The first flap 
(72) also has a first inner surface (74) and a first outer surface (76), 
with the first inner surface (74) having hook fabric. The outer surface 
(76) is pile fabric. 
The second fastener (54) is attached to the belt body (48) at a medial 
point along the tubing (16) of the catheter apparatus (14). Similarly to 
the first fastener (52), the second fastener (54) has a second flap (78) 
adapted to fold over the transfer set tubing (28) and subsequently 
attaches securely upon itself. With the use of a second fastener (54), 
further stabilization is achieved for the tubing (16) against the belt 
body (48). Again, similar to the first flap (72) on the first fastener 
(52), the second flap (78) has an inner (80) and an outer (82) surface. 
The second inner surface (80) also has hook fabric (84), while the second 
outer surface (82) is pile fabric as well. 
The receptacle (56) is pocket-shaped, integrally attached to the belt body 
(48). The receptacle (56) forms an envelope so that the transfer set valve 
(30) is manually insertable into the envelope. The receptacle (56) is also 
preferably fabricated from the same fabric as the body belt (48). The 
length of the receptacle (56) generally conforms to the length of the 
transfer set valve (30), while the width of the receptacle (56) conforms 
generally to the dimensions of the belt body (48). 
Now referring to FIG. 3, a perspective representation view shows the 
construction details of the belt (46). An overlap (84) of fabric which 
forms the belt body (48) is illustrated which forms the receptacle (56), 
creating the protective envelope for storage of the transfer set valve 
(30) while the valve (30) is not in use during an exchange. Also 
illustrated are the construction details of the first (52) and second (54) 
fasteners. More clearly illustrated in FIG. 3 are the first flap (72) of 
the first fastener (52) and the first inner surface (74). Also shown are 
details of the second inner surface (80) of the second fastener (54) and 
the second outer surface (82). Similarly, the second fastener (54) has a 
second hook tab (90) and a second pile tab (92). 
The adhesive-backed band (50) has an inner (68) and outer (70) surface. The 
band (50) is preferably fabricated from fabric available under the 
Velcro.TM. label. The inner surface (68) of the band (50) is 
adhesive-backed. A key aspect in achieving stability of the catheter 
apparatus (14) is attaching the inner surface (68) of the band (50) around 
the catheter tubing (16) in a cylindrical fashion at a distance from the 
proximal end (18) of the tubing (16) where the catheter tubing (16) exits 
the abdomen (26), and in a proximate position to the first fastener (52) 
on the belt body (48). The band (50) advantageously offers protection by 
keeping the catheter tubing (16) from any slippage or movement along the 
belt body (48). The band (50) also has a pile outer surface (70) which is 
used to further secure the catheter apparatus (14) by securely contacting 
the first fastener (52). 
Lastly referring to FIG. 4, a schematic view shows how the belt (46) is 
worn by a user, providing constant protection 24 hours a day to the user's 
exit site (22). The catheter tubing (16) is prevented from movement during 
sleep, work, exercise, bathing, and all other daily routine activities. 
Operation 
The method for using the belt (46) of the present invention includes 
numerous steps. Generally speaking, the belt (46) is placed around the 
user, the two fasteners (52, 54) are secured over the catheter tubing 
(16), and the transfer set valve (30) is inserted into the receptacle 
(56). More specifically, the first step is placing the belt (46) around 
one's waist. The second step is positioning the belt body (48) so that the 
first flap (72) of the first fastener (52) is located approximately above 
the exit site (22). Then the next step is making a short flexible loop 
with the proximal end (18) of the catheter tubing (16). Next, the tubing 
(16) is placed parallel to the belt (46) and atop the first fastener (52), 
leaving the flexible loop in the tubing (16). Now, the adhesive-backed 
band (50) is secured around the tubing (16) in the vicinity of the first 
flap (72) so that the adhesive-backed inner surface (68) of the band (50) 
is in firm contact around the tubing (16). 
Continuing the method, the first flap (72) is overlaid on the tubing (16). 
Now, the first flap (72) and the tubing (16) are squeezed together with 
thumb and index fingers, thereby securing the tubing firmly adjacent to 
the belt body (48) atop the hook and pile outer surface (70) of the 
adhesive-backed band (50). Next, the first flap (72) is attached again to 
the first fastener (52). The next to last step is inserting the transfer 
set valve (30) of the catheter (14) inside the receptacle (56). 
Lastly, the second flap (78) of the second fastener (54) is closed over the 
tubing (16). Using this method, the belt (46) is worn unobtrusively under 
normal street clothing. 
Additionally, a user pinches the first flap (72) at the bottom portion of 
the first fastener (52), thereby snugging up the tubing (16) to prevent 
additional movement of the tubing (16) at the exit site (22). Also., the 
user pinches the second flap (78) at another bottom portion of the second 
fastener (54), thereby snugging up the tubing (16) to further secure it 
against the belt body (48). To perform the dialysis exchange, street 
clothing is loosened at the waistband for access to the belt (46) and 
catheter apparatus (14). The, second fastener (54) is released and the 
transfer set valve (30) is withdrawn from the receptacle (56). These steps 
release sufficient length of the tubing (16) for the transfer set valve 
(30) to be attached to the dialysis drain bag (38). Normal manufacturers' 
instructions and patients' medical training procedures are followed. Due 
to the design of the belt (46), the exit site (22) remains undisturbed 
during the entire process. After the exchange is completed, the user 
reverses steps to re-secure the catheter apparatus (14) to the belt body 
(48), the valve (30) is reinserted in the receptacle (56), and street 
clothing is readjusted. 
The present invention prevents the many problems associated previously with 
CAPD No longer does the user experience tugging, pulling, or excess 
manipulation of the catheter (14) at the peritoneal exit site (22). 
Therefore, no longer is the tissue at the surgical implant site irritated, 
inflamed and damaged. With the development of the belt (46), a situation 
is corrected to which previously there was no good alternative. The belt 
(46) is designed in such a way as to totally support the catheter (14) so 
it is no longer hanging and dangling. It is anchored securely to prevent 
trauma to the exit site (22). The belt (46) ends the need to use tape 
which causes skin irritation. Even when sleeping or showering, the belt 
(46) provides complete stabilization of the catheter tubing (16). 
Accordingly, it will be appreciated that the present invention can be used 
24 hours a day to protect the patient from injury to the catheter exit 
site (22). Improved health and comfort as well as medical cost savings 
will accrue when infections are decreased. The belt (46) is economical and 
inexpensive in that it is reusable for several months. It is comfortable 
enough to become an integral item of apparel. It also will be understood 
by those skilled in the art that since peritoneal catheter insertions are 
implanted into the body (20) on either side, the belt (46) will be 
manufactured in left or right side versions. 
While a particular embodiment of the invention has been described, all 
patients having an abdominal catheter (14) may benefit from this product. 
For example, as advanced materials become available or as surgical 
techniques change modifications may be made to improve the user's comfort 
by improving this product. Consequently, while the foregoing description 
has described the principle and operation of the present invention in 
accordance with the provisions of the patent statutes, it should be 
understood that the invention may be practiced otherwise as illustrated 
and described above and that various changes in the size, shape, and 
materials, as well as on the details of the illustrated construction may 
be made, within the scope of the appended claims without departing from 
the spirit and scope of the invention.