Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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FIELD OF INVENTION
This invention relates to a device for retaining a supra pubic catheter and
particularly relates
to a supra pubic catheter with a moveable device along a catheter for improved
sealing
characteristics as well as the use of the system and method relating thereto.
Background to the Invention
Whether due to disease, stroke or Alzheimer's, a percentage of the population
cannot urinate
through their urethras. Such patients may be catheterized with a urinary
catheter where the
catheter is passed through the urethral of the patient until a distal end of
the catheter is
located in the patient's bladder. Thereafter, an expandable balloon is
expanded to lodge the
distal end of the catheter in the bladder. During catheterization, with a
urinary catheter, urine
drains from the bladder through the catheter, and through a drainage tube
attached to a
proximal end of the catheter to a drainage bag for collection therein.
Another system comprises the use of supra pubic catheters where the catheter
passes through
the abdomen wall of the patient until the distal end of the catheter is
located in the bladder.
This technique bypasses the urethra all together, and the bladder is connected
to the outside
of the body in the pelvic region. A surgical procedure is conducted where a
stoma tunnel
made of body tissue leads from the bladder to the outside of the abdomen.
Such supra pubic catheters have been used to drain urine by placing a urethral
catheter
through the tunnel or stoma. A balloon at one end, namely the distal end, is
inflated with
ZS sterile water or saline inside the patient's bladder in order to keep the
catheter in place. Thus,
fluid from the bladder exits through the hollow passageway of the catheter to
the exterior of
the patient's body. Examples of such prior art devices and procedures are
disclosed in U.S.
Publication No. U.5. 2003/0009079, US Patent No. 4,867,745 and US Patent No.
4,143,651.
Moreover, US Patent No. 4,888,000 discloses a supra pubic catheter inserted by
way of a
cannula which is positioned using a trocar, the trocar being withdrawn to
leave the cannula in
position through the wall of the bladder, allowing passage of the supra pubic
catheter, the
cannula being provided with means for subsequent removal from the catheter.
Also, US Patent No. 5,520,636 teaches a device for flushing the urinary
bladder.
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Furthermore, US Patent No. 6,350,255 illustrates a pad for use with a
continent ostomy port
which includes a body portion having a internal wall defining an aperture
appropriately sized
placed around a stoma, the body portion of the pad being sized and shaped for
placement
against the user's skin beneath a face place of an ostomy port. The pad is
formed of a soft,
flexible material to thereby cushion and protect the skin from contact with
the ostomy port
face plate.
One of the difficulties with the current technique and prior art devices
resides in the fact that
the inflated balloon does not stay in place, either due to patient's movement
or the play in
migration inwards and outwards of the catheter which breaks the seal.
Furthermore, the
weight of the saline filled balloon may cause leaking of air and fluid.
Ideally, the fluid or
I S urine drains from the bladder with the use of the relatively higher
pressure in the bladder
when compared to the atmosphere pressure in the drainage bag or the like, as
well as due to
the gravity. In those circumstances, where there is no seal, drainage relies
on gravity alone.
In addition, when a good seal is not maintained, urinary leakage occurs. The
patient is wet
and in addition the weight of the patient in bed and the pressure on the skin
increases a
patient's risk o f infection, skin b reakdown a nd formation of d ecubitus a
lcers. There l s a
general concern for decubitus ulcers in the sacrum and bilateral hips which
manifest itself as
Ishial tuberosities. If a patient already has decubitus ulcers in these areas
with urine leakage
on such dressing affects the effectiveness of the dressing and the medication
under the
dressing, which ultimately leads to various complications.
Moreover, leakage of air and fluid around catheter provides an avenue for
infection. If air
and o r fluid c an 1 eak o ut, o rganisms c an b a l ntroduced t hrough t his
a ccess. T he catheter
outside the skin and any organisms on this catheter will be deposited in the
bladder by the
migration and play of the catheter.
Moreover, it has been documented that, without properly securing the urethral
catheter, the
stoma over time, becomes larger and eventually causing insertion of a larger
catheter. This
causes the patient more trauma and discomfort. Much of the existing
difficulties may stem
from the fact that urethral catheters are used in supra pubic catheter
applications.
Accordingly, there is a need for improved apparatus and method as well as
system for a supra
public catheter.
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Retention bolsters for gastrostomy and other ostomy tubes have been disclosed
as illustrated
in the US Patent No. 6,039,714. Moreover, retention bolster for percutaneous
catheters
which have a convexly curved exterior surface which contacts the epidermal
surface of the
patient are shown on US Patent No. 5,484,420.
Finally, US Patent No. 3,976,080 teaches an endotracheal tube holder.
There is a need for an improved apparatus, method and system for supra pubic
catheters.
Summary of the Invention
It is an aspect of this invention to provide a device for retaining a supra
pubic catheter having
an expansible balloon at one end of the catheter for maintaining the catheter
in place and a
slidable flange received by the other end of the catheter.
It is another aspect of this invention to provide the combination of a supra
pubic catheter
adapted to be placed through a stoma, the catheter having one end with an
inflatable balloon
adapted to be inflated inside the bladder, and a device axially moveable along
the catheter
towards the balloon.
There is another aspect of this invention to provide a method of treating a
bladder by use of
supra pubic catheter comprising: placing a supra pubic catheter through a
stoma in an
abdomen of a patient into the bladder, inflating a balloon disposed at one end
of the catheter
in the bladder to maintain one end of the catheter and said bladder, moving a
retainer along
the catheter towards the abdomen to draw said catheter balloon against said
bladder.
It is a further aspect of this invention to provide for the use of a supra
pubic catheter for a
bladder comprising: inserting a supra pubic catheter through a stomal tunnel
in an abdomen
of a patient into the patient's bladder, inflating a balloon disposed at one
end of the catheter
in the bladder, moving the catheter towards the abdomen to draw said catheter
balloon
against the bladder.
These are the objectives and features of the invention should all be described
in relation to the
following drawing:
Brief Description of Drawings
Fig. 1 illustrates a prior art urethral or urinary catheter.
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Fig. 2 illustrates the supra pubic catheter disclosing the invention.
Fig. 3 illustrates the retainer.
Fig. 4 is a cross sectional view along the lines of 4-4 of Fig 3.
Description of the Invention
In the description which follows, like parts are marked throughout the
specification and the
drawings with the same respective reference numerals. The drawings are not
necessarily to
scale and in some instances proportions may have been exaggerated in order to
more clearly
depict certain features of the invention.
Figure 1 illustrates a prior art urethral or urinary catheter 2 which has one
end of distal end 4
adapted to be placed through a stoma 6 of a body 8 towards a bladder 10. The
stomal tunnel
is produced by a trocar under sterile conditions. The catheter 2 has a "Y"
branch 12 where
one of the branches 14 is adapted for inserting saline solution through the
catheter so as to
inflate the balloon 18 in a manner well known to those persons' skill and art.
Moreover, the abdomen 8 generally comprises of the public wall.
In the system illustrated in Figure l, the catheter 2 has one end or distal
end 4 inserted
directly into the bladder through the supra pubic area. The balloon 18 of the
catheter 2 is
then inflated within the bladder, by introduction of saline solution through
branch 14 by way
of example, and then pulled snuggly to occlude the opening 20 from the bladder
to the stomal
tunnel 22. In particular the catheter has two coaxial passages one that
communicates with the
balloon 44 and branch 50 , and the other that communicates with the holes 43
at the distal end
to drain urine through end 19 . One of the problems encountered in the prior
art is that the
balloon moves (hence the seal is broken) due to the flexibility of the rubber
or silicone
catheter, the weight o f the fluid f filled b alloon 18. along w ith a ny s
light m ovement o f the
patient or catheter.
Figure 2 illustrates and describes therein a catheter 40 having at its distal
end 42 an inflated
balloon 44. In particular, the catheter 40 is inserted directly into the
bladder 46 through the
supra pubic area through a stomal tunnel 48 produced by the surgical use of
the trocar (not
shown) in the abdomen or pelvic wall. The balloon 44 on the catheter 40 is
then inflated
within the bladder by means of the "Y" branch 50 in a manner well known to
those persons
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skill in the art. Upon inflating the balloon 44, the catheter is then pulled
snuggly to occlude
the opening from the bladder 46 to the stomal tunnel 48. Figure 2 also
discloses that one of
the branches 16 communicates with the remainder of the catheter to present a
passage way 17
which permits voiding of urine through the catheter out the exit 19.
A flange 52 is disposed along the catheter. The flange, more particularly
described in
Figure 3 consists of a sleeve and hollow cylindrical portion 54 having a hole
or bore 58 there
through. Cylindrical portion 54 is symmetrical about axis 60. The retainer
device 52 also
comprises the radially extending flange portion 56.
In particular, the inner diameter of the hole 58 is sized so as to be slidably
moveable along
the longitunal axis 70 of catheter 40 in the region between the pelvic wall 49
and the
1 S proximal end 72 of the catheter 40, yet frictionally engage the outer
diameter of catheter 40
when contacting the epidermal skin layer of the patient.
More particularly in one embodiment shown the hole 58 has capturing means 59
disposed
interiorially of the hole 58. In particular the capturing means comprise a
plurality of
internally disposed projections or rings 59 . Therefore the catheter 40 which
is comprised of
stretchable material is adapted to be received Go axially within hole 58 and
ride past the rings
59 . Once the retaining device is placed in the desired position the flexible
nature of the
retainer and Gather relaxes and the rings 59 assist in retaining the retainer
52 in the desired
position on the catheter.
The retainer 52 also includes one wall 60 which is adapted to contact the
pelvic wall 49. In
the embodiment shown in Figures 2 and 3, the catheter 40 is inserted directly
into the bladder
46 through the supra pubic area through stomal tunnel 48. The balloon 44 and
the catheter 40
is inflated within the bladder 46 and pulled snuggly to occlude the opening
from the bladder
46 to the stomal tunnel 48. The retainer 52 is then slidably disposed along
the axial length 70
(exterior of the body of the patient) towards the balloon 44 so as to secure
the balloon 44
under slight tension in its ideal location thereby creating a substantially
closed or sealed
system. In other words the length of catheter between the balloon 44 and the
disc 52
contacting the exterior skin is under slight tension.
The system described herein comprises:
(a) Placing a supra pubic catheter through a stomal tunnel from the outside
skin of the
abdomen of the patient to the bladder;
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(b) Inflating a balloon disposed at one end of the catheter, in said bladder
to maintain said
one end of the catheter in said bladder;
(c) Moving a retainer along the catheter towards the abdomen to draw said
catheter
balloon against the bladder.
With the system described herein, the retainer 52 holds the balloon over the
inner, namely the
bladder side opening to the stomal tunnel thereby providing a chance from the
mucosa in the
tunnel to dry and crust thus permitting healing to take place. Thereby, the
opportunity for
infection is minimized thus improving the patient comfort and providing the
least disruption
to the body image.
The system described herein provides the following advantages:
1. Reduces leakage from the stoma opening, due to a seal created from the
flange and
balloon.
2. The catheter stays in place, as the flange secures the catheter from any
type of
movement within the stoma.
3. The skin breakdown is significantly reduced, because the leakage is stopped
since the
stoma is sealed by the balloon secured in place by the retaining device.
4. Infection to the stoma area is reduced when the seal is create with the
retainer,
inhibiting any foreign matter from entering the stoma tunnel, thereby lowering
the incident of
Urosepsis and sepsis with air and fluid.
5. With a seal, the stoma has a chance to heal; since air contacts the normal
mucosa in
the stomal tunnel thus allowing granulation and healing.
6. Stoma enlargement is minimized.
7. Patient comfort and body image is significantly improved, because the seal
keeps the
area from leaking, giving the patient peace of mind that they will not have
leakage in public.
8. Physical activity of the patient is significantly improved since the seal
keeps the area
from leaking which intern allows the patient the freedom to participate in
activities they
normally would not with previously used catheters.
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S Moreover, the catheter can be comprised of plastic such as bio compatible
polymers,
including silicone, rubber, silicone elastomers, polyurethane, silicone
copolymers,
polypropylene andlor similar materials or combination thereof typically used
in the art.
The flange can be comprised of the similar material.
Furthermore the invention comprises the kit which includes the supra pubic
catheter and
retainer.
Various embodiments of the invention have now been described in detail. Since
changes in
and/or additions to the above-described best mode may be made without
departing from the
nature, spirit or scope of the invention, the invention is not to be limited
to said details.
