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
abdomeri 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 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.S.
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cannula which is positioned using a trocar, the trocar being withdrawn to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
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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.
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 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
of infection, skin breakdown and formation of decubitus ulcers. There is 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 or
fluid can leak out, organisms can be introduced through this access. The
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
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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.
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
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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.
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.
Fig. 5 is a perspective view of another embodiment of the flange.
Fig. 6 is a partial perspective view of Figure 5 in an open position.
Fig. 7a and 7b illustrate another embodiment of the flange.
Fig. 8 provides a perspective view of another embodiment of the flange.
Fig. 9a and 9b illustrate a further embodiment of the flange.
Figures 10a, lOb and lOc illustrate yet another embodiment of the flange.
Figure 11 is a perspective view of still a further embodiment of the flange.
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.
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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 1, 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 of
the fluid filled balloon 18. along with any slight movement of 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 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.
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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 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 co 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 cather
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;
(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.
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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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Moreover, the catheter can be comprised of plastic such as bio compatible
polymers, including
silicone, rubber, silicone elastomers, polyurethane, silicone copolymers,
polypropylene and/or
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.
Moreover other embodiments of the flange may be used to frictionally engage
the catheter in the
operable position described above and releasable from the catheter in a second
inoperable
position .
Figures 5 and 6 illustrate another embodiment of the invention which shows the
flange having
the cylindrical portion 54 cut axially and the flange portion 56 cut radially
as shown, so that the
flange can be opened as shown in Figure 6 and closed as shown in figure 5.
Generally speaking
the flange material comprises of a flexible material such as plastic including
biocompatible
polymers such as silicon, rubber, silicon elastomers, polyurethane silicon
copolymers,
polypropylene and/or similar materials or combinations thereof typically used
in the art. Such
materials have a memory so that the flange as shown in figure 6 would tend to
move to a closed
position as shown in figure 5.
Accordingly, the flange shown in figure 6 could be manipulated so that the cut
edges 57 and 59
of the cylindrical portion and the cut edges 61 and 63 of the flange portion
56 could be spread
apart so as to receive the catheter 40 as shown in figure 5. The flange as
shown in Figure 7a
and 7b can be equipped with Velcro material . In particular, the Velcro
material 90 can
comprises of loop means which is adapted to be received by hoop means 94 in
the manner well
known to the persons skilled in the art. Accordingly, the flange can thereby
be secured to the
catheter as previously discussed. Alternatively, the Velcro material shown in
figure 7b can be
pulled apart to the position shown in figure 7a. Furthermore, the Velcro
material 94 and 96 can
extend further along the cylindrical portion 54 as well as the flange portion
56 so that the edge 57
can extend beyond the edge 59 so as to make a smaller diameter bore 58. In
this manner, the
edge of flange 61 would also extend beyond edge 63. In this embodiment the
internal corner 65
of the flange shown in figure 6 would ride up so as to contact along the inner
circular edge 67.
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Alternatively, as shown in figure 8, adhesive tape 80 and 82 can be utilized
so as to secure the
flange frictionally along the catheter as previously described.
Figures 9a and 9b illustrate another embodiment of the invention whereby the
cylindrical portion
54 includes the slit 55 having retaining shoulders 57 and 59 as shown which
are adapted to be
clasped and held in place by a slidable channel 61 as shown. The flange
portion also includes
similar retaining shoulders 51 and 53 with slidable channe171.
Figure 10a and 10b illustrate another embodiment of the invention whereby the
cylindrical
portion of the flange includes a recess to selectively releasably receive a
projection 43 as shown.
Finally, figure 11 shows another embodiment of the invention which has a
tapered cylindrical
portion 53 with indicia or marks 3, 5 and 7 which correspond to different
sized outer diameter of
catheters. Accordingly, the friction fit between the inner bore 58 of the
flange can be selected
by cutting along the mark 3, 5 or 7 for the appropriate sized diameter to
frictionally fit with the
catheters previously described. For example markation line 3 may indicate a
three millimeter
diameter catheter while markation line 5 can indicate a 5 millimeter diameter
catheter and
markation line 7 indicate a 7 millimeter outer diameter catheter. Thereafter,
the outer diameter
of the cylindrical portion of the flange can be cut along one of the lines so
as to present a flange
having an appropriately sized inner diameter to frictionally fit with the
outer diameter of the
flange.
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.
