U.S. patent number 3,860,007 [Application Number 05/333,926] was granted by the patent office on 1975-01-14 for catheter with safety deflation means.
This patent grant is currently assigned to The Kendall Company. Invention is credited to William J. Binard, John F. Dye.
United States Patent |
3,860,007 |
Binard , et al. |
* January 14, 1975 |
**Please see images for:
( Certificate of Correction ) ** |
CATHETER WITH SAFETY DEFLATION MEANS
Abstract
A catheter including, a shaft having a proximal end, a distal
end for insertion into a body cavity, a drainage eye adjacent the
distal end of the shaft, and a main lumen extending from the
drainage eye to the proximal end of the shaft for draining the
cavity. The catheter has an inflatable retention balloon adjacent
the distal end of the shaft for retaining the shaft in the cavity,
an inflation lumen extending between the inside of the balloon and
adjacent the proximal end of the shaft, and valve means for
controlling inflation and deflation of the balloon. The catheter
also has at least one separate deflation lumen communicating
between the balloon and adjacent the proximal end of the shaft, in
order that the balloon may be deflated through the deflation lumen
by severing the catheter shaft adjacent its proximal end when the
inflation lumen is obstructed.
Inventors: |
Binard; William J. (Barrington,
IL), Dye; John F. (Barrington, IL) |
Assignee: |
The Kendall Company (Walpole,
MA)
|
[*] Notice: |
The portion of the term of this patent
subsequent to April 10, 1990 has been disclaimed. |
Family
ID: |
23304832 |
Appl.
No.: |
05/333,926 |
Filed: |
February 20, 1973 |
Current U.S.
Class: |
604/99.02;
604/920 |
Current CPC
Class: |
A61M
25/10185 (20131105); A61M 25/00 (20130101); A61M
25/0017 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/10 (20060101); A61m
025/00 () |
Field of
Search: |
;128/348,349B,349BV,35R,351,344,246,325 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Sprunger; Powell L.
Claims
We claim:
1. A catheter, comprising:
a shaft having a proximal end, a distal end for insertion into a
body cavity, a drainage eye adjacent the distal end of the shaft,
and a main lumen extending from the drainage eye to the proximal
end of the shaft for draining liquid from the body cavity;
an inflatable retention balloon adjacent the distal end of the
shaft for retaining the shaft in the cavity;
an inflation lumen extending between the inside of said balloon and
adjacent the proximal end of the shaft;
valve means for controlling inflation and deflation of said balloon
through said inflation lumen; and
at least one separate deflation lumen communicating between the
balloon and adjacent the proximal end of the shaft, with the
proximal end of said deflation lumen being closed and spaced from
the proximal end of the catheter shaft, said deflation lumen having
an outer wall defining an outer surface of the catheter shaft, and
with said proximal end of the deflation lumen being separated from
communication with the inflation lumen, whereby the balloon may be
deflated through the deflation lumen by severing the catheter shaft
and deflation lumen adjacent the proximal end of the shaft when the
inflation lumen is obstructed.
2. The catheter of claim 1 wherein said shaft has a pair of
deflation lumens.
3. The catheter of claim 1 wherein said deflation lumen is defined
by a longitudinally extending groove in the outside of the catheter
shaft and a thin layer of flexible material covering said
groove.
4. The catheter of claim 1 wherein said deflation lumen is defined
by a thin layer of expandable flexible material covering the
catheter shaft, said layer being separated from the shaft through a
longitudinally extending portion thereof.
5. The catheter of claim 1 wherein said outer wall of the deflation
lumen and balloon are both a one-piece construction of flexible
material covering the catheter shaft.
Description
CROSS-REFERENCE TO RELATED APPLICATION
"Body-Retained Catheter," Ser. No. 187,370, filed Oct. 7, 1971,
issued as U.S. Pat. No. 3,726,283 invented by the applicants of the
present application, and assigned to the assignee of the present
application.
BACKGROUND OF THE INVENTION
The present invention relates to catheters.
Catheters, such as urinary drainage catheters, have long been used
to drain a body cavity of a patient. As an example of a
catheterization procedure, the distal end of a urinary catheter is
inserted through the urethra into the patient's bladder, such that
the proximal end of the catheter extends outside of the patient's
body. The catheter has a drainage eye adjacent its distal end and a
main lumen extending from the drainage eye to the proximal end of
the catheter, in order that liquid drains from the bladder through
the eye and main lumen of the catheter. Such a catheter usually has
an inflatable retention balloon adjacent its distal end, and an
inflation lumen communicating between the balloon and valve means
adjacent the proximal end of the catheter to control inflation and
deflation of the balloon. The balloon is inflated in the bladder
through the valve means and inflation lumen to prevent the
inadvertent removal of the catheter from the bladder. When
catheterization has been completed, the ballon is deflated through
the inflation lumen and valve means to permit removal of the
catheter from the patient.
Experience has shown that one of the most common problems
associated with such retention catheters is that the balloon may
fail to deflate after catheterization is complete. A number of
different causes may result in this failure. First, the standard
latex Foley catheter is made by a series of dipping procedures, and
the inflation lumen is formed by a mandrel positioned in the wall
of the catheter. The balloon is formed by making a final dip of the
catheter over an area covered with bentonite, preventing adherence
of the layer formed by the last dip and the underlying catheter
shaft. After the dipping procedure has been completed, the mandrel
is removed from the inflation lumen of the catheter.
A residual of bentonite remaining under the balloon may later clog
the inflation lumen after inflation of the balloon, and thus
prevent deflation of the balloon. Also, the series of laminations
formed by the series of dips may sometimes delaminate in the region
of the inflation lumen, and block the inflation lumen. Usually the
balloon may readily be inflated by a syringe when such conditions
exist, since substantial inflation pressures are created by a
syringe. However, successful deflation of the balloon is primarily
dependent upon the substantially less pressures generated by the
expanded balloon, since suction created by the syringe during
deflation frequently accentuates the problem leading to failure,
such as delamination of the catheter. It is known that the
retention balloons frequently inflate assymetrically, and one other
possible cause of deflation failure is that a portion of the
balloon may cover and close the end of the inflation lumen which
terminates in an opening under the balloon. Also, the valve means
has been known to malfunction during deflation of the balloon.
Another possible cause for failure results from incomplete punching
or cutting of the opening communicating between the inflation lumen
and the balloon, which may form a flap like member in the opening
acting as a one-way valve and preventing deflation.
Since the inflated balloon is too large to pull through the
patient's urethra, when the balloon fails to deflate, the physician
or other attendant often severs the catheter at a point near its
entry into the urethra. If the obstruction is intermediate the
point of severance of the proximal end of the catheter, the balloon
will deflate through the severed inflation lumen. However, more
frequently, the obstruction is intermediate the point of severance
and the balloon. In such a case, the balloon will fail to deflate,
and further procedures are necessary to deflate the balloon. For
example, the physician may pass a wire having a sharp tip through
the inflation lumen in an attempt to puncture the balloon, may
introduce a chemical which is incompatible with the balloon, such
as ether, through the inflation lumen into the balloon in order to
cause bursting of the balloon, or may resort to a surgical
procedure to obtain access to the balloon.
It is apparent that failures associated with balloon deflation
failure are not only inconvenient, but are also traumatic to both
the physician and the patient.
SUMMARY OF THE INVENTION
A principal feature of the present invention is the provision of a
catheter of simplified construction having safety deflation means
for a retention balloon on the catheter.
The catheter of the present invention includes a shaft having a
proximal end, a distal end for insertion into a body cavity, a
drainage eye adjacent the distal end of the shaft, and a main lumen
extending from the drainage eye to the proximal end of the shaft
for draining the cavity. The catheter has an inflatable retention
balloon adjacent the distal end of the shaft for retaining the
shaft in the cavity, an inflation lumen extending between the
inside of the balloon and adjacent the proximal end of the shaft,
and valve means for controlling inflation and deflation of the
balloon. The catheter also has at least one separate deflation
lumen communicating between the balloon and adjacent the proximal
end of the shaft.
Thus, a feature of the invention is that the inflated balloon may
be deflated through the deflation lumen when the inflation lumen is
obstructed by severing the catheter shaft adjacent its proximal end
and opening the deflation lumen.
Further features will become more fully apparent in the following
description of the embodiments of this invention and from the
appended claims.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a fragmentary elevational view of the catheter of the
present invention, with a retention balloon on the catheter in a
deflated condition;
FIG. 2 is a fragmentary sectional view of the catheter of FIG. 1,
with the retention balloon in an inflated condition;
FIG. 3 is a sectional view taken substantially as indicated along
the line 3--3 of FIG. 1;
FIG. 4 is a sectional view taken substantially as indicated along
the line 4--4 of FIG. 1;
FIG. 5 is a sectional view taken substantially as indicated along
the line 5--5 of FIG. 2;
FIG. 6 is a sectional view of an alternate embodiment of the
present invention; and
FIG. 7 is a fragmentary perspective view, showing a catheter being
severed to permit deflation of the balloon through deflation lumens
of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to FIGS. 1-4, there is shown a catheter, generally
designated 10, including a shaft designated generally 12 having a
proximal end 14, a distal end 16, at least one drainage eye 18
adjacent the distal end 16 of the shaft 12, and a main lumen 12
extending from the drainage eye 18 to the proximal end 14 of the
shaft 12. The catheter 10 also has a retention balloon 22 adjacent
the distal end 16 of the shaft 12, a sidearm 24 extending outwardly
from the shaft 12 adjacent its proximal end 14, and an inflation
lumen 26 extending through the sidearm 24 and the wall of the shaft
12, such that the inflation lumen communicates between valve means
28 at the outer end of the sidearm and the inside of the balloon 22
through an opening 30 underlying the balloon.
In use, the distal end 16 of the catheter is inserted through the
urethra of a patient into the bladder, and the balloon 22 is
inflated in the patient's bladder by forcing fluid through the
valve means 28 and inflation lumen 26 into the balloon 22 with
suitable means, such as a syringe (not shown). The inflated balloon
prevents the inadvertent removal of the catheter from the patient's
bladder. (The balloon is shown in its inflated condition in FIG. 2,
while it is shown deflated in FIG. 1.) While the balloon is
inflated during catheterization, urine from the bladder drains
through the drainage eye 18 and the main lumen 20. The balloon is
normally deflated to permit removal of the catheter from the
patient by withdrawing fluid with a syringe from the balloon
through the inflation lumen 26 and valve means 28.
As previously discussed, catheters sometimes fail to properly
deflate, causing a considerable amount of difficulty in removing
the catheter from the patient. The catheter of the present
invention has at least one, and preferably two, as shown, deflation
lumens 32 extending longitudinally along the catheter shaft 12. The
deflation lumens communicate with the retention balloon and are
closed adjacent the proximal end of the catheter. When the
retention balloon fails to deflate, the catheter may be severed
adjacent its proximal end, as shown in FIG. 7, to open the
deflation lumens 32 and permit drainage of fluid from the balloon
through the deflation lumens. Thus, the balloon will deflate even
if there is blockage in the inflation lumen 26 intermediate the
point of severance and the balloon due to pressure exerted by the
inflated balloon.
FIGS. 3 and 6 are illustrative of the cross sectional appearance of
lumens 32 which may be used to deflate the retention balloon. In
FIG. 6, the lumens 32 are formed by grooves 34 in the wall of the
catheter with a thin layer 35 covering the groove and defining the
outer wall of the lumens 32. This construction is preferably
obtained during the manufacturing of the entire catheter, such as
by a latex dipping process. Prior to the final dipping of the
catheter, grooves 34 are formed in the exterior of the catheter
wall, and a separating material, such as bentonite, is painted over
the grooves at the same time the balloon area is coated with a
separating material such that the coating is continuous between the
two areas. The final dipping then produces the layer 36 and balloon
22 over the separating material, and thereafter the separating
material is flushed or removed from the lumens 32 so formed.
An alternate structure for the lumens 32 is shown in FIG. 3, in
which the lumens are formed in a similar manner, except that the
catheter wall has no grooves. The catheter walls are painted with a
separating material, and the catheter undergoes a final dip to form
the layer 36 and balloon 22 over the separating material. After the
separating material is removed from under the layer 36, the lumens
32 are defined by the layer 36 and the underlying catheter
shaft.
It is possible to utilize the relatively thin layer 36 to form the
outer wall of the deflation lumens 32, since the deflation lumens
32 are not subjected to the relatively large pressure reached in
the inflation lumen 26 when the retention balloon is inflated by
the syringe. However, the relatively thin layer 36 bulges out
slightly, as shown in FIG. 5, when the balloon is inflated, due to
back pressure into the deflation lumens 32 from the balloon. The
layer 36 contracts toward the catheter shaft when the balloon is
deflated, as shown in FIG. 3. It is apparent that bulging of the
deflation lumen wall 36 may serve as an indication that the balloon
22 is inflated.
Since the deflation lumens 32 and inflation lumen 26 are
constructed in a different manner, the deflation lumens 32 are not
subject to most of the same types of failures associated with the
inflation lumen 26, as previously described. Also, the provision of
a multiplicity of lumens through which the balloon may be deflated
significantly increases the probability that the balloon may be
deflated at least through one of the lumens.
The foregoing detailed description is given for clearness of
understanding only, and no unnecessary limitations should be
understood therefrom, as modifications will be obvious to those
skilled in the art.
* * * * *