U.S. patent number 3,818,903 [Application Number 05/350,304] was granted by the patent office on 1974-06-25 for self-inflating catheter with deflating means and reservoir.
This patent grant is currently assigned to C. R. Bard Inc.. Invention is credited to John A. Bleecker.
United States Patent |
3,818,903 |
Bleecker |
June 25, 1974 |
SELF-INFLATING CATHETER WITH DEFLATING MEANS AND RESERVOIR
Abstract
An inflatable retention catheter having a resilient, valved,
reservoir retaining a fluid under pressure, for automatic inflation
of a retention balloon, is provided with an auxiliary reservoir
enclosing or attached to the resilient reservoir and having in its
wall a valve release device adapted to be manipulated to open the
reservoir valve and permit emptying of the balloon, the fluid being
received in the auxiliary reservoir.
Inventors: |
Bleecker; John A. (Summit,
NJ) |
Assignee: |
C. R. Bard Inc. (Murray Hill,
NJ)
|
Family
ID: |
23376127 |
Appl.
No.: |
05/350,304 |
Filed: |
April 11, 1973 |
Current U.S.
Class: |
604/98.01;
604/920 |
Current CPC
Class: |
A61M
25/1018 (20130101); A61M 25/10187 (20131105); A61M
25/10185 (20131105) |
Current International
Class: |
A61M
25/10 (20060101); A61m 025/02 () |
Field of
Search: |
;128/349B,349BV |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Attorney, Agent or Firm: Martine, Jr.; C. E.
Claims
What I claim is:
1. A self-inflatable retention balloon catheter comprising a main
shaft having a drainage lumen extending from the proximal end of
said shaft to a first lateral opening adjacent the distal end
thereof and an inflation lumen extending from a first point spaced
from said proximal end to a second point proximal of said first
lateral opening, an inflatable balloon surrounding said shaft at
said second point, a second lateral opening connecting the distal
end of the inflation lumen with the interior of said balloon, a
tubular inflation arm communicating with the proximal end of the
inflation lumen at said first point, valve means having an inlet
communicating with the interior of said inflation arm, means for
selectively closing said inflation arm at a point spaced from said
valve to form an inflation reservoir in said arm adapted to contain
inflation fluid, an auxiliary reservoir loosely enclosing said
valve means inlet, and a valve opening device in said auxiliary
reservoir and manually movable to a valve opening position, the
capacity of the auxiliary reservoir being at least substantially
equal to the inflated volume of the balloon.
2. A catheter according to claim 1 wherein the auxiliary reservoir
is constituted by two sheets of plastic film edge sealed together,
and wherein the valve opening device is held between said sealed
edges.
3. A catheter according to claim 1 wherein the auxiliary reservoir
loosely encloses the inflation reservoir.
4. A catheter according to claim 2 wherein the valve means is held
between said sealed edges.
5. A catheter according to claim 2 wherein the inflation arm is
held between said sealed edges and the auxiliary reservoir loosely
encloses the inflation reservoir.
6. A catheter according to claim 1 wherein the valve opening device
includes a handle and a prod, the prod being adapted for insertion
into the valve means inlet to open the valve.
7. A catheter according to claim 6 wherein the prod is
longitudinally grooved.
8. A catheter according to claim 6 wherein the prod is traversed by
a longitudinal bore.
9. A catheter according to claim 6 wherein the auxiliary reservoir
is constituted by two sheets of plastic film edge sealed together
and wherein the handle and the prod are connected by a web, the web
being held between the sealed edges of the auxiliary reservoir.
Description
This invention relates to Foley (balloon) catheters of the
self-inflating type, i.e. provided with a resilient, valved,
reservoir which is initially loaded with a fluid, such as sterile
water, under pressure such that when released into the inflation
lumen of the catheter, it will flow into and inflate the balloon
for retention of the distal end of the catheter in a body cavity
such as the bladder. A catheter of this type is shown in Rosecrans
U.S. Pat. No. 3,275,001. The reservoir is normally provided with a
valve through which the fluid may be passed, under pressure, from a
syringe. When the catheterization is to be terminated the balloon
must be allowed to deflate, and this is effected most neatly by
using a syringe to withdraw the fluid through the valve. On the
other hand it is quite a common practice to merely cut off the
reservoir and let the fluid spill out, hopefully but not
necessarily into a suitable receptacle.
It is an object of this invention to provide an auxiliary reservoir
which surrounds at least the valve, which has sufficient capacity
to hold the fluid expelled from the balloon (when deflation is
desired) and which has conveniently located in its wall a device
which can be manipulated (externally) to open the valve and enable
the fluid to escape from the balloon and first reservoir into the
auxiliary reservoir, where it is retained without spilling and can
be discarded with the used catheter.
A further object of the invention, in one of its aspects, is to
enclose the inflation reservoir within the auxiliary reservoir to
minimize loss of the inflation fluid through the inflation
reservoir wall during storage, thus greatly increasing the shelf
life of the catheter. This function is disclosed (without provision
of deflation means) in the patents to Vitello, U.S. Pat. No.
3,378,011; Hayes, U.S. Pat. No. 3,379,197; Balin, U.S. Pat. No.
3,599,620, and Ericson, U.S. Pat. No. 3,602,226.
Practical embodiments of the invention are shown in the
accompanying drawing, wherein:
FIG. 1 represents an elevation of a complete self-inflating
catheter, the auxiliary reservoir being in longitudinal section,
the inflated shape of the balloon being in broken lines, and part
of the catheter shaft being broken away;
FIG. 2 represents a detail view of the reservoir end of the
catheter shown in FIG. 1 looking upward from the bottom of that
figure;
FIG. 3 represents a detail view, corresponding to the reservoir end
of FIG. 1, showing in section a modified form of auxiliary
reservoir.
FIG. 4 represents a view of the parts shown in FIG. 3, looking
upward from the bottom of that figure;
FIG. 5 represents an elevation of one form of valve opening
device;
FIG. 6 represents a longitudinal section on the line VI--VI of FIG.
5;
FIG. 7 represents an elevation of an alternative form of valve
opening device; and
FIG. 8 represents a longitudinal section on the line VIII--VIII of
FIG. 7.
Referring to the drawing, a typical self-inflating Foley catheter
has a shaft 10, a distal tip 11, drainage eyes 12, drainage funnel
13, inflatable retention balloon 14, side arm 15 and inflation
reservoir 16. The drainage lumen 17 extends from the eyes 12 to the
funnel 13 and a small inflation lumen 18 extends from one or more
holes 19, within the balloon, through the side arm 15 to the
reservoir 16. The reservoir is designed to be closed by a clamp 20,
at a point between the reservoir and the shaft 10, and is filled
with an inflation fluid, such as sterile water, through a one-way
valve 21 (which may be of the type shown in Garth U.S. Pat. No.
3,087,492). The elasticity of the reservoir 16 is such that, upon
removal of the clamp, a substantial part of the inflation fluid
will be forced into the balloon 14, inflating it to perform its
intended function of retaining the catheter tip within the body
cavity (e.g., bladder).
According to the present invention, as exemplified in FIGS. 1 and
2, the auxiliary reservoir 22 is formed of two flat sheets 23, 24
of flexible heatsealable plastic film having narrow ends 25 and
wider ends 26. The narrow ends are sealed into fluid-tight
engagement around the valve 21, the seal being perfected, if
necessary, by one or more bands of adhesive 27, and the wider ends
26 are similarly sealed into fluid-tight engagement with a valve
opening device 28, the side edges of the sheets being sealed
together flatwise to form a somewhat flattened bag, as shown in
FIG. 2.
In the modified form, shown in FIGS. 3 and 4, the auxiliary
reservoir 30 encloses the inflation reservoir, the narrow ends 31
of the flat sheets 32,33 being sealed into fluid-tight engagement
around the side arm 15 between the reservoir 16 and the clamp 20,
the tightness of the seal being assured by bands of adhesive 34, if
necessary. The wider ends 35 of the sheets 32,33 are similarly
sealed around a valve opening device 36 (which may be the same as
the device 28) and the side edges of the sheets are sealed together
flatwise to form an elongated flattened bag, as shown in FIG.
4.
Each of the auxiliary reservoirs 22 or 30 must, initially, have
sufficient free capacity to enable it to receive, without back
pressure, a quantity of fluid corresponding to the capacity of the
retention balloon. This is normally either 5 cc. or 30 cc. and the
invention is particularly applicable to the 5 cc. type, although
larger auxiliary reservoirs could be provided, if desired.
The valve opening device 28 (or 36) comprises handle 40, a flat web
41 and a prod portion 42, said portion having an axial bore 43
extending from the distal end of the prod to a transverse passage
44 adjacent to the proximal inlet 37 thereof. The prod may be
tapered and must be small enough to be received easily in the end
of the valve 21 and to push in the valve stem in order to open the
valve.
The alternative form of valve opening device, shown in FIGS. 5 and
6, has a handle 45, a flat web 46 and a prod portion 47, said
portion being tapered and provided with longitudinal grooves 48,
extending from the distal tip to points adjacent the proximal end
of the prod.
In the manufacture of a self-inflating catheter having an auxiliary
reservoir, the inflation reservoir must be loaded with fluid before
the auxiliary reservoir is closed. One suitable sequence of step
comprises, preparing the loaded catheter, providing an auxiliary
reservoir with the valve opening device sealed in its wider end,
placing the narrower end of said reservoir in position to be
sealed, and sealing it, e.g., to the valve as shown in FIGS. 1 and
2. Otherwise the auxiliary reservoir, with both ends open, can have
its narrower end sealed to the valve (FIGS. 1 and 2) or to the side
arm (FIGS. 3 and 4) before the fluid is placed in the inflation
reservoir, the wider end of the auxiliary reservoir being sealed
around the valve opening device thereafter.
A self-inflating catheter provided with the auxiliary reservoir is
inserted into and retained in a patient in the normal manner. When
it is desired to remove the catheter, the valve opening device is
manipulated to insert the prod into the end of the valve, against
the end of the valve stem (which is usually grooved or ridged) to
open the valve and permit fluid to escape. As the balloon deflates
to an extent permitting removal of the catheter, the fluid is
collected in the auxiliary reservoir with no possiblity of
spillage.
Since the function of the prod is merely to open the valve and
permit escape of the fluid, its cross-sectional form may be varied
widely so long as it retains sufficient strength and cannot occlude
the valve opening.
It will be understood that various changes may be made in the form,
construction and arrangement of the several parts without departing
from the spirit and scope of the invention and hence I do not
intend to be limited to the details shown or described herein
except as the same are included in the claims or may be required by
disclosures of the prior art.
* * * * *