U.S. patent number 3,742,960 [Application Number 05/187,371] was granted by the patent office on 1973-07-03 for deflatable retention catheter.
This patent grant is currently assigned to The Kendall Company. Invention is credited to William J. Binard, John F. Dye.
United States Patent |
3,742,960 |
Dye , et al. |
July 3, 1973 |
DEFLATABLE RETENTION CATHETER
Abstract
An improved safety-deflating retention catheter wherein the
balloon empties directly into the drainage lumen through a short
passageway under the retention balloon. Temporary blocking means
are positioned within or over the passageway, the blocking means
being overridden due to the flexible nature of the distal end when
that end is stretched by a force which might otherwise pull the
balloon into the urethra in its inflated state.
Inventors: |
Dye; John F. (Barrington,
IL), Binard; William J. (Barrington, IL) |
Assignee: |
The Kendall Company (Walpole,
MA)
|
Family
ID: |
22688706 |
Appl.
No.: |
05/187,371 |
Filed: |
October 7, 1971 |
Current U.S.
Class: |
604/99.03;
604/915; 604/247 |
Current CPC
Class: |
A61M
25/10 (20130101); A61M 2025/1077 (20130101) |
Current International
Class: |
A61M
25/10 (20060101); A61m 027/00 (); A61m
025/00 () |
Field of
Search: |
;128/348,246,349,351,350,349BV |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Claims
What is claimed is:
1. In a drainage device having a proximal end and an open distal
end for insertion into an animal body cavity, a main lumen
connecting said distal and proximal ends for draining the cavity,
inflatable retaining means overlying a portion of the wall of said
device adjacent said distal end for retaining said device within
the cavity when inflated, and means for releasing the contents of
said retaining means so as to deflate the same; the improvement
comprising said releasing means including a release passageway
adjacent the retaining means and extending from said retaining
means to said main lumen, means for blocking said passageway, and
means for overriding said blocking means, said overriding means
being activated upon longitudinal tensioning of said device
responsive to attempted withdrawal of the retaining means, while in
its inflated state, from the cavity.
2. The improved device as defined in claim 1, wherein said
overriding means is arrestable so as to be effective to release
further contents of said retaining means to said main lumen
whenever such tensioning is repeatedly applied to said device.
3. The improved device as defined in claim 1, wherein said
passageway is relatively short in length compared to said lumen,
whereby access time from said retaining means to said lumen is
minimized.
4. The improved device as defined in claim 3, wherein no part of
said passageway extends longitudinally beyond that portion of said
device which mounts said retaining means.
5. The improved device as defined in claim 4, wherein said
passageway extends only generally perpendicularly to said
lumen.
6. The improved device as defined in claim 1, wherein at least a
portion of said passageway is positioned approximately within the
proximal half of said wall portion under said retaining means,
whereby said overriding means are promptly effective during
tensioning to release said retaining means.
7. The improved device as defined in claim 1, wherein said blocking
means includes a valve operatively positioned between said
passageway and said retaining means, said valve closing off flow
from said retaining means to said passageway and wherein said
overriding means includes means for altering the shape of said
passageway so as to extend the same beyond the effective closing
region of said valve.
8. The improved device as defined in claim 8, wherein said valve is
a flap valve attached externally to said device operatively between
said retaining means and said device, said attachment being
longitudinally displaced from said passageway, said valve loosely
covering said passageway, and wherein said altering means includes
longitudinally flexible walls defining said lumen and said
passageway, whereby longitudinal stretching of said walls causes
said passageway and said flap valve to longitudinally displace with
respect to each other so as to remove said flap valve from its
covering relationship to said passageway.
9. The improved device as defined in claim 8 wherein said
attachment of said flap valve is distal to said passageway.
10. The improved device as defined in claim 8 wherein said
attachment is proximal to said passageway.
11. The improved device as defined in claim 8, wherein said walls
at least in part are formed from an elastomeric material having a
breaking elongation quality commensurate to that of latex
rubber.
12. The improved device as defined in claim 8, wherein said walls
defining said lumen include embedded within a portion thereof in
the vicinity of said passageway, an inelastic deformable element
oriented so as to permanently deform in the presence of said
longitudinal stretching.
13. The improved device as defined in claim 12, wherein said
element is a coiled inelastic wire.
14. The improved device as defined in claim 7, wherein said
effective closing region and said altering means are positioned
under said retaining means adjacent to the proximal portion
thereof, whereby said overriding means are promptly effective under
said tensioning to release said retaining means.
15. The improved device as defined in claim 1, wherein said
blocking means includes a plug seated within said passageway, said
plug being relatively inflexible, and wherein said overriding means
includes relatively flexible walls defining said passageway and
said lumen, whereby longitudinal stretching of said device causes
said passageway to enlarge in amount sufficient to unseat said
plug.
16. The improved device as defined in claim 1, wherein said
passageway and said blocking means are defined by at least one
grooved slot in a portion of the walls of said device, extending
generally parallel to said lumen, and by a mating tongue portion of
walls which opposes and extends into said slot.
17. The improved device as defined in claim 16, wherein said mating
portion and said slot mate along a direction which is longitudinal
to said lumen, and wherein said portions of said walls are
flexible, whereby longitudinal stretching of said walls causes said
mating portion and said slot to separate, releasing said retaining
means.
Description
BACKGROUND OF THE INVENTION
In body drainage systems, a significant advance is provided by U.S.
Pat. No. 3,482,576, issued to R. E. Ericson, et al. on Dec. 9,
1969. This patent provides safety deflating means on a body cavity
drainage device which is retained in the cavity by an inflatable
retention balloon, the deflating means serving to prevent
inadvertent or accidental removal of the drainage device without
deflating the balloon first. The safety deflating mechanism of that
patent thus significantly reduces the incidence of injury to the
body upon attempted forceable withdrawal of an inflated drainage
tube. The specific mechanism of that patent features an ordinarily
sealed opening at the proximal end of the device which, when
opened, allows drainage of the inflation medium through the
inflation lumen.
SUMMARY OF THE INVENTION
This application is directed towards an improvement of the device
disclosed in the aforesaid patent whereby a quicker release of the
inflation fluid from the retention balloon is obtained. Also, with
the present invention, the safety mechanism will be activated only
in those circumstances where the force applied to the drainage
device is actually transmitted to the retention balloon. More
specifically, there is provided a drainage device wherein the
releasing means empties the retention balloon directly into the
drainage lumen rather than into an inflation lumen, the mechanism
being positioned in the distal end of the drainage device so as to
be activated only when sufficient tension is applied to the
retention balloon as opposed to some other part of the drainage
device. The result is an improvement in a drainage device having a
proximal end and an open distal end for insertion into an animal
body cavity, a drainage lumen connecting the distal and proximal
ends for draining the cavity, inflatable retaining means adjacent
the distal end for retaining the device within the cavity when
inflated, and means for releasing the contents of the retaining
means to deflate the same. The improvement features a release
passageway or opening through which the retaining means
communicates with the drainage lumen, blocking means for blocking
the release passageway or opening, and overriding means for
overriding the blocking means, the overriding means being activated
upon longitudinal tensioning of the device in the area of the
retaining means by an amount which is preferably slightly less than
that tensioning which would withdraw the retaining means from the
cavity with the retaining means still in an inflated state.
Accordingly, it is an object of the invention to provide an
improved drainage device having an inflatable retention balloon
which will quickly deflate when tension is inadvertently or
improperly placed upon the drainage device at the location of the
retention balloon, thus eliminating injury to the urethra which
might result from withdrawing the drainage device through the
urethra while the balloon is fully inflated.
It is a related object of the invention to provide such a drainage
device which is so constructed as to be inexpensive to
manufacture.
Other objects and advantages will become apparent upon reference to
the following drawings and detailed discussion.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a fragmentary, partially sectioned elevational view
illustrating the improved drainage device constructed in accordance
with the invention;
FIG. 2 is a fragmentary sectional view, partially broken away, of
the device shown in FIG. 1 illustrating the device in use;
FIG. 3 is a fragmentary partially broken away sectional view
similar to FIG. 2 but illustrating the safety device in operation
when the drainage device is under tension;
FIG. 4 is a fragmentary sectional view similar to FIG. 1 but
illustrating the state of the device as shown in FIG. 3;
FIG. 5 is a fragmentary sectional view of an alternate embodiment
of the device;
FIG. 6 is a fragmentary sectional view, partially broken away, of
yet another alternate form of the embodiment shown in FIGS.
1-4;
FIG. 7 is a fragmentary, partially broken away section view similar
to FIG. 6 but illustrating the device under tension;
FIGS. 8 and 9 are fragmentary, partially broken away sectional
views of still another embodiment of the invention, illustrating,
respectively, the relaxed condition and the condition of the device
under tension;
FIG. 10 is a fragmentary sectional view, partially broken away,
illustrating yet another embodiment of the device;
FIG. 11 is a sectional view taken along the lines 11--11 of FIG.
10; and
FIG. 12 is a fragmentary, partially broken away sectional view
similar to FIG. 11, but showing the embodiment in the stretched
releasing condition.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The description of preferred embodiments set forth hereinafter
concern a Foley-type catheter having a deflation device in
accordance with this invention. However, any drainage tube whether
of rubber latex, synthetic stretchable polymer or a combination of
the two, or stretchable polymer with a non-stretchable, flexible
material which has inflatable retaining means and is fitted with
the described and claimed deflation device is considered within the
invention.
Referring now to FIGS. 1-4, the safety deflating mechanism of the
invention is provided in a Foley-type catheter 20 which
conventionally has a distal end 22 for insertion in a bladder 21, a
drainage eye 24 in that end, a proximal end 26, a main or drainage
lumen 28 extending from the distal end 22 to the proximal end 26
and generally formed and surrounded by the exterior catheter wall
29, an inflatable retention balloon 30 adjacent to the distal end
22 and overlying a portion 31 of the wall 29 (FIG. 1), an inflation
lumen 32 defined by a wall 33, the lumen 32 extending from the
retention balloon to the proximal end of the catheter 20 where it
forms a side arm 34, and means in the side arm for inflating the
retention balloon 30 through the inflation lumen 32. The entire
catheter itself, its distal end or portions thereof, is
conveniently formed from a flexible elastomer. The inflating means
commonly includes a permanently maintained opening 38 in the wall
29 permitting fluid flow from the lumen 32 into the retention
balloon 30, and an inflating balloon 40 forming part of the side
arm 34. The balloon 40 contains, when inflated to the position
shown in dotted lines in FIG. 1, the inflating fluid which is to
fill the balloon 30. A clip 42 closes lumen 32 to retain the
inflating fluid in the balloon 40 until such time as the catheter
20 is positioned within a body cavity, such as the bladder.
Inflation of balloon 30 is indicated by arrows in the lumen 32,
while drainage of the bladder is indicated by the arrow 48.
In accordance with one aspect of the invention, the safety
deflating mechanism is provided at the distal end 22 of the
catheter so as to give a quick release of the retention balloon 30
when force is applied to the retention balloon in a manner which
would otherwise force the withdrawal of the distal end 22 into the
urethra with the balloon 30 fully inflated. As shown in FIG. 1,
this is accomplished by providing a passageway or opening 50 which
extends from the drainage lumen 28 through the catheter wall into
the balloon 30 (FIGS. 1 and 4). The passageway 50 is located so
that the balloon 30 overlies the passageway in its position in the
catheter 20, and preferably the passageway 50 is positioned under
the balloon 30 in the proximal half 54 of the wall portion 31
overlaid by balloon 30. The location of the passageway under the
proximal half 54 is for a purpose hereinafter stated.
To block flow of inflating fluid from the retention balloon 30 out
through the passageway 50, a one-way flap valve 60 is attached at
portion 62 to the exterior wall 29 (FIG. 3). As shown in FIG. 1,
this attachment is distal to the passageway 50, the flap valve
being positioned so as to overlap and cover the passageway 50 when
the catheter is normally positioned without any longitudinal stress
thereupon. The flap valve 60 thus functions to retain inflating
fluid in the balloon 30 after it enters the balloon from the lumen
32, the pressure of the fluid in the direction of the arrow 66
acting upon the valve to keep it closed. FIG. 2 further illustrates
the catheter in this normal, unstretched condition with the
exterior walls of the retention balloon 30 abutting against the
wall of the bladder 21.
Referring now to FIGS. 3 and 4, when tension is longitudinally
applied as indicated to the catheter 20 in an amount preferably
less than that which would be otherwise sufficient to pull the
balloon 30 into the urethra, the catheter and the bladder 21 take
the configuration shown. The stretching of the flexible wall 29 of
the catheter 20 causes the passageway 50 to stretch so as to
override the blocking effect of the flap valve 60. That is, the
passageway 50 alters in size and shape so as to extend beyond the
area covered by the flap valve 60. In such an arrangement, the
inflating fluid flows out of the balloon 30 under pressure and into
the drainage lumen 28 where it quickly empties out through the
drainage eye 24 or out through the proximal end 26, as indicated by
the arrows in FIG. 4. The passageway 50 must be positioned
approximately under the proximal half 54 so as to promptly respond
to the stretching in the vicinity of the retention balloon, which
stretching represents tension which would otherwise be sufficient
to pull the retention balloon in its inflated state into the
urethra.
Several advantages will be seen in the aforedescribed structure.
First of all, the extreme shortness and location of the passageway
50 connecting the retention balloon 30 with the drainage lumen 28
permits quick emptying of the retention balloon. The aforesaid
location of the passageway also permits the release of the balloon
to occur only when sufficient tension is applied in the vicinity of
the retention balloon. This is to be contrasted with those
arrangements which could permit a release of the balloon when
tension is applied to some other portion of the catheter such as
the proximal end 26, the tension not being further transmitted to
the distal end. A further advantage of the embodiment shown in FIG.
1-4 is that the operation of the deflating device is arrestable.
That is, if the accidental tugging on the catheter causing the
longitudinal tension is released or terminated before the retention
balloon 30 is pulled into the urethra, the catheter will assume its
relaxed state as shown in FIG. 2 so that the passageway 50 moves
back under the flap valve 60. The result is that any inflating
fluid still retained by the balloon 30 will close the flap valve
60, permitting the retention balloon 30 to maintain the catheter in
place. Only continued improper stressing or stretching of the
catheter 20 will completely empty the balloon 30.
Preferably, the catheter walls 29 and 33 as well as the passageway
50 are formed from a flexible, stretchable polymer such as natural
rubber latex, so as to permit the walls to stretch to pull at least
a portion of the passageway 50 out from under the flap valve 60. If
materials other than rubber are used, the material forming the
walls in the distal end of the catheter should be an elastomeric
material having a breaking elongation which is similar to that of
latex rubber. However, a latex rubber has the further advantage
that the mechanisms involved in the aforedescribed structure are
easily manufactured. For example, the flap valve 60 is readily
formed during the dipping process which is conventional in
manufacturing catheters out of the aforementioned latex rubber.
That is, a separating material, such as talc, is placed over those
portions where the flap valve 60 is not to attach to exterior wall
29 of the catheter, and the dipping process is performed.
ALTERNATE EMBODIMENTS
FIG. 5 illustrates an alternate embodiment wherein the flap valve
is attached to the wall of the catheter in a different location and
wherein the passage from the main lumen to the retention balloon is
direct rather than through an inflation lumen. Parts similar to
those previously described bear the same reference numeral to which
distinguishing suffix a has been added. Thus, catheter 20a has a
distal end 22a, a retention balloon 30a, and a drainage eye 24a as
in the previous embodiment, pressure in the direction of arrows 66a
being normally effective to keep the balloon inflated. However,
this embodiment differs from the previous embodiment in that the
drainage lumen 28a is the only lumen within the walls 29a of the
catheter. For this reason, the passageway 50a is simply an opening
within the wall portion 31a under the balloon 30a and the lumen 28a
serves both to inflate the retention balloon and to drain the
bladder in the direction of arrow 48a in a manner disclosed and
claimed in our copending U.S. Pat. application Ser. No. 187340,
filed simultaneously herewith. To this end, there is provided a
second flap valve 70 positioned on the interior surface of the wall
29a so as to overlie the drainage eye 24a. The flap valve 70 serves
to close off the drainage eye when inflating fluid passes through
the lumen 28a and into the retention balloon 30a, while permitting
reverse flow of urine from the bladder through the drainage eye 24a
and into the drainage lumen 28a.
The other primary distinction in the embodiment shown in FIG. 5 is
that the flap valve 60a is attached to the exterior surface of the
wall 29a at a portion 62a which is located not distal as in the
previous embodiment, but rather proximal to the passageway 50a. It
is thus apparent that the location of the attachment of the flap
valve 60a is not critical, provided that it is longitudinally
displaced from the passageway extending from the drainage lumen to
the retention balloon. However, when the portion 62a is located
proximally as in FIG. 5, it should attach approximately to the
proximal half 54a of the wall portion 31a. This insures prompt
release when tension is applied to the balloon by permitting the
flap valve 60a to promptly uncover the passageway 50a due to the
stretching of the proximal half 54a.
FIGS. 6 and 7 illustrate another embodiment of the invention
wherein the safety drainage mechanism is not reversible but instead
is maintained in the release configuration when improper stretching
at the distal end occurs. Parts similar to those previously
described bear the same reference numeral to which the
distinguishing suffix b has been added. Thus, FIG. 6 illustrates a
catheter 20b positioned in its normal unstretched state in bladder
21b, the retention balloon 30b abutting the bladder walls. As in
the previous embodiments, a flap valve 60b covers a passageway 50b
extending from the interior of the balloon 30b into a drainage
lumen 28b. The instant embodiment is characterized by having an
inelastic deformable coiled wire 80 imbedded within the walls 29b
and extending distally past 50b of the catheter. Thus, as shown in
FIG. 7, when force is transmitted to the distal end, in the
direction of the arrows 82 of an amount which would otherwise force
the retention balloon to be drawn into the urethra, the following
two things occur. The passageway 50b is stretched so as to extend
out from under the flap valve 60b as in the previous embodiments,
and the coiled wire 80 is permanently deformed to the state shown
in FIG. 7. The result is that the retention balloon 30b is caused
to completely empty into the drainage lumen, whether or not the
force in the direction of the arrow 82 is maintained.
FIGS. 8 and 9 illustrate still another embodiment in which the
safety releasing mechanism for the retention balloon is
irreversible and which features a plug rather than a flap as the
mechanism blocking the passageway between the lumen and the
balloon. Parts similar to those previously described bear the same
reference numeral to which the distinguishing suffix c has been
added. Thus, FIG. 8 illustrates the catheter 20c in the normal
unstretched state within the bladder 21c. A retention balloon 30c
overlies the release passageway 50c as in the previous embodiments.
Unlike the previous embodiments, instead of a flap valve, a plug 90
is positioned within the passageway 50c, the latter occupying a
position approximately within the proximal half 54c of the wall
portion 31c overlaid by the balloon. The edges of the passageway
are beveled so as to hold the plug 90 in position even when
external pressure is generated by fluid flowing into the retention
balloon 30c through the opening 38c. As shown in FIG. 9, when force
is exerted in the direction of arrow 82c, the catheter 20c
stretches at the distal end so as to cause the wall portion 31c to
pull away from the plug 90, thereby allowing the pressure of the
inflating fluid to force the plug 90 into the drainage lumen 28c.
The largest dimension of the plug 90 is such as to be substantially
less than the diameter of the lumen 28c, thereby permitting the
inflating fluid to drain out through the drainage lumen.
Preferably, the plug 90 is formed of relatively inelastic material
so as to maintain its shape rather than stretch under the influence
of the stretched wall portion 31c.
FIGS. 10-12 illustrate yet another embodiment wherein a tongue and
groove configuration is utilized to define the release passageway
extending from the retention balloon to the drainage lumen. Parts
similar to those previously described bear the same reference
numeral to which the distinguishing suffix d has been added. Thus,
the catheter 20d of this embodiment has a drainage lumen 28d and an
inflation lumen 32d for inflating the retention balloon 30d as in
the embodiment of FIGS. 1-4. When in the normal unstretched state,
the catheter 20d is positioned within the bladder 21d with the
retention balloon and the bladder taking the position shown in
FIGS. 10 and 11. Unlike the previous embodiments, the passageway
50d extending from the drainage lumen 28d to the retention balloon
30d is formed by a groove or slot 100 approximately within the
proximal half 54d of the wall portion 31d. A mating tongue 104
extends from the proximal half 54d into the groove 100, both the
tongue and the groove extending generally parallel to the lumen
28d. The surface appearance of the mating tongue and groove can
take any configuration, one possible configuration being an C curve
106 as shown in FIG. 10. The mating of the groove 100 and the
tongue 104 is therefore in a direction which is longitudinal with
the lumen 28d. Therefore, a stretching of the wall portion 31d
under tension exerted in the direction of the arrows 82d of an
amount sufficient to otherwise withdraw the balloon into the
urethra causes a separation as shown in FIG. 12 of the tongue 104
from the groove 100. This separation permits the exiting of the
inflation fluid from the retention balloon 30d and into the
drainage lumen 28d.
Due to the flexing of tongue 104, reseating of the combination
100-104 is generally impossible. Consequently this embodiment is
normally irreversible as are the embodiments shown in FIGS. 6, 7, 8
and 9. As in all the previous embodiments, the walls of the
catheter in the distal end 22d must be flexible to permit the
stretching necessary to operate the unblocking of the passageway
50d.
It will be recognized that all of the preceding embodiments provide
the advantage of prompt emptying of the balloon only when
sufficient longitudinal force is applied to the balloon. This is
accomplished by the location of the passageway under the retention
balloon and in a manner such as to empty the balloon by a short
traverse from the balloon into the drainage lumen.
Although the invention has been described in connection with
certain preferred embodiments, it is not intended that it be
limited thereto. To the contrary, it is intended that the invention
cover all arrangements, alternate embodiments, and equivalents as
may be included within the scope of the following claims.
* * * * *