U.S. patent number 3,752,158 [Application Number 05/091,885] was granted by the patent office on 1973-08-14 for apparatus and method for suprapubic drainage of the urinary bladder.
This patent grant is currently assigned to Snyder Manufacturing Company, Inc.. Invention is credited to Donald H. Kariher.
United States Patent |
3,752,158 |
Kariher |
August 14, 1973 |
APPARATUS AND METHOD FOR SUPRAPUBIC DRAINAGE OF THE URINARY
BLADDER
Abstract
Apparatus and method for suprapubic drainage of the urinary
bladder comprises a small trocar for puncturing the bladder wall
following which a flexible drainage tube is inserted through the
lumen of the trocar and into the bladder. The trocar is then
retracted from the patient and withdrawn from the tubing over the
proximal end thereof. The proximal end of the tubing is then
connected through a three way stopcock which is in turn connected
to an additional piece of flexible tubing, the latter running to a
portable suction-producing device which may be secured to the
patient's garment. A fully closed evacuating system is provided.
The stopcock has an auxiliary passageway into which a hypodermic
needle may be inserted to irrigate or flush the system, or to
introduce medication into the bladder.
Inventors: |
Kariher; Donald H. (St. John's,
Antigua, WI) |
Assignee: |
Snyder Manufacturing Company,
Inc. (New Philadelphia, OH)
|
Family
ID: |
22230095 |
Appl.
No.: |
05/091,885 |
Filed: |
November 23, 1970 |
Current U.S.
Class: |
604/133 |
Current CPC
Class: |
A61M
25/06 (20130101); A61M 1/0011 (20130101); A61M
39/02 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61M 1/00 (20060101); A61M
39/02 (20060101); A61m 001/00 () |
Field of
Search: |
;128/347,348,349R,35R,276,278,295,215,214.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Hodgkinson et al.-Amer. Jour. Obstet. & Gynec. Vol. 96, No. 6,
Nov. 15, 1966, pp. 773-783. .
Medical-Surgical Review-April, 1970-pg. 16. .
Surgical Procedures-Phamplet Zimmer Manufact. Co., pgs. 6 relied
on. .
Lancet September 1963-pg. 607..
|
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. Apparatus for suprapubic drainage of the human urinary bladder
comprising a drainage tube of flexible material and of relatively
small transverse dimension and compatible with human tissue and
arranged for insertion through a puncture in the abdomen and in the
wall of the bladder, a self-contained, independently operable
evacuator for ambulatory use comprising a container of flexible
material, said container being resiliently compressible when
subjected to manual pressure and upon release of said manual
pressure being resiliently expansible to a normal expanded
position, a conduit connecting said drainage tube to said
container, an auxiliary fluid passageway arranged for connection to
a receptacle, and valve means interconnecting said conduit,
drainage tube and auxiliary passageway, said valve means having a
first position interconnecting said conduit and drainage tube, a
second position interconnecting said auxiliary passageway and said
conduit, and a third position interconnecting said auxiliary
passageway and said drainage tube, whereby fluid may be transmitted
from the drainage tube into said container upon the expansion
thereof, and fluid may be transmitted from the container into said
receptacle, and treatment fluid may be transmitted from the
receptacle into the drainage tube.
2. Apparatus for suprapubic drainage as set forth in claim 1
wherein said container is provided with an exhaust opening, and a
closure valve for the exhaust opening.
Description
This invention relates to methods and systems for body drainage,
and more particularly to a suprapubic urinary drainage system and
method.
BACKGROUND OF THE INVENTION
In connection with the post-operative care of gynecologic patients
and other surgical procedures where voiding is a problem, it is a
common practice to insert a catheter through the urethra and into
the bladder to effect drainage of the bladder. However, the patient
frequently suffers considerable discomfort from the catheter, and
moreover, the catheter tends to inhibit the patient from resuming
voiding naturally. Consequently, to induce a return to natural
voiding, the catheter may have to be frequently removed and
reinserted. This further traumatizes the bladder and contributes to
the discomfort of the patient. Furthermore, the repeated insertions
of the catheter is frequently a source of infection, which
complicates the post-operative care.
OBJECTS AND SUMMARY OF THE INVENTION
An object of the present invention is to provide a method and
system for suprapubic drainage from the bladder which eliminates
the need for repeated insertions and withdrawals of a catheter
through the urethra. The system of the present invention reduces
the possibility of infection, increases patient comfort, encourages
the patient to begin voiding naturally, and is easily disconnected
and removed from the patient when no longer needed.
A further object of the present invention is to provide a method
and system of the type stated which is fully closed and wherein the
urine is gently sucked out of the bladder in such a manner as to
preclude bladder collapse. The evacuator unit of the apparatus can
be attached to the patient so that the latter can be made
ambulatory as soon as otherwise possible. The apparatus includes a
small drainage tube that is inserted into the bladder
suprapubically. The suction is effected by means of a portable
device which applies the suction over a limited period of time
after which the suction ceases until the device is reactivated. In
the interim, the patient is encouraged to begin voiding naturally.
Gravity drainage of the bladder is avoided and the system prevents
back flow of urine into the bladder, which might cause
infection.
In accordance with the foregoing objects, there is provided an
apparatus, which may be in kit form, that includes a small diameter
trocar or like cannulated needle for puncturing the bladder wall,
and a small diameter flexible drainage tube insertable at one end
through the lumen of the cannula and into the bladder. After the
small diameter tube has been inserted into the bladder, the trocar
is slid off of the tube through the proximal end thereof and
discarded. The aforesaid proximal end of the tube is connected to a
three way stopcock that forms part of the kit. Also connected at
one end to the stopcock is a length of large drainage tubing which,
at its other end, is connected to a suction-imposing device capable
of being secured to the patient's garment or otherwise attached to
or carried by the patient so that the latter may be ambulatory. The
stopcock has an auxiliary passageway in communication with the
tubing through the stopcock valve. The auxiliary passageway is kept
sterile by a removable seal cap. However, the cap may be removed
for insertion of a hypodermic needle into the auxiliary passageway
to withdraw fluid, to irrigate the system, or to introduce
medication, such as antibiotics, into the bladder.
BRIEF DESCRIPTION OF THE FIGURES
In the drawing:
FIG. 1 is a front view of a portion of the body and showing the
apparatus of the present invention in use as a suprapubic urinary
drainage device;
FIG. 2 is a view of a step in the surgical procedure which forms
part of the present invention and is carried out in conjunction
with the use of the apparatus of the invention;
FIGS. 3 and 4 are fragmentary elevational views, on an enlarged
scale, of a portion of FIG. 2 and showing further successive steps
in connection with the surgical procedure;
FIG. 5 is a fragmentary sectional view, on an enlarged scale, taken
along line 5--5 of FIG. 4;
FIG. 6 is a fragmentary perspective view showing the proximal end
of the small drainage tube and a portion of the stopcock housing
into which it is insertable;
FIG. 7 is a fragmentary perspective view of the stopcock shown
attached to the small drainage tubing and to an end of the larger
drainage tubing;
FIG. 8 is a fragmentary longitudinal sectional view taken
substantially along line 8--8 of FIG. 7;
FIG. 9 is a fragmentary sectional view taken along line 9--9 of
FIG. 8;
FIG. 10 is a fragmentary elevational view, on a reduced scale, of
the structure of FIG. 8, but showing the use of a hypodermic needle
for injection of fluid into the system or removal of fluid from the
system;
FIG. 11 is a fragmentary perspective view of the evacuator or
suction-imposing device that forms part of the present invention,
the device being shown in its normal expanded position;
FIG. 12 is a sectional view taken approximately along line 12--12
of FIG. 11; and
FIG. 13 is a sectional view similar to FIG. 12 and showing the
evacuator collapsed preparatory to imposing suction on the drainage
tubing of the system.
Referring in more detail to the drawing, the apparatus is shown as
a means for evacuating urine from a human bladder. Accordingly, 2
designates an evacuator unit, hereinafter more fully described, for
creating a suction or negative pressure in a flexible conduit 4
which includes a large diameter drainage tube 6, a three way
stopcock 8, and a small diameter drainage tube 10 which projects
through an opening 12 in the lower abdomen of the patient and into
the bladder 14. The tubes 6, 10 may be of a vinyl resin or other
material compatible with human tissue. The evacuator 2 may be
suitably secured to the garment 15 of the patient as by a safety
pin 16. Suitable bandages 18, 20 may be wrapped around the patient
to retain the tubes 6, 10.
In the surgical procedure, a catheter may be inserted through the
urethra to empty the bladder 14, after which the bladder may be
distended by introduction of a sterile saline solution or distilled
water through the catheter. If desired, methylene blue may be added
to the solution as a color indicator. In emergency treatment
evacuation and filling of the bladder may be dispensed with, it
being considered that the bladder is sufficiently distended.
After sterile preparation of the lower abdomen, a trocar 22 is used
to perforate the bladder wall. The trocar 22 comprises a cannula 24
that has a pointed puncturing end 26 and a lumen 28 (FIG. 5). The
cannula may have an outside diameter of about 0.109 inches while
the lumen may have a diameter of about 0.085 inches. Opposite to
the piercing end 26 the trocar 22 has a plastic hub 30 rigidly
secured and including a radial flange 32. As shown in FIG. 2 the
trocar 22 is inserted into the skin and into the bladder 14, the
hub 32 serving as an abutment against which manual force may be
applied to the trocar 22. Perforation of the bladder wall will be
indicated by fluid fountaining through the hub-containing end of
the trocar 22. The precise location of the puncture will vary with
the surgical procedure. However, in a typical procedure, the trocar
22 should be inserted just off the midline of the bladder
approximately 3 centimeters above the top of the symphysis and at
an angle of about 30.degree. from the vertical (the patient being
horizontal as shown in FIG. 2) and directed toward the pubis. The
puncture is rather small and so bleeding is minimal.
With the trocar 22 in place, the distal end 34 of the small
diameter drainage tube 10 is inserted into the lumen of the cannula
24, as shown in FIG. 4. The tube 10 is slidably advanced through
the trocar 22 and into the bladder. This is easily accomplished
since the tube 10 may have an outside diameter of about 0.060
inches and an inside diameter of about 0.040 inches. If desired the
tube 10 may have a suitable indicator mark (not shown) a known
distance from the distal end 34 which aids in indicating that a
predetermined length of the tube 10 has been inserted. Adjacent to
the distal end 34, the wall of the tube 10 may have a series of
apertures 36 spaced along the length of the tube and through which
the urine will pass. A small piece of tape may be used to retain
the tube 10 against the abdomen adjacent to the puncture. It should
be noted that the angularly directed puncture wound of the trocar
22 pierces the muscle tissue of the abdomen over a sufficiently
large region that the muscle tissue aids in retention of the tubing
10.
The trocar 22 may then be withdrawn from the patient by pulling on
the hub 32 while at the same time pushing slightly on the tube 10
so that the latter is not also withdrawn. The trocar 22 is slid off
of the exposed or proximal end 38 of the tube 10 and discarded. If
a catheter has been inserted into the urethra to distend the
bladder, as earlier described, it may now be used to evacuate the
bladder after which the catheter will be removed. At its proximal
end 38 the tube 10 is internally fitted with a rigid tubular
extension or connector 40, which may be of metal, and by which the
tube 10 may be connected to the stopcock 8 so that when the
evacuator 2 is activated to produce suction, the urine will be
withdrawn from the bladder through the tube 10, connector 40,
stopcock 8 and large diameter drainage tube 6 for discharge into
the evacuator 2, as more fully hereinafter described. For
convenience and sterility, the evacuator 2, the large tube 6 and
the stopcock 7 may be pre-assembled so that the connector 40 may
simply be joined to the stopcock 8.
The stopcock 8 comprises a valve housing 42 of a suitable molded
plastic and integrally having a central portion 44 and opposed
tubular stems or fittings 46, 48 with axially aligned bores 50, 52.
An end of the tube 6 is telescoped over the fitting 46, and a
rubber-like tubular reducer 54 is telescoped over the fitting 48.
The rigid connector 40 is pressed into the small diameter bore
portion 56 of the reducer 54, such connection being generally made
immediately after the trocar 22 has been withdrawn, as previously
described. Extending from the central portion 44 at substantially
right angles to the fittings 46, 48 is an auxiliary stem or fitting
58 having a passageway 60 which may be closed by a removable seal
cap 62 that fits over the free end of the fitting 58.
A rotary three way valve 64 is disposed in the central portion 44
of the valve housing 42 and is provided with a manipulating handle
65. The valve 64 is rotatable from the positions shown in FIGS.
7-10 through an angle of 180.degree.. In the position illustrated,
the valve 64 is positioned so that fluid may flow through the main
passageway in the valve housing, namely from the bore 52 through
the valve orifice and to the bore 50. In the position 180.degree.
from that shown, the bores 50, 52 are in communication and in
addition the auxiliary passageway 60 is in communication with the
bores 50, 52. In the position ninety degrees counterclockwise from
that shown in FIG. 8 the valve 64 shuts off fluid flow from between
the bores 50, 52 but provides communication between the auxiliary
passageway 60 and the bore 52. If desired, the valve and central
part of the valve housing may have a conventional axial overlapping
stop arrangement 61 (FIG. 7) so that the valve may be rotated
through only a single half circle.
The evacuator 2 may be of a known type, for instance one similar to
that shown in McElvenny et al. U. S. Pat. No. 3,115,138, issued
Dec. 24, 1963. Suffice it to say that such device comprises opposd
parallel circular walls 66, 68 that are joined by an annular
connecting side wall 69 to define a chamber 70. The side and
annular walls may be of pliable plastic sheets and may be joined by
annular heat seals 71, 72. The annular wall 69 may be transparent,
and may include graduations (not shown) for indication of the
volume of fluid therein. Each wall 66, 68 is internally provided
with a somewhat rigid plastic backings 73, 74 having flanges 76, 77
that are substantially adjacent to the wall 69 to enhance the
rigidity of the backings 73, 74. Formed on the backings 73, 74 are
inwardly projecting tubular spring retainers 76, there being four
on each backing and axially aligned in pairs for retaining four
springs 78. The springs 78 normally bias the backings 73, 74 and
their associated walls 66, 68 to the normal expanded positions
shown in FIGS. 11 and 12. On exterior of the wall 66 in alignment
with two of the retainers 76 are tubular plastic nipples 80, 82
with radial flanges 83, 84 that are heat-sealed to the wall 66. One
of the nipples 82 integrally includes on its flange 84 a short
strap 85 that carries a removable closure plug 86 for the nipple
82.
As will be seen in FIG. 6, the large tube 6 fits into and seals
within the element 80. Consequently, when the unit 2 is activated
for applying suction the urine will be withdrawn through the
conduit 4 and be discharged into the chamber 70 from the tube 6
through the opening provided by the nipple 80. To activate the unit
2 for suction, the plug 86 is withdrawn from the nipple 82 and the
two walls 66, 68 are pressed relatively toward each other,
compressing the spring 78 as shown in FIG. 13, the wall 70
collapsing. It will be apparent that movement of the walls 66, 68
relatively toward each other may be effected by supporting the wall
68 on a suitable surface flat and manually pressing against the
wall 66. With the springs 78 compressed, the plug 86 is replaced to
seal the unit. The system is now fully closed and can begin
evacuating urine slowly from the bladder. To this end, the
expansion of the springs 78 results in progressive enlargement of
the chamber 70 causing a gradual suction to be applied to the
conduit 4 to gently withdraw urine from the patient's bladder. When
the chamber 70 has expanded fully back to the size shown in FIG.
12, the plug 86 may be removed to empty the unit through the
exhaust opening formed by the nipple 82. In the meantime, the
patient can be encouraged to void naturally.
In some instances it may be desired to irrigate the system, obtain
samples of urine, or to introduce medication into the bladder. For
these purposes, the seal cap 62 may be removed from the fitting 58
and the cannula of a hypodermic syringe 90 may be inserted into the
passageway 60 as shown in FIG. 10. The handle may then be rotated
ninety degrees to expose the passageway 60 to the bore 52 and close
off access from the passageway 60 and bore 52 to the bore 50.
Thereafter, the hypodermic syringe 90 may be used, as required.
When the system is no longer needed, the small tubing 10 may be
gently withdrawn from the bladder through the puncture in the
abdomen wall and the puncture taped with a bandage.
* * * * *