Title:
APPARATUS AND METHOD FOR SUPRAPUBIC DRAINAGE OF THE URINARY BLADDER
United States Patent 3752158
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 The trocar is then retracted from the patient and withdrawn from the tubing over the proximal end thereof.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 D
Application Number:
05/091885
Publication Date:
08/14/1973
Filing Date:
11/23/1970
Assignee:
Snyder Manufacturing Company, Inc. (New Philadelphia, OH)
Primary Class:
International Classes:
A61M1/00; A61M25/06; A61M39/02; (IPC1-7): A61M1/00
Field of Search:
128/347,348,349R,35R,276,278,295,215,214.4
View Patent Images:
US Patent References:
3568679CATHETER PLACEMENT UNIT1971-03-09Reif
3545443SUPRAPUBIC CYSTOSTOMY NEEDLE1970-12-08Ansari
3421504VACUUM RECEPTOR1969-01-14Gibbons
3186437Stopcock1965-06-01Buono
3115138Evacuator1963-12-24McElvenny et al.
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° 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°. 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° 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.