US3410268A - Automatic bladder irrigation apparatus operated by either a vacuum, hydraulic or pneumatic source - Google Patents

Description

Nov. 12, 1968 Filed Oct. 4, 1965 G. LEUCCI AUTOMATIC BLADDER IRRIGATION APPARATUS OPERATED BY EITHER A VACUUM, HYDRAULIC OR PNEUMATIC SOURCE 4 Sheets-Sheet l {i J6 i l /8/ m; 2 M 7 'i l 25 9 I 0 Q a; l 26c OFF aFF 'k l 1/44 0 ll/7U m5 f9 INVENTOR. 6/4 0 z'z/c'd/ NOV. 12, 1968 r 3,410,268

AUTOMATIC BLADDER IRRIGATION APPARATUS OPERATED BY EITHER A VACUUM, HYDRAULIC OR PNEUMATIC SOURCE Tiled Oct. 4, 1965 4 Sheets-Sheet 2 Nov. 12, 1968 s. LEUCCI AUTOMATIC BLADDER IRRIGATION APPARATUS OPERATED BY EITHER A VACUUM, HYDRAULIC OR PNEUMATIC SOURCE .1, 1965 4 Sheets$heet 3 Fil-Ed Oct.

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AUTOMATIC BLADDER IRRIGATION APPARATUS OPERATED BY EITHER A VACUUM, HYDRAULIC 0R PNEUMATIC SOURCE Filed Oct. Q, 1965 4 ShQGtS-ShGet 4 WA 9,1 6, 9.? I 2 Jr 5 3 Mg/9m wad Ififl/ 22 m. .34 "/Z7 Z// 5 F 1 i L in fi 27 34 zslgl 2 zz llL Q 5 35 7 .2- 4:+ 5%.

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United States Patent O "we 3,410,268 AUTOMATIC BLADDER IRRIGATION APPARA- TUS OPERATED BY EITHER A VACUUM, HY- DRAULIC R PNEUMATIC SOURCE Gino Leucci, Philadelphia, Pa., assignor to Irrigation Control, Inc., Philadelphia, Pa., a corporation of Pennsylvania Filed Oct. 4, 1965, Ser. No. 492,767 12 Claims. (Cl. 128227) ABSTRACT OF THE DISCLOSURE Apparatus for use in post-operative procedures and the like, incorporating vacuum apparatus or other similar hydraulic means for controlling irrigation and drainage of a bladder and including electronic timing means which is completely electrically isolated from the patient to prevent any danger from electrical shock. The vacuum apparatus controls the flow of fluid into the bladder for any preselected time period. In a second position the vacuum apparatus controls the drainage of fluid from the bladder into an intermediate waste container before passage into a final waste container, Balancing means is provided for determining the amount of fluid drained from the bladder in order to provide a positive indication, including alarm means when an insutficient amount of fluid has been drained from the bladder. The system is normally biased to permit drainage in the case of a power failure so as to assure the fact that fluid will not be inserted into the bladder in such amounts as to cause any harm to the patient.

The instant invention relates to medical apparatus and more particularly to a novel vacuum operated automatic irrigation apparatus for cyclically irrigating and draining the bladder of a patient and having means for instantaneously indicating the presence of a constriction or flow stoppage during the irrigation procedure.

There presently exists a variety of manual semi-automatic and automatic irrigation devices which may be employed for the purpose of irrigating the urinary bladder and prostate gland, for example. Such devices may be employed during the healing process of the affected organs so as to remove undesirable formations within the organ by sterile methods, One manually operable device is set forth in copending application, Ser. No. 101,094, entitled Irrigation Device Used During Post-Operative Procedures, filed Apr. 6, 1961 by the instant inventor now US. Patent No. 3,233,609. An automatic device is set forth in detail in US. Patent No. 3,185,153, issued May 25, 1965 to the instant inventor and entitled, Automatic Regulating Device for Bladder Irrigation Devices. Basically, such devices, whether they be manual, semiautomatic or fully automatic, are comprised of a suitable catheter member which is inserted into the affected organ so as to inject a sterile fluid into the bladder for a predetermined time period, drain the fluid from the bladder for a second predetermined time period and then after a third predetermined time period renew the above mentioned cycle.

The manually operable device has the disadvantage of at least periodically requiring the presence of an operator in order to carry out the irrigation-drainage cycle. The automatic device mentioned above has the disadvantage of being electrically operated thereby placing the patient in some danger of possibly experiencing an electric shock due to the simultaneous presence of a live electrical circuit and a substantially conductive fliud.

The instant invention overcomes all of the disadvan- Patented Nov. 12, 1968 tages of the prior art through the use of a vacuum operated irrigation device which, although employing an electric circuit, has the vacuum system interposed between the patient and the electric circuit so as to avoid any possibility whatsoever of an electric shock being experienced by the patient.

The irrigation apparatus of the instant invention is comprised of a vacuum operated apparatus for controlling the irrigation and drain-age cycles of a sterile fluid introduced into the urinary bladder of the patient. The sterile fluid is fed by gravity from its source to the bladder by suitable supply tube means. A second tube means feeds the sterile fluid to a waste container (preferably by gravity) during the drainage cycle.

The vacuum operated apparatus is provided with a pair of reciprocally mounted cut-oft valve means which operate in complementary fashion so as to close the drainage tube when the supply tube is unobstructed and to close the supply tube when the drainage tube is unobstructed. Both valves are coupled to biasing means normally urging the supply tube valve closed and the drainage tube valve opened. The vacuum source is normally decoupled from both valve means. An electronic control circuit including adjustable timing means automatically couples the vacuum source to the valve means when an irrigation cycle is indicated to move both valve means against the bias source to open and close the supply and drainage tubes, respectively.

A safety monitoring circuit is provided to generate an alarm, i.e., buzzer, bell, light and the like, if the vacuum source fails for any reason, or if the monitoring device balance platform provides an indication that an obstruction has occurred.

During the post operative procedure in which the instant apparatus is employed it is not uncommon to find the bladder being irrigated as containing clots or other masses of material which it is desirable for the bladder to pass off. Occasionally such masses are of a size which causes a constriction in either the passage between the bladder and the drainage tube or the drainage tube itself. Such constrictions will prevent drainage of the fluids from the bladder such that the sterile source will attempt to flood an already filled bladder causing the patient to suffer undue pain and placing unwanted stress upon the bladder.

The apparatus of the instant invention automatically monitors all of these conditions by means of a weighing device which is comprised of a pivotally mounted platform having a removable weight at one end of the platform and an intermediate waste container at the other end of the platform. An adjusted weight is movably mounted along on side of said platform and may be moved to either side of the platform balancing fulcrum.

Once the amount of fluid to be introduced into the bladder has been selected the platform is balanced so that a first side of the platform supporting the intermediate waste container is slightly heavier than the opposite side of said platform when the intermediate Waste container is filled with the drained sterile fluid. The first side of the platform thereby bears against, and airtightly seals, an opening in .a by-pass tube which branches off from the vacuum supply tube coupled between said valve means and the vacuum source. If, for any reason, the amount of fluid drained from the bladder being irrigated is less than the amount supplied to the bladder the platform balance will be upset causing the first side of said platform to lift and hence unseal the opening in the by-pass tube. This opens the normally closed vacuum system, which condition is monitored by a suitable diaphragm, causing the diaphragm to move to its rest position, thereby operating switch means which simultaneously shuts off the vacuum source and energizes an alarm such as a lamp, a buzzer or a combination of the two. The apparatus once turned on will continue to repeat its cycle indefinitely and may be left completely unattended. The alarm indication may be located at a remote point such as at a main desk lo- .cated on each floor or wing of the hospital, clinic and the like.

The timing source is adjustable to provide an irrigation cycle of any length, a drainage cycle of any length, with the time period between irrigation and drainage also being adjustable.

The third cutoff valve is provided to control the flow of fluid from the intermediate waste container to the final Waste container. The third cutoff valve is normally closed during a drainage cycle to permit the intermediate waste container to be filled with the fluid drained from the bladder. The third cut-off valve is opened .at the start of an irrigation cycle to permit the fluid contained in the intermediate waste container to flow into the final waste container. Since the second cut-off valve is closed at this time the sterile fluid being supplied to irrigate the bladder is prevented from passing to the intermediate waste container. Thus each dosage of sterile fluid is processed independently to assure accuracy and reliability of the balancing operation.

While the preferred activating source for the automatic irrigation apparatus of the instant invention is a vacuum source, it should be further understood that the vacuum source may be substituted by either pneumatically or hydraulically operated means with the substituted means requiring only the simplest of modifications to adapt their use to the irrigation apparatus of the instant invention. Also, whereas the monitoring device is preferably comprised of balance means for indicating the presence of an obstruction the balance means may be substituted by liquid level or liquid volume indicating means to provide the same monitoring function.

It is therefore one object of the instant invention to provide a novel irrigation apparatus for use in postoperative procedures and the like.

Another object of the instant invention is to provide a novel vacuum operated irrigation apparatus.

Still another objert of the instant invention is to provide a novel vacuum operated irrigation apparatus having automatic means to detect a failure of the vacuum apparatus for any reason.

Another object of the instant invention is to provide a novel vacuum operated irrigation apparatus having automatic means for detecting obstructions which may occur in the drainage of sterile fluid from the patient being so treated.

Still another object of the instant invention is to provide novel vacuum operated irrigation means for use in post-operative procedures and the like, comprising balance means having an intermediate waste container and being adapted to isolate the vacuum source from the irrigation apparatus in the case where obstructions occur during the drainage phase of the irrigation operation.

Another object of the instant invention is to provide novel vacuum operated irrigation means for use in postoperative procedures and the like, and having first cut-off valve means for controlling the flow of sterile fluid from the source to the bladder being treated.

Another object of the instant invention is to provide novel vacuum operated irrigation means for use in postoperative procedures and the like, and having first cut-off valve means for controlling the flow of sterile fluid from the source to the bladder being treated; and second cutoff valve means for controlling the drainage of sterile fluid from the bladder being treated to the intermediate container of the balance or liquid level means.

Another object of the instant invention is to provide novel vacuum operated irrigation means for use in postoperative procedures and the like, and having first cut-olf valve means for controlling the flow of sterile fluid from the source to the bladder being treated; and second cut- 4 off valve means for cont-rolling the drainage of sterile fluid from the bladder being treated to the intermediate container at the balance means; and having third cut-off valve means for controlling the flow of fluid from the intermediate waste container to the final waste container.

Another object of the instant invention is to provide novel vacuum operated irrigation means for use in postoperative procedures and the like, and having first cut-oil. valve means for controlling the flow of sterile fluid from the source to the bladder being treated; and second cutoff valve means for controlling the drainage of sterile fluid from the bladder being treated to the intermediate container at the balance means; and having third cut-off valve means for controlling the flow of fluid from the intermediate waste container to the final waste container; wherein upon cut-off of the vacuum source, for any reason, the first cut-off valve means is biased to cut-oil the flow of sterile fluid from the fluid source to the bladder being treated in order to prevent the occurrence of any undue pressure or strain upon the bladder being treated.

Still another object of the instant invention is to provide novel vacuum operated irrigation means for post-operative procedures and the like having electronic control means which is completely isolated from the patient being treated so as to completely prevent the possibility of the patient suflering any electric shock.

Still another object of the instant invention is to provide novel vacuum operated irrigation means for use in post-operative procedures and the like comprising electronic control means for automatically cycling the irrigation apparatus.

Still another object of the instant invention is to provide novel vacuum operated irrigation means for use in post-operative procedures and the like comprising elec- .tronic control means for automatically cycling the irrigation apparatus wherein the electronic controi means is further provided with automatic timing means for adjustably controlling the relation of the irrigation phase, the drainage phase and the idle phase of the overall irrigation cycle.

These and other objects of the instant invention will become apparent when reading the accompanying description and drawing in which:

FIGURE 1 is a perspective view of an irrigation apparatus designed in accordance with the principles of the instant invention.

FIGURE 2 is a perspective view showing the balancing platform of FIGURE 1 in greater detail.

FIGURE 2a is an elevational view showing an alternative embodiment for the balancing platform of FIG- URE 2.

FIGURE 3 is an elevational view showing the cut-off valve means of FIGURE 1 in greater detail.

FIGURES 3a and 3b are elevational views similar to FIGURE 3 presented to describe the operation of the cut-off valves.

FIGURE 30 is an elevational view showing an alternative embodiment for the cut-olt means of FIGURE 3.

FIGURE 4 is a top view showing the internal components contained within the electronic control apparatus of FIGURE 1.

The irrigation device 10 of the instant invention is shown in FIGURE 1 and is comprised of a vacuum source or pump 11 which is capable, in the exemplary embodiment described herein, of generating a vacuum of 15 to 20" Hg. It should be understood that there is no criticality in the capabilities of the vacuum pump as its inherent vacuum producing ability lends no specific novelty to the instant invention.

The vacuum pump 11 is coupled through a vacuum pipe *or hose 12 to the electronic control apparatus 13. Electronic control apparatus 13 *will be more fully described in detail subsequent hereto, but is sufficient at the present moment to understand that the control a pparatus is capable of selectively coupling or isolating the vacuum pump source 11 from the output vacuum line 14.

The irrigation apparatus generally designated by numeral is comprised of a base plate 16 having secured thereto suitable legs, casters or the like 17 for supporting base plate 16 upon a supporting surface such as, for example, a floor. The base plate 16 which is a substantially rigid and flat metallic member is provided with a suitable aperture 18 for rigidly securing a T-coupler 19 thereto. The T-coupler which has a hollow interior has one opening coupled to the vacuum line 14. A second opening which is preferably coupled to base plate 16 by means of a fitting 20 receives a vacuum line 21 (see FIGURE 3), the oposite end of which is coupled through a fitting 22 which is inserted through an opening 23 in base plate 16 thereby coupling the vacuum source to the base of a piston cylinder 24. The bottom edge of cylinder 24 preferably fits into a circular shaped groove of appropriate diameter in base plate 16 and may further be provided with an O-ring or gasket to provide airtight engagement between base plate 16 and cylinder 24. The upper opening of cylinder 24 is covered by a rigid metallic cover plate 25 which may also be provided with a circular shaped groove of appropriate diameter and/or gasket means to provide an airtight seal between cylinder 24 and coverplate 25. The coverplate 25, piston cylinder 24 and base plate 16 are rigidly secured to one another through use of fastening means 26a-26d which pass through suitable apertures (not shown) in coverplate 25 and base plate 16.

A hollow cylindrical shaped supporting post 27 is rigidly secured to an opening 28 provided in cover-plate 25, as can best be seen in FIGURE 3.

The irrigation apparatus is further provided with first, second and third cut-off valve means 30, and 40, respectfully, which operate under control of the vacuum source to control the flow of sterile fluid to and from the bladder of the patient being treated. As can clearly be seen, these cut-off valve means are arranged at spaced intervals along post 27.

The upper end of post 27 has secured thereto a substantially S-shaped support member which is provided with a hooked portion 46 at its free end. This hooked portion 46 supports a sterile fluid source 47 having a U- shaped supporting wire or string 48 which rests upon hook 46. The supporting bracket 45 is adjustable either upwardly or downwardly to control the rate of flow of sterile fluid from its source or container 47. The opening in container 47 may further be provided with a valve metering means 49 which may likewise be employed for the purpose of controlling rate of flow from container 47. The sterile fluid within container 47 passes through valve means 49 and supply tube to one 'opening of a catheter Y-coupling 51, the opposite end of which is coupled to one end of a catheter 51a, which may be appropriately inserted into the bladder of the patient being treated. The catheter 51a is provided with an opening 51b to permit fluid to leave catheter 51a and enter into the bladder 'of the patient being treated. Likewise in the reverse process, opening 51b serves to permit fluid to return from the bladder to catheter 51a.

The remaining opening of the Y-coupling 51 is coupled to one end of a drainage tube 52, the opposite end of which communicates with an opening 54 in intermediate waste container 55. The bottom of waste container is provided with a suitable opening which communicates with one end of a second drainage hose 56, the opposite end of which communicates with an opening 58 in final waste container 57. As shown in FIGURE 1, the supply tube 50 has an intermediate portion thereof passing through cut-off valve means 30. The cut-off valve means 30 is comprised of an adjustably mounted block member 31 having a suitable opening for receiving supporting post 27 and being provided with fastening means for rigidly securing stationary block 31 to the post. Block 31 is further provided with a pair of projecting pins 32 and 33 for taping or otherwise securing the tubes so as to properly position these tubes adjacent their cut-off valves.

Cut-ofi valve means 30 is further comprised of a reciprocally movable projection pin member 34 which is. rigidly mounted to a stilt metallic rod 59 positioned within hollow supporting post 27, which pin 34 projects through elongated slot 27a in post 27. Pin 34 is normally biased in the upward vertical direction so as to bear against supply tube 50 and pinch it closed between pin 34 and rigid stop member 31, as can best be seen in FIGURE 3a. When the vacuum apparatus is appropriately activated, in a manner to be more fully described, pin means 34 is urged in the downward vertical direction so as to occupy the position shown in FIGURE 3b where it lies at a spaced distance from stop means 31 thereby permitting the flow of sterile fluid from container 47 through supply tube 50 to the catheter and ultimately to the bladder of the patient being treated (not shown).

The cut-off valve means 35 is comprised of a stop member 36 having projecting pins 37 and 38, which stop member and projecting pins are substantially identical to stop member 31 and projecting pins 32 and 33, previously described. The second cut-oif valve means is further comprised of a projecting pin 39 which is rigidly secured to the interior rod 59 and which projects through elongated opening 27b for cooperation with its stop member 36. Referring to FIGURE 3a, pin 39 is normally in its uppermost position, this being a spaced distance above stop member 36 thus permitting the flow of sterile fluid from the bladder and through first drainage tube 52, which is positioned between pin 39 and stop means 36, to enter into the intermediate waste container 55. The second position which may be occupied by pin 39 as shown in FIGURE 3b, in which position pin 39 bears against tube 52 so as to pinch it closed and prevent any flow of sterile fluid from the patients bladder (not shown) to the intermediate waste container.

The third cut-off valve means 40 is comprised of a stop member 41 having projecting pins 42 and 43 for securing the second drainage tube 56 thereto. This cut-off valve means is also provided with a projecting pin 44 which is likewise rigidly secured to the internally mounted rod 59 and is capable of occupying a first position shown in FIGURE 3a wherein second drainage tube 56 is rigidly held or pinched closed to prevent the flow of sterile fluid from the intermediate waste container 55 to the final waste container 57. The second position which may be occupied by pin 44, as shown in FIGURE 3b, that being a spaced distance below stop member 41 so as to freely permit the flow of the fluid contained within intermediate waste container 55 through second drainage tube 56 into final waste container 57 The irrigation apparatus 10 is further comprised of balancing means 70, which can best be seen in FIGURES 1 and 2. The balancing means is comprised of a substantially rectangular-shaped platform consisting of two rigid elongated metallic bars 71 and 72 secured to one another at their left-hand ends by a rigid metallic crossbar 73 and which are secured to one another at their righthand ends by means of a metallic plate 86 secured to bars 71 and 72 by fastening means 85a and 85b, respectively. The balancing platform is further comprised of a slidable weight 74 selectively positionable and :movable along scale member 75 secured to the platform element 71 by fastening means 76 and 77, respectively. The scale member 75 may he graduated in a manner shown in FIG. 2.

Each of the platform member components 71 and 72 are provided with suitable openings 71a and 72a, respectively, for receiving a balancing pin member 7 3 which also passes through a suitable opening (not shown) in a stationary member 79 which is rigidly secured to a supporting post 27 by any suitable means such as, for example, by a set screw (not shown). The balancing pin is adapted to permit the platform to pivot relative to stationary member 79 to perform the monitoring operation, which will be more fully described.

The right-hand portion of stationary member 79 is provided with a substantially vertically aligned opening 7% which on its underside is provided with a fitting 80, which can best be seen in FIGURE 1, which fitting secures the first end of vacuum by-pass tube 81 thereto in an airtight manner. The opposite end of by-pass tube 81 is coupled to one opening in the hollow T-coupler 19 and is secured thereto in an airtight manner.

The platform is further provided with a second rigid metallic crossbar member 82 secured to the elongated bars 71 and 72 by fastening means 83a and. 83b, respectively. The underside of crossbar member 32 has rigidly secured thereto an O-ring 84 which may preferably be formed of rubber or any other suitable resilient material and further may be received by a circular shaped groove provided on the underside of crossbar member 82 and may be secured in place either by a force-fitting, a suitable adhesive or both of these means. The O-ring is so positioned upon the underside of crossbar member 82 as to lie directly above and surround the opening 79a in stationary block 79. As Will be more fully described subsequently, the balancing arrangement is adjusted so that, when the intermediate waste container is filled with sterile fluid drained from the bladder of the patient being treated, the balancing assembly has its slidable weight 74 and the removably positionable weight 87 located atop crosspiece 73 selectively adjusted so as to cause the righthand side of the platform to be slightly heavier than the left-hand side of the platform causing crossbar member 82 to bear down upon the right-hand end of stationary block 79 in order to seal opening 79a with O-ring 84.

The intermediate waste container 55 is positioned in an inverted manner with its narrow neck passing through a suitable opening provided in plate 86. The end portion of the narrow neck of intermediate waste container 55 is preferably provided with a threaded exterior surface which threadedly engages a cap member 55a thereby rigidly mounting the waste container to plate 86 and hence to the platform. The cap 55a is provided with a suitable opening for receiving a first end of the second drainage tube 56 previously described.

Turning to a consideration of FIGURE 3, it can be seen that the supporting cylindrical post 27 has a hollow interior for reciprocally mounting the stiff inner rod member 59. The lower end of rod 59 is rigidly secured to piston 89 which has an O-ring completely surrounding its circumference. The piston 89 is reciprocally mounted within cylinder 24 and is capable of being moved either vertically upward or vertically downward, in a manner to be more fully described. O-ring 90 substantially prevents equalization of any pressure differential which may exist within the cylinder between the upper region of the cylinder and the lower region of the cylinder separated by the piston member 89.

The upper end of inner rod 59 passes through a suitable opening 91a in a substantially rigid rubber gasket 91 which is preferably force-fitted into the upper end of the cylindrical supporting post 27.

The upper end of inner rod 59 is also threaded through a helical coil spring 92 which has its lower end bearing against the upper surface of rubber gasket 91 and which has its upper end bearing against the underside of a nut 93 which threadedly engages the upper portion of inner rod 59. Spring 92 is under compression so as to normally urge inner rod 59 in the upward vertical direction, as shown by arrow 94. The amount of compression which spring 92 is under is adjustable by rotating nut 93.

The assembly of the upper end of rod 59 is covered by means of a cap having a central opening upon its upper surface to permit the upper end of rod 59 to pass therethrough. Cap 95 is seated upon the upper surface of nut 93 and is rigidly secured to rod 59 by means of a second nut 96 with rod 95 in its uppermost vertical position. The lower edge of cap 95 completely conceals spring 92 and rubber gasket 91 and telescopes over the upper end of supporting post 27.

As was previously described, the projecting pins 34,

' 39 and 44 of the cut-off valve mechanisms are all rigidiy secured to inner rod 59 along spaced intervals thereof and further project through elongated slots 27a-27c, respectively, provided in supporting post 27.

The operation of the irrigation apparatus occurs in the following manner:

Whereas the control unit will be described subsequently in greater detail, it is sufiicient for the purpose of understanding the operation of the irrigation apparatus to understand that the control unit 13, shown in FIG. 1, couples the vacuum pump 11 to the piston assembly to perform the irrigation phase of the cycle and alternatively isolates the vacuum pump 11 from the piston assembly in order to initiate the performance of the drainage phase of the irrigation cycle.

Let it now be assumed that the electronic control mechanism 13 is about to begin an irrigation phase of the cycle. This causes the vacuum source to be coupled through supply line 12, control mechanism 13, supply line 14, T-coupler 19 and supply line 21 to the opening 22 in the bottom of the cylinder assembly. The vacuum is of sufiicient magnitude as to draw piston 89 in a downward vertical direction, as shown by arrow 94a, against force of spring 92. This causes interior rod 59, which is rigidly secured to piston 89, to likewise be drawn in the downward vertical direction until each of the projecting pins 34, 39 and 44 bear against the lowermost edges of the elongated slots 27a-27c, respectively, through which they protrude, thus preventing any further motion in the downward vertical direction.

Turning to a consideration of FIGURE 3b which shows the position of pins 34, 39 and 44 at this time, it can be seen that pin 34 is positioned a spaced distance below its stop member 31; pin 39 is drawn toward its stop member 36 and pin 44 is positioned a spaced distance below its stop member 41. With pin 34 in a position as shown in FIGURE 31), the fluid supply tube 50 which passes between pin 34 and stop member 31 is free to permit the passage of sterile fluid from container 48 through valve 49, supply tube 50 and catheter 51 into the bladder of the patient being treated.

The sterile fluid which has been fed into the bladder is prevented from draining therefrom due to the fact that first drainage tube 52 which is positioned between pin member 39 and stop member 36 is pinched closed.

It will be noted that pin member 44 lies a spaced distance beneath its stop member 41 so as to permit the free flow of any fluid which may be present in the intermediate waste container 55 through the second drainage tube 56 into the final waste container 57.

The irrigation phase may last as long as is desirable, but its duration is normally a function of the amount of sterile fluid which it is desired to insert into the bladder and the rate of flow of this fluid from the fluid container 47 into the bladder. Typically, the irrigation phase lasts of the order of one minute and the preferred range may be anywhere from 30-90 seconds, for example. This feature is fully provided for by suitable timing means included within the electronic control means 13 such that at the end of the irrigation phase a control device automatically operates to isolate the vacuum pump 11 from the piston chamber and admit air to piston chamber. At this time, in the absence of the vacuum condition, the inner rod 59 comes under control of the coil spring 92 so as to be urged in the upward vertical direction, as shown by arrow 94. Piston member 89, which is coupled to inner rod 59, is free to move in this direction due to the fact that the vacuum source no longer pulls it in the downward vertical direction as the source has now become isolated from the piston chamber. The coil spring 92 moves all three projecting pins 27a-27c upward until they bear against the upper edge of the elongated slots through which they protrude. Thus the pins move from the position shown in FIG. 3b to the positions shown in FIGURE 3a. In this state, pins 34 and 44 bear against their stop members 31 and 41, respectively, whereas pin 39 is positioned a spaced distance above its stop member 36. Thus the supply tube 50 is pinched closed and the second drainage tube 56 is likewise pinched closed, while the first drainage tube 52 is free to pass fluid therethrough. The new pin positions, as shown in FIGURE 30, thereby cut off the flow of sterile fluid from the container 47 to the bladder being treated and permit the sterile fluid within the bladder to be drained from the bladder into the intermediate waste container 55. The intermediate waste container may not empty at this time due to the fact that the second drainage tube 56 is now pinched closed. The drainage phase of the overall cycle is normally substantially longer than the irrigation phase and typically lasts at least a few minutes. Since the intermediate waste container was empty during the previous phase and is now being filled with the fluid drained from the bladder, the left-hand side of the platform of monitoring assembly 70 will be heavier than the right-hand side, causing the O-ring sealing opening 79a to be lifted away from this opening, thereby opening the normally closed vacuum system. This has no effect upon the operation during this phase since the vacuum pump 11 has already been isolated from the output vacuum line 14 emanating from the electronic control device 13 by means of a suitable valve contained within control 13 and which is to be more fully described. The drainage phase of the overall cycle typically is 15 minutes in duration, but is adjustable to any other suitable period.

At the end of the drainage phase, a new irrigation phase will automatically be initiated.

It should be noted at this time that the intermediate waste container has been filled by the sterile fluid drained from the bladder. If at the instant at which the new irrigation phase is instituted, the intermediate waste container 55 contains the requisite amount of sterile fluid, the righthand side of the platform will be heavier, by at least a slight amount, than the left-hand side of the platform causing the O-ring 84 to seal the opening 79a. Thus, the closed vacuum system remains closed at the initiation of the new irrigation cycle and the piston member 89 will be pulled in the downward vertical direction, as shown by the arrow 94a, to again permit sterile fluid to flow from container 48 into the bladder being treated.

At this same instant it will be noted that the pin 44 moves away from its stop member 41 to permit the intermediate waste container to be drained of its contents simultaneously with the flow of fresh sterile fluid from container 48 to the bladder being treated. During the time that the fiuid is being drained from intermediate waste container 55 it becomes obvious that the right hand of the platform will, at some point, weigh less than the lefthand side of the platform so that it would normally want to tilt counterclockwise about the balancing pin 78. However, this action is prevented due to the fact that the vacuum is of such magnitude as to retain the O-ring 84 in its airtight sealing position above the opening 79a. Thus, so long as, at the initiation of the new drainage cycle, the intermediate waste container 55 is found to contain the requisite amount of sterile fluid; the new irrigation cycle, once having been initiated, will continue throughout its duration which is typically one minute.

Considering the case where the bladder being treated may develop an obstruction so as to prevent all or some of the sterile fluid within the bladder from being drained into intermediate container 55 the desired condition will be upset causing the left-hand side of the platform to weigh more than the right-hand side of the platform so as to cause the platform to pivot counterclockwise about the balancing pin 78 so as to unseal O-ring 84 from opening 79a.

Then, as soon as a new irrigation phase of the cycle is initiated the vacuum system is automatically reconnected with the piston assembly by means of the control mechanism 13. However, at this time the opening 79a which is coupled to bypass tube 81, is unsealed thereby destroying the closed vacuum system. Since the unsealed bypass tubing 81 offers less resistance to the vacuum source than the biased piston member 89, the piston 89 will be prevented from being moved in the downward vertical direction as shown by arrow 94a. It can therefore be seen that the monitoring assembly automatically prevents the initiation of a new irrigation phase in the case where the intermediate waste container is not filled with the requisite amount of fluid drained from the bladder of the patient being treated.

An alternative embodiment to the balance monitoring means 70, shown in FIGURES 1 and 2, and which may be substituted therefore, is designated by numeral 70' as shown in.FIGURE 20. Only a portion of the apparatus of FIGURE 1 has been reproduced in FIGURE 2a for p 1I- poses of simplification. As can be seen, the drainage tube 52 is coupled through fitting 54 to the intermediate waste container 55. This intermediate waste container 55 is provided with a ball float mounted upon a balance arm 151 which is pivoted at point 152 along the surface of container 55. The left-hand end of balance arm 151 is rigidly secured to ball float 150. The opposite end is pivotally linked to a vertically movable push arm 153 which is reciprocally movable within a guide tube 154 rigidly secured at its lower end to platform 86 and having an opening 155. The underside of platform 86 is provided with a fitting 156 which is coupled to bypass tube 81 of the vacuum system in the same manner as previously described with reference to FIGURES l and 2. The operation of the fluid monitoring means 70" is as follows:

Let it first be assumed that substantially the same amount of fluid which has entered the bladder, leaves the bladder to fill intermediate waste container 55. This causes the ball float 150 to move vertically upward as shown by arrow 157 thereby causing balance arm 152 to rotate clockwise as shown by arrow 158. This moves the push arm 153 vertically downward causing its sealing tip 154a to move beneath the opening in guide cylinder 154 thereby sealing the vacuum system.

In the case where less fluid flows into intermediate waste container 55 than has been fed to the bladder, the ball float 159 will remain substantially at the level as shown in FIGURE 2a, preventing the sealing tip 154a from moving beneath the opening 155 in guide cylinder 154 thereby leaving the vacuum system open so that when the vacuum system attempts to pull down piston 89 (previously described with reference to FIGURE 3) the close vacuum system will have been destroyed thereby providing a positive indication of the fact that an obstruction has apparently occurred in the bladder of the patient being treated.

Since the detection of this condition may be an indication of rather serious consequences, it is important that a suitable alarm be provided to notify the hospital staff automatically and immediately since the device of the instant invention, under normal operation procedures, may be left completely unattended.

FIGURES l and 4 show the exterior and interior elements of the control center 13 which is comprised of suitable conductor means 101 for connecting the electronic control mechanism 13 to a source of energy represented schematically and designated by the numeral 102. Typically, the source of energy will be an outlet which is normally provided in rooms and wards of a hospital. One of the leads 101 coming from source 102 is provided with a toggle switch 103 which is on the front face of the control center for turning the device ON or OFF. In the open position the electronic control center is completely OFF. In the ON position or closed position the electronic control center is ON and an indication that it is ON is given by means of lamp 104. Once this circuit is established, the first timing or clock means 105 becomes energized for the purpose of establishing the duration of each phase of the cycle and hence of the overall cycle. The timing or clock source is provided with a manually settable pair of knobs 106 and 1%7 Which are ganged one atop the other. Knob 106 controls the timing of the irrigation and drainage cycles, in a manner to be more fully described, whereas knob 107 controls the total elapsed time during'which the total number of cycles are to be performed. Knob 106 sets the pointer 106a while knob 107 sets the pointer 107a. Let it be assumed that it is desired to provide a cycle comprised of a one minute irrigation phase followed by a fifteen minute drainage phase. Pointer 106a is thereby manually set to provide a fifteen minute cycle and pointer 107a is manually set to provide the total number of cycles desired. Initially, the one minute irrigation phase is set up by causing a second clock source 103 to be reset by coupling 109. The clock source 108 is provided with a manually settable knob 110 for positioning pointer 110a. The clock source 108 is preferably a clutch timer having the capability of being adjusted for a period of from zero to two minutes. At the resetting of the clutch timer 108 the clutch timer automatically begins its cycle which may, for example, be one minute during which period it energizes a control valve 111.

To understand the operation of control valve 111, it should be understood that the vacuum source supply line 12 enters into the electronic control center through a fitting 112 which, in turn, couples the vacuum supply through hose 113 to a hollow T-cou-pler 114. The T- coupler has a first branching hose 115 coupled to one side of control valve 111 through a fitting 111a. The output of control valve 111 is coupled through fitting 111b, tube 116 and fitting 117 to the output vaccum supply line 14, previously described.

The previously mentioned clutch timer 108 upon initiation of its cycle energizes the control valve 111. While no details of the control valve 111 are given, it is sufficient to understand that the control valve is provided with an internal mechanism which is normally biased so as to isolate the vacuum source coupled to its input fitting 111a from its output fitting 1111) and to expose the output fitting to the atmosphere so that the vacuum source will hence be isolated from the piston assembly previously described. When the control valve 111 is energized it is moved to a second position causing the input fitting 111a to communicate with the output fitting 11112 and the output fitting to be sealed from the atmosphere and hence connecting the vacuum source 11 shown in FIGURE 1 to the piston asembly described previously. After a one minute interval has been timed out, timer pointer 110a of clutch timer 108 will automatically stop while timer pointer 106a of timer 105 will time-out a fourteen minute drainage phase at the end of which it will automatically reset to permit the pointer 106a to again time-out a fifteen minute cycle. As soon as pointer 106a resets to repeat the fifteen minute cycle it automatically resets clutch timer 108 causing it to time-out a one minute irrigation cycle. At the end of this repeated irrigation phase the pointer 106a will timeout the remainder of the fifteen .minute cycle which is now identified as a drainage phase. Pointer 107a works continuously to provide an indication of elapsed time and hence of the total number of elapsed cycles. In one preferred embodiment the total elapsed time may be anything from 0-3 hours, but any other timing cycle may be employed.

By providing the automatic coupling means 109 to reset the clutch timer 108 each time a cycle begins this protects the irrigation apparatus against any faulty operation. For example, let it be assumed that a power failure occurs half-way through the one minute irrigation cycle. Let it now be assumed that this power failure is cleared and the irrigation apparatus again begins to operate automatically. By resetting the cycle timer pointer 12 it automatically resets the clutch timer 108 causing it to time-out a full one minute cycle instead of allowing it to time-out a 30 second cycle which would occur if the clutch timer 108 were not reset.

The monitoring device for indicating a failure in the vacuum system for any reason whatsoever is comprised of a diaphragm member'lltl which is suitably held to the base of the electronic control center housing by means of a bracket 119. The diaphragm is coupled into the vacuum system by means of a copper tube 120 and supply hose 121 which are coupled between T-couplcr 114 and diaphragm 118. The diaphragm assembly is comprised of a diaphragm contained within the housing 113a and which is normally biased in the direction shown by arrow 122. This diaphragm has coupled thereto (in a manner not shown) a plunger member 11811 which cooperates with the arm 123:: of a microswitch 123. In the case where the vacuum system is fully closed and in normal operating condition, the vacuum will appear in line 121 drawing the diaphragm member (not shown) in the direction shown by arrow 122a so as to bias plunger member 1181; in the same direction and maintain it out of engagement with the arm 123a of microswitch 123. If the vacuum system fails for any reason such as, for example, due to an obstruction in the bladder of the patient being treated the vacuum and supply line 121 will be destroyed causing the diaphragm member (not shown) to move in a direction shown by arrow 122 causing plunger 11811 to move in the same direction so that microswitch 123 will disconnect control valve 111 (through microswitch 110) and wiIl connect audible alarm 124 and visible alarm (i.e., lamp) 125 to the source of energy 102. It should be understood that these alarms 12.4 and 125 need not be mounted directly upon the electronic control center housing but may be located at any remote location such as, for example, at the main desk of the hospital floor.

The electronic control center is further provided with a socket 126 for receiving the plug 127 of the vacuum pump 11 and is so connected to the microswitch 123 as to deenergize the vacuum pump simultaneously with the closure of control valve 111 to prevent operation of the vacuum pump during the time at which a failure in the closed vacuum system has been indicated. A fuse 128 may be provided for the purpose of protecting vacuum pump 11 against any overload or short-circuit condition.

The electronic control center is further provided with a manually settable control knob 129 on its front panel for selectively operating the irrigation apparatus either manually or automatically. For automatic operation the manually scttablc knob 129 is set to the automatic position causing the arm 12% of the switch to engage terminal 129:2 in order to establish an electrical path between source 102 and timer clock 105, thereby permitting automatic operation of the apparatus.

In the case where it is desired to provide manual operation, knob 129 is set to the HAND position, thereby electrically disconnecting the timer 105 from electrical source 102 and electrically connecting control valve 111 to electrical source 102. This energizes control valve 111 to cause its inlet fitting 111a to communicate with outlet fitting 1111) to permit the vacuum source to be directly coupled with the piston assembly previously described. This will thereby initiate the irrigation phase of the overall cycle. This phase will be maintained so long as knob 12% is maintained in the HAND position. In order to terminate the irrigation phase of the overall cycle and still maintain manual operation of the device, knob 129 may be moved to the first OFF position which deenergizes control valve 111 and still maintains the timer device 105 deenergized. Two OFF positions have been provided so that if the knob 129 is moved too abruptly and passes the first OFF position then the knob will surely settle in the second OFF position. By returning knob 129 to the automatic position, control valve 111 will be energized only through control timer 105 and micro- 13 switch 110 and will be disconnected from direct electrical contact with control source 102.

In the case where the patient being treated is in no danger whatsoever of passing any particles or masses which may obstruct the drainage of sterile fluid from the bladder, it is not necessary that the balancing device 70 be adjusted to monitor for this condition. In such instances the slidable weight 74, shown in FIGURE 2, may be moved to the extreme right-hand end of scale 75 to effectively disable the balancing mechanism 70 from its normal monitoring activity.

While the preferred embodiment described herein is shown as employing a vacuum source 11 for actuating the irrigation apparatus 10, it should be understood that pneumatic or hydraulic sources may be substituted therefor. For example, the device of FIGURE 3 may be moditied by rigidly securing the cover member 95 to the support cylinder 27 and rigidly securing the upper end of spring member 92 to fastening means 93 and the lower end of spring member 92 to shaft 59, as shown in FIG- URE 30. Spring 92 is placed under compression so that it normally urges shaft 59 in the downward vertical direction as shown by arrow 171. The stop members 31, '36 and 41 are positioned on the reverse sides of the openings 27a27c, respectively, as shown in FIGURE 30. In the absence of pneumatically or hydraulically applied pressure, spring 92 thereby closes tubes 50 and 56 in the same manner as previously described and opens tube 52. Upon the application of pneumatic or hydraulic pressure this causes the piston 89 to be urged in the upward vertical direction as shown by arrow 172, causing the openings of tubes 50 and 56 and the closing of tube 52. As a further modification the monitoring device 70 of FIGURE 2 or the monitoring device 70 of FIGURE 2a may then be coupled to suitable microswitch means such as for example, the microswitch means 175 shown in FIGURE 2a which is operated to the closed position to indicate a suitable liquid level in the intermediate waste container 55 and which is moved to the open position to indicate full level of fluid in intermediate waste container 55. By coupling the microswitch 175 into the source of electrical energy which drives the pneumatic or hydraulic means its electric circuit may be opened when the liquid level is of insufficient height and may remain closed when it is of sufficient height so as to operate in substantially the same manner as the vacuum source previously described. The one further modification required in the preferred embodiment is that of the vacuum sensing means 118 shown in FIGURE 4. By reversing the biasing condition of the diaphragm and by reversing the operation of microswitch 123 this device may be employed to monitor the condition of the hydraulic or pneumatic activating source. For example, instead of the diaphragm normally being biased in the direction shown by arrow 122, the diaphragm will now be biased in the direction shown by arrow 122a. Reversing the switch contacts of microswitch 123 will cause the contacts now to be closed, indicating absence of sufiicient hydraulic or pneumatic pressure. -By applying pressure upon the diaphragm within the housing, this will urge plunger -118b in the direction shown by arrow 122, operating microswitch 123 so as to open its contacts and thereby prevent an indication being provided of absence of the s-ufiicient hydraulic or pneumatic pressure.

It can clearly be seen from the foregoing description that the instant invention provides a novel vacuum operated irrigation apparatus which is capable of providing an operating cycle comprised of an irrigation phase and a drainage phase, each of which phases may be adjustable to any desired durations. The device has the further capability of automatically providing an alarm indication in the case where a failure in the vacuum system occurs for any reason and specifically in the case where a lesser amount of sterile fluid is drained from the bladder during the drainage phase than was supplied to the bladder during the irrigation phase, which condition is a good indication of the fact that an obstruction may be present in the bladder of the patient being treated.

Although I have described preferred embodiments of my novel invention, many variations and modifications will now be obvious to those skilled in the art, and I prefer, therefore, to be limited not by the specific disclosure herein but only by the appended claims.

What is claimed is:

1. Irrigation apparatus for use in post-operative procedures which employ a sterile fluid for irrigating a bladder, said apparatus comprising a vacuum pump; an intermediate waste container; first means having an open and a closed position for controlling the flow of sterile fluid into the bladder and intermediate waste container, 21 second means having an open and closed position for controlling the drainage of the sterile fluid from the bladder to said intermediate waste container, third means having an open and a closed position for controlling the emptying of said waste container, fourth means coupled to said vacuum pump for controlling the operation of said first, second and third means, said fourth means being comprised of means movable in a first direction to open said first and third means and close said second means and movable in a second direction to open said second means and close said first and third means.

2. The apparatus of claim 1 wherein said fourth means is comprised of a cylinder, a piston mounted to reciprocate in said cylinder; a rod coupled to said piston; means for coupling said cylinder to said vacuum pump; biasing means to urge said rod in said first direction; said vacuum pump being connected to urge said rod in said second direction against the force of said biasing means.

3. The apparatus of claim 2 further comprising monitoring means for monitoring the vacuum condition, alarm means coupled to said monitoring means to provide an alarm indication due to a failure in the vacuum pump.

4. The apparatus of claim 3 further comprising control valve means coupled between said vacuum pump and said cylinder and having a first position maintaining the vacuum system closed and a second position for opening the vacuum system, timing means coupled to said control valve means for adjustably controlling the duration in which said control valve means is maintained in the first position.

5. The apparatus of claim 4 wherein said monitoring means is comprised of an airtight housing coupled to the connection between said vacuum pump and said control valve means and is normally biased in a first direction in the absence of a vacuum to operate said alarm means.

6. The device of claim 1 further comprising balancing means supporting said intermediate waste container, said balancin-g means including means coupled to vacuum pump for maintaining the vacuum closed when the contents of said waste is slightly heavier than a predetermined value, said means being movable to open said vacuum system when the contents of said waste container is lighter than said predetermined value.

7. The apparatus of claim 6 wherein said balancing means is comprised of a pivotally mounted platform with the pivot point being positioned intermediate the ends of said platform, adjustable scale means mounted upon said platform for biasing said platform to tip toward one side when said intermediate waste container is filled with a predetermined amount of fluid.

8. Irrigation apparatus for use in post-operative procedures which employ a sterile fluid for irrigating a bladder, said apparatus comprising an activating source; an intermediate waste container; first means having an open and a closed position for controlling the flow of sterile fluid into the bladder and intermediate waste container, a second means having an open and closed position for controlling the drainage of the sterile fluid from the bladder to said intermediate waste container, third means having an open and a closed position for controlling the emptying of said waste container, fourth means coupled to said activating source for controlling the operation of said first, second and third means; said fourth means being comprised of means movable in a first direction to open said first and third means and close said second means and movable in a second direction to open said second means and close said first and third means.

9. The apparatus of claim 8 wherein said fourth means a comprised a cylinder, a piston mounted to reciprocate in said cylinder; a rod coupled to said piston; means for coupling said cylinder to said activating source; biasing means to urge said rod in said first direction; said activating source being connected to urge said rod in said second direction against the force of said biasing means.

10. The apparatus of claim 9 wherein said activating source is a hydraulic pressure means.

11. The apparatus of claim 9 wherein said activating source is a pneumatic pressure means.

16 12. The apparatus of claim 8 further comprising monitoring means for monitoring the activating source condition, alarm means coupled to said monitoring means to provide an alarm indication due to a failure in the activating source.

References Cited RICHARD A. GAUDET, Primary Examiner.

R. L. FRINKS, Assistant Examiner.

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