Patent Publication Number: US-2005119628-A1

Title: Lavage control apparatus and method of using same

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
      The present invention relates to, and is entitled to the benefit of the earlier filing date and priority of, Application No. 60/517,898, filed on Nov. 7, 2003, which is herein incorporated by reference as if fully set forth. 
    
    
     FIELD OF INVENTION  
      The present invention relates to a control apparatus and in particular, a control apparatus with which a therapist administers, or a patient self-administers, a lavage or irrigation treatment.  
     BACKGROUND  
      The cleansing of the large intestine, and specifically the colon of a human subject by lavage techniques is well documented. At the ileocecal valve, partially digested material passes from the small to large intestine and thereafter, through the ascending, transverse, and descending colon to the rectum where it is eliminated. The corrugated, sacculated wall of the colon frequently traps exiting waste material that can subsequently become a source for infection, e.g., colitis, constipation, irritable bowel and occasionally, the nidus for disease processes, e.g., Chrohn&#39;s disease, heart burn and diverticulitis.  
      Lavaging of the colon commonly involves the insertion of a speculum, a product exampled in U.S. patent application Ser. No. 10/465,641, which is herein incorporated in its entirety by reference, a tapered tubular instrument, into the rectum to a precise position within the pelvic colon. The speculum&#39;s smaller tube end is positioned within a patient&#39;s colon while its larger is attached, outside, to a drain tube through which previously trapped waste from the colon is discharged. An irrigation tube is attached to the speculum&#39;s inlet detailing enabling delivery of fluid to the colon. The previously referenced speculum assembly is removeably attached via its irrigation and drain hoses, to the apparatus of this invention, the apparatus aiding the administration of lavage therapy.  
      The fundamental principal of colon lavage therapy requires that, with the drain line occluded, pressurized irrigation fluid is supplied to a speculum and there-through, to the colon of a human subject: the fluid&#39;s temperature, delivery pressure and rate may be adjusted. When the colon has reached its empirically determined, patient procedure-specific fill-point, fluid infusion to the colon is interrupted. Following a chosen dwell-time during which the patient&#39;s abdomen may be massaged, the flow of irrigation fluid is restored and the drain line opened allowing any previously trapped waste material within the colon to flow through the speculum and drain line assembly to an appropriate point of disposal.  
      Colon lavage and irrigation therapies have found society&#39;s increasing favor in recent times and as a consequence, a number of product/treatment innovations have occurred within the industry for which patent protection has been granted. The benefit to the therapeutic value of lavage consequent to these innovations has been as varied as the patented ideas, the most frequently cited of which are hereinafter discussed.  
      Improvements to lavage fundamentals described in U.S. Pat. No. 4,626,239 to Ardizzone include a programmable apparatus having a housing in which hot, cold and drain water conduits are mounted, and to which a flow circuit comprising a plurality of flow sensors and a pressure switch are attached. The pressure-sensing scheme described determines that the rate at which irrigation fluid flows to the colon via a speculum, and at which wastewater is subsequently extracted, is inversely proportional. The circuit facilitates the selection of flow rate, continuous or discontinuous, between pre-established upper and lower boundaries thereby preventing over-pressurization of the colon, a potential problem with this design. When pressure in the colon has reached its upper limit, a valve is activated and waste begins to flow from the colon, and as the pressure normalizes, the process can be repeated. The drain conduit spans the housing&#39;s entire width, as it flows towards an appropriate point of disposal. Its progress may be observed through a ‘view window.’ 
      Subsequent to Ardizzone, improvements described in U.S. Pat. No. 4,682,979 to Girouard comprise an apparatus in which irrigation fluid is either gravity or pump-fed to the colon via a rectal nozzle. The gravity option necessitates the elevation of a frequently heavy fluid tank above the treatment plane, while the pump option requires the momentary overriding of valves within the flow circuit. The irrigation fluid is heated before it enters the tank by; 1) the blending of individually valved hot and cold water supplies, 2) an ‘immersion-type’ heater positioned within the tank, or 3) a combination of methods 1&amp;2.  
      The provision of irrigation fluid of constant temperature and therapy-appropriate delivery rates by means 1-3 is intrinsically problematic. For patient safety, temperature gauges/displays are incorporated within the delivery lines of both sources of heated fluid. As Ardizzone, the product incorporates a drain conduit ‘view window.’ 
      Embodiments described in U.S. Pat. No 4,769,015 to Bloxom, Jr. include a base member to which a container of irrigation fluid and related flow monitoring instrumentation is removably attached. The gravity concept is as Girouard and of similar restricted utility. The externally calibrated container is positioned above the patient, and irrigation fluid flowing there from passes through the instrumentation and thereafter into the subject colon by way of an introducer means. The instrumentation&#39;s positioning enables optimal visual control of the system.  
      Embodiments described in U.S. Pat. No. 4,842,580 to Ouelette relate generally to a speculum product incorporating an obturator, said speculum receiving gravity-fed irrigation fluid, thereby replicating the shortcomings peculiar to all previously described systems.  
      Embodiments described in U.S. Pat. No. 4,874,363 to Abell include a roll-around structure to which lavage system elements including distinct containers for irrigation and waste-contaminated fluids, a potential health risk, are attached. The flow circuit is similar in principle to Ardizzone, U.S. Pat. No. 4,626,239 but is modified to incorporate a fluid pump, which is operatively connected to a drain line-incorporated pinch valve by electronic, timer-based signals. An air pressure or manually activated switch controls counterpoised functioning (when the pump is on the colon fills, and when the pump is off the colon empties) of drain line pinch valve and pump, and provides constant or pulsed flow alternatives.  
      Embodiments described in U.S. Pat. No. 5,405,319 also to Abell et al. issued Apr. 11, 1995 include a gravity feed irrigation system as in Girouard. The irrigation flow circuit is derivative of both Ardizzone, and Abell, U.S. Pat. No. 4,874,363 differing from the latter in its utilization of air pressure variation rather than timer-based signals to activate the operatively connected inlet and drain-line valves.  
      Embodiments described in U.S. Pat. No. 5,788,650 to Dotolo include a housing, flow circuit and associated hardware/principles of use, which are similar to Ardizzone. A unique filter linked in series with a source of ultraviolet radiation, a feature that kills water-borne bacteria and viruses before they enter the colon, is inserted between water pressure valve and hand controlled pressure-limiting switch of the generic flow circuit, which ultimately passing through a supply conduit, terminates in the speculum. Also as in Ardizzone, the drain line from the speculum passes through the housing behind a ‘view window’ as it is flows towards an appropriate point of disposal, and may be detailed to enable sampling of exiting material.  
      Embodiments described in U.S. Pat. No. 5,019,056 to Lee et al. describe an apparatus which, derivative of Abell, U.S. Pat. No. 4,874,363, comprises a cart configuration to which lavage system elements including distinct containers for irrigation and waste-contaminated fluids, again a potential health risk, are attached. The incorporated flow circuit and associated hardware/principles of use are similar to Abell and to Ardizzone. The generic flow circuit was improved and the irrigation fluid container is now filled with on-board-blended warm water (continuously cooling) that enters the apparatus via flexible hot and cold conduits, removably attached to the domestic supply. A battery powered pump positioned between the outlet of the container and inlet of speculum controls the flow pressure of fluid to the colon, with an associated in-line gauge.  
      Embodiments described in U.S. Pat. No. 5,190,519 to Mead et al. incorporates distinct containers for irrigation and waste-contaminated fluids and a source of warm irrigation fluid, features conceptually identical to Lee. A unique pumping circuit comprising an auxiliary pump, whose functioning is controlled by a plurality of manually set timers, is positioned between the irrigation container and speculum. It also incorporates a pressure tube positioned on the pump&#39;s outlet side, which operatively connected to a pressure port and associated valve (normally closed), 1) returns pumping irrigation fluid to the reservoir if restriction to flow in the colon is sensed by the pressure port, and 2) as Ardizzone, activates the colon draining cycle when the valve is opened at the successful completion of the fill cycle.  
      Embodiments described in U.S. Pat. No. 5,871,463 to Baker et al. include a portable machine having a unique exterior form in which large vertical scallops are made on left and right sides, enabling the discrete and protected positioning of system inlets/outlets including hot, cold and blended water lines from a domestic source, irrigation outlet and waste return. The incorporated flow circuit with associated hardware/principles of use and, a view window behind which exiting flows towards an appropriate point of disposal, are similar to Abell and to Ardizzone.  
      Embodiments described in U.S. Pat. No. 5,951,511 to Lowder include individual water tanks that are mounted to a base member as Girouard, at an appropriate height above the treatment plane to insure the gravity feed of irrigation fluid to a patient. A first reservoir receives blended hot &amp; cold water, a second receives cold water, both are constantly replenished by a source of pressurized fluid. Delivery conduits emanating from the two-reservoirs, each incorporating hand operated valves, transition into a single lumen at an intermediate point between reservoir and speculum.  
      Embodiments described in U.S. Pat. No. 6,106,506, to Abell et al. include a product iterative of an earlier Abell submission, U.S. Pat. No. 4,874,363 having a roll-around structure to which lavage system elements including distinct containers for irrigation, a potential health risk, are attached. The fill/drain scheme is similarly iterative in that a pump draws irrigation fluid from a reservoir through a fill conduit having a sphincter valve integrated at an intermediate positioning along its length to control fluid flow to the speculum inlet, an operatively counterpoised sphincter valve exists between the outlet of the speculum and waste container. The pump of the former iteration functioned as the inlet sphincter valve of the present configuration. Valve and pump performance is computer controlled.  
      Embodiments described in U.S. Pat. No. 6,228,048, to Robbins comprise a housing in which hot and cold water conduits are mounted and flow circuit together with associated hardware/principles of use are incorporated, similar to Ardizzone. Particular attention is paid in this gravity-fed system to control of temperature and flow pressures, which is implemented by software control.  
      As experienced lavage therapists, Applicants believe that the improvements described in a significant proportion of the previously cited products would more appropriately be referred to as automations. Colon lavage therapy is by its nature patient centric/patient specific and efforts to promote or codify a universal solution would appear to be contraindicated. It is an advantage of the present invention to provide an apparatus that provides therapeutic assistance to the colon of a human subject, in contradistinction to the irrigation, and only possible cleansing, provided by the previously cited products.  
      It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus that places the control of lavage treatments with the patient and/or therapist; such that the apparatus may adapt to each user&#39;s unique and constantly changing therapeutic needs, unlike the cited products.  
      It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus whose requirement for a source of fluid-under-pressure is satisfied by an in-house supply, thus obviating the problems of pump and gravity feed methods. It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus that can be readily connected to or disconnected from fluid supply hoses and/or to a facilities existing water-supply.  
      It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus having a toggle-operated hot fluid valve that can terminate hot fluid flow to the system to manually control temperature to assist in protecting the patient and to assist in exercising the colon as it contracts and expands synchronously with alternating streams of hot and cold fluids.  
      It is a related advantage of one but not necessarily all embodiments of the present invention to provide an apparatus in which the adjustment of cold-fluid flow rate modifies the temperature of fluid within the flow circuit. It is an advantage of one but not necessarily all embodiments of the present invention to provide color-coded fluid lines and corresponding control knobs.  
      It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus having within its flow module a toggle-operated hot fluid flow valve that may function in cooperation with a flow meter that provides irrigation fluid to the speculum at a constant pressure and temperature. The flow meter may be a Watt&#39;s type flow meter and may provide fluid to the speculum at a constant pressure and/or temperature.  
      It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus that may incorporate digital panel meters which display both lapsed treatment time and total volume of infused irrigation fluid. The meters may have manufacturer set/ experience-derived limits. It is an advantage of one but not necessarily all embodiments of the present invention to provide an apparatus that is compact, self contained, portable, and is adaptable for use in various user environments.  
      Additional advantages of various embodiments of the invention are set forth, in part, in the description that follows for an apparatus and method for controlling a lavage procedure.  
     SUMMARY OF INVENTION  
      This invention provides a method and an apparatus for use in lavaging of the colon. In one embodiment of the invention, fluid is supplied to the colon by a lavage control apparatus in which the user is able to control the temperature and the pressure of the fluid supplied to the colon through the use of two control valves that typically are connected to a hot and a cold fluid, although the apparatus could be also envisioned to be used with any two different liquids. The two valves can be used to separately adjust the amount of each fluid that is supplied to the colon. Therefore, the user can adjust the temperature of the fluid supplied to the colon, assuming that the two fluids are not already the same temperature. In one embodiment, one of the valves is a toggle-action valve. A toggle-action valve allows one fluid to be stopped and started instantaneously, which allows for a more immediate temperature fluctuation. In addition, one embodiment of this invention is capable of measuring and displaying both the amount of fluid that is introduced into the colon and the amount of time that it takes to introduce that fluid into the colon. This information is displayed on the apparatus allowing it easily to be recorded by an operator and used to track the process of an individual patient. These embodiments allow the operator of the machine to be capable of administering a wide range of lavage treatments due to the apparatus&#39; ability to adjust to each user&#39;s unique and constantly changing therapeutic needs.  
      In an additional embodiment of the invention, the lavage control apparatus also includes a clean-out capability in which a solution is directed through the waste conduit to assist in the process of keeping the waste conduit clean. In one embodiment, this can be accomplished by using a valve that directs fluid from the lavage control apparatus and blends it with a cleaning fluid and sprays this mixed fluid through the viewable waste conduit and waste outlet to a point of disposal.  
      In an additional embodiment of the invention, the lavage control apparatus includes a three-way valve to be used to facilitate the transport of the waste product into an acceptable waste disposal. The valve is closed during the filling of the colon, and opened to cease the filling of the colon. When this valve is opened, the waste product is transported through the open three-way valve to an acceptable waste disposal.  
      It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention, as claimed. The accompanying drawings, which are incorporated herein by reference, and which constitute a part of this specification, illustrate certain embodiments of the invention, and together with the detailed description serve to explain the principles of the present invention. 
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
      In order to assist the understanding of this invention, reference will now be made to the appended drawings, in which like reference characters refer to like elements.  
       FIG. 1  is an isometric view of an apparatus according to an embodiment of the present invention.  
       FIG. 2  is a front view of an apparatus according to an embodiment of the present invention.  
       FIG. 3  is an elevational view of an apparatus according to an embodiment of the present invention.  
       FIG. 4  is an elevational view of an apparatus according to an embodiment of the present invention.  
       FIG. 5  is a front view of an apparatus according to an embodiment of the present invention.  
       FIG. 6  is a flow-circuit, hardware schematic of an apparatus according to an embodiment of the present invention.  
       FIG. 7  is a perspective sketch of a typical connection between a fluid conduit and the source of irrigation fluid under pressure according to an embodiment of the present invention.  
       FIG. 8  is a top view of the apparatus according to an embodiment of the present invention.  
       FIG. 9  is an isometric view of the apparatus according to an embodiment of the present invention.  
       FIG. 10  is a front view of the apparatus according to an embodiment of the present invention.  
       FIG. 11  is an elevational view of a first side of the apparatus according to an embodiment of the present invention.  
       FIG. 12  is an elevational view of a second side of the apparatus according to an embodiment of the present invention.  
       FIG. 13  is a bottom view of the apparatus according to an embodiment of the present invention.  
       FIG. 14  is a flow-circuit, hardware schematic according to an embodiment of the present invention.  
       FIG. 15  is a front view of the apparatus according to an embodiment of the present invention.  
       FIG. 16  is a front view of a speculum of the apparatus according to an embodiment of the present invention. 
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION  
      Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in accompanying  FIGS. 1-16 . With reference to  FIG. 1 , an embodiment of the lavage controller apparatus  1  is illustrated. Lavage controller apparatus  1  comprises a molded or otherwise fabricated housing  10 , which is manufactured from thermoplastic material, aluminum, or similar lightweight material having appropriate mechanical integrity or any other suitable material. Transport means may be provided by handle  15 , which may permanently or temporarily mounted to the housing top  11  or any reasonable means of moving the apparatus  1 . An access panel  12 , which is positioned in coplanar relationship with the housing&#39;s rear surface  13 , may be detachably assembled thereto and aids in the product&#39;s manufacture and maintenance. Housing  10  front surface comprises a control panel  14  to which manually controlled flow devices, gauges and system-related panel displays, directly linked to the fluid control module  20  (not shown) of apparatus  1 , are mounted.  
      Hardware components together comprising the fluid control module  20  are arranged in functional relationship as illustrated in flow-circuit schematic,  FIG. 6  and physically located as defined by the positioning of their related control hardware on the exterior surfaces of the housing  10 , as shown in  FIG. 2 .  FIGS. 2, 4 ,  5 ,  6 , and  8  show bulkhead shut-off couplers  21  and  37  mounted through a housing side wall  18  establishing the attachment point of fluid control module  20  to an external source fluid. Coupler  21  may be, but not necessarily, used to introduce hot or warm fluid into the flow control module  20 . Coupler  37  may be, but not necessarily, used to introduce cold or cool fluid into the flow control module  20 . As shown in  FIG. 6 , a first fluid line  100  extends from coupler  21  to a control panel  14  mounted, toggle-action valve  25  then through a temperature switch  26  and temperature gauge  27 . Thereafter, the first fluid line  100  passes sequentially through a pressure regulator  28 , flow meter  29 , solenoid valve  30 , a first needle valve  31  and pressure gauge  32  to a pressure switch  33 . From this point the first fluid line  100  passes through a DEMA valve  34  (or any other suitable valve) and finally, through a check valve  35  and panel-mounted outlet  36  to the inlet of a speculum. Ozone may be drawn from an appropriate source through a check valve  40  and then blends with fluid flowing through the first DEMA valve  34 . The blending may occur by a venturi effect where the ozone is drawn into the DEMA valve  34  due to the pressure difference created by the narrowing of the passage through which fluid in the first fluid line  100  passes.  
      The temperature switch  26  is set at a preset temperature that the fluid cannot exceed. If this preset temperature is exceeded, a signal is sent to the solenoid valve  30  causing it to close until the temperature of the fluid is below the preset threshold. In one embodiment, this temperature could be set between about 102° F. and about 106° F. However, this maximum temperature threshold could vary depending on the needs of the user. In one embodiment, the pressure switch  33  also ensures that a maximum pressure is not exceeded by the fluid. Typically, the pressure switch is set so that if a pressure greater than about 3 psi is reached at the pressure switch, the solenoid valve  30  will open and close until the pressure of the water is back below about 3 psi. While about 3 psi would be a typical pressure that should not be exceeded for the introduction of water into a colon, this value could be adjusted to accommodate the individual needs of a user.  
      The second fluid line  101  extends from a second bulkhead coupler  37 , and having passed through a valve  38 , transitions into the first fluid line  100  at an intermediate positioning between toggle-action valve  25  and temperature switch  26 . A third fluid line  102  transitions from the second fluid line  101  between valve  38  and the point where the second fluid line  101  transitions into the first fluid line  100 . This third fluid line  102  passes through fill/drain valve  39 . When fill/drain valve  39  is open, water passes through valve  39  to a waste valve  110  through waste valve connection  56 . In one embodiment, waste valve  110  is a water-pressure-activated pinch valve where the water that passes through fill/drain valve  39  fills a bladder in waste valve  110  so that when the bladder is full, fluid is not capable of flowing through waste valve  110 . Waste fluid flowing from the speculum into the waste conduit  104 , passes through waste valve  110 , which is controlled by fill/drain valve  39 . When fill/drain valve  39  is closed, fluid from the third fluid line  102  cannot flow through valve  39  and any fluid inside the bladder in waste valve  110  flows back through fill/drain valve  39  and out to a drain through drain outlet  55 . Fill/drain valve  39  may be a manual action switch/3way valve, or any other suitable type of valve. Waste valve  110  may be a water-pressure-activated valve such as a Viton bladder valve, or any other suitable type of valve.  
      As shown in  FIG. 16 , speculum  105  has three openings. The first opening  106  is inserted into a user&#39;s colon, the second opening  107  is attached to the waste conduit  104 , and the third opening  108  receives the fluid from the fluid control module  20  through fluid outlet  36  via tubing  110 . When fluid passes through to the speculum  105 , it first passes into the waste conduit  104 , because typically the second opening  107  is lower than the first opening  106  when the first opening  106  is inserted into the user&#39;s colon. Additionally, the fluid will flow through the path of least resistance which would be through the second opening  106  until the waste conduit  104  is full of fluid. When waste valve  110  is in a closed position, fluid is not capable of passing through and collects in the waste conduit  104 . When waste conduit  104  is full of fluid and the waste conduit  104  has been entered into the user&#39;s colon, fluid is then collected inside the user&#39;s colon. Fluid is collected in the user&#39;s colon until the desired amount of fluid has been entered. Upon reaching this point, waste valve  110  is opened allowing the fluid in waste conduit  104  to pass through waste valve  110  and to a point of disposal. In one embodiment, a plastic tubing  109  can be attached to waste valve  110  to collect this fluid and direct it to an appropriate point of disposal. Because fluid is no longer being forced into the user&#39;s colon, the fluid that is now in the colon will pass out of the colon through the waste conduit  104 , go through waste valve  110 , and to an appropriate point of disposal through plastic tubing  109 . Additionally, fluid from the third opening  108  continues to flow through the second opening  107  to the waste conduit and assists the flow of waste from the first opening  106  as it passes through the waste conduit  104 . Plastic tubing  109  typically flows from waste valve  110  via continuous gravity flow. Therefore, waste valve  110  must be a slightly higher level then the opening of the plastic tubing  109  at the point of disposal for waste to properly flow downhill to the point of disposal.  
      As shown in  FIG. 2 , control panel  14  may comprise a lever or toggle action first fluid valve  25  and related temperature gauge  27 , a knob-controlled second fluid valve  38 , a fill/drain valve  39 , a needle valve  31  and related pressure gauge  32 . A power on/off button  50  may be positioned on control panel  14  and may be located between a timer  51  that measures and displays lapsed treatment time and may have a preset time limit including, but not limited to, about  40  minutes, and a flow meter  29  that measures and displays total volume of fluid infused and may have a preset volume limit, including but not limited to, about  110  fluid ounces. A power inlet  53  and an ozone infusion inlet  54  may be mounted on side panel  16  of housing  10 . Shut-off bulkhead quick couplers  21  and  37  receiving a first and second fluid, respectively, from a source of fluid under pressure are mounted on the opposite side panel  18  together with a drain outlet  55 , a fluid outlet  36  and a waste valve connection  56 . The flow meter  29  that displays the total volume of fluid infused because it allows the operator to calculate the total amount of fluid that has been introduced into the colon each time that an individual uses the apparatus  1 . Typically, a user is capable of accepting somewhere between about 30-110 ounces of fluid into their colon. Recordation of the amount accepted each time that the apparatus I is used allows the operator to compare results of the amount of fluid that a user has previously been able to accept into their colon and the amount typically accepted by a person of similar size and weight. This data could provide valuable information regarding the user&#39;s colon. Additionally, the timer  51  which measures and displays the amount of time that fluid has been entering the colon can be used by the operator to determine the flow rate of the fluid into the user&#39;s colon by reading the amount of fluid from flow meter  29  that enters the colon in a measured amount of time from timer meter  51  . Again, comparison of this result with other results of this user or other user&#39;s could provide valuable information regarding the user&#39;s colon.  
      Fluid supply hose components may be reversibly connected to an in-house or portable fluid supply. Each of the fluid lines  100 - 101  has termination-detailing  62 - 63  at a first end, complimentary to the housing-mounted bulkhead quick couplers  21  and  37 . Both second ends  64 - 65  of the lines  100 - 101  may be pressed into an ‘o’ ring sealed/valved branch feature or any other suitable mechanism of a fluid coupling  66  which may be incorporated within the source&#39;s plumbing or other fluid source. Incorporation of the coupling  66  is affected by transecting the source conduit and then pressing the resulting tube-ends, one in each of the coupling&#39;s  66  through the lumen or by any other suitable mechanism. One advantage to the present system is that it allows the apparatus to adapt to each user&#39;s unique and constantly changing therapeutic needs. For example, the present invention allows the toggle-action valve  25  to terminate fluid to the system from the first fluid line  100  instantaneously which assists in protecting the patient. But the toggle-action valve  25  also can be used to exercise the colon by creating an instantaneous temperature change in the fluid causing the colon to either expand or contract. For example, during the draining process, fluid continues to flow through the speculum  105  to the waste conduit  104 . Because this fluid is still in close proximity to the colon, a temperature change from hot to cold causes the colon to contract, which assists the draining process by forcing fluid and waste out of the colon. The instantaneous temperature change is achieved by either opening or closing the toggle-action valve  25  when there are fluids of two different temperatures in the first fluid line  100  and the second fluid line  101 . A normal rotational valve would only gradually closes, which allows for a substantially less instantaneous temperature change of the fluid. In addition, the operator is also capable of adjusting the temperature using valve  38  (a typically more gradual change in flow) which modifies the temperature of the fluid within the fluid control module  20  when less severe temperature variations are desired. As a means to help identify which lines correspond to which valve, one embodiment of the present invention has color coded lines and valves to assist the operator in determining which line each valve corresponds.  
      With reference to  FIG. 9 , an alternative embodiment of a lavage apparatus  1  is illustrated. The lavage apparatus  1  comprises a molded or otherwise fabricated housing  10 , which is manufactured from thermoplastic material, aluminum or similar lightweight material having appropriate mechanical integrity or any other suitable material. Transport means may be provided either by a handle detail  15  (not shown) which may be temporarily or permanently mounted to the housing top  11  or, by detailing incorporated therein. An access panel  12  which is positioned in coplanar relationship with the housing&#39;s rear surface  13 , may be detachably assembled thereto and aids the product&#39;s manufacture and maintenance. The housing&#39;s front surface comprises a control panel  14  to which manually-controlled flow devices, gauges and system-related panel displays, directly linked to the fluid control module  20  (not shown) of the apparatus  1 , are mounted.  
      Hardware components together comprising the fluid control module  20  are arranged in functional relationship as illustrated in flow-circuit schematic,  FIG. 14 , and physically located as defined by the positioning of their related control hardware on the exterior surfaces of the housing  10 , as shown in  FIG. 10 .  
      As shown in  FIGS. 10, 13  and  14 , bulkhead shut-off couplers  21  and  37  mounted through the housing base  17  establish the attachment point of fluid control module  20  to external source fluid. The first line extends from coupler  21  to a control panel mounted, toggle-action valve  25  then, through a temperature switch  26 , temperature gauge  27  and a second pressure gauge  22 . Thereafter the first line passes sequentially through a pressure regulator  28 , flow meter  29 , solenoid valve  30 , a first needle valve  31  and pressure gauge  32  to a pressure switch  33 . From this point the first line passes through a DEMA valve  34  and finally, through a check valve  35  and panel-mounted outlet  39  to the inlet of a speculum. Ozone may be drawn from an appropriate source through a check valve  40  and then blends with fluid flowing through the first DEMA valve  34 . The blending may occur by a venturi effect. The temperature switch  26  is set at a preset temperature that the fluid cannot exceed. If this preset temperature is exceeded, a signal is sent to the solenoid valve  30  causing it to close until the temperature of the fluid is below the preset threshold. In one embodiment, this temperature could be set between about 102° F. and about 106° F. However, this maximum temperature threshold could vary depending on the needs of the user. In one embodiment, the pressure switch  33  also ensures that a maximum pressure is not exceeded by the fluid as it enters the colon. If a pressure greater than about 3 psi is reached at the pressure switch, the solenoid valve  30  will open and close until the pressure of the water is back below about 3 psi. While about 3 psi would be a typical pressure that should not be exceeded for the introduction of water into a colon, this value could be adjusted to accommodate the individual needs of a user. Coupling  21  may be used to introduce hot or warm fluids, but could be used to introduce any temperature fluid. The second line extends from a second bulkhead coupler  37 , and having passed through a valve  38 , transitions in to the first line at an intermediate positioning between toggle-action valve  25  and temperature switch  26 .  
      Waste conduit  104  connects to waste inlet  43  which in turn connects to the viewable waste conduit  58  on the front side of the housing  10  allowing the operator to view the contents through the front side of the housing. Preferably, a clear glass or plastic portion of the front side of the housing  10  is used to allow viewing access; however, other transparent embodiments including a hole in the front side of the housing  10  could be used. The viewable waste conduit  58  is then connected to a waste outlet  59  which is used to dispose of the waste, possibly by connecting to a sewer line or any other appropriate waste conduit or housing.  
      Speculum  105  has three openings. The first opening  106  is inserted into a users colon, the second opening  107  is attached to the waste conduit  104 , and the third opening  108  receives the fluid from the fluid control module  20  through fluid outlet  36  via tubing  112 . When fluid passes through to the speculum  105 , it first passes into the waste conduit  104 , because typically the second opening  107  is lower than the first opening  106  when the first opening  106  is inserted into the user&#39;s colon. Additionally, the fluid will flow through the path of least resistance which would be through the second opening  106  until the waste conduit  104  is full of fluid. Further, it is advantageous to direct the fluid toward the second opening  107  so that fluid is not directly sprayed on the colon. When drain valve  68  is in a closed position, fluid is not capable of passing through and collects in the waste conduit  104 . When waste conduit  104  is full of fluid and the waste conduit  104  has been entered into the user&#39;s colon, fluid is then collected inside the user&#39;s colon. Fluid is collected in the user&#39;s colon until the desired amount of fluid has been entered. Upon reaching this point, drain valve  68  is opened allowing the fluid in waste conduit  104  to pass through drain valve  68  and into the viewable waste conduit  58  and then through to waste outlet  59  which is used to dispose of the fluid waste, possibly by connecting to a sewer line or any other appropriate waste conduit or housing.  
      In an alternative embodiment, a drain line clean-out capability is added to the flow control module  20 . The flow circuit directing irrigation fluid from the first and second lines to the speculum is intersected by a connector at an intermediate positioning between the second pressure gauge  22  and pressure regulator  28 . Redirected irrigation fluid at the connector flows through a ¼-turn shut-off valve  23  and a second DEMA valve  44 . A clean-out fluid reservoir  45  may also be incorporated within the apparatus housing. A hose attached to reservoir  45  transitions through a cleaning solution valve  24  and transitions into the second DEMA valve  44 .  
      As shown in  FIGS. 10 and 11 , during a clean-out cycle a flexible conduit  57  having a first end inserted into the fluid-sealed clean-out outlet  47 , and a second end adapted to a spray head detail  48 , is inserted into short tubular adaptor  49  that in turn is attached by barb detailing to the housing-mounted waste inlet  43 . While a spray head detail  48  is used in this embodiment, any method of transferring the fluid from the clean-out outlet  47  including plastic tubing or any other type of tubing that is easily attached and removed could be used. When the clean-out valve  23  is set to the ‘open’ position, irrigation fluid passes through second DEMA valve  44  and ‘clean-out’ outlet  47  to spray head  48  and thereafter, through an open drain valve  68 , through viewable waste conduit  58  and waste outlet  59  to a point of disposal (if drain valve  68  is closed, fluid will not be able to pass through to the viewable waste conduit). During a ‘clean-out cycle’ irrigation fluid flows through the ‘viewing chamber’  67  to a point of disposal. Simultaneously with clean-out solution valve  24  open, clean-out fluid is drawn from reservoir  45  through valve  24  to second DEMA valve  44  where it blends with irrigation fluid flowing to the disposal point. The blend may occur due to a venturi effect or by any other suitable means.  
      As shown in  FIG. 10 , the front panel of housing  10  defines the control panel  14  to which a lever-activated first fluid valve  25  and related temperature gauge  27 , a knob-controlled second fluid valve  38 , a cleaning cycle on/off valve  23 , and a second pressure gauge  22  that displays the pressure of source fluid entering the apparatus, are attached. Additionally, a needle valve  31  for controlling the pressure of the outputted fluid and related pressure gauge  27  together with elements of the clean-out system, a fluid level view window and a cleaning fluid supply on/off valve  24  and, the waste view system, a drain valve  68  controlling flow of waste through the housing, a view window  67  and a power on/off switch  69  controlling the illumination of the viewing chamber are present on the control panel.  
      A power on/off button  50  may be positioned towards the top of front panel  14  and directly beneath chamber light switch  69 , and may be located between digital panel meter  51  that records/displays lapsed treatment time and may have a preset time limit, including but not limited to, about 40 minutes, a digital panel meter  52  that records/displays total volume of irrigation fluid infused and may have a preset volume limit, including but not limited to, 110 fluid ounces.  
      As shown in  FIG. 11 , a power inlet  53  may be mounted to a first housing side panel  18  together with a fluid outlet  36  (to speculum), cleaning solution outlet  47  and, a waste inlet  43 . As shown in  FIG. 13 , an ozone infusion inlet  54  may be mounted on the opposite side housing  16 . As shown in  FIG. 13 , two female shut-off bulkhead quick couplers  21  and  37 , independently receiving a first and a second fluid, respectively, from a source of fluid under pressure are mounted on housing&#39;s underside side  17  together with a waste outlet  59 .  
      It will be apparent to those skilled in the arts that various modifications and variations can be made in the construction and configuration of the present invention, without departing from the scope or spirit of the invention. It is intended that the present invention cover the modifications and variations of the invention, provided they come within the scope of the appended claims and their equivalence.