WO1987001596A1

WO1987001596A1 - Method, colonic speculum and control device for colonic lavage

Info

Publication number: WO1987001596A1
Application number: PCT/US1985/001740
Authority: WO
Inventors: George H. Holt
Original assignee: Dotolo, Vincent
Priority date: 1985-09-12
Filing date: 1985-09-12
Publication date: 1987-03-26
Also published as: EP0235129A1; EP0235129A4; JPS63501127A; KR870700366A

Abstract

Colonic lavage is accomplished with disposable speculum (10) and disposable hoses (14, 16) connected between the speculum (10) and a machine (54) which controls temperature (62) and pressure (70) of treatment fluid. A valve (90) on the machine opens the waste hose to a waste line in the machine. A three-way valve (136) at the exit of the waste line directs flow from the waste line to a drain or to a collection chamber (160). A flushing hose (96) mounted on the machine connects to an inlet connector (126) on the waste line after the waste hose has been removed to flush the waste line and ready the machine for a new disposable waste hose and treatment fluid hose. Sterilization fluid is dispensed from the machine (120) into a flushing line (102) which supplies the flushing hose.

Description

Method, Colonic Speculum and Control Device for Colonic Lavage

Background of the Invention

This invention relates to colonic lavage apparatus and methods.

Colonic lavage is described in United States patent 4,190,059.

The present invention has improvements to that machine and also overcomes problems existing in current colonic lavage systems.

Summary of the Invention

The present invention provides colonic lavage apparatus which includes disposable specula, obturators and hoses which attach the specula to machine connections.

The entire distal portion of the specula is made without seams. The obturator is made to dissolve in the treatment fluid without damage to the patient or is made removable before attach¬ ment of the large waste hose to the specula. The entire specula, waste hose and treatment hose are disposable following use.

A large waste line in the machine enables the slowing and controlling of flow of waste through a transparent section of the waste line. A valve at the inlet of the waste line controls flow from the waste hose into the waste line. A three-way valve immediately following the transparent viewing section of the waste line in the machine controls flow of fluid through the waste line and through the transparent viewing section and provides accurate sample collection immediately following the viewing section.

A magnifying lens is provided by the viewing section in one embodiment. A bracket is provided by the viewing section to attach magnifying and recording instruments.

A flushing hose has a proximal end permanently connected to an output of a flushing line. A distal end of the flushing hose is connectable to a connector on the inlet of the waste line. After the disposable waste hose has been connected from the waste line inlet, the flushing hose is snapped into place on the inlet. Water is admitted to the flushing hose through the flushing line -3- to rinse the waste line in the machine. Sterilizing solution from a reservoir is pumped or flowed into water in the flushing line to sterilize the waste line.

The present invention provides a new and improved speculum assembly for use in colonic lavage and provides a new and improved disposable speculum assembly which is simple to use and inexpensive to manufacture.

The present invention provides a new and improved disposable speculum assembly which eliminates the necessity of a mixing manifold and the double input ports for directing treatment fluids to the manifold.

The present invention is to provide a new and improved disposable speculum assembly which has a special insertion end to eliminate the need for an obturator and has both the treatment fluid input tube or hose and the waste removal tube or hose fixedly carried thereon to simplify use and to allow the speculum and the attached hoses to be disposed of afte.r use for sanitation purposes.

• The speculum body is molded or otherwise formed from a suitable synthetic resin and defines a hollow tube of cylindrical configuration with the insertion and waste removal ends being at opposite ends of the hollow tube, with the axial bore extending therebetween and forming a flow passage.

The injector boss is located proximate the waste removal end of the hollow tube and preferably extends angularly from the hollow tube so as to form an actue angle which is included between the injector boss and the waste removal end of the speculum body. Both the waste removal hose and the treatment fluid input hose are preferably formed of a suitable synthetic resin material and are fixedly attached to the speculum body, such as by means of a suitable adhesive.

An advantage of the present invention is that both the speculum body and the above described hoses are sufficiently inexpensive to fabricate thus making it ecomonically feasible to dispose of both the speculum and the hoses after a single use thereby eliminating any risk of contamination between patients which could result from the reuse of improperly cleaned and sanitized prior art speculums and hoses.

Another advantage of the present invention is that the insertion end of the speculum body is configured so that the use of an obturator is not required which- simplifies pretreatment preparations, eliminates post treatment obturator sanitization, and eliminates the possibility of contamination between patients resulting from an improperly cleaned and sanitized obturator.

Still another advantage of the present invention is that the unitary structure of the speculum assembly further simplifies pretreatment preparation and by disposing of the entire assembly after a single use, post treatment procedures are significantly reduced, thus saving time and reducing costs.

The preferred disposable speculum assembly for administration of colonic lavage therapy comprises: a speculum body including,

I. an elongated cylindrical portion having an axial bore extending therethrough and having an insertion end for insertion into the rectum of a patient and having a -5- waste removal end,

II. an injection boss extending laterally from said cylin¬ drical portion proximate the waste removal end thereof, said injection boss defining an axial passage which is in communication with the axial bore of said cylindrical portion; a treatment fluid input hose on the extending end of said injection boss of said speculum body, and a waste removal hose on the waste removal end of said cylindrical portion of said speculum body.

Preferably, the treatment fluid input hose is fixed to the extending end of said injection boss of said speculum body.

The preferred waste removal hose is fixed on the waste removal end of said cylindrical portion of said speculum body.

Preferably, the treatment fluid input hose is adhesively attached to the extending end of said injection boss and said waste removal hose is adhesively attached to the waste removal end of said elongated cylindrical body.

Preferably, the insertion end of said elongated cylindrical portion of said speculum body is rounded to facilitate rectal insertion.

The preferred injection boss extends angularly from said elongated cylindrical body to form an acute included angle between said injection boss and the waste removal end of said elongated cylindrical portion.

Preferably, the speculum body, the injection boss and the treatment fluid input hose and the waste removal hose are made of plastic materials. -6- The preferred plastic material is selected from the group of materials consisting of polypropylene, PET, Barex and PVC.

In a preferred embodiment, an obturator is positioned in the speculum body before the speculum body is attached to the waste removal hose, the obturator having a rounded distal projecting through the insertion end and having an enlarged handle -extending across a proximal waste removal end of the cylindrical portion of the speculum body and having a stem interconnecting the handle and the distal end.

In one embodiment, a dissolvable, meltable suppository body having a rounded, tapered distal end and having a generally cylindrical proximal end is mounted on the insertion end of the speculum body.

Preferably, a portion of the speculum body between the insertion end and the injection boss is seamless.

The preferred waste removal hose has a distal end which is connected to the waste removal end of the speculum body. A machine is connected to the proximal end of the waste removal hose. An injection fluid means is connected to a proximal end of the treatment fluid input hose.

The preferred machine further has a flushing hose having a proximal end permanently connected to the machine and having a distal end connectable to the machine in place of the proximal end of the waste removal hose for flushing the machine when the waste removal hose is removed from the machine.

Preferably, a waste control valve is connected to the machine adjacent the connection for the proximal end of the waste removal hose for selectively closing and opening the connection -7- to permit waste to flow through the machine or to prevent communication of the machine with the hose connection.

In a preferred embodiment, a flushing valve is connected to the machine near a proximal end of the flushing hose for selectively admitting flushing fluid to the flushing hose.

The preferred apparatus further has a flushing fluid reservoir mounted on the machine and means for conducting flushing fluid from the reservoir to a flushing line.

Preferably, a pump is connected between the reservoir and the flushing line.

One preferred pump comprises a hand-operated dispensing pump connected between the reservoir and the flushing line for dispensing a pre-determined amount of cold sterilization solution in the reservoir and to water flowing in the flushing line.

Another pre erred means comprises a metering device connected between the reservoir and the flushing line for automatically metering cold sterilization solution from the reservoir into the flushing water and the flushing line.

Preferably, the distal end of the flushing tube has a quick connector lock mounted for connection to a connector from which a proximal end of the waste removal hose has been removed.

In a preferred embodiment, waste line extends through the machine. The waste line has an input end and an output end, an open and close valve connected to the input end and a three-way valve connected to the output end. A drain line is connected to the three-way valve, and a specimen collection line is connected to the three-way valve. The three-way valve selectively connects the waste line in the machine with the drain line or the specimen -8- collection line.

Preferably, the drain line connects to the bottom of the machine, and the specimen collector line is connected to a side of the machine adjacent the three-way valve, which is mounted in the machine.

Preferably, the machine has a transparent viewing section connected to the waste line in the machine. A viewing instrument mounting means is connected to the machine adjacent the viewing section for mounting a viewing instrument on the machine.

The preferred mounting means is a bracket mounted on the machine adjacent the viewing section and a frame connected to the bracket. The frame is provided with openings for mounting a viewing device such as a television camera or a microscope.

In one embodiment, magnifying means mounted adjacent the viewing section.

The preferred colonic lavage apparatus has a machine. A waste removal hose has a distal end which is connected to a waste removal end of a speculum body. A proximal end of the waste removal hose is connected to the machine. The machine further has injection fluid means connected to a proximal end of a treatment fluid input hose.

A flushing hose has a proximal end permanently connected to the machine and has a distal end connectable to the machine in place of the proximal end of the waste removal hose for flushing the machine when the waste removal hose is removed from the machine.

A waste control valve is. connected to the machine adjacent the connection for the proximal end of the waste removal hose for -9- selectively closing and opening the connection to permit waste to flow through the machine or to prevent communication of the machine with the hose connection.

A flushing valve is connected to the machine near a proximal end of the flushing hose for selectively admitting flushing fluid to the flushing hose.

A flushing fluid reservoir mounted on the machine, and control means conduct flushing fluid from the reservoir to a flushing line.

The preferred method of colonic lavage comprises controlling temperature of treatment fluid in a machine, connecting a proximal end of a wate hose to a machine, connecting a proximal end of a treatment fluid hose to a machine and connecting a distal end of the treatment fluid hose to a speculum, inserting an obturator in the speculum, installing the speculum, connecting a distal end of a waste hose to a proximal end of the speculum, introducing treatment fluid through the speculum, opening a waste line in the machine and flowing waste through the machine, closing the waste line outlet and reopening the waste line.

The preferred method further comprises turning a three-way valve in an outlet to control outlet of the waste line in the machine to a drain and alternatively to a collection chamber.

The preferred method further comprises disconnecting the waste hose and the treatment hose from the machine and disposing of the waste hose, the treatment hose and the speculum, connecting a flushing hose to the waste line in the machine and flushing the waste line.

The preferred method further comprises connecting a distal -10- end of the flushing hose to a connector on the waste line for receiving the waste hose and relatively permanently connecting a proximal end of the flushing hose to the machine.

Preferably, the method further comprises supplying sterilization fluid to the flushing line.

The preferred method further comprises disconnecting the distal end of the flushing hose from the waste line connector and connecting a new disposable waste hose to the waste line connector and repeating the steps of the method.

The above and further objects and features of the invention are apparent in the disclosure which is the above and ongoing specification and claims and the drawings.

Brief Description of the Drawings

Figure 1 is a perspective view of the speculum assembly of the present invention showing the various features thereof.

Figure 2 is an enlarged side view of the speculum assembly which is partially broken away to show the various features thereof.

Figure 3 is an enlarged fragmentary sectional view showing the fixed attachment of the waste removal and the fluid input tubes to the speculum body.

Figure 4 is a detail of a disposable speculum with a disposable obturator inserted therein.

Figure 5 is a detail of a disposable speculum with a dissolvable multiple suppository-type obturator mounted thereon.

Figure 6 is a detail of a mold for forming a seamless speculum.

Figure 7 is a detail of a machine constructed according to the present invention.

Figure 8 is a rear view of the machine shown in Figure 7.

Figure 9 is a detail of a flushing hose.

Figure 10 is a detail of a two-way valve which opens and closes the waste line.

Figure 11 is a detail of a quick-connect distal end of a flushing hose.

Figure 12 is a detail of the connection of a proximal end of a waste hose.

Figure 13 is a detail of a dispensing pump connected between a sterilization fluid reservoir and a flushing line. .. .

-12- Figure 14 is a detail of an alternate form of metering device for metering sterilization fluid into a flushing line.

Figure 15 is a detail of a preferred form of three-way valve for the waste line in the machine.

Figure 16 is an internal detail of a preferred three-way valve.

Figure 17 is a detail of the connection between the three- way valve and a collector.

Figure 18 is a detail of a bracket mounted adjacent a transparent section of the waste line in the machine.

Figure 19 is a detail of a frame for attaching to the bracket shown in Figure 18.

Figures 20, 21 and 22 are details of elements of the frame shown in Figure 19.

Figure 23 is a detail of a preferred form of the invention in which medicators are provided for adding treatment medication to the treatment fluid.

Figure 24 is a detail of a portable machine with waste storage.

Figure 25 is a detail of a waste storage tank.

Figure 26 is a detail of a compact or home-type unit.

Figure 27 is a detail of a speculum used in a child or home unit .

Figure 28 is a detail of a hose of smaller speculum.

Figures 29, 30, and 31 are details of flushing hose connections.

Figures 32, 33, and 34 are details of flushing systems used in compact machines. -13- Figure 35 is a detail of a sterilizing system.

Figure 36 is a detail of modified water flow lines.

-14- DETAILED DESCRIPTION OF THE DRAWINGS

Referring more particularly to the drawings, a speculum assembly 10 includes a speculum body 12, a waste removal hose 14, and a treatment fluid input hose 16.

The speculum body 12, which may be molded or otherwise formed of a suitable synthetic resin, such as polypropylene, defines an elongated cylindrical portion 17 with a bore 18 extending axially therethrough. One end 20 of the cylindrical portion 17 may be defined as the insertion end of the speculum body, with that end being rounded as shown to facilitate insertion of the end 20 of the speculum body into the rectum of a patient in the usual and well-known manner. Such a rounded configuration of the insertion end 20 of the speculum body eliminates the need for an obturator. The opposite end 22 of the cylindrical portion 17 which may be defined as the waste removal end, has the waste removal hose 14 mounted thereon, as will hereinafter be described in detail.

The speculum body 12 further includes an injector boss 24 which may be formed integrally with the cylindrical portion 17 or suitably attached thereto so as to be proximate the waste removal end 22 thereof. The injector boss 24 is of cylindrical configuration defining an axial passage 26, with an extending end 27 to which the treatment fluid input hose 16 is affixed as will hereinafter be described. The axial passage 26 of the injector boss 24 is in communication with the axial bore 18 of the elongated cylindrical protion 17 and the boss 24 extends laterally therefrom. The boss 24 may be disposed to extend at any convenient angle which maybe as great as 90 degrees. However, it is preferred that the injector boss 24 extends at an acute angle, such as than shown, with the angle being included between the boss 24 and the waste removal end 22 of the speculum body.

As hereinbefore mentioned, the speculum body 12 is configured to eliminate the need for the use of an obturator. As a result of this, access to the waste removal end 22 of the speculum body for insertion and removal of the obturator is not needed. Therefore, the treatment fluid input hose 16 and the waste removal hose 14 may both be fixedly attached to the speculum body, with, for example, a suitable adhesive 28 as shown in Figure 3.

The treatment fluid input hose 16 is for connection to the colonic lavage apparatus (not shown) such as of the type disclosed in the hereinbefore mentioned U.S. Patent No. 4,190,059. The colonic lavage apparatus directs warm water, or the like, through the input hose 16 at controlled pressures and temperatures, and may mix oxygen or other medicinal substances therewith. After such treatment fluids have been introduced by the speculum body 12 into the patient, dislodged matter will return through the axial core 18 of the speculum body 12, and is carried away by means of the waste removal hose 14. In most cases, the waste removal hose 14 is connected to the colonic lavage apparatus so that the waste matter may be visually analyzed and specimens taken for laboratory analysis if warranted.

As can be readily uknderstood from the above description and from the drawings, the speculum apparatus 10 of the present invention permits administration of colon therapy in a simple and convenient manner. The simplicity of the speculum assembly allows simplified attachment to an associated colonic lavage apparatus and simplified usage thereby reducing the risk of error in treatment. Additionally, the simplicity of the speculum assembly 10 results in a significant savings in manufacturing costs which makes it economically feasible to dispose of the entire assembly after a single use, thus eliminating the possibility of patient contamination and eliminating the cleaning and sanitizing operations.

As shown in Figure 4, an obturator 30 may be provided for use with the speculum 10. A distal end 32 of the obturator extends from the lumen 18 to beyond the distal end 20. A flat handle 34 abuts proximal end 22 so that the obturator may be withdrawn through lumen 18 after the speculum has been installed. After the obturator 30 is removed, the distal end of a waste hose is attached to the proximal end 22 of the obturator 10.

As shown in Figure 5, the obturator may be replaced by a cone-shaped dissolvable, meltable suppository-like obturator 38 with a cylindrical proximal end 39 which holds the obturator in the opening of distal end 20 of the speculum.

As shown in Figure 6, the preferred speculum is constructed without a seam in the entire distal portion. Mold 40 in which the seamless speculum is constructed has a first outer member 42 with a hole forming cylinder 44 extending upward from cavity 46 which has outwardly and upwardly sloped walls. The upper portion fo the mold is formed in two identical semicricular halves 48 -17- which are hinged at 49. One of the halves 48 may be permanently joined or formed from the same block as lower half 42. Cores 50 and 52 are insertable in the mold to form the smooth insides of the speculum and boss, respectively.

The seamless construction is particularly important to avoid any seams in the insert area of the speculum which may tend to scrape or cut tissues.

Referring to Figure 7, the preferred machine is generally indicated with the numeral 54. The machine is about six to eight inches longer than the previously existing machine which is described in patent 4,190,059. The machine has an enclosure 56 which supports a timer 58, a pressure guage 60 and a temperature gauge 62 and oxygen pressure gauge 64 and an oxygen control 66. A water temperature control 68 adjusts the mixture of hot and cold water from separate supplies and controls the temperature of the output. A water pressure control valve 70 shuts off the water and controls the output pressure. In a preferred embodiment of the invention, the fluid treatment tube 72 which conducts the water and the fluid treatment tube 74 which conducts the oxygen join in a T-connector 76. The oxygen line may have a conventional surgical clamp 78 to prevent flow of fluid through the lines. In the preferred form of the invention the connector 76 is a "Y" connector which leads from fluid lines 72 and 74 to a common fluid line 80 which is in turn connected to the boss 24 on the speculum 10. The speculum 10, the common fluid treatment hose 80 and the waste hose 82 are all disposable as a unit.

The proximal end 84 of the waste hose 82 is connected to a connector 86 on the machine which leads to the waste line 88 in -18- the machine. A valve 90 opens and closes the inlet end of the waste line.

The waste line 88 has a transparent viewing section 92 which is visible through a window 94 in the face of the machine 54.

A flushing hose 96 has a proximal end 98 permanently connected to a connector 100 on a flushing line 102. A three-way valve 104 supplies water from line 106 to the flushing line 102 or to the water treatment line 108 to which water tube 72 is ultimately connected.

Hot and cold water input lines 110 and 112 are connected to the mixing valve 68. Water at the desired temperature flows to the pressure control valve 70 and then fco the preset water presure limiting valve 114 which limits output pressure at two pounds per square inch. Water then flows to the temperature gauge 62 and then to the water supply line 106. The oxygen supply line 116 is connected from a fixed oxygen supply to the oxygen control valve 66.

In the preferred embodiment of the invention, a reservoir 120 for sterilizing the solution is provided at the top of the machine. The reservoir connects with the flushing line 102 through a metering means 122.

The flushing water from the flushing line 102 flows through the flushing hose 96 to its distal end 124, as shown in Figure 9, which is ^"connected with a quick-connect sleeve 126 to connector 86. Valve 90, as shown in Figure 10, remains in the open position during the connection of the flushing hose 96 to the connector 86.

The preferred form of the quick-connect swagelock 126 is . ..

-19- shown in Figure 11. The distal end 124 of the flushing hose 96 has a rotatable internally threaded sleeve 128 with a collar 130 which engages a ferrule 132 which seals against surface 134 of the externally threaded collar 136 on the swagelock 126. The swagelock has a body 138. with a groove 140 which engaes a projection 142 on the connector 86. The quick-connect device 126 is connected with the connector 86 simply by pushing the device

126 on the connector whereupon the groove 140 engaes with the projection 142 and holds the flushing hose in tightly assembled readily releasable connection with the connector 86.

As shown in Figure 12, when flushing and sterilizing is completed, connector 86 receives the proximal end 84 of the waste hose 82. A clamp 144 may be provided when necessary to ensure a tight fit between the proximal end 84 and the connector 86.

Referring to Figure 13, after the distal end of the flushing hose has been connected tothe connector 86, valve 104 is turned to connect the water supply to the flushing line 102 and flushing water is delivered through the flushing hose to the waste line within the machine. After a period of flushing with clear water, dispenser 122 is operated to dispense sterilization fluid through pump 144 by operating plunger 146. Sterilization fluid is then supplied from the reservoir 120 into the flushing line 102 and then into the waste line 88 within the machine.

In one preferred embodiment of the invention the dispensing means 122 incorporates a syphon from flushing line 102 to reservoir 120 which syphons sterilization liquid from reservoir 120 into the flushing line 102 as water flows therethrough. The use of a commercially available syphon ensure a continuous -20- precise mixture of the sterilization liquid with the water flowing through the flushing line.

As shown in Figure 14, reservoir 120 has a ball valve 148 which is dislodged upward by water pressure flowing through line 150.

Water flowing through line 102 and thus forced into tube 150 lifts ball 148 and permits sterilization liquid from reservoir 120 to be entrained in line 152 and thus to be drawn into water flowing through the flushing line 102 and flushing hose 96.

Preferred three-way ball valves 154 are shown in Figures 15 and 16. The preferred ball valve may be used as the water directing valve 104. An enlarged version of the preferred ball valve may be used as the three-way valve 156 in the waste line 88 in machine 54.

In the preferred embodiment as shown in Figure 17, the three-way ball valve 156 conducts waste from waste line 88 within the machine to either the drain line 158 or to the collection system generally indicated by the numeral 160.

In one preferred form of the invention, the entire collection system 160 is connected to fill line 162 by a snapoff connector 164. The cover 166 has a vertical vent 168. Container cup 170 is secured to the cover by threads 172. Instead of snapping off the entire collector 160 form the fill line 162, the cup 170 may be removed from the cover 166 which remains attached ^' to the fill line 162. In the preferred form of the invention as shown, the three-way valve 156' is mounted close to the transparent section 92 of the waste line 88 so that the valve may be turned to direct fluid into the collector when specimens are -21- seen moving through the transparent portion 92. It is intended that only small specimen samples be diverted into the collector.

In one preferred embodiment of the invention as shown in Figure 18, a bracket 174 is mounted adjacent the plate 94 which covers the viewing section 92 of the tube. Bracket 174 is channel-shaped with one flange 176 mounted on the face of the machine 54. Horizontally extending sections 178 extend outward from the face of the machine and vertically extending flanges 180 extend inward to capture a fram 182 as shown in Figure 19. The frame 182 has horizontal channel members 184 which are held within the brackets 174 by flanges 180. Openings 186 in the channel members 184 permit horizontal adjustment of cross pieces 188. The vertically extending openings 190 receive mounting bolts for mounting microscopes or television cameras or other viewing, photographing or recording devices.

Figures 20-22 show the frame elements. Spacer blocks 192 shown in Figure 22 offset the vertical members 188 from the channels 184 to permit sliding along the flanges 180 of brackets 174.

Figure 23 shows a mahcine 54 which has brackets 194 to hold disposable medication containers 196 with lines 198 which pas through conventional shutoff clamps and are connected to the fluid input hoses 72.

Figure 24 shows a portable machine 54 mounted on a cart 200 which carries a waste tank 202. The machine 54 shown in Figure 24 may be supplied with hot and cold water form parallel lines or from a single line connected to a bathroom faucet. As an example, the water lines may be conventional water hose type . .

-22- connections or may be push-on water lines. A singel water line may connect the portable device to a fixed mixing faucet. The drain tank 202 shown in Figure 25 has a valved drain line 204 which may be connected to a floor drain or other drain. Drain line 158 receives waste from machine 54. Rinsing spray tips 206 are mounted in walls of the tank and are connected with supply lines 208 and 210 which are connected to faucets. Line 212 leads from a sterilization supply, for example, a siphon metering supply.

Figure 26 shows a home-type unit which has a conventional disposable water supply line 72 and a waste line 82 connected to a disposable speculum 10. An on/off two-way ball valve 90 controls fluid through the waste line 88. A preset temperature control mixing valve and preset water pressure valve control the water input to the water line 7. Alternatively, a manual mixing valve 68 and handset pressure valve 70 may be provided. Timer 58 is desireable.

A reduced size speculum 214 shown in Figure 27 is a seamless speculum intended for use with a home unit.

The seamless insertion end 216 of the speculum tapers from a maximum diameter of 3/4 of an inch at the large end to 18 near the boss to a small 1/2 inch diameter at the small insertion end 220. The wall thickness of the entire speculum is about 1/32 of an inch. The proximal end 222 of the speculum has an inner diameter of about 3/4 of an inch and an outer diameter of about 13/16 of an inch to receive a 3/4 inch waste hose in tightly fitting connection. Boss 224 has a step 226 at its remote end to tightly hold the water supply line. The seamless tapered -23- construction 216 of the device shown in Figure 27 and end structure 220 are important features of the apparatus which make the speculum suitable for use with a home unit. The thin plastic speculum and its connecting hoses are disposable.

The connection of the hoses on speculum 214 is shown in Figure 28.

As shown in Figure 29, a modified form of flushing hose 230 may be used with the home unit. The flushing hose has clamps 232 for connecting to a connector 100 on flushing line 204 in the machine. A quick connect 234 connects the flushing line 230 and connector 86 of waste line 88 in the machine. Valve 90 opens and closes the waste line 88 near the connection 86.

As shown in Figure 30, the quick connector 234 has a spray end 236 which sprays flushing water from hose 230 into the entrance -end of waste line 88 to ensure cleaning and sanitation of the waste line.

The quick connector 234 and spray head 236 are shown in Figure 31 which shows the flushing hose 230. A quick connector 238 may replace the clamp 232 shown in Figure 29.

In the preferred home embodiment of the flushing hose, a sterilization fluid supply line 240 is connected directly to hose 230.

As shown in Figures 32 and 33, the sterilization hose 240 has a clamp 242 which controls the flow of fluid from a disposable cold sterilization pouch 244 which is hung on hook 246 of the arm 248 which is mounted externally on the machine 250.

In the preferred embodiment of the machine as shown in Figures 32, 33 and 34, a single water supply line 252 is employed. When the machine is in use, the water supply line 252 is coupled to fluid treatment hose 254 with a quick connect coupling 256. The waste hose 82 leading from the speculum 214 is connected to the connector 86 on waste line 88 within the machine 250. Flushing hose 230 is stored by connecting the quick connect connectors 234 and 238 with blank holders 256 and 258 on the side of the machine. After the waste hose 82 and the fluid treatment hose 254 have been disconnected from the machine 250, the flushing hose 230 is connected as a short circuit between the water outlet 252 and the waste line connector 86 and a valve in the water line 252 is turned on to flush the waste line 88.

Figures 35 shows the preferred disposable cold sterilization pouch 244 which is hung on hook 246 of the bracket 248 which is attached to the side of the machine 250. Bracket 248 and hook 246 may be used -to suspend a medication pouch with a line which is connected to the treatment line 254 as shown in- igure 32. In the configuration shown in Figure 36, a "y" connector 260 has input from a water line 262 which supplies water at a controlled temperature and low pressure. A cold solution line 264 is connected to the line 260. Clamp 266 controls the flow of fluid through the cold solution line. Water output flow line 268 supplies water to clean the machine and also supplies water to the patient when being treated.

While the invention has been described with reference to specific embodiments, modifications and variations of the invention may be constructed without departing from the scope of the invention.

The scope of the invention is defined in the following claims.

Claims

-25-What is claimed is:

1. A disposable speculum assembly for administration of colonic lavage therapy comprising: a) a speculum body including,

I. an elongated cylindrical portion having an axial bore extending therethrough and having an inserti.on end for insertion into the rectum of a patient and having a waste removal end,

II. an injection boss extending laterally from said cylindrical portion proximate the waste removal end thereof, said injection boss defining an axial passage which is in communication with the axial bore of said cylindrical portion; b) a treatment fluid input hose on the extending end of said injection boss of said speculum body; and c) a waste removal hose on the waste removal end of said cylindrical portion of said speculum body.

2. A disposable speculum assembly as claimed in Claim 1 wherein said treatment fluid input hose is fixedly attached to the extending end of said injection boss of said speculum body.

3. A disposable speculum assembly as claimed in Claim 1 wherein said waste removal hose is fixedly attached to the waste removal end of said cylindrical portion of said speculum body.

4. A disposable speculum assembly as claimed in Claim 1 wherein said treatment fluid input hose is adhesively attached to the extending end of said injection boss and said waste removal hose is adhesively attached to the waste removal end of -26- said elongated cylindrical body.

5. A disposable sp-eculum assembly as claimed in Claim 1 wherein the insertion end of said elongated cylindrical portion of said speculum body is rounded to facilitate rectal insertion.

6. A disposable speculum assembly as claimed in Claim 1 wherein said injection boss extends angularly from said elongated cylindrical body to form an acute included angle between said injection boss and the waste removal end of said elongated cylindrical portion.

7. A disposable speculum assembly as claimed in Claim 1 wherein said speculum body is formed of a synthetic resin.

8. A disposable speculum assembly as claimed in Claim 1 wherein said treatment fluid input hose and said waste removal hose are formed of a synthetic resin.

9. A disposable speculum assembly as claimed in Claim 1 wherein the speculum body, the injection boss and the treatment fluid input hose and the waste removal hose are made of plastic materials.

10. The disposal speculum assembly as claimed in Claim 8 wherein the speculum body is made of a plastic material selected from the group of materials consisting of polypropalene, PET, barex and PVC.

11. The apparatus of Claim 1 further comprising an obturator in the speculum body before the speculum body is attached to the waste removal hose, the obturator having a rounded distal projecting through the insertion end and having an enlarged handle extending across a proximal waste removal end of the cylindrical portion of the speculum body and having a stem interconnecting the handle and the distal end.

12. The apparatus of Claim 1 further comprising a dissolvable, meltable suppository body having a rounded tapered distal end and having a generally cylindrical proximal end for mounting on the insertion end of the speculum body.

13. The apparatus of Claim 1 wherein a portion of the speculum body between the insertion end and the injection boss is seamless.

14. The apparatus of Claim 1 wherein the waste removal hose has a distal end which is connected to the waste removal end of the speculum body and has a proximal end and further comprising a machine connected to the proximal end of the waste removal hose and further comprising injection fluid means connected to a proximal end of the treatment fluid input hose.

15. The apparatus of Claim 14 wherein the machine further comprises a flushing hose having a proximal end permanently connected to the machine and having a distal end connectable to the machine in place of the proximal end of the waste removal hose for flushing the machine when the waste removal hose is removed from the machine.

16. The apparatus of Claim 15 further comprising a waste control valve connected to the machine adjacent the connection for the proximal end of the waste removal hose for selectively closing and opening the connection to permit waste to flow through the machine or to prevent communication of the machine with the hose connection.

17. The apparatus of Claim 15 further comprising a flushing valve connected to the machine near a proximal end of the flushing hose for selectively admitting flushing fluid to the flushing hose.

18. The apparatus of Claim 17 further comprising a flushing fluid reservoir mounted on the machine and means for conducting flushing fluid from the reservoir to a flushing line.

19. The apparatus of Claim 18 wherein the means for conducting comprises a pump connected between the reservoir and the flushing line.

.

20. The apparatus of Claim 19 wherein the pump comprises a hand-operated dispensing pump connected between the reservoir and the flushing line for dispensing a pre-determined amount of cold sterilization solution in the reservoir and to water flowing in the flushing line.

21. The apparatus of Claim 19 wherein the means comprises a metering device connected between the reservoir and the flushing line for automatically metering cold sterilization solution from the reservoir into the flushing water and the flushing line.

22. The apparatus of Claim 21 wherein the distal end of the flushing tube has a quick connector lock mounted for connection to a connector from which a proximal end of the waste removal hose has been removed.

23. The apparatus of Claim 13 further comprising a waste line extending through the machine, the waste line having an input end and an output end, an open and close valve connected to the input end and a three-way valve connected to the output end, a drain line connected to the three-way valve, and a specimen collection line connected to the three-way valve, whereby the three-way valve selectively connects the waste line in the machine with the drain line or the specimen collection line.

24. The apparatus of Claim 23 wherein the drain line connects to the bottom of the machine and wherein the specimen collection line is connected to a side of the machine adjacent the three-way valve which is mounted in the machine.

25. The apparatus of Claim 13 wherein the machine has a transparent viewing section connected to the waste line in the machine and further comprising viewing instrument mounting means connected to the machine adjacent the viewing section for mounting a viewing instrument on the machine.

26. The apparatus of Claim 25 wherein the mounting means comprises a bracket mounted on the machine adjacent the viewing section and a frame connected to the bracket whereby the frame is provided with openings for mounting a viewing device such as a television camera or a microscope.

27. The apparatus of Claim 26 further comprising magnifying means mounted adjacent the viewing section.

28. The colonic lavage apparatus comprising a machine, a the waste removal hose having a distal end which is connected to a waste removal end of a speculum body and a proximal end of the waste removal hose connected to the machine, the machine further comprising injection fluid means connected to a proximal end of a treatment fluid input hose.

29. The apparatus of Claim 28 wherein the machine further comprises a flushing hose having a proximal end permanently connected to the machine and having a distal end connectable to the machine in place of the proximal end of the waste removal hose for flushing the machine when the waste removal hose is removed from the machine.

30. The apparatus of Claim 29 further comprising a waste control valve connected to the machine adjacent the connection for the proximal end of the waste removal hose for selectively closing and opening the connection to permit waste to flow through the machine or to prevent communication of the machine with the hose connection.

31. The apparatus of Claim 29 further comprising a flushing valve connected to the machine near a proximal end of the flushing hose for selectively admitting flushing fluid to the flushing hose.

32. The apparatus of Claim 31 further comprising a flushing fluid reservoir mounted on the machine and means for conducting flushing fluid from the reservoir to a flushing line.

33. The apparatus of Claim 32 wherein the means for conducting comprises a pump connected between the reservoir and the flushing line.

34. The apparatus of Claim 32 wherein the pump comprises a hand-operated dispensing pump connected between the reservoir and the flushing line for dispensing a pre-determined amount of cold sterilization solution in the reservoir and to water flowing in the flushing line.

35. The apparatus of Claim 32 wherein the means comprises a metering device connected between the reservoir and the flushing line for automatically metering cold sterilization solution from the reservoir into the flushing water and the flushing line.

36. The apparatus of Claim 31 wherein the distal end of the flushing tube has a quick connector lock mounted for connection to a connector from which a proximal end of the waste removal hose has been removed.

37. The apparatus of Claim 31 further comprising a waste line extending through the machine, the waste line having an input end and an output end, an open and close valve connected to the input end and a three-way valve connected to the output end, a drain line connected to the three-way valve, and a specimen collector line connected to the three-way valve, whereby the three-way valve selectively connects the waste line in the machine with the drain line in the specimen collection line.

38. The apparatus of Claim 37 wherein the drain line connects to the bottom of the machine and wherein the specimen collector line is connected to a side of the machine adjacent the three-way valve which is mounted in the machine.

39. The apparatus of Claim 28 wherein the machine has a transparent viewing section connected to the waste line in the machine and further comprising viewing instrument mounting means connected to the machine adjacent the viewing section for mounting a viewing instrument on the machine.

40. The apparatus of Claim 39 wherein the mounting means comprises a bracket mounted on the machine adjacent the viewing section and a frame connected to the bracket whereby the frame is provided with openings for mounting a viewing device such as a television camera or a microscope.

41. The apparatus of Claim 39 further comprising magnifying means mounted adjacent the viewing section.

42. The method of colonic lavage comprising controlling temperature of treatment fluid in a machine, connecting a proximal end of a waste hose to a machine, connecting a proximal end of a treatment fluid hose to a machine and connecting a. distal end of the treatment fluid hose to a speculum, inserting an obturator in the speculum, in.stalling the speculum, connecting a distal end of a waste hose to a proximal end of the speculum, introducing treatment fluid through the speculum, opening a waste line in the machine and flowing waste through the machine, closing the waste line outlet and reopening the waste line.

43. The method of claim 42 further comprising turning a three-way valve in an outlet to control outlet of the waste line in the machine to a drain and alternatively to a collection chamber.

44. The method of claim 42 further comprising disconnecting the waste hose and the treatment hose from the machine and disposing of the waste hose, the treatment hose and the speculum, connecting a flushing hose to the waste line in the machine and flushing the waste line.

45. The method of claim 44 further comprising connecting a distal end of the flushing hose to a connector on the waste line for receiving the waste hose and relatively permanently connecting a proximal end of the flushing hose to the machine.

46. The method of claim 45 further comprising supplying sterilization fluid to the flushing line.

47. The method of claim 46 further comprising disconnecting -33- the distal end of the flushing hose from the waste line connector and connecting a new disposable waste hose to the waste line connector and repeating the steps of claim 42.