CA1152833A

CA1152833A - Colon cleansing system and technique

Info

Publication number: CA1152833A
Application number: CA000333163A
Authority: CA
Inventors: Ralph S. Clayton
Original assignee: Individual
Current assignee: Individual
Priority date: 1978-08-28
Filing date: 1979-08-03
Publication date: 1983-08-30
Also published as: GB2041760B; WO1980000414A1; GB2041760A

Abstract

ABSTRACT

According to the present system and technique, with the patient lying on his right side, a soap containing enema solution, preferably with a laxative therein, is introduced into the colon through the anal opening via a suitable tube held in the rectum by an inflated balloon (18), preferably from a bag (11) held above the patient, in a volume, usually sufficient to completely fill the colon all the way to the cecum, usually 1500 cc to 3000 cc in a normal adult. Inflation of the balloon can be accurately controlled by using a calibrated syringe (40), acting through a suitable valve containing conduit (21).
The balloon and tube can be further secured in place with a limiting means (19) on the tube outside of the patient's anal opening and/or with specially made device (60) designed to squeeze the patient's buttocks together.

Description

8;~
.

This invention relates to an improved method and technique for cleansing the colon.

There are of course numerous situations which require emptying the colon of solid fecal material, liquid or gas. Healthy persons could need such a cleansing for any one of a number of reasons including constipation. In addltion it would be required in a number of medical situations including preparation Eor conducting tests, ~preparation for surgery and routine emptying of the colon 10for patients such as paralyzed persons or any person who .
cannot perform this function naturally. Preparation for testing would include essentially emptying of the colon of ~;
-solids, liquid or gas prior to injecting therein a barium ::
enema for visual observation under an x-ray mach1ne. It is preferable to empty the colon for virtually any type of surgery in which an anesthetic is used, even if the surgery does not involve opening up the thoracic cavity or the abdomen si~nce fecal material or gas in the colon exerts a ~pressure on the diaphram, hence imposing limitations~ on the 20ability of the patient to breath, and this in turn can lead to collapse of the lungs, pneumonia, vomiting and other problems. Disabled persons such as fecally incon~tinent persons would include those disabled by age as well as those paralysed below the waist, or disabled for any reason.~

.

Present systems for attempting to cleanse the colon include two basic procedures; first the use of enemas for the lower colon (from the splenic flexure to the anal opening) and second, the use of oral laxatives for clearing out the upper colon (from the splenic flexure to the cecum). The giving of enemas normally includes multiple enemas of less than lOOOcc, normally approximately 500cc each, which, incidently, are often inadequate, while having the patient lay on his or her (referred to generically here-inafter as "his") left side. In practice the limit may be approximately 500cc since above this level the enema solution will tend to leak out of the anal opening around the tube and onto the bed. A single enema of this type is almost never sufficient to cleanse out the entire lower colon so that the nurse or aide is normally given directions to continue giving additional enamas using the same volume of liquid~ i.e. about 500cc, usually until the expelled liquid is "clear". At this time the usefulness of the enema procedure is considered terminated and as noted above any additional waste material within the patient's upper colon is removed by having the patient take laxatives orally and waiting the necessary time until such orally taken laxatives pass completely through the patient's stomach and small intestine, supposedly or with the purpose of cleansing the upper colon including the cecum, the ascending colon, the hepatic flexure, and the transverse colon, urging the solid ~;~33 ::

, , waste material into and hopefully out of the alreadycleansed lower colon. Or the enemas may be given after the laxatives.
:; ' ' Although the above described use of the enema concept, i.e. essentially for cleaning only the patient's lower colon, has been used since time immemorial, such procedure has certain ~ignificant disadvantages. Multiple e;nemas are physically exhausting to the patient. Moreover, they can cause dehydratlon of the patient's body with the ~10 attendant loss of water and electrolytes, thereby upsetting both the moistare and electrlcal balance of the patient's body. This of course can~have severe repercusslons on the~
operation of vital organs including the heart. Further~
:
multiple enemas irrltate the anus and internal linlng of the colon and this can be very dangerous, especially in the case ; of aged~patients~or those with a diseased colon.~ In addi-tion to the physical disadvantages, because of the odors and ~ ;
mess of enemas there are the psychological disadvantages of ~;
:
humiliation and embarrassment. In addition to the physical ;20 and phychological effects on the patient, there are the very considerable monetary disadvantages in this age of sky-rocketing hospital costs. The procedure of giving multiple enemas followed or preceded by the giving of oral laxatives to complete cleansing of the colon will require in virtually all cases at least one additional day in the hospital, with its attendant costs.

~5~3 Hence, there exists a need for a new and improved system and technique for more effectively cleansing the colon.

It is a purpose of the present invention to pro-vide a new system and technique for cleansing the colon.
More particularly, its purpose is to provide a new system and technique so significantly advanced relatlve to pre-viously known procedures that it will permit cleansing of the entire colon from the cecum, lncluding the ascending, 10~ transverse and descending colons~, to the anal opening, in a ; single injection of a cleansing solution.
'-':' The present inventlon is based initially on an analysis of the conventional procedure for giving enemas, with and without oral laxatives, the shortcomings and defects of these procedures, and the~ reasons for such short-comings and defects. In accordance with the conventional enema procedure, the patient is placed on his left~side so that the enema solution can flow "downhill' from the anal opening toward the descending colon located on the left side. This is entirely consistent with the purpose of a conventional enema procedure, which apparently is to cleanse only up to and through the descending colon to the splenic '~' .

`~

flexure. This well recognize limitation of the conventional enema procedure probably resulted because, inker alia, once a sufficient volume of enema solution was introduced to fill the colon up to the splenic flexure, i.e. including the rectum, the sigmoid and the descending colon, the patient could hold no more liquid, and any additional liquid would slmply leak out between the walls of the anal opening and the outer surface of the enema tube. In any event, as .
discussed above, the remaining portions of the colon, the ascending and transverse colon are not ~ cleansed by the conventional enema but are cIeaned by the use of laxatives :;
~ and the like. -: :
Upon analyzing the conventional enama procedure, with and without the use of orally taken laxatives, and upon noting the well recognized limitations thereof, I made several discoveries. First, I ascertained the reasons for `
: ~ ~
~ the well accepted limitations on the conventional enema ~ ;
.
~ ~ procedures and I recognized that whatever reasons histori-:: :
cally supported these limitation, they were not valid. For reasons set forth above, the patient lS placed with his left side down. I recognized that liquid then entering the rectum, sigmoid and descending colon would then reach a barrier at the splenic flexure which could not be crossed.
Beyond the splenic flexure, the liquid would be travelling uphill. But located in the colon beyond the splenic flexure is a body of fecal matter and gas which together form a gas lock opposing the flow of cleansing fluid upwardly into and through the transverse colon. That is, the solid fecal matter and the gas are relatively fixed in place, not easily moved, such that further movement of the enema solu-tion would oppose gravity in two ways, the upward vement of the liquid and the downward movement of the gas. This problem is aggravated by the fact that the liquid entering the descending colon would flow under any gas located there1n, forcing that gas upward into the transverse colon, thus enlarg1ng the body of gas whi~h the llquid would have to cross, opposing gravity, to enter the transverse colon.
Some~ have suggested altering the conventional enema proce~
dure slightly by placing the patient on the ~right side rather than the left side. This did allow some of the enema liquid reaching the splenic flexure to run down the trans-verse colon, possibly entering the~ ascending colon. How-ever, considering the small volume of liquid used in the conventional enema procedures, and absent recognization of my subsequent disco;veries to be discussed ~below, this ~ .
20 alternative did not come close to cleansing the en-tire `;~

colon.
', A further discovery involved an analysis of the actual mechanics of the interaction between the solid fecal matter or "stool" and the anatomy of the colon. A signif-icant problem in cleansing the colon is that the stool and the sticky mucus material within the colon become attached ~ ~ ~4~ ~ 3 to the lining of the colon and must be detached. Recogniz-ing that the colon stretches, whereas the stool and mucus material do not stretch, I recognized that such detachment could be brought about by causing distension of the colon throughout its entire length. I accomplished this dis-tension by introducing into the patient not the the con-ventional volumes of liquid solution but a much greater volume, namely whatever volume is necessary to completely distend the colon and fill all interstlces between the stool material and the colon lining, except of course ~or the volume thereof occupied by gas, all the way from the anal opening to the cecum. I accomplished this by placing the patient on his right side and introducing the necessary quantity of liquid solution into the patient while sealing the anal opening by a balloon device to prevent any portion of this larger quantlty of liquid from leaking out of the anal opening around the exterior of the liquid tube. I found that introducing liquid in this manner worked quite differ-ently from a conventional left side down enema procedure in many respects. Firstly, initially liquid does not cleanse the descending colon as well as the left side down procedure since gases will now have risen to and collected at the ~Itop~ of the descending colon ("top" meaning the uppermost part when the patient is on his right side) and the liquid solution entering the colon will pass beneath these gases.

But when the liquid then reaches the splenic flexure it easily runs down the transverse colon, easily displacing gases therein which further collect in the descending colon. Soon the liquid fills the ascending colon. This, to my knowledge, was the first time that anyone had utilized an enema solution in such a manner as to completely fill the ascending colon. A point is soon reached when the colon is essentially completely full of fecal matter, gases and liquid throuyhout its entire ~length, whereupon it begins to enlarge or "distend", 1.e. stretchj and since it is full throughout its Iength, this stretching will take place completely from one end to the other end, i.e. from the anal opening to the cecum. Such stretching will cause the walls of the colon to detach from the stool and mucus attached thereto which of course do not stretch along with the colon walls.

I have further found that best results are achieved by combining this distention with an agitating washing action, preferably employing mechanical agitation.
This is preferably accomplished by rolling the patient to the left side down position and possihly back to the right side down position, and possibly repeating this procedure several times. This causes the liquid in the ascending and transverse colons partially to flow back through the transverse colon, displacing the gas in the descending colon which now moves back up the transverse colon, the effect of this being to permit the liquid to contact the en'ire inner lining of the colon, while agitating same along the entire inner surface of the colon. Summarizing, the colon is dis~
tended to some extent, causing an initial separation of the colon from the attached mucus and stool material, and in this state the entire inner lining of the colon may be washed and concurrently mechanically agitated. The stool and mucus, thus separated, are more readily capable of being : ~:
expelled.

In carrying out the present invention, I would preferably use a liquid ~solution containing a lubricant, ~10 preferably castile soap. As is kno~wn, castile soap assists in softening and fragmenting the~ skool. The soap also lubricates the fecal matter and the lining,~ thus facilitat-ing expulsion~of the Çecal matter.~What is new, however, is `
that prior to the present invention, the advantages of such -~
a lubricant were realized only with respect to the descend-ing colon, whereas utilizing the pre;sent invention, these advantages are experienced throughout the entire length of i~
the colon. Additionally, the abllity of this lubricant to - :, stimulate contractions of the colon can now be experienced throughout the entire length of the colon, in cooperation with the above described distention of the entire colon, -~
thus for the first time providing means for cooperatively distending and contracting the entire colon, throughout its length, with its attendant increased ability to expel all solid and gaseous material throughout the entire length of the colon.

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"~ ... .

~33 I have further discovered that my new technique is enhanced by including a laxative in the liquid solution, and as a result thereof I have discovered a new way to administer a laxative. Heretofore, either laxatives and/or adequate volumes of water have been taken orally. The delay in gastric emptying and the variable small intestinal transit time and absorption make the results unpredictable and uncontrollable. A laxative can have no effect or can cause violent purging~ result1ng in severe proctitis, and exacerbation of hemorrhoids occurs, and there is a risk of perforating a diseased colon. Moreover, what does arrive at the colon arrives only ~at the cecum. If the patient has hard, impacted fecal mater1al in his trans~verse colon and/or descending colon, the laxative action in the ascending colon ::
can be disadvantageous and indeed extremely dangerous since it can perform its functlon at that location but be insuf-ficient to break the impaction in the downstream areas, ~resuIting only in painful cramping, exhaustive and~ dehydra-:
tion of the patient, not to mention the imbalancing of the patient's electrolytes. Another recently developed tech- -nique has been to place a laxative in a container having 37cc of an aqueous enema solution and to introduce such solution into only the lowest lOcm or so of the colon in-cluding essentially the anal canal and the rectum.

. . .

f~333 A discovery of the present invention is that my technique of completely filling and distending the colon with enema solution can further encompass the inclusion therein of a laxative material, whereby for the first time such laxative material can be uniformely and reliably carried directly to the entire mucosa of the colon from the anal opening to the cecumr uniformly contactlng the mucosa over its entire length as the mucosa distends and separates from the fecal material located therein under the force of the liquid completely filling the colon, thereby avoiding the delays and other disadvantages of orally taken laxa-tives. Never prior to this invention, to my knowledge, has there been any method or procedure for carrying a laxative ingredient directly and uniformly to the entire length of the colon as is accomplished in the manner expressed above.
An additional advantage of applying a laxative to the entire colon in this manner is that if a pool of fluid remains in any segment of the colon, after the first defecation ses-sion, the correct concentration of laxative is present in the fluid and provides a continuous stimulation to that segment of the colon resulting in complete expulsion of the contents of the colon. Contrasting this with the use of a non-laxative liquid solution, if a pool then remains at any location in the colon, since it does not contain laxative to stimulate expulsion, there is thus incomplete expulsion of the contents of the colon.

-~33 Another feature of the present invention is the provision of an enema solution containing both a soap for providing lubricating properties and a laxative ingredient.
One laxative ingredient which I have found -to be advanta-geous for this purpose is a non-soluble substance sold under the trade mark Bisacodyl carried in an aqueous suspension.

' The use of soap and Bisacodyl solution is safer than water enemas since it is more nearly isotonic (the same osmotic pressure as the tissues and hence will not be absorbed) thereb~ a~oiding fluid and electrolyte imbalance risks which occur with respect to w~atèr enemas. The soap and Bisacodyl are much safer than oral laxatives and oral .. ..
purgatives.

; ~ As described above, the present system and technique employs and inflatable balloon at the end of the enema solution tube to hold in the necessary volume of liquid solutlon. Such a balloon has the additional ad-vantage in the present invention of pennitting the patient to relax, thereby relaxing the abdominal wall muscles and allowing greater and more comfortable distension of the colon throughout its length and hence stimulating better contractions. However, such balloons do present certain problems, solutions to which form a part of the present invention. When inflating the balloon there is no way to visually observe the size of the balloon within the ~5~833 `~

' patientc It has been known and documented that in numerows cases a balloon has become overinflated and, especially in the case of a diseased colon, has ruptured the colon, resulting ultimately in the death of the patient. Attempts to limit the amount of air inflated into such a balloon have included a small puffer of a known size and capable of ~a single poff. However, such~devices are unreliable sinc~ they do not take into account the residual air present in a ~ , ~
balloon prior to inflation and they do not measure exactly 10~ the volume of a1r injected. Moreover, at~;best such devices provide only an upper limit, i.e. they do ~not permit com-ple~te control over the~vol;ume of alr in the balloon at all -times.
: .. . .

In accordance with another feature of the present~
nv~ention I have provided a technique for absolutely con~
tro111ng the~ volume of air withln the balloon at al~l times.
Such arrangement includes attaching the conduit which leads : ~ :
; ;to the~balloon to one end of a conventional sy;ringe with callbrated marklngs thereon. The conduit should preferably include a spring loaded one-way valve normally closlng this conduit but opened by the end~of the calibrated syringe when it is attached to the conduit. If the balloon is of the type having residual air therein, then the syringe can be ~-applied and the piston therein withdrawn to completely evacuate the balloon. This of course has the advantage of providing a minimal size of the balloon to facilitate in-~ : .

sertion of the tube and balloon within the patient. The calibrated syringe would then be separated from the conduit ~closing the valve) after which the piston therein would be reset back to its rearwardmost position, after which the calibrated syringe would be reconnected to the conduit, open1n~g the valve, and the piston moved within the syringe by an amount positively known by observlng the calibrated markings, whereby the operator could very closely control and visually observe the precise volume of air delivered to the balloon and therefore the size of the balloon. Indeed, as has not been possible heretofore, with this technique, the operator can increase or decrease the size of a balloon already in a patient by precisely determined amounts, to alleviate pain or otherwise meet changing conditions, all the time having complete knowledge of the volume of air in the balloon and therefore the size of the balloon.

Another characteristic of balloons as have been used heretofore for holding tubes within patients is that they are subjected to asymmetrical and significant forces tending to tilt the balloon and otherwise pull it up into the rectum whereby it will not perform its sealing func-tion. In the past, balloons have been stabilized in place by pulling on the enema tube or by means of a bar, disc or the like located on the tube outside of the patient and exerting a force onthe balloon holding it down into sealing contact with the rectum adjacent the anal canal. However, ~J

:

these bars, discs and the like have tended to be inadequate since they have not in all cases perfectly adapted to dif-ferent size patients. Also, a bar or the like extending essentially fore and aft will not prevent tilting of the balloon about the fore and aft axis of the patient and hence will not completely stabilize the balloon in place. These disadvantages are overcome in accordance with the feature of the present invention whereby a hard or firm oval or c1rcular disc is attached to the tube at a location farther ~10 ~from the balloon then wil;l be des1rable for any given~
patient but arranged such that it can slide in only one direction, namely toward the balloon. ~In combination .:
therewith, the tube can have lnd~icia thereon marking positions for diff;erent size patients, i.e. one for a very - :
thin patientl one for a normal patient and one for a heavy patient. Then after the balloon has been inflated within ;
.
the patient, and pulled down snugly over the lower opening ; ~of the rectum, the disc can be slid toward the balloon, ~stopping at the appropriate marker, whereas it will prevent `
20the balloon from moving up away from the lower opening of the rectum.

As another feature of the invention, the disc can be connected with suitable straps, one in the rear an two in the front, each off center to pass to each side of the genitals, for connection to a waistband or the like on the patient, thereby preventing involuntary expulsion of the balloon and tube. The disc with the straps attached thereby stabilizes the balloon against movement in either direction, i.e. in or out.

A system for carrying out the present method will further include a bag for holding the enema solution and a tube leading from the bag and to which the balIoon would be ::: :
attached for insertion into a patient. The bag should of cour;se~be of a large enough size to hold the desired quan- ; -tity of enema solution which can desirably be as high as 3000cc~ Such~ bags~have~ been used heretofore for barium enemas slnce barlum fllls ~the entire colon.~ However, bags intend;ed for cleanslng the~colon have of course not been of~
;~ ~ this size. The tube leading from the bag to the patient ,.: -; must be of the smaller size conventionally used for enema solutions and not of the much larger type used heretofore ~, :
for~barium enemàs. One reason for~this~is that the thicker;

; ~ barium~tubes are required because of the heavy dénsity of the barlum material. However, enema solutions are es~

~20 sentially aqueous solutions which are much less dense than a ~,;, barium enema. Smaller size tube is required to restri~ct the rate of liquid flow therethrough to an appropriate rate. It has been found for example that too rapid a flow of Iiquid into the colon will tend to distend the colon walls very rapidly, thus causing pain to the patient. It has been found that pain is sensed not by the extent of distention ,. . .

.
:: , of the colon walls, since full distention will merely give a sensation of fullness, not pain, but rather, by the rate of distending, or stretchingO

Another feature of my invention is to provide the liquid tube with a smooth rounded tip with smalI openings on the slde. With such a tube, insertlon lS safer and more comfortable, avoiding injury to the anus or anterior wall of the rectum, or perforation of the rectum wall, as could more likely occur with a flat tip. Also it is less likely that ~10 the side holes would occlude with feces.

Another advantageous feature of the ~ present invention is the limitatlon on the`length of tube~ from the enema solution bag to the patient. Prior enema kits include ; a tube approximately 60 inches or 150cm in length,~which, if fully extended, subjects a patient's rectum to the con-siderable pressure of 150cm of water, which is unnecessary in must ~cases and very dangerous in that it can cause rupture of a weak or diseased colon, and in fact has done so in some documented cases, resulting in the death of the patient. As a safety factor, therefore, I would llmit the length of the tube to approximately 25-30 inches or 60-75cm since this provides an adequate pressure head, without the attendant dangers of too great a head.

-~L~3;~

The balloon used in the present invention should preferably be of a type having a large dimension perpendic-ular to the wall of the tube as compared with its dimension parallel to the axis of the tube. Such a balloon, however, is necessarily of the type having a residual quantity of air in the balloon even in ltS most relaxed condition~ In accordance with the present invention, su;ch a more desirable balloon can be utilized, notwithstanding the residual air, by combining same with the above described calibrated 10syringe and valve arrangement since the latter can be used to completely evacuate even this residual air.

.
A patient will always have an urge to completely expel any device held within his anal opening, such as the tube and balloon. I have successfully prevented such expulslon by varlous means includlng straps attached to the disc as described above. As another advantageous feature of the present colon cleansi~ng system and technique, I have provided a device which causes the patient's buttocks to be squeezed together along the mid-plane and agalnst the 20perineum of the patient and held in that position while the balloon is in place in the patient. In accordance with the present invention, this device is so constructed that it can be applied to the patient after the liquid introduction tube and its balloon have been inserted into the patient and so as not to interfere therewith. In accordance with a pre-ferred arrangement, this device comprises a band which wraps .. , ~.

around the patient and which includes straps at its ends which can be sequentially connected, starting from the bottom and working upwardly.

I'he specific manner of applying the method of the present invention will vary for different situations . .
and different patients. However, briefly summarizing the method of the present invention for a typical patient where-n it is required to cleanse the eDtire~colon, but whereinthe patient has no highly specific problem associated with the colon such as a diseased or weak colon or the like, such a genera~l procedure would be as follows. The bag would flrst of all be filled~ with a suitable volume o~f liquid solution, for example approximately 2000 to 3000 cc of a castile soap aqueous solut~ion having therein approximately 10 to 20mg, or more, of Bisacodyl in aqueous suspension.
This bag~ would also have associated with it a liquid tube leading therefrom with a suitable clamp thereon and at the end thereof a balloon ;adapted to be inflated at a later time withln the patient and an oval disc adapted to be moved up against the patient. The patient would be connected to the conduit leading to the balloon to withdraw residual air, thereby completely collapsing the balloon. Standing in front of the patient, the nurse would then insert the end of the tube and the balloon into the patient's anal opening and the calibrated syringe would be moved a specific amount, as observed on the calibrated markings on the syringe to ~!L15'~8~3 inflate the balloon to a precise predetermined size. The disc located on the tube is slid therealong to secure the tube and balloon in place in the patient. If the patient is of the type which might expel the balloon, straps or the ; device for squeezing the buttocks together and against the , perineum can then be applied if desired, to keep the tube and balloon in place in the patient. The clamp is then opened, permitting the liquid solution to flow through the ~ tube and into the patientO The liquid at this time has a ; 10 sufficient head to flow "uphill" (wlth the patient on its right side) along the rectum and slgmoid and along the descending colon. The liquid then flows downwardly along the transverse colon, displacing upwardly to the descending colon any gases located therein. The liquid then continues its movement along the ascending colon to the cecum. After liquid has reached the cecuTn thereby filling the colon (i.e. filling the interstices in the colon between the pieces of stool, and not taken up by gas in the colon), the next phase is entered, whereby this liquid tends to distend the lining of the colon which has the capability of stretch ing, said action thereby separating the lining from the fecal material located therein by shearing forces since the fecal material does not stretch. If the rate of flow of the liquid into and through the colon is ]cept at a relatively slow rate, the distention of the colon will not be too fast, and consequently the patient will feel only a sensation of fullness, but not pain. This separation of the colon from - 20 ~

. . . .

~5~33 the fecal material therein tends to expose the surface of the mucosa to the liquid which has been introduced. Hence the laxative ingredient included therein can now reach the entire lining of the colon in a uniform manner not possible wlth any otùer procedure of which I am aware. The liquid is held in the patient for a short period of time. Although the emphasis of my method is "right side down" during ~insertlon, durlng the holding period the patient will preferably be rolled several times to a ~left side down .:
position to detach stool and mucus and to permit the liquid to move ~nto those portions of the~descending colon where gases may still be located to permit the liquid solution,~
, including the laxative ingredient therein, to contact the~
mucosa in those portions. The patient is then taken to a , ~ suitable receptacle, the balloon is deflated, any straps or ~
: ~ :
devices squeezlng the buttocks together are released, the tube is removed and the patient at this time can~ expel the entire contents of the colon including all of the liquid and `
-, all of the;solid material and gases therein. ~
: :, ~ `
As noted in the preceding ~paragraph I have found ~`
it advantageous for the nurse to stand in front of the patient as contrasted to the conventional technique of standing behind the patient. In front the nurse can observe the patient's reactions more accurately and communicate with the patient more effectively than if standing behind the patient. Also the nurse, standing in front, need not lose 13~

contact with the patient when assistiny the patient off of the bed and to the potty chair or toilet. Otherwise, if standing behind the patient, the nurse would have to leave the patient's side and move around the foot of the bed to the other side to assist the patient. Finally it is much safer for the nurse to stand in front of the patient as it eliminates the possibility of the nurse being soiled by feces as could occur if the nurse were standing behind the patient and the patient involuntarily expelled the balloon.

Tests to date lndicate that the single procedure is effective to remove more than 95% of the fecal material and gas in over 95% of the cases thereof tested If removal of more nearlv 100% of the fecal material is desired for any reason, the entire procedure can be quickly and easily repeated as often as necessary~ The present concept of cleansing the entire colon in a single procedure has the advantages, as compared to the conventional enema, of avoid-ing the risks, humiliation, embarrassment and the indignity of multiple enemas and the humiliation, embarrassment and indignity of the unpredictable results of laxatives given orally. Moreover, precisely because the entire colon is cleansed, leaving no feces in the ascending or transverse colons, fecal impaction is prevented, as are the dangers of repeated digital fragmentation of impacted feces, and its associated humiliation and embarrassment. Also eliminated is the humiliation, embarrassment and indignity of accidental ~ i;~33 bed soiling (a) due to leakage of the enema liquid during the conventional enema procedure, this being prevented by the use of a balloon, and (b) due to subsequent involuntary expulsion of fecal matter, especially in the case of fecally incontinent patients, this being prevented by the fact that the entire colon was cleansed in the first place. Moreover, the risk of infection from soiling the patient, the bed linen and the nurse with feces is minimized. ~dditionally there are the significant cost savings since a colon can be completely cleansed in a single hour rather than by an 18 hour overnight program. Less personnel time and less equip-ment are required. The costs of changing and laundering soiled bed linen and bathing the patient are virtually eliminated~

Hence, it is an object of the present invention to provide a new and improved system and technique for cleans-ing the colon wherein the entire colon can be cleansed in a single operation.

It is another object of this invention to provide a new material as a vehicle and a new system for carrying a laxative ingredient uniformly to the entire ~ining of the colon.

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3~

It is another object of this invention to provide a new system and method for safely inflating a balloon adapted to hold a tube in the anal opening oE a patientO

It is another object of this invention to provlde a new device for positively holding a tube and its in-flatable balloon withln a patient by moving the patient's buttocks together and against the patient's perineum.

It is still another object of this invention to . :.:
provide a new and novel system for carrying out the above ob~ects, w7hich system is new, and whlch includes a number of separate~integers whi~ch~work with each other, many of which~
integers are them elves new.

These and other objects and advantages of the present invention wlll become apparent from the detailed ~ ;
description to follow.

This invention therefore provides a method of cleansing the entire colon of a patient which comprises the steps of inserting into the patient rectum through the anal opening a tube of appropriate inside diameter for the flow therethrough of an aqueous liquid solution and having there-on near the end thereof an inflatable balloon in the col-lapsed condition, inflating the balloon sufficiently to seal the anal canal around the tube by injecting fluid into the J~

balloon by the use of an inflating device located outside of the patient and leading via a conduit to the balloon, plac-ing the patient on the patient's right side and with the patient thus positioned on the right side introducing into the patient through the tube an aqueous lubricant containing liquid solation, continuing to introduce sald liquid solu-tlon until the solution flows through the descending colon, the~transverse colon and the ascending colon to the cecum, applying a volume o said~liquid solutlon~sufficient to ~;10~ substantially fill the ~enti~re colon, exce~pt f~or the~ space already taken up therein by fecal matter and gases, dis--tending the wall of colon throughout i~ts leng~th ~and thus loosenlng~the~;fecal matter throughout the entlre length of the colon~from ~the ~rectum to and lncludlng ~the ascending~
colon. The ~olume of the liquid solution is held in the patlent for a llmlted period of tlme~to~ permit Interactlon;
of the liquid solution with fecal matter and wall of the ~colon over the entire length Of the~ colon. The balloon has then~defleted and the tube and balloon are removed to permit the patlent to~expel the liquld solution and fecal matter from substantlally the full length of the patient's colon.
Preferably the lubricant is soap and the liquid solution contains a laxative.

The invention also provides a method of preparing a patient for cleansing the entire colon of the patient which comprises the step of placing the patient on the ~5Z~33;3~

patient's right side, placing in the patient's anal opening a tube sealed about its outer periphery and within the ;
patient rectum to prevent the flow of liquid therearound, outside of the tube, and introducing through the tube and into the colon a soap containing aqueous liquid solution , having a non-soluble laxative in suspension therein, and continuing to introduce said liquid solution until the liquid flows completely through the colon through the cecum ~;~ in a volume sufficient to substantially fill the colon ~10 except for the space already taken up therein by fecal matter and gases and distendlng the wall of the colon throughout its length. The~ introduced volume of l1quid is ;held~ in the patient for a limited~perlod of time and the patient is moved in order to move the liquid solution within the colon to cause;1nteractlon of the liquid solution and laxative contained therein with the fecal matter and with the wall of the colon over the entire length of the colon.
As a final step in the method one permits removal of the liquid solution and fecal matter from substantially the full :: :
length of a patient'~s colon.

In accordance with a different aspect of this invention, there is provided a liquid solution for cleaning out the colon comprising castile soap in an aqueous solution with Bisacodyl held in suspension therein. Preferably the enema solution includes at least 20cc of castile soap in a solution of 1500cc. -~

, .

: , ~\ ~
~S;~33;~ ~ ~

This invention also provides a method of preparing a patient for the passage of a liquid through a tube located in the patient's anal canal which comprises the steps of taking a tube adapted to insertion into a patient's anal opening with an inflatable balloon attached thereto, said inflatable balloon attachable via a conduit having a valve therein to a piston type syringe, with calibrated markings thereon showing the volume in the syringe displaces by the piston into the balloon, inserting the tube into the pa~
tient's anal opening with the balloon positioned at the rectum just inside the anal canal, inflating the balloon through the valve and ~conduit by a certain ascertainable volume by moving the piston of the piston syringe a length corresponding to said ascertainable amount by observing the calibrated ~markings on the syringe as the piston moves therein, and~closing the valve to retain said certain ascertainable volume in the balloon to thereby retain the tube in the patient's rectumD

~: :
This invention further provldes a system for cleansing the entire colon of the patient comprising a tube having an inside diameter of a size appropriate for the passage therethrough of an aqueous solution, a balloon attached to the exterior of the tube near said one end thereof, said balloon positioned to be located and inflated in the patient's rectum when said one end of the tube is passed through the patient's anal opening, so as to seal the "~f~'~

~ 52~33 rectum to prevent fluid from passing through the anal open- :
ing outside of the tube, a condult leading from the balloon -for inflating the balloon when the balloon is located in the :~ patient, a normally closed spring biased valve in said :
conduit near the end thereof remote from the balloon, a piston and cylinder syringe having calibrated markings thereon indicating the volume displaced by the piston within . -~: the syringe, the syringe being insertable in said conduit :
and having means for opening the valve when~inserted therein ~ .
to permit inflation and deflation of the balloon through the ;~ 10 valve and conduit, by operation of the piston in:one direc- `~tion or the other, respectively, so that the amount of fluid inflated into the balloon can be visually and directly ~ascertalned by observ1ng the callbrated marklngs on~the ~ .
piston and cylinder syringe, as the piston moves relative to ;the~cylinder, and a bag hav~ing:~a: capaclty of at least~
: 1500cc,~said bag connected to the said other end of the tube ~: wlth its lnslde be:ing in fluid communication with the in-: terior of:the said tube. ~ :::

Also part of this invention is a device for squeezing a person's buttocks together to hold a tube in : place in the patient's anal openlng, comprising an elongated band shaped to wrap around a person's mid-section including the lower abdomen in the front, the hips on the side and the buttocks on the back, the central section of a band adapted ' , `:\

against the front of a person while the end of the band are adapted to overlap in the back of a person such that when the device is pulled tight and secured, the band pulls the person's buttocks together, each said end of the band formed as a plurality of straps. Each said strap including a first connecting means at the outer end thereof, said band further includiny, on both sides of the central section, second connecting means positioned to cooperate with the first connecting means of the end of the strap farthest therefrom to form a connection therewith, whereby with the band wrapped around the person generally opposed straps are pulled to tightened the band on the person and then its first ~connecting means is connected to a corresponding second connecting means to tightened the band and; hold a , person buttocks together. Preferably the connecting means is of a type having a hook pad to felt pad connection such as that sold nn~eL the t-^ade~ mark ~elcro, wlth ~l~e of the first or second connecting means being the felt pad of and the other be~ing the hook pad ther~eof. It is also preferred to provide the central section of the band with a quick release connection which preferably is also using a Velcro connection as a mean of connection.

The invention further provides a device for squeezing toyether and against the perineum, the buttocks of a patient, comprising a band adapted to wrap around the mid-section of the front of a patient, straps extending out-wardly beyond both ends of the band, each strap having connecting means thereon, a further connecting means on the f ~3.SZ~;~3 ,; ,:

ends of the band, when such further connecting means posi-tioned opposite each strap for cooperating with the con- - -necting means on that strap, the strap and further con-necting means at each end alternating with each other along that end, anù the straps at one end being staggered relative to the straps at the other end, whereby in applying the device to a patient, the straps may be alternatively tightened and connected in sequence, first from one side and then from the other side.

10Finally the present invention provide a method ., for holding~a tube securally in a person~'s anal opening ~which comprises the steps of inserting into a person's anal opening a tube having a ~balloon near the end~ thereof and then inflating the balloon when it is inside a person's anal openlng to position it therein, and preventlng removal of the~balloon by pushing the person's buttocks together, said pushlng includ1ng wrapplng a band a~round the person's mid~
section including the abdomen, the hips and the~buttocks by placing the central section of a device against the person's abdomen and pulling the ends thereof~tight as the end over-lapped at the person's buttocks to pull the person's buttocks together to hold the tube tightly in place.

There follows a detailed description of preferred embodiments of the invention to be read together with the accompanying drawings wherein:

~SZ~33 Figure 1 is a schematic view showing certain elements arranged for use in accordance with the system and method of the present invention.

Figure 2 is an enlarged view of a portion of Figure 1, with certain elements shown in cross-section.

Figure 3 is a sectional view taken along line 3-3 of Figure 2.

, :
Figure 4 is an enlarged view showing another portion of Figure 1 with certain portlons thereof shown in :::
cross-section.

Figures 5A, 5B and 5C are enlarged views of the balloon of Figures 1, 3 but showing different inflated positions thereof.

Figure 6 illustrates a device laid out flat to be used for squeezing together the patient's buttocks.

Figure 7 illustrates the device of Figure 6, on a patient seen from the rear.

Figure 8 illustrates the device of Figure 6, on a patient, and viewed from the left side.

~S~2~33 Figures 9A through 9E are schematic drawings of a human colon and illustrating the functioning thereof under different conditions.

, Figure 9A illustrates the colon filled with solid waste~material and gases prior to any cleansing.

Figure 9B lllustrates the funct~ionning of a colon using a conventional enema procedure.

Figures 9C through 9E illustrate the functionning of a colon ~when ~cleansed in accordance with the present ~ inventlon.

: : : : : :
There follows a detailed description of the preferred method~ and system of the present inventlon. When~
ever, in~this discussion~, reference is made to the drawings, e elements are represented by like numerals throughout the several views.

Referring now to Figures 1 through 5, there is shown and described those elements which comprise the system or apparatus for carrying out my new colon cleansing tech-nique.
.~ ,' The system 10 would include a solution bag 11 for storage of cleansing solution. The bag would be of a ~,'~' ;

~ .

~S~ 3 conventional character and in fack can be of the type now sold by Bard, except that it would have a larger volume, for example a volume of over 2000cc, and preferably 2500 or 3000cc. Such a bag would be provided with graduations 12 and an opening 13 at the upper end, such as an unscrewable watertight cap for introducing liquid into the bag. A
suitable aperture 14 may be provided at the very top for hanging the bag on a hook in use.

At its lower end, the bag 11 would include a connection 15 to a tube 16 for delivering the liquid solu-tion to the patient. The tube would include a suitable clamp 25 thereon. It is important that the tube 16 be of a type and size appropriate for delivering an aqueous liquid solution to the patlent, as contrasted with other types of tubes which are larger and stiffer for delivering thicker liquids such as barium enemas. One suitable tube for this purpose has an inside diameter of 3/16 of an inch and an outside diameter o~ 1/4 inch, leaving a thickness of 1/16 of an inch. The thickness may preferably vary in the range between 1/32 of an inch and 1/16 of an inch There are several reasons for preferring, if not requiring a tube of a suitable type. Firstly, if it is preferred to use a tube which extends more than a minimal distance beyond the bal-loon (such as balloon 18 to be described in greater detail below), then that end of the tube will engage the inside wall of the rectum as it is inserted therein, and unless ~.5~333 :

it is soft enough and thin enough to bend up within the rectum, the tube may cause injury to the wall of the rectum and pain or injury to the prostate (in a male) or cervix (in a female) located immediately therebeyond. Secondly, a small inside diameter tube is required for the proper rate of liquid flow. Pa1n is caused ln the~ patient not by the insertion of a large quantity~ of liquid (this will only provide a sensation of fullness)~but by a rapid introduction of such liquid which results In excessively rapid distension and stretching of the lining and wall of the colvn. This is -:
especially important in cases where there is~an obstruction or a diseased colon Which might be friable and tear easily A torn colon can result in infection and death.

:: .
Another advantageous characteristic of the tube 16 is~ its length which-h~retofore has been provlded in most ~;
enema kits approximately 60 inches long, which length is .
unnecessary and dangerous in that it makes posslble the placing of the bag a full 60 inches above the patient, thus providing a pressure or head equal to 60 inches of water ::
felt by the patient. This is excessive, unnecessary, and can cause rupture of the colon, especially in the case of an aged or diseased colon. Hence, a feature of the present invention is that the tube 16 is limited to approximately 30 inches or 60-75cm, thereby acting as a safety measure preventing the bag from being placed at too great a height above the patient.

: :: .
: , The end of the tube remote from the bag is shown in Figure 1 and associated elements thereof are shown in greater detail in Figures 2 and 3. The remote end 17 is preferably a solid rounded end with a pair of openings 17a and 17b on the side thereof. The smooth rounded tip is , safer to insert past the deIicate anal tissues and is less kely to damage the anterior (front) wall of the rectum.
~;~ ALso, the side holes on the tip are less likely to occlude with fecal matter. Referring to these figures, near to remote end 17 of the tube 16, there is provided an inflat-able balloon 18, which balloon is deflated completely during insertion, and then inflated after being inserted, said balloon located at the lower end of the rectum thereby hold-ing the li~uid in the colon. In order to prevent injury to the patient, it is important that the amount of air deliv-:
~; ered to the balloon 18 be carefully controlled. One way to accomplisb this lS to make the ba~lloon out of a flexible non-stretchable material, thereby limiting its maximum size. This arrangement has the advantage of absolutely limiting the maximum size of the balloon, thereby positively preventing overinflation. However, such embodiment does not permit inflation of the balloon by varying amounts. Accord-ingly, to provide such absolute control oE balloon 18 by different amounts, the conduit 21 deading to the balloon 18 is connected via a valve 22 to a piston and cylinder type syringe 23, to be described in greater detail below.

:

5;~;~

Referring to Figures 2 and 3, there is also shown a limiting means 19 in the form of a disc. This disc 19 may be necessary for at least two reasons. Firstly, in practice the end 17 of the tube and the balloon 18 may be subjected to varying asymmetrical forces tending to tilt the balloon, pulling lt out of sealing contact with the walls of the rectum at the lower end thereof. Hence, to stabilize the balloon and maintain it in place to assure a good seal prevènting fluids from passlng between the exterior of the balloon and the walls o the~rectum~and~anal canal, the disc 19 would be movea~up against the exterlor~of the patient's anal opening and pressed thereagainst. Contrary to some : .
previous limitlng~means used heretofore, I~have found that stabilization of the balloon 18 is best achieved by the use of a generally circular, prefera~ly oval, disc shape limit~
ng~ means. A feature of the present Inventi~on~is a con-struction whereby the disc 19 can be moved in one direction only and positively prevented against movement in the other direction, so that lt can for example be slid to different positions, indicated as A, B and C at the graduations 20 in Figure 2, to represent a heavy person, a normal person, and a thin personj respectively, the disc being so constructed ; that after moved to such positions, it cannot be moved back. While many different constructions can achieve this purpose, such as ridges with one sloped side and one narrow side, in the drawings I have shown attached to the disc 19 a sleeve 24 for example a flexible plastic material extending , "

. ~

~s~

for a distance relatively large as compared with the thick ness of disc 19, such that movement of disc 19 to the right would be possible, but movement of the disc to the left would exert on the sleeve 24 frictional forces too great to be overcome with reasonable or usual forces.

To positively prevent expulsion of the tube and balloon 18, loops 30, 30a and 30b could be provided on the disc 19, each having attached thereto suitable straps 31, 31a and 31b respectively, to be attached to a suitable waistband on the patient.

Referring to Figures 2 and 5, the balloon 18 is preferably of such a shape that when inflated it extends outwardly for a relatively large distance as compared for example to its dimension parallel to the axis of tube 16.
There are two reasons for this. Firstly, such a shape minimizes the distance which the balloon, in its collapsed condition, must pass up into the anal canal before it is properly inserted. Secondly, such a balloon would provide a smaller volume, and hence a smaller surface area against which can act those muscles of the patient tending to expel the device. One disadvantage of such a balloon, however, is that in its natural, completely relaxed state it would tend to include residual air therein which should preferably be removed during insertion of the tube and balloon. However, cornplete evacuation of even this type of balloon is possible PD. .

with the use of a piston and cylinder syringe control device and valve to be described below.

:
Referrlng to Flgure 4, the end of the conduit 21 includes a one-way valve 22 having a valve element 51 spring biased by a spring 54 into the closed condition wherein a surface 52 thereof firmly seats against a valve seat 53.
The spring 54 rests at its other end against an open cage~
55. A calibrated piston and cylinder syringe is provided for cooperating therewith. This device includes a cylinder 1040 having a plston rod 41 extendlng therethrough with a piston 42 at the end thereof, which piston sealingly engages , the~inside wall of cylinder~ 40. On its~si~dej the cylinder ncludes calibrated markings i9 for positlvely indicating the precise volume of air which has been introduced into and/or removed from the~balloon 18 via conduit 21. Cylinder~
40~includes a finger grip portion 48 and the piston rod 41 termlnate~s at its outer end at a thumb push 47. In a manner~
which is known with respect to syringes, the operator would engage the portion 47 with the thumb and hold the finger 20 grip portions 48 with the first two fingers of that hand.
At its other end, the cylinder 40 includes a sealing flange 43 and the end would be closed by a structure including a raised central boss 44 with a fluid opening 45 passing ~ -therethrough. In practice the end of the syringe would be ; - 38 -~L152~3 ~

engaged with the end of the conduit 21, whereby end 56 of the conduit would pass into the annular recess 46 between the boss 44 and the flange 43, thereby providing an air tight seal while the boss 44 engaged element 51, pushing it to the right, and unseating the valve. With this arrange-ment, the conduit 21 would then be closed at all times except when engaged by the syringe 23, at which time the valve would be opened for air flow in either direction.

:The provision of a calibrated piston and cylinder syringe, and the use thereof for inflating a balloon ln the present invention provides significant advantages. It permits the operator to accurately control the precise size of the balloon, which control is not otherwise possible since the balloon is not visible during the filling proce-dure. Heretofore, various devices such as limited capacity ~"puffers" hav~ been used wh.7.ch r~rovid~ a Ina~ m quantity of air to the balloon to prevent overinflation. Nowever, even these have not provided a way to precisely and visually measare the volume of air thus delivered to the balloon, and such previous means did not provide a way to precisely and exactly change the volume of the balloon after it has once been inflated with complete knowledge as to the amount of air added or removed. Hence, the operator is then able to precisely control the size of the balloon for different size patients and for different conditions within a given patient , ,, ~S~33 ,~

as well as positively protect against overinflation which could rupture the colon and kill the patient.

It is important that the valve mechanism posi-tively be closed to prevent leakage from the balloon and to be positively opened for deslred air flow through the con-dult 21 in either dlrection. Only in this manner can the precise volume of air introduced be known as otherwise (~or example if the valve were a one-way check valve opened by air pressure introduced into the balloon) the air would~ ~;
comp~ress before opening the valve so that the operator would -not have~an accurate vlsual indlcation of the volume of air introduced.

Another feature of the present invention is the liquid solution to be used~ Preferaùly the solution will be a known concentration soapy aqueous solution including approxlmately 20cc of castile soap, or known additional~
volume~of~soap as required, in a volume of 1500cc to 2000cc of water with the addition thereto of a nonsoluble~laxative in aqueous suspension. In practice, I have found it desir-able to include such a laxative in a concentration suitable for a particular patientis problems. In most cases I have found it suitable to add the laxative in an amount between .006 and .015mg per cc of solution, although for ~ifferent situations even this range could vary. I believe the provi-sion of a castile soap solution with a laxative ingredient , ,:, ~,, .,,~, , ::: ' 1~S;2~3 "
in suspension is new. Further, I believe the present inven-tion includes a new vehicle for introducing such a laxative inyredient to the patient, namely by applying it in a procedure which completely fills and distends the colon, thereby carrying the laxative ingredient in a single step :
~ uniformly to the entire surface of the colon from the anal :
opening all the way to the cecum.

; Another feature of the present invention is a i~
;means~ for squeezing the patient';s buttocks together and 10~ against the per1neum to prevent;~ involuntary premature~ ex-pul~slon~of the balloon~18 and the~liquld~ contained in~ the colon. ~ Reférring ~to Figures 6 through;8, and~ first to . :: : : : : :
Pigure 6, there lS s~hown a band 60 having a right side 62 and~a left side 63. ~igure 6 views the outer side ~of the device, i.e. the s~lde~whlch~ would face away from the;~pa-tient, when the device is~ in use. ~he left and right sides~
: :
join along~ a front portion which is narrower than the re-mainder~of~the~ device so as not to lnhibit the patient's bending his legs at the hips. When applied to the patient (in the manner as described below), the left and rlght sldes must be rigidly attached together, as shown. However, for providing a quick release after the patient is finished with it, the left and right s1des may be connected together at the front by a suitable quick release connection. In the preferred embodiment, this quick release means would com-, 1~2~33 prise an overlapping hook and felt pad connection such as that sold under the trade mark Velcro i.e., an extension 62a of the right side could comprise a felt pad which would be engaged by a hook pad on an extension 63a of left side 62.
For a quick release, one would simply grab the end 61 of 63a and st~ip 63a from 62a. It will be apparent that other quick release~ means such as buckles, snaps or the like can be provided. ~he device includes a plurality of straps 67, 69 and 71 on the right side each having at its outer end a felt pad 68, 70 and 72, respectively (these pads are on the opposite side and hence not visible in Figure 6j. Between the planes of these straps there are provided hook pads 64, 65 and 66. 3n the left side there are provided further series of straps 75, 77 and 79, each with a similar felt pad 76, 78 and 80, respectively. While the~pad 78 lS not visible, the pads 76 and 80~are visible since the ends of straps 75 and 79 ha~e b~en turned~ back. Als~ incl~ded are hook pads 7~, 73 and 74 located between thè planes of the strap~s 75, 77 and 79. It will be observed that the three straps on each side are spaced vertically from the planes of the three straps on the other side, and each of the six straps in fact lines up horizontally with a hook type pad on the opposite side.

In operation of the device 60, the tube 16 with balloon 18 would first be inserted . Referring to E'igure 7, the attendant would then apply device 60 by wrapping the -~1~2~33 device 60 around the patient, at first with none of the straps attached but with 62a and 63a secured together. To squeeze the buttocks together it is preferable to start frorn the bottom and work up. The operator would grap the two straps 71 and 79 and pull them tightly to the left and right, respectively, attaching the strap 71 by connectlng the felt pad 72 to the hook pad 74. The operator would then grab the two straps 79 and 69 and pull them to the ~right and le~t, respectively attaching the pad 80 to the hook pad 66.
m is process would be repeated until all of the straps were attached in this manner~ While attachments such as those sold under the trade mark Velc~o are preferable, it will be apparent that other types of attaching means such as belt buckles and the like will also be operable in carrying out the present invention. With the tube 16, and balloon 13, ~and device 60 in place~ the attendant would inflate the ba~loon and pull it down snugly against the lower end of the rectum adjacent the anal canal~ The friction between the tube 16 and the straps wl~lch it engages (69 and 79 in Figures 7 and 8) will hold the balloon down into sealing engayeJnent with the lower end of the rectum, thus performing the function described above to disc 19, stabilizing the balloon in a fluid sealing position, in addition to its function of ~reventing involuntary expulsion of the balloon and tube.

The method of the present invention and the opera-tion of the above described system for carrying out the .~ - 43 -~ .

~S2~333 purposes of the invention is as follows. The method will be better understood with reference to Figures 9A through 9E.
Fiyure 9A illustrates the entire colon with the parts la-beled, such labels followed with such representative letters which are those letters used in subsequent Figures 9B
`: :
through 9E. Flgure 9A illustrates a colon filled with solid waste material, i.e., loosened fecal matter and gas. The :: :
figure is intended to illustrate that the gas pockets can ; actually be located randomly at different locations although 10 ` obvlously~as the patient moves to dlf~ferent positions, the : ~
gas will tend to rise to a high point.

Flgure 9B lllust~rates the application~of~ a con-vent1onal left side down enema to the colon filled as~ shown in Figure 9A, and in particular it illustrates the colon after all~ of the liquid solution, usually between 500cc and~
lOOOcc has been introduced into the~ patient's coIon. In Figure 9A the unloosened~ fecal matter was particularly diff~lcult~ to move because it would tend to stick to the inside lining of the colon. In Figure 9B~the liquid moves along the side of the rectum, down the sigmoid and along the bottom of the descend1ng colon (ie. !'bottom" as shown in Figure 9B). The only portions of the colon lining which have been "washed", i.e. which have been subjected to the action of liquid in motion are the "lower" portions of the rectum and descending colon as shown in Figure 9B with the wide gray border. The upper surfaces of the rectum and i21333 descending colon, as shown in Figure 9B, may or may not have been washed, depending on the quantity of gas existing therein and possibly blocking contact of the liquid with those wall portions. However, the liquid cannot rise :
upwardly~ in the transverse colon. Firstly, it would have to oppose gravity just to travel in that direction. Secondly, gases whlch may have been located in the descending colon wlll now form~a rather substantial gas 1OGk. The body of solid fecal matter and the large gas lock tend to form a ~10 "wall" identlfied generally by the letter W in the Figure. The liquid introduced in this manner may cause some ~ ~`
dlstent1on in the~wall of the~rectum, sigmoid and~descending colon, but not beyond those parts. If additional liquid is introduced, it will tend to leak outwardly around the tube and through the anal opening as shown by~the arrow in the~
flgore. Slnce under no circumstances can this l1quid pass the area of the splenic flexture and rise in the transverse colon,~ the transverse and~ascendi~ng colons wlll remain filled no matter how many enemas are given (and it is a common practice to give multiple enemas). Indeed, Flgure 9B
illustrates the fallacy in believing that the colon is clean when, after a number of enemas, the solution runs out "clear". This would most likely indicate that only the rectum, sigmoid and descending colon have been cleansed, and that the liquid in the area of the splenic flexture, being blocked by the gas body in this area, simply did not touch ' ' ' ;, the solid fecal matter in the transverse colon and ascending colon. Hence, the liquid would of course run out "clear".

When the left side down conventional procedure has been completed, the entire mass in the ascending and transverse colon must then be cleaned by oral laxatives with all of their attendant disadvantages as discussed above or ; remain in the colon to harden or "impact" or soil the bed if the patient is fecally incontinent.

.
Figures 9C through 9E illustrate the functioning of the colon in the operation of the present invention. ~
' ' With clamp 25 closing tube 16, an appropriate volume of liquid solution would be introduced through open-ing 13 into bag 11. The balloon 18 would then be completely evacuated. Referring to Figures 5A through 5C, Figure 5A
illustrates the balloon in its completely inflated condition and Figure 5B illustrates the balloon in its completely relaxed condition. However, the residual air still located therein should preferably be removed prior to insertion of the tube. For this purpose the conduit 21 can be connected to the syringe 23 and the piston 42 withdrawn thereby evacu-ating the balloon 18 as shown in Figure 5C. The syringe would then be disconnected from the valve 22, permitting the valve to close, and the piston 42 would then be pulled back enough to provide precisely the desired amount of air to , . ... .
., ~, :~

~3152~3;~

inflate balloon 18 which might be for example 60 or 120cc.
With the attendant preferably standing in front of the patient, the tube is then inserted into the patient. If the device 60 is to be used, it is applied at this time in the manner described above. With the syringe 23 attached again to the conduit 21 the piston 42 is moved forwardly, intro-duclng precisely the correct quantity of air, e.g. ~Occ to 120cc, the exact amount being visually observed by noting the calibrated markings 49 on syringe 40. If device 60 has not yet been applied, the disc 19 may now be slid along tube 17 to the correct position to stabilize and secure the seal of balloon 18~ To prevent expulslon of balloon 18, the straps 31, 31a and 31b could now be connected to a waist-band or the like on the patient. ~lternatively to said straps, the device 60 could now be applied, this time ser-ving only the functlon of preventing involuntary expulsion of the balloon.
:

With the patient on his right side, the clamp 25 , ~
is then opened, permitting the liquid solution to flow through the tube 16. Referring to Figure 9C, this quantity of liquid, prevented from escaping by balloon 18, flows along the rectum, up the sigmoid and along the "bottom" of the descending colon (gas having risen to the top thereof) and then down the transverse colon, displacing upwardly any gases located therein, around the hepatic flexure, and along the ascending colon to the cecum. As the liquid solution is initially being introduced, some distention may occur in the vicinity of the rectum, the sigmoid, descending, transverse and ascending colon. However, operable levels of distention throughout the colon do not occur until after a sufficient quantity of liquid has been introduced to the colon to fill the colon throughout its length, but for the space taken up by the solid fecal matter and gases already located there-:, in. As shown in Figure 9C, at this time those walls boundedby the wide gray margin, namely the lowermost part of the rectum, the sigmoid, the "bottom" of the descending colon and the ascending colon have most likely been contacted by a sufficient amount of liquid solution in motion to have been agitated or "washed". As distention of the walls occurs along with this washing action, the lubricating action of the castile soap ln the liquid will cause the stool and mucus attached to the walls of the colon to soften, to fragment and to detach from the lining of the colon, and to become lubricated. Further as the fecal matter or "stool"
is detached, the laxative within the liquid solution is ~ permitted to contact the lining of ~the colon, causing it to contract. At this time it cannot be certain whet her the entire lining of the colon has been contacted by the liquid solution. For example, as shown in Figure 9Cj gases col-lected at the top of the rectum and descending colon may have prevented the liquid solution from removing fecal matter and mucus from the lininy of these places.

~, , ~ :

iizl~33 Similarly, as the liquid ran down the transverse colon~ it cannot be certain whether the walls of the transverse colon were "washed" sufficiently to remove stool and mucus there-from. ~o assure that the liquid "washed" and that the laxative contacts the entire surface area of the colon lining, the patient may then be rolled cver to his left side, creating the situation shown in Figure 9D. Now the :
liquid flows to the "down" side of all segments of the colon assuring contact with and washing of all areas of the lining bordered by the speckled margin in Figure 9D. The swashing action of the liquid back and forth through the transverse colon as the patient is moved from this right side to his left side (and this action of right side to left side may be repeated as many times as necessary~ will surely have caused the necessary washing of the entire surface area of the lining of the colon with the resultant softening, fragmenting and lubricating of the attached fecal matter and the consequent contacting of the entire lining with the laxative containing liquid~

Finally, the patient will be rolled back to the right side, as shown in Figure 9E all lining surfaces having been contacted by the liquid so that all of the fecal matter and mucus material within the colon will have heen loosened, softened, fragmented and lubricated, and the entire lining of the colon, having been contacted with the laxative, will be capable of undergoing contraction to expel all solid liquid and gaseous materials contained therein.

,~

1~5~

The volume of liquid solution will vary depending on several factors, including the size of the patient, the amount of solid and yaseous materials already present in the colon prior to introduction of the liquid solution, and the condition of the patient's colon. For example, while I have ndlcated previously that the lSOOcc to 3000cc of liquid solution would normally be used,~;even le~ss than 1500cc may be necessary to fill the colon in the case of a child,~
infant, or person who has had a ~portion of his colon re-moved.

:
The~advantage of bringing the laxative to the entire lining throughout the ~entlre colon is ac~complished especially well in the course of the present invention. The laxative, to carry out its stimulating functionj~must con-tact the~ lining itself, and not merely the mucus layer on the linlng. The colon cleansing technique of the present invention, with its ability to clean off the entire colon l1nlng,~ assures that~the mucus layer is detached along with the stool to thereby fully expose the lining itself to the laxative.

It was suggested above that the patient be rolled to the left side to provide further agitation to enhance "washing" of the walls of the colon and thereby better effect detachment of the stool and mucus from the lining.
However, such agitation can be carried out in other ways.

.',, .
:, . .... .
.. ~ ,, .;, ,~ .

~L5~833 For example direct in and out motion of the anterior abdom-inal wall can be provided by direct hand pressure or by a vibrator placed against the abdominal wall. Also liquid can be moved in and out of the colon by having the fluid located in the colon connected through the tube to a fluid column :
which can then be raised or lowered, resulting in the fluid being introduced into and temporarily removed from the colon. Alternatively, the balloon 18 can be slightly in- ;
flated and deflated at proper frequency to cause a wave or churning action of the liquid in the colon. Or alterna-. .
tively uItra sound procedures can be utilized to effect agitation by vibration, for example by having the liquid run through the tube and to a fluid column which can be acted upon.
~:

Whatever, mechanical agitation is used, when it is :
completed, the patient is taken to a proper receptaclej the device 60, if used, is released by uncoupling extension 63a from 62a, the balloon 18 is fully deflated and removed with the tube 16, and at this time the patient can expel the entire contents of the colon.

Although the invention has been described in considerable detail with respect to a preferred embodiment thereof and a preferred operation thereof, it will be apparent that the invention is capable of numerous modifi-cations and variations which will be apparent to those skilled in the art.

,:,. ,:

~ . , ~i2~33 SUPPLEMENTARY DISCLOSURE
' :~
It has been found that in certain cases where it is desired to cleanse the entire colon of the patient~according with the methods described above ~and~using the meanings described and~disclosed above, there is need for more securaly holding the tube with the inflated balloon~ thereon wlthin the anal opening, and that certain improvements can be achieved in .,.
the design of the device used for squeezing together the buttocks of the patient.
.~ :
In accordance with this invention, the person's buttocks are ~;
~10 squeezed together~to apply a slgnificantly greater area of the person~'s buttocks against the surface of a tube to better hold it in placej and prior to squeez~ing together of ~ ~-.
a~person's;~buttocks t~he tabe with the balloon already in-flated~ within the anal openlng, is preferably pulled out-wardly to pull the balloon against the interior of the anal opening. The tube is also stabilized in position by wrap-ping a thick cord of absorbent material around the tube up against the outside of the anal opening prior to squeezing together of the buttocks.

~r 5 2 ~S;~ 3 The device for squeezing the patient's buttocks together comprises an elongated band Eormed with a strap like hand having connecting means at the outer ends there-of. The band is wrapped around a person after the tube has been placed within the person's anal opening. The central section of a band is placed against the person's abdornen and the outer ends of the band, formed as straps, are made to overlap each other in the area of the person's buttocks and ~ -are pulled tight, the straps being so shaped that when they are pulled tight they squeeze the person's buttocks together and ln the pulled tight condition they are secured. Each ~band will have a plurality of straps at its ends and the straps will be so connected that the tube can easily pass through the device between adjacent straps.

-- 'Preferably the device includes Velcro connecting means and as a quick release connection at the front of the ::
band i.e. at the central section thereof, so that when the time comes for removal of the band it can be removed quickly by this qulck release connection throughout the need Eor 20 disconnecting the strap bands.

The device may be formed as any convenient material such as non-woven paper, cloth, plastic, netted material, etc., the straps can be very wide or very narrow;

and while there is no specific limitations on the number of ,.,,,~,t/ .

iZ~333 straps extending to each side, preferably 2 or 3 straps will be provided extending from each side.
~, .
In accordance with the method proposed herein for securely holding a tube within a person's anal opening, the tube is first inserted and the balloon extended in the manner described earlier in the main disclosure. If desired, the absorbent cord may be wrapped around the tube at this time to stabilize the balloon at the interior bottom of the anus. Whether or not the cord is used, the buttocks squeezing device of the present invention is then applied by placing the central section against the person's abdomen and pulling the straps ends across the person's~ buttocks squeezing the buttocks together and then attaching the straps ends securely in place.

Preferably the device is made of a nonwooven ;; CottoA paper material, and it is also a feature of the present invention that the band ends include large upper straps whlch overlapped each other with one passing through an opening in the other and including thinner lower straps.
It is also preferred that the first connecting means be the hook pads while the second connecting means, on both side of the central section, positionned to cooperate with the first connecting means, are felted pads of the Velcro type.
.' ~5~'~33;~

These additional features of the present inven-tion will now be described with reference to examplary embodiments thereof which are illustrated in the accompa~
nying drawings wherein ,~:
Figure 10 is a plane view oE a device laid out flat to be used for squeezing together patient's buttocks, Fig~re 11, is an elevational view of the rear slde of the device of Figure 10 illustrated in coiled con-dition as if installed onto a patient, Figure 12, IS a partial side elevational view of a patient's body whose mid section is fitted with a tube and a device in accordance with this invention, Figure 13, is a side view of a length :~
of a thick cord which may be used for wrapping around the outer section of the tube as showned in Figure 14, and Figure 14, is a cross-sectional view to the buttocks of the patient showing the tube and the inflated balloon in place with the cord wrapped around the outer end of the tube.

Referring now to the drawings, like elements are represented by like numerals throughout the several views.
' Although the device and method of the present invention may have different uses, a primary use is to retain in place within a person's anal opening a tube which , ",~j. ,~, ,;, , ~5~ 3 has been introduced therein for purposes of introducing a liquid into the colon. Such a tube which is designated as 120 is shown in Figure 14 with an opening at the end thereof and with a balloon 121 also attached to the end thereof, said balloon having been inflated after the tube and balloon have entered the rectum.
~' The present device and method are particularly suitable with the method and technique as set forth in the main disclosure wherein there is introduced into the colon a much larger volume of liquid than has been used in cleansing procedures heretofore, namely enough liquid to completely fill the colon and distend the walls thereof. Moreover, this increased volume of liquid is held within the colon for a short period of time before the tube is removed, permitting the person to expel the contents of the colon.
~' ' A preferred embodiment of the invention is illus-trated in Figures 10, 11 and 12. The device may be made of any suitable material having sufficient strength. In a preferred form of the invention, the device is made of a non-woven cotton paper material while in other embodiments it may be made of cloth, plastic, a netted material, etc. ~;

Referring to Figures 10 through 12 the buttocks squeezing device 40 has a central section 111 which will be placed against the front of the person, i.eO against the . , ,~ "

abdomen. Specifically, figure 10 illustrates the exterior after the device has been wrapped around the wearer.

The device is in the form of a band. For refer-ence purposes, the part to the left in figure 10 represented by the numeral 12 will be referred to hereinafter as the "right part" because it will be wrapped around the right side of the wearer while the part toward the right hand side ;~ in Figure 10, referred to by the numeral 116, will be re-ferred to herelnafter as the "left part" because it will be ` lO wrapped around the left side of the wearer.

Right part 112 is formed at its outer extremity with a pair of straps 113 and 114 while left part 116 is formed at its outer periphery as a pair of straps 117 and 118. In this embodiment the upper straps 113 and 117 are formed as large main straps ~while the lower straps 114 and 118 are rather narrow. This arrangement has the ~advantage of efficiency and simpliclty, i.e. it involves a small number of straps, and yet they are sufficient to carry out .
the purpose of the present lnvention.

Although certain features illustrated in Figure 10 will be more readily understood in the subsequent descrip- ~-tion of the operation of the device, it is nonetheless help-ful to specifically indentify all elements of the band at this point. When the band is applied the various parts will preferably be connected together by hook and felt pad connections such as those sold under the trade mark Velcro.
~s is well known, this type of connection comprise the enga-gement of a pad having small hooks thereon, referred to hereinafter as "hook pads" with other pads formed of a felt material and referred to hereinafter as "felt pads". In Figure 10 each of the felt pads are referred to by the capita1~ letter "F" followed by a subscript to specifically dent~ify that pad, especially in the subsequent views~
Similarly, all of the hook pad~ are identified~ by "H"
followed by a subscript so that any specific hook pad can also be identified in the subsequent views. In Fi~ure 10 all of the felt pads face the viewer and are hence shown in solid lines (except for a portion of F4 which is hidden as will be explained be'ow). All of the hook pads are hidden in figure 10, i.e. on the opposite side of the band as shown , ~ ; ~ theraiq and hence th7_y are shown in do~ted lines ln Figure : 10.
, ~:

Finally, in Figure 10 there is also shown a slit 115 which passes completely through the device and in a manner which will be described in greater detail belowt is adapted to receive the outer end of strap 117 when the band is applied to the person.

Figure 13~ illustrates a type oE~cord which can be wrapped around the tube 120 to stabilize the balloon 121 in place. This cord is characterized by a wide body of absorbent material 125a such as cotton or the like formed as " C~, ' elongated strands and held together by threads 25b. After the tube 120 has been inserted into the person's anal open-ing and the balloon 121 expanded, the tube is pulled out-wardly to pull the balloom 121 expanded, the tube is pulled outwardly to pull the balloon 121 against the inside of the anal opening and the absorbent cord 125 can then be wrapped around the tube 120. The absorbent characteristics of this cord tend to absorb liquid and hence create a frictional engagement between the cord, the tube and the outer surface of the person's anal opening. It will be understood that the use of this cord 125 is optional and that the use of the buttocks squeezing device to be described beIow does not necessitate prior use of such a cord.

Referring once again to Figures 10 to 12, ini-tially the device is formed as one elongated band. The central section includes a quick release mechanism formed by making the band of two parts, one having felt pads F4 and F5 and the other having hosk pads HS and H6. Actually, if a quick release mechanism;is not formed, the whole band can be formed of a single piece, eliminating F4, F5, H5 and H6.
But if it is formed in this preferable manner with this quick release mechanisrn, it will be understood that ini-tially H5 and H6 are connected to H4 and H5, i.e. this quick release mechanism has no function until it is subsequently desired to remove the band from the wearer.
:

~ - 59 -" , . ~ .': ' ,', ~5~

In the use of the device and in the method of the present invention, after the tube 120 has been inserted and the balloon 121 inflated, with or without use of the cord 125, the device is placed against the wearer with the central section 111 against the wearer's abdomen. The strap ends are then pulled across the person's buttocks with the , outer end~ of strap 117 passing through the slit 115. These straps are then pulled tight and secured in position with hook pad H2 secured to any one or more of felt pads Fl, F2 or F3 and with the hook pad Hl at the end of strap 113 .
connected to any one or more of felt pads F6, F7 or F8. It will be noted that felt pads Fl-F3 and F6-F8 have a greater ~height than the helght of hook pads Hl or H2. The reason for this is to provide some room at the bottom of felt pads Fl-F3 and F-6 F-8 for having secured thereto hook pad H4 on : ~ .
strap 118 and H3 on strap 114, respectively. In applying the device, after the hook pads Hl and H2 have been secured in place, the straps 114 and 118 are in fact pulled tight ~ ;
and connected to said felt pads.
" ;' -Figure 11 illustrates the back of the device as it would appear secured in place on a person.

The reason for having a plurality of straps at each end is to squeeze the buttocks together on both sides, i.e. above and below the tube. Hence, in Figure 11 the tube , " , .
, '., ~ ' .

120 would pass through the device below the straps 113 and 117 and above the straps 114 and 11%.

Figure 12 illustrates the device of Figures 10, 11 applied to a wearer and viewed from the wearer's right side.

While Velcro attachments are preferable, it will be apparent that other types of attaching means such as belt buckles and the like will also be operable in carrying out the present invention.

Although the invention has been described in considerable detail with respect to preferred embodiment thereof, it will be apparent that the invention is capable of numerous modificatlons and varlations without departing from the spirit and scope of the invention, as defined in the claims.
: :, ~, ' ~ :;
:'' ,: ..

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.

1- A colon cleansing kit having component parts capable of being assembled at the point of use to provide a system for cleansing out a person's entire colon, from rectum to cecum without the need for prior orally taken laxatives, comprising:
a fluid carrying bag having a capacity of at least 1500 cc.
a tube connected to the bag and extending therefrom, the tube having an inside diameter of a size appropriate for the passage therethrough of an aqueous liquid solution, the tube being open in the vicinity of its end remote from the bag for the delivery of such liquid, an inflatable balloon attached to the exterior of the tube near its said remote end, the balloon positioned to be located and inflated in the person's rectum when said remote end of the tube is passed through the person's anal opening, so as to seal the rectum to prevent fluid from passing through the anal opening around the exterior of the tube, a conduit attached to and leading from the balloon for inflating the balloon when located in the person's rectum, a valve in the conduit at the end thereof opposite from the balloon, the valve normally urged closed by a spring biased means acting toward the said opposite end of the conduit, the valve being capable of opening for flow therethrough in either direction only by engagement of the valve by an object placed into the valve through the said opposite end of the conduit, and a piston and cylinder syringe having calibrated markings thereon indicating the volume displaced by the piston within the syringe, the volume of the syringe related to the volume of the balloon so that calibrations on the syringe indicate the volume delivered into the balloon, the syringe being insertable in said conduit and having means for opening the valve when inserted therein to permit inflation and deflation of the balloon through the valve and conduit, by operation of the piston in one direction or the other, respectively, so that the amount of fluid introduced into the balloon can be visually and directly ascertained by observing the calibrated markings on the piston and cylinder syringe, as the piston moves relative to the cylinder.

2. A colon cleansing kit having component parts capable of being assembled at the point of use to provide a system for cleansing out a person's entire colon, from rectum to cecum without the need for prior orally taken laxatives, comprising:
a fluid carrying bag having a capacity of at least 1500 cc, a tube connected to the bag and extending therefrom, the tube having an inside diameter of a size appropriate for the passage therethrough of an aqueous liquid solution, the tube being open in the vicinity of its end remote from the bag for the delivery of such liquid, an inflatable balloon attached to the exterior of the tube near its said remote end, the balloon positioned to be located and inflated in the person's rectum when said remote end of the tube is passed through the person's anal opening, so as to seal the rectum to prevent fluid from passing through the anal opening around the exterior of the tube, a container of liquid soap of a volume which, when dispersed in the said volume of liquid in the bag is of proper concentration to have a lubricating action throughout the entire colon from the cecum to the rectum, and a container having a laxative of a volume which, when dispersed in said volume of liquid in the bag, is of proper concentration to have a laxative effect on the wall of the colon throughout the entire colon from the cecum to the rectum.

3- A colon cleansing kit having component parts capable of being assembled at the point of use to provide a system for cleansing out a person's entire colon, from rectum to cecum without the need for prior orally taken laxatives, comprising:
a fluid carrying bag having a capacity of at least 1500 cc, a tube connected to the bag and extending therefrom, the tube having an inside diameter of a size appropriate for the passage therethrough of an aqueous liquid solution, the tube being open in the vicinity of its end remote from the bag for the delivery of such liquid, an inflatable balloon attached to the exterior of the tube near its said remote end, the balloon positioned to be located and inflated in the person's rectum when said remote end of the tube is passed through the person's anal opening, so as to seal the rectum to prevent fluid from passing through the anal opening around the exterior of the tube, a conduit attached to and leading from the balloon for inflating the balloon when located in the person's rectum, a valve in the conduit at the end thereof opposite from the balloon, the valve normally urged closed by a spring biased means acting toward the said opposite end of the conduit, the valve being capable of opening for flow therethrough in either direction only by engagement of the valve by an object placed into the valve through the said opposite end of the conduit, a piston and cylinder syringe having calibrated markings thereon indicating the volume displaced by the piston within the syringe, the volume of the syringe related to the volume of the balloon so that calibrations on the syringe indicate the volume delivered into the balloon, the syringe being insertable in said conduit and having means for opening the valve when inserted therein to permit inflation and deflation of the balloon through the valve and conduit, by operation of the piston in one direction or the other, respectively, so that the amount of fluid introduced into the balloon can be visually and directly ascertained by observing the calibrated markings on the piston and cylinder syringe, as the piston moves relative to the cylinder, a container of liquid soap of a volume which, when dispersed in the said volume of liquid in the bag is of proper concentration to have a lubricating action throughout the entire colon from the cecum to the rectum, and a container having a laxative of a volume which, when dispersed in said volume of liquid in the bag, is of proper concentration to have a laxative effect on the wall of the colon throughout the entire colon from the cecum to the rectum.

4- A kit according to Claim 1, 2, or 3, wherein the tube has an inside diameter of approximately 1/4 of an inch, and sald tube having a length from the bag to the balloon of approximately 60 to 75 cm.

5- A system for cleansing a person's entire colon, from the rectum to the cecum, in the absence of prior orally taken laxatives, comprising;

a fluid bag for carrying a sufficient amount of an aqueous liquid to f ill completely the remaining space in a person's colon not taken up by solid, liquid or gas materials already located therein, a tube connected at a first end thereof to the bag to deliver the liquid therefrom, the inside diameter of the tube being appropriate for the passage therethrough of the aqueous liquid, a balloon attached to the exterior of the tube near the end thereof remote from the bag, the balloon being located just inside the person's rectum and inflatable to seal the person's rectum to prevent fluid from passing through the anal opening outside of the tube, a conduit attached to and leading from the balloon for inflating the balloon when located in the person's rectum, a valve in the conduit at the end thereof opposite from the balloon, the valve normally urged closed by a spring biased means acting towards the said opposite end of the conduit, the valve being capable of opening for flow therethrough in either direction only by engagement of the valve by an object placed into the valve through the said opposite end of the conduit, and a piston and cylinder syringe having calibrated markings thereon indicating the volume displaced by the piston within the syringe, the volume of the syringe related to the volume of the balloon so that calibrations on the syringe indicate the volume delivered into the balloon, the syringe being insertable in said conduit and having means for opening the valve when inserted therein to permit inflation and deflation of the balloon through the valve and conduit, by operation of the piston in one direction or the other, respectively, so that the amount of fluid introduced into the balloon can be visually and directly ascertained by observing the calibrated markings on the piston and cylinder syringe, as the piston moves relative to the cylinder.

6- A system according to Claim 5, including a limiting means mounted on the tube and slidable in only one direction therealong towards the balloon so as to be positioned on the outside of the patient against the exterior of the anal opening to maintain the balloon in a fluid tight seal with the wall of the rectum.

7- A system according to Claim 6, including straps connected to the limiting means and extending two forwardly to the right and left of the patient's mid plane, and one rearwardly therefrom, for connection to a waistband for securing the tube and balloon within the patient to prevent involuntary expulsion thereof.

8- A system according to Claim 6, including indicia on the tube indicating different locations for sliding of the limiting means along the tube for different size patients.

9- A system according to Claim 6, said limiting means being a hard generally oval disc.

10- A system according to Claim 5, said balloon being generally disc shaped and extending outwardly from the sidewall of the tube farther than its dimension parallel to the axis of the tube.

11- A system for cleansing a person's entire colon, from the rectum to the cecum, in the absence of prior orally taken laxatives, comprising:
a fluid carrying bag including a quantity of an aqueous liquid in an amount sufficient to fill completely the remaining space in a person's colon not taken up by solid, liquid or gas materials already located therein, a tube connected at a first end thereof to the bag to deliver the liquid therefrom, the inside diameter of the tube being appropriate for the passage therethrough of the aqueous liquid, a soap ingredient contained in the said aqueous liquid located in the bag in sufficient concentration to have a lubricating action throughout the entire colon from the cecum to the rectum, and a laxative ingredient in the liquid in the bag in sufficient concentration to have a laxative effect throughout the entire colon from the cecum to the rectum.

12- A system according to Claim 11, including an inflatable balloon attached to the exterior of the tube near the end thereof remote from the bag, the balloon being located just inside of the person's rectum and inflatable to seal the person's rectum to prevent fluid from passing through the anal opening outside of the tube, and a conduit attached to and leading from the balloon for inflating the balloon when it is located in the person's rectum.

13- A system according to Claim 12, including:
a valve in the conduit at the end thereof opposite from the balloon, the valve normally urged closed by a spring biased means acting toward the said opposite end of the conduit, the valve being capable of opening for flow therethrough in either direction only by engagement of the valve by an object placed into the valve through the said opposite end of the conduit, and a piston and cylinder syringe having calibrated markings thereon indicating the volume displaced by the piston within the syringe, the volume of the syringe related to the volume of the balloon so that calibrations on the syringe indicate the volume delivered into the balloon, the syringe being insertable in said conduit and having means for opening the valve when inserted therein to permit inflation and deflation of the balloon through the valve and conduit, by operation of the piston in one direction or the other, respectively, so that the amount of fluid introduced into the balloon can be visually and directly ascertained by observing the calibrated markings on the piston and cylinder syringe, as the piston moves relative to the cylinder.

14- A system according to either of Claim 5 or Claim 11, said tube having an inside diameter of approximately 3/16 of an inch and an outside diameter of approximately 1/4 inch.

15- A system according to either of Claim 5 or Claim 11, said tube having a length from the bag to the balloon of approximately 60 to 75 cm.

16- A system according to Claim 5, wherein the end of the tube near the balloon is solid and rounded with openings on the side thereof.

17- A system according to Claim 16, wherein the tube has an inside diameter of approximately 3/16 of an inch and an outside diameter of approximately 1/4 of an inch and is between 60 to 75 cm long from its connection with the bag to the end near the balloon.

18- A system for introducing fluid into a person's colon through the anal opening, comprising:
a tube for introducing the fluid, the tube being rounded and closed at its extreme forward end, and including fluid outlet openings on the side of the tube just behind the rounded end thereof, a balloon attached to and circumventing the exterior of the tube just to the rear of the said openings, the balloon being located, when in use, just inside the person's rectum and being inflatable to seal the person's rectum to prevent fluid from passing through the anal opening of the tube, a conduit attached to and leading from the balloon for inflating the balloon when located in the person's rectum, a valve in the conduit at the end thereof opposite from the balloon, the valve normally urged closed by a spring biased means acting toward the said opposite end of the conduit, the valve being capable of opening for flow therethrough in either direction only by engagement of the valve by an object placed into the valve through the said opposite end of the conduit, and a piston and cylinder syringe having calibrated markings thereon indicating the volume displaced by the piston within the syringe, the volume of the syringe related to the volume of the balloon so that calibrations on the syringe indicate the volume delivered into the balloon, the syringe being insertable onto said conduit and having means for opening the valve when inserted thereon to permit inflation and deflation of the balloon through the valve and conduit, by operation of the piston in one direction or the other, respectively, so that the amount of fluid introduced into the balloon can be visually and directly ascertained by observing the calibrated markings on the piston and cylinder syringe, as the piston moves relative to the cylinder.

19- A system according to Claim 18, said tube having an inside diameter of approximately 3/16 of an inch and an outside diameter of approximately 1/4 of an inch.

20- A system according to Claim 18, including a bag connected to the end of the tube remote from the person for containing a liquid to be introduced into the person.

21- A method of preparing a patient for the passage of a liquid through a tube located in the patient's anal canal, comprising the steps of:
taking a tube adapted for insertion into a patient's anal opening with an inflatable balloon attached thereto, said inflatable balloon attachable via a conduit having a valve therein to a piston type syringe, with cali-brated markings thereon showing the volume in the syringe displaced by the piston into the balloon, inserting the tube into the patient's anal opening with the balloon positioned at the rectum just inside the anal canal, inflating the balloon through the valve and conduit by a certain ascertainable volume by moving the piston of the piston syringe a length corresponding to said ascertainable amount by observing the calibrated markings on the syringe as the piston moves therein, and closing the valve to retain said certain ascertainable volume in the balloon, to thereby retain the tube in the patient's rectum.

22- A method according to Claim 21, wherein the balloon is of a material having sufficient rigidity such that in its fully relaxed condition it contains residual air therein, and prior to inserting the tube, including the step of opening the valve and fully collapsing the balloon by moving the piston relative to the cylinder in a direction opposite from that direction applicable in inflating the balloon.

23- A method according to Claim 21, wherein the valve is located at the end of the conduit remote from the balloon, and the piston and cylinder syringe has a projection at the end thereof which connects with the conduit, and wherein opening of the valve is accomplished by attaching the said end of the piston and cylinder syringe to the conduit.

24- A method according to Claim 23, wherein the valve is closed by a spring when not engaged with the said end of the syringe.