WO2010020985A1

WO2010020985A1 - An inflatable rectal sleeve device and method

Info

Publication number: WO2010020985A1
Application number: PCT/IL2009/000806
Authority: WO
Inventors: Boris Levin; Bnaiahu Levin; Ulanovsky Levy
Original assignee: Torus Medical Ltd
Priority date: 2008-08-18
Filing date: 2009-08-17
Publication date: 2010-02-25
Also published as: WO2010020985A8

Abstract

Devices and methods are providing for enabling an access to the colon, the devices comprising a suppository which envelops an inflatable colon enema for insertion into the anal canal of a patient. The inflatable colon enema is made of an inflatable ring-shaped balloon with a wide sleeve attached thereto. Before being inflated, the ring-shaped balloon is coated with meltable or dissolvable material and molded into the shape of a suppository to ease the insertion of the device into the anal, rectal, or colon canal of a patient.

Description

AN INFLATABLE RECTAL SLEEVE DEVICE AND METHOD FIELD OF THE INVENTION

The present invention relates generally to rectal sleeve devices and methods, and more specifically to devices for insertion into an anal canal and uses thereof.

BACKGROUND OF THE INVENTION

A number of people have difficulty with their bowel movements or do not have the ability to voluntarily evacuate their bowels (i.e. especially the elderly and the handicapped) . Some people suffer from colitis or other related colon, rectal, or bowel ailments or diseases, that require ravaging or washing of the lower intestinal tract (i.e. the colon or rectal areas) . In many of these cases, people have to use an enema, or manually remove the fecal matter.

Another difficulty that people face is fecal incontinence which is a medical problem that causes much discomfort, embarrassment, and loss of self-esteem for patients and causes irritation and considerable work for health care staff. Elderly patients are especially prone to this problem, with sometimes over half of geriatric patients in care facilities having occasional fecal incontinence problems and often over ten percent having persistent fecal incontinence problems.

Causes for fecal incontinence vary from treatable situations of fecal incontinence caused by fecal stasis and some physical diseases such as carcinoma of the rectum and colon and ischemic colitis or diverticular disease, to untreatable fecal incontinence caused by neurological disorders such as dementia, and physical diseases such as megacolon, Crohn's disease, and rectal prolapse. Drugs such as analgesics and hematinics and excessive use of purgatives can also cause fecal incontinence . In untreatable cases, trying to contain the fecal matter as it is excreted seems to be the primary goal to save embarrassment and considerable mess. Diapers are not the best solution since there is still a considerable mess and cleanup care associated with the contained mess in the diapers, as well as occasional problems of leakage out of the diapers. All the external fecal collection means have a similar problem of still having a contained localized mess and periodic leakage.

Fecal incontinence devices that are inserted in the rectum tend to be harsh on tissues and cause irritation and potential infection problems. Prolonged use of such devices is generally not possible due to the damage caused by the devices themselves.

U.S. Pat. No. 3,938,521 describes a fecal collecting bag with an insertable collar which is inflated to form a donut-shaped collar. Such a donut-shaped inflated collar would not lie flat against the rectal mucosal tissue and, therefore, would not provide a good seal and would likely permit leakage around the outside of the collar. The relatively small area of the collar contacting the rectal mucosal tissue would be likely to cause irritation and infection of the tissue.

U.S. Pat. No. 4,182,332 shows an insertable rectal catheter with a series of flanges contacting the rectal mucosal tissue, which would be likely to cause leakage, irritation, and infection of the tissue.

U.S. Pat. No. 4,067,335 provides a fecal matter collecting unit with an insertable funnel with a series of ribs contacting the rectal mucosal tissue allowing leakage and putting too much pressure on the tissue adjacent to each rib which would cause irritation and infection.

U.S. Pat. No. 5,741,239 provides a fecal collection receptacle and tapered neck, a broad-lipped sealing ring with a bottom broad smooth flat sealing rim surface for contacting the rectal mucosal tissue that needs an external device for insertion and takes much space, causing uncomfortable feeling in the rectum area.

U.S. Pat. No. 5,941,860 provides a fecal collector which comprises an elongated, flaccid pouch having an entrance end; an anchor attached to the pouch entrance end to anchor the entrance end in the lower bowel, and; a positioner attached to the pouch in spaced relation to the anchor O-ring, to remain outside the lower bowel and adjacent to the body, for blocking tilting of the anchor in the bowel. This arrangement needs an external device for insertion and takes much space which causes uncomfortable feeling in the rectum area.

Lubricants or gels have been used to aid the insertion of devices through the rectum or anal canal area. U.S. Pat. No. 3,881,485 to Davis, Jr. ("Davis") discloses a device for insertion through the anus into the upper rectum for the purpose of wiping the walls of the rectum clean of feces and stopping and retaining feces in the colon and rectum at a distance from the anus. The invention is a preformed fiber device that is shaped for insertion through the anus into the upper rectum. The device is inserted through the anus and up through the rectum with a coating of non-irritating lubricant applied to the wiper. The lubricant should preferably be an organic, inert, water soluble gel, but other suitable lubricants may be used.

Other prior art patents disclose enabling an access to the colon systems and methods that introduce enema solution (i.e. preferably with a laxative) into the colon through the anal opening via a suitable tube held in the rectum by an inflated bladder or balloon. The balloon and tube is secured to the patient (i.e. via the anus and to the rectum/colon) .

U.S. Patent No. 4,403,982 to Clayton, U.S. Patent No. 4,406,655 to Clayton, and U.S. Patent No. 4,842,583 to Majlessi provides examples of such devices. However, these bladder or balloon devices require regulation of the pressure to the bladder or balloon, and they have the problem of the possibility of injury occurring to the patient if the pressure is not regulated properly.

A tip that dissolves in a person used in conjunction with a catheter appears to have been taught. U.S. Patent No. 5,049,138 to Chevalier et al. ("Chevalier") discloses a catheter having such a dissolvable tip. The catheter includes a flexible tubular member that has an inner lumen and a rigid solid tip disposed at the end of the inner lumen. The tip (i.e. cone shaped) is formed of a material that is slippery when wet, soluble in the bodily fluids and capable of absorbing radiographic fluids that are- injected into the inner men for identification of the location of X-rays. The solid tip is preferably formed of a water soluble polymer such as polyvinyl alcohol although alternatives are available such as polyethylene oxide, polyethylene glycol, polyacrylamides, polyvinyl pyrolidone, polyacrylic and the like. A narrow passageway is disposed in the tip and extends from the inner men to the distal end of the tip. The passageway is adapted to receive a guide wire for insertion of the catheter into an internal organ. There is still a need for user-friendly rectal sleeve devices and methods, which overcome the limitations of the prior art devices and methods.

SUMMARY OF THE INVENTION It is an object of some aspects of the present invention to provide user-friendly rectal sleeve devices and methods .

In preferred embodiments of the present invention, improved methods and apparatus are provided for rectal sleeve, which are simple for health professionals to apply to a patient.

In preferred embodiments of the present invention, improved methods and apparatus are provided for rectal sleeve, which are not too uncomfortable for a patient. Presently, it would appear that there are no suppositories available on the market, which envelop an inflatable catheter or enema, which can be used for aiding the insertion of the catheter or enema into the anus or rectum/colon area of a patient. Therefore, an apparatus and method, which is cost effective, environmentally safe and produces no waste hazard or problems, and would allow easy and less painful inserting of a catheter or enema into the rectum or colon area of a person or animal are needed and desired. Additionally, a suppository that envelops an inflatable colon enema and is composed of meltable or dissolvable material that can deodorize, disinfect, function as a laxative,, or as a medicine does not exist either.

Accordingly, it is an object and advantage of the present invention to provide a suppository that envelops an inflatable colon enema for insertion the colon enema device and/or a rectal catheter. The inflatable colon enema is made of an inflatable ring-shaped balloon with a wide sleeve attached to it. Before being inflated, the ring-shaped balloon is coated with meltable or dissolvable material and molded into the shape of a suppository to ease the insertion of the device or catheter into the anal, rectal, or colon canal of a patient . It is a further aspect and advantage of the present invention to provide an additional balloon, outside the patient's body, to have an indication of the pressure of the inflated balloon inside the colon.

It is another object and advantage of the present invention to provide a method of making an inflatable enema that is inserted with the help of a suppository, which enema/catheter system provides colonic lavage to a patient wherein the suppository has been molded into a shape that can be inserted into the anal canal of a patient.

It is another object and advantage of the present invention to provide an apparatus and method that is cost effective, environmentally safe and produces minimal waste hazard or problems, and would allow easy and less painful inserting of a rectal catheter/enema into the rectum or colon area of a person or animal.

It is an object of the present invention to overcome the problems and limitations of the prior art that have been discussed. It is also another object of the present invention to be able to apply the principles and advantages of this invention to other related applications (i.e. including but not limited to animals).

There is thus provided according to an embodiment of the present invention, an inflatable colon enema system for enabling the access to a colon of a mammal, the system including; a) an inflatable folded colon enema device including; i) a hollow sleeve having a proximal end with an inflatable cuff and a control balloon disposed at a distal end; and ii) a tube for with a first end disposed inside the inflatable cuff and a second end, b) a formable material adapted to cover the inflatable cuff, the proximal end and optionally an intermediate portion of the sleeve disposed between the proximal and distal ends to form a suppository; and c) an inflating device connected to the second end, wherein the suppository is constructed and configured to be introduced into an anal canal of the mammal and further adapted to form a toroidal ring from the inflatable cuff upon inflation thereof and further to enable unfolding of the sleeve, wherein the toroidal ring and sleeve unfold into a funnel-like shape, the funnel like shape serving to funnel fecal matter out of the body of the mammal. Further, according to an embodiment of the present invention, the hollow sleeve is made of a plastic material. Additionally, according to an embodiment of the present invention, the plastic material is selected from the group consisting of polyethylene, polypropylene, and polyurethane. Yet further, according to an embodiment of the present invention, the hollow sleeve is made of a sheet material of a thickness in the range of 10 to 150 micron.

Moreover, according to an embodiment of the present invention, n the inflatable cuff further includes a seal encompassing a lower edge thereof.

Further, according to an embodiment of the present invention, the tube includes a one way valve.

Additionally, according to an embodiment of the present invention, the inflating device is a syringe. Yet further, according to an embodiment of the present invention, the inflating device is adapted to pump one of air and a liquid into the inflatable cuff via the tube.

Moreover, according to an embodiment of the present invention, the formable material is a water soluble polymer. In some cases, the water soluble polymer is selected from the group consisting of polyethylene oxide, polyethylene glycol, polyacrylamide, polyvinyl pyrolidone, and a polyacrylic material.

There is thus provided according to an embodiment of the present invention, an inflatable colon enema method for enabling the access to a colon of a mammal, the method including; a. providing the inflatable colon enema system, as described herein; b. inserting the suppository into the anal canal of the mammal so as to unfold the device; and c. inflating the inflatable cuff, thereby forming a funnel shape with the sleeve and enabling funneling of fecal matter out of the body of the mammal

Yet further, according to an embodiment of the present invention, the mammal is a human patient.

Additionally, according to an embodiment of the present invention, the inserting step is designed to unfolding the device by unrolling of the sleeve.

Moreover, according to an embodiment of the present invention, the unrolling step is adapted to reduce discomfort to the patient.

Yet further, according to an embodiment of the present invention, an order of the unfolding step favors the inclusion of the fecal matter inside the funnel shape relative to the colon.

Additionally, according to an embodiment of the present invention, the order of the unfolding step minimizes the formation of kinks in the inflated cuff. Yet further, according to an embodiment of the present invention, the unfolding step allows for gradual unfolding of the sleeve under pressure.

Moreover, according to an embodiment of the present invention, inserting step further includes at least partially dissolving the suppository prior to the unfolding step.

Furthermore, according to an embodiment of the present invention, the dissolving step depends upon a distribution of at least one of thickness and softness of the formable material. Yet further, according to an embodiment of the present invention, the inserting step includes at least one of softening or dissolving the formable inside the body of the mammal responsive to at least one of a) a rise in a temperature of the formable material; and an increase in moisture around material. Yet further, according to an embodiment of the present invention, the method further includes; d. removing at least a part of the formable material from the anal canal.

Yet further, according to an embodiment of the present invention, an external inflatable balloon serves as an indication to an internal pressure of the inflated cuff.

Moreover, according to an embodiment of the present invention the formable material includes a dry powder mixture of alfalfa, calcium sulfate, modified cellulose gum, polyplasdone XL, and magnesium stearate. In some cases, the formable material includes mint and aloe vera.

Yet further, according to an embodiment of the present invention, the formable material performs at least one of the following functions; deodorizes, disinfects, functions as laxative, functions as a medicine, functions as a natural product.

The present invention will be more fully understood from the following detailed description of the preferred embodiments thereof, taken together with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in connection with certain preferred embodiments with reference to the following illustrative figures so that it may be more fully understood.

With specific reference now to the figures in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings:

Fig. 1 is a simplified pictorial illustration showing a side view of an inflated enema in the rectum of a patient, in accordance with an embodiment of the present invention; Fig. 2 is a simplified pictorial illustration of a side view of a suppository before its insertion into a rectum, in accordance with an embodiment of the present invention;

Fig. 3 is a simplified pictorial illustration of a cross sectional view of an enema inflated when outside a patient, in accordance with an embodiment of the present invention; and

Figs. 4A-4D are simplified pictorial illustrations of a method for forming the suppository of Fig. 2, in accordance with an embodiment of the present invention.

In all the figures similar reference numerals identify similar parts.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In the detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that these are specific embodiments and that the present invention may be practiced also in different ways that embody the characterizing features of the invention as described and claimed herein.

A method is described hereinbelow for propelling an inflatable colon enema device 100 (Fig. 1) and/or a rectal catheter through the anal, rectal, or colon canal of a patient. The device itself and its operation are also described hereinbelow.

Reference is now made to Fig. 1, which is a simplified pictorial illustration 100 showing a side view of the inflated enema in the rectum of a patient, in accordance with an embodiment of the present invention. The colon enema 100, when fully inflated and unfolded, comprises a wide soft sleeve 23. At least one end 102 of the sleeve is open and thus has a topologically circular edge 104. This edge is rimmed with a cuff 23 attached to it along the circular edge. When inflated, the cuff forms a toroidal ring-shaped balloon 42 (See Figs. 4A-4D hereinbelow) .

Fig. 1 shows the state of the device following the insertion into an anal canal 32 of a patient. A ring- shaped cuff 21 is disposed in a rectum 31 and a control ring 22 is disposed outside of the patient. The cuff and ring are inflated by the pressure of a gas or liquid, generated by an inflating device 15, such a syringe. Additionally, a one-way valve 46 is disposed on a tube 14, which connects the inflating device to the cuff. The amount of gas or liquid inside the cuff or internal ring 21 is controlled by the size of control ring 22, due to the balance in pressures. Ring-shaped cuff 21 is attached to sleeve 23 that leads through the anal canal 32 and connects to control ring 22. Sleeve 23 is made of thin material that, where squeezed by the anal canal 32, does not exert significant pressure on a sphincter muscle 106 in the anal cannal. Sleeve 23 is wide enough to allow large fecal bodies 108 to go through it.

Sleeve 23 and cuff 21 are made of materials having a texture similar to that of commonly used plastic bag materials. Non-limiting examples of such materials include polyethylene, polypropylene, and polyurethane. The materials should be biocompatible and have no or minimal toxic or harmful effects on biological function. The thickness of the sheet materials of cuff 21 and sleeve 23 typically ranges between 10 and 150 micrometers. A common method of producing this type of sleeve and cuff is by extrusion or dip molding.

Reference is now made to Fig. 3, which is a simplified pictorial illustration of a cross sectional view of an enema 300 inflated when outside a patient, in accordance with an embodiment of the present invention.

Fig. 3 shows a cross-section of enema device 300, comprising sleeve 23 and cuff 21, when inflated outside the body of a patient. A distal end 24 of sleeve 23 can be connected to a bag or other container (not shown) for fecal collection purpose or a bag for enema purposes.

Cuff 21, when fully inflated, has an inner diameter of between 30 and 80 millimeters. Its outer diameter is typically around 5 to 40 millimeters bigger than the inner diameter. The diameter of sleeve 23 is typically close to the inner diameter of cuff 21 and thus ranges typically between 30 and 80 millimeters. The diameter of sleeve 23 does not have to be uniform along a longitudinal axis of the sleeve, but rather can be designed to vary, depending on such requirements as the desired folding order, unfolding dynamics, and for other reasons. Therefore, the cylindrical shape of sleeve 23 in Fig. 3 is only a non-limiting example. The inflated ring of cuff 21 does not have to be exactly circular either, neither do any of its cross-sections. The thickness and the nature of the sheet materials of which sleeve 23 and cuff 21 are made do not have to be uniform.

Reference is now made to Fig. 2, which is a simplified pictorial illustration of a side view of a suppository before its insertion into a rectum, in accordance with a preferred embodiment of the present invention. Fig. 2 shows the device before its insertion into the rectum of the patient.

As shown in Fig. 2, a suppository 10 envelops a deflated cuff 16. Suppository 10 has the general ovular shape, general egg shape, or any other appropriate shape (not shown) . An extension 11 of sleeve 23 hangs out of suppository 10. An operator inserts suppository 10 into anus 31 shown in Fig. 1. Tube 14 is connected to pre inflated cuff 16, which becomes inflated cuff 21 (see Fig. 1) and control ring 22 to enable the introduction of gas or liquid by syringe 15 into both inflating cuff 21 and control ring 22.

For propelling suppository 10 (Fig. 2), which is the coated enema) through the anal, rectal, or colon canal of a patient, the suppository is gently inserted into the anal canal and rectum into the large intestine beyond the rectum. A part of the sleeve always remains outside of the body of the patient. The coating material (of suppository 10) can be made such that it either softens or dissolves inside the body of the patient, or both. The two changes can be caused by such factors as rising temperature or moisture around the enema within the body. Neither softening nor dissolving is essential for the method, but is often desirable. As an alternative to softening or dissolving, the coating material can be withdrawn from the anal canal after the inflation of the cuff, while the inflated cuff and the part of the sleeve attached to the cuff remain inside the body of the patient .

While the inflatable cuff is inside the body of the patient, the operator inflates the cuff by pumping gas or liquid through thin tube 14 into the cuff by means of syringe 15. The diameter of tube 14 is typically between 0.5 and 20 millimeters. A one way valve 46 can optionally be used in tube 14 or syringe 15. The volume of air or liquid to be pumped by the syringe should be pre-defined and known to be sufficient to ensure that the cuff will assume the required shape and resilience. Dip molding is one way to make tube 14 together with cuff 21, if both are made of the same material, which is one possibility. Upon the inflation of cuff 21 (Fig. 1) , it assumes its toroidal ring shape within the patient. As cuff 21 (Fig. 1) expands, the portion of sleeve 23 in the body tract between anus 31 and cuff 21 unfolds into a funnel-like shape, see Fig. 1. Sleeve 23 subsequently serves to funnel fecal matter out of the body of the patient. The inflated ring-like shape of cuff 21 (Fig. 1) keeps the outer edge of the funnel away from the anal canal.

Optionally, a second, smaller inflatable ring, (not shown) , concentric with cuff 21, can be imbedded in the sleeve. The smaller (inner) ring can be inflated instead of cuff 21 ring during the time of inaction of the enema, to minimize the feel of the enema presence in the tract of the patient. If the two rings are inflated simultaneously, extra stability is provided to the shape of the enema. This is especially true if the inflation pressure in the inner ring is higher than that of the outer ring. Thus the more resilient inner ring provides shape stability, while the softer outer ring fits the shape of the body tract without folding up by kinking. Furthermore, inflating the inner ring before the outer one minimizes kinking and folding up of both.

. Since cuff 21 is inflated under low pressure, it may be sufficient to fill the shape of the ring and because sleeve 23 is soft, and they adapt themselves to the shape of the body canal, in which they are located. Thus they exert little pressure on the canal wall.

The end of sleeve 23 that is attached to cuff 21 is located inside the body of the patient, on the inner side of the anus. The other end of the sleeve is located on the outer side of the anus, outside of the body of the patient. Between the two ends of the sleeve, anus 31 of the patient is sleeve 23. Being soft, sleeve 23 essentially assumes the shape of the anal canal with minimal discomfort to the patient. The sleeve reopens when liquid or solid materials move inside sleeve 23 through the anal canal. Optionally, a flexible soft surface is created in the sphincter area, thereby decreasing the external pressure required to open it.

Optionally, a control balloon 25 (ring) , disposed outside the patient's body, provides an indication of the pressure of the inflated balloon inside the colon.

Reference is now made to Figs. AA-AO, which are simplified pictorial illustrations of a method for forming the suppository of Fig. 2, in accordance with an embodiment of the present invention. As can be seen in Fig. 4A, enema 400, similar or identical to colon enema device 100 (Fig. 1) , is formed from plastic sleeve with an upper end 42 folded over and sealed with a seal line 44 forming a circle, parallel and below end 104. . At a preliminary stage, before the patient is treated, cuff 21 is deflated and sleeve 23 is folded with longitudinal folds 50 (Fig. 4C) . Additionally or alternatively an enema device 500 may be wound spirally (Fig. 4B) . Thereafter, the folded cuff 21 or part thereof, together with part of sleeve 23, is then coated with a coating material 40 (Fig. 4C) . The coating material should be soft enough to be molded into an appropriate shape. The required softness can be achieved, if necessary, by warming or soaking in a liquid. The shape, such as a suppository 10 or candle- like, is appropriate for subsequent insertion into the anal, rectal, or colon canal of a patient. One example of such as shape of the suppository is shown in a colon enema device 700 in Fig. 4D. Examples of coating materials include combinations of a dry powder mixture of alfalfa, calcium sulfate, modified cellulose gum, polyplasdone XL, magnesium stearate, and a variety of materials commonly used for manufacturing rectal suppositories, known in the art. The dry powder mixture can further include mint and aloe Vera. The coating is then hardened for its shape to be preserved. This can be done, for example, by cooling or drying of the coated enema, depending on the coating material. The coated enema thus forms a suppository, such as suppository 10 in Fig. 2. The hardness should be sufficient for subsequent insertion into the anal, rectal, or colon canal of a patient. The hardening of the coating essentially completes the manufacturing of suppository 10, which then be stored for later use.

One application of this enema/catheter system 100 is for assisting patients suffering from fecal incontinence, to minimize their embarrassment in society. Additionally, in care facilities, it may be used to ease the task of health care staff. Additionally, it reduces the requirement for adult diapers and the associated hygiene and environmental problems associated therewith.

In this usage, the funnel part of the device

(located in the colon) funnels the discharged matter through the portion of sleeve 23 that is in the anal canal and further into the portion of sleeve 23 that is located outside the body. There, sleeve 23 is connected to a bag or container (not shown) , outside the body.

Alternatively, the movement of feces through the anal canal can be temporarily blocked by inserting a blocking means. In another application, the enema of the present invention is used to provide colonic alleviation and to collect feces resulting from such alleviation. For this purpose, alleviating liquid can be pumped into the colon through sleeve 23. Then sleeve 23 is squeezed to block passage through it, then connected to a collector of feces and then the sleeve is reopened to allow defecation. Fecal matter is collected outside the body in an easy and neat manner, unavailable in conventional enema procedures.

Yet another application of enema/catheter system 100 provides a method for colonic lavage, due to the soft material sleeve that eases the sensitivity of the rectal tissues, when the device is placed therein, in comparison to a large diameter tube, for example.

Once the enema is no longer needed inside the body tract of the patient, the enema is deflated and withdrawn by gently pulling it out.

The material used for the coating material of suppository 10 can have further properties or characteristics of a deodorizer or a disinfectant or can function as a laxative or a type of medicine that benefits the colon or rectal area of a patient. The coating can also be made of a natural product (e.g. made of herbs and other such components) , which can easily soften or dissolve within the patient without any serious risks or hazards to the patient. A natural product of suppository 10, which is not considered a medicine or drug, would have the further advantage of not being an environmental hazard and would not pose any serious waste disposal issues. The natural product of suppository 10 may not have to be as strictly scrutinized by the Food and Drug Administration (FDA) if suppository 10 is not classified as a drug or medicine.

Furthermore, the principles and advantages of the present invention can be applied to not only to humans but also to animals, as well as to body tracts other than anal, rectal, and colonic tracts. The invention could also be used for additional applications. As stated earlier, a dissolvable suppository 10 for a colon hydrotherapy spectrum system that comprises dissolvable material, which can deodorize, disinfect, function as a laxative, or a medicine has been disclosed by the present invention. Suppository 10 has the further advantage in that it can be made of natural products

(i.e. made of herbs and other such components) that can be easily dissolved within the patient without any serious risk or hazard to the patient. A natural product of dissolvable suppository 10 that is not considered a drug or medicine has the further advantage of not being an environmental hazard and would not pose a large waste disposal issue. The natural product classification of suppository 10 could avoid the high standard of scrutiny for drugs and medicines that are set by the Food and Drug Administration (FDA) . Furthermore, the principles and advantages of the present invention can be applied not only to humans, but also to animals. It could also be applied to any other related applications.

The foregoing description of a preferred embodiment and best mode of the invention known to applicant at the time of filing the application has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in the light of the above teaching. The embodiment was chosen and described in order to best explain the principles of the invention and its practical application to thereby enable other skilled in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. The references cited herein teach many principles that are applicable to the present invention. Therefore the full contents of these publications are incorporated by reference herein where appropriate for teachings of additional or alternative details, features and/or technical background.

It is to be understood that the invention is not limited in its application to the details set forth in the description contained herein or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Those skilled in the art will readily appreciate that various modifications and changes can be applied to the embodiments of the invention as hereinbefore described without departing from its scope, defined in and by the appended claims.

Claims

1. An inflatable colon enema system for enabling an access to a colon of a mammal, the system comprising: a) an inflatable folded colon enema device comprising: i) a hollow sleeve having a proximal end with an inflatable cuff and a control balloon disposed at a distal end; and ii) a tube for with a first end disposed inside the inflatable cuff and a second end, b) a formable material adapted to cover the inflatable cuff, the proximal end and optionally an intermediate portion of the sleeve disposed between the proximal and distal ends to form a suppository; and c) an inflating device connected to the second end, wherein said suppository is constructed and configured to be introduced into an anal canal of the mammal and further adapted to form a toroidal ring from said inflatable cuff upon inflation thereof and further to enable unfolding of the sleeve, wherein said toroidal ring and sleeve unfold into a funnel-like shape, said funnel like shape serving to funnel fecal matter out of the body of the mammal.

2. An inflatable colon enema system according to claim 1, wherein said hollow sleeve is made of a plastic material .

3. An inflatable colon enema system according to claim 2, wherein said plastic material is selected from the group consisting of polyethylene, polypropylene, and polyurethane .

4. An inflatable colon enema system according to claim 2, wherein said hollow sleeve is made of a sheet material of a thickness in the range of 10 to 150 micron.

5. An inflatable colon enema system according to claim 2, wherein said inflatable cuff further comprises a seal encompassing a lower edge thereof.

6. An inflatable colon enema system according to claim 1, wherein said tube comprises a one way valve.

7. An inflatable colon enema system according to claim 6, wherein said inflating device is a syringe.

8. An inflatable colon enema system according to claim 7, wherein said inflating device is adapted to pump one of air and a liquid into said inflatable cuff via said tube.

9. An inflatable colon enema system according to claim 1, wherein said formable material is a water soluble polymer.

10. An inflatable colon enema system according to claim 9, wherein said water soluble polymer is selected from the group consisting of polyethylene oxide, polyethylene glycol, polyacrylamide, polyvinyl pyrolidone, and a polyacrylic.

11. An inflatable, colon enema method for enabling an access to a colon of a mammal, the method comprising: a. providing the inflatable colon enema system, according to any of claims 1-10; b. inserting the suppository into the anal canal of the mammal so as to unfold the device; and c. inflating the inflatable cuff, thereby forming a funnel shape with said sleeve and enabling funneling of fecal matter out of the body of the mammal

12. An inflatable colon enema method according to claim 11, wherein the mammal is a human patient.

13. An inflatable colon enema method according to claim 12, wherein said inserting step is designed to unfolding the device by unrolling of the sleeve.

14. An inflatable colon enema method according to claim 13, wherein said unrolling step is adapted to reduce discomfort to the patient.

15. An inflatable colon enema method according to claim 14, wherein an order of said unfolding step favors the inclusion of said fecal matter inside said funnel shape relative to said colon.

16. An inflatable colon enema method according to claim 15, wherein said order of said unfolding step minimizes the formation of kinks in the inflated cuff.

17. An inflatable colon enema method according to claim 15, wherein said unfolding step allows for gradual unfolding of the sleeve under pressure.

18. An inflatable colon enema method according to claim 17, wherein inserting step further comprises at least partially dissolving said suppository prior to said unfolding step.

19. An inflatable colon enema method according to claim 18, wherein said dissolving step depends upon a distribution of at least one of thickness and softness of said formable material.

20. An inflatable colon enema method according to claim 11, wherein the inserting step comprises at least one of softening or dissolving the formable inside the body of the mammal responsive to at least one of a) a rise in a temperature of the formable material; and b) an increase in moisture around material.

21. An inflatable colon enema method according to claim 20, further comprising: removing at least a part of said formable material from said anal canal .

22. An inflatable colon enema method according to claim 21, wherein an external inflatable balloon serves as an indication to an internal pressure of the inflated

5 cuff.

23. An inflatable colon enema method according to claim 21, wherein the formable material comprises a dry powder mixture of alfalfa, calcium sulfate, modified cellulose gum, polyplasdone XL, and magnesium stearate.

.0 24. An inflatable colon enema method according to claim 23, wherein said formable material comprises mint and aloe vera.

25. An inflatable colon enema method according to claim 22, wherein said formable material performs at

L5 least one of the following functions: deodorizes, disinfects, functions as laxative, functions as a medicine, functions as a natural product.

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