An enema nozzle arranged for stimulating peristalsis, and an enema system comprising said enema nozzle

Abstract

The present invention relates to an enema nozzle (1;1';1'') arranged for delivering an enema to a user and for initiating peristalsis, said enema nozzle (1;1';1'') comprises a catheter (2) and a flexible stimulation member (3;3') that at least partly surrounds the catheter (2), and wherein said flexible stimulation member (3;3') defines a first flow channel (11;11') arranged such that there is an enema flow through and / or in said first flow channel (11;11') during the entire enema administration procedure. By using the enema nozzle (1;1';1''), the patient in need of bowel management can administer an enema and at the same time stimulate the rectal nerves thereby initiating peristalsis, i.e. induce a reflex bowel movement to open and allow stool to exit the body.

Description

[0001]An enema nozzle arranged for stimulating peristalsis, and an enema system comprising said enema nozzle The present invention relates to an enema nozzle arranged for delivering an enema and for initiating peristalsis, and an enema system comprising said enema nozzle. A large number of people experience the inability to empty the bowels spontaneously and accordingly becomes reliant on onerous and time-consuming bowel programs to manage constipation and stool retention. Others may develop stool incontinence secondary to constipation or anal sphincter weakness. Such bowel dysfunctions have a deleterious effect on patients’ health and quality of life, and patients often find their symptoms to be socially disabling. Although bowel dysfunction is a common event, to date the condition is still surrounded by stigma and taboo. There has been a number of different ways to activate bowel movements includes abdominal massage; manual removal of stool; administration of an enema; and digital rectal stimulation. Where abdominal massage and manual removal of stool is self explanatory, digital stimulation (also called digital rectal stimulation) aims at initiating peristalsis i.e. encourage a loosening of the anal sphincter in order to pass the stool. Digital stimulation involves the insertion of a well-lubricated finger (or dilstick) into the rectum with stimulation applied in a circular manner with finger tip pointing towards the spine (and away from the bladder) to provide physical stimulation of the nerves in the rectal wall. Digital rectal stimulation is an inexpensive intervention, requiring limited supplies, and is often used as part of a daily bowel routine as it stimulates peristalsis and bowel evacuation. However, digital stimulation is time-consuming and requires the assistance of another person. Accordingly, the patient often finds the performance of digital stimulation to be stressful, discomfortable, and demeaning. Mechanical devices (dilsticks) used for digital stimulation are generally made of hard metal and / or plastic and are normally difficult and uncomfortable to use. Furthermore, the anatomy of the rectal cavity may prevent adequate stimulation of the nerves of the rectum when such mechanical devices are used. WO2011 / 063243 describes a rectal stimulation device aiming at overcoming said problems. The device comprises a squeeze bulb, a hollow insertion portion, and a balloon overlying said insertion body. In order to initiates peristalsis, the user inserts the insertion portion and the balloon into the rectum, and applies pressure to the squeeze bulb, whereby fluid distends the balloon and stimulates the rectal nerves. Upon release of the squeeze bulb, the balloon returns to its undistended shape. Even though this device can be used by the patient him- or herself person, the system has a number of drawbacks. For instance, since it is unknown how much the balloon is distended, it is possible to either dilate the balloon to much, causing damage to the rectal wall, or too little not obtaining the desired digital rectal stimulation at all. Since the fluid in the device is placed in a closed system, it is impossible to e.g. add / remove fluid from the device if desired, in order to adjust the distension of the balloon. Furthermore, since the balloon is not able to provide a seal between the balloon and the rectum / rectal wall, the surroundings may be contaminated with bodily excretions during the process. Administration of an enema is a common medical procedure whereby a liquid (enema) is injected into the rectum and lower intestine of a patient in order to induce bowel movement. The need for such a procedure typically arises in patients suffering from certain physical ailments in which voluntary bowel control is impaired or when the bowel needs to be cleaned before e.g. a coloscopy or a surgical operation. However, it can be difficult for the patient to self-administer the enema since the conventional enema devices often causes discomfort and irritation when being inserted. Moreover, it is difficult for the patient to administer the enema while steadily holding the enema nozzle in place during the procedure. Often another individual assists the patient but assistance may not always be available, if for instance, the patient lives alone. In order to overcome these problems, a number of enema devices, comprising different retention means for retaining the nozzle in the rectum / colon during administration of the enema have been developed. Such a device is e.g. disclosed in US5,074,842 which describes an irrigation device having a fixation balloon that is inflated using air, and wherein the air is delivered through a syringe valve communicating with an air passage. Similar systems are known from EP1531885, which describes an irrigation device comprising a liquid reservoir and an air-inflated balloon for fixation of a tubular part inserted in the rectum, and WO2011023196, which describes a system which uses liquid to inflate the balloon / retention member. Use of an air-filled retention balloon has the problem that the balloon will react to the body movements, e.g. peristaltic reflexes, whereby the nozzle inconveniently may be displaced causing leakage, and the air from the balloon cannot be delivered to the colon as this will result in an additional distention or dilation of the colon resulting in pain and discomfort for the patient. A further problem with the use of inflated balloons is that if the balloon is overfilled the balloon may rupture causing both damage to the fragile wall of the colon / rectum and leakage of the liquid filled content of the colon / rectum. Furthermore, if the balloon is filled too little it cannot safely keep the enema nozzle in place during use. This is not only unwelcoming for the patient but also very demeaning, as the surroundings inevitability will be contaminated with irrigation liquid and bodily excretions if the enema nozzle unintentionally falls out. As stated earlier some patents may benefit from both digital rectal stimulation and administration of an enema, however since these are two different actions, it is presently not possible to both administer an enema and at the same time initiates peristalsis using digital stimulation. It is therefore a first aspect of the present invention to provide an enema nozzle which both can administer an enema and provide digital rectal stimulation in order to initiate peristalsis. It is a second aspect of the present invention to provide an enema nozzle which easily can be retained in the colon / rectum without use of an expandable retention means e.g. an inflatable balloon. It is a third aspect of the present invention to provide an enema nozzle arranged for being connected to an enema device, which nozzle can be inserted into an opening to be irrigated, without causing discomfort, trauma and / or injuries. It is a fourth aspect of the present invention to provide an enema nozzle that is inexpensive to manufacture and is simple and reliable to use, and which is relatively small and easy to operate. These and further aspects are achieved according to the present invention by providing an enema nozzle arranged for administering an enema to a user, said enema nozzle comprises a catheter and a flexible stimulation member that at least partly surrounds the catheter, and wherein said flexible stimulation member defines a first flow channel arranged such that there is an enema flow through and / or in said first flow channel during the enema administration procedure, i.e. when enema is administered to the user. In a first embodiment the first flow channel is an open flow channel and is arranged for administering at least a part of the enema directly to a user via an outlet. Within the context of the present invention the term ‘‘an open flow channel’’ means a flow channel open at both ends, i.e. liquid can flow through said flow channel. Thus, in a first embodiment according to the invention enema will flow into the first flow channel at one end, preferably at the proximal end of the flow channel, and out of the flow channel in the opposite end, preferably at the distal end of the flow channel. In the present application, the distal end of the enema nozzle (and its parts), is the end inserted first into the rectum of a user. In a second embodiment the first flow channel is a blind flow channel and is arranged for administering at least a part of the enema to a user via a second flow channel. Within the context of the present invention the term ‘‘a blind flow channel’’ means a flow channel having only one open end, and the enema will flow into and out of the flow channel through said open end. The remaining part of the flow channel is closed. The open end of the flow channel is preferably located at the proximal end of the flow channel. The first and second flow channels are in fluid communication with each other via the open end of the first flow channel. Since the first flow channel is blind, enema cannot be delivered directly to the user via said first flow channel as in the first embodiment. During administration of the enema, the first flow channel will be filled with enema and as more enema is added to said first flow channel during the enema administration procedure, the enema in the first flow channel will due to fluid dynamics flow and / or circulate in the first flow channel and then be forced into the second flow channel from where it can be delivered to the user. Accordingly enema is indirectly administered to a user from the first flow channel via the second flow channel. Within the context of the present invention the term ‘‘enema flow’’ means that at least a part of the enema moves from one place to another. In the first embodiment all or a part of the enema is transferred (flows) through the first flow channel and in the second embodiment a part of the enema moves in (within) the first flow channel and is transferred from the first flow channel to the second flow channel, and thereafter to the user. Thus, for both embodiments least some of the enema will flow through / in the first flow channel of the flexible stimulation member. The enema nozzle of the first embodiment may also comprise a second flow channel arranged for administering at least a part of the enema to the user, i.e. enema will be administered to the user via both the first and second flow channel. In the second embodiment the enema nozzle according to the invention may be arranged such that at least part of the enema is directly transferred to the second flow channel. Thus, a part of the enema is transferred to the second flow channel via the first flow channel, and some of the enema is transferred directly to the second flow channel. Such embodiments, i.e. embodiments in which the enema is administered directly to the user via the second flow channel, is especially advantageously if it is desired to provide a faster delivery of enema, as a enema administered to the user, will by-pass, i.e. not flow through, the flexible stimulation member. Preferably, the second flow channel is extending inside the catheter in both the first and second embodiment of the enema nozzle according to the invention. In both embodiments the stimulation member will distend as liquid (enema) is added to the first flow channel of the stimulation member. However, as liquid is simultaneously administered to the patient from said stimulation member (either directly in the first embodiment or indirectly in the second embodiment) and accordingly flows out of the first flow channel, said stimulation member will only be slightly distended. In this respect the inventors of the present invention have found that the distension obtained when liquid (enema) flows though (first embodiment) or in (second embodiment) the flexible stimulation member will stimulate the rectal nerves by providing a gentle, adjustable, and flexible stimulation and accordingly initiate peristalsis. Without being bound by theory, it is believed that the enema flowing though / in the flexible stimulation member together with the administered enema will stimulate the nerves in the rectal wall; causing a reflex reaction that is a defecatory response of the lower bowel. Thus, the stimulation member will stimulate the same nerves as stimulated by conventional digital rectal stimulation using a finger or dilstick. However, by using the enema nozzle according to the invention the patient is able to obtain said stimulation at home, without the need of a helper. The reflex reaction provided by the flow of enema through / in the flexible stimulation member includes the initiation of peristaltic waves beginning at the splenic flexure, which is the start of the descending colon, down through the sigmoid, and into the rectum. This response also includes relaxation of the internal anal sphincter, which enables emptying of the lower bowel. Thus, by using the enema nozzle according to the invention, the patient in need of bowel management can administer an enema and at the same time stimulate the rectal nerves thereby initiating peristalsis, i.e. induce a reflex bowel movement to open and allow stool to exit the body. It has further been found that the enema (liquid) flowing through / in the stimulation member also activates the user’s anal sphincters, and ensures that said muscles are contracted and maintained in a substantially contracted condition during the administration of the enema. In this way the enema nozzle can be maintained in place in the rectum / colon without a conventional retention member during the enema administration, while at the same time preventing leakage of bodily fluids and / or enema. Thus, the enema nozzle according to the invention ensures that the rectal nerves are stimulated causing peristalsis, while at the same time ensuring that the user’s anal sphincters remains contracted during the administration procedure effectively preventing leakage to the surroundings. The inventors of the present invention has found that the stimulation of the rectal nerves is even more effective if the enema flowing though / in the stimulation member is delivered to the stimulation member as a discontinuous flow, as this will create a pulsating motion in said stimulation member. By ‘‘discontinuous flow’’ is meant that the enema is delivered to the flexible stimulation member in stages with intervals between each delivery, preferably in a periodic manner. The periods and intervals may be the same throughout the administration procedure, or they may differ, depending on the requirements of a user. The administration of the discontinuous flow may be effected in a number of different ways e.g. manually by simply using a squeeze bulb to deliver the enema, or by using a cyclic pump to delivery the enema. It is preferred that the flexible stimulation member is arranged for only distending / expanding slightly, and only to an extent sufficiently for initiating peristalsis and / or activating the user’s anal sphincters, and ensure that said muscles are contracted and maintained in a substantially contracted condition when the enema nozzle is placed in the rectum. Accordingly, the flexible stimulation member is preferably made of a material which is sufficiently rigid to prevent the stimulation member to distend (stretch or expand) too much when enema flow through / in said member, but will have some measure of flexibility to facilitate the desired distention. It is in this respect preferred that the flexible stimulation member is made of a material with a shore A hardness from 25 to 50 as measured in accordance with ASTM D2240. The best results have been provided when the stimulation member tip has a shore A hardness from 30 to 45, preferably about 30. The elasticity of the material used for the flexible stimulation member, i.e. the ability of the deformed flexible stimulation member to return to its original shape and size when the forces causing deformation are removed, is preferably from 200% to 1000%, i.e. the material of the flexible stimulation member can be extended from 200% to 1000% in any direction. It is however preferred that said material can be extended from 300% to 700%, e.g. about 400%, 500% or 600%. Said elasticity can be calculated using Hook’s law and / or by conventional testing methods. It is preferred that the flexible stimulation member is arranged to expand in a direction substantially perpendicular to the longitudinal axis of the catheter. It is in this respect preferred that when enema is flowing through / in the flexible stimulation member the cross-sectional diameter of the flexible stimulation member, has increased less than 50% even more preferred less than 30% and even more preferred less than 15%, compared to the cross sectional diameter of the flexible stimulation member when there is no enema flow though said stimulation member. The flexible stimulation member may increase more, e.g. about 100%, and even though this is not preferred, it may be relevant for some patients in dependence of their anatomy. The cross-sectional diameter may in this respect be taken in a plane perpendicular to the longitudinal axis of the catheter in an area where the flexible stimulation member surrounds the catheter. Thus, if the flexible stimulation member has a cross-sectional diameter of 13 mm when no enema is flowing though the first flow channel, then the cross-sectional diameter when enema is flowing through said first channel is less than about 20 mm, preferably less then about 17 mm, and even more preferred about 15 or 16 mm. The flexible stimulation member may in some embodiments distend uniformly over its entire length, and in other with an increasing distention towards one or more sections of the flexible stimulation member. For instance, the flexible stimulation member has its maximal distension in the middle section, and said distension is gradually decreasing towards the distal and proximal ends of the flexible stimulation member. It is furthermore preferred that the flexible stimulation member cannot, or only to a limited extent (less than 5%), expand in the longitudinal direction. The difference is distention over the length of the flexible stimulation member, may e.g. be obtained by making certain sections of the flexible stimulation member less flexible than the remaining parts of the stimulation member, e.g. by placing reinforcements at specific sections of the flexible stimulation member, e.g. the ends; or it may be obtained by the way the flexible stimulation member is attached to the catheter e.g. by glue or welding. In order to provide an enema nozzle which is both small and easy to operate, has a consistent and aesthetic appearance for the user both before and after use, and / or provide the desired limited distention of said flexible stimulation member, it is preferred that the flexible stimulation member has a predefined shape and is made of a material with an shape memory, i.e. the flexible stimulation member will return to its predefined shape when said retention member is not subjected to external or internal forces. Such a predefines shape also assist in creating a pulsating motion when the enema is administered in a discontinuous flow, as the flexible stimulation member will return to it’s original shape in intervals where no enema is administered via said stimulation member. In a similar way the stimulation member can have intermediates shapes etc. depending on the volume of enema administered. It is preferred that the flexible stimulation member is made of a relatively thin material e.g. a polymer film (e.g. silicone) having a thickness from 0.3 to 1.0 mm, preferably from 0.3 mm to 0.5 mm, as a flexible stimulation member made of a film with said thickness provides a durable and safe system, and at the same time ensures that the rectal nerves easily can be stimulated by the enema flowing through the stimulation member and accordingly initiate peristalsis and / or activate / contract the user’s anal sphincters. The flexible stimulation member may be made of any soft, resilient, flexible and biocompatible material that is able to provide the desired properties of the flexible stimulation member and at the same time resists tearing, and decomposition. Examples are natural rubber, synthetic rubber, silicone, latex, urethane (polyurethane), polyvinylchloride, polyethylene, or any other expandable elastomer, polymer or other similar material. The properties of the material used for the flexible stimulation member may be altered, e.g. by changing the length of the polymer chains, creating branched chains from linear polymer chains, cross linking the polymer chains and / or adding plasticizers into the polymer. In an especially advantages embodiment the flexible stimulation member is made of a silicone, as said material is both flexible but still allows the flexible stimulation member to have a predefined shape before use, and at the same time ensures that the material cannot stretch more than desired when enema (liquid) is added to the material. In a preferred embodiment the flexible stimulation member extends along the length of the catheter, and has the form of an elongated tube, elongated pouch or has an elongated pouch- like shape. Within the context of the present invention the term ‘‘pouch’’ refers to a bag, balloon or container arranged along at least part of the catheter. Said tube or pouch may have any form and dimension as long as said tube / pouch is capable of initiating peristalsis, e.g. by providing the desired pulsation motion when enema is administered to the patient via the flexible stimulation member. It is preferred that the first flow channel of the flexible stimulation member is arranged for containing between 1 and 20 ml during the enema administration procedure, i.e. when liquid (enema) is added to said first flow channel, preferably between 2 and 10 ml, and even more preferred between 4 and 8 ml, e.g. around 7 ml. In an alternative embodiment according to the present invention the flexible stimulation member is made of a resilient compressible foam body. The foam body will conform to the shape of the rectal wall, and accordingly provide a very comfortable stimulation member that directly stimulates the rectal nerves. The first flow channel may be arranged in a flexible channel / tube inside the foam body. Alternatively, if the foam body is made of a porous material; the enema may also be administered to the rectum / colon via the surface and / or sides of said foam body. Such an embodiment is especially relevant if the body tissue is inflamed or otherwise damaged, as the pressure from the enema will be distributed over a larger area, thereby reducing any discomfort that the user might otherwise experience. In a preferred embodiment the flexible stimulation member substantially surrounds the entire length of the catheter, thereby ensuring that the recital nerves are stimulated over the entire catheter’s length. Even though the tip of the catheter, i.e. the distal end of the catheter inserted first into the rectum, in some embodiments also can be surrounded by the flexible stimulation member, it is preferred that the tip or at least part of the tip of the catheter is left free, i.e. the flexible stimulation member does not cover (extend over) the insertion tip or at least not the outermost tip of said insertion tip. By leaving the insertion tip free, the possibility that the flexible stimulation member slides / moves relative to the insertion tip during insertion is eliminated, whereby a more reliable and comfortable insertion into the anal opening is obtained. The catheter preferably comprises an elongated insertion body and an insertion tip. In one embodiment the insertion tip is ball-shaped and the elongated insertion body is tube-shaped. It is preferred that the elongated insertion body is substantially straight, i.e. has the same cross-sectional diameter along the entire length of said body. However in an alternative embodiment the elongated insertion body has the shape of a truncated cone, with a top circular base (the base connected to the ball-shaped insertion tip), that is smaller (between 0.3 and 0.9 times) than the bottom circular base. In either case the cross-sectional diameter of the insertion body is smaller than the cross-sectional diameter of the ball-shaped insertion tip in the entire length of the insertion body. Thus, the ball- shaped insertion tip is larger in cross-sectional diameter than the insertion body irrespectively of where the cross-sectional diameter is measured along the elongated insertion tip. Within the context of the present invention the term ‘‘cross- sectional diameter’’ of the elongated insertion body and the ball-shaped insertion tip or other parts of the enema nozzle, means a diameter taken in a plane perpendicular to the longitudinal axis of the elongated insertion body and / or catheter. Furthermore, the term ‘‘ball-shaped’’ means that the insertion tip has the shape of a sphere or a substantial sphere e.g. a spheroid (oblate or prolate) having a minor or major axis that differ less than 5% from each other. The term ‘‘insertion tip’’ refers to the distal section / end of the enema nozzle, i.e. the part which is inserted first in the rectum / colon, and the term ‘‘insertion body’’ refers to the section of the enema nozzle (below the ball-shaped insertion tip) that is intended for being placed at and inside the anal opening. The inventors of the present invention has surprisingly found that using a catheter in the form of a ball-shaped insertion tip and a thinner elongated insertion body, will activate the user’s anal sphincters, and / or enhance the effect obtained by enema flowing though the stimulation member. Thus, the enema nozzle according to the invention is arranged for activating the sphincter muscles and ensures that said muscles are contracted and maintained in a substantially contracted condition when the enema nozzle is placed in the user’s anus / rectum. Thus, when the enema nozzle according to the invention is inserted into a user’s anus, said enema nozzle will initially activate the anal sphincters, i.e. the user’s anal sphincter will remain contracted and hold itself in the substantially contracted condition thereby not only keeping the enema nozzle in place, but also ensure that the irrigation liquid and bodily excretions are maintained in the rectum and colon during the enema administration procedure. Thus, the unique design of the enema nozzle will provide an effective seal with the anal opening. However, when the administration of the enema begins, the enema will flow through / in the flexible stimulation member, and assist in activating the user’s anal sphincters. However, said flexible stimulation member will also begin to stimulate the rectal nerves and initiate peristalsis. When the enema has been delivered to the user about 2 - 10 minutes after the enema nozzle was inserted, the stimulation of the rectal nerves together with the administered enema, will enables an easier emptying of the bowel. It has been found that conventional enema nozzles are incapable of being both retained in rectum / colon and initiate peristalsis in a similar manner as the enema nozzle according to the invention. The inability of such conventional enema nozzles to remain in the rectum / colon is likely due to the form (such as a trumpet head) and / or relatively large cross-sectional diameter (more than 1 cm) of the insertion body / catheter of these conventional enema nozzles that are placed in the anal opening, as such constructions and / or dimensions will stretch the anal sphincter muscles whereby the sphincters cannot contract sufficiently to maintain the enema nozzle in place and / or the keep the fluids in the rectum. Thus, the conventional enema nozzles cannot be held in place (retained) simply by means of the function of the anal sphincters. As a result, the conventional enema nozzles require the aid of more or more retention member(s) that can expand to a large degree, e.g. two to three times, when placed in the rectum. Furthermore, leakage of the enema fluid commonly occurs using these conventional enema nozzles, since the anal sphincters cannot provide a tight fit around the conventional enema nozzles, and this may led to insufficient colonic filling. Accordingly, imperfect procedural results may be obtained, or an insufficient dosage of enema (or medicine if this is administered) may be received by the patient. Thus, by using the enema nozzle according to the invention, said problems are effectively eliminated, as said enema nozzle simply uses the users own anal sphincters both to keep the enema nozzle safely in place and to prevent any leakage. The inventors of the present invention have also found that the insertion of the enema nozzle into the anus / rectum of the patient is even easer than with the known enema nozzles in the art. The use of a ball-shaped insertion tip having a larger cross-sectional diameter than the elongated insertion body ensures that during insertion the squeezing action of the anal sphincters against the insertion body pushes (sucks) the enema nozzle into the rectum, thereby ensuring that the enema nozzle according to the invention will be placed in the correct position in the rectum / colon. The ball-shaped insertion tip preferably has a diameter between about 0.8 cm and about 3 cm, preferably between about 1 and about 2 cm, and even more preferred between about 1.2 cm and about 1.5 cm, e.g. about 1.3 cm. In a preferred embodiment the ball-shaped insertion tip has a cross-sectional diameter which is about 1.2 to 5 times larger than the cross-sectional diameter of the elongated insertion body, preferably between 2 and 4 times, and even more preferred about 2.6 times, as it has been shown that such ratios are especially advantageously for ensuring that the enema nozzle according to the invention is correctly and sealing retained in the rectum during administration of an enema. In a preferred embodiment the flexible stimulation member extends from a middle section of the ball-shaped insertion tip to the proximal end of the elongated insertion body, i.e. said flexible stimulation member surrounds a lower section of the insertion tip, and the entire insertion body, and accordingly provides a smooth transition from the insertion tip to a proximal part of the catheter, e.g. a stop section. The cross- sectional diameter of the flexible stimulation member, when there is no enema flow through / in the first flow channel, e.g. before use, is preferably the same as, or smaller than (less than 10%), the cross-sectional diameter of the ball-shaped insertion tip. In this way the differences in dimension between the ball-shaped insertion tip and insertion body is covered by the flexible stimulation member, and said enema nozzle therefore becomes visually more acceptable to patients. In a preferred embodiment of the enema nozzle according to the invention, the cross-sectional diameter of the ball shaped tip is about 13 mm, the cross-sectional diameter of the insertion body is about 5 mm, and the cross-sectional diameter of the flexible stimulation member is about 13 mm. The catheter and / or insertion body may have any suitable length, depending on the intended delivery site of the enema in the rectum / colon, the longer the insertion body the further into the colon the enema may be delivered. It is however preferred that the insertion body have a length sufficient to place the ball-shaped insertion tip above the dentate line when placed in the rectum of a user, as this will prevent the ball- shaped insertion tip from irritating the sensitive nerve endings that may be positioned within the anal canal between the opening and the dentate line (also referred to as a pectinate line). Thus, is it preferred that the length of the insertion body (i.e. the elongated section of the enema nozzle intended for being placed inside the rectum), taken along the longitudinal axis of the elongated insertion body, is between 3 cm and 7 cm, preferably between 4 cm and 6 cm, and even more preferred about 5 cm as the inventors have found that such a length will place the ball-shaped insertion tip above the dentate line (for most users) and at the same time provide the unique self-retention of the enema nozzle by use of the anal sphincters and obtain the desired stimulation of the rectal nerves and / or anal sphincters when enema flows through the flexible stimulation member. Once the enema is administered and the rectal nerves has been stimulated the enema nozzle can be safely and quickly removed by a simply pulling action. The enema will together with the stimulation of the rectal nerves have initiated peristalsis. Thus, the user can use the restroom when the urge occurs and since the user neither has to deflate a retention member and / or worry about injuries when an expandable retention member folds in upon itself, the administration procedure, including the insertion and removal of the enema nozzle, is safe and can be performed quickly. In some embodiments the enema nozzle may comprise a stop section, e.g. a flared section or annular plate, arranged for preventing the enema nozzle from being pushed and / or sucked to far into the rectum. Said stop section is preferably placed / arranged adjacent to the proximal part of the elongated insertion body. If the flexible stimulation member is made of a relatively thin material (preferably from 0.3 to 0.5 mm) the catheters ability to be sucked into the rectum and provide the self-sealing effect is not compromised, as the flexible stimulation member will collapse around the elongated insertion body during insertion into the body opening, and accordingly not increase the thickness of the elongated insertion body to an extend that will affect said effects. The flexible stimulation member is preferably attached to the insertion tip along the circumference of said tip in a plane perpendicular to the longitudinal axis of the insertion part. Said plane may in a preferred embodiment go though the center of the ball-shaped insertion tip. The retention member may be attached to the catheter and / or enema nozzle in any suitable way, e.g. via gluing or welding. In the first embodiment of the enema nozzle according to the invention, the outlet of the first flow channel either is in fluid communication with at least one first delivery opening for delivering the enema to the rectum / colon. Said first delivery opening(s) may in one embodiment be arranged in the side wall of the flexible stimulation member, e.g. as one or more openings just below (e.g. 0.5 - 3 mm) the insertion tip, or as a number (e.g. 2 - 30) of perforations distributed in the walls of said flexible stimulation member allowing enema to be expelled into the rectum in all directions. Such perforations may be evenly or unevenly distributed, depending on which enema delivery pattern is desired. A number of perforations may be particularly desirable where the user's rectum or colon is inflamed or otherwise sensitive to contact by a pressurized stream of enema. It may however be preferred to place the at least one first delivery opening at the end of the tip of the catheter, e.g. the ball-shaped insertion tip, i.e. the at least one first delivery opening extends through the tip of the catheter. This may easily be obtained simply by placing at least one first internal flow channel in the insertion tip. In the second embodiment the second flow channel is arranged for receiving the enema from the blind first flow channel and then delivery said enema to the user via at least one second delivery opening. It is preferred that the second flow channel is placed inside the catheter, preferably the elongated insertion body (e.g. as a channel or tube inside said catheter) and extends into the least one second delivery opening at or near the insertion tip, e.g. via at least one second internal flow channel extending through the ball-shaped insertion tip. In the second embodiment the first flow channel is blind, and accordingly the enema will flow into and out of the first channel via the open end. One or more first flow openings may be provided in the open end of the first flow channel, and enema may flow into and out of the first flow channel via the same one or more first flow openings. Alternatively, the open end comprises at least two second flow openings, wherein at least one is arranged for providing a flow of enema into the first flow channel, and at least one is arranged for providing a flow of enema out of the first flow channel. The direction of the flow in said at least two openings may be controlled by one-way valves or by other means arranged for providing a uni- directional flow. The at least one first or at least two second flow openings are preferably placed at the proximal end or near said proximal end (e.g. 1 mm - 1 cm from said end) of the flexible stimulation member. In this way it is ensured that when enema is added to the first flow channel, said channel will initially be filled with enema, but since enema simultaneously is administered to the user via the second flow channel enema is also removed from the first flow channel. Accordingly enema will flow in and / or circulate in said first flow channel, enhancing the pulsating movements as the stimulation member is slightly distended. In a preferred embodiment according to the invention, the enema nozzle comprises a third flow channel arranged in fluid communication with the first flow channel of the flexible stimulation member, e.g. via a manifold. The manifold may preferably be a chamber, receiving the enema from the third flow channel via at least one first inlet, and which manifold branches into at least one first outlet that leads to the first flow channel. In the second embodiment said first outlet is preferably the at least one first flow opening or one or more of the at least two first flow openings, that leads the enema into the first flow channel. Thus, in a preferred version of the second embodiment according to the present invention, the first and second flow channels are in fluid communication with each other via the manifold. The manifold is preferably arranged at the proximal end of the catheter e.g. at the proximal end of the elongated insertion part, such that when the enema is added to the flexible insertion member, the enema flows in the entire length of said stimulation member in order to provide the desired distension of the stimulation member and accordingly the stimulation of the rectal nerves and / or anal sphincters. When the enema nozzle also comprises a second flow channel, the third flow channel may also extends into the second flow channel, preferably via the at least one second outlet in the manifold. The second flow channel will extend though the entire elongated insertion body or catheter, and extends into at least one second delivery opening at or near the insertion tip, e.g. via at least one second internal flow channel extending thought the ball-shaped insertion tip. Such an embodiment is especially advantageously if it is desired to provide a faster delivery of enema, as all enema administered to the user, will not flow through the flexible stimulation member. The first flow channel, and optionally the second and / or third flow channel, is arranged for being connected to any suitable enema reservoir (delivery container), e.g. a delivery container in a large bed-side irrigation system for the use in medical or hospital facilities and / or a small compact delivery container for home-administration of enema. In an especially advantage embodiment it is the third flow channel that is connected to the enema reservoir, and said third flow channel then distributes the enema to the first flow channel, and optionally the second flow channel. The flow channel(s) may be removable connected to the delivery container by means of conventional coupling unit, e.g. a snap fit or the like. Said coupling unit can e.g. comprise a first coupling part attach to the enema nozzle and a second coupling part attached to the delivery container for providing a fluid communication between the two parts. In an especially simple embodiment the first coupling part is the tube for the first flow channel and the second coupling part is a second tube on the delivery container. Said second tube is preferably adapted for providing a liquid tight fit together with the first tube in order to provide the coupling, e.g. by providing that at least one of the first and second tube is made of a flexible material, such that e.g. the one tube can be placed in the other tube. It is preferred that the catheter is sufficiently rigid to facilitate insertion into the rectum, but will have some measure of flexibility to facilitate bending or shaping the nozzle for comfort as it is inserted into the rectum. In order to provide the desired combination of rigidity / flexibility of the enema nozzle, the catheter may be made of a suitable polymer. Suitable materials in this respect are elastomeric polymers, preferably selected from the group consisting of thermoplastic elastomers (TPE), polypropylene (PP), polyurethane (PU), polyethylene (PE), polyvinyl chloride (PVC), silicone, styrene ethylene butylene styrene (SEBS), thermoplastic polyester elastomer (TPC), thermoplastic styrenic elastomer (TPS), and other similar polymers. The flexibility of the catheter can be altered by conventional means, e.g. by cross linking the polymer chains and / or adding plasticizers into the polymer. In embodiments comprising a ball-shaped insertion tip, it may be preferred that the insertion tip is made of one material, and the elongated insertion body of a different material. For instance the insertion body can be made of a relatively stiff material, thereby providing the longitudinal rigidity and strength required for easily advancing the catheter in the body opening, and the ball-shaped insertion tip can be made of a softer, more elastic, and more flexible material such that the insertion tip can deform and / or flex slightly when it is inserted into the rectum and colon. However in an especially simple embodiment according to the invention, the ball-shaped insertion tip and the elongated insertion body are made of the same material, preferably as an integrated unit. The flexible stimulation member may in one embodiment be attached to the catheter after the catheter has been provided, but is preferred that the flexible stimulation member is connected / attached to the catheter when the catheter is manufactured, e.g. simultaneously. The enema nozzle according to the present invention may be manufactured using any conventional process. It is however preferred that the enema nozzle is manufactured in a single injection molding procedure by 1K injection molding, 2K injection molding or 3K injection molding. 2K or 3K injection molding consists of processing two or three different polymers (or polymer compositions) into an end product by means of one injection molding process. With the 2K and 3K technique a possible assembly step of e.g. the flexible stimulation member and the catheter is prevented. This technology enables a simple and effective manner of integrating the properties of the polymers into the enema nozzle according to the invention. For instance, the 2K injection molding process can be used to combine two different elastomeric polymers with different properties, e.g. one first elastomeric polymer that will form the catheter and one second elastomeric polymer that will form the flexible stimulation member. The 2K or 3K injection molding process is preferably performed on one machine that is programmed to perform the injection of the polymers in a single cycle. The injection molding may either be a co-injection molding process, a sequential injection molding process or an over molding injection process. The inventors of the present invention has found that inserting the enema nozzle according to the present invention into a body opening e.g. the rectum, requires significantly less force than inserting a conventional enema nozzle as the enema nozzle according to the invention is ‘‘sucked’’ into the rectum, and the present enema nozzle is therefore especially advantageously for disabled patients and / or patients suffering form an impairment e.g. relating to aging, diagnose or trauma. Such patients normally have reduced hand strength and / or dexterity, and the force needed to insert a conventional enema nozzle or / or be digitally stimulated may have the consequence that the user is no longer able to use the device him- or herself. This is remedied by the present enema nozzle, which therefore is excellently suited for use at home. It is preferred that the enema nozzle according to the invention does not comprise any inflatable / expandable retention members, i.e. balloons, or the like, in which air and / or liquid is maintained in a closed system during administration of the enema, in order to keep the enema nozzle in place during use. In this way the risk of an inflatable balloon rupturing and thereby damaging the colon wall, is also eliminated. Furthermore, the enema nozzle according to the invention is easy and simple to use. The enema is allowed to flow though / in the flexible stimulation member during the entire enema administration procedure, whereby the rectal nerves and the anal sphincters automatically is stimulated, and accordingly the user does not have to worry about how to provide the relevant stimulation, e.g. how much liquid should be allowed to be present in the stimulation member etc. Furthermore, the enema nozzle will appear small and harmless especially in comparison with the more complicated enema systems e.g. having tubes for inflating / deflating a balloon, and the enema nozzle can be removed at any time, since the user does not have to deflate or collapse a retention member before removal. The simplicity of the enema nozzle according to the invention ensures that any patient or user, e.g. an elderly person without undue efforts can use the enema nozzle for both self- administrating irrigation liquid / enema and for being digitally stimulated. Since the flexible stimulation member remains pliable, flexible and soft during use, and continues to conform and adapt to the users anatomy, the use of the enema nozzle according to the invention will significantly reduce the discomfort and inconvenience of the patient associated with the known systems. The present invention also relates to an enema system comprising the enema nozzle according to the invention. Said system comprises an enema reservoir in fluid communication with the first flow channel and optionally the second and / or third flow channel. In a preferred embodiment the enema reservoir is an enema delivery container, arranged as a hand held pump. The enema contained in the delivery container is administered by repeatedly squeezing and releasing the delivery container until the desired enema dosage has been administered. During said administration enema will flow though / in the first flow channel of the flexible stimulation member in a discontinuous flow, providing a pulsating movement that effectively will initiate peristalsis and / or activate the anal sphincters. In alternative embodiment enema nozzles is used for larger irrigations systems wherein the enema nozzle is connected to the enema reservoir via a relatively long delivery tube, and wherein the enema system may comprise one or more of pumping means, control means, collection means for the stool, etc. The enema system and / or the enema nozzle may comprises one or more second one-way valve(s) that effectively will prevent backflow of liquid and faces from the colon and / or rectum into the device and said one-way valve(s) will therefore preclude any contamination of the delivery container and it's remaining content, which may occur after administration of the enema to a patient. Furthermore, since backflow efficiently is prevented, the delivery container can easily be used for several applications, e.g. by refilling the container with a second dose of the same - or a different - enema (liquid). The enema system may also comprise one or more one-way valves will prevent any intake of air into the container during use, i.e. the delivery container will remain in a collapsed state, even if the user releases the pressure on said container. This ensures that user easily can expel the remaining content from the delivery container, by alternating applying pressure and releasing said pressure from the container, until the desired dosage or the entire enema content has been expelled from the enema device. As the delivery container collapses when the enema is expelled, the user can furthermore easily fell when the enema has been expelled thereby providing a simple indication to the user, when the desired e.g. entire dosage of enema has been administered, i.e. when the delivery container is in a complete or substantially complete compressed condition. The enema may be any desired liquid such as water, saline, a liquid containing a salt e.g. phosphate, sodium, etc., or a liquid containing a medicament or a softening agent. Even though the enema nozzle and enema system according to the invention is intended for both digitally stimulating and administering an enema to the colon via the rectum, the enema nozzle and device may also be used for irrigation, cleansing and / or infusion into other body cavity, e.g. artificial stomas and fistulas. The invention will be explained in greater detail below, describing only exemplary embodiments of the enema nozzle with reference to the drawing, in which Figs. 1 - 4 shows a first version of a first embodiment of an enema nozzle according to the present invention, Figs. 5 - 6 show a second version of the first embodiment of an enema nozzle according to the present invention, and Figs. 7 - 9 show a version of the second embodiment of an enema nozzle according to the present invention. Figs. 1 - 4 show a first version of a first embodiment of the enema nozzle 1 according to the invention, wherein figs. 1 and 2 shows the enema nozzle 1 without an enema flow through the nozzle and figs. 3 and 4 shows said enema nozzle 1 with an enema flow trough said nozzle. Said enema nozzle 1 comprises a catheter 2 and a flexible stimulation member 3 that surrounds the catheter 2. Said flexible stimulation member 3 has the shape of an elongated tube. As best seen in fig. 2, which is a cross-sectional view of the enema nozzle in fig. 1, the catheter 2 comprises an elongated insertion body 4, a ball-shaped insertion tip 5 arranged at the distal end 6 of the insertion body 4, and a manifold 7 and a flared stop section 8 both arranged at the proximal end 9 of the insertion body. The flexible stimulation member 3 extends from a middle section 10 of the ball-shaped insertion tip 5 to the flared stop section 8, narrowly surrounding the entire elongated insertion body 4. The flexible stimulation member 3 has same cross- sectional diameter (A), when no enema is flowing through the first flow channel, as the cross-sectional diameter (B) of the ball-shaped insertion tip 5. The flexible stimulation member 3 defines a first flow channel 11 that ends in at least one outlet 12a in fluid communication with a number (six in the embodiment shown) of first delivery openings 12b at the tip 13 of the ball-shaped insertion tip 5 via corresponding first internal flow channels 14 that extends though the ball-shaped insertion tip 5. The enema nozzle 1 further comprises a third flow channel 15 arranged in fluid communication with the first flow channel 11 via the manifold 7. In the embodiment shown the manifold 7 is a chamber that receives the enema from the third flow channel 15 via a first inlet 16, and then branch into a number of first outlets 17 that leads the enema into the first flow channel 11. Since the manifold 7 is placed at the proximal end 9 of the elongated insertion body 4, it is ensured that when the enema is added to the enema nozzle 1, the enema will flows along the entire flexible stimulation member 3, thereby stimulating a larger section of the rectal wall. Said manifold 7 is also branched into a second outlet 19 that leads into a second flow channel 20 which extends through the elongated insertion body 4 and extends into a second delivery opening 21 via a second internal channel 22 in the ball-shaped insertion tip 5. When enema is delivered to the enema nozzle 1, and enema begins to flow through the first flow channel 11, the flexible stimulation member 3 will start to distend. However, as enema is simultaneously administered to the patient via the first delivery openings 12b, said stimulation member 3 will only be distended slightly, as is best shown in figs. 3 and 4. The flexible stimulation member 3 is in this respect arranged to expand in a direction substantially perpendicular to the longitudinal axis X of the catheter, and as shown in figs. 3 and 4 the primary distension if provided at a middle section 23 of the flexible stimulation member 3. Thus, when there is an enema flow through the first flow channel 11, see fig. 4, the cross-sectional diameter A’, of the flexible stimulation member 3 is only increased by about 15% of the cross sectional diameter A, see fig. 2, of the catheter when there is no flow through said first flow channel 11. Thus, if the cross sectional diameter A is about 13 mm, then the cross sectional diameter A’ is about 15 mm. However said relatively small distension has proven to be sufficient for providing a gentle, adjustable, and flexible stimulation of the rectal nerves by and accordingly initiate peristalsis and / or activate the anal sphincters. The flexible stimulation member 3 is not or only insignificantly distended in the longitudinal direction of the catheter. The third flow channel 15 is arranged for being connected to any suitable enema reservoir (not shown) via a first coupling part 24. In a preferred embodiment the enema reservoir is an enema delivery container arranged as a hand held pump. During administration enema will initially flow though the third flow channel 15 and via the manifold 7 be divided into the first flow channel 11 of the flexible stimulation member 3 and the second flow channel 20 for direct delivery of the enema to the patient. Figs. 5 and 6 show a second version of a first embodiment of an enema nozzle 1’ according to the invention. Said embodiment corresponds basically to the first version 1, and works in a similar manner, and the same reference numbers are therefore used for like parts. The only difference between the first and second version shown in the figures is that the second version 1’ does not comprise a second flow channel 20, and accordingly all enema is administered directly via the first flow channel 11 of the flexible stimulation member 3. Figs. 7, 8 and 9 shows a preferred version of the second embodiment of an enema nozzle 1’’ according to the invention. Said embodiment corresponds in a number of ways to the first embodiment shown in figs. 1 to 4, and the same reference numbers are therefore used for like parts. The main difference between the first embodiments shown in figs. 1 to 4 and the second embodiment shown in figs. 7 to 9 is that the first flow channel 11’ of the flexible stimulation member 3’ is blind, i.e. the first flow channel 11’ is closed at its distal end, near the ball-shaped insertion tip 5, and enema is delivered to a user via the second flow channel 20 arranged in fluid communication with the first flow channel 11’ via the manifold 7. Thus, enema will flow both into and out of the first channel 11’ via the outlets 17, i.e. in this embodiment the outlets 17 will function as first flow openings 17’, i.e. enema can flow both in and out of the first flow channel 11’. In this way it is ensured that the when enema is added to the first flow channel 11’, said channel will initially be filled with enema, but since enema simultaneously is administered to the user via the second flow channel 20 enema is also removed from the first flow channel 11’. Thus, as for the first embodiments the stimulation member 3’ in the second embodiment will distend as liquid (enema) is added to the first flow channel 11’. However, as liquid is simultaneously forced back to the manifold 7 and transferred to the second flow channel 20, said stimulation member 3’ will only be slightly distended, preferably to the same extent as for the first embodiments. Preferably the enema is added in a pulsating manner, and the rectal nerves will be stimulated in a similar manner as is discussed for the first embodiments. As illustrated with arrows in fig. 9, when enema is administered to a user in the second embodiment the enema flows first through the third flow channel 15 into the manifold 7 from where it is partly distributed to the first flow channel 11’ via the first flow openings 17’ and partly to the second flow channel 20 via the second outlet 19. Since there are no first delivery openings in the ball-shaped insertion tip 2, the first flow channel 11’ will be blind at its distal end 25. Accordingly, when enema is added to the enema nozzle 1’’ via the third flow channel 15, a part of the enema will be delivered to the stimulation member 3’ during the entire enema administration procedure. The enema will accordingly fill and distend the first flow channel 11’. However, since the flexible stimulation member 3’ is arranged such that it can only be distended slightly, the enema in the first flow channel 11’ will be forced (circulate) back into the manifold 7 via the flow openings 17’, and be delivered to the user via the second flow channel 20. Accordingly, enema will flow into and out (circulate) of said first flow channel 11’, as schematically shown by the arrows in fig. 9, thereby enhancing the pulsating movements of the slightly distended stimulation member 3’. In use the enema nozzle 1;1’;1’’ is inserted into the rectum of a patient, and the user the patient or a helper) starts to administer the enema. This can be via use of an automatic pump, e.g. a cyclic pump, or if the enema reservoir is a hand held pump, by repeatedly squeezing and releasing said hand held pump. In any case, the enema is administered until the desired enema dosage has been administered and peristalsis has been obtained, after which the enema nozzle 1;1’;1’’ can be removed. The inventors of the present invention has found that using the enema nozzle 1;1’;1’’ according to the invention will activate the user’s and ensure that said muscles are contracted and maintained in a substantially contracted condition, i.e. the enema nozzle 1;1’;1’’ according to the invention does not require any expandable retention means to retain the nozzle 1;1’;1’’ in place during the enema administration Thus, when the enema nozzle 1;1’;1’’ is inserted into the rectum, said enema nozzle initially ensure that the user’s anal remain contracted and hold itself in the substantially contracted condition thereby not only keeping the enema nozzle in place, but also keep fluids, e.g. bodily excretions, liquid and gas from escaping unexpectedly from the colon. However, when the administration of the enema begins, the enema will flow through the flexible stimulation member 3;3’ as described above, and begin to stimulate the rectal nerves thereby initiating peristalsis. When the desired amount of enema has been delivered e.g. about 2 - 10 minutes after the enema nozzle 1;1’;1’’ was inserted, the stimulation of the rectal with the administered enema enables an easier emptying of the bowel. If the enema is administered in a discontinuous flow, a pulsating movement in the flexible stimulation member 3;3’ is provided and it is believed that such a pulsating movement very effectively stimulates the rectal nerves and initiates peristalsis and / or activate the anal sphincters. In the embodiments shown in the figures the flexible stimulation member 3;3’ has a predefined shape and is made of silicone film having a thickness of about 0.3 mm to 0.5 mm, e.g. 0.4 mm as such a material will have the desired shape memory, provide the desired restriction in distention of the stimulation member, and at the same time be so thin that the rectal nerves can be stimulated sufficiently when enema flows through the first flow channel 11;11’. Since the flexible stimulation member 3;1’ is made of a relatively thin film material (preferably from 0.3 to 0.5 mm) the nozzles 1;1’;1’’ ability to be sucked into the rectum and provide sealing effect, is not compromised. The person skilled in the art will understand that the flexible stimulation member 3;3’ could be made of a different material e.g. a polymer film; have a different thickness etc. The only requirement being that that flexible stimulation member is arranged for stimulating rectal nerves, and preferably also has a shape memory, and / or provides the desired restriction in distention of said stimulation member. As is shown in the figures, the cross-sectional diameter b of the insertion body 4 is significantly smaller than the cross- sectional diameter B of the ball-shaped insertion tip 5 in the entire length of the insertion body 4. However, since the flexible stimulation member 3;3’ has a cross-sectional diameter A (when no enema flows through / in said stimulation member 3;3’) which corresponds to the cross- sectional diameter of the ball-shaped insertion tip 5, i.e. from a middle section 10 of the ball-shaped insertion tip 5 to the flared stop section 8, a smooth transition from the insertion tip 5 to the stop section 8 is provided. In this way the differences in dimension between the ball-shaped insertion tip 5 and insertion body 4 is covered by the flexible stimulation member 3, and said enema nozzle 1;1’ therefore becomes visually more acceptable to patients. Modifications and combinations of the above principles and designs are foreseen within the scope of the present invention.

Claims

Claims 1. An enema nozzle (1;1’;1’’) arranged for administering an enema to a user, said enema nozzle comprises a catheter (2), and a flexible stimulation member (3:3’) that at least partly surrounds the catheter (2), and wherein said flexible stimulation member (3:3’) defines a first flow channel (11) arranged such that there is an enema flow through and / or in said first flow channel (11;11’) during the enema administration procedure.

2. An enema nozzle (1;1’) according to claim 1, wherein the first flow channel (11) is an open flow channel and is arranged for administering at least a part of the enema directly to a user via an outlet (12a).

3. An enema nozzle (1;1’’) according to claim 1 or 2, wherein the enema nozzle comprises a second flow channel (20) arranged for administering at least a part of the enema.

4. An enema nozzle (1’’) according to claim 3, wherein the first flow channel (11’) is a blind flow channel and is arranged for administering the enema to a user via the second flow channel (20).

5. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) is made of a material with a shore A hardness from 25 to 50 as measured in accordance with ASTM D2240.

6. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) is arranged to expand in a direction substantially perpendicular to the longitudinal axis (X) of the catheter.

7. An enema nozzle (1;1’;1’’) according to claim any of the preceding claims, wherein the cross-sectional diameter (A’) of the enema nozzle (1;1’;1’’) measured where the flexible stimulation member (3:3’) surrounds the catheter (2), and when there is an enema flow through the flexible stimulation member (3:3’), increases less than 50%, even more preferred less than 30% and even more preferred less than 5%, compared to the cross sectional diameter (A) of the enema nozzle (1;1’;1’’) when there is no enema flow though said flexible stimulation member (3:3’).

8. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) has a predefined shape and / or is made of a material with a shape memory.

9. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) is made of a polymer film having a thickness from 0.3 to 1.0 mm, preferably from 0.3 mm to 0.5 mm.

10. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) is made of a silicone, latex, urethane (polyurethane), polyvinylchloride, or polyethylene.

11. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) extend along the longitudinal length of the catheter (2), and wherein said flexible stimulation member (3:3’) is an elongated tube or an elongated pouch or has an elongated pouch-like shape.

12. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the first flow channel is arranged for containing between 1 and 20 ml when enema isadded to said flow channel (11;11’) during the enema administration procedure, preferably between 2 and 10 ml, and even more preferred between 4 and 8 ml, such as 7 ml.

13. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the flexible stimulation member (3:3’) surrounds the entire length of the catheter (5) except the outermost tip (13) of said catheter (2).

14. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the catheter comprises an elongated insertion body (4) and a ball-shaped insertion tip (5), and wherein the cross-sectional diameter (b) of the insertion body (4) is smaller than the cross-sectional diameter (B) of the ball-shaped insertion tip (5) in the entire length of the insertion body (4).

15. An enema nozzle (1;1’;1’’) according to claim 14, wherein the ball-shaped insertion tip (5) has a diameter between about 0.8 cm and about 3 cm, preferably between about 1 and about 2 cm, and even more preferred between about 1.2 cm and about 1.5 cm, e.g. about 1.3 cm.

16. An enema nozzle (1;1’;1’’) according to claim 14 or 15, wherein the ball-shaped insertion tip (5) has a cross- sectional diameter which is about 1.2 to 5 times larger than the cross-sectional diameter of the elongated insertion body, preferable between 2 and 4 times, and even more preferred about 2.6 times.

17. An enema nozzle (1;1’;1’’) according to any of claims 14 to 16, wherein the flexible stimulation member (3:3’) extends from a middle section (10) of the ball-shaped insertion tip (5) to the proximal end (9) of the catheter (2), e.g. the proximal end of the elongated insertion body (4).

18. An enema nozzle (1;1’;1’’) according to any of the claims 14 to 17, wherein the flexible stimulation member (2), has a cross-sectional diameter (A), when no enema is flowing though the first flow channel (11), which is the same as, or smaller than, the cross-sectional diameter of the ball- shaped insertion tip (2).

19. An enema nozzle (1;1’) according to any of the preceding claims except claim 3, wherein the outlet (12a) of the first flow channel (11) is in fluid communication with at least one first delivery opening (12) for delivering the enema to the user.

20. An enema nozzle (1;1’;1’’) according to claim 19, wherein said at least one first delivery opening (12) extends through the tip of the catheter (2), e.g. the ball-shaped insertion tip (5) and preferably via one or more internal flow channels (14) in said ball-shaped tip (5).

21. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the enema nozzle (1;1’;1’’) comprises a third flow channel (15) arranged in fluid communication with the first flow channel (11) of the flexible stimulation member (3:3’) and optionally with the second flow channel (20).

22. An enema nozzle (1;1’;1’’) according to claim 21, wherein said enema nozzle (1;1’;1’’) further comprises a manifold (7) arranged for receiving the enema from the third flow channel (15) via at least one first inlet (16) and which manifold (7) branches into at least one first outlet (17) or flow opening (17’) that leads into the first flow channel (11;11’).

23. An enema nozzle (1;1’’) according to claim 21 or 22, wherein the third flow channel (15) further extends into the second flow channel (20), optionally via the manifold (7), and wherein said second flow channel (20) ends in at least one second delivery opening (21) at or near the tip (14) of the catheter (2).

24. An enema nozzle (1’’) according to any of the claims 3 to 23, wherein the first flow channel (11’) and second flow channel (20) are in fluid communication with each other at the open end of the first flow channel (11’), and optionally via the manifold (7).

25. An enema nozzle (1;1’;1’’) according to any of the preceding claims, wherein the first flow channel (11;11’), is arranged for being connected to any suitable enema reservoir.

26. An enema system comprising the enema nozzle (1;1’;1’’) according to any of the claim 1 - 25.

27. An enema system according to claim 26, wherein said enema system comprises an enema reservoir and means for delivering the enema to the first flow channel (11;11’) in a discontinuous flow.

28. An enema system according to claim 26 or 27, wherein the enema reservoir is an enema delivery container, arranged as a hand held pump.

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