Enema nozzle arranged for stimulating peristalsis and enema system comprising the enema nozzle

Abstract

The invention relates to an enema nozzle (1; 1'; 1'') arranged for delivering enema fluid to a user and for initiating peristalsis, the enema nozzle (1; 1'; 1'') comprising a conduit (2) and a flexible stimulation member (3; 3') at least partially surrounding the conduit (2), and wherein the flexible stimulation member (3; 3') defines a first flow passage (11; 11') arranged such that there is a flow of enema fluid through and / or in the first flow passage (11; 11') during the entire enema fluid administration. By using the enema nozzle (1; 1'; 1'') a patient in need of bowel management can administer enema fluid and at the same time stimulate the rectal nerves, thereby initiating peristalsis, i.e. inducing reflex bowel movement to open and allow the feces to exit the body.

Description

Technical Field

[0001] The present invention relates to an enema nozzle arranged for delivering enema fluid and for initiating peristalsis, and an enema system including said enema nozzle. Background Technology

[0002] Many people experience the inability to empty their bowels on their own, thus relying on cumbersome and time-consuming bowel protocols to manage constipation and fecal retention. Others may develop fecal incontinence secondary to constipation or weak anal sphincter muscles. Such bowel dysfunction has a detrimental impact on a patient's health and quality of life, and patients often find their symptoms causing social barriers. Although bowel dysfunction is a common condition, it remains associated with stigma and taboo even today.

[0003] There are several different ways to activate bowel movements, including: abdominal massage; manual removal of stool; administration of enema solution; and digital rectal stimulation.

[0004] Abdominal massage and manual removal of stool are self-explanatory, while finger stimulation (also known as digital rectal stimulation) aims to initiate peristalsis, that is, to promote relaxation of the anal sphincter to facilitate the expulsion of stool. Finger stimulation involves inserting a lubricated finger (or stimulator) into the rectum and applying stimulation in a circular motion with the fingertip pointing towards the spine (and away from the bladder), thus providing physical stimulation to the nerves in the rectal wall. Finger rectal stimulation is an inexpensive intervention requiring limited supplies and is often used as part of a routine bowel movement regimen because it stimulates peristalsis and bowel emptying. However, finger stimulation is time-consuming and requires assistance from another person. Therefore, patients often find finger stimulation stressful, uncomfortable, and undignified.

[0005] Mechanical devices used for finger stimulation (stimulators) are typically made of hard metal and / or plastic and are often difficult and uncomfortable to use. Furthermore, the anatomy of the rectal cavity may prevent adequate stimulation of the rectal nerves when such devices are used.

[0006] WO 2011 / 063243 describes a rectal stimulation device designed to overcome the aforementioned problems. The device includes a squeeze ball, a hollow insertion portion, and a balloon covering the insertion body. To initiate peristalsis, the user inserts the insertion portion and balloon into the rectum and applies pressure to the squeeze ball, causing fluid to expand the balloon and stimulate rectal nerves. After releasing the squeeze ball, the balloon returns to its unexpanded shape. Although the device can be used by the patient themselves, the system has several drawbacks. For example, because the extent of balloon expansion is unknown, the balloon may be over-expanded, potentially damaging the rectal wall, or under-expanded, failing to provide the desired digital rectal stimulation. Since the fluid within the device is in a closed system, it is not possible to add / remove fluid from the device if adjustments to the balloon's expansion are needed. Furthermore, because the balloon cannot provide a seal between the balloon and the rectum / rectal wall, the surrounding environment may be contaminated with bodily excrement during the process.

[0007] Administering an enema is a common medical procedure in which a liquid (enema solution) is injected into a patient's rectum and lower intestine to induce bowel movements. This procedure is typically needed for patients with certain medical conditions that impair bowel control, or for patients who require bowel cleansing before procedures such as colonoscopy or surgery.

[0008] However, patients may find it difficult to administer the enema solution themselves because traditional enema devices often cause discomfort and irritation upon insertion. Furthermore, it is challenging for patients to maintain a steady grip on the enema nozzle while administering the solution during the procedure. Assistance from another person is usually required, but this assistance may not always be available, for example, if the patient lives alone.

[0009] To overcome these problems, many enema devices have been developed, including various retention devices for holding the nozzle in the rectum / colon during enema fluid administration.

[0010] For example, US 5,074,842 discloses an apparatus for flushing with a retaining balloon that is inflated with air, wherein the air is delivered through a syringe valve in communication with an air passage. Similar systems are known from EP 1531885 and WO 2011023196, EP 1531885 describing an flushing apparatus comprising a fluid reservoir and an inflatable balloon for retaining a tubular portion inserted into the rectum, and WO 2011023196 describing a system for inflating a balloon / retaining member using fluid.

[0011] The problem with using an inflatable retention balloon is that the balloon responds to body movements (such as peristaltic reflexes), which can cause the nozzle to shift unnoticed, leading to leaks. Furthermore, air from the balloon cannot be delivered to the colon, as this would cause the colon to expand or swell, resulting in pain and discomfort for the patient.

[0012] Another problem with using an inflatable balloon is that if the balloon is overinflated, it may rupture, damaging the delicate walls of the colon / rectum and causing leakage of the fluid-filled contents. Furthermore, if the balloon is underinflated, the enema nozzle cannot be safely held in place during use. This is not only unwelcome to patients but also very embarrassing, as the surrounding environment will inevitably be contaminated with flushing fluid and bodily waste if the enema nozzle accidentally dislodges.

[0013] As mentioned earlier, some patients may benefit from both digital rectal stimulation and the application of enema solution; however, since these are two different procedures, it is not currently possible to initiate peristalsis by applying enema solution and simultaneously using digital stimulation. Summary of the Invention

[0014] Therefore, a first aspect of the present invention is to provide an enema nozzle that can both administer an enema solution and provide finger-rectal stimulation to initiate peristalsis.

[0015] A second aspect of the invention is to provide an enema nozzle that can be easily held in the colon / rectum without the need for an expandable holding device (e.g., an inflatable balloon).

[0016] A third aspect of the invention is to provide an enema nozzle configured to be connected to an enema apparatus, the nozzle being insertable into an opening to be flushed without causing discomfort, trauma, and / or injury.

[0017] A fourth aspect of the present invention is to provide an enema nozzle that is inexpensive to manufacture, simple and reliable to use, relatively small and easy to operate.

[0018] According to the invention, these and further aspects are achieved by providing an enema nozzle arranged for administering an enema solution to a user, the enema nozzle comprising a conduit and a flexible stimulating member at least partially surrounding the conduit, wherein the flexible stimulating member defines a first flow channel configured such that during the enema solution administration process (i.e., when the enema solution is administered to the user), there is an enema solution flow through and / or within the first flow channel.

[0019] In a first embodiment, the first flow channel is an open flow channel and is configured to directly apply at least a portion of the enema fluid to the user through an outlet. In the context of this invention, the term "open flow channel" means a flow channel open at both ends, i.e., through which liquid can flow. Therefore, in a first embodiment according to the invention, the enema fluid will flow into the first flow channel at one end (preferably the proximal end of the flow channel) and out of the flow channel at the opposite end (preferably the distal end of the flow channel).

[0020] In this application, the distal end of the enema nozzle (and its components) is the end that is first inserted into the user's rectum.

[0021] In the second embodiment, the first flow channel is a blind-ended flow channel and is configured to apply at least a portion of the enema solution to the user via the second flow channel. In the context of this invention, the term "blind-ended flow channel" means a flow channel with only one open end through which the enema solution flows in and out. The remainder 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 through the open end of the first flow channel. Because the first flow channel is blind-ended, the enema solution cannot be directly delivered to the user via the first flow channel as in the first embodiment. During enema application, the first flow channel is filled with enema solution, and as more enema solution is added to the first flow channel during the application process, the enema solution in the first flow channel flows and / or circulates within the first flow channel due to hydrodynamics, and is then forced into the second flow channel and delivered to the user from there. Thus, the enema solution is indirectly applied to the user from the first flow channel via the second flow channel.

[0022] In the context of this invention, the term "enema fluid flow" means that at least a portion of the enema fluid moves from one place to another. In a first embodiment, all or a portion of the enema fluid is transferred (flowed) through a first flow channel, while in a second embodiment, a portion of the enema fluid moves within (inside) the first flow channel and is transferred from the first flow channel to a second flow channel before reaching the user.

[0023] Therefore, in both embodiments, at least some of the enema fluid will flow through / in the first flow channel of the flexible stimulating member.

[0024] The enema nozzle of the first embodiment may further include a second flow channel configured to apply at least a portion of the enema fluid to the user, i.e., the enema fluid is applied to the user via both the first flow channel and the second flow channel.

[0025] In a second embodiment, the enema nozzle according to the invention can be configured such that at least a portion of the enema fluid is directly transferred to the second flow channel. Therefore, a portion of the enema fluid is transferred to the second flow channel via the first flow channel, while some enema fluid is directly transferred to the second flow channel.

[0026] Such embodiments (i.e., embodiments in which the enema fluid is applied directly to the user via a second flow channel) are particularly advantageous if faster enema fluid delivery is desired, because the enema fluid applied to the user will bypass (i.e., not flow through) the flexible stimulating member.

[0027] Preferably, in both the first and second embodiments of the enema nozzle according to the invention, the second flow channel extends inside the conduit.

[0028] In both embodiments, the stimulating member expands when liquid (enema fluid) is added to the first flow channel of the stimulating member. However, because the liquid is simultaneously applied to the patient from the stimulating member (directly in the first embodiment, or indirectly in the second embodiment) and thus flows out of the first flow channel, the stimulating member expands only slightly. In this respect, the inventors of the present invention have discovered that the expansion obtained when the liquid (enema fluid) flows through (the first embodiment) or within the flexible stimulating member (the second embodiment) will stimulate the rectal nerves by providing mild, adjustable, and gentle stimulation, and thus initiate peristalsis.

[0029] Unbound by theory, it is believed that the enema fluid flowing through / in the flexible stimulating member, along with the applied enema fluid, will stimulate nerves in the rectal wall; causing a reflex response, namely the defecation reflex in the lower intestine. Therefore, the stimulating member will stimulate the same nerves stimulated by conventional finger-rectal stimulation using a finger or stimulating stick. However, by using the enema nozzle according to the invention, the patient can obtain said stimulation at home without an assistant.

[0030] The reflex response provided by the enema fluid flowing through / within the flexible stimulating member includes the initiation of peristaltic waves that begin at the splenic flexure (the starting point of the descending colon), proceed downwards through the sigmoid colon, and into the rectum. This response also includes relaxation of the internal anal sphincter, which allows the lower intestine to empty.

[0031] Therefore, by using the enema nozzle according to the invention, patients requiring bowel management can be given an enema solution while stimulating the rectal nerves, thereby initiating peristalsis, i.e. inducing reflexive intestinal movement to open and allow feces to be expelled from the body.

[0032] It has been further discovered that the enema fluid (liquid) flowing through / in the stimulating component also activates the user's anal sphincter and ensures that the muscle contracts and remains in a substantially contracted state during enema fluid application. In this way, the enema nozzle can be held in the proper position in the rectum / colon without the need for conventional retaining components during enema fluid application, while preventing leakage of bodily fluids and / or enema fluid.

[0033] Therefore, the enema nozzle according to the invention ensures that the rectal nerves are stimulated to induce peristalsis, while ensuring that the user's anal sphincter remains contracted during the application process, thereby effectively preventing leakage into the surrounding environment.

[0034] The inventors of this invention have discovered that stimulation of the rectal nerves is even more effective when the enema fluid flowing through / in the stimulating member is delivered to the stimulating member in a discontinuous flow manner, as this will generate pulsating motions within the stimulating member. "Discontinuous flow" refers to the phased delivery of the enema fluid to the flexible stimulating member, with intervals between each delivery, preferably in a periodic manner. The period and intervals can be the same throughout the application, or they can vary according to the user's requirements. Discontinuous flow application can be achieved in various different ways, such as manually delivering the enema fluid simply using a squeeze ball, or using a circulation pump.

[0035] Preferably, the flexible stimulation component is configured to expand / inflate only slightly, and only to the extent that it is sufficient to initiate peristalsis and / or activate the user's anal sphincter, and to ensure that the muscle contracts and remains in a substantially contracted state when the enema nozzle is placed in the rectum.

[0036] Therefore, the flexible stimulation member is preferably made of a material that is rigid enough to prevent excessive expansion (stretching or swelling) of the member when the enema fluid flows through / in the member, but has a certain degree of flexibility to facilitate the desired expansion.

[0037] In this regard, it is preferred that the flexible stimulation member be made of a material with a Shore A hardness of 25 to 50 (measured according to ASTM D2240). Optimal results have been obtained when the tip of the stimulation member has a Shore A hardness of 30 to 45, preferably about 30.

[0038] 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 force causing the deformation is removed, is preferably 200% to 1000%, meaning the material of the flexible stimulation member can stretch 200% to 1000% in any direction. However, it is preferable that the material can stretch 300% to 700%, for example, about 400%, 500%, or 600%. The elasticity can be calculated using Hooke's Law and / or by conventional testing methods.

[0039] Preferably, the flexible stimulation member is configured to expand in a direction substantially perpendicular to the longitudinal axis of the catheter.

[0040] In this regard, it is preferred that the cross-sectional diameter of the flexible stimulation member increases by less than 50%, more preferably less than 30%, and even more preferably less than 15%, when the enema fluid flows through / in the flexible stimulation member, compared to when no enema fluid flows through the stimulation member. The increase may be greater, for example, about 100%, although this is not preferred, but may be relevant for some patients depending on their anatomy. In this regard, the cross-sectional diameter can be measured in a plane perpendicular to the longitudinal axis of the catheter, in the region of the flexible stimulation member surrounding the catheter. Thus, if the cross-sectional diameter of the flexible stimulation member is 13 mm when no enema fluid flows through the first flow channel, then when the enema fluid flows through the first channel, the cross-sectional diameter is less than about 20 mm, preferably less than about 17 mm, and even more preferably about 15 or 16 mm.

[0041] In some embodiments, the flexible stimulation member may expand uniformly along its entire length, while in other embodiments, the expansion gradually increases toward one or more segments of the flexible stimulation member. For example, the flexible stimulation member has the maximum expansion in its middle segment, and the expansion gradually decreases toward the distal and proximal ends of the flexible stimulation member.

[0042] Furthermore, it is preferable that the flexible stimulation member cannot expand in the longitudinal direction or can only expand in the longitudinal direction to a limited extent (less than 5%).

[0043] The expansion along the length of the flexible stimulating member can be achieved, for example, by making certain sections of the flexible stimulating member less flexible than the rest of the stimulating member, for example by placing reinforcements in specific sections (e.g., the ends) of the flexible stimulating member; or by attaching the flexible stimulating member to a conduit (e.g., by gluing or welding).

[0044] To provide a small, easy-to-operate enema nozzle with a consistent and aesthetically pleasing appearance before and after use, and / or to provide the desired limited expansion of the flexible stimulating member, the flexible stimulating member preferably has a predefined shape and is made of a material with shape memory, meaning that when the retaining member is not subjected to external or internal forces, the flexible stimulating member will return to its predefined shape. Such a predefined shape also helps to generate pulsating motion when the enema fluid is applied in a discontinuous flow, because the flexible stimulating member will return to its original shape during the intervals when no enema fluid is applied via the stimulating member. Similarly, the stimulating member may have an intermediate shape, etc., depending on the volume of enema fluid applied.

[0045] Preferably, the flexible stimulation member is made of a relatively thin material, such as a polymer membrane (e.g., silicone) with a thickness of 0.3 to 1.0 mm, preferably 0.3 mm to 0.5 mm, because the flexible stimulation member made of a membrane with said thickness provides a durable and safe system, while ensuring that the enema fluid flowing through the stimulation member can easily stimulate the rectal nerves, thereby initiating peristalsis and / or activating / contracting the user's anal sphincter.

[0046] Flexible stimuli can be made from any soft, elastic, flexible, and biocompatible material that provides the desired properties while resisting tearing and decomposition. Examples include natural rubber, synthetic rubber, silicone resins, latex, polyurethane (polyurethane), polyvinyl chloride, polyethylene, or any other expandable elastomer, polymer, or other similar materials. The properties of materials used for flexible stimuli can be altered, for example, by changing the length of the polymer chains, creating branches from linear polymer chains, crosslinking polymer chains, and / or adding plasticizers to the polymer.

[0047] In a particularly advantageous embodiment, the flexible stimulation member is made of silicone resin because the material is both flexible and still allows the flexible stimulation member to have a predefined shape before use, while ensuring that the material does not stretch beyond the desired extent when enema fluid (liquid) is added to the material.

[0048] In a preferred embodiment, the flexible stimulation member extends along the length of the catheter and has the form of an elongated tube, an elongated bag, or an elongated pouch shape. In the context of this invention, the term "bag" refers to a pouch, balloon, or container disposed along at least a portion of the catheter. The tube or bag can have any form and size, as long as it is capable of initiating peristalsis, for example by providing the desired pulsatile movement when the enema fluid is applied to the patient via the flexible stimulation member.

[0049] Preferably, the first flow channel of the flexible stimulating member is configured to hold 1 to 20 ml, preferably 2 to 10 ml, or even more preferably 4 to 8 ml, for example about 7 ml, during the enema application process (i.e. when the liquid (enema fluid) is added to the first flow channel).

[0050] In an alternative embodiment according to the invention, the flexible stimulation member is composed of an elastic, compressible foam body. The foam body will conform to the shape of the rectal wall, thereby providing a very comfortable stimulation member that directly stimulates the rectal nerves. A first flow channel may be provided in a flexible channel / tube within the foam body. Alternatively, if the foam body is made of a porous material, the enema fluid may also be applied to the rectum / colon via the surface and / or sides of the foam body. Such an embodiment is particularly relevant if the body tissue is inflamed or otherwise damaged, as the pressure from the enema fluid will be distributed over a larger area, thereby reducing any discomfort the user may experience.

[0051] In a preferred embodiment, the flexible stimulating member surrounds substantially the entire length of the catheter, thereby ensuring that the rectal nerve is stimulated along the entire length of the catheter. Although the distal end of the catheter, i.e., the end into which the catheter is first inserted into the rectum, may also be surrounded by the flexible stimulating member in some embodiments, it is preferred that the distal end of the catheter, or at least a portion thereof, remains free, i.e., the flexible stimulating member does not cover (extend beyond) the insertion end, or at least does not cover the outermost tip of the insertion end. By keeping the insertion end free, the possibility of the flexible stimulating member sliding / moving relative to the insertion end during insertion is eliminated, resulting in a more reliable and comfortable insertion into the anal opening.

[0052] The catheter preferably comprises an elongated insert body and an insert tip. In one embodiment, the insert tip is spherical, and the elongated insert body is tubular. Preferably, the elongated insert body is substantially straight, i.e., has the same cross-sectional diameter along its entire length. However, in an alternative embodiment, the elongated insert body has a truncated cone shape with a smaller apical base (the base surface connected to the spherical insert tip), which is smaller than the base (0.3 to 0.9 times). In either case, the cross-sectional diameter of the insert body is smaller than the cross-sectional diameter of the spherical insert tip along its entire length. Therefore, the cross-sectional diameter of the spherical insert tip is larger than the cross-sectional diameter of the insert body, regardless of where the cross-sectional diameter is measured along the elongated insert tip.

[0053] In the context of this invention, the term "cross-sectional diameter" for the elongated insert body and the spherical insert tip or other portions of the enema nozzle means the diameter obtained in a plane perpendicular to the longitudinal axis of the elongated insert body and / or the catheter.

[0054] Furthermore, the term "spherical" refers to the insertion tip having a spherical or substantially spherical shape, such as a sphere whose major and minor axes differ by less than 5% (oblate or elongated sphere). The term "insertion tip" refers to the distal section / distal end of the enema nozzle, i.e., the portion that is first inserted into the rectum / colon, and the term "insertion body" refers to the portion of the enema nozzle (below the spherical insertion tip) intended to be placed at and inside the anal opening.

[0055] The inventors of this invention have surprisingly discovered that using a catheter in the form of a spherical insertion end and a thinner, elongated insertion body activates the user's anal sphincter and / or enhances the effect obtained by the flow of enema fluid through the stimulating member. Therefore, the enema nozzle according to the invention is configured to activate the sphincter and ensure that when the enema nozzle is placed in the user's anus / rectum, the muscle contracts and remains in a substantially contracted state.

[0056] Therefore, when the enema nozzle according to the invention is inserted into the user's anus, the enema nozzle will first activate the anal sphincter, that is, the user's anal sphincter will remain contracted and in a basically contracted state, thereby not only keeping the enema nozzle in place, but also ensuring that the flushing fluid and bodily excretions remain in the rectum and colon during the enema application process. Thus, the unique design of the enema nozzle will provide an effective seal with the anal opening.

[0057] However, when the enema solution is administered, it flows through / within the flexible stimulating component, assisting in activating the user's anal sphincter. The flexible stimulating component will also begin to stimulate the rectal nerves and initiate peristalsis. When the enema solution has been delivered to the user approximately 2-10 minutes after the enema nozzle is inserted, the stimulation of the rectal nerves, along with the administered enema solution, will make bowel emptying easier.

[0058] It has been found that conventional enema nozzles cannot both remain in the rectum / colon and initiate peristalsis in a manner similar to that of the enema nozzle according to the invention. This inability of conventional enema nozzles to remain in the rectum / colon is likely due to the shape (e.g., trumpet-shaped tip) and / or relatively large cross-sectional diameter (greater than 1 cm) of the insert body / catheter placed at the anal opening. Such construction and / or size stretches the anal sphincter, preventing it from contracting sufficiently to hold the enema nozzle in place and / or retain fluid in the rectum.

[0059] Therefore, conventional enema nozzles cannot rely solely on the function of the anal sphincter to remain in place. As a result, conventional enema nozzles require one or more additional retaining components that can expand considerably, for example, two to three times their original size, when placed in the rectum. Furthermore, leakage of the enema fluid often occurs with these conventional enema nozzles because the anal sphincter cannot provide a tight fit around the nozzle, which can lead to insufficient colonic distension. Consequently, imperfect procedural results may be obtained, or the patient may receive an insufficient dose of enema fluid (or, if medication is administered). Therefore, by using the enema nozzle according to the invention, these problems are effectively eliminated because the nozzle simply utilizes the user's own anal sphincter to both securely hold the nozzle in place and prevent any leakage.

[0060] The inventors of this invention have also discovered that inserting the enema nozzle into a patient's anus / rectum is easier than with enema nozzles known in the prior art. Using a spherical insertion tip with a larger cross-sectional diameter than the elongated insertion body ensures that during insertion, the squeezing action of the anal sphincter against the insertion body pushes the enema nozzle into (draws in) the rectum, thereby ensuring that the enema nozzle according to the invention is placed in the correct position in the rectum / colon.

[0061] The diameter of the spherical insertion end is preferably between about 0.8 cm and about 3 cm, more preferably between about 1 cm and about 2 cm, and even more preferably between about 1.2 cm and about 1.5 cm, for example about 1.3 cm.

[0062] In a preferred embodiment, the cross-sectional diameter of the spherical insertion end is about 1.2 to 5 times, preferably 2 to 4 times, and even more preferably about 2.6 times, the cross-sectional diameter of the elongated insertion body, because such a ratio has proven particularly advantageous for ensuring that the enema nozzle according to the invention remains properly and sealed in the rectum during the application of the enema solution.

[0063] In a preferred embodiment, the flexible stimulation member extends from the middle section of the spherical insert tip to the proximal end of the elongated insert body, i.e., the flexible stimulation member surrounds the lower section of the insert tip and the entire insert body, thereby providing a smooth transition from the insert tip to the proximal portion of the catheter (e.g., the stop section). When no enema fluid is flowing through / in the first flow channel (e.g., before use), the cross-sectional diameter of the flexible stimulation member is preferably the same as or smaller (less than 10%) than the cross-sectional diameter of the spherical insert tip. In this way, the dimensional difference between the spherical insert tip and the insert body is covered by the flexible stimulation member, thus making the enema nozzle visually more acceptable to the patient.

[0064] In a preferred embodiment of the enema nozzle according to the invention, the cross-sectional diameter of the spherical end 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.

[0065] The catheter and / or insert body can have any suitable length, depending on the intended delivery site of the enema solution in the rectum / colon; the longer the insert body, the deeper the enema solution can be delivered into the colon. However, it is preferred that the insert body be long enough to position the ball-shaped insert tip above the dentate line when placed in the user's rectum, as this will prevent the ball-shaped insert tip from stimulating sensitive nerve endings that may be located within the anal canal between the opening and the dentate line (also known as the comb line).

[0066] Therefore, it is preferred that the length of the insert body (i.e., the elongated section of the enema nozzle intended to be placed inside the rectum), measured along the longitudinal axis of the elongated insert body, be between 3 cm and 7 cm, preferably between 4 cm and 6 cm, and even more preferably about 5 cm, because the inventors have found that such a length (for most users) places the spherical insert end above the serrated line, while providing the enema nozzle with unique self-holding properties through the use of the anal sphincter and obtaining the desired rectal nerve and / or anal sphincter stimulation as the enema fluid flows through the flexible stimulation member.

[0067] Once the enema solution has been applied and the rectal nerves have been stimulated, the enema nozzle can be safely and quickly removed with a simple pulling motion. The enema solution, along with the stimulation of the rectal nerves, will have already initiated peristalsis. Therefore, users can use the toilet when they feel the urge to defecate, and because users do not need to deflate the retainer and / or worry about damage caused by the inflatable retainer collapsing on its own, the application process, including inserting and removing the enema nozzle, is safe and can be performed quickly.

[0068] In some embodiments, the enema nozzle may include a stop section, such as a flared section or annular plate, configured to prevent the enema nozzle from being pushed into and / or drawn into the rectum too deeply. The stop section is preferably positioned / arranged adjacent to the proximal portion of the elongated insert body.

[0069] If the flexible stimulation member is made of a relatively thin material (preferably 0.3 to 0.5 mm), the ability of the catheter to be aspirated into the rectum and provide a self-sealing effect will not be impaired, because during insertion into the body opening, the flexible stimulation member will collapse around the elongated insertion body, thus not increasing the thickness of the elongated insertion body to the extent that it affects the effect.

[0070] The flexible stimulation member is preferably attached to the insertion end along its circumference in a plane perpendicular to the longitudinal axis of the insertion portion. In a preferred embodiment, the plane may pass through the center of the spherical insertion end. The retention member may be attached to the catheter and / or enema nozzle in any suitable manner, such as by gluing or welding.

[0071] In a first embodiment of the enema nozzle according to the invention, the outlet of the first flow channel is in fluid communication with at least one first delivery opening for delivering enema fluid to the rectum / colon. In one embodiment, the first delivery opening may be disposed in the sidewall of the flexible stimulating member, for example as one or more openings immediately below the insertion end (e.g., 0.5-3 mm), or as a plurality of (e.g., 2-30) perforations distributed in the wall of the flexible stimulating member, allowing the enema fluid to be sprayed into the rectum in various directions. Such perforations may be uniformly or non-uniformly distributed, depending on the desired enema fluid delivery pattern. Multiple perforations may be particularly desirable in cases where the user's rectum or colon is inflamed or otherwise sensitive to pressure enema fluid flow.

[0072] However, it may be preferable to place at least one first delivery opening at the distal end of the catheter, such as at the ball-shaped insertion end, i.e., at least one first delivery opening extends through the end of the catheter. This can be easily achieved simply by placing at least one first internal flow channel in the insertion end.

[0073] In the second embodiment, the second flow channel is configured to receive enema fluid from the first flow channel at the blind end, and then deliver the enema fluid to the user via at least one second delivery opening.

[0074] Preferably, the second flow channel is placed inside the catheter, preferably an elongated insertion body (e.g., as a channel or tube within the catheter), and extends into at least one second delivery opening at or near the insertion end, for example via at least one second internal flow channel extending through the spherical insertion end.

[0075] In the second embodiment, the first flow channel is blind-ended, so the enema fluid will flow in and out of the first channel via the open end. One or more first flow openings can be provided at the open end of the first flow channel, and the enema fluid can flow in and out of the first flow channel via said one or more first flow openings. Alternatively, the open end includes at least two second flow openings, at least one configured to provide enema fluid inflow into the first flow channel, and at least one configured to provide enema fluid outflow from the first flow channel. The flow direction in said at least two openings can be controlled by a one-way valve or other device configured to provide unidirectional flow. At least one first flow opening or at least two second flow openings are preferably located at or near the proximal end of the flexible stimulating member (e.g., 1 mm - 1 cm from that end). This ensures that when enema fluid is added to the first flow channel, the channel will first be filled with enema fluid, but since the enema fluid is simultaneously applied to the user via the second flow channels, it is also removed from the first flow channel. Therefore, the enema fluid will flow and / or circulate in the first flow channel, enhancing the pulsating motion caused by the slight expansion of the stimulating member.

[0076] In a preferred embodiment of the invention, the enema nozzle includes a third flow channel configured to be in fluid communication with a first flow channel of the flexible stimulating member, for example, via a manifold. The manifold is preferably a chamber that receives enema fluid from the third flow channel via at least one first inlet, and branches into at least one first outlet leading to the first flow channel.

[0077] In a second embodiment, the first outlet is preferably one or more of at least one first flow opening or at least two first flow openings that introduce enema fluid into the first flow channel. Therefore, in a preferred version of the second embodiment according to the invention, the first and second flow channels are in fluid communication with each other via a manifold.

[0078] The manifold is preferably positioned proximal to the catheter, for example, at the proximal end of the elongated insertion portion, such that when enema fluid is added to the flexible insertion member, the enema fluid flows along the entire length of the stimulation member to provide the desired dilation of the stimulation member, thereby stimulating the rectal nerves and / or the anal sphincter.

[0079] When the enema nozzle also includes a second flow channel, a third flow channel may also extend into the second flow channel, preferably via at least one second outlet in the manifold. The second flow channel will extend through the entire elongated insert body or conduit and extend into at least one second delivery opening at or near the insert end, for example via at least one second internal flow channel extending through the ball-shaped insert end. Such an embodiment is particularly advantageous if faster enema fluid delivery is desired, because all the enema fluid applied to the user will not flow through the flexible stimulating member.

[0080] A first flow channel, and optionally a second and / or a third flow channel, is configured to connect to any suitable enema fluid reservoir (delivery container), such as a delivery container in a large bedside flushing system for medical or hospital facilities, and / or a small, compact delivery container for home application of enema fluid. In a particularly advantageous embodiment, the third flow channel is connected to the enema fluid reservoir, and then the third flow channel distributes the enema fluid to the first flow channel, and optionally the second flow channel.

[0081] The flow channel can be detachably connected to the delivery container via conventional connecting units (e.g., snap-fit). The connecting unit may, for example, include a first connecting part attached to the enema nozzle and a second connecting part attached to the delivery container, providing fluid communication between the two parts. In a particularly simple embodiment, the first connecting part is a tube for the first flow channel, and the second connecting part is a second tube on the delivery container. The second tube is preferably adapted to provide a liquid-tight fit with the first tube to provide connection, for example, by making at least one of the first and second tubes made of a flexible material, such that, for example, one tube can be placed inside the other.

[0082] Preferably, the catheter is sufficiently rigid to facilitate insertion into the rectum, but will possess a degree of moderate flexibility to facilitate bending or shaping of the nozzle, making it comfortable during insertion. To provide the desired combination of rigidity and flexibility for the enema nozzle, the catheter can be made of a suitable polymer. Suitable materials in this regard are elastomeric polymers, preferably selected from the group consisting of: thermoplastic elastomers (TPE), polypropylene (PP), polyurethane (PU), polyethylene (PE), polyvinyl chloride (PVC), silicone resins, styrene-ethylene-butene-styrene (SEBS), thermoplastic polyester elastomers (TPC), thermoplastic styrene-based elastomers (TPS), and other similar polymers. The flexibility of the catheter can be modified by conventional means, such as by crosslinking polymer chains and / or adding plasticizers to the polymer.

[0083] In embodiments including a bulbous insertion tip, it may be preferable that the insertion tip is made of one material, while the elongated insertion body is made of a different material. For example, the insertion body may be made of a relatively rigid material, thereby providing the longitudinal rigidity and strength required for easy insertion of the catheter into the body opening, while the bulbous insertion tip may be made of a softer, more elastic, and more flexible material, allowing the insertion tip to deform and / or bend slightly when inserted into the rectum and colon. However, in a particularly simple embodiment according to the invention, the bulbous insertion tip and the elongated insertion body are made of the same material, preferably as a single integral unit.

[0084] In one embodiment, the flexible stimulation member may be attached to the catheter after the catheter has been provided, but preferably the flexible stimulation member is attached to / attached to the catheter during (e.g., simultaneously) the manufacturing of the catheter.

[0085] The enema nozzle according to the invention can be manufactured using any conventional process. However, it is preferred that the enema nozzle be manufactured in a single injection molding process by 1K injection molding, 2K injection molding, or 3K injection molding.

[0086] 2K or 3K injection molding involves processing two or three different polymers (or polymer compositions) into a final product using a single injection molding process. Utilizing 2K and 3K technologies, possible assembly steps, such as those involving flexible stimulating components and catheters, can be eliminated. This technology enables the integration of polymer properties into the enema nozzle according to the invention in a simple and efficient manner. For example, the 2K injection molding process can be used to combine two different elastomeric polymers with different properties, such as a first elastomeric polymer that will form a catheter and a second elastomeric polymer that will form a flexible stimulating component.

[0087] 2K or 3K injection molding processes are preferably performed on a single machine programmed to inject the polymer in a single cycle. The injection molding can be a co-injection process, a sequential injection process, or an overmolding process.

[0088] The inventors of this invention have discovered that the force required to insert the enema nozzle according to the invention into a body opening (e.g., the rectum) is significantly less than that required to insert a conventional enema nozzle because the enema nozzle according to the invention is "sucked" into the rectum. Therefore, this enema nozzle is particularly advantageous for disabled patients and / or patients with injuries such as those related to aging, diagnosis, or trauma. These patients often have reduced hand strength and / or dexterity, and the force required to insert a conventional enema nozzle and / or perform finger stimulation may render the user unable to use the device independently. This enema nozzle overcomes this limitation and is therefore ideal for home use.

[0089] Preferably, the enema nozzle according to the invention does not include any inflatable / expandable retaining member, i.e., a balloon, etc., wherein air and / or liquid are held in a closed system during enema application to keep the enema nozzle in place during use. This also eliminates the risk of the inflatable balloon rupturing and damaging the colonic wall.

[0090] Furthermore, the enema nozzle according to the invention is easy to use and simple to operate. Throughout the enema application process, the enema fluid is allowed to flow through / into the flexible stimulating member, thereby automatically stimulating the rectal nerves and anal sphincter. Therefore, the user does not need to worry about how to provide the relevant stimulation, such as how much fluid should be allowed in the stimulating member, etc. In addition, the enema nozzle will appear compact and harmless, especially compared to more complex enema systems (e.g., tubes with balloons for inflation / deflation), and the enema nozzle can be removed at any time because the user does not need to cause the retaining member to contract or collapse before removal.

[0091] The simplicity of the enema nozzle according to the invention ensures that any patient or user, such as the elderly, can use the enema nozzle for self-administration of flushing fluid / enema solution and to receive finger stimulation without excessive effort. Because the flexible stimulation component remains supple, resilient, and soft during use, and continues to conform to and adapt to the user's anatomy, the use of the enema nozzle according to the invention will significantly reduce patient discomfort and inconvenience associated with known systems.

[0092] The present invention also relates to an enema system comprising an enema nozzle according to the invention. The system includes an enema fluid reservoir in fluid communication with a first flow channel and optionally a second and / or a third flow channel.

[0093] In a preferred embodiment, the enema fluid reservoir is an enema fluid delivery container configured as a handheld pump. The enema fluid contained in the delivery container is administered by repeatedly squeezing and releasing the delivery container until the desired dose of enema fluid has been administered. During administration, the enema fluid will flow in a discontinuous flow through / in a first flow channel of the flexible stimulating member, providing pulsating motion that will effectively initiate peristalsis and / or activate the anal sphincter.

[0094] In an alternative embodiment, the enema nozzle is used in a larger flushing system, wherein the enema nozzle is connected to an enema liquid reservoir via a relatively long delivery pipe, and wherein the enema system may include one or more pumping devices, control devices, fecal collection devices, etc.

[0095] The enema system and / or enema nozzle may include one or more second one-way valves that effectively prevent backflow of liquid and feces from the colon and / or rectum into the device, and thus prevent any contamination of the delivery container and its remaining contents, which could occur after the enema solution has been administered to the patient. Furthermore, due to the effective prevention of backflow, the delivery container can be readily used for multiple applications, for example, by refilling the container with a second dose of the same or a different enema solution (liquid).

[0096] The enema system may also include one or more one-way valves that prevent any air from entering the container during use; that is, the delivery container will remain collapsed even if the user releases pressure on the container. This ensures that the user can easily expel the remaining contents from the delivery container by alternately applying and releasing pressure until the desired dose or the entire enema contents have been expelled from the enema device. The collapse of the delivery container as the enema fluid is expelled also allows the user to easily sense when the enema fluid has been expelled, thus providing a simple indication of when the desired (e.g., the entire) dose of enema fluid has been administered, i.e., when the delivery container is fully or substantially fully compressed.

[0097] Enema solution can be any desired liquid, such as water, saline, liquid containing salt (e.g., phosphate, sodium, etc.), or liquid containing drugs or softeners.

[0098] Although the enema nozzle and enema system according to the invention are intended for use in the digital stimulation of the colon and application of enema fluid via the rectum, the enema nozzle and device may also be used for rinsing, cleaning and / or instilling into other body cavities, such as stomas and fistulas. Attached Figure Description

[0099] The invention will now be explained in more detail by describing an exemplary embodiment of the enema nozzle with reference to the accompanying drawings, wherein: Figures 1-4 A first version of a first embodiment of an enema nozzle according to the present invention is shown. Figures 5-6 A second version of the first embodiment of the enema nozzle according to the present invention is shown, and Figures 7-9 A version of a second embodiment of the enema nozzle according to the present invention is shown. Detailed Implementation

[0100] Figures 1-4 A first version of a first embodiment of the enema nozzle 1 according to the present invention is shown, wherein, Figure 1 and Figure 2 An enema nozzle 1 is shown with no enema fluid flowing through it, and Figure 3 and Figure 4 The enema nozzle 1 is shown, through which enema fluid flows.

[0101] The enema nozzle 1 includes a conduit 2 and a flexible stimulation member 3 surrounding the conduit 2. The flexible stimulation member 3 has the shape of an elongated tube.

[0102] Best as Figure 2 (that is) Figure 1 As shown in the cross-sectional view of the enema nozzle, the catheter 2 includes an elongated insertion body 4, a spherical insertion end 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.

[0103] The flexible stimulating member 3 extends from the middle section 10 of the spherical insertion end 5 to the flared stop section 8, closely surrounding the entire elongated insertion body 4. When no enema fluid flows through the first flow channel, the flexible stimulating member 3 has the same cross-sectional diameter (A) as the cross-sectional diameter (B) of the spherical insertion end 5.

[0104] The flexible stimulation member 3 defines a first flow channel 11 that terminates at at least one outlet 12a, which is in fluid communication with a plurality of (six in the illustrated embodiment) first delivery openings 12b at the end 13 of the spherical insertion end 5 via a corresponding first internal flow channel 14 extending through the spherical insertion end 5.

[0105] The enema nozzle 1 also includes a third flow channel 15, which is configured to be in fluid communication with the first flow channel 11 via a manifold 7. In the illustrated embodiment, the manifold 7 is a chamber that receives enema fluid from the third flow channel 15 via a first inlet 16 and then branches into a plurality of first outlets 17 that introduce enema fluid into the first flow channel 11.

[0106] Because the manifold 7 is positioned at the proximal end 9 of the elongated insert body 4, it ensures that when the enema fluid is added to the enema nozzle 1, the enema fluid will flow along the entire flexible stimulating member 3, thereby stimulating a larger section of the rectal wall.

[0107] The manifold 7 further branches into a second outlet 19, which leads into a second flow channel 20. The second flow channel 20 extends through the elongated insert body 4 and extends into the second delivery opening 21 via a second internal channel 22 in the spherical insert end 5.

[0108] When the enema solution is delivered to the enema nozzle 1 and begins to flow through the first flow channel 11, the flexible stimulating member 3 will begin to dilate. However, since the enema solution is simultaneously applied to the patient through the first delivery opening 12b, the stimulating member 3 will only dilate slightly, preferably as follows: Figure 3 and Figure 4 As shown.

[0109] In this respect, the flexible stimulation member 3 is configured to expand in a direction substantially perpendicular to the longitudinal axis X of the catheter, and as... Figure 3 and Figure 4 As shown, the main expansion occurs in the middle section 23 of the flexible stimulation component 3.

[0110] Therefore, when enema fluid flows through the first flow channel 11 (see...) Figure 4 The cross-sectional diameter A' of the flexible stimulation component 3 is only slightly larger than that when no enema fluid flows through the first flow channel 11 (see...). Figure 2 The cross-sectional diameter A of the catheter increases by approximately 15%.

[0111] Therefore, if the cross-sectional diameter A is approximately 13 mm, then the cross-sectional diameter A' is approximately 15 mm. However, it has been shown that the relatively small dilation is sufficient to provide mild, adjustable, and gentle stimulation of the rectal nerves, and thus initiate peristalsis and / or activate the anal sphincter. The gentle stimulation member 3 dilates little or no in the longitudinal direction of the conduit.

[0112] The third flow channel 15 is configured to connect to any suitable enema fluid reservoir (not shown) via the first connecting member 24. In a preferred embodiment, the enema fluid reservoir is an enema fluid delivery container configured as a handheld pump.

[0113] During administration, the enema fluid initially flows through the third flow channel 15 and is diverted via the manifold 7 to the first flow channel 11 of the flexible stimulation member 3 and the second flow channel 20 for delivering the enema fluid directly to the patient.

[0114] Figure 5 and Figure 6 A second version of a first embodiment of the enema nozzle 1' according to the present invention is shown. This embodiment corresponds substantially to the first version 1 and operates in a similar manner; therefore, the same parts are referred to by the same reference numerals. The only difference between the first and second versions shown in the figures is that the second version 1' does not include a second flow channel 20, so all enema fluid is applied directly via the first flow channel 11 of the flexible stimulating member 3.

[0115] Figure 7 , Figure 8 and Figure 9 A preferred version of a second embodiment of the enema nozzle 1'' according to the present invention is shown. This embodiment differs from [the previous one] in many respects. Figures 1 to 4 The first embodiment shown corresponds to this one, therefore the same parts use the same reference numerals.

[0116] Figures 1 to 4 The first embodiment shown is the same as Figures 7 to 9 The main difference between the second embodiments shown is that the first flow channel 11' of the flexible stimulation member 3' is blind-ended, meaning that the first flow channel 11' is closed at its distal end (near the ball-shaped insertion end 5), and the enema fluid is delivered to the user through a second flow channel 20, which is configured to be in fluid communication with the first flow channel 11' via a manifold 7. Therefore, the enema fluid will flow into and out of the first flow channel 11' via an outlet 17; that is, in this embodiment, the outlet 17 will act as a first flow opening 17', allowing the enema fluid to flow into and out of the first flow channel 11'. This ensures that when enema fluid is added to the first flow channel 11', the channel will initially be filled with the enema fluid, but since the enema fluid is simultaneously applied to the user via the second flow channel 20, it is also removed from the first flow channel 11'.

[0117] Therefore, similar to the first embodiment, the stimulating member 3' in the second embodiment will expand as liquid (enema fluid) is added to the first flow channel 11'. However, since the liquid is simultaneously forced back into the manifold 7 and transferred to the second flow channel 20, the stimulating member 3' will only expand slightly, preferably to the same extent as in the first embodiment. Preferably, the enema fluid is added in a pulsatile manner, and the rectal nerves will be stimulated in a manner similar to that discussed in the first embodiment.

[0118] like Figure 9 As indicated by the arrows, when the enema solution is applied to the user in the second embodiment, the enema solution first flows through the third flow channel 15 into the manifold 7, and from the manifold 7 is partially distributed to the first flow channel 11' via the first flow opening 17' and partially distributed to the second flow channel 20 via the second outlet 19. Since there is no first delivery opening in the ball-shaped insert end 2, the first flow channel 11' will be blind at its distal end 25. Therefore, when the enema solution is added to the enema nozzle 1'' via the third flow channel 15, a portion of the enema solution will be delivered to the stimulating member 3' throughout the entire enema application process. The enema solution will thus fill and expand the first flow channel 11'. However, since the flexible stimulating member 3' is configured to expand only slightly, the enema solution in the first flow channel 11' will be forced (circulated) back to the manifold 7 via the flow opening 17' and delivered to the user via the second flow channel 20. Therefore, the enema solution will flow in and out (circulate) through the first flow channel 11', as... Figure 9 As indicated by the middle arrow, this enhances the pulsating motion of the slightly dilated stimulation member 3'.

[0119] In use, the enema nozzle 1;1';1'' is inserted into the patient's rectum, and the user (patient or assistant) begins administering the enema solution. This can be achieved using an automatic pump (e.g., a circulation pump), or, if the enema solution reservoir is a handheld pump, by repeatedly squeezing and releasing the handheld pump. In either case, the enema solution is administered until the desired dose is achieved and peristalsis is obtained, after which the enema nozzle 1;1';1'' can be removed.

[0120] The inventors of this invention have discovered that using the enema nozzle 1;1';1'' according to the invention will activate the user's anal sphincter and ensure that the muscle contracts and remains in a basically contracted state, i.e., the enema nozzle 1;1';1'' according to the invention does not require any expandable holding device to hold the nozzle 1;1';1'' in place during the enema application process.

[0121] Therefore, when the enema nozzle 1;1';1'' is inserted into the rectum, the enema nozzle 1;1';1'' will first ensure that the user's anal sphincter remains contracted and maintains itself in a state of basic contraction, thereby not only keeping the enema nozzle in place, but also preventing fluids (such as bodily excretions, liquids and gases) from accidentally escaping from the colon.

[0122] However, when the enema fluid is administered, it will flow through the flexible stimulating member 3;3' as described above and begin to stimulate the rectal nerves, thereby initiating peristalsis.

[0123] Once the desired amount of enema fluid has been delivered (e.g., approximately 2–10 minutes after the enema nozzle 1;1';1'' is inserted), the stimulation of the rectal nerves, along with the administered enema fluid, makes it easier to empty the bowels.

[0124] If the enema fluid is administered in a discontinuous flow, pulsating motion is provided in the flexible stimulation member 3;3', and it is believed that this pulsating motion very effectively stimulates the rectal nerves and initiates peristalsis and / or activates the anal sphincter.

[0125] In the embodiment shown in the figure, the flexible stimulation member 3;3' has a predefined shape and is made of a silicone membrane with a thickness of about 0.3 mm to 0.5 mm, for example 0.4 mm, because such a material will have the desired shape memory, providing the desired limitation on the expansion of the stimulation member, and at the same time is thin enough that the rectal nerves can be adequately stimulated when the enema fluid flows through the first flow channel 11;11'. Since the flexible stimulation member 3;1' is made of a relatively thin membrane material (preferably 0.3 to 0.5 mm), the ability of the nozzle 1;1';1'' to be drawn into the rectum and provide a self-sealing effect is not impaired.

[0126] Those skilled in the art will understand that the flexible stimulating member 3;3' can be made of different materials, such as polymer films; have different thicknesses, etc. The only requirement is that the flexible stimulating member is configured to stimulate the rectal nerve, and preferably also has shape memory, and / or provides desired limitation on the expansion of the stimulating member.

[0127] As shown in the figure, the cross-sectional diameter b of the insertion body 4 is significantly smaller than the cross-sectional diameter B of the spherical insertion end 5 along the entire length of the insertion body 4.

[0128] However, since the cross-sectional diameter A of the flexible stimulation member 3;3' (when no enema fluid flows through the stimulation member 3;3' / in the stimulation member 3;3') (i.e., from the middle section 10 of the spherical insertion end 5 to the flared stop section 8) corresponds to the cross-sectional diameter of the spherical insertion end 5, a smooth transition from the insertion end 5 to the stop section 8 is provided. In this way, the dimensional difference between the spherical insertion end 5 and the insertion body 4 is covered by the flexible stimulation member 3, thus making the enema nozzle 1;1' visually more acceptable to the patient.

[0129] Modifications and combinations of the above principles and designs can be foreseen within the scope of this invention.

Claims

1. An enema nozzle (1;1';1''), the enema nozzle being arranged for administering an enema solution to a user, the enema nozzle comprising a conduit (2) and a flexible stimulating member (3;3') at least partially surrounding the conduit (2), and wherein, The flexible stimulating member (3; 3') defines a first flow channel (11), which is arranged such that there is an enema fluid flow through the first flow channel (11; 11') and / or in the first flow channel (11; 11') during the enema fluid application process.

2. The enema nozzle (1; 1') according to claim 1, wherein, The first flow channel (11) is an open flow channel and is arranged to directly apply at least a portion of the enema fluid to the user via an outlet (12a).

3. The enema nozzle (1; 1'') according to claim 1 or 2, wherein, The enema nozzle includes a second flow channel (20) arranged for applying at least a portion of the enema fluid.

4. The enema nozzle (1'') according to claim 3, wherein, The first flow channel (11') is a blind flow channel and is arranged to apply enema fluid to the user via the second flow channel (20).

5. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The flexible stimulation member (3;3') is made of a material with a Shore A hardness of 25 to 50 as measured according to ASTM D2240.

6. The enema nozzle (1;1';1'') according to any one 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. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, Compared to the cross-sectional diameter (A) of the enema nozzle (1;1';1'') when there is no enema fluid flow through the flexible stimulation member (3;3'), the cross-sectional diameter (A') of the enema nozzle (1;1';1'') measured at the location of the flexible stimulation member (3;3') surrounding the conduit (2) when there is enema fluid flow through the flexible stimulation member (3;3') increases by less than 50%, more preferably less than 30%, and more preferably less than 5%.

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

9. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The flexible stimulation member (3;3') is made of a polymer film with a thickness of 0.3 mm to 1.0 mm, preferably 0.3 mm to 0.5 mm.

10. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The flexible stimulation component (3;3') is made of silicone resin, latex, polyurethane (polyurethane), polyvinyl chloride or polyethylene.

11. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The flexible stimulation member (3; 3') extends along the longitudinal length of the conduit (2), and wherein the flexible stimulation member (3; 3') is an elongated tube or elongated bag, or has an elongated bag-like shape.

12. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The first flow channel is arranged to hold 1 to 20 ml, preferably 2 to 10 ml, more preferably 4 to 8 ml, for example 7 ml, when the enema fluid is added during the enema fluid administration process.

13. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The flexible stimulation member (3; 3') surrounds the entire length of the catheter (5) except for the outermost end (13) of the catheter (2).

14. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The catheter includes an elongated insertion body (4) and a spherical insertion end (5), wherein the cross-sectional diameter (b) of the insertion body (4) is smaller than the cross-sectional diameter (B) of the spherical insertion end (5) over the entire length of the insertion body (4).

15. The enema nozzle (1; 1'; 1'') according to claim 14, wherein, The diameter of the spherical insertion end (5) is between about 0.8 cm and about 3 cm, preferably between about 1 cm and about 2 cm, and even more preferably between about 1.2 cm and about 1.5 cm, for example, about 1.3 cm.

16. The enema nozzle (1;1';1'') according to claim 14 or 15, wherein, The cross-sectional diameter of the spherical insertion end (5) is about 1.2 to 5 times the cross-sectional diameter of the elongated insertion body, preferably between 2 and 4 times, and even more preferably about 2.6 times.

17. The enema nozzle (1;1';1'') according to any one of claims 14 to 16, wherein, The flexible stimulation member (3; 3') extends from the middle section (10) of the spherical insertion end (5) to the proximal end (9) of the catheter (2), such as the proximal end of the elongated insertion body (4).

18. The enema nozzle (1; 1'; 1'') according to any one of claims 14 to 17, wherein, When no enema fluid flows through the first flow channel (11), the flexible stimulation member (2) has a cross-sectional diameter (A) that is the same as or smaller than the cross-sectional diameter of the spherical insertion end (2).

19. The enema nozzle (1; 1') according to any one 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 enema fluid to the user.

20. The enema nozzle (1; 1'; 1'') according to claim 19, wherein, The at least one first delivery opening (12) extends through the end of the conduit (2), such as the spherical insertion end (5), and preferably extends via one or more internal flow channels (14) in the spherical end (5).

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

22. The enema nozzle (1; 1'; 1'') according to claim 21, wherein, The enema nozzle (1;1';1'') also includes a manifold (7) arranged to receive enema fluid from the third flow channel (15) via at least one first inlet (16), and the manifold (7) branches into at least one first outlet (17) or flow opening (17') leading to the first flow channel (11;11').

23. The enema nozzle (1; 1'') according to claim 21 or 22, wherein, The third flow channel (15) extends further into the second flow channel (20), optionally via the manifold (7), and wherein the second flow channel (20) terminates at at least one second delivery opening (21) at or near the end (14) of the conduit (2).

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

25. The enema nozzle (1;1';1'') according to any one of the preceding claims, wherein, The first flow channel (11; 11') is arranged for connection to any suitable enema fluid reservoir.

26. An enema system comprising an enema nozzle (1;1';1'') according to any one of claims 1 to 25.

27. The enema system according to claim 26, wherein, The enema system includes an enema fluid reservoir and means for delivering the enema fluid to the first flow channel (11; 11') in a discontinuous flow.

28. The enema system according to claim 26 or 27, wherein, The enema fluid reservoir is an enema fluid delivery container arranged as a handheld pump.

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