Sausage filling nozzle and sausage filling equipment comprising same

Abstract

The invention discloses a sausage filling nozzle and sausage filling equipment comprising the sausage filling nozzle. The present invention relates to an enema nozzle (1, 31, 34, 35) arranged for delivering an enema agent to a user, the enema nozzle comprising a spherical insertion tip (3) and an elongated insertion body (2) having the shape of a frustoconical body, and wherein the cross-sectional diameter (A, B) of the insertion body (2) is smaller than the cross-sectional diameter (C) of the spherical insertion tip (3). When the enema nozzle (1, 31, 34, 35) is inserted into the user's rectum, the user's anal sphincter holds itself in a substantially contracted state, thereby both holding the enema nozzle (1, 31, 34, 35) in place and preventing any leakage of fluid.

Description

TECHNICAL FIELD

[0001] The present invention relates to an enema nozzle for delivering an enema, and an enema device comprising said enema nozzle. BACKGROUND

[0002] Administering enemas is a common medical procedure by which a fluid is injected into the rectum and lower intestine of a patient in order to induce bowel movement. The need for such a procedure often arises in patients suffering from certain physical ailments in which voluntary bowel control is impaired, or when the bowel needs to be cleaned prior to, for example, a colonoscopy or a surgical operation.

[0003] When the need for medical assistance does not require a physician or other health care assistant, the enema is often administered to the patient at home. In this respect, it is often difficult for the patient to administer the enema to him or herself, as conventional enema devices often cause discomfort and irritation upon insertion. Furthermore, it is difficult for the patient to administer the enema while at the same time stably keeping the enema nozzle in place during the procedure. Often, another person assists the patient, but assistance can not always be available if, for example, the patient lives alone.

[0004] In order to overcome these problems, a number of enema devices have been developed, including different retention means for retaining the nozzle in the rectum / colon during administration of the enema.

[0005] Such devices are for example disclosed in US Patent No. 5,074,842, which describes a flushing device having a fixation balloon which is inflated using air, and wherein the air is delivered through a syringe valve in communication with an air channel. Similar systems are known from EP 1531885, which describes a flushing device comprising a liquid reservoir and an air-inflated balloon for retaining a tubular member inserted into the rectum, and from WO 201 1023196, which describes a system for inflating a balloon / retention member using a liquid.

[0006] As air or liquid is used in these known devices to inflate the retention member / balloon, these known enema systems are relatively complex constructions which can be difficult and time consuming to use. Not only must the device be arranged to deliver air / liquid to the balloon in order to retain the enema nozzle in the body opening to be flushed, but the air / liquid must also be removed from the balloon when the enema nozzle has to be removed from the body opening. The air or liquid can be discharged to the surroundings or delivered to the rectum and / or colon before the nozzle is removed from the rectum, and the user needs to ensure that the balloon is completely deflated in order to prevent damage to, for example, the rectal wall.

[0007] Furthermore, a problem with using air-filled balloons is that the balloon will react to body movements (e.g. peristaltic reflexes), whereby the nozzle can be inconveniently displaced resulting in a leak, and air from the balloon cannot be delivered to the colon as this would result in additional pathological distension or medical dilation of the colon, resulting in pain and discomfort for the patient.

[0008] A further problem with using inflatable balloons is that if the balloon is overfilled, the balloon can rupture, resulting in damage to the fragile walls of the colon / rectum and leakage of the liquid-filled contents of the colon / rectum. Furthermore, if the balloon is underfilled, it cannot safely hold the enema nozzle in place during use. This is not only unfriendly to the patient, but also degrading, as the surrounding environment will inevitably be contaminated with the flushing liquid and bodily excretions if the enema nozzle inadvertently falls off. SUMMARY

[0009] It is therefore a first aspect of the present invention to provide an enema nozzle that can be retained in the colon / rectum without the use of an inflatable retention device, such as an inflatable balloon.

[0010] It is a second aspect of the present invention to provide an enema nozzle that is arranged for connection to an enema device, which enema nozzle can be inserted into the opening to be flushed without causing discomfort, trauma and / or harm.

[0011] It is a third aspect of the present invention to provide an enema nozzle that is inexpensive to manufacture and simple and reliable to use.

[0012] It is a fourth aspect of the present invention to provide an enema nozzle that is relatively small and easy to handle.

[0013] According to the invention, these and other aspects are achieved by providing an enema nozzle for delivering an enema to a user, the enema nozzle comprising a spherical insertion tip and an elongated insertion body, the insertion body having the shape of a truncated cone, and wherein the cross-sectional diameter of the insertion body is smaller than the cross-sectional diameter of the spherical insertion tip.

[0014] In the context of the present invention, the term "cross-sectional diameter" of the elongated insertion body and the spherical insertion tip refers to the diameter taken in a plane perpendicular to the longitudinal axis of the elongated insertion tip. Furthermore, the term "spherical" refers to the insertion tip having the shape of a sphere or substantially a sphere, e.g. a spheroid (oblate or prolate) having a minor axis or major axis that differs from each other by less than 5%. The term "insertion tip" refers to the distal section / end of the enema nozzle, i.e. the part that is inserted into the rectum / colon first, and the term "insertion body" refers to the section of the enema nozzle (below the spherical insertion tip) that is intended to be placed at and within the anal opening.

[0015] The inventors of the present invention have surprisingly found that as soon as the enema nozzle is placed in the anus / rectum of a user, the enema nozzle activates the anal sphincter of the user and ensures that said muscle contracts and remains in a substantially contracted state.

[0016] Thus, the enema nozzle according to the present invention makes use of the functionality of the anal sphincter, which effectively prevents fluids (e.g. bodily excretions, liquids and gases) from escaping from the colon unintentionally.

[0017] The anal sphincter is a short tube of muscle around the lower part of the anal canal and controls the expulsion of faeces, thereby maintaining the ability to control faeces. The anal sphincter comprises two muscles: the internal anal sphincter and the external anal sphincter. The external anal sphincter is largely under voluntary control of the somatic nervous system, which keeps it in a contracted state, whereas the control of the internal sphincter is involuntary, as it is innervated by the autonomic nervous system. The internal anal sphincter is in a tonic contracted state most of the time to prevent leakage of fluids or gas, but relaxes upon distension of the rectal ampulla, e.g. when faeces accumulate in said cavity.

[0018] The inventors of the present invention have surprisingly found that when the enema nozzle according to the present invention is inserted into the anus of a user, said enema nozzle does not affect the functionality of the anal sphincter and, thus, the anal sphincter of the user will remain contracted and keep itself in a substantially contracted state, thereby not only keeping the enema nozzle in place, but also ensuring that the flushing liquid and bodily excretions remain in the rectum and colon during the enema administration.

[0019] It has been found that conventional enema nozzles cannot be kept in the rectum / colon in a similar manner as the enema nozzle according to the present invention. This can be due to the form of the insertion body / catheter (such as a flared head) and / or the relatively large cross-sectional diameter (at least more than 1 cm over one or more sections of the part that is inserted into the rectum / colon) of these conventional enema nozzles, as such structures / dimensions would stretch the anal sphincter, whereby the sphincter cannot contract sufficiently to keep the enema nozzle in place and / or the fluids in the rectum.

[0020] Thus, the conventional enema nozzle cannot simply stay in place (be retained) by the function of the anal sphincter. Therefore, the conventional enema nozzle requires more and more help from retention members which can be inflated when placed in the rectum. Moreover, leakage of the enema fluid usually occurs when using these conventional enema nozzles because the anal sphincter cannot provide a tight fit around the conventional enema nozzle and this can result in insufficient colon filling. Thus, an imperfect surgical outcome can be obtained or the dose of enema (or drug, if a drug is administered) received by the patient can be insufficient. The enema nozzle according to the present invention effectively prevents said problems because said enema nozzle simply uses the user's own anal sphincter to keep the enema nozzle safely in place and prevent any leakage.

[0021] Said spherical insertion tip is located at the insertion end of the insertion body and will provide a smoother insertion which will effectively reduce the physical discomfort and pain that a patient can experience during insertion of a conventional enema nozzle.

[0022] Moreover, since the insertion tip is spherical and preferably does not contain sharp edges, any damage to the rectal and colonic wall is minimized. In this regard, it is well known that repeated tissue trauma, which does not allow time to heal, leads to more serious conditions. This is particularly worrying for pediatric patients who usually walk around during the enema process, since it is important to avoid breaking the fragile rectal wall with the enema nozzle. The enema nozzle according to the present invention effectively eliminates these problems since the spherical insertion tip conveniently reduces this risk. Thereby, repeated enema administration can be performed using the enema nozzle according to the present invention without causing trauma to the surrounding tissue.

[0023] The inventors of the present invention have also found that the insertion of this enema nozzle into the patient's anus / rectum is even easier than the enema nozzles known from the prior art. The use of a spherical insertion tip with a cross-sectional diameter larger than the elongated frustoconical insertion body ensures that during the insertion process, the squeezing action of the anal sphincter on the insertion body pushes (sucks) the enema nozzle into the rectum, thereby ensuring that the enema nozzle according to the present invention will be placed in the correct position in the rectum / colon.

[0024] Preferably, the cross-sectional diameter of the insertion body is smaller than the cross-sectional diameter of the spherical insertion tip throughout the length of said insertion body. Thus, the cross-sectional diameter of the spherical insertion tip is larger than the cross-sectional diameter of the insertion body, regardless of where along the elongated insertion tip this cross-sectional diameter is measured. As mentioned above, this particular configuration is believed to facilitate the squeezing action of the anal sphincter on the insertion body which ensures that the enema nozzle according to the present invention is "sucked" into the rectum, thereby ensuring that the enema nozzle according to the present invention will be placed in the correct position in the rectum.

[0025] In some embodiments, the enema nozzle can comprise a flared baffle arranged to prevent the enema nozzle from being pushed and / or sucked into the rectum too far. Preferably, the flared baffle is placed near and directly below the top circular base of the elongate insertion body.

[0026] As the elongate insertion body is formed as a frustum, it will have a top circular base and a bottom circular base, and the top circular base will have a smaller radius / diameter than the bottom circular base.

[0027] In preferred embodiments, the elongate insertion body is connected to the spherical insertion tip such that the top circular base of the insertion body (i.e. the part of the insertion body having the smallest diameter) is connected / attached to the spherical insertion tip, and the sides of the insertion body gradually extend outwardly from the top circular base towards the bottom circular base which has a larger diameter.

[0028] In one preferred embodiment, the cross-sectional diameter of the spherical insertion tip is about 1.2 to 7 times larger than the cross-sectional diameter of the top circular base of the insertion body, preferably between 2 and 5 times larger than the cross-sectional diameter of the top circular base of the insertion body, even more preferably about 2.6 times larger, as it has been shown that such a ratio is particularly advantageous for ensuring that the enema nozzle according to the present application is correctly and sealingly seated in the rectum during enema administration.

[0029] The cross-sectional diameter of the bottom circular base can preferably be about 1.1 to 3.5 times larger than the cross-sectional diameter of the top circular base, preferably about 1.2 to 2 times larger than the cross-sectional diameter of the top circular base, even more preferably about 1.6 times larger than the cross-sectional diameter of the top circular base. The cross-sectional diameters of the top circular base and the bottom circular base are chosen so as to ensure that the cross-sectional diameter of the spherical insertion tip will be larger than the cross-sectional diameter of the elongate insertion body, preferably along the entire length of the insertion body (over its entire length).

[0030] In one embodiment, the cross-sectional diameter of the bottom circular base is about 10 mm or less, as such a size ensures that the anal sphincter remains contracted to a degree that prevents leakage during administration.

[0031] The diameter of the spherical insertion tip is preferably between about 0.8 cm and about 2.5 cm, preferably between about 1.0 cm and about 2.0 cm, and even more preferably between about 1.2 cm and about 1.5 cm, for example about 1.3 cm.

[0032] In a preferred embodiment of the enema nozzle according to the present application, the cross-sectional diameter of the bulbous tip is about 13 mm, the cross-sectional diameter of the top base of the insertion body is about 4.5 mm, the cross-sectional diameter of the bottom base is about 8 mm, and the insertion body has a length of about 5 cm, as such dimensions will provide a comfortable fit for most teenagers / adults.

[0033] Thus, the cross-sectional diameter of the enema nozzle according to the present application is relatively small compared to the cross-sectional diameter of conventional enema nozzles, which typically have a cross-sectional diameter of more than 1.5 cm. This ensures that the rectal ampulla and / or the anal sphincter muscles, including both the internal and external sphincter muscles, of the user are not stretched, and thus remain tonically contracted, whereby the enema nozzle according to the present application is firmly retained in the rectum, and any fluid (liquid and gas) is kept in the rectum for the desired period of time, and at least the period of time taken to deliver the enema, e.g. 3-5 minutes.

[0034] The insertion body can have any suitable length, depending on the intended delivery site of the enema in the rectum / colon, the longer the insertion body, the deeper the enema can be delivered in the colon. However, it is preferred that the length of the insertion body is sufficient to place the bulbous insertion tip above the dentate line when placed in the rectum of a user, as this will prevent the bulbous insertion tip from irritating sensitive nerve endings that can be located inside the anal canal between the opening and the dentate line (also known as the anodental line). Thus, it is preferred that the length of the insertion body, taken along the longitudinal axis of the elongated insertion body, i.e. the length of the elongated section of the enema nozzle to be placed inside the rectum, is between 3 cm and 7 cm, preferably between 4 cm and 6 cm, and even more preferably about 5 cm, as the inventors have found that such a length will place the bulbous insertion tip above the dentate line for most users, and at the same time provide the unique self-retention function of the enema nozzle by use of the anal sphincter muscles.

[0035] Thus, using the above dimensions, the elongated insertion body will be relatively long and thin, and when the sphincter muscles close around the elongated insertion body, not only is any leakage of bodily fluids prevented, but the sphincter muscles will also hold the insertion body in the correct position in the rectum. Once the enema has been administered, the enema nozzle can be safely and quickly removed by a simple pulling action. The enema will build up pressure (dilate / stretch the rectal cavity) within the rectal ampulla together with the feces etc. in the rectum, thereby creating an urge to eliminate the feces. Thus, when this urge occurs, the user can use the washroom, and as the user does not have to deflate and / or worry about damaging the retention member when it folds in on itself, the procedure of administration, including insertion and removal of the enema nozzle, is safe and can be performed quickly.

[0036] For delivering / evacuating the enema, the enema nozzle comprises at least one flow channel extending into at least one delivery opening, i.e. the at least one delivery opening is in flow communication with the at least one flow channel.

[0037] The flow channel of the enema nozzle can be in the form of one or more tubes placed within the elongated insertion body and extending in the longitudinal direction of the insertion body, i.e. along the longitudinal axis of the insertion body. However, in a preferred embodiment, the at least one flow channel is defined by the side wall of the elongated insertion body, and if the flow channel extends into the spherical insertion tip, the at least one flow channel is also defined by the side wall of the spherical insertion tip or a tubular opening in the insertion tip. This is particularly relevant when the spherical insertion tip and the elongated insertion body are made as an integral unit, as such an integral unit can be formed as a hollow shell, wherein the interior space or a part of the interior space forms the flow channel.

[0038] In some embodiments, the one or more delivery openings can be arranged at the distal end of the insertion body, directly below the top circular base, e.g. between 2 mm and 5 mm below the base. Hereby, the spherical insertion tip will act independently of the flow channel of the enema.

[0039] However, in some embodiments, it can be preferred to arrange the at least one delivery opening in the spherical insertion tip, e.g. at the end of the tip. This can easily be obtained by simply extending the one or more internal flow channels into the spherical insertion tip.

[0040] A preferred delivery opening, both for use in the enema nozzle according to the present application and for use in other enema nozzles, is a delivery opening in the form of a circumferential gap in the spherical insertion tip. The circumferential gap extends in a first plane perpendicular to the longitudinal axis of the insertion body. Preferably, the first plane is arranged closer to the distal end of the enema nozzle compared to a second plane through the center of the spherical insertion tip, and wherein the first plane and the second plane are parallel to each other. Such a circumferential gap allows the enema to be evacuated into the body opening in all directions, which can be particularly desirable when the rectum or colon of the user is inflamed or otherwise sensitive to contact with a pressurized flow of enema.

[0041] In one embodiment, the circumferential gap can be divided into a plurality of openings, e.g. two, three or more openings along the circumference of the insertion body.

[0042] However, in a preferred embodiment, the circumferential gap is a 360-degree circumferential gap continuously extending along the entire circumference of the spherical insertion tip along the first plane. In said embodiment, the spherical insertion tip comprises a first and a second spherical portion, and wherein the first and second spherical portions are arranged connected to each other such that the spherical insertion tip is provided with a 360-degree circumferential gap between the two spherical portions.

[0043] The first spherical portion is preferably formed as a part of a sphere, e.g. as a hollow sphere shaped as a missing upper section in the form of a spherical cap having a first height. In this way, a first opening is provided to the inside of the first spherical portion defined by the wall of said first spherical portion. The first spherical portion is connected to the elongated insertion body at a top circular base, and the flow channel extends to the interior of the first spherical portion.

[0044] The second spherical portion comprises a second spherical cap having a second height, and wherein said second height is smaller than the first height of the first spherical cap missing from the first spherical portion, such that when the first and second spherical portions are combined into a substantially spherical shape, a circumferential gap is provided between said two spherical portions.

[0045] Preferably, the outer surface of the first spherical portion and the outer surface of the second spherical cap have the same radius of curvature, such that when the two spherical portions are combined a substantially spherical insertion tip is provided. It is further preferred that the circumferential gap along the outer edge, i.e. the edge of the outer surface facing the spherical enema nozzle, is rounded, such that the provided spherical insertion tip does not have any sharp edges or portions.

[0046] The two spherical portions can be connected to each other via any suitable connection system, with the only requirement being that a delivery opening in the form of a 360-degree circumferential gap is provided between the two spherical portions.

[0047] In a preferred embodiment, the first spherical portion comprises an interior space defined by the inner wall of said first spherical portion, i.e. said interior space is in the form of a part of a sphere, and the second spherical portion comprises a male connection portion arranged for connection / attachment to the inner wall of the first spherical portion.

[0048] In this regard, said male connection portion can comprise a protrusion comprising a plurality of legs, e.g. three to eight legs, each leg being arranged for engaging the inner wall of the first spherical portion. The space between said plurality of legs will provide an opening between the inner wall of the first spherical portion and the male connection portion, thereby allowing the enema to flow out from the flow channel and out through the circumferential gap.

[0049] Preferably, each leg is equally spaced about the longitudinal axis of the male coupling portion, which preferably overlaps the longitudinal axis of the enema nozzle. Each leg can be a plate-like configuration whose first edge is complementary to a portion of the inner wall of the first spheroid portion, thereby allowing the first and second spheroid portions to be securely attached to each other, for example by gluing or ultrasonic welding. The inventors of the present invention have also found that if each leg comprises a recess having a curvature extending towards the circumferential gap, liquid applied via the circumferential gap will be applied by a vortex motion.

[0050] As an alternative to, for example, gluing the first and second spheroid portions together, the first spheroid portion can comprise a female coupling portion, for example one or more barbs arranged on the inner wall of the first spheroid, and the male coupling portion can comprise one or more engagement means, for example teeth and / or hooks adapted to engage the one or more barbs in the female coupling portion, such that when the male coupling portion is inserted into the first spheroid portion, a snap-fit is provided between the male and female coupling portions.

[0051] Regardless of how the first and second spheroid portions are connected, it is preferred that they cannot be disengaged in any way after combination / connection.

[0052] The inventors of the present invention have found that a particularly advantageous embodiment of the enema nozzle according to the present invention is provided when the circumferential gap is about 0.5-2 mm wide, preferably about 1 mm wide, when taken along the outer surface of the spherical insertion tip in the longitudinal direction of the enema nozzle, i.e. from the distal end towards the proximal end of the enema nozzle, and when the angle a by which the circumferential gap is offset from the longitudinal axis of the enema nozzle is about 30-45 degrees, preferably about 40 degrees.

[0053] The enema nozzle is preferably arranged to be connected to a delivery container containing a liquid / enema, such that the delivery container communicates with the delivery opening for administering a liquid, such as an enema, to a patient / user. The delivery container can be any suitable irrigation reservoir, such as an enema delivery container used in large bedside irrigation systems in medical or hospital facilities and / or a small, compact delivery container for home enema administration. The nozzle can be removably connected to the delivery container using any conventional coupling unit. The coupling unit can, for example, include a first coupling portion, such as via a tubular extension, attached to the enema nozzle to provide distance between the elongated insert body and the coupling unit, and a second complementary coupling portion attached to the delivery container to provide fluid communication between the two components. In a particularly simple embodiment, the first coupling portion is a tube for the flow channel, and the second coupling portion is a second tube on the delivery container. The second tube is preferably adapted to provide a fluid-tight fit with the first tube, thereby providing a coupling, such as achieved by the first and second tubes being made of a flexible material, such that one tube can be placed within the other.

[0054] In some embodiments, it may be preferable to have the spherical insertion tip made of one material and the elongated insertion body 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 to easily advance the nozzle into the body opening, and the spherical insertion tip may be made of a softer, more resilient, and more flexible material, allowing the insertion tip to deform and / or flex slightly during insertion into the rectum and colon. However, in a particularly simple embodiment according to the present invention, the spherical insertion tip and the elongated insertion body are made of the same material, preferably as an integrated unit.

[0055] In order to provide the desired rigidity / flexibility combination for the enema nozzle, the spherical insertion tip and / or the insertion body, or at least a portion of the insertion body, can be made of a 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, styrene ethylene butylene styrene (SEBS), thermoplastic polyester elastomers (TPC), thermoplastic styrene elastomers (TPS), and other similar polymers. The flexibility of the spherical insertion tip and the insertion body can be varied accordingly, for example, by varying the length of the polymer chains, generating branches from linear polymer chains, crosslinking the polymer chains, and / or adding plasticizers to the polymers.

[0056] The enema nozzle according to the present application can be manufactured using any conventional process. However, it is preferred that the enema nozzle is manufactured in a single injection molding process by means of 1 K injection molding, 2K injection molding or 3K injection molding.

[0057] 2K or 3K injection molding comprises the processing of two or three different polymers (or polymer compositions) into the final product by means of one injection molding process. By means of the 2K and 3K technology, possible assembly steps of e.g. the spherical insertion tip and the elongated insertion body are prevented.

[0058] This technology enables the integration of the properties of polymers into the enema nozzle according to the present application in a simple and effective manner. For example, a 2K injection molding process can be used to combine two different elastomeric polymers with different properties, e.g. one first elastomeric polymer which will form the insertion body and one second elastomeric polymer which will form the spherical insertion tip.

[0059] The 2K or 3K injection molding process is preferably carried out on one machine which is programmed to inject the polymers in a single cycle. The injection molding can be a co-injection molding process, a sequential injection molding process or an overmolding injection process.

[0060] The inventors of the present application have found that the insertion of the enema nozzle according to the present application into a body opening, e.g. the rectum, requires significantly less force than the insertion of a conventional enema nozzle, because the enema nozzle according to the present application is "sucked" into the rectum and, thus, the enema nozzle according to the present application is particularly advantageous for disabled patients and / or patients suffering from impairments related to e.g. aging, diagnosis or trauma. Such patients often have a reduced hand strength and / or flexibility and the force required for the insertion of a conventional enema nozzle can result in the consequence that the user is no longer able to use the device by himself. The enema nozzle of the present application remedies this and, thus, is very suitable for use at home. It is noted that in case of a user having a normal impaired sphincter function, the enema nozzle can of course also be used, but the self-sealing, self-retaining effect surprisingly obtained by the enema nozzle according to the present application is not observed to the same extent. This of course depends on the degree of the sphincter impairment and / or whether there are other conditions present at the insertion site, e.g. obstructions such as fistulas or abscesses.

[0061] Preferably, the enema nozzle according to the present invention does not include any components or elements that are arranged to change form and / or size during use. In this way, the enema nozzle does not include any expandable components, such as an inflatable balloon and / or other retention members that can be folded or expanded during use (e.g., after insertion). In addition, since the retention member does not need to be inflated / deflated, the time-consuming and complicated process of inflating and deflating the balloon is eliminated, thereby providing a fast and reliable method of using the enema nozzle according to the present invention and ensuring that the nozzle is firmly held in place throughout the application process. In addition, the user does not have to worry about adjusting the amount of fluid in the retention member in order to provide the expansion required for retaining the nozzle in the rectum, and the enema nozzle will appear smaller and harmless, especially compared to more complex enema systems with a tube for inflating / deflation of the balloon. In addition, the risk of the inflatable balloon rupturing and thus damaging the colon wall is also eliminated.

[0062] In some embodiments, at least a portion of an enema nozzle for insertion into a body cavity can be coated with a hydrophilic coating, for example, as a full-coverage coating or as islands of hydrophilic spots separated by uncoated areas. When the hydrophilic coating becomes wet, for example, simply by contact with water, saline, or other liquid swelling medium prior to insertion of the enema nozzle, the hydrophilic coating gels and / or swells, providing a friction-reducing surface for the outer end surface of the coated section or portion of the enema nozzle, thereby facilitating gentle insertion of the nozzle into, for example, the rectum. However, it is preferred that only the spherical insertion tip include the hydrophilic coating to ensure that the self-retaining and self-sealing effect of the enema nozzle according to the present invention is not compromised.

[0063] The enema nozzle may include other features such as a plurality of one-way valves to prevent backflow into the nozzle.

[0064] Even though the enema nozzle and the enema system according to the invention are intended for administering an enema to the colon via the rectum, the enema nozzle and the device may also be used for irrigation, cleansing and / or infusion into other body cavities, such as stomas and fistulas. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The present invention will be explained in more detail below, only an exemplary embodiment of an enema nozzle will be described with reference to the accompanying drawings, in which

[0066] Figures 1-5 A first embodiment of an enema nozzle according to the invention is shown,

[0067] Figure 6 and Figure 7 A second embodiment of the enema nozzle according to the invention is shown,

[0068] Figure 8 A third embodiment of an enema nozzle according to the invention is shown,

[0069] Figure 9 A fourth embodiment of an enema nozzle according to the present invention is shown,

[0070] Figure 10 A conventional enema nozzle inserted into a user's rectum / colon is shown, and

[0071] Figure 11 An enema nozzle according to the present invention inserted into a user's rectum / colon is shown. DETAILED DESCRIPTION

[0072] The present invention is described below with the assumption that the entire enema nozzle is made of the same material, e.g. polypropylene. This assumption should not be interpreted as limiting, as the spherical insertion tip and the elongated insertion body in the embodiments described below can also be made as separate units / parts, e.g. made of different materials, and wherein these separate units / parts are connected to each other by conventional measures, e.g. welding, heating, etc.

[0073] Figures 1-5 A first embodiment of an enema nozzle 1 according to the present invention is shown. The nozzle essentially consists of an elongated insertion body 2 and a spherical insertion tip 3 arranged at a distal end 4 of the insertion body 2.

[0074] As best seen in Figure 3 , Figure 3 is a cross-sectional view of the enema nozzle 1, the elongated insertion body 2 has the shape of a truncated cone 5, the top circular base 6 of which is connected / attached to the spherical insertion tip 3, such that the side 7 of the insertion body 2 extends outwardly from the top circular base 6 towards a bottom circular base 8. The cross-sectional diameter A of the top circular base 6 is smaller than the cross-sectional diameter B of the bottom circular base 8.

[0075] It further appears from these figures, e.g. Figure 3 , that the cross-sectional diameter A, B of the insertion body 2 is smaller than the cross-sectional diameter C of the spherical insertion tip 3, irrespective of where said cross-sectional diameters A, B are taken / measured between the top base and the bottom base. The cross-sectional diameters A, B, C are all taken in a plane perpendicular to the longitudinal axis X of the enema nozzle 1.

[0076] The enema nozzle 1 comprises a flow channel 9, which is best observed in Figure 3 . The flow channel 9 is defined by the inner side wall 10 of the elongated insertion body 2 and the inner side wall 11 of the spherical insertion tip 3. In Figures 1-5In the embodiment shown, the delivery opening 12 is in the form of a 360-degree circumferential gap 13 which continuously extends along the entire periphery 14 in the upper half 15 of the spherical insertion tip 3 along a plane P perpendicular to the longitudinal axis X of the enema nozzle, such that the circumferential gap provides a 360-degree opening / gap 13 in the spherical insertion tip 3 above a second plane P’ coinciding with a plane passing through the centre of the spherical insertion tip 3.

[0077] In a first embodiment 1 of the enema nozzle according to the application, the spherical insertion tip 3 comprises a first bulb portion 16 and a second bulb portion 17.

[0078] The first bulb portion 16 is connected to the elongated insertion body 2 and can be integral with the insertion body or attached to the insertion body by other means, for example by gluing. The first bulb portion 16 has the shape of a hollow bulb with a missing upper section in the form of a bulb cap having a first height. In this way, a first opening 18 is provided to the inside of the first bulb portion defined by the wall 11 of the first bulb portion. The inside of the insertion body 2 defining the flow channel 9 is in flow communication with the inside of the first bulb portion.

[0079] The second bulb portion 17 comprises a second bulb cap 19 and a male coupling portion 20 arranged to be inserted into the first opening 18 and connected / attached to the inner wall 11 of the first bulb portion 16.

[0080] The second bulb cap 17 has a second height which is smaller than the first height of the first bulb cap (missing from the first bulb portion) such that when the first bulb portion 16 and the second bulb portion 17 are connected to each other, a substantially bulb form is provided with the circumferential gap 13 located between the two bulb portions 16, 17.

[0081] The outer surface of the first bulb portion 16 has the same radius of curvature as the outer surface of the second bulb cap 19 such that when the two bulb portions 16, 17 are combined, a substantially spherical insertion tip 3 is provided with the circumferential gap 13 disposed between the two bulb portions 16, 17.

[0082] As best seen in Figure 2 and Figure 5 The male coupling portion 20 comprises four plate-like legs 21 equally spaced around a longitudinal axis Z of the male coupling portion which coincides with the longitudinal axis X of the enema nozzle and each plate-like leg 21 has a first edge 22 complementary to a portion of the inner wall 11 of the first bulb portion 16, allowing the first bulb portion and the second bulb portion to be securely attached to each other, for example by gluing or ultrasonic welding.

[0083] The space 23 provided between the leg 21 of the male coupling part 20 and the inner wall 11 of the first spherical part 16 will provide four flow openings 24 allowing the enema to flow from the flow channel 9 and out through the circumferential gap 13. These flow openings 24 are best shown in Figure 5 , Figure 5 are cross sections taken along the line V-V in Figure 3 and Figure 4 . Figure 4 is an enlarged view of the spherical insertion tip shown in Figure 3 .

[0084] As shown in Figure 4 each leg has a notch 25 with a curvature 26 extending towards the circumferential gap 13, which allows the liquid applied via the circumferential gap 13 to flow out in a swirling motion.

[0085] Preferably, the circumferential gap 13 is offset from the longitudinal axis of the enema nozzle by an angle a of about 30-45 degrees, preferably about 40 degrees. The circumferential gap preferably has a width x taken along the outer surface 27 of the spherical insertion tip, e.g. about 0.5-2 mm.

[0086] The enema nozzle 1 is arranged at the proximal end of the insertion body 2 to be connected to any suitable irrigation or enema delivery container by means of a coupling unit 28 connected to / integrated with the elongated insertion body via a tubular extension 28a, so as to provide a suitable distance between the elongated insertion body and the coupling unit 28. Said coupling unit comprises a first coupling part 29 attached to the enema nozzle 1 and a second coupling part located on the enema delivery container (not shown) and complementary to the first coupling part 29.

[0087] In order to prevent the enema nozzle 1 from being placed / sucked too deep into the rectum, the enema nozzle 1 can comprise a flared baffle 30 placed in the intersection between the bottom circular base 8 of the elongated insertion body 2 and the tubular extension 28a, so that the spherical insertion tip 3 will be placed above the user's dentate line after insertion.

[0088] Figure 6 and Figure 7 shows a second embodiment 31 of an enema nozzle according to the present invention. Said embodiment mainly corresponds to the first embodiment 1 and the same reference numerals are used for the same parts.

[0089] In a second embodiment 31, the spherical insertion tip 3 and the elongated insertion body 2 are made in one unit, wherein the flow channel 9 is defined by the inner side wall 10 of the elongated insertion body 2 and a tubular channel 32 extending through the spherical insertion tip 3, the tubular channel 32 terminating in a central delivery opening 33 provided at the distal end of the spherical insertion tip 3.

[0090] Figure 8 and Figure 9 A third embodiment 34 and a fourth embodiment 35 of an enema nozzle according to the present application are shown, respectively. Said embodiments 34, 35 substantially correspond to the embodiment 31 in Figure 6 and Figure 7 , and like components use like reference numerals. The main difference between the second embodiment and the third and fourth embodiments is that the third embodiment has only one delivery opening, while the third and fourth embodiments have several delivery openings.

[0091] In the third embodiment 34 shown in Figure 8 , the flow channel 9 is also defined by the inner wall 10 of the insertion body, whereas with the second embodiment, the flow channel 9 terminates in a plurality of delivery openings 36 provided at the distal end of the insertion body 2, i.e. directly below the top circular base 6, for example between 2 mm and 5 mm below said base. Thus, in this embodiment, the flow channel 9 does not extend into the spherical insertion tip 3.

[0092] In the fourth embodiment 35 shown in Figure 9 , the flow channel 9 extends into the spherical insertion tip 3, but is arranged such that it terminates in a plurality of delivery openings 37 provided in the side wall 38 of the spherical insertion tip 3.

[0093] As is apparent from Figures 1-9 , the enema nozzles 1, 31, 34, 35 according to the present application are relatively long and slim, such that they can be simply retained in the rectum of a user using the normal function of the user's anal sphincter.

[0094] The difference between using a conventional enema nozzle (e.g. in the form of a trumpet head) and using an enema nozzle 1, 31, 34, 35 according to the present application is shown in Figure 10 and Figure 11 .

[0095] As indicated by the arrows in Figure 10 , a conventional enema nozzle 39 will stretch the anal sphincter 40 to such an extent that the anal sphincter cannot sufficiently contract to maintain the enema nozzle 40 in place and / or to maintain the fluid in the rectum.

[0096] In contrast, for the enema nozzle 1, 31, 34, 35 according to the present invention, the unique combination of a thin elongated insertion body 2 with a slightly truncated cone shape and a larger spherical insertion tip 3 ensures that the sphincter muscles of the anus (internal 41 and external 42) in a natural resting state naturally pull the spherical insertion tip in and then close behind it. This is illustrated by the arrows in Figure 11 . .

[0097] The user's sphincter muscles 40 will accordingly remain contracted and hold themselves in a substantially contracted state, thereby not only holding the enema nozzle 1, 31, 34, 35 in place, but also ensuring that the flushing liquid and bodily waste is held in the rectum / colon 43 during the enema administration procedure. .

[0098] The inventors of the present invention have also found that the insertion of the enema nozzle 1, 31, 34, 35 into the anus / rectum of a patient is easier than with the known enema nozzle 39 of the prior art. The unique shape of the spherical insertion tip 3 and the elongated truncated insertion body 2 ensures that during insertion, the squeezing action of the sphincter muscles 40 on the insertion body 2 pushes (sucks) the enema nozzle 1, 31, 34, 35 into the rectum 43, thereby ensuring that the enema nozzle according to the present invention will be placed in the correct position in the rectum / colon 43. .

[0099] The person skilled in the art will understand that the dimensions of the embodiments shown in the figures can vary, but in a preferred embodiment of the enema nozzle 1 shown in Figures 1-5 , the spherical insertion tip 3 has a cross-sectional diameter of about 13 mm, the elongated truncated insertion body 2 has a length of about 5 cm, the cross-sectional diameter of the top circular base 6 is about 4.5 mm, i.e. the cross-sectional diameter of the spherical insertion tip 3 is about 2.6 times larger than the cross-sectional diameter of the top circular base 6, and the cross-sectional diameter of the bottom circular base 8 is about 8 mm, i.e. the cross-sectional diameter of the spherical insertion tip 3 is about 1.6 times larger than the cross-sectional diameter of the bottom circular base 8. The circumferential gap 13 is offset 40 degrees from the longitudinal axis X of the transverse enema nozzle and is about 1 mm when taken along the outer surface 27 of the spherical insertion tip 3. .

[0100] The enema nozzle disclosed herein can be used in a small handheld enema device, for example connected to a handheld delivery pump, or can be used in a larger flushing system, wherein the enema nozzle is connected to the enema agent reservoir via a relatively long delivery tube, and wherein the flushing system for example comprises a pumping device, a control device, a collecting device for feces, etc. The enema nozzle can be a disposable nozzle, or the nozzle can be cleaned and / or sterilized separately. .

[0101] Within the scope of the present invention, modifications and combinations of the above-described principles and designs are conceivable.

Claims

1. An enema nozzle (1, 31, 34, 35) arranged for delivering an enema to a user, the enema nozzle comprising a spherical insertion tip (3) and an elongated insertion body (2), the insertion body (2) having the shape of a truncated cone (5), and wherein a cross-sectional diameter (A, B) of the insertion body (2) is smaller than a cross-sectional diameter (C) of the spherical insertion tip.

2. The enema nozzle (1, 31, 34, 35) according to claim 1, wherein The cross-sectional diameter (A, B) of the insertion body (2) is smaller than the cross-sectional diameter (C) of the spherical insertion tip (3) over the entire length of the insertion body (2).

3. The enema nozzle (1, 31, 34, 35) according to claim 1 or 2, wherein The spherical insertion tip (3) is connected to a top circular base (6) of the insertion body (2), and a side face (7) of the insertion body (2) extends outwardly from the top circular base (6) towards the bottom circular base (8).

4. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The cross-sectional diameter (C) of the spherical insertion tip (3) is about 1.2 to 7 times larger than the cross-sectional diameter (A) of the top circular base (6) of the insertion body (2), preferably between 2 and 5 times larger, and even more preferably about 2.6 times larger.

5. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The cross-sectional diameter (B) of the bottom circular base (8) is about 1.1 to 3.5 times larger, preferably about 1.2 to 2 times larger, and even more preferably about 1.6 times larger than the cross-sectional diameter (A) of the top circular base (6).

6. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The cross-sectional diameter (B) of the bottom circular base (8) is 10 mm or less.

7. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The cross-sectional diameter (C) of the spherical insertion tip (3) is between 0.8 cm and 2.5 cm, preferably between 1.0 cm and 2.0 cm, and even more preferably between 1.2 cm and 1.5 cm, for example 1.3 cm.

8. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The cross-sectional diameter (C) of the spherical insertion tip (3) is about 13 mm, the cross-sectional diameter (A) of the top base (6) of the insertion body (2) is about 4.5 mm, the cross-sectional diameter (B) of the bottom base (8) is about 8 mm, and the insertion body (2) has a length of about 5 cm.

9. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The enema nozzle (1, 31, 34, 35) comprises at least one flow channel (9) and at least one delivery opening (1, 33, 36, 37) in flow communication with the at least one flow channel (9).

10. The enema nozzle (1, 31, 34, 35) according to claim 9, wherein The flow channel (9) is defined by a side wall (10) of the elongated insertion body (2), and by a side wall (11) of the spherical insertion tip (3) or by a tubular channel (32) in the insertion tip (3).

11. The enema nozzle (1) according to claim 9 or 10, wherein The at least one delivery opening (12) is formed as a circumferential gap (13) in the spherical insertion tip (3), and wherein the circumferential gap (13) extends in a first plane (P) perpendicular to a longitudinal axis (X) of the insertion body.

12. The enema nozzle (1) according to claim 11, wherein The first plane (P) is arranged closer to a distal end of the enema nozzle (1) compared to a second plane (P) passing through the centre of the spherical insertion tip (3), and wherein the first and second planes are parallel to each other.

13. The enema nozzle (1) according to claim 11 or 12, wherein The spherical insertion tip (3) comprises a first bulb portion (16) and a second bulb portion (17), the second bulb portion (17) comprising a second bulb cap (19), and wherein the first and second bulb portions are arranged connected to each other such that the spherical insertion tip (3) is provided with a circumferential gap (13) of 360 degrees between the two bulb portions (16, 17).

14. The enema nozzle (1) according to claim 13, wherein The outer surface of the first bulb portion (16) and the outer surface of the second bulb cap (19) have the same radius of curvature.

15. The enema nozzle (1) according to claim 13 or 14, wherein The first bulb portion (16) comprises an inner space defined by an inner wall (11) of the first bulb portion, and the second bulb portion (17) comprises a male coupling portion (20) arranged for connection / attachment to the inner wall (11) of the first bulb portion.

16. The enema nozzle (1) according to any one of claims 11-15, wherein The circumferential gap (13) is offset from the longitudinal axis (X) of the enema nozzle (1) by an angle a of about 30 to 45 degrees, preferably about 40 degrees, and wherein the circumferential gap is about 0.5 to 2 mm wide, preferably about 1 mm wide, when taken in the longitudinal direction of the enema nozzle along the outer surface of the spherical insertion tip (3).

17. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The enema nozzle (1, 31, 34, 35) does not comprise components or elements arranged for changing form and / or size during use, such as inflatable components and / or inflatable balloons.

18. The enema nozzle (1, 31, 34, 35) according to any one of the preceding claims, wherein The enema nozzle (1, 31, 34, 35) is arranged for connection to a delivery container containing liquid.

19. An enema system comprising an enema nozzle (1, 31, 34, 35) according to any one of claims 1-18.

20. A method of manufacturing a sausage nozzle (1, 31, 34, 35) according to any one of claims 1-18, wherein, The enema nozzle is made by 1K injection moulding, 2K injection moulding or 3K injection moulding.

21. A method of assembling a sausage nozzle (1) according to any one of claims 15-18, wherein, The first bulb portion (16) comprises an inner space defined by an inner wall (11) of the first bulb portion (16), and the male coupling portion (20) of the second bulb portion (17) comprises a plurality of plate-like legs (21), wherein the method comprises: placing the male coupling portion (20) inside the inner space of the first bulb portion (16); and attaching a first edge (22) of each leg (21) to a complementary section on the inner wall (11) of the first bulb portion (16).

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