Self-retaining enema nozzle and enema system comprising the same

Abstract

The present invention relates to a self-retaining enema nozzle (1, 1', 1", 1'") and an enema system (34) comprising the same. The enema nozzle (1, 1', 1", 1'") comprises a catheter (2) provided with a retaining member (3), the retaining member (3) being arranged for placement in a compact form during insertion into a body cavity and for placement in an expanded form for retaining the enema nozzle in the body cavity, and wherein the enema nozzle (1, 1', 1", 1'") further comprises a restriction unit (4) being arranged for placement of the retaining member (3) in its compact form. Since the restriction unit (4) retains (e.g., keeps, places and / or maintains) the retaining member (3) in the compact form both before and during insertion, any discomfort and / or injury that may be experienced using conventional enema nozzles / devices is effectively prevented.

Description

Technical Field

[0001] The invention relates to a self-retaining enema nozzle and an enema system comprising the enema nozzle. Background Art

[0002] Administering an enema is a common medical procedure in which liquid is injected into a patient's rectum and lower intestine in order to induce a bowel movement. The need for such a procedure typically arises in patients with certain medical conditions that impair voluntary bowel control or when the bowel needs to be cleansed prior to, for example, a colonoscopy or surgical procedure.

[0003] When the need for medical assistance does not require a physician or another healthcare assistant, enemas are often administered to patients at home. In this regard, since conventional enema devices often cause discomfort and irritation when inserted, it is often difficult for the patient to administer the enema liquid to themselves. Furthermore, it is difficult for the patient to administer the liquid while maintaining a stable position of the enema nozzle during the procedure. Typically, another person assists the patient, but if, for example, the patient lives alone, assistance may not always be available.

[0004] To overcome these problems, a number of enema devices have been developed that include an inflatable balloon for retaining a nozzle in the rectum / colon during enema administration. Such a device is disclosed, for example, in U.S. Patent No. 5,074,842, which describes an irrigation device having a fixed balloon that is inflated with air, and wherein the air is delivered via a syringe valve communicating with an air passage. A similar system is known from European Patent Publication No. 1 531 885, which describes an irrigation device that includes a liquid reservoir and an air-inflated balloon for securing a tubular portion inserted into the rectum.

[0005] Because air is used to inflate the balloon in these known devices, additional components are required in the device to ensure that air can be obtained from the surrounding environment during the inflation procedure and discharged back into the surrounding environment (rather than into the body cavity) when the irrigation is complete. If the air in the balloon is delivered to the rectum and / or intestines before the nozzle is removed from the rectum, this can lead to additional distension or expansion of the colon, causing pain and discomfort to the patient. In addition, a problem with using an air-filled balloon is that the balloon will react to body movements (such as the peristaltic reflex), whereby the nozzle may be inconveniently displaced, resulting in leakage.

[0006] To overcome these shortcomings, some enema devices (e.g., see WO2011023196) use a liquid to inflate a balloon. However, even though the balloon in this system helps the patient by keeping the enema nozzle inside the rectum during the enema administration procedure, the device also has the problem that if the balloon is overfilled, it may rupture, causing damage to the delicate rectal wall and leakage of the liquid-filled contents of the colon / rectum, while if the balloon is underinflated, it cannot securely hold the enema nozzle in place during use. This is not only unpleasant for the patient, but also extremely degrading, because if the enema nozzle accidentally falls out, the surrounding environment will inevitably be contaminated by the irrigation liquid and bodily waste. Because some users of enema devices have no sense of sensation in the rectum, they may not even notice if the device falls out.

[0007] Furthermore, self-administration of enemas using conventional enema systems with an inflatable balloon containing water or liquid can be particularly difficult for the elderly or patients with physical problems, not only because of the complexity of the system, but also because the system requires many different components to work together. A catheter must be inserted, the balloon must be inflated, the pump must be activated, the correct dose of liquid must be delivered, and finally, the balloon must be deflated before the enema device can be safely removed from the rectum. Consequently, conventional devices are not only difficult to use, for example by users with reduced hand function, but the complexity of the system also makes the devices expensive and time-consuming to use. Summary of the Invention

[0008] It is therefore a first aspect of the present invention to provide an enema nozzle and an enema system that can be retained in the rectum during an enema administration procedure in a quick and efficient manner without the use of an inflatable balloon.

[0009] A second aspect of the present invention is to provide an enema nozzle and an enema system which will speed up the holding procedure and will require less physical effort when using the enema system.

[0010] A third aspect of the present invention is to provide an enema nozzle and an enema system that can be safely and effectively inserted into a body cavity and removed without causing injury and / or discomfort.

[0011] A fourth aspect of the present invention is to provide an enema nozzle and an enema system which are inexpensive to manufacture and simple and reliable to use and which can therefore be used for self-administration of enemas, for example at home.

[0012] According to the present invention, these and further aspects are achieved by providing an enema nozzle for an enema system, and wherein the enema nozzle comprises a catheter provided with a holding member arranged for placement in a compact form during insertion into a body cavity and for placement in an expanded form after insertion for holding the enema nozzle in the body cavity, and wherein the enema nozzle further comprises a restriction unit arranged for holding / positioning the holding member in its compact form during insertion into the body cavity.

[0013] The rectum is a very sensitive area of ​​the human body and must therefore be protected from abrasion, perforation, infection, and excessive pressure. Therefore, the restriction unit is preferably configured to at least partially surround / enclose the retaining member during insertion into the body cavity, i.e., the retaining member is preferably at least partially positioned within the restriction unit. Because the restriction unit holds (e.g., retains, positions, and / or maintains) the retaining member in a compact form before and during insertion, any discomfort and / or injury that may be experienced using conventional enema nozzles / devices is effectively prevented.

[0014] After insertion into the body cavity, the restriction unit and the holding member are preferably configured for displacement relative to each other and / or the restriction unit is configured for at least partial removal from the holding member, thereby allowing the holding member to expand for holding the enema nozzle in the body cavity.

[0015] Preferably, when the holding member is in its compact form, the restriction unit is arranged to conform the holding member to the shape and / or size of the catheter and / or to prevent the holding member from extending and / or protruding from the annular outer longitudinal side / surface of the catheter. In this way, the holding member and, optionally, the restriction unit will also have an outer surface that corresponds to and / or overlaps the outer surface of the catheter, i.e., they will be perceived as a single unit, thereby effectively preventing abrasion and perforation of the rectal wall during insertion of the enema nozzle, since any unnecessary discomfort during insertion, such as discomfort caused by protruding and / or sharp elements, is effectively prevented.

[0016] It is further preferred that the dimensions of the outer periphery of the retaining member in its compact form are the same, substantially the same, or smaller than the dimensions of the outer periphery of the catheter (e.g., dimensions taken in cross-section at the distal end (i.e., tip) of the catheter). This has the advantage that the user cannot perceive or feel the retaining member during insertion.

[0017] In some embodiments, the holding member may be placed on the outside of the catheter when in compact form, however it is preferred that the holding member is placed parallel to the longitudinal axis of the catheter so that it takes up as little space as possible.

[0018] Preferably, the enema nozzle is configured such that the holding member and the catheter are distinct elements of the enema nozzle and / or the enema nozzle is configured such that the holding member is inserted into the body opening in a compact form and the holding member does not expand until the catheter is preferably fully inserted into the body opening. In this way, any discomfort for the user during insertion is completely eliminated.

[0019] To further prevent any irritation and / or damage to tissue during insertion / use, it is preferred that no sharp edges are present on the portion of the enema nozzle that is inserted into the body cavity, including any transition areas between the retaining member, restriction unit and catheter.

[0020] In the context of the present invention, the term "compact form" means that by the limiting unit, the holding member is placed in a compact, compressed, folded or other suitable form, in which the holding member takes up less space than when the holding member is placed in its expanded (deployed) form.

[0021] In the expanded form, the maximum direct distance of the holding member is significantly greater than the maximum width (direct distance) of the holding member in its compact form, whereby the holding member effectively secures the enema nozzle in the body cavity (e.g., the rectum). In the context of the present invention, the term "maximum direct distance" refers to the maximum possible diameter or maximum possible length / distance between two external points placed at the longest possible distance from each other. In this regard, it is preferred that the maximum direct distance of the holding member in the expanded form is at least three times the size of the maximum direct distance of the holding member in the compact form, preferably at least four times the size of the maximum direct distance of the holding member in the compact form, and even more preferably at least five times the size thereof.

[0022] Preferably, the retaining member is not a balloon arranged to be inflated with a fluid (air or liquid), thereby providing a very simple and inexpensive system with very few components. Furthermore, since the retaining member does not need to be inflated / deflated, the time-consuming and complicated process of inflating and deflation of the balloon is eliminated, thereby providing a quick and reliable method of using the enema nozzle according to the present invention and ensuring that the nozzle remains securely in place throughout the application procedure. Furthermore, the user does not need to worry about adjusting the amount of fluid in the balloon to provide the required expansion for retaining the nozzle in the rectum, and the enema nozzle will appear small and innocuous, especially compared to more complex enema systems that have tubes for inflating / deflation of the balloon.

[0023] The retaining member can be provided in a variety of ways and can be, for example, a mechanical structure and / or a resiliently compressible body of foam material, the only requirement being that the size / dimensions of the retaining member can be limited by the limiting unit before and during insertion into the body cavity and that the retaining member can expand after insertion.

[0024] In a preferred embodiment, the retaining member in its compact form has a substantially longitudinal configuration with its longitudinal axis positioned parallel to the longitudinal axis of the catheter via the restriction unit, and wherein the retaining member in its expanded form extends outwardly from the longitudinal axis of the catheter, thereby acting as an anchor to retain the enema nozzle within the body cavity.

[0025] In one embodiment, the retaining member may include one or more expandable structures including, but not limited to, posts, wings, fins, pigtail rings, struts, plugs, and / or discs that can be folded or placed around the outer surface of the catheter in a compact form by the restraining unit. Alternatively, the expandable structure may include a swivel structure that can be opened or closed between an expanded form and a compact form by rotating a control unit or the like.

[0026] In one embodiment, the restriction unit is an integral part of the catheter, preferably an internal channel of the catheter, and wherein the internal channel can extend into the distal opening of the catheter. It is also preferred that the retaining member is arranged to be displaced in the internal channel or to move into and / or out of the internal channel in a movable manner so that the retaining member extends from and / or withdraws into the distal opening of the catheter.

[0027] In order to allow the user to easily control whether the holding member is placed in a compact form or in an expanded form, the enema nozzle and / or enema system according to the present invention may include a control unit. The control unit may be arranged so that: when the control unit is placed in a first position, the holding member is placed in a compact form, while when the control unit is placed in a second position, the holding member is placed in an expanded form. In this way, the user can easily activate / adjust the form of the holding member. Preferably, the control unit includes a logical instruction for changing the form of the holding member. The control unit may, for example, include a stop device so that the holding member can only be placed in its compact form or in its expanded form, and cannot be placed in an intermediate position between the two forms.

[0028] In a preferred embodiment, the retaining member is made of a material that can conform to the shape of the colon and provide a tight fit with the colon wall regardless of any deformities in the colon (e.g., hemorrhoids, fistulas, and / or abscesses). Furthermore, the tight fit between the retaining member and the colon will effectively provide a seal and prevent premature and undesirable leakage of fluids and feces from, for example, the anus during the flushing phase.

[0029] In a preferred embodiment, the retaining member is made of an elastic material which preferably has shape memory, i.e. it will automatically expand when it is no longer restrained by the restraining unit. This allows the enema nozzle to be securely retained within the body cavity and additionally resists forces exerted by body fluids, waste and / or excretions which tend to push the catheter out of the body opening after it has been inserted.

[0030] In a preferred embodiment, the retaining member can be made of the same material as the catheter, preferably one or more elastomeric polymers, such as selected from the group consisting of thermoplastic elastomers (TPE), polyurethane (PU), polyethylene (PE), polyvinyl chloride (PVC), silicone, styrene ethylene butylene styrene (SEBS), thermoplastic polyester elastomer (TPC), thermoplastic styrene elastomer (TPS), and other similar polymers. The elasticity of the retaining member can be modified, 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 polymer.

[0031] In a preferred embodiment, the holding member comprises an expandable ring, preferably made of an elastic material with shape memory, thereby ensuring that a ring shape is obtained. The inventors of the present invention have found that such a ring shape is particularly advantageous for holding the enema nozzle in the rectum / colon.

[0032] Prior to use and during insertion, the ring can be placed within the internal passageway, forcing the ring into a collapsed, or compact, configuration in which the ring's longitudinal axis is parallel to the catheter's longitudinal axis. In one embodiment, the distal end of the ring can extend beyond the distal opening of the restriction element, thereby providing a flexible insertion tip. In this compact configuration, the catheter with the retaining member can be easily inserted into the user's rectum or other body cavity without risk of damaging the rectal and / or colonic wall.

[0033] When the catheter has been inserted into the body cavity, preferably in response to operation of the control unit, the ring is forced away from the distal opening, allowing the expansible ring to expand into the desired annular shape by its own inherent elasticity, thereby ensuring that the catheter / enema nozzle is retained in the body cavity.

[0034] When the desired dose of enema has been administered, in one embodiment, the operator can activate the control unit to pull the ring back into the internal channel, whereby the expandable ring is collapsed, thereby allowing simple and easy removal of the enema nozzle according to the present invention. In an alternative embodiment, the user can simply pull the enema nozzle out, during which time the ring will fold on itself due to its elastic properties.

[0035] The specific annular shape in its expanded form may be any convenient shape, such as a substantially circular or oval shape. However, it is preferred to provide the ring with a square, rhombus or diamond shape having rounded corners that can serve as an anchor in a body cavity, such as the rectum / colon.

[0036] In a preferred embodiment, the (multiple) ends of the ring can pass through the internal passage into the control unit, and the ends of the ring are attached to the control unit so that the ends of the ring can move simultaneously or individually to change the shape of the ring outside the distal opening. In one embodiment, the control unit includes a cylinder that the user can manually activate, for example by axially shifting the cylinder inside the internal passage in the longitudinal direction of the catheter. This shift will cause the ring to expand or contract depending on the direction of the shift. When the control unit is advanced axially (i.e., toward the distal end of the catheter), the ring extends from the distal opening and expands in an annular shape by its own elasticity. When the control unit is retracted axially, the ring is pulled into the internal passage and folded. Therefore, the user can control the form of the expandable ring in a simple and quick manner. In an alternative embodiment, the control unit includes a plunger mechanism or a control member that can slide along the handle, but the principle of advancing or retracting the ring is the same.

[0037] In one embodiment, the internal channel can be a catheter flow channel, and the distal opening can be a delivery opening. However, in a simple and inexpensive embodiment, the enema is delivered via the internal flow channel in the cylinder of the control unit. The flow channel terminates in one or more first delivery openings, which are in a position for administering the enema, i.e., when the expandable ring is placed in an extended configuration, the one or more first delivery openings are in fluid communication with corresponding second delivery openings arranged in the catheter for delivering the enema to the rectum / colon.

[0038] In an alternative embodiment, the enema flow channel is provided within an expandable ring, ie the ring is a tube arranged for delivering the enema via one or more delivery openings placed in the side wall of the tube.

[0039] In a modified version of the enema nozzle according to the invention comprising an expandable ring, the retaining member is not constrained by the retaining unit (e.g., the inner channel) before and during insertion into the rectum. Instead, the expandable ring is held in a folded position by the user during insertion, whereby when the user releases the ring, the expandable ring will automatically expand after insertion.

[0040] In an alternative embodiment according to the present invention, the expandable ring is replaced with a resilient, compressible foam that can be moved out of the interior passage of the catheter in response to operation of a control unit, which preferably corresponds to the control unit used for the expandable ring embodiment. In one embodiment, the foam can be made of a compressible material that is compressed by the inner wall of the interior passage and thus will automatically expand when it is forced out of the interior passage. However, in an alternative embodiment, the foam material will expand when it comes into contact with a liquid (e.g., bodily fluids / moisture in a body cavity and / or enema fluid when an enema is administered).

[0041] In this embodiment, the internal channel can be a flow channel for the enema, but in a preferred embodiment, the internal flow channel is arranged inside the foam body and leads to a delivery opening at the top of the foam body. However, if the foam body is made of a porous material, the enema can 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 liquid will be distributed over a larger area, thereby reducing any discomfort the user may otherwise experience.

[0042] In an alternative embodiment, the holding unit comprises one or more expandable wings / arms and / or discs which in compact form are arranged parallel to the longitudinal axis of the enema nozzle and in expanded form extend radially outwards, eg in a curved or arcuate shape.

[0043] In a preferred embodiment, the retaining member in the expanded form has a form corresponding to the tip of a Malecot catheter.

[0044] Each of the one or more expandable wings / arms and / or discs includes a distal end and a proximal end that can abut or be flush with an outer surface of the catheter.

[0045] In the expanded form, a plurality of slots / openings may be provided between the expandable wings / arms and / or discs and in a preferred embodiment serve as delivery openings for the enema, providing a simple and inexpensive embodiment.

[0046] The one or more inflatable wings / arms and / or discs can be moved between a compact form and an expanded form by a control unit. In this embodiment, the control unit can be a simple pull / push mechanism, which, for example, includes one or more wires connected to the distal ends of the enema nozzle and / or the inflatable wings / arms and / or discs, so that when the user pulls in the wire(s), the inflatable wings / arms and / or discs are forced into their radially outward expanded form, thereby ensuring that the enema nozzle can be securely held in place during administration of the enema. When the desired dose of enema has been administered, the user can then, if necessary, push the wires, whereby the wings / arms and / or discs are substantially straightened and become compact, whereby the enema nozzle can be easily removed from the body cavity.

[0047] In yet another embodiment, the restriction unit is made of a biodegradable material. The restriction unit is preferably arranged to restrict the size / dimensions of the retaining member before and during insertion, but is arranged to rapidly dissolve and / or disintegrate when the restriction unit comes into contact with moisture and warmth of the body cavity.

[0048] The biodegradable restriction element can be a thin cover, coating, film, tape or hollow cylindrical body having a wall defining an inner cavity that limits the size of the retaining member. The biodegradable restriction element can, for example, be perforated and / or include a plurality of openings / slots that ensure that the biodegradable restriction element can degrade more quickly when it comes into contact with moisture and / or body heat in the colon.

[0049] Preferably, at least the section of the catheter including the retaining member is housed within the biodegradable restriction unit; however, the retaining member may also be at least partially located within the restriction unit, or simply placed as a band around the compact retaining member; the only requirement being that the retaining member be placed in a compacted form by the restriction unit. In this manner, the restriction unit will partially or completely surround / enclose the retaining member, maintaining the retaining member in a compacted form until the nozzle is inserted into the body opening.

[0050] The biodegradable material of the restriction unit is preferably selected so as to dissolve or disintegrate rapidly upon contact with moisture and / or body heat in the colon, examples of such materials may be gelatin, polyvinyl alcohol (PVA) film and / or starch. Preferably, in less than two minutes, preferably less than one minute, the biodegradable restriction unit dissolves / disintegrates and the retaining member is placed in an expanded form. Although the period of time required for the biodegradable restriction unit to dissolve / disintegrate may vary from person to person, the thickness of the biodegradable restriction unit, for example, may be adjusted to ensure a substantially uniform degradable period. In any case, it is preferred that the thickness of the biodegradable restriction unit is less than 0.5 millimeters (mm), preferably less than 0.1 mm.

[0051] Once the restriction unit dissolves / disintegrates, the retaining member can be allowed to expand into the expanded form. As already discussed with respect to previous embodiments, in this regard, the retaining member can be a mechanical structure held in place by the restriction unit, and / or a resiliently compressible foam, for example, a material that is self-expandable upon contact with bodily fluids in a body cavity.

[0052] In the latter case, the restriction unit may compress the foam until it comes into contact with bodily fluids in the colon, which will first dissolve / disintegrate the restriction unit; thereafter, the fluids in the colon will expand the foam to a self-sustaining state.

[0053] The embodiment comprising the foam body represents a particularly simple embodiment according to the invention, since the foam body ensures that the enema nozzle according to the invention not only remains in place during the administration procedure, but also that the expandable foam body conforms to the shape of the colon and provides a tight fit, regardless of any deformities in the colon, such as hemorrhoids, fistulas and / or abscesses. Furthermore, the tight fit between the foam body and the colon will effectively prevent premature and undesirable leakage of fluids and feces from the anus during the irrigation phase.

[0054] In some embodiments, the enema nozzle may not be arranged to change the expanded retaining member back into a compact form. However, the inherent elasticity and / or flexibility of the retaining member ensures that the enema nozzle can be easily removed from a body cavity (e.g., the rectum) simply by pulling the enema nozzle into the enema nozzle. During the removal process, the retaining member will automatically compact, deform, and / or collapse due to the internal forces of the colon / rectum wall.

[0055] The simplicity of the enema system according to the present invention ensures that any patient or user (e.g., the elderly) can use the enema nozzle to self-administer irrigation liquid without undue effort. Since the retaining member is placed in a compact form during insertion, the use of the nozzle according to the present invention will significantly reduce the patient discomfort and inconvenience associated with known systems.

[0056] The enema nozzle according to the present invention can have any desired shape and size. The conduit has an insertion portion that is inserted into a body opening and a proximal end that preferably extends via a smooth transition into a flared funnel-shaped portion. The flared funnel-shaped portion is preferably arranged to provide a sealing effect with the rectum.

[0057] The catheter may be of any suitable length depending on the intended site of delivery of the enema in the colon; the longer the insertion portion, the further into the colon the enema can be delivered.

[0058] The holding member is preferably placed at or near the distal end of the enema nozzle, preferably in a position such that the holding member, in its expanded form, will be placed above the dentate line when inserted into the anal cavity, as this will prevent the holding member from irritating sensitive nerve endings that may be located between the anal opening and the dentate line (also known as the pectinate line). In this regard, it is preferred that the one or more delivery openings for draining / delivering the enema be placed in or above the holding member so that the enema is delivered to the colon above the holding member.

[0059] Furthermore, at least the portion of the catheter intended for insertion into a body lumen (including the retaining member and any exposed portions of the restriction unit) may be coated with a hydrophilic coating, for example as a full coverage coating or as island coatings consisting of hydrophilic spots separated by uncoated areas.

[0060] When the hydrophilic coating becomes wet, for example, upon contact with water, saline, or other liquid swelling medium prior to insertion of the enema nozzle, the hydrophilic coating gels and / or swells and imparts a friction-reducing surface to the exterior of the coated section or portion of the nozzle, thereby facilitating gentle insertion of the nozzle, for example, into the rectum. The swollen hydrophilic coating is resilient and flexible, and this characteristic, along with the remaining liquid-absorbing properties of the hydrophilic coating, enables the hydrophilic coating to also function as an effective seal, preventing leakage along the length of the tubular distal portion and out of the rectum or other body cavity.

[0061] The enema nozzle may include other features such as a plurality of one-way valves to prevent backflow into the nozzle, etc.

[0062] The enema nozzle is arranged to be connected to any suitable transport container, such as a transport container for use in large bedside irrigation systems used in medical or hospital facilities and / or a small, compact transport container for home administration of enemas. The nozzle can be removably connected to the transport container by a conventional coupling unit. The coupling unit can, for example, include a first coupling part attached to the enema nozzle and a second coupling part attached to the transport container to provide fluid communication between the two parts. In a particularly simple embodiment, the first coupling part is a tube for the first flow channel, and the second coupling part is a second tube on the transport container. The second tube is preferably adapted to provide a liquid-tight fit with the first tube to provide the connection, for example by providing that at least one of the first tube and the second tube is made of a flexible material so that, for example, the one tube can be placed within the other tube.

[0063] Although the enema nozzle and enema system according to the present invention are intended for administering enemas to the colon via the rectum, the enema nozzle and device may also be used for irrigation, cleansing and / or infusion into other body cavities (eg, stomas and fistulas). BRIEF DESCRIPTION OF THE DRAWINGS

[0064] The invention will be explained in more detail below, only an exemplary embodiment of an enema nozzle being described with reference to the accompanying drawings, in which:

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

[0066] Figures 1 to 4 A first embodiment of an enema nozzle according to the invention is shown,

[0067] Figure 5 A second embodiment of the enema nozzle according to the invention is shown,

[0068] Figures 6 to 9 A third embodiment of an enema nozzle according to the invention is shown,

[0069] Figures 10 to 12 A fourth embodiment of an enema nozzle according to the invention is shown,

[0070] Figure 13 A first alternative embodiment of the holding member is shown,

[0071] Figure 14 Shown is placed in the first limiting unit Figure 13 The holding member,

[0072] Figure 15 Shown is placed in the second confinement unit Figure 13 The holding member,

[0073] Figure 16 A second alternative embodiment of the holding member is shown,

[0074] Figure 17 A third alternative embodiment of the holding member is shown,

[0075] Figure 18 An alternative embodiment of the retaining member is shown, and

[0076] Figure 19 Shown include Figures 1 to 4 A perspective view of an enema system with an enema nozzle shown in FIG. DETAILED DESCRIPTION

[0077] Figures 1 to 4 A first embodiment of an enema nozzle 1 according to the invention is shown. The nozzle essentially consists of a conduit 2, a retaining member 3 in the form of an expandable ring 7, and a restriction unit 4. The conduit 2 comprises a substantially elongated tubular portion 5 defining an insertion body and a proximal end extending via a smooth transition into a flared funnel-shaped portion 6.

[0078] like Figure 2is most clearly shown in the Figure 1 ), the limiting unit 4 is defined by an internal channel 8 of the catheter 2, which extends into the distal opening 9, and wherein the holding member 3 is arranged for movably entering and / or leaving the internal channel 8, so that the holding member 3 is extended from and / or withdrawn into the distal opening 9 of the catheter 2 by a control unit 10. In the embodiment shown, the control unit 10 includes a cylinder 11.

[0079] The two ends 12, 13 of the expandable ring 8 are attached to the distal end 14 of the barrel 11, and the proximal end 15 of the barrel is arranged for connection to an enema reservoir and / or an enema pump via conventional coupling means (e.g. a snap fitting). The barrel 11 comprises two first delivery openings 16 which are located at the point of administration of the enema (i.e. when the expandable ring 7 is in the form of a Figure 3 ) will be in fluid communication with two corresponding second delivery openings 17 for delivering the enema to the rectum / colon.

[0080] like Figure 1 and Figure 2 As shown in , the expandable ring 7 is placed in its compact form inside the internal passage 8, forcing the ring 7 into a folded form, i.e. into a compact form in which the longitudinal axis of the ring is parallel to the longitudinal axis of the catheter. The end 18 of the ring 7 extends out of the distal opening 9 of the internal passage 8, thereby providing a flexible insertion tip, i.e. a tip that is softer, more elastic and more flexible than the catheter 2, whereby the flexible tip 18 can deform and / or flex in response to distortions and obstructions during insertion into the rectum and colon. However, it will be understood by those skilled in the art that the ring 7 can also be placed completely inside the internal passage 8. In any case, in the compact form of the ring 7, the catheter 2 can be easily inserted into the rectum or other body cavity without the risk of damaging the rectal and / or colon walls.

[0081] After the catheter 2 has been inserted into the body cavity, the user can, for example, manually displace the cylinder 11 (or a tube connected to the cylinder) to push the cylinder 11 toward the distal opening 9, thereby displacing the cylinder 11 axially inside the internal channel 9 in the longitudinal direction of the catheter 2, after which the ring 7 extends from the distal opening 9. Since the expandable ring 7 is made of an elastic material with shape memory, the expandable ring 7 will automatically expand into a shape as shown by its own elasticity. Figure 3 The annular shape shown in , thereby ensuring that the enema nozzle 1 is retained in the body cavity. Figure 3 It is evident that the maximum dimension of the holding member (ie the maximum direct distance X between the two points Z1 , Z2 that are the longest apart from each other) is greater than five times the maximum diameter (direct distance) x of the distal end of the catheter 2 .

[0082] When the desired enema dose has been delivered to the colon, the ring 7 can be pulled back into the internal passage 8 by retracting the cylinder 11, returning to the Figure 1 Alternatively, the user may simply pull the enema nozzle 1 out of the rectum due to the inherent elasticity of the ring 7, during which time the ring 7 will fold upon itself due to its elastic properties, as shown in FIG. Figure 4 As shown in .

[0083] Figure 5 A second embodiment of an enema nozzle 1 ' according to the invention is shown. Said embodiment corresponds to Figures 1 to 4 The embodiment shown in FIG, and like parts are marked with the same reference numerals. The main difference between the first and second embodiments is that instead of delivering the enema via first and second delivery openings 16, 17 in the cylinder 11 and the conduit, respectively, the expandable ring 7 of the second embodiment is a hollow tube 19 arranged for delivering the enema via one or more third delivery openings 20 placed in the side wall of the tube. Figure 5 In the embodiment shown in , the tube comprises three third delivery openings 13 .

[0084] Figures 6 to 9 A third embodiment of an enema nozzle 1" according to the invention is shown. Said embodiment corresponds to Figures 1 to 4 In the third embodiment, the expandable ring 7 is replaced by a resiliently compressible foam 21 which can be moved out of the internal passage 8 of the catheter 2 in response to operation of the control unit 10 .

[0085] The foam body 21 is made of a compressible material which is compressed by the inner wall 22 of the inner channel 8, as shown in FIG. Figure 9 As shown in FIG, and when the foam 21 is forced out of the internal passage 8, for example when the foam 21 comes into contact with liquid (e.g., body fluid / moisture in a body cavity), the foam 21 will automatically expand. Figure 7 In the embodiment, the foam 21 partially leaves the inner channel 8 and Figure 8 and Figure 9 In the embodiment shown in FIG. 2 , the foam 21 is placed in a fully expanded position in which the maximum direct distance Y (diameter) of the holding member is higher than four to five times the diameter y of the end of the conduit 2 .

[0086] like Figure 9As most clearly shown in FIG, the enema flow passage 23 extending through the barrel 11 of the control unit 10 terminates at a delivery opening 24 at the distal end 25 (top) of the foam body 21. However, in alternative embodiments, the flow passage can end inside the foam body 21 for delivering the enema through the porous structure of the foam body. Such an embodiment is particularly relevant if body tissue is inflamed or otherwise damaged, as the pressure from the enema liquid will be distributed over a larger area, thereby reducing any discomfort that the user may otherwise experience.

[0087] exist Figures 10 to 12 In the fourth embodiment shown in FIG, the restriction unit 4 is made of a thin cover 26 of biodegradable material that will quickly dissolve and / or disintegrate when in contact with liquid / moisture. The cover 26 is placed on the holding member 3, as shown in FIG. Figure 11 , the holding member 3 is arranged on the outer surface 27 of the catheter 2 so that the circumference of the holding member 3 in its compact form is substantially the same as the circumference of the catheter 2. The holding member is a foam 31 that will automatically expand when it comes into contact with liquid (e.g., body fluids / moisture in a body cavity).

[0088] Before and during insertion, the cap 26 limits the size of the foam 31, thereby providing easy insertion without any discomfort caused by the extension and / or protective portion. Since it is preferred that the biodegradable cap 26 dissolves / disintegrates in less than two minutes (preferably less than one minute) and the foam 31 is placed in an expanded form, the cap 26 includes a small orifice 28 at the distal end of the cap, thereby allowing the enema liquid to drain from the orifice 28 via the flow channel 29 and the delivery opening 30, whereby the enema liquid can help dissolve / disintegrate the cap 26 and / or expand the foam 31.

[0089] Once the restriction elements 26 dissolve / disintegrate, the foam 31 may be allowed to expand into an expanded form, such as Figure 12 As the retaining member is placed only in the middle section 32 of the catheter 2, the distal end 33 of the catheter 2 is not expanded.

[0090] To protect the biodegradable cap 26 prior to use, the enema nozzle may be stored in an airtight packaging, for example made of a laminate with intermittent layers of aluminum foil.

[0091] Figure 13 、 Figures 16 to 18 A number of alternative retaining members are shown in . The retaining members correspond to the retaining members discussed previously and the same reference numerals are used for similar parts.

[0092] You can also use the corresponding Figures 1 to 9The restriction unit shown in FIG (i.e. the restriction unit defined by the inner channel of the catheter extending into the distal opening) places the holding members all in a compact form and wherein the holding members are arranged for, for example, by a control unit or, for example, Figures 10 to 12 The biodegradable restriction unit discussed in (ie, a unit made of a biodegradable material that will rapidly dissolve and / or disintegrate upon contact with liquid / moisture) can thereby movably enter and / or leave the internal passage.

[0093] Figure 13 A first alternative embodiment of a holding member 3a in the form of a foam is shown comprising a single disc 34 arranged such that said holding member 3a in expanded form has an umbrella / mushroom shape, wherein the disc 34 represents a cover / cap and the conduit 2 represents a stem.

[0094] exist Figure 14 middle, Figure 13 The holding member 3a is placed in a compact form by a restriction unit 4, which is defined by an internal channel 8 of the catheter 2 extending into the distal opening 9, and wherein the holding member 3a is arranged for movably entering and / or leaving said internal channel 8, so that the holding member 3a is extended from and / or withdrawn into the distal opening 9 of the catheter 2 by a control unit (not shown), but the control unit may correspond, for example, to Figures 1 to 4 control unit.

[0095] like Figure 14 As shown in FIG, the disc 34 is folded in a compact form and pressed against the inside of the restriction unit 4, and the enema flow channel 23 extends through the conduit / restriction unit 4 and terminates in the delivery opening 24 at the distal end (top) of the disc 34.

[0096] As by Figure 14 As an alternative to placing the holding member 3a in a compact form by the restriction unit 4 shown in FIG, the holding member 3a may alternatively be held by a restriction unit 4 in the form of a small strap 35 which holds the disc 34 in a folded, compact form parallel to the outside of the catheter 2, as shown in FIG. Figure 15 The strip 35 is made of a biodegradable material that will dissolve and / or disintegrate upon contact with liquid / moisture.

[0097] Before and during insertion, the band 35 limits the size of the retaining member 3a, thereby providing easy insertion without any discomfort caused by the extension and / or protective portion. Once the band 35 dissolves / disintegrates, the retaining member 3a can be allowed to expand to the expanded form, such as Figure 13 As shown in .

[0098] when Figure 15When the tape 35 dissolves / disintegrates (or the holding member 3a leaves Figure 14 The inner channel 8 of the catheter 2), the disc 34 will automatically expand axially in the outward direction to place the retaining member in the Figure 13 The expanded form shown in .

[0099] The holding member 3a may be made of any suitable material, such as foam or an elastomeric polymer.

[0100] exist Figure 16 In the embodiment of the present invention, the holding member 3b comprises a plurality of circular disks 36, and wherein the diameter of each disk (starting from the distal end 37 of the holding member) gradually increases towards the proximal end 38. In this way, the disk 36a in the middle section of the holding member will have a diameter slightly smaller than the disk 36b placed below but slightly larger than the disk 36c placed above. In this way, the holding member 3b has a shape similar to a Christmas tree. In the embodiment shown, the holding member 3b comprises five disks, but if considered relevant, the number can be higher or lower.

[0101] The disc 36 of the holding member 3b may be the same as discussed with respect to embodiment 3a and Figure 14 and Figure 15 is restricted and expanded in a similar manner as shown in .

[0102] exist Figure 17 In the embodiment of the present invention, the retaining member 3c is in the form of an inverted soft cone 37, which is made, for example, from a shape having a star-shaped cutout section 38. The cutout section 38 ensures that the inverted soft cone can be placed in a compact form during insertion and can be folded during removal. The inverted soft cone provides an efficient seal with the colon wall and is comfortable for the user.

[0103] The discs 36 may be made of a foam material and / or an elastomeric polymer, in either case, when placed in an expanded form, it will provide a seal with the colon wall.One or more delivery openings may be provided between the discs.

[0104] The inverted soft cone 37 can be described in detail with respect to embodiment 3a. Figure 14 and Figure 15 is restricted and expanded in a similar manner as shown in .

[0105] Figure 18 Example 3d shown in corresponds to Figure 133b, but here the disc 39 comprises a thin (about 1-5 mm) cover 40 made of a flexible elastomeric material with a soft foam ring 41 placed along the entire circumference. The soft ring 41 will provide a tight fit with the colon wall and effectively prevent premature and undesirable leakage of fluid and feces from the anus during the irrigation phase. The thin cover 40 will ensure that the holding member 3d can be easily placed in a compact form (where it will take up very little space) or in an expanded form, but will easily fold upward when the enema device is pulled out or the holding member is retracted into the restriction unit (the inner channel of the catheter).

[0106] The holding member 3d may be the same as discussed with respect to embodiment 3a and Figure 14 and Figure 15 is restricted and expanded in a similar manner as shown in .

[0107] Figure 19 An enema system 42 according to the present invention is shown, wherein Figures 1 to 4 The enema nozzle shown in the figure is connected to a substantially bulb-shaped enema delivery container 43 that is arranged to hold the enema. Depending on the desired dose, the enema is administered by squeezing the delivery container 43 one or more times. The enema system 42 may include a one-way valve (not shown) that effectively prevents backflow of liquid and feces from the colon and / or rectum into the device, and the one-way valve thus prevents any contamination of the delivery container 43 and its remaining contents, which may occur after the enema is administered to the patient. Furthermore, since backflow is effectively prevented, the delivery container can be easily used for several applications, for example by refilling the container with a second dose of the same or different enema (liquid).

[0108] The enema nozzle 1 can be removably connected to the transport container by a coupling (not shown). Thus, the enema nozzle can be a disposable nozzle, or the nozzle can be cleaned and / or sterilized separately. The transport container can be reused several times.

[0109] The enema nozzle disclosed herein may also be used in larger irrigation systems, wherein the enema nozzle is connected to an enema reservoir via a relatively long delivery tube, and wherein the irrigation system comprises, for example, a pumping device, a control device, a collection device for feces, and the like.

[0110] Modifications and combinations of the above principles and designs are contemplated within the scope of the present invention.

Claims

1. An enema nozzle for an enema system (34), wherein: The enema nozzle (1, 1', 1", 1"') comprises a catheter (2) provided with a holding member (3), the holding member (3) being arranged for placement in a compact form during insertion into a body cavity and for placement in an expanded form after insertion for holding the enema nozzle (1, 1', 1", 1"') in the body cavity, and the enema nozzle (1, 1', 1", 1"') further comprising a restriction unit (4) being arranged for placement of the holding member (3) in its compact form during insertion and the restriction unit being arranged for at least partially surrounding the holding member during insertion into the body cavity, and the enema nozzle comprising a one-way valve arranged for preventing backflow into the enema nozzle, The limiting unit (4) is an internal channel (8) in the catheter (2), and the retaining member (3) is arranged to enter and / or leave the internal channel (8) in a movable manner, so that the retaining member (3) extends from and / or withdraws into the distal opening (9) of the catheter (2).

2. The enema nozzle according to claim 1, wherein: The limiting unit (4) and the holding member (3) are arranged for displacement relative to each other after the enema nozzle has been inserted into the body cavity, and / or the limiting unit is configured for at least partially removal from the holding member after the enema nozzle has been inserted into the body cavity, thereby allowing the holding member (3) to expand for holding the enema nozzle in the body cavity.

3. The enema nozzle according to claim 1 or 2, wherein: The limiting unit (4) is arranged to conform the holding member (3) to the shape and / or size of the conduit (2) when the holding member (3) is in a compact form; and / or to prevent the holding member (3) from extending and / or protruding from the annular outer longitudinal surface of the conduit (2).

4. The enema nozzle according to claim 1 or 2, wherein: The outer circumference of the holding member (3) in its compact form is the same as or smaller than the outer circumference of the conduit (2).

5. The enema nozzle according to claim 1 or 2, wherein: The holding member (3) is not arranged as a balloon for inflation with air or liquid.

6. The enema nozzle according to claim 1 or 2, wherein: The retaining member (3) in its compact form is arranged parallel to the longitudinal axis of the conduit (2) and in its expanded form extends outwardly from the conduit (2).

7. The enema nozzle according to claim 1 or 2, wherein: The holding member (3) and the conduit (2) are distinct elements.

8. The enema nozzle according to claim 1 or 2, wherein: The restriction unit (4) is configured such that the retaining member (3) will not be fully expanded at least until after the catheter is fully inserted.

9. The enema nozzle according to claim 1 or 2, wherein: The retaining member (3) comprises one or more expandable structures (31) arranged to be folded or placed around the outer surface of the catheter (2) by the restriction unit in a compact form.

10. The enema nozzle according to claim 1 or 2, wherein: The enema nozzle (1, 1', 1", 1'") comprises a control unit (10) arranged to place the holding member (3) in a compact form in a first position and in an expanded form in a second position.

11. The enema nozzle according to claim 10, wherein: The control unit (10) comprises a cylinder (11) arranged for axial displacement inside the internal channel (8) in the longitudinal direction of the conduit (2).

12. The enema nozzle according to claim 11, wherein: The control unit (10) comprises an internal flow channel (11a) terminating in one or more first delivery openings (16), and the one or more first delivery openings (16) are in fluid communication with corresponding second delivery openings (17) arranged in the side wall of the conduit (2).

13. The enema nozzle according to claim 1 or 2, wherein: The holding member (3) is made of elastic material.

14. The enema nozzle according to claim 13, wherein: The elastic material has shape memory.

15. The enema nozzle according to claim 1 or 2, wherein: The retaining member (3) comprises an expandable ring (7).

16. The enema nozzle according to claim 15, wherein The ends (12, 13) of the expansile loop (7) are attached to a control unit (10) such that the ends of the expansile loop can be moved simultaneously or individually to change the shape of the expansile loop outside the distal opening of the catheter (2).

17. The enema nozzle according to claim 15, wherein: The expandable ring is a tube arranged for delivering an enema via one or more openings (20) placed in the side wall of the tube.

18. The enema nozzle according to claim 1 or 2, wherein: The holding member (3) comprises a foam body.

19. The enema nozzle according to claim 18, wherein The foam is made of a compressible material and / or a material that expands when it comes into contact with a liquid.

20. The enema nozzle of claim 18, wherein: Enemas are administered to the rectum / colon via the foam.

21. The enema nozzle according to claim 1 or 2, wherein: The retaining member (3) comprises a plurality of expandable wings which, in a compact form, are arranged parallel to the longitudinal axis of the conduit (2) and, in an expanded form, extend radially outwardly from the conduit (2).

22. The enema nozzle according to claim 1 or 2, wherein: The retaining member (3) comprises a plurality of expandable arms which, in a compact form, are arranged parallel to the longitudinal axis of the catheter (2) and which, in an expanded form, extend radially outwardly from the catheter (2).

23. The enema nozzle according to claim 1 or 2, wherein: The retaining member (3) comprises a plurality of expandable discs which, in a compact form, are arranged parallel to the longitudinal axis of the conduit (2) and which, in an expanded form, extend radially outwardly from the conduit (2).

24. The enema nozzle of claim 23, wherein: The retaining member (3) in its expanded form has a form corresponding to the tip of a Malecot catheter.

25. The enema nozzle of claim 24, wherein: The disk, in expanded form, has a form corresponding to that of a mushroom.

26. The enema nozzle of claim 24, wherein: In the expanded form, the disc has a form corresponding to an umbrella.

27. The enema nozzle of claim 24, wherein: The disk, in expanded form, has a form corresponding to a Christmas tree.

28. The enema nozzle according to claim 1 or 2, wherein: The restriction unit is made of biodegradable material.

29. The enema nozzle of claim 28, wherein: The limiting unit is a thin cover having a wall defining an inner cavity that limits the size of the holding member.

30. The enema nozzle of claim 28, wherein: The limiting unit is a coating having a wall defining an inner cavity that limits the size of the holding member.

31. The enema nozzle of claim 28, wherein: The limiting unit is a membrane having a wall defining an inner cavity that limits the size of the holding member.

32. The enema nozzle of claim 28, wherein: The limiting unit is a belt having a wall defining an inner cavity that limits the size of the holding member.

33. The enema nozzle of claim 28, wherein: The limiting unit is a hollow cylindrical body having a wall defining an inner cavity that limits the size of the holding member.

34. The enema nozzle of claim 28, wherein: The restriction unit is perforated.

35. The enema nozzle of claim 28, wherein: The limiting unit includes a plurality of openings.

36. The enema nozzle of claim 28, wherein: The limiting unit includes a plurality of slots.

37. An enema system comprising the enema nozzle according to any one of claims 1 to 36.

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