Connector for ostomy implant or cap

Abstract

To provide a lid for a medical implant.SOLUTION: The present invention relates to a lid. In particular, the invention relates to a lid for a medical implant, more particularly for an ostomy implant. The invention also relates to a connector for a lid for an ostomy implant or a connector for an ostomy implant. A lid for an ostomy implant comprises attachment means for attachment to the implant; and an opening part. The opening part is arranged such that it can be opened and closed while the lid is attached to the implant.SELECTED DRAWING: Figure 6

Description

Technical Field

[0001] The present invention relates to a lid. Specifically, the present invention relates to a lid for a medical implant, and more specifically, to a lid for a stoma implant. The present invention also relates to a connector for a lid of a stoma implant or a connector for a stoma implant.

Background Art

[0002] Ileostomy and colostomy are common surgeries that may be required, for example, due to malignant diseases or chronic enteritis. The surgical procedure is called ileostomy when the colon and rectum are removed, and colostomy when only the rectum is removed. Similarly, an abdominal urinary diversion is created when the bladder needs to be removed, for example, due to bladder cancer. In these surgeries, a stoma is formed within the abdominal wall to which the intestinal segment is connected.

[0003] Stoma is a general term for any such procedure in which a stoma is created.

[0004] The stoma usually needs to be connected to a bag for collecting body excreta. However, instead of a conventional ileostomy, it is possible to create a reservoir known as a "Kock pouch" from the distal portion of the ileum. The pouch is formed such that a nipple valve is created that serves to close the reservoir while allowing intermittent drainage using a catheter. This is an example of so-called continent ileostomy (CI), which was previously an attractive alternative to conventional ileostomy but is now rarely used. The complexity of the procedure and the high potential for complications (most of which relate to the malfunction of the continent nipple valve) are today deterring many surgeons from adopting this surgery.

[0005] Ileal pouch anal anastomosis (IPAA) is today the gold standard for these patients, but like CI, this operation is also risky, often fails, and most often leads to pouch excision with bowel loss. Conversion of failed IPAA to CI is a preferred option, but again, surgeons are reluctant to perform this complex and unreliable technique. Similarly, conversion of a dysfunctional orthotopic neobladder or Bricker urinary diversion would also be desirable.

[0006] For example, it is known to provide an implant to facilitate connection of a fistula to a lid or bag.

[0007] For example, as shown in FIGS. 1 and 2, the applicant's prior application WO2014 / 140344A1 discloses a percutaneous fistulostomy implant 1 comprising a tubular inner section 2 mainly formed from a mesh, and a circular, radially extending anchoring flange, i.e., a skin anchor 3.

[0008] The implant 1 is designed to be implanted through the patient's abdominal wall and receive an intestinal section that is pulled through it. The serosal tissue from the intestinal section then grows through the mesh into the implant 1 and adheres to or grows into the surrounding skin tissue. This can provide a safe, stable, leak-free, and well-angiogenic tissue-implant junction.

[0009] The tubular inner section 2 is attached to an outer section 4, which projects from the patient's body when the implant 1 is implanted into the patient. A groove 6 around the outer periphery of the outer section 4 allows a lid, bag, or other device (not shown) to be attached to the implant 1.

[0010] Once the implant has been implanted into the patient, it is necessary to close it in some way, or seal and connect it to some form of drainage means (e.g., a bag, sleeve, or catheter) to prevent leakage of excrement from the fistula and enable the excrement to be cleanly collected and / or discarded. This usually means that some form of lid or bag needs to be attached to the outer end of the implant.

[0011] The applicant's prior application WO2006 / 046210A1 discloses a removable lid for an implant with mounting means (e.g., grooves or ridges) arranged such that the removable lid can be mounted on and removed from the outer end of the implant by sliding the lid in a direction perpendicular to the longitudinal axis of the implant.

[0012] However, the problem with this method of attaching a lid to the implant is that the lid may apply a force to the implant that can damage the tissue-implant junction. Attaching the lid in this way can also be difficult for the patient.

[0013] A further problem is that it can be difficult to properly seal the lid to the implant, i.e., in a leak-proof manner, using this sliding method of attachment.

[0014] WO2006 / 046210A1 also discloses a connector for connecting a stoma bag to the implant. The connector is arranged to slide the lid off the implant and connect the bag to the implant.

[0015] In the more recent application WO2011 / 039517A1 of the present applicant, a medical closure device is disclosed that includes a connecting portion and a closing portion (e.g., a lid or a cap). The connecting portion can be attached to a medical device such as an implant, and the closing portion can then be attached to the connecting portion to close the implant. The connecting portion is a circumferential flexible member that demarcates a connecting opening, and it can be configured between a relaxed configuration in which the connecting opening cannot pass across the medical device and a stress-applied configuration in which the connecting opening of the connecting portion can pass across the medical device. Thus, when the connecting portion is compressed, the connecting portion will deform from its relaxed configuration to a stress-applied configuration in which the connecting portion can be passed across the end of the implant. When the pressure is released (i.e., the compression is stopped), the connecting portion attempts to return to the relaxed configuration and will thus grip the end of the implant. To remove the connecting portion, the reverse procedure can be carried out.

[0016] However, a problem with the connecting portion of WO2011 / 039517A1 is that the connecting portion can be removed from the implant unintentionally or accidentally. For example, when pressure is applied to the connecting portion by leaning against an object, the connecting portion is compressed into the stress-applied configuration, whereby the connecting portion is removed from the implant.

[0017] The closure device of WO2011 / 039517A1 is also relatively wide and extends downward close to the patient's skin when attached to the implant, resulting in a risk of abrasion and inflammation.

[0018] Two hands are required to attach the closing portion of WO2011 / 039517A1 to the connecting portion of WO2011 / 039517A1, which can be a problem for the user. Also, since the closure device includes two separate parts (the connecting portion and the closing portion), there is a greater chance that one part will be lost or dropped compared to a closure device made from a single part. Handling can also be more inconvenient.

[0019] Furthermore, when using this closure device, it may be attached (locked) to the implant at an inaccurate position, resulting in it not being properly seated and sealed on the implant. For example, in many cases, the user cannot see the lid-implant interface (e.g., due to interfering clothing or the stomach), so the user may attach or lock the closure device onto the implant at an inappropriate position.

[0020] Applicant's more recent application WO2017 / 216302A2 discloses a lid for a medical implant, the lid comprising a first part, a second part, and engaging means, wherein in use, the rotation of the second part relative to the first part (or vice versa) causes the engaging means to engage with the implant and attach the lid to the implant, such that the second part is rotatable relative to the first part (or the first part is rotatable relative to the second part). SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0021] According to one aspect of the present invention, there is provided a lid for a stoma implant, the lid comprising attachment means for attaching to the implant, and an opening, and the opening is arranged such that the opening can be opened and closed while the lid is attached to the implant.

[0022] The lid comprises an opening portion that can be opened and closed while the lid remains attached to the implant. This means that while the lid is still attached to the implant, the excrement can be discharged from the fistula opening to which the fistulization implant is connected (preferably through the opening created / released by opening the opening portion), because the opening portion of the lid can be opened for this purpose without the need to remove the lid. Since there is no need to first remove the lid from the implant before discharging, the discharge from the fistula opening can be carried out more straightforwardly and with less disruption. Once discharged from the fistula opening, the opening portion can then be closed again, for example, preventing any leakage until the user can next empty the fistula opening.

[0023] Preferably, the opening portion is a hatch or comprises a hatch. Thus, the hatch in the lid can be opened to enable discharge from the fistula opening. The hatch is preferably an opening portion that opens by pivoting upward (i.e., in a direction away) from the rest of the lid. Alternative types of opening portions can also be used, for example, opening portions that open in different ways such as twisting, rotating, or sliding.

[0024] The lid preferably comprises operating means that are operable to enable the lid to be attached to or removed from the implant and / or to open and / or close the opening portion. In a preferred embodiment, the operating means are operable to enable both the attachment or removal of the lid from the implant and the opening and / or closing of the opening portion (e.g., in different ways).

[0025] The operating means is arranged such that when the operating means is operated in a first manner, the operating means enables the lid to be attached to or removed from the implant, and when the operating means is operated in a second manner, the operating means is arranged to open and / or close the opening portion. The first operating method and the second operating method are preferably different. For example, the operating means may be arranged such that when the operating means is operated in the first manner, the operating means can attach the lid to the implant or remove it from the implant. When the operating means is operated in the second manner, it can open and / or close the opening portion.

[0026] The operating means may include, for example, a sliding part (e.g., a slider). Operating the operating means may include sliding the sliding part.

[0027] The sliding part may be arranged such that when the sliding part is slid along a first sliding path, the sliding part can open or close the opening portion. Additionally or alternatively, in some embodiments, the sliding part is further arranged such that when the sliding part is slid along a second sliding path, the sliding part enables the lid to be attached to or removed from the implant. The first and second sliding paths are preferably different. For example, they may be on the same line.

[0028] In a preferred embodiment, sliding the sliding part in a first direction from a first state (sliding part position) where the opening portion is closed can open the opening portion. Sliding the sliding part in the opposite direction again can close the opening portion.

[0029] In some embodiments, additionally or alternatively, moving the sliding part, for example, in a direction opposite to the first direction, from the same first state (position of the sliding part), for example, a state where the lid cannot (also) be attached to the implant or cannot be removed from the implant, can change the lid to a configuration (e.g., a stress - applying configuration) where the lid can be attached to the implant or can be removed from the implant. Moving the sliding part back to the first state (position of the sliding part) can change the lid to a configuration (e.g., a relaxation configuration or a configuration with less stress application) where the lid cannot be attached to the implant or cannot be removed from the implant (however, at this point, the lid may be attached to the implant and, in some cases, preferably is attached).

[0030] In alternative embodiments, the lid (e.g., its operating means) may comprise a lever part. This may be an alternative to or an addition to the sliding part. In some preferred embodiments, the slider part and the lever part may be the same part, i.e., the slider / lever part can function as either a slider or a lever or both. In such a case, the opening part may need to be open for the slider / lever part to function as a lever.

[0031] The lever part is preferably arranged such that when it is moved or operated in a first direction or manner, it changes the lid to a configuration (e.g., a stress - applying configuration) where the lid can be attached to or removed from the implant. Preferably, when the lever is moved in a second direction or manner, preferably opposite to the first direction or manner, this changes the lid to a configuration (e.g., a relaxation configuration or a configuration with less stress application) where the lid cannot be attached to the implant or cannot be removed from the implant (however, at this point, the lid may be attached to the implant and, in some cases, preferably is attached).

[0032] Preferably, the lever portion is arranged such that the lever portion can move in the circumferential direction around the lid. Alternatively, the lever portion can move by torsional or tilting movement.

[0033] Preferably, moving the lever portion in the first direction or manner causes the lid, or a part of the lid (e.g., the base or a part of the base described later), to bend and / or extend, thereby changing the lid to a configuration (e.g., a stress-applying configuration) in which the lid can be attached to or removed from the implant.

[0034] Preferably, moving the lever portion in the second direction or manner (or simply reducing or removing the force acting on the lever portion such that the lever portion moves in the second direction or manner) causes the lid, or a part of the lid (e.g., the base or a part of the base described later), to change to a configuration (e.g., a relaxation configuration or a low-stress-applying configuration) in which the lid cannot be attached to or removed from the implant (however, at this point, the lid may be attached to the implant and, in some cases, preferably is attached).

[0035] Preferably, changing the lid to a configuration (e.g., a stress-applying configuration) in which the lid can be attached to or removed from the implant includes expanding an opening in the lid (e.g., such that the lid can fit over the implant).

[0036] Preferably, changing the lid to a configuration (e.g., a relaxation configuration or a low-stress-applying configuration) in which the lid cannot be attached to or removed from the implant includes reducing the size of an opening in the lid (e.g., such that the lid cannot fit over the implant).

[0037] The operating means (e.g., a sliding part or a lever part) preferably comprises a surface or a protrusion, and when the operating means is operated, the surface or the protrusion, for example and preferably, causes the lid, by expanding an opening in the lid (e.g., such that the lid can fit over the implant), to change the configuration (e.g., a stress-applying configuration) such that the lid can be attached to or removed from the implant, by applying a force to another part of the lid (e.g., the base as described below).

[0038] The surface or protrusion of the operating means may comprise, for example, one or more inclined portions or members. The lid preferably comprises one or more additional surfaces or protrusions (e.g., inclined portions or members), and the additional surfaces or protrusions are arranged such that when the lid expands an opening in the lid (e.g., such that the lid can fit over the implant), the surface or protrusion of the operating means can apply a force to one or more additional surfaces or protrusions of the lid (e.g., within the base as described below) to change the configuration (e.g., a stress-applying configuration) such that the lid can be attached to or removed from the implant. The inclined portions of the members preferably extend radially inwardly, for example, from the radial edge of the operating means and / or preferably towards each other.

[0039] The lid preferably further comprises connection means such that a further device can be attached to the lid. The further device may be, for example, a connector, a stoma bag, a catheter, or an irrigation sleeve. The connection means may include, for example, one or more elevations or depressions such as ridges, bumps, depressions, and / or grooves. Alternatively or additionally, the connection means may comprise, for example, a magnet or a magnetic portion for connection to a magnetic portion or magnet on the further device. The attachment means is preferably provided around the lid. Other connection means may of course be possible. The connection means may be provided, for example, within and preferably around the perimeter of the base of the lid (as described below).

[0040] The further device may preferably have its own connecting means that can be attached to the connecting means of the lid.

[0041] The connecting means provided on the further device is preferably arranged to connect / attach corresponding to or in cooperation with the connecting means provided on the lid.

[0042] In one example, the connecting means of the further device may comprise, for example, a suction portion for connection with a smooth and / or polished (preferably side) surface on the lid, such as a suction ring (ring-shaped suction portion). The suction ring may comprise, for example, two concentric discs along a concentric disc section, preferably with a vacuum formed around a complete circumference (360 degrees). The suction ring is preferably arranged and / or has a sufficiently large inner diameter such that it does not (cannot) suction any contents from the fistula when the opening is released.

[0043] In such a case, the connecting means provided on the lid is a smooth and / or polished (preferably side) surface on the lid.

[0044] By providing such connecting means on the lid (and the further device), this means that such a further device can be attached to the lid and, for example, there is no need to attach it to the patient's skin (which can cause problems such as irritation, pain, or inflammation). Providing the connecting means on the lid can also, for example, keep such a further device away from the patient's skin at an appropriate position, which also helps to prevent any irritation that may be caused when the further device is attached.

[0045] Furthermore, such additional devices may be attached to the implant through the lid without the need to first remove the lid. For example, in the case of an irrigation sleeve, catheter, or fistula bag, this may be particularly advantageous because, for example, after the sleeve or bag is (sealed and) connected to the lid, the opening of the lid can be opened, for example, through the sleeve or bag, so that, for example, discharge from the fistula can be carried out without the potential of soiling the user's hands.

[0046] The lid comprises attachment means for attaching to the implant. The attachment means preferably comprises an edge or protrusion for engaging with the implant. Alternatively or additionally, the attachment means may comprise, for example, a depression or groove for engagement with a raised portion on the implant. Other examples of possible attachment means include magnets, magnetic parts, suction parts (e.g., a suction ring (ring-shaped suction part), for connection with a smooth and / or polished (preferably side) surface on the implant). Other attachment means are of course possible.

[0047] Preferably, the attachment means is arranged to attach to the outer side, for example the radially outer side, of the surface or part of the implant.

[0048] Preferably, the attachment means is also or alternatively arranged to attach to an external part of the implant. The external part of the implant may be a part of the implant that is outside the patient (outside the patient's body) when the implant is implanted in the patient.

[0049] The attachment means preferably comprises a seal or sealing surface for sealing engagement with the implant. For example, the attachment means may be formed, or partially formed, from a soft (e.g., rubber) and / or flexible sealing material.

[0050] The lid is preferably operable between a relaxed (or low stress application) configuration where the lid cannot fit onto the implant and a stress application (e.g., partially compressed and / or stretched) configuration where the lid can fit onto the implant. Thus, once the lid is fitted onto the implant, the lid is attached to the implant and cannot be removed until it is again placed in the stress application configuration. The lid may (become capable of returning) return to its relaxed configuration (e.g., by stopping or reducing the forces acting on the lid components).

[0051] The lid preferably comprises a sealing surface (or sealing component) for sealing engagement with the implant. This means that when the lid is attached to the implant, the lid can seal with the implant, thereby preventing leakage. The sealing surface is preferably at least partially ring-shaped so as to provide a sealing portion around the perimeter of the implant.

[0052] The lid preferably comprises a sealing surface (or sealing component) for sealing engagement with the opening portion (e.g., when the lid is closed). This means that when the opening portion is closed, the lid can be in a sealing engagement with the remaining part (e.g., the base) of the lid to prevent the leakage of excreta from the fistula while the lid is closed and attached to the implant.

[0053] The sealing surface for sealing engagement with the implant and the sealing surface for sealing engagement with the opening portion may be provided (are preferably provided in a preferred embodiment) by the same sealing component, e.g., a sealing ring. Thus, the sealing component is preferably arranged such that the sealing component (e.g., its sealing surface) can form a sealing portion between the implant and the opening portion.

[0054] The lid preferably comprises a base to which the opening portion is, for example, movably connected. The base preferably comprises (or is connected to) attachment means for attachment to the implant.

[0055] The base may comprise at least one extensible part. The extensible part may comprise, for example, one or both of the sealing surfaces (e.g., sealing component(s)) mentioned above.

[0056] The extensible part may be formed from a soft and flexible plastic or rubber material.

[0057] The base, for example, the extensible part including the extensible part, is preferably extensible from a relaxed (or low stress-applied) configuration where the base cannot fit onto the implant to a stress-applied configuration where the base can fit onto the implant.

[0058] The lid, for example, its base preferably comprises (or forms) an opening that can be closed or closed by an opening portion. Preferably, the opening is an opening through which excrement can pass when the lid is attached to the implant (and, for example, the opening portion is open).

[0059] Extending the lid, for example, its base or the extensible part of the base, or placing the base in a stress-applied configuration includes or may result in enlarging the opening so that the lid can fit onto the implant.

[0060] The lid or base preferably comprises an extensible part and at least one less extensible part (e.g., relatively rigid) that is less easily extensible than the extensible part. The less extensible part may comprise a gap that can bend or flex, for example, to enlarge the opening.

[0061] The base preferably comprises, for example, one or more grooves through which operating means (e.g., a slider) can slide or move.

[0062] In a preferred embodiment, the base comprises an upper part, an intermediate part, and a lower part.

[0063] The upper part may be substantially C-shaped (e.g., ring-shaped, but with a gap through which the slider can fit or slide).

[0064] The lower part may be of a generally ring-shaped configuration, but preferably with a gap that blocks its periphery.

[0065] The intermediate part may be, for example, an extensible part. The intermediate part may be positioned, for example, at least partially between the upper part and the lower part. The intermediate part may comprise an upper intermediate part and a lower intermediate part. The upper intermediate part may be positioned, for example, at least partially between the upper part and the lower part. The lower intermediate part may be positioned, for example, below the upper part. The intermediate part (e.g., the lower intermediate part) may fill the gap in the lower part.

[0066] Preferably, a circular opening is formed in the base, preferably in its intermediate part. The upper and / or lower parts preferably (only partially) surround the opening.

[0067] The upper and lower parts are preferably more rigid than the intermediate part.

[0068] The base (e.g., the bottom part) preferably comprises a recess or groove in which the axis of the opening part can seat and rotate.

[0069] The base preferably comprises or forms an opening delimited, for example, by a soft flexible edge of the intermediate part.

[0070] The operating means (e.g., the sliding part and / or the lever part) may be operable to apply a force to the lid (e.g., on the base) so as to expand the opening and fit over the lid implant.

[0071] The operating means (e.g., a sliding part and / or a lever part) may be additionally or alternatively operable to apply a force to the opening part so as to open or close the opening part and / or to keep the opening part open or closed.

[0072] The operating means may be a movable part (e.g., a part movable relative to the remaining part of the lid), preferably a movable part.

[0073] Preferably, the lid is substantially circular (e.g., when viewed from above or below) or cylindrical.

[0074] In a preferred embodiment, the opening and / or the opening part is not positioned at the center of the lid.

[0075] In a preferred embodiment, the operating means is a slider arranged to be slidable radially inwardly and outwardly with respect to the lid. The slider may also or alternatively be arranged to be twisted or rotated (e.g., to expand the opening part) so as to function as a lever (e.g., when the slider is slid radially outwardly with respect to the lid).

[0076] The base preferably comprises at least one extensible part and at least one less extensible part, the less extensible part preferably being substantially ring-shaped but preferably having a circumferential gap at one point.

[0077] The slider and the base are preferably arranged such that when the slider is moved, for example, radially inwardly, the slider applies a force to the base to extend or bend the less extensible part so that the circumferential gap increases. The extensible part is also preferably extended. In this way, the (said) opening in the base is preferably enlarged so that, for example, the lid can be fitted over the implant.

[0078] The slider preferably comprises a projecting member (e.g., a tongue), which preferably projects radially inwards with respect to the lid (and may also project slightly downwards). The slider preferably may have an upper portion from which the projecting member preferably extends downwards, for example.

[0079] The slider, for example, its projecting member, may comprise an engaging portion (e.g., a hook) for engaging with an opening portion (e.g., a projection as described later).

[0080] The slider (or other operating means) may, for example, comprise one or more gripping means on its upper surface. The gripping means may, for example, comprise one or more rising and / or falling surfaces (e.g., with respect to the rest of the slider or other operating means). The gripping means can assist in sliding the slider or operating the operating means in other ways.

[0081] The slider preferably comprises one or more ridges, for example, along both sides of the sliding direction. The ridges are preferably arranged to slide through the remaining portion of the lid (e.g., a through groove provided in the base of the lid).

[0082] The engaging member may be provided, for example, at the end of each ridge or at other locations on the slider, for engaging with a part of the remaining portion of the lid (e.g., within its base). Such an engaging member can prevent the slider from being completely slid out from the remaining portion of the lid.

[0083] The slider (e.g., its projecting member) and the opening portion are preferably arranged such that when the slider is moved, for example, radially outwards, the slider (e.g., its projecting member) applies a force to the opening portion, thereby opening the opening portion and preferably holding it in the open position. Preferably, the slider and the opening portion are further arranged such that when the slider is moved backwards, for example, radially inwards, the slider (e.g., its projecting member) applies a force to the opening portion, thereby closing the opening portion and preferably holding it in the closed position.

[0084] The opening preferably has a protrusion arranged such that, during use, the slider (e.g., its protruding member) applies a force to the protrusion of the opening (e.g., as described above).

[0085] The opening may comprise an opening end portion and a pivoting end portion.

[0086] The protrusion is preferably positioned at the pivoting end portion of the opening. The protrusion of the opening and the protruding member of the slider are preferably arranged such that when the protruding member applies a force to the protrusion and moves it downward, this causes the opening end portion of the opening to move upward, thereby opening the opening.

[0087] Preferably, when the opening is closed, the protrusion protrudes upward. Preferably, when the opening is open, the protrusion protrudes more radially outward from the lid (but still, for example, slightly upward).

[0088] The opening preferably comprises a top portion and a bottom portion. The top portion and the bottom portion may be connected or joined, for example, only at the opening end portion of the opening. Preferably, there is a recess or space between the top portion and the bottom portion. Preferably, the top portion can bend or flex towards the bottom portion, for example, when a force is applied to it.

[0089] The opening preferably has a shaft, for example, at its pivoting end portion. The shaft is preferably arranged horizontally such that the opening can be opened upward by pivoting about the shaft.

[0090] The slider, e.g., preferably its protruding member, is preferably arranged to be able to slide (or partially slide) between the top portion and the bottom portion of the opening.

[0091] The slider, preferably its upper part, is arranged so as to be able to slide (or partially slide) above the opening part (for example, preferably its top part).

[0092] Preferably, the lid is provided separately from the implant, for example, there is no physical connection between the lid and the implant, and the lid can be completely removed from the implant (for example, without breaking any physical connection) when it is removed from / does not cover the implant.

[0093] A connector for connection to a stoma implant or the lid of a stoma implant is provided, and the connector comprises attachment means for attachment to the stoma implant or the lid and connection means or a connection surface for connection to a further device (connecting to the further device).

[0094] By providing such a connector, the implant or the lid can be easily connected to a further device. The further device can be, for example, a stoma bag, a catheter (for washing and / or emptying), or an irrigation sleeve.

[0095] The connection surface preferably comprises a relatively flat surface for attachment to a further device such as a sleeve, a bag, or a catheter. The sleeve, the bag, or the catheter (or other device) can be attached to the connection surface, for example, with an adhesive. Other attachment means for attaching a further device to the connector can include, for example, a tapered nozzle, a Luer connection, and a bayonet lock. Other attachment means can be used alternatively.

[0096] The connector preferably comprises a sealing portion, for example, a sealing ring or portions (plural), for sealing engagement with the stoma implant or the lid. This helps to prevent leakage, for example, when discharging from the stoma.

[0097] The connector is preferably substantially ring-shaped or comprises or forms a substantially ring-shaped portion or region such that, for example, the connector can connect to a lid or an implant around the lid or implant. This helps to improve the safety of the connection and can provide a larger surface for attaching bags, catheters, sleeves, etc. without gaps.

[0098] Preferably, the connector is formed from one or more parts that are not movable relative to each other. For example, the connector may comprise a ring having a flexible inner portion. The flexible inner portion is preferably arranged (e.g., sized and dimensioned) for engagement (e.g., a sealing engagement) with the lid or implant. Preferably, the outer portion of the ring is less flexible than the flexible inner portion. The flexible inner portion can bend slightly, but the relative positions of the flexible inner portion and the less flexible outer portion cannot change, i.e., the flexible inner portion and the less flexible outer portion are fixedly connected to each other.

[0099] Preferably, the less flexible outer portion comprises one or more tongues that project radially inwards into, through, over, and / or under the flexible inner portion. The one or more tongues are preferably less flexible than the flexible inner portion. For example, they may be made of the same material as the less flexible outer portion and are preferably made.

[0100] Alternatively, the connector may comprise two or more movable parts, and the two or more movable parts are movable, for example, between a stress-applying configuration in which the two or more movable parts can be placed on the lid or implant and a relaxation configuration in which the two or more movable parts are connected to the lid or implant.

[0101] The connector may be made of one or more plastic materials such as polypropylene and / or Mediprene. In a preferred embodiment, the less flexible outer portion (and optionally also its tongue) is preferably made of polypropylene, and the more flexible inner portion is preferably made of Mediprene.

[0102] The present invention also relates to the lid described above to which the connector described above is attached.

[0103] Preferably, when the connector is connected to the lid, the opening portion can be opened and closed.

[0104] Preferably, when the connector is connected to the lid, the lid cannot be placed in a stress-applying configuration such that, for example, the lid can be removed from the implant.

[0105] The present invention also relates to a system for discharging from a fistula opening, the system comprising the lid described above and the connector described above, the connector being connectable (or connected) to the lid. The system may also comprise a stoma implant, and the lid and / or the connector are preferably connectable (or connected) to the implant. The system may also comprise further devices such as an irrigation sleeve, a catheter, and / or a stoma bag, and the further devices are preferably connectable to or connected to the connector.

[0106] The present invention also relates to a kit comprising the lid described above and one or more connectors described above, the one or more connectors being connectable to the lid. The kit may also comprise further devices such as an irrigation sleeve, a catheter, and / or a stoma bag, and the further devices are preferably connectable to or connected to the connector.

[0107] The present invention also relates to a stoma implant to which the lid described above is attached.

[0108] The present invention also relates to a stoma implantation device to which the above-described connector is attached.

[0109] The present invention also relates to a stoma bag to which the above-described connector is attached.

[0110] The present invention also relates to an irrigation sleeve to which the above-described connector is attached.

[0111] The present invention also relates to a catheter to which the above-described connector is attached.

[0112] The present invention also relates to a stoma bag provided with the above-described connector.

[0113] The present invention also relates to an irrigation sleeve provided with the above-described connector.

[0114] The present invention also relates to a catheter provided with the above-described connector.

[0115] In the case of a device provided with the above-described connector (for example, a stoma bag, an irrigation sleeve, or a catheter), the connector is preferably an integral part of the device. For example, the device may include the connector as part of the device, rather than for separate / subsequent attachment to the device. Thus, such a device preferably does not include a plate for adhesion (e.g., to the patient's skin) as is commonly provided in such devices currently. Rather, the device includes an integral connector (or connection means) for connecting to the lid and / or implant and is preferably manufactured thereby.

[0116] The present invention also relates to a method of discharging from a stoma, where the stoma is attached to a stoma implantation device, and the method includes attaching a lid to the implant, where the lid has an opening, opening the opening, and discharging from the stoma.

[0117] The lid is preferably the lid described above.

[0118] Attaching the lid to the implant may include operating the operating means (e.g., a slider) of the lid to place the lid in a stress-applying configuration where it can be placed on top of the implant, and placing the lid on top of the implant. Placing the lid on top of the implant may include attaching the attachment means on the lid to corresponding or cooperating attachment means on the implant. The operating means may then be further operated (or moved) so that the lid (e.g., its attachment means) is placed in a (more) relaxed configuration where the lid cannot be removed from the implant (e.g., its attachment means).

[0119] The method may also include attaching a connector to the lid before opening the opening portion. The connector is preferably the lid described above.

[0120] Further devices such as a stoma bag, a catheter, or an irrigation sleeve may be attached to the connector.

[0121] The method may include attaching further devices such as a stoma bag, a catheter, or an irrigation sleeve to the connector.

[0122] The method preferably includes opening the opening portion through a further device (e.g., a stoma bag or an irrigation sleeve).

[0123] If a further device is or comprises a catheter (or other such device), and the catheter (or other such device) is sufficiently flexible, the aperture can be opened through the catheter. If the catheter (or other such device) is more rigid, the catheter (or other such device) can, for example, be twisted, rotated, bent, and / or pushed downwards relative to the lid, thereby acting on the operating means to open the aperture. Alternatively, the operating means may be provided adjacent to or outside the catheter (for example, adjacent to or outside the position where the catheter or other device is connected to the lid) such that the operating means can be operated to open the aperture through which the catheter (or other such device) is connected to the lid. For example, the operating means may comprise compression means and / or a rotatable lever, for example, which, when operated, causes the aperture to open.

[0124] The method preferably includes discharging from the fistula into or through a further device, such as a stoma bag, catheter, or irrigation sleeve.

[0125] The present invention also relates to a method of attaching a lid to a stoma implant, the lid being the lid described above, the method including attaching the lid to the implant using attachment means.

[0126] The present invention also relates to a method of opening a lid for a stoma implant, the lid being the lid described above, the method including opening the aperture. The lid is preferably positioned (for example, attached) on the implant.

[0127] The present invention also relates to a method of connecting a connector to a lid for a stoma implant, wherein the lid and the connector are the lids and connectors described above, and the method includes connecting the connector to the lid. The method may also include attaching a further device (such as a stoma bag, irrigation sleeve, or catheter) to the connector. Alternatively, a further device (such as a stoma bag, irrigation sleeve, or catheter) may already be connected to the connector. The method may include opening the opening portion of the lid. The lid is preferably attached to the implant. The method may include discharging excrement from the stoma through the lid, for example, into or through a further device.

[0128] The present invention also relates to a method of manufacturing a lid for a stoma implant, wherein the lid is the lid described above. The method may include manufacturing the lid by injection molding.

[0129] The present invention also relates to a method of manufacturing a connector for a stoma implant or for a lid for a stoma implant, wherein the connector is the connector described above. The method may include manufacturing the connector by injection molding.

[0130] The present invention also relates to a method of manufacturing a further device such as a stoma bag, irrigation sleeve, and / or catheter, wherein the further device preferably also comprises (or is attached to) the connector described above. The method may include manufacturing the further device (preferably having the connector) by injection molding.

[0131] The lid and / or the connector and / or the further device may be made of one or more plastic materials such as medical grade copolymer granules of polyoxymethylene, medical grade copolymer granules of polybutylene terephthalate (polyester), medical grade elastomer granules of polypropylene and / or styrene ethylene butylene styrene.

[0132] For example, the operating means or slider may be made of POM, i.e., medical grade copolymer granules of polyoxymethylene.

[0133] The opening part may be made of PBT, i.e., medical grade copolymer granules of polybutylene terephthalate (polyester).

[0134] The base or a part of the base (e.g., the top and bottom parts) may be made of polypropylene or ABS, i.e., medical grade copolymer granules of acrylonitrile butadiene styrene. The base or a part of the base (e.g., the middle part) may be made of Mediprene, i.e., medical grade elastomer granules of styrene ethylene butylene styrene.

[0135] The lid (or its parts) and / or the connector and / or the further device are preferably formed by injection molding. For example, the operating means, the opening part, and the base may each be injection molded and then preferably assembled.

[0136] The manufacture of the lid and / or the connector and / or the further device (e.g., a stoma bag, a catheter, or an irrigation sleeve with a connector, for example) is preferably carried out by a controlled process and / or in a controlled environment that is clean but (not necessarily) sterilized.

[0137] The base can be manufactured, for example, by first injection molding the top and bottom parts in separate first and second tools. Then, these parts are preferably inserted into a third tool and a material (e.g., Mediprene) is injected to form the middle part and join the top and bottom parts (e.g., via the middle part), thereby creating the base. This process is often called 2K injection molding.

[0138] Additional devices (e.g., ostomy bags, irrigation sleeves, or catheters) are preferably manufactured from the same material(s) as the connector. However, different shaped tools can be used for this, for example, in an (e.g., 2K) injection molding process. In some cases, a third material may be used in a 3K injection molding process.

[0139] Alternatively, (e.g., compact) connectors can be manufactured that have connection means for connecting to the lid but do not have, for example, a large flat surface (e.g., for connection to an additional device). Instead, the connector can have a surface (preferably a smaller one) for welding (e.g., thermal or ultrasonic welding) to an additional device such as an ostomy bag, irrigation sleeve, or catheter. Thus, by attaching (e.g., by welding) a (e.g., compact) connection part to an additional device, an additional device such as an ostomy bag, irrigation sleeve, or connector with an integrated connector can be created.

[0140] Additional devices such as ostomy bags, irrigation sleeves, or catheters can be manufactured in alternative versions, for example, without a large, for example, self - adhesive plate and instead having a small surface suitable for welding to a (e.g., compact) connector.

[0141] Instead of welding, other attachment methods such as the use of adhesives or (strong) self - adhesives can be used for joining the parts. The present invention provides, for example, the following. (Item 1) A lid for an ostomy implant, wherein the lid has attachment means for attachment to the implant and an opening portion, and the opening portion is arranged such that the opening portion can be opened and closed while the lid is attached to the implant. (Item 2) The lid according to item 1, wherein the opening portion is provided with a hatch. (Item 3) Further comprising operating means, the operating means enables the lid to be attached to or removed from the implant, and / or is operable to open and / or close the opening portion, the lid according to item 1 or 2. (Item 4) The operating means is arranged such that when the operating means is operated in a first manner, the operating means enables the lid to be attached to or removed from the implant, and when the operating means is operated in a second manner, the operating means opens and / or closes the opening portion, the lid according to item 3. (Item 5) The lid according to item 3 or 4, wherein the operating means comprises a sliding portion. (Item 6) The sliding portion is arranged such that when the sliding portion is slid along a first sliding path, the sliding portion enables the lid to be attachable to or removable from the implant, and when the sliding portion is slid along a second sliding path, the sliding portion opens or closes the opening portion, the lid according to item 5. (Item 7) Further comprising connecting means such that a further device can be attached to the lid, the lid according to any one of items 1 to 6. (Item 8) The lid according to item 7, wherein the connecting means comprises one or more rising or falling portions, ridges, and / or grooves. (Item 9) The lid according to any one of items 1 to 8, wherein the attachment means comprises an engaging edge for engagement with the implant. (Item 10) The lid according to any one of items 1 to 9, wherein the lid is operable between a relaxed configuration in which the lid cannot fit over the implant and a stress-applied configuration in which the lid can fit over the implant. (Item 11) The lid according to any one of Items 1 to 10, wherein the lid comprises a sealing surface for sealing engagement with the implant. (Item 12) The lid according to any one of Items 1 to 11, wherein the lid comprises a sealing surface for sealing engagement with the opening portion. (Item 13) The lid according to any one of Items 1 to 12, wherein the lid comprises a base portion to which the opening portion is movably connected. (Item 14) The lid according to Item 13, wherein the base portion comprises at least one extensible portion. (Item 15) The lid according to Item 14, wherein the base portion can be extended from a relaxed configuration in which it cannot fit onto the implant to a stress-applying configuration in which it can fit onto the implant. (Item 16) A connector for connection to a stoma implant or a lid of a stoma implant, the connector comprising attachment means for attachment to the stoma implant or lid and connection means or a connection surface for connection to a further device. (Item 17) The connector according to Item 16, wherein the connection surface comprises a relatively flat surface for attachment to a further device. (Item 18) The connector according to Item 16 or 17, wherein the connector comprises a sealing portion for sealing engagement with the stoma implant or lid. (Item 19) The connector according to Item 16, 17, or 18, wherein the connector is substantially ring-shaped. (Item 20) The connector according to any one of items 16 to 19, wherein the connector includes two or more movable parts, and the two or more movable parts are movable between a stress application configuration in which the two or more movable parts can be disposed on the lid or the implant and a relaxation configuration in which the two or more movable parts are connected to the lid or the implant. (Item 21) A lid according to any one of items 1 to 15, to which the connector according to any one of items 16 to 20 is attached. (Item 22) A system for discharge from a fistula, the system comprising a lid according to any one of items 1 to 15 and one or more connectors according to any one of items 16 to 20, wherein the one or more connectors are connectable to the lid. (Item 23) A kit comprising a lid according to any one of items 1 to 15 and one or more connectors according to any one of items 16 to 20, wherein the one or more connectors are connectable to the lid. (Item 24) A stoma implant to which a lid according to any one of items 1 to 15 is attached. (Item 25) A stoma implant to which a connector according to any one of items 16 to 20 is attached. (Item 26) A stoma bag comprising a connector according to any one of items 16 to 20. (Item 27) An irrigation sleeve comprising a connector according to any one of items 16 to 20. (Item 28) A stoma bag to which a connector according to any one of items 16 to 20 is attached. (Item 29) An irrigation sleeve to which a connector according to any one of items 16 to 20 is attached. (Item 30) A method of discharging from a fistula, wherein the fistula is attached to a stoma implant, and the method comprises Attaching a lid to the implant, the lid having an opening portion; Opening the opening portion within the lid; Discharging from the fistula opening. A method comprising the above steps. (Item 31) The method according to item 30, wherein the lid is the lid according to any one of items 1 to 15. (Item 32) The method according to item 30 or 31, further comprising attaching a connector to the lid before opening the opening portion. (Item 33) The method according to item 32, wherein the connector is the connector according to any one of items 16 to 20. (Item 34) The method according to item 32 or 33, wherein a stoma bag or irrigation sleeve is attached to the connector. (Item 35) The method according to item 32 or 33, further comprising attaching a stoma bag or irrigation sleeve to the connector. (Item 36) The method according to item 34 or 35, further comprising opening the opening portion through the stoma bag or irrigation sleeve. (Item 37) The method according to item 34 or 36, further comprising discharging from the fistula opening into the stoma bag or through the irrigation sleeve. (Item 38) A method of attaching a lid to a stoma implant, the lid being the lid according to any one of items 1 to 15, the method comprising attaching the attachment means of the lid to the implant. (Item 39) A method of opening a lid for a stoma implant, the lid being the lid according to any one of items 1 to 15, the method comprising opening the opening portion of the lid. (Item 40) A method of connecting a connector to a lid for an implant for stoma formation, wherein the lid is the lid described in any one of Items 1 to 15, the connector is the connector described in any one of Items 16 to 20, and the method includes connecting the connector to the lid. (Item 41) A method of manufacturing a lid for an implant for stoma formation, wherein the lid is the lid described in any one of Items 1 to 15. (Item 42) The method according to Item 41, including manufacturing the lid by injection molding. (Item 43) A method of manufacturing a connector for an implant for stoma formation or for a lid for an implant for stoma formation, wherein the connector is the connector described in any one of Items 16 to 20. (Item 44) The method according to Item 43, including manufacturing the connector by injection molding.

[0142] Here, preferred embodiments of the present invention will be described with reference to the accompanying drawings.

Brief Description of the Drawings

[0143]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

Figure 27

Figure 28

Figure 29

Figure 30

Figure 31

Figure 32

Figure 33

Figure 34

DETAILED DESCRIPTION OF THE INVENTION

[0144] FIGS. 1 and 2 show a known stoma implant 1 from the applicant's prior application WO2014 / 140344A1. As described above, the implant 1 comprises a tubular inner section 2 mainly formed from a mesh, and a circular radially extending anchoring flange or skin anchoring portion 3. The tubular inner section 2 is attached to an outer section 4 which projects from the patient's body when the implant 1 is implanted in the patient. A groove 6 around the outer periphery of the outer section 4 enables a lid, bag, catheter, irrigation sleeve, or other device to be attached to the implant 1.

[0145] The implant 1 is designed to be implanted in the subcutaneous tissue of the patient's abdominal wall and receive the intestinal section pulled therethrough.

[0146] Figure 3 is a cross-sectional view of the implant 1 implanted into the patient's body through the peritoneum 101 and the skin 102. The patient's ileum 103 grows into the implant 1 and helps to fix the implant 1 in place. The lid 10 according to an embodiment of the present invention is attached to the outer section 4 of the implant 1. This enables the lid 10 to hold the patient's body excrement within the internal reservoir 100 until the lid 10 is removed from the implant 1. The internal reservoir 100 is formed within the patient's ileum after the regular wearing of the lid 10 is started.

[0147] Figures 4(a) to 4(d) show the implant 1 with the lid 10 attached. For the purpose of this illustration, in these figures, the implant 1 is not implanted into the patient. This is simply to more clearly illustrate the location where the lid 10 is attached on the implant 1. However, during use, as described above with reference to Figure 3, the implant 1 will of course be implanted into the patient.

[0148] As shown in Figures 4(a) to 4(d), the lid 10 is attached to the outer section 4 of the implant 1. More specifically, the lid 10 is attached to the groove 6 around the outer periphery of the outer section 4. This groove 6 is not visible in Figures 4(a) to 4(d) because it is covered by the lid 10.

[0149] The lid 10 has a hatch 11 that can be opened and closed while the lid 10 is attached to the implant 1. Figures 4(a) and 4(b) show the lid 10 with the hatch 11 in the closed configuration. Figures 4(c) and 4(d) show the lid 10 with the hatch 11 in the open configuration.

[0150] Specifically, as can be seen in Figures 4(b) and 4(d), the lid 10 is circular (when viewed from above or below), but the lid 10 is attached to the implant 1 such that its axial center line does not coincide with the axial center line of the substantially tubular implant 1. The lid 10 protrudes over the implant 1 on one side more than on the opposite side.

[0151] FIG. 5 shows the lid 10 with the hatch 11 in the closed configuration. FIG. 6 shows the lid 10 with the hatch 11 in the open configuration.

[0152] The lid 10 is made of three main components: the hatch 11, the slider 12, and the base 13. Sliding the slider 12 along a first path enables the lid 10 to be attached to / removed from the implant. Sliding the slider 12 along a second path opens / closes the hatch 11. These processes will be described in more detail later.

[0153] The lid 10 has a first side surface 42a and a second side surface 42b, and the first side surface 42a and the second side surface 42b are on both sides of the first sliding path and the second sliding path of the slider 12.

[0154] The hatch 11 is shown in FIGS. 19 and 20. The hatch 11 has a pivot end 29 and an opening end 41. The pivot end 29 is arranged to pivot within the lid 10, and at the opening end 41, the pivot end 29 pivots upward in an arc about the pivot end 29 relative to the rest of the lid 10. The hatch 11 is formed from a top portion 31 and a bottom portion 32 joined together at the opening end 41, and a recess 24 is provided between the top portion 31 and the bottom portion 32. At the pivot end 29 of the bottom portion 32, there is a shaft 30 and a protrusion 20. When the hatch 11 is closed, the protrusion 20 protrudes upward. When the hatch 11 is open, the protrusion 20 protrudes more radially outward from the lid 10 (although still slightly upward). The shaft 30 extends horizontally and defines the axis about which the hatch 11 opens.

[0155] Slider 12 is shown in FIGS. 16, 17, and 18. The slider 12 has a top portion 33 that protrudes radially inwardly from below the upper portion 33 in a direction away from the radial edge 34 of the slider, and a tongue portion 19. The tongue portion 19 has an engaging portion (e.g., a hook) 28 at or near its radially inner (or protruding) end. The gripping portion 40 is provided on the upper surface of the top portion 33. The gripping portion 40 includes rising and / or falling portions for assisting a user in gripping and sliding the slider 12. Two ridges 21 are provided along both side edges of the slider 12. The ridges 21 extend parallel to the tongue portion 19 in the sliding direction. Each ridge 21 has a hook 26 at its radially inner end. On the lower surface of the top portion 33 at the end of its radial edge 34, a pair of inclined members 17 are provided. The inclined members 17 extend radially inwardly from the radial edge 34 of the slider 12 and toward each other.

[0156] An embodiment of the base 13 is shown in FIGS. 13, 14, and 15. The base is formed of three parts: an upper portion 13a, an intermediate portion 13b, and a lower portion 13c. The upper portion 13a and the lower portion 13c are formed from a relatively rigid (but still slightly flexible) plastic, while the intermediate portion 13b is formed from a soft and more flexible plastic or rubber material.

[0157] The upper portion 13a forms a "C" shape around the circular opening 15. The gripping portion 22 (e.g., a groove and / or a ridge, or other rising / falling portion) is provided on the upper surface of the upper portion 13a around its edge. The upper portion 13a has two opposing radially inner protruding portions 37 that form the upper surface of a groove 25 in which the ridge 21 of the slider 12 can slide. The lower surface of the groove 25 is formed from the lower portion 13c.

[0158] The middle part 13b is formed from an upper middle part 13ba and a lower middle part 13bb. The upper middle part 13ba is positioned between the upper part 13a and the lower part 13c. The lower middle part 13bb is positioned below the upper part 13a and partially fills the circumferential gap 39 within the lower part 13c (described later). The middle part 13b is formed of a soft, flexible, and slightly extensible plastic or rubber material. The circular opening 15 is formed in the upper middle part 13ba demarcated by the inner circular edge part 38 of the middle part 13b.

[0159] The bottom part 13c has a generally ring-shaped configuration but has a gap 39 that breaks its perimeter. The gap 39 can be seen, for example, in FIG. 11. The opening 15 passes through the bottom part 13b. The bottom part 13c includes a pair of grooves 36 positioned under the protrusion part 37 of the upper part 13a, thereby forming grooves 25 in which the ridges 21 of the slider 12 can slide. The recesses 27 (as shown in FIG. 8) are positioned at the ends of each groove 36 so as to assist in holding the hatch 11 in the open position (this will be described in more detail later). Further grooves 35 are provided on either side of the gap 39 (across the gap 39) for the shaft 30 of the hatch 11 to rest and rotate within. A pair of inclined members 18 are provided on the bottom part 13b on either side of the gap 39. These inclined members 18 of the bottom part 13c. As seen in FIG. 8, the inclined members 18 are positioned and arranged such that when the slider 12 is in the closed configuration, the inclined member 17 of the slider 12 abuts against the inclined member 18.

[0160] When the upper, middle, and lower parts 13a - c of the base 13 are assembled, the opening 15 is demarcated by the soft flexible edge part 38 of the middle part 13b, and when the lid 10 is connected to the implant 1, it seats on and engages with the groove 6 on the implant 1 by the edge part 38.

[0161] The groove 14 is provided around the outer periphery of the base 13 of its lower portion 13c and the lower middle portion 13bb. This groove 14 enables other devices (such as connectors, discharge sleeves, bags, catheters, etc.) to be connected to the lid 10, for example, while the lid 10 remains attached to the implant 1. A protrusion 43 is provided around the lid 10 on the lower side surface of the groove 14. This protrusion 43 can help prevent any device connected to the groove 14 from sliding along the lid 10. The hatch 11 can be opened and closed to allow the discharge of excrement from the patient while such other devices remain connected to the lid 10.

[0162] Figures 33 and 34 show alternative embodiments of the bases 13' and 13''. In these bases 13' and 13'', the upper portion 13a and the bottom portion 13c are the same as those of the base 13. However, the middle portions 13b' and 13b'' are slightly different. Specifically, the shapes of their respective edge portions 38' and 38'' that demarcate the opening 15 are slightly different from the shape of the edge 38 of the middle portion 13b.

[0163] Here, the operation of the lid 10 will be described.

[0164] There are two main operations of the lid 10, namely, (i) attaching / removing the lid 10 to / from the implant 1, and (ii) opening / closing the hatch 11 of the lid 10 (while remaining attached to the implant 1).

[0165] First, the attachment / removal of the lid 10 to / from the implant 1 will be described.

[0166] To attach the lid 10 to the implant 1, the lid 10 must start in the closed and relaxed configuration shown in FIG. 12. The user must then compress the lid 10 by depressing the hatch 12 such that the ridge 21 moves through / along the groove 25 and simultaneously pushing the radial edge 34 of the slider 12 radially inward. As a result, the top portion 33 of the slider 12 moves over the top portion 31 of the hatch 11. The top portion 31 of the hatch 11 then extends partially between the top portion 33 of the slider 12 and the tongue 19.

[0167] The recess 23 between the top portion 31 and the bottom portion 32 of the hatch 11 allows the top portion 31 to be pushed downward in this way. This is illustrated in FIGS. 9 and 10 showing the "stress application" configuration of the lid 10. It can be seen that the recess 23 is smaller in FIG. 10 (stress application configuration) than in FIG. 12 (closed and relaxed configuration).

[0168] By pushing the slider 12 radially inward in this way, the inclined portion 17 of the slider 12 is pressed against the inclined portion 18 of the base 13. As a result, the inclined portion 18 of the base 13 is pushed outwards and the distance between the opposing halves of the top portion 13a and the bottom portion 13c increases, and the intermediate portion 13b elongates, thereby increasing the size of the opening 15. This is shown in FIGS. 11(a) and 11(b) where the size of the gap 39 in the bottom portion 13c of the base 13 is larger in the stress application configuration (b) than in the relaxed configuration (a).

[0169] By increasing the size of the opening 15 in this way, the user can then place the lid 10 over the end of the implant 1.

[0170] The user then relaxes the gripping portion on the lid 10 such that the slider 12 is no longer compressed radially inward. As a result, the slider 12 returns to the relaxed configuration of FIG. 12 (although not fully).

[0171] Next, the user presses the lid 10 at its first side surface 42a and second side surface 42b (e.g., using the gripping portion 22) perpendicular to the sliding movement of the slider 12, whereby the slider 12 returns completely to the relaxed configuration of FIG. 12. At this point, the opening 15 returns to its normal or relaxed size, whereby the edge portion 38 of the intermediate portion 13b of the base 13 is positioned in the groove 6 of the outer portion 4 of the implant 1. At this point, a "click" sound can be heard, indicating to the user that the lid 10 is properly attached to the implant 1. Next, the lid 10 is attached to and positioned on the implant 1.

[0172] Since the intermediate portion 13b, specifically its edge portion 38, is made of a flexible and soft material, this creates a sealing portion with the implant 1, and thus the lid 10 is in sealing engagement with the implant 1.

[0173] To remove the lid 10 from the implant 1, the same steps are performed in reverse. The lid 10 is pressed by pushing the radial edge 34 of the slider 12 radially inward to increase the size of the opening 15. Then, the lid 10 can be removed from the implant 1. Next, the user relaxes the gripping portion on the lid 10 so as not to press the slider 12 radially inward, thereby returning the lid 10 to its normal or relaxed configuration.

[0174] Here, the opening / closing of the hatch 11 of the lid 10 will be described. This is performed when attaching the lid 10 to the implant 1 to enable the discharge of excrement from the ileum.

[0175] As described above, the two protrusions 21 are provided on both sides of the slider 12. The protrusions 21 can slide along / within a pair of grooves 25 provided in the base 13 of the lid 10. The hook portion 26 is provided at the end of each protrusion 21.

[0176] To open the hatch 11, the slider 12 is slid radially outward from the remainder of the lid 10 such that the ridge 21 moves along through the groove 25. This process is described in more detail with reference to FIGS. 7 and 12.

[0177] FIG. 7 is a cross-sectional side view of the lid 10 with the hatch 11 in the open configuration, and FIG. 12 is a cross-sectional side view of the lid 10 with the hatch 11 in the closed configuration.

[0178] When the slider 12 is slid radially outward from the remainder of the lid 10, the engaging portion 28 (e.g., a hook) on the tongue 19 slides along and engages with the protrusion 20 on the hatch 11, pressing against the protrusion 20, thereby pivoting the hatch 11 about the shaft 30 at its pivot end 29 and opening it upward.

[0179] When the slider 12 is slid and the hatch 11 is opened, the hooks 26 on the ends of each ridge 21 of the slider 12 are positioned within the recesses 27 of the base 13.

[0180] In this state, the shape and material (plastic) of the tongue 19 combined with the shape of the base 13 causes the tongue 19 to function like a spring, applying a spring force to the hatch 11, so the hatch 11 remains open. While the slider 12 is being slid from the remainder of the lid body 10, if the user applies a force (or accidentally presses the hatch 11) to try to close the hatch 11, the hatch 11 will close, but due to the spring force of the tongue 19 acting on the hatch 11, when the force is removed, the hatch 11 will spring open again.

[0181] To close the hatch 11, the slider 12 is pushed back radially inward into / onto the remainder of the lid 10. This stops the spring force of the tongue 19 acting on the hatch 11 when the engaging portion 28 of the tongue 19 moves away from the protrusion 20 and slides over the bottom portion 32 of the hatch 11, thereby pushing down the bottom portion 32 of the hatch 11 and closing it.

[0182] Slider 12 has two "spring" bumps 44 (see FIG. 18) on both its lower side surface and both sides of the tongue portion 19. The spring bumps 44 slide on two corresponding bumps 45 positioned on either side inside the base 13 (see FIG. 13). The slider 12 is held in the closed position by having its spring bumps 44 held in place (sliding is prevented) by the bumps 45 on each side of the base 13. The slider 12 needs to be pushed in with sufficient force so that its spring bumps 44 overcome the resistance from the bumps 45 within the base 13 and can move.

[0183] When the slider 12 is in the closed position, the tongue portion 19 is pushed downward on the bottom portion 32 of the hatch 11, thereby pushing the hatch 11 downward relative to the base 13, specifically its middle portion 13b, whereby the hatch 11 closes in sealing engagement with the base 13.

[0184] The lid 10 is made of a plastic material. The slider 12 is made of POM, i.e., medical grade copolymer granules of polyoxymethylene.

[0185] The hatch 11 is made of PBT, i.e., medical grade copolymer granules of polybutylene terephthalate (a polyester).

[0186] The top portion 13a and the bottom portion 13c of the base 13 are made of PP (polypropylene). In an alternative embodiment, the top portion 13a and the bottom portion 13c of the base 13 are made of ABS, i.e., medical grade copolymer granules of acrylonitrile butadiene styrene. The middle portion 13b of the base 13 is made of Mediprene, i.e., medical grade elastomer granules of styrene ethylene butylene styrene.

[0187] The slider 12, the hatch 11, and the top, middle, and bottom portions 13a - c of the base 13 are injection molded, assembled, and packaged in a controlled process and environment that is clean but not sterilized (not necessarily required to be sterilized).

[0188] The base 13 is manufactured by first injection molding the top portion 13a and the bottom portion 13c from PP in separate first and second tools. These portions 13a, 13c are then inserted into a third tool and the Mediprene is injected to form the intermediate portion 13b and join the top portion 13a and the bottom portion 13c (via the intermediate portion 13b), thereby creating the complete base 13. This process is often referred to as 2K injection molding.

[0189] The lid 10 is reusable but needs to be replaced weekly.

[0190] To clean the lid 10, it is recommended to rinse it with tap water. However, the lid 10 can withstand soap, household detergents, and hot water. The lid 10 can also be immersed in 70% alcohol. After such cleaning, it is necessary to carefully rinse it afterwards.

[0191] The connector can be attached to the lid 10 in or partially in the groove 14.

[0192] A preferred embodiment of the connector 50 is shown in FIGS. 21 - 23. FIG. 24 shows the connector 50 attached to the lid 10.

[0193] The connector 50 provides a flat surface to which a further device such as a discharge sleeve, catheter, or bag can be attached (e.g., with an adhesive). Alternatively, such a further device may already be equipped with the attached connector 50 for attachment to the lid 10.

[0194] The connector 50 is a circular disc having an opening 51 in the center. The diameter of the opening 51 is sized such that the inner edge 52 of the connector 50 fits around the lid 10 just above the groove 14.

[0195] In an alternative embodiment, the connector 50 is slightly smaller in size such that its inner edge 52 conforms around the implant 1 just above the groove 6. The connector 50 may then be attached directly to the implant 1.

[0196] The connector 50 has an upper side 50a and a bottom or skin side 50b. The upper side 50a provides a flat surface to which additional devices can be attached (e.g., with an adhesive).

[0197] The connector 50 is made of two main parts, an outer ring 53 and an inner ring 54.

[0198] The outer ring 53 is made of a relatively hard or rigid plastic (e.g., polypropylene), and the inner ring 54 is made of a soft rubber material such as Mediprene. Forming the inner ring 54 from a soft material allows the inner ring 54 to seal and engage with the lid 10 (or implant 1), thereby preventing leakage. Forming the outer ring 53 from a more rigid material allows the outer ring 53 to form a rigid base to which additional devices can be attached, for example, and facilitates positioning and attaching the connector 50 to the lid 10 (or implant 1).

[0199] The rigid outer ring 53 of the connector 50 has several tongues 55 (seven tongues are provided in the embodiment shown). The tongues 55 extend from the rest of the outer ring 53 through the inner ring 54 towards (but not too far) the inner edge 52 of the connector 50. The tongues 55 are provided on the skin side 50b of the connector 50.

[0200] The inner diameter of the inner tip (end) of the tongue portion 55 matches or substantially matches the diameter of the groove 14 provided around the lid 10 (i.e., it is slightly smaller than, slightly larger than, or the same as the diameter at the bottom of the groove 14, depending on how tight a fit is desired against the connector 50 on the lid 10). The inner diameter of the inner ring 54 is smaller than the inner diameter of the tip (end) of the tongue portion 55 and smaller than the outer diameter of the lid 10, thus creating a snug sealing fit of the inner ring 54 against the lid 10.

[0201] The tongue portions 55 are made of the same rigid material as the remaining part of the outer ring 53. These tongue portions 55 bend slightly and, when the connector 50 is connected to the lid 10 (or the implant 1), snap into the groove 14 in the lid 10 (or the groove 6 in the implant 1) as shown in FIGS. 25 and 26, thereby fixing the connector 50 to the lid 10 (or the implant 1).

[0202] The soft rubber inner ring 54 forms a very thin and smooth inner ring, and its inner diameter is slightly smaller than the outer diameter of the lid 10 just above the groove 14. This means that, as shown in FIGS. 25 and 26, the inner ring 54 can seal tightly against the lid 10 just above the groove 14.

[0203] Thus, the tongue portions 55 engage with the lid 10 in the groove 14, and the inner ring 54 seals against the lid 10 just above the groove 14. Together, the tongue portions 55 and the inner ring 54 function to connect and seal the connector 50 to the lid 10. However, this only operates correctly when the connector 50 is arranged with the correct side facing up, i.e., when the tongue portions 55 are arranged on the lower (or skin) side surface 50b.

[0204] In an alternative embodiment, both sides of the connector are the same, so either side can be used facing up.

[0205] As described above, the protrusion 43 around the lid 10 on the lower side surface of the groove 14 helps to prevent the connector 50 from being pushed down against the lid 10, for example, between the lid 10 and the patient's skin when the lid 10 is connected.

[0206] The connector 50 is manufactured using injection molding. First, the outer ring 53 (having its tongue 55) is formed by injection molding the outer ring 53 within a first tool. Next, the outer ring 53 (having its tongue 55) is placed within a second tool, and the inner ring 54 is injection molded onto the outer ring 53 within the second tool, thereby joining the two ring portions 53, 54 together.

[0207] Alternative connectors are shown in FIGS. 27 - 32.

[0208] FIGS. 27 and 28 show a connector 60 in a closed configuration and an open configuration, respectively. The connector 60 is substantially ring-shaped and is formed from two relatively planar halves 64a and 64b. Each half 64a, 64b has joining ends 64a', 64b' and connection ends 64a'', 64b''.

[0209] Devices such as a sleeve, catheter, or bag may be adhered to the upper surfaces of these halves 64a, 64b.

[0210] The connection edge 62 is provided around the inner circumference of the two halves 64a, 64b. The connection edge 62 is formed of a soft rubber-like material and is sized and dimensioned to fit into and seal the groove 14 within the lid (or within the groove 6 in the implant 1).

[0211] The two halves 64a, 64b are joined by a pair of relatively thin, flexible bending members 63a, 63b at their joining ends 64a', 64b'.

[0212] Connection end portions 64a'', 64b'', gripping portions 61a and 61b protruding radially outward are provided, and these can be connected together (thereby closing the connector 60) by a hook 66b provided on the second gripping portion 61b and a hooking member 66a provided on the first gripping portion 61a, and the hook 66b can be hooked when the compression portion 65 provided on the second gripping portion 61b is compressed and then released.

[0213] A pair of opening arms 67a and 67b are also provided at the connection end portions 64a'' and 64b'' of the half portions 64a, 64b. Specifically, the opening arm 67b is provided at the connection end portion 64a'' that passes under a holding member 68b provided at the other connection end portion 64b''. Similarly, the opening arm 67a is provided at the connection end portion 64b'', which passes under a holding member 68a provided at the other connection end portion 64a''. Hooks 69a and 69b are provided at the ends of the respective opening arms 67a, 67b, and these hook onto the holding members 68a and 68b when the connector 60 is opened to the maximum extent, thereby preventing the connector 60 from opening too far.

[0214] The same soft rubber material provided along the connection edge portion 62 is also provided along the joining end portion of the connector 60 at the joining edge portions 64a', 64b' and the connection end portions 64a'', 64b'' such that when the connector 60 is closed, the two half portions 64a, 64b are in sealed connection with each other.

[0215] The connector 60 is provided in a closed state as shown in FIG. 27. To attach the connector 60 to the lid 10, the connector 60 is opened by pressing the compression portion 65 to release the hook 66b from the hook member 66a. Then, the two halves 64a, 64b of the connector 60 can be opened. Next, the connector 60 is disposed around the groove 14 in the lid 10 (or around the groove 6 in the implant 1), and then the two halves 64a, 64b of the connector 60 are returned together such that the hook 66b engages again on the hook member 66a and the connecting edge 62 is positioned within the groove 14 in the lid (within the groove 6 in the implant 1), thereby holding the connector 60 in place.

[0216] To remove the connector 60 from the lid 10 or the implant 1, the same procedure is carried out again, except that the connector 60 is removed from the lid 10 or the implant 1 instead of being disposed around the lid 10 or the implant 1.

[0217] The connector 60 is manufactured by injection molding. The two halves 64a, 64b of the connector 60 are injection molded together within a first tool. Then, they are placed within a second tool and a soft rubber-like material is injection molded along the connecting edge 62 thereto to join the edges between the two halves 64a, 64b.

[0218] Next, the two halves 64a, 64b of the connector 60 are connected together at their connecting ends 64a'', 64b'' by inserting the opening arms 67a and 67b under their respective holding members 68a, 68b such that the connector 60 becomes usable.

[0219] FIGS. 29 and 30 show a connector 70 in a closed configuration and an open configuration, respectively. The connector 70 is substantially ring-shaped and is formed from two relatively planar halves 74a and 74b. Each half 74a, 74b has a joining end 74a', 74b' and connecting ends 74a'', 74b''.

[0220] Devices such as sleeves, catheters, or bags may be adhered to the upper surfaces of these halves 74a 74b.

[0221] The connection edge 72 is provided around the inner circumference of the two halves 74a 74b. The connection edge 72 is formed of a soft rubber material and is sized and dimensioned to fit into and seal the groove 14 within the lid (or within the groove 6 in the implant 1).

[0222] The two halves 74a, 74b are joined at their joining ends 74a’, 74b’ by a pair of relatively thin flexible bending members 73a, 73b.

[0223] Each connection end 74a’‘, 74b’‘ is provided with compression members 71a, 71b that, when pressed together, move the connection ends 74a’‘, 74b’‘ apart to open the connector 70. The compression members 71a and 71b slightly overlap the connection ends 74b’‘, 74a’‘ to which they are not attached. Further, retaining members 77a, 77b are provided at each connection end 74a’‘, 74b’‘ that also overlap the other connection ends 74b’‘, 74a’‘. These overlapping features act to maintain the two halves 74a, 74b in the same plane.

[0224] Additional members 76a, 76b are provided at each connection end 74a’‘, 74b’‘. These additional members 76a, 76b project out of the plane of the connector 70 and have flattened end portions such that one or more elastic bands (not shown) can be disposed around the additional members 76a, 76b. The elastic bands are sized to act to maintain the connector 70 in the closed position.

[0225] The same soft rubber material provided along the connection edge 72 is also provided along the joining edges 74a’, 74b’ and the connection ends 74a’‘, 74b’‘ of the connector 70 such that when the connector 70 is closed, the two halves 74a, 74b are in sealed connection with each other.

[0226] The connector 70 is provided in a closed state as shown in FIG. 29. To attach the connector 70 to the lid 10, the connector 70 is opened by compressing the compression members 71a, 71b together. Thereby, the elastic band(s) is stretched and the two halves 74a, 74b of the connector 70 are opened (as shown in FIG. 30). Next, the connector 70 is placed around the groove 14 in the lid 10 (or around the groove 6 in the implant 1), and the pressure on the compression members 71a, 71b is released so that the two halves 74a, 74b of the connector 70 are pulled back together by the elastic band(s). As a result, the connection edge 72 is positioned within the groove 14 in the lid (in the groove 6 in the implant 1), thereby holding the connector 70 in place.

[0227] To remove the connector 70 from the lid 10 or the implant 1, the same procedure is carried out again, except that the connector 70 is removed from around the lid 10 or the implant 1 rather than being placed around the lid 10 or the implant 1.

[0228] The connector 70 is manufactured by injection molding. The two halves 74a, 74b of the connector 70 are injection molded together in a first tool. Then they are placed in a second tool and a soft rubber-like material is injection molded onto them along the connection edge 72 to join the edges between the two halves 74a, 74b.

[0229] Next, the two halves 74a, 74b of the connector 70 are connected together at their connection ends 74a'', 74b'' by positioning the connection ends 74a'', 74b'' (partially) under their respective holding members 77a, 77b. Then, one or more elastic bands are placed around the members 76a, 76b so that the connector 70 is ready for use.

[0230] FIGS. 31 and 32 show the connector 80 in a closed configuration and an open configuration, respectively. The connector 80 is substantially ring-shaped and is formed from first and second relatively planar, overlapping, interlocking ring portions 84a and 84b.

[0231] Devices such as sleeves, catheters, or bags may be adhered to the upper surfaces of these ring portions 84a, 84b.

[0232] The first ring portion 84a is formed from an outer ring portion 84a' and an inner ring portion 84a''. Similarly, the second ring portion 84b is formed from an outer ring portion 84b' and an inner ring portion 84b''. The two inner ring portions 84a'' and 84b'' are the same size and shape and form the inner circumference of the connector 80. The two outer ring portions 84a' and 84b' form the outer circumference of the connector 80, and the outer ring portion 84a' is larger than the outer ring portion 84b' and forms a larger portion of its outer circumference.

[0233] The inner ring portions 84a', 84b', 84a'', 84b'' are interlocked in that the inner ring portion 84a'' of the first ring portion 84a is positioned on top of the outer ring portion 84b'' of the second ring portion 84b, and the inner ring portion 84b'' of the second ring portion 84b is positioned on top of the outer ring portion 84a'' of the first ring portion 84a. This interlocking feature serves to hold the two ring portions 84a, 84b together.

[0234] The inner ring portions 84a'' and 84b'' each have retaining members 81a, 81b around their inner circumferences, around which an elastic band (not shown) is positioned. The elastic band acts to pull the ring portions 84a and 84b together across the diameter of the connector 80, thereby maintaining the connector 80 in a closed configuration, as shown in Figure 31.

[0235] An inner groove (not visible in the figure) is provided on each side surface between the outer ring portion 84a' and the inner ring portion 84a'' of the first ring portion 84a. Similarly, corresponding ridges (not visible in the figure) are provided on the inner surface of the inner ring portion 84b'' of the second ring portion 84b. The ridges can move along the inside of the grooves, thereby enabling the two ring portions 84a and 84b to move towards / away from each other. Similarly, the grooves and ridges also act to hold the two ring portions 84a, 84b together.

[0236] The connecting edges 85a, 85b are provided around the inner edges of the two inner ring portions 84a'', 84b''. The connecting edges 85a, 85b are formed of a soft rubber-like material and are sized and dimensioned to fit into and seal the groove 14 within the lid (or within the groove 6 in the implant 1).

[0237] The same soft rubber-like material provided along the connecting edges 85a, 85b is also provided along the joining edges of the interlocking ring portions 84a and 84b such that when the connector 80 is closed, the two ring portions 84a and 84b are in a sealed connection with each other.

[0238] The connector 80 is provided in a closed state as shown in FIG. 31. To attach the connector 80 to the lid 10, the connector 80 is opened by pressing the two outer ring portions 84a'', 84b'' together. Thereby, the ridges move along the inside of the grooves, stretching the elastic band and causing the inner ring portions 84a', 84b' to move away from each other, opening the connector 80 (as shown in FIG. 32).

[0239] Next, the connector 80 is disposed around the groove 14 in the lid 10 (or around the groove 6 in the implant 1), and pressure on the two outer ring portions 84a'', 84b'' is relaxed or reduced so that the inner ring portions 84a', 84b' of the connector 80 are pulled back together by an elastic band. As a result, their inner edges are positioned within the groove 14 in the lid (or within the groove 6 in the implant 1), thereby holding the connector 80 in place.

[0240] To remove the connector 80 from the lid 10 or the implant 1, the same procedure is performed again, except that instead of disposing the connector 80 around the lid 10 or the implant 1, the connector 80 is removed from the lid 10 or the implant 1.

[0241] The connector 80 is manufactured by injection molding. The two interlocking ring portions 84a and 84b are separately injection molded in their respective first tools. Next, the two interlocking ring portions 84a and 84b are disposed in their respective second tools, and a soft rubber-like material is injection molded thereonto along the connecting edges 85a, 85b and the joining edges of the interlocking ring portions 84a and 84b.

[0242] Next, the two interlocking ring portions 84a and 84b of the connector 80 are fitted together, and one or more elastic bands are disposed around the holding members 81a, 81b so that the connector 80 is ready for use.

[0243] The connectors 60, 70, 80 are made of plastic, specifically polypropylene, and Mediprene is used as the soft rubber-like material. In any of the connectors 50, 60, 70, 80, acrylonitrile butadiene styrene (ABS), polybutylene terephthalate (PBT), or polyoxymethylene (POM) may be used instead of polypropylene to increase rigidity.

[0244] When connectors 50, 60, 70, 80 are connected to the lid 10, the presence of the connectors 50, 60, 70, 80 around the lid 10 prevents the base 13 of the lid 10 from stretching or bending into the widened state (the state where the opening 15 is enlarged) required to remove the lid 10 from the implant 1 (or attach the lid 10 to the implant 1), so that the lid 10 cannot be inadvertently removed from the implant 1.

[0245] The lid 10 and the connectors 50, 60, 70, 80 are for external treatment and can be applied by either medical staff or the patient themselves.

[0246] The system consisting of the implant 1, the lid 10, and the connectors 50, 60, 70, 80 is intended to eliminate the need to always wear an external device (e.g., a pouch / bag) on the abdomen, together with additional devices such as a sleeve, a catheter, or a bag, to prevent leakage and collect intestinal contents.

[0247] After the implant 1 is implanted into the patient, the patient typically has to use a standard ostomy bag for an initial period until they can start using the lid 10. However, once the tissue has healed and is fully integrated with the implant 1, the outer end of the implant 1 can be closed with the lid 10.

[0248] The use of the lid 10 should be gradually introduced by momentary use over an adaptation period, the length of which may vary from patient to patient. During this adaptation phase, the lid 10 may be used for only short periods, which should be gradually increased in duration and frequency. It is recommended to use the ostomy bag between uses of the lid. The lid 10 should not be used permanently until the adaptation to the lid is complete.

[0249] When the lid 10 is used, the intestine gradually develops a natural reservoir 100 behind the implant 1. The development of this reservoir 100 means that the frequency of emptying the intestinal contents can be reduced.

[0250] Once the adaptation phase is complete, the use of the lid 10 means that the patient usually no longer needs to use the stoma bag during the day. However, in some cases, it may still be preferable to use the stoma bag at night.

[0251] The length of time until the bowel is emptied varies from person to person, but usually it is necessary to empty the bowel 2 to 10 times a day.

[0252] The process for emptying the bowel will be described later.

[0253] First, connect the connectors 50, 60, 70, 80 to the lid 10 and fix the irrigation sleeve to the connectors 50, 60, 70, 80. Position the open end of the irrigation sleeve (i.e., the end not fixed to the connectors 50, 60, 70, 80) over the toilet.

[0254] Next, open the hatch 12 of the lid 10 inside the sleeve. The opening of the lid 10 is performed from the outside of the sleeve to avoid dirt, i.e., the patent operates the lid 10 through the sleeve without directly touching the lid 10.

[0255] When the hatch 12 is open, the bowel can be emptied. To do this, the patient bends slightly forward and empties all the contents of the bowel through the irrigation sleeve.

[0256] When emptying is complete, the hatch 12 is closed, then the sleeve is removed and discarded, the connectors 50, 60, 70, 80 are removed, and either washed with water for further use or also discarded.

[0257] At this stage, it may be convenient for the patient to replace the lid 10 with a second lid 10 and then wash the first lid 10 in preparation for emptying again.

[0258] Before replacing the lid 10, the patient's skin, stoma, and the outer surface of the implant 1 should, if possible, preferably be wiped clean with warm water. Disinfectants should be avoided.

[0259] If the emptying procedure requires a longer time period, instead of the irrigation sleeve, a stoma bag can be temporarily used on the skin around the implant 1 after removing the irrigation sleeve and connectors 50, 60, 70, 80, and in some cases the lid 10. Alternatively, instead of the irrigation sleeve, a stoma bag can be fixed to the connectors 50, 60, 70, 80. In either case, once the emptying is complete, the lid 10 must be closed from the outside of the bag before removing the bag.

[0260] Once the lid 10 is used continuously, it needs to be replaced weekly for hygienic reasons. The connectors 50, 60, 70, 80 need to be replaced daily. Alternative embodiments of the lid and / or connectors may require more or less frequent replacement.

[0261] Throughout this specification, terms such as upper / lower / side / upper side / lower side are used. These are used for clarity and simply refer to the way in which the implant, lid, and / or connector are typically (as shown in the figures, unless otherwise indicated) viewed or considered, i.e., the external end of the implant is at the top and the hatch of the lid is open upward. However, of course, during use, the implant (and thus the lid) may have a different orientation, and thus the parts referred to as the top / bottom / side / upper side / lower side may of course have different relative positions.

Claims

1. A connector for connection to an ostomy implant or to a lid of an ostomy implant, said connector comprising attachment means for attachment to said ostomy implant or lid and connection means or a connection surface for connection to a further device, the connecting surface comprises a relatively planar surface for attachment to a further device selected from the group including an ostomy bag, an irrigation sleeve, or a catheter; the connector comprises a ring having a flexible inner portion disposed for sealing engagement with the lid or the ostomy implant, the ring having an outer portion less flexible than the flexible inner portion; A connector, wherein the outer portion includes one or more tongues that project radially inwardly into, through, above, and / or below the flexible inner portion.

2. The connector of claim 1 , wherein the connector is substantially ring-shaped.

3. A connector according to any preceding claim, wherein the one or more tongues are less flexible than the flexible inner portion.

4. 4. A connector as claimed in any one of claims 1 to 3, wherein the one or more tongues extend from the remainder of the outer portion towards, but not as far as, an inner edge of the flexible inner portion.

5. 5. The connector of claim 1, wherein each of the one or more tongues includes an inner end, the inner end being arranged to engage a circumferential groove in the ostomy implant or lid, thereby securing the connector to the ostomy implant or lid.

6. 6. A connector as claimed in any one of claims 1 to 5, wherein the one or more tongues project radially inwardly above and below the flexible inner portion such that the connector is arranged to connect to the ostomy implant or lid from either side of the connector.

7. 7. The connector of claim 1, wherein the connector comprises two or more movable parts, the two or more movable parts being movable between an open configuration in which they may be positioned over the ostomy implant or lid, and a closed configuration in which they are arranged to be attached to the ostomy implant or lid.

8. 8. The connector of claim 7, comprising a connection edge arranged to fit and seal in a groove in the ostomy implant or lid, the connection edge being provided around an inner circumference of the connector when the connector is in the closed configuration.

9. The connector according to any one of claims 7 to 8, wherein the connector comprises two parts, the two parts being joined at their joining ends by a pair of relatively thin, flexible bending members.

10. A connector as claimed in any one of claims 7 to 9, wherein the connector comprises two parts, each of the two parts having a connecting end, the connecting ends abutting when the connector is in the closed configuration and spaced apart when the connector is in the open configuration.

11. A connector as claimed in any one of claims 7 to 10, wherein the connector comprises a locking arrangement for releasably locking the connector in the closed configuration, the locking arrangement comprising a barb member located on a first connecting end and a hook located on a second connecting end.

12. A connector as claimed in any one of claims 7 to 11, wherein each portion further comprises a further member protruding out of the plane of the connector, the further member arranged to receive an elastic band such that a closing force is applied to the connector acting to move the connector to the closed configuration.

13. A device comprising a connector according to any one of claims 1 to 12 attached thereto.

14. The device of claim 13, wherein the device is an ostomy bag, a catheter, or an irrigation sleeve.

15. 13. A method for manufacturing a connector for an ostomy implant or for a cap for an ostomy implant, said connector being configured as a connector according to any of claims 1 to 12.

16. forming an outer ring by injection molding; joining the outer ring to the inner links by injection molding.

16. The method of claim 15, comprising:

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