BR122020011715B1 - COVER FOR A MEDICAL IMPLANT AND IMPLANT WITH A COVER - Google Patents

Abstract

The present invention relates to a cover (10) for a medical implant (1) comprising a first part (12), a second part (11) and engaging means (15). The second part (11) is rotatable with respect to the first part (12) so that, in use, rotation of the second part (11) with respect to the first part (12) causes the engagement means (15) to engage and attach the cover (10) to the implant (1).

Description

Split from BR112018072324-0, filed on June 15, 2017.

[0001] The present invention relates to a lid or closing device. In particular, it relates to a cap or closure device for a medical implant, more particularly, for an ostomy implant.

[0002] Ileostomy and colostomy are common operations that may be necessary, for example, due to malignancy or chronic inflammation of the intestine. The surgery is called an ileostomy if the colon and rectum are removed and a colostomy if the rectum alone is removed. Similarly, an abdominal urostomy is created when the urinary bladder has to be removed due to, for example, bladder cancer. In these operations, a stoma is formed in the abdominal wall to which a segment of intestine is connected.

[0003] Ostomy is a generic term for any such procedure in which a stoma is created.

[0004] The stoma, in most cases, has to be connected to a bag to collect body waste. However, instead of a conventional ileostomy, it is possible to produce a reservoir known as a "Kock's pouch" from the distal part of the ileum. The bag is formed such that a nipple valve is created which serves to close the reservoir while allowing it to be drained intermittently via a catheter. This is an example of a so-called continent ileostomy (CI) and 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 them related to continence nipple valve dysfunction - have discouraged many surgeons from adopting the operation today.

[0005] The ileoanal anastomosis with ileal pouch (IPAA) is, today, the gold standard worldwide for these patients but, as with an IC, this operation is also risky and failures are common, leading, mainly, excision of the pouch with loss of intestine. Conversion of a failed IPAA to an IC would be a preferred option, but again, surgeons are reluctant to perform this complex and unreliable technique. Likewise, conversion from a neospeech orthotopic bladder or Bricker urostomy would be desirable.

[0006] It is known to provide an implant to facilitate the connection of a stoma to a lid or bag, for example.

[0007] For example, and as illustrated in Figures 1 and 2, applicant's previous application No. WO 2014/140344 A1 discloses a paracutaneous ostomy implant 1 comprising a tubular inner section 2, formed primarily of mesh, and a radially extending circular anchor flange or dermal anchor 3.

[0008] Implant 1 is designed to be implanted through the abdominal wall of a patient and to receive a section of intestine dragged through it. The serous tissue from the intestine section can then grow into the implant 1, through the mesh, and attach or grow into the surrounding dermal tissue. This can provide a safe, stable, leak-proof, and well-vascularized implant-tissue junction.

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

[0010] Once an implant has been implanted in a patient, it is necessary to close it in some way, or sealingly connect it to some form of evacuation means (e.g., a bag or catheter), to prevent waste from leaking from the stoma, and to allow waste to be collected and/or disposed of cleanly. This means that typically some form of cap needs to be attached to the outer end of the implant.

[0011] Applicant's previous application No. WO 2006/046210 A1 discloses a peelable cap for an implant with mounting means (e.g., a groove or ridge) arranged so that the peelable cap can be mounted and removed from one end outside of the implant by sliding the cover in a direction perpendicular to the longitudinal geometric axis of the implant.

[0012] However, a problem with this method of mounting a cap on an implant is that it can cause forces to be exerted on the implant, which can damage the junction between tissue and implant. It may also be difficult for a patient to assemble a lid in this way.

[0013] An additional problem is that with this sliding method of fixation, it may be difficult for the cap to seal properly, i.e. in a seal-tight manner, with the implant.

[0014] Document WO 2006/046210 A1 also discloses a connector for connecting an ostomy bag to the implant. The connector is arranged to slide the cover off the implant and to connect the bag to the implant.

[0015] Applicant's most recent application No. WO 2011/039517 A1, a medical closure device is disclosed comprising a coupling part and a closure part (for example, a lid or plug). The coupling part can be attached to a medical device such as an implant and the closing part can then be attached to the coupling part to close the implant. The coupling part is a circumferential flexible member that delimits a closing opening, and is configurable between a relaxed configuration in which the closing opening cannot pass over the medical device and a tensioned configuration in which the closing opening of the coupling part coupling can pass over the medical device. Therefore, if the coupling part is squeezed, it will deform from its relaxed configuration to a tensioned configuration in which it can be passed over the end of the implant. When the pressure is released (i.e., compression is stopped), the coupling part will attempt to return to the relaxed configuration, thereby securing the end of the implant. The reverse procedure can be performed to remove the coupling part.

[0016] However, a problem with this attachment mechanism is that it may be possible for the coupling part to become detached from the implant, unintentionally or accidentally, for example, if, for example, by tilting an object, the pressure is applied to the coupling part causing it to be squeezed into its tensioned configuration whereby it can become detached from the implant.

[0017] The closure device of document No. WO 2011/039517 A1 is also relatively wide and, when attached to an implant, extends downward close to the patient's skin so that there is a risk of abrasion and irritation.

[0018] Attaching the closing part to the coupling part requires two hands, which can be problematic for a user. Also, as the closing device comprises two separate parts (the coupling part and the closing part) there is a greater chance of one part becoming lost or falling off, compared to a closing device made from a single part. . Handling can also be inconvenient.

[0019] Furthermore, there is a possibility with this closure device that it could become fixed to the implant (locked) in an incorrect position, so that it is not properly seated and sealed on the implant. For example, a user often cannot see the cap and implant interface (e.g., due to clothing or stomach being in the way) and then it may catch or lock the closure device on the implant. in an incorrect position.

[0020] According to a first aspect of the present invention, there is provided a lid for a medical implant, the lid comprising a first part, a second part and coupling means, wherein the second part is rotatable with respect to the first part (or the first part is rotatable with respect to the second part) so that, in use, rotation of the second part with respect to the first part (or vice versa) causes the engaging means to engage and secure the cover to the implant.

[0021] Thus, according to the invention, the second part of the cap can be rotated relative to the first part (or vice versa) to cause the cap to engage and be fixed to the implant. Accordingly, a portion of the cap (e.g., the first portion) may be held stationary relative to the implant while the cap is being secured thereto. This can reduce or eliminate any forces applied to the implant during fixation, thereby helping to reduce or eliminate potential damage to an implant-tissue junction. Furthermore, a cap with such a fastening mechanism provides a relatively straightforward and easy way for a user to attach the cap to an implant and accidental removal of the cap can be minimized or prevented.

[0022] Since the cap can be attached, or detached, from an implant simply by rotating one of its parts, it may be possible to secure the cap with one hand. This has the benefit, logically, that a second hand can be used to retain other items that may be needed, for example after a cover has been removed (e.g. by evacuation/cleaning). (Alternatively, logically, two hands can be used).

[0023] Furthermore, since the cap can be attached to an implant, or detached from it, simply by rotating one of its parts, users with, for example, arthritis, weak hands or small hands may be able to perform this procedure.

[0024] The medical implant with which the cap can be used could, for example, be an ostomy implant and the present invention is, in fact, particularly suitable for this purpose. However, the cap is not limited to use with ostomy implants or, indeed, any other type of medical implant, and could be used for any medical implant or, indeed, to cover any other structure in or on which it is useful to provide a lid with such a clamping mechanism, for example. Examples of medical implants with which such a cap could be used may include, but are not limited to, colostomy implants, urostomy implants and gastrostomy implants, for example. An additional example of a medical system with an implant, with which this cap could be used, is an enteral feeding system (e.g., delivering nutrition directly to the stomach via an indwelling transcutaneous catheter).

[0025] When attached to an implant, the cap, particularly the engaging means, is preferably strong enough and secure enough so that it can withstand overpressures within the patient (e.g., due to a build-up of gas).

[0026] The simple mechanism described above means that the lid can be, and preferably is, relatively thin. For example, the cover may have a depth of 2.0 cm or less, 2.8 cm or less, 2.6 cm or less, 2.4 cm or less, 2.2 cm or less, 2.0 cm or less, 1.8 cm or less, 1.6 cm or less, 1.4 cm or less, 1.2 cm or less, 1.0 cm or less. The provision of such a thin cover means that, in use, the cover is less likely to bump into other objects that a user might bring into contact with tables, clothing, door frames, belts, etc.

[0027] The cap may have a smooth, rounded-topped or outer surface that curves downward to a point at which it would come into contact with a user's skin. This way, the lid could not have corners or protruding parts that could bump against other objects.

[0028] The first part, the second part and the engaging means are preferably arranged so that, in use, rotation of the second part with respect to the first part (or vice versa) causes the first part to press against the coupling means. This arrangement can provide a simple mechanism by which rotation of the second (or first) part causes engagement of the engagement means with an implant.

[0029] The coupling means could be or comprise any form of coupling mechanism or coupler.

[0030] The coupling means are preferably located in the second part. The engaging means could be a part of the second part or, alternatively, the engaging means could be a separate component which, for example, is provided with the second part.

[0031] The engagement means could be or comprise any type of engagement part, for example, which is suitable for engagement with an implant. For example, the engaging means could comprise one or more protruding engaging means or protuberances (e.g., a projection, ridge, protrusion, pin, hook) that may be arranged and/or sized to engage a portion of corresponding receipt (e.g., a groove, slit, hole, or recess) provided in the implant.

[0032] Alternatively or additionally, the engaging means could comprise one or more recesses or cavities (e.g., slot, slot, hole), provided, for example, within the second part, which recesses or cavities may be arranged and/or sized to receive or fit over a protruding engagement means or protuberance (e.g., a projection, ridge, protrusion, pin, or hook) provided on the implant.

[0033] Preferably, the engaging means comprises one or more components that are separate from the second part (not integrally formed therewith) and are preferably contained in the second part, but movable, for example, at least to a certain extent. degree, in relation to the second part.

[0034] Alternatively or additionally, the engaging means may comprise one or more fixed or integral (e.g., fixed or integrally formed with the second part) engaging components such as a protuberance (e.g., a projection, ridge, protrusion, pin or hook) or receiving part (e.g., a slot, slot, hole, or recess).

[0035] The engaging means are preferably arranged so that, when the second part is rotated relative to the first part (or vice versa), the engaging means are projected into an engaging recess or cavity provided in the implant.

[0036] Alternatively, the engaging means could be arranged so that, when the second part is rotated relative to the first part (or vice versa), the engaging means is projected over, around or through a protuberance of coupling provided on the implant

[0037] In a preferred embodiment, the engaging means comprise one or more, preferably three, pins. When more than one pin is provided, the two or more pins can be arranged at preferably equal spacings around the second part so that the two or more pins can engage with an implant around its circumference.

[0038] Preferably, the one or more pins are arranged so that it is a longitudinal side of the one or more pins that would engage with the implant. However, in an alternative embodiment, the one or more pins could be arranged so that one end of each of the one or more pins would engage with the implant.

[0039] The pin or pins are preferably supported by the second part and preferably movable, at least to some degree, relative to the second part.

[0040] The pin or pins are preferably straight, for example, with a circular cross-section and, preferably, rounded ends.

[0041] Preferably, the first part, the second part and the engaging means are arranged so that as the second part is rotated relative to the first part (or vice versa), the first part also moves more to or about the second part.

[0042] Preferably, the first part, the second part and the engaging means are further arranged so that as the first part moves further towards or over the second part, the first part exerts a force, pushes or presses the engagement means, so that the engagement means can engage with an implant.

[0043] In this way, by rotating the second (or first) part, the coupling means can be engaged with an implant.

[0044] Further, preferably, the first part, the second part and the engaging means are arranged so that as the first part moves further into or towards the second part, and the first part exerts a force, pushes or presses the engagement means, the engagement means engages with the implant by being moved radially inward toward the implant and/or (then) upward, preferably both. By causing the engagement means to move both radially inward and then upward (e.g., a groove) of the implant, a more secure engagement with the implant can be provided.

[0045] Furthermore, as the engaging means are forced upwardly onto the implant, the first part, and preferably also a seal provided in the lid, e.g. in the first part, can be dragged downwardly towards the implant. implant, thereby compressing the seal. This can create a strong and secure seal between the implant and cap, which can ideally withstand pressures from intestinal fluid, for example.

[0046] In a preferred embodiment, the first part is a plug. For example, the first part, or plug, may be substantially circular.

[0047] The plug can be formed from a circular top part and a ring-shaped side part.

[0048] The plug and, preferably, its top part, may comprise one or more grooves.

[0049] For example, the plug may comprise a first groove which preferably passes from one side of the top part, preferably through the center of the top part, to the opposite side of the top part. A recess may be provided along one or both sides of the groove.

[0050] The plug may comprise a second groove provided, for example, at the base of the first groove. The base of the first groove may otherwise be flat. The second groove is preferably narrower than the first groove and preferably passes on one side of the top part, for example, where the first groove preferably starts through the center of the top part and , preferably almost, but not too much, to the opposite side of the top. The centerlines of the first and second grooves are preferably collinear.

[0051] At the base of the second groove and preferably spaced along its center line, one or more, preferably two, upwardly projecting projections may be provided. The one or more projections preferably do not project further above the depth of the second groove, so that they do not project further upward into the first groove.

[0052] The side part of the plug preferably projects below the circumferential edge of the top part.

[0053] Within the plug and, preferably, on an external surface of the side part, there may be provided one or more, preferably three, preferably identical and preferably equally circumferentially spaced grooves or recesses. Each groove or recess may comprise an upwardly extending portion or a circumferentially extending portion, and preferably both an upwardly extending portion and a circumferentially extending portion. The upwardly extending part may extend upwards from the bottom of the side part to the top part, but not too far therefrom. The groove may then continue into a portion extending circumferentially from the top of the portion extending circumferentially upward around the side portion. Preferably, each groove does not extend as far around the side as the next groove so that a gap without any groove is present between the grooves.

[0054] The upwardly extending portion of each groove may be shallower than the circumferentially extending portion. Thus, there may be a small step "downward" (or radially inward relative to the plug) from the upwardly extending portion to the circumferentially extending portion, which may begin just above it.

[0055] Additionally, or alternatively, there is preferably a ridge or protrusion (relatively small) provided along or at a top end of the upwardly extending portion before the circumferentially extending one.

[0056] On the circumferentially extending part of each groove there may be a (relatively thin) ridge, preferably along most, but not all, the length of the center line of the circumferentially extending part. The ridge preferably does not extend as far as either end of the circumferentially extending portion.

[0057] Preferably, as each circumferentially extending part extends around the side part, the same also extends slightly upward, so that each circumferentially extending part preferably slopes upward around the side.

[0058] Preferably, on the upper side of the top part, and, for example, within the side part, there is a radially internal groove and/or a radially external groove. The radially outer groove may be connected to or formed by the radially inner surface of the side part and a first circular wall. The radial inner groove may be connected to or formed by the first circular wall and a second circular wall.

[0059] Preferably, the second part is a base, with the base preferably being substantially ring-shaped, for example, with a substantially circular opening in its center.

[0060] For example, the base may comprise a side portion and, for example, a radically inwardly extending portion that may extend radially inwardly from a lower circumferential edge (in use) of the side portion. The radically inwardly extending part may form or comprise, for example, at its center, the substantially circular opening of the base.

[0061] On the outer surface of the side or base there are preferably gripping regions with, for example, ridges to facilitate gripping of the base, for example, for rotation and/or when placing it on an implant.

[0062] Preferably, the base has a rounded or curved bottom, for example, in which the side part joins the part that extends radically inward. Alternatively or additionally, the cap (e.g., its base) and/or the implant are sized so that when the cap is attached to an implant there is a small gap between the patient's skin and the bottom of the cap/base. This means there would be little or no abrasion to a patient's skin, for example when sitting or bending over.

[0063] The base is preferably sized so that the first part or plug can fit inside it, preferably exactly. In other words, an internal diameter of the base is preferably equal to an external diameter of the first part or plug.

[0064] On the upper or inner surface of the base or, preferably, the radically inwardly extending part thereof, there is preferably, for example, a circumferential groove which may be formed by the inner surface of the side part and a ridge circular, e.g., e.g., extending upwards, e.g., from the inner circumference of the inwardly extending part. The ridge is preferably sized to fit into a groove (e.g., radially external) of the first part or plug when the lid is assembled.

[0065] In one or more, preferably three portions circumferentially, preferably equally, separated along the circumferential groove there are, for example, one or more straight recesses or grooves, which may be slightly deeper than the circumferential groove. The one or more straight recesses or grooves are preferably arranged and sized so that they can retain, support or contain the coupling means.

[0066] Above, for example, the central point of each such straight recess or groove, and extending, for example, from the inner surface of the side part, may be one or more, preferably three guide projections, preferably , circular. The one or more guide projections are preferably sized to fit into, and slide along, a groove provided in the plug or first part.

[0067] Associated with each straight recess or groove, for example, at either end of each straight groove, preferably on a radially inner side, a resilient tongue may be provided which may, for example, act as a weak spring (e.g. example, against the engaging means in each recess or straight groove).

[0068] A recess is preferably provided in the side part above one of the guide projections. The recess is preferably sized so that a slide (described below) can fit into or be slid through it.

[0069] The lid preferably comprises means for providing tactile feedback to a user that indicates when the lid is in an engaged and/or disengaged state. For example, the ends of the recess in the side may be such tactile feedback when a part of a slide, or other means of rotation (see below), for example, rests against them (e.g. following the rotation of the slide/ base).

[0070] Preferably, the first part is or can be press-fitted to the second part. This is an easy and safe way to assemble the two parts while still ensuring that they can rotate relative to each other.

[0071] Preferably, the first and second parts comprise complementary guide means, or guide parts, for example, to facilitate their relative rotation.

[0072] One part (e.g., first or second part) may comprise a projection and the other part, a groove for guiding the projection.

[0073] For example, the complementary guiding means may comprise one or more grooves provided in the first part or the second part, and one or more complementary protruding parts or projections provided in the other of the first part and the second part, wherein the one or more protruding parts are arranged to extend into the one or more grooves, thereby allowing the first and second parts to rotate relative to each other.

[0074] Preferably, the first and second parts are arranged so that as the second part is rotated relative to the first part (or vice versa), the first part is also moved (e.g., by means of complementary guide) axially in relation to the second part. Thus, as the first part is rotated relative to the second part, the first part can be moved toward or away from, or into or away from, the second part, depending on the direction of rotation.

[0075] The first part may comprise or have connected thereto a rotation means (or anvil) to facilitate rotation of the second part relative to the first part (or vice versa). For example, the rotating means may project, or be capable of projecting, from the first part to facilitate rotation of the second part, for example, by keeping the first part stationary. Alternatively, the rotation means could be used to facilitate rotation of the first part while the second part is held stationary.

[0076] Although the term "means of rotation" is used, it will be noted that the means of rotation themselves do not necessarily need to rotate, they may merely facilitate the rotation of another part. Therefore, in this application, "rotation means" should be interpreted as a means for facilitating rotation of the second or first part (or "rotation facilitating means"), which do not necessarily need to be rotated. In fact, in a preferred form of use, the rotation means are held stationary and used as a type of "anvil" or rotation means. For example, the rotation means can be, and preferably is, used to keep the first part stationary while the second part is rotated relative to the first part. However, alternatively, the rotation means could be used to rotate the first part relative to the second (stationary) part.

[0077] The rotation means is preferably retractable between a first position in which the second part can be rotated relative to the first part (or vice versa) (the lid is "unlocked"), and a second position in that the second part may not be rotated relative to the first part (or vice versa) (the lid is "locked"). In this way, when the rotation means is in the second (locked) position, inadvertent rotation of the first part can be prevented.

[0078] The rotation means may, for example, be a slide arranged to slide, preferably radially, in a groove, for example, provided in the first part.

[0079] The rotation means is preferably sized so as to extend through a diameter of the first part.

[0080] In a preferred embodiment, the rotation means is substantially rectangular, but may have curved ends, for example, to be compatible with or correspond to the circumference of the first part.

[0081] The rotation means preferably has a curved upper surface, for example, with the curvature of its surface extending along the length of the rotation means.

[0082] On a bottom surface of the rotation means and, for example, towards an end, one or more, preferably two, preferably parallel ridges, for example, of equal length and, preferably extending along a (relatively short) length of the rotation means.

[0083] Additionally or alternatively, a projection is preferably provided on the bottom surface of the rotation means. For example, the protrusion may be provided in a region between two ridges and the protrusion may extend between the two ridges. The projection is preferably curved. The ridges preferably extend slightly further along the length of the rotating means than the projection.

[0084] The lid preferably comprises means for providing tactile and/or audible (preferably both) feedback (e.g., part(s) of tactile and/or audible feedback to a user to indicate when the lid is in locked/unlocked states/positions. For example, the interaction between one or more projections, ridges or grooves provided in the rotating means and/or first part (e.g. in a groove in the first part) may provide such feedback. Preferably , the projection and/or one or more ridges provided under the rotation means, and/or the one or more upwardly projecting projections and/or an end of the second groove in the first part, are arranged so that the interaction between they can provide such feedback.

[0085] A preferably curved groove is provided on the bottom surface of the rotation means, for example around its longitudinal intermediate point. The curved groove preferably extends from one edge of the rotation means to, but preferably not as far as, the opposite edge. The curved groove preferably has a radius of curvature on its inner edge that corresponds to that of the outer circumference of the first part, or the inner circumference of the top of the second part.

[0086] Preferably, on the upper surface of the rotation means, for example at one end, there may be provided a marking or sign such as a single or double ended arrow, which shows, for example, the direction (or directions) in that the means of rotation must be moved or slid, in use.

[0087] The rotation means may comprise, for example, at one (other) end of, for example, its upper surface, a gripping area, with one or more ridges or other gripping means, for example, for facilitate movement or sliding of the rotation means in use.

[0088] Along one or, preferably, both edges of the rotation means, for example its bottom side, one or more protruding parts may be provided. A protruding part may be broken, or have a slot, at a point, for example, where it extends over a curved groove provided in the bottom surface of the rotating means. The protruding part (or parts) is preferably sized to fit the recesses present within a groove provided in the first part.

[0089] As described above, the rotation means may, in addition to providing a means for rotating the second (or first) part, provide a means for locking/unlocking the lid (a locking means). However, it is also possible for a locking means to be provided separately from, and in addition to, the rotation means, for example as a separate part.

[0090] Thus, in some embodiments, the lid may comprise locking means for locking/unlocking the lid. Preferably, the locking means is movable between a first position in which the first part can be rotated with respect to the second part (the lid is "unlocked"), and a second position in which the first part can not be rotated with respect to to the second part (the lid is "locked"). In this way, when the locking means is in the second (locked) position, inadvertent rotation of the first part can be prevented.

[0091] The locking means could be any type of locking part capable of allowing/preventing rotation of the second part relative to the first part (or vice versa). For example, the locking means could comprise a retractable member (e.g., a pin or slide) that can be moved between a first position, e.g., inserted, wherein rotation of the second part relative to the first part (or vice versa) -versa) is prevented (the lid is locked), and a second position, for example retracted, in which rotation of the second part relative to the first part (or vice versa) is possible (the lid is unlocked). For example, in its first position, the retractable member could extend, for example, in an axial direction, through the first part to a hole or recess in the second part, thereby preventing its relative rotation and locking the lid.

[0092] Preferably, the locking means is arranged so that, when the cover is positioned on an implant, the locking means can only be moved from its unlocked position to its locked position when the cover is properly engaged with the implant. This way, when the cover is not properly engaged, the cover is prevented from being locked. This can help prevent improper positioning of the cap on an implant, which could result in leakage.

[0093] The lid preferably additionally comprises a seal, for example, to provide sealing engagement with the implant. The seal may be provided in or be part of the first part.

[0094] For example, the seal may be a sealing ring, for example provided in a groove, preferably circular in the first part.

[0095] Alternatively, the seal, for example, a sealing ring, can be injection molded into the first part. This could be done by first molding the first part, for example, in a molding tool, and then removing an insert from the tool so that the sealing material (i.e., material to form the seal) can, then be molded directly into the first part (or the first part could be moved to a second chamber in the molding tool, shaped so that the sealing material forms a seal when molded into place in the first part).

[0096] The sealing ring is preferably circular and sized to fit into a radially internal groove in the first part. The sealing ring preferably has a flat side and a curved side and is preferably positioned in the first part with its flat side facing the bottom of the radially internal groove (i.e. upwards in use). One or more, preferably two, small projections may be provided, for example opposite each other, on the sealing ring, and may extend, for example, perpendicularly from the flat side of the ring.

[0097] Other forms of sealing could then be used.

[0098] Preferably, as the second part is rotated relative to the first part (or vice versa), the seal can be moved to and pressed against a surface of the implant, for example, by the relative axial movement of the first part .

[0099] Thus, the cap preferably comprises a double locking mechanism, for example, as the second part is rotated relative to the first part (or vice versa) the engaging means engages with the implant and the seal is compressed against the implant. Once engaged and sealed in this manner, the cap may preferably be locked (e.g., by placing the rotation means in a locked position) in a position where the engagement means cannot disengage from the implant and/or the seal must not be uncompressed. The lid, for example, the first part, preferably comprises one or more visual signs or indicators to show in which position the lid is in an open/closed/locked/unlocked position, for example.

[00100] The lid can be produced from metal, plastic, wood, a combination of material, a composite material and/or rubber. Preferably, the lid is preferably produced from plastic, for example polypropylene or silicone.

[00101] Preferably, the first and second parts of the lid are produced from different materials, for example, different types of plastic. This is due to the fact that (e.g. plastic) materials can tend to stick together when under some pressure. Therefore, to minimize the possibility of this type of friction occurring between the first and second parts, it is preferable that they are produced from different materials.

[00102] The coupling means can be produced from metal, for example, stainless steel, fiber, hardwood, a soft metal, or plastic, for example.

[00103] However, preferably, the coupling means is produced from a softer material than that of the implant (for example, titanium). This can help ensure that the engagement means wears out before the edge of a groove in the implant, for example, (or other receiving part for the engagement means) over which the engagement means moves.

[00104] For example, the coupling means could be produced from a plastic/polymeric material and possibly fiber reinforced.

[00105] Preferably, the engaging means, and all parts of the lid, are produced from non-magnetic materials (e.g., aluminum, brass) for MRI compatibility.

[00106] The seal is preferably produced from a soft medical grade polymer.

[00107] The lid can be cleaned with normal household methods, for example, which include one or more of rinsing, detergent, soap, boiling, bleaching and alcohol.

[00108] The present invention also relates to an implant with a cap as described above or below attached thereto.

[00109] The present invention also relates to a method of manufacturing a cover for a medical implant, for example, as described above, the method comprising: providing a first part, a second part and engaging means; and assembling the first part, the second part and the engaging means to form a cover so that the first part is rotatable with respect to the second part and, in use, rotation of the first part with respect to the second part causes the means engage and secure the cap to the implant. The first part, the second part and/or the engaging means are preferably as described above.

[00110] The method of manufacturing a lid may comprise one or more of the following steps:

[00111] providing, inserting or locating the coupling means in the second part;

[00112] providing, inserting or locating a seal, for example, as described above in the first part;

[00113] providing, inserting or locating a means of rotation, for example, as described above in the first part.

[00114] These steps can be performed in any order and/or in parallel with one or more of the others.

[00115] The method may alternatively or additionally comprise (e.g., preferably, after the above steps) inserting or locating the first part (with sealing and/or rotating means, if provided) into the second part (e.g., with means of coupling).

[00116] The first part can then be rotated relative to the second part.

[00117] The rotation means may, for example, be inserted or slid into, for example, a groove in the first part.

[00118] In a preferred method, the second part is placed with a radically inwardly extending part located at the bottom. The engaging means, for example one or more, preferably three, pins, are then preferably placed in the second part, for example in each of the (three) preferably straight grooves.

[00119] The first part is preferably placed with a groove, for example, a radially internal groove, facing upwards. The seal is then preferably placed in the groove, for example with a flat side facing downwards into the groove.

[00120] The first part is preferably placed, for example, with an upper surface facing upwards. The rotation means may be inserted or connected to the first part, for example, by sliding or inserting the rotation means into a groove or recess in the first part.

[00121] As the rotating means is slid into the first part, resistance may be felt as, for example, a curved protrusion provided under the rotating means (e.g., as described above) encounters one or more protrusions on the first part (e.g. as described above). Some additional force may therefore be necessary to, for example, get the curved protrusion to pass over the one or more protrusions in the first part.

[00122] After the rotating means has been inserted into the first part, the projection at the ends of one or more ridges on the rotating means (e.g., as described above) may rest against a closed end of a groove in the first part ( for example, as described above) and the rotation means can be prevented from being further inserted into or through the first part.

[00123] The one or more ridges and the closed end of the groove are preferably positioned so that at that point, that is, when the one or more ridges rest against the closed end of the groove, a curved groove (e.g. , as described above) on the upper side of the rotation means is positioned so that it extends around the outer circumference of the first part.

[00124] The rotation means should preferably be moved or slid into position, i.e. as described above, before further lid assembly steps described below are carried out.

[00125] The first assembled part (e.g., with a rotation and/or sealing means as described above) is preferably inserted or placed around the second assembled part (e.g., with the engaging means as described above).

[00126] In order to accomplish this, the first mounted part is preferably positioned with its upper surface facing upwards, and the second mounted part is preferably positioned, for example, on a level surface, with a extending radically inward (e.g., as described above) located at the bottom or facing downwards. The first part is further positioned preferably so that one or more walls or boundaries of one or more slots in the first part, for example one or more parts extending upwardly from the slots in the first part, are each , located directly above a guide, for example a guide projection, preferably circular, for example as described above, provided in the second part.

[00127] The first assembled part is further preferably positioned so that its engaging means (if provided) slightly overlaps a recess in a side part of the second part (e.g. as described above).

[00128] The first assembled part and the second assembled part are, for example, after the above alignment procedure, preferably pressed or pressed together, for example, by pressing the first part into or on the second part, so that, for example, the guides provided in the second part pass over, for example, the ridges provided, for example, at a top end of each upwardly extending part, and preferably then into the parts that extend circumferentially.

[00129] As the assembled first part has preferably been positioned so that the engaging means slightly overlaps a recess in a side part of the second part, the part of a top edge of the second part can be fitted into the groove curve on the upper side of the coupling means, if provided.

[00130] Next, the first assembled part is preferably rotated, for example, clockwise, when viewed from above, relative to the second part, (or vice versa), for example, by pushing or pulling or, otherwise, moving the means of rotation. When moving the rotation means in this way, the first part is preferably rotated as far as possible, for example until the guides in the second part reach the upper ends (e.g. of circumferentially extending parts) of the grooves in the first part (e.g. opposite the ends where the circumferentially extending parts meet the upwardly extending parts) and can then be prevented from moving further.

[00131] As the first part is rotated in this way, it is also preferably dragged (additionally) downwards or towards the second part, for example due to a slope of the grooves in the first part.

[00132] When the first part has been rotated as far as possible, for example, when the guides in the second part reach the ends of the grooves in the first part, the rotation means is preferably located within the recess on the side of the second part.

[00133] Next, the rotation means is preferably pushed inwards, for example through the recess and/or a groove in the first part, until, for example, the rotation means is prevented from moving more, for example, leaning against a side part of the second part. At this point, the rotation means is preferably positioned across the (e.g. entire) diameter of the lid, within, for example, a groove in the first part.

[00134] The rotation means is, at this point, preferably level with the surrounding area of the first part.

[00135] Additionally or alternatively, the longitudinal length of the rotation means is preferably equal to an external diameter of the second part so that, at that point, the rotation means does not project outside the base.

[00136] This means that the cap provides a relatively smooth and continuous outer surface, which would not, for example, get caught on clothing or other objects, which would apply a force against it and potentially damage the junction between tissue and implant. . This also means the lid is distinctive to a user.

[00137] Once the cover has been assembled, for example, in the above way, it can be established, for example, that a patient or other user fits, for example, an implant.

[00138] The present invention also relates to a method of attaching a cap for a medical implant, for example, as described above, to an implant, the cap comprising a first part, a second part and engaging means, wherein the method comprises: placing the cap over a protruding end of the implant and then rotating the second part relative to the first part (or vice versa) so that the coupling means engage and secure the cap to the implant. The first part, the second part and/or the engaging means are preferably as described above.

[00139] The method preferably comprises first extending (e.g., sliding) a rotation means (e.g., as described above) of the first part, so that the rotation means can be used to rotate the first part. For example, starting from a cap with inserted rotation means or through the first part, before the cap is fitted to an implant, the rotation means may be extended or slid outwards, for example along a groove in the first part. part.

[00140] The first part can be rotated, for example, counterclockwise with respect to the second part when viewed from above, so that the first part preferably rises slightly away from the second part. At this point, the rotation means may, for example, be only slightly overlapped (or not overlapped at all) with a recess in the second part (e.g. as described above).

[00141] The cap can then be ready to be fitted to an implant.

[00142] A user preferably retains a projecting end of the rotation means and can place the cap over an outer section of the implant.

[00143] The second part is then preferably rotated, for example, by pushing/pulling/moving the rotation means, for example, in a counterclockwise direction relative to the first part. when viewed from above (or vice versa) until, for example, the rotation means is positioned completely in a recess in the second part (e.g. as described above).

[00144] As the second part is rotated relative to the first part (or vice versa), the first part is preferably dragged down to or over the second part, for example, by virtue of one or more guides in the second part (e.g. as described above) that are slid along grooves in, for example, the first part (e.g. as described above).

[00145] As the first part is dragged downwardly into or over the second part in this manner, a side part of the first part preferably moves downwardly, for example, into a groove within the second part, and forces the engagement means to engage with the implant.

[00146] The second part preferably comprises one or more resilient tabs arranged to press against the engaging means.

[00147] Preferably, the engaging means may be forced, for example, by a portion of the first portion as it moves downwardly into and over the second portion, radially inwardly, preferably against the one or more resilient tabs and preferably slightly upward to a groove or other recess in the implant, for example a groove around an outer circumference of an outer section of the implant.

[00148] This engagement of the engagement means with the implant can secure and retain the cap on the implant and, for example, prevent users, clothing or other objects from being able to simply move or pull the cap straight away from the implant, for example, unintentionally.

[00149] Furthermore, as the first part is dragged down into or over the second part, a seal (e.g., as described above), provided, for example, on an upper side of the first part, may be compressed against the implant, for example against an upper surface of an outer section of the implant, thereby forming a leak-proof seal between the implant and the cap.

[00150] Once the cap has been secured to the implant, the rotation means is preferably slid or moved back to its unextended position, e.g., back through the cap, e.g., through and into a groove in the first part. In this way, once the cap has been secured to an implant, the rotation means can be retracted so that they no longer protrude from the cap.

[00151] The present invention also relates to a method of removing a cover for a medical implant, for example, as described above, from an implant, the cover comprising a first part, a second part and means of engagement, wherein the method comprises: rotating the second part relative to the first part (or vice versa) so that the engagement means disengage from the implant and then removing the implant cover. The first part, the second part and/or the engaging means are preferably as described above.

[00152] In order to remove a cap from an implant, the reverse procedure for this described above can be performed.

[00153] For example, the lid may begin with a means of rotation in a retracted or unextended position relative to the rest of the lid. The rotation means can then be extended, for example pulled out, for example through a groove in the first part. When extended, for example, the rotation means can be used to rotate the second part, for example, in a clockwise direction relative to the second part (or vice versa). This rotation preferably causes the first part to move upward and slightly away from the second part, so that, for example, a part (e.g. a side part) of the first part no longer provides or retains the means of engagement in engagement with the implant. The one or more resilient tabs, for example, preferably cause the engagement means to be retracted from the implant, for example, from a groove in the implant. At this point, as the first part has moved slightly upward, a seal is ideally no longer compressed against the implant.

[00154] The user can then lift the implant cover, for example, with little or no resistance.

[00155] After removing an implant cover, it should preferably be washed.

[00156] The concept of a lid with a locking means is seen as inventive in its own right and then, viewed from a further aspect, a lid is provided for a medical implant, the lid comprising hooking means and locking means, wherein the locking means is movable between a locked position, wherein the engaging means may not engage/disengage from an implant, and an unlocked position, wherein the engaging means may engage/disengage from an implant. an implant.

[00157] Thus, when the locking means is in the locked position (i.e., the cover is locked), the cover may not, for example, be accidentally disengaged from an implant and accidental removal of the cover from an implant may be prevented. Conversely, when the locking means is in the unlocked position (i.e., the cover is unlocked), the cover can be engaged/disengaged from the implant. In this way, the cover can be locked onto an implant in its engaged state, and a conscious and active step can be taken so that the cover can be unlocked and then disengaged from the implant.

[00158] The locking means could be or comprise a locking part suitable for locking/unlocking the lid and preferably also engaging/disengaging the engagement means.

[00159] The phrase "lock the cap" means to place the cap in a locked state in which its engaging means cannot be engaged/disengaged from an implant. Conversely, the phrase "unlock the cap" means to place the cap in an unlocked state in which its engaging means cannot be engaged/disengaged from an implant.

[00160] The locking means could, for example, be the rotation means as described above.

[00161] Alternatively, the locking means could be any type of locking part capable of allowing/preventing rotation of the second part relative to the first part (or vice versa). For example, the locking means could comprise a retractable member (e.g., a pin or slide) that can be moved between a first position, e.g., inserted, wherein rotation of the second part relative to the first part (or vice versa) -versa) is prevented, and a second position, e.g. retracted, in which rotation of the second part relative to the first part (or vice versa) is possible. For example, in its first position, the retractable member could extend, for example, in an axial direction, through the first part to a hole or recess in the second part, thereby preventing its relative rotation.

[00162] The lid may comprise any or all of the other features described above or below.

[00163] Viewed from a further aspect, there is provided a method of locking a cover for a medical implant, the cover comprising engaging means and locking means, the method comprising moving the locking means to a position locked in which the engagement means may not engage/disengage from an implant. The lid may be as described above or below, and the method may comprise any of the additional features described above or below.

[00164] Viewed from a further aspect, there is provided a method of unlocking a cover for a medical implant, the cover comprising engaging means and locking means, the method comprising moving the locking means to a position unlocked device in which the coupling means can engage/disengage from an implant. The lid may be as described above or below, and the method may comprise any of the additional features described above or below.

[00165] The concept of a cap with compression means that can be used to drag the cap down onto an implant is also seen as inventive in its own right and then, viewed from a further aspect, a cap is provided for a medical implant, the cap comprising a seal and compression means, wherein the compression means are arranged so that, when the cap is placed over an implant, activation or use of the compression means causes at least the seal moves down toward the implant so that the seal is compressed against the implant.

[00166] In this way, the compression means can be used to cause the seal to move downwardly towards the implant, so that the seal is compressed to preferably seal engagement with the implant, thereby providing a leak-proof seal.

[00167] The seal (e.g., as described above) is preferably provided on an upper side of the lid.

[00168] The lid preferably also comprises engaging means, for example, as described above. The compression means are preferably arranged so that activation of the compression means causes the engagement means to engage with the implant (as well as the cap and its seal to move downwardly onto the implant so that the seal is compressed against the implant), for example, as described above. Thus, the compression means may preferably be used to control both the attachment and engagement of the cap to an implant, as well as the sealing of the cap to an implant.

[00169] The compression means could be or comprise any type of compression part, for example, or is suitable for compressing the seal against the implant.

[00170] For example, and as described above, the compression means could be or comprise a rotational means that can be used to cause the cap (or a portion of the cap) to rotate downwardly onto the implant, thereby causing , causing the seal to be compressed onto the implant. The compression means could, for example, be the rotation means as described above.

[00171] Alternatively or additionally, the compression means could comprise a push button, for example, on the top, of the lid, or one or more, preferably two, protruding parts/levers/buttons, for example, on the side of the lid to press/squeeze.

[00172] The coupling means could comprise one or more fixed parts and one or more moving parts.

[00173] For example, as a fixed part, the engagement means could comprise a fixed edge, ridge or other protuberance provided on the cap to engage with a corresponding groove or indentation on the implant (or vice versa). The edge, ridge or other protuberance could, for example, be provided on or around a lower inner edge of the lid, e.g. its base. It could, for example, cover half or less than half (for example, around a third or less, around a quarter or less) of an internal circumference of the lid.

[00174] As one or more movable parts, the engagement means could comprise one or more levers, pins, hooks or other movable engagement means. The one or more movable parts could be distributed, preferably evenly, along the remaining circumference of the lid, i.e. that which was not covered by the fixed part (or parts).

[00175] In one embodiment, the lid could comprise a rim or ridge covering the circumference along a quadrant of the lid and one or more, preferably two or three, levers, pins or hooks, preferably evenly distributed , on the circumference of the remaining three quadrants.

[00176] With such a cap, the cap could be slid onto an implant, for example, to engage the fixed part (or parts) with the implant, and then the movable part (or parts) could be activated (e.g., by the compression means) to further engage with the implant, and preferably compressing a seal provided on the cap with the implant to ensure sealing engagement of the cap with the implant.

[00177] The lid may comprise any or all of the other features described above or below.

[00178] A method of sealing a cap for a medical implant with or to an implant, the cap comprising a seal and compression means, the method comprising placing the cap over the implant and activating or using the compression means. compression to cause the seal to move downward toward the implant so that the seal is compressed against the implant. The lid may be as described above or below, and the method may comprise any of the additional features described above or below.

[00179] The preferred embodiments of the present invention will now be shown, by way of example only and with reference to the attached drawings, in which:

[00180] Figure 1 shows a perspective view of an ostomy implant;

[00181] Figure 2 shows a side view of the ostomy implant of Figure 1;

[00182] Figure 3 shows an exploded perspective view of components of a lid according to an embodiment of the invention;

[00183] Figures 4(a) to (c) show a top side perspective view, respectively, of the lid shown in Figure 3;

[00184] Figures 5(a) to (h) show a bottom side cross-sectional view, side cross-sectional view, top view and additional cross-sectional view, respectively, of the lid plug shown in Figure 3;

[00185] Figures 6(a) to (d) show a top, side and end view, respectively, of the lid slide shown in Figure 3;

[00186] Figures 7(a) to (i) show a view in perspective, bottom, cross-section, side, additional side, in detail, in more detail, further in cross-section and in additional cross-section, respectively, the base of the lid shown in Figure 3;

[00187] Figures 8(a) and (b) show side and end views, respectively, of a pin of the lid shown in Figure 3;

[00188] Figures 9(a) to (c) show a top, cross-sectional and side view, respectively, of the lid sealing ring shown in Figure 3;

[00189] Figures 10(a) to (c) show steps for inserting the pins of Figure 8 into the base of Figure 7;

[00190] Figures 11(a) to (e) show steps for inserting the sealing ring of Figure 9 into the plug of Figure 5;

[00191] Figures 12(a) to (c) show steps for inserting the slides of Figure 6 into the plug of Figure 5;

[00192] Figure 13 shows how to insert the assembled plug of Figure 12 into the assembled base of Figure 10;

[00193] Figure 14 shows a perspective view of a lid after the step of Figure 13;

[00194] Figures 15(a) to (d) show steps to complete the lid assembly process after the step in Figure 13;

[00195] Figure 16 is a flow diagram showing the steps for assembling the lid;

[00196] Figures 17(a) to (d) show steps for fitting a cover of Figure 3 to an implant;

[00197] Figures 18(a) to (e) show steps for removing a cover of Figure 3 from an implant; It is

[00198] Figure 19 shows a perspective view of an implant fitted with a cap from Figure 3.

[00199] Figure 3 shows an exploded perspective view of components of a lid 10 according to an embodiment of the invention.

[00200] The components of the lid 10 consist of: a substantially ring-shaped base 11, a substantially circular plug 12, a slide 13, a sealing ring 14 and three pins 15. The respective components 11, 12, 13, 14 , 15, of lid 10 are described in more detail below.

[00201] Figures 4(a) to (c) show a top side perspective view, respectively, of the lid 10 of Figure 3.

[00202] Figures 5(a) to (h) show a bottom side cross-sectional view, side cross-sectional view, top view and additional cross-sectional view, respectively, of the plug 12 of the lid 10 shown in Figure 3.

[00203] The plug 12 is circular and is formed from a circular top part 28 and a ring-shaped side part 29.

[00204] In the top part 28 there is a first groove 20 which passes from one side of the top part 28, through the center of the top part 28, to the opposite side of the top part 28. The upper surface 28a of the top part 28 top 28 projects slightly over both sides of the first groove 20 forming a small recess 22 along either side of the groove 20.

[00205] Within the first groove 20, at its base (which is otherwise flat), there is a second groove 21. The second groove 21 is narrower than the first groove 20 and passes on one side of the top 28 wherein the first groove 20 begins, through the center of the top part 28, and almost, but not quite, to the opposite side of the top part 28. The center lines of the first and second grooves 20 and 21 are collinear .

[00206] At the otherwise flat base of the second groove 21, and spaced along its center line, there are two upwardly projecting projections 23a and 23b. The protrusions 23a and 23b do not project more than the depth of the second groove 21, so that they do not project upwards into the first groove 20. These protrusions 23a and 23b are provided and positioned so as to provide a sound of " defined click" and feedback of sensation to the user when the slide is pushed all the way to each of its two end positions. The "click" sound and feedback sensation is provided as the protrusions 23a and 23b pass over a corresponding protrusion 31 provided on the bottom surface of the slide 13 (see below).

[00207] On the upper surface 28a of the top part 28 there are two logos 27a and 27b marking the locked and unlocked positions of the cover 10.

[00208] The side part 29 projects below the circumferential edge of the top part 28.

[00209] Within the outer surface of the side part 29 three identical and equally circumferentially spaced grooves 24 are provided. Each groove 24 consists of an upwardly extending part 24a and a circumferentially extending part 24b. The upwardly extending portion 24a extends upwardly from the bottom of the side portion 29 to the top portion 29, but not far therefrom. The groove 24 then continues into the circumferentially extending part 24b from the top of the upwardly extending part 24a circumferentially around the side part 29. Each groove 24 does not extend as far around the side part 29 as the next groove 24 so that a gap without any groove is present between the grooves 24.

[00210] The upwardly extending portion 24a of each groove 24 is shallower than the circumferentially extending portion 24b of each groove 24. Thus, there is a small step "downward" (or radially inward in relation to to the plug 12) from the upwardly extending part 24a to the circumferentially extending part 24b, which starts just above it. Furthermore, there is a small ridge 24d provided along the top end of the upwardly extending portion 24a prior to the "drop" to the circumferentially extending portion 24b.

[00211] On the circumferentially extending part 24b of each groove 24 there is a thin ridge 24c along most of, but not the entire length of, the center line of the circumferentially extending part 24b. The ridge 24c does not extend as far as either end of the circumferentially extending portion 24b.

[00212] When the cover 10 is assembled, the three ridges 24c are in contact with three corresponding circular guide projections 44 located on the inside of the base part 11 (see below).

[00213] As each circumferentially extending part 24b extends around the side part 29, it also extends slightly upward, so that each circumferentially extending part 24b slopes upward around the side part 29 .

[00214] On the upper side of the top part 28, and within the side part 29, there is a radially internal groove 25 and a radially external groove 26. The radial external groove 26 is connected to or formed by the radially internal surface of the side part 29 and the first circular wall 26a. The radial internal groove 25 is connected to or formed by the first circular wall 26a and a second circular wall 25a.

[00215] Figures 6(a) to (d) show a top, side and end view, respectively, of the slide 13 of the lid 10 shown in Figure 3.

[00216] Slide 13 is sized to extend across a diameter of lid 10 when assembled. Thus, the slide 13 is substantially rectangular, but slightly curved ends 38a, 38b to be compatible with the circumference of the lid 10. The slide 13 has a curved upper surface 37 with the curvature of that surface 37 extending along the length of the slide 13 (i.e., when assembled, through the diameter of the cover 10).

[00217] On the bottom surface of the slide 13 and towards an end 38b, there are two parallel ridges 30a, 30b of equal length extending along a short length of the slide 13. Extending between the two ridges 30a, 30b is a curved projection 31. The ridges 30a, 30b extend slightly further along the length of the slide 13 than the projection 31.

[00218] Around the midpoint of the slide 13, and on its bottom surface, is a curved groove 32 that extends from one edge 39a of the slide 13 towards, but not as far as, the opposite edge 39b . The curved groove 32 has a radius of curvature on its inner edge that corresponds to that of the outer circumference of the plug 12.

[00219] At one end of the upper surface 37 of the slide 13 there is a double-ended arrow 24 marked, which shows the directions in which the slide 13 should be slid, in use. At the other end of the upper surface 37 there is a ridge area 33 with ridges to facilitate the sliding of the slide 13 in use.

[00220] Along each edge 39a, 39b of the slide 13, starting from its bottom side, there is a protruding part 36b, 36a, respectively. The protruding part 36b is broken, or has a slot 36b', at a point where it extends over the curved groove 32. The protruding parts 36a, 36b are sized to fit into the recesses 22 present within the first groove. 20 of buffer 12.

[00221] Figures 7(a) to (i) show a view in perspective, bottom, cross-section, side, additional side, in detail, in more detail, further in cross-section and in additional cross-section, respectively, of the base 11 of the lid 10 shown in Figure 3.

[00222] The base 11 is ring-shaped and has a side portion 40 and a radically inwardly extending portion 42 that extends radially inwardly from a lower circumferential edge (in use) of the side portion. 40.

[00223] On the outer surface of the side part 40 there are gripping regions 41 with ridges to facilitate gripping of the base 11, for example in use, for example, to rotate the base 11.

[00224] The base 11 is sized so that the plug 12 can fit inside it exactly.

[00225] On the upper or inner surface of the radically inwardly extending part 42 there is a circumferential groove 45 formed by the inner surface of the side part 40 and a circular ridge 45a extending upwardly from the inner circumference of the extends inwardly 42. The ridge 45a is sized to fit into the radially outward groove 26 of the plug 12 when the lid 10 is assembled.

[00226] At three equally circumferentially spaced positions along the circumferential groove 45 there are three straight grooves 43 that are slightly deeper than the circumferential groove 45. Above the center point of each of these straight grooves 43, and which extending from the inner surface of the side portion 40, there are three circular guide projections 44. These circular guide projections 44 are sized to fit into, and slide along, the groove 24 of the plug.

[00227] These circular guide projections 44 are provided on the short flexible arms and, as the base 11 or plug 12 is rotated, the guide projections 44 are arranged to run over the ridges 24c provided in the grooves 24, as described above. As the guide projections move over the ridges 24c, this produces a slight breaking action for (or frictional force exerted against) the rotation between the plug 12 and the base 11, this provides a good, solid "quality" feel. " for a lid user. At the two rotating end positions, i.e., when the guide projections 44 are at either end of the groove 24, the ridges 24c disappear and the breaking action also disappears, thereby creating distinct end positions, with the frictional force provided by the crest 24c, which means that the plug 12 and the base 11 do not unintentionally rotate relative to each other.

[00228] In the radically inwardly extending part 42 below each circular guide projection 44, there is a rectangular hole 47. These holes 47 are not related to the function of the cover 10, but are present due to the injection molding process used to produce the lid 10. These holes 47 are required for the movable anvils in the injection molding tool to create the circular guide projections 44 described above.

[00229] At either end of each straight groove 43, on a radially inner side, there is a resilient tongue 49 that can act as a weak spring.

[00230] A recess 46 is provided in the side part 40 above one of the circular guide projections 44. The recess 46 is sized so that the slide 13 can be slid therethrough.

[00231] Figures 8(a) and (b) show side and end views, respectively, of the pins 15 of the cover 10 shown in Figure 3. The pins 15 are straight with a circular cross-section and curved ends. Three pins 14 are provided for each cover 10 and they are sized to fit into the three straight slots 43 of the base 11.

[00232] Figures 9(a) to (c) show a top, cross-section, side view, respectively, of the sealing ring 14 of the lid 10 shown in Figure 3. The sealing ring 14 is circular and sized so as to fit into the radially internal groove 25 of the plug 12. The ring 14 has a flat side 14b and a curved side 14c. Two small projections 14a are provided opposite each other on the sealing ring 14 and extend perpendicularly from the flat side 14b of the ring 14. The small projections 14a serve no purpose once the cover 10 is assembled, but merely serve to identify the flat side 14b of the ring 14 more clearly so that it can be inserted into the internal groove 25 of the plug 12 in the correct orientation.

[00233] Before the lid 10 is assembled from its component parts 11, 12, 13, 14, 15 and then packaged, it is cleaned and disinfected. The cleaning process includes ultrasonic cleaning-disinfection with 70% ethanol for 3 to 5 minutes. Thereafter, and before assembly and packaging, all parts 11, 12, 13, 14, 15 are dried by heat (maximum 70°C) or in ambient air in a protected area to prevent condensation upon packaging. Cleaning is carried out in a clean, controlled environment in combination with assembly and packaging in sealable bags.

[00234] When the lids 10 are produced in volume, the lid parts 11, 12, 13, 14, 15 will be molded in a clean room environment directly. This means that no cleaning (as described above) will be required before (or after) assembly.

[00235] The assembly process for cover 10 will now be described.

[00236] Figures 10(a) to (c) show steps for inserting the three pins 15 into the base 11 for mounting the cover 10.

[00237] First, as shown in Figure 10(a), the base 11 is placed with its radically inwardly extending part 42 located at the bottom. A pin 15 is then placed in each of the three straight slots 43, as shown in Figure 10(b). The final configuration of the base 11 and pins 15 after performing these steps in Figure 10(c).

[00238] Figures 11(a) to (e) show steps for inserting the sealing ring 14 into the plug 12 for assembling the lid 10.

[00239] First, the plug 12 (as shown in Figure 11(a)) is placed with its radially internal groove 25 facing upwards, as shown in Figure 11(b). The sealing ring 14 is then placed in the radially inner groove 25 with its flat side 14b facing downward into the groove 25, and its curved side 14c facing upward out of the groove 25, as shown in Figures 11(c). and (d). The final configuration of plug 12 and sealing ring 14 after performing these steps in Figure 11(e).

[00240] In an alternative embodiment, the plug 12 and sealing ring 14 are formed together using a two-step injection molding process (which first forms the plug 12 and then the sealing ring 14 in buffer 12) so that the method shown in Figures 11(a) to (e) is not necessary.

[00241] Figures 12(a) to (c) show steps for inserting the slide 13 into the plug 12 for assembling the lid 10.

[00242] First, as shown in Figure 12(a), the plug 12 is placed with its upper surface 28a facing upwards and the slide 13 is placed with its upper surface 37 facing upwards. The end 38a of the slide 13 is then slid into the first slot 20 of the plug 12 along the axis L. The slide 13 is slid into the first slot 20 at the end of the first slot 20 into which the second slot 21 extends. to the right to the circumferential edge of the plug 12. As the slide 13 is slid into the first groove 20, the protruding parts 36a, 36b of the slide 13 slide through the recesses 22 along either side of the groove 20.

[00243] As the slide 13 is slid through the first groove 20, resistance is felt as the curved protrusion 31 under the slide 13 meets the protrusions 23b and then 23a in the second groove 21 of the plug 12. Some Additional force is therefore required to cause the curved projection 31 to pass over the projections 23b and then 23a into the second groove 21.

[00244] After the projection 31 on the slide 13 has passed over the projection 23a in the second groove 21, the ends of the parallel ridges 30a, 30b rest against the closed end 21a of the second groove 21 and the slide 13 can no longer be slid through. of the plug 12. The ridges 30a, 30b and the ends 21a of the second groove 21 are positioned so that at that point, i.e. when the parallel ridges 30a, 30b rest against the closed end 21a of the second groove 21, the groove curve 32 on the top side of slide 13 extends around the outer circumference of plug 12, as shown in Figures 12(b) and (c). The slide 13 must be slid into position, i.e. where the ends of the parallel ridges 30a, 30b rest against the closed end 21a of the second groove 21 and the curved groove 32 on the upper side of the slide 13 extends around of the outer circumference of the cap 12 before the additional cap 10 assembly steps described below are performed.

[00245] Figure 13 shows how to insert the assembled plug 12 (i.e., with the slide 13 and the sealing ring 14 inserted therein) into the assembled base 11 (i.e., with the pins 15 inserted therein).

[00246] The assembled plug 12 is positioned with its upper surface 28a facing upwards and the assembled base 11 is positioned, for example, on a level surface, with its radically inwardly extending part 42 located at the bottom and facing down. The plug 12 is positioned so that the upwardly extending portions 24a of the grooves 24 in the plug 12 are each located directly above a circular guide projection 44 in the base 11. The assembled plug 12 (with slide 13) is additionally positioned so that the slide 13 slightly overlaps the recess 46 in the side part 40 of the base 11.

[00247] The assembled plug 12 and the assembled base 11 are then pressed or press-fit together by pressing the plug 12 into the base 11 so that the circular guide projections 44 on the base 11 pass over the ridges 24d on the top end of each upwardly extending portion 24a, and for the circumferentially extending portions 24b.

[00248] As the assembled plug 12 (i.e., which includes the slide 13) has been positioned so that the slide 13 slightly overlaps the recess 46 in the side part 40 of the base 11, the top edge part 48 of the base 11 is fitted into the curved groove 32 on the upper side of the slide 13.

[00249] Figure 14 shows a perspective view of a lid 10 comprising the base 11, the plug 12 and the slide 13 (as well as the pins 15 and the sealing ring 14, which are not visible) after the associated steps to Figure 13 described above.

[00250] Figures 15(a) to (d) show the steps to complete the lid 10 assembly process after the steps in Figure 13 described above.

[00251] First, the plug 12 and the slide 13 are rotated clockwise relative to the base 11, when viewed from above, pushing the slide 13 along path P, as shown in Figure 15(a). By pushing the slide 13, the plug 12 is rotated as far as possible, that is, until the circular guide projections 44 reach the upper ends of the circumferentially extending parts 24b of the grooves 24 (opposite the ends at which the parts circumferentially extending parts 24b encounter the upwardly extending parts 24a) and are then prevented from moving further.

[00252] As the plug 12 is rotated in this way, it is also dragged further down towards the base 11 due to the slope of the circumferentially extending parts 24b on the plug 12.

[00253] When the plug 12 has been rotated as far as possible, that is, when the circular guide projections 44 reach the upper ends, the circumferentially extending parts 24b of the grooves 24, the slide 13 is located within the recess 46 of the base 11, as shown in Figure 15(b).

[00254] Then, as shown in Figure 15(c), the slide 13 is pushed inwards, along arrow A through the recess 46 and the first groove 20, until it is prevented from moving further by supporting it. against the side part 40 of the base 11. At this point, the slide 13 is positioned across the entire diameter of the cover 10, within the first groove 20, as shown in Figure 15(d). The longitudinal length of the slide 13 is equal to the external diameter of the base 11 so that, at this point, the slide 13 does not protrude in any way outside the base 11.

[00255] Figure 16 is a flow diagram showing the steps for assembling the cover 10 from its component parts 11, 12, 13, 14, 15.

[00256] In step 50, pins 15 are inserted into base 11, as shown in Figures 10(a) to (c) and described above.

[00257] In step 51, the sealing ring 14 is inserted into the plug 12, as shown in Figures 11(a) to (e) and described above. In an alternative embodiment, where the plug 12 and the sealing ring 14 are/were formed together (e.g., in a two-step injection molding process as described above), this step 51 is not necessary.

[00258] In step 52, slide 13 is inserted into plug 12, as shown in Figures 12(a) to (c) and described above.

[00259] In Figure 16, step 51 is performed before step 52, but in other embodiments, step 52 is performed before step 51, and in still other embodiments, steps 51 and 52 are performed in parallel.

[00260] In Figure 16, step 50 is performed in parallel with steps 51 and 52, but in other embodiments, steps 50, 51, and 52 are performed in series in any order, e.g., 50, then 51, then, 52; or 51, then 52, then 50. The other sequences of these steps would be possible.

[00261] After steps 50-52 have been carried out (in any order, and in series or in parallel), step 53 is carried out in which the plug 12 (with the slide 13 and the sealing ring 14) is inserted into the base 11 (with pins 15), as shown in Figures 13 and 14 and described above.

[00262] Then, in step 54, the plug 12 is rotated relative to the base 11, as shown in Figures 15(a) and (b) and described above.

[00263] Finally, in step 55, slide 13 is slid into groove 20 in plug 12, as shown in Figures 15(c) and (d) and described above, and is ready for packaging, use and storage.

[00264] Once the cap 10 has been assembled in this way, it can be provided to a patient for fitting to an implant 1.

[00265] Figures 17(a) to (d) show steps for fitting the cap 10 to an implant 1.

[00266] Starting from a cap 10 with the slide 13 slid through the plug 12, before the cap 10 can be fitted to an implant 1, the slide 13 must be slid out along the groove 30 in the plug 12. The plug 12 should then be rotated counterclockwise relative to the base 11 when viewed from above (or vice versa), so that the plug 12 rises out of the base 11 slightly, and the slide 13 is only slightly overlapping the recess 46. The cap 10 is then ready to be fitted to an implant 1.

[00267] As shown in Figure 17(a) a user retains the projecting end of the slide 13 and places the cap 10 over the outer section 4 of the implant 1.

[00268] Slide 13 is then used to hold plug 12 stationary while base 11 is rotated in a counterclockwise direction relative to plug 12 when viewed from above, as shown by the arrow in Figure 17(b ) (alternatively, the slide 13 could be used to rotate the plug 12 in a clockwise direction relative to the base 11 when viewed from above, while the base 11 is held stationary) until the slide 13 is positioned completely in the recess 46 from base 11.

[00269] As the base 11 is rotated counterclockwise relative to the plug 12 (or vice versa), the plug 12 is dragged downward onto the base 11 by virtue of the circular guide projections 44 that are slid along the along the circumferentially extending parts 24b that slope upward from the grooves 24 around the plug 12.

[00270] As the plug 12 is dragged down into the base 11 in this manner, the side portion 29 of the plug 12 moves down into the circumferential groove 45 within the base 11, thereby forcing the three pins 15 located in the three straight grooves 43 around the circumferential groove 45 radially inwards against the resilient tabs 49 and slightly upwards towards the groove 6 around the outer circumference of the outer section 4 of the implant 1. This engagement of the pins 15 against the upper surface internal groove 6 of the implant 1 secures and retains a cover 10 on the implant 1 and prevents users from being able to simply move or pull the cover 10 right on the implant 1, with or without intention.

[00271] Furthermore, as the plug 12 is dragged down to the base 11, the sealing ring 14 on the top side of the plug 12 is compressed against the upper surface of the outer section 4 of the implant 1, thereby forming , a leak-proof seal between the implant 1 and the cap 10.

[00272] Once the lid 10 has been secured and sealed in this way, the slide 13 is slid back through the rest of the lid 10, through the groove 20, as shown in Figure 17(c), so that it no longer protrudes. radially outwards from the rest of the lid 10, as shown in Figure 17(d).

[00273] In order to remove a cap 10 from an implant 1, the reverse procedure is performed, as shown in Figures 18(a) to (d).

[00274] Lid 10 begins with slide 13 in a "slid" position relative to the rest of lid 10, as shown in Figure 18(a). Slide 13 is then pulled out through groove 20 in plug 12, as shown in Figure 18(b). When fully dragged out, the slide 13 is then used to hold the plug 12 stationary while the base 11 is rotated in a clockwise direction relative to the plug 12 (or, alternatively, the base 11 is held stationary and the slide 11 is used to rotate the plug 12 in a counterclockwise direction relative to the base 11). This rotation causes the plug 12 to move upward and slightly away from the base 11 so that the side 29 no longer forces or holds the pins 15 in the groove 6 around the implant 1 and the resilient tabs 49 cause the pins 15 are retracted from the groove 6. Furthermore, the sealing ring 14 is no longer compressed against the upper surface of the outer section 4 of the implant 1.

[00275] The user can then lift the cover 10 of the implant 1 with little or no resistance.

[00276] After removing the cover 10, thus, from an implant 1, it must be washed, as shown in Figure 18(e).

[00277] Figure 19 shows a perspective view of an implant 1' (not implanted in a patient) fitted with a cap 10.

[00278] Cap 10 is reusable, but has a limited life. It can be used by a patient for up to two weeks before a new cap 10 must be used.

[00279] Cap 10 is sized to fit an implant with an outer diameter that corresponds to an inner diameter of cap 10. However, cap 10 can be fitted to implants 1, 1' with divergent axial lengths and/or internal structures many different.

[00280] The slide 13, the plug 12 and the base 11 are all produced from plastic through injection molding.

[00281] Pins 15 are produced from stainless steel.

[00282] In an alternative embodiment, the pins 15 are produced from plastic. This can ensure that the pins 15 wear out well before the edge of the groove 6 in the implant 1, 1 over which the pins 15 move.

[00283] Sealing ring 14 is produced from a soft medical grade polymer.

[00284] Each lid 10 is provided to a user in a disinfected state in an individual semi-sealed bag (that is, the bags are perforated along one side to be easy to tear open. However, the lid 10 does not need to be sterile .

[00285] The cover 10 (except pins 15 and sealing ring 14) is flesh-colored and intended to be inconspicuous.

[00286] Cap 10 is designed so that one cap size can fit different implant sizes. For example, implants can be provided with different internal diameters (i.e. the diameter of the opening through the implant), e.g. optimized for different sizes (thicknesses/diameters) of the ileum. However, as the implants (particularly their outer sections) have the same outer diameter, the same cap 10 can fit implants with different inner diameters.

[00287] The sealing ring 14 is located sufficiently close to the outer diameter of the cap 10 so that the cap 10 can fit implants even with a relatively large inner diameter (and, consequently, a relatively thin outer section top surface against which the sealing ring 14 can be compressed).

[00288] Cap 10 can also fit implants with different axial lengths, as long as the outer diameter of the outer section of the implant is the same.

[00289] The fact that the same cap 10 can fit implants of different sizes is advantageous due to the fact that there is no need to produce caps of different sizes for implants with different internal diameters and/or axial lengths. This makes manufacturing simpler, saves time and costs, and is safer (there is no way to put a 10 cap of the wrong size on an implant).

Claims (12)

1. Cap (10) for a medical implant (1), characterized in that it comprises: a seal (14) and compression means, wherein the compression means are arranged so that when the cap (10) is placed over an implant, activation or use of the compression means at least causes the seal (14) to move downward toward the implant (1) so that the seal (14) is compressed against the implant. 2. Lid (10), according to claim 1, characterized in that the seal (14) is provided on an underside of the lid (10). 3. Cap (10), according to claim 1 or 2, characterized by the fact that it additionally comprises coupling means for engaging the cap (10) with an implant. 4. Cap (10), according to claim 3, characterized by the fact that the compression means are additionally arranged so that, when the cap (10) is placed over an implant (1), activation or use of the compression means also cause the engagement means (15) to engage with the implant (1). 5. Lid (10), according to claim 3 or 4, characterized by the fact that the coupling means comprise one or more fixed parts and one or more movable parts. 6. Cap (10) according to claim 5, characterized in that the one or more fixed parts comprise a fixed edge, ridge or other protuberance provided on the cap (10) to engage with a corresponding groove or indentation on the implant (1) or vice versa. 7. Lid (10), according to claim 6, characterized by the fact that the edge, ridge or other protuberance is provided on or around a lower inner edge of the lid (10). 8. Lid (10), according to claim 6 or 7, characterized by the fact that the edge, ridge or protuberance covers half or less than half of an internal circumference of the lid (10). 9. Lid (10), according to any one of claims 5 to 8, characterized in that the one or more movable parts comprise one or more levers, pins, hooks or other movable engagement means. 10. Lid (10), according to any one of claims 5 to 9, characterized by the fact that the one or more moving parts are distributed, preferably uniformly, along the circumference of the lid (10) that has not been covered by one or more fixed parts. 11. Lid (10), according to any one of the preceding claims, characterized by the fact that the compression means comprise a rotation means, a pressure button provided on the lid (10), and/or one or more protruding parts , levers or buttons. 12. Implant (1) with a cap (10), characterized in that the cap is as defined in any of the preceding claims, in which the implant is fixed thereto.