build

Abstract

A cap (10) for a medical implant (1) and comprising a first part (12), a second part (11) and an engagement means (15). The second part (11) is rotatable relative to the first part (12), such that, in use, rotation of the second part (11) relative to the first part (12) causes the engagement means (15) to engage with the implant (1) and attach the cap (10) to the implant (1).

Description

[0001] Division Application Description

[0002] This application is a divisional application of the PCT patent application with an international filing date of June 15, 2017, an entry date into the Chinese national phase of December 5, 2018, a national application number of 201780034958.4, and an invention title of "Cover". Technical Field

[0003] The present invention relates to a cover or a closing device. Specifically, the present invention relates to a cover or a closing device for a medical implant (more specifically, a stoma implant). Background Art

[0004] Ileostomy and colostomy are common surgeries that may be required, for example, for malignant tumors or chronic intestinal inflammation. If the colon and rectum are removed, the surgery is called ileostomy, and if only the rectum is removed, the surgery is called colostomy. Similarly, when the bladder must be removed due to, for example, bladder cancer, an abdominal artificial urethral orifice is created. In these procedures, a stoma is formed in the abdominal wall to which the intestinal segment is connected.

[0005] Stoma is a general term for any such procedure that creates a stoma.

[0006] In most cases, the stoma must be connected to a bag to collect body excreta. However, instead of a conventional ileostomy, a reservoir called a "Kock pouch" can be made from the distal part of the ileum. The pouch is formed in such a way that a connection valve is created, where the connection valve is used to close the reservoir while allowing the reservoir to be emptied intermittently through a catheter. This is an example of so-called continent ileostomy (CI), and was previously an attractive alternative to a conventional ileostomy, but is now rarely used. Today, the complexity of the procedure and the higher likelihood of complications (most of which are related to the malfunction of the continent connection valve) have prevented many surgeons from adopting this surgery.

[0007] Today, ileal pouch anal anastomosis (IPAA) is the gold standard worldwide for these patients, but like CI, this surgery also has risks and failures are common, mostly resulting in pouch excision with intestinal loss. Conversion of a failed IPAA to CI would be a preferred option, but again, surgeons are reluctant to perform this complex and unreliable technique. Similarly, conversion of a malfunctioning orthotopic neobladder or Bricker ureterostomy would be desirable.

[0008] For example, it is known to provide implants to facilitate the connection of a stoma to a cover or a bag.

[0009] For example, as Figure 1 and Figure 2As illustrated, the applicant's earlier application WO 2014 / 140344 A1 discloses a percutaneous ostomy implant 1 comprising a tubular inner section 2 formed mainly of a mesh and a circular radially extending anchoring flange or dermal anchor 3 .

[0010] The implant 1 is designed to be implanted through the abdominal wall of the patient and receive the intestinal segment pulled through it. The serosal tissue from the intestinal segment can then grow into the implant 1, pass through the mesh, and be attached or grow into the surrounding dermal tissue. This can provide a tight, stable, leakproof and well vascularized tissue-implant joint.

[0011] The tubular inner section 2 is attached to an outer section 4 which protrudes 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 allows a cover, bag or other device (not shown) to be attached to the implant 1 .

[0012] Once the implant has been implanted in the patient, it is necessary to close the implant in some way, or sealingly connect it to some form of drainage means (e.g., a bag or catheter) to prevent excreta from leaking out of the stoma and to allow excreta 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.

[0013] The applicant's earlier application WO 2006 / 046210 A1 discloses a removable cover for an implant, in which mounting means (e.g. grooves or ridges) are arranged so that the removable cover can be mounted on and removed from the outer end of the implant by sliding the cover in a direction perpendicular to the longitudinal axis of the implant.

[0014] However, the problem with this method of mounting the cap on the implant is that it may result in forces being applied to the implant, which may damage the tissue-implant interface. It may also be difficult for the patient to mount the cap in this manner.

[0015] Another problem is that with this sliding attachment method, it may be difficult for the cap to seal properly (ie, in a leak-proof manner) with the implant.

[0016] WO 2006 / 046210 A1 also discloses a connector for connecting an ostomy bag to an implant. The connector is arranged to slide a cover off the implant and connect the bag to the implant.

[0017] In the recent application WO 2011 / 039517 A1 of the present applicant, a medical closure device is disclosed, comprising a coupling portion and a closure portion (e.g., a cover or cap). The coupling portion can be attached to a medical device such as an implant, and the closure portion can then be attached to the coupling portion to close the implant. The coupling portion is a circumferential flexible member that limits a coupling opening, and can be constructed between a loose configuration and a stressed configuration, wherein in the loose configuration, the coupling opening cannot pass over the medical device, and in the stressed configuration, the coupling opening of the coupling portion can pass over the medical device. Therefore, if the coupling portion is squeezed, the coupling portion will be deformed from its loose configuration to a stressed configuration, wherein in the stressed configuration, the coupling portion can pass over the end of the implant. When the pressure is released (i.e., stop squeezing), the coupling portion will attempt to return to the loose configuration, therefore clamping the end of the implant. Reverse procedures can be performed to remove the coupling portion.

[0018] However, a problem with this attachment mechanism is that the coupling part may inadvertently or accidentally detach from the implant if pressure is applied to the coupling part, for example by resting against an object, causing the coupling part to be squeezed into its force-bearing configuration and thus detachable from the implant.

[0019] The closure device of WO 2011 / 039517 A1 is also relatively wide and, when attached to the implant, extends down close to the patient's skin, so that there is a risk of abrasions and irritation.

[0020] Attaching the closure portion to the coupling portion requires two hands, which can be problematic for the user. Also, because the closure comprises two separate parts (coupling portion and closure portion), there is a greater chance that one part could be lost or dropped compared to a closure made of a single part. Disposal can also be less convenient.

[0021] In addition, it is possible for this closure device to be attached to the implant (locked) in an incorrect position so that it is not properly seated and sealed on the implant. For example, typically the user cannot see the cap-implant interface (e.g., due to clothing or stomach getting in the way), and therefore they may attach or lock the closure device to the implant in an incorrect position. Summary of the invention

[0022] According to a first aspect of the present invention, there is provided a cover for a medical implant, the cover comprising a first part, a second part and an engagement means, wherein the second part is rotatable relative to the first part (or the first part is rotatable relative to the second part), such that in use, rotation of the second part relative to the first part (or vice versa) causes the engagement means to engage with the implant and attach the cover to the implant.

[0023] Therefore, according to the present invention, the second part of cover can rotate relative to the first part (or vice versa), to cause the cover to engage with the implant and be attached to the implant. Therefore, a part of cover (for example, the first part) can remain fixed relative to the implant while the cover is being attached to the implant. This can reduce or eliminate any force applied to the implant during attachment, so helping to reduce or eliminate the potential damage to the implant-tissue interface. In addition, the cover with this attachment mechanism provides a relatively easy and easy way for the user to attach the cover to the implant, and the accidental removal of the cover can be minimized or prevented.

[0024] Because the cover can be attached to or detached from the implant by rotation of one portion of the cover, the cover can be attached with one hand. This, of course, has the benefit that the other hand can be used to hold other items that may be needed, for example, after the cover has been removed (e.g., for drainage / cleaning). (Alternatively, of course, two hands may be used.)

[0025] Furthermore, because the cover can be attached to or detached from the implant by rotation of one portion of the cover, users with arthritis, weak hands, or small hands, for example, may be able to perform this procedure.

[0026] A medical implant that can be used with the cover can be, for example, an ostomy implant, and the present invention is indeed particularly suitable for this purpose. However, the cover is not limited to use with ostomy implants, but is indeed used with any other kind of medical implant, and can be used for any medical implant, or indeed covers any other structure suitable therein or on top, such as to provide such an attachment structure for the cover. Examples of medical implants that this cover can be used with can, for example, include (but are not limited to) colostomy implants, urethrostomy implants, and gastrostomy implants. Yet another example of a medical system with an implant that this cover can be used with is an enteral feeding system (e.g., nutrition is delivered directly to the stomach through a permanent percutaneous catheter).

[0027] When attached to the implant, the cover (in particular the engagement means) is preferably strong enough and tight enough that it can withstand overpressure in the patient (eg due to accumulation of gas).

[0028] The simple mechanism described above means that the cover can 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. Providing such a thin cover means that in use, the cover is less likely to get stuck on other objects that a user may come into contact with, such as tables, clothing, door frames, belts, etc.

[0029] The cover may have a smooth, rounded top or outer surface that curves downward to a point that will contact the user's skin. In this way, the cover will not have corners or protrusions that may get caught on other objects.

[0030] The first part, the second part and the engagement means are preferably arranged so that in use, the rotation of the second part relative to the first part (or vice versa) causes the first part to be pressed against the engagement means. This arrangement can provide a simple mechanism by which the rotation of the second (or first) part causes the engagement of the engagement means with the implant.

[0031] The engagement means may be or include any form of engagement mechanism or engager.

[0032] The engagement means is preferably located in the second part.The engagement means may be part of the second part, alternatively the engagement means may be a separate component, for example provided in the second part.

[0033] The engagement means can be, for example, any kind of engagement portion suitable for engagement with the implant, or include the engagement portion. For example, the engagement means can include one or more protruding engagement means or projections (e.g., projections, ridges, bumps, pins, hooks) that can be arranged and / or dimensioned to fit in a corresponding receiving portion (e.g., groove, slot, hole or recess) disposed on the implant.

[0034] Alternatively or in addition, the engagement means may comprise, for example, one or more recesses or cavities (e.g., grooves, slots, holes) disposed within the second portion, which grooves or cavities may be arranged and / or dimensioned to receive or engage a protruding engagement means or protrusion (e.g., a bump, ridge, nub, pin or hook) disposed on the implant.

[0035] Preferably the engagement means comprises one or more components separate from (not integrally formed with) the second part, and is preferably contained within the second part but is movable relative to the second part, for example at least to some extent.

[0036] Alternatively, the engaging means may comprise one or more fixed or integral engaging components (e.g. fixed to or integrally formed with the second part), such as a protrusion (e.g. a bump, ridge, lug, pin or hook) or a receiving portion (e.g. a groove, slot, hole or recess).

[0037] The engagement means is preferably arranged such that when the second part is rotated relative to the first part (or vice versa), the engagement means protrudes into an engagement recess or cavity provided on the implant.

[0038] Alternatively, the engagement means may be arranged such that when the second part is rotated relative to the first part (or vice versa), the engagement means protrudes over, around or through an engagement projection provided on the implant.

[0039] In a preferred embodiment, the engagement means comprises one or more (preferably, three) pins. When more than one pin is provided, two or more pins may be arranged at preferably equal intervals around the second portion so that the two or more pins may engage with the implant around the periphery of the implant.

[0040] Preferably, the one or more pins are arranged such that the longitudinal sides of the one or more pins will engage with the implant. However, in alternative embodiments, the one or more pins may be arranged such that the end of each of the one or more pins will engage with the implant.

[0041] The pin is preferably supported by the second part, and is preferably movable relative to the second part at least to some extent.

[0042] The pins are preferably straight, for example having a circular cross-section and preferably rounded ends.

[0043] Preferably, the first part, the second part and the engagement means are arranged such that as the second part rotates relative to the first part (or vice versa), the first part also moves further into or onto the second part.

[0044] Preferably, the first part, the second part and the engagement means are further arranged such that as the first part moves further into or onto the second part, the first part exerts a force on the engagement means, pushing or pressing against the engagement means so that the engagement means can engage with the implant.

[0045] Thus, by rotating the second (or first) part, the engagement means may engage with the implant.

[0046] In addition, preferably, the first part, the second part and the engagement means are arranged so that as the first part moves further into or on the second part and the first part applies force, pushes or presses against the engagement means, the engagement means engages with the implant by moving radially inwards and / or (then) upwards, preferably radially inwards and upwards, toward the implant. By moving the engagement means radially inwards and then upwards into the implant (e.g., in a groove in the implant), a tighter engagement with the implant can be provided.

[0047] Furthermore, as the engagement means is forced upward into the implant, the seal of the first portion and preferably disposed on the cover (e.g., on the first portion) can be pulled downward onto the implant, thereby compressing the seal. This can create a strong and secure seal between the implant and the cover, which can ideally withstand pressure from intestinal fluids, for example.

[0048] In a preferred embodiment, the first portion is a cap. For example, the first portion (or cap) may be substantially circular.

[0049] The cap may be formed from a circular top portion and annular side portions.

[0050] The cap (and preferably the top portion thereof) may comprise one or more grooves.

[0051] For example, the cap may comprise a first groove, preferably extending from one side of the top portion, preferably across the centre of the top portion, to an opposite side of the top portion.The recess may be provided along one or both sides of the groove.

[0052] The cap may include, for example, a second groove disposed in the base of the first groove. Otherwise, the base of the first groove may be flat. The second groove is preferably narrower than the first groove and preferably extends from one side of the top portion (e.g., the side where the first groove begins) preferably across the center of the top portion and preferably almost (but not) to the opposite side of the top portion. The center lines of the first groove and the second groove are preferably co-linear.

[0053] At the base of the second groove, and preferably spaced apart along its centerline, one or more (preferably two) upwardly protruding bumps may be provided. The one or more bumps preferably do not protrude higher than the depth of the second groove so that they do not protrude upwardly into the first groove.

[0054] The side portions of the cap protrude downwardly from the peripheral edge of the top portion.

[0055] In the cap and preferably on the outer surface of the side portion, one or more (preferably three) preferably identical and preferably equally circumferentially spaced grooves or recesses may be provided. Each groove or recess may include an upwardly extending portion or a circumferentially extending portion, and preferably both the upwardly extending portion and the circumferentially extending portion. The upwardly extending portion may extend upwardly from the bottom of the side portion toward the top portion (but not as far as the top portion). The groove may then continue circumferentially around the side portion from the top of the upwardly extending portion in the circumferentially extending portion. Preferably, each groove does not extend as far as the next groove around the side portion, so that a gap without any grooves exists between the grooves.

[0056] The upwardly extending portion of each groove may be shallower than the circumferentially extending portion. Thus, there may be a small "downward" step (or radially inward relative to the cap) from the upwardly extending portion to the circumferentially extending portion, which may start just above the circumferentially extending portion.

[0057] Additionally or alternatively, there is preferably a (relatively small) ridge or bump provided along or at the top end of the upwardly extending portion, preceding the circumferentially extending portion.

[0058] In the circumferentially extending portion of each groove, preferably along most but not the entire length of the centre line of the circumferentially extending portion, there may be a (relatively thin) ridge. The ridge preferably does not extend as far as either end of the circumferentially extending portion.

[0059] Preferably, each circumferentially extending portion may extend slightly upwardly as it extends around the side portion, such that each circumferentially extending portion preferably slopes upwardly around the side portion.

[0060] Preferably, on the underside of the top portion and for example inside the side portion, there is a radially inner groove and / or a radially outer groove. The radially outer groove may be defined or formed by the radially inner surface of the side portion and the first circular wall. The radially inner groove may be defined or formed by the first circular wall and the second circular wall.

[0061] Preferably, the second part is a base, which is preferably substantially annular, eg having a substantially circular opening in the centre of the base.

[0062] For example, the base may include a side portion and, for example, a radially inwardly extending portion, wherein the radially inwardly extending portion may extend radially inwardly from a lower (in use) peripheral edge of the side portion. The radially inwardly extending portion may, for example, form or include a substantially circular opening of the base at its center.

[0063] On the outer surface of the side portion or the base, there is preferably a gripping area with ridges that facilitate gripping of the base (eg for rotation and / or when placing it on an implant).

[0064] Preferably, the base has a rounded or curved bottom, e.g. where the side portions join the radially inwardly extending portions. Alternatively or in addition, the cover (e.g., the base thereof) and / or the implant is sized such that when the cover is attached to the implant, there is a small gap between the patient's skin and the bottom of the cover / base. This means, for example, that there is little or no wear on the patient's skin when sitting or bending.

[0065] The base is preferably dimensioned so that the first part or cap can preferably fit exactly therein. In other words, the inner diameter of the base is preferably equal to the outer diameter of the first part or cap.

[0066] On the upper or inner surface of the base or preferably the radially inwardly extending portion of the base, there is preferably a groove, e.g. a perimeter, wherein the groove may be formed by the inner surface of the side portion and, e.g. a circular ridge extending upwardly from the inner periphery of the e.g. inwardly extending portion. The ridge is preferably sized to fit in the (e.g. radially outer) groove of the first portion or cap when the cover is assembled.

[0067] At one or more (preferably three) preferably equally circumferentially spaced positions along the circumferential groove, there are, for example, one or more grooves or straight grooves, which may be slightly deeper than the circumferential groove. The one or more grooves or straight grooves are preferably arranged and dimensioned so that they can hold, support or contain the engagement means.

[0068] For example, above the center point of each of these recesses or straight grooves and extending from the inner surface of the side portion, for example, there may be one or more (preferably three) preferably circular guide protrusions. The one or more guide protrusions are preferably dimensioned to fit in and slide along a groove provided in the cap or first part.

[0069] Associated with each recess or straight groove, for example, at either end of each straight groove, preferably on the radial inner side, a resilient tongue may be provided, wherein the resilient tongue may, for example, act as a weak spring (for example, against the engagement device in each recess or straight groove).

[0070] The recess is preferably provided in the side portion above one of the guide projections.The recess is preferably dimensioned such that a slide (described below) can fit in or slide through the recess.

[0071] The cover preferably includes means for providing tactile feedback to the user to indicate when the cover is engaged and / or disengaged. For example, the ends of the recesses in the side portions may provide this tactile feedback when parts of the slider or other rotating means (see below) for example abut against them (e.g., following rotation of the slider / base).

[0072] Preferably, the first part snap fits or can snap fit into the second part. This is an easy and secure way of assembling the two parts while still ensuring that the two parts can rotate relative to each other.

[0073] Preferably, the first part and the second part comprise complementary guide means or guide portions, for example to facilitate their relative rotation.

[0074] One portion (eg, the first portion or the second portion) may include a protrusion, and the other portion may include a groove for guiding the protrusion.

[0075] For example, the complementary guiding means may comprise one or more grooves provided on the first part or the second part and one or more complementary protrusions or projections provided on the other of the first part and the second part, whereby one or more protrusions are arranged to extend into the one or more grooves, thereby allowing the first part and the second part to rotate relative to each other.

[0076] Preferably, the first part and the second part are arranged such that as the second part rotates relative to the first part (or vice versa), the first part also moves axially relative to the second part (e.g. by complementary guide means). Thus, as the first part rotates relative to the second part, the first part may move towards or away from the second part, or move into or out of the second part, depending on the direction of rotation.

[0077] The first part may include or have a rotating device (or anvil) connected to the first part to facilitate rotation of the second part relative to the first part (or vice versa). For example, the rotating device may protrude or be able to protrude from the first part to facilitate rotation of the second part (e.g., by holding the first part fixed). Alternatively, the rotating device can be used to facilitate rotation of the first part while the second part remains fixed.

[0078] Although the term "rotating device" is used, it should be understood that the rotating device itself does not necessarily rotate, it can only promote the rotation of another part. Therefore, in the present application, the "rotating device" should be interpreted as a device (or "rotation promoting device") for promoting the rotation of the second part or the first part, which does not necessarily need to rotate itself. In fact, in the preferred form of use, the rotating device remains fixed and acts as a kind of "anvil" or holding device. For example, the rotating device can be used and preferably used to keep the first part fixed, while the second part rotates relative to the first part. However, alternatively, the rotating device can be used to rotate the first part relative to the (fixed) second part.

[0079] The swivel device is preferably retractable between a first position in which the second part can be rotated relative to the first part (or vice versa) (the cover is "unlocked") and a second position in which the second part cannot be rotated relative to the first part (or vice versa) (the cover is "locked"). Thus, when the swivel device is in the second (locked) position, inadvertent rotation of the first part is prevented.

[0080] The rotating means may for example be a slide which is arranged to slide, preferably radially, for example in a groove provided in the first part.

[0081] The swivel means is preferably dimensioned to extend across the diameter of the first portion.

[0082] In a preferred embodiment, the swivel is substantially rectangular, but may have curved ends, for example, to match or correspond to the periphery of the first portion.

[0083] The swivel device preferably has a curved upper surface, wherein for example the curvature of this surface extends along the length of the swivel device.

[0084] On the bottom surface of the swivel and eg towards one end, one or more, preferably two, preferably parallel ridges may be provided, wherein the ridges are eg of equal length and preferably extend along the (relatively short) length of the swivel.

[0085] Additionally or alternatively, the projection is preferably disposed on the bottom surface of the rotating device. For example, the projection may be disposed in the region between two ridges, and the projection may extend before the two ridges. The projection is preferably curved. The ridges preferably extend slightly further along the length of the rotating device than the projection.

[0086] The cover preferably includes means (e.g., tactile and / or audible feedback portions) for providing tactile and / or audible feedback (preferably both) to the user to indicate when the cover is in a locked / unlocked state / position. For example, interaction between one or more bumps, ridges or grooves provided on the rotating means and / or the first part (e.g., in a groove in the first part) may provide this feedback. Preferably, a bump provided under the rotating means and / or one or more ridges and / or one or more upwardly projecting bumps and / or ends of the second groove on the first part are arranged such that interaction therebetween may provide this feedback.

[0087] Preferably, the curved groove is provided on the bottom surface of the rotating device (e.g., about its longitudinal midpoint). The curved groove preferably extends from one edge of the rotating device toward (but preferably not as far as) the opposite edge. The curved groove preferably has a radius of curvature on its inner edge corresponding to the radius of curvature of the outer periphery of the first part or the inner periphery of the top of the second part.

[0088] Preferably on an upper surface of the swivel (eg at one end) a marking or indicia (eg a single or double ended arrow) may be provided which shows, for example, the direction in which the swivel will move or slide in use.

[0089] The swivel may comprise a gripping region with one or more ridges or other gripping means, eg at an end (the other end) of eg its upper surface, for example, to facilitate movement or sliding of the swivel in use.

[0090] Along one edge or preferably both edges of the rotating device, for example from its bottom side, one or more protrusions may be provided. One protrusion may be disconnected or have a gap at one point, for example where it extends over a curved groove provided on the bottom surface of the rotating device. The protrusion is preferably dimensioned to fit into a recess present in a groove provided in the first part.

[0091] As mentioned above, in addition to being provided with the device for rotating the second (or first) part, the rotating device may also be provided with a device (locking device) for locking / unlocking the cover. However, the locking device may also be provided separately from the rotating device and in addition to the rotating device, for example, as an independent part.

[0092] Thus, in some embodiments, the cover may comprise a locking device for locking / unlocking the cover. Preferably, the locking device is movable between a first position, wherein in the first position the first part is rotatable relative to the second part (the cover is "unlocked"), and a second position, wherein the first part is not rotatable relative to the second part (the cover is "locked"). Thus, when the locking device is in the second (locked) position, an inadvertent rotation of the first part may be prevented.

[0093] The locking device may be any kind of locking portion capable of allowing / preventing a rotation of the second part relative to the first part (or vice versa). For example, the locking device may comprise a retractable member (e.g. a pin or a slide) that is movable between a first (e.g. an inserted) position in which a rotation of the second part relative to the first part (or vice versa) is prevented (the cover is locked) and a second (e.g. a retracted) position in which a rotation of the second part relative to the first part (or vice versa) is possible (the cover is unlocked). For example, in its first position, the retractable member may extend, e.g. in an axial direction, through the first part into a hole or recess in the second part, thereby preventing their relative rotation and locking the cover.

[0094] Preferably, the locking means is arranged so that when the cover is positioned on the 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. Thus, the cover is prevented from being locked when the cover is not properly engaged. This can help prevent improper positioning of the cover on the implant, wherein improper positioning can lead to leakage.

[0095] The cover preferably further comprises a seal, for example for providing a sealing engagement with the implant.The seal may be provided in or be part of the first portion.

[0096] For example, the seal may be a sealing ring which is arranged, for example, in a preferably circular groove in the first part.

[0097] Alternatively, the seal (e.g., a sealing ring) may be injection molded into the first part. This may be done by first molding the first part (e.g., in a molding tool) and then removing the insert from the tool so that the sealing material (i.e., the material used to form the seal) can then be molded directly onto the first part (or the first part can be moved into a second chamber in the molding tool and molded such that the sealing material will form the seal when molded in place on the first part).

[0098] The sealing ring is preferably circular and is sized to fit in the radially inner 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 inner groove (i.e., upwards in use). One or more (preferably two) small protrusions may be provided on the sealing ring (e.g., opposite each other) and may, for example, extend vertically from the flat side of the ring.

[0099] Other types of seals may also be used.

[0100] Preferably, as the second part rotates relative to the first part (or vice versa), the seal is movable towards and pressed against a surface of the implant, for example by relative axial movement of the first part.

[0101] Therefore, the cover preferably includes a double locking mechanism, for example, as the second part rotates relative to the first part (or vice versa), the engaging means engages with the implant, and the seal is compressed on the implant. Once engaged and sealed in this way, the cover can preferably be locked in a position where the engaging means cannot be disengaged from the implant and / or the seal cannot be decompressed (for example, by placing a rotating device in a locked position). The cover (for example, the first part) preferably includes one or more visual marks or indicators to, for example, show at what position the cover is in an open / closed / locked / unlocked position.

[0102] The cover may be made of plastic, metal, wood, a combination of materials, a composite material and / or rubber. Preferably, the cover is preferably made of plastic (eg, polypropylene or silicone).

[0103] Preferably, the first and second parts of the cap are made of different materials (e.g., different kinds of plastic). This is because some (e.g., plastic) materials can stick to each other when under pressure. Therefore, in order to minimize the possibility of such friction occurring between the first and second parts, it is preferred that the first and second parts are made of different materials.

[0104] For example, the engagement means may be made of metal (eg, stainless steel), fabric, hardwood, soft metal, or plastic.

[0105] However, preferably the engagement means is made of a material softer than the implant (eg titanium).This can help ensure that the engagement means wears before, for example, the edge of a groove in the implant over which the engagement means moves (or other receiving portion of the engagement means).

[0106] For example, the engagement means may be made of a plastic / polymer and possibly fiber-reinforced material.

[0107] Preferably, for MRI compatibility, the engagement means as well as all parts of the cover are made of non-magnetic material (eg, aluminum, brass).

[0108] The seal is preferably made of a medical grade soft polymer.

[0109] The cover may be cleaned by normal household methods including, for example, one or more of washing, detergent, soap, boiling, bleach, and alcohol.

[0110] The invention also relates to an implant, wherein the implant has a cover as described above or below attached to the implant.

[0111] The invention also relates to a method of manufacturing a cover of a medical implant, for example as described above, the method comprising: providing a first part, a second part and an engagement device; and assembling the first part, the second part and the engagement device to form the cover, so that the first part can rotate relative to the second part, and in use, the rotation of the first part relative to the second part causes the engagement device to engage with the implant and attach the cover to the implant. The first part, the second part and / or the engagement device are preferably as described above.

[0112] The method of manufacturing a cover may include one or more of the following steps:

[0113] providing, inserting or positioning the engagement means in the second portion;

[0114] providing, inserting or positioning a seal, such as described above, in the first portion;

[0115] A rotating device, for example as described above, is arranged, inserted or positioned in the first part.

[0116] These steps may be performed in any order and / or in parallel with each other.

[0117] The method may alternatively further comprise (eg preferably after the above steps) inserting or positioning the first part (eg with the sealing and / or rotating means if provided) in the second part (eg with the engaging means).

[0118] The first part may then be rotated relative to the second part.

[0119] The rotating device may for example be inserted or slid into for example a groove in the first part.

[0120] In a preferred method, the second part is placed so that the radially inwardly extending portion is located at the bottom. Engagement means (e.g., one or more (preferably three) pins) are then preferably placed in the second part, e.g., in each of the (three) preferably straight grooves.

[0121] The first part is preferably placed with the groove (eg, the radially inner groove) facing upwards. The seal is then preferably placed into the groove, for example, with the flat side facing downwards into the groove.

[0122] The first part is preferably placed with, for example, the upper surface facing upwards.The swivel device may be inserted in or connected to the first part, for example by sliding or inserting the swivel device into a groove or recess in the first part.

[0123] As the rotating device slides into the first part, resistance may be felt as, for example, a curved projection (e.g., as described above) disposed under the rotating device meets one or more projections (e.g., as described above) on the first part. Thus, some additional force may be required to cause, for example, the curved projection to pass over the one or more projections on the first part.

[0124] After the rotating device has been inserted into the first part, a bump on the end of one or more ridges on the rotating device (e.g., as described above) may abut the closed end of a groove in the first part (e.g., as described above), and the rotating device may be prevented from being further inserted into or across the first part.

[0125] The one or more ridges and the closed end of the groove are preferably positioned so that at this time, i.e. when the one or more ridges abut the closed end of the groove, the curved groove on the underside of the rotating device (e.g. as described above) is positioned so that it extends around the outer periphery of the first part.

[0126] The rotating device should be moved or slid into this position before carrying out the other steps of assembly of the cover described below, ie as described above.

[0127] The first part of the assembly (eg, having the rotating means and / or the seal as described above) is preferably inserted into or placed around the second part of the assembly (eg, having the engaging means as described above).

[0128] To do so, the assembled first part is preferably positioned with its upper surface facing upwards, and the assembled second part is preferably positioned, for example, in a horizontal plane, with the radially inwardly extending portion (e.g., as described above) located at the bottom or facing downwards. The first part is further preferably positioned so that one or more walls or boundaries of one or more grooves in the first part (e.g., one or more upwardly extending portions of the grooves in the first part) are each located directly above a guide (e.g., a preferably circular guide protrusion provided in the second part, for example, as described above).

[0129] The assembled first part is further preferably positioned so that its engagement means (if provided) slightly overlaps a recess in a side portion of the second part (eg as described above).

[0130] The assembled first part and the assembled second part are preferably pressed or snapped together, for example after the above-mentioned alignment procedure, for example by pressing the first part into or onto the second part, so that, for example, a guide member provided in the second part passes over a ridge provided at, for example, the top end of each upwardly extending part and preferably then enters into the circumferentially extending part.

[0131] With the assembled first part preferably positioned so that the engagement means slightly overlaps the recess in the side portion of the second part, parts of the top edge of the second part may fit into the curved groove on the underside of the engagement means (if provided).

[0132] The assembled first part is then preferably rotated relative to the second part, e.g. clockwise (when viewed from above) (or vice versa), preferably by, e.g. pushing or pulling or otherwise moving the rotating device. By moving the rotating device in this way, the first part is preferably rotated as far as possible, e.g. until the guide in the second part reaches the upper end (e.g. of the circumferentially extending portion) of the groove in the first part (e.g. opposite the end where the circumferentially extending portion meets the upwardly extending portion), and can thus be prevented from moving further.

[0133] As the first part is rotated in this way, the first part is preferably also pulled (further) downwardly into or onto the second part, for example due to the slope of the grooves in the first part.

[0134] When the first part has been rotated as far as possible, for example when the guide in the second part reaches the end of the groove in the first part, the rotation means is preferably located in a recess in a side portion of the second part.

[0135] The rotating device is then preferably pushed inwardly, e.g. through a recess and / or groove in the first part, until, e.g., the rotating device is prevented from further movement, e.g., by abutting against a side portion of the second part. At this point, the rotating device is preferably positioned, e.g., within a groove on the first part, across the (e.g., entire) diameter of the cover.

[0136] In this case, the rotating device is preferably flush with the surrounding area of ​​the first part.

[0137] Additionally or alternatively, the longitudinal length of the swivel device is preferably equal to the outer diameter of the second portion, so that the swivel device does not protrude outwardly from the base.

[0138] This means that the cover provides a relatively smooth and continuous outer surface, which will not, for example, get caught on clothing or other objects that may apply force to it and potentially damage the tissue-implant interface. This also means that the cover is discrete to the user.

[0139] Once the cover has been assembled, for example in the manner described above, the cover may be provided, for example, to a patient or other user to be fitted onto, for example, an implant.

[0140] The invention also relates to a method of attaching a cover of a medical implant, e.g. as described above, to the implant, the cover comprising a first part, a second part and an engagement means, wherein the method comprises placing the cover on the protruding end of the implant and then rotating the second part relative to the first part (or vice versa) so that the engagement means engages with the implant and attaches the cover to the implant. The first part, the second part and / or the engagement means are preferably as described above.

[0141] The method preferably first comprises extending (e.g., sliding) a rotation device (e.g., as described above) from the first portion so that the rotation device can be used to rotate the first portion. For example, starting with a cap having the rotation device inserted in or across the first portion, the rotation device can be extended or slid outwardly, e.g., along a groove in the first portion, before the cap is fitted on the implant.

[0142] The first part can be rotated relative to the second part, for example counterclockwise (when viewed from above), so that the first part is preferably slightly raised from the second part. In this case, the rotating device can, for example, overlap only slightly (or not at all) with a recess in the second part (for example, as described above).

[0143] The cover may then be ready to fit onto the implant.

[0144] The user preferably holds the protruding end of the rotation device and can place the cover over the outer section of the implant.

[0145] The second part is then preferably rotated, e.g. in a counterclockwise direction (when viewed from above) relative to the first part, e.g. by pushing / pulling / moving the rotating means, until, e.g., the rotating means is fully positioned in a recess in the second part (e.g. as described above).

[0146] As the second part rotates relative to the first part (or vice versa), the first part is preferably pulled downward into or onto the second part, for example by one or more guides in the second part (e.g., as described above), wherein the guides slide along, for example, grooves in the first part (e.g., as described above).

[0147] As the first portion is pulled downwardly into or onto the second portion in this manner, the side portions of the first portion preferably move downwardly (eg, into grooves in the second portion) and force the engagement means into engagement with the implant.

[0148] The second part preferably comprises one or more resilient tongues, wherein the resilient tongues are arranged to press against the engagement means.

[0149] Preferably, the engaging device can be forced radially inward, for example as the first part moves downward into the second part or onto the second part through a portion of the first part, preferably against one or more resilient tongues, and preferably slightly upward into a groove or other recess in the implant (for example, a groove around the outer periphery of an outer section of the implant).

[0150] Such engagement of the engagement means with the implant may secure and hold the cover to the implant and, for example, prevent a user, clothing or other object from being able to simply move or pull the cover straight off the implant (eg, inadvertently).

[0151] In addition, as the first part is pulled downward into or onto the second part, a seal, for example, disposed on the underside of the first part (e.g., as described above) can be compressed against the implant, for example, on the upper surface of an outer section of the implant, thereby forming a leak-proof seal between the implant and the cover.

[0152] Once the cover has been attached to the implant, the rotating device preferably slides or moves back to its unextended position, e.g., across the cover back, e.g., through the groove in the first part and into the groove. Thus, once the cover has been attached to the implant, the rotating device can be retracted so that it no longer protrudes from the cover.

[0153] The invention also relates to a method for removing a cover of a medical implant, such as described above, from an implant, the cover comprising a first part, a second part and an engagement device, wherein the method comprises: rotating the second part relative to the first part (or vice versa) so that the engagement device is disengaged from the implant, and then removing the cover from the implant. The first part, the second part and / or the engagement device are preferably as described above.

[0154] To remove the cap from the implant, the reverse procedure of that described above may be performed.

[0155] For example, cover can start from the rotating device being in the retracted or unstretched position relative to the remainder of cover.The rotating device can then stretch, for example, pull outward, for example, through the groove in the first part.When stretching, for example, the rotating device can be used for rotating the second part relative to the second part (or vice versa) (for example, in a clockwise direction).This rotation preferably causes the first part to move upward and slightly leave the second part, so that for example the part of the first part (for example, the side part) no longer forces or holds the engagement device to engage with the implant.For example, one or more elastic tongues preferably cause the engagement device to retract from the implant (for example, from the groove in the implant).At this point, along with the first part slightly moving upward, the seal is preferably no longer compressed on the implant.

[0156] The user can then lift the cap off the implant, for example, with little or no resistance.

[0157] After removing the cover from the implant, the cover should preferably be cleaned.

[0158] The concept of a cover with a locking device is itself considered to be inventive and therefore, from a further aspect, a cover for a medical implant is provided, the cover comprising an engaging device and a locking device, wherein the locking device is movable between a locked position and an unlocked position, wherein in the locked position the engaging device cannot engage / disengage with the implant and in the unlocked position the engaging device can engage / disengage with the implant.

[0159] Therefore, when the locking device is in the locked position (that is, the cover is locked), the cover may not (for example, accidentally) disengage from the implant, and the accidental removal of the cover from the implant can be prevented. On the contrary, when the locking device is in the unlocked position (that is, the cover is unlocked), the cover can engage / disengage with the implant. Therefore, the cover can be locked to the implant in its engaged state, and deliberate and positive steps must be taken so that the cover can be unlocked and then disengaged from the implant.

[0160] The locking means may be or comprise a locking portion adapted to lock / unlock the cover and preferably also adapted to engage / disengage the means.

[0161] The term "locking cover" means that the cover is placed in a locked state, wherein the engaging means of the cover cannot engage / disengage with the implant. On the contrary, the term "unlocking cover" means that the cover is placed in an unlocked state, wherein the engaging means of the cover can engage / disengage with the implant.

[0162] The locking means may for example be a rotating means as described above.

[0163] Alternatively, the locking device may be any kind of locking portion capable of allowing / preventing a rotation of the second part relative to the first part (or vice versa). For example, the locking device may comprise a retractable member (e.g. a pin or a slide), wherein the retractable member is movable between a first (e.g. an inserted) position in which a rotation of the second part relative to the first part (or vice versa) is prevented, and a second (e.g. a retracted) position in which a rotation of the second part relative to the first part (or vice versa) is possible. For example, in its first position, the retractable member may extend, e.g. in an axial direction, through the first part into a hole or recess in the second part, thereby preventing relative rotation thereof.

[0164] The cover may include one or all of the other features described above or below.

[0165] From another aspect, a method for locking a cover of a medical implant is provided, the cover comprising an engagement device and a locking device, the method comprising moving the locking device into a locked position, wherein in the locked position, the engagement device cannot engage / disengage with the implant. The cover may be as described above or as described below, and the method may include any one of the other features described above or below.

[0166] From another aspect, a method for unlocking a cover of a medical implant is provided, the cover comprising an engagement device and a locking device, the method comprising moving the locking device into an unlocked position, wherein in the unlocked position, the engagement device can engage / disengage with the implant. The cover may be as described above or as described below, and the method may include any of the other features described above or below.

[0167] The concept of a cover having a compression device which can be used to pull the cover downwardly onto an implant is also considered inventive in itself and therefore from a further aspect a cover for a medical implant is provided, the cover comprising a seal and a compression device, wherein the compression device is arranged such that when the cover is placed on the implant, activation or use of the compression device causes at least the seal to move downwardly towards the implant so that the seal is compressed onto the implant.

[0168] Thus, the compression means may be used to cause the seal to move downwardly onto the implant so that the seal is compressed into a preferably sealing engagement with the implant, thereby providing a leak-proof seal.

[0169] A seal (eg, as described above) is preferably provided on the underside of the cover.

[0170] The cover preferably also includes an engagement device, such as described above. The compression device is preferably arranged so that activation of the compression device causes the engagement device to engage with the implant (and the cover and its seal move downward toward the implant so that the seal is compressed on the implant), such as described above. Therefore, the compression device can preferably be used to control both the attachment or engagement of the cover to the implant and the sealing of the cover to the implant.

[0171] The compression means may be, for example, or comprise, any kind of compression portion suitable for compressing the seal onto the implant.

[0172] For example and for example as described above, the compression means may be, or include, a rotation means which may be used to cause the cover (or part of the cover) to rotate down onto the implant thereby compressing the seal onto the implant. The compression means may for example be a rotation means as described above.

[0173] Alternatively or additionally, the compression device may include a button located on the cover (e.g., on the top of the cover) and one or more (preferably, two) protrusions / leavers / buttons located on the cover (e.g., on the sides of the cover).

[0174] The engagement means may comprise one or more fixed parts and one or more movable parts.

[0175] For example, as fixed part, coupling device can comprise fixed edge, ridge or other projection, and they are arranged on cover to engage (or vice versa) with corresponding groove or indentation on implant.Edge, ridge or other projection can for example be arranged on the lower inner edge (for example, its pedestal) of cover or around the lower inner edge of cover.It can for example cover half of the inner periphery of cover or less than half (for example, about 1 / 3 or less, about 1 / 4 or less).

[0176] As one or more moving parts, the engagement means may comprise one or more levers, pins, hooks or other moving engagement means.The one or more moving parts may be preferably evenly distributed along the remaining periphery of the cover (ie the remaining periphery not covered by the fixed part).

[0177] In one embodiment, the cover may include an edge or ridge covering the perimeter along one quadrant of the cover and one or more (preferably two or three) levers, pins or hooks, preferably evenly distributed around the perimeter of the remaining three quadrants.

[0178] In the case of this cover, the cover can be slid onto the implant, for example, to engage the fixed portion and the implant, and the movable portion can then be activated (for example, by a compression device) to further engage with the implant and preferably compress a seal provided on the cover against the implant to ensure a sealed engagement of the cover with the implant.

[0179] The cover may include one or all of the other features described above or below.

[0180] A method of sealing a cover of a medical implant to or from an implant, the cover comprising a seal and a compression device, the method comprising placing the cover on the implant and activating or using the compression device to cause the seal to move downwardly toward the implant so that the seal is compressed against the implant. The cover may be as described above or as described below, and the method may include any of the other features described above or below. BRIEF DESCRIPTION OF THE DRAWINGS

[0181] Preferred embodiments of the present invention will now be described by way of example only and with reference to the accompanying drawings, in which:

[0182] Figure 1 A perspective view showing an ostomy implant;

[0183] Figure 2 Show Figure 1 Side view of an ostomy implant;

[0184] Figure 3 An exploded perspective view showing components of a cover according to an embodiment of the present invention;

[0185] Figure 4(a) to Figure 4(c) Shown separately Figure 3 A top view, a side view and a perspective view of the cover shown;

[0186] Figure 5(a) to Figure 5(h) Shown separately Figure 3 a perspective view, a bottom view, a side view, a cross-sectional view, a top view, a side view, a cross-sectional view, and yet another cross-sectional view of the cap of the cover shown;

[0187] Figure 6(a) to Figure 6(d) Shown separately Figure 3 Bottom, top, side and end views of the slide of the cover shown;

[0188] Figure 7(a) to Figure 7(i) Shown separately Figure 3 a perspective view, a bottom view, a cross-sectional view, a side view, a further side view, a detail view, a further detail view, a further cross-sectional view, and a further cross-sectional view of the base of the cover shown;

[0189] Figure 8(a) to Figure 8(b) Shown separately Figure 3side and end views of the pin of the cover shown;

[0190] Figure 9(a) to Figure 9(c) Shown separately Figure 3 A top view, a cross-sectional view and a side view of the sealing ring of the cover shown;

[0191] Figure 10(a) to Figure 10(c) Shown are steps for inserting the pin of FIG. 8( a ) into the base of FIG. 7( a );

[0192] Figure 11(a) to Figure 11(e) Showing the steps for inserting the sealing ring of FIG. 9( a ) into the cap of FIG. 5( a );

[0193] Figure 12(a) to Figure 12(c) Shown are steps for inserting the slider of FIG. 6( a ) into the cap of FIG. 5( a );

[0194] Fig.13 Shows how to insert the assembled cap of Figure 12 into Figure 10(a)-10(c) In the assembled base;

[0195] Fig.14 Show Fig.13 a perspective view of the cover after the step of;

[0196] Figure 15(a) to Figure 15(d) Shown for end Fig.13 a step of a cover assembly process after the step;

[0197] Fig.16 is a flow chart showing the steps of assembling the cover;

[0198] Figure 17(a) to Figure 17(d) Shown for Figure 3 The step of fitting the cover onto the implant;

[0199] Figure 18(a) to Figure 18(e) Shown for removal from implant Figure 3 The step of covering; and Fig.19 Shown with Figure 3 A stereoscopic view of the cap implant. DETAILED DESCRIPTION

[0200] Figure 3 An exploded perspective view of components of a cover 10 according to an embodiment of the present invention is shown.

[0201] The components of the cover 10 consist of a substantially annular base 11, a substantially circular cap 12, a slide 13, a sealing ring 14 and three pins 15. The respective components 11, 12, 13, 14, 15 of the cover 10 are described in more detail below.

[0202] Figure 4(a) to Figure 4(c) Shown separately Figure 3A top view, a side view and a perspective view of the cover 10 are shown.

[0203] Figure 5(a) to Figure 5(h) Shown separately Figure 3 The cap 12 of the cover 10 is shown in a perspective view, a bottom view, a side view, a cross-sectional view, a top view, a side view, a cross-sectional view, and another cross-sectional view.

[0204] The cap 12 is circular and is formed by a circular top portion 28 and annular side portions 29 .

[0205] In the top portion 28, there is a first groove 20 extending from one side of the top portion 28 across the center of the top portion 28 to the opposite side of the top portion 28. The upper surface 28a of the top portion 28 protrudes slightly on both sides of the first groove 20, thereby forming a small recess 22 along either side of the groove 20.

[0206] Within the first groove 20, in its base (which is originally flat), there is a second groove 21. The second groove 21 is narrower than the first groove 20 and spans the center of the top portion 28 from one side of the top portion 28 (the side where the first groove 20 starts) and almost (but not quite) extends to the opposite side of the top portion 28. The center lines of the first groove 20 and the second groove 21 are co-linear.

[0207] On the originally flat base of the second groove 21, and spaced apart along its centerline, there are two upwardly projecting bumps 23a and 23b. The bumps 23a and 23b do not project higher than the depth of the second groove 21, so that they do not project upward into the first groove 20. These bumps 23a and 23b are arranged and positioned to give a clear "click" sound and feel feedback to the user when the slider is pushed all the way into each of its two end positions. The "click" sound and feel feedback are provided as the bumps 23a and 23b pass over corresponding bumps 31 (see below) arranged on the bottom surface of the slider 13.

[0208] On the upper surface 28 a of the top portion 28 , there are two markings 27 a and 27 b which mark the locked position and the unlocked position of the cover 10 .

[0209] The side portions 29 protrude downward from the periphery of the top portion 28 .

[0210] In the outer surface of the side portion 29, three identical and equally circumferentially spaced grooves 24 are provided. Each groove 24 consists of an upwardly extending portion 24a and a circumferentially extending portion 24b. The upwardly extending portion 24a extends upwardly from the bottom of the side portion 29 toward the top portion 28 (but not as far as the top portion 28). The grooves 24 then continue circumferentially around the side portion 29 from the top of the upwardly extending portion 24a in the circumferentially extending portion 24b. Each groove 24 does not extend as far as the next groove 24 around the side portion 29, so that a gap without any grooves exists between the grooves 24.

[0211] 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 "downward" step (or radially inward relative to the cap 12) from the upwardly extending portion 24a to the circumferentially extending portion 24b, which begins just above the circumferentially extending portion 24b. In addition, there is a small ridge 24d provided along the top end of the upwardly extending portion 24a before the "downward" drop to the circumferentially extending portion 24b.

[0212] In the circumferentially extending portion 24b of each groove 24, there is a thin ridge 24c along most, but not the entire, length of the centerline of the circumferentially extending portion 24b. The ridge 24c does not extend as far as either end of the circumferentially extending portion 24b.

[0213] When the cover 10 is assembled, the three ridges 24c come into contact with three corresponding circular guide protrusions 44 (see below) located on the interior of the base portion 11 .

[0214] As each circumferentially extending portion 24 b extends around the side portion 29 , the circumferentially extending portion 24 b may also extend slightly upwardly such that each circumferentially extending portion 24 b slopes upwardly around the side portion 29 .

[0215] On the underside of the top portion 28 and within the side portion 29, there is a radially inner groove 25 and a radially outer groove 26. The radially outer groove 26 is defined or formed by the radial inner surface of the side portion 29 and the first circular wall 26a. The radially inner groove 25 is defined or formed by the first circular wall 26a and the second circular wall 25a.

[0216] Figure 6(a) to Figure 6(d) Shown separately Figure 3 The slide 13 of the cover 10 is shown in bottom, top, side and end views.

[0217] When assembled, the slider 13 is sized to extend across the diameter of the cap 10. Thus, the slider 13 is substantially rectangular but has slightly curved ends 38a, 38b to match the perimeter of the cap 10. The slider 13 has a curved upper surface 37, wherein the curvature of this surface 37 extends along the length of the slider 13 (i.e., across the diameter of the cap 10 when assembled).

[0218] On the bottom surface of the slider 13 and towards one end 38b, there are two parallel ridges 30a, 30b of equal length, wherein the parallel ridges 30a, 30b extend along the shorter length of the slider 13. Extending between the two ridges 30a, 30b is a curved tab 31. The ridges 30a, 30b extend slightly further along the length of the slider 13 than the tab 31.

[0219] Around the midpoint of the slider 13 and on its bottom surface is a curved groove 32, which extends from one edge 39a of the slider 13 toward (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 the radius of curvature of the outer periphery of the cap 12.

[0220] At one end of the upper surface of the slider 13, a double-ended arrow 34 is marked, which shows the direction in which the slider 13 will slide in use. At the other end of the upper surface 37, there is a ridged area 33 having ridges for facilitating the sliding of the slider 13 in use.

[0221] Along each edge 39a, 39b of the slide 13, from its bottom side, there is a protrusion 36b, 36a, respectively. The protrusion 36b is interrupted or has a gap 36b' at a point where it extends on the curved groove 32. The protrusions 36a, 36b are sized to fit in the recess 22 present inside the first groove 20 of the cap 12.

[0222] Figure 7(a) to Figure 7(i) Shown separately Figure 3 A perspective view, a bottom view, a cross-sectional view, a side view, a further side view, a detail view, a further detail view, a further cross-sectional view and a further cross-sectional view of the base 11 of the cover 10 are shown.

[0223] The base 11 is annular and has a side portion 40 and a radially inwardly extending portion 42 which extends radially inwardly from a lower (in use) periphery of the side portion 40 .

[0224] On the outer surface of the side portion 40 there is a gripping area 41 having ridges facilitating gripping of the base 11 (eg in use, for example in order to rotate the base 11 ).

[0225] The base 11 is dimensioned so that the cap 12 fits accurately therein.

[0226] On the upper or inner surface of the radially inwardly extending portion 42, there is a circumferential groove 45, wherein the circumferential groove 45 is formed by the inner surface of the side portion 40 and a circular ridge 45a extending upwardly from the inner circumference of the inwardly extending portion 42. The ridge 45a is sized to fit in the radially outer groove 26 of the cap 12 when the cover 10 is assembled.

[0227] At three equally circumferentially spaced locations 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 extending from the inner surface of the side portion 40, there are three circular guide protrusions 44. These circular guide protrusions 44 are sized to fit in and slide along the groove 24 of the cap.

[0228] These circular guide protrusions 44 are provided on the shorter flexible arms, and as the base 11 or cap 12 rotates, the guide protrusions 44 are arranged to travel on the ridges 24c provided in the grooves 24, as described above. As the guide protrusions move on the ridges 24c, this creates a slight stop effect (or applies friction to) the rotation between the cap 12 and the base 11, which provides a nice and substantial "texture" to the user of the cap. At the two rotational end positions, i.e., when the guide protrusions 44 are at either end of the groove 24, the ridges 24c disappear, and the stop effect also disappears, thus creating different end positions, wherein the friction provided by the ridges 24c means that the cap 12 and the base 11 do not inadvertently rotate relative to each other.

[0229] In the radially inwardly extending portion 42 below each circular guide protrusion 44, there are oblong holes 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 manufacture the cover 10. These holes 47 are required for the moving anvil to produce the circular guide protrusions 44 described above in the injection molding process.

[0230] At either end of each straight groove 43 , on the radially inner side, there is a resilient tongue 49 , which may act as a weak spring.

[0231] A recess 46 is provided in the side portion 40 above one of the circular guide projections 44. The recess 46 is dimensioned such that the slider 13 can slide through it.

[0232] Figure 8(a) to Figure 8(b) Shown separately Figure 3Side and end views of the pin 15 of the cover 10 shown. The pin 15 is straight, with a circular cross section and a curved end. Three pins 14 are provided for each cover 10 and are dimensioned to fit in three straight grooves 43 of the base 11.

[0233] Figure 9(a) to Figure 9(c) Shown separately Figure 3 1 and 2. The sealing ring 14 of the cap 10 is shown in top, cross-sectional and side views. The sealing ring 14 is circular and is sized to fit in the radial inner groove 25 of the cap 12. The ring 14 has a flat side 14b and a curved side 14c. Two small protrusions 14a are provided on the sealing ring 14 opposite to each other and can extend vertically from the flat side 14b of the ring 14. Once the cap 10 is assembled, the small protrusions 14a are not used for any purpose, but only to more clearly identify the flat side 14b of the ring 14 so that it can be inserted into the inner groove 25 of the cap 12 in the correct orientation.

[0234] The lid 10 is cleaned and sterilized before being assembled from its parts 11, 12, 13, 14, 15 and then packaged. The cleaning process includes ultrasonic cleaning and sterilization 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 (up to 70°C) or dried in room air in a protected area to avoid condensation in the packaging. Cleaning is performed in a clean and controlled environment in conjunction with assembly and packaging in a sealable bag.

[0235] When the cover 10 is mass produced, the cover parts 11, 12, 13, 14, 15 will be molded directly in a clean room environment. This means that before (or after) assembly, no cleaning (as described above) will be required.

[0236] The assembly process of the cover 10 will now be described.

[0237] Figure 10(a) to Figure 10(c) The steps for inserting three pins 15 in the base 11 to assemble the cover 10 are shown.

[0238] First, as shown in Figure 10 (a), the base 11 is placed so that its radially inwardly extending portion 42 is located at the bottom. The pin 15 is then placed in each of the three straight grooves 43, as shown in Figure 10 (b). The final configuration of the base 11 and the pin 15 after performing these steps is shown in Figure 10 (c).

[0239] Figure 11(a) to Figure 11(e) The steps for inserting the sealing ring 14 in the cap 12 to assemble the cover 10 are shown.

[0240] First, the cap 12 (as shown in FIG. 11( a) ) is placed with the radially inner groove 25 of the cap 12 facing upward, as shown in FIG. 11( b). The sealing ring 14 is then placed into the radially inner groove 25 with the flat side 14 b of the sealing ring 14 facing downward toward the groove 25 and the curved side 14 c of the sealing ring 14 facing upward away from the groove 25, as shown in FIG. 11( c) and FIG. 11( d). The final configuration of the cap 12 and the sealing ring 14 after performing these steps is shown in FIG. 11( e).

[0241] In an alternative embodiment, the cap 12 and the sealing ring 14 are formed together using a two-step injection molding process (first forming the cap 12 and then forming the sealing ring 14 on the cap 12), so that no Figure 11(a) to Figure 11(e) The method shown.

[0242] Figure 12(a) to Figure 12(c) The steps for inserting the slide 13 in the cap 12 to assemble the cover 10 are shown.

[0243] First, as shown in FIG. 12( a), the cap 12 is placed with the upper surface 28a of the cap 12 facing upward, and the slider 13 is placed with the upper surface 37 of the slider 13 facing upward. The end 38a of the slider 13 then slides into the first groove 20 of the cap 12 along the axis L. The slider 13 slides into the first groove 20 at the end of the first groove 20 extending rightwardly from the second groove 21 to the periphery of the cap 12. As the slider 13 slides into the first groove 20, the protrusions 36a, 36b of the slider 13 slide through the recesses 22 along either side of the groove 20.

[0244] As the slider 13 slides through the first groove 20, resistance is felt as the slider 13 encounters the bump 23b and then the bump 23a in the second groove 21 of the cap 12. Therefore, some additional force is required to cause the bent bump 31 to pass over the bump 23b in the second groove 21 and then over the bump 23a.

[0245] After the lug 31 on the slider 13 has passed over the lug 23a in the second groove 21, the ends of the parallel ridges 30a, 30b abut against the closed end 21a of the second groove 21, and the slider 13 cannot slide further across the cap 12. The ridges 30a, 30b and the end 21a of the second groove 21 are positioned so that at this time, i.e., when the parallel ridges 30a, 30b abut against the closed end 21a of the second groove 21, the curved groove 32 on the underside of the slider 13 extends around the outer periphery of the cap 12, as shown in Figures 12(b) and 12(c). Before performing the other steps of assembly of the cap 10 described below, the slider 13 should be slid into this position, i.e., where the ends of the parallel ridges 30a, 30b abut against the closed end 21a of the second groove 21 and the curved groove 32 on the underside of the slider 13 extends around the outer periphery of the cap 12.

[0246] Fig.13 It is shown how the assembled cap 12 (ie, with the slide 13 and the sealing ring 14 inserted therein) is inserted into the assembled base 11 (ie, with the pin 15 inserted therein).

[0247] The assembled cap 12 is positioned with the upper surface 28a of the cap 12 facing upward, and the assembled base 11 is positioned, for example, in a horizontal plane with the radially inwardly extending portion 42 of the base 11 located at the bottom or facing downward. The cap 12 is positioned so that the upwardly extending portions 24a of the grooves 24 in the cap 12 are each located directly above the circular guide protrusions 44 in the base 11. The assembled cap 12 (with the slide 13) is further positioned so that the slide 13 slightly overlaps the recess 46 in the side portion 40 of the base 11.

[0248] The assembled cap 12 and assembled base 11 are then pressed or snapped together by pressing the cap 12 into the base 11 so that the circular guide protrusions 44 in the base 11 pass over the ridge 24d at the top of each upwardly extending portion 24a and then enter into the circumferentially extending portion 24b.

[0249] With the assembled cap 12 (ie, containing the slide 13 ) positioned so that the slide 13 slightly overlaps the recess 46 in the side portion 40 of the base 11 , portions of the top edge 48 of the base 11 fit into the curved groove 32 on the underside of the slide 13 .

[0250] Fig.14 Shown above Fig.13 A perspective view of the cover 10 after the associated step, the cover 10 comprising the base 11 , the cap 12 and the slide 13 (with the pin 15 and the sealing ring 14 not visible).

[0251] Figure 15(a) to Figure 15(d)Shown is used to end the above Fig.13 The steps are followed by steps of the assembly process of the cover 10 .

[0252] First, the cap 12 and the slider 13 are rotated clockwise (when viewed from above) relative to the base 11 as shown in Fig. 15(a) by pushing the slider 13 along the path P. By pushing the slider 13, the cap 12 is rotated as far as possible, i.e., until the circular guide protrusion 44 reaches the upper end of the circumferentially extending portion 24b of the groove 24 (e.g., opposite to the end where the circumferentially extending portion 24b meets the upwardly extending portion 24a), and is thus prevented from moving further.

[0253] As the cap 12 is rotated in this manner, the cap 12 is also preferably pulled further downward into the base 11 due to the slope of the circumferentially extending portion 24 b in the cap 12 .

[0254] When the cap 12 has been rotated as far as possible, ie, when the circular guide protrusion 44 reaches the upper end of the circumferentially extending portion 24b of the groove 24, the slider 13 is located in the recess 46 of the base 11, as shown in Figure 15(b).

[0255] Then, as shown in FIG. 15( c ), the slider 13 is pushed inwardly along arrow A through the recess 46 and / or the first groove 20 until the slider 13 is prevented from further movement by abutting against the side portion 40 of the base 11. At this point, the slider 13 is positioned within the first groove 20 across the entire diameter of the cover 10, as shown in FIG. 15( d ). The longitudinal length of the slider 13 is equal to the outer diameter of the base 11, so that at this point the slider 13 does not protrude outwardly from the base 11 at all.

[0256] Fig.16 1 is a flow chart showing the steps of assembling the cover 10 from the parts 11 , 12 , 13 , 14 , 15 of the cover.

[0257] In step 50, the pin 15 is inserted into the base 11, as shown in FIG. Figure 10(a) to Figure 10(c) As shown and described above.

[0258] In step 51, the sealing ring 14 is inserted into the cap 12, as shown in FIG. Figure 11(a) to Figure 11(e) In an alternative embodiment where the cap 12 and sealing ring 14 are formed together (eg, in a two-step injection molding process, as described above), this step 51 is not required.

[0259] In step 52, the slider 13 is inserted into the cap 12, as shown in FIG. Figure 12(a) to Figure 12(c) As shown and described above.

[0260] exist Fig.16In some embodiments, step 51 is performed before step 52, but in other embodiments, step 52 is performed before step 51, and in other embodiments, steps 51 and 52 are performed in parallel.

[0261] exist Fig.16 In the embodiment, 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, for example, 50 then 51 then 52; or 51 then 52 then 50. Other orders of these steps are also possible.

[0262] After steps 50 to 52 have been performed (in whatever order, and in series or in parallel), step 53 is performed, in which the cap 12 (with the slide 13 and the sealing ring 14) is inserted into the base 11 (with the pin 15), as shown in FIG. Fig.13 and Fig.14 As shown and described above.

[0263] Then, in step 54, the cap 12 is rotated relative to the base 11, as shown in Figures 15(a) and 15(b) and as described above.

[0264] Finally, at step 55, the slider 13 is slid into the groove 20 in the cap 12, as shown in Figures 15(c) and 15(d) and described above, and is ready for packaging, use or storage.

[0265] Once the cover 10 has been assembled in this way, the cover 10 may be provided to the patient to be fitted onto the implant 1 .

[0266] Figure 17(a) to Figure 17(d) The steps for fitting the cap 10 onto the implant 1 are shown.

[0267] Starting with the cap 10 having the slider 13 slid in across the cap 12, the slider 13 must be slid outwardly along the groove 30 in the cap 12 before the cap 10 can be fitted onto the implant 1. The cap 12 must then be rotated counterclockwise (when viewed from above) relative to the base 11 (or vice versa) so that the cap 12 is slightly raised from the base 11 and the slider 13 only slightly overlaps the recess 46. The cap 10 is then ready to be fitted onto the implant 1.

[0268] As shown in FIG. 17( a ), the user holds the protruding end of the slider 13 and places the cover 10 on the outer section 4 of the implant 1 .

[0269] The slide 13 is then used to hold the cap 12 fixed while the base 11 is rotated in a counterclockwise direction (when viewed from above) relative to the cap 12, as shown by the arrow in Figure 17(b) (alternatively, the slide 13 can be used to rotate the cap 12 in a clockwise direction (when viewed from above) relative to the base 11 while the base 11 remains fixed) until the slide 13 is fully positioned in the recess 46 in the base 11.

[0270] As the base 11 rotates counterclockwise relative to the cap 12 (or vice versa), the cap 12 is pulled downwardly into the base 11 by the circular guide protrusion 44 which slides along the upwardly inclined circumferentially extending portion 24 b of the groove 24 around the cap 12 .

[0271] As the cap 12 is pulled downwardly into the base 11 in this manner, the side portions 29 of the cap 12 move downwardly into the circumferential groove 45 in the base 11, thereby forcing the three pins 15 located in the three straight grooves 43 around the circumferential groove 45 radially inwardly, against the resilient tongues 49, and slightly upwardly into the grooves 46 around the outer periphery of the outer section 4 of the implant 1. This engagement of the pins 15 against the inner upper surfaces of the grooves 6 of the implant 1 secures and holds the cap 10 to the implant 1, and prevents the user from being able to simply move or pull the cap 10 straight off the implant 1 (either intentionally or accidentally).

[0272] Furthermore, as the cap 12 is pulled downwardly into the base 11 , the sealing ring 14 on the underside of the cap 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 cover 10 .

[0273] Once the cover 10 has been secured and sealed in this manner, the slider 13 slides back through the groove 20 across the remainder of the cover 10, as shown in Figure 17(c), so that it no longer protrudes radially outwardly from the remainder of the cover 10, as shown in Figure 17(d).

[0274] To remove the cap 10 from the implant 1, the reverse procedure may be performed, such as Figure 18(a) to Figure 18(d) shown.

[0275] The cover 10 begins with the slide 13 being in the "slide-in" position relative to the remainder of the cover 10, as shown in Figure 18 (a). The slide 13 is then pulled outward through the groove 20 in the cap 12, as shown in Figure 18 (b). When fully pulled out, the slide 13 is then used to keep the cap 12 fixed, and the base 11 is rotated in a clockwise direction relative to the cap 12 (alternatively, the base 11 remains fixed, and the slide 11 is used to rotate the cap 12 in a counterclockwise direction relative to the base 11). This rotation causes the cap 12 to move upward and slightly leave the base 11, so that the side portion 29 no longer forces or holds the pin 15 in the groove 6 around the implant 1, and the elastic tongue 49 causes the pin 15 to retract from the groove 6. In addition, the sealing ring 14 is no longer compressed downward on the upper surface of the outer section 4 of the implant 1.

[0276] The user can then lift the cap 10 off the implant 1 with little or no resistance.

[0277] After the cover 10 is removed from the implant 1 in this manner, it should be cleaned as shown in Figure 18(e).

[0278] Fig.19 A perspective view of an implant 1 ′ (not implanted in a patient) with a cap 10 is shown.

[0279] The cap 10 is reusable but has a limited lifespan. The cap 10 can be used by a patient for up to two weeks before a new cap 10 must be used.

[0280] The cap 10 is dimensioned to fit an implant having an outer diameter corresponding to the inner diameter of the cap 10. However, the cap 10 may be fitted onto implants 1, 1' having a different axial length and / or a different internal structure.

[0281] The slide 13, the cap 12 and the base 11 are all made of plastic by injection molding.

[0282] The pin 15 is made of stainless steel.

[0283] In an alternative embodiment, the pin 15 is made of plastic. This ensures that the pin 15 wears out long before the edge of the groove 6 in the implant 1, 1' over which the pin 15 moves.

[0284] The sealing ring 14 is made of a medical grade soft polymer.

[0285] Each cover 10 is provided to the user in a sterile state in a semi-sealed individual bag (ie, the bag is perforated along one side for easy tearing). However, the cover 10 need not be sterile.

[0286] The cover 10 (except for the pin 15 and the sealing ring 14) is skin-colored and is intended to be inconspicuous.

[0287] The cap 10 is designed so that one cap size can fit different implant sizes. For example, the implant can be provided with different inner diameters (i.e., the diameter of the opening through the implant), for example, optimized for different sizes (thickness / diameter) of the ileum. However, because the implant (specifically, the outer section of the implant) can have the same outer diameter, the same cap 19 can fit implants of different sizes with different inner diameters, with the sealing ring 14 located close enough to the outer diameter of the cap 10 that the cap 10 can fit even implants with relatively large inner diameters (and therefore with a relatively thin outer section top surface on which the sealing ring 14 can be compressed).

[0288] The cap 10 can also be fitted to implants having different axial lengths, so that the outer diameters of the outer sections of the implants are the same.

[0289] The fact that the same cap 10 can fit implants of different sizes is advantageous because there is no need to manufacture caps of different sizes for implants with different inner diameters and / or axial lengths. This makes manufacturing simpler, saves time and costs, and is safer (no chance of putting the wrong size cap 10 on the implant).

Claims

1. A cover (10) for a medical implant (1), the cover (10) comprising: Part I (12), Part II (11), and an engaging device (15), the engaging device (15) being located in the second part (11) or being formed integrally with the second part (11), the engaging device (15) comprising an engaging portion, wherein the second part (11) is rotatable relative to the first part (12), or the first part (12) is rotatable relative to the second part (11), characterized in that the first part (12) and the second part (11) are arranged so that when the second part (11) is assembled with the first part (12) in use, the cover can be located on the implant, and the rotation of the first part (12) relative to the second part (11) causes the first part (12) to be pressed against the engagement device (15), so that the engagement portion moves radially inward toward the implant (1), thereby the engagement portion engages with the implant (1) and holds the cover (10) on the implant (1).

2. The cover (10) of claim 1, wherein the engagement portion is one or more pins.

3. The cover (10) according to claim 2, wherein: The engaging portion is three pins.

4. The cover (10) according to claim 1 or 2, wherein: The first part (12) is a cap.

5. The cover (10) according to claim 1 or 2, wherein: The second part (11) is a base.

6. The cover (10) according to claim 5, wherein: The base is annular.

7. The cover (10) according to claim 1 or 2, wherein: The first part (12) is snap-fitted into the second part (11).

8. The cover (10) according to claim 1 or 2, wherein: The first part (12) and the second part (11) comprise complementary guiding means.

9. The cover (10) according to claim 8, wherein: The complementary guiding means comprises one or more grooves provided on the first part (12) or the second part (11) and one or more complementary protrusions provided on the other of the first part (12) and the second part (11), whereby the one or more protrusions are arranged to extend into the one or more grooves, thereby allowing the first part (12) and the second part (11) to rotate relative to each other.

10. The cover (10) according to claim 1 or 2, wherein: The first part (12) and the second part (11) are arranged so that as the second part (11) rotates relative to the first part (12) or the first part (12) rotates relative to the second part (11), the first part (12) is also caused to move axially relative to the second part (11).

11. The cover (10) according to claim 1 or 2, wherein: The first part (12) comprises or has a rotating device (13) connected to the first part (12) for rotating the first part (12) relative to the second part (11).

12. The cover (10) according to claim 11, wherein The rotating device (13) is capable of moving between a first position and a second position, in which the second part (11) is capable of rotating relative to the first part (12) or the first part (12) is capable of rotating relative to the second part (11), and in which the second part (11) is not capable of rotating relative to the first part (12) or the first part (12) is not capable of rotating relative to the second part (11).

13. The cover (10) according to claim 11, wherein: The rotating device (13) is a moving member or a slide, which is arranged to move or slide in a groove or a recess provided in the first part (12).

14. The cover (10) according to claim 13, wherein: The rotating device (13) is arranged to move radially or to slide radially in the groove or recess.

15. The cover (10) according to claim 1 or 2, wherein: The cover (10) also includes a seal (14).

16. The cover (10) according to claim 15, wherein: The seal (14) is disposed in the first portion (12) or is a part of the first portion (12).

17. The cover (10) according to claim 15, wherein: The sealing element (14) is a sealing ring.

18. An implant (1) having a cap (10) according to claim 1 or 2 attached to the implant.

19. A method of manufacturing a cover (10) according to claim 1 or 2, the method comprising: Providing a first part (12), a second part (11) and a joining device (15); as well as The first part (12), the second part (11) and the engaging means (15) are assembled to form a cover (10) so that the second part (11) can rotate relative to the first part (12) or the first part (12) can rotate relative to the second part (11), and in use, the rotation of the second part (11) relative to the first part (12) or the rotation of the first part (12) relative to the second part (11) causes the engaging means (15) to engage with the cover (10) and attach the cover (10) to the implant (1).

20. A method of attaching a cap (10) according to claim 1 or 2 to an implant (1), the method comprising: placing the cap (10) on the protruding end of the implant (1); Then Rotating the second part (11) relative to the first part (12) or rotating the first part (12) relative to the second part (11) causes the engagement means (15) to engage with the cover (10) and attach the cover (10) to the implant (1).

21. A method of removing a cap (10) according to claim 1 or 2 from an implant (1), the method comprising: The second part (11) is rotated relative to the first part (12) or the first part (12) is rotated relative to the second part (11) so that the engagement device (15) is disengaged from the cover (10); and then The cap (10) is removed from the implant (1).

Images