Emptying device

Abstract

The present disclosure relates to an emptying device assembly for emptying a stoma, comprising: a first film layer and a second film layer attached along a peripheral portion to form an emptying device, where the first film layer comprises a first aperture; and an integrated connector ring, the integrated connector ring comprising: an annular base defining a second bore concentric with the first bore, where the annular base is attached to the emptier assembly around the first bore; a plurality of radially inwardly projecting flanges, wherein at least one subset of the projecting flanges is adapted to engage with an outer circumferential groove of a cylindrical stoma implant or a cap of a stoma implant. The present disclosure also relates to a method of manufacturing the emptier assembly.

Description

Technical Field

[0001] The present disclosure relates to a draining device, in particular to a draining bag and a draining sleeve for draining a stoma. Background Art

[0002] Ileostomies and colostomies 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 an ileostomy, and if only the rectum is removed, the surgery is called a colostomy. Similarly, an abdominal urethrostomy is created when the bladder must be removed, for example due to bladder cancer. In these surgeries, a stoma is created in the abdominal wall to which segments of intestine are connected.

[0003] An ileostomy is a stoma constructed by bringing the end or loop of the small intestine (ileum) out to the surface of the skin, or a surgical procedure that creates this opening. Intestinal waste flows out of the ileostomy and is collected in an external stoma system that is placed over the opening.

[0004] A colostomy is a stoma in the large intestine (colon), or a surgical procedure that creates a stoma. The opening is created by pulling the healthy end of the colon through an incision in the anterior abdominal wall and sewing it into place. This opening is often combined with an attached stoma system, providing an alternative passage for stool to leave the body.

[0005] A stoma pouching system is a medical device that provides a means for collecting waste from a stoma. Traditional pouching systems typically consist of a collection bag, a barrier on the skin, and a connection to the stoma itself, which is the part of the body that has moved to the skin.

[0006] In traditional ostomy pouching systems, the pouch is typically attached directly to the skin.

[0007] As an alternative to traditional stoma pouching systems, an implant-based system has been developed. The system is based on a percutaneous stoma implant that is anchored in the user's body and allows the serosal tissue of the intestinal segment to attach to the implant. The stoma implant comprises a generally cylindrical body with an open end to which a cap can be attached. When the cap is removed, the open end can be connected to an emptying device, such as an ostomy bag. This solution allows users to meet their needs when it suits them and minimizes skin complications as well as discomfort, noise and odor.

[0008] However, attaching a stoma bag to a stoma implant is associated with several technical challenges, which relate to, for example, ease of use, potential leakage, and the ability to withstand forces caused by waste in the stoma bag. Many existing devices have attempted to address these limitations. US 5,269,774 discloses a combination ring and collecting bag for stoma, the combination comprising a ring portion having a first side, a second side, and a hole roughly centered through the first side and the second side. US 5,139,492 discloses a two-piece stoma appliance comprising a bag and a panel with a matching coupling ring. US 2012 / 012336 discloses a percutaneous stoma implant for implantation in the abdominal wall of a patient. US 4,183,357 discloses a chronic transdermal implant device for intestinal stoma, comprising a barrel portion and a flange portion.

[0009] While these documents address some of the limitations of conventional bag systems, there are still significant shortcomings that need to be addressed, such as prevention of leakage, ease of use, and prevention of accidental disconnection between the bag system and the stoma. Summary of the invention

[0010] The present disclosure relates to an emptying device assembly for emptying a stoma, comprising:

[0011] - a first membrane layer and a second membrane layer, the first membrane layer and the second membrane layer being attached along a peripheral portion to form an emptying device, wherein the first membrane layer comprises a first hole; and - an integrated connector ring, the integrated connector ring comprising:

[0012] ° an annular base defining a second hole concentric with the first hole, wherein the annular base is attached to the emptying device around the first hole, such as welded to the emptying device;

[0013] ° A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0014] The connector ring may be attached to the cover of the stoma implant. Preferably, the connector ring is attached to the cover by positioning a subset of the protruding flanges to fit into a circumferential groove of the cover. From this position, in the case where the emptying device is a closed bag, the emptying device can be opened at one end. The cover can then be opened from the outside of the emptying device to avoid soiling the user's hands.

[0015] Preferably, the plurality of radially inwardly projecting flanges of the connector ring comprise an engagement flange adapted to engage with an outer circumferential groove of a cylindrical stoma implant or a cover of a stoma implant. The engagement flange may be made of a resilient but relatively rigid material so that the engagement may flex slightly when the connector ring is positioned, but once the connector ring is in the correct position, the engagement flange will return to its original non-flexed shape. This may result in a clicking sound. The engagement flange may have a hook or guide element at the inner engagement flange edge towards the center of the second hole. The hook or guide element may increase the ability of the connector ring to stay in the attached position even if the emptying device contains waste from the stoma.

[0016] A further improvement in the ability to carry the weight of the emptying device is the possibility of having additional radially inwardly protruding flanges, which include support flanges suitable for stabilizing the integrated connector ring. The support flange can generally be hard and slightly shorter than the engagement flange. The support flange can have an inner support flange edge towards the center of the second hole, wherein the support flange size is determined so that the inner support flange edge abuts the outer circumferential ring of the cover of the cylindrical stoma implant or stoma implant during use. The support flange can therefore contribute to the overall structural strength of the connector ring without affecting usability. The protruding flanges can be arranged so that every other radially inwardly protruding flange is an engagement flange, and every other radially inwardly protruding flange is a support flange.

[0017] The present disclosure also relates to a method of manufacturing an emptying device assembly according to any one of the preceding claims, the method comprising the following steps (in any order):

[0018] Attaching the first film layer and the second film layer along a peripheral portion of the layers to form a sleeve or bag;

[0019] forming a first circular hole in the first film layer;

[0020] Attaching a connector ring to the first membrane layer around the first hole, wherein the connector ring comprises:

[0021] - an annular base defining a second hole concentric with the first hole; and

[0022] - A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0023] In yet another aspect, the present disclosure relates to a connector ring for attaching a further device to a stomal implant or a cover of a stomal implant, the connector ring comprising:

[0024] an annular base defining a connector aperture; and

[0025] - A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0026] The connector ring may comprise attachment means, such as an adhesive, for attaching the further device to the connector ring, alternatively the connector ring may form an integral part of the further device, such as where the connector ring has been welded to the further device, such as by plastic welding.

[0027] A further aspect of the present disclosure relates to the use of a connector ring for attaching a further device to a stomal implant or a cover of a stomal implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 An embodiment of the presently disclosed emptying device assembly for emptying a stoma is shown.

[0029] Figure 2 A top view of an embodiment of an emptying device is shown.

[0030] Figure 3 A side view of an embodiment of an emptying device assembly is shown.

[0031] Figure 4 A perspective view of an embodiment of a connector ring is shown.

[0032] Figure 5 A top view of an embodiment of a connector ring is shown.

[0033] Fig. 6 shows an example of a cover for a stoma implant.

[0034] Figure 7 An example of a stoma implant is shown. DETAILED DESCRIPTION

[0035] The present disclosure relates to an emptying device assembly for emptying a stoma. The emptying device assembly comprises at least an emptying device and a connector ring. The emptying device advantageously comprises a first film layer and a second film layer, the first film layer and the second film layer being attached so that a compartment is formed between the first film layer and the second film layer. The first and second film layers may, for example, be formed by separate film layers, or may be formed by a single layer that has been folded so as to form a first film layer covering the second film layer. Alternatively, the emptying device may be formed by a single component (typically a polymer component), for example by blow molding. Thus, the first and second film layers may be different parts of the same surface, including, for example, partially overlapping parts.

[0036] In any case, the first and second film layers are preferably attached / connected along a peripheral portion so that a compartment is formed between the first and second film layers. The compartment can be connected to the external environment through a plurality of openings / holes (such as one, two or even three holes) in and / or between the first and second film layers. Therefore, the attachment / connection of the first and second film layers can be performed by aligning the first film layer and the second film layer and attaching the two film layers along the peripheral portion of the layers. For example, along at least a portion of the periphery, such as the entire periphery. In a particular example, before attaching / connecting the film layers, at least one of the first and second film layers includes a hole, and in other examples, after attaching the film layers, at least one hole is formed in the first or second film layer.

[0037] The evacuation means typically comprises a compartment between the first membrane layer and the second membrane layer, and may also comprise one or more apertures, such as the first aperture.

[0038] Alternatively, one or more holes may be formed, for example in the first film layer and / or the second film layer, after the emptying device is formed. In a particular example, the first and second film layers are attached / connected only along a portion of the periphery of the film layers, so that a hole is formed at the end of the emptying device, i.e. where the first and second film layers are not attached. The hole may, for example, be arranged to allow the contents of the emptying device to be emptied.

[0039] At least one of the membrane layers (such as the first membrane layer) advantageously includes a first hole. Preferably, the integrated connector ring is attached / connected to an area of ​​the first membrane layer surrounding the first hole, so that the connector ring can be considered an integrated part of the emptying device assembly. However, the integrated connector ring can be detachable from the first and / or second membrane layer, so integration should not be understood as limiting the integrated connector ring to embodiments in which the connector ring is not detachable from the emptying device (e.g., the first and / or second membrane layer). As used herein, integrated refers to a component that is attached or connected to another component, in this example, the two components are integrated into the assembly (consisting of the two components) in this way.

[0040] The integrated connector ring preferably comprises a base defining a second hole (also referred to as the connector hole), the second hole being at least partially concentric with the first hole, preferably wherein the first hole and the second hole are completely concentric. The connector ring typically forms an annulus, and thus, the second hole may be defined by a radial inner circle of the annulus. In particular examples, the first hole and the second hole coincide, however in other examples, the size (such as radius) of the second hole is larger than the size (such as radius) of the first hole.

[0041] The first hole and the second hole are preferably formed to have the same shape. For example, the first and second holes may have a circular, oval, rectangular or square shape. However, preferably, the first and second holes have a circular shape. The base of the integrated connector may have an annular base, defining a second hole having a circular shape. Alternatively, the integrated connector may have any other shape as described above, so as to define a second hole having a shape different from a circular shape. Preferably, the base is an annular base and / or the second hole has a circular shape, and / or the first hole has a circular shape. The base is preferably attached to the emptying device, preferably to the area of ​​the first membrane layer surrounding the first hole. The base may be, for example, welded to the area surrounding the first hole, such as by heat welding or solvent welding. However, in other embodiments of the present disclosure, the base may be attached to the area surrounding the first hole by other means (such as by using an adhesive). The integrated connector ring generally includes a plurality of flanges protruding inwardly, preferably a plurality of flanges protruding radially inwardly. It is further preferred that the flange or a subgroup thereof is arranged to engage with a stoma implant and / or a cover of a stoma implant. Therefore, the flange may be referred to as an engagement flange. Therefore the flange of the connector ring or its subgroup (i.e. the engagement flange) can be arranged to engage with the cover of the stoma implant and / or the stoma implant.Preferably, wherein the engagement flange is arranged to engage with the connecting means of the cover of the stoma implant and / or the stoma implant.The connecting means of the stoma implant and / or the cover of the stoma implant can be one or more of the raising and / or lowering part, ridge, protrusion, notch, groove, hook, recess and / or pit, preferably wherein the connecting means is circumferential, such as one or more of the circumferential part, circumferential ridge, circumferential protrusion, circumferential notch, circumferential groove, circumferential hook, circumferential recess and / or circumferential pit that are raised and / or lowered.Most preferably, the engagement flange is arranged to engage with the circumferential groove of the cover of the stoma implant and / or the stoma implant.

[0042] It is preferred that the connector includes a limiting device for limiting the bending of the engagement flange in one direction, and the connector is fixed to the stoma implant and / or the cover during use. Usually, the limiting device is arranged so that the engagement flange (for example, at least the edge portion) can be bent inwards (that is, enter the compartment formed between the first and second film layers). During use, the engagement flange can therefore be arranged to be easily engaged with the connecting device of the cover of the stoma implant and / or the stoma implant by bending inwards (that is, inwards towards the compartment formed between the first and second film layers). It is usually necessary to bend the flange, because the diameter of the stoma implant and / or the cover of the stoma implant is greater than the circle / annular band formed by the inner engagement flange edge. However, the ring / circle is preferably sized to match the connecting device of the stoma implant / cover.

[0043] At the same time, while allowing easy engagement, the limiting means is preferably arranged to limit bending of each engagement flange or a subgroup thereof in the opposite direction, i.e. in a direction away from the second membrane layer (i.e. outwards). This ensures the connection between the connector and the stoma implant and / or the cover. Typically, the engagement flanges are arranged so that an accidental disconnection between the connector and the stoma implant and / or the cover is avoided, for example even when the emptying device contains a large amount of waste and therefore has a considerable weight. At the same time, while preferably allowing accidental disconnection, it is preferred that a person can disconnect the connector and the stoma implant and / or the cover without significant force.

[0044] Thus, the limiting means may be arranged to limit bending of one or more engagement flanges in a first direction, but to allow bending of the engagement flanges in a direction opposite to the first direction. Typically, the limiting means limits bending in the direction in which the limiting means is located. For example, if the limiting means is located on a first side of the connector, bending of the engagement flange towards the first side may be limited. At the same time, the limiting means may be arranged to allow bending of the engagement flange in the opposite direction (i.e., opposite to the first side).

[0045] The limiting device may include or consist of one or more protrusions, recesses, grooves and / or notches, which are arranged so that the joining flange is more easily bent inwardly (i.e., in the direction of the compartment formed between the first membrane layer and the second membrane layer) than outwardly (i.e., away from the compartment formed between the first membrane layer and the second membrane layer).

[0046] In a preferred example, the restriction means comprises a radially outer protrusion and a radially inner protrusion, i.e., wherein the radially outer protrusion is located radially outside the radially inner protrusion (i.e., the radially outer protrusion is further away from the center of the second hole than the radially inner protrusion). Preferably, the radially outer protrusion and the radially inner protrusion are arranged on the side of the connector facing outwards (i.e., away from the compartment formed between the first and second membrane layers).

[0047] The radially inner projection is preferably arranged adjacent to the radially outer projection, for example when the engagement flange is not bent, but the radially inner projection is preferably arranged radially inwardly (that is, towards the center of the second hole) from the radially outer projection. When the user positions the connector to engage with the implant and / or the cover, this arrangement allows the engagement flange between the outer projection and the inner projection to bend.

[0048] However, the projection limits the bending of the engagement flange in opposite directions (that is, away from the compartment formed between the first and second film layers), and is therefore used to fix the connector to the implant and / or the cover. In these arrangements, when the projections are adjacent to each other, they limit the bending of the engagement flange in the same direction as the one side of the connector where the projection is located (i.e. the side facing outwards). The limiting device can be located completely on one or more (e.g., all) of the engagement flange, or a part of the limiting device can be located on the annular base of the connector ring. For example, the limiting device can include a radially outer projection located on the base, each of which is positioned to be adjacent to the radially inner projection located on (one or more) engagement flanges. Alternatively, two projections can be located on (one or more) engagement flanges.

[0049] Preferably, the emptying device assembly is arranged such that after attaching the emptying device assembly to the cover of the stoma implant, at least a portion of the cover protrudes into a compartment of the emptying device formed between the first and second membrane layers. More preferably, the cover and preferably at least a portion of the stoma implant protrudes into said compartment after said attachment.

[0050] The drain device may have a single opening, typically a first hole formed in the first film layer. The first hole is typically formed towards the proximal end of the drain device. Thus, the drain device may be a drain bag. In this arrangement, the drain device assembly is arranged to hold stoma waste to be discharged into the drain device (e.g., drain bag). Such drain device assemblies are typically used in situations where it is necessary to empty stoma waste for a long period of time.

[0051] Preferably, if the emptying device has only a single hole, i.e. the first hole, the emptying device is equipped with tearing means for forming the emptying hole towards the distal end of the emptying device. The tearing means may for example be one or more notches, one or more perforations and / or one or more tearing tabs, which are for example welded to the first and / or second film layer. Preferably, the emptying device further comprises means for resealing the emptying hole after formation, such as a Velcro strip or an adhesive patch. Similar tearing means and resealing means for forming the emptying hole may be provided for an emptying device comprising a plurality of holes.

[0052] The emptying device may alternatively comprise a plurality of holes, such as two holes. In this embodiment, the emptying device may comprise a first hole for receiving stoma waste, the first hole being formed in the first film layer generally towards the proximal end of the emptying device, and the emptying device further comprises an emptying hole for emptying stoma waste, the emptying hole being formed at or towards the proximal end of the emptying device. The emptying hole may be formed, for example, along an edge of the first film layer not attached to the second film layer.

[0053] Typically the first hole is formed towards the proximal end of the emptying device, while the emptying hole is formed towards the distal end of the emptying device. In this arrangement, the emptying device may be referred to as a sleeve. Preferably, the emptying device comprises means for resealing the emptying hole, such as a Velcro strip or an adhesive patch.

[0054] The emptying device assembly may thus be arranged such that a user can wear the assembly for a long period of time whilst the user is able to carry out normal daily activities.During such use it is important that the connector ring is able to provide a secure and stable attachment to the stoma implant and / or the cover of the stoma implant.

[0055] Typically, a lid attached to the open end of the stoma implant is used to seal the stoma. The emptying device and / or the emptying device assembly may be arranged to receive at least a portion of the lid in a compartment formed between the first and second membrane layers through a first hole. In this position, the lid can be opened by the emptying device, i.e., by one of the first and second membrane layers, in order to avoid soiling the user's hands. The lid of the stoma implant is typically opened by radially sliding an opening portion that covers the opening of the lid in a closed position. It is therefore preferred that the emptying device is arranged so that the user can perform this movement from the outside of the emptying bag, i.e., by the first and / or second membrane layers.

[0056] In addition, the integrated connector of the presently disclosed device allows a secure attachment between the emptying device assembly and the cover of the stoma implant and / or the stoma implant. The connector ring further reduces the risk of leakage by being used to form a seal between the compartment of the emptying device and the stoma implant and / or the cover of the stoma implant.

[0057] Various covers for stoma implants are known from the prior art. However, it is strongly preferred that the cover comprises connection means, such as an engagement flange, for engaging with the connector ring. Typically, the connection means of the cover are provided on a base portion of the cover. Furthermore, the base is preferably arranged to seal the open end of the stoma implant and comprises an opening portion adapted to move between an open position for emptying waste and a closed position for preventing waste from leaking from the stoma. Preferably, the opening portion is attached to the base in both the closed position and the open position. The opening portion can be opened, for example, by sliding, pulling, twisting or screwing a portion of the cover so that the cover is preferably opened by radially sliding the opening portion.

[0058] Preferably, the lid is arranged so that reverse movement of the opening portion moves the lid to its closed position. Once emptying of the stoma is complete, the user can close the lid, typically by reversing the movement of the opening portion to open the lid. After the lid is closed, the emptying device (i.e. the emptying device assembly) can be detached from the lid and disposed of.

[0059] Preferably, the connector ring is arranged to be attached to the stoma implant or the cover of the stoma implant by positioning the connector ring so that the protruding flange or a subset thereof (preferably the engaging flange) engages with a complementary surface of the cover and / or the stoma implant, for example wherein the complementary surface is a circumferential groove of the cover and / or the stoma implant and / or wherein the complementary surface is complementary to an inner engaging flange edge of the engaging flange.

[0060] Alternatively or additionally, the complementary surface of the stoma implant and / or the cover of the stoma implant can be one or more of a raised and / or lowered portion, a ridge, a protrusion, a recess, a notch, a groove, a hook and / or a pit. Preferably, the complementary surface of the cover and / or the stoma implant is arranged so that the protruding flange or a subgroup thereof can engage with the cover and / or the stoma implant. Typically, the complementary surface is one or more of a raised and / or lowered portion, a ridge, a protrusion, a recess, a notch, a groove, a hook and / or a pit of the cover and / or the stoma implant, which is complementary to the inner portion (i.e. the radially inward portion) of the protruding flange or a subgroup thereof (e.g., an engagement flange). Typically, the complementary surface of the stoma implant and / or the cover of the stoma implant is a circumferential complementary surface, such as a circumferential groove.

[0061] It is preferred that the plurality of radially inwardly projecting flanges of the connector ring comprise or consist of engagement flanges adapted to engage with one or more of raised and / or lowered portions, ridges, protrusions, recesses, notches, grooves, hooks and / or pits of a stoma implant and / or a cover of a stoma implant. Typically, the plurality of radially inwardly projecting flanges of the connector ring comprise or consist of engagement flanges adapted to engage with one or more circumferentially raised or lowered portions, circumferential ridges, circumferential protrusions and / or circumferential grooves of a stoma implant and / or a cover of a stoma implant.

[0062] The engaging flange can be made of an elastic but relatively rigid material so that the engaging flange can be slightly flexed during the attachment of the emptying device (i.e., the emptying device assembly) to the cover and / or the stoma implant, but once the connector is in the correct position, the engaging flange will return to its original non-flexed shape. Therefore, the engaging flange can form a snap-fit ​​connection / joint, such as an annular snap-fit ​​connection / joint, with one or more complementary surfaces on the stoma implant or the cover of the stoma implant. This allows a reversible but firm attachment between the emptying device and the cover and / or the implant. Various types of snap-fit ​​connections are known to those skilled in the art, including various types of complementary surfaces for forming a firm but reversible attachment.

[0063] Typically, the attachment of the connector to the cover / implant initially causes the engagement flange to be slightly flexed, which is typically due to the slightly larger diameter of the stoma implant and / or the cover of the stoma implant. When the engagement flange moves to a position where they can engage with the connecting means (e.g., complementary surface and / or circumferential groove), the engagement flange can be moved from a flexed position to a non-flexed position. The engagement flange can snap into the non-flexed position, which may cause an audible click. Typically, when engaging with the cover / stoma implant, the inner engagement flange edge is in direct contact with the complementary surface.

[0064] The engagement flange may comprise engagement means at an inner engagement flange edge, i.e. at a protruding end of the engagement flange. The engagement means may for example comprise one or more of raised and / or lowered portions, ridges, protrusions, recesses, notches, grooves, hooks, pits and / or guiding elements arranged to form a connection with a complementary surface of the stoma implant and / or a cover of the stoma implant, e.g. a connection with a complementary surface of the connecting means.

[0065] Typically, the engagement means of the connector comprises a surface complementary to a surface of the connection means of the stoma implant and / or the cover of the stoma implant. Typically, the engagement means is formed along an inner engagement flange edge. Thus, each engagement flange may comprise a guiding element along its inner engagement flange edge, preferably wherein the guiding element is complementary to a circumferential groove of the stoma implant and / or the cover of the stoma implant.

[0066] The engagement means of the engagement flange provide support and stability for the attachment of the connector ring to the stoma implant / cover and therefore allow a secure connection to be formed between the emptying device assembly and the stoma implant / cover even where the emptying bag is arranged to contain stoma waste which may exert significant forces on the connector ring. The presently disclosed embodiments therefore provide means for secure attachment whilst allowing the connector ring to be easily attached to and removed from the stoma implant / cover. The effect is even more pronounced if the engagement flange includes the engagement means, further serving to increase the support and stability provided to the connection.

[0067] A further improvement of the ability to bear the weight of the emptying device is the possibility to have additional radially inwardly protruding flanges, such as comprising support flanges adapted to stabilise the integrated connector ring during use, e.g. when the connector ring is connected to a cover and / or a stoma implant.

[0068] Thus, the connector may comprise a plurality of flanges, wherein the plurality of flanges comprises or consists of a subgroup of engagement flanges and / or a subgroup of support flanges. Preferably, the connector ring comprises an engagement flange and a support flange, more preferably, the connector ring comprises a plurality of radially inwardly projecting flanges, wherein every other flange is a support flange and every other flange is an engagement flange, i.e. each support flange is located between two engagement flanges and vice versa.

[0069] The support flange can be rigid generally, and is preferably also slightly shorter than the engagement flange. The support flange can have an inner support flange edge towards the center of the second hole. Preferably, the support flange is arranged so that when engaged with the stoma implant / cover, the inner support flange edge abuts the outer surface of the stoma implant / cover. The outer surface can be, for example, an outer circumferential ring of a stoma implant and / or the cover of a stoma implant. Typically the outer surface is a cylindrical surface. In this way, the support flange is arranged to provide support to the connector ring and is used to be fixedly connected to the stoma implant / cover.

[0070] Advantageously, the engagement flange and the support flange are arranged to engage the individual surface of the cover of the stoma implant and / or the stoma implant. This can be achieved, for example, by arranging the engagement flange and the support flange in a separated plane. Alternatively, the engagement flange can be provided with an inner engagement flange edge comprising a projection, the projection being arranged to engage the corresponding recess of the cover of the stoma implant and / or the stoma implant, and the support flange is provided with an inner support flange edge, the inner support flange edge being arranged to abut the outer surface of the stoma implant / cover. Typically, the support flange is arranged to abut an outer surface, for example an outer circumferential ring, the outer surface being near the complementary surface (for example circumferential recess) of the stoma implant / cover, for example adjacent thereto.

[0071] The support flange is usually arranged to abut against a surface separated from the surface to which the engagement flange is arranged to engage, for example by being arranged in a separation plane of the connecting ring. Therefore, the relative lengths of the support flange and the engagement flange may be less important, and on the contrary it may be more important that the size of the annulus formed by the inner engagement flange edge matches the size of the surface (e.g. circumferential recess) of the cover / stoma implant to which they will engage. Similarly, it may be more important that the size of the annulus formed by the inner support flange edge matches the size of the surface (e.g. outer circumferential ring) of the cover / stoma implant to which they will abut. Therefore, the inner support flange edge can form an annulus that is smaller, larger or has the same size as the annulus formed by the inner engagement flange edge.

[0072] It is preferred that the connector is attached to the outer surface of the first film layer, i.e. the surface of the first film layer away from the second film layer. It is further preferred that the emptying device assembly includes an annular protection area for forming a protective layer around the stoma implant or the cover of the stoma implant. During use, the protective layer can protect and / or provide a seal for the safe emptying of the stoma. Therefore, the annular protection area can be arranged to contact the outer part of the stoma implant and / or the cover of the stoma implant during use. The outer part is generally a circumferential surface, which is positioned towards the second film layer relative to the connecting device of the implant or the cover during use. The outer surface can be, for example, a circumferential surface between the connecting device (i.e. the outer surface of the implant or the cover) and the top part of the implant or the cover, i.e. wherein the top part is positioned away from the user during use.

[0073] The annular protection area is therefore typically concentric with the first hole and / or the connector ring. Preferably, the annular protection area extends radially inward from the connector ring and / or the annular attachment area of ​​the first membrane layer to which the connector ring is attached. The annular protection area may form a part of the first membrane layer, and in this case, the size of the first hole may be defined by the inner edge of the annular protection area. Therefore, the annular protection area may be defined as an annular band between the outer part of the first hole (i.e., its circumference) and the outer part of the second hole (i.e., its periphery). Alternatively, the annular protection area may not form a part of the first membrane layer. Therefore, in this arrangement, the annular protection area may be a separate layer attached to the connector ring and may at least partially overlap with the first hole.

[0074] Preferably, the annular protection area extends radially inwards from the connector ring, preferably across at least a portion of the length of the flange, more preferably across the entire length of the flange, and even more preferably beyond the entire length of the flange. Therefore, it is preferred that the annular protection area extends radially inwards so that it covers at least a portion of the flange, more preferably wherein the annular protection area extends radially inwards beyond the flange, for example at least 5 mm beyond the edge of the flange. The annular protection area may be arranged in the same plane as the connector, or in a separate plane, for example in a plane between the connector ring and the first membrane layer, in a layer of the first membrane layer, or in a layer between the first membrane layer and the second membrane layer. Furthermore, the emptying device and / or the emptying device assembly may comprise a plurality of annular protection areas for further improving protection and / or sealing.

[0075] Preferably, the annular protection area is formed by an elastic material, preferably by plastic. In a particular example, the annular protection area does not constitute a part of the connector ring, the first membrane layer and / or the second membrane layer, but it can be connected thereto. Alternatively, the annular protection area can form a part of the first membrane layer. In this example, the first hole in the first membrane layer is preferably smaller than the second hole of the connector ring. Preferably, the first hole is smaller than the annulus formed by any flange (e.g., support flange and / or engagement flange). In this example, and in the case where the connector ring is concentric with the first hole, the first membrane can form an annular protection area protruding beyond the flange. During use, the annular protection area is arranged to contact the stoma implant / cover, preferably the annular protection area is made of an elastic material, and the diameter of its inner edge is less than the diameter of the stoma implant / cover, so that a seal can be formed when the emptying device assembly is attached to the stoma implant / cover. It is preferred that the first membrane layer is made of an elastic material, preferably made of plastic, thereby allowing the first membrane layer to form an annular protection area for protecting / sealing the implant and / or the cover.

[0076] For embodiments in which the first and second film layers are attached along their entire periphery so as to form a bag, the tearing device is preferably arranged at the distal end of the emptying device. This allows the user to connect the emptying device to the stoma implant or the cover of the stoma implant and begin to empty the stoma. As known to those skilled in the art, under certain conditions, the emptying of the stoma may be time consuming. Providing the emptying device in the form of a bag allows the user to carry out normal daily activities while emptying the stoma. Once the emptying is completed, the user can dispose of the waste by positioning the distal end of the emptying device into, for example, a toilet, and, for example, forming an opening at the distal end of the emptying device by tearing, so that the waste is discharged into the toilet.

[0077] The tearing device may consist of or include one or more perforations and / or tearing notches formed in the surface of the first film layer where it is attached to the second film layer. For example, the tearing device may include a pair of notches located on opposite sides of the distal end of the emptying device. Alternatively or additionally, the tearing device may include a tab attached (e.g. welded) to the first and / or second film layer, and wherein the tab is arranged so that pulling the tab tears the opening at the distal end of the emptying device.

[0078] Advantageously, the emptying device is arranged such that the integrated connector ring forms a fluid connection between the emptying device and the stoma when attached to the stoma implant and / or the cover of the stoma implant.Thereby stoma waste can be safely drained from the stoma into the emptying device.

[0079] Preferably, the annular base is attached (such as welded) to the first membrane layer at an annular attachment area. The annular attachment area is preferably concentric with the first hole. Therefore, the annular attachment area can be an annular surface around the first hole and it is concentric with the first hole, that is, the center of the annular attachment is concentric with the first hole.

[0080] In an embodiment of the present disclosure, the first membrane layer includes an annular protective region extending radially inwardly from the annular attachment region. Preferably, the flange or a portion of the flange (e.g., the support flange and / or the engagement flange) does not extend radially inwardly beyond the annular protective region. Thus, the annular band formed by the inner support flange edge and / or the inner engagement flange edge is larger than the circular opening of the annular protective region, e.g., the first hole.

[0081] In an embodiment of the present disclosure, the annular protection area at least partially overlaps the first hole. Thus, the annular protection area may extend radially inwardly into at least a portion of the first hole. Thus, the annular protection area may be formed by a membrane layer that is separate from the first membrane layer. Preferably, the annular protection area is concentric with the first hole, i.e., the centers of the annular protection area and the first hole coincide.

[0082] In an embodiment of the present disclosure, the first hole and the second hole are substantially circular. In addition, it is preferred that the first hole and the second hole substantially overlap. Therefore, the center of the circular first hole can coincide with the center of the circular second hole.

[0083] In an embodiment of the present disclosure, a plurality of radially inwardly projecting flanges are separated by gaps that are generally of the same size. The gaps may thus separate a support flange from an engagement flange and / or other support flanges, and similarly, they may separate an engagement flange from a support flange or other engagement flanges. The gaps may enable a flange to move, e.g. bend, independently of an adjacent flange. Thus, the gaps may facilitate separate bending of the engagement flanges during attachment to a stoma implant and / or a stoma implant cover.

[0084] In an embodiment of the present disclosure, a plurality of radially inwardly projecting flanges comprise an engagement flange adapted to engage with a connecting means of a cylindrical stoma implant or a cover of a stoma implant. The connecting means of the stoma implant and / or the cover may, for example, comprise one or more of a raised and / or lowered portion, a ridge, a protrusion, a recess, a notch, a groove, a hook and / or a pit, preferably wherein the connecting means is circumferential, such as one or more of a circumferential hook, a circumferential protrusion, a circumferential ridge, a circumferential notch, a circumferential pit and / or a circumferential recess. Therefore, a plurality of radially inwardly projecting flanges may each be adapted to engage with one or more of a raised and / or lowered portion, a ridge, a protrusion, a recess, a notch, a groove, a hook and / or a pit, preferably wherein the connecting means is circumferential, such as one or more of a circumferential hook, a circumferential protrusion, a circumferential ridge, a circumferential notch, a circumferential pit and / or a circumferential recess.

[0085] In a particular example, the connection means is an outer circumferential groove of a cylindrical ostomy implant and / or a cover of a ostomy implant. The engagement flanges are thus each adapted to engage said circumferential groove, e.g. by each comprising an inner engagement flange edge adapted to engage with said groove, e.g. wherein said inner engagement flange edge comprises a surface complementary to said circumferential groove, preferably wherein said inner engagement flange edge comprises a guiding element.

[0086] In a preferred embodiment of the present disclosure, each engagement flange has a hook element or a guide element at the inner engagement flange edge towards the center of the second hole. Preferably, the hook element or the guide element is sized to fit into a circumferential groove of a cylindrical stoma implant or a cover of a stoma implant.

[0087] Preferably, each joining flange may have one or more of raised and / or lowered portions, ridges, protrusions, recesses, notches, grooves, hook elements, pits and / or guide elements preferably formed along at least a portion of the inner joining flange edge of each joining flange.

[0088] In an embodiment of the present disclosure, the engagement flange is made of elastic material.Preferably, the engagement flange is elastic and / or flexible, because the annulus formed by the inner engagement flange edge is usually smaller than the diameter of the part of the cover of the stoma implant and / or the stoma implant, and the flange needs to move across the part during attachment.Usually, when the engagement flange engages with the cover of the stoma implant and / or the stoma implant, the engagement flange snaps back to its original unbent configuration with an audible click sound.At this position, the engagement flange is usually engaged with the complementary surface (such as complementary circumferential surface) of the cover of the stoma implant and / or the stoma implant.In order to reach the complementary surface, the engagement flange must be slightly bent usually, i.e. when the cover of the stoma implant and / or the stoma implant passes the connector ring.Therefore, the engagement flange can be arranged to engage the stoma implant and / or the stoma implant cover by a snap-fit ​​mechanism.

[0089] In an embodiment of the present disclosure, the plurality of radially inwardly protruding flanges comprises a support flange adapted to stabilize the integrated connector ring. Preferably, the support flange is generally hard. The support flange is thus preferably harder than the engagement flange.

[0090] It is further preferred that each support flange has an inner support flange edge towards the center of the second hole, wherein the support flange size is determined so that the inner support flange edge abuts the outer circumferential ring of the cover of the cylindrical stoma implant or stoma implant. The support flange can be positioned in the same plane as the engagement flange, or alternatively, they can be positioned in a plane separated from the plane of the engagement flange. By arranging the support flange and the engagement flange in the separated plane, the support provided by the connector ring for attaching the emptying device assembly can be increased. It is further preferred that each support flange has a support structure. The support structure provides increased support for the entire structure. Therefore, when the connector ring is attached / connected to the cover or stoma implant for stoma implant, and when the connector ring is not attached to the cover and stoma implant, the support structure can allow the rigidity of the connector ring to be increased. Therefore, the support structure can increase the structural rigidity of the connector ring, such as flexural rigidity or bending rigidity.

[0091] The support structure typically includes at least one radially extending support element and / or at least one edge support element disposed along an edge of the inner support flange.

[0092] It is preferred that every other radially inwardly projecting flange is an engagement flange and every other radially inwardly projecting flange is a support flange. Thus, each support flange may be adjacent to two engagement flanges and each engagement flange may be adjacent to two support flanges. This arrangement of flanges has been shown to increase the structural rigidity of the connector and therefore increase the ability to provide a secure means for attaching the emptying device assembly to a stoma implant and / or a cover for a stoma implant.

[0093] In a preferred embodiment of the present disclosure, the engagement flange protrudes more than the support flange. Therefore, the engagement flange may protrude more radially inwardly than the support flange. Therefore, the annulus formed by the inner engagement flange edge may be smaller than the annulus formed by the inner support flange edge. However, as described elsewhere herein, the arrangement may depend on the structure of the stoma implant and / or the cover of the stoma implant to which the emptying device assembly is to be attached, and / or whether the different types of flanges are located in the same plane or in separate planes.

[0094] In an embodiment of the present disclosure, the support flange is harder than the engagement flange. The hardness may be attributed to the material and / or size of the flange. However, the support flange is preferably harder than the engagement flange. In this way, the engagement flange can be arranged to easily engage with the stoma implant and / or the cover of the stoma implant, for example by bending and snapping into place, while the short and more rigid support flange abuts the outer surface of the stoma implant and / or the cover of the stoma implant. It has been shown that this arrangement of the flange provides a secure attachment of the emptying device assembly to the stoma implant and / or the cover of the stoma implant, even when the emptying device is a bag and the connection must be able to withstand the weight of the waste collected in the bag.

[0095] In an embodiment of the present disclosure, the emptying device has a conical shape, preferably a substantially flat conical shape. In an embodiment of the present disclosure, the emptying device has a triangular shape with one truncated corner.

[0096] In an embodiment of the present disclosure, the evacuation device is an open-ended evacuation sleeve.

[0097] In an embodiment of the present disclosure, the emptying device is an emptying bag. Preferably, the emptying bag comprises tearing means, such as one or more tabs, perforations and / or notches for opening one end of the emptying bag.

[0098] Another aspect of the present disclosure relates to a method of making a venting device and / or venting device assembly as disclosed herein. The method includes attaching a first film layer and a second film layer along a peripheral portion of the layers to form a sleeve or bag having a compartment between the first and second film layers. Thus, the first and second film layers can be attached along their entire periphery to form a bag. In other examples, the first and second film layers are attached along only a portion of their periphery, so that an opening is formed along the non-attached portion of the periphery.

[0099] The method preferably comprises forming a first circular hole in the first membrane layer, or alternatively the first membrane layer may be provided with the first circular hole, so that the first circular hole may be present before attaching the first membrane layer and the second membrane layer.

[0100] The method preferably comprises attaching a connector ring to an annular attachment area of ​​the first membrane layer, wherein the annular attachment area is arranged around the first hole. The connector is typically attached to the outside of the first membrane layer, i.e. the side of the first membrane layer facing away from the second membrane layer. The annular base of the connector ring is typically attached to the first membrane layer so that its center coincides with the center of the first hole. The annular base may define a second hole concentric with the first hole. However, preferably the centers of the first hole and the second hole coincide. For example, the first hole may be smaller than the second hole and concentric with the second hole.

[0101] The integrated connector ring generally includes a plurality of flanges protruding inwardly, preferably a plurality of flanges protruding radially inwardly. It is further preferred that the flange or a subgroup thereof is arranged to engage with a stoma implant and / or a cover of a stoma implant. Therefore, the flange can be referred to as an engagement flange. Therefore, the flange of the connector ring or a subgroup thereof (i.e., the engagement flange) can be arranged to engage with a stoma implant and / or a cover of a stoma implant. Preferably, wherein the engagement flange is arranged to engage with a connecting device of a stoma implant and / or a cover of a stoma implant. The connecting device of a stoma implant and / or a cover of a stoma implant can be one or more of a raised and / or lowered portion, a ridge, a protrusion, a notch, a groove, a hook, a recess and / or a pit, preferably wherein the connecting device is circumferential, such as one or more of a raised and / or lowered circumferential portion, a circumferential ridge, a circumferential protrusion, a circumferential notch, a circumferential groove, a circumferential hook, a circumferential recess and / or a circumferential pit.

[0102] Most preferably, the engagement flange is arranged to engage with a circumferential groove of the stoma implant and / or a cover of the stoma implant.

[0103] It should be noted that the order of the method is not important, because the first hole can be formed in the membrane layer before or after the attachment of the first and second membrane layers. Similarly, the connector ring can be attached to the first membrane layer before forming the first hole and / or before attaching the first membrane layer to the second membrane layer.

[0104] As an example, the order of steps may be, for example: 1. attaching the first film layer and the second film layer along the peripheral portion of the layer to form a sleeve or bag; 2. forming a first circular hole in the first film layer; and 3. attaching a connector ring to the first film layer around the first hole. Alternatively, the order may be: 1. attaching the first film layer and the second film layer along the peripheral portion of the layer to form a sleeve or bag; 2. attaching the connector ring to the first film layer around the location of the first hole; and 3. forming the first circular hole in the first film layer. Alternatively, the order may be: 1. forming a first circular hole in the first film layer; 2. attaching the first film layer and the second film layer along the peripheral portion of the layer to form a sleeve or bag; and 3. attaching the connector ring to the first film layer around the first hole. Alternatively, the order may be: 1. forming a first circular hole in the first film layer; 2. attaching the connector ring to the first film layer around the first hole; and 3. attaching the first film layer and the second film layer along the peripheral portion of the layer to form a sleeve or bag. Alternatively, the sequence may be: 1. attaching a connector ring to the first film layer around the location of the first hole; 2. forming a first circular hole in the first film layer; and 3. attaching the first film layer and the second film layer along the peripheral portion of the layer to form a sleeve or bag. Alternatively, the sequence may be 1. attaching a connector ring to the first film layer around the location of the first hole; 2. attaching the first film layer and the second film layer along the peripheral portion of the layer to form a sleeve or bag; and 3. forming a first circular hole in the first film layer at the location of the first hole.

[0105] A further improvement of the ability to bear the weight of the emptying device is the possibility of having an additional radially inwardly protruding flange, said flange comprising a support flange adapted to stabilize the integrated connector ring. Thus, the connector may comprise a plurality of flanges, wherein said plurality of flanges comprises or consists of a subgroup of an engagement flange and / or a support flange. Preferably, the connector comprises an engagement flange and a support flange, more preferably wherein every other flange is a support flange and every other flange is an engagement flange.

[0106] The support flange can be hard usually, usually harder than the engagement flange. In addition, the support flange can be slightly shorter than the engagement flange. The support flange can have an inner support flange edge towards the center of the second hole, wherein the support flange size is determined so that the inner support flange edge abuts the outer circumferential ring of the cover of the cylindrical stoma implant and / or the stoma implant. Therefore, the support flange can contribute to the overall structural strength of the connector ring without affecting usability. The protruding flange can be arranged so that every other radially inward protruding flange is an engagement flange, and every other radially inward protruding flange is a support flange. The support flange and the engagement flange can be located in different planes to increase support. Therefore, the support flange can be arranged to prevent the connector ring from tilting axially when being attached to the stoma implant and / or the cover of the stoma implant.

[0107] It is preferred that the connector is positioned on the outer surface of the first film layer, ie away from the compartment formed between the two inner surfaces of the first and second film layers.The connector is thus exposed and can be connected to the stoma implant or a cover of the stoma implant.

[0108] It is further preferred that the connector comprises an annular protective region for forming a protective layer around the stoma implant or the cover of the stoma implant. During use, the protective layer can protect and / or provide a seal for the safe emptying of the stoma. The annular protective region can therefore be arranged to contact the outer surface of the stoma implant or the cover of the stoma implant.

[0109] The annular protection area is usually concentric with the first hole and / or the connector ring. Preferably, the annular protection area extends radially inwardly from the connector ring or the area of ​​the first membrane to which the connector ring is attached. Therefore, the size of the first hole can be defined by the annular protection area.

[0110] Preferably, the annular protection area extends radially inwards beyond the flanges, i.e. the support flange and / or the engagement flange. The annular protection area may be arranged in the same planar layer as the connector, or in a layer below the connector ring, such as between the connector ring and the first film layer, in a layer of the first film layer, or in a layer between the first film layer and the second film layer.

[0111] Preferably, the annular protection area is formed by an elastic material, preferably by plastic. The annular protection area can be formed by a material that is separated from the connector ring, the first membrane layer and / or the second membrane layer but may be connected to it. However, the annular protection area can also be formed by the first membrane layer. In this example, the hole in the first membrane layer is made smaller than the annulus formed by any flange (e.g., a support flange and / or an engagement flange). In the case where the connector ring is concentric with the first hole, the first membrane layer therefore protrudes beyond the flange, thereby forming an annular protection area for connecting to a stoma implant or a cover of a stoma implant during use. Therefore, in an embodiment of the present disclosure, the size (e.g., diameter) of the first hole formed is smaller than the annulus formed by any flange (e.g., an engagement flange and / or a support flange) of the connector.

[0112] For embodiments in which the first and second film layers are attached along their entire periphery so as to form a bag, the tearing device is preferably arranged at the distal end of the emptying device. This allows the user to connect the emptying device to the stoma implant or the cover of the stoma implant and start emptying the stoma. As known to those skilled in the art, under certain conditions, the emptying of the stoma may be time consuming. Providing the emptying device in the form of a bag allows the user to carry out normal daily activities while emptying the stoma. Once the emptying is completed, the user can position the distal end of the emptying device, for example, in a toilet, and tear open the opening at the distal end of the emptying device so that the emptying device is emptied.

[0113] The tearing means may comprise or consist of one or more perforations or tearing notches formed in the surface of the first film layer attached to the second film layer. For example, the tearing means may comprise a pair of notches located on opposite sides of the distal end of the emptying device. Alternatively or additionally, the tearing means may comprise a tab attached (e.g. welded) to the first and / or second film layer, and wherein the tab is arranged such that pulling the tab tears the opening at the distal end of the emptying device.

[0114] In a further aspect, the present disclosure relates to a connector ring for attaching a further device to a stomal implant or a cover of a stomal implant, the connector ring comprising:

[0115] - an annular base defining a connector aperture; and

[0116] - A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0117] Preferably, the connector ring is as disclosed elsewhere herein.The connector ring may, for example, be arranged to facilitate connection between an emptying device (such as connection to a ostomy bag, catheter or sleeve) and a stomy implant and / or cover.

[0118] Detailed description of the drawings

[0119] The present invention will be described in more detail below with reference to the accompanying drawings. The drawings are exemplary and are intended to illustrate some features of the presently disclosed emptying device assembly and the method of manufacturing the emptying device according to the present disclosure, and should not be interpreted as limiting the presently disclosed invention.

[0120] Figure 1 A top view of an embodiment of a currently disclosed emptying device assembly (100) for emptying a stoma is shown. It can be seen that the emptying device assembly (100) for emptying a stoma includes an emptying device (110), the emptying device including a first film layer (111) and a second film layer (112), wherein the first film layer and the second film layer are attached along a peripheral portion (113) to form the emptying device (110). An exemplary emptying device (110) is a bag, however, as disclosed elsewhere herein, the emptying device (111) can be, for example, an open-ended emptying sleeve, for example, if the first film layer and the second film layer are not attached along a distal end (117) of the emptying device (111). Typically the emptying device has a tapered shape, such as a tapered conical shape. The emptying device is preferably tapered from the proximal end (116) toward the distal end (117). Therefore, the emptying device (110) can be said to have a triangular shape with a truncated corner (118). Thus, the length of the distal end (117) is typically shorter than the length of the proximal end (116).

[0121] The emptying device assembly further comprises a first hole (114) formed in the first film layer of the emptying device. The first hole is generally formed towards the proximal end (116) of the emptying device. The emptying device comprises a tearing device (115), here shown as a pair of notches formed towards the distal end (117) of the emptying device. Preferably, the notches or any other form of tearing device are provided in the surface where the first film layer is attached to the second film layer.

[0122] The evacuation device assembly also includes an integrated connector ring (150) arranged around the first hole (114). The connector ring is attached to the outer surface of the first membrane layer (111). The connector ring includes an annular base defining a second hole (151), which is also called a connector hole, and wherein the second hole is concentric with the first hole, i.e., the centers of the first hole and the second hole coincide. The annular base of the connector ring is attached (such as welded) to the evacuation device around the first hole.

[0123] The emptying device (110) of the emptying device assembly (100) is Figure 2 . It can be seen that the evacuation device includes an annular attachment area (119) and an annular protection area (120) surrounding the first hole (114). The size of the annular protection area can be considered to define the size of the first hole, i.e. the diameter. The connector ring (150) is attached to the annular attachment area (119) so that the centers of the second hole (151) and the first hole (114) coincide, and wherein the first hole (114) is smaller than the second hole (151), as shown in FIG. Figure 1 Visible in.

[0124] Figure 3 A side view of the emptying device assembly (100) is shown. It can be seen that the emptying device (110) includes a first film layer (111) attached to and overlapping a second film layer (112). In addition, a connector ring (150) is provided toward the proximal end (116) of the emptying device (110) and is attached to the first film layer (111).

[0125] Figure 4 A perspective view of a connector ring (150) is shown comprising an annular base (152) defining a second hole (151) concentric with the first hole, also referred to as the connector hole. The connector ring comprises a plurality of radially inwardly protruding flanges (153), wherein at least a subset of the protruding flanges are engagement flanges (155) adapted to engage with an outer circumferential groove of a cylindrical ostomy implant (300) or a cover (200) of the ostomy implant. Each engagement flange (155) has a connection means, such as a hook element / guiding element (156), for engaging with the cylindrical ostomy implant (300) or the cover (200) of the ostomy implant. The connection means, such as the hook element or the guiding element, is sized to fit into the circumferential groove of the cylindrical ostomy implant or the cover of the ostomy implant.

[0126] The connection means are arranged at each inner engagement flange edge (157) towards the centre of the second hole (151). The connector ring further comprises a radially inwardly projecting support flange (158). The inner engagement flange edge (157) forms a smaller circle / annular band than that formed by the inner support flange edge (160). Thus, the engagement flange (155) projects radially inwardly more than the support flange (158).

[0127] Figure 5 A top view of a connector ring (150) is shown, the connector ring comprising an annular base (152) and a plurality of radially inwardly projecting flanges (153). Here, every other radially inwardly projecting flange is an engagement flange (155) and every other radially inwardly projecting flange is a support flange (158). It can be seen that the radially inwardly projecting flanges (153) are separated by gaps (154) and wherein gaps are formed along each radially inwardly projecting flange. Each support flange has a support structure (159) comprising at least one radially extending support element (161) and / or at least one edge support element (162) disposed along an inner support flange edge (160). In the example shown, the support structure comprises one radially extending support element (161) and one edge support element (162) disposed along an inner support flange edge (160). The support structure is arranged to provide increased rigidity to the connector ring and is typically stiff, preferably stiffer than the engagement flanges.

[0128] Figure 6 shows a cover (200) for a stoma implant. The cover (200) comprises an annular base portion (230) adapted to engage with the open end of the stoma implant, Figure 6C Furthermore, the cover comprises a cap portion (220) adapted to fit within the interior of the annular base portion, Figure 6B , wherein the cap portion is rotatable relative to the annular base portion to lock and unlock the cover to the stoma implant, and wherein the cap portion has a through hole. The cap portion also has a slider (210), Fig. 6A , the slider is configured to slide radially into the recess of the cap portion in a closed configuration, wherein the slider completely covers the through hole of the cap portion, and to slide radially out of the recess in an open configuration, wherein the slider does not cover the through hole of the cap portion.

[0129] The cover (200) includes a connection device (231) in the form of a circumferential groove formed on the outer surface of the base portion of the cover. In addition, the cover includes an outer circumferential ring (232). During use, the cover is attached to the stoma implant and prevents waste from leaking from the stoma. In order to empty the stoma, the user attaches the emptying device assembly (100) to the cover (200) by pushing the connector ring above the cover so that at least the slider moves inside the emptying device (i.e., moves to the compartment formed between the first film layer and the second film layer). Once the engagement flange engages with the connection device of the cover (i.e., the circumferential groove (231)), the emptying device assembly is attached to the cover (200). In this position, the support flange can abut the outer circumferential ring (232) located below the circumferential groove (231), i.e., toward the user of the cover. In this position, the engagement flange and the support flange provide support for the emptying device (110) and / or the emptying device assembly (100), thereby allowing safe emptying of the stoma.

[0130] Figure 7 An example of an ostomy implant (300) is shown, the implant being formed of an inner section (305) and an outer section (306). When implanted in a patient, the inner section (305) is mostly or completely inside the patient's body, while the outer section (306) is mostly or completely outside the patient's body.

[0131] The inner section (305) includes an inner section inner portion (307) comprising a generally cylindrical structure formed by a hexagonal mesh structure. An inner section outer portion (308) connects the inner section inner portion to the outer section (306). The inner section outer portion is formed by a plurality of rods arranged circumferentially around the implant, the plurality of rods extending between the inner section inner portion and the outer section.

[0132] The outer section (306) is annular and includes a connecting device (301) in the shape of an outer circumferential groove. The connector ring of the emptying device assembly (100) can be attached to the implant by pushing the connector ring onto the outer section of the implant. The open end (302) and the upper circumferential edge portion of the implant are made to protrude into the compartment of the emptying device formed between the first membrane layer and the second membrane layer. When the engagement flange engages with the circumferential groove (301) of the implant, the connector ring engages with the implant. When the connector ring is pushed into the correct position to engage with the implant, the engagement flange snaps into the appropriate position in the circumferential groove (301). In this position, the support flange abuts the outer surface of the implant, such as the outer circumferential ring (304), thereby providing increased support.

[0133] List of elements in the drawings

[0134] 100-Emptying Device Assembly

[0135] 110-Emptying device

[0136] 111-First film layer

[0137] 112-Second film layer

[0138] 113-Surrounding area

[0139] 114 – First Hole

[0140] 115-Notch

[0141] 116-Proximal

[0142] 117-Remote

[0143] 118-Cut Angle

[0144] 119-Annular attachment area

[0145] 120-Ring protection area

[0146] 150-Connector Ring

[0147] 151-Second hole

[0148] 152-Ring base

[0149] 153-Radially inward protruding flange

[0150] 154-Gap

[0151] 155-Joint flange

[0152] 156-Hook element / Guide element

[0153] 157-Inner joint flange edge

[0154] 158-Support flange

[0155] 159-Support structure

[0156] 160-Inner support flange edge

[0157] 161-Radially Extended Support Element

[0158] 162-Edge support element

[0159] 200-cap

[0160] 210-Sliders

[0161] 220-cap part

[0162] 230-base part

[0163] 231-outer circumferential groove

[0164] 232-Peripheral Ring

[0165] 233-External part

[0166] 300-Ostomy Implant

[0167] 301- Circumferential groove

[0168] 302-Open end

[0169] 303-Last week to the edge

[0170] 305-Internal Section

[0171] 306-External section

[0172] 307-Inner section

[0173] 308-Inner section outer part

[0174] project

[0175] 1. An emptying device assembly for emptying a stoma, comprising:

[0176] - a first membrane layer and a second membrane layer, the first membrane layer and the second membrane layer being attached along a peripheral portion to form an emptying device, wherein the first membrane layer comprises a first hole; and - an integrated connector ring, the integrated connector ring comprising:

[0177] ° an annular base defining a second hole concentric with the first hole, wherein the annular base is attached to the emptying device around the first hole, such as welded to the emptying device;

[0178] ° A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0179] 2. An emptying device assembly according to item 1, wherein the integrated connector ring is suitable for forming a fluid connection between the emptying device and the stoma.

[0180] 3. Emptying device assembly according to any of the preceding items, wherein the first membrane layer is elastic.

[0181] 4. An emptying device assembly according to item 3, wherein the first hole is smaller than the second hole.

[0182] 5. Emptying device assembly according to any of the preceding items, wherein the annular base is attached to, for example welded to, an annular attachment area of ​​the first membrane layer.

[0183] 6. An emptying device assembly according to item 5, wherein the first membrane layer includes an annular protection area, which extends radially inwardly relative to the annular attachment area so as to overlap at least a portion of the second hole.

[0184] 7. Emptying device assembly according to item 6, wherein the annular protection area at least partially overlaps the second hole.

[0185] 8. An emptying device assembly according to any one of items 5-7, wherein the annular protective area is arranged to protect an outer part of the implant or the cover during use and / or to form a seal against the outer part.

[0186] 9. An emptying device assembly according to any one of items 5 to 8, wherein the annular protective area extends radially inwardly so that it covers the flange.

[0187] 10. Emptying device assembly according to any one of item 9, wherein the annular protective area extends radially inwardly beyond the flange, for example at least 5 mm beyond the edge of the flange.

[0188] 11. Emptying device assembly according to any of the preceding items, wherein the first hole and the second hole are substantially circular, and / or wherein the first hole and the second hole are substantially concentric.

[0189] 12. Emptying device assembly according to any of the preceding items, wherein the plurality of radially inwardly projecting flanges are separated by gaps.

[0190] 13. The emptying device assembly according to any of the preceding items, wherein the plurality of radially inwardly protruding flanges comprises an engagement flange adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0191] 14. The emptying device assembly according to item 13, wherein the engagement flange is made of an elastic material.

[0192] 15. An emptying device assembly according to any one of items 13-14, wherein the connector ring comprises limiting means for limiting bending of one or more engagement flanges in a direction away from the second membrane layer.

[0193] 16. Emptying device assembly according to item 15, wherein the limiting device comprises two adjacent protrusions, which are arranged to limit the bending of the engagement flange in the direction of the protrusions.

[0194] 17. Emptying device assembly according to any of items 13-16, wherein each engagement flange has a hook element or a guide element at an inner engagement flange edge towards the center of the second hole.

[0195] 18. Emptying device assembly according to item 17, wherein the hook element or the guide element is dimensioned to fit into the circumferential groove of the cylindrical ostomy implant or the cover of the ostomy implant.

[0196] 19. Emptying device assembly according to any of the preceding items, wherein said plurality of radially inwardly protruding flanges comprises support flanges adapted to stabilize said integrated connector ring.

[0197] 20. The emptying device assembly according to item 19, wherein the support flange is generally rigid.

[0198] 21. An emptying device assembly according to any one of items 19-20, wherein each support flange has an inner support flange edge toward the center of the second hole, wherein the size of the support flange is determined so that the inner support flange edge is adjacent to the outer circumferential ring of the cylindrical stoma implant or the cover of the stoma implant.

[0199] 22. An emptying device assembly according to any one of items 19-21, wherein each support flange has a support structure.

[0200] 23. An emptying device assembly according to item 22, wherein the support structure comprises at least one radially extending support element and / or at least one edge support element arranged along the edge of the inner support flange.

[0201] 24. The emptying device assembly according to any one of items 13 to 18 and any one of items 19 to 23, wherein every other radially inwardly protruding flange is an engagement flange and every other radially inwardly protruding flange is a support flange.

[0202] 25. Emptying device assembly according to any one of items 13 to 18 and any one of items 19 to 24, wherein the engagement flange protrudes further than the support flange.

[0203] 26. Emptying device assembly according to any one of items 13 to 18 and any one of items 19 to 25, wherein the support flange is harder than the engagement flange.

[0204] 27. Emptying device assembly according to any of the preceding items, wherein the emptying device has a conical shape, preferably a substantially flat conical shape.

[0205] 28. Emptying device assembly according to item 27, wherein the emptying device has a triangular shape with one truncated corner.

[0206] 29. Emptying device assembly according to any of the preceding items, wherein the emptying device is an open-ended emptying sleeve.

[0207] 30. An emptying device assembly according to any one of items 1 to 28, wherein the emptying device is an emptying bag.

[0208] 31. An emptying device assembly according to item 30, wherein the emptying bag comprises a perforation and / or one or more notches for opening one end of the emptying bag.

[0209] 32. A method of manufacturing an emptying device assembly according to any of the preceding clauses, the method comprising the following steps (in any order):

[0210] forming a first circular hole in the first film layer;

[0211] Attaching the first film layer and the second film layer along a peripheral portion of the layers to form a sleeve or bag;

[0212] Attaching a connector ring to the first membrane layer around the first hole, wherein the connector ring comprises:

[0213] ° an annular base defining a second aperture concentric with the first aperture; and

[0214] ° A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0215] 33. A method according to item 32, wherein the emptying device assembly is arranged according to any of items 1-31.

[0216] 34. A connector ring for attaching a further device to a ostomy implant or a cover of a ostomy implant, the connector ring comprising:

[0217] an annular base defining a connector aperture; and

[0218] - A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0219] 35. Connector ring according to item 34, wherein the connector ring comprises attachment means for attaching the further device to the connector ring.

[0220] 36. A connector ring according to any of items 34-35, wherein the connector ring forms an integral part of the further device.

[0221] 37. A connector ring according to any of items 34-39, wherein the connector ring forms an integral part of the further device.

[0222] 38. A connector ring according to any of items 34-40, wherein the integrated connector ring is adapted to form a fluid connection between the further device and the stoma.

[0223] 39. A connector ring according to any one of items 34-41, wherein the connector hole is generally circular.

[0224] 40. A connector ring according to any one of items 34-44, wherein the plurality of radially inwardly projecting flanges are separated by gaps.

[0225] 41. A connector ring according to any one of items 34-45, wherein the plurality of radially inwardly protruding flanges comprises an engagement flange adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

[0226] 42. A connector ring according to item 41, wherein the connector ring comprises limiting means for limiting bending of one or more engagement flanges in a direction away from the second membrane layer.

[0227] 43. Connector ring according to item 42, wherein the limiting means comprises two adjacent protrusions, which are arranged to limit the bending of the engagement flange in the direction of the protrusions.

[0228] 44. A connector ring according to any one of items 41-43, wherein the engagement flange is made of an elastic material.

[0229] 45. Connector ring according to any of items 41-44, wherein each engagement flange has a hook element or a guiding element at an inner engagement flange edge towards the center of the second hole.

[0230] 46. ​​Connector ring according to item 45, wherein the hook element or the guiding element is dimensioned to fit into the circumferential groove of the cylindrical ostomy implant or the cover of the ostomy implant.

[0231] 47. A connector ring according to any of items 34-46, wherein the plurality of radially inwardly projecting flanges comprises a support flange suitable for stabilizing the integrated connector ring.

[0232] 48. The connector ring of item 47, wherein the support flange is generally rigid.

[0233] 49. A connector ring according to any one of items 47-48, wherein each support flange has an inner support flange edge toward the center of the second hole, wherein the size of the support flange is determined so that the inner support flange edge is adjacent to the outer circumferential ring of the cylindrical ostomy implant or the cover of the ostomy implant.

[0234] 50. A connector ring according to any one of items 47-49, wherein each support flange has a support structure.

[0235] 51. A connector ring according to item 50, wherein the support structure includes at least one radially extending support element and / or at least one edge support element arranged along the edge of the inner support flange.

[0236] 52. A connector ring according to any one of items 41-46 and any one of items 47-51, wherein every other radially inwardly projecting flange is an engagement flange and every other radially inwardly projecting flange is a support flange.

[0237] 53. A connector ring according to any one of items 41-46 and any one of items 47-52, wherein the engagement flange protrudes further than the support flange.

[0238] 54. A connector ring according to any one of items 41-46 and any one of items 47-53, wherein the support flange is harder than the engagement flange.

[0239] 55. A connector ring according to any one of items 34-54, wherein the connector ring is arranged according to the connector ring of any one of items 1-31.

[0240] 56. Use of a connector ring according to any of items 34-54 for attaching a further device to a ostomy implant or a cover of a ostomy implant.

[0241] 57. The use according to item 56, wherein the further device is an ostomy bag, a catheter or a sleeve, such as an emptying sleeve or an irrigation sleeve.

[0242] 58. Use according to any of items 56-57, wherein the connector ring forms an integral part of the further device.

Claims

1. An emptying device assembly for emptying a stoma, the emptying device assembly comprising: - a first membrane layer and a second membrane layer, the first membrane layer and the second membrane layer being attached along a peripheral portion to form the evacuation device, wherein the first membrane layer comprises a first hole; and - An integrated connector ring, comprising: ° an annular base defining a second hole concentric with the first hole, wherein the annular base is attached to an annular attachment area of ​​the first membrane layer around the first hole; ° A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

2. The emptying device assembly according to claim 1, wherein: The first membrane layer is elastic, and wherein the first pores are smaller than the second pores.

3. An emptying device assembly according to any one of the preceding claims, wherein: The emptying device assembly comprises an annular protective area arranged to reduce leakage and / or form a seal to the stomal implant or a cover of the stomal implant during use.

4. An emptying device assembly according to any one of the preceding claims, wherein: The annular protective region is formed by extending the first membrane layer radially inwardly from the annular attachment region.

5. The emptying device assembly according to claim 4, wherein: The annular protective region extends radially inwardly and beyond a radially inner edge of the flange.

6. An emptying device assembly according to any one of the preceding claims, wherein: The plurality of radially inwardly protruding flanges comprises an engagement flange adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant; and wherein the engagement flange is made of an elastic material.

7. The emptying device assembly according to claim 6, wherein: The connector ring includes a limiting device for limiting bending of at least one of the engagement flanges in an outward direction away from the second membrane layer; while the at least one engagement flange is not limited by the limiting device to bend in an inward direction toward the second membrane layer.

8. The emptying device assembly according to claim 7, wherein: The limiting means comprises two adjacent protrusions arranged to limit a bending of at least one engagement flange in the direction of the protrusions.

9. An emptying device assembly according to any one of claims 6 to 8, wherein: Each engagement flange comprises a hook element or a guide element at an inner engagement flange edge towards the center of the second hole.

10. An emptying device assembly according to any one of the preceding claims, wherein: The plurality of radially inwardly projecting flanges include support flanges adapted to stabilize the integrated connector ring.

11. The emptying device assembly according to claim 10, wherein: Each support flange has an inner support flange edge towards the centre of the second hole and wherein the support flanges are dimensioned such that the inner support flange edge abuts an outer circumferential ring of the cylindrical ostomy implant or of a cover of the ostomy implant.

12. An emptying device assembly according to any one of claims 10-11, wherein: Each support flange has a support structure.

13. An emptying device assembly according to any one of claims 6 to 9 and any one of claims 10 to 12, wherein: Every other radially inwardly protruding flange is an engagement flange, and every other radially inwardly protruding flange is a support flange.

14. An emptying device assembly according to any one of claims 6 to 9 and any one of claims 10 to 13, wherein: The engaging flange protrudes further than the supporting flange.

15. A method of manufacturing an emptying device assembly according to any one of the preceding claims, the method comprising the steps of: forming a first circular hole in the first film layer; Attaching the first film layer and the second film layer along the peripheral portion of the layers to form a sleeve or bag; Attaching a connector ring to the first membrane layer around the first hole, wherein the connector ring comprises: ° an annular base defining a second aperture concentric with the first aperture; and ° A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

16. A connector ring for attaching a further device to a ostomy implant or a cover of a ostomy implant, the connector ring comprising: An annular base defining a connector aperture; as well as - A plurality of radially inwardly protruding flanges, wherein at least a subset of said protruding flanges are adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

17. The connector ring according to claim 16, wherein: The plurality of radially inwardly projecting flanges are separated by gaps.

18. The connector ring according to any one of claims 16-17, wherein: The plurality of radially inwardly protruding flanges comprises an engagement flange adapted to engage with an outer circumferential groove of a cylindrical ostomy implant or a cover of a ostomy implant.

19. The connector ring according to claim 18, wherein: The connector ring includes a limiting means for limiting flexure of one or more engagement flanges in a first direction but allowing flexure of the engagement flanges in a direction opposite to the first direction.

20. The connector ring according to any one of claims 16 to 19, wherein: The plurality of radially inwardly projecting flanges include a support flange adapted to stabilize the connector ring during use.

21. The connector ring according to claim 20, wherein: Each support flange has an inner support flange edge towards the centre of the connector hole, wherein the support flange is dimensioned such that the inner support flange edge is arranged to abut an outer circumferential ring of the cylindrical ostomy implant or of a cover of the ostomy implant.

22. A connector ring according to any one of claims 20-21, wherein: Each support flange has a support structure adapted to increase the structural rigidity of the connector ring.

23. A connector ring according to any one of claims 18-19 and any one of claims 20-22, wherein: Every other radially inwardly protruding flange is an engagement flange, and every other radially inwardly protruding flange is a support flange.

24. A connector ring according to any one of claims 18-19 and any one of claims 20-23, wherein: The engaging flange protrudes further than the supporting flange.

25. A connector ring according to any one of claims 18-19 and any one of claims 20-24, wherein: The supporting flange is harder than the engaging flange.

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