Evacuation device

Abstract

The present disclosure relates to an evacuation device assembly for evacuation from a stoma, the evacuation device assembly comprising a first film layer and a second film layer attached along a peripheral component to form an evacuation device, the first film layer comprising a first hole, an integrated connector ring, the integrated connector ring defining a second hole concentric with the first hole, an annular base attached to the evacuation device assembly around the first hole, and a plurality of radially inwardly projecting flanges, at least a subset of the projecting flanges adapted to engage with a circumferential groove of a cylindrical ostomy implant or a lid of an ostomy implant. The present disclosure further relates to a method of manufacturing the evacuation device assembly.

Description

[Technical field]

[0001] The present disclosure relates to drainage devices, in particular drainage pouches and drainage sleeves for drainage from a stoma. [Background technology]

[0002] (background) Ileostomy and colostomy are common surgeries that may be necessitated, for example, by malignancy or chronic intestinal inflammation. The surgery is called an ileostomy when the colon and rectum are removed, and a colostomy when only the rectum is removed. Similarly, abdominal nephrostomy is created when the bladder needs to be removed, for example, due to bladder cancer. In these surgeries, a fistula is created in the abdominal wall to which a segment of the intestine is connected.

[0003] An ileostomy is a fistula created by bringing an end or loop of the small intestine (ileum) above the surface of the skin or by a surgical procedure that creates an opening. Bowel waste passes out of the ileostomy and is collected in an external ostomy system that is placed across the opening.

[0004] A colostomy is a surgical procedure that creates or creates a fistula in the large intestine (colon). An opening is created by drawing the healthy end of the colon through an incision in the anterior abdominal wall and suturing it in place. This opening, often in conjunction with an attached ostomy system, provides an alternative channel for feces to exit the body.

[0005] An ostomy pouching system is a medical device that provides a means for the collection of waste from a stoma. Conventional pouching systems usually consist of a collection pouch, a barrier on the skin, and a connection to the stoma itself, which is a part of the body that is bypassed to the skin.

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

[0007] As an alternative to traditional ostomy pouch systems, implant-based systems have been developed. The system is based on a percutaneous ostomy implant, which is anchored in the user's body and allows the serosal tissue of the intestinal compartment to be attached to the implant. The ostomy implant usually comprises a cylindrical body with an open end, to which a lid may be attached. When the lid is removed, the open end can be connected to an evacuation device such as an ostomy pouch. The solution allows the user to meet their needs at their own convenience, minimizing skin complications as well as discomfort, noise, and smell.

[0008] However, attaching an ostomy pouch to an ostomy implant is associated with several technical challenges, for example, related to ease of use, potential leakage, and the ability to withstand forces caused by waste in the ostomy pouch. Some previous devices have attempted to address these limitations. US 5,269,774 discloses a combination ring and collection pouch for ostomy, the combination comprising a ring portion having a first side, a second side, and an opening substantially aligned through the first side and the second side. US 5,139,492 discloses a two-piece ostomy appliance comprising a pouch and a face plate with a matching mating ring.

[0009] US 2012 / 012336 discloses a percutaneous ostomy implant for implantation into the abdominal wall of a patient. US 4,183,357 discloses a conventional transepidermal implant device for enterostomy, consisting of a barrel portion and a flange portion.

[0010] While these documents address some of the limitations of conventional pouch systems, there are still significant shortcomings that need to be addressed, for example, in terms of leak prevention, ease of use, and prevention of accidental disconnection between the pouch system and the stoma. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Patent No. 5,269,774 [Patent Document 2] U.S. Patent No. 5,139,492 [Patent Document 3] US Patent Application Publication No. 2012 / 012336 [Patent Document 4] U.S. Patent No. 4,183,357 Summary of the Invention [Means for solving the problem]

[0012] (summary) The present disclosure relates to an evacuation device assembly for drainage from a stoma, the evacuation device assembly comprising: - a first film layer and a second film layer, the first film layer and the second film layer being attached along a peripheral part and forming an evacuation device, the first film layer comprising a first hole; -With integrated connector ring Equipped with The integrated connector ring an annular base defining a second hole concentric with the first hole, the annular base being attached, e.g. welded, to the evacuation device around the first hole; A plurality of radially inwardly projecting flanges; Equipped with At least a subset of the protruding flanges are adapted to engage circumferential grooves in the cylindrical ostomy implant or in the lid of the ostomy implant.

[0013] The connector ring can be attached to the lid of the ostomy implant. Preferably, the connector ring is attached to the lid by positioning a subset of the protruding flanges to fit into the circumferential grooves of the lid. From this position, the evacuation device can be opened at one end when it is a closed pouch. The lid can then be opened from the outside of the evacuation device to avoid soiling the user's hands.

[0014] Preferably, the plurality of radially inwardly protruding flanges of the connector ring comprise engagement flanges adapted to engage with the circumferential grooves of the cylindrical ostomy implant or the lid of the ostomy implant. The engagement flanges may be made of a material that is resilient but relatively rigid such that the engagement portion may flex slightly when the connector ring is positioned, but the engagement flanges will return to their original unflexed shape once the connector ring is in place. This may cause a clicking sound. The engagement flanges may have a hook or guide element on the inner engagement flange edge toward 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 evacuation device contains waste from the stoma.

[0015] A further improvement for the capacity to carry the weight of the evacuation device is the possibility of having further radially inwardly projecting flanges with support flanges adapted to stabilize the integrated connector ring. The support flanges are generally rigid and may be slightly shorter than the engagement flanges. The support flanges may have an inner support flange edge toward the center of the second hole, the support flanges being sized such that the inner support flange edge will abut against the circumferential ring of the cylindrical ostomy implant or the lid of the ostomy implant during use. The support flanges can thus contribute to the overall structural strength of the connector ring without affecting its usefulness. The projecting flanges may be arranged such that every other radially inwardly projecting flange is an engagement flange and every other radially inwardly projecting flange is a support flange.

[0016] The present disclosure further relates to a method for manufacturing an evacuation device assembly according to any one of the preceding claims, the method comprising the steps of: attaching the first film layer and the second film layer along peripheral parts of the layers to form a sleeve or pouch; forming a first circular hole in a first film layer; attaching a connector ring to the first film layer around the first hole; (in any order), The connector ring is an annular base defining a second bore concentric with the first bore; a plurality of radially inwardly projecting flanges; Equipped with At least a subset of the protruding flanges are adapted to engage circumferential grooves in the cylindrical ostomy implant or in the lid of the ostomy implant.

[0017] In yet a further aspect, the present disclosure relates to a connector ring for attachment of an additional device to an ostomy implant or a lid of an ostomy implant, the connector ring comprising: an annular base defining a connector hole; A plurality of radially inwardly projecting flanges; Equipped with At least a subset of the protruding flanges are adapted to engage circumferential grooves in the cylindrical ostomy implant or in the lid of the ostomy implant.

[0018] The connector ring may be provided with attachment means for attachment of the further device to the connector ring, such as an adhesive, alternatively the connector ring may form an integral part of the further device, for example the connector ring is welded to the further device, for example by plastic welding.

[0019] A still further aspect of the present disclosure relates to the use of a connector ring for attachment of additional devices to the ostomy implant or the lid of the ostomy implant. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 shows an embodiment of a drainage device assembly for stoma drainage of the present disclosure.

[0021] [Diagram 2] FIG. 2 shows a top view of an embodiment of an evacuation device.

[0022] [Diagram 3] FIG. 3 shows a side view of an embodiment of an evacuation device assembly.

[0023] [Figure 4] FIG. 4 illustrates a perspective view of an embodiment of a connector ring.

[0024] [Diagram 5] FIG. 5 illustrates a top view of an embodiment of a connector ring.

[0025] [Figure 6]FIG. 6 shows an embodiment of a lid for an ostomy implant.

[0026] [Figure 7] FIG. 7 shows an embodiment of an ostomy implant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] (Detailed Description) The present disclosure relates to an evacuation device assembly for evacuation from a stoma. The evacuation device assembly comprises at least an evacuation device and a connector ring. The evacuation device advantageously comprises a first film layer and a second film layer attached such that a compartment is formed between the first film layer and the second film layer. The first and second film layers may be formed, for example, by separate film layers or may be formed from a single layer, which is folded to form the first film layer covering the second film layer. Alternatively, the evacuation device may be formed from a single component, typically a polymer component, for example by blow molding. The first and second film layers may thus be different components, for example including partially co-extensive overlapping components.

[0028] In either case, the first and second film layers are preferably attached / connected along the periphery such that a compartment is formed between the first and second film layers. The compartment may be connected to the external environment through several openings / holes in and / or between the first and second film layers, such as one, two or even three holes. Thus, the attachment / connection of the first and second film layers may be performed by aligning the first and second film layers and attaching the two film layers along the periphery of the layers, for example along at least a part of the periphery, such as the entire periphery. In a specific embodiment, at least one of the first and second film layers comprises a hole prior to the attachment / connection of the film layers, while in other embodiments, at least one hole in either the first or second film layer is formed following attachment to the film layers.

[0029] The evacuation device typically comprises a compartment between a first film layer and a second film layer and may further comprise one or more apertures, such as the first aperture.

[0030] Alternatively, one or more holes may be formed subsequent to forming the evacuation device, for example in the first and / or second film layers. In a specific embodiment, the first and second film layers are attached / connected along only a portion of the periphery of the film layers, i.e., the first and second film layers are not attached, such that holes are formed at the ends of the evacuation device. The holes may be arranged, for example, to evacuate the contents of the evacuation device.

[0031] At least one of the film layers, such as the first film layer, advantageously comprises a first hole. Preferably, an integrated connector ring is attached / connected to the area of ​​the first film layer surrounding said first hole, and thus the connector ring may be considered an integrated part of the evacuation device assembly. However, the integrated connector ring may be removable from the first and / or second film layers, and thus "integrated" shall not be understood as limiting the integrated connector ring to embodiments in which the connector ring is not removable from the evacuation device (e.g., relative to the first and / or second film layers). "Integrated" as used herein refers to a part that is attached or connected to another part, and the two parts are thus integrated into an assembly (consisting of the two parts) in this embodiment.

[0032] The integrated connector ring preferably comprises a base defining a second hole, also known as a connector hole, that is at least partially concentric with the first hole, and preferably 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 the radially inner circular shape of the annulus. In a specific embodiment, the first hole and the second hole are coincident, however in other embodiments, the size, such as the radius, of the second hole is larger than the size, such as the radius, of the first hole.

[0033] The first and second holes are preferably formed to have the same shape. For example, the first and second holes may have a circular, oval, rectangular, or quadratic shape. However, preferably, the first and second holes have a circular shape. The base of the integrated connector may have an annular base that defines the second hole having a circular shape. Alternatively, the integrated connector may have any other shape to define the second hole having a shape different from circular, as described above. 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 evacuation device, preferably to the area of ​​the first film layer surrounding the first hole. The base may be welded, for example, to the area surrounding the first hole, for example, 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 through other means, such as through the use of an adhesive.

[0034] The integrated connector ring typically comprises a plurality of flanges projecting inwardly, preferably radially inwardly. More preferably, said flanges or a subset thereof are arranged to engage with the ostomy implant and / or the lid of the ostomy implant. Said flanges may therefore be referred to as engagement flanges. The flanges of the connector ring or a subset thereof, i.e. the engagement flanges, may therefore be arranged to engage with the ostomy implant and / or the lid of the ostomy implant. Preferably, the engagement flanges are arranged to engage with a connection means of the ostomy implant and / or the lid of the ostomy implant. The connection means of the ostomy implant and / or the ostomy implant lid may be one or more of convex and / or concave parts, ridges, protrusions, depressions, grooves, hooks, recesses and / or holes, preferably said connection means are circumferential such as one or more of convex and / or concave circumferential parts, circumferential ridges, circumferential protrusions, circumferential recesses, circumferential grooves, circumferential hooks, circumferential recesses and / or circumferential holes. Most preferably, the engagement flange is arranged to engage with the circumferential groove of the ostomy implant and / or the ostomy implant lid.

[0035] Preferably, the connector comprises a limiting means for limiting the bending of the engagement flange in a certain direction and securing the connector to the ostomy implant and / or lid during use. Typically, the limiting means is arranged such that the engagement flange (e.g. at least the edge part) can be bent inwardly (i.e. into the compartment formed between the first and second film layers). During use, the engagement flange can thus be arranged to simply engage with the connection means of the ostomy implant and / or lid of the ostomy implant by being bent inwardly (i.e. inwardly towards the compartment formed between the first and second film layers). Bending of the flange is typically required as the diameter of the ostomy implant and / or lid of the ostomy implant becomes larger than the circular / annular shape formed by the inner engagement flange edge. However, the annular / circular shape is preferably sized to match the connection means of the ostomy implant / lid.

[0036] At the same time, while allowing easy engagement, the limiting means is preferably arranged to limit bending of each engagement flange or a subset thereof in the opposite direction, i.e. away from the second film layer (i.e. outward). This ensures connection between the connector and the ostomy implant and / or lid. Typically, the engagement flanges are arranged such that accidental disconnection between the connector and the ostomy implant and / or lid is avoided, even when, for example, the drainage device contains a large amount of waste and thus has a significant weight. At the same time, while preferably allowing accidental disconnection, preferably a person is able to disconnect the connector and the ostomy implant and / or lid without significant force.

[0037] Thus, the limiting means may be arranged to limit bending of one or more engagement flanges in a first direction, but allow bending of the engagement flanges in a direction opposite 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 flanges towards the first side may be limited. At the same time, the limiting means may be arranged to allow bending of the engagement flanges in the opposite direction (i.e., the direction opposite the first side).

[0038] The restricting means may comprise or consist of one or more protrusions, recesses, grooves and / or indentations arranged such that the engaging flange is more easily bent inwardly (i.e., towards the compartment formed between the first and second film layers) than outwardly (i.e., away from the compartment formed between the first and second film layers).

[0039] In a preferred embodiment, the restriction means comprises a radially outer protrusion and a radially inner protrusion, i.e. the radially outer protrusion is located radially outward of the radially inner protrusion (i.e. the radially outer protrusion is located further away from the center of the second hole compared to the radially inner protrusion). Preferably, the radially outer protrusion and the radially inner protrusion are arranged on an outwardly facing side of the connector (i.e. away from the compartment formed between the first and second film layers).

[0040] The radially inner protrusion is preferably arranged adjacent to the radially outer protrusion, such as when the engagement flange is not flexed, however, the radially inner protrusion is preferably arranged radially inward from the radially outer protrusion (i.e., toward the center of the second hole) Such an arrangement allows for flexing of the engagement flange between the outer and inner protrusions when a user positions the connector to engage with an implant and / or lid.

[0041] However, the protrusions act to limit bending of the engagement flanges in the opposite direction (i.e., away from the compartment formed between the first and second film layers), thus securing the connector to the implant and / or lid. In these arrangements, since the protrusions are adjacent to each other, they limit bending of the engagement flanges in the same direction, i.e., the outwardly facing side, as the side of the connector on which they are located. The limiting means may be located entirely on one or more (e.g., all) of the engagement flanges, or a portion of the limiting means may be located on the annular base of the connector ring. For example, the limiting means may comprise radially outer protrusions located on the base, each of which is positioned adjacent to a radially inner protrusion located on the engagement flange. Alternatively, both protrusions may be located on the engagement flanges.

[0042] Preferably, the evacuation device assembly is arranged such that following attachment of the evacuation device assembly to the lid of the ostomy implant, at least a portion of the lid projects into a compartment of the evacuation device formed between the first and second film layers, more preferably at least a portion of the lid, preferably the ostomy implant, projects into said compartment following said attachment.

[0043] The evacuation device may have a single opening, typically a first hole formed in the first film layer. The first hole is typically formed toward the proximal end of the evacuation device. The evacuation device may thus be a drainage pouch. In this arrangement, the evacuation device assembly is arranged to maintain the ostomy output that is expelled in the evacuation device (e.g., drainage bag). Such evacuation device assemblies are typically used when there is a need to expel stoma output for an extended period of time.

[0044] Preferably, when the evacuation device has only a single hole, i.e. the first hole, the evacuation device is equipped with tearing means for forming the evacuation hole towards the distal end of the evacuation device. The tearing means may be, for example, one or more notches, one or more perforations, and / or one or more tear tabs welded to the first and / or second film layers, etc. Preferably, the evacuation device further comprises means for resealing the evacuation hole after formation, such as a velcro strap or an adhesive patch. Similar tearing and resealing means for forming the evacuation hole may be provided for evacuation devices with multiple holes.

[0045] The drainage device may alternatively comprise a plurality of holes, such as two holes. In this embodiment, the drainage device may comprise a first hole for receiving stoma waste, typically formed in the first film layer towards the proximal end of the drainage device, and further a drainage hole for drainage of stoma waste, formed at or towards the proximal end of the drainage device. The drainage hole may be formed, for example, along an edge where the first film layer is not attached to the second film layer.

[0046] Typically, the first hole is formed toward the proximal end of the evacuation device, while the evacuation hole is formed toward the distal end of the evacuation device. In this arrangement, the evacuation device may be referred to as a sleeve. Preferably, the evacuation device includes a means for resealing the evacuation hole, such as a velcro strap or adhesive patch.

[0047] The evacuation device assembly may thus be arranged to enable a user to carry out normal daily activities whilst wearing the assembly for extended periods of time. During such use, it is important that the connector ring is able to provide a secure and stable attachment to the ostomy implant and / or the ostomy implant lid.

[0048] Typically, a lid, attached to the open end of the ostomy implant, is used to seal the stoma. The evacuation device and / or evacuation device assembly may be arranged to receive at least a part of the lid in a compartment formed between the first and second film layers through the first hole. In this position, the lid may be opened through the evacuation device, i.e. through one of the first and second film layers, to avoid soiling the user's hands. The lid of the ostomy implant is typically opened by radially sliding an opening part, which in the closed position covers the opening of the lid. Thus, preferably, the evacuation device is arranged so that the user can perform such movement from the outside of the evacuation bag, i.e. through the first and / or second film layers.

[0049] Additionally, the integrated connector of the device of the present disclosure allows a secure attachment to be formed between the evacuation device assembly and the ostomy implant lid and / or ostomy implant. The connector ring acts to form a seal between the evacuation device compartment and the ostomy implant and / or ostomy implant lid, thereby further reducing the risk of leakage.

[0050] Various lids for ostomy implants are known from the prior art. However, it is highly preferred that the lid comprises a connection means for engaging with a connector ring, such as an engagement flange. Typically, the connection means of the lid are provided on the base part of the lid. Furthermore, the base preferably comprises an opening part arranged to seal the open end of the ostomy implant and adapted to move between an open position for the discharge of waste and a closed position for preventing the leakage of waste from the stoma. Preferably, the opening part is attached to the base in both the closed and open positions. The opening part may be opened, for example, by sliding, pulling, twisting or screwing a part of the lid to open the lid, preferably by sliding the opening part radially.

[0051] Preferably, the lid is arranged such that reverse movement of the opening part moves the lid to its closed position. Once drainage from the stoma is complete, the user may close the lid, typically by reversing the movement of the opening part for opening the lid. After the lid is closed, the evacuation device (i.e., the evacuation device assembly) may be removed from the lid and discarded.

[0052] Preferably, the connector ring is arranged to be attached to the ostomy implant or the lid of an ostomy implant by positioning the connector ring so that the protruding flanges or a subset thereof, preferably the engagement flanges, engage complementary surfaces on the lid and / or the ostomy implant, e.g. the complementary surfaces are circumferential grooves on the lid and / or the ostomy implant and / or the complementary surfaces are complementary to inner engaging flange edges of the engagement flanges.

[0053] Alternatively or in addition, the complementary surfaces of the ostomy implant and / or lid of the ostomy implant may be one or more of convex and / or concave parts, ridges, protrusions, recesses, indentations, grooves, hooks, and / or holes. Preferably, the complementary surfaces of the lid and / or ostomy implant are arranged such that a protruding flange or a subset thereof may engage with the lid and / or ostomy implant. Typically, the complementary surfaces are one or more of convex and / or concave parts, ridges, protrusions, recesses, indentations, grooves, hooks, and / or holes of the lid and / or ostomy implant that are complementary to the inner parts (i.e. radially inward parts) of the protruding flange or a subset thereof, such as an engagement flange. Typically, the complementary surfaces of the ostomy implant and / or lid for the ostomy implant are circumferential complementary surfaces, such as circumferential grooves.

[0054] Preferably, the plurality of radially inwardly projecting flanges of the connector ring comprise or consist of engaging flanges adapted to engage with one or more of the convex and / or concave parts, ridges, protrusions, recesses, indentations, grooves, hooks, and / or holes of the ostomy implant and / or the lid for the ostomy implant. Typically, the plurality of radially inwardly projecting flanges of the connector ring comprise or consist of engaging flanges adapted to engage with one or more circumferentially convex or concave parts, circumferential ridges, circumferential protrusions, and / or circumferential grooves of the ostomy implant and / or the lid for the ostomy implant.

[0055] The engagement flanges may be made from a resilient, yet relatively rigid, material such that they may flex slightly during attachment of the evacuation device (i.e., evacuation device assembly) to the ostomy implant lid and / or ostomy implant, but will return to their original, unflexed shape once the connector is in place. Thus, the engagement flanges may form a snap-fit ​​connection / joint, such as an annular snap-fit ​​connection / joint, with one or more complementary surfaces on the ostomy implant or a lid for the ostomy implant. This allows for a reversible, yet strong, attachment between the evacuation device and the lid and / or implant. Various types of snap-fit ​​connections are known to those skilled in the art and include various types of complementary surfaces to form a strong, yet reversible attachment.

[0056] Typically, attachment of the connector to the lid / implant initially causes the engagement flanges to flex slightly, typically due to the slightly larger diameter of the ostomy implant and / or ostomy implant lid. When the engagement flanges are moved to a position where they may engage the connection means, e.g., a complementary surface and / or circumferential groove, the engagement flanges may move from a flexed position to a non-flexed position. The engagement flanges may snap into the non-flexed position, which may cause an audible click. Typically, when engaged with the lid / ostomy implant, the inner engagement flange edge directly contacts the complementary surface.

[0057] The engagement flange may comprise an engagement means at an inner engagement flange edge, i.e. a protruding end of the engagement flange. The engagement means may for example comprise one or more of convex and / or concave parts, ridges, protrusions, recesses, depressions, grooves, hooks, holes and / or guide elements arranged to form a connection to a complementary surface of the ostomy implant and / or the lid for the ostomy implant, for example a complementary surface of the connection means.

[0058] Typically, the engagement means of the connector comprises a surface which is complementary to a surface of the connection means of the ostomy implant and / or the lid for the ostomy implant. Typically, the engagement means is formed along an inner engagement flange edge. Thus, each engagement flange may be provided along its inner engagement flange edge with a guide element, preferably which is complementary to a circumferential groove of the ostomy implant and / or the lid for the ostomy implant.

[0059] The engagement means of the engagement flange provide support and stability for the attachment of the connector ring to the ostomy implant / lid, which therefore allows for the formation of a secure connection between the evacuation device assembly and the ostomy implant / lid, even when the evacuation bag is arranged to contain stoma waste, which may impart significant force on the connector ring. The embodiments of the present disclosure therefore provide a means for secure attachment, while at the same time allowing for easy attachment and removal of the connector ring to and from the ostomy implant / lid. The effect is even more pronounced when the engagement flange comprises an engagement means which further acts to increase the support and stability provided to the connection.

[0060] A further improvement for the ability to carry the weight of the evacuation device is the possibility of having a further radially inwardly protruding flange with a support flange adapted to stabilize the integrated connector ring during use, e.g. when the connector ring is connected to a lid and / or an ostomy implant.

[0061] Thus, the connector may comprise a plurality of flanges, the plurality of flanges comprising or consisting of a subset of the engagement flanges and / or a subset of the support flanges. Preferably, the connector ring comprises engagement flanges and support flanges, more preferably the connector ring comprises a plurality of radially inwardly projecting flanges, every second flange being a support flange and every second flange being an engagement flange, i.e. each support flange is located between two engagement flanges and vice versa.

[0062] The support flange is generally rigid and may also preferably be slightly shorter than the engagement flange. The support flange may have an inner support flange edge toward the center of the second hole. Preferably, the support flange is arranged such that the inner support flange edge will abut an outer surface of the ostomy implant / lid when engaged with said ostomy implant / lid. The outer surface may be, for example, a circumferential ring of the ostomy implant and / or the ostomy implant lid. Typically, the outer surface is a cylindrical surface. In this manner, the support flange is arranged to provide support to the connector ring and act to secure the connection to the ostomy implant / lid.

[0063] Advantageously, the engagement flange and the support flange are arranged to engage separate surfaces of the ostomy implant and / or the lid for the ostomy implant. This may be achieved, for example, by providing the engagement flange and the support flange in separate planes. Alternatively, the engagement flange may comprise an inner engagement flange edge with a protrusion arranged to engage a corresponding recess in the ostomy implant and / or the lid for the ostomy implant, while the support flange comprises an inner support flange edge arranged to abut an outer surface of the ostomy implant / lid. Typically, the support flange is arranged to abut a complementary surface of the ostomy implant / lid, for example an outer surface of a circumferential ring or the like that is adjacent, such as next to, a circumferential recess.

[0064] The support flanges are typically arranged to abut a surface that is separate from the surface that the engagement flanges are arranged to engage, e.g., by being provided on separate planar surfaces of the connection ring. Thus, the relative lengths of the support flanges and the engagement flanges may not be as important; instead, the size of the annulus formed by the inner engagement flange edges that match that of the surface of the lid / ostomy implant where they will engage, e.g., with the circumferential recess, may be more important. Similarly, the size of the annulus formed by the inner support flange edges that match that of the surface of the lid / ostomy implant where they will abut, e.g., with the circumferential ring, may also be more important. Thus, the inner support flange edges may form an annulus that is smaller, larger, or the same size as the annulus formed by the inner engagement flange edges.

[0065] Preferably, the connector is attached to the outer surface of the first film layer, i.e. the surface of the first film layer facing away from the second film layer. It is further preferred that the evacuation device assembly comprises an annular protective area to form a protective layer around the ostomy implant or the lid for the ostomy implant. The protective layer may protect and / or provide a seal for safe evacuation from the stoma during use. The annular protective area may thus be arranged to contact the outer part of the ostomy implant and / or the lid of the ostomy implant during use. The outer part is typically a circumferential surface that is located towards the second film layer relative to the connecting means of the implant or the lid during use. The outer surface may for example be a circumferential surface between the connecting means (i.e. the outer surface of the implant or the lid) and the upper part of the implant or the lid, i.e. the upper part is located away from the user during use.

[0066] The annular protective area is thereby typically concentric with the first hole and / or the connector ring. Preferably, the annular protective area extends radially inward from the connector ring and / or the annular attachment area of ​​the first film layer to which the connector ring is attached. The annular protective area may form part of the first film layer, and in such a case the size of the first hole may be defined by the inner edge of the annular protective area. The annular protective area may thus be defined as an annulus between the outer part of the first hole (i.e. its circumference) and the outer part of the second hole (i.e. its perimeter). Alternatively, the annular protective area may not form part of the first film layer. In such an arrangement, the annular protective area may thus be a separate layer that is attached to the connector ring and may overlap, at least in part, with the first hole.

[0067] Preferably, the annular protective area extends radially inward 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, even more preferably beyond the entire length of the flange. Thus, preferably, the annular protective area extends radially inward to cover at least a portion of the flange, more preferably, the annular protective area extends radially inward beyond the flange, such as at least 5 mm beyond the edge of the flange. The annular protective area may be provided in the same plane as the connector, or in a separate plane, such as in a plane 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. Furthermore, the evacuation device and / or evacuation device assembly may comprise multiple annular protective areas for still further improved protection and / or sealing.

[0068] Preferably, the annular protective area is formed in an elastic material, preferably plastic. In a specific embodiment, the annular protective area does not constitute part of the connector ring, the first film layer, and / or the second film layer, but may be connected thereto. Alternatively, the annular protective area may form part of the first film layer. In this embodiment, the first hole in the first film layer is preferably smaller than the second hole in the connector ring. Preferably, the first hole is smaller than the annulus formed by the flange, e.g., either the support flange and / or the engagement flange. In this embodiment, the first film together with the connector ring, which is concentric with the first hole, may form an annular protective area that protrudes beyond said flange. During use, the annular protective area is arranged to contact the ostomy implant / lid, preferably the annular protective area is made of an elastic material and the diameter of its inner edge is smaller than the diameter of the ostomy implant / lid, so that a seal can be formed upon attachment of the evacuation device assembly to the ostomy implant / lid. Preferably, the first film layer is made from an elastic material, preferably plastic, thus allowing the first film layer to form an annular protective area for protecting / sealing the implant and / or the lid.

[0069] For the embodiment in which the first and second film layers are attached along their entire perimeter so as to form a pouch, a tearing means is preferably provided at the distal end of the evacuation device. This allows the user to connect the evacuation device to the ostomy implant or the lid of the ostomy implant and initiate evacuation from the stoma. As known to those skilled in the art, under certain conditions, evacuation from the stoma can take time. Providing the evacuation device in the form of a pouch allows the user to carry out normal daily activities while evacuation from the stoma. Once evacuation is completed, the user can discard the waste by, for example, positioning the distal end of the evacuation device in a toilet bowl and forming an opening in the distal end of the evacuation device, for example by tearing, so that the waste is discharged into the toilet bowl.

[0070] The tearing means may consist of or comprise one or more perforations and / or tear notches formed in a surface where the first film layer is 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 evacuation device. Alternatively, or in addition, the tearing means may comprise a tab attached, e.g., welded, to the first and / or second film layers, the tab being arranged such that pulling the tab tears an opening in the distal end of the evacuation device.

[0071] Advantageously, the evacuation device is arranged such that the integrated connector ring, when attached to the ostomy implant and / or the lid of the ostomy implant, forms a fluid connection between the evacuation device and the stoma, whereby stoma waste can be reliably removed from the stoma into the evacuation device.

[0072] Preferably, the annular base is attached, e.g., welded, to the first film layer at an annular attachment area, which is preferably concentric with the first hole. Thus, the annular attachment area may be an annular surface that surrounds and is concentric with the first hole, i.e., the center of the annular attachment is concentric with the first hole.

[0073] In an embodiment of the present disclosure, the first film layer comprises an annular protective area extending radially inward from the annular mounting area. Preferably, a flange or a portion of a flange, such as a support flange and / or an engagement flange, does not extend radially inward beyond the annular protective area. Thus, the annulus formed by the inner support flange edge and / or the inner engagement flange edge is larger than the circular opening, e.g., the first hole, of the annular protective area.

[0074] In an embodiment of the present disclosure, the annular protective area at least partially overlaps the first hole. The annular protective area may therefore extend radially inward into at least a portion of the first hole. The annular protective area may therefore be formed from a film layer separate from the first film layer. Preferably, the annular protective area is concentric with the first hole, i.e., the centers of the annular protective area and the first hole coincide.

[0075] In an embodiment of the present disclosure, the first hole and the second hole are generally circular. Moreover, preferably, the first hole and the second hole are substantially overlapping. Thus, the center of the circular first hole can coincide with the center of the circular second hole.

[0076] In certain embodiments of the present disclosure, the multiple radially inwardly projecting flanges are typically separated by gaps of the same size. The gaps may thus separate the support flanges from the engaging flanges and / or other support flanges, which in turn may separate the engaging flanges from the support flanges or other engaging flanges. The gaps may allow the flanges to be moved, e.g., bent, independently of adjacent flanges. Thus, the gaps may facilitate individual bending of the engaging flanges during attachment to the ostomy implant and / or ostomy implant lid.

[0077] In an embodiment of the present disclosure, the plurality of radially inwardly projecting flanges comprise an engagement flange adapted to engage with a connection means of a cylindrical ostomy implant or a lid of an ostomy implant. The connection means of the ostomy implant and / or the lid may comprise, for example, one or more of convex and / or concave parts, ridges, protrusions, recesses, depressions, grooves, hooks, and / or holes, and preferably the connection means is circumferential, such as one or more of circumferential hooks, circumferential protrusions, circumferential ridges, circumferential depressions, circumferential holes, and / or circumferential depressions. Thus, each of the plurality of radially inwardly projecting flanges may be adapted to engage with one or more of convex and / or concave features, ridges, protrusions, recesses, depressions, grooves, hooks, and / or holes, and preferably the connection means are in the circumferential direction, such as one or more of circumferential hooks, circumferential protrusions, circumferential ridges, circumferential depressions, circumferential holes, and / or circumferential recesses.

[0078] In a specific embodiment, the connection means is a circumferential groove in the cylindrical ostomy implant and / or in the lid of the ostomy implant. Each of the engagement flanges is thus adapted to engage said circumferential groove, for example by comprising an inner engagement flange edge adapted to engage said groove, for example said inner engagement flange edge comprising a surface that is complementary to said circumferential groove, preferably said inner engagement flange edge comprising a guide element.

[0079] In a preferred embodiment of the present disclosure, each engagement flange has a hook or guide element on its inner engagement flange edge toward the center of the second hole. Preferably, the hook or guide element is sized to fit within a circumferential groove in the cylindrical ostomy implant or the lid of the ostomy implant.

[0080] Preferably, each engagement flange may have one or more of convex and / or concave features, ridges, protrusions, recesses, depressions, grooves, hook elements, holes, and / or guide elements formed along at least a portion of an inner engagement flange edge of each engagement flange.

[0081] In an embodiment of the present disclosure, the engagement flange is made of a resilient material. Preferably, the engagement flange is resilient and / or flexible because the annulus formed by the inner engagement flange edge is typically smaller than the diameter of the portion of the ostomy implant and / or ostomy implant lid across which the flange needs to be moved during installation. Typically, when the engagement flange engages with the ostomy implant and / or ostomy implant lid, the engagement flanges snap back to their original unbent configuration, typically with an audible click. In this position, the engagement flange typically engages with a complementary surface, such as a complementary circumferential surface of the ostomy implant and / or ostomy implant lid. To reach the complementary surface, the engagement flange typically needs to be bent slightly, i.e., when the ostomy implant and / or ostomy implant lid passes through the connector ring. Thus, the engagement flange may be arranged to engage the ostomy implant and / or the lid of the ostomy implant through a snap-fit ​​mechanism.

[0082] In an embodiment of the present disclosure, the plurality of radially inwardly projecting flanges comprise support flanges adapted to stabilize an integrated connector ring. Preferably, the support flanges are generally rigid. The support flanges are thus preferably more rigid than the engagement flanges.

[0083] It is further preferred that each support flange has an inner support flange edge toward the center of the second hole, the support flanges being sized such that the inner support flange edge abuts a circumferential ring of the cylindrical ostomy implant or the lid of the ostomy implant. The support flanges may be positioned in the same plane as the engagement flanges, or alternatively, they may be positioned in a plane separate from that of the engagement flanges. By providing the support flanges and the engagement flanges in separate planes, the support provided by the connector ring for attachment of the evacuation device assembly may be increased.

[0084] It is further preferred that each support flange has a support structure. The support structure provides increased support to the overall structure. The support structure may therefore allow increased stiffness of the connector ring both when the connector ring is attached / connected to a lid for an ostomy implant or to an ostomy implant and when the connector ring is not attached to said lid and ostomy implant. The support structure may therefore increase the structural stiffness, e.g., the flexural stiffness or bending stiffness of the connector ring.

[0085] The support structure typically comprises at least one radially extending support element and / or at least one edge support element disposed along the inner support flange edge.

[0086] Preferably, 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 adjacent two engagement flanges and each engagement flange may adjacent two support flanges. This arrangement of flanges has been shown to increase the structural rigidity of the connector and thus its ability to provide a fastening means for attachment of the evacuation device assembly to an ostomy implant and / or a cap for an ostomy implant.

[0087] In a preferred embodiment of the present disclosure, the engagement flange protrudes above the support flange. Thus, the engagement flange may protrude radially inward above the support flange. The annulus formed by the inner engagement flange edge may thus be smaller than the annulus formed by the inner support flange edge. However, as defined elsewhere herein, this arrangement may depend on the configuration of the ostomy implant and / or the lid of the ostomy implant to which the evacuation device assembly is to be attached, and / or whether the different types of flanges are to be located in the same plane or in separate planes.

[0088] In an embodiment of the present disclosure, the support flange is stiffer than the engagement flange. Stiffness may be due to the material and / or dimensions of the flange. However, the support flange is preferably stiffer than the engagement flange. In this way, the engagement flange can be arranged to simply engage with the ostomy implant and / or the lid for the ostomy implant, for example by bending and snapping into place, while the shorter and more stiff support flange abuts the outer surface of the lid for the ostomy implant and / or the lid for the ostomy implant. This arrangement of flanges has been shown to provide a secure attachment of the evacuation device assembly to the lid for the ostomy implant and / or the lid for the ostomy implant, even when the evacuation device is a pouch and the connection needs to be able to withstand the weight of waste collected in the pouch.

[0089] In an embodiment of the present disclosure, the evacuation device has a tapered shape, preferably a substantially flat tapered shape, In an embodiment of the present disclosure, the evacuation device has a triangular shape with one truncated angle.

[0090] In an embodiment of the present disclosure, the evacuation device is an open-ended evacuation sleeve.

[0091] In an embodiment of the present disclosure, the evacuation device is an evacuation pouch. Preferably, the evacuation pouch includes tear means, such as one or more tabs, perforations, and / or notches, for opening one end of the evacuation pouch.

[0092] A further aspect of the present disclosure relates to a method of manufacturing an evacuation device and / or evacuation device assembly as disclosed herein, the method comprising attaching a first film layer and a second film layer along peripheral parts of the layers, thereby forming a sleeve or pouch having a compartment between the first and second film layers. Thus, the first and second film layers may be attached along their entire perimeter, thus forming a pouch. In other examples, the first and second film layers are attached along only a portion of their perimeter, such that an opening is formed along the unattached portion of the perimeter.

[0093] The method preferably includes forming a first circular hole in the first film layer, or alternatively, the first film layer may be provided with the first circular hole, such that the first circular hole may be present prior to attaching the first and second film layers.

[0094] The method preferably includes attaching a connector ring to an annular mounting area of ​​the first film layer, the annular mounting being arranged around the first hole. The connector is typically attached to the outside of the first film layer, i.e., the side of the first film layer facing away from the second film layer. The annular base of the connector ring is typically attached to the first film layer such that its center coincides with the center of the first hole. The annular base may define a second hole that is 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 and concentric with the second hole.

[0095] The integrated connector ring typically comprises a plurality of flanges projecting inwardly, preferably radially inwardly. It is further preferred that said flanges or a subset thereof are arranged to engage with the ostomy implant and / or the lid of the ostomy implant. Said flanges may therefore be referred to as engagement flanges. The flanges of the connector ring or a subset thereof, i.e. the engagement flanges, may therefore be arranged to engage with the ostomy implant and / or the lid of the ostomy implant. Preferably, the engagement flanges are arranged to engage with a connection means of the ostomy implant and / or the lid of the ostomy implant. The connection means of the ostomy implant and / or the ostomy implant lid may be one or more of convex and / or concave parts, ridges, protrusions, depressions, grooves, hooks, recesses and / or holes, preferably the connection means are circumferential, such as one or more of convex and / or concave circumferential parts, circumferential ridges, circumferential protrusions, circumferential recesses, circumferential grooves, circumferential hooks, circumferential recesses and / or circumferential holes.

[0096] Most preferably, the engagement flange is arranged to engage a circumferential groove in the ostomy implant and / or the lid of the ostomy implant.

[0097] It should be noted that the order of the method is not important as the first hole may be formed in the film layer before or after attachment of the first and second film layers. Similarly, the connector ring may be attached to the first film layer before the formation of the first hole and / or before attachment of the first film layer to the second film layer.

[0098] As an example, the sequence of steps may be, for example, 1. attaching the first and second film layers along the periphery of the layer to form a sleeve or pouch; 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 sequence may be 1. attaching the first and second film layers along the periphery of the layer to form a sleeve or pouch; 2. attaching a connector ring to the first film layer around the location of the first hole; and 3. forming a first circular hole in the first film layer. Alternatively, the sequence may be 1. forming a first circular hole in the first film layer; 2. attaching the first and second film layers along the periphery of the layer to form a sleeve or pouch; and 3. attaching a connector ring to the first film layer around the first hole. Alternatively, the sequence may be: 1. forming a first circular hole in the first film layer; 2. attaching a connector ring to the first film layer around the first hole; 3. attaching the first film layer and the second film layer along the peripheral part of the layer to form a sleeve or pouch. 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; 3. attaching the first film layer and the second film layer along the peripheral part of the layer to form a sleeve or pouch. 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 part of the layer to form a sleeve or pouch; 3. forming a first circular hole in the first film layer at the location of the first hole.

[0099] A further improvement for the capacity to carry the weight of the evacuation device is the possibility of having further radially inwardly projecting flanges with support flanges adapted to stabilize the integrated connector ring. Thus, the connector may comprise a plurality of flanges, the plurality of flanges comprising or consisting of a subset of engagement flanges and / or support flanges. Preferably, the connector comprises an engagement flange and a support flange, more preferably every second flange is a support flange and every second second flange is an engagement flange.

[0100] The support flange may be generally rigid, typically more rigid than the engagement flange. Additionally, the support flange may be slightly shorter than the engagement flange. The support flange may have an inner support flange edge toward the center of the second hole, and the support flange is sized so that the inner support flange edge abuts the circumferential ring of the cylindrical ostomy implant and / or the lid for the ostomy implant. The support flange may thus contribute to the overall structural strength of the connector ring without affecting its usefulness. The protruding flanges may be arranged such that every other radially inwardly protruding flange is an engagement flange, and every other radially inwardly protruding flange is a support flange. The support flange and the engagement flange may be located in different planes for increased support. The support flange may thus be arranged to prevent axial tilt of the connector ring when attached to the ostomy implant and / or the lid for the ostomy implant.

[0101] Preferably, the connector is located on the outer surface of the first film layer, i.e. away from the compartment formed between the two inner surfaces of the first and second film layers, the connector is thus exposed and capable of being connected to the ostomy implant or a lid for the ostomy implant.

[0102] It is further preferred that the connector comprises an annular protective area to form a protective layer around the ostomy implant or a lid for the ostomy implant. The protective layer may protect and / or provide a seal for safe evacuation from the stoma during use. The annular protective area may thus be arranged to contact an outer surface of the ostomy implant or a lid for the ostomy implant.

[0103] The annular protective area is typically concentric with the first hole and / or the connector ring. Preferably, the annular protective area extends radially inward from the connector ring or the area of ​​the first film to which the connector ring is attached. Thus, the size of the first hole may be defined by the annular protective area.

[0104] Preferably, the annular protective area extends radially inwardly beyond the flanges, i.e., the support flange and / or the engagement flange. The annular protective area may be provided in a layer flush with 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.

[0105] Preferably, the annular protective area is formed in an elastic material, preferably plastic. The annular protective area may be formed by a material separate from the connector ring, the first film layer, and / or the second film layer, but potentially connected thereto. However, the annular protective area may also be formed by the first film layer. In this embodiment, the hole in the first film layer is made smaller than the annulus formed by the flange, e.g., either the support flange and / or the engagement flange. By using a connector ring that is concentric with the first hole, the first film layer thus protrudes beyond the flange, thereby forming an annular protective area for connecting to an ostomy implant or a lid for an ostomy implant during use. Thus, in an embodiment of the present disclosure, the first hole is formed to have a size, e.g., a diameter, smaller than the annulus formed by either the flange of the connector, such as the engagement flange and / or the support flange.

[0106] For embodiments in which the first and second film layers are attached along their entire perimeter so as to form a pouch, a tearing means is preferably provided at the distal end of the evacuation device. This allows the user to connect the evacuation device to the ostomy implant or the lid of the ostomy implant and initiate drainage from the stoma. As known to those skilled in the art, under certain conditions drainage from the stoma can take time. Providing the evacuation device in the form of a pouch allows the user to carry out normal daily activities while draining the stoma. Once drainage is complete, the user may position the distal end of the evacuation device, for example, in a toilet bowl, and tear the opening at the distal end of the evacuation device so that the evacuation device is evacuated.

[0107] The tearing means may comprise or consist of one or more perforations or tear notches formed in a surface where the first film layer is 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 evacuation device. Alternatively, or in addition, the tearing means may comprise a tab attached, e.g., welded, to the first and / or second film layers, the tab being arranged such that pulling the tab tears an opening in the distal end of the evacuation device.

[0108] In a further aspect, the present disclosure relates to a connector ring for attachment of a further device to an ostomy implant or a lid of an ostomy implant, the connector ring comprising: an annular base defining a connector hole; a plurality of radially inwardly projecting flanges; Equipped with At least a subset of the protruding flanges are adapted to engage circumferential grooves in the cylindrical ostomy implant or in the lid of the ostomy implant.

[0109] Preferably, the connector ring is as disclosed elsewhere herein. The connector ring may be arranged, for example, to facilitate connection between a drainage device (e.g., connected to an ostomy bag, catheter, or sleeve) and an ostomy implant and / or lid.

[0110] Detailed Description of the Drawings The invention will be described in more detail below with reference to the accompanying drawings, which are exemplary and are intended to illustrate some of the features of the disclosed evacuation device assembly and the method of manufacturing an evacuation device according to the present disclosure and are not to be construed as limiting the disclosed invention.

[0111] FIG. 1 shows a top-down view of an embodiment of the disclosed evacuation device assembly (100) for stoma drainage. The evacuation device assembly (100) for stoma drainage can be seen to comprise an evacuation device (110) comprising a first film layer (111) and a second film layer (112), the first and second film layers attached along a peripheral piece (113) to form the evacuation device (110). The illustrated evacuation device (110) is a pouch, however, as disclosed elsewhere herein, the evacuation device (111) can be, for example, an open-ended evacuation sleeve, for example, when the first and second film layers are not attached along the distal end (117) of the evacuation device (111). Typically, the evacuation device has a tapered shape, such as a tapered cone shape. The evacuation device is preferably tapered from the proximal end (116) to the distal end (117). Thus, the evacuation device (110) may be referred to as having a "triangular shape with a truncated angle (118)." Thus, the length of the distal end (117) is typically shorter than the length of the proximal end (116).

[0112] The evacuation device assembly further comprises a first hole (114) formed in the first film layer of the evacuation device. The first hole is typically formed towards the proximal end (116) of the evacuation device. The evacuation device comprises tear means (115), here shown as a pair of notches, formed towards the distal end (117) of the evacuation device. Preferably, the notches or any other form of tear means are provided in the surface where the first film layer is attached to the second film layer.

[0113] The evacuation device assembly further comprises an integral connector ring (150) arranged around the first hole (114). The connector ring is attached to the outer surface of the first film layer (111). The connector ring comprises an annular base that defines a second hole (151), also known as a connector hole, which is concentric with the first hole, i.e., the centers of the first and second holes are coincident. The annular base of the connector ring is attached, e.g., welded, to the evacuation device around the first hole.

[0114] The evacuation device (110) of the evacuation device assembly (100) is shown in Figure 2. The evacuation device can be seen to comprise an annular mounting area (119) and an annular protective area (120) surrounding a first hole (114). The size of the annular protective area can be considered to define the size, i.e., diameter, of the first hole. A connector ring (150) is attached to the annular mounting area (119) such that the centers of the second hole (151) and the first hole (114) are coincident, the first hole (114) being smaller than the second hole (151) as can be seen in Figure 1.

[0115] 3 shows a side view of the evacuation device assembly (100). The evacuation device (110) can be seen to comprise a first film layer (111) attached to and overlapping a second film layer (112). Additionally, a connector ring (150) is provided towards the proximal end (116) of the evacuation device (110) and attached to the first film layer (111).

[0116] 4 shows a perspective view of a connector ring (150) comprising an annular base (152) defining a second bore (151), also known as a connector bore, concentric with the first bore. The connector ring comprises a plurality of radially inwardly projecting flanges (153), at least a subset of which are engagement flanges (155) adapted to engage with a circumferential groove of a cylindrical ostomy implant (300) or ostomy implant lid (200). Each engagement flange (155) has a connection means, such as a hook / guide element (156), for engaging with the cylindrical ostomy implant (300) or ostomy implant lid (200). The connection means, such as a hook element or guide element, are sized to fit within the circumferential groove of the cylindrical ostomy implant or ostomy implant lid.

[0117] Connection means are provided at each inner engagement flange edge (157) toward the center of the second hole (151). The connector ring further comprises a support flange (158) projecting radially inward. The inner engagement flange edge (157) forms a smaller circular / annular shape than that formed by the inner support flange edge (160). Thus, the engagement flange (155) projects radially inward further than the support flange (158).

[0118] FIG. 5 shows a top-down view of a connector ring (150) 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), the gaps being 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 the inner support flange edge (160). In the illustrated embodiment, the support structure comprises one radially extending support element (161) and one edge support element (162) disposed along the inner support flange edge (160). The support structures are arranged to provide the connector ring with increased rigidity and are generally stiffer, preferably stiffer than the mating flanges.

[0119] FIG. 6 shows a lid (200) for an ostomy implant. The lid (200) comprises a ring-shaped base part (230) adapted to engage with an open end of an ostomy implant (FIG. 6C). The lid further comprises a cap part (220) adapted to fit inside the ring-shaped base part (FIG. 6B), the cap part being rotatable relative to the ring-shaped base part to lock and unlock the lid to and from the ostomy implant, the cap part having a through hole. The cap part further has a slider (210) configured to be slid radially into a recess of the cap part in a closed configuration, where the slider completely covers the through hole of the cap part, and to be slid radially out of the recess in an open configuration, where the slider does not cover the through hole of the cap part (FIG. 6A).

[0120] The lid (200) comprises a connection means (231) in the form of a circumferential groove formed on the outer surface of the base part of the lid. Furthermore, the lid comprises a circumferential ring (232). During use, the lid is attached to the ostomy implant and prevents leakage of waste from the stoma. For evacuation from the stoma, the user attaches the evacuation device assembly (100) to the lid (200) by pushing the connector ring over the lid so that at least the slider is moved to the inside of the evacuation device, i.e. into the compartment formed between the first and second film layers. Once the engagement flange engages with the connection means of the lid, i.e. the circumferential groove (231), the evacuation device assembly is attached to the lid (200). In this position, the support flange may abut against the circumferential ring (232) located below the circumferential groove (231), i.e. towards the user of the lid. In this position, the engagement flange and the support flange provide support to the evacuation device (110) and / or the evacuation device assembly (100) to allow safe evacuation from the stoma.

[0121] 7 shows an embodiment of an ostomy implant (300) formed from an inner section (305) and an outer section (306). When implanted within a patient, the inner section (305) is located primarily or entirely inside the patient, while the outer section (306) is located primarily or entirely outside the patient.

[0122] The inner section (305) comprises an inner inner section piece (307) having a generally cylindrical structure formed from a hexagonal mesh structure. An outer inner section piece (308) connects the inner inner section piece to the outer section (306). The outer inner section piece is formed from a number of rods arranged circumferentially around the implant that extend between the inner inner section piece and the outer section.

[0123] The external section (306) is ring-shaped and comprises a connecting means (301) in the form of a circumferential groove. The connector ring of the evacuation device assembly (100) may be attached to the implant by pushing the connector ring onto the external section of the implant. Thus, the open end (302) and the upper circumferential edge part of the implant protrude into the compartment of the evacuation device formed between the first and second film layers. The connector ring is engaged with the implant when the engagement flange engages with the circumferential groove (301) of the implant. When the connection ring is pushed into the correct position for engagement with the implant, the engagement flange snaps into place in the circumferential groove (301). In this position, the support flange abuts the outer surface of the implant, such as the circumferential ring (304), thereby providing increased support.

[0124] (List of elements in the diagram) 100-Air Exhaust Device Assembly 110-Air exhaust device 111-First film layer 112-Second film layer 113-Peripheral parts 114-First hole 115-Notch 116-proximal end 117-Distal end 118-Truncated angle 119-Annular mounting area 120-Circular Protected Area 150-connector ring 151-Second hole 152-Ring base 153-Radial inwardly projecting flange 154-Gap 155-Engagement flange 156-Hook element / Guide element 157-Inner engagement flange edge 158-Support flange 159-Support structure 160-Inner support flange edge 161—Radially extending support element 162-Edge support element 200-lid 210-Slider 220-Cap parts 230-Base part 231-Outer circumferential groove 232-Outer Ring 233-Outer parts 300-Ostomy Implant 301-Circumferential groove 302-Open end 303-Upper circumferential edge part 305-Internal division 306-External division 307 - Inner Parts 308-Outer internal division parts

[0125] (item) 1. A drainage device assembly for drainage from a stoma, comprising: - a first film layer and a second film layer, the first film layer and the second film layer being attached along a peripheral part and forming an evacuation device, the first film layer comprising a first hole; -With integrated connector ring Equipped with The integrated connector ring an annular base defining a second hole concentric with the first hole, the annular base being attached, e.g. welded, to the evacuation device around the first hole; A plurality of radially inwardly projecting flanges; Equipped with An evacuation device assembly, wherein at least a subset of the protruding flanges are adapted to engage with circumferential grooves in a cylindrical ostomy implant or in a lid of an ostomy implant.

[0126] 2. The evacuation device assembly according to item 1, wherein the integrated connector ring is adapted to form a fluid connection between the evacuation device and the stoma.

[0127] 3. The evacuation device assembly of any one of the preceding items, wherein the first film layer is elastic.

[0128] 4. The evacuation device assembly according to item 3, wherein the first hole is smaller than the second hole.

[0129] 5. The evacuation device assembly of any one of the preceding items, wherein the annular base is attached, e.g., welded, to an annular mounting area of ​​the first film layer.

[0130] 6. The evacuation device assembly of item 5, wherein the first film layer comprises an annular protective area extending radially inward relative to the annular mounting area so as to overlap at least a portion of the second hole.

[0131] 7. The evacuation device assembly according to item 6, wherein the annular protective area at least partially overlaps the second hole.

[0132] 8. The evacuation device assembly according to any one of items 5-7, wherein the annular protective area is arranged to protect and / or form a seal against an outer part of the implant or lid during use.

[0133] 9. The evacuation device assembly according to any one of items 5-8, wherein the annular protective area extends radially inward such that it covers the flange.

[0134] 10. An evacuation device assembly according to any one of items 9, wherein the annular protective area extends radially inwardly beyond the flange, such as at least 5 mm beyond the edge of the flange.

[0135] 11. The evacuation device assembly of any one of the preceding items, wherein the first hole and the second hole are generally circular and / or the first hole and the second hole are generally concentric.

[0136] 12. The evacuation device assembly of any one of the preceding claims, wherein the plurality of radially inwardly protruding flanges are separated by gaps.

[0137] 13. The evacuation device assembly of any one of the preceding items, wherein the plurality of radially inwardly protruding flanges comprise an engagement flange adapted to engage with a circumferential groove of a cylindrical ostomy implant or a lid of an ostomy implant.

[0138] 14. The evacuation device assembly according to item 13, wherein the engagement flange is made from a resilient material.

[0139] 15. An evacuation device assembly according to any one of items 13-14, wherein the connector ring is provided with a limiting means for limiting bending of the one or more engaging flanges in a direction away from the second film layer.

[0140] 16. An evacuation device assembly according to item 15, wherein the limiting means comprises two adjacent protrusions arranged to limit flexure of the engagement flange in the direction of the protrusions.

[0141] 17. The evacuation device assembly according to any one of items 13-16, wherein each engagement flange has a hook or guide element on an inner engagement flange edge toward the center of the second hole.

[0142] 18. The evacuation device assembly according to item 17, wherein the hook or guide element is sized to fit into a circumferential groove in a cylindrical ostomy implant or in the lid of the ostomy implant.

[0143] 19. An evacuation device assembly according to any one of the preceding items, wherein the plurality of radially inwardly protruding flanges comprise support flanges adapted to stabilize an integrated connector ring.

[0144] 20. The evacuation device assembly according to item 19, wherein the support flange is generally rigid.

[0145] 21. An evacuation 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, and the support flanges are sized so that the inner support flange edge abuts a cylindrical ostomy implant or a circumferential ring of the ostomy implant lid.

[0146] 22. The evacuation device assembly according to any one of claims 19-21, wherein each support flange has a support structure.

[0147] 23. The evacuation 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 inner support flange edge.

[0148] 24. The evacuation device assembly according to any one of items 13-18 and any one of items 19-23, wherein every other radially inwardly protruding flange is an engagement flange and every other radially inwardly protruding flange is a support flange.

[0149] 25. The evacuation device assembly of any one of items 13-18 and any one of items 19-24, wherein the engagement flange protrudes above the support flange.

[0150] 26. The evacuation device assembly according to any one of items 13-18 and any one of items 19-25, wherein the support flange is more rigid than the engagement flange.

[0151] 27. The evacuation device assembly according to any one of the preceding items, wherein the evacuation device has a tapered shape, preferably a substantially flat tapered shape.

[0152] 28. The evacuation device assembly according to item 27, wherein the evacuation device has a triangular shape with one truncated angle.

[0153] 29. The evacuation device assembly according to any one of the preceding items, wherein the evacuation device is an open-ended evacuation sleeve.

[0154] 30. The evacuation device assembly according to any one of items 1-28, wherein the evacuation device is an evacuation pouch.

[0155] 31. The evacuation device assembly according to item 30, wherein the evacuation pouch is provided with perforations and / or one or more notches to open one end of the evacuation pouch.

[0156] 32. A method for producing an evacuation device assembly according to any one of the preceding items, the method comprising: forming a first circular hole in a first film layer; attaching the first film layer and the second film layer along peripheral parts of the layers to form a sleeve or pouch; attaching a connector ring to the first film layer around the first hole; (in any order), The connector ring is an annular base defining a second aperture concentric with the first aperture; A plurality of radially inwardly projecting flanges; Equipped with The method, wherein at least a subset of the protruding flanges are adapted to engage with circumferential grooves in a cylindrical ostomy implant or a lid of an ostomy implant.

[0157] 33. The method according to item 32, wherein the evacuation device assembly is arranged according to any one of items 1-31.

[0158] 34. A connector ring for attachment of a further device to an ostomy implant or to the lid of an ostomy implant, the connector ring comprising: an annular base defining a connector hole; A plurality of radially inwardly projecting flanges; Equipped with A connector ring, wherein at least a subset of the protruding flanges are adapted to engage circumferential grooves in a cylindrical ostomy implant or in a lid of an ostomy implant.

[0159] 35. The connector ring according to item 34, wherein the connector ring comprises attachment means for attachment of a further device to the connector ring.

[0160] 36. A connector ring according to any one of items 34-35, wherein the connector ring forms an integral part of a further device.

[0161] 37. A connector ring according to any one of items 34-39, wherein the connector ring forms an integral part of a further device.

[0162] 38. A connector ring according to any one of items 34-40, wherein the integrated connector ring is adapted to form a fluid connection between a further device and the stoma.

[0163] 39. A connector ring according to any one of items 34-41, wherein the connector hole is approximately circular.

[0164] 40. The connector ring of any one of items 34-44, wherein the multiple radially inwardly protruding flanges are separated by gaps.

[0165] 41. A connector ring according to any one of items 34-45, wherein the plurality of radially inwardly protruding flanges comprise an engagement flange adapted to engage with a circumferential groove of a cylindrical ostomy implant or a lid of an ostomy implant.

[0166] 42. The connector ring according to item 41, wherein the connector ring comprises a limiting means for limiting flexure of the one or more engaging flanges in a direction away from the second film layer.

[0167] 43. The connector ring according to item 42, wherein the limiting means comprises two adjacent protrusions arranged to limit flexure of the engaging flange in the direction of the protrusions.

[0168] 44. The connector ring of any one of items 41-43, wherein the engagement flange is made from a resilient material.

[0169] 45. A connector ring according to any one of items 41-44, wherein each engagement flange has a hook or guide element on an inner engagement flange edge toward the center of the second hole.

[0170] 46. ​​The connector ring according to item 45, wherein the hook or guide element is sized to fit into a circumferential groove in a cylindrical ostomy implant or in the lid of an ostomy implant.

[0171] 47. A connector ring according to any one of items 34-46, wherein the plurality of radially inwardly protruding flanges comprise support flanges adapted to stabilize the integrated connector ring.

[0172] 48. The connector ring of item 47, wherein the support flange is generally rigid.

[0173] 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, and the support flanges are sized so that the inner support flange edge abuts against a cylindrical ostomy implant or a circumferential ring of an ostomy implant lid.

[0174] 50. A connector ring according to any one of items 47-49, wherein each support flange has a support structure.

[0175] 51. The connector ring of item 50, wherein the support structure comprises at least one radially extending support element and / or at least one edge support element disposed along the inner support flange edge.

[0176] 52. The connector ring according to any one of items 41-46 and any one of items 47-51, wherein every other radially inwardly protruding flange is an engagement flange and every other radially inwardly protruding flange is a support flange.

[0177] 53. The connector ring of any one of items 41-46 and any one of items 47-52, wherein the engagement flange protrudes above the support flange.

[0178] 54. The connector ring of any one of items 41-46 and any one of items 47-53, wherein the support flange is stiffer than the engagement flange.

[0179] 55. A connector ring according to any one of items 34-54, wherein the connector ring is arranged according to the connector ring according to any one of items 1-31.

[0180] 56. Use of a connector ring according to any one of items 34-54 for attachment of a further device to an ostomy implant or to the lid of an ostomy implant.

[0181] 57. The use according to item 56, wherein the further device is an ostomy bag, catheter, or sleeve, such as a drainage sleeve or an irrigation sleeve.

[0182] 58. The use according to any one of items 56-57, wherein the connector ring forms an integral part of a further device.

Claims

1. An air exhaust device assembly for discharge from a fistula, - A first film layer and a second film layer, wherein the first film layer and the second film layer are mounted along a peripheral component and form an air exhaust device, and the first film layer has a first hole, - Integrated connector ring and Equipped with, The aforementioned integrated connector ring is ○ An annular base defining a second hole concentric with the first hole, wherein the annular base is attached to the annular mounting area of ​​the first film layer around the first hole, 〇 Multiple flanges that protrude radially inward and Equipped with, An air extraction device assembly in which at least a subset of the protruding flanges are fitted to engage with a cylindrical fistula implant or a circumferential groove of a fistula implant cover.

2. The exhaust device assembly according to claim 1, wherein the first film layer is elastic and the first holes are smaller than the second holes.

3. The exhaust device assembly according to claim 1 or 2, wherein the exhaust device assembly comprises an annular protective area arranged to reduce leakage during use and / or to form a seal with respect to the fistula implant or the lid of the fistula implant.

4. The air exhaust device assembly according to claim 3, wherein the annular protective area is formed by extending the first film layer radially inward from the annular mounting area.

5. The exhaust device assembly according to claim 4, wherein the annular protective area extends radially inward and extends beyond the radially inner edge of the flange.

6. The exhaust device assembly according to claim 1, wherein the plurality of radially inwardly projecting flanges include engaging flanges that are adapted to engage with circumferential grooves of a cylindrical fistula implant or a lid of a fistula implant, and the engaging flanges are made of an elastic material.

7. The exhaust device assembly according to claim 6, wherein the connector ring includes a restricting means for restricting the bending of at least one of the engaging flanges in an outward direction away from the second film layer, while the at least one engaging flange is not restricted by the restricting means and is bent inward toward the second film layer.

8. The exhaust device assembly according to claim 7, wherein the restricting means comprises two adjacent protrusions, the two adjacent protrusions being arranged to restrict the bending of at least one engaging flange in the direction of the protrusions.

9. The exhaust device assembly according to claim 6, wherein each engaging flange is provided with a hook element or guide element on the inner engaging flange edge toward the center of the second hole.

10. The exhaust device assembly according to claim 1, wherein the plurality of radially inwardly projecting flanges are provided with support flanges adapted to stabilize the integrated connector ring.

11. The air exhaust device assembly according to claim 10, wherein each support flange has an inner support flange edge toward the center of the second hole, and the support flange is sized such that the inner support flange edge abuts against the cylindrical fistula implant or the outer circumferential ring of the lid of the fistula implant.

12. Each support flange has a support structure, as described in claim 10, for the exhaust device assembly.

13. The exhaust device assembly according to claim 6, wherein the plurality of radially inward projecting flanges each comprises a support flange adapted to stabilize the integrated connector ring, and every other radially inward projecting flange is an engagement flange, and every other radially inward projecting flange is a support flange.

14. The exhaust device assembly according to claim 6, wherein the plurality of radially inwardly projecting flanges each comprises a support flange adapted to stabilize the integrated connector ring, and the engaging flange protrudes above the support flange.

15. A method for manufacturing an air exhaust device assembly according to claim 1 or 2, wherein the method is: - The step of forming a first circular hole in the first film layer, - The steps of attaching the first film layer and the second film layer along the peripheral components of the layers to form a sleeve or pouch, - The step of attaching the connector ring to the first film layer around the first hole. Includes, The aforementioned connector ring is ○ An annular base defining a second hole that is concentric with the first hole, 〇 Multiple flanges that protrude radially inward and Equipped with, A method wherein at least a subset of the protruding flanges is fitted to engage with a cylindrical fistula implant or a circumferential groove of the lid of a fistula implant.

16. A connector ring for attaching a further device to a fistula implant or the lid of a fistula implant, wherein the connector ring is - An annular base defining the connector hole, - Multiple flanges that protrude radially inward and Equipped with, A connector ring in which at least a subset of the protruding flanges is fitted to engage with a cylindrical fistula implant or a hood of a fistula implant.

17. The connector ring according to claim 16, wherein the plurality of radially inwardly protruding flanges are separated by a gap.

18. The connector ring according to claim 16, wherein the plurality of radially inwardly projecting flanges are fitted to engage with a cylindrical fistula implant or a hood of a fistula implant, wherein the plurality of radially inwardly projecting flanges are fitted to engage with an outer circumferential groove of the hood of the fistula implant.

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

20. The connector ring according to claim 16, wherein the plurality of radially inwardly projecting flanges are fitted with support flanges 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 toward the center of the connector hole, and the support flanges are sized such that the inner support flange edges abut against the cylindrical fistula implant or the outer circumferential ring of the lid of the fistula implant.

22. The connector ring according to claim 20, wherein each support flange has a support structure adapted to increase the structural rigidity of the connector ring.

23. The connector ring according to claim 18, wherein the plurality of radially inward projecting flanges are each fitted with a support flange to stabilize the connector ring during use, and every other radially inward projecting flange is an engagement flange, and every other radially inward projecting flange is a support flange.

24. The connector ring according to claim 18, wherein the plurality of radially inwardly projecting flanges are fitted to stabilize the connector ring during use, and the engaging flanges project beyond the support flanges.

25. The connector ring according to claim 18, wherein the plurality of radially inwardly projecting flanges are fitted to stabilize the connector ring during use, and the support flanges are more rigid than the engagement flanges.

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