Outlet member for an ostomy appliance

Abstract

An outlet member (1) for an ostomy appliance is provided. The outlet member comprises an outlet tube (5) for allowing stomal output to exit the ostomy appliance, and a pinching action zone (4) for receiving stomal output from the ostomy appliance and delivering it to the outlet tube, wherein the pinching action zone comprises opposing flexible walls, each wall narrowing in a direction towards the outlet tube for pinching the stomal output towards the outlet tube, wherein the outlet tube is relatively rigid for secure fluid connection of the outlet tube with an external device, and wherein the pinching action zone and the outlet tube are integrally formed from the same material.

Description

Technical Field

[0001] This invention relates to an outlet element for an ileostomy device. In particular, this invention relates to an ileostomy device and a flexible outlet element for drainage of the ileostomy device. Background Technology

[0002] Ostomy devices may be provided with an outlet element for draining liquid and semi-liquid contents from the bag of the ostomy device for direct disposal or treatment via an additional device such as a drainage bag that can be attached to the outlet element. To facilitate drainage, the outlet element is typically located at the bottom of the bag so that, when needed, gravity drives the contents of the bag toward and out of the outlet element.

[0003] This is particularly important for ileostomy devices used to connect to ileostomies, which are stomas formed from the small intestine. Due to their connection to the small intestine, stoma drainage is more frequent than in stomas formed from the large intestine (colostomies). Furthermore, stoma drainage has a high fluid content and is typically a mixture of liquid and small solid clumps.

[0004] The outlet element of an ileostomy device typically needs to be compatible with external drainage tubes and other devices so that the ileostomy device can be connected to them for continuous drainage. This is especially common in patients undergoing ileostomy, as output can occur frequently and in large volumes. At night, this may necessitate connecting the outlet element to a nighttime drainage bag to ensure proper handling of ostomy output. Such connections to external elements require a relatively rigid outlet element to ensure a secure, leak-free connection can be established.

[0005] Another requirement for many stoma devices designed for ileostomy is the provision of a squeeze operation area. This is to allow the user to gradually squeeze and push the stoma output through the outlet element, often referred to as "squeeze-and-drain operation." Therefore, the squeeze operation area needs to be relatively flexible so that the user can easily squeeze the internal stoma output.

[0006] While existing outlet elements may be effective, further optimization is still needed in this field. Balancing the requirements for relatively rigid components needed for connection to external drainage devices with the requirements for relatively flexible components needed for squeeze-and-drainage operations remains a continuous challenge for the efficient design and manufacture of outlet elements for ileostomy applications. This has led some existing devices to use different materials to overmold different parts / sections of the outlet element with the correct physical properties.

[0007] Therefore, the object of the present invention is to at least partially solve the above-mentioned problems. Summary of the Invention

[0008] In a broad sense, this invention relates to an outlet element for an ostomy device. The outlet element may include an outlet tube for allowing ostomy outputs to exit the ostomy device. The outlet element may include a squeezing actuation zone for receiving ostomy outputs from the ostomy device and conveying them to the outlet tube. The squeezing actuation zone may include relatively flexible opposing walls, each wall narrowing in the direction toward the outlet tube for squeezing the ostomy outputs toward the outlet tube. The outlet tube may be relatively rigid for a secure / reliable fluid connection to an external device. The squeezing actuation zone and the outlet tube may be integrally formed from the same material.

[0009] Therefore, in a first aspect of the invention, an outlet element for an ostomy apparatus is provided, the outlet element comprising an outlet tube for allowing ostomy outputs to exit the ostomy apparatus, and a squeezing operating area for receiving ostomy outputs from the ostomy apparatus and conveying them to the outlet tube, wherein the squeezing operating area comprises relatively flexible opposing walls, each wall narrowing in a direction toward the outlet tube for squeezing the ostomy outputs toward the outlet tube, wherein the outlet tube is relatively rigid for secure / rigid fluid connection to an external device, and wherein the squeezing operating area and the outlet tube are integrally formed of the same material.

[0010] Here, the statements regarding the relative flexibility and relative rigidity of the walls of the squeezing operating area and the outlet tube respectively mean that the squeezing operating area is more flexible than (i.e., relative to) the outlet tube, and conversely, that the outlet tube is more rigid than (i.e., relative to) the walls of the squeezing operating area. Advantageously, the squeezing operating area is relatively flexible compared to the outlet tube. The physical shape of the squeezing operating area contributes to this, as it includes opposing walls that narrow, providing a relatively weaker region compared to the outlet tube at points away from it. Conversely, the outlet tube is relatively rigid compared to the squeezing operating area. This can be achieved by controlling the shape of the outlet tube, as described in more detail below. This allows the outlet element to be integrally formed, which reduces manufacturing complexity and cost. Therefore, the outlet element is formed from a single continuous piece of material. There may be no joints or seals between the different parts of the outlet element. The outlet element may have no joints. The squeezing operating area and the outlet tube are integrally formed, and are therefore single continuous pieces of material, with no joints between them.

[0011] This increases the lifespan of the device because there are no joints between the different components of the outlet element. This one-piece design overcomes the problems of existing devices formed by combining multiple different materials and components, such as through overmolding; that is, the one-piece design surprisingly still provides the relative flexibility required for the different components of the outlet element.

[0012] The optional features of the export element of the first aspect are described below. In a broader sense, any one or more of these features also apply to the export element described above. This includes any one or more optional features of the export element described broadly, without requiring all features of the export element of the first aspect.

[0013] Export components may have a Shore A hardness. The Shore A hardness described herein is preferably measured using a type A indenter according to standard ASTM D2240-15.

[0014] The outlet element can be formed from a material with a Shore A hardness of at least 60. This provides a baseline level of rigidity for the outlet element, especially the outlet tube, ensuring it maintains sufficient rigidity to form a robust, leak-free seal with the external drainage device. The outlet element can also be formed from a material with a Shore A hardness of at least 70 or at least 80. This helps to increase rigidity, thereby providing a more robust sealing connection between the outlet tube and the external drainage device.

[0015] The outlet element can be formed from a material with a Shore A hardness not exceeding 95. This ensures that the material retains sufficient flexibility to allow the squeezing operation area to function properly. The outlet element can also be formed from a material with a Shore A hardness not exceeding 90. This makes the squeezing operation area more flexible and easier to "squeeze".

[0016] The outlet element can have a Shore A hardness of 85. This has been found to provide optimal material properties, where the squeezing operation zone is easy to squeeze, and the outlet tube also provides a highly robust, leak-free seal for external drainage devices.

[0017] The outlet element can be formed from a material with a Shore A hardness of 60 to 95. (This is repeated 6 times in the original text.) These different combinations help to change the inherent hardness of the outlet element, thereby achieving the aforementioned benefits.

[0018] The outlet element can be formed from one or more of a variety of materials, but preferably, it is formed from a plastic material. The outlet element can be formed from a thermoplastic material. The outlet element can be formed from a polymer. The outlet element can be formed from a copolymer. Therefore, a wide range of plastics and polymers can be used for the outlet element. Examples include ethylene vinyl acetate (EVA), polyethylene, low-density polyethylene, thermoplastic polyurethane, and styrene-ethylene-butene-styrene plastics.

[0019] The outlet element may include ethylene-vinyl acetate copolymer (EVA). This provides optimal material properties and can be easily welded to the bag wall of the ostomy device, which may also be formed of the same or similar material.

[0020] The relative concentration of VA in the outlet element can be selected as follows: The VA concentration in EVA can be at least 15% by weight. The ethylene concentration in EVA can not exceed 85% by weight. These concentrations have been found to ensure that the formed material is not too rigid, preventing the extrusion zone from functioning properly. The VA concentration in EVA can be at least 18% by weight. The ethylene concentration in EVA can not exceed 82% by weight. This has been found to provide optimal rigidity when a more flexible extrusion zone is desired.

[0021] The VA concentration in EVA can not exceed 32% by weight. The ethylene concentration in EVA can be at least 68% by weight. These concentrations have been found to ensure that the formed material is heat-resistant and does not melt at excessively low temperatures for practical use, while maintaining suitable rigidity to provide the aforementioned advantages. The VA concentration in EVA can not exceed 25% by weight, or not more than 20% by weight. The ethylene concentration in EVA can be at least 75% by weight, or at least 80% by weight. These concentrations provide more reliable material properties, are less sensitive to heat, and are more rigid to ensure a more secure attachment to external drainage devices.

[0022] The VA concentration in EVA can be 18% by weight. The ethylene concentration in EVA can be 82% by weight. These concentrations have been found to provide an optimal balance of properties, with the outlet element being heat-resistant and the outlet pipe and the extrusion operation zone having an optimal balance of rigidity and flexibility.

[0023] The VA concentration in EVA can be from 15 wt% to 32 wt%. The ethylene concentration in EVA can be from 68 wt% to 85 wt%. The VA concentration can be from 15 wt% to 25 wt%. The ethylene concentration in EVA can be from 75 wt% to 85 wt%. The VA concentration in EVA can be from 15 wt% to 20 wt%. The ethylene concentration in EVA can be from 80 wt% to 85 wt%. The VA concentration in EVA can be from 18 wt% to 32 wt%. The ethylene concentration in EVA can be from 68 wt% to 82 wt%. The VA concentration in EVA can be from 18 wt% to 25 wt%. The ethylene concentration in EVA can be from 75 wt% to 82 wt%. The VA concentration in EVA can be from 18 wt% to 20 wt%. The ethylene concentration in EVA can be from 80 wt% to 82 wt%. These different combinations change the properties of the copolymer to achieve the aforementioned benefits.

[0024] Thermoplastic materials may include a melt flow index. The melt flow index is defined as the mass of polymer that flows through a capillary of a specific diameter and length over ten minutes at a given pressure. Therefore, the melt flow index is preferably the melt mass flow index. The melt flow index of the materials described herein is preferably measured according to standard ASTM D1238-10 at 190 degrees Celsius and under an applied load of 2.16 kg mass / weight.

[0025] The melt flow index can be at least 2.5 g / 10 min. This has been found to provide optimal processability during manufacturing and ensure that the cured product has the correct mechanical properties.

[0026] The melt flow index may not exceed 43 g / 10 min. This ensures that the polymer is not too flowable and therefore difficult to process. The melt flow index may not exceed 30 g / 10 min. The melt flow index may not exceed 20 g / 10 min. The melt flow index may not exceed 10 g / 10 min. In some embodiments, the melt flow index may be 14 g / 10 min. It has been found that these melt flow indices improve the final material properties of the resulting outlet element once the polymer has solidified.

[0027] Melt flow index can range from 2.5 g / 10 min to 43 g / 10 min. Melt flow index can range from 2.5 g / 10 min to 30 g / 10 min. Melt flow index can range from 2.5 g / 10 min to 20 g / 10 min. Melt flow index can range from 2.5 g / 10 min to 10 g / 10 min. These different combinations offer the different technological advantages described above.

[0028] In some embodiments, materials with a melt flow index in the range of 2.5 g / 10 min to 43 g / 10 min can be, but are not limited to, ethylene-vinyl acetate copolymer (EVA), low-density polyethylene (LDPE), or high-density polyethylene (HDPE). The ethylene-vinyl acetate copolymer can be ELVAX. TM 450, ELVAX TM 460, ELVAX TM 550, ELVAX TM 660 or Exxon Escorene TM Ultra LD 726.07 EVA resin.

[0029] The outlet element may have an axis extending therethrough. This axis may extend in a direction generally parallel to the fluid flow through the outlet element. This axis may be centered relative to the tubular cross-section of the outlet element. This axis is intended to be generally vertical in use. The outlet pipe may include an axis. The axes of the outlet pipe and the outlet element may be parallel, and preferably coaxial.

[0030] These walls can be sheet-like. These walls can be planar. Each wall may include a planar surface defining the wall surface. The walls may extend parallel to the axis of the outlet element. The walls may extend perpendicular to the axis of the outlet element. This preferably makes the squeezing operation area relatively flexible when squeezed together in a direction perpendicular to the wall plane.

[0031] The walls may have a height measured parallel to the axis of the outlet element. The walls may have a width measured perpendicular to the axis of the outlet element. The height and / or width may be measured on the inner surface of the walls. The walls may have a thickness perpendicular to their width and height measurements, preferably perpendicular to the planar surface of each wall. The outlet pipe may have a thickness measured in a radial direction extending from the axis of the outlet element perpendicular to the axis of the outlet element.

[0032] These walls can be spaced apart by a distance equal to the width of the outlet tube as measured perpendicular to the walls. Therefore, the walls can have a spacing equal to the width of the outlet tube. These walls can have a substantially constant spacing. These walls can be parallel to each other. This ensures they remain easily compressed together and that ostomy output can more easily enter the outlet tube.

[0033] The outlet element may include an outlet end. The outlet end may be configured to allow stoma output to exit the outlet element. The outlet end may be located at one end of the outlet tube distal to the squeezing operation area.

[0034] The outlet element may include an inlet end. The inlet end may be configured to connect to an ostomy device. The inlet end may be configured to receive ostomy output from the ostomy device. The inlet end may be larger than the outlet end. The inlet end may include a wall thicker than the outlet end. The inlet end may be oval-shaped. The inlet end may have a lens shape. The long axis of the inlet end may be arranged parallel to the wall of the ostomy device, for example, as described below. The inlet end may be configured to be positioned between two pocket walls of the ostomy device. This helps ensure efficient flow of ostomy output into the outlet element, and that the inlet end is reliable and does not become easily detached from the ostomy device.

[0035] The width of the wall can be at least the wall spacing. The minimum width of the wall can be at least the wall spacing. The wall may have a minimum width near the outlet tube. This helps ensure that stoma output can effectively flow into the outlet tube. The maximum width of the wall can be at least twice the wall spacing. These walls may have a maximum width near the inlet end. The minimum width of the wall can not exceed 50% or 40% of the maximum width of the wall. The minimum width of the wall can be at least 20% or at least 30% of the maximum width of the wall. The minimum width of the wall can be approximately 30-40% of the maximum width of the wall. The edges of the wall may taper towards the outlet tube. The edges may be sloping edges. These walls may have an inverted trapezoidal shape. This helps provide effective squeezing of stoma output towards the outlet tube.

[0036] The height of the wall can be at least the wall spacing. The height of the wall can be greater than the minimum width of the wall. The height of the wall can not exceed the maximum width of the wall. The height of the wall can not exceed 75% of the maximum width of the wall, or not exceed 50%. This helps to ensure that the wall is flexible in both the width and height directions to allow for easy squeezing of the squeezing operation area.

[0037] The squeezing maneuver zone can be tubular. When viewed along the axis of the outlet element / outlet tube, the squeezing maneuver zone may have an oval cross-section. The squeezing maneuver zone may have a substantially constant short axis. The squeezing maneuver zone may have a narrowing long axis. This shape advantageously allows for effective squeezing or pressing along the short axis of the squeezing maneuver zone to force the ostomy output toward the outlet tube and out of the outlet element.

[0038] The aspect ratio of the squeezing operating zone can be defined by its major and minor axes. The major axis can be substantially parallel to the wall and perpendicular to the axis of the outlet element. The minor axis can be perpendicular to both the wall and the axis of the outlet element. The aspect ratio (major axis:minor axis) of the squeezing operating zone can vary along the outlet element. At the point where the squeezing operating zone connects to the outlet pipe, the aspect ratio can be at least 1:1. At the inlet end, the aspect ratio can be at least 2:1. At the inlet end, the aspect ratio can not exceed 4:1 or 3:1. This helps ensure that the aspect ratio is controlled to provide a suitable squeezing operating zone.

[0039] The aspect ratio of the outlet tube can be measured perpendicular to the axis of the outlet tube / outlet element. The aspect ratio can be defined as the ratio of the widths of the outlet tube cross-sections measured in two orthogonal directions perpendicular to the outlet tube axis. The aspect ratio of the outlet tube can be smaller than the aspect ratio of the squeezing operating area. The aspect ratio of the outlet tube can not exceed 3:1, or 2:1. The aspect ratio of the outlet tube can be 1:1. The aspect ratio of the outlet tube can be smaller than the aspect ratio of the squeezing operating area. That is, the aspect ratio of the outlet tube can be closer to 1:1 than the aspect ratio of the squeezing operating area. Advantageously, these aspect ratios help ensure relative rigidity of the outlet tube compared to the squeezing operating area, even if both are integrally formed and have similar thicknesses.

[0040] The outlet pipe may have a substantially circular cross-section. This helps ensure that the outlet pipe provides a robust, leak-free interference fit with the external drainage device, and as if compressed, it can support itself evenly in all directions.

[0041] Along the outlet tube, for example from the squeezing operation area to the outlet end, the outlet element may include a substantially constant inner circumference or inner diameter. This helps to provide consistent mechanical properties along the outlet tube to facilitate secure attachment to an external drainage device. The inner width or inner diameter of the outlet end may be at least 1 cm, or at least 1.2 cm, or at least 1.3 cm. The inner width or inner diameter of the outlet end may not exceed 3 cm, or not exceed 2 cm, or not exceed 1.5 cm. Preferably, the inner width or inner diameter of the outlet end may be 1.3 cm. This helps to provide an optimally sized outlet for ileostomy devices and can handle typical ostomy outputs including both solid and liquid substances.

[0042] A stepped portion may be provided between the squeezing operating area and the outlet pipe. This stepped portion may comprise an area with a relatively high pipe wall thickness, for example, compared to the squeezing operating area and / or the outlet pipe. The stepped portion may be inclined / angled. The stepped portion may narrow towards the outlet pipe. This stepped portion thereby provides a relatively rigid area between the squeezing operating area and the outlet pipe. This helps prevent any forces applied to the squeezing of the squeezing operating area from causing undesirable deformation of the outlet pipe and potentially jeopardizing the sealed connection between the outlet pipe and the external drainage device.

[0043] The outlet element may include a tube wall thickness that defines the thickness of the tubular outlet element along its length. The tube wall thickness of the outlet tube may be substantially the same as the tube wall thickness of the extrusion operation zone. In the extrusion operation zone, the wall thickness may define the tube wall thickness. The tube wall thickness of the outlet tube may be within 50%, 40%, or 30% of the tube wall thickness of the extrusion operation zone. This ensures that the two components can be formed more efficiently and reliably through the molding / forming process without being affected by human factors.

[0044] The tube wall thickness may not exceed 4 mm, or 3 mm, or 2 mm. The tube wall thickness may be at least 0.5 mm or at least 1 mm. The tube wall thickness may range from 0.5 mm to 4 mm. The tube wall thickness may range from 0.5 mm to 3 mm. The tube wall thickness may range from 0.5 mm to 2 mm. The tube wall thickness may range from 1 mm to 4 mm. The tube wall thickness may range from 1 mm to 3 mm. The tube wall thickness may range from 1 mm to 2 mm. The walls of the extrusion operating area may have the thicknesses described above related to tube wall thickness. These thicknesses help ensure the selection of the correct mechanical properties and facilitate the formation of reliable products using simple and cost-effective raw materials and manufacturing processes.

[0045] The inlet end may include a tubular inlet. The tubular inlet may have a constant wall thickness. The tubular inlet may have a greater wall thickness than the squeezing operating area. The squeezing operating area may be more flexible than the tubular inlet. The wall thickness of the squeezing operating area may not exceed 95% or 90% of the wall thickness of the tubular inlet. The wall thickness of the squeezing operating area may be at least 70% or at least 80% of the wall thickness of the tubular inlet. This helps ensure that the squeezing operating area is more flexible while maintaining sufficient strength to prevent breakage during use, and is sufficiently similar in thickness to the tubular inlet to reduce human error during manufacturing.

[0046] The length of the tubular inlet is at least 2 mm, or at least 4 mm, or at least 6 mm, or at least 10 mm. The length of the tubular inlet does not exceed 20 mm, or at least 15 mm, or at least 10 mm. This helps to provide a reliable section for attachment to the ostomy device and minimizes any potential damage to the seal of the ostomy device due to squeezing, as described below.

[0047] Compared to the squeezing operation area, the inlet end may include a relatively large wall thickness. The inlet end may include a wall thickness at least 50%, at least 100%, or at least 150% greater than that of the squeezing operation area. Compared to the squeezing operation area, the inlet end may be relatively rigid. This helps ensure that the inlet end provides a safe / secure point for attachment of the outlet element to the bag of the ostomy device.

[0048] The inlet end may include two flaps. The two flaps may extend outward from the inlet end. The two flaps may extend parallel to the long axis of the inlet end. The two flaps are intended to extend between the walls of the stoma device. The two flaps may extend downward along the tubular inlet. The two flaps may be tapered. Therefore, the two flaps provide a stronger sealing connection between the stoma device and the outlet element.

[0049] The outlet element may include a closure element configured to releasably close the outlet end of the outlet tube to prevent the release of ostomy output from the ostomy instrument. The closure element may include an actuating element. The actuating element may be tubular. The actuating element may be provided with an opening. This opening may be adapted to receive a user's fingertip to assist in disengaging the closure element from the outlet tube. The actuating element may include an axis. When the outlet tube is closed, the axes of the outlet tube and the actuating element may be parallel, and preferably coaxial.

[0050] The opening may have a diameter / width of at least 12 mm. This width can be the maximum width measured between two points on opposite sides of the opening. This helps ensure the opening is large enough to accommodate enough of the user's fingertips, allowing greater force to be transmitted from the fingertips to the closing element. The opening may also have a diameter / width of at least 13 mm. This size is particularly preferred because it corresponds to the finger width that 95% of adult male and female fingers can exceed, as cited in Johnson et al.'s work published in the Scandinavian Journal of Occupational Health and Environment Supplement (SJWEH Suppl), 2007, Vol. 3, pp. 26-32. The inventors have found that this size is well-suited for operation by most users.

[0051] The diameter / width of the opening may not exceed 25 mm. This size helps ensure that the manipulator itself is not too large or adds unnecessary weight to the stoma apparatus. It also allows most users to operate the manipulator by wedging their fingers straight or at an angle into the opening without applying a strong grip. The opening may have a diameter / width of no more than 20 mm. This size is preferred because the corresponding opening diameter / width does not exceed the finger width of 95% of adult men and women, as cited in Johnson et al., SJWEH Suppl, 2007, Vol. 3, pp. 26-32. The inventors have found that the vast majority of users are able to insert their fingers into the opening with a relatively tight fit, which helps them apply force intuitively without gripping the manipulator. The diameter / width of the opening may not exceed 15 mm. At this size, the finger width of most adult men and 50% of adult women is greater than this. Advantageously, the inventors have found that this size helps users operate the control element better because it forces their fingertips into it and allows them to use the natural elasticity of the fingers and the elasticity of the opening (if that elasticity exists) to grip the control element.

[0052] The opening can have a diameter / width of 12 mm to 25 mm. The opening can have a diameter / width of 13 mm to 25 mm. The opening can have a diameter / width of 12 mm to 20 mm. The opening can have a diameter / width of 13 mm to 20 mm. The opening can have a diameter / width of 12 mm to 15 mm. The opening can have a diameter / width of 13 mm to 15 mm. These different combinations advantageously combine the benefits of the aforementioned different ranges. The opening can have a diameter / width of 13 mm. It has been found that this provides an optimal balance between being large enough to allow most people to insert part of their fingertips into the opening and small enough to ensure that most people can generate a clamping force around the opening around their fingers without needing to manually grasp the manipulator.

[0053] The aforementioned size also has the advantage of being small enough that users can easily place their fingers across the opening to push the closure element back into engagement with the outlet tube / outlet end. The size of the opening makes this easy to do without the fingertip entering the opening, which would otherwise cause the closure element to accidentally disengage from the outlet tube when the user retracts their finger.

[0054] The actuating element can be elastically deformable. The actuating element can be formed from an elastically deformable material. The actuating element can be configured to elastically deform when a fingertip is inserted into an opening. For example, the opening can elastically deform from a generally circular shape to a generally oval shape. The opening can be configured to elastically expand when a fingertip is inserted into the opening. This provides the benefit of allowing the opening to dynamically change size to accommodate a variety of different fingertip sizes and to actively hold the fingertip once it is received. These features are most advantageous when combined with openings with a diameter / width not exceeding 25 mm, 20 mm, or 15 mm. Furthermore, since the cross-section of a user's fingertip is typically different for different users and is oval rather than circular, openings with these features will be able to better conform to the shape of the fingertip.

[0055] The closure element may include a stop. The stop may be configured to abut the outlet end of the outlet tube. This helps control the corresponding positioning of the closure element and the outlet tube to ensure effective closure and easy opening. An opening may be spaced apart from the stop. Thus, the opening and the stop may be spaced apart in a direction parallel to the axis of the outlet tube. An actuating element may extend from the stop away from the outlet end and preferably into the opening. The opening may be spaced apart from the stop by at least one-third of its diameter / width. This helps provide a spaced opening so that the user's fingertip can transmit effective force to remove the closure element, such as a force required away from the end of the outlet tube. The opening may be spaced apart from the stop by at least half its diameter / width. This helps to better "grip" the user's finger due to the deformation of the finger and / or the opening. The opening may be spaced apart from the stop by at least two-thirds of its diameter / width. This helps to ensure that the opening is sufficiently spaced from the outlet tube to reduce the risk of leakage from the ostomy instrument contacting the user when the outlet element is opened using the actuating element. The opening can be spaced from the stop by a distance of at least the opening diameter / width. These larger dimensions provide the further benefit of increased clamping / gripping, and make it easier to position the actuating element without looking at the exit element.

[0056] The sealing element may include a plug. The plug may be configured to be received into the outlet tube. This provides a simple and reliable way for the sealing element to seal the end of the outlet tube by push-in fit or interference fit.

[0057] The plug can be tubular. The plug may include a capped end. This helps to provide a simple and effective design.

[0058] The plug can be configured to seal against the inner surface of the outlet tube. The plug can have a shape that matches the internal shape of the outlet tube. The plug can include an outer circumference slightly larger than the inner circumference of the outlet tube. Therefore, slight deformation of the plug and / or the outlet tube provides the necessary force to achieve an interference fit when the outlet element is closed by the sealing element. The outlet tube can be generally cylindrical at the outlet end. The plug can also be generally cylindrical. This simple shape further provides the advantage of rotational symmetry, making it easier to assemble the plug into the outlet tube.

[0059] The plug and actuating element can be arranged linearly along the closing element. Therefore, the plug and actuating element are arranged sequentially along the closing element. The length of the closing element can be defined from the tip of the plug to the opening. The tip of the plug can be defined by the capped end of the plug. The length of the plug can be defined from the tip of the plug to the base of the plug. The actuating element can be attached to the base of the plug. The actuating element can be directly attached to the base of the plug. This provides a simple structure that allows for intuitive use of the plug and actuating element, as the plug is essentially an extension of the actuating element. Therefore, the user can close the outlet element by inserting the plug into the outlet tube.

[0060] The plug may converge toward the capped end. The plug may converge toward its tip. The plug may include a converging shape. This makes it easier to close the outlet element, as the converging shape can be used to guide the remainder of the plug into the outlet tube.

[0061] The plug may include a conical end. The conical end can provide the converging shape. The conical end can also provide a capped end. This makes closure easier because the conical shape helps guide the plug into the outlet element more efficiently, and also visually provides an arrow shape to guide the user on how to use the plug.

[0062] The plug or conical end may include a slight point / tip / a point at its tip. The plug may be blunt at its tip. The plug may be rounded at its tip. The converging shape of the plug may be truncated. The conical end may be truncated. No more than 10%, 5%, or 3% of the area of ​​the converging shape or conical end may be truncated. At least 0.5% or at least 1% of the area of ​​the converging shape or conical end may be truncated. The width of the truncated portion may not exceed 5 mm, or 3 mm, or 2 mm. The width of the truncated portion may be at least 0.5 mm or at least 1 mm. Therefore, the capped end may not be pointed. This ensures that there are no sharp points on the plug while maintaining usability due to the overall converging shape.

[0063] The plug may include one or more sealing ribs. These sealing ribs are configured to seal against the inner surface of the outlet pipe. Therefore, the sealing ribs provide additional sealing capability to the plug. The one or more sealing ribs may extend from the outer surface of the plug. The one or more sealing ribs may extend circumferentially around the plug, preferably circumferentially around the entire circumference of the plug. The sealing ribs may be sealing rings. This helps ensure that they provide a tight / leak-free seal between the plug and the outlet pipe.

[0064] The plug may include one or more sealing ribs arranged along its length. The plug may include two or more sealing ribs, or three or more sealing ribs, or four or more sealing ribs. The plug may include five sealing ribs. This ensures a highly resilient and reliable seal. When the plug includes two or more sealing ribs, the sealing ribs may have different lengths measured from the beginning of the plug. The sealing ribs become longer the closer they are to the actuating element along the plug. The outlet tube may narrow in a direction away from the outlet end. The variation in the length of the sealing ribs may match the narrowing of the outlet tube. Therefore, the shapes of the sealing ribs and the outlet tube are complementary to ensure an effective seal and improve ease of manufacture.

[0065] The sealing ribs can be spaced evenly along the length of the plug. The sealing ribs can be positioned along a plug region with a constant outer circumference. The sealing ribs can be spaced to cover approximately half the length of the plug. This helps to evenly distribute the sealing force of adjacent ribs, ensuring a better seal.

[0066] The sealing ribs can be positioned generally close to the tip of the plug. The sealing ribs can also be positioned generally away from the operating element. This helps ensure a seal at a distance from the operating element, reducing the possibility of ostomy output leakage to the user.

[0067] The plug may include a proximal sealing rib. The proximal sealing rib may be positioned close to the tip of the plug. The proximal sealing rib may be positioned around or near the capped end of the plug. The proximal sealing rib may be positioned around or near the base of the conical end of the plug. The proximal sealing rib helps to provide an initial seal around the plug. The proximal sealing rib may be structurally supported by the capped end of the plug, or preferably by the conical end of the plug (if present). This helps to provide additional sealing capability and helps to reduce the passage of ostomy output between the plug and the outlet tube. In the presence of two or more sealing ribs, the proximal sealing rib may be the shortest.

[0068] The actuating element may include an inner bore extending from the opening into the actuating element. This provides additional depth to the opening, allowing fingertips to grip and / or be held more effectively by the opening. The inner bore may be cylindrical. The inner bore may extend from the opening through most of the length of the actuating element. The inner bore may extend from the opening through the entire length of the actuating element. The length of the actuating element may be defined from the opening to the plug. This helps allow the sides of the actuating element to bend and stretch around the opening to better accommodate the user's fingertips. The inner bore may extend to a stop. The inner bore may extend through the entire actuating element. This helps allow users to insert their fingers into the actuating element and operate it more safely without having to hold it tightly. It also provides additional bending when the actuating element needs to stretch to accommodate the user's fingers.

[0069] The inner bore extends into the plug. The inner bore extends substantially the entire length of the closure element. The inner bore extends from the opening to the capped end of the closure element. The inner bore extends from the opening to the capped end of the plug. Of course, the inner bore does not extend through the entire length of the closure element, because otherwise it would provide a channel for ostomy output through the closure element. This advantageously reduces the material required for the closure element and provides a shape that is easy to injection mold without a tendency to defects.

[0070] The inner bore may include a stepped portion between the actuating element and the plug. This stepped portion may correspond to the location of the stop. The plug may include an inner circumference (or inner diameter) smaller than that of the actuating element. This helps to provide a simple and efficient method for constructing a closed element with an integrally formed stop / integrated stop.

[0071] The closure element may include a wall. This wall may be tubular. This wall may define the shape of the actuating element. This wall may define the shape of the plug. This wall may extend from the capped end to the opening. Sealing ribs may extend from the wall. The closure element may be hollow. The wall may have a substantially constant thickness in the plug. The wall may have a substantially constant thickness in the actuating element. The wall in the actuating element may be thicker than the wall in the plug. This ensures that the closure element is easy to manufacture while providing the required mechanical properties and other characteristics.

[0072] The sealing element may include a relatively thick-walled region adjacent to the plug. The plug may have a wall thickness less than that of the relatively thick-walled region; for example, the plug may have a thickness not exceeding 80%, 70%, 60%, 50%, 40%, or 30% of the thickness of the relatively thick-walled region. The relatively thick-walled region may be provided by a stop. The wall thickness of the actuating element may be greater than that of the plug. The wall thickness of the actuating element may be at least 25%, at least 50%, at least 75%, or at least 100% greater than that of the plug. This provides structural support for the plug to help ensure it does not easily collapse during use and to ensure the sealing ribs function effectively.

[0073] The actuating element may include one or more flanges. These flanges may extend outwards, thus extending from an outer surface of the actuating element. The flanges may extend from a wall. The flanges may extend in a direction perpendicular to the axis of the actuating element. In the case of a tubular shape, it may define the axis of the actuating element. The axis of the actuating element may extend parallel to its length. The flanges advantageously provide additional features that allow for easy gripping, enabling the user to better manipulate the actuating element or apply force to it in a more controlled manner.

[0074] The actuating element may include a proximal flange. The proximal flange may extend outwards. The proximal flange may be located at or near the end of the actuating element. The proximal flange may be located around or near the stop. When the outlet end is closed by a sealing element, the proximal flange may be adjacent to or toward / close to the outlet tube. Advantageously, the proximal flange helps prevent stoma output leakage onto the user's hand / finger during use because it provides a leak-proof lip. It also physically aids in separating fingers from the outlet tube, which may contain stoma output on its outer surface.

[0075] The proximal flange is positioned around the stop. This ensures that the proximal flange effectively defines the termination position of the operating element and the location where the outlet tube will reach along the sealing element. This helps users ensure they do not accidentally access the outlet tube.

[0076] The actuating element may include a distal flange. The distal flange may extend outwards. The distal flange may be positioned around or near the opening. The distal flange advantageously provides an element that a user can use to assist in applying a force away from the outlet tube to remove the closure element from the outlet end. Furthermore, the distal flange may provide a region around the opening that is less flexible compared to the central section of the actuating element. This may be a case where the inner bore extends into the actuating element. This means that the user can insert their fingertip through the opening, and the opening will then provide additional resistance for the user to remove their fingertip. This allows for better control and a greater force to be transmitted to the actuating element to remove the closure element from the outlet end.

[0077] The actuating element can be cylindrical. It may include a central section. This central section may include a straight wall. The actuating element may have flanges at both ends of the central section, such as a proximal flange and a distal flange. For the reasons described above, this structure provides a simple and effective actuating element.

[0078] The actuating element may bend outward to meet one or more flanges. Preferably, the actuating element may bend outward to meet each flange. The actuating element may bend outward to meet the proximal flange. The actuating element may bend outward to meet the distal flange. Therefore, the sides of the actuating element may not have sharp corners. This provides the actuating element with a smoother appearance and feel, and helps it conform to the user's fingers when gripping the sides of the actuating element. The actuating element may bend outward to meet both the proximal and distal flanges. This helps to provide a "U" shape along the sides of the actuating element, which more naturally receives the contours of the fingers.

[0079] The outlet element may include a connector. The connector connects the sealing element to the outlet tube. The connector is configured to prevent the sealing element and the outlet tube from separating when the sealing element is not sealing the outlet end. This helps ensure that the sealing element is not lost or becomes inaccessible to the user. It also facilitates disposal or recycling because the components of the outlet element remain together.

[0080] The connector may include a lateral arm. The lateral arm may extend from the outlet tube at the connector location. The lateral arm may extend perpendicular to the axis of the outlet tube. The length of the lateral arm may be at least the distance along the axis of the outlet tube between the connector location and the outlet end. Therefore, the lateral arm facilitates the movement of the closure element to a position where it can close the outlet end. Furthermore, when the closure element is not closing the outlet end, it helps to separate the closure element from the outlet end to ensure that the closure element does not obstruct the ostomy output leaving the ostomy instrument or the connection between the outlet end and other devices.

[0081] The distance from the connector location to the outlet end can be approximately the same as the length of the plug. This helps ensure that the plug is more easily assembled into the outlet end by maintaining alignment with the axial end during assembly.

[0082] The connector may include a bend section. The bend section may extend from the closure element. The bend section may connect to the end of the lateral arm away from the outlet tube. The bend section may include an axial arm extending parallel to the axis of the outlet tube. The bend section may include a second lateral arm extending perpendicular to the axis of the outlet tube. The second lateral arm may connect to the closure element. The axial arm may connect the lateral arm to the second lateral arm. The connector may be S-shaped. The axial arm may be shorter than the lateral arm. The second lateral arm may be shorter than the axial arm. As described above, the bend section can keep the closure element axially away from the outlet end. This helps ensure that it does not come into contact with the stoma output and does not obstruct the outlet end when not closed. Furthermore, the arm dimensions are further controlled to provide these benefits.

[0083] The connector can extend in a direction parallel to the long axis of the inlet end. The connector can also be designed to extend parallel to the wall of the stoma device. This helps to provide a more compact shape for the stoma device once the outlet element is attached to it.

[0084] The outlet tube may include one or more internal ridges. The outlet tube may include two internal ridges. The ridges may extend inwardly from the inner surface of the outlet tube. The ridges may be configured to abut against the plug for a seal. The ridges may be configured to mate with the sealing ribs of the plug. The ridges may extend around the circumference of the outlet tube, preferably around the entire circumference of the outlet tube. This helps to provide additional sealing.

[0085] The outlet tube can be configured to connect to an external drainage device, such as an external tube. The outlet tube can be configured to receive the external drainage device within its interior. In this case, the cross-sectional dimensions / shape of the external drainage device may correspond to the cross-sectional dimensions / shape of the plug. The outlet element may be provided with an adapter that can be received within the outlet tube, and provide an adapter outlet smaller than the outlet tube. The adapter may be generally annular. This facilitates easy attachment of smaller devices within the outlet tube.

[0086] The outlet tube can be configured to receive an external drainage device. The outlet end can be tapered. The outlet end may include a tapered section. This facilitates insertion of the outlet tube into the external drainage device.

[0087] The outlet tube provides a circuitous path for the stoma output to drain between the outlet tube and the connected external drainage device. This ensures that fluid / stoma output leakage is unlikely.

[0088] One or more features of the outlet element may be formed on the outlet tube by one or more reinforcing ribs. These are preferably added to increase the structural strength of the outlet tube. The ribs may have a substantially constant thickness. The ribs may be formed on the surface of the outlet tube. This helps to ensure that the features are molded / shaped with a lower risk of manufacturing defects. The one or more ribs may include circumferential ribs extending around the circumference of the outlet tube. Preferably, the outlet element may include four circumferential ribs. In the presence of two or more circumferential ribs, they may be equidistant along the length of the outlet tube. The connector location may be set in one circumferential rib, which is preferably the circumferential rib furthest from the outlet end. The one or more ribs may include axial ribs extending along the axis of the outlet tube. Chamfered edges may be provided by one or more ribs, such as two or more spaced-apart axial ribs, preferably four spaced-apart axial ribs.

[0089] The one or more reinforcing ribs may be spaced apart from the outlet end in a direction along the axis of the outlet tube. The one or more reinforcing ribs may be spaced apart from the tapered section in a direction along the axis of the outlet tube. A recessed section may be disposed between the tapered section and the one or more reinforcing ribs. The recessed section may be substantially cylindrical. The recessed section may have a constant outer diameter. The recessed section provides an area for receiving a connector for an external drainage device. The outlet end may be spaced apart from the recessed section by a lip. The outlet end may widen toward the lip. The lip may include an inwardly stepped portion in the outer contour of the outlet tube. The lip may constitute a reduction of at least 10% of the outer diameter of the outlet tube. This stepped portion may be configured to prevent the connector of the external drainage device from slipping off the outlet tube. The recessed section may have a length of approximately 7 mm. The lip may be disposed between the tapered section and the recessed section. Therefore, the recessed section and the lip help ensure that the external drainage device can be effectively attached to the outlet tube.

[0090] In another key aspect of the invention, an ostomy apparatus is provided that includes an outlet element. The outlet element may be the outlet element described broadly above and may have any of the features of the outlet element described herein.

[0091] Therefore, in a second aspect of the invention, an ostomy apparatus is provided, which includes the outlet element described in the first aspect.

[0092] That is, according to a second aspect of the invention, an ostomy apparatus is provided, comprising an outlet element, wherein the outlet element includes an outlet tube for allowing ostomy outputs to exit the ostomy apparatus, and a squeezing operation area for receiving ostomy outputs from the ostomy apparatus and conveying them to the outlet tube, wherein the squeezing operation area includes relatively flexible opposing walls, each wall narrowing in the direction toward the outlet tube for squeezing the ostomy outputs toward the outlet tube, wherein the outlet tube is relatively rigid for a secure fluid connection to an external device, and wherein the squeezing operation area and the outlet tube are integrally formed of the same material.

[0093] The stoma device can be an ileostomy device. That is, the stoma device may include features that make it particularly suitable for ileostomy. For example, it may include a squeeze-operating area as described above. A squeeze-operating area is not necessary for a urostomy bag that primarily / specifically contains liquid output (urine), nor is it useful for a colostomy bag that primarily contains solid output, which typically cannot be "squeezed out" from a relatively small diameter tube. As those skilled in the art know, drainable colostomy bags typically have a drainage tube / drainage portion integrally formed with the bag wall of the stoma device, which can be pulled open to create a larger outlet end, for example, in the range of 7 cm in width. This width is much larger than the outlet end used in ileostomy devices, which may have an outlet end width of 1 cm to 2 cm.

[0094] The ileostomy device can be a high-output ileostomy device. That is, the ileostomy device may include features that make it particularly suitable for high-output ileostomies. For example, it may have a capacity of at least 500 ml, and it may have a capacity of up to 1 L. By using the outlet element of the first aspect, the ileostomy device allows for easier and more hygienic drainage, and also maintains easy connection to external drainage devices, such as a night bag, which is important for ileostomy patients.

[0095] An ostomy device may include two bag walls. The two bag walls are sealably connected around their periphery to form a bag. An outlet element may be located at the bottom of the bag. The outlet element may be located between the two bag walls. The two bag walls are sealably connected to the outer side of the outlet element, preferably sealably connected to the outer side of the outlet element around the inlet end / tubular inlet. This facilitates effective drainage of ostomy outputs into and through the outlet element.

[0096] An ostomy device may include two bag walls. The two bag walls may be sealed together around their periphery to form a bag. An outlet element may be arranged to drain the contents of the bag. The outlet element may be configured to receive ostomy output from the bag. The outlet element may be located at or near the bottom of the bag. The outlet element may be positioned between the two bag walls. The two bag walls may be sealably connected to the outer surface of the outlet element, preferably sealably connected to the outer surface of the outlet element around the inlet end / tubular inlet. This facilitates effective drainage of ostomy output into and through the outlet element.

[0097] The two bag walls can be formed of plastic materials, such as thermoplastic materials, like thermoplastic elastomers. Each of the two bag walls can be formed of multiple layers of material. The two bag walls can be formed of polyvinylidene chloride (PVDC), EVA, VA, or combinations thereof. Preferably, the bag walls and the outlet element are formed of materials that can be welded together. For example, materials that can be thermally welded together. This helps to provide a simple structure without the need for unnecessary use of adhesives or other attachment devices. Furthermore, when the outlet element is formed of the same or similar materials, it ensures that the outlet elements can be easily welded together.

[0098] The two bag walls may include a front wall and a rear wall. The front wall may be arranged to face away from the user during use. The rear wall may be arranged to face the user during use.

[0099] The posterior wall may include an ostomy inlet. The ostomy inlet may be configured to receive a user's ostomy. The posterior wall may include an adhesive sheet. The sheet may be configured to attach an ostomy instrument to the user's body. The sheet may be disposed around the ostomy inlet. Therefore, the sheet may be annular. The sheet may contain an aqueous colloidal adhesive. The sheet may be directly attached to the posterior wall. In several other embodiments, a relatively rigid disc may be provided between the sheet and the posterior wall. This may help provide a rigid object to aid in the adhesion of the sheet to the body.

[0100] The rear wall may include connecting elements. These connecting elements may be configured to attach to corresponding connecting elements disposed on a separate substrate. The substrate may include a sheet. Thus, the ostomy appliance can be a two-piece ostomy appliance.

[0101] Ostomy appliances may include a vent. The vent may be located on the front wall. The vent may be configured to allow gas to exit the ostomy appliance. The vent may include an odor-eliminating filter, such as a carbon filter. This helps ensure that the ostomy appliance does not expand due to gas.

[0102] In a broader sense, the present invention also relates to a method for forming an outlet element.

[0103] Therefore, in a third aspect of the invention, a method is provided for forming an outlet element for an ostomy device, the outlet element including an outlet tube for allowing ostomy outputs to exit the ostomy device, and a squeezing operating area for receiving ostomy outputs from the ostomy device and conveying them to the outlet tube, wherein the squeezing operating area narrows in a direction toward the outlet tube and is relatively flexible to allow ostomy outputs to be squeezed toward the outlet tube, wherein the outlet tube is relatively rigid to allow connection to an external device, and the method includes forming the squeezing operating area and the outlet tube together in a single forming step.

[0104] Advantageously, a single molding step produces an integrally formed outlet element. This is simpler than other techniques that form the outlet element in two or more different steps (such as overmolding or welding different parts together). These other techniques result in an outlet element that is not integrally formed and includes different materials and / or a joint between the outlet tube and the extrusion operating area. This makes manufacturing more difficult and expensive because different materials need to be sourced separately and manufacturing processes need to be optimized for both materials.

[0105] This method may include mixing polyethylene and vinyl acetate (VA). This method may also include forming a copolymer by adding VA to polyethylene.

[0106] The method may include heating a thermoplastic material with a melt flow index of 2.5 g / 10 min to 43 g / 10 min to form a melt. The melt may be a molten thermoplastic material.

[0107] This method may include using melt to form the outlet element.

[0108] The molding process may include injection molding. This is preferred because it allows for simple and repeatable molding at low cost.

[0109] This method can be a method for manufacturing export components in the first aspect.

[0110] This method may include two bag walls providing an ostomy device. The method may include forming a bag by sealing the peripheries of the two walls together. The method may include sealing the two bag walls together with an outlet element disposed at the bottom of the bag. The outlet element may be fused to the bag walls while the bag walls are fused together with each other. This provides a simple and reliable method for manufacturing ostomy devices.

[0111] Therefore, this method can be a method for manufacturing stoma devices. The stoma device can be the stoma device described in the second aspect of this invention.

[0112] The method may include attaching an ostomy instrument around the stoma to the user's body. The method may include draining the ostomy instrument. The method may include inserting a fingertip into the opening and disengaging a closure element from the outlet tube. The method may include connecting an external drainage device to the outlet tube. As described above, the invention therefore includes a method of using an ostomy instrument of the second aspect. Invention Details Attached Figure Description

[0113] To better understand the present invention, one or more embodiments of the invention will now be described by way of example only, with reference to the accompanying drawings, in which:

[0114] Figure 1 This is a front view of the outlet element of an ostomy instrument;

[0115] Figure 2 yes Figure 1 Export components such as Figure 1 The front view of the plug indicated by detail A in the diagram;

[0116] Figure 3 yes Figure 1 Top view of the outlet component;

[0117] Figure 4 yes Figure 1 Side view of the outlet element;

[0118] Figure 5 It is along Figure 3 BB or Figure 4 A sectional view of line CC;

[0119] Figure 6 It includes Figure 1 Rear view of an ostomy instrument with the outlet element open;

[0120] Figure 7 It is along Figure 3 BB or Figure 4 A cross-sectional view of line CC, in which the outlet element is closed by a plug;

[0121] Figure 8 It is connected to an external drainage device. Figure 1 Front view of the outlet component;

[0122] Figure 9A This is a schematic axial sectional view of the fingertip;

[0123] Figure 9B yes Figure 9A A schematic side sectional view of the fingertip;

[0124] Figure 10A yes Figure 1A schematic axial cross-sectional view of the control element of the outlet element;

[0125] Figure 10B yes Figure 10A A schematic side sectional view of the control element;

[0126] Figure 11A It is inserted into Figure 10A The opening of the control element Figure 9A A schematic axial cross-sectional view of the fingertip;

[0127] Figure 11B It is inserted into Figure 10A The opening of the control element Figure 9A A schematic side sectional view of the fingertip;

[0128] Figure 12A It is an insertion. Figure 10A A schematic axial cross-sectional view of the large fingertip in the opening of the control element;

[0129] Figure 12B It is an insertion. Figure 10A A schematic side sectional view of the large fingertip in the opening of the control element;

[0130] Figure 13A It is an insertion. Figure 10A A schematic axial cross-sectional view of the little fingertip in the opening of the control element;

[0131] Figure 13B It is an insertion. Figure 10A A schematic side sectional view of the little fingertip in the opening of the operating element; and

[0132] Figure 14 It is along Figure 3 BB or Figure 4 Alternative section view of line CC. Detailed Implementation

[0133] This invention relates to an outlet element 1 for a stoma device 2. The stoma device of this invention is an ileostomy device, particularly a "high-output" ileostomy device. Reference Figures 1 to 5 The outlet element 1 includes an inlet end 3, a squeezing operation zone 4, an outlet pipe 5, an outlet end 6, and a closing element 7 attached to the outlet element 1 via a connector 8. The outlet element 1 is tubular, and its tubular shape extends from the inlet end 3 through the squeezing operation zone 4 and the outlet pipe 5 to the outlet end 6. As described in more detail below, this provides a fluid path through the outlet element 1 from the inlet end 3 via the squeezing operation zone 4 and the outlet pipe 5 to the outlet end 6. The tubular shape of the outlet element 1 defines an axis of the outlet element 1 that extends along the pipe from the inlet end 3 to the outlet end 6. Therefore, this axis is parallel to... Figure 4The line CC in the middle.

[0134] The inlet end 3 is used to connect to the bag 37 of the stoma device 2 and to receive stoma output from the bag 37 to allow drainage from the stoma device 2. When viewed downwards along the axis of the outlet element 1, the inlet end 3 is generally oval and has a lenticular shape. This provides an optimal shape for the front wall 9 and rear wall 10 of the stoma device 2 and the inlet end 3 of the outlet element 1 so that they can be welded together during manufacturing, as will be further described below. In this embodiment, the inlet end 3 includes a long axis of approximately 5.5 cm, which is perpendicular to the axis of the outlet element 1 and extends parallel to the walls 9 and 10. In this embodiment, the inlet end 3 has a short axis of approximately 2 cm.

[0135] In this embodiment, the inlet end 3 has a length of approximately 1 cm along the axis of the outlet element 1. The inlet end 3 has a shape that is substantially constant along this length to provide a tubular inlet to the outlet element 1. The inlet end 3 includes two flaps 11, one on each side of the inlet end 3 along its long axis. The flaps 11 extend outward from the outlet element 1 and provide a tapered / recessed shape to the lens-shaped inlet end 3 to provide enhanced attachment to the ostomy appliance 2, as described below. In this embodiment, the flaps 11 extend the entire length of the inlet end 3.

[0136] The squeezing operation zone 4 extends from the inlet end 3 to the outlet pipe 5. In this embodiment, the squeezing operation zone 4 has a length of approximately 4-5 cm, or preferably approximately 4.2 cm, along the axis of the outlet element 1. The squeezing operation zone 4 has a generally oval cross-section, similar to the cross-section of the inlet end 3, but is rounded at each end along the long axis and has no outwardly extending fins. Where the squeezing operation zone 4 connects to the inlet end 3, the long and short axes of the squeezing operation zone match the long and short axes of the inlet end 3. It then extends away from the inlet end 3 along the length of the squeezing operation zone 4. In this embodiment, the short axis remains approximately constant at approximately 2 cm, while the long axis tapers from approximately 5 cm until the long and short axes are the same at the junction of the squeezing operation zone 4 and the outlet pipe 5.

[0137] In this embodiment, the squeezing operation area 4 has a wall thickness of approximately 1.5 mm, and the inlet has a wall thickness of approximately 1.7 mm. This helps ensure that the squeezing operation area remains relatively flexible compared to the inlet, while maintaining sufficient strength to prevent breakage during use. The similarity in thickness also facilitates the manufacturing process and reduces the possibility of molding / forming artifacts.

[0138] In this embodiment, the major axis of the squeezing operation area 4 decreases linearly along its length. Therefore, the squeezing operation area 4 can be defined by two opposing walls 12, which are sheet-like and generally inverted trapezoidal in shape. The inclined sides of the walls 12 are connected to each other to form the squeezing operation area 4. Thus, the walls 12 narrow in the direction toward the outlet pipe.

[0139] The outlet pipe 5 extends from the squeezing operation area 4 to the outlet end 6. In this embodiment, the outlet pipe 5 has an inner diameter slightly smaller than that of the squeezing operation area 4 at its junction with the outlet pipe, and thus, an angled / inclined step 13 is provided between the outlet pipe and the squeezing operation area. In this embodiment, the outlet pipe 5 is thus cylindrical and has a constant inner diameter of approximately 1.3 cm up to the outlet end 6, which also has an inner diameter of 1.3 cm. The step 13 has a wall thickness slightly thicker than that of the squeezing operation area and the outlet pipe. The step 13 thereby provides a relatively rigid region between the squeezing operation area and the outlet pipe, which helps to ensure that any deformation of the squeezing operation area does not impair the sealing capability of the outlet pipe.

[0140] As described above, the shapes of the squeezing operation zone 4 and the outlet tube 5 mean that the squeezing operation zone 4 is relatively flexible compared to the outlet tube 5, even when both have substantially the same wall thickness of about 1.5 mm and are formed of the same material. For example, the squeezing operation zone has a higher aspect ratio over most of its length compared to the outlet tube, which allows the user to easily compress the squeezing operation zone in a direction parallel to its minor axis to expel ostomy output toward the outlet tube, as described in more detail below.

[0141] The outlet tube 5 also includes a pair of internal ridges 14 extending inwardly from the interior of the outlet tube 5. These internal ridges extend around the circumference of the outlet tube 5 and are configured to facilitate sealing of objects inserted into the outlet tube 5, as described below. In this embodiment, the internal ridges 14 are located at approximately one-third to one-half of the distance along the outlet tube 5 from the outlet end 6 to the squeezing operation area 4.

[0142] In this embodiment, the outer circumference or outer diameter of the outlet pipe 5 varies to define different features that enable more efficient connection of devices around the outlet pipe 5. At the outlet end 6, the outlet pipe 5 includes a wedge-shaped tapering section 15 to facilitate the fitting of external tubular devices onto and around the outlet pipe 5. In this embodiment, the tapering section 15 increases the outer diameter of the outlet pipe 5 from the outlet end 6, with the outer diameter at the outlet end 6 being approximately 1.5 cm to approximately 1.7 cm.

[0143] The outlet pipe 5 also includes a series of reinforcing ribs in the form of four axial ribs 20 and four circumferential ribs 21. The axial ribs 20 extend parallel to the axis of the outlet element 1, and the circumferential ribs 21 extend around the circumference of the outlet pipe 5. These ribs 20, 21 are provided on the outer surface of the outlet pipe 5 to increase its strength and prevent the pipe from deforming or collapsing during use.

[0144] In this embodiment, a recessed section 17 is provided between ribs 20 and 21 and the tapered section 15. In this embodiment, the recessed section 17 has a constant outer diameter of approximately 1.5 cm. A lip 17a is provided at the interface between the recessed section 17 and the tapered section 15. The lip 17a forms a stepped decrease in the outer diameter of the outlet pipe 5 from the tapered section to the recessed section, approximately 14%. This allows the recessed section 17 to better retain the connector of the external drainage device, as it abuts against the lip 17a to prevent it from slipping off the outlet pipe 5.

[0145] At the interface between the recessed section 17 and the ribs 20, 21, the outer diameter of the outlet tube 5 tapers to provide a chamfered edge 18 that extends all the way to the recessed section 17. This makes the exterior of the outlet element feel smoother and more comfortable to hold.

[0146] In this embodiment, the outlet pipe 5 has a length of approximately 2 cm along the axis of the outlet element 1 (which is also the axis of the outlet pipe 5). In this embodiment, the tapered section 15 and the recessed section 17 are both approximately 0.5 cm long, the ribs 20 and 21 also cover a length of approximately 0.5 cm, and the step portion 13 is also approximately 0.5 cm. Of course, these dimensions are merely exemplary and can be changed or adjusted as needed.

[0147] Four circumferential ribs 21 are spaced approximately 0.5 cm apart along the length of the outlet tube 5, with the rib 21 furthest from the outlet end located along the outlet tube where the connector 8 connects to the outlet tube. Four axial ribs 20 are equidistantly spaced around the circumference of the outlet tube 5 and connect to the three circumferential ribs 21 closest to the outlet end. These ribs 20, 21 help ensure that the outlet tube 5 is less susceptible to human-induced variations in overall tube thickness during injection molding, while also increasing the strength of the outlet tube. This also helps optimize the use of raw materials and reduce the weight of the outlet element 1.

[0148] The outlet end 6 is configured to be closed by a sealing element 7 to prevent fluid from flowing out of the outlet element 1. To achieve this, the sealing element 7 includes a tubular plug 22 having a cylindrical shape and an outer diameter that matches the inner diameter of the outlet pipe 5. The plug 22 has a capped end 23 that can be inserted into the outlet pipe 5 to seal the outlet end 6.

[0149] To facilitate insertion of the plug 22 into the outlet tube 5, the capped end 23 is conical with a truncated point 24 at its tip. In this embodiment, the truncated point 24 has a width of approximately 1.5 mm and provides a truncated conical shape to the capped end 23. Therefore, the truncated point 24 covers approximately 1-2% of the total cross-sectional area of ​​the plug 22 / area of ​​the capped end 23. This facilitates the insertion of the plug 22 into the outlet end 6 while ensuring that the end of the plug 22 has no sharp points.

[0150] To aid in sealing between the plug 22 and the outlet tube 5, the plug 5 includes a proximal sealing rib 25 disposed around the base of the conical capped end 23 and four additional sealing ribs 26 spaced apart along the length of the plug 22. The sealing ribs 25 and 26 have lengths measured from the plug 22, with the proximal sealing rib 25 being the shortest and the other ribs 26 becoming longer as they approach the actuating element. This is to accommodate the slight narrowing of the outlet tube in the direction away from the outlet end.

[0151] Sealing ribs 25 and 26 span approximately half the total length of the plug 22 and are positioned close to the capped end 23. The sealing ribs 25 and 26 extend around the circumference of the plug 22 and are positioned at an angle of approximately 45 degrees away from the capped end 23. Combined with the internal rib 14 of the outlet tube 5, this contributes to providing an effective seal between the plug and the outlet tube. The proximal sealing rib 25 is particularly advantageous because it is structurally supported by the capped end 23 to provide a better seal.

[0152] In this embodiment, an actuating element 27 is provided at the end of the plug 22 located distal to the truncated point 24. The actuating element 27 is tubular and provides an area for the user to grip or hold in order to move the plug 22 to engage and disengage with the outlet tube 5. Thus, the plug 22 and the actuating element 27 are arranged linearly along the closure element 7.

[0153] The diameter of the actuating element 27 is larger than that of the plug 22, thus providing a flat, outwardly extending proximal flange 28 around the end of the plug 22 located distal to the capped end 23. A stop 29 is also provided on the surface of the proximal flange 28 facing the plug 22, which is configured to prevent the plug 22 from being over-inserted into the outlet tube 5. The stop 29 provides a relatively thick-walled region compared to the plug 22, thus structurally supporting the plug 22 to ensure its effective sealing of the outlet tube 5. In this embodiment, the wall thickness of the actuating element 27 is greater than that of the plug along its entire length to provide additional structural strength to the sealing element and the plug. For example, in this embodiment, the wall thickness of the actuating element is approximately 100% greater than that of the plug.

[0154] In this embodiment, the proximal flange 28 has an outer diameter of approximately 2.2 cm and a rounded outer edge to ensure that the user does not feel any sharp edges. From the proximal flange 28, the shape of the actuating element curves inward with a concave curvature to a cylindrical intermediate section 30. In this embodiment, the intermediate section 30 includes an outer diameter of approximately 1.7 cm and a length of approximately 1 cm. The shape then curves outward with a concave curvature to define a distal flange 31, which defines the end of the closure element 7 located distal to the capped end 23. In this embodiment, the distal flange 31 is larger than the proximal flange 28 and has an outer diameter of approximately 2 cm. Along the length of the actuating element 27, the proximal and distal flanges, as well as the intermediate section, provide a generally flat-bottomed U-shape, which is adapted to comfortably receive the user's finger during use, as described below.

[0155] A distal flange 31 is disposed around an opening 32 in the actuating element 27. The opening 32 leads to an inner bore 33 extending through the actuating element 27 and the plug 22, the inner bore extending until the plug meets the conical capped end 23. This provides the hollow and tubular shape of the closure element 7. Thus, in this embodiment, the closure element 7 includes walls continuously forming the tubular actuating element 27 and the plug 22, the actuating element 27 and the plug 22 having an inner bore 33 that passes through the middle and is closed by the capped end 23.

[0156] As the size of the closing element 7 changes from the larger operating element 27 to the smaller plug 22, there is a corresponding angled / inclined step 34 in the inner side of the wall, which is defined by the inner hole 33 at a position corresponding to the proximal flange 28.

[0157] In this embodiment, the opening 32 is configured to receive the user's fingertip 44 to aid in the movement of the closure element 7, particularly in helping the user disengage the closure element 7 from the outlet tube 5. In this embodiment, the size of the opening 32 contributes to this, and is preferably 13 mm in diameter (although other sizes and shapes are conceivable). It has been found that this provides a suitable balance between being large enough for most people to insert their fingers into the opening and small enough to reduce the need for the user to manually grasp or manipulate the element. For example, due to the natural elasticity of the finger, it can be pressed into the opening and then held in place, thus providing a holding force that can be used to remove the plug from the outlet tube, as further described below.

[0158] Of course, other sizes and shapes of openings can also be envisioned. When using non-circular openings, the maximum width measured between opposite sides of the opening is typically at least 12 mm, or at least 13 mm. For example, in the case of an oval opening, the major axis can be at least 12 mm.

[0159] In this embodiment, the remaining portions of the actuating element 27 and the outlet element 1 are formed of an elastically deformable material, such as ethylene-vinyl acetate copolymer (EVA), wherein the vinyl acetate (VA) concentration is 15-32% by weight, preferably 18% by weight. This provides a material with a Shore A hardness of 60 to 95, or preferably about 85, as measured using a type A indenter according to standard ASTM D2240-15. Therefore, the outlet element can have a final Young's modulus of about 3.6 MPa. This is optimally suited to provide elasticity that complements the finger's resilience, ensuring that the fingertip is "clamped" by the opening 32, and that the opening 32 deforms to match the shape of the user's finger. Furthermore, when formed of the same material and having a similar thickness, it is specifically chosen to suit the flexible squeezing operating area and the relatively rigid outlet element.

[0160] In this embodiment, the actuating element 27 has a length of approximately 1.8 cm to 2 cm from the stop 28 to the opening 32, or a length at least equal to the diameter of the opening 32. This helps ensure that the user can easily apply force to the actuating element with their fingertips, allowing the fingertips to be fully inserted to generate a good grip through the opening, and that when connected to the outlet tube, the opening is adequately spaced from the outlet tube, minimizing the risk of the user coming into contact with any ostomy output that may leak or be present outside the outlet tube.

[0161] Furthermore, because the outer diameter of the distal flange 31 is larger than the size of the opening 32, an annular region made of elastic material is formed around the opening 32. The wall thickness of this annular region is greater than the wall thickness of the actuating element in the adjacent intermediate section 30. Therefore, the actuating element is relatively more rigid around the opening 32 compared to the intermediate section 30. This allows the user to force their fingertip through the opening 32 when it is received in the intermediate section 30. Since the opening expands smaller than the intermediate section accommodating the fingertip, the opening 32 thus provides additional clamping force to help the user remove the closure element from the exit end.

[0162] In this embodiment, connector 8 extends parallel to the long axis of inlet end 3 and the walls 9, 10 of ostomy appliance 2. This ensures that connector 8 keeps closure element 7 away from outlet element 1, but in the plane of walls 9, 10, it makes the entire device more compact in the direction perpendicular to walls 9, 10.

[0163] In this embodiment, the connector 8 includes a transverse arm 33 extending from the outlet tube 5 at a connector position 34 at the interface between the squeezing operation area 4 and the outlet stop 19. The transverse arm 33 extends perpendicular to the axis of the outlet tube 5 and parallel to the long axis of the inlet end 3. In this embodiment, the length of the transverse arm 33 is approximately 50% greater than the distance from the connector position 34 to the outlet end 6, which balances the need for a longer connector so that the plug 22 can be received in the outlet tube 5 while reducing material waste and minimizing the overall size of the outlet element 1. Furthermore, the length of the plug 22 is equal to the distance from the connector position 34 to the outlet end 6, which helps ensure better alignment of the plug 22 with the outlet end 6 when it is moved in / out of the outlet end 6.

[0164] The connector 8 also includes a curved section formed by an axial arm 35 and a second transverse arm 36. The axial arm 35 extends from the transverse arm 33 toward the inlet end 3 in a direction parallel to the axis of the outlet tube 5. The second transverse arm 36 extends from the axial arm 35 to the closure element 7 in a direction parallel to the transverse arm 34. In this embodiment, the second transverse arm 36 is connected to the closure element 7 at a location adjacent to the proximal flange 28 in the intermediate section 30. This helps ensure that the plug 22 is received more directly at the center of the outlet end 6.

[0165] In this embodiment, the length of the lateral arm 33 is approximately 2-3 cm, the axial arm 35 is approximately 1 cm, and the second lateral arm 36 is approximately 0.5-1 cm. Of course, as with all disclosed dimensions, these dimensions can vary to suit specific applications. Longer lateral arms are generally preferred to help provide clearance between the axial arm and the squeezing operating area 4.

[0166] Reference Figure 14The outlet tube 5 may include a first segment 50 and a second segment 51. An internal rib 14 may define the boundary between the first segment 50 and the second segment 51 of the outlet tube 5. In some embodiments, the inner diameter of the second segment 51 is smaller than the inner diameter of the first segment 50. This ensures an effective tight seal when the plug 22 is further inserted into the outlet tube 5. In some embodiments, the diameter of the first segment may be in the range of 10 mm to 20 mm, or it may be in the range of 10 mm to 19 mm, 10 mm to 18 mm, 10 mm to 17 mm, 10 mm to 16 mm, 10 mm to 15 mm, 10 mm to 14 mm, 10 mm to 13 mm, 10 mm to 12 mm, or 10 mm to 11 mm. In some embodiments, the diameter of the second section is in the range of 10 mm to 15 mm, or may be in the range of 10 mm to 14 mm, 10 mm to 13 mm, 10 mm to 12 mm, or 10 mm to 11 mm. In some embodiments, the inner diameter of the first section of the outlet pipe is in the range of 10 mm to 16 mm, and the inner diameter of the second section of the outlet pipe is in the range of 10 mm to 15.5 mm. For example, the inner diameter of the first section of the outlet pipe may have a minimum diameter of 10.28 mm and a maximum diameter of 15.8 mm. In another example, the first section of the outlet pipe may have a minimum diameter of 12 mm and a maximum diameter of 13.2 mm, or it may have a minimum diameter of 12.85 mm and a maximum diameter of 13.16 mm. The inner diameter of the second section of the outlet pipe may have a minimum diameter of 10 mm and a maximum diameter of 15.5 mm, for example, a minimum diameter of 10.07 mm and a maximum diameter of 15.48 mm. In another example, the second section of the outlet pipe may have a minimum diameter of 12.5 mm and a maximum diameter of 13 mm, or it may have a minimum diameter of 12.59 mm and a maximum diameter of 12.90 mm.

[0167] Reference Figure 6 and 7 The outlet element 1 is provided as part of the stoma device 2. As described above, the stoma device 2 includes walls 9, 10 sealed around its periphery to form a bag 37 for receiving stoma outputs from the user's stoma. In this embodiment, the walls 9, 10 are fused together to form the bag 37, and the inlet end 3 of the outlet element 1 is located at the bottom of the bag 37 to receive stoma outputs from the bag 37, as described below.

[0168] In this embodiment, walls 9 and 10 include a front wall 9 and a rear wall 10. The rear wall 10 is intended to face the user's body in use and includes a coupling element 38 for attachment to an ostomy substrate (not shown). The ostomy substrate is configured to attach to the user's body around the user's ostomy. In several other embodiments, the rear wall itself may include an adhesive sheet or other means to attach an ostomy appliance directly to the user's body.

[0169] The posterior wall 10 also includes a stoma inlet to receive the user's stoma and allow stoma outputs into the bag 37.

[0170] In this embodiment, the front wall 9 includes a vent 39 to allow any ostomy gas in the bag 37 to escape and to prevent the bag 37 from "bloating" during use.

[0171] Injection molding is the preferred method for manufacturing the outlet element 1. Due to the generally tubular and hollow design of the outlet tube 5 and the sealing element 7, the overall design is suitable for injection molding in a single step. Of course, other molding techniques or other manufacturing techniques, such as additive manufacturing, can be used.

[0172] To form the outlet element, polyethylene and vinyl acetate (VA) are mixed to form a copolymer. The copolymer is then heated until a melt is formed. The melt flow index is measured according to standard ASTM D1238-10 at 190°C and under a 2.16 kg mass / weight load. The melt flow index should be approximately 2.5 g / 10 min. The copolymer can be heat-stable, for example by adding a BHT antioxidant, i.e., butylated hydroxytoluene. A suitable commercially available copolymer is ELVAX (RTM) 460 ethylene-vinyl acetate copolymer, available from Dow Chemical Company, and corresponding to the product datasheet revised on February 26, 2021. When using ELVAX (RTM) products or similar commercially available copolymers, the method may include providing the copolymer in granular or powder form and melting the copolymer to form a melt. This ensures both good processability of the melt and that the properties of the final material are within the preferred range described above.

[0173] Then, the melt is used to form the outlet element during a single-step injection molding process. This results in a one-piece forming design of the outlet element with no joints between the different components. This contrasts with prior art, where different components are formed and attached together at different times; for example, an outlet tube may be formed, then a squeezing operation area may be formed, and the squeezing operation area may be attached to the outlet tube by overmolding the outlet tube. This results in a joint between the two, which provides a weakening location and significantly increases manufacturing complexity.

[0174] Once the outlet element 1 is formed, the walls 9 and 10 of the ostomy apparatus can be provided. These may be provided with connecting elements 38 and vents 39, which have been assembled to the rear and front walls respectively according to known manufacturing processes. Preferably, the walls 9 and 10 are formed of a material that can be welded to the material of the outlet element 1, such as materials including EVA and / or VA, or thermoplastics compatible with them. The bag 37 is then formed by fusing around the periphery of the walls, wherein the outlet element 3 is positioned between the two walls at the base of the ostomy apparatus. This allows the outlet element 3 to be welded to the walls 9 and 10, while they are also welded together around the remainder of the bag 37. In this embodiment, thermal welding is used, but other welding or attachment techniques can certainly be used, such as friction welding, laser welding, or attachment with adhesives, etc.

[0175] To use the ostomy device 2, it is first assembled into the user's body by attaching the device to a base plate attached to the user's body. The outlet element 1 may be provided with a plug 22 that seals the end of the outlet tube 4. However, if not, the user can grasp the operating element 27 and insert the plug 22 into the outlet end 6 until the outlet end 6 abuts against the stop 29. This will ensure that there is no accidental leakage from the outlet end 6.

[0176] When the bag 37 needs to be emptied or drained, the user can insert their fingertips into the opening 32. Due to the elasticity of the fingertips and the opening 32, a clamping action is provided between the opening 32, the inner hole 33, and the fingertips 44. Advantageously, because the opening 32 is spaced apart from the stop 29, the operating element is not structurally directly supported by the outlet tube. This makes stretching the opening 32 and the operating element easier for the user.

[0177] The elasticity of the opening 32 allows it to change shape and / or size to accommodate and hold a user's fingertip. For example, for a relatively small but oval fingertip, the opening 32 can change from a circle to an oval shape when the oval fingertip is inserted. This will generate a restoring force, forcing the opening back to a circle that holds the fingertip. In another example, with a larger fingertip, the opening 32 can simply increase in diameter or width and can also change shape to accommodate the fingertip. This elasticity provides the force to force the opening back to its original size, thus "gripping" the fingertip.

[0178] Typically, human fingers have an oval cross-section, so the opening usually changes shape to accommodate this. Of course, in some embodiments, the opening can be oval to match the cross-section of the finger, so it does not change shape.

[0179] This clamping action allows the user to pull their fingers back from the outlet end 6 and remove the plug 22 from the outlet end 6 without manually gripping the actuating element 27 to the same extent as before. To provide additional clamping action, the user can also tilt their fingers relative to the axis of the outlet tube 5 to provide additional stretching of the actuating element, for example, see [link to relevant documentation]. Figure 13A and 13B As described later. This can also help provide torque to the actuating element to assist in removing plug 22 from outlet pipe 5.

[0180] If needed, the user can also pinch the outer side of the middle section 30 between one finger and the finger inserted into the opening 32. The distal flange 31 can also help the user apply force to remove the plug 22 from the outlet tube 5. When doing so, the proximal flange 28 provides a barrier to prevent the user from accidentally coming into contact with the outlet tube 5 itself, which may be dirty.

[0181] Once the plug 22 is removed from the outlet tube 5, the stoma output can exit the stoma device 2 through the outlet end 6. To assist this process, the user can gently squeeze the operating area 4 from the inlet end 3 towards the outlet tube 5 to gradually push the stoma output downwards and allow it to exit from the outlet end 6. This is helpful when the stoma output is a mixture of solids and liquids, which is typical for ileostomies.

[0182] In addition, during the process, connector 8 keeps the closure element 7 in an unobstructed position to ensure that the user will not accidentally touch it while squeezing, and to ensure that the ostomy output flowing out of outlet end 6 will not come into contact with the closure element 7.

[0183] Once drainage is complete, the user can grasp the manipulator 27 again, optionally reuse the opening 32, and reinsert the plug 22 into the outlet end 6 to close the outlet tube 5. During this action, the user can place their fingers over the opening 32 to press the manipulator into the outlet end without their fingertips entering the opening 32. This ensures that the opening 32 does not trap the fingertips, which could otherwise cause the plug to accidentally detach from the outlet end when the user withdraws their fingers.

[0184] As mentioned above, users may wish to drain directly from the stoma device into a container such as a toilet. However, they may also wish to connect an external drainage device, such as drainage tube 39, to handle stoma output. This is particularly beneficial for use at night in conjunction with a nighttime drainage bag (not shown). Once the external drainage device is connected to the outlet tube, the relative rigidity of the outlet tube helps ensure a tight seal is formed. Of course, the user can still “squeeze” the outlet element by squeezing the squeezing operating area. The relative rigidity of the outlet tube, supported by the stepped portion 13, helps ensure that any movement of the flexible squeezing operating area does not cause deformation of the outlet tube, which could lead to leakage.

[0185] refer to Figure 8 An example is shown where a drainage tube 39 is connected to an outlet tube 5. In this embodiment, the drainage tube 39 includes a clamping region 40 configured to hold a recessed section 17 of the outlet tube 5. This allows the user to insert the outlet tube 5 into the drainage tube 39, ensuring a tight fit with the recessed section 17, and the lip 17a prevents disengagement between the drainage tube 39 and the outlet tube 5. In several other embodiments, the locking clamp is provided by an elastic band, hose clamp, or a zipper-like device or other type of pipe connection device. This provides a more secure connection if desired.

[0186] Of course, many other drainage devices can be connected to the outlet tube 5. In another example, an adapter is connected inside the outlet tube. This adapter facilitates the connection of a drainage tube that is narrower than the one that would otherwise be connected to the outlet tube.

[0187] Reference Figures 11A to 13B The image shows three examples of how different users would use opening 32, including end and side views. Figure 11A and 11B In the first example shown, the user's fingertip 44 has a region similar to the opening 32, but oval-shaped. Thus, when the fingertip 44 is inserted into the opening 32, it changes shape to fit the fingertip 44, but the size does not change significantly.

[0188] refer to Figure 12A and 12B In the second example, the user's fingertip 44 is larger than the opening 32 and is also oval-shaped. In this example, the opening 32 changes shape but is also stretched to accommodate the user's fingertip 44. Because the intermediate section 30 is more flexible than the opening 32 (due to the presence of the distal flange 31 surrounding the opening 32 providing thicker material), a bulge 43 is formed in the intermediate section. This bulge 43 means that the user can pull the opening 32 with greater force to remove the closure element from the outlet tube 5.

[0189] refer to Figure 13A and 13BIn the third example, the user's fingertip 44 is smaller than the opening 32. Thus, they insert their fingers at an angle, creating a bulge 43 by pushing the fingertip 44 into the middle section 30 below the opening 32. This allows the user to apply force to disengage the closure element from the outlet tube 5. In this example, the user hooks their fingertip 41 under one side of the opening 32 to be able to pull the manipulator 27.

[0190] The example portion described above is achieved through the size of the opening and the depth of the inner bore, allowing a user to insert their fingertips into the opening and the stop portion spaced apart from it. Spaced apart by the stop portions ensures that the outlet tube itself does not support the sides of the intermediate section 30, which could make it difficult or impossible to form the effective bulge 43 as described above.

[0191] The above description of one or more embodiments is by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. An outlet element for an ostomy apparatus, the outlet element comprising an outlet tube for allowing ostomy outputs to exit the ostomy apparatus, and a squeezing actuation zone for receiving ostomy outputs from the ostomy apparatus and conveying the ostomy outputs to the outlet tube, wherein the squeezing actuation zone includes relatively flexible opposing walls, each wall narrowing in a direction toward the outlet tube for squeezing the ostomy outputs toward the outlet tube, wherein the outlet tube is relatively rigid for a secure fluid connection to an external device, wherein the squeezing actuation zone and the outlet tube are integrally formed of the same material.

2. The export element according to claim 1, wherein, The outlet element is formed of a material with a Shore A hardness of at least 60.

3. The export element according to claim 1 or claim 2, wherein, The outlet element is made of a material with a Shore A hardness not exceeding 95.

4. The export element according to any one of the preceding claims, wherein, The outlet element is formed of a material with a Shore A hardness of 70 to 90.

5. The export element according to any one of the preceding claims, wherein, The outlet element is formed from ethylene-vinyl acetate copolymer (EVA).

6. The export element according to claim 5, wherein, The vinyl acetate (VA) concentration in the ethylene-vinyl acetate copolymer is at least 15% by weight.

7. The export element according to claim 5 or claim 6, wherein, The vinyl acetate concentration in the ethylene-vinyl acetate copolymer does not exceed 32%.

8. The export element according to any one of claims 5 to 7, wherein, The vinyl acetate concentration in the ethylene-vinyl acetate copolymer is 18%.

9. The export element according to any one of the preceding claims, wherein, The outlet element is formed from a thermoplastic material with a melt flow index of 2.5 g / 10 min to 43 g / 10 min.

10. The export element according to any one of the preceding claims, wherein, The wall is sheet-like.

11. The export element according to any one of the preceding claims, wherein, The thickness of the wall is in the range of 0.5 mm to 4 mm.

12. The export element according to any one of the preceding claims, wherein, The outlet pipe is tubular and has a thickness of at least 0.5 mm.

13. The outlet element according to any one of the preceding claims, further comprising a sealing element configured to releasably seal the outlet end of the outlet tube to prevent the release of ostomy output from the ostomy apparatus.

14. The export element according to claim 13, wherein, The closure element includes a tubular actuating element that provides an opening adapted to receive a user's fingertip to facilitate disengagement of the closure element from the outlet tube.

15. The outlet element according to claim 13 or claim 14, wherein, The opening has a diameter of at least 12 mm.

16. An ostomy appliance comprising two bag walls sealed around its periphery to form a bag and an outlet element disposed between the two bag walls to receive ostomy output from the bag, according to any one of the preceding claims.

17. A method of forming an outlet element for an ostomy device, the outlet element comprising an outlet tube for allowing ostomy outputs to exit the ostomy device, and a squeezing operating area for receiving ostomy outputs from the ostomy device and conveying the ostomy outputs to the outlet tube, wherein the squeezing operating area narrows in a direction toward the outlet tube and is relatively flexible to allow squeezing of the ostomy outputs toward the outlet tube, wherein the outlet tube is relatively rigid to allow connection to an external device, and the method comprising forming the squeezing operating area and the outlet tube together in a single forming step.

18. The method of claim 17, further comprising: Thermoplastic materials with a melt flow index of 2.5 g / 10 min to 43 g / 10 min are heated to form a melt; And then, the outlet element is formed using the melt.

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