Outlet valve for ostomy appliances - Patent Application 20070122997

Abstract

The outlet valve for an ostomy appliance includes a shaft defining a hollow bore for receiving fluid from the ostomy appliance. The shaft includes a curved sidewall. The outlet element includes a cap concentrically disposed about the shaft and an outlet tube attached to the cap. A valve opening is defined in the curved sidewall. The cap is rotatable about the shaft to move from a closed configuration, in which the valve opening is not in fluid communication with the outlet tube, to an open configuration, in which the valve opening is in fluid communication with the outlet tube. The outlet valve further includes an outlet element seal configured to provide a seal between the cap and the shaft around the outer periphery of the shaft and a seal between the valve opening and the intake opening when the outlet element is in the closed configuration.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to outlet valves for ostomy appliances, and more particularly to outlet valves for the evacuation of fluids from an ostomy pouch. [Background technology]

[0002] Ostomy appliances may include an outlet valve to allow fluid to be drained from the pouch of the ostomy appliance, either directly to waste or via an additional device such as a drainage bag (which is attached to the outlet valve during use). Ostomy appliances come in many forms that attempt to provide an appliance that is easily drained.

[0003] EP0680296 discloses an outlet valve device comprising a base member and at least one movable means which together form a discharge pipe or hose member, a stop valve and a closing valve, the movable means being rotatably and / or linearly movable, and which allows the outlet valve device to be set in three positions: a first position in which the stop valve and the closing valve are both open, a second position in which the stop valve is closed and the closing valve is open, and a third position in which both valves are closed. The outlet valve device is provided on a collecting bag.

[0004] US 4,280,498 discloses a drainage device for a urostomy bag or other similar collection device that allows continuous overnight drainage of fluid from the bag into a suitable container. The device includes a body member attached to the bag at a lower portion thereof and defining a path for the outflow of the fluid contents of the bag, a rotatable valve member for selectively opening and closing the flow path, and a drainage tube with a connector that removably engages the stem of the valve member.

[0005] There remains a need for ostomy appliances that provide improved usability for ostomates, particularly in the area of ​​ease of connecting the outlet valve to additional appliances, such as a drainage bag. Summary of the Invention

[0006] As used herein, the term "stomal output" refers to any gas or fluid or solid produced by an ostomate that may be secreted from or exit the stoma.

[0007] As used herein, the term "stoma" refers to an opening in the body. Typically, the stoma is a surgical opening in the body torso. In some embodiments, the term "stoma" also refers to the internal tissue, organ, or portion thereof exposed by the opening. By way of non-limiting example, the internal tissue may be selected from the colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or loop of the small intestine or large intestine.

[0008] As used herein, the term "ostomate" refers to a subject who may have the use of an ostomy appliance disclosed herein. Although an ostomate typically refers to a subject with a surgical opening, as used herein, "ostomate" can also refer to a subject with a stoma, whether the stoma is created by surgery or other means.

[0009] As used herein, the term "user" may refer to an ostomate or another person assisting the ostomate, for example, in emptying stoma waste from the cavity.

[0010] As used herein, the ostomy appliances disclosed herein include, for example, esophagostomy, gastrostomy, cholecystostomy, choledochostomy, cecostomy, colostomy, duodenostomy, ileostomy, The ostomy appliances disclosed herein may be used for the management of a stoma created by an ileostomy, jejunostomy, appendicostomy, tracheostomy, urostomy, nephrostomy, ureterostomy, or vesicostomy. The ostomy appliances disclosed herein may be used with additional devices, including, but not limited to, shunts, catheters, plugs, or fecal management systems.

[0011] Beneficially, the ostomy appliances of the present disclosure may enable ostomates to increase the duration of use of each ostomy appliance compared to prior art appliances. This may be achieved by providing a means for reliably and hygienically evacuating the stoma cavity, increasing ostomates' confidence in reusing the ostomy appliance compared to some prior art appliances. Because the ostomates may tend to use each ostomy appliance of the present disclosure for longer periods of time, the total number of ostomy appliances used by the ostomates in a given period of time may be reduced. This may result in environmental benefits, such as reduced environmental waste generation.

[0012] As used herein, the location and orientation of features may be described with reference to the ostomy appliance "in use," "orientation as it might be in use," or the like. Such terms refer to the intended orientation of the ostomy appliance when it is attached to the ostomy appliance's body while the ostomate is standing, regardless of whether the ostomy appliance is currently being used in this manner or the ostomate's actual posture. The terms "upper" and "lower" and related terms refer to the relative position of a part or portion of the ostomy appliance when it is oriented as it might be in use. For example, the apex of the ostomy appliance may be referred to as the "lower" apex of the ostomy appliance when it is in use. In such an example, the apex would be intended to be the lowermost apex (vertically) of the ostomy appliance when it is attached to the ostomy appliance's body while standing. However, one skilled in the art will understand that the apex may not always be the lowest apex prior to application to the ostomate, and furthermore, when applied, the apex may not always be the lowest apex if the ostomate assumes a non-upright position, such as a recumbent position.

[0013] As used herein, the term "front" refers to the relative position of a portion or portions of an ostomy appliance relative to the ostomate's body when the appliance is attached to the body. "Front" refers to a position that is relatively farther from the ostomate's body than a comparable position that is relatively closer to the body. Similarly, "back" refers to a position that is relatively closer to the ostomate's body than a comparable position that is "front."

[0014] As used herein, the terms "inner" and "outer" with respect to components of the outlet valve refer to the relative location of a part or parts of the ostomy appliance with respect to the axis of rotation of the outlet element, with a relatively "inner" part being closer to the axis of rotation than a relatively "outer" part.

[0015] As used herein, the term "affixed" refers to a connection in which the part in question cannot be removed during normal use of the outlet valve or cannot be removed without damaging the part.

[0016] The present disclosure provides: 1. An outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall and a shaft end wall disposed across the hollow bore; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in a portion of the shaft end wall; The cap is rotatable about the axis to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet conduit to an open configuration in which the valve opening is in liquid communication with the outlet conduit. Provide something.

[0017] the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; The intake opening may have an arcuate shape that coincides with a circumference about the axis of rotation of the cap. This allows a user to control the flow rate of fluid through the valve by rotating the cap, and the valve may be configured with multiple cap positions corresponding to the open configuration.

[0018] the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; a gasket seal disposed about a periphery of the valve opening for sealing between the axial end wall and a portion of the cap about a periphery of the valve opening; The intake opening may include a protrusion extending across at least a portion of the intake opening. Thus, the protrusion across the intake opening ensures that the gasket seal is retained even if the intake opening moves relative to the gasket seal.

[0019] The projection may be configured to at least partially compress the gasket seal while the gasket seal is adjacent the intake opening, thereby securely retaining the gasket seal against the axial end wall.

[0020] the outer surface of the curved sidewall includes a circumferential projection about the outer periphery of the shaft; The cap may include retention teeth configured to engage the circumferential projections to prevent axial movement of the cap relative to the shaft during rotation. The cap is thus retained on the stem, which ensures that a good seal is maintained and leakage is minimized without requiring retention teeth around the entire circumference of the cap.

[0021] The retention teeth may be located adjacent the outlet tube so that they are conveniently located to allow the tube to be used to snap fit the cap onto the shaft.

[0022] The cap may include an inner wall concentrically disposed about the curved side wall of the shaft and an outer wall concentrically disposed about the inner wall, thereby defining a flow space between the inner and outer walls, the flow space being in liquid communication with the outlet tube.

[0023] The stem may be located on a valve base for attachment to an outer surface of the ostomy appliance and may project from the valve base away from the outer surface of the ostomy appliance in use.

[0024] Additionally or alternatively, the axial end wall may be generally planar.

[0025] Additionally or alternatively, a gasket seal may be disposed around the periphery of the valve opening to seal between the axial end wall and a portion of the cap around the periphery of the valve opening.

[0026] Additionally or alternatively, the cap includes an inner wall; the inner wall includes a generally cylindrical inner sidewall portion and an inner cap end; the inner sidewall defines a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the inner wall; The inner cap end may be disposed across the generally cylindrical cavity such that the inner cap end covers the axial end wall.

[0027] A gasket seal may be disposed on the axial end wall around the periphery of the valve opening to seal between the axial end wall and the planar surface of the inner cap end.

[0028] an intake opening at the inner cap end; The intake opening may be rotatably positioned to at least partially align with the valve opening, thereby placing the outlet element in the open configuration. The outlet element may be rotatable from a fully open position in which the intake opening is fully aligned with the valve opening to a fully closed position in which the valve opening is blocked by the inner cap end and liquid cannot pass from the hollow bore of the shaft through the valve opening and into the flow space. The inner cap end may be generally planar. The cap may further include an outer wall concentrically disposed around the inner wall, thereby defining a flow space between the inner and outer walls, the flow space being in liquid communication with the outlet tube. the outer wall includes an outer sidewall portion and an outer cap end; The outer cap end covers the inner cap end and is axially spaced from the inner cap end, thereby disposing at least a portion of the flow space between the outer cap end and the inner cap end.

[0029] Additionally or alternatively, the axis of rotation of the outlet element defined by the shaft may be perpendicular to the elongate axis of the outlet tube, and optionally, the axis of rotation may be perpendicular to the body of the ostomate in use. The axial end wall may be arranged transversely to the axis of rotation, and optionally perpendicularly to the axis of rotation defined by the shaft.

[0030] The present disclosure also provides an ostomy appliance, comprising: the outlet valve as described above; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. Provide something. In the closed configuration, the outlet element substantially covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy pouch.

[0031] An aspect of the present disclosure is an outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in the curved sidewall; the cap is rotatable about the axis to move from a closed configuration in which the valve opening is not in fluid communication with the outlet conduit to an open configuration in which the valve opening is in fluid communication with the outlet conduit; The outlet valve further includes at least one seal configured to provide a seal between the cap and the shaft around an outer periphery of the shaft and a seal between the intake opening and the valve opening when the outlet element is in the closed configuration. It is something.

[0032] The valve is therefore less susceptible to leakage because it prevents leakage both around the circumference of the stem: between the cap and the stem, and between the valve opening and the intake opening when the outlet element is in the closed configuration, and from the intake opening to the valve opening when the valve is closed.

[0033] In some embodiments, the at least one seal includes a continuous first seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft; The distance between the first seal and the proximal end of the shaft varies around the circumference of the shaft. In this manner, the first seal can be positioned to provide a seal between the intake opening and the valve opening when the outlet element is in a closed configuration, since the distance between the first seal and the proximal end of the shaft varies around the circumference of the shaft.

[0034] In some embodiments, the at least one seal includes a first seal configured to provide a seal around a periphery of the intake opening when the outlet element is in the closed position; The first seal is integrally formed with a second seal configured to provide a seal about the shaft between the cap and the shaft.

[0035] In a further aspect, the present disclosure provides an outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; the outlet pipe has an intake opening; a valve opening defined in the shaft; the cap is rotatable about the axis to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet conduit to an open configuration in which the valve opening is in liquid communication with the outlet conduit; a first seal configured to provide a seal between the cap and the shaft around a periphery of the intake opening when the outlet element is in the closed configuration; The first seal is integrally formed with a second seal configured to provide a seal between the cap and the shaft about the shaft. Provide something.

[0036] As mentioned above, the seal may provide a seal between the intake opening and the valve opening when the outlet element is in the closed configuration. Thus, in some embodiments, there is provided an outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in the curved sidewall; the cap is rotatable about the axis to move from a closed configuration in which the valve opening is not in fluid communication with the outlet conduit to an open configuration in which the valve opening is in fluid communication with the outlet conduit; the outlet valve further includes at least one seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft and a seal between the intake opening and the valve opening when the outlet element is in the closed configuration; the at least one seal includes a first seal configured to provide a seal around a periphery of the intake opening when the outlet element is in the closed position; The first seal is integrally formed with a second seal configured to provide a seal between the cap and the shaft about the shaft. Provide something.

[0037] Additionally or alternatively, the shaft includes a shaft end wall, which is optionally generally planar.

[0038] Additionally or alternatively, the valve opening may be disposed on a curved sidewall of the shaft. The first seal may include a gasket seal disposed on the curved sidewall of the shaft, the first seal being spaced from the valve opening around the outer periphery of the shaft. The gasket seal may have a profile corresponding to the shape of the intake opening. The outlet tube may be configured to rotate with the cap such that rotation of the cap moves the outlet tube's intake opening between an open configuration in which the outlet tube's intake opening is in fluid communication with the valve opening and a closed configuration in which the outlet opening is not in fluid communication with the valve opening. In the closed position, the first seal may be positioned around a periphery of the intake opening, thereby providing a seal between the intake opening and the curved sidewall of the shaft.

[0039] Additionally or alternatively, the cap may include a curved cap wall defining a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the curved cap wall. The second seal may be disposed axially between the intake opening and the distal end of the curved cap wall about the outer periphery of the shaft, between the curved cap wall and the shaft.

[0040] Additionally or alternatively, the stem may be disposed on a valve base for attachment to the exterior surface of the ostomy appliance and project from the valve base away from the exterior surface of the ostomy appliance in use.

[0041] Additionally or alternatively, a third, circumferential seal may be disposed between the valve base and the cap, axially between the proximal end of the cap and the valve opening.

[0042] Additionally or alternatively, the axis of rotation of the outlet element defined by the shaft may be perpendicular to the elongate axis of the outlet tube, and optionally, the axis of rotation may be perpendicular to the body of the ostomate in use.

[0043] In a further aspect, the present disclosure provides an ostomy appliance comprising: the outlet valve as described above; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. Provide something. In the closed configuration, the outlet element substantially covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy pouch.

[0044] In a further aspect, the present disclosure provides an outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in the curved sidewall; the cap is rotatable about the axis to move from a closed configuration in which the valve opening is not in fluid communication with the outlet conduit to an open configuration in which the valve opening is in fluid communication with the outlet conduit; the outlet valve further includes a continuous first seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft; The distance between the first seal and the proximal end of the shaft varies around the circumference of the shaft. Provide something.

[0045] As noted above, the seal provides a seal between the cap and the shaft around the circumference of the shaft, and between the intake opening and the valve opening when the outlet element is in the closed configuration. Thus, in some embodiments, there is provided an outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in the curved sidewall; the cap is rotatable about the axis to move from a closed configuration in which the valve opening is not in fluid communication with the outlet conduit to an open configuration in which the valve opening is in fluid communication with the outlet conduit; the outlet valve further includes at least one seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft and a seal between the intake opening and the valve opening when the outlet element is in the closed configuration; the at least one seal includes a continuous first seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft; The distance between the first seal and the proximal end of the shaft varies around the circumference of the shaft. Things are provided.

[0046] Additionally or alternatively, the first seal may follow a curved or stepped path around the curved sidewall.

[0047] Additionally or alternatively, at a first circumferential position on the shaft, the first seal may be positioned a distance from the proximal end of the shaft that is equal to or less than the distance from the proximal end to the proximal edge of the valve opening. At a second circumferential position on the shaft, the first seal may be positioned a distance from the proximal end that is equal to or greater than the distance from the proximal end to the distal end of the valve opening. The first circumferential position may be opposite the second circumferential position on the shaft. The outlet element may be rotatable to a fully open position, in which the outlet element is in the open configuration and the intake opening is fully aligned with the valve opening. In the closed configuration, the intake opening may be positioned at the second circumferential position, thereby positioning the first seal between the intake opening and the valve opening. The first circumferential position may be the circumferential position of the valve opening.

[0048] Additionally or alternatively, an annular second seal may be disposed about the circumference of the shaft, the distance between the annular second seal and the proximal end of the shaft may be constant about the circumference of the shaft, and the annular second seal may be disposed between the proximal end of the shaft and the proximal end of the valve opening.

[0049] Additionally or alternatively, the outlet conduit may have an intake opening configured to rotate with the cap such that rotation of the cap moves the outlet conduit between an open configuration in which the intake opening is in fluid communication with the valve opening and a closed configuration in which the intake opening is not in fluid communication with the valve opening, wherein in the open configuration at least a portion of the intake opening is disposed between the valve opening and the first seal, thereby placing at least a portion of the intake opening in fluid communication with the valve opening.

[0050] Additionally or alternatively, the cap may include a curved cap wall defining a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the curved cap wall. The cap may further include a cap end extending across a front end of the generally cylindrical cavity.

[0051] Additionally or alternatively, the shaft may be disposed on a backing flange for attachment to the exterior surface of the ostomy appliance and project from the backing flange away from the exterior surface of the ostomy appliance in use.

[0052] Additionally or alternatively, the axis of rotation of the outlet element defined by the shaft may be perpendicular to the elongate axis of the outlet tube, and optionally, the axis of rotation may be perpendicular to the body of the ostomate in use.

[0053] In a further aspect, the present disclosure provides an ostomy appliance comprising: the outlet valve as described above; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. Provide something. In the closed configuration, the outlet element substantially covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy pouch. [Brief explanation of the drawings]

[0054] One or more aspects of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 is a schematic perspective view of an outlet valve according to a first aspect of the present disclosure. [Figure 2] 2 is a schematic cross-sectional view of the outlet valve of FIG. 1 in a closed configuration. [Figure 3]2 is a schematic partial cross-sectional view of the outlet valve of FIG. 1 in an open configuration. [Figure 4] 2 is a schematic partial perspective view of the outlet valve of FIG. 1 in an open configuration. [Figure 5a] FIG. 10 is a schematic perspective view of an outlet valve according to a second aspect of the present disclosure. [Figure 5b] 5b is a schematic partial perspective view showing hidden details of the outlet valve of FIG. 5a; FIG. [Figure 6] 5b is a schematic partial cross-sectional view of the outlet valve of FIG. 5a in a closed configuration; [Figure 7] 5b is a schematic partial cross-sectional view of the outlet valve of FIG. 5a in an open configuration; [Figure 8] FIG. 10 is a schematic perspective view of an outlet valve according to a third aspect of the present disclosure. [Figure 9] 9 is a schematic partial cross-sectional view of the outlet valve of FIG. 8 in a closed configuration. [Figure 10] 9 is a schematic partial cross-sectional view of the outlet valve of FIG. 8 in an open configuration. DETAILED DESCRIPTION OF THE INVENTION

[0055] In the following description, like reference numerals are used in different aspects to denote like or similar features.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter belongs. It should be understood that the foregoing summary of the disclosure and the following examples are exemplary and explanatory only and are not intended to be limiting of any claimed subject matter.

[0057] The following description is directed to exemplary embodiments of the present disclosure. The description of the above aspects is not intended to include all possible aspects of the present disclosure as set forth in the appended claims. Many modifications, improvements, and equivalents not expressly described in the following aspects may fall within the scope of the appended claims. Features described as part of one aspect may be combined with features of one or more other aspects, unless the context clearly dictates otherwise.

[0058] As used herein, the use of the singular includes the plural unless the context clearly dictates otherwise. As used herein, the use of "or" means "and / or" unless specifically stated otherwise. Furthermore, the use of the word "including" is not limiting, as are other forms such as "include," "includes," and "included."

[0059] As used herein, ranges and amounts may be expressed as "about" with respect to a particular value or range. "About" includes the exact amount. For example, "about 5 mm" means "about 5 mm" and also "5 mm." Typically, the term "about" includes amounts that are expected to be within experimental error. The term "about" includes values ​​that are within a range of 10% less than or greater than the provided value. For example, "about 50%" means between 45% and 55%. Also, for example, "about 30" means between 27 and 33.

[0060] An outlet valve 1 of a first embodiment of an ostomy appliance according to the present disclosure is shown in Figures 1-4. The ostomy appliance may include an ostomy bag 30 (shown in Figure 1) and an outlet valve 1. The outlet valve 1 is attached to the outer surface of the ostomy bag 30, preferably to the outer surface of the outer wall of the ostomy bag 30.

[0061] The outlet valve 1 includes an outlet element 20 and a shaft 13 defining a hollow bore 14 for receiving fluids discharged from an ostomy bag 30. The outlet element 20 includes a cap 22 concentrically disposed about the shaft 13 and an outlet tube 21 secured to the cap 22. The cap 22 is rotatable about the shaft 13 about an axis of rotation 25 defined by the shaft 13 to move the outlet element 20 from a closed configuration in which a valve opening 15 disposed through the shaft 13 is not in fluid communication with the outlet tube 21, to an open configuration in which the valve opening 15 is in fluid communication with the outlet tube 21.

[0062] The outlet valve 1 may be configured such that when the outlet element 20 is in the open configuration, the flow path for liquid from the ostomy bag 30 is through the hollow bore 14, through the valve opening 15 and the cap 22, into the outlet conduit 21 and out the outlet opening 24 of the outlet conduit 21. In the closed configuration, the flow of liquid along the flow path is blocked so that liquid does not flow into the outlet conduit 21.

[0063] The valve base 10 of the outlet valve 1 may be configured to be attached to the outer surface of the ostomy bag 30 and may include a backing flange 11 having a generally planar mounting surface 12 located on the underside of the valve base 10 (i.e., the side configured to be adjacent the body of the ostomy in use). The generally planar mounting surface 12 may be attachable to the outer surface of the ostomy bag 30, for example, by welding or with an adhesive. The valve base 10 may include a stem 13. The stem may protrude from the outer surface 18 of the backing flange 11. The stem 13 may be integrally formed with the backing flange 11, for example, by molding.

[0064] A valve opening 15 is provided through the stem 13 for receiving fluid from the ostomy bag 30. The outlet valve 1 may be positioned overlying an ostomy bag opening in the wall of the ostomy bag 30, thereby allowing fluid from the ostomy bag opening to pass through the hollow bore 14 to the valve opening 15. When the outlet element 20 is in the closed configuration, the valve opening 15 is not in fluid communication with the outlet conduit 21. When the outlet element 20 is in the open configuration, the valve opening 15 is in fluid communication with the outlet conduit 21.

[0065] The shaft 13 may include a curved sidewall 13a and a shaft end wall 13b that may be disposed across the hollow bore 14. The shaft end wall 13b may be generally planar. The shaft end wall 13b may be disposed transversely, or optionally perpendicularly, to the axis of rotation 25 defined by the shaft 13.

[0066] The valve opening 15 may be defined in a portion of the axial end wall 13b, as shown in Figures 2-4. The valve opening 15 may have a generally circular shape. A gasket seal 16 may be disposed around the periphery of the valve opening 15 to seal between the axial end wall 13b and a portion of the cap 22 around the periphery of the valve opening 15, thereby preventing liquid from entering any space defined between the axial end wall 13b and the cap 22.

[0067] The cap 22 may include an inner wall including an inner sidewall portion 22a, which may be generally cylindrical, and an inner cap end portion 22b. The inner sidewall portion 22a may define a generally cylindrical cavity for receiving the shaft 13, whereby the shaft 13 may be rotatably disposed within the inner wall.

[0068] The inner cap end 22b may be generally planar. The inner cap end may be disposed across the generally cylindrical cavity such that the inner cap end covers the axial end wall 13b. A gasket seal 16 may be disposed on the axial end wall 13b around the periphery of the valve opening 15 to seal between the axial end wall 13b and the generally planar back surface of the inner cap end 22b.

[0069] The intake opening 23 may be provided in the inner cap end 22b and in fluid communication with the outlet tube 21. The intake opening 23 may be rotatably positioned to at least partially align with the valve opening 15 to define a fluid path therethrough, thereby placing the outlet element 20 in an open configuration. The intake opening 23 may have a width substantially equal to the diameter of the valve opening 15. The intake opening 23 may have an arcuate shape that corresponds to a circumference around the axis of rotation 25, and the central axis 15a of the valve opening 15 may be located on the same circumference. The arcuate shape may allow for perfect alignment of the valve opening 15 and the intake opening 23 over a range of angular positions of the cap 22. A protrusion 23b may be provided across at least a portion of the intake opening 23 to partially compress the gasket seal 16 while it is adjacent to the intake opening 23. This limits the expansion of the gasket seal 16 into the opening 23b, thereby limiting pinching or tearing of the gasket seal 16 when it comes into contact with the edge of the intake opening 23 as the cap 22 moves.

[0070] The cap 22 may include an outer wall concentrically disposed around the inner wall, thereby defining a flow space 17 between the inner and outer walls. The flow space 17 may be in fluid communication with the outlet tube 21. The intake opening 23 may provide a fluid flow path for liquid to enter the flow space 17 from the valve opening 15. The outer wall may include an outer sidewall 22c and an outer cap end 22d. The outer cap end 22d may cover the inner cap end 22b and be axially spaced apart from the inner cap end 22b. At least a portion of the flow space 17 is thereby located between the outer cap end 22d and the inner cap end 22b. The outer cap end 22d may be formed as a separate piece and secured to the outer sidewall 22c with an adhesive or a mechanical clip to facilitate manufacturing and assembly of the cap 22. A seal (not shown) may be provided between the outer cap end 22d and the outer sidewall 22c.

[0071] The inner and outer side walls 22a, 22c may be joined at their proximal ends (i.e., the ends adjacent the backing flange 11 of the valve base 10) by an annular flange, thereby eliminating a liquid flow path from the flow space 17 at the proximal end of the cap 22.

[0072] The shaft 13 may be retained within the cap 22 by one or more retention features, which may be in the form of one or more interengaging protrusions 26a, 26b located on the outer surface of the curved sidewall 13a and the inner surface of the inner sidewall 22a of the shaft 13. The interengaging protrusions 26a, 26b may be configured to prevent axial movement of the cap 22 relative to the shaft 13 during rotation.

[0073] At the proximal end of the shaft 13, an additional seal 27 may be disposed between the outer surface of the curved side wall 13a of the shaft 13 and the inner surface of the inner side wall portion 22a to prevent fluid from passing between the cap 22 and the shaft 13 at the proximal end of the shaft 13.

[0074] One or more detents 19 may be provided on the backing flange 11 of the valve base 10 to cooperate with one or more recesses or protrusions located on the cap 22. The detents 19 may be positioned to provide audible and / or tactile feedback to the user to confirm the rotational position of the outlet element 20, thereby confirming when the outlet element 20 is in the open and / or closed configuration.

[0075] The outlet tube 21 may extend laterally from the cap 22 such that the axis of rotation 25 of the outlet element 20 defined by the shaft 13 is perpendicular to the elongate axis 21 a of the outlet tube 21 .

[0076] In use, the outlet element 20 is rotatable so that the outlet tube 21 may move through an arc of rotation from an upward position at a first end of the arc of rotation to a downward position at a second end of the arc of rotation (as shown in Figure 1).

[0077] At the first end of the rotational arc, the outlet element 20 may be in a closed configuration. A user may rotate the outlet element 20 downward by rotating the cap 22 to a limit position. The limit position may be defined as the furthest point on the rotational arc from its first end at which the outlet element 20 is still in the closed configuration. As the outlet element 29 is rotated from the limit position toward the second end of the rotational arc, the valve opening 15 and the intake opening 23 will become aligned, gradually increasing the area of ​​the flow path, until a fully open configuration is reached in which the valve opening 15 and the intake opening 23 align. The fully open configuration of the outlet element, i.e., the position in which the base opening and the intake opening 23 align, may coincide with the second end of the rotational arc.

[0078] Thus, at the first end of the rotational arc, the outlet element 20 may be in a fully closed position in which the valve opening 15 is blocked by the inner cap end 22b and liquid does not pass from the hollow bore 14 of the shaft 13 through the valve opening 15 to the flow space 17. At the second end of the rotational arc, the outlet element 20 may be in a fully open position in which the intake opening 23 is fully aligned with the valve opening 15.

[0079] The circumferential positions of the valve opening 15 and the intake opening 23 may be arranged such that the intake opening 23 is fully aligned with the valve opening 15 and the outlet pipe 21 is directed generally downward when the outlet element 20 is in an open configuration. At the first end of the rotational arc, the outlet opening 24 of the outlet pipe 21 may be directed generally upward and / or overlap the backing flange 11 when the outlet element is in a closed configuration.

[0080] The outlet valve 1 may be configured such that, in use, the axis of rotation 25 is generally horizontal but positioned perpendicular to the mounting surface 12 of the backing flange 11 of the valve base 10 .

[0081] Further examples of outlet valves according to the present disclosure are described below. In the following description, only the features that differ in this aspect compared to the previous aspects are described in detail. For features that are common to one or more aspects, please refer to the description as a whole.

[0082] A second embodiment of an outlet valve 101 according to the present disclosure is shown in Figures 5a to 7. The outlet valve 101 includes a stem 113 and a cap 122.

[0083] The valve base 110 of the outlet valve 101 includes a backing flange 111 and a stem 113, which may define the hollow bore 14. The stem 113 may be molded as a separate piece relative to the backing flange 111. The stem 113 is secured to the backing flange 111 using, for example, a snap fit or an interference fit of retention features 126a and 126b as shown in Figures 6 and 7. A liquid path through the stem end wall 113b may not be defined.

[0084] A valve opening 115 for receiving fluids drained from the ostomy bag is provided through the shaft 113. The shaft 113 may include a curved side wall 113a and a shaft end wall 113b, which may be disposed across the hollow bore 14.

[0085] The stem 113 may extend through the entire height of the valve, such that the stem end wall 113b comprises the front face of the outlet valve 101 (ie the stem end wall is not covered by the cap 122 of the outlet element 120).

[0086] The valve opening 115 may be defined in a portion of the curved sidewall 113a of the shaft 113, as shown in FIGS.

[0087] The outlet element 120 of the outlet valve 101 may include a cap 122 and an outlet tube 121. The cap 122 may include a curved cap wall 122a that defines a generally cylindrical cavity for receiving the shaft 113, whereby the shaft is rotatably disposed within the curved cap wall 122a. Thus, the cap 122 may have a generally annular shape.

[0088] The outlet tube 121 may be integrally formed with or secured to the cap 122. The outlet tube 121 has an intake opening 123 at its inner end disposed through the curved cap wall 122a. The intake opening 123 may be configured to receive liquid from the valve opening 115 when the outlet valve 101 is in an open configuration.

[0089] Cap 122 may be disposed concentrically about axis 113 such that cap 122 rotates about axis 113. Outlet tube 121 may be affixed to cap 122 such that the outlet tube rotates with cap 122 about axis 113. Thus, as outlet element 120, including cap 122, rotates, intake opening 123 of outlet tube 121 may move between an open position in which intake opening 123 is in fluid communication with valve opening 115 (whereby said outlet element is in an open configuration) and a closed position in which intake opening 123 is not in fluid communication with valve opening 115 (whereby said outlet element is in a closed configuration).

[0090] The circumferential position of the valve opening 115 about the axis 113 may be arranged such that when the intake opening 123 is aligned with the valve opening 115, i.e., when the outlet element 120 is in the open configuration, the outlet tube 121 is directed generally downward. The intake opening 123 may have substantially the same shape and size as the size and shape of the valve opening 115. The intake opening 123 and the valve opening 115 may be located the same axial distance from the valve base 110.

[0091] A first seal 116a may be provided to seal between the cap 122 and the shaft 113 around the periphery of the intake opening 123 when the outlet element 120 is in the closed configuration. The first seal 116a may be integrally formed with a second seal 116b configured to provide a seal between the cap 122 and the shaft 113 around the outer periphery of the shaft 113.

[0092] The first seal 116a may include a gasket seal disposed on the curved cap wall 122a of the shaft 113. The first seal 116a is spaced from the intake opening 123 around the circumference of the shaft 113.

[0093] The gasket seal forming first seal 116a may have a profile corresponding to the shape of intake opening 123. When outlet element 120 is in the closed position, first seal 116a may be aligned with and disposed around the periphery of intake opening 123, thereby providing a seal between intake opening 123 and the curved sidewall of shaft 113 such that outlet tube 121 is not in fluid communication with valve opening 115.

[0094] The second seal 116b may be positioned axially around the outer periphery of the axis 113 between the curved cap wall 122a and the axis 113, between the valve opening 115 and the front end of the curved cap wall 122a (i.e., the end of the curved cap wall distal from the backing flange 111 of the valve base 110).

[0095] The first seal 116a and the second seal 116b may be configured to be stationary relative to the shaft 113. The first seal 116a and the second seal 116b may be attached to the shaft 113 using an adhesive or by providing grooves on the shaft 113 that can receive the first seal 116a and the second seal 116b so that they do not rotate relative to the shaft 113 when the cap 122 is rotated due to the resiliency of the first seal 116a and the second seal 116b, for example.

[0096] In use, the outlet element 120 may be rotatable such that the outlet tube 121 moves through a rotational arc from an upward position at a first end of the rotational arc to a downward position at a second end of the rotational arc. At the first end of the rotational arc, the outlet element 120 may be in a closed configuration. A user may rotate the outlet element 120 downward by rotating the cap 122 to a limit position. The limit position may be defined as the furthest point on the rotational arc from its first end at which the outlet element 120 is still in a closed configuration. As the outlet element 120 is rotated from the limit position toward the second end of the rotational arc, the intake opening 23 will gradually move out of alignment with the first seal 116a, thereby defining a flow path from the valve opening 115 through the flow space 117 to the intake opening 123. As outlet element 120 is rotated further from the first end of the rotational arc, the area of ​​the flow path will gradually increase until outlet element 120 reaches a fully open position where valve opening 15 and intake opening 123 are aligned, which may coincide with the second end of the rotational arc.

[0097] A third circumferential seal 127 may be disposed between the valve base 110 and the cap 122 (as shown in FIGS. 6 and 7 ). The third circumferential seal 127 may be disposed between the backing flange 111 and the cap 122, for example, received in a recess provided in the proximal face of the curved cap wall 122 a and adjacent to a seal protrusion 111 a provided on the forward face of the backing flange 111. The third circumferential seal 127 may therefore provide a seal between the valve base 110 and the cap 122 adjacent the proximal end of the stem 113, thereby preventing fluid entering the flow space 117 between the cap 122 and the stem 113 from passing out of the outlet valve 101 between the cap 122 and the valve base 110. In an alternative example, the third circumferential seal 127 may be disposed between the stem 113 and the cap 122.

[0098] The relative axial positions of the backing flange 111, the shaft 113, and the outlet element 120 may be secured using retention features, for example, in the form of a pair of base flanges 126a at the proximal end of the shaft 113 and a distal flange 126b at the distal end of the shaft 113. The backing flange 111 may be provided with an opening for receiving the shaft 113. The pair of base flanges 126a may be configured to receive a portion of the backing flange 111 therebetween to provide a push-fit assembly of the shaft 113 to the backing flange 111. The distal flange 126b may extend outward from the shaft 113 to retain the outlet element 120 between the distal flange 126b and the backing flange 111.

[0099] 8 to 10 show an outlet valve 201 according to a third embodiment of the present disclosure. The outlet valve 201 includes a stem 213 and a cap 222.

[0100] The valve base 210 of the outlet valve 201 may include a backing flange 211 and a stem 213, the stem 213 defining the hollow bore 14. The stem 213 may be integrally formed with the backing flange 111, for example, by forming the stem and backing flange as a single molding.

[0101] A valve opening 215 is provided through the shaft 213 for receiving fluid drained from the ostomy bag. The shaft 213 may include a curved side wall 213a and a shaft end wall 213b. The shaft end wall 213b is disposed across the hollow bore 14. A fluid path may not be defined through the shaft end wall 113b. The valve opening 215 may be defined in a portion of the curved side wall 213a of the shaft 213, as shown in Figures 9 and 10.

[0102] The outlet element 220 of the outlet valve 201 may include a cap 222 and an outlet tube 221. The cap 222 may include a curved cap wall 222a that defines a generally cylindrical cavity for receiving the shaft 213, whereby the shaft is rotatably disposed within the curved cap wall. The cap 222 may further include a cap end wall 222b that is disposed across and seals a distal end of the generally cylindrical cavity.

[0103] The outlet tube 221 may be integrally formed with or secured to the cap 222. The outlet tube 221 may include an intake opening 223 at an inner end thereof disposed through the curved cap wall 222a. The intake opening 223 may be configured to receive liquid from the valve opening 215 when the outlet valve 201 is in an open configuration.

[0104] Cap 222 may be disposed concentrically about axis 213 such that cap 222 rotates about axis 213. Outlet tube 221 may be affixed to cap 222 such that outlet tube 221 rotates with cap 222 about axis 213. Thus, as cap 222 rotates, intake opening 223 of outlet tube 221 can move between an open position in which intake opening 223 is in fluid communication with valve opening 215 and a closed position in which intake opening 223 is not in fluid communication with valve opening 215.

[0105] The intake opening 223 may have substantially the same size and shape as the valve opening 215. Additionally, the intake opening 223 and the valve opening 215 may be located the same axial distance from the valve base 210.

[0106] As cap 222 is rotated, outlet element 220 is moved between an open configuration in which intake opening 223 is in fluid communication with valve opening 215 and a closed configuration in which intake opening 223 is not in fluid communication with valve opening 215. The circumferential position of valve opening 215 about axis 213 may be arranged such that when intake opening 223 is aligned with valve opening 215, i.e., when outlet element 220 is in the open configuration, outlet tube 221 is directed generally downward.

[0107] The outlet valve may further include a first seal 216 that may be continuous and configured to provide a seal between the cap 222 and the shaft 213 around the circumference of the shaft 213. The first seal 216 may follow a curved or stepped path on the shaft 213 such that the distance between the first seal 216 and the proximal end of the shaft 213 varies around the circumference of the shaft 213 (measured parallel to the axis of rotation 225 defined by the shaft 213). Therefore, the number or complexity of seals required to seal the outlet valve 201 may be reduced.

[0108] At a first circumferential location on the shaft 213, the first seal 216 may be positioned a distance from the proximal end of the shaft 213 that is less than or equal to the distance from the proximal end of the shaft 213 to the proximal edge 215a of the valve opening 215. The first circumferential location may be a circumferential location of the valve opening 215. The first circumferential location may extend around a circumferential arc that corresponds to the circumferential arc along which the valve opening 215 extends.

[0109] At the second circumferential position on the axis 213, the first seal 216 is at a distance from the proximal end of the axis 213 that is equal to or greater than the distance from the proximal end of the axis 213 to the distal end 215b of the valve opening. The second circumferential position may extend around a circumferential arc that corresponds to the circumferential arc along which the valve opening 215 is disposed when the outlet element 220 is in the closed configuration.

[0110] The first circumferential position may be located opposite the second circumferential position of the first seal 216, i.e., the first circumferential position may be located approximately 180 degrees circumferentially about the axis 213 from the second circumferential position.

[0111] An annular second seal 227 may be disposed around the circumference of the shaft 213 adjacent the proximal end of the shaft 213 to seal a flow space 217 disposed between the cap 222 and the shaft 213. The annular second seal 227 may be disposed between the proximal end of the shaft 213 and the first seal 216, such that the annular second seal 227 is disposed between the proximal end of the shaft 213 and the proximal edge 215a of the valve opening 215. The distance between the annular second seal 227 and the proximal end of the shaft 213 may be constant around the circumference of the shaft 213.

[0112] In use, outlet element 220 may be rotatable such that outlet tube 221 moves through an arc of rotation from an upward position at a first end of the arc of rotation to a downward position at a second end of the arc of rotation. At the first end of the arc of rotation, outlet element 220 may be in a closed configuration. In the closed configuration, intake opening 223 may be disposed at a second circumferential position such that first seal 216 is disposed between intake opening 223 and valve opening 215.

[0113] A user can rotate the outlet element 20 downward by rotating the cap 222 to a limit position. The limit position may be defined as the furthest point on the rotational arc from its first end at which the outlet element 220 is still in the closed configuration. As the outlet element 220 is rotated from the limit position toward the second end of the rotational arc, the intake opening 223 will gradually move across a portion of the first seal 216, thereby defining a flow path from the valve opening 215 through the flow space 217 to the intake opening 223. As the outlet element 220 is further rotated from the first end of the rotational arc, the area of ​​the flow path may gradually increase until the outlet element 220 reaches a fully open position (where the valve opening 215 and the intake opening 223 are aligned). The fully open position may coincide with the second end of the rotational arc. In the open configuration, at least a portion of the intake opening 223 is disposed between the valve opening 215 and the first seal 216.

[0114] When the outlet element 220 is in the open configuration, at least a portion of the intake opening 223 is positioned between the valve opening 215 and the first seal 216 in the liquid flow path through the outlet valve 201, thereby placing at least a portion of the intake opening 223 in liquid communication with the valve opening 215.

[0115] The relative axial position of the shaft 213 and the outlet element 220 may be fixed using a retaining feature, for example in the form of an annular clip 226 provided between the cap 222 and the shaft 213 .

[0116] In a further aspect of the present disclosure, an outlet valve according to any aspect of the present disclosure may form part of an ostomy appliance further including an ostomy bag. The outlet valve may be attached to an outer surface of a wall of the ostomy bag to drain fluid from the cavity of the ostomy bag. An ostomy bag opening may be provided through the wall. A backing flange of the outlet valve is affixed or attached to the wall, thereby placing the ostomy bag opening in fluid communication with the hollow bore. Thus, the outlet valve may be operated to open or close fluid exiting the cavity of the ostomy bag.

[0117] The outlet valve may be positioned adjacent a lower edge or apex of the ostomy pouch. The outlet valve may be oriented such that in the closed configuration, the outlet element substantially covers the cavity of the ostomy pouch, and in the open configuration, at least a portion of the outlet element extends across the lower edge of the cavity of the ostomy pouch.

[0118] While preferred embodiments of the present disclosure have been described, they are illustrative and not limiting. Those skilled in the art will recognize that many alternatives are possible within the scope of the present disclosure. For example, features described as part of one aspect may be combined with features of one or more other aspects unless the context clearly requires otherwise. Furthermore, the following features are applicable to any aspect of the present disclosure.

[0119] As noted above, the location and orientation of features may be described herein with reference to the ostomy appliance being "in use," "oriented as it might be in use," or the like. Such terms refer to the intended orientation of the ostomy appliance when it is adhered to the body of an ostomate in an upright position.

[0120] Any outlet valve according to the present disclosure may be configured such that, when attached to the exterior surface of an ostomy bag in use, the axis of rotation of the outlet element is disposed generally perpendicular to the elongate axis of the outlet tube and perpendicular to the generally planar mounting surface of the backing flange, such that the axis is generally perpendicular to the body of the ostomate in use.

[0121] In use, the outlet tube may be positioned in a storage position at a first end of the rotational arc with the outlet element in a closed configuration. In the storage position, the outlet tube may be oriented with its outlet end facing generally upward and overlying the backing flange. In the storage position, the outlet tube may overlie a cavity of an ostomy pouch.

[0122] To drain fluid from an ostomy appliance including an outlet valve according to any aspect of the present disclosure, a user may grasp the outlet element and rotate the outlet tube along a rotational arc away from a first, upper end of the rotational arc. A limit position of the outlet element may be defined as the point on the rotational arc farthest from its first end at which the outlet element is still in a closed configuration.

[0123] The limit position may provide a convenient location for a user to pause valve rotation and attach a drainage device, such as an overnight bag, to the outlet tube before the outlet tube is moved to the open configuration, thereby limiting the possibility of spillage of the drained liquid. The outlet tube may then be further rotated to increase the flow area from the base opening to the intake opening, for example, by increasing the alignment of the base opening with the intake opening or by moving the intake opening beyond the seal, thereby allowing more liquid to flow out of the valve and pointing the outlet tube downward for convenient drainage into an overnight bag or externally.

[0124] In use, the outlet element is in an open configuration when the valve opening and the intake opening are at least partially aligned or otherwise in at least partial fluid communication. As the outlet conduit moves from its limit position toward the second end of the rotational arc, both openings gradually align, or the area of ​​the flow path therebetween increases, until a fully open position is reached in which both openings are aligned. The fully open position may coincide with the second end of the rotational arc.

[0125] After draining the ostomy bag, or when the user wishes to discontinue the flow of fluid through the outlet valve, the user can rotate the outlet tube upward to return the outlet element to the closed configuration. If used, an overnight drainage bag or other device can be removed from the outlet tube once the outlet element is in the closed configuration, thereby avoiding spillage.

[0126] In either aspect, retention features may be provided to retain the shaft within the cap. For example, these retention features may include cooperating protrusions and / or recesses and may be configured to prevent relative axial movement between the cap and the shaft during rotation.

[0127] In either aspect, the valve opening may define the only fluid path out of the hollow bore away from the ostomy pouch.

[0128] In either aspect, the outlet element and / or the valve base may include a detent configured to prevent accidental opening and may provide audible and / or tactile feedback to a user confirming the rotational position of the outlet element and, therefore, whether the outlet element is in the open or closed configuration. For example, a detent may be located at or near the limit position to indicate the point at which the outlet element moves to the open configuration.

[0129] In either aspect, one or more of the seals may be in the form of an O-ring.

[0130] In either aspect, the backing flange and the shaft may be integrally formed, e.g., formed as a single molding, or may be formed separately and then assembled, with the shaft secured to the backing flange. If formed separately, assembly may occur after the backing flange is attached to the ostomy pouch. This may facilitate assembly because the height of the shaft does not need to be accommodated by assembly machinery (e.g., welding equipment) during attachment of the backing flange to the ostomy pouch.

[0131] In either aspect, at least a portion of the outlet tube may be integrally formed with the cap, or alternatively, the outlet tube may be formed separately and then secured to the cap.

[0132] In either aspect, the outlet tubing may include a relatively rigid intake portion and a relatively flexible outlet portion. The relatively flexible outlet portion may be secured to the relatively rigid intake portion in any suitable manner, for example, by overmolding the relatively flexible outlet portion onto the relatively rigid intake portion. The relatively flexible outlet portion may be resilient. An outlet valve according to any aspect of the present disclosure may be configured for use with a relatively rigid connector, for example, to connect the outlet valve to a drainage bag or other device. The relatively rigid connector may have an outer diameter, and the relatively flexible outlet portion of the outlet tubing may have an outlet outer diameter slightly smaller than the outer diameter of the connector. Thus, when the connector is inserted into the relatively flexible outlet tubing portion in use, the relatively flexible outlet tubing portion may flex to accommodate the connector, thereby forming an effective seal.

[0133] In either aspect, the valve opening may define the only fluid path out of the hollow bore away from the ostomy pouch.

[0134] In either aspect, the seal(s) may be stationary (i.e., non-rotating) relative to the shaft in use. One or more seals may be fixed to the shaft.

[0135] Lubricant may be provided between the rotating members to facilitate rotation and improve sealing.

[0136] In any aspect of the disclosure, the outlet element may be held axially relative to the housing such that there is no relative axial movement between the outlet element and the valve base during rotation.

[0137] Other features of the ostomy appliance, such as the shape and configuration of the inner wall, outer wall, and comfort layer of the ostomy appliance, may differ from that shown in the illustrated embodiment. Similarly, the shape of the valve opening may differ from that shown in the illustrated embodiment.

[0138] Although the outlet valves of the present disclosure are described herein as being suitable for ostomy appliances, including ostomy pouches, the outlet valves according to any aspect of the present disclosure may also be suitable for use in other applications, such as drainage bags or catheter retrieval bags. The following items 1-49 are within the scope of the present disclosure. [Item 1] 1. An outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in the curved sidewall; the cap is rotatable about the axis to move from a closed configuration in which the valve opening is not in fluid communication with the outlet conduit to an open configuration in which the valve opening is in fluid communication with the outlet conduit; The outlet valve further includes at least one seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft and a seal between the intake opening and the valve opening when the outlet element is in the closed configuration. An outlet valve characterized by: [Item 2] In the outlet valve according to item 1, the at least one seal includes a continuous first seal configured to provide a seal between the cap and the shaft about an outer periphery of the shaft; The distance between the first seal and the proximal end of the shaft varies around the circumference of the shaft. An outlet valve characterized by: [Item 3] In the outlet valve according to item 2, The first seal follows a curved or stepped path around the curved sidewall. An outlet valve characterized by: [Item 4] In the outlet valve according to item 2 or 3, At a first circumferential position on the shaft, the first seal is disposed a distance from the proximal end of the shaft that is equal to or less than a distance from the proximal end of the shaft to a proximal edge of the valve opening. An outlet valve characterized by: [Item 5] In the outlet valve according to item 4, At a second circumferential position on the shaft, the first seal is at a distance from the proximal end that is equal to or greater than a distance from the proximal end to a distal end of the valve opening. An outlet valve characterized by: [Item 6] In the outlet valve according to item 5, The first circumferential position is on an opposite side of the shaft from the second circumferential position. An outlet valve characterized by: [Item 7] Item 5 or 6, the outlet valve the outlet element is rotatable to a fully open position; In the fully open position, the outlet element is in the open configuration; The intake opening is perfectly aligned with the valve opening. An outlet valve characterized by: [Item 8] In the outlet valve according to any one of items 5 to 7, In the closed configuration, the intake opening is located at the second circumferential position, thereby positioning the first seal between the intake opening and the valve opening. An outlet valve characterized by: [Item 9] In the outlet valve according to any one of items 4 to 8, The first circumferential position is the circumferential position of the valve opening. An outlet valve characterized by: [Item 10] The outlet valve according to any one of items 1 to 9, further comprising: a second annular seal disposed around the outer periphery of the shaft; An outlet valve characterized by: [Item 11] In the outlet valve according to item 10, The distance between the annular second seal and the proximal end of the shaft is constant around the circumference of the shaft. An outlet valve characterized by: [Item 12] Item 12. The outlet valve according to item 10 or 11, The annular second seal is disposed between the proximal end of the shaft and the proximal end of the valve opening. An outlet valve characterized by: [Item 13] 13. The outlet valve according to any one of items 1 to 12, the outlet pipe has an intake opening; The outlet tube is configured to rotate with the cap such that rotation of the cap moves the outlet tube between an open configuration in which the intake opening is in fluid communication with the valve opening and a closed configuration in which the intake opening is not in fluid communication with the valve opening. An outlet valve characterized by: [Item 14] Item 14. The outlet valve according to item 13, In the open configuration, at least a portion of the intake opening is disposed between the valve opening and the first seal, whereby at least a portion of the intake opening is in fluid communication with the valve opening. An outlet valve characterized by: [Item 15] 15. The outlet valve according to any one of items 1 to 14, The cap includes a curved cap wall defining a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the curved cap wall. An outlet valve characterized by: [Item 16] Item 16. The outlet valve according to item 15, The cap further includes a cap end extending across a front end of the generally cylindrical cavity. An outlet valve characterized by: [Item 17] 17. The outlet valve according to any one of items 1 to 16, The shaft is disposed on a backing flange for attachment to an outer surface of the ostomy appliance and projects from the backing flange away from the outer surface of the ostomy appliance in use. An outlet valve characterized by: [Item 18] In the outlet valve according to item 1, the at least one seal includes a first seal configured to provide a seal around a periphery of the intake opening when the outlet element is in the closed position; The first seal is integrally formed with a second seal configured to provide a seal between the cap and the shaft about the shaft. An outlet valve characterized by: [Item 19] Item 19. The outlet valve according to item 18, The shaft includes a shaft end wall, the shaft end wall optionally being generally planar. An outlet valve characterized by: [Item 20] Item 18 or 19, the outlet valve, the first seal includes a gasket seal disposed on the curved sidewall of the shaft; The first seal is spaced from the valve opening around the circumference of the shaft. An outlet valve characterized by: [Item 21] Item 20. The outlet valve according to item 20, The gasket seal has a profile corresponding to the shape of the intake opening. An outlet valve characterized by: [Item 22] Item 21. The outlet valve according to item 21, The outlet tube is configured to rotate with the cap such that rotation of the cap moves the outlet tube between an open position in which the intake opening is in fluid communication with the valve opening and a closed position in which the intake opening is not in fluid communication with the valve opening. An outlet valve characterized by: [Item 23] Item 23. The outlet valve according to item 22, In the closed position, the first seal fits around a periphery of the intake opening, thereby providing a seal between the intake opening and the curved sidewall of the shaft. An outlet valve characterized by: [Item 24] 24. The outlet valve according to any one of items 18 to 23, The cap includes a curved cap wall defining a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the curved cap wall. An outlet valve characterized by: [Item 25] Item 25. The outlet valve according to item 24, The second seal is disposed axially about the shaft between the curved cap wall and the shaft, between the intake opening and the distal end of the curved cap wall. An outlet valve characterized by: [Item 26] 26. The outlet valve according to any one of items 18 to 25, The stem is disposed on the valve base for attachment to the exterior surface of the ostomy appliance and projects from the valve base away from the exterior surface of the ostomy appliance in use. An outlet valve characterized by: [Item 27] 27. The outlet valve according to any one of items 18 to 26, A third circumferential seal is disposed between the valve base and the cap at an axial location between the proximal end of the cap and the valve opening. An outlet valve characterized by: [Item 28] 28. The outlet valve according to any one of items 1 to 27, The axis of rotation of the outlet element defined by the shaft is perpendicular to the elongate axis of the outlet conduit, and optionally the axis of rotation is perpendicular to the body of the ostomate in use. An outlet valve characterized by: [Item 29] 1. An outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall and a shaft end wall disposed across the hollow bore; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in a portion of the shaft end wall; The cap is rotatable about the axis to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet conduit to an open configuration in which the valve opening is in liquid communication with the outlet conduit. An outlet valve characterized by: [Item 30] Item 29. The outlet valve according to item 29, the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; The intake opening has an arcuate shape that coincides with a circumference around the rotation axis of the cap. An outlet valve characterized by: [Item 31] In the outlet valve according to item 29 or 30, the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; a gasket seal disposed about a periphery of the valve opening for sealing between the axial end wall and a portion of the cap about a periphery of the valve opening; The intake opening includes a protrusion disposed across at least a portion of the intake opening. An outlet valve characterized by: [Item 32] Item 32. The outlet valve according to Item 31, The protrusion is configured to at least partially compress the gasket seal while the gasket seal is adjacent the intake opening. An outlet valve characterized by: [Item 33] In the outlet valve according to any one of items 29 to 32, the outer surface of the curved sidewall includes a circumferential projection about the outer periphery of the shaft; The cap includes retention teeth configured to engage the circumferential projections to prevent axial movement of the cap relative to the shaft during rotation. An outlet valve characterized by: [Item 34] Item 34. The outlet valve according to Item 33, The retaining teeth are disposed adjacent the outlet tube. An outlet valve characterized by: [Item 35] 35. The outlet valve according to any one of items 29 to 34, The cap includes an inner wall concentrically disposed about the curved side wall of the shaft and an outer wall concentrically disposed about the inner wall, thereby defining a flow space between the inner wall and the outer wall, the flow space being in fluid communication with the outlet tube. An outlet valve characterized by: [Item 36] 36. The outlet valve according to any one of items 29 to 35, The shaft end wall is generally planar. An outlet valve characterized by: [Item 37] 37. The outlet valve according to any one of items 29 to 36, The stem is disposed on a valve base for attachment to an exterior surface of the ostomy appliance and projects from the valve base away from the exterior surface of the ostomy appliance in use. An outlet valve characterized by: [Item 38] Item 38. The outlet valve according to any one of items 29 to 37, A gasket seal is disposed around the periphery of the valve opening to seal between the axial end wall and a portion of the cap around the periphery of the valve opening. An outlet valve characterized by: [Item 39] 39. The outlet valve according to any one of items 29 to 38, the cap includes an inner wall; the inner wall includes a generally cylindrical inner sidewall portion and an inner cap end; the inner sidewall defines a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the inner wall; The inner cap end is disposed across the generally cylindrical cavity such that the inner cap end covers the axial end wall. An outlet valve characterized by: [Item 40] Item 39. The outlet valve according to item 39, A gasket seal is disposed on the axial end wall around the periphery of the valve opening to seal between the axial end wall and the planar surface of the inner cap end. An outlet valve characterized by: [Item 41] Item 39 or 40, the outlet valve, an intake opening at the inner cap end; The intake opening is rotatably positioned to at least partially align with the valve opening, thereby placing the outlet element in the open configuration. An outlet valve characterized by: [Item 42] Item 41. The outlet valve according to item 41, The outlet element is rotatable from a fully open position in which the intake opening is fully aligned with the valve opening to a fully closed position in which the valve opening is blocked by the inner cap end such that liquid cannot pass from the hollow bore of the shaft through the valve opening and into the flow space. An outlet valve characterized by: [Item 43] 43. The outlet valve according to any one of items 39 to 42, The inner cap end is generally planar. An outlet valve characterized by: [Item 44] In the outlet valve according to any one of items 39 to 43, The cap further includes an outer wall concentrically disposed about the inner wall, thereby defining a flow space between the inner and outer walls, the flow space being in fluid communication with the outlet tube. An outlet valve characterized by: [Item 45] Item 45. The outlet valve according to item 44, the outer wall includes an outer sidewall portion and an outer cap end; The outer cap end overlies the inner cap end and is axially spaced from the inner cap end, thereby disposing at least a portion of a flow space between the outer cap end and the inner cap end. An outlet valve characterized by: [Item 46] 46. ​​The outlet valve according to any one of items 39 to 45, The axis of rotation of the outlet element defined by the shaft is perpendicular to the elongate axis of the outlet conduit, and optionally the axis of rotation is perpendicular to the body of the ostomate in use. An outlet valve characterized by: [Item 47] Item 47. The outlet valve according to item 46, The shaft end wall is disposed transversely to the axis of rotation, optionally perpendicular to the axis of rotation defined by the shaft. An outlet valve characterized by: [Item 48] an outlet valve according to any one of items 1 to 47; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. An ostomy appliance characterized by: [Item 49] Item 49. The ostomy appliance according to Item 48, In the closed configuration, the outlet element substantially covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element extends across a lower edge of the cavity of the ostomy pouch. An ostomy appliance characterized by:

Claims

1. 1. An outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in the curved sidewall; the cap is rotatable about the axis to move from a closed configuration in which the valve opening is not in fluid communication with the outlet conduit to an open configuration in which the valve opening is in fluid communication with the outlet conduit; the outlet valve further includes at least one seal configured to provide a seal between the cap and the shaft around an outer periphery of the shaft and a seal between an intake opening of the outlet conduit and the valve opening when the outlet element is in the closed configuration; the at least one seal includes a first seal configured to provide a seal around a periphery of the intake opening when the outlet element is in the closed configuration; The first seal is integrally formed with a second seal configured to provide a seal between the cap and the shaft about the shaft. An outlet valve characterized by:

2. 2. The outlet valve of claim 1, The shaft includes a shaft end wall. An outlet valve characterized by:

3. In the outlet valve according to claim 2, The shaft end wall is generally planar. An outlet valve characterized by:

4. 4. The outlet valve according to claim 1, wherein the first seal includes a gasket seal disposed on the curved sidewall of the shaft; The first seal is spaced from the valve opening around the circumference of the shaft. An outlet valve characterized by:

5. 5. The outlet valve of claim 4, The gasket seal has a profile corresponding to the shape of the intake opening. An outlet valve characterized by:

6. 6. The outlet valve of claim 5, The outlet tube is configured to rotate with the cap such that rotation of the cap moves the outlet tube between an open position in which the intake opening is in fluid communication with the valve opening and a closed position in which the intake opening is not in fluid communication with the valve opening. An outlet valve characterized by:

7. 7. The outlet valve of claim 6, In the closed position, the first seal fits around a periphery of the intake opening, thereby providing a seal between the intake opening and the curved sidewall of the shaft. An outlet valve characterized by:

8. 8. An outlet valve according to any one of claims 1 to 7, The cap includes a curved cap wall defining a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the curved cap wall. An outlet valve characterized by:

9. 9. The outlet valve of claim 8, The second seal is disposed axially about the shaft between the curved cap wall and the shaft, between the intake opening and the distal end of the curved cap wall. An outlet valve characterized by:

10. 10. An outlet valve according to any one of claims 1 to 9, The stem is disposed on the valve base for attachment to the exterior surface of the ostomy appliance and projects from the valve base away from the exterior surface of the ostomy appliance in use. An outlet valve characterized by:

11. 11. The outlet valve of claim 10, A third circumferential seal is disposed between the valve base and the cap at an axial location between the proximal end of the cap and the valve opening. An outlet valve characterized by:

12. 12. An outlet valve according to any one of claims 1 to 11, The axis of rotation of the outlet element defined by the shaft is perpendicular to the elongated axis of the outlet tube. An outlet valve characterized by:

13. The outlet valve according to claim 12, The above rotation axis is perpendicular to the ostomate's body when in use. An outlet valve characterized by:

14. An outlet valve according to any one of claims 1 to 13; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. An ostomy appliance characterized by:

15. The ostomy device according to claim 14, In the closed configuration, the outlet element covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element extends across a lower edge of the cavity of the ostomy pouch. An ostomy appliance characterized by:

16. 1. An outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall and a shaft end wall disposed across the hollow bore; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in a portion of the shaft end wall; the cap is rotatable about the axis to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet conduit to an open configuration in which the valve opening is in liquid communication with the outlet conduit; the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; a gasket seal disposed about a periphery of the valve opening for sealing between the axial end wall and a portion of the cap about a periphery of the valve opening; The intake opening includes a protrusion disposed across at least a portion of the intake opening. An outlet valve characterized by:

17. 17. The outlet valve of claim 16, The intake opening has an arcuate shape that coincides with a circumference around the rotation axis of the cap. An outlet valve characterized by:

18. 18. The outlet valve according to claim 16 or 17, The protrusion is configured to at least partially compress the gasket seal while the gasket seal is adjacent the intake opening. An outlet valve characterized by:

19. 19. An outlet valve according to any one of claims 16 to 18, the outer surface of the curved sidewall includes a circumferential projection about the outer periphery of the shaft; The cap includes retention teeth configured to engage the circumferential projections to prevent axial movement of the cap relative to the shaft during rotation. An outlet valve characterized by:

20. 20. The outlet valve of claim 19, The retaining teeth are disposed adjacent the outlet tube. An outlet valve characterized by:

21. An outlet valve according to any one of claims 16 to 20; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. An ostomy appliance characterized by:

22. The ostomy device according to claim 21, In the closed configuration, the outlet element covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element extends across a lower edge of the cavity of the ostomy pouch. An ostomy appliance characterized by:

23. An outlet valve for an ostomy appliance, comprising: a shaft defining a hollow bore for receiving fluids discharged from the ostomy appliance, the shaft including a curved sidewall and a shaft end wall disposed across the hollow bore; an outlet element including a cap concentrically disposed on the axis and an outlet tube secured to the cap; a valve opening defined in a portion of the shaft end wall; the cap is rotatable about the axis to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet conduit to an open configuration in which the valve opening is in liquid communication with the outlet conduit; The cap includes an inner wall concentrically disposed about the curved side wall of the shaft and an outer wall concentrically disposed about the inner wall, thereby defining a flow space between the inner wall and the outer wall, the flow space being in fluid communication with the outlet tube. An outlet valve characterized by:

24. 24. The outlet valve of claim 23, The shaft end wall is generally planar. An outlet valve characterized by:

25. 25. The outlet valve of claim 23 or 24, The stem is disposed on a valve base for attachment to an exterior surface of the ostomy appliance and projects from the valve base away from the exterior surface of the ostomy appliance in use. An outlet valve characterized by:

26. 26. An outlet valve according to any one of claims 23 to 25, A gasket seal is disposed around the periphery of the valve opening to seal between the axial end wall and a portion of the cap around the periphery of the valve opening. An outlet valve characterized by:

27. 27. An outlet valve according to any one of claims 23 to 26, the cap includes an inner wall; the inner wall includes a generally cylindrical inner sidewall portion and an inner cap end; the inner sidewall defines a generally cylindrical cavity for receiving the shaft, whereby the shaft is rotatably disposed within the inner wall; The inner cap end is disposed across the generally cylindrical cavity such that the inner cap end covers the axial end wall. An outlet valve characterized by:

28. 28. The outlet valve of claim 27, A gasket seal is disposed on the axial end wall around the periphery of the valve opening to seal between the axial end wall and the planar surface of the inner cap end. An outlet valve characterized by:

29. 29. The outlet valve of claim 27 or 28, an intake opening at the inner cap end; The intake opening is rotatably positioned to at least partially align with the valve opening, thereby placing the outlet element in the open configuration. An outlet valve characterized by:

30. 30. The outlet valve of claim 29, The outlet element is rotatable from a fully open position in which the intake opening is fully aligned with the valve opening to a fully closed position in which the valve opening is blocked by the inner cap end such that liquid cannot pass from the hollow bore of the shaft through the valve opening and into the flow space. An outlet valve characterized by:

31. 31. An outlet valve according to any one of claims 27 to 30, The inner cap end is generally planar. An outlet valve characterized by:

32. 32. An outlet valve according to any one of claims 27 to 31, the outer wall includes an outer sidewall portion and an outer cap end; The outer cap end overlies the inner cap end and is axially spaced from the inner cap end, thereby disposing at least a portion of a flow space between the outer cap end and the inner cap end. An outlet valve characterized by:

33. 33. An outlet valve according to any one of claims 27 to 32, The axis of rotation of the outlet element defined by the shaft is perpendicular to the elongated axis of the outlet tube. An outlet valve characterized by:

34. The outlet valve according to claim 33, The above rotation axis is perpendicular to the ostomate's body when in use. An outlet valve characterized by:

35. 35. The outlet valve of claim 33 or 34, The shaft end wall is disposed transversely to the rotation axis. An outlet valve characterized by:

36. The outlet valve according to claim 35, The shaft end wall is disposed perpendicular to the axis of rotation defined by the shaft. An outlet valve characterized by:

37. The outlet valve according to any one of claims 23 to 36, the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; The intake opening has an arcuate shape that coincides with a circumference around the rotation axis of the cap. An outlet valve characterized by:

38. The outlet valve according to any one of claims 23 to 37, the cap includes an inner cap end disposed over the axial end wall; the inner cap end includes an intake opening and is rotatably positioned so that the intake opening is at least partially aligned with the valve opening, thereby placing the outlet element in the open configuration; a gasket seal disposed about a periphery of the valve opening for sealing between the axial end wall and a portion of the cap about a periphery of the valve opening; The intake opening includes a protrusion disposed across at least a portion of the intake opening. An outlet valve characterized by:

39. The outlet valve according to claim 38, The protrusion is configured to at least partially compress the gasket seal while the gasket seal is adjacent the intake opening. An outlet valve characterized by:

40. The outlet valve according to any one of claims 23 to 38, the outer surface of the curved sidewall includes a circumferential projection about the outer periphery of the shaft; The cap includes retention teeth configured to engage the circumferential projections to prevent axial movement of the cap relative to the shaft during rotation. An outlet valve characterized by:

41. The outlet valve according to claim 40, The retaining teeth are disposed adjacent the outlet tube. An outlet valve characterized by:

42. an outlet valve according to any one of claims 23 to 41; Ostomy bag and Equipped with The outlet valve is attached to the exterior surface of the ostomy bag. An ostomy appliance characterized by:

43. 43. The ostomy appliance of claim 42, In the closed configuration, the outlet element covers a cavity of the ostomy pouch; In the open configuration, at least a portion of the outlet element extends across a lower edge of the cavity of the ostomy pouch. An ostomy appliance characterized by:

Images