Outlet valve for a stoma device

Abstract

The present invention relates to an outlet valve (201) for a stoma device, which comprises a shaft (213) that defines a hollow orifice (14) for receiving liquid output from the stoma device. The shaft includes a curved sidewall (213a). The outlet element (220) includes a cap (222) arranged concentrically with the shaft and an outlet tube (221) fixed to the cap. A valve opening (215) 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 liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube. The outlet valve further includes an outlet element seal (216, 227) configured to provide a seal between the cap and the shaft around the outer periphery of the shaft; and to seal between the valve opening and the inlet opening when the outlet element is in the closed configuration.

Description

Technical Field

[0001] The present invention relates to an outlet valve for a stoma device / instrument, particularly an outlet valve for discharging liquid from a stoma bag / medical fistula bag. Background Art

[0002] A stoma device may be provided with an outlet valve for discharging liquid from the bag of the stoma device, or for directly treating the liquid, or through an additional device, such as a drainage bag that can be attached to the outlet valve in the use state. There are many forms of stoma devices that attempt to provide an easily dischargeable device.

[0003] EP0680296 discloses an outlet valve that includes a base member and at least one movable device that together form a discharge tube or hose member, a shut-off valve, and a closing valve. The movable device can move rotationally and / or linearly, and by means of this movable device, the valve system can be set in three positions, namely a first position where both the shut-off valve and the closing valve are open, a second position where the shut-off valve is closed and the closing valve is open, and a third position where both valves are closed. A collection bag is provided with an outlet valve as described above.

[0004] US4280498 discloses a discharge assembly for a urethral stoma bag or other similar collection device for allowing the bag to be continuously discharged overnight into a suitable container. The assembly includes: a body member adapted to be fixed to the bag at its lower end and defining an outflow path for the fluid contents in the bag; a rotary valve member for selectively opening and closing the flow channel; and a discharge tube equipped with a coupling for releasably engaging a rod portion of the valve member.

[0005] For stoma users, there is still a need for a stoma device with enhanced usability, especially in terms of ease of use, particularly when connecting the outlet valve to an additional device (such as a drainage bag). Summary of the Invention

[0006] In this specification, the term "stoma output" refers to any gas, liquid, or solid produced by a stoma user that can be secreted or discharged from the stoma.

[0007] In this specification, the term "stoma" refers to an opening in the body. Generally, a stoma is a surgical opening in the body trunk. In some cases, the term "stoma" also refers to the internal tissue, organ, or part thereof exposed by the opening. As a non-limiting example, the internal tissue can be selected from the colon, ileum, small intestine, large intestine, jejunum, and duodenum and combinations thereof. The internal tissue can be the end or loop of the small intestine or large intestine.

[0008] In this specification, the term "ostomate" refers to an individual who can use the ostomy device disclosed herein. While an ostomate typically refers to a subject with a surgical opening, as used herein, an "ostomate" can refer to a subject with an ostomy, whether the ostomy is created surgically or by other means.

[0009] The term "user" can refer to the ostomate or another person assisting the ostomate, such as the person who empties the ostomy output from the lumen.

[0010] In this specification, the ostomy devices disclosed herein can be used, for example, to manage ostomies created by esophagostomy, gastrostomy, cholecystostomy, choledochostomy, cecostomy, colostomy, duodenostomy, ileostomy, jejunostomy, appendicostomy, tracheostomy, urethrostomy, nephrostomy, ureterostomy, or cystostomy. The ostomy devices disclosed herein can be used with additional devices, including but not limited to diverters, catheters, plugs, or fecal management systems.

[0011] Advantageously, compared to devices of the prior art, the ostomy devices of the present invention can allow the ostomate to increase the usage time of each ostomy device. This can be achieved by providing means for reliably and hygienically emptying the cavity of the ostomy output, thereby increasing the ostomate's confidence in reusing the ostomy device compared to some prior art devices. Since the ostomate may be inclined to use each ostomy device disclosed herein for a longer period of time, the total number of ostomy devices used by the ostomate within a given time period can be reduced. This can have an environmental benefit in terms of reducing the amount of environmental waste generated.

[0012] In this specification, the position and orientation of features can be described with reference to the ostomy device "in the (down) use state", "oriented as it is in the use state", or similar. These terms refer to the expected orientation of the ostomy device when the ostomate is in a standing position and the ostomy device is attached to the ostomate's body, regardless of whether the ostomy device is currently being used in this manner or the actual position of the ostomate. The terms "upper / above" and "lower / below" and related terms refer to the relative position of a component or part of the ostomy device in the use state. For example, in the use state of the ostomy device, the apex of the ostomy device can be referred to as the "lower" apex. In such an example, when attached to the body of a standing ostomate, the apex will be the (vertically) lowest / lowest apex of the ostomy device. However, those skilled in the art will understand that the apex may not always be the lowest apex before attachment to the ostomate, and further, when attached, if the ostomate assumes a non-standing posture (such as lying down), the apex may not always be the lowest apex.

[0013] In this specification, the term "front" refers to the relative position of a component or part of the ostomy device with respect to the body of the ostomate when the ostomy device is attached to the body. "Front" means a position that is relatively farther from the body of the ostomate compared to a reference position that is relatively closer to the body. Similarly, "rear" refers to a position that is relatively closer to the body of the ostomate than the relative position of "front".

[0014] In this specification, the terms "inner" and "outer" with respect to components of the outlet valve refer to the relative position of a component or part of the ostomy device with respect to the axis of rotation of the outlet element, and the component that is relatively "inner" is closer to the axis of rotation than the component that is relatively "outer".

[0015] In this specification, the term "fixed connection" is used to refer to a connection where the component cannot be removed under normal use of the outlet valve or without damaging the component.

[0016] The present invention provides an outlet valve for an ostomy device, comprising:

[0017] a shaft that defines a hollow orifice for receiving liquid output from the ostomy device, the shaft including a curved sidewall and a shaft end wall spanning the hollow orifice; and

[0018] an outlet element, the outlet element including a cap arranged concentrically with the shaft and an outlet tube fixed to the cap;

[0019] wherein:

[0020] a valve opening is defined in a portion of the shaft end wall; and

[0021] the cap is rotatable about the shaft to move the outlet element from a closed configuration, in which the valve opening is not in liquid communication with the outlet tube, to an open configuration, in which the valve opening is in liquid communication with the outlet tube.

[0022] The cap may include a cap inner end portion arranged to cover the shaft end wall, and the cap inner end portion may include an inlet opening arranged to rotate to a position where the inlet opening is at least partially aligned with the valve opening such that the outlet element is in the open configuration, wherein the inlet opening may have an arcuate shape that aligns with the circumference about the axis of rotation of the cap. Thus, the user can control the flow rate of fluid through the valve by rotating the cap, and the valve is also configurable such that multiple cap positions correspond to the open configuration.

[0023] The cap may include an inner end portion of the cap arranged to cover the end wall of the shaft, and the inner end portion of the cap may include an inlet opening arranged to be rotatable to a position where the inlet opening is at least partially aligned with the valve opening such that the outlet element is in an open configuration, wherein a sealing gasket may be arranged around the valve opening so as to seal between the end wall of the shaft and a portion of the cap around the perimeter of the valve opening, and wherein the inlet opening may include a protrusion provided across at least a portion of the inlet opening. Thus, a protrusion is provided across the inlet opening to ensure that the sealing gasket remains in place when the inlet opening moves relative to the sealing gasket.

[0024] The protrusion may be configured to at least partially compress the sealing gasket when the sealing gasket is adjacent to the inlet. Thus, the sealing gasket is firmly held on the end wall of the shaft.

[0025] The outer surface of the curved side wall may include a circumferential protrusion around the circumference / periphery of the shaft, and the cap may include retaining teeth configured to engage with the circumferential protrusion to prevent axial movement of the cap relative to the shaft during rotation. Thus, the cap is held on the shaft, which ensures good sealing and minimizes leakage without the need for retaining teeth around the entire outer periphery / circumference of the cap.

[0026] The retaining teeth may be provided adjacent to the outlet tube. Thus, the teeth are placed in a convenient position to allow the tube to be used to snap the cap onto the shaft.

[0027] The cap may include an inner wall concentrically arranged around the curved side wall of the shaft and an outer wall concentrically arranged around the inner wall such that a flow space is defined between the inner wall and the outer wall, and the flow space is in liquid communication with the outlet tube.

[0028] The shaft may be arranged on a valve seat for attachment to the outer surface of a stoma device and protrudes away from the outer surface of the stoma device from the valve seat in a use state.

[0029] Additionally or alternatively, the end wall of the shaft may be substantially flat.

[0030] Additionally or alternatively, a sealing gasket may be arranged around the valve opening so as to seal between the end wall of the shaft and a portion of the cap around the perimeter of the valve opening.

[0031] Additionally or alternatively, the cap may include an inner wall that includes:

[0032] a substantially cylindrical inner side wall portion; and

[0033] an inner end portion of the cap;

[0034] wherein the inner side wall portion defines a substantially cylindrical cavity for receiving the shaft such that the shaft is rotatably arranged within the inner wall; and

[0035] The inner end portion of the cap is arranged to span a generally cylindrical cavity so as to cover the shaft end wall.

[0036] A sealing gasket can be arranged on the shaft end wall around the periphery of the valve opening to effect a seal between the shaft end wall and the flat surface of the inner end portion of the cap.

[0037] An inlet opening can be provided in the inner end portion of the cap, and the inlet opening is arranged to be rotatable to a position where the inlet opening is at least partially aligned with the valve opening such that the outlet element is in an open configuration. The outlet element can be rotated from a fully open position, where the inlet opening is fully aligned with the valve opening, to a fully closed position, where the valve opening is blocked by the inner end portion of the cap such that no liquid can flow through the valve opening from the hollow orifice of the shaft to the flow space. The inner end portion of the cap can be generally flat. The cap can further include an outer wall concentrically arranged around the inner wall so as to define a flow space between the inner wall and the outer wall, and the flow space is in liquid communication with the outlet tube. The outer wall can include an outer side wall portion and an outer end portion of the cap, wherein the outer end portion of the cap covers the inner end portion of the cap and is axially spaced apart from the inner end portion of the cap such that at least a portion of the flow space is arranged between the outer end portion of the cap and the inner end portion of the cap.

[0038] Additionally or alternatively, the axis of rotation of the outlet element defined by the shaft can be perpendicular to the axis of extension / longitudinal axis of the outlet tube, and optionally, in the use state, the axis of rotation is perpendicular to the body of the ostomist. The shaft end wall can be arranged transversely to the axis of rotation, and optionally perpendicular to the axis of rotation defined by the shaft.

[0039] The present disclosure also provides an ostomy device, comprising:

[0040] An outlet valve as described above; and

[0041] An ostomy pouch,

[0042] wherein the outlet valve is attached to the outer surface of the ostomy pouch. In the closed configuration, the outlet element can be substantially superposed on the cavity of the ostomy pouch; in the open configuration, at least a portion of the outlet element can extend across the lower edge of the cavity of the ostomy pouch.

[0043] Aspects of the present disclosure provide an outlet valve for a stoma device, comprising: a shaft defining a hollow orifice for receiving liquid output from the stoma device, the shaft including a curved sidewall; and an outlet element including a cap concentrically arranged with the shaft and an outlet tube secured to the cap; wherein a valve opening is defined in the curved sidewall; and the cap is rotatable about the shaft to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further includes at least one seal configured to provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration and to provide a seal between the cap and the shaft around the outer periphery of the shaft.

[0044] Since a seal is provided around the outer periphery of the shaft, leakage between the shaft and the cap is prevented, and leakage between the valve opening and the inlet opening is also prevented when the outlet element is in the closed configuration. Thus, the valve is not prone to leakage, preventing leakage from the valve opening to the inlet opening when the valve is closed.

[0045] In some embodiments, the at least one seal includes a continuous first seal configured to provide a seal between the cap and the shaft around the outer periphery of the shaft, and wherein the distance between the first seal and the base end of the shaft varies circumferentially along the shaft. Thus, when the distance between the first seal and the base end of the shaft varies circumferentially along the shaft, the first seal can be arranged to provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration.

[0046] In some embodiments, the at least one seal includes a first seal configured to provide a seal around the periphery of the inlet opening when the outlet element is in the closed position, the first seal being integrally formed with a second seal configured to provide a seal between the cap and the shaft around the outer periphery of the shaft.

[0047] In another aspect, the present disclosure provides an outlet valve for a stoma device, comprising:

[0048] a shaft defining a hollow orifice for receiving liquid output from the stoma device, the shaft including a curved sidewall; and

[0049] an outlet element, the outlet element including a cap concentrically arranged with the shaft and an outlet tube secured to the cap, the outlet tube including an inlet opening;

[0050] wherein:

[0051] a valve opening is defined in the shaft;

[0052] The hood is rotatable about an axis to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; and

[0053] The first seal is configured to provide a seal around the periphery of the inlet opening between the hood and the shaft when the outlet element is in the closed configuration. The first seal is integrally formed with a second seal, which is configured to provide a seal between the hood and the shaft around the outer periphery of the shaft.

[0054] As described above, the seal can provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration. Thus, in some embodiments, an outlet valve for a stoma device is provided, the outlet valve comprising: a shaft defining a hollow orifice for receiving liquid output from the stoma device, the shaft including a curved sidewall; and an outlet element including a hood concentrically arranged with the shaft and an outlet tube secured to the hood; wherein a valve opening is defined in the curved sidewall; and the hood is rotatable about the shaft to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further comprises at least one seal configured to: provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration, and provide a seal between the hood and the shaft around the outer periphery of the shaft, wherein the at least one seal includes a first seal configured to provide a seal around the periphery of the inlet opening when the outlet element is in the closed position, the first seal being integrally formed with a second seal configured to provide a seal between the hood and the shaft around the outer periphery of the shaft.

[0055] Additionally or alternatively, the shaft may include a shaft end wall, where the shaft end wall is optionally substantially flat.

[0056] Additionally or alternatively, the valve opening may be arranged in the curved sidewall of the shaft. The first seal may include a sealing gasket arranged on the curved sidewall of the shaft, the first seal being spaced apart from the valve opening around the outer periphery of the shaft. The sealing gasket may have a profile corresponding to the shape of the inlet opening. The outlet tube may be configured to rotate with the hood such that when the hood rotates, the inlet opening of the outlet tube moves between an open position in which the inlet opening is in liquid communication with the valve opening and a closed position in which the inlet opening is not in liquid communication with the valve opening. In the closed position, the first seal may be aligned with and arranged at the periphery of the inlet opening to provide a seal between the inlet opening and the curved sidewall of the shaft.

[0057] Additionally or alternatively, the cap may include a curved cap wall that defines a generally cylindrical cavity for receiving the shaft such that the shaft is rotatably disposed within the curved cap wall. A second seal may be disposed between the curved cap wall and the shaft around the outer periphery of the shaft at an axial position between the inlet opening and the distal end of the curved cap wall.

[0058] Additionally or alternatively, the shaft may be disposed on a valve seat for attachment to an outer surface of the ostomy device and may project away from the outer surface of the ostomy device from the valve seat in a use state.

[0059] Additionally or alternatively, a third circumferential seal may be disposed between the valve seat and the cap at an axial position between the proximal end of the cap and the valve opening.

[0060] Additionally or alternatively, the axis of rotation of the outlet element defined by the shaft may be perpendicular to the longitudinal axis of the outlet tube, and optionally, in a use state, the axis of rotation may be perpendicular to the body of the ostomist.

[0061] According to another aspect, the present disclosure also provides an ostomy device including:

[0062] an outlet valve as described above; and

[0063] an ostomy pouch;

[0064] wherein the outlet valve is attached to an outer surface of the ostomy pouch. In a closed configuration, the outlet element may be substantially superimposed on the cavity of the ostomy pouch; and in an open configuration, at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy pouch.

[0065] Thus, in another aspect, the present disclosure provides an outlet valve for an ostomy device, including:

[0066] a shaft that defines a hollow orifice for receiving liquid output from the ostomy device, the shaft including a curved sidewall; and

[0067] an outlet element including a cap concentrically disposed with the shaft and an outlet tube secured to the cap;

[0068] wherein a valve opening is defined in the curved sidewall; and

[0069] the cap is rotatable about the shaft to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube;

[0070] wherein the outlet valve further includes a continuous first seal configured to provide a seal between the cap and the shaft around the outer periphery of the shaft; and

[0071] The distance between the first seal and the base end of the shaft varies circumferentially along the shaft.

[0072] As described above, the seal can provide a seal between the cap and the shaft around the outer periphery of the shaft, and between the inlet opening and the valve opening when the outlet element is in the closed configuration. Thus, in some embodiments, an outlet valve for a stoma device is provided, the outlet valve comprising: a shaft defining a hollow orifice for receiving liquid output from the stoma device, the shaft including a curved sidewall; and an outlet element including a cap concentrically arranged with the shaft and an outlet tube secured to the cap; wherein the valve opening is defined in the curved sidewall; and the cap is rotatable around the shaft to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further comprises at least one seal configured to: provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration, and provide a seal between the cap and the shaft around the outer periphery of the shaft, wherein the at least one seal includes a continuous first seal configured to provide a seal between the cap and the shaft around the outer periphery of the shaft, and wherein the distance between the first seal and the base end of the shaft varies circumferentially along the shaft.

[0073] Additionally or alternatively, the first seal can follow a curved path or a stepped path around the curved sidewall.

[0074] Additionally or alternatively, at a first circumferential position of the shaft, the first seal can be located at a distance from the base end that is less than or equal to the distance from the base end to the proximal edge of the valve opening. At a second circumferential position of the shaft, the first seal can be located at a distance from the base end that is greater than or equal to the distance from the base end to the distal edge of the valve opening. The first circumferential position can be opposite the second circumferential position of the annular seal. The outlet element can be rotated to a fully open position, wherein: the outlet element is in the open configuration; and the inlet opening is fully aligned with the valve opening. In the closed configuration, the inlet opening can be arranged at the second circumferential position such that the first seal is arranged between the inlet opening and the valve opening. The first circumferential position can be the circumferential position of the valve opening.

[0075] Additionally or alternatively, an annular second seal can be arranged around the outer periphery of the shaft. The distance between the annular second seal and the base end of the shaft can be constant circumferentially along the shaft. The annular second seal can be arranged between the base end of the shaft and the proximal edge of the valve opening.

[0076] Additionally or alternatively, the outlet tube may include an inlet opening, wherein the outlet tube is configured to rotate with the cap such that, as the cap rotates, the inlet opening of the outlet tube moves between an open configuration in which the inlet opening is in liquid communication with the valve opening and a closed configuration in which the inlet is not in liquid communication with the valve opening. In the open configuration, at least a portion of the inlet opening may be disposed between the valve opening and the first seal such that at least a portion of the inlet opening is in liquid communication with the valve opening.

[0077] Additionally or alternatively, the cap may include a curved cap wall that defines a generally cylindrical cavity for receiving the shaft such that the shaft is rotatably disposed within the curved cap wall. The cap may further include a cap end that extends across the front end of the generally cylindrical cavity.

[0078] Additionally or alternatively, the shaft may be provided on a backing plate for attachment to the outer surface of the ostomy device and may project away from the outer surface of the ostomy device from the backing plate in a use state.

[0079] Additionally or alternatively, the axis of rotation of the outlet element defined by the shaft may be disposed perpendicular to the longitudinal axis of the outlet tube, and optionally, in a use state, the axis of rotation may be perpendicular to the body of the ostomate.

[0080] According to another aspect, the present disclosure also provides an ostomy device including:

[0081] an outlet valve as described above; and

[0082] an ostomy pouch

[0083] wherein the outlet valve is attached to the outer surface of the ostomy pouch. In the closed configuration, the outlet element may be substantially superimposed on the cavity of the ostomy pouch; and in the open configuration, at least a portion of the outlet element may extend across the lower edge of the cavity of the ostomy pouch. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] 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:

[0085] Figure 1 a schematic perspective view of an outlet valve according to a first aspect of the present disclosure is shown;

[0086] Figure 2 a schematic cross-sectional view of the Figure 1 outlet valve in a closed configuration is shown;

[0087] Figure 3 a schematic partial cross-sectional view of the Figure 1 outlet valve in an open configuration is shown;

[0088] Figure 4shows a schematic partial perspective view of the Figure 1 outlet valve in an open configuration;

[0089] Figure 5a shows a schematic perspective view of an outlet valve according to a second aspect of the present disclosure;

[0090] Figure 5b shows Figure 5a a schematic partial perspective view of the outlet valve of

[0091] Figure 6 showing hidden details; Figure 5a shows a schematic partial cross-sectional view of the outlet valve of

[0092] Figure 7 in a closed configuration; Figure 5a shows a schematic partial cross-sectional view of the outlet valve of

[0093] Figure 8 in an open configuration;

[0094] Figure 9 shows a schematic partial cross-sectional view of the outlet valve of Figure 8 in a closed configuration; and

[0095] Figure 10 shows a schematic partial cross-sectional view of the outlet valve of Figure 8 in an open configuration. Detailed Description

[0096] In the following description, the same reference numerals are used in different aspects to denote the same or similar features.

[0097] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. It should be understood that the foregoing summary and the following examples of the present disclosure are merely exemplary and explanatory and are not limiting of any subject matter claimed.

[0098] The following description pertains to exemplary aspects of the present disclosure. The description of these aspects is not meant to encompass all possible aspects of the present disclosure claimed in the appended claims. Many variations, improvements, and equivalents that are not explicitly recited 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.

[0099] In this specification, the singular forms also include the plural forms unless the context clearly dictates otherwise. In this specification, unless otherwise indicated, the use of "or" means "and / or". Further, the use of the term "comprising" and other forms (such as "comprises" and "comprised of") is not limiting.

[0100] As used herein, ranges and amounts can be expressed as "about" a particular value or range. "About" also includes the exact amount. For example, "about 5 millimeters" means "about 5 millimeters" and also means "5 millimeters". Generally, the term "about" includes amounts expected to be within experimental error. The term "about" includes values within 10% less than to 10% greater than the value provided. For example, "about 50%" means "between 45% and 55%". Similarly, by way of example, "about 30" means "between 27 and 33".

[0101] Figures 1 to 4 Shown is a first exemplary outlet valve 1 for a stoma device according to the present disclosure. The stoma device can include a stoma bag 30 (as Figure 1 shown) and an outlet valve 1, the outlet valve 1 being attached to an outer surface of the stoma bag 30, preferably to an outer surface of an outer wall of the stoma bag 30.

[0102] The outlet valve 1 includes an outlet element 20 and a shaft 13, the shaft 13 defining a hollow orifice 14 for receiving liquid output from the stoma bag 30. The outlet element 20 includes a cap 22 concentrically arranged with the shaft 13 and an outlet tube 21 secured to the cap 22. The cap 22 is rotatable about the shaft 13 about a rotational axis 25 defined by the shaft 13 to move the outlet element 20 from a closed configuration to an open configuration, in the closed configuration, a valve opening 15 disposed through the shaft 13 is not in liquid communication with the outlet tube 21, and in the open configuration, the valve opening 15 is in fluid communication with the outlet tube 21.

[0103] The outlet valve 1 can be configured such that when the outlet element 20 is in the open configuration, a flow path for liquid from the stoma bag 30 can be defined as passing through the hollow orifice 14, through the valve opening 15 and the cap 22 and into the outlet tube 21 for discharge from an outlet opening 24 of the outlet tube 21. In the closed configuration, the flow of liquid along the flow path is blocked such that liquid cannot flow into the outlet tube 21.

[0104] The valve seat 10 of the outlet valve 1 can be configured to be attached to the outer surface of the ostomy pouch 30 and can include a backing plate 11 having a generally flat attachment surface 12 disposed on the back side of the valve seat 10 (i.e., the surface configured to be proximal to the body of the ostomate in the use state). The generally flat attachment surface 12 can be attached to the outer surface of the ostomy pouch 30, for example, by welding or by using an adhesive. The valve seat 10 can include a shaft 13. The shaft can project from the outer surface 18 of the backing plate 11. The shaft 13 can be integrally formed with the backing plate 11, for example, by molding.

[0105] The valve opening 15 is provided through the shaft 13 for receiving the liquid output from the ostomy pouch 30. The outlet valve 1 can be arranged to cover the ostomy pouch opening provided in the wall of the ostomy pouch 30. Thus, the liquid from the ostomy pouch opening can pass through the hollow orifice 14 to reach the valve opening 15. When the outlet element 20 is in the closed configuration, the valve opening 15 is not in liquid communication with the outlet tube 21. When the outlet element 20 is in the open configuration, the valve opening 15 is in liquid communication with the outlet tube 21.

[0106] The shaft 13 can include a curved side wall 13a and a shaft end wall 13b, and the shaft end wall 13b is arranged across the hollow orifice 14. The shaft end wall 13b can be generally flat. The shaft end wall 13b can be arranged transversely and optionally perpendicular to the axis of rotation 25 defined by the shaft 13.

[0107] As Figures 2 to 4 shown, the valve opening 15 can be defined in a part of the shaft end wall 13b. The valve opening 15 can have a generally circular shape. A sealing washer / sealing gasket 16 can be arranged around the valve opening 15 so as to seal around the perimeter of the valve opening 15 between the shaft end wall 13b and a part of the cap 22, such that liquid cannot enter any space defined between the shaft end wall 13b and the cap 22.

[0108] The cap 22 can include an inner wall, which includes a generally cylindrical inner side wall portion 22a and a cap inner end portion 22b. The inner side wall portion 22a can define a generally cylindrical cavity for receiving the shaft 13, such that the shaft 13 is rotatably disposed within the inner wall.

[0109] The cap inner end portion 22b can be generally flat. It can be arranged across the generally cylindrical cavity such that it covers the shaft end wall 13b. The sealing washer 16 can be arranged around the perimeter of the valve opening 15 on the shaft end wall 13b to seal between the shaft end wall 13b and the generally flat back side of the cap inner end portion 22b.

[0110] The inlet opening 23 may be provided in the inner end portion 22b of the bonnet and may be in fluid communication with the outlet pipe 21. The inlet opening 23 is arranged to be rotatable to a position where the inlet opening 23 is at least partially aligned with the valve opening 15 to define a fluid path therethrough such that the outlet element 20 is in the open configuration. The width of the inlet opening 23 may be substantially equal to the diameter of the valve opening 15. The inlet opening 23 may have an arcuate shape aligned with a circumference about the axis of rotation 25, and the central axis 15a of the valve opening 15 is arranged on the same circumference. This arcuate shape may allow the valve opening 15 to be fully aligned with the inlet opening 23 within the angular position range of the bonnet 22. Protrusions 23b may be provided on at least a portion of the inlet opening 23 to partially compress the sealing gasket 16 when the sealing gasket 16 is adjacent to the inlet opening 23. This may limit the expansion of the sealing gasket 16 into the opening 23 and thus may limit the sealing gasket 16 from being squeezed or cut when in contact with the edge of the inlet opening 23 during movement of the bonnet 22.

[0111] The bonnet 22 may include an outer wall concentrically arranged around the inner wall such that a flow space 17 is defined between the inner wall and the outer wall, and the flow space 17 is in fluid communication with the outlet pipe 21. The inlet opening 23 may provide a fluid flow path from the valve opening 15 into the flow space 17. The outer wall may include an outer side wall portion 22c and an outer end portion 22d of the bonnet, where the outer end portion 22d of the bonnet covers the inner end portion 22b of the bonnet and is axially spaced apart from the inner end portion 22b of the bonnet such that at least a portion of the flow space 17 is arranged between the outer end portion 22d of the bonnet and the inner end portion 22b of the bonnet. The outer end portion 22d of the bonnet may be formed as a separate part to facilitate the manufacture and assembly of the bonnet 22 and may be secured to the outer side wall portion 22c by an adhesive or a mechanical clip. A seal (not shown) may be provided between the outer end portion 22d of the bonnet and the outer side wall portion 22c.

[0112] The inner side wall portion 22a and the outer side wall portion 22c may be joined by an annular flange at their base ends (i.e., the ends adjacent to the backing plate 11 of the valve seat 10) such that there is no fluid flow path for the fluid to flow out of the flow space 17 at the base end of the bonnet 22.

[0113] The shaft 13 may be held in the bonnet 22 by one or more retaining structures. The retaining structures may be in the form of one or more mutually engaging protrusions 26a, 26b arranged on the outer surface of the curved side wall 13a of the shaft 13 and the inner surface of the inner side wall portion 22a. The mutually engaging protrusions 26a, 26b may be configured to prevent the bonnet 22 from moving axially relative to the shaft 13 during rotation.

[0114] Another seal 27 may be disposed between the outer surface of the curved sidewall 13a of the shaft 13 and the inner surface of the inner sidewall portion 22a at the base end of the shaft 13 to prevent fluid from flowing out between the cap 22 and the shaft 13 at the base end of the shaft 13.

[0115] One or more detents 19 may be provided on the backing plate 11 of the valve seat 10 for cooperating with one or more recesses or protrusions disposed on the cap 22. The detents 19 may be positioned to provide audible and / or tactile feedback to confirm to the user the rotational position of the outlet element 20 and thereby confirm when the outlet element 20 is in the open configuration and / or the closed configuration.

[0116] The outlet pipe 21 may extend laterally from the cap 22 such that the rotational axis 25 of the outlet element 20 defined by the shaft 13 is perpendicular to the extension axis / longitudinal axis 21a of the outlet pipe 21.

[0117] In the use state, the outlet element 20 may be rotatable such that the outlet pipe 21 moves through a rotational arc from a position pointing upward at the first end point of the rotational arc to a position pointing downward at the second end point of the rotational arc (as Figure 1 shown).

[0118] At the first end point of the rotational arc, the outlet element 20 may be in the closed configuration. The user may rotate the outlet element 20 downward by rotating the cap 22 to the limit position. The limit position may be defined as the point on the rotational arc that is farthest from its first end point at which the outlet element 20 is still in the closed configuration. When the outlet element 29 rotates from the limit position toward the second end point of the rotational arc, the valve opening 15 and the inlet opening 23 will gradually move into alignment, gradually increasing the area / cross-section of the flow path until the fully open configuration in which the valve opening 15 and the inlet opening 23 are aligned is reached. The position of the outlet element in the fully open configuration, i.e., the position at which the base opening and the inlet opening are fully aligned, may coincide with the second end point of the rotational arc.

[0119] Thus, at the first end point of the rotational arc, the outlet element 20 may be in the fully closed position, in which the valve opening 15 is blocked by the inner end portion 22b of the cap such that no liquid can flow through the valve opening 15 from the hollow orifice 14 of the shaft 13 to the flow space 17. At the second end point of the rotational arc, the outlet element 20 may be in the fully open position, in which the inlet opening 23 is fully aligned with the valve opening 15.

[0120] The circumferential positions of the valve opening 15 and the inlet opening 23 can be arranged such that when the inlet opening 23 is fully aligned with the valve opening 15 and the outlet element 20 is in the open configuration, the outlet tube 21 is oriented substantially downward. At the first end point of the rotation arc, with the outlet element in the closed configuration, the outlet opening 24 of the outlet tube 21 can be arranged substantially upward and / or can be superimposed on the backing plate 11.

[0121] The outlet valve 1 can be configured such that in the use state, the axis of rotation 25 is arranged substantially horizontally but perpendicular to the attachment surface 12 of the backing plate 11 of the valve seat 10.

[0122] Other examples of the outlet valve according to the present disclosure are described below. In the following description, only those features that are different in this regard compared to the previous aspects will be described in detail. For features common to one or more aspects, reference should be made to the specification as a whole.

[0123] According to a second exemplary outlet valve 101 of the present disclosure is Figures 5a to 7 shown. The outlet valve 101 includes a shaft 113 and a cap 122.

[0124] The valve seat 110 of the outlet valve 101 can include a backing plate 111 and a shaft 113 that defines a hollow orifice 14. The shaft 113 can be molded as a separate part onto the backing plate 111 and is secured to the backing plate 111, for example, by a snap fit or an interference / interference fit of retaining structures 126a and 126b as Figure 6 and Figure 7 shown. No liquid path is formed through the shaft end wall 113b.

[0125] A valve opening 115 is provided through the shaft 113 for receiving liquid output from the ostomy pouch. The shaft 113 can include a curved side wall 113a and a shaft end wall 113b that spans the hollow orifice 14.

[0126] The shaft 113 can extend through the entire height of the valve such that the shaft end wall 113b includes the front face of the outlet valve 101 (i.e., the part not covered by the cap 122 of the outlet element 120).

[0127] As Figure 6 and Figure 7 shown, the valve opening 115 can be defined in a part of the curved side wall 113a of the shaft 113.

[0128] The outlet element 120 of the outlet valve 101 can include a cap 122 and an outlet tube 121. The cap 122 can include a curved cap wall 122a that defines a substantially cylindrical cavity for receiving the shaft 113 such that the shaft is rotatably arranged within the curved cap wall 122a. Thus, the cap 122 can have a substantially annular shape.

[0129] The outlet pipe 121 can be integrally formed with or secured to the cowl 122. The outlet pipe 121 includes an inlet opening 123 at its inner end, and the inlet opening 123 is disposed through the curved cowl wall 122a. The inlet opening 123 can be configured to receive liquid from the valve opening 115 when the outlet valve 101 is in the open configuration.

[0130] The cowl 122 can be concentrically arranged with the shaft 113 such that the cowl 122 can rotate about the shaft 113. The outlet pipe 121 can be secured to the cowl 122 such that it rotates with the cowl 122 about the shaft 113. Thus, when the outlet element 120 including the cowl 122 rotates, the inlet opening 123 of the outlet pipe 121 can move between an open position where the inlet opening 123 is in liquid communication with the valve opening 115 (such that the outlet element is in the open configuration) and a closed position where the inlet opening 123 is not in liquid communication with the valve opening 115 (such that the outlet element is in the closed configuration).

[0131] The circumferential position of the valve opening 115 about the shaft 113 can be arranged such that when the inlet opening 123 is aligned with the valve opening 115, i.e., when the outlet element 120 is in the open configuration, the outlet pipe 121 generally points downward. The inlet opening 123 can have a shape and size substantially the same as those of the valve opening 115. The inlet opening 123 and the valve opening 115 can be disposed at the same axial distance from the valve seat 110.

[0132] When the outlet element 120 is in the closed configuration, a first seal 116a can be provided to seal between the cowl 122 and the shaft 113 around the periphery of the inlet opening 123. The first seal 116a can be integrally formed with a second seal 116b that is configured to provide a seal between the cowl 122 and the shaft 113 around the outer periphery of the shaft 113.

[0133] The first seal 116a can include a sealing gasket disposed on the curved cowl wall 122a of the shaft, and the first seal 116a is spaced from the outer periphery of the shaft 113 around the inlet opening 123.

[0134] The sealing gasket forming the first seal 116a can have a profile corresponding to the shape of the inlet opening 123. When the outlet element 120 is in the closed position, the first seal 116a can be aligned with and disposed around the periphery of the inlet opening 123, thereby providing a seal between the inlet opening 123 and the curved side wall of the shaft 113 such that the outlet pipe 121 is not in liquid communication with the valve opening 115.

[0135] The second seal 116b may be disposed between the curved cap wall 122a and the shaft 113 around the outer periphery of the shaft 113, at an axial position between the valve opening 115 and the front end of the curved cap wall 122a (i.e., the end of the curved cap wall remote from the backing plate 111 of the valve seat 110).

[0136] The first seal 116a and the second seal 116b may be configured to be fixed relative to the shaft 113. The first seal 116a and the second seal 116b may be attached to the shaft 113 such that they do not rotate relative to the shaft 113 when the cap 122 rotates, e.g., due to the elasticity of the first seal 116a and the second seal 116b, using an adhesive or by providing a groove in the shaft 113 in which the first seal 116a and the second seal 116b may be received.

[0137] In the use state, the outlet element 120 may be rotatable such that the outlet tube 121 moves through a rotation arc, from a position pointing upward at a first end point of the rotation arc to a position pointing downward at a second end point of the rotation arc. At the first end point of the rotation arc, the outlet element 120 may be in a closed configuration. The 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 locus on the rotation arc that is farthest from its first end point at which the outlet element 120 remains in the closed configuration. When the outlet element 120 rotates from the limit position toward the second end point of the rotation arc, the inlet opening 123 will gradually become misaligned with the first seal 116a, thereby defining a flow path from the valve opening 115 through the flow space 117 to the inlet opening 123. As the outlet element 120 rotates further from the first end point of the rotation arc, the cross-sectional area of the flow path may gradually increase until the outlet element 120 reaches a fully open position, at which the valve opening 15 and the inlet opening 123 are aligned. The fully open position may coincide with the second end point of the rotation arc.

[0138] A third circumferential seal 127 may be disposed between the valve seat 110 and the cap 122 (as Figure 6 and Figure 7 shown). The third circumferential seal 127 may be disposed between the backing plate 111 and the cap 122, e.g., received in a recess provided in the base surface of the curved cap wall 122a and adjacent to a sealing projection 111a provided on the front surface of the backing plate 111. Thus, the third circumferential seal 127 may provide a seal between the valve seat 110 and the cap 122 adjacent the base end of the shaft 113 such that fluid entering the flow space 117 between the cap 122 and the shaft 113 cannot flow out of the outlet valve 101 between the cap 122 and the valve seat 110. In an alternative example, the third circumferential seal 127 may be disposed between the shaft 113 and the cap 122.

[0139] The relative axial positions of the backing plate 111, the shaft 113, and the outlet element 120 can be fixed using a retaining structure, such as in the form of a pair of base flanges 126a provided at the base end of the shaft 113 and a distal flange 126b provided at the distal end of the shaft 113. Openings can be provided in the backing plate 111 to receive the shaft 113. The pair of base flanges 126a can be configured to receive a portion of the backing plate 111 therebetween to provide a press-fit assembly of the shaft 113 to the backing plate 111. The distal flange 126b can extend outwardly from the shaft 113 to hold the outlet element 120 between the distal flange 126b and the backing plate 111.

[0140] According to a third exemplary outlet valve 201 of the present disclosure Figures 8 to 10 is shown in. The outlet valve 201 includes a shaft 213 and a cap 222.

[0141] The valve seat 210 of the outlet valve 201 can include a backing plate 211 and a shaft 213, and the shaft 213 defines a hollow orifice 14. The shaft 213 can be integrally formed with the backing plate 111, for example, by forming them as a single molded piece.

[0142] A valve opening 215 is provided through the shaft 213 for receiving liquid output from the ostomy pouch. The shaft 213 can include a curved sidewall 213a and a shaft end wall 213b, and the shaft end wall 213b spans across the hollow orifice 14. No liquid path can be defined through the shaft end wall 113b. As Figure 9 and Figure 10 shown, the valve opening 215 can be defined in a portion of the curved sidewall 213a of the shaft 213.

[0143] The outlet element 220 of the outlet valve 201 can include a cap 222 and an outlet tube 221. The cap 222 can include a curved cap wall 222a that defines a generally cylindrical cavity for receiving the shaft 213 such that the shaft is rotatably disposed within the curved cap wall. The cap 222 can also include a cap end wall 222b that is arranged to span and seal the distal end of the generally cylindrical cavity.

[0144] The outlet tube 221 can be integrally formed with or secured to the cap 222. The outlet tube 221 includes an inlet opening 223 at its inner end, and the inlet opening 223 is arranged through the curved cap wall 222a. The inlet opening 223 can be configured to receive liquid from the valve opening 215 when the outlet valve 201 is in the open configuration.

[0145] The hood 222 can be arranged concentrically with the shaft 213 such that the hood 222 can rotate about the shaft 213. The outlet pipe 221 can be fixed to the cap 222 such that it rotates about the shaft 213 together with the hood 222. Thus, when the hood 222 rotates, the inlet opening 223 of the outlet pipe 221 can move between an open position in which the inlet opening 223 is in fluid communication with the valve opening 215 and a closed position in which the inlet opening 223 is not in fluid communication with the valve opening 215.

[0146] The inlet opening 223 can have dimensions and a shape that are substantially the same as those of the valve opening 215. The inlet opening 223 and the valve opening 215 can be arranged at the same axial distance from the valve seat 210.

[0147] When the hood 222 rotates, the outlet element 220 moves between an open configuration and a closed configuration, in which the inlet opening 223 is in fluid communication with the valve opening 215 in the open configuration and the inlet opening 223 is not in fluid communication with the valve opening 215 in the closed configuration. The circumferential position of the valve opening 215 about the shaft 213 can be arranged such that when the inlet opening 223 is aligned with the valve opening 215, i.e., when the outlet element 220 is in the open configuration, the outlet pipe 221 points substantially downward.

[0148] The outlet valve can further include a first seal 216, which can be continuous and is configured to provide a seal between the hood 222 and the shaft 213 around the outer circumference of the shaft 213. The first seal 216 can follow a curved path or a stepped path along the curved sidewall 213a of the shaft 213 such that the distance between the first seal 216 and the base end of the shaft 213 varies circumferentially along the shaft 213, and this distance is measured parallel to the axis of rotation 225 defined by the shaft 213. Thus, the number or complexity of the seals required to seal the outlet valve 201 can be reduced.

[0149] At a first circumferential position of the shaft 213, the first seal 216 can be positioned at a distance from the base end of the shaft 213 that is less than or equal to the distance from the base end of the shaft 213 to the proximal edge 215a of the valve opening 215. The first circumferential position can be the circumferential position of the valve opening 215. The first circumferential position can extend around a circumferential arc that corresponds to the circumferential arc along which the valve opening 215 extends.

[0150] At a second circumferential position of the shaft 213, the distance of the first seal 216 from the base end of the shaft 213 is greater than or equal to the distance from the base end of the shaft 213 to the distal edge 215b of the valve opening. The second circumferential position can extend around a circumferential arc that corresponds to the circumferential arc along which the valve opening 215 is arranged when the outlet element 220 is in the closed configuration.

[0151] The first circumferential position may be arranged to be opposite to the second circumferential position of the first seal 216, that is, the first circumferential position may be arranged at about 180 degrees circumferentially around the axis 213 from the second circumferential position.

[0152] The annular second seal 227 may be arranged around the outer circumference of the shaft 213 for sealing the flow space 217 arranged between the cap 222 and the shaft 213 adjacent to the base end of the shaft 213. The annular second seal 227 may be arranged between the base end of the shaft 213 and the first seal 216 such that the annular second seal 227 may be arranged between the base 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 base end of the shaft 213 may be constant along the circumference of the shaft 213.

[0153] In the use state, the outlet element 220 may be rotatable such that the outlet pipe 221 moves through a rotation arc, moving from a position pointing upward at the first end point of the rotation arc to a position pointing downward at the second end point of the rotation arc. At the first end point of the rotation arc, the outlet element 220 may be in a closed configuration. In the closed configuration, the inlet opening 223 may be arranged at the second circumferential position such that the first seal 216 is arranged between the inlet opening 223 and the valve opening 215.

[0154] The user may rotate the cap 222 to the limit position to rotate the outlet element 20 downward. The limit position may be defined as the point on the rotation arc that is farthest from its first end point at which the outlet element 220 is still in the closed configuration. When the outlet element 220 rotates from the limit position towards the second end point of the rotation arc, the inlet opening 223 will gradually move past a part of the first seal 216, thereby defining a flow path from the valve opening 215 through the flow space 217 to the inlet opening 223. As the outlet element 220 further rotates from the first end point of the rotation arc, the cross-sectional area of the flow path may gradually increase until the outlet element 220 reaches the fully open position, at which position the valve opening 215 and the inlet opening 223 are aligned. The fully open position may coincide with the second end point of the rotation arc. In the open configuration, at least a part of the inlet opening 223 is arranged between the valve opening 215 and the first seal 216.

[0155] When the outlet element 220 is in the open configuration, at least a part of the inlet opening 223 is arranged between the valve opening 215 and the first seal 216 in the liquid flow path through the outlet valve 201 such that at least a part of the inlet opening 223 is in liquid communication with the valve opening 215.

[0156] The relative axial position of the shaft 213 and the outlet element 220 may be fixed using a retaining structure, such as in the form of an annular clip 226 arranged between the cap 222 and the shaft 213.

[0157] In another aspect of the present disclosure, an outlet valve according to any aspect of the present disclosure may form part of a stoma device that further includes a stoma bag. The outlet valve may be attached to an outer surface of the wall of the stoma bag for discharging liquid from the cavity of the stoma bag. A stoma bag opening may be provided through the wall; the backing plate of the outlet valve is fixedly attached or adhered to the wall such that the stoma bag opening is in fluid communication with the hollow orifice. Thus, the outlet valve can be operated to open and close the fluid passage leaving the cavity of the stoma bag.

[0158] The outlet valve may be disposed near the lower edge or apex of the stoma bag. The outlet valve may be oriented such that in the closed configuration, the outlet element may be substantially superimposed on / within the cavity of the stoma bag, while in the open configuration, at least a portion of the outlet element extends across the lower edge of the cavity of the stoma bag.

[0159] Although the preferred aspects of the present disclosure have been described, these are merely exemplary and not restrictive. Those skilled in the art will understand 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. Additionally, the following features may apply to any aspect of the present disclosure.

[0160] As described above, in this specification, the position and orientation of features may be described with reference to the stoma device "in the (down) use state", "oriented as it is in the use state", or similar. These terms refer to the intended orientation of the stoma device when the stoma device is attached to the body of the stoma patient and the stoma patient is in a standing position.

[0161] Any outlet valve according to the present disclosure may be configured such that when attached to the outer surface of the stoma bag in the use state, the axis of rotation of the outlet element may be arranged to be substantially perpendicular to the longitudinal axis of the outlet tube and perpendicular to the substantially flat attachment surface of the backing plate, such that the axis is substantially perpendicular to the body of the stoma patient in the use state.

[0162] In the use state, the outlet tube may be disposed in a storage position at the first end point of the arc of rotation, with the outlet element in the closed configuration. In this storage position, the outlet tube may be oriented such that the outlet end is arranged substantially upward and superimposed on / within the backing plate. In the storage position, the outlet tube may be superimposed on / within the cavity of the stoma bag.

[0163] To drain liquid from a stoma device including an outlet valve according to any aspect of the present disclosure, a user can grasp the outlet element and rotate the outlet tube along a rotation arc away from a first upper end of the rotation arc. A limit position of the outlet element can be defined as the locus on the rotation arc that is furthest from its first end point at which the outlet element remains in a closed configuration.

[0164] The limit position can provide a convenient position for the user to pause the rotation of the valve and attach a drainage device, such as a night bag, to the outlet tube before the outlet tube moves to an open configuration, thereby limiting the possibility of output liquid overflowing. Then, the outlet tube can be further rotated to increase the area of the flow path from the base opening to the inlet opening, for example, by increasing the alignment of the base opening and the inlet opening, or by moving the inlet opening past the seal, thereby allowing more fluid to flow out of the valve and orienting the outlet tube downward for easy drainage into the night bag or externally.

[0165] In the use state, when the valve opening and the inlet opening are at least partially aligned or at least partially in liquid communication, the outlet element is in an open configuration. As the outlet tube moves from its limit position towards the second end point of the rotation arc, the orifices will gradually become more aligned, or the cross-sectional area of the flow path between them will increase until a fully open position where both orifices are aligned is reached. The fully open position can coincide with the second end point of the rotation arc.

[0166] After the ostomy bag is emptied, or when the user wishes to block the liquid from flowing out of the outlet valve, the user can turn the outlet tube upward to move the outlet element back to the closed configuration. If used, once the outlet element is in the closed configuration, the night drainage bag or other device can be disconnected from the outlet tube, thus avoiding overflow.

[0167] In any aspect, a retaining structure can be provided to hold the shaft within the cap. For example, these can include cooperating protrusions and / or recesses. The retaining structure can also be configured to prevent relative axial movement between the cap and the shaft during rotation.

[0168] In any aspect, the valve opening can define the only fluid path leaving the ostomy bag and flowing out through the hollow orifice.

[0169] In any aspect, the outlet element and / or the valve seat can be provided with detents configured to prevent accidental opening and / or to provide the user with audible and / or tactile feedback to confirm the rotational position of the outlet element, thereby confirming whether the outlet element is in an open configuration or a closed configuration. For example, detents can be arranged at or near the limit position to indicate a locus at which the outlet element is about to move to the open configuration.

[0170] In any aspect, one or more seals can be in the form of O-rings.

[0171] In any aspect, the backing plate and the shaft may be integrally formed, such as formed as a single molded piece, or may be formed separately and then assembled such that the shaft is secured to the backing plate. If formed separately, the assembly may be performed after attaching the backing plate to the ostomy pouch. This may facilitate assembly because during the process of attaching the backing plate to the ostomy pouch, it is not necessary to adjust the assembly machinery (e.g., welding equipment) to accommodate the height of the shaft.

[0172] In any aspect, at least a portion of the outlet tube may be integrally formed with the cap. Alternatively, the outlet tube may be formed separately and then secured to the cap.

[0173] In any aspect, the outlet tube may include a relatively rigid inlet portion and a relatively flexible outlet portion. The relatively flexible outlet portion may be secured to the relatively rigid inlet portion in any suitable manner, such as by overmolding the relatively flexible outlet portion onto the relatively rigid inlet portion. The relatively flexible outlet portion may be elastic. The outlet valve according to any aspect of the present disclosure may be configured to be used with a relatively rigid connector, such as for attaching 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 tube may have an outlet diameter slightly smaller than the outer diameter of the connector such that when the connector is inserted into the relatively flexible outlet tube portion in the use state, the relatively flexible outlet tube portion may flex to accommodate the connector, thereby forming an effective seal.

[0174] In any aspect, the valve opening may define the only fluid path leaving the ostomy pouch and flowing out of the hollow orifice.

[0175] In any aspect, the seal may be fixed (i.e., non-rotating) relative to the shaft in the use state. One or more seals may be secured to the shaft.

[0176] A lubricant may be provided between the rotating components to facilitate rotation and improve the seal.

[0177] In any aspect of the present disclosure, the outlet element may be held in place axially relative to the housing such that there is no relative axial movement between the outlet element and the valve seat during rotation.

[0178] Other features of the ostomy device, such as the inner and outer walls of the ostomy device and the shape and structure of the comfort layer, may be different from those shown in the illustrated aspects. Similarly, the shape of the valve opening may be different from the shape shown in the illustrated aspects.

[0179] The outlet valve of the present disclosure is herein described as being suitable for an ostomy device including an ostomy pouch. The outlet valve according to any aspect of the present disclosure may be suitable for other applications, such as a drainage bag or a catheter collection bag.

Claims

1. An outlet valve for a stoma device, the outlet valve comprising: a shaft that defines a hollow orifice for receiving liquid output from the stoma device, the shaft including a curved sidewall; and an outlet element that includes a cap disposed concentrically with the shaft and an outlet tube secured to the cap, wherein the outlet tube includes an inlet opening; wherein a valve opening is defined in the curved sidewall; and the cap is rotatable about the shaft to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further includes at least one seal configured to provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration and to provide a seal between the cap and the shaft around the outer periphery of the shaft, wherein the at least one seal includes a continuous first seal configured to provide a seal between the cap and the shaft around the outer periphery of the shaft, and a distance between the first seal and a base end of the shaft varies circumferentially along the shaft.

2. The outlet valve according to claim 1, wherein, The first seal follows a curved path or a stepped path along the curved sidewall.

3. The outlet valve according to claim 1 or 2, wherein At a first circumferential position of the shaft, a distance between the first seal and the base end is less than or equal to a distance from the base end to a proximal edge of the valve opening.

4. The outlet valve according to claim 3, wherein, At a second circumferential position of the shaft, a distance between the first seal and the base end is greater than or equal to a distance from the base end to a distal edge of the valve opening.

5. The outlet valve according to claim 4, wherein, The first circumferential position of the shaft is opposite to the second circumferential position of the shaft.

6. The outlet valve according to claim 4 or 5, wherein The outlet element is rotatable to a fully open position, wherein: the outlet element is in the open configuration; and the inlet opening is fully aligned with the valve opening.

7. The outlet valve according to claim 4 or 5, wherein In the closed configuration, the inlet opening is disposed at the second circumferential position such that the first seal is disposed between the inlet opening and the valve opening.

8. The outlet valve according to claim 3, wherein, The first circumferential position is a circumferential position of the valve opening.

9. The outlet valve according to claim 1 or 2, further comprising an annular second seal disposed around the outer periphery of the shaft.

10. The outlet valve according to claim 9, wherein, A distance between the annular second seal and a base end of the shaft is constant circumferentially along the shaft.

11. The outlet valve according to claim 9, wherein, The annular second seal is disposed between the base end of the shaft and a proximal edge of the valve opening.

12. The outlet valve according to claim 1 or 2, wherein, The outlet tube is configured to rotate with the cap such that an inlet opening of the outlet tube moves between the open configuration and the closed configuration as the cap rotates, wherein in the open configuration the inlet opening is in liquid communication with the valve opening and in the closed configuration the inlet opening is not in liquid communication with the valve opening.

13. The outlet valve according to claim 12, wherein, In the open configuration, at least a portion of the inlet opening is disposed between the valve opening and the first seal such that at least a portion of the inlet opening is in liquid communication with the valve opening.

14. The outlet valve according to claim 1 or 2, wherein, The cap includes a curved cap wall that defines a generally cylindrical cavity for receiving the shaft such that the shaft is rotatably disposed within the curved cap wall.

15. The outlet valve according to claim 14, wherein, The cap further includes a cap end extending across a front end of the generally cylindrical cavity.

16. The outlet valve according to claim 1 or 2, wherein, The shaft is disposed on a backing plate for attachment to an outer surface of the stoma device and projects from the backing plate away from the outer surface of the stoma device in a use state.

17. An outlet valve for a stoma device, the outlet valve comprising: a shaft that defines a hollow orifice for receiving liquid output from the stoma device, the shaft including a curved sidewall; and An outlet element, said outlet element comprising a cowl arranged concentrically with the shaft and an outlet pipe secured to the cowl, wherein the outlet pipe includes an inlet opening; wherein a valve opening is defined in the curved side wall; and the cowl is rotatable about the shaft to move from a closed configuration in which the valve opening is not in liquid communication with the outlet pipe to an open configuration in which the valve opening is in liquid communication with the outlet pipe; wherein the outlet valve further includes at least one seal configured to provide a seal between the inlet opening and the valve opening when the outlet element is in the closed configuration and to provide a seal between the cowl and the shaft around the outer periphery of the shaft, wherein the at least one seal includes a first seal configured to provide a seal around the perimeter of the inlet opening when the outlet element is in the closed position, the first seal being integrally formed with a second seal configured to provide a seal between the cowl and the shaft around the outer periphery of the shaft.

18. The outlet valve according to claim 17, wherein, The shaft includes a shaft end wall.

19. The outlet valve according to claim 17 or 18, wherein The first seal includes a sealing gasket disposed on the curved side wall of the shaft, the first seal being spaced from the valve opening around the outer periphery of the shaft.

20. The outlet valve according to claim 19, wherein, The profile of the sealing gasket corresponds to the shape of the inlet opening.

21. The outlet valve according to claim 20, wherein, The outlet pipe is configured to rotate with the cowl such that the inlet opening of the outlet pipe moves between an open position and a closed position as the cowl rotates, in the open position, the inlet opening is in liquid communication with the valve opening, and in the closed position, the inlet opening is not in liquid communication with the valve opening.

22. The outlet valve according to claim 21, wherein, In the closed position, the first seal is aligned with and disposed around the perimeter of the inlet opening to provide a seal between the inlet opening and the curved side wall of the shaft.

23. The outlet valve according to claim 17 or 18, wherein, The cowl includes a curved cowl wall that defines a generally cylindrical cavity for receiving the shaft such that the shaft is rotatably disposed within the curved cowl wall.

24. The outlet valve according to claim 23, wherein, The second seal is disposed around the outer periphery of the shaft between the curved cowl wall and the shaft, at an axial position between the valve opening and the front end of the curved cowl wall.

25. The outlet valve according to claim 17 or 18, wherein, The shaft is disposed on a valve seat for attachment to the outer surface of the ostomy device and projects from the valve seat away from the outer surface of the ostomy device in the use state.

26. The outlet valve according to claim 17 or 18, wherein, A third circumferential seal is disposed between the valve seat and the cowl, at an axial position between the proximal end of the cowl and the valve opening.

27. The outlet valve according to claim 17 or 18, wherein, The axis of rotation of the outlet element defined by the shaft is perpendicular to the longitudinal axis of the outlet pipe, and in the use state, the axis of rotation is perpendicular to the body of the ostomist.

28. The outlet valve according to claim 18, wherein, The shaft end wall is substantially flat.

29. An outlet valve for an ostomy device, comprising: a shaft defining a hollow orifice for receiving liquid output from the ostomy device, the shaft including a curved side wall and a shaft end wall spanning the hollow orifice; and an outlet element including a cowl arranged concentrically with the shaft and an outlet pipe secured to the cowl; wherein: a valve opening is defined in a portion of the shaft end wall; and the cowl is rotatable about the shaft to move the outlet element from a closed configuration in which the valve opening is not in liquid communication with the outlet pipe to an open configuration in which the valve opening is in liquid communication with the outlet pipe, Wherein, the cap includes an inner end portion of the cap arranged to cover the shaft end wall, the inner end portion of the cap includes an inlet opening, the inlet opening is arranged to be rotatable to a position where the inlet opening is at least partially aligned with the valve opening, such that the outlet element is in an open configuration, a sealing gasket is arranged around the valve opening so as to seal between the shaft end wall and a part of the cap around the periphery of the valve opening, and the inlet opening includes a protrusion provided across at least a part of the inlet opening.

30. The outlet valve according to claim 29, wherein, The inlet opening has an arcuate shape aligned with the circumference around the axis of rotation of the cap.

31. The outlet valve according to claim 29 or 30, wherein, The protrusion is configured to at least partially compress the sealing gasket when the sealing gasket is adjacent to the inlet opening.

32. The outlet valve according to claim 29 or 30, wherein, The outer surface of the curved side wall includes a circumferential protrusion around the outer circumference of the shaft, and the cap includes retaining teeth configured to engage with the circumferential protrusion to prevent axial movement of the cap relative to the shaft during rotation.

33. The outlet valve according to claim 32, wherein, The retaining teeth are arranged adjacent to the outlet tube.

34. The outlet valve according to claim 29 or 30, wherein, The cap includes an inner wall concentrically arranged around the shaft and an outer wall concentrically arranged around the inner wall, thereby defining a flow space between the inner wall and the outer wall, and the flow space is in liquid communication with the outlet tube.

35. The outlet valve according to claim 29 or 30, wherein, The shaft end wall is substantially flat.

36. The outlet valve according to claim 29 or 30, wherein, The shaft is arranged on the valve seat so as to be attached to the outer surface of the ostomy device, and protrudes from the valve seat away from the outer surface of the ostomy device in the use state.

37. The outlet valve according to claim 29 or 30, wherein, The cap includes an inner wall, and the inner wall includes: a substantially cylindrical inner side wall portion; and the inner end portion of the cap; wherein the inner side wall portion defines a substantially cylindrical cavity for receiving the shaft such that the shaft is rotatably arranged inside the inner wall; and the inner end portion of the cap is arranged across the substantially cylindrical cavity such that the inner end portion of the cap covers the shaft end wall.

38. The outlet valve according to claim 37, wherein, The sealing gasket is arranged around the periphery of the valve opening on the shaft end wall to seal between the shaft end wall and the flat surface of the inner end portion of the cap.

39. The outlet valve according to claim 34, wherein, The outlet element can be rotated from a fully open position to a fully closed position. In the fully open position, the inlet opening is fully aligned with the valve opening; in the fully closed position, the valve opening is blocked by the inner end portion of the cap such that no liquid can flow from the hollow orifice of the shaft to the flow space through the valve opening.

40. The outlet valve according to claim 37, wherein, The inner end portion of the cap is substantially flat.

41. The outlet valve according to claim 37, wherein, The cap further includes an outer wall concentrically arranged around the inner wall such that a flow space is defined between the inner wall and the outer wall, and the flow space is in liquid communication with the outlet tube.

42. The outlet valve according to claim 41, wherein, The outer wall includes an outer side wall portion and an outer end portion of the cap. The outer end portion of the cap covers the inner end portion of the cap and is axially spaced apart from the inner end portion of the cap such that at least a part of the flow space is arranged between the outer end portion of the cap and the inner end portion of the cap.

43. The outlet valve according to claim 37, wherein, The axis of rotation of the outlet element defined by the shaft is perpendicular to the longitudinal axis of the outlet tube, and in the use state, the axis of rotation is perpendicular to the body of the ostomist.

44. The outlet valve according to claim 43, wherein, The shaft end wall is arranged transversely to the axis of rotation.

45. The outlet valve according to claim 43 or 44, wherein, The shaft end wall is arranged perpendicular to the axis of rotation defined by the shaft.

46. An ostomy device, the ostomy device comprising: an outlet valve according to any one of the preceding claims; and a stoma bag, wherein the outlet valve is attached to the outer surface of the stoma bag.

47. The ostomy device according to claim 46, wherein: in the closed configuration, the outlet element is substantially superimposed on the cavity of the stoma bag; In the open configuration, at least a portion of the outlet element extends across the lower edge of the cavity of the ostomy pouch.

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