Patent Application
20210251795
The present disclosure relates to an outlet valve an ostomy appliance, particularly for a drainage of a liquid output from an ostomy bag.
An ostomy appliance may be provided with an outlet valve for draining liquid from teh bag of the ostomy appliance, either for direct disposal of the liquid or via an additional appliance such as a drain bag which may be attached to the valve in use. There are many forms of ostomy appliance which try to provide an easily drainable appliance.
U.S. Pat. No. 6,021,928 discloses a tap for a drainage bag which can be welded to the bag material with the tap in a ready-assembled condition. The tap includes an integral attachment portion and a housing. An L-shaped tubular tap member with a handle is inserted in an aperture of the housing, and is rotatable in the aperture between a closed position in which the outlet points upwardly, and an open position in which the outlet points downwardly. In the closed position, a peripheral region of the attachment portion projects beyond the tap member on all sides, to enable the assembled tap to be welded to the bag material.
GB2285496 discloses a valve, particularly for use as an outlet valve of a medical bag, such as a urine drainage bag, which is opened and closed by relative rotation of its inlet and outlet pipes about an axis perpendicular to theft longitudinal axes. The inlet and outlet pipes project from housing parts. One housing part has a barrel fitting inside the other housing part. The housing parts each have an aperture that are in alignment when the pipes are aligned. When the pipes both face the same direction the valve is closed. The apertures may take various forms. Also, a ball may be used or there may be a separate barrel interengaging with each pipe housing and having a lost motion drive therewith.
EP0680296 discloses an outlet valve consisting of a base member and at least one movable means which together form a discharge tube or hose member, a stop valve and a closing valve, said movable means being rotatably and/or linearly displaceable and by means of which the valve system can be set in three positions, a first position in which both the stop valve and the closing valve are 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. A collection bag provided with an outlet valve as stated above.
There remains a need for ostomy appliances with enhanced usability for ostomates, particularly in the area of ease of use, particularly when connecting the outlet valve to an additional appliance, for example a drain bag.
In this specification, the term “stomal output” refers to any gases or fluids or solids produced by an ostomate that may be secreted from the stoma or that exit the stoma.
In this specification, teh term “stoma” refers to an opening in the body. Generally, the stoma is a surgical opening in the torso of the body. In some instances, the term “stoma” also refers to internal tissue, organs or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue may be selected from colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine.
In this specification, the term “ostomate” refers to a subject that may have use of the ostomy appliance disclosed herein. While ostomate usually refers to a subject with a surgical opening, as used herein, “ostomate” may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means.
The term “user” may refer to an ostomate, or to another person assisting the ostomate, for example, with emptying of the stomal output from the cavity.
In this specification, the ostomy appliances disclosed herein may, for example, be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, an ureterostomy, or a vesicostomy. The ostomy appliances disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug or a fecal management system.
Beneficially, the ostomy appliances of the present disclosure may permit an ostomate to increase the period of use of each ostomy appliance compared to prior art appliances. This may be achieved by providing means for draining the cavity of stomal output reliably and hygienically so as to increase an ostomate's confidence in reusing the ostomy appliance compared to some prior art appliances. Since the ostomate may be inclined to use each ostomy appliance of the present disclosure for longer, the total number of ostomy appliances used by the ostomate in a given time period may be reduced. This may produce an environmental benefit in reducing the amount of environmental waste produced.
In this specification locations and orientations of features may be described with reference to the ostomy appliance being “in use”, “orientated as it would be in use” or similar. Such terms refer to the intended orientation of the ostomy appliance when it is adhered to a body of an ostomate with the ostomate in a standing position, irrespective of whether the ostomy appliance is currently performing such a use or the actual position of the ostomate. The terms “upper” and “lower” and related terms refer to the relative position of a part or portion of the ostomy appliance when orientated as it would be in use. For example, an apex of the ostomy appliance may be referred to as an “upper” apex in use of the ostomy appliance. In such an example, said apex will be intended to be the uppermost apex (in the vertical direction) of the ostomy appliance when attached to the body of a standing ostomate. However, the reader skilled in the art will appreciate that before attachment to the ostomate said apex may not always be the uppermost apex and in addition when attached the apex may not always be the uppermost apex if the ostomate adopts a non-standing position, for example lying down.
In this specification the term “outer” or “front” refers to the relative position of a part or portion of the ostomy appliance with reference to the body of an ostomate when the ostomy appliance is attached to the body. “Outer” or “front” refers to a position relatively further away from the body of the ostomate than a comparative position that is relatively closer to the body. Similarly, “back” refers to a position relatively closer to the body of the ostomate than a comparative position that is “outer” or “front”.
In this specification the term “peripheral region” refers to a portion situated on or towards an edge of the item being referred to.
In this specification, the term “affixed” is used to refer to a connection in which teh component in question cannot be removed during normal use of the outlet valve or without damaging the component.
The present disclosure provides an outlet valve for an ostomy bag comprising:
In some embodiments, one of the outlet element and the valve base may comprise the detent and the other of the outlet element and the valve base may comprise two or more protrusions. Accordingly in one embodiment of the invention, there is provided an outlet valve for an ostomy bag comprising: a valve base for attachment to a face of the ostomy appliance, the valve base defining a base opening for receiving a liquid output from the ostomy bag; and an outlet element configured to be rotatable relative to the valve base from a closed configuration in which discharge of the liquid received through the base opening is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled; wherein one of the outlet element and the valve base comprises a detent and the other of the outlet element and the valve base comprises two or more protrusions; and wherein the detent is configured to engage the one or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the protrusions during the rotation. Thus, the valve provides tactile feedback at multiple positions of the outlet element allowing for better control of the valve.
Preferably, the valve base may comprise the detent, and the outlet element may comprise two or more protrusions. Accordingly in one embodiment of the invention, there is provided an outlet valve for an ostomy bag comprising: a valve base for attachment to a face of the ostomy appliance, the valve base defining a base opening for receiving a liquid output from the ostomy bag; and an outlet element configured to be rotatable relative to the valve base from a closed configuration in which discharge of the liquid received through the base opening is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled; wherein the valve base comprises a detent and the the outlet element comprises two or more protrusions and wherein the detent is configured to engage the one or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the protrusions during the rotation. Thus, the valve can operate more effectively as the outlet element is more suited to comprising two or more protrusions than the valve base. This is due to the rotation of the outlet element which allows each protrusion to move into and out of contact with the valve base as required.
The outlet element may be rotatable such that the outlet tube moves through an arc of rotation and wherein at a first end of the arc of rotation, the outlet element may be in the closed configuration, and at a second end of the arc of rotation, the outlet element may be in the open configuration. The detent may be configured to engage at least one protrusion at a point during rotation of the outlet element that does not correspond to the first end of the arc of rotation. Accordingly in one embodiment of the invention, there is provided an outlet valve for an ostomy bag comprising: a valve base for attachment to a face of the ostomy appliance, the valve base defining a base opening for receiving a liquid output from the ostomy bag; and an outlet element configured to be rotatable relative to the valve base from a closed configuration in which discharge of the liquid received through the base opening is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled; wherein one of the outlet element and the valve base comprises a detent and the other of the outlet element and the valve base comprises one or more protrusions; and wherein the detent is configured to engage the one or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the protrusions during the rotation, wherein the outlet element is rotatable such that the outlet tube moves through an arc of rotation, and wherein at a first end of the arc of rotation, the outlet element is in the closed configuration, and at a second end of the arc of rotation, the outlet element is in the open configuration, and wherein the detent is configured to engage at least one protrusion at a point during rotation of the outlet element that does not correspond to the first end of the arc of rotation. Thus, the detent/protrusions engage at a point not corresponding to the first end of the arc of rotation, allowing the user better control/feedback as the outlet element is moved from the closed to open positions and vice versa.
The detent may be configured to engage at least one protrusion at a point during rotation of the outlet element that corresponds to the second end of the arc of rotation. Thus, the outlet element is securely retained in the closed configuration.
The detent may be configured to engage at least one protrusion when the outlet element is at, or near a limit position. The limit position may be defined as a point on the arc of rotation at which the outlet element is furthest from the first end and also still in the closed configuration. Thus, the user can easily judge when the valve is about to open and therefore control the valve more efficiently and effectively.
As described above, the detent/protrusions in the present invention are arranged to improve the usability of the valve. Accordingly in a preferred embodiment of the invention, there is provided an outlet valve for an ostomy bag comprising: a valve base for attachment to a face of the ostomy appliance, the valve base defining a base opening for receiving a liquid output from the ostomy bag; and an outlet element configured to be rotatable relative to the valve base from a closed configuration in which discharge of the liquid received through the base opening is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled; wherein one of the outlet element and the valve base comprises a detent and the other of the outlet element and the valve base comprises one or more protrusions; and wherein the detent is configured to engage the one or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the protrusions during the rotation, wherein the valve base comprises the detent, and the outlet element comprises two or more protrusions, and wherein the outlet element is rotatable such that the outlet tube moves through an arc of rotation, and wherein at a first end of the arc of rotation, the outlet element is in the closed configuration, and at a second end of the arc of rotation, the outlet element is in the open configuration, and wherein the detent is configured to engage at least one protrusion at a point during rotation of the outlet element that corresponds to the first end of the arc of rotation, and wherein the detent is configured to engage at least one protrusion when the outlet element is at, or near a limit position, wherein the limit position is defined as a point on the arc of rotation at which the outlet element is furthest from the first end and also still in the closed configuration.
In some embodiments the outlet element may comprise an outlet tube at its distal end. The outlet tube may be rotatable in a plane generally perpendicular to an attachment face of the valve base. The outlet element may be rotatable such that the outlet tube moves through an arc of rotation;
The outlet element may further comprise an intake tube, the intake tube and the outlet tube together defining a continuous hollow bore for passage of the liquid from the intake opening to an outlet opening arranged at an end of the outlet tube distal to the intake tube.
The outlet element may have a generally L-shaped form, the intake tube optionally being arranged at an angle of substantially 90 degrees to the outlet tube. The housing may protrude from an outer face of the valve base, the housing defining a cylindrical bore, a portion of the intake tube being rotatably mounted with the cylindrical bore. The detent may be arranged on the outer face of the valve base adjacent to the housing and the one or more protrusions are arranged on the intake tube adjacent to the housing.
Additionally, or alternatively, in some embodiments the outlet element may rotate about an axis of rotation arranged generally parallel to an attachment face of the valve base and generally horizontally in use.
Additionally, or alternatively, in some embodiments the detent may be arranged on the valve base and the one or more protrusions are arranged on the outlet element.
Additionally, or alternatively, in some embodiments in the closed configuration the base opening may be obstructed by a wall of the outlet element.
Additionally, or alternatively, in some embodiments the detent may formed of a material which is less rigid than a material forming the one or more protrusions.
Additionally, or alternatively, in some embodiments the detent may be integrally formed with the valve base, and optionally the valve base and the detent may be formed as a single moulding.
Additionally, or alternatively, in some embodiments the one or more protrusions may be integrally formed with the outlet element, and optionally the outlet element and the one or more protrusions may be formed as a single moulding.
The present disclosure also provides an ostomy appliance comprising an outlet valve as described above and an ostomy bag, wherein the outlet valve is attached to an outer face of the ostomy bag.
Additionally, or alternatively, in some embodiments in the closed configuration the outlet element may substantially overlie a cavity of the ostomy bag; and in the open configuration at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy bag.
The present disclosure also provides an ostomy appliance comprising:
In some embodiments the relatively flexible outlet tube portion may be formed from a deformable material, wherein the deformable material is optionally resilient.
Additionally, or alternatively, in some embodiments the relatively rigid component may be formed from a material having a Shore hardness of at least 50 A.
Additionally, or alternatively, in some embodiments the outlet element may comprise an outlet tube, the outlet tube comprising the relatively flexible outlet tube portion.5. The relatively rigid component may comprise an intake tube and a relatively rigid outlet tube portion, the relatively rigid outlet tube portion being affixed to the relatively flexible outlet tube portion. The intake tube and the outlet tube may together define a continuous hollow bore for passage of the liquid from the intake opening to an outlet opening arranged at an end of the outlet tube distal to the intake tube. The outlet element may have a generally L-shaped form, the intake tube optionally being arranged at an angle of substantially 90 degrees to the outlet tube. A housing may protrude from an outer face of the valve base, the housing defining a cylindrical bore, a portion of the intake tube being rotatably mounted with the cylindrical bore.
Additionally, or alternatively, in some embodiments the outlet element may be rotatable about an axis of rotation arranged generally parallel to an attachment face of the valve base and generally horizontally in use.
Additionally, or alternatively, in some embodiments the outlet valve may be configured for use with a relatively rigid connector having a connector diameter, the relatively flexible outlet tube portion having an outlet diameter marginally smaller than the connector diameter such that, on insertion of the relatively rigid connector into the relatively flexible outlet tube portion in use, the relatively flexible outlet tube portion flexes to accommodate the relatively rigid connector.
Additionally, or alternatively, in some embodiments the relatively flexible outlet tube portion may be over-moulded onto the relatively rigid component. Accordingly in one embodiment, there is provided an outlet valve for an ostomy appliance comprising: a valve base for attachment to a face of the ostomy appliance, the valve base defining a base opening for receiving a liquid output from the ostomy appliance; and an outlet element configured to be rotatable relative to the valve base from a closed configuration in which discharge of the liquid received through the base opening is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled; wherein the outlet element comprises a relatively rigid component rotatably attached to the valve base and a relatively flexible outlet tube portion affixed to the relatively rigid component, wherein the relatively flexible outlet tube portion is over-moulded onto the relatively rigid component.
Additionally, or alternatively, in some embodiments the valve base may be formed of a material which is more rigid than the relatively flexible outlet tube portion and optionally which is less rigid than the relatively rigid component.
Additionally, or alternatively, in some embodiments the relatively rigid component may comprise a protruding flange for gripping by the user in use. Accordingly, in one embodiment, there is provided an outlet valve for an ostomy appliance comprising: a valve base for attachment to a face of the ostomy appliance, the valve base defining a base opening for receiving a liquid output from the ostomy appliance; and an outlet element configured to be rotatable relative to the valve base from a closed configuration in which discharge of the liquid received through the base opening is prevented, to an open configuration in which discharge of the liquid received through the base opening is enabled; wherein the outlet element comprises a relatively rigid component rotatably attached to the valve base and a relatively flexible outlet tube portion affixed to the relatively rigid component, wherein the relatively rigid component comprises a protruding flange for gripping by the user in use.
The present disclosure also provides an ostomy appliance comprising an outlet valve as as described above. In the closed configuration the outlet element may substantially overlie a cavity of the ostomy appliance; and in the open configuration at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy appliance.
One or more aspects of the disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:
In the following description, the equivalent reference numerals are used in different aspects to denote equivalent or similar features.
Unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as is commonly understood by the reader skilled in the art to which the claimed subject matter belongs. It is to be understood that the foregoing summary of the disclosure and the following examples are exemplary and explanatory only and are not restrictive of any subject matter claimed.
The following description is directed to exemplar aspects of the disclosure. The description of the aspects is not meant to include all the possible aspects of the disclosure that are claimed in the appended claims. Many modifications, improvements and equivalents which 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 requires otherwise.
In this specification, the use of the singular includes the plural unless the context clearly dictates otherwise. In this specification, the use of “or” means “and/or” unless stated otherwise. Furthermore, use of the term “including” as well as other forms, such as “include”, “includes,” and “included,” is not limiting.
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 mm” means “about 5 mm” and also “5 mm.” Generally, the term “about” includes an amount that would be expected to be within experimental error. The term “about” includes values that are within 10% less to 10% greater of the value provided. For example, “about 50%” means “between 45% and 55%.” Also, by way of example, “about 30” means “between 27 and 33.”
A first example outlet valve 1 for an ostomy appliance according to the present disclosure is shown in
The outlet valve comprises a valve base 10 and an outlet element 20. The valve base 10 and outlet element 20 are shown assembled in
The valve base 10, as shown in
A housing 13 of the valve base 10 may protrude from an outer face 18 of the back flange 11. The housing 13 may be integrally formed with the backing flange 11, for example by moulding. The housing 13 may define a generally cylindrical bore 14 for rotatable attachment to the outlet element 20 in use.
A base opening 15 is provided through the valve base 10 for receiving a liquid output from the ostomy bag 30. An ostomy bag aperture may be provided in a wall of the ostomy bag 30 through which liquid may be output from the ostomy bag 30 to the base opening 15, the outlet valve 1 being arranged overlying the ostomy bag aperture. The base opening 15 may be arranged within the cylindrical bore 14 of the housing 13 such that base opening 15 may be in liquid communication with a cavity of the ostomy bag 30. The base opening 15 may have an elongate shape, preferably generally parallel in its elongate direction to an axis of rotation 25 of the outlet element 20. The base opening 15 may have a generally rectangular shape, preferably with rounded corners.
A recess 16 may be formed in the generally planar attachment face 12 around the base opening 15. The presence of the recess 16 may allow for the housing 13 to have a generally constant wall thickness while providing the other required features, thereby facilitating moulding of the housing 13.
A ridge 17 for abutting a portion of the outlet element 20 when it in the closed configuration is provided on the outer face 18 of the backing flange 11. The ridge 17 may provide a barrier to restrict access to at least a part of the outlet element 20 when it is in the closed configuration, thereby avoiding unintended rotation of the outlet element 20. The ridge 17 may also provide an indication that the nozzle is in the closed configuration.
The outlet element 20 is configured to be rotatable relative to the valve base 10 from a closed configuration in which discharge of the liquid received through the base opening 15 is prevented, to an open configuration in which discharge of the liquid received through the base opening 15 is enabled.
The outlet element 20 may be rotatably mounted to the housing 14, and may define an intake opening 23 configured to align with and receive liquid from the base opening 15 in use. The outlet element 20, as shown in
The outlet element 20 may comprise a relatively rigid component rotatably attached to the valve base 10 and a relatively flexible outlet tube portion 21a affixed to the relatively rigid component. The relatively flexible outlet tube portion 21a may be formed from a resiliently deformable material. The relatively flexible outlet tube portion 21a may form a part of the outlet tube 21 distal to the intake tube 22 and may comprise the outlet opening 24.
The relatively rigid component may be formed from a material having a Shore hardness of at least about 50 A. The relatively rigid component may comprise the intake tube 22 and a relatively rigid outlet tube portion 21b, the relatively flexible outlet tube portion 21a being affixed to the relatively rigid outlet tube portion 21b, for example by over-moulding the relatively flexible outlet tube portion 21a onto the relatively rigid outlet tube portion 21b.
A portion of the intake tube 22 may be rotatably mounted with the cylindrical bore 14 of the housing 15. The outlet element 20 may therefore rotate about an axis of rotation 25, being the longitudinal axis of the cylindrical bore 14. In use, the outlet valve 1 may be arranged on the ostomy bag 30 such that in a closed configuration the outlet tube 21 may be arranged with the outlet opening 24 directed upwards, and in the open configuration the outlet tube 21 may be arranged with the outlet opening 24 directed downwards.
An open end of the intake tube 22 may be fluidly sealed by contact with an adjacent wall of the housing 13.
The intake tube 21 may be retained in the housing 13 by a retention feature 29 comprising an annular recess 29a arranged on the intake tube 22 and a corresponding annular protrusion arranged on a wall of the housing inside the cylindrical bore 14. The retention feature 29 may form a seal between the cylindrical bore 14 and the outer surface of the intake tube 22. The retention feature 29 may prevent axial movement of the outlet element 20 relative to the valve base 10 during rotation.
The axis of rotation 25 may be arranged generally parallel to the attachment face 12 of the valve base 10 and may be generally horizontal in use. The outlet element 20 may have a L-shaped form, the intake tube 22 being arranged at an angle of substantially 90 degrees to the outlet tube 21. The outlet tube 21 may therefore be rotatable in a plane generally perpendicular to the attachment face 12 of the valve base 10 and generally vertical in use.
The outlet element 20 may be rotatable such that the outlet tube 21 moves through an arc of rotation from an upward-pointing position shown in
The intake opening 23 may be arranged in the intake tube 22 such that the intake opening 23 is in fluid connection the outlet opening 24 via the hollow bore arranged through the intake tube 22 and the outlet tube 21. As shown in
In the open configuration of the outlet element 20, the base opening 15 and the intake opening 23 are partially or fully aligned such that liquid may be received into the intake opening 23 from the base opening 15 and discharged through the outlet tube 21. In the closed configuration the base opening 15 and the intake opening 23 are not aligned such that discharge of the liquid received through the base opening 15 is prevented. In the closed configuration passage of liquid from the base opening 15 into the intake tube 22 may be obstructed by an adjacent portion of a wall of the intake tube 23.
The base opening 15 and the intake opening 23 may be positioned such that when the outlet element 20 is arranged at the first end of the arc of rotation, the outlet element 20 is in the closed configuration. In use the outlet element 20 may be rotated downwards away from the first end of the arc of rotation. The intake opening 23 may move closer to the base opening 15 as the outlet element is rotated. A limit position of the outlet tube 21 may be defined at a point on the arc of rotation furthest from its first end at which the outlet element 20 is still in the closed configuration. On further rotation of the outlet element 20 away from the first end and past the limit position, the base opening 15 may start to come into alignment with, and then progressively align with, the intake opening 23 such that liquid may pass from the base opening 15 into the intake opening 23 and the outlet element 20 is therefore in the open configuration. Continued rotation of the outlet element 20 away from the first end increases the alignment of the base opening 15 and the intake opening 23 such that the resulting flow path through the base and intake openings increases in cross section. At a second end of the arc of rotation, the outlet element 20 may be in the open configuration with the base opening 15 and the intake opening 23 fully aligned.
The outlet valve 1 may be configured such that in the limit position in use, the outlet tube 21 is angled generally upwards and at an acute angle to the attachment face 12 of the valve base 10.
The outlet element 20 may comprise a first protrusion 27 and a second protrusion 26 arranged around the circumference of an outer face of the intake tube 22, adjacent to the portion of the intake tube 22 received in the cylindrical bore 14 of the housing 13. The first and second protrusions 26, 27 may be integrally formed with the intake tube 22, for example being formed in a single moulding with the intake tube 22. The first protrusion 27 and the second protrusion 26 may be arranged at the same distance along the intake tube 22 and spaced apart around the circumference of the intake tube 22.
The valve base 10 may comprise a detent 19 in the form of an elongate protrusion arranged on the outer face 18 of the back flange 11, outside and adjacent to the housing 13. The detent 19 may be adjacent to an opening of the cylindrical bore 13. The detent 19 may be aligned with the longitudinal axis of the cylindrical bore 14 and therefore the axis of rotation 25 of the outlet element 20.
The detent 19 and the first protrusion 27 may be positioned such that on rotation of the outlet tube 21 away from the first end of its arc of rotation, the first protrusion 26 contacts and rides over the detent 19, thereby providing audible and/or tactical confirmation to the user that the outlet tube 21 has been moved out of its initial storage position.
The detent 19 and the second protrusion 26 may be positioned such that on rotation of the outlet element to or near the limit position, the first protrusion 26 contacts and rides over the detent 19, thereby providing audible and/or tactical confirmation to the user that the outlet tube 21 has reached or is approaching the limit position.
The backing flange 11 may have a length from the axis of rotation 25 to its upper edge which is shorter than the length of the outlet tube 20 from the axis of rotation to the outlet opening 24. The outlet opening 24 may therefore be arranged outside a footprint of the backing flange 11 (i.e. does not overlie the backing flange 11) when the outlet element 20 is in the closed configuration at the first, upper end of its arc of rotation, as shown in
The relatively rigid outlet tube portion 21b may have a length from its axis of rotation 25 to the relatively flexible outlet tube portion 21a which is shorter than a length of the backing flange 11 from a line parallel to the axis of rotation 25 to a lower edge of the backing flange 11 such that at the second, lower end of its arc of rotation the distal end of the relatively rigid outlet tube portion 21b (distal to the intake tube 22) overlies the backing flange 11. The relatively flexible outlet tube portion 121a may extend from the distal end of the relatively rigid outlet tube portion 21b. Therefore, a portion of the relatively flexible outlet tube portion 21a may be arranged across the lower edge of the backing flange 11 such that a distal portion of the relatively flexible outlet tube portion 21a may be arranged outside a footprint of the backing flange 11 when the outlet element 20 is at the second, lower end of its arc of rotation. The outlet valve 1 may be arranged adjacent to a lower edge or lower apex of the ostomy bag 30 such that all of the relatively flexible outlet tube portion 21a may be arranged outside a footprint of the ostomy bag 30 when the outlet element 20 is at the second, lower end of its arc of rotation.
In use, the outlet valve 1 may be attached to an outer face of an ostomy bag 30 (shown in
A grip flange 28 may be attached to the outlet element 20 for gripping by the user to rotate the outlet element 20 between the open and closed configurations. The flange 28 may extend laterally from the outlet tube 21. The flange 28 may be integrally formed with the rigid portion of the outlet element 20. The flange 28 may have a generally triangular form and may be provided with surface features to assist in gripping the flange by the user. The backing flange 11 may comprise a lateral flange extending laterally on an opposite side of the outlet valve to the grip flange 28, thereby providing a gripping surface for the user to press or hold while moving the outlet element 20 using the grip flange 28.
Further examples of an outlet valve according to the present disclosure are described below. Only those features that differ in this aspect compared to the previous aspect will be described in detail in the following description. For features that are common to one or more aspects, reference should be made to the description as a whole.
A second example outlet valve 101 for an ostomy appliance according to the present disclosure is shown in
The backing flange 111 may have a length from a line parallel to the axis of rotation 25 to its upper edge which is longer than the length of the outlet tube 120 from the axis of rotation to the outlet opening 24. The outlet opening 24 may therefore be arranged inside a footprint of the backing flange 111 (i.e. overlies the backing flange 111) when the outlet element 120 is at the first end of its arc of rotation, as shown in
The relatively rigid outlet tube portion 121b may have a length from its axis of rotation 25 to the relatively flexible outlet tube portion 121a which is the same as or longer than a length of the backing flange 111 from a line parallel to the axis of rotation 25 to its lower edge such that at the second, lower end of its arc of rotation the distal end of the relatively rigid outlet tube portion 121b (distal to the intake tube 22) is arranged beyond a lower edge of the backing flange 111. Therefore, all of the relatively flexible outlet tube portion 121a may be arranged outside a footprint of the backing flange 111 when the outlet element 120 is at the second, lower end of its arc of rotation. The outlet valve 101 may be arranged adjacent to a lower edge or lower apex of the ostomy bag 30 such that all of the relatively flexible outlet tube portion 121a may be arranged outside a footprint of the ostomy bag 30 when the outlet element 120 is at the second, lower end of its arc of rotation.
The grip flange 128 may have a generally rectangular form. The generally rectangular grip flange 128 may have rounded corners.
A third example outlet valve 201 for an ostomy appliance according to the present disclosure is shown in
The valve base 210 of outlet valve 201 may comprise a backing flange 211 and a housing in the form of an axle 213. The axle 213 comprises a hollow bore for receiving liquid from the ostomy bag 30 and a base opening arranged in a wall of the axle 213.
The outlet valve 201 may be configured such that in use the axis of rotation 225 the axis of rotation is arranged generally horizontally but perpendicular to an attachment face 212 of the backing flange 211 of the valve base 210.
The outlet element 220 of outlet valve 201 may comprise an outlet tube 221 and an intake portion in the form of a cap 222. The cap 222 may be arranged concentrically with the axle 213. The cap 222 may be rotatable around the axle 213 to move the outlet element 220 from the closed configuration to the open configuration. The cap 222 may comprise an intake opening which may be brought into alignment with the base opening by rotation of the outlet element 220 such that a flow path is opened between from the base opening to the outlet tube 221.
One of the outlet element 220 and the valve base 210 may comprise a detent and the other of the outlet element 220 and the valve base 210 may comprise one or more protrusions. The detent may be configured to engage the one or more protrusions during a rotation of the outlet element such that the detent contacts and rides over one or more of the protrusions during the rotation. The detent may be arranged on the cap 222. The one or more protrusions may be arranged on the axle 213 or on the backing flange 211 of the valve base 210.
The outlet element 220 may comprise relatively flexible outlet tube portion. The relatively flexible outlet tube portion 221a and relatively rigid outlet tube portion 221b may be as described in the above aspects of the present disclosure.
In use, to drain liquid from an ostomy appliance comprising an outlet valve according to the present disclosure, the user may grip the grip flange and rotate the outlet element away from the first, upward end of its arc of rotation. A first protrusion and the detent may be positioned such that on movement of the bag audible and/or tactile feedback is provided to the user to confirm movement of the outlet element out of the upward position. At or near the limit position, a second protrusion may contact the detent, indicating the limit point in the arc of rotation beyond which the base opening and the inlet opening begin to align to open a fluid path from the base opening into the outlet tube. At the limit position, the outlet tube may be angled upwards and away from the user's body, thereby providing a convenient position for attachment of a drain appliance such as a night bag to the outlet tube before the outlet tube is moved into the open configuration, thereby limiting the possibility of spillage of the output liquid. The outlet tube may then be rotated further, the second protrusion passing the detent, to increase the alignment of the base and intake openings and thereby allow more fluid to flow out of the valve, and to orient the outlet tube downwards for convenient drainage into the night bag or to the exterior.
After drainage of the ostomy bag, or when the user wishes to interrupt the flow of liquid out of the outlet valve, the user may rotate the outlet tube upwards. On reaching or passing the limit position, the second protrusion will come into contact with the detent, confirming to the user that the base opening and the intake opening are no longer aligned. If used, a night drainage bag or other appliance can be disconnected from the outlet tube once the outlet element is in the closed configuration, avoiding spillages. On continued rotation, the first protrusion and detent will provide audible and/or tactile feedback when the outlet element reaches the upper end of its arc of rotation, the outlet opening facing upwards, confirming to the user that he outlet valve is securely closed.
The outlet valve according to any aspect of the disclosure may be configured for use with a relatively rigid connector, for example for connecting the outlet valve to a drainage bag or other appliance. The relatively rigid connector may have an outer diameter and the relatively flexible outlet tube portion of the outlet valve may have an outlet diameter marginally smaller than the connector outer diameter such that, on insertion of the connector into the relatively flexible outlet tube portion in use, the relatively flexible outlet tube portion may flex to accommodate the connector and thereby form an effective seal.
Whilst preferred aspects of the present disclosure have been described, these are by way of example only and non-limiting. It will be appreciated by those skilled in the art that many alternatives are possible within the ambit of the 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. Further, the following features may be applicable to any aspect of the disclosure.
As noted above, in this specification locations and orientations of features may be described with reference to the ostomy appliance being “in use”, “orientated as it would be in use” or similar. Such terms refer to the intended orientation of the ostomy appliance when it is adhered to a body of an ostomate with the ostomate in a standing position.
The axis of rotation of the outlet element may be arranged generally parallel to the attachment face of the valve base and may be generally horizontally in use, for example as in the aspects shown in
The outlet element may have a L-shaped form, the intake tube being arranged at an angle of substantially 90 degrees to the outlet tube. The outlet tube may therefore be rotatable in a plane which is generally perpendicular to the attachment face of the valve base and generally vertical in use, about an axis perpendicular to a longitudinal axis of the outlet tube.
The intake opening and sealing surfaces surrounding it may therefore be arranged along and rotate around an axis parallel to the attachment face of the outlet valve. This may reduce the profile depth of the valve from back to front when the outlet element is in a storage position at the first end of its arc of rotation, when compared to an outlet valve in which the intake opening and sealing surfaces surrounding it are arranged along and rotate around an axis perpendicular to the attachment face of the outlet valve.
The intake tube may be fixedly attached or integrally formed with at least a portion of the outlet tube, such that the inlet tube is not rotatable from or rotatable relative to the outlet tube.
In use, the outlet opening may be oriented generally upwards when the outlet element is in the closed configuration at the first end of its arc of rotation and generally downwards when the outlet opening is in the open configuration at a second end of its arc of rotation.
At the first end of the arc of rotation, the outlet tube may lie in contact with the backing flange along substantially all of its length, such that the outlet valve does not protrude more than necessary away from the attachment face.
The outlet tube may rotate in a plane generally perpendicular to an attachment face of the valve base such that, in use, the plane of rotation of the outlet tube is generally parallel or at an acute angle to the sagittal plane of the user.
The outlet element may be configured such that in the limit position in use, the outlet tube is angled generally upwards and away from the body of the user (i.e. at an acute angle to the attachment face of the valve base).
In use, when the base opening and intake opening are at least partially aligned the outlet element is in the open configuration. As the outlet tube is moved from its limit position towards the second end of the arc of rotation the apertures will become gradually more aligned, increasing the area of the open portion of the aperture gradually until reaching a fully open configuration in which both apertures are aligned. The position at which the outlet element is in a fully open configuration, i.e. in which the base and intake openings are fully aligned, may coincide with the second end of the arc of rotation.
An ostomy bag of an ostomy appliance according to the present disclosure may comprise a weld or other sealing line arranged adjacent to and below an opening in the bag for passing liquid to the outlet valve, thereby limiting the amount of liquid collecting below the opening inside the ostomy bag.
The outlet element may comprise a relatively flexible outlet tube portion for attachment of the outlet tube to a drainage appliance such as a night bag. Alternatively, the outlet tube element may comprise a relatively rigid portion at its outlet end. Where present, the flexible outlet tube portion may be attached to a relatively rigid outlet tube portion by over-moulding the flexible component onto the rigid component.
The outlet tube may have a generally circular cross-section at the outlet end as shown in the first and second illustrated aspects. Alternatively, the outlet tube may comprise a different cross-sectional shape. For example, the outlet tube may be generally oval or generally flattened at the outlet tend. The cross section may have an elongate shape with two generally parallel longer sides, joined by shorter curved ends, the longer sides being arranged generally parallel to the attachment face of the valve base in use, thereby reducing the profile of the outlet valve.
The outlet element may be retained in or around the housing by one or more retention features. The retention feature(s) may comprise one or more annular recesses and corresponding annular protrusions. The retention feature(s) may comprise one or more detents and corresponding protrusions. The retention feature(s) may form a seal between the outlet element and the housing.
The relatively flexible outlet tube portion may have a resilient tubular form and may be permanently affixed to the relatively rigid portion of the outlet tube, defining a continuous bore for passage of liquid from the intake portion/opening to the outlet end.
The relatively flexible outlet tube portion may be attached to the relatively rigid outlet tube portion by over-moulding the flexible material onto the rigid material during manufacture, to thereby permanently affix the relatively flexible outlet tube portion. Alternatively, the relatively flexible outlet tube portion may be affixed by other means, for example using adhesives.
The one or more detents may be in the form of a further protrusion extending from a face of the component. In use, the one or more detents may contact and pass over one or more of the protrusions, thereby providing tactile and/or audible feedback to the user confirming the position of the outlet tube relative to the valve base.
In the illustrated aspects, a single detent and multiple protrusions are provided. In any aspect, different numbers of detents and/or protrusions may be provided.
In the illustrated aspects, the detent and protrusions are arranged outside the cylindrical bore of the housing. The detent may be arranged on an outer face of the valve base, outside and adjacent to the housing. Placing the detent(s) outside the cylindrical bore of the housing may prevent them affecting the fit of the intake tube in the cylindrical bore, may improve sealing. In any aspect, the detent(s) and or protrusion(s) may be provided in positions other than those shown in the illustrated aspects.
The valve base may be formed of a material which is relatively more rigid than the relatively flexible outlet tube portion and which is less rigid than the relatively rigid component of the outlet element. The detent(s) may be formed of a material which is relatively less rigid than a material forming the protrusion(s) to facilitate passing of the detent(s) and protrusion(s) over each other in use.
The valve base and relatively rigid component of the outlet element may be formed, for example, from polypropylene or High-density polyethylene (HDPE), acrylonitrile butadiene styrene (ABS). or polycarbonate. The materials of the valve base and relatively rigid component of the outlet element components may be chosen to have different shrinkage rates to allow for hot assembly of these two components to produce a good seal therefore preventing leakage. The use of different materials must also be different to avoid sticking between the two components over time.
The relatively flexible outlet tube portion may be formed, for example, from ethylene-vinyl acetate (EVA) or a thermoplastic elastomer (TPE) and may be over-moulded over the relatively rigid portion of the outlet tube.
The detent(s) may be integrally formed with the valve base. The valve base and the detent(s) may be formed as a single moulding. The one or more protrusions may be integrally formed with the outlet element. The outlet element and the one or more protrusions may be formed as a single moulding.
In any aspect, one or more stops may be provided for contacting the detent or protrusions or other the outlet element to prevent rotation of the outlet element beyond the ends of the arc of rotation.
The detent(s) may engage a protrusion when the outlet element rotates away from its storage position at the first end of its arc of rotation and on moving to or from the limit position. The protrusion arranged to indicate movement of the outlet element away from its storage position may also assist in retaining the outlet element in the storage position until deliberately rotated by the user. The protrusion arranged to indicate movement of the outlet element on moving to or from the limit position may be positioned to make contact with the detent when the outlet element is at the limit position or near to the limit position (such that the outlet element may remain in the closed configuration for a small amount of rotation after contacting the detent, such that the flow path is not opened immediately on moving the outlet element past this protrusion.
The detent(s) may be located on a section of the valve base that allows it to flex out of the way on contact with the protrusion(s) of the outlet element, such that the detent(s) may flex away rather than permanently deforming. This may reduce wear of the detent(s) and protrusion(s).
The intake tube may be assembled with the housing or axle using a hot assembly method, such that after shrinkage of the housing on cooling, the intake tube is retained within the housing.
The outlet element may comprise a grip flange as described above. The grip flange may be integrally formed with the relatively rigid component, or may be attached, for example by adhesive.
A lubricant may be provided between the rotating components to ease rotation and improve sealing.
In any aspect of the present disclosure, the outlet element may be retained in an axial direction relative to the housing, such that there is no relative axial movement between the outlet element and the valve base during rotation.
Other features of the ostomy appliance, for example the shape and construction of the ostomy appliance inner and outer walls and comfort layer, may vary from those shown in the illustrated aspects.
The outlet valve of the present disclosure is described herein as being suitable for an ostomy appliance comprising an ostomy bag. An outlet valve according to any aspect of the present disclosure may be suitable for use in other applications, for example a drainage bag or catheter collection bag.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2002314.9 | Feb 2020 | GB | national |
| 2002316.4 | Feb 2020 | GB | national |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/GB2021/050391 | Feb 2021 | US |
| Child | 17178501 | US |
