WO2024095001A1 - An ostomy appliance - Google Patents

An ostomy appliance Download PDF

Info

Publication number
WO2024095001A1
WO2024095001A1 PCT/GB2023/052858 GB2023052858W WO2024095001A1 WO 2024095001 A1 WO2024095001 A1 WO 2024095001A1 GB 2023052858 W GB2023052858 W GB 2023052858W WO 2024095001 A1 WO2024095001 A1 WO 2024095001A1
Authority
WO
WIPO (PCT)
Prior art keywords
outlet
ostomy appliance
stiffening member
wall
stiffening
Prior art date
Application number
PCT/GB2023/052858
Other languages
French (fr)
Inventor
Lee Howard
Lee TRETHEWAY
Original Assignee
Salts Healthcare Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Salts Healthcare Limited filed Critical Salts Healthcare Limited
Publication of WO2024095001A1 publication Critical patent/WO2024095001A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404Details or parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404Details or parts
    • A61F5/4407Closure means other than valves

Definitions

  • This invention relates to ostomy appliances.
  • this invention relates to drainable ostomy appliances.
  • Ostomy appliances are well known in the field. They are typically attached to a user via an adhesive member that surrounds the user’s stoma with adhesive and they provide a collecting volume to collect waste exiting the stoma. A means of draining waste from the collecting volume is often provided - in many instances, this may be in the form of a drainage outlet in communication with the collecting volume which is formed from the walls of the ostomy appliance.
  • Embodiments of the present invention seek to alleviate one or more problems associated with the prior art.
  • an ostomy appliance including: first and second walls connected to each other at or near their peripheries; a stoma-receiving opening for receipt of a stoma; a collecting cavity defined between the first and second walls wherein the stoma-receiving opening is fluidly connected to the collecting cavity; a connection member connected to the first and/or second wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user; an outlet which extends away from the stoma-receiving opening, the outlet terminating in an opening, wherein the outlet is movable between an in-use position and a stowed position; a fastener member for releasably fastening the outlet in the stowed position, said first fastener member being connected, directly or indirectly, to the outlet; a comfort layer positioned over the first and/or second wall; wherein the comfort layer includes an aperture
  • the fastener member and aperture may fasten the outlet in a stowed position.
  • the aperture may be an elongate slot which extends in a direction from the stoma-receiving opening towards the opening of the outlet.
  • the aperture may have first and second sides which are generally parallel.
  • the first and second sides may be connected by first and second curved ends.
  • a distance between the first and second sides may be less than a length of the first and/or second sides.
  • a distance between the first and second sides may be less than a width of the formation.
  • the outlet may be foldable upon itself to a stowed position.
  • a stiffening member may be provided on the first or second wall and positioned immediately adjacent the opening of the outlet.
  • the fastener member may be provided on the first or second wall of the outlet.
  • the fastener member may be provided on the same wall as the stiffening member and positioned between the stiffening member and the stoma receiving opening, or the fastener member may be provided on the wall which does not include the stiffening member and positioned opposite the stiffening member.
  • a first stiffening member may be provided on the first or second wall and positioned immediately adjacent the opening of the outlet and a second stiffening member may be provided on the first or second wall.
  • the second stiffening member may be provided on the same wall as the first stiffening member, positioned next to the first stiffening member and further away from the opening than the first stiffening member.
  • the fastener member may be provided on the same wall as the first and second stiffening members, positioned next to the second stiffening member and further away from the opening than the first and second stiffening members.
  • the second stiffening member may be provided on the wall which does not include the first stiffening member and positioned opposite the first stiffening member.
  • the fastener member may be provided on the first or second wall, positioned next to the first or second stiffening member and further away from the opening than the first and second stiffening members.
  • the second stiffening member may be provided on the wall which does not include the first stiffening member and may be positioned further away from the opening than the first stiffening member.
  • the fastener member may be provided on the same wall as the first stiffening member and may be positioned opposite the second stiffening member.
  • the outlet may be foldable upon itself about the stiffening member, or first and second stiffening members, to a stowed position.
  • the fastener member may be rigid.
  • the fastener member may be slidably movable within the aperture.
  • At least a part of the fastener member may be rotatably movable relative to the wall of the outlet to which the fastener member is connected.
  • the ostomy appliance may include a plurality of fastener members, and preferably may further include a plurality of apertures corresponding to the plurality of fastener members.
  • FIGURE 1 is a rear view of an ostomy appliance in an in-use position in accordance with the present disclosure
  • FIGURE 2 is a front view of the appliance of figure 1 ;
  • FIGURE 3a is a front view of a part of the appliance of figure 1 ;
  • FIGURE 3b is a front view of a part of the appliance of figure 1 ;
  • FIGURE 4 is a front view of the appliance of figure 1 in a stowed position
  • FIGURE 5a is a perspective view of a fastener member of the appliance of figure 1 ;
  • FIGURE 5b is a front view of the fastener member of figure 5a;
  • FIGURE 5c is a side view of the fastener member of figure 5a;
  • FIGURE 6 is a rear view of an ostomy appliance in an in-use position in accordance with the present disclosure
  • FIGURE 7a is a side view of a fastener member of the appliance of figure 6;
  • FIGURE 7b is a front view of the fastener member of figure 7a in an unlocked position
  • FIGURE 7c is a front view of the fastener member of figure 7a in a locked position
  • FIGURE 8 is a front view of the appliance of figure 6 in a stowed position
  • FIGURE 9 is a rear view of an ostomy appliance in an in-use position in accordance with the present disclosure.
  • FIGURE 10 is a front view of the appliance of figure 9 in a stowed position
  • FIGURE 11a is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure
  • FIGURE 11 b is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure
  • FIGURE 12 is a side view of the appliance of figure 11a in a stowed position
  • FIGURE 13 is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure
  • FIGURE 14 is a side view of the appliance of figure 13 in a stowed position
  • FIGURE 15a is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure.
  • FIGURE 15b is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure.
  • an ostomy appliance 10 has an upper end 1 1 and a lower end 13.
  • the ostomy appliance 10 has first and second walls 12, 14 connected to each other at or near their peripheries, by any suitable means known in the art. For example, they could be adhered to each other, or heat welded.
  • the first wall 12 includes a stoma-receiving opening 16 for receipt of a user’s stoma and also supports a connection member or flange 20 for attaching the appliance 10 to a user.
  • the connection member 20 may be a hydrocolloid wafer for securing the ostomy appliance 10 to the skin of a user around their stoma.
  • the connection member 20 may be for attaching the ostomy appliance 10 to a flange for attaching the appliance 10 to a user (e.g. a two-piece appliance as it is known in the art).
  • the first and second walls 12, 14 define a waste collecting cavity 18 therebetween, which is fluidly connected to the stoma-receiving opening 16 such that waste from the stoma may be collected and stored within the cavity 18.
  • the lower end 13 end of the appliance 10 is provided with an outlet 22 formed by portions of the first and second walls 12, 14.
  • the outlet 22 extends downwardly away from the stoma-receiving opening 16 and terminates at an opening 24.
  • the opening 24 permits waste collected in the waste collecting cavity 18 to be expelled from the appliance 10.
  • the outlet 22 may be moved between an in-use position and a stowed positioned.
  • the outlet 22 In the in-use position, the outlet 22 may be unfurled such that the user may drain or otherwise expel waste from the waste collecting cavity 18 through the opening 24.
  • the opening 24 In this in-use position, the opening 24 may be opened and closed by the user manipulating the walls 12, 14 of the outlet 22 close to the opening 24, or the opening 24 may be biased into an open state.
  • the outlet 22 may be at least partially folded or rolled up such that the opening 24 of the outlet 22 is sealed or otherwise held in a closed or shut condition so that waste collected in the waste collecting cavity 18 cannot escape or leak through the opening 24.
  • maintaining the outlet 22 in a folded or rolled up condition during use of the appliance 10 minimizes the amount of waste that may collect within the outlet 22.
  • Moving the outlet between the in-use position and the stowed position may be assisted by the use of at least one stiffening member 26 provided on the first or second wall 12, 14, or a plurality of stiffening members 26a, 26b provided on the first and/or second wall 12, 14 as described in more detail below.
  • the ostomy appliance 10 also includes a comfort layer 17.
  • the comfort layer 17 may be formed of a flexible material, which may be a woven material or a non- woven material as known in the art.
  • the comfort layer 17 may be positioned over the first or second wall 12, 14 of the appliance 10.
  • the comfort layer 17 may be connected to first or second wall 12, 14 of the appliance 10 at or near their peripheries, by any suitable means known in the art.
  • only a portion of the comfort layer 17 may be connected to the first or second wall 12, 14 such that a portion 17a, or portions, of the comfort layer 17 is/are not connected directly to the first or second wall 12, 14 and is/are freely movable with respect to the appliance 10.
  • Figures 2 and 4 shows an example of a freely movable portion 17a of the comfort layer 17 as a portion of the comfort layer 17 positioned below the dashed line X.
  • the appliance 10 may include a plurality of comfort layers 17 each positioned over the first and second walls 12, 14.
  • the comfort layer 17 may extend across a portion of the external surface of the first or second walls 12, 14 which define the waste collecting cavity 18. In other embodiments, the comfort layer 17 may extend only partially across the external surface of the first or second wall 12, 14, or it may extend across the entire external surface of the first or second wall 12, 14 which define the waste collecting cavity 18 and also across a portion of, the entirety of, or beyond the opening 24 of, the outlet 22.
  • the comfort layer 17 further includes an aperture 19 which extends through the comfort layer 17.
  • the aperture 19 may be provided on a freely movable portion 17a of the comfort layer 17.
  • the aperture 19 may be an elongate slot which extends in a direction from the stoma-receiving opening 16 and towards the opening 24 of the outlet 22.
  • the aperture 19 may extend in a vertical direction with respect to the appliance 10 in normal use.
  • the aperture 19 may extend in other directions, such as horizontally between a left and right side of the comfort layer 17, or inclined with respect to a vertical/horizontal direction.
  • the aperture 19 may include first and second sides 19a, 19b which extend in a direction from the stoma-receiving opening 16 and towards the opening 24 of the outlet, and which may be generally parallel to each other.
  • the first and second sides 19a, 19b of the aperture 19 may be connected by first and second curved ends 19c, 19d .
  • the first and second sides 19a, 19b may be arranged such that they are non-parallel to each other, and/or may be connected by first and second ends 19c, 19d which are not curved.
  • a distance D1 between the first and second sides 19a, 19b may be less than a length L1 of the first and second sides 19a, 19b.
  • the comfort layer 17 may be formed of a flexible material
  • the comfort layer 17 may be deformable such that the material surrounding the aperture 19 may also be deformable.
  • the user may deform or otherwise manipulate the shape of the aperture 19.
  • the appliance 10 also includes a fastener member 30 which is connected, directly or indirectly, to the first or second wall 12, 14 of the outlet 22.
  • the fastener member 30 may be permanently connected to the first or second wall 12, 14 by the use of an adhesive or by welding.
  • the fastener member 30 may be releasably connected to the first or second wall 12, 14, for instance by the use of a hook and loop fastener or other temporary and reversible form of connecting means.
  • the fastener member 30 is used to releasably fasten or otherwise secure or hold the outlet 22 in a stowed position. As shown in figures 4, 8, 12 and 14, the fastener member 30 and the aperture 19 may be used together to fasten the outlet in a stowed position, such that the aperture 19 cooperates with the fastener member 30 to fasten the outlet 22 relative to the comfort layer 17.
  • the fastener member 30 includes a formation 32.
  • the formation 32 In use of the appliance 10, the formation 32, or a portion of the formation 32, passes through the aperture 19 to fasten the outlet 22 relative to the comfort layer 17.
  • the fastener member 30 may further include a base 34 which may be used to connect the fastener member 30 to the first or second wall 12, 14, and a connecting portion 36 which connects the formation 32 to the base 34.
  • the formation 32 may be substantially circular or elliptical in profile. In other embodiments, the formation 32 may have a profile of a different shape, such as substantially square or rectangular or any other appropriate shape.
  • the fastener member 30, or at least a part of the fastener member 30, may be formed from a rigid material such as a plastic material or a metal material. In other embodiments, the fastener member 30, or at least a part of the fastener member 30 may be formed from a flexible and/or resilient material. In embodiments, parts of the fastener member 30 may be made from differing materials or may be formed from the same material as a unitary component.
  • the formation 32 may have a width W which may correspond to the outer extremities of the perimeter of the profile of the formation 32.
  • the width W may correspond to the diameter of the formation 32.
  • the distance D1 between the first and second sides 19a, 19b of the aperture 19 may be less than the width W of the formation 32.
  • the difference between the distance D1 between the first and second sides 19a, 19b the aperture 19 and the width W of the formation 32 means that the outlet 22 may be securely fastened to the comfort layer 17 with a reduced risk of the formation 32 inadvertently passing back through the aperture 19.
  • the greater width W of the formation 32 relative to the distance D1 between the first and second sides 19a, 19b of the aperture 19 assists in preventing the accidental decoupling of the outlet 22 from the comfort layer 17 in the absence of manipulation of the aperture 19 and/or the cover layer 17 by a user of the appliance 10.
  • the profile of the formation 32 may change along a length L of the formation 32.
  • this formation 32 may have a top surface 32a and a bottom surface 32b which are linked by a connecting surface 32c.
  • a width W1 of the profile of the top surface 32a may be less than a width W2 of the bottom surface 32b, such that the top surface 32a and bottom surface 32b are connected by a sloped or otherwise inclined connecting surface 32c.
  • the formation 32 may be substantially frustoconical in shape.
  • This construction of a formation 32 is advantageous because the formation 32 may be more easily passed through the aperture 19 in a direction which corresponds to the user of the appliance fastening the outlet 22 to the comfort layer 17, due to the top surface 32a being of a lesser width than the bottom surface 32b. However, due to the greater width W2 of the bottom surface 32b relative to the width W1 of the top surface 32a, the accidental decoupling of the outlet 22 from the comfort layer 17 may be prevented.
  • a part of the fastener member 30 which is held within the aperture 19 may be slidably movable within the aperture 19.
  • the connecting portion 36 may be positioned within the aperture 19 and may be slidably movable within the aperture 19.
  • the ability of the fastener member 30 to slide within the aperture 19 reduces the risk of the comfort layer 17 tearing or being pulled away from the first or second wall 12, 14 to which it is attached, and also reduces the risk of the fastener member 30 becoming damaged or removed from the first or second wall 12, 14 to which it is attached, when a force is applied, directly or indirectly, to the comfort layer 17 and/or fastener member 30.
  • the fastener member 30 may be rotatable relative to the first or second wall 12, 14 to which it is attached between an unlocked and a locked position.
  • the formation 32 may be configured such that rotation of the formation 32 relative to the aperture 19 causes the width of the formation 32 to change relative to the width of the aperture 19.
  • the formation 32 may have only one order of rotational symmetry, meaning that in any rotational orientation other than 0° or 180° relative to an initial orientation the overall width of the of the formation 32 relative to the aperture may change.
  • the formation 32 may have a first width W’1 measured in a first direction across the formation 32, and a second width W’2 measured in a second direction across the formation 32 which may be perpendicular to the first direction, with the first width W’1 being different to the second width W’2.
  • the first width W’1 of the formation 32 may be greater than, or may be the same as, the distance D1 between the first and second sides 19a, 19b of the aperture 19 through which the formation 32 is to be passed through.
  • the first width W’1 may be selected so that when the fastener member 30 is in the unlocked position, the formation 32 may be easily passed through the aperture 19, without the requirement to significantly deform the aperture 19 and cover layer 17.
  • the first width W’1 of the formation 32 may be less than the distance D1 between the first and second sides 19a, 19b of the aperture 19, so that the formation 32 may pass through the aperture 19 without any deformation of the aperture 19 and the cover layer 17.
  • the user may then rotate the formation 32 relative to the first or second wall 12, 14 to which it is attached into a locked position.
  • Rotation of the formation 32 causes the comparatively wider part of the formation 32 to span the distance D1 between the first and second sides 19a, 19b of the aperture 19, such that the part of the formation 32 having a width W’2 is now oriented substantially perpendicularly, or inclined, relative to the first and second sides 19a, 19b of the aperture 19.
  • the width W’2 of the formation 32 may be selected so that it is significantly greater than the distance D1 between the first and second sides 19a, 19b of the aperture 19 so that the formation 32 is prevented from passing through the aperture 19 even if the cover layer 17 and aperture are deformed significantly. This greatly reduces the likelihood that the outlet 22 will be inadvertently decoupled or unfastened from the comfort layer 17.
  • the formation 32 may be rotationally movable relative to the connecting portion 36 and the base 34, or both the formation 32 and the connection portion 36 may be rotationally movable relative to the base 36, about an axis of rotation R.
  • the rotation of the formation 32, and in some embodiments the connection portion 36, into the locked position may be clearly identified to the user by the use of a detent, a stop, and/or an audible click.
  • the formation 32 may include a central portion 35 and at least one protrusion 37.
  • the central portion 35 may be generally circular or elliptical in profile or may be of any other appropriately shaped profile.
  • the protrusion(s) 37 may extend away from the central portion 35 in a direction which is generally perpendicular to the axis of rotation R.
  • the central portion 35 and protrusion(s) 37 may be rotatable about the axis of rotation R, or only the protrusions 37 may be rotatable about the axis of rotation R.
  • the appliance 10 may include a plurality of fastener members 30 connected to the first and/or second walls 12, 14. As shown in figures 9 and 10, the appliance 10 may include a fastener member 30 and a further fastener member 30’.
  • the further fastener member 30’ may be similar to, or identical to the fastener member 30.
  • the fastener member 30 and the further fastener member 30’ may be of a different size and/or shape, and one or both of them may be rotationally movable.
  • the fastener member 30 and further fastener member 30’ may cooperate with a shared aperture 19, which may be configured such that it can accommodate both fastener members 30, 30’.
  • each fastener member 30, 30’ may cooperate with a respective aperture 19 and a further aperture 19’.
  • the apertures 19, 19’ may be similar, or may be identical.
  • the aperture 19 and further aperture 19’ may be of a different size and/or shape and may be positioned in different rotational orientations.
  • the outlet 22 may be fastened to the comfort layer 17 with the fastener member 30, and in some embodiments, the further fastener member 30’, in conjunction with other means of securing the outlet in a stowed position, such as a hook and loop fastener or any other appropriate means.
  • the appliance 10 may also include at least one stiffening member 26 which is/are provided to assist with opening and closing the opening 24 of the outlet 22 and for moving the outlet between the in use and stowed positions.
  • Figures 11a to 12 show an embodiment of an appliance having one stiffening member 26.
  • the stiffening member 26 may be provided on the first or second wall 12, 14 of the outlet 22, and may be positioned close to, or immediately adjacent, the opening 24 of the outlet 22.
  • the stiffening member 26 may be connected to an exterior surface of the first or second wall 12, 14 of the appliance 10, e.g., by the use of an adhesive or by welding.
  • the stiffening member 26 may extend substantially laterally across a portion of, or the entirety of, the outlet 22, such that it extends generally perpendicularly to the direction in which waste exits the appliance 10.
  • the stiffening member 26 need only be stiff in the sense it is relatively stiff compared to the walls 12, 14 of the ostomy appliance 10.
  • the stiffening member 26 may be injection moulded from a plastics material.
  • the stiffening member 26 may be substantially square or rectangular in shape, and may be generally planar such that it is of a constant thickness. In other embodiments, the stiffening member 26 may be provided in any other appropriate shape, and at least one surface of the stiffening member 26 may be contoured or otherwise generally non-planar.
  • the outlet 22 may be moved from an in-use position to a stowed position by rolling the walls 12, 14 of the outlet 22 around the stiffening member 26, as is generally known in the art.
  • Such rolling up of the walls 12, 14 uses a laterally extending edge of the stiffening member 26 as a fulcrum to assist in tight closing of the outlet 22 to prevent leakage of collected waste through the opening 24, and to prevent the build-up of waste within the outlet 22 when the outlet 22 is in a stowed position.
  • Embodiments are shown in figures 11a to 12 which include a fastener member 30 and a stiffening member 26 provided on the outlet 22 of the appliance 10. It should be understood that a stiffening member 26 may be used to assist in closing the outlet 22 in conjunction with a single fastener member 30, or a plurality of fastener members 30, 30’. Therefore, references to the fastener member 30 in this context should be construed as also being applicable to embodiments of an appliance 10 which include a plurality of fastener members 30, 30’.
  • the fastener member 30 may be provided on the same wall as the stiffening member 26.
  • Figure 11a shows the fastener member 30 and stiffening member 26 connected to the first wall 12 of the outlet 22.
  • the fastener member 30 and stiffening member 26 may be connected to the second wall 14 of the outlet 22.
  • the fastener member 30 may be positioned on the first wall 12 between the stoma-receiving opening 16 and the stiffening member 26, such that it is positioned further away from the opening 24 of the outlet 22 relative to the stiffening member 26.
  • the fastener member 30 may be directly or indirectly connected to, or formed integrally, with the stiffening member 26.
  • the user pivots or rotates the stiffening member 26 about its top laterally extending edge 27 such that it is now held opposite the fastener member 30.
  • the user then pivots or rotates the stiffening member 26 about its bottom laterally extending edge 28 to an orientation whereby the fastener member 30 is pivoted or rotated such that the base 34 of the fastener member 30 is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19.
  • the user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
  • the fastener member 30 may be provided on a wall which does not include the stiffening member 26, i.e., it is provided on a wall which is opposite the stiffening member 26.
  • Figure 11b shows the fastener member 30 connected to the first wall 12 of the outlet 22, and the stiffening member 26 connected to the second wall 14 of the outlet 22.
  • the walls 12, 14 to which the fastener member 30 and stiffening member 26 are connected may be the opposite to that described above.
  • the fastener member 30 is positioned on the first wall 12 between the stoma-receiving opening 16 and the opening 24 of the outlet 22, and opposite the stiffening member 26.
  • the user pivots or rotates the stiffening member 26 about a top laterally extending edge 27 such that the fastener member 30 is pivoted or rotated to an orientation whereby the base 34 of the fastener member 30 is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19.
  • the user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
  • the appliance 10 may include a first stiffening member 26a and a second stiffening member 26b which are provided to assist with opening and closing the opening 24 of the outlet 22 and for moving the outlet between the in-use and stowed positions.
  • the outlet 22 is foldable upon itself about the first and second stiffening members 26a, 26b to a stowed position.
  • the first and second stiffening members 26a, 26b may be identical, or substantially similar. In other embodiments, the first and second stiffening members 26a, 26b may differ in size, shape and/or contour.
  • first stiffening member 26a may be provided on the first or second wall 12, 14 of the outlet 22 and may be positioned close to, or immediately adjacent the opening 24 of the outlet 22.
  • the second stiffening member 26b may be provided on the first or second wall 12, 14 of the outlet 22.
  • the first and second stiffening members 26a, 26b may be provided on the first wall 12 of the outlet 22.
  • the second stiffening member 26b may be positioned next to the first stiffening member 26a such that a bottom laterally extending edge 28b of the second stiffening member 26b is close to or adjacent a top laterally extending edge 27a of the first stiffening member 26a.
  • the second stiffening member 26b may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
  • the fastener member 30 may also be provided on the first wall 12 of the outlet 22 and may be positioned next to the second stiffening member 26b such that it is close to or adjacent a top laterally extending edge 27b of the second stiffening member 26b. In other words, the fastener member 30 may be positioned further away from the opening 24 of the outlet 22 than the second stiffening member 26b.
  • the user pivots or rotates the first stiffening member 26a about its top laterally extending edge 27a such that it is now held opposite the second stiffening member 26b.
  • the user then pivots or rotates the second stiffening member 26b about its top laterally extending edge 27b such that the first and second stiffening members 26a, 26b are now held opposite the fastener member 30.
  • the first stiffening member 26a may be provided on the first wall 12 of the outlet 22, and the second stiffening member 26b may be provided on the second wall 14 of the outlet 22.
  • the second stiffening member 26b may be positioned opposite the first stiffening member 26a such that a bottom laterally extending edge 28b of the second stiffening member 26b is close to or adjacent the opening 24 of the outlet 22.
  • the fastener member 30 may be provided on the first wall 12 of the outlet 22 and may be positioned next to the first stiffening member 26a such that it is close to or adjacent a top laterally extending edge 27a of the first stiffening member 26a. In other words, the fastener member 30 may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
  • the user pivots or rotates the first stiffening member 26a and second stiffening member 26b about their respective top laterally extending edges 27a, 27b such that they are now held opposite fastener member 30.
  • the user then pivots or rotates the first stiffening member 26a and second stiffening member 26b about their respective bottom laterally extending edges 28a, 28b to an orientation whereby the fastener member 30 is pivoted or rotated such that the base 34 of the fastener member is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19.
  • the user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
  • the first stiffening member 26a may be provided on the first wall 12 of the outlet, and the second stiffening member 26b may be provided on the second wall 14 of the outlet 22.
  • the second stiffening member 26b may be positioned such that a bottom laterally extending edge 28b of the second stiffening member 26b is positioned above a top laterally extending edge 27a of the first stiffening member 26a.
  • the second stiffening member 26b may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
  • the fastener member 30 may be provided on the first wall 12 of the outlet 22 and may be positioned opposite the second stiffening member 26b, and next to the first stiffening member 26a such that it is close to or adjacent a top laterally extending edge 27a of the first stiffening member 26a. In other words, the fastener member 30 may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
  • the user pivots or rotates the first stiffening member 26a about a top laterally extending edge 27a such that it is now held opposite the second stiffening member 26b and fastener member 30, with a portion of the second wall 14 of the outlet 22 held in between the first and second stiffening members 26a, 26b.
  • first and second stiffening members 26a, 26b, and fastener member(s) 30, are possible including arrangements whereby the fastener member(s) 30 are connected to the second wall 14 of the outlet 22.
  • more than two stiffening members 26 may be used to assist in moving the outlet 22 between in-use and stowed positions and may be used with a fastener member 30 as described above to fasten the outlet 22 to the comfort layer 17 in a stowed position.
  • stiffening member 26 or a plurality of stiffening members 26a, 26b to assist in moving the outlet 22 between in-use and stowed positions in conjunction with a fastener member 30 is advantageous as the stiffening member(s) 26 ensure that the outlet 22 can be accurately folded or rolled up in a predetermined, repeatable manner. This reduces the wear and tear of the outlet 22 when it is subjected to repeated movement between in-use and stowed positions, and also means that the fastener member 30 can be optimally positioned on the outlet 22 such that when the outlet 22 is moved to a stowed position the fastener member 30 will always be positioned in a known location relative to the aperture 19 of the comfort layer 17. Therefore, the aperture 19 may be positioned on the comfort layer 17 such that the fastener member 30 may be held centrally, or in any other desired relative position, in the aperture 19 when the outlet 22 is in a stowed position.
  • a stiffening member 26, or a plurality of stiffening members 26a, 26b. enhances the closure of the outlet 22 as the laterally extending edges 27, 28 of the stiffening member(s) 26 assist in the tight closing of the walls 12, 14 of the outlet 22 to prevent leakage of collected waste through the opening 24.
  • the prevention of leakage ensures that when the appliance 10 is used to collect waste, the waste cannot leak out of the opening 24 and onto the fastener member 30 and comfort layer 17, thereby enhancing the hygienic use of the fastener member 30 and comfort layer 17.
  • the terms "comprises” and “comprising” and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components.
  • the invention may also broadly consist in the parts, elements, steps, examples and/or features referred to or indicated in the specification individually or collectively in any and all combinations of two or more said parts, elements, steps, examples and/or features. In particular, one or more features in any of the embodiments described herein may be combined with one or more features from any other embodiment(s) described herein.

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Abstract

An ostomy appliance including: first and second walls connected to each other at or near their peripheries; a stoma-receiving opening for receipt of a stoma; a collecting cavity defined between the first and second walls wherein the stoma-receiving opening is fluidly connected to the collecting cavity; a connection member connected to the first and/or second wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user; an outlet which extends away from the stoma-receiving opening, the outlet terminating in an opening, wherein the outlet is movable between an in-use position and a stowed position; a fastener member for releasably fastening the outlet in the stowed position, said first fastener member being connected, directly or indirectly, to the outlet; a comfort layer positioned over the first and/or second wall; wherein the comfort layer includes an aperture which cooperates with the fastener member to fasten the outlet relative to the comfort layer; wherein the fastener member includes a formation which passes through the aperture to fasten the outlet relative to the comfort layer.

Description

Title: An
Figure imgf000002_0001
FIELD
This invention relates to ostomy appliances. In particular, this invention relates to drainable ostomy appliances.
BACKGROUND
Ostomy appliances are well known in the field. They are typically attached to a user via an adhesive member that surrounds the user’s stoma with adhesive and they provide a collecting volume to collect waste exiting the stoma. A means of draining waste from the collecting volume is often provided - in many instances, this may be in the form of a drainage outlet in communication with the collecting volume which is formed from the walls of the ostomy appliance.
Embodiments of the present invention seek to alleviate one or more problems associated with the prior art.
BRIEF DESCRIPTION OF THE INVENTION
According to a first aspect of the invention we provide an ostomy appliance including: first and second walls connected to each other at or near their peripheries; a stoma-receiving opening for receipt of a stoma; a collecting cavity defined between the first and second walls wherein the stoma-receiving opening is fluidly connected to the collecting cavity; a connection member connected to the first and/or second wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user; an outlet which extends away from the stoma-receiving opening, the outlet terminating in an opening, wherein the outlet is movable between an in-use position and a stowed position; a fastener member for releasably fastening the outlet in the stowed position, said first fastener member being connected, directly or indirectly, to the outlet; a comfort layer positioned over the first and/or second wall; wherein the comfort layer includes an aperture which cooperates with the fastener member to fasten the outlet relative to the comfort layer; wherein the fastener member includes a formation which passes through the aperture to fasten the outlet relative to the comfort layer.
The fastener member and aperture may fasten the outlet in a stowed position. The aperture may be an elongate slot which extends in a direction from the stoma-receiving opening towards the opening of the outlet.
The aperture may have first and second sides which are generally parallel.
The first and second sides may be connected by first and second curved ends.
A distance between the first and second sides may be less than a length of the first and/or second sides.
A distance between the first and second sides may be less than a width of the formation.
The outlet may be foldable upon itself to a stowed position.
A stiffening member may be provided on the first or second wall and positioned immediately adjacent the opening of the outlet.
The fastener member may be provided on the first or second wall of the outlet.
The fastener member may be provided on the same wall as the stiffening member and positioned between the stiffening member and the stoma receiving opening, or the fastener member may be provided on the wall which does not include the stiffening member and positioned opposite the stiffening member.
A first stiffening member may be provided on the first or second wall and positioned immediately adjacent the opening of the outlet and a second stiffening member may be provided on the first or second wall.
The second stiffening member may be provided on the same wall as the first stiffening member, positioned next to the first stiffening member and further away from the opening than the first stiffening member.
The fastener member may be provided on the same wall as the first and second stiffening members, positioned next to the second stiffening member and further away from the opening than the first and second stiffening members.
The second stiffening member may be provided on the wall which does not include the first stiffening member and positioned opposite the first stiffening member. The fastener member may be provided on the first or second wall, positioned next to the first or second stiffening member and further away from the opening than the first and second stiffening members.
The second stiffening member may be provided on the wall which does not include the first stiffening member and may be positioned further away from the opening than the first stiffening member.
The fastener member may be provided on the same wall as the first stiffening member and may be positioned opposite the second stiffening member.
The outlet may be foldable upon itself about the stiffening member, or first and second stiffening members, to a stowed position.
The fastener member may be rigid.
The fastener member may be slidably movable within the aperture.
At least a part of the fastener member may be rotatably movable relative to the wall of the outlet to which the fastener member is connected.
The ostomy appliance may include a plurality of fastener members, and preferably may further include a plurality of apertures corresponding to the plurality of fastener members.
BRIEF DESCRIPTION OF THE FIGURES
In order that the present disclosure may be more readily understood, preferable embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, in which:
FIGURE 1 is a rear view of an ostomy appliance in an in-use position in accordance with the present disclosure;
FIGURE 2 is a front view of the appliance of figure 1 ;
FIGURE 3a is a front view of a part of the appliance of figure 1 ;
FIGURE 3b is a front view of a part of the appliance of figure 1 ;
FIGURE 4 is a front view of the appliance of figure 1 in a stowed position;
FIGURE 5a is a perspective view of a fastener member of the appliance of figure 1 ;
FIGURE 5b is a front view of the fastener member of figure 5a;
FIGURE 5c is a side view of the fastener member of figure 5a;
FIGURE 6 is a rear view of an ostomy appliance in an in-use position in accordance with the present disclosure;
FIGURE 7a is a side view of a fastener member of the appliance of figure 6;
FIGURE 7b is a front view of the fastener member of figure 7a in an unlocked position;
FIGURE 7c is a front view of the fastener member of figure 7a in a locked position;
FIGURE 8 is a front view of the appliance of figure 6 in a stowed position;
FIGURE 9 is a rear view of an ostomy appliance in an in-use position in accordance with the present disclosure;
FIGURE 10 is a front view of the appliance of figure 9 in a stowed position; FIGURE 11a is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure;
FIGURE 11 b is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure;
FIGURE 12 is a side view of the appliance of figure 11a in a stowed position;
FIGURE 13 is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure;
FIGURE 14 is a side view of the appliance of figure 13 in a stowed position;
FIGURE 15a is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure; and
FIGURE 15b is a side view of an ostomy appliance in an in-use position in accordance with the present disclosure.
DETAILED DESCRIPTION OF THE DISCLOSURE
Referring to figures 1 to 15b there is provided an ostomy appliance 10. The ostomy appliance 10 has an upper end 1 1 and a lower end 13. The ostomy appliance 10 has first and second walls 12, 14 connected to each other at or near their peripheries, by any suitable means known in the art. For example, they could be adhered to each other, or heat welded.
The first wall 12 includes a stoma-receiving opening 16 for receipt of a user’s stoma and also supports a connection member or flange 20 for attaching the appliance 10 to a user. In embodiments, the connection member 20 may be a hydrocolloid wafer for securing the ostomy appliance 10 to the skin of a user around their stoma. Alternatively, the connection member 20 may be for attaching the ostomy appliance 10 to a flange for attaching the appliance 10 to a user (e.g. a two-piece appliance as it is known in the art).
The first and second walls 12, 14 define a waste collecting cavity 18 therebetween, which is fluidly connected to the stoma-receiving opening 16 such that waste from the stoma may be collected and stored within the cavity 18.
The lower end 13 end of the appliance 10 is provided with an outlet 22 formed by portions of the first and second walls 12, 14. The outlet 22 extends downwardly away from the stoma-receiving opening 16 and terminates at an opening 24. The opening 24 permits waste collected in the waste collecting cavity 18 to be expelled from the appliance 10.
The outlet 22 may be moved between an in-use position and a stowed positioned. In the in-use position, the outlet 22 may be unfurled such that the user may drain or otherwise expel waste from the waste collecting cavity 18 through the opening 24. In this in-use position, the opening 24 may be opened and closed by the user manipulating the walls 12, 14 of the outlet 22 close to the opening 24, or the opening 24 may be biased into an open state.
In the stowed positioned, the outlet 22 may be at least partially folded or rolled up such that the opening 24 of the outlet 22 is sealed or otherwise held in a closed or shut condition so that waste collected in the waste collecting cavity 18 cannot escape or leak through the opening 24. In addition, maintaining the outlet 22 in a folded or rolled up condition during use of the appliance 10 minimizes the amount of waste that may collect within the outlet 22.
Moving the outlet between the in-use position and the stowed position may be assisted by the use of at least one stiffening member 26 provided on the first or second wall 12, 14, or a plurality of stiffening members 26a, 26b provided on the first and/or second wall 12, 14 as described in more detail below.
As shown in figures 2 and 4, the ostomy appliance 10 also includes a comfort layer 17. The comfort layer 17 may be formed of a flexible material, which may be a woven material or a non- woven material as known in the art. In embodiments, the comfort layer 17 may be positioned over the first or second wall 12, 14 of the appliance 10. The comfort layer 17 may be connected to first or second wall 12, 14 of the appliance 10 at or near their peripheries, by any suitable means known in the art. In embodiments, and as shown in figures 2 and 4, only a portion of the comfort layer 17 may be connected to the first or second wall 12, 14 such that a portion 17a, or portions, of the comfort layer 17 is/are not connected directly to the first or second wall 12, 14 and is/are freely movable with respect to the appliance 10. Figures 2 and 4 shows an example of a freely movable portion 17a of the comfort layer 17 as a portion of the comfort layer 17 positioned below the dashed line X. In embodiments, the appliance 10 may include a plurality of comfort layers 17 each positioned over the first and second walls 12, 14.
As shown in figures 2 and 4, the comfort layer 17 may extend across a portion of the external surface of the first or second walls 12, 14 which define the waste collecting cavity 18. In other embodiments, the comfort layer 17 may extend only partially across the external surface of the first or second wall 12, 14, or it may extend across the entire external surface of the first or second wall 12, 14 which define the waste collecting cavity 18 and also across a portion of, the entirety of, or beyond the opening 24 of, the outlet 22.
In the present embodiment, the comfort layer 17 further includes an aperture 19 which extends through the comfort layer 17. The aperture 19 may be provided on a freely movable portion 17a of the comfort layer 17. As shown in figures 2, 3a and 3b, the aperture 19 may be an elongate slot which extends in a direction from the stoma-receiving opening 16 and towards the opening 24 of the outlet 22. In other words, the aperture 19 may extend in a vertical direction with respect to the appliance 10 in normal use. In other embodiments, the aperture 19 may extend in other directions, such as horizontally between a left and right side of the comfort layer 17, or inclined with respect to a vertical/horizontal direction.
In embodiments, the aperture 19 may include first and second sides 19a, 19b which extend in a direction from the stoma-receiving opening 16 and towards the opening 24 of the outlet, and which may be generally parallel to each other. The first and second sides 19a, 19b of the aperture 19 may be connected by first and second curved ends 19c, 19d . In other embodiments, the first and second sides 19a, 19b may be arranged such that they are non-parallel to each other, and/or may be connected by first and second ends 19c, 19d which are not curved. As shown in figure 3b, a distance D1 between the first and second sides 19a, 19b may be less than a length L1 of the first and second sides 19a, 19b.
As the comfort layer 17 may be formed of a flexible material, the comfort layer 17 may be deformable such that the material surrounding the aperture 19 may also be deformable. Thus, in use of the appliance 10, the user may deform or otherwise manipulate the shape of the aperture 19. The appliance 10 also includes a fastener member 30 which is connected, directly or indirectly, to the first or second wall 12, 14 of the outlet 22. In embodiments, the fastener member 30 may be permanently connected to the first or second wall 12, 14 by the use of an adhesive or by welding. In other embodiments, the fastener member 30 may be releasably connected to the first or second wall 12, 14, for instance by the use of a hook and loop fastener or other temporary and reversible form of connecting means. The fastener member 30 is used to releasably fasten or otherwise secure or hold the outlet 22 in a stowed position. As shown in figures 4, 8, 12 and 14, the fastener member 30 and the aperture 19 may be used together to fasten the outlet in a stowed position, such that the aperture 19 cooperates with the fastener member 30 to fasten the outlet 22 relative to the comfort layer 17.
In the present embodiment, the fastener member 30 includes a formation 32. In use of the appliance 10, the formation 32, or a portion of the formation 32, passes through the aperture 19 to fasten the outlet 22 relative to the comfort layer 17. The fastener member 30 may further include a base 34 which may be used to connect the fastener member 30 to the first or second wall 12, 14, and a connecting portion 36 which connects the formation 32 to the base 34. As shown in figures 5a to 5c, the formation 32 may be substantially circular or elliptical in profile. In other embodiments, the formation 32 may have a profile of a different shape, such as substantially square or rectangular or any other appropriate shape. The fastener member 30, or at least a part of the fastener member 30, may be formed from a rigid material such as a plastic material or a metal material. In other embodiments, the fastener member 30, or at least a part of the fastener member 30 may be formed from a flexible and/or resilient material. In embodiments, parts of the fastener member 30 may be made from differing materials or may be formed from the same material as a unitary component.
As shown in figure 5b, the formation 32 may have a width W which may correspond to the outer extremities of the perimeter of the profile of the formation 32. For instance, for formation 32 with a substantially circular profile, the width W may correspond to the diameter of the formation 32. In embodiments, the distance D1 between the first and second sides 19a, 19b of the aperture 19 may be less than the width W of the formation 32. In use of the appliance 10, the difference between the distance D1 between the first and second sides 19a, 19b the aperture 19 and the width W of the formation 32 means that the outlet 22 may be securely fastened to the comfort layer 17 with a reduced risk of the formation 32 inadvertently passing back through the aperture 19. Once the user of the appliance 10 has passed the formation 32 through the aperture 19 or passed the aperture 19 over the formation 32, the greater width W of the formation 32 relative to the distance D1 between the first and second sides 19a, 19b of the aperture 19 assists in preventing the accidental decoupling of the outlet 22 from the comfort layer 17 in the absence of manipulation of the aperture 19 and/or the cover layer 17 by a user of the appliance 10.
In embodiments, the profile of the formation 32 may change along a length L of the formation 32.
As shown in figure 5c, this formation 32 may have a top surface 32a and a bottom surface 32b which are linked by a connecting surface 32c. A width W1 of the profile of the top surface 32a may be less than a width W2 of the bottom surface 32b, such that the top surface 32a and bottom surface 32b are connected by a sloped or otherwise inclined connecting surface 32c. As shown in figure 5a, when the profiles of the top surface 32a and bottom surface 32b are substantially circular, the formation 32 may be substantially frustoconical in shape. This construction of a formation 32 is advantageous because the formation 32 may be more easily passed through the aperture 19 in a direction which corresponds to the user of the appliance fastening the outlet 22 to the comfort layer 17, due to the top surface 32a being of a lesser width than the bottom surface 32b. However, due to the greater width W2 of the bottom surface 32b relative to the width W1 of the top surface 32a, the accidental decoupling of the outlet 22 from the comfort layer 17 may be prevented.
A part of the fastener member 30 which is held within the aperture 19 may be slidably movable within the aperture 19. For instance, when the outlet 22 is in a stowed position and the outlet 22 is fastened to the comfort layer 17, the connecting portion 36 may be positioned within the aperture 19 and may be slidably movable within the aperture 19. Advantageously, the ability of the fastener member 30 to slide within the aperture 19 reduces the risk of the comfort layer 17 tearing or being pulled away from the first or second wall 12, 14 to which it is attached, and also reduces the risk of the fastener member 30 becoming damaged or removed from the first or second wall 12, 14 to which it is attached, when a force is applied, directly or indirectly, to the comfort layer 17 and/or fastener member 30.
In embodiments, at least a part of the fastener member 30 may be rotatable relative to the first or second wall 12, 14 to which it is attached between an unlocked and a locked position. As shown in figures 6 to 8, the formation 32 may be configured such that rotation of the formation 32 relative to the aperture 19 causes the width of the formation 32 to change relative to the width of the aperture 19. In embodiments, the formation 32 may have only one order of rotational symmetry, meaning that in any rotational orientation other than 0° or 180° relative to an initial orientation the overall width of the of the formation 32 relative to the aperture may change.
As shown in figures 7b and 7c, the formation 32 may have a first width W’1 measured in a first direction across the formation 32, and a second width W’2 measured in a second direction across the formation 32 which may be perpendicular to the first direction, with the first width W’1 being different to the second width W’2.
In embodiments, the first width W’1 of the formation 32 may be greater than, or may be the same as, the distance D1 between the first and second sides 19a, 19b of the aperture 19 through which the formation 32 is to be passed through. The first width W’1 may be selected so that when the fastener member 30 is in the unlocked position, the formation 32 may be easily passed through the aperture 19, without the requirement to significantly deform the aperture 19 and cover layer 17. In other embodiments, the first width W’1 of the formation 32 may be less than the distance D1 between the first and second sides 19a, 19b of the aperture 19, so that the formation 32 may pass through the aperture 19 without any deformation of the aperture 19 and the cover layer 17.
Once the user has passed the formation 32 through the aperture 19, the user may then rotate the formation 32 relative to the first or second wall 12, 14 to which it is attached into a locked position. Rotation of the formation 32 causes the comparatively wider part of the formation 32 to span the distance D1 between the first and second sides 19a, 19b of the aperture 19, such that the part of the formation 32 having a width W’2 is now oriented substantially perpendicularly, or inclined, relative to the first and second sides 19a, 19b of the aperture 19. The width W’2 of the formation 32 may be selected so that it is significantly greater than the distance D1 between the first and second sides 19a, 19b of the aperture 19 so that the formation 32 is prevented from passing through the aperture 19 even if the cover layer 17 and aperture are deformed significantly. This greatly reduces the likelihood that the outlet 22 will be inadvertently decoupled or unfastened from the comfort layer 17.
In embodiments, the formation 32 may be rotationally movable relative to the connecting portion 36 and the base 34, or both the formation 32 and the connection portion 36 may be rotationally movable relative to the base 36, about an axis of rotation R. The rotation of the formation 32, and in some embodiments the connection portion 36, into the locked position may be clearly identified to the user by the use of a detent, a stop, and/or an audible click.
In embodiments, the formation 32 may include a central portion 35 and at least one protrusion 37. The central portion 35 may be generally circular or elliptical in profile or may be of any other appropriately shaped profile. The protrusion(s) 37 may extend away from the central portion 35 in a direction which is generally perpendicular to the axis of rotation R. The central portion 35 and protrusion(s) 37 may be rotatable about the axis of rotation R, or only the protrusions 37 may be rotatable about the axis of rotation R.
In embodiments the appliance 10 may include a plurality of fastener members 30 connected to the first and/or second walls 12, 14. As shown in figures 9 and 10, the appliance 10 may include a fastener member 30 and a further fastener member 30’. The further fastener member 30’ may be similar to, or identical to the fastener member 30. In embodiments, the fastener member 30 and the further fastener member 30’ may be of a different size and/or shape, and one or both of them may be rotationally movable.
In embodiments, the fastener member 30 and further fastener member 30’ may cooperate with a shared aperture 19, which may be configured such that it can accommodate both fastener members 30, 30’. In other embodiments, and as shown in figure 10, each fastener member 30, 30’ may cooperate with a respective aperture 19 and a further aperture 19’. In embodiments, the apertures 19, 19’ may be similar, or may be identical. In other embodiments, the aperture 19 and further aperture 19’ may be of a different size and/or shape and may be positioned in different rotational orientations. In embodiments, the outlet 22 may be fastened to the comfort layer 17 with the fastener member 30, and in some embodiments, the further fastener member 30’, in conjunction with other means of securing the outlet in a stowed position, such as a hook and loop fastener or any other appropriate means.
In embodiments, the appliance 10 may also include at least one stiffening member 26 which is/are provided to assist with opening and closing the opening 24 of the outlet 22 and for moving the outlet between the in use and stowed positions. Figures 11a to 12 show an embodiment of an appliance having one stiffening member 26. The stiffening member 26 may be provided on the first or second wall 12, 14 of the outlet 22, and may be positioned close to, or immediately adjacent, the opening 24 of the outlet 22. The stiffening member 26 may be connected to an exterior surface of the first or second wall 12, 14 of the appliance 10, e.g., by the use of an adhesive or by welding.
The stiffening member 26 may extend substantially laterally across a portion of, or the entirety of, the outlet 22, such that it extends generally perpendicularly to the direction in which waste exits the appliance 10.
The stiffening member 26 need only be stiff in the sense it is relatively stiff compared to the walls 12, 14 of the ostomy appliance 10. In embodiments, the stiffening member 26 may be injection moulded from a plastics material. The stiffening member 26 may be substantially square or rectangular in shape, and may be generally planar such that it is of a constant thickness. In other embodiments, the stiffening member 26 may be provided in any other appropriate shape, and at least one surface of the stiffening member 26 may be contoured or otherwise generally non-planar.
In use of the appliance 10, the outlet 22 may be moved from an in-use position to a stowed position by rolling the walls 12, 14 of the outlet 22 around the stiffening member 26, as is generally known in the art. Such rolling up of the walls 12, 14 uses a laterally extending edge of the stiffening member 26 as a fulcrum to assist in tight closing of the outlet 22 to prevent leakage of collected waste through the opening 24, and to prevent the build-up of waste within the outlet 22 when the outlet 22 is in a stowed position.
Embodiments are shown in figures 11a to 12 which include a fastener member 30 and a stiffening member 26 provided on the outlet 22 of the appliance 10. It should be understood that a stiffening member 26 may be used to assist in closing the outlet 22 in conjunction with a single fastener member 30, or a plurality of fastener members 30, 30’. Therefore, references to the fastener member 30 in this context should be construed as also being applicable to embodiments of an appliance 10 which include a plurality of fastener members 30, 30’.
The fastener member 30 may be provided on the same wall as the stiffening member 26. Figure 11a shows the fastener member 30 and stiffening member 26 connected to the first wall 12 of the outlet 22. In other embodiments, the fastener member 30 and stiffening member 26 may be connected to the second wall 14 of the outlet 22. The fastener member 30 may be positioned on the first wall 12 between the stoma-receiving opening 16 and the stiffening member 26, such that it is positioned further away from the opening 24 of the outlet 22 relative to the stiffening member 26. In other embodiments, the fastener member 30 may be directly or indirectly connected to, or formed integrally, with the stiffening member 26.
To move the outlet 22 from an in-use position to a stowed position, the user pivots or rotates the stiffening member 26 about its top laterally extending edge 27 such that it is now held opposite the fastener member 30. The user then pivots or rotates the stiffening member 26 about its bottom laterally extending edge 28 to an orientation whereby the fastener member 30 is pivoted or rotated such that the base 34 of the fastener member 30 is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19. The user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
In another embodiment the fastener member 30 may be provided on a wall which does not include the stiffening member 26, i.e., it is provided on a wall which is opposite the stiffening member 26. Figure 11b shows the fastener member 30 connected to the first wall 12 of the outlet 22, and the stiffening member 26 connected to the second wall 14 of the outlet 22. In other embodiments, the walls 12, 14 to which the fastener member 30 and stiffening member 26 are connected may be the opposite to that described above. The fastener member 30 is positioned on the first wall 12 between the stoma-receiving opening 16 and the opening 24 of the outlet 22, and opposite the stiffening member 26.
To move the outlet 22 from an in-use position to a stowed position, the user pivots or rotates the stiffening member 26 about a top laterally extending edge 27 such that the fastener member 30 is pivoted or rotated to an orientation whereby the base 34 of the fastener member 30 is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19. The user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
As shown in figures 1 , 6, 9 and 13 to 15, in other embodiments the appliance 10 may include a first stiffening member 26a and a second stiffening member 26b which are provided to assist with opening and closing the opening 24 of the outlet 22 and for moving the outlet between the in-use and stowed positions. In these embodiments, the outlet 22 is foldable upon itself about the first and second stiffening members 26a, 26b to a stowed position. The first and second stiffening members 26a, 26b may be identical, or substantially similar. In other embodiments, the first and second stiffening members 26a, 26b may differ in size, shape and/or contour.
In embodiments, the first stiffening member 26a may be provided on the first or second wall 12, 14 of the outlet 22 and may be positioned close to, or immediately adjacent the opening 24 of the outlet 22. The second stiffening member 26b may be provided on the first or second wall 12, 14 of the outlet 22.
As shown in figure 1 , 6, 9 and 13, the first and second stiffening members 26a, 26b may be provided on the first wall 12 of the outlet 22. The second stiffening member 26b may be positioned next to the first stiffening member 26a such that a bottom laterally extending edge 28b of the second stiffening member 26b is close to or adjacent a top laterally extending edge 27a of the first stiffening member 26a. In other words, the second stiffening member 26b may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
The fastener member 30 may also be provided on the first wall 12 of the outlet 22 and may be positioned next to the second stiffening member 26b such that it is close to or adjacent a top laterally extending edge 27b of the second stiffening member 26b. In other words, the fastener member 30 may be positioned further away from the opening 24 of the outlet 22 than the second stiffening member 26b.
To move the outlet 22 from an in-use position to a stowed position, the user pivots or rotates the first stiffening member 26a about its top laterally extending edge 27a such that it is now held opposite the second stiffening member 26b. The user then pivots or rotates the second stiffening member 26b about its top laterally extending edge 27b such that the first and second stiffening members 26a, 26b are now held opposite the fastener member 30. The user then pivots or rotates the first stiffening member 26a about its top laterally extending edge 27a and the second stiffening member 26b about its bottom laterally extending edge 28b to an orientation whereby the fastener member 30 is pivoted or rotated such that the base 34 of the fastener member 30 is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19, as shown in figure 14. The user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
In another embodiment, as shown in figure 15a, the first stiffening member 26a may be provided on the first wall 12 of the outlet 22, and the second stiffening member 26b may be provided on the second wall 14 of the outlet 22. The second stiffening member 26b may be positioned opposite the first stiffening member 26a such that a bottom laterally extending edge 28b of the second stiffening member 26b is close to or adjacent the opening 24 of the outlet 22.
The fastener member 30 may be provided on the first wall 12 of the outlet 22 and may be positioned next to the first stiffening member 26a such that it is close to or adjacent a top laterally extending edge 27a of the first stiffening member 26a. In other words, the fastener member 30 may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
To move the outlet 22 from an in-use position to a stowed position, the user pivots or rotates the first stiffening member 26a and second stiffening member 26b about their respective top laterally extending edges 27a, 27b such that they are now held opposite fastener member 30. The user then pivots or rotates the first stiffening member 26a and second stiffening member 26b about their respective bottom laterally extending edges 28a, 28b to an orientation whereby the fastener member 30 is pivoted or rotated such that the base 34 of the fastener member is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19. The user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
In another embodiment, as shown in figure 15b, the first stiffening member 26a may be provided on the first wall 12 of the outlet, and the second stiffening member 26b may be provided on the second wall 14 of the outlet 22. The second stiffening member 26b may be positioned such that a bottom laterally extending edge 28b of the second stiffening member 26b is positioned above a top laterally extending edge 27a of the first stiffening member 26a. In other words, the second stiffening member 26b may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
The fastener member 30 may be provided on the first wall 12 of the outlet 22 and may be positioned opposite the second stiffening member 26b, and next to the first stiffening member 26a such that it is close to or adjacent a top laterally extending edge 27a of the first stiffening member 26a. In other words, the fastener member 30 may be positioned further away from the opening 24 of the outlet 22 than the first stiffening member 26a.
To move the outlet 22 from an in-use position to a stowed position, the user pivots or rotates the first stiffening member 26a about a top laterally extending edge 27a such that it is now held opposite the second stiffening member 26b and fastener member 30, with a portion of the second wall 14 of the outlet 22 held in between the first and second stiffening members 26a, 26b. The user then pivots or rotates the first stiffening member 26a about a bottom laterally extending edge 28a and the second stiffening member 26b about a top laterally extend edge 27b to an orientation whereby the fastener member 30 is pivoted or rotated such that the base 34 of the fastener member 30 is positioned close to or adjacent the second wall 14 of the appliance 10, and such that the formation 32 is close to or adjacent the freely movable portion 17a of the comfort layer 17 which is provided with an aperture 19. The user then fastens the outlet 22 relative to the comfort layer 17 and the appliance 10 by passing the formation 32 of the fastener member 30 through the aperture 19, as described above.
The skilled person would readily understand that other arrangements of first and second stiffening members 26a, 26b, and fastener member(s) 30, are possible including arrangements whereby the fastener member(s) 30 are connected to the second wall 14 of the outlet 22. In addition, the skilled person would understand that more than two stiffening members 26 may be used to assist in moving the outlet 22 between in-use and stowed positions and may be used with a fastener member 30 as described above to fasten the outlet 22 to the comfort layer 17 in a stowed position.
The use of a stiffening member 26 or a plurality of stiffening members 26a, 26b to assist in moving the outlet 22 between in-use and stowed positions in conjunction with a fastener member 30 is advantageous as the stiffening member(s) 26 ensure that the outlet 22 can be accurately folded or rolled up in a predetermined, repeatable manner. This reduces the wear and tear of the outlet 22 when it is subjected to repeated movement between in-use and stowed positions, and also means that the fastener member 30 can be optimally positioned on the outlet 22 such that when the outlet 22 is moved to a stowed position the fastener member 30 will always be positioned in a known location relative to the aperture 19 of the comfort layer 17. Therefore, the aperture 19 may be positioned on the comfort layer 17 such that the fastener member 30 may be held centrally, or in any other desired relative position, in the aperture 19 when the outlet 22 is in a stowed position.
In addition, the use of a stiffening member 26, or a plurality of stiffening members 26a, 26b. enhances the closure of the outlet 22 as the laterally extending edges 27, 28 of the stiffening member(s) 26 assist in the tight closing of the walls 12, 14 of the outlet 22 to prevent leakage of collected waste through the opening 24. The prevention of leakage ensures that when the appliance 10 is used to collect waste, the waste cannot leak out of the opening 24 and onto the fastener member 30 and comfort layer 17, thereby enhancing the hygienic use of the fastener member 30 and comfort layer 17.
When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components. The invention may also broadly consist in the parts, elements, steps, examples and/or features referred to or indicated in the specification individually or collectively in any and all combinations of two or more said parts, elements, steps, examples and/or features. In particular, one or more features in any of the embodiments described herein may be combined with one or more features from any other embodiment(s) described herein.
Protection may be sought for any features disclosed in any one or more published documents referenced herein in combination with the present disclosure. Although certain example embodiments of the invention have been described, the scope of the appended claims is not intended to be limited solely to these embodiments. The claims are to be construed literally, purposively, and/or to encompass equivalents.

Claims

1. An ostomy appliance including: first and second walls connected to each other at or near their peripheries; a stoma-receiving opening for receipt of a stoma; a collecting cavity defined between the first and second walls wherein the stoma-receiving opening is fluidly connected to the collecting cavity; a connection member connected to the first and/or second wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user; an outlet which extends away from the stoma-receiving opening, the outlet terminating in an opening, wherein the outlet is movable between an in-use position and a stowed position; a fastener member for releasably fastening the outlet in the stowed position, said first fastener member being connected, directly or indirectly, to the outlet; a comfort layer positioned over the first and/or second wall; wherein the comfort layer includes an aperture which cooperates with the fastener member to fasten the outlet relative to the comfort layer; wherein the fastener member includes a formation which passes through the aperture to fasten the outlet relative to the comfort layer.
2. An ostomy appliance according to claim 1 wherein the fastener member and aperture fasten the outlet in a stowed position.
3. An ostomy appliance according to any preceding claim wherein the aperture is an elongate slot which extends in a direction from the stoma-receiving opening towards the opening of the outlet.
4. An ostomy appliance according to any preceding claim wherein the aperture has first and second sides which are generally parallel.
5. An ostomy appliance according to claim 4 wherein the first and second sides are connected by first and second curved ends.
6. An ostomy appliance according to claim 4 or claim 5 wherein a distance between the first and second sides is less than a length of the first and/or second sides.
7. An ostomy appliance according to any one of claims 4 to 6 wherein a distance between the first and second sides is less than a width of the formation.
8. An ostomy appliance according to any preceding claim wherein the outlet is foldable upon itself to a stowed position.
9. An ostomy appliance according to any preceding claim including a stiffening member provided on the first or second wall and positioned immediately adjacent the opening of the outlet.
10. An ostomy appliance according to claim 9 wherein the fastener member is provided on the first or second wall of the outlet.
11. An ostomy appliance according to claim 10 wherein the fastener member is provided on the same wall as the stiffening member and positioned between the stiffening member and the stoma-receiving opening, or wherein the fastener member is provided on the wall which does not include the stiffening member and positioned opposite the stiffening member.
12. An ostomy appliance according to any preceding claim including: a first stiffening member provided on the first or second wall and positioned immediately adjacent the opening of the outlet; and a second stiffening member provided on the first or second wall.
13. An ostomy appliance according to claim 12 wherein the second stiffening member is provided on the same wall as the first stiffening member, positioned next to the first stiffening member and further away from the opening than the first stiffening member.
14. An ostomy appliance according to claim 13 wherein the fastener member is provided on the same wall as the first and second stiffening members, positioned next to the second stiffening member and further away from the opening than the first and second stiffening members.
15. An ostomy appliance according to claim 12 wherein the second stiffening member is provided on the wall which does not include the first stiffening member and positioned opposite the first stiffening member.
16. An ostomy appliance according to claim 15 wherein the fastener member is provided on the first or second wall, positioned next to the first or second stiffening member and further away from the opening than the first and second stiffening members.
17. An ostomy appliance according to claim 12 wherein the second stiffening member is provided on the wall which does not include the first stiffening member and is positioned further away from the opening than the first stiffening member.
18. An ostomy appliance according to claim 17 wherein the fastener member is provided on the same wall as the first stiffening member and is positioned opposite the second stiffening member.
19. An ostomy appliance according to any of claims 9 to 18 wherein the outlet is foldable upon itself about the stiffening member, or first and second stiffening members, to a stowed position.
20. An ostomy appliance according to any preceding claim wherein the fastener member is rigid.
21. An ostomy appliance according to any preceding claim wherein the fastener member is slidably movable within the aperture.
22. An ostomy appliance according to any preceding claim wherein at least a part of the fastener member is rotatably movable relative to the wall of the outlet to which the fastener member is connected.
23. An ostomy appliance according to any preceding claim including a plurality of fastener members, and preferably further including a plurality of apertures corresponding to the plurality of fastener members.
PCT/GB2023/052858 2022-11-04 2023-11-02 An ostomy appliance WO2024095001A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2216471.9A GB2624022A (en) 2022-11-04 2022-11-04 An ostomy appliance
GB2216471.9 2022-11-04

Publications (1)

Publication Number Publication Date
WO2024095001A1 true WO2024095001A1 (en) 2024-05-10

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Application Number Title Priority Date Filing Date
PCT/GB2023/052858 WO2024095001A1 (en) 2022-11-04 2023-11-02 An ostomy appliance

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GB (1) GB2624022A (en)
WO (1) WO2024095001A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200214875A1 (en) * 2017-09-22 2020-07-09 Salts Healthcare Limited Drainable ostomy appliance
CA3180726A1 (en) * 2020-06-05 2021-12-09 Iain POWNER An ostomy appliance

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2566722B (en) * 2017-09-22 2022-02-23 Salts Healthcare Ltd A drainable ostomy appliance

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200214875A1 (en) * 2017-09-22 2020-07-09 Salts Healthcare Limited Drainable ostomy appliance
CA3180726A1 (en) * 2020-06-05 2021-12-09 Iain POWNER An ostomy appliance

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GB2624022A (en) 2024-05-08
GB202216471D0 (en) 2022-12-21

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