Patent Description:
Ostomy appliances are used by people with a stoma to capture stomal output that passes out fo the stoma such that it can be conveniently and hygienically disposed of. To reduce the number of times that a person needs to replace an ostomy appliance, drainable (or "open") ostomy appliances have been developed that have a drain which can be opened to allow the contents of the ostomy appliance to be disposed of. The drain can then be re-sealed to allow continued use of the ostomy appliance which has corresponding cost savings as well as being more convenient for the user and environmentally friendly.

The addition of a drain as described above can however lead to some problems with use of the ostomy appliance. For example, if the user is not able to securely reseal the drain then there is an increased likelihood of the contents of the ostomy appliance leaking through the drain which can lead to a hygienic risk and an unpleasant smell as well as discomfort and embarrassment for the user. In addition, through multiple use cycles, the opposing internal walls of the drain are likely to become wet. This makes opening of the drain more difficult as the flexible plastics material typically used sticks to itself when wet.

To overcome the above issues, drainable ostomy appliances have been developed with one or more pursing strips provided on the drain to provide a rigid structure the drain. The drain can then be folded around the pursing strips which improves the re-sealability of the drain. The pursing strips can also be used to assist with opening of the drain, for example in <CIT> a pair of pursing strips are provided with intrinsic curvature to separate the drain, however, this intrinsic curvature adds additional size to the drain which could be uncomfortable for the user.

In a different example <CIT> discloses a small notch provided in a pursing strip and also in a corresponding position on the drain to allow the user to insert their finger into the drain to open it. Howver, this is likely to be unpleasant for the user and could also present a hygienic risk as the drain is typically not clean after one use cycle and even on the first use they would need to both open the drain to let stomal output flow out the drain and remove their finger before the liquids in the stomal output got down to their finger, which is likely to be difficult.

In another example <CIT> discloses a drain with axially and transversely extending fold-lines covering one side of the drain to guide the opening and closing of the drain. In one embodiment, the axially extending fold lines are slanted so that they converge at a distal end of the drain. Howver, this is likely to be unpleasant for the user because of the additional bulk that is present in the drain due to the additional rigidity added over all of one side of the drain. In addition, this additional bulk means the drain is not well suited to being folded back onto itself and so an optional stiffening is provided on the other side of the fold-lines at the distal end of the drain to allow the flexible drain material to be folded around something. Of course, this optional stiffening adds further bulk to the drain exacerbating any discomfort due to the size of the drain.

<CIT> discloses an ostomy instrument that comprises a storage unit for storing excrement, a discharge path having a base end section connected to a housing section and a tip section. A discharge port allows discharge of excreta from the storage section through a discharge path. The tip section can be folded towards the storage section.

<CIT> discloses a drainable ostomy pouch outlet with a single-piece closure member including at least one transversely extending fold line. The fold line facilitates folding up and closing of the outlet.

<CIT> discloses a disposable pouch for continuously receiving feces from a patient. The pouch comprises an outlet that is closed by a clamp.

<CIT> discloses a medical device opening system. The medical device is foldable from an open condition to a closed condition and may be secured in the closed condition.

It is therefore an object of the present invention to provide an ostomy appliance that at least partially addresses the above problems.

The invention provides an ostomy appliance according to claim <NUM>. A pursing strip of the one or more pursing strips may incorporate a notch. The pursing strip may comprise a transverse edge. The notch may span at least half of the transverse edge. At least one of the one or more pursing strips may be a first pursing strip. The first pursing strip may be the pursing strip as outlined above, i.e. it may comprise a notch. The first pursing strip may comprise an upper and a lower edge which may be substantially perpendicular to the two lateral edges of the drain. The lower edge may be the transverse edge outlined above. The transverse edge may therefore be substantially perpendicular to the two lateral edges of the drain.

According to a first aspect of the present invention, there is provided an ostomy appliance according to claim <NUM>. A pursing strip of the one or more pursing strips may comprise a transverse edge substantially perpendicular to the two lateral edges of the drain and the transverse edge comprises a notch spanning at least half of the transverse edge.

The inventors have found that by providing a notch that spans at least half of the width of a pursing strip provides the pursing strip with mechanical properties that enable it to effectively separate the walls of the drain and open the drain when compressed. As the notch is provided along one transverse edge, this side of the pursing strip is both weaker and has more space to flex as compared to the other transverse edge. So when compressed, the pursing strip has a varying curvature in a direction parallel to the lateral edges which causes the two walls to separate. In addition, once the compression is released, the pursing strip is not damaged and can recover a flat shape to allow the drain to be efficiently closed without adding additional bulk to the ostomy appliance.

Each of the one or more pursing strips may be planar. Each of the one or more pursing strips may be substantially flat (at rest). Each of the one or more pursing strips may have an intrinsic curvature of approximately zero (at rest). The intrinsic curvature of each of the one or more pursing strips may be approximately zero as measured in any plane perpendicular to the walls of the drain. Thus, at rest, i.e. in the absence of a compressive force perpendicular to the walls of the drain, the pursing strips are not bent and therefore do not project out of the plane of the walls to cause potential discomfort and inconvenience to the user during use.

The drain may have a width measured between the lateral edges of the drain. Each of the one or more pursing strips may have a width substantially parallel to the width of the drain. The width of the drain may be the same, or substantially the same, as the width of the pursing strip. Thus, the pursing strips may be used to effectively seal the drain as it spans all the way across the width of the drain.

Each of the one or more pursing strips has two side edges corresponding to the lateral edges of the drain. Each of the one or more pursing strips may have a length defined parallel to their two side edges. The length of a pursing strip may be the same as the length of a side edge. Each of the one or more pursing strips may have an upper edge and a lower edge. Thus, each of the one or more pursing strips may be substantially rectangular.

Each of the one or more pursing strips may be more rigid than the walls of the drain. Each of the one or more pursing strips may comprise a strip of flexible material attached to a wall of the drain. Each of the one or more pursing strips may be formed from a flexible plastics material, such as high density polyethylene (HDPE), or polystyrene. Each of the walls may be formed from a flexible plastics material, such as low density polyethylene (LDPE) or ethylene-vinyl acetate (EVA). Thus, the pursing strips provide increased resilience to the drain and can be used to effectively open and seal the drain.

The drain may comprise a proximal end to receive stomal output from the pouch. The distal end may be at an opposite end of the drain from the proximal end when the drain is in an open, or "unfurled" configuration. The drain may have a length measured between the proximal and distal ends of the drain. The pursing strip may be arranged at the distal end of the drain. The notch may be provided in a distal transverse edge. The distal transverse edge may be arranged at the distal end of the drain, Thus, the pursing strip can be used to separate the walls of the drain at the end of the drain to allow better control of emptying the pouch.

The notch may have a width parallel to the transverse edge. The notch may have a length perpendicular to its width. The length of the notch may be in a plane defined by the pursing strip. The notch may have an aspect ratio (width:length) of at least <NUM>:<NUM>, <NUM>:<NUM>, <NUM>:<NUM>, or <NUM>:<NUM>. The notch may have an aspect ratio (width:length) of no more than <NUM>:<NUM>, <NUM>:<NUM>, <NUM>:<NUM>, or <NUM>:<NUM>. Preferably, the notch has an aspect ratio (width:length) of <NUM>:<NUM>. Thus, the notch has an aspect ratio that optimises the mechanical properties of the pursing strip to help with opening of the drain without significant risk of damage to the pursing strip during bending.

The notch may be curved. The notch may be arced. The shape of the notch may be defined by an arc. The arc may have a radius of curvature that is greater than the width of the notch. The arc may have a radius of curvature that is greater than a width of the pursing strip, for example about <NUM>% greater than the width of the pursing strip. The arc may have a radius of curvature that is greater than a width of the drain. Thus, the arced shape helps to ensure the notch deforms predictably to open the drain.

The pursing strip may have a length parallel to the length of the notch. The length of the notch may be less than half, a third or a quarter of the length of the pursing strip. The length of the notch may at least a fifth or a quarter of the length of the pursing strip. Preferably, the length of the notch is about a quarter the length of the pursing strip. Thus, the length of the notch is chosen to provide adequate deformation of the pursing strip with risking damage of the pursing strip.

The notch may span at least <NUM>%, <NUM>%, <NUM>% or <NUM>% of the transverse edge. The notch may span no more than <NUM>%, <NUM>%, <NUM>% or <NUM>% of the transverse edge. Preferably, the notch spans no more than <NUM>% of the transverse edge, for example the notch may span <NUM>% to <NUM>% of the transverse edge. The notch may span <NUM>% of the transverse edge. Thus, a section of the transverse edge is free of the notch and ensures the pursing strip retains some mechanical strength to support deformation and opening of the drain.

The notch may be arranged towards a midpoint along the transverse edge. Preferably, the notch is arranged at the midpoint along the transverse edge. An apex of the arc of the notch may be arranged at or towards the midpoint along the transverse edge. The notch may be symmetrical about a midline of the pursing strip (the midline expending perpendicular to the transverse edge). Thus, the notch is centrally located to ensure even and predictable deformation of the drain during opening.

The parts of the transverse edge adjacent the side edges may not comprise the notch. Thus, compression of the pursing strip is easier.

The distal end of the drain may be straight. The notch may expose an end region of the distal end of the drain. The end region may not be directly attached to the one or more pursing strips. Thus, the end region provides further variation in the mechanical strength of the respective parts of the drain which increase the likelihood of separation of the walls of the drain during compression of the pursing strips.

The drain may have closed configuration in which passage of stomal output through the drain is inhibited. The drain may be rolled and/or folded in the closed configuration. The drain may define a tortuous channel in the closed configuration. The drain may be folded about the, or each, pursing strip in the closed configuration. Each pursing strip may define the locations and orientations of one or more folds of the drain. The drain may be foldable about one or more fold lines, or folds. One or more of the folds may close the tortuous channel. Thus, the pursing strip(s) may allow the drain to be effectively sealed shut.

The drain may have open configuration in which passage of stomal output through the drain is permitted. In the open configuration, the drain may be unfurled, e.g. unrolled and unfolded. The drain may define a substantially linear channel in the open configuration. Thus, the drain may be placed in the open configuration to allow draining of the pouch's contents.

The pouch may be formed from two walls sealed about their periphery. The two walls of the pouch may be formed from the same pieces of material as the corresponding two walls (i.e. the proximal and distal walls) of the drain. The two walls of the pouch may comprise the proximal wall and the distal wall of the drain. The pouch and drain may therefore be integrally formed. The proximal wall intended to be closest to the body of the user in use. The distal wall may be on an opposite side of the pouch and/or drain to the proximal wall.

The first pursing strip may be arranged on the proximal wall of the drain. The first pursing strip may be the only pursing strip arranged on the proximal wall of the drain. The one or more pursing strips may comprise a second pursing strip. The second pursing strip may be arranged on the distal wall. The second pursing strip may be the only pursing strip arranged on the distal wall of the drain. A lateral gap may be provided between the upper edge of the first pursing strip and a lower edge of the second pursing strip. The lateral gap may be at least <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. The lateral gap may be sized to allow the formation of a fold in the drain between the first and second pursing strips. Thus, the bulk of the drain is minimised without compromising performance.

The pouch may comprise a closure mechanism configured to retain the drain in the closed configuration. The closure mechanism may comprise one or more fastening elements. The one or more fastening elements may comprise a pouch fastening element provided on the pouch. The pouch fastening element may be positioned adjacent to the drain. The pouch fastening element may be configured to attach to the drain to retain it in the closed configuration. The pouch fastening element may be provided on the distal wall. Thus, the pouch fastening element is easily accessible to the user.

In the closed configuration, the drain may be folded about the first pursing strip at least three times. Thus, a fluid tight seal is generated by folding the drain.

The closure mechanism may comprise a closure flap. The closure flap may be provided on the pouch adjacent to the drain. The closure flap may be provided on distal wall. The closure flap may be configured to overlie the drain when the drain is in the closed configuration. The pouch fastening element may be provided on a closure flap. Thus, the closure flap can be used to more securely seal the drain.

The one or more fastening elements may comprise a drain fastening element provided on the drain. The drain fastening element may be positioned towards the proximal end of the drain. The drain fastening element may be configured to fasten to the pouch to retain the drain in the closed configuration. Thus, the drain may be retained in the closed configuration by a fastening element positioned on the drain.

The one or more fastening elements may comprise two fastening elements configured to fasten to one another. The two fastening elements may comprise corresponding complementary fastening surfaces. The fastening surfaces may comprise any of: hook and loop fasteners; hook and hook fasteners; and mushroom-head fasteners. The two fastening elements may comprise the pouch fastening element and drain fastening element as described above.

The drain may be provided at a bottom of the ostomy appliance. The pouch may comprise a stomal inlet configured to allow stomal output to pass from the user's stoma and into the pouch. The proximal wall may comprise the stomal inlet. The stomal inlet may be provided towards a top of the ostomy appliance. The bottom of the ostomy appliance may be at or towards the lowest point of the ostomy during use. Stomal output stored in the pouch may flow out of the drain under the action of gravity. The top of the ostomy appliance may be at or towards an opposite end of the ostomy appliance from the bottom.

The pouch may comprise an adhesive collar configured to attach the pouch to the body of the user. The adhesive collar may be generally annular in shape and provided around the stomal inlet. The adhesive collar may be provided on the proximal wall. The adhesive collar may be formed of a mouldable adhesive material, for example a hydrocolloid adhesive. The adhesive collar may be provided with a release liner to protect the adhesive collar prior to use.

The pouch may comprise a gas vent configured to allow gases in the pouch to leave the pouch. The gas vent may be provided in the distal wall of the pouch. The gas vent may be provided in register with the stomal inlet.

Each of the one or more pursing strips may have substantially the same width. Each of the one or more pursing strips may have substantially the same length. This helps to ensure a better sealing action.

The first and second pursing strips may have equal widths. The first and second pursing strips may have equal lengths. The second pursing strip may not comprise a line of weakness. Alternatively, the second pursing strip may also comprise a line of weakness, or at least two lines of weakness which may have any of the optional features set out above. Thus, the first and second pursing strips can be used to effectively seal the drain as they are the same length and width.

The lateral gap may be free of pursing strips. Thus, the drain may be folded to place the first pursing strip and second pursing strip on top of one another to create a tighter seal when the drain is in the closed configuration.

The first pursing strip may comprise a line of weakness. Where the first pursing strip comprises a line of weakness, it may not comprise a notch as described above.

The second pursing strip may have substantially constant mechanical properties. The second pursing strip may not comprise a line of weakness. Thus, the second pursing strip has a constant rigidity and is therefore able to securely seal the drain.

Where there are two or more pursing strips, at least two of them may have unequal widths. The drain may comprise a narrow pursing strip that has a smaller width than the first pursing strip. The narrow pursing strip may have a width about <NUM>-<NUM>% less than the width of the first pursing strip. Each of the one or more pursing strips may have a width that is no larger than the width of the drain. Two of the two or more pursing strips may each be arranged at the distal end of the drain. The narrow pursing strip may be arranged at the distal end of the drain. The narrow pursing strip may be arranged on the distal wall of the drain. The narrow pursing strip may be a second or third pursing strip, or the weakened pursing strip (see below), depending on the configuration of the drain. Thus, the unequal widths may be used to increase the propensity for the drain to open because one flexes before the other during compression.

The ostomy appliance may comprise only the first pursing strip and the second pursing strip (i.e. the ostomy appliance may comprise no further pursing strips).

The one or more pursing strips may comprise a weakened pursing strip. The weakened pursing strip comprises one or more lines of weakness.

The weakened pursing strip may be a second pursing strip where there are two or more pursing strips.

The ostomy appliance may comprise three or more pursing strips. The weakened pursing strip may be a third pursing strip where there are three or more pursing strips.

The weakened pursing strip may have any one or more of the features of the one or more pursing strips, first pursing strip and/or second pursing strip as outlined above. Where a pursing strip comprises a line of weakness, it may be referred to as a weakened pursing strip, or just a pursing strip, interchangeably. The weakened pursing strip may have side, upper and lower edges. The transverse edge may be the lower edge of the weakened pursing strip.

The weakened pursing strip may be positioned adjacent to the distal end of the drain. The weakened pursing strip may be positioned on the opposite side of the drain to the first pursing strip. The weakened pursing strip may be positioned on the distal wall of the ostomy appliance.

The weakened pursing strip may be positioned on the proximal wall of the ostomy appliance, especially where the weakened pursing strip is the first pursing strip. A narrow pursing strip may be provided on the distal wall where the weakened pursing strip is provided on the proximal wall.

The, or each, of the lines of weakness may comprise a groove. Each pursing strip may comprise an outside surface. The outside surface may be distal from the two walls of the drain. Each groove may be formed in the outside surface of the weakened pursing strip. Thus, each groove allows the weakened pursing strip to bend more easily without breaking and also while reducing the risk of damage to the walls of the drain by pinching. Each groove may have a width measured perpendicular to a respective line of weakness. The width of each groove may be about <NUM>.

Each, or a, line of weakness may comprise one or more perforations.

Each, or a, line of weakness may be at least partially straight, or they may be substantially straight, or completely straight. Thus, the line of weakness has a simple but effective straight shape.

The whole of any one or more of the one or more pursing strips may be attached to a wall of the drain. Thus, the wall matches the shape of each such pursing strip to help ensure it can separate from the other wall.

The one or more lines of weakness may comprise a longitudinal line of weakness that spans the majority of the way, or more preferably all the way from the upper edge to the lower edge of the weakened pursing strip. Thus, the weakened pursing strip can more effectively and predictably separate the walls of the drain.

The one or more lines of weakness may comprise two converging lines of weakness. The first pursing strip may comprise the two converging lines of weakness.

The inventors have found that by providing lines of weakness that are converging provides the weakened pursing strip with mechanical properties that enable it to effectively separate the walls of the drain and open the drain when compressed. This is because the converging lines create an imbalance, because when compressed, the weakened pursing strip flexes with a varying angle that encourages the two walls to separate.

Each of the converging lines of weakness may be a longitudinal line of weakness. Thus, the one or more lines of weakness may comprise two longitudinal lines of weakness that are converging. The converging lines of weakness may be arranged to converge at a point that is not on the weakened pursing strip. Consequently, the converging lines of weakness are converging but do not converge on the weakened pursing strip. This helps to ensure that there is always a gap between the converging lines of weakness which allows the weakened pursing strip to flex out of the plane of the drain more easily.

The two converging lines of weakness may be separated by at least one quarter or one third of the width of the drain. Preferably the two converging lines of weakness may be separated by at least one half of the width of the drain. This helps ensure the central region of the drain is generally flat and able to move uniformly out of the plane of the drain to open the drain.

A point along each of the converging lines of weakness may correspond to a midpoint along the length of the weakened pursing strip. A midpoint along each of the converging lines of weakness may correspond to a midpoint along the length of the weakened pursing strip.

The shape of each of the converging lines of weakness may be asymmetric about a line connecting the two side edges. The shape of each of the converging lines of weakness may be asymmetric about a line perpendicular to the two side edges. The converging lines of weakness may be a mirror image of one another about a line extending midway between the two side edges from the upper edge to the lower edge. The converging lines of weakness may be a mirror image of one another about a line parallel the two side edges. Thus, the converging lines of weakness are shaped to ensure asymmetric bending of the weakened pursing strip to open the drain.

The converging lines of weakness may be arranged at an angle of <NUM>-<NUM> degrees from a lateral edge of the drain. The converging lines of weakness may be arranged at an angle of at least <NUM>, <NUM>, <NUM> or <NUM> degrees from, or with respect to, a lateral edge of the drain. The converging lines of weakness may be arranged at an angle of no more than <NUM>, <NUM>, <NUM>, <NUM> or <NUM> degrees from a lateral edge of the drain. Preferably, the converging lines of weakness may be arranged at an angle of about <NUM> degrees from a lateral edge of the drain.

The converging lines of weakness may be arranged at an angle of <NUM> to <NUM> degrees with respect to one another. The converging lines of weakness may be arranged at an angle of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> degrees with respect to one another. The converging lines of weakness may be arranged at an angle of no more than <NUM>, <NUM>, <NUM> or <NUM> degrees with respect to one another. Preferably, the converging lines of weakness are arranged at an angle of <NUM> degrees with respect to one another. Thus, the converging lines of weakness are optimally angled to ensure efficient opening of the drain.

The two converging lines of weakness may diverge in a direction towards the distal end of the drain. The two converging lines of weakness may diverge in a direction away from the proximal end of the drain. The two converging lines of weakness may converge in a direction towards the proximal end of the drain. The two converging lines of weakness may converge in a direction away from the distal end of the drain. The lower edge of each of the one or more pursing strips may be closer to the distal end of the drain than the upper edge. The two converging lines of weakness may be closer to one another at the upper edge of the weakened pursing strip than at the lower edge of the weakened pursing strip. Thus, this helps to ensure the distal end of the drain is opened widest to allow efficient passage of stomal output out of the drain.

The two converging lines of weakness may converge in a direction towards the distal end of the drain. The two converging lines of weakness may diverge in a direction towards the proximal end of the drain. The two converging lines of weakness may be closer to one another at the lower edge of the weakened pursing strip than at the upper edge of the weakened pursing strip.

Each of the two converging lines of weakness may be arranged in a respective (lateral) half of the weakened pursing strip. Each of the one or more pursing strips may have a width measured between the side edges of the pursing strip. Each of the two converging lines of weakness may cover no more than <NUM>%, <NUM>%, <NUM>%, or <NUM>% of the width of the weakened pursing strip. Each of the two converging lines of weakness may cover at least <NUM>%, <NUM>%, <NUM>%, or <NUM>% of the width of the weakened pursing strip. Preferably, each of the two converging lines of weakness may cover about <NUM>% of the width of the weakened pursing strip. Thus, the line of weakness does not cause excessive changes to the structural properties of the weakened pursing strip which could lead to poor sealing performance of the drain.

The one or more lines of weakness comprise a transverse line of weakness that is arranged, extending and/or spanning between the side edges of the weakened pursing strip. The transverse line of weakness is curved. The one or more lines of weakness may be completely curved.

Thus, in one aspect there is provided an ostomy appliance comprising a pouch and a drain, wherein the drain is formed of two walls attached to one another along two lateral edges of the drain to define a channel therebetween and the drain comprises one or more pursing strips configured to separate the walls of the drain when compressed in a direction perpendicular to the two lateral edges of the drain; wherein a pursing strip of the one or more pursing strips comprises two side edges corresponding to the two lateral edges of the drain and a line of weakness spanning between the side edges, and the line of weakness is curved.

The inventors have found that by providing a transverse line of weakness that is curved and spans between the side edges provides the weakened pursing strip with mechanical properties that enable it to effectively separate the walls of the drain and open the drain when compressed. This is because the curvature creates an imbalance as the parts of the weakened pursing strip on either side of line of weakness have different mechanical properties and furthermore, the mechanical properties of each side varies along the line of weakness between the side edges. So when compressed, the weakened pursing strip flexes with a varying curvature that encourages the two walls to separate.

The first pursing strip may comprise the transverse line of weakness.

The transverse line of weakness may extend from a point along one of the two side edges that is offset from a midpoint along the length of the side edge. The transverse line of weakness may extend from a point along each of the two side edges that is offset from a midpoint along the length of the corresponding side edge. The transverse line of weakness may extend from the same point along each of the two side edges (i.e. if the midpoint of one side edge, then the midpoint of the opposing side edge, and if a point that is offset from a midpoint along the length of one side edge, then a correspondingly offset point along the length of the opposing side edge). The transverse line of weakness may span the majority of the way, or more preferably all the way from one side edge to the opposing side edge. Thus, the weakened pursing strip can more effectively and predictably separate the walls of the drain.

The transverse line of weakness may be arranged in a half of the pursing strip distal from the distal end of the drain. The midpoint along the transverse line of weakness may be the closest point on the line of weakness to the distal end of the drain. The ends of the transverse line of weakness, which may be positioned at the side edges of the pursing strip, may be the furthest points on the transverse line of weakness from the distal end of the drain. Thus, the midpoint may flex more than the ends to allow the walls to separate.

The length of the weakened pursing strip may be the same as the length of a side edge. A point along the transverse line of weakness may correspond to a midpoint along the length of the weakened pursing strip. A midpoint along the transverse line of weakness may correspond to a midpoint along the length of the weakened pursing strip. Thus, the transverse line of weakness is shaped to encourage bending at the centre of the weakened pursing strip but preferably not at the centre along its length at the side edges to help create non-uniform bending and separation of the walls.

The shape of the transverse line of weakness may be asymmetric about a line connecting the two side edges. The shape of the transverse line of weakness may be asymmetric about a line perpendicular to the two side edges. The shape of the transverse line of weakness may be symmetric about a line extending midway between the two side edges. The shape of the transverse line of weakness may be symmetric about a line parallel the two side edges. Thus, the transverse line of weakness is shaped to ensure asymmetric bending of the weakened pursing strip to open the drain.

The transverse line of weakness may be arranged in one half of the weakened pursing strip, that is it may extend in one half of the pursing strip. The other half of the pursing strip may be free of lines of weakness. The transverse line of weakness may span less than half of the length of the weakened pursing strip, or less than a third of the length of the weakened pursing strip, or less than a quarter of the length of the weakened pursing strip. Thus, the transverse line of weakness does not cause excessive changes to the structural properties of the weakened pursing strip which could lead to poor sealing performance of the drain.

The transverse line of weakness may be arced. The transverse line of weakness may define an arc. The arc may have a radius of curvature that is greater than the width of the weakened pursing strip. The arc may have a radius of curvature that is at least two times greater than the width of the weakened pursing strip. Thus, the transverse line of weakness has a simple but effective arced shape.

The transverse may be convex on a side facing the distal end of the drain. This can help to preferentially open the distal end as the section of pursing strip in the midpoint across the distal end is thinner and so easier to bend.

The curvature of the notch and line of weakness may be opposing along the length of the drain. A first pursing strip comprising a notch may be arranged on one side of the drain. A second pursing strip comprising a curved line of weakness may be arranged on the other side of the drain. The first and second pursing strips may be arranged at the same point along the length of the drain. The notch and line of weakness may not overlap. Thus, the opposing curvature and respective positions of the notch and line of weakness helps the drain to open more effectively.

The line of weakness may be curved such that folding of the pursing strip and/or drain about the line of weakness is inhibited. The line of weakness may resist folding of the pursing strip and/or drain by at least <NUM> degrees, at least <NUM> degrees, at least <NUM> degrees, or at least <NUM> degrees about the line of weakness. The drain may not be foldable about the curved line of weakness. The line of weakness may be provided on one side of at least one of the one or more fold lines of the drain. The line of weakness may be provided between adjacent fold lines of the drain. Thus, the curvature is designed to help the drain open and not to allow folding of the drain about the line of weakness.

The optional features of the line of weakness, transverse line of weakness, longitudinal line of weakness and converging lines of weakness may equally apply to any one line of weakness, such as the transverse line of weakness, longitudinal line of weakness, or a or each of the converging lines of weakness. Thus, the invention provides for flexible design of a weakened pursing strip depending on the requirements of a specific ostomy appliance. Similarly, the features of any aspect defined herein may apply to an ostomy appliance, ostomy drain or pursing strip as described herein. Certain non-limiting preferred embodiments and combinations of features are additionally described below.

According to a second aspect of the present invention there is provided a method of manufacturing an ostomy appliance according to claim <NUM>. The method may comprise providing a pouch and two walls, forming a drain of the pouch by attaching the two walls to one another along two lateral edges of the drain to define a channel therebetween, and providing one or more pursing strips on the drain, wherein the one or more pursing strips are configured to separate the walls of the drain when compressed in a direction perpendicular to the two lateral edges of the drain, and a pursing strip of the one or more pursing strips comprises a transverse edge substantially perpendicular to the two lateral edges of the drain and the transverse edge comprises a notch spanning at least half of the transverse edge.

The method of the second aspect of the invention may be a method of manufacturing the ostomy appliance of the first aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise forming the notch in the pursing strip through any suitable means, for example cutting or punching the notch out of the pursing strip. The method may comprise forming a notch in the pursing strip during formation of the pursing strip, for example curing the pursing strip in a mould that is shaped to result in a notch in the cured pursing strip.

The method may comprise moving the drain from the open configuration to the closed configuration. The method may comprise folding the drain about the pursing strips, such as the first and/or second pursing strip(s). The method may comprise retaining the drain in the closed configuration using the closure mechanism. Thus, the ostomy appliance is supplied to the user in a closed state and ready to be used immediately.

The method may comprise forming a line of weakness in the pursing strip through any suitable means, for example scoring, perforation, or forming (e.g. by pressing or cutting) a groove in the pursing strip. The method may comprise forming a line of weakness in the pursing strip during formation of the pursing strip, for example curing the pursing strip in a mould that is shaped to result in a line of weakness (such as a groove) in the cured pursing strip.

The method may comprise attaching the pursing strip to one of the two walls of the drain. The method may comprise attaching the pursing strip adjacent the distal end of the drain. The method may comprise arranging the pursing strip with the line of weakness on a distal side of the pursing strip from the distal end of the drain.

According to a third aspect of the present invention there is provided a method of draining an ostomy appliance according to claim <NUM>. The method may comprise compressing a pursing strip of the drain in a direction perpendicular to the two lateral edges of the drain to separate the two walls, wherein the pursing strip comprises a transverse edge substantially perpendicular to the two lateral edges of the drain and the transverse edge comprises a notch spanning at least half of the transverse edge.

The method of the third aspect of the invention may be a method of draining the ostomy appliance of the first aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the second aspect of the invention.

The method may comprise moving the drain from the closed configuration to the open configuration. The method may comprise moving drain from closed configuration to the open configuration by unrolling and/or unfolding the drain.

The method may comprise releasing the one or more fastening elements.

The method may comprise releasing the pursing strip and allowing it to flatten. The method may comprise moving the drain from the open configuration to the closed configuration after draining. The method may comprise folding the drain about the pursing strip. The method may comprise retaining the drain in the closed configuration using the closure mechanism. Thus, the ostomy appliance is re-sealed so that it can be re-used by the user.

The method may comprise changing the position of the line of weakness with respect to a lower edge of the pursing strip less than the position of the line of weakness with respect an upper edge of the pursing strip. The lower edge may be arranged at the distal end of the drain. The upper edge may be at the other end of the pursing strip from the lower edge. The upper edge and lower edge may span all the way between the side edges of the pursing strip. The method may comprise changing the curvature of the pursing strip between the side edges more at points between the line of weakness and the lower edge than at points between the line of weakness and the upper edge.

According to a fourth aspect of the present invention there is provided a method of using an ostomy appliance according to claim <NUM>. The ostomy appliance may be that according to the first aspect of the present invention. The method may comprise attaching the pouch to the body of the user around a stoma and allowing stomal effluent to pass from the stoma and into the pouch.

The method of the fourth aspect of the invention may be a method of using an ostomy appliance manufactured according to the second aspect of the invention.

The method of the fourth aspect may include draining the ostomy appliance according to the method of the third aspect.

The methods of the second to fourth aspects, including any methods described generally herein, may of course include any one or more features of one another as well as the features of the ostomy appliance of the first aspect or an ostomy appliance, ostomy drain or pursing strip as described generally herein.

In order that the invention may be more clearly understood one or more embodiments relating to the invention will now be described, by way of example only, with reference to the accompanying drawings. In the following description and associated drawings, the second, fifth and seventh embodiments are covered by the appended claims whereas the other embodiments are shown for information purposes only and to aid understanding of the invention. The drawings are briefly described as follows:.

As is conventional, in the Figures broken lines are used to denote hidden features.

Referring to <FIG>, a first embodiment of an ostomy appliance <NUM> comprises a pouch <NUM>, a drain <NUM> and a closure mechanism <NUM>. The pouch <NUM> and drain <NUM> are both formed from two walls of material sealed about their periphery. Consequently, in this embodiment the pouch <NUM> and drain <NUM> are integrally formed. The two walls comprise a proximal wall <NUM> intended to be closest to the body of the user in use and a distal wall <NUM> on an opposite side of the ostomy appliance <NUM> to the proximal wall <NUM>. In this embodiment, the two walls <NUM>, <NUM> are both formed of a flexible plastics material such as ethylene-vinyl acetate (EVA).

In this embodiment, the drain <NUM> is arranged at a bottom of the ostomy appliance <NUM> in use such that stomal output in the pouch <NUM> is able to flow down towards and through the drain <NUM> under the action of gravity.

In this embodiment, the pouch <NUM> comprises a stomal inlet <NUM> arranged towards a top of the ostomy appliance <NUM> distal from the drain <NUM> and on the proximal wall <NUM>. The stomal inlet <NUM> comprises a circular aperture in the proximal wall <NUM> to surround the user's stoma in use and allow stomal output to pass from the stoma and into the pouch <NUM>.

In this embodiment, the pouch <NUM> is "one piece" and comprises an adhesive collar <NUM> arranged around the stomal inlet <NUM>. The adhesive collar <NUM> is annular with an inner perimeter defined by the stomal inlet <NUM> and an outer perimeter that spans about twice the width of the inner perimeter but is completely within the outer edges of the ostomy appliance <NUM>. In this embodiment, the outer perimeter has the square-diamond shape with rounded edges, of course in other embodiments different sizes/shapes may be used. The adhesive collar <NUM> is formed from a mouldable adhesive material such as a hydrocolloid adhesive. The adhesive collar <NUM> is attached to the proximal wall <NUM> and is used to attach the ostomy appliance <NUM> to the body of a user around the stoma.

In this embodiment, the adhesive collar <NUM> is provided with a release liner (not shown) to protect the adhesive collar <NUM> before use and ensure that it does not inadvertently adhere to other objects before use.

In an alternative embodiments, the adhesive collar may be replaced with a coupling element to fit onto a corresponding coupling element that is provided with an adhesive collar. In such embodiments, the ostomy appliance may be a two-piece ostomy appliance.

In this embodiment, the pouch <NUM> comprises an optional gas vent <NUM> provided in the distal wall <NUM> and in register with the stomal inlet <NUM>. The gas vent <NUM> is configured to allow gases in the pouch <NUM> to leave the pouch <NUM> and in this embodiment comprises a deodorising material to neutralise and/or mask any unpleasant smells associated with the gases leaving the pouch <NUM>.

In this embodiment, the drain <NUM> extends from the pouch <NUM> at the bottom of the ostomy appliance <NUM>. The drain <NUM> is formed by a seal between the walls <NUM>, <NUM> along the two lateral edges <NUM> of the drain <NUM>, thus forming a channel therebetween. In this embodiment, the drain <NUM> is rectangular with a width defined between the lateral edges <NUM> of the drain <NUM> and a length perpendicular to its width. The length of the drain <NUM> is about <NUM>-<NUM>% larger than the width of the drain <NUM>, for example about <NUM>% larger. In this embodiment, the width of the drain <NUM> is about <NUM>.

In this embodiment, the drain <NUM> comprises a proximal end <NUM> to receive stomal output from the pouch <NUM> and which corresponds to the bottom of the pouch referred to herein, and an opposite distal end <NUM> to allow stomal output to exit the drain <NUM> and ostomy appliance <NUM>. The length of the drain is thus measured between the proximal and distal ends <NUM>, <NUM>.

In this embodiment, the drain <NUM> comprises a first pursing strip <NUM> and a second pursing strip <NUM>. The first and second pursing strips <NUM>, <NUM> are both the same rectangular shape with a width spanning the entire width of the drain <NUM>, e.g. about <NUM>, and a length approximately one third to one quarter their width, for example about <NUM>. The first and second pursing strips <NUM>, <NUM> are both flat in that (at rest) they have an intrinsic curvature of zero; this helps keep the drain <NUM> and ostomy appliance <NUM> compact.

The first and second pursing strips <NUM>, <NUM> are formed of a material that is more rigid than the walls <NUM>, <NUM> that form the drain <NUM>, for example high density polyethylene (HDPE) or polystyrene.

In this embodiment, both the first and second pursing strips <NUM>, <NUM> comprise a pair of side edges <NUM>, <NUM> that are aligned with and positioned over the lateral edges <NUM> of the drain <NUM>. The first and second pursing strips <NUM>, <NUM> also each comprise an upper edge 224u, 225u and a lower edge <NUM>, <NUM>, the lower edges <NUM>, <NUM> being closer to the distal end <NUM> of the drain <NUM> than the upper edges 224u, 225u. The first pursing strip <NUM> is arranged on the proximal wall <NUM> at the distal end <NUM> of the drain <NUM> with the lower edge <NUM> of the first pursing strip <NUM> aligned with and positioned over the distal end <NUM> of the drain <NUM>. The second pursing strip <NUM> is arranged on the distal wall <NUM> at a distance from the distal end <NUM> of the drain <NUM> that is greater than the length of the first pursing strip <NUM> such that a thin lateral gap <NUM> is present between the two pursing strips <NUM>, <NUM>. In this embodiment, the first and second pursing strips <NUM>, <NUM> thus define a fold line of the drain <NUM> at the position of the lateral gap <NUM> due to higher rigidity of the pursing strips <NUM>, <NUM>.

In this embodiment, the drain <NUM> comprises an open configuration in which passage of stomal output through the drain <NUM> is permitted. In the open configuration, the drain <NUM> is unfolded to define a substantially linear channel therethrough, for example as shown in <FIG>. In this embodiment, the drain <NUM> comprises a closed configuration in which passage of stomal output through the drain <NUM> is inhibited. In the closed configuration, the drain <NUM> is folded to define a closed tortuous channel, for example as shown in <FIG>.

Referring to <FIG>, in this embodiment the first pursing strip <NUM> is configured to separate the walls <NUM>, <NUM> of the drain <NUM> when compressed in a direction perpendicular to the lateral edges <NUM> of the drain <NUM>. In order to improve the ability of the first pursing strip <NUM> to separate the walls <NUM>, <NUM> of the drain <NUM>, the first pursing strip <NUM> comprises a notch <NUM> in its lower edge <NUM>. This can help to encourage the walls <NUM>, <NUM> to separate even when wet. The lower edge <NUM> may also be referred to as a transverse edge as it is substantially perpendicular to the lateral edges of the drain.

In this embodiment, as the first pursing strip <NUM> is arranged on the proximal wall <NUM> with the lower edge <NUM> and notch <NUM> aligned with and positioned over the distal end <NUM> of the drain <NUM>. This configuration allows the first pursing strips <NUM> to open the drain <NUM> when compressed as described further below.

In this embodiment, the notch <NUM> spans about <NUM>% of the lower edge <NUM> and is positioned centrally in the lower edge <NUM>. The notch <NUM> is symmetrical about the midline of the pursing strip, which corresponds to a longitudinal axis of symmetry of the pouch <NUM>. This helps to ensure more even and predictable deformation during opening of the drain <NUM> while also providing a significant difference between the mechanical properties of the upper and lower edges 224u, <NUM> of the first pursing strip <NUM> to help in separating the proximal and distal walls <NUM>, <NUM>.

In this embodiment, the notch <NUM> has a width measured parallel to the lower edge <NUM> and a length perpendicular to its width. The notch <NUM> has an aspect ratio (width:length) of about <NUM>:<NUM>, this helps to ensure the third pursing strip <NUM> retains sufficient strength and flexibility to prevent damage during bending and opening of the drain <NUM>.

In this embodiment, the notch <NUM> is arced. The notch <NUM> has a radius of curvature that is about <NUM>% greater than the width of the first pursing strip <NUM> as measured between the side edges <NUM> of the first pursing strip. This shape ensures the first pursing strip <NUM> deforms more predictably which helps to improve opening performance.

In this embodiment, the distal end <NUM> of the drain <NUM> is straight. Consequently, an end region <NUM> of the proximal wall <NUM> is exposed where the notch <NUM> cuts into the first pursing strip <NUM>. The end region <NUM> can therefore flex and move away from the first pursing strip <NUM> as it is not attached to any of the pursing strips directly. This further increases the propensity that the proximal and distal walls <NUM>, <NUM> will separate during opening.

Referring to <FIG>, in this embodiment the first pursing strip <NUM> is compressed to open the drain <NUM> and separate the proximal and distal walls <NUM>, <NUM>. When compressed, the notch <NUM> provides an imbalance in the mechanical properties of the first pursing strip <NUM> that causes the proximal and distal walls <NUM>, <NUM> to separate. The lower edge <NUM> of the third pursing strip <NUM> is weaker than the upper edge 224u and therefore flexes more under compression which results in a larger displacement away from the normally closed position at the lower edge <NUM> and opening of the drain <NUM>.

In this embodiment, when uncompressed, the notch <NUM> allows the first pursing strip <NUM> to return to a flat configuration which facilitates more efficient closure and storage of the drain as described below.

In this embodiment, the closure mechanism <NUM> is configured to retain the drain <NUM> in the closed configuration and the exemplary closure mechanism comprises two fastening elements: a pouch fastening element <NUM> and a drain fastening element <NUM>. The fastening elements <NUM>, <NUM> are the same shape and size; both are rectangular with lengths and widths approximately half those of the first and second pursing strips <NUM>, <NUM>. The fastening elements <NUM>, <NUM> comprise complementary fastening surfaces in the form of mushroom-head fasteners configured to engage one another when pressed into contact, of course in other embodiments different fastening surfaces such as hook and hook or hook and loop fasteners may be used.

In this embodiment, the drain fastening element <NUM> is positioned on the proximal wall <NUM> and between the proximal end <NUM> of the drain <NUM> and the second pursing strip <NUM>. In this embodiment, the pouch fastening element <NUM> is positioned on a closure flap <NUM> that is attached to the distal wall <NUM>. The closure flap <NUM> is attached to the distal wall <NUM> along a base 233b of the closure flap <NUM>. The closure flap <NUM> is formed of a flexible plastics material, such as that used to form the walls <NUM>, <NUM> and consequently, the closure flap <NUM> can bend to pivot with respect to the pouch <NUM> about the base 233b. The closure mechanism <NUM> and drain <NUM> are arranged such that when the drain <NUM> is in the closed configuration, the drain <NUM> is folded up between the distal wall <NUM> and under the closure flap <NUM> such that the closure flap <NUM> can be rotated about its base 233b until the pouch fastening element <NUM> contacts the drain fastening element <NUM>, for example as described below in more detail.

In this embodiment, in order to manufacture the ostomy appliance <NUM>, the two walls <NUM>, <NUM> may be provided pre-cut into the required shape. The stomal inlet <NUM> may be formed in the proximal wall <NUM>, or may be pre-cut in a different embodiment. The pouch fastening element <NUM> can then be attached to the closure flap <NUM>, for example using adhesive, and then the closure flap <NUM> may be attached to the distal wall <NUM> by sealing the base 233b to the wall <NUM>, for example by welding. The drain fastening element <NUM> may then be added to the proximal wall <NUM>.

In this embodiment, the adhesive collar <NUM> may then be attached to the proximal wall <NUM> and a release liner placed over the adhesive collar <NUM>. The gas vent <NUM> may be formed in the distal wall <NUM>, for example by making a small hole in the distal wall <NUM> and fitting a deodorising filter over the hole.

In this embodiment, the two walls <NUM>, <NUM> can then be sealed together around their periphery except at the distal end <NUM> of the drain <NUM>. The first pursing strip <NUM> is then provided either with the notch <NUM> pre-formed, or the notch <NUM> can then be formed for example by cutting the first pursing strip <NUM>. The second pursing strip <NUM> is then provided and the first and second pursing strips <NUM>, <NUM> are attached to the proximal and distal walls <NUM>, <NUM> respectively in the positions described above.

In this embodiment, before being provided to the user, the drain <NUM> is moved into the closed configuration by folding the drain <NUM> along a line between the first and second pursing strips <NUM>, <NUM> (e.g. at the lateral gap <NUM>) with the distal wall <NUM> on the inside of the fold such that the first pursing strip <NUM> overlies the second pursing strip <NUM>. The drain <NUM> is then folded again twice more in the same manner so as to effectively roll up the distal end <NUM> of the drain <NUM> within the folded drain <NUM>. The final fold of the drain <NUM> is about the proximal end <NUM> of the drain <NUM> and consequently the entire drain <NUM> overlaps the distal wall <NUM> of the pouch <NUM> in the closed configuration.

In this embodiment, as the drain fastening element <NUM> is positioned on the proximal wall <NUM>, when the drain <NUM> is folded the drain fastening element <NUM> pivots around to a position where it is exposed and facing away from the distal wall <NUM> of the pouch <NUM>. In this position, the closure flap <NUM> may be pivoted over the drain <NUM> and the pouch fastening element <NUM> brought into contact with the drain fastening element <NUM> to seal the drain <NUM> in the closed configuration. The ostomy appliance <NUM> is now ready to be supplied to a user.

In this embodiment, to use the ostomy appliance <NUM>, the user first removes the optional release liner and then attaches the ostomy appliance <NUM> to the body with the user's stoma surrounded by the stomal inlet <NUM>. This allows stomal output to pass from the body and into the pouch <NUM> where it collects due to the drain <NUM> being provided in the closed configuration.

In this embodiment, the user may empty the contents of the pouch <NUM>, for example when it is full or otherwise necessary to do so, by moving the drain <NUM> into the open configuration. To do this, the user grasps the closure flap <NUM> in one hand and the pouch <NUM> in the other hand and moves the closure flap <NUM> and pouch <NUM> apart to release the pouch fastening element <NUM> from the drain fastening element <NUM>. The drain <NUM> can then by unfolded/unrolled completely such that it defines a substantially linear channel from the proximal end <NUM> to the distal end <NUM> of the drain <NUM>.

Referring to <FIG>, in this embodiment, the walls <NUM>, <NUM> of the drain <NUM> can be separated by compressing the first pursing strip <NUM> in a direction perpendicular to the side edges <NUM> of the first pursing strip <NUM> or parallel to the width of the drain <NUM>; for example, the user may pinch side edges <NUM> together between their fingers and thumb. This causes the first pursing strip <NUM> to bend out of the plane of the drain <NUM>.

When compressed in this manner the first pursing strip <NUM> flexes in a non-uniform manner to separate the two walls <NUM>, <NUM>. This is guided by the notch <NUM> which generates an imbalance in the mechanical properties of the first pursing strip <NUM> both along its length and along its width.

In this embodiment, as the proximal wall <NUM> is attached to the first pursing strip <NUM> across the entire area of the first pursing strip <NUM>, the proximal wall <NUM> follows the shape of the first pursing strip <NUM> and this leads it to separate from the distal wall <NUM> more easily.

In this embodiment, now that the walls <NUM>, <NUM> are separated, the ostomy appliance <NUM> can be emptied by allowing the contents of the pouch <NUM> to flow out of the drain <NUM>. After emptying, the drain <NUM> can be resealed by moving the drain <NUM> from the open configuration to the closed configuration and sealing it closed using the closure mechanism <NUM> as described above. The ostomy appliance <NUM> can then be refilled, emptied and resealed repeatedly by the user.

A second embodiment of an ostomy appliance <NUM> is shown <FIG> and a third embodiment of an ostomy appliance <NUM> is shown in <FIG>. The second and third embodiments share many of the same features of the first embodiment above and consequently only the differences are described below and like numerals are used to denote like features. The main difference between the first embodiment and the second and third embodiments is that in the second and third embodiments the first pursing strip <NUM>, <NUM> is attached to the distal wall <NUM>, <NUM> in the same manner as it is attached to the proximal wall <NUM> in the first embodiment. Consequently, it exposes an end region <NUM>, <NUM> of the distal wall <NUM>, <NUM> rather than the proximal wall as in the first embodiment. However, otherwise, the first pursing strip <NUM>, <NUM> is the same as that described in the first embodiment and has all the same features.

In the second and third embodiments, the ostomy appliance <NUM>, <NUM> comprises three pursing strips: a first pursing strip <NUM>, <NUM>, a second pursing strip <NUM>, <NUM> and a third pursing strip <NUM>, <NUM>. The second pursing strip <NUM>, <NUM> has all the same features as the second pursing strips of the first embodiment described above. The third pursing strip <NUM>, <NUM> has the same properties as the second pursing strip <NUM>, <NUM> except that comprises at least one line of weakness <NUM>, <NUM>. The at least one line of weakness provides the third pursing strip <NUM>, <NUM> with mechanical properties that allow it to work with the first pursing strip <NUM>, <NUM> to more easily separate the walls of the drain <NUM>, <NUM> as described further below. The third pursing strip <NUM>, <NUM> may therefore be referred to as a weakened pursing strip.

In the second and third embodiments, as best seen in <FIG>, and <FIG> respectively, each line of weakness <NUM>, <NUM> comprises a groove in an outside surface 440o, 640o of the third pursing strip <NUM>, <NUM> distal from the walls of the drain <NUM>, <NUM>. The lines of weakness <NUM>, <NUM> are therefore scored or cut out of the third pursing strip <NUM>, <NUM> to allow it to bend more easily about the line of weakness <NUM>, <NUM> as described below. In this embodiment, each groove has a width perpendicular to each line of weakness of about <NUM>.

In the second and third embodiments, the third pursing strip <NUM>, <NUM> is positioned on the proximal wall <NUM>, <NUM> at the same place that the first pursing strip is positioned in the first embodiment described above. In the second and third embodiments, the first and third pursing strips are therefore on either side of the distal end of the drain <NUM>, <NUM>.

In the second and third embodiments, when closing and opening the drain <NUM>, <NUM>, the third pursing strip <NUM>, <NUM> provides an additional rigid element to help fold the drain <NUM>, <NUM> around. This can improve the sealing action of the drain as it can be folded more tightly.

Referring to <FIG>, in the second embodiment, the at least one line of weakness comprises a line of weakness <NUM> spanning completely between the side edges <NUM> of the third pursing strip <NUM> (all the way from one side edge <NUM> to the opposing side edge <NUM>). Consequently, the line of weakness <NUM> is a transverse line of weakness. The line of weakness <NUM> is curved such that it is asymmetrical about lines connecting the two side edges <NUM> and lines perpendicular to the side edges <NUM>. In addition, the line of weakness <NUM> is convex on a side facing the distal end of the drain and thus the curvature of the line of weakness <NUM> and notch <NUM> is opposing. In addition the notch <NUM> and line of weakness <NUM> are not overlapping, so they each act on different parts of the drain. Consequently, when compressed, the first and third pursing strips <NUM>, <NUM> flex in a non-uniform manner that tends to cause the walls <NUM>, <NUM> to separate even when stuck to each other, such as when wet.

In this embodiment, the line of weakness <NUM> is arranged in a half of the third pursing strip <NUM> distal from the distal end <NUM> of the drain <NUM>. The line of weakness <NUM> meets the side edges <NUM> at approximately three-quarters of the length of the third pursing strip <NUM> from its lower edge <NUM>, which corresponds to the points on the line of weakness <NUM> furthest from the lower edge <NUM>. A midpoint of the line of weakness <NUM> is the point on the line of weakness <NUM> closest to the lower edge <NUM> and is arranged at a midpoint of the third pursing strip <NUM>, both in terms of length and width. Consequently, the line of weakness <NUM> only spans about one quarter the length of the third pursing strip <NUM>.

In this embodiment, the line of weakness <NUM> is an arc and is parallel to the lower edge <NUM> at the midpoint along the line of weakness <NUM>. The line of weakness <NUM> curves away from the lower edge <NUM> either side of the midpoint and has a radius of curvature that is about twice the width of the third pursing strip <NUM>, for example about <NUM>. The line of weakness <NUM> is therefore symmetric about a line extending midway between the side edges <NUM> of the third pursing strip <NUM>.

Referring to <FIG>, in this embodiment, the walls <NUM>, <NUM> of the drain <NUM> can be separated by compressing the first and third pursing strips <NUM>, <NUM> in a direction perpendicular to the side edges <NUM> of the third pursing strip <NUM> or parallel to the width of the drain <NUM>; for example, the user may pinch side edges <NUM> together between their fingers and thumb. This causes the third pursing strip <NUM> to bend out of the plane of the drain <NUM>.

When compressed in this manner the first pursing strip <NUM> acts as described in relation to the first embodiment but on the distal wall <NUM>, and the third pursing strip <NUM> also flexes in a non-uniform manner to separate the two walls <NUM>, <NUM>. This is guided by the line of weakness <NUM> which generates an imbalance in the mechanical properties of the third pursing strip <NUM> both along its length and along its width.

During compression the angle of the pursing strip between the line of weakness <NUM> and lower edge <NUM> changes less than the angle of the pursing strip between line of weakness <NUM> and the upper edge 440u (See <FIG>). However, simultaneously the curvature of the third pursing strip <NUM> between the side edges <NUM> changes more at points between the line of weakness <NUM> and the lower edge <NUM> than between the line of weakness <NUM> and the upper edge 440u (see <FIG>). Thus, the line of weakness <NUM> creates a situation where there are different changes in angle and curvature of the third pursing strip <NUM> either side of the line of weakness <NUM> to help separate the walls <NUM>, <NUM> of the drain.

In this embodiment, as the proximal wall <NUM> is attached to the third pursing strip <NUM> across the entire area of the third pursing strip <NUM>, the proximal wall <NUM> follows the shape of the third pursing strip <NUM> and this leads it to separate from the distal wall <NUM> more easily.

Of course, in this embodiment, the drain remains foldable about the fold lines defined by the edges of the pursing strips. The drain is not intended to be foldable about the line of weakness as it is a curved groove which cannot be easily folded.

Referring to <FIG>, in the third embodiment, the at least one line of weakness comprises two converging lines of weakness <NUM> spanning all the way from the upper edge 640u and lower edge <NUM> of the third pursing strip <NUM>. Each of the lines of weakness <NUM> are therefore longitudinal lines of weakness. Each of the lines of weakness <NUM> are straight and angled such that they are asymmetrical about lines connecting the two side edges <NUM> and lines perpendicular to the side edges <NUM>. Consequently, when compressed, the third pursing strip <NUM> flexes in a non-uniform manner that tends to cause the walls <NUM>, <NUM> to separate even when stuck to each other, such as when wet.

In this embodiment each of the lines of weakness <NUM> are angled with respect to each other by about <NUM> degrees, and as such are angled with respect to the side edges <NUM> (and the longitudinal axis of the appliance) by about <NUM> degrees. In addition, the lines of weakness <NUM> are mirror images of one another about the longitudinal axis of the drain (i.e. a line extending parallel to the side edges <NUM> and midway between the side edges <NUM>). This helps to ensure asymmetric bending along the length of the third pursing strip <NUM> which encourages the drain <NUM> to open as described below.

In this embodiment, the lines of weakness <NUM> are closer to one another along the upper edge 640u than the lower edge <NUM> of the third pursing strip <NUM>. Nevertheless, along the upper edge 640u, the lines of weakness <NUM> are still separated by approximately half the width of the third pursing strip <NUM>. Consequently, while the lines of weakness <NUM> are converging they do not converge which helps ensure the third pursing strip <NUM> can flex a significant distance out of the plane of the drain <NUM> and open the drain <NUM>.

In this embodiment, each line of weakness <NUM> is arranged in a respective half of the third pursing strip <NUM>. Each line of weakness 641meets the upper edge 640u at a point about one quarter from a respective side edge <NUM> across the upper edge 640u. Each line of weakness <NUM> meets the lower edge <NUM> at a point about <NUM>% from a respective side edge <NUM> across the lower edge <NUM>. Consequently, each line of weakness <NUM> spans the entire length, and about <NUM>% of the width of the third pursing strip <NUM>.

In view of the above, in this embodiment the lines of weakness <NUM> diverge towards the distal end <NUM> of the drain <NUM>. This is beneficial as it ensures the distal end of the drain opens widest which helps efficient passage of stomal output out of the drain.

Referring to <FIG>, in this embodiment the first and third pursing strips <NUM>, <NUM> are compressed to open the drain <NUM> and separate the proximal and distal walls <NUM>, <NUM>. When compressed the first pursing strip <NUM> acts as described in relation to the first embodiment but on the distal wall <NUM>. In addition, during compression the angle of the third pursing strip <NUM> between each line of weakness <NUM> and side edges <NUM> changes less closer to the upper edge 640u than at points closer to the lower edge <NUM>, which creates a twisting of the third pursing strip between the upper and lower edges adjacent to the side edges. Simultaneously, the angle across the width of the third pursing strip <NUM> between the side edges <NUM> changes non-linearly at each line of weakness <NUM> which encourages the walls <NUM>, <NUM> to separate (see <FIG>). In this embodiment, the ostomy appliance <NUM> is manufactured in a similar way to the first embodiment except that the distal wall <NUM> is additionally provided with the third pursing strip <NUM> in the position described above.

Referring to <FIG> a fourth embodiment of an ostomy appliance <NUM> shares many of the same features of the first embodiment above and consequently only the differences are described below and like numerals are used to denote like features.

In this embodiment, the drain <NUM> comprises a third pursing strip <NUM>. The third pursing strip <NUM> is the same size and shape as the first pursing strip <NUM> except that it is about <NUM>% smaller than the width of the first pursing strip <NUM>. Thus, the third pursing strip <NUM> is a narrow pursing strip. The third pursing strip <NUM> is arranged on the distal wall <NUM> at the distal end <NUM> of the drain.

Thus, in this embodiment, when the drain <NUM> is compressed, initially only the first and second pursing strips <NUM>, <NUM> flex because they are wider than the third pursing strip <NUM>. Then, after continued compression the third pursing strip <NUM> also flexes. This helps to open the drain <NUM> because it separates the opening action into two different phases where the forces on the walls of the drain are different in each phase. In addition, the curvature of the second and third pursing stripes <NUM>, <NUM> are different from each other which helps to encourage the walls of the drain to separate.

In a variation on the third embodiment, the second pursing strip <NUM> may be omitted entirely and the drain <NUM> may have just two pursing strips: the first pursing strip <NUM> and third pursing strip <NUM>.

Referring to <FIG> and <FIG>, a fifth embodiment of an ostomy appliance <NUM> and a sixth embodiment of an ostomy appliance <NUM> are shown respectively. The fifth and sixth embodiments are similar to the first embodiment above and so like numerals are used for corresponding features and only the differences are described below.

In both the fifth and sixth embodiments, the first pursing strip does not comprise a notch as in the first embodiment. Instead, the first pursing strip <NUM>, <NUM> has one or more lines of weakness <NUM>, <NUM>.

The first pursing strip <NUM> of the fifth embodiment is equivalent to the third pursing strip of the second embodiment above and comprises a curved line of weakness <NUM> spanning completely between the side edges <NUM> of the first pursing strip <NUM>.

The first pursing strip <NUM> of the sixth embodiment is equivalent to the third pursing strip of the third embodiment above and comprises two converging lines of weakness <NUM>.

The first pursing strips <NUM>, <NUM> of the fifth and sixth embodiments have all the features of the third pursing strips of the second and third embodiments above respectively, so are not described in detail.

In the fifth and sixth embodiments, the first pursing strips <NUM>, <NUM> operate as described above in relation to the second and third embodiments to assist opening the drain <NUM>, <NUM> when compressed in a similar manner due to the lines of weakness <NUM>, <NUM>. As described above, the lines of weakness <NUM>, <NUM> enable non-uniform compression and flexion of the pursing strips <NUM>, <NUM> which assists in opening of the drain, this is shown in more detail in <FIG> and <FIG>.

Referring to <FIG> and <FIG>, a seventh embodiment of an ostomy appliance <NUM> and an eighth embodiment of an ostomy appliance <NUM> are shown respectively. The seventh and eighth embodiments are based on the fifth and sixth embodiments described above and so, like numerals are used to describe like features and only the differences are described.

The seventh and eighth embodiments additionally comprise a third pursing strip <NUM>, <NUM> that is narrower than the first pursing strips <NUM>, <NUM> arranged on the distal wall <NUM>, <NUM> at the distal end <NUM>, <NUM> of the drain. The third pursing strip <NUM>, <NUM> is equivalent to the third pursing strip of the fourth embodiment described above and has all the same features.

As described above, the seventh and eighth embodiments thereby provide variations in which one or more lines of weakness on the first pursing strip are used in synergy with a narrower pursing strip to help assist in opening the drain.

Claim 1:
An ostomy appliance (<NUM>, <NUM>, <NUM>) comprising a pouch (<NUM>, <NUM>) and a drain (<NUM>, <NUM>, <NUM>), wherein the drain is formed of two walls (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) attached to one another along two lateral edges (<NUM>, <NUM>) of the drain to define a channel therebetween and the drain comprises one or more pursing strips configured to separate the two walls of the drain when compressed in a direction perpendicular to the two lateral edges of the drain; wherein a pursing strip (<NUM>, <NUM>, <NUM>) of the one or more pursing strips comprises two side edges (<NUM>, <NUM>) corresponding to the two lateral edges of the drain and a line of weakness (<NUM>, <NUM>, <NUM>) spanning between the side edges, characterised in that the line of weakness is curved.