A COLLECTING DEVICE

20230081026 · 2023-03-16

    Inventors

    Cpc classification

    International classification

    Abstract

    An ostomy pouch or wound bag includes a fluid tight collecting bag for containing bodily fluid or waste matter. The collecting bag includes an opening for receiving bodily fluid or waste matter. A flexible material cover is provided that at least partially covers the collecting bag. The cover comprises a front part arranged on a first side of the collecting bag that in use faces forward away from the wearer. The front part of the cover includes a first panel section having a viewing window through which the opening is visible and a cover panel section that is reconfigurable between a closed configuration in which at least part of the cover panel section covers and obscures the viewing window and the opening is obscured, and an open configuration in which the viewing window is uncovered and the stoma opening is at least partially visible.

    Claims

    1. A collecting device such as an ostomy pouch or wound bag comprising: a collecting bag for containing bodily fluids or waste matter; an opening in the collecting bag for receiving the bodily fluids or waste matter; a flexible material cover at least partially covering the collecting bag, the cover comprising a front part arranged on a first side of the collecting bag that in use faces forward away from the wearer; wherein the front part of the cover includes a first panel section having a viewing window through which the opening is visible and a second panel section that is reconfigurable between a closed configuration in which at least part of the second panel section covers the viewing window and the opening is obscured, and an open configuration in which the viewing window is uncovered and the opening is visible.

    2. The collecting device according to claim 1, further comprising holding means arranged to hold the second panel section in the open configuration.

    3. The collecting device according to claim 1, wherein the second panel section comprises a flap portion and the holding means comprises a retaining slit located at the lower end of the flap portion that is arranged to receive part of the upper edge of the device when the flap portion is in the open configuration to hold the flap portion in the open configuration.

    4. The collecting device according to claim 3, further comprising a locking tab projecting from the upper end of the pouch and the retaining slit and the locking tab are configured and arranged such that the locking tab is able to be inserted through the slit when the flap portion is in the open configuration to hold the flap portion in the open configuration

    5. (canceled)

    6. The collecting device according to claim 1, wherein the opening is located towards and upper end of the pouch, the second panel section is an upper panel section located at an upper end of the collecting device and the first panel section is a lower panel section located below the upper panel section.

    7. (canceled)

    8. The collecting device according to claim 1, wherein the collecting bag comprises a front wall and rear wall formed of a flexible polymeric material, and wherein at least the front part of the cover and the front and rear walls of the collecting bag are bonded together along their peripheral edges.

    9. The collecting device according to claim 8, wherein the pouch further comprises a mounting plate having a front surface bonded to the rear wall of the collecting bag in a bonding region, an adhesive rear surface for securing the mounting plate to the skin of a wearer, and an aperture for receiving the stoma that is aligned with the stoma opening of the collecting bag, wherein the viewing window is configured such that the stoma opening and the bonding region are visible therethrough.

    10. The collecting device according to claim 1, wherein at least part of the outer peripheral edge of the second panel section is bonded to the collecting bag and the second panel section includes a flap portion that is movable between the open and closed configurations.

    11. The collecting device according to claim 10, wherein the first panel section has an upper edge that extends across the collecting bag and is shaped to form the viewing window.

    12. The collecting device according to claim 11, wherein the upper edge comprises a curved cut away section that forms the viewing window, the curved cut away section having a concave substantially semi-circular shape.

    13. (canceled)

    14. (canceled)

    15. The collecting device according to claim 12, wherein the first panel section is bonded to the collecting bag around its peripheral edge defining a lower bonding seam, and the second panel section is bonded to the collecting bag around its outer peripheral edge defining an upper bonding seam, and the upper ends of the lower bonding seam and the lower ends of the upper bonding seam are immediately adjacent each other.

    16. The collecting device according to claim 15, wherein upper bonding seam of the second panel section has lower ends and lower bonding seam of the first panel section has upper ends located adjacent and below the lower ends of lower bonding seam, and the point at which upper and lower ends meet defines the outer ends of a fold line about which the flap portion of the second panel section is foldable to move between the open and closed configurations.

    17. The collecting device according to claim 16, wherein in the closed configuration the flap portion of the second panel extends downwardly below the fold line and at least partially overlaps the first panel section.

    18. The collecting device according to claim 17, wherein the flap portion tapers inwardly in the downward direction in the closed configuration.

    19. The collecting device according to claim 16, wherein the fold line of the flap is located above the stoma opening.

    20. The collecting device according to claim 14 wherein the cutaway section of the first panel section curves convexly downwards away from the fold line.

    21. The collecting device according to claim 1, wherein the second panel section has a lower edge that is lowermost in the closed configuration and the second cover section includes a strengthening zone located along the lower edge to strengthen the lower edge and maintain the form of the upper cover section in use.

    22. The collecting device according to claim 21, wherein the second panel section includes inner and outer flexible material panels and an intermediate flexible polymer film that are bonded together to form the strengthening zone along the lower edge of the upper panel section.

    23. The collecting device according to claim 22, wherein the first panel section includes a flap portion, the lower edge forms part of the flap section and the strengthening zone extending along the lower edge supports the flap section in the open configuration.

    24. The collecting device according to claim 1, wherein the second panel section includes a flap portion having an inner side that faces towards the collecting bag in the closed configuration and wherein a first fastener is located at the lower end of the rear part of the cover and a corresponding second fastener is located on the inner side of the flap, and the pouch is foldable to a compact configuration in which the lower end of the rear part is located beneath the flap portion of the front part and the first and second fasteners are configured to hold the pouch in the compact configuration.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0041] The present invention will now be described by way of example only with reference to the following illustrative figures in which:

    [0042] FIG. 1 is a rear view of an ostomy pouch according to an embodiment of the present invention;

    [0043] FIG. 2 is a front view of the ostomy pouch of FIG. 1 with the flap in the open configuration;

    [0044] FIG. 3 is a front view of the ostomy pouch of FIG. 1 with the flap in the closed configuration;

    [0045] FIG. 4 is a front view of an ostomy pouch according to an embodiment of the present invention folded to the compact configuration with the flap raised;

    [0046] FIG. 5 is the ostomy pouch of FIG. 4 with the flap closed position;

    [0047] FIG. 6 is a rear view of an ostomy pouch according to another embodiment of the present invention;

    [0048] FIG. 7 is a front view of an ostomy pouch according to another embodiment of the present invention;

    [0049] FIG. 8 is a rear view of an ostomy pouch according to another embodiment of the present invention;

    [0050] FIG. 9 is a rear view of the ostomy pouch of FIG. 8 in the compact folded configuration;

    [0051] FIG. 10 is a rear view of an ostomy pouch according to another embodiment of the present invention;

    [0052] FIG. 11 is a front view of the ostomy pouch of FIG. 10;

    [0053] FIG. 12 is a rear view of an ostomy pouch according to another embodiment of the present invention;

    [0054] FIG. 13 is a front view of the ostomy pouch of FIG. 12; and

    [0055] FIG. 14 is a rear view of an ostomy pouch according to a yet further embodiment of the present invention.

    DESCRIPTION OF THE PREFERRED EMBODIMENTS

    [0056] Referring to FIG. 1, there is provided an ostomy pouch 1 including a sealed waterproof collecting bag 2 formed from two opposing films of flexible impermeable material. The collecting bag 2 is preferably formed from a plastics film material known in the art for forming ostomy pouches and may be a multiple ply film, although it will be appreciated that other suitable materials could be used. The two opposing films define a front wall 3 and a rear wall 4. The front wall 3 and rear wall 4 are sealed along their common peripheral edges 6 to form a receptacle for receiving liquid and solid waste. The peripheral edges 6 may be sealed by welding such as thermal or RF welding, bonded such as by adhesion, or by any other suitable means.

    [0057] A mounting plate or flange 8 is provided for mechanically securing the ostomy pouch 1 to the body of the wearer. The present embodiment relates to a one-piece ostomy system in which the mounting plate 8 is secured to the rear wall 4 of the collecting bag 2. It will however be appreciated that the invention is also applicable to a two-piece ostomy system in which the mounting plate is releasably connectable to the collecting bag by a coupling arrangement. The mounting plate 8 is an adhesive wafer comprising a foam disc and a hydrocolloid skin barrier layer, which are adhered together to form a flexible adhesive pad. The mounting plate 8 may be a flat disc or may include a convex central portion. Where the mounting plate 8 includes a convex central portion, it may further include a plastic mounting plate which provides a stiffer substrate to which the foam and hydrocolloid layers conform, enabling the convex profile to be maintained.

    [0058] The rear wall 4 of the collecting bag 2 is sealed to the front face of the mounting plate 8 at a bonding region 14. The term ‘front’ as used herein refers to a surface which in use faces away from the body of the user, and the term ‘rear’ refers to a surface which in use faces towards the body of the wearer. The terms ‘upper’, ‘lower’, ‘top’ and ‘bottom’ as used herein relate to the pouch as oriented on the wearer in use. The mounting plate 8 includes an aperture 10 arranged substantially centrally on the mounting plate 8. The bonding region 14 is annular and surrounds the aperture 10. A corresponding aperture 16 is formed in the rear wall 4 with an edge 18 to which the inner edge of the sealing region 14 extends such that the rear wall 4 is sealed to the mounting plate 8 around the entire periphery of the aperture 16. A region 19 of the mounting plate 8 extends radially inwards from the inner edge 18 of the aperture 16 to the edge of the aperture 10.

    [0059] The aperture 16 defines an inlet opening into the collecting bag 2 through which the wearer's stoma is extended in use. The mounting plate 8 surrounds the stoma in use. The size of the stoma inlet 10 formed in the mounting plate 8 is able to be selectively increased within an expansion zone defined on the mounting plate 8 by cutting the mounting plate 8, and guide-lines may be printed on the mounting plate for indicating openings of increasing diameter to assist in accurate cutting of the stoma inlet 10. The bonding layer 14 is sized to be larger than the expansion zone, the outer boundary of which defines the maximum stoma inlet size, so there is always of region of bonding between the bag 2 and the mounting plate 8 that surrounds and seals the stoma opening 10. The hydrocolloid adhesive layer at the rear surface of the mounting plate 8 provides a barrier seal with the wearer's skin extending from the peripheral edge 18 of the mounting plate 8 to the stoma inlet 10. In this way, when the stoma is extended through the stoma inlet 10 in use a barrier seal is created between the mounting plate 8 and the skin of the wearer that is airtight and watertight from the edge of the stoma inlet 10 outwardly, thereby sealing the contents of the collecting bag 2 from the external environment.

    [0060] The mounting plate 8 is arranged at the upper end of the pouch 1 such that when the pouch 1 is arranged vertically in use a significant portion of the volume of the collecting bag 2 is arranged beneath the opening 10. In use, waste from the stoma passes directly into the volume of the collecting bag 2 beneath the stoma inlet 10.

    [0061] As shown in FIG. 2, the pouch 1 includes a cover 20 for covering the collecting bag 2. The cover 20 is formed from an opaque, lightweight comfort fabric, that may be a woven or a non-woven material that is bio-sensitive to avoid skin irritation. The cover material may for example be formed from polyethylene, polypropylene or polyester fibres. The cover 20 includes a rear panel 22 arranged at the outer surface of the rear wall 4 such that in use it is located between the rear wall 4 and the wearer's skin. The rear panel 22 has a shape conforming to the shape of the collecting bag 2 with the peripheral edge of the rear panel 22 and the peripheral edge of the rear wall 4 being aligned. The rear panel 22 is located between the rear wall 4 and the mounting plate 8. Therefore, the rear panel 22 is provide with an aperture 24 corresponding in size and shape to the outer edge of the bonding region 14 between the rear wall 4 and the mounting plate 8. In this way, mounting plate 8 is able to bond to the rear wall 4 in the bonding region 14 of the rear wall 4 exposed by the aperture 24. The rear panel 22 is bonded to the rear wall 4 of the collecting bag 2 along its peripheral edge by RF or thermal welding, wherein rear wall 4 is caused to melt and partially penetrate the material of the rear panel 22 to bond the rear panel 22 to the rear wall 4. The welding process is controlled such that the plastic material of the rear wall 4 does not penetrate to the outer surface of the rear panel 22, such that the comfort feel of the fabric material at the outer surface is maintained.

    [0062] The cover 20 further includes a front section 26 comprising a lower panel 28 and an upper panel 30. The lower panel 28 has a peripheral edge 32 that conforms to the shape of the front wall 3. The outer peripheral edge of the lower panel 28 is bonded to the underlying peripheral edge of the front wall 3 by RF of thermal welding in the same manner as the rear panel 22 is bonded to the rear wall 4. The upper edge 34 of the lower panel 28 includes a cut away section 36 that is configured to reveal the underlying stoma inlet 10 and bonding region 14 of the mounting plate 8. At the outer edges of lower panel 28 the upper edge 34 extends to a height h1 from the base 29 of the pouch 1. Inboard of the outer edges, the upper edge 34 curves downwardly to form a scalloped, substantially semi-circular cut away having a radius r1 corresponding to the radius of the bonding region 14, and a lowermost point at height h2. The cut away section 36 is aligned with the bonding region 14, with the cut away section 36 defining a viewing window 37 configured such that the bonding region 14 and the stoma inlet 10 are substantially uncovered by the lower panel 28. The bonding region 14 will always be larger than the stoma inlet 10, and therefore ensuring the bonding region 14 is fully visible through the viewing window means the stoma inlet 10 will always be fully visible.

    [0063] FIG. 3 shows the closure flap 48 in the closed configuration. The upper panel 30 is arranged above the lower panel 28 and forms a flap for covering the viewing window 36 of the lower panel 28. In the closed configuration the upper panel 30 covers the viewing window 37 of the lower panel 28 and obscures the underlying mounting plate 8 and stoma inlet 10 from view. The upper panel 30 has an outer peripheral edge 40 that corresponds to the shape of the underlying front wall 3. The outer peripheral edge 40 of the upper panel 30 is bonded to the underlying peripheral edge of the front wall 3 by RF or thermal welding in the same manner as the rear panel 22 is bonded to the rear wall 4. The lower ends 44 of the peripheral bonding seam 42 are adjacent to the upper edge 34 of the lower panel 28 at height h1. The lower edge 46 of the upper panel 30 is free and is not bonded to the front wall 3. The lower edge 46 tapers downwardly an inwardly from either side to form a substantially v-shaped flap 48. The lower end 50 of the flap 48 is located at height h3, lower than height h2, and has a curved form corresponding to, and spaced radially outwardly of and beneath the curved edge of the cutaway section 36. The flap 48 extends downwardly past the upper edge 34 of the lower panel and overlaps the lower panel 28 to obscure the viewing window 37.

    [0064] The upper panel 30 is formed of two fabrics layers and an intermediate polymer film layer that may be the same film material as the collecting bag 2. The three layers are bonded together about their peripheral edges by RF or thermal welding as described above, such the intermediate layer melts and penetrates both fabric layers. The triple ply thickness of the upper panel 30 provides additional weight that helps maintain the flap 48 in the closed configuration. The lower edge 46 of the upper panel 30 is provided with a bonding region 51 of increased thickness between the two layers of the upper panel 28 as measured inwardly from lower edge 46. The thickened bonding region 51 increases stiffness along the lower edge 46, which maintains the form of the flap 48 and further assists in maintaining the flap 48 in the closed configuration, for example by preventing wrinkling of the flap 48. A curved slit 52 is formed in the bonding region 51, inboard of the tip 50 of the flap 48 at the centre of the flap 48. The slit 52 curves upwardly, in a convex manner away from and in the opposing direction to the downward curve of the tip. A locking tab 54 projects from the upper end of the cover 20 at its apex and is laterally aligned with the slit 52. The slit 52 and locking tab 54 are used to hold the flap in the open configuration, as will be described in further detail below. In an alternative arrangement, the slit 52 may be configured such that it receives and hooks over the curved upper edge 40 of the upper panel section 30 such that a portion of the curved upper edge 40 defines the locking tab without the requirement for a pronounced projection.

    [0065] Referring again to FIG. 2, the lower ends 44 of the bonding region 42 are the lowest points at which the upper panel 20 is secured to the front wall 3. The lower end 44 of the bonding region 42 locate immediately adjacent the upper ends 41 of the peripheral bonding region 29 of the lower panel 28. The point at which the lower ends 44 of the bonding region 42 and the upper ends 41 of the bonding region 29 meet defines the outer edges of a fold line A-A about which the flap 48 is folded upwards. The height h1 at which the lower ends 4 are located, and hence the height of the fold line A-A is above the height of the stoma inlet 10. As such, when the flap 48 is folded upwards the stoma opening 10 and the viewing window 36 are uncovered, allowing full visibility of the stoma inlet. The curved shape of the viewing window forms side parts 56 which cover the underlying collecting bag 2 and ensure that only the section of the collecting bag 2 within the viewing window 36 is visible, thereby limiting the extent to which the contents are exposed.

    [0066] In the open configuration, the slit 52 in the flap 48 is hooked over the upwardly extending locking tab 54 such that the locking tab 54 extends through the slit 52. Hooking the slit 52 over the locking tab 54, the flap is held in the upwardly folded open configuration. The stiffened bonding region 51 maintains the form of the flap 48 when in the upwards open configuration and prevents the tip of the flap 48 from flopping downwards. In other embodiments alternative holding means may be provided. For example, the lower end of the flap 48 may be provided with a Velcro tab, and a corresponding Velcro tab may be affixed at the upper end of the flap 48 and positioned such that it is aligned with the lower Velcro tab when the flap 48 is folded to the open configuration to connect therewith.

    [0067] In use, when a care giver wishes to inspect the wearer's stoma and/or monitor stoma output or the contents of the pouch the flap 48 is moved to the open configuration by gripping the tip 50 and lifting the flap 48 upwardly. The flap 48 folds about fold line A-A as it is lifted. The flap 48 is then hooked over the tab 54, and the tab 54 inserted into the slit 52 to hold the flap 48 in the open configuration. The care giver is then provided with a full view of the stoma area and can periodically glance at the pouch and monitor the stoma condition and/or pouch contents from a distance, with less frequent close inspections required. If the wearer requires privacy, the flap 48 may be easily lifted and released from the locking tab 54 and folded down to return it to the closed configuration.

    [0068] Referring to FIG. 4, the pouch 1 is further provided with means for reducing the size of the pouch 1 if required, for example where output is low, and it is preferred to make the pouch 1 less noticeable. The rear panel 22 is provided with a fastener 58, for example a hook and eye fastener such as Velcro. The fastener 58 is affixed to the lower end of the rear panel 22 on its outer surface 59, although in alternative embodiments the fastener may be affixed directly to the rear wall 4 of the collecting bag 2. A corresponding fastener 60 is provided on the inner surface 62 of the flap 48, preferably towards the lower end 50 of the flap 48. It will be appreciated that the term ‘lower’ used herein is a relative term used with reference to the orientation of the flap 28 in the closed configuration. A fold line C-C is defined across the pouch 1 that is substantially aligned with the lower end 50 of the flap 48 at height h3. To reduce the size of the pouch the lower end of the pouch 1 is folded forwards and upwards such that the lower end of the rear wall 22 is now forward facing. The lower end of the pouch 1 is lifted upward and placed beneath the flap 48 until the fastener of the rear wall 22 and the fastener on the inner surface of the flap 48 are aligned. The fastener 58 and fastener 60 are located equidistant from the fold line C-C above and below the fold line C-C respectively such that when the lower end of the pouch is folded upwards about the fold line C-C the two fasteners 58,60 align. The two fasteners are secured to each other once in this position, and by doing so the pouch 1 is held in a folded, compact configuration in which it is substantially halved in length, as shown in FIG. 5.

    [0069] In the arrangement of FIG. 6, an aperture 70 is formed in the rear panel 22 of the cover 20. The fastener 58 is affixed to rear wall 4 of the collecting bag 2 rather than to the rear panel 22. The aperture 70 corresponds in shape and location to the fastener 58 and is arranged about the fastener 58, with the fastener 58 being exposed through the aperture 70. This allows direct bonding of the fastener 58 to the polymer film of the rear wall 4 rather than to the fabric material of the cover 20. A more secure bond may be created with the polymer film of the rear wall 4 than with the fabric material, which mitigates the risk of the fastener 58 de-bonding in use. A strengthening zone 72 may be formed around the aperture 70 by a region of bonding between the rear panel 22 and the rear wall 4, in a similar manner to the strengthening zones described above. This ensures that the shape of the aperture is maintained and that the position of the aperture 70 is fixed relative to the fastener 59, ensuring the fastener 58 and aperture 70 remain aligned.

    [0070] In the arrangement of FIG. 7 the cutaway section 36 of upper edge 34 of the lower panel 28 includes a secondary cutaway section or recess 74 located in the saddle of the cutaway 36. The substantially semi-circular recess 74 is arranged to reveal a fastener 76 bonded to the underlying front wall 3 of the collecting bag 2. The fastener 76 is a Velcro® tab or any other suitable fastener and is located at a level stoma inlet 10. The fastener 76 is arranged to align with the fastener 60 on the inside surface of the upper panel 30 to secure the upper panel section 30 to the front wall 3 and secure the upper panel section 30 in the closed position. The faster 76 and fastener 60 are corresponding complementary fasteners such as opposing parts of a hook and eye fastener such as Velcro®. Alternatively, they may be push fittings or any other suitable two-part fasteners. It will be appreciated that the semi-circular cutaway 74 is not essential and in other arrangements the fastener 76 may be bonded directly to the collecting bag 2 above the level of the first cutaway 36.

    [0071] FIG. 8 shows an embodiment in which the fastener on the rear panel 22 comprises a transverse slit 78 formed in the material of the rear panel 22. The corresponding fastener of the upper panel section 30 is created by the curved slit 52 formed in the bonding region 51. The slit 52 forms a substantially semi-circular movable tab section 53, as can be seen in FIG. 3, that faces upwardly and folds about the lower ends of the slit 52. The slit 78 is arranged such that it is level with the tab 53 when the lower end of the pouch 1 is folded upwardly to the compact configuration. The lower end is tucked beneath the flap 48 and the tab 53 is bent rearwardly and inserted into the slit 78, extending upwardly into the slit 78. The lower end of the pouch 1 is thereby hooked over the tab 52 to hold the pouch 1 in the compact configuration, as shown in FIG. 9.

    [0072] In the alternative embodiment of FIG. 10, the lower edge 46 tapers downwardly and inwardly from either side to the lower end 50 of the flap 48, which is squared off rather than V-shaped such that it has a flat lower edge. The cutaway section 36 defining the window 37 is provided with a corresponding squared off shape, as shown in FIG. 11.

    [0073] In the arrangement of FIG. 12, the peripheral edge 32 of the lower end of the pouch 1 includes notches or slits 80a and 80b formed by the peripheral edge curving inwardly to create a valley. The notches or slits 80a and 80b are arranged on opposing sides of the pouch 1 at a common height h3 corresponding to the fold line C-C. The peripheral weld 29 follows and confirms to shape of the notches 80a and 80b, which creates a hinge point in the peripheral edge 32 at the fold line C-C as well as providing a visual indication of the fold line C-C. This improves the ease of folding the pouch 1 and ensures more accurate and immediate alignment of the fasteners 58,60.

    [0074] Folding of the pouch 1 about the fold line C-C is further enhanced by lateral stiffening elements 82 and 84 located on the rear panel 22. The lateral stiffening elements 82 and 84 are created by regions of bonding between the rear panel 22 and the rear wall 4. The lateral stiffening elements 82 and 84 are arranged parallel with and spaced immediately adjacent the fold line C-C above and below the fold line C-C respectively. The stiffening elements 82 and 84 provide additional structure to the rear part 22 of the cover 20 that promote folding about the fold line C-C. The stiffening elements 82 and 84 may also be used independently of the notches 80,80b, as shown in the embodiment of FIG. 14.