• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    OSTOMY APPARATUS An ostomy appliance for fixing to a stoma, the ostomy appliance comprising: an adhesive tablet (100) defining a passageway for receiving a stoma from a user, the adhesive tablet comprising a support layer and an adhesive layer facing the skin; and a collection bag (116) which in use is attached to the adhesive pad; wherein the support layer in a first zone has a first set of properties and in a second zone (104) has a second set of properties, the first zone defining two or more zones that extend radially, where the second zone defines one or more interconnecting parts (110), each of which interconnects at least two of the radially extending zones (108).
    公开号:BR112013032050B1
    申请号:R112013032050-8
    申请日:2012-06-29
    公开日:2020-10-27
    发明作者:Dorrit Diana Israelson；Hasse Buus；Charlotte Klein；Kristoffer Hansen；Henrik Edvardsen
    申请人:Coloplast A/S；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention relates to an ostomy apparatus comprising an adhesive tablet defining a first and a second zone. The first zone defines three or more zones that extend radially, at least two of which are interconnected by interconnecting pieces. BACKGROUND OF THE INVENTION
    [002] Ostomy devices with non-rounded adhesive pads have the disadvantage that each of the radially extending parts of the adhesive pad must be detached separately in order to remove the entire adhesive pad. This means that the removal of such adhesive pads can be time-consuming and complicated.
    [003] It is an objective of one or more embodiments of the present invention to provide an ostomy apparatus that overcomes this problem. DESCRIPTION OF THE INVENTION
    [004] In a first aspect, the present invention relates to an ostomy apparatus for fixation to a stoma, the ostomy apparatus comprising: an adhesive tablet defining a passage for receiving a stoma from a user, the adhesive tablet comprising a layer support and an adhesive layer facing the skin; and a collection bag that in use is attached to the adhesive pad; where the adhesive pad in a first adhesive zone has a first set of properties and in a second adhesive zone has a second set of properties, the first zone defines a central zone from which three or more radially extending zones extend for the edge of the insert, the second zone defines one or more interconnecting pieces, each of which interconnects at least two of the zones extending radially from the first zone, where a part of the second zone defines at least 30% of the total circumference the outer edge of the adhesive pad.
    [005] An advantage of the present invention is that two neighboring zones that extend radially, which are interconnected by an interconnecting piece, can be removed in the same movement. The reason for this is that the detachment of one of the two radially extending zones will cause the interconnection part to be detached and therefore also the other of the two radially extending zones. Therefore, the tablet of the invention is able to provide a better fit to curved surfaces of the body, due to the presence of the radially extending portions, such as a protruding stoma, but at the same time it is easy to detach from the skin after use.
    [006] Furthermore, the provision of an adhesive on the interconnection part makes the interconnection part serve as a barrier between the ostomy and the surrounding environment. If no interconnecting part has been provided between two neighboring zones that extend radially, then it may be possible for the fecal matter to escape in the space defined between these two zones that extend radially.
    [007] Compared to a traditional adhesive insert that is round or rounded (for example, circular or oval), providing a combination of radially extending zones and interconnecting parts, provides an adhesive insert that may be easier to attach to the user's skin. As an example, zones that extend radially may have a first property while interconnecting parts may have another property, such as being more flexible. Therefore, it may be easier for the user to personalize the adhesive pad to the 3D geometry of the peristomal zone, just as in cases where the stoma is associated with a hernia. Preferably, the areas extending radially will, together with the interconnecting parts, provide a tablet having a substantially round contour. By substantially round contour here means that the contour is circular or oval, not necessarily strictly symmetrical, but having a pronounced rounded shape without distinct deviations. However, the insert, a non-adhesive tab element, may be present at the edge of the insert in order to facilitate initial gripping during the detachment of the insert.
    [008] The collection bag may be suitable for collecting waste from the intestinal system of a human being. In this way, the ostomy device can be adapted for use in connection with colostomies, ileostomies or urostomies, both temporary and permanent types. However, the device can also be used to collect fecal matter from the rectum of a person suffering from fecal incontinence, who has not undergone stoma surgery.
    [009] The passage defined in the adhesive insert can be circular, oval or polygonal. It will be appreciated that in some embodiments, this passage is small enough to allow the user to customize the passage to the shape of the user's stoma, while at the same time being large enough to allow a cutting medium, such as scissors, to be inserted to inside the passage. Thus, in one embodiment, the largest dimension of the passage is less than 50 mm, such as less than 40 mm, such as less than 30 mm, such as less than 20 mm, such as less than 15 mm, such as less than 10 mm, such as less than 5 mm.
    [010] The adhesive layer facing the skin can comprise any suitable adhesive. The adhesive layer facing the skin comprises a first layer of skin facing the first zone and a second layer facing the skin of the second zone. The first and second zones of adhesive layer facing the skin may comprise the same adhesive or may comprise different adhesives. The adhesive may comprise absorbent particles such as hydrocolloids.
    [011] The first zone may comprise a hydrocolloid adhesive and the second zone may comprise a soft, substantially non-absorbent adhesive.
    [012] Preferred adhesives are soft adhesives, such as silicone or polyurethane adhesives. In one embodiment, the adhesive comprises a polyalkylene oxide polymer and an organosiloxane based crosslinked adhesive system. Other suitable adhesives may be adhesives based on block copolymers of styrene isoprene styrene (SIS) or ethylene vinyl acetate (EVA).
    [013] In one embodiment, the backing layer comprises a polymer film, coated, laminated, woven or non-woven. The backing layer is preferably a highly flexible film, being strong enough to hold, for example, couplings and / or bags and to remove the entire device, but soft enough to follow the movements of the body.
    [014] A preferred backing layer is a polyurethane film. Other suitable films may be mixtures or laminates of polyurethane / polyolefin.
    [015] Preferably, the support layer has thermoplastic elements that allow the welding of, for example, a pouch or coupling ring to the adhesive insert. The preferred thickness of the backing layer is between 15-100 pm, for example 15-60 pm, such as 30-60 pm in order to maintain the softness of the adhesive pad.
    [016] During use, the collection bag is attached to the adhesive pad. Therefore, in one embodiment, the ostomy device is a one-piece ostomy device in which the collection bag is permanently attached to the adhesive pad, for example by adhesive or welding. In the last embodiment, the collection bag can be integrated with the tablet. The collection bag can be attached to the adhesive tablet by means of an adhesive provided between the collection bag and the adhesive tablet. This latter adhesive can be provided on the opposite side of the adhesive tablet to the adhesive layer facing the skin. Alternatively, or as a supplement, the collection bag can be attached to the adhesive tablet by means of mechanical coupling means.
    [017] In another embodiment, the collection bag and the adhesive form a two-piece ostomy device, which is delivered to the user in two parts that must be connected to each other by the user. In the last embodiment, the adhesive can be provided on surfaces of coupling the collection bag and the tablet. In one embodiment, the collection bag is separably attached to the adhesive tablet, that is, in such a way that the collection bag can be separated from the adhesive tablet.
    [018] In one embodiment, the collection bag is reappliedly attached to the adhesive pad. By reattachable attachment, it should be understood that the collection bag is attached or attachable to the adhesive pad in such a way that it can subsequently be detached and reattached to the adhesive pad.
    [019] In one embodiment, the shape of the adhesive pad is round such as circular or oval. The adhesive layer facing the skin can be covered by a release liner. The release liner may be siliconized or otherwise provided with a non-stick surface on the side that faces the adhesive layer facing the skin. This release must be removed so that the user can adhere to the skin the adhesive layer facing the user's skin, and does not form a part of the invention.
    [020] The first zone can define a central zone from which the zones that extend radially extend. In one embodiment, the central zone is substantially round, such as circular or oval. Most of the central part of the tablet can be inside the pocket when it is attached. The bag attachment line can be inside the central zone. The fixing line can be concentric to the central zone. The central zone is at least 10 mm wider (measured in the radial direction) than the fixing line, in order to ensure a good insert fixation and leak control.
    [021] The adhesive pad may comprise a plurality of radially extending zones, such as three, four, five, six, seven, eight, etc. The zones that extend radially can be spaced equidistant around the circumference of the central zone.
    [022] In one embodiment, the first zone is shaped like a flower in which the zones that extend radially correspond to the leaves of the flower. In one embodiment, each of the radially extending zones ends at a point with a predetermined radius. In one embodiment, the width of each radially extending zone decreases in the direction of the point to which the radially extending zone ends.
    [023] In one embodiment, the radially extending zone comprises a part along which the width is constant. The width of the radially extending zone being measured in the direction transverse to the longitudinal direction of the radially extending zone. In one embodiment, one or more of the radially extending zones comprise a part in which the width increases towards one end of the radially extending zone.
    [024] In one embodiment, the interconnecting parts extend in a radial direction. In other embodiments, the interconnecting parts are provided in the form of bands that interconnect the radially extending zones. Any two neighboring zones that extend radially can be interconnected by one or more of such strips, each of which extends in a direction transversal to the longitudinal direction of the zones that extend radially. Thus, in one embodiment, the adhesive tablet is shaped like a spider web.
    [025] In one embodiment, the second zone surrounds the first zone. In the last embodiment, each of the interconnection parts can extend (radially inward) towards the center of the first zone, for example in such a way that they fill the space defined between the zones that extend radially. In addition, the outer shape of the second zone can be round, such as oval or circular. In the last embodiment, the second zone defines the outer edge of the adhesive pad.
    [026] In embodiments where the second zone does not surround the first zone, a part of the outer edge of the adhesive pad can be defined by the first zone, while the other part of the adhesive pad is defined by the second zone.
    [027] A part of the second zone defines at least 30% of the total circumference of the outer edge of the adhesive pad. The part of the second zone can for example constitute at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such at least 90%, such as 100% of the total circumference of the outer edge of the adhesive pad.
    [028] The area of the second zone can for example comprise 10-80%, such as 20-70%, such as 30-70%, such as 30-60% of the total area of the tablet.
    [029] In one embodiment, the second zone defines a unitary zone while the second zone in other embodiments defines a plurality of non-unitary zones. These last non-unit zones can be interconnected through the first zone.
    [030] In one embodiment, an interconnection part is defined between the two neighboring zones that extend radially. In another embodiment, each part that extends radially is only connected to another part that extends radially by means of an interconnection part.
    [031] The tablet has a first set of properties in a first zone and a second set of properties in a second zone. The properties of the first and second zones can be achieved by the properties of the adhesive layer, the backing layer or a combination of both.
    [032] The skin-facing surface of both the first and second zones is adhesive.
    [033] In one embodiment the support layer in a first zone has a first set of properties and in a second zone it has a second set of properties.
    [034] As an example, the flow limit of the first zone and the flow limit of the second zone are identical. In the context of the present invention the term "yield point" or "yield point" is to be understood as the degree of stress to which a material must be subjected before it begins to deform plastically. Before the flow point, the material will deform elastically, and will return to its original shape, when the applied stress is removed. Once the flow point has passed, some fraction of the deformation will be permanent and not reversible. By providing identical flow limits in the first and second zones, it can be ensured that none of the first zones and second zones are more likely to deform plastically than the other.
    [035] In another embodiment, the flow limit of the second zone is greater than the flow limit of the first zone. The effect is that the second zone - which defines the interconnecting parts - can be elastically deformed over a greater stress range than the first zone. In effect, the second zone is more elastic than the first zone.
    [036] In yet another embodiment, the flow limit of the second zone is lower than the flow limit of the first zone. The effect is that the second zone - which defines the interconnecting parts - can easily be stretched in relation to the first zone, which defines the zones that extend radially. This gives the user the advantage of being easier to adapt the geometry of the adhesive pad to the geometry of the user - which is especially advantageous, for example, in cases where a hernia is associated with the stoma.
    [037] Another example of properties different from the first and second zones is stiffness. In this way, the stiffness of the first zone may be greater than the stiffness of the second zone. An advantage of providing first more rigid zones is that the zones that extend radially will be more rigid than the interconnecting parts. This can make it easier to remove the adhesive pad from the user's skin while the user can disengage the adhesive pad from the skin by peeling off the relatively rigid parts that extend radially. As these radially extending parts are interconnected by means of the interconnecting parts, the adhesive insert can be removed in a single movement. When the second zones are less rigid than the radially extending zones, it may be easier for the user to attach the adhesive pad to the user's skin. This is especially the case when the second zones are more flexible than the zones that extend radially. In addition, an adhesive tablet with rigid zones and less rigid zones may be more comfortable to use as less rigid zones can allow the more rigid zones to move easily in relation to one another for example when the user bends his stomach.
    [038] One way to make the second zone more rigid than the first zone is to provide the two zones in different thicknesses. Thus, in one embodiment, the second zone is thicker than the first zone in a direction transverse to the line that extends radially from the passage of the adhesive pad.
    [039] The first and second zones may comprise different adhesives, for example a soft adhesive and a more rigid adhesive or adhesives with different absorption properties. The different adhesive can be combined with different thicknesses in order to improve the difference in properties.
    [040] The first zone can have a sticky adhesive being larger than the sticky sticker of the second zone.
    [041] The adhesive of the first zone can be an adhesive being suitable to have close to the stoma, for example an absorbent adhesive or an erosion resistant adhesive.
    [042] The second zone can be very thin and flexible. When applying the tablet to a protruding surface such as a hernia or an internal stoma, the radially extending areas can be applied without wrinkles and any surplus of the tablet in the second interconnection zone can be wrinkled, broken up to fit. If the second area is thin and flexible, any folds and wrinkles will be very small and flat and will not give rise to leaks or rubbing, but on the contrary will provide a perfect fit to the skin.
    [043] The thickness of the second zone may be less than the thickness of the first zone. The second zone can have a thickness being less than 70%, such as less than 60%, such as less than 50, such as less than 40%, such as less than 30%, such as less than 20% or less than 10% of the thickness of the first zone.
    [044] The thickness of the second zone can be 50-1500 pm, such as 50-1000 pm, such as 50-750 pm. The thickness of the second zone can vary, such that for example the interconnecting part can be thicker than the outer part of the ring or the outer part of the ring can be thicker than the interconnecting parts.
    [045] The thickness of the first zone can be 500-3000 pm, such as 1000-3000 pm. The thickness of the first zone can vary, such that, for example, the zones that extend radially can be thicker than the central zone or the central zone can be thicker than the zones that extend radially. The thickness of the zones that extend radially can increase or decrease radially.
    [046] The thickness of the tablet is measured in a direction perpendicular to the surface facing the skin of the tablet.
    [047] The support layer can be elastic in order to better adapt to the contours of the skin.
    [048] The end portion of the tablet can be chamfered to provide a smooth transition to the skin and avoid curling of the edges. The first zone can be chamfered on the edge portions in the event that the first zone is thicker than the second zone.
    [049] In one embodiment, the absorption capacity of the first and second zones are identical. Alternatively, an absorption capacity of the second zone is higher than an absorption capacity of the first zone or the absorption capacity of the first zone may be greater than the absorption capacity of the second zone. BRIEF DESCRIPTION OF THE FIGURES
    [050] The invention will now be described with reference to the figures in which
    [051] Fig. 1 discloses a first embodiment of the adhesive insert,
    [052] Fig. 2 discloses a second embodiment of the adhesive pad, and
    [053] Fig-3 discloses an ostomy apparatus according to the present invention. DETAILED DESCRIPTION OF THE FIGURES
    [054] Fig. 1 describes an adhesive tablet 100 comprising a first zone 102 and a second zone 104. Each first zone 102 defines a central zone 106 which is indicated by the dashed line 107 and one or more radially extending zones 108 In the embodiment of Fig. 1, five radially extending zones 108 are provided. The second zone 104 defines one or more interconnecting pieces 110 each of which interconnects at least two of the radially extending zones. In the embodiment of Fig. 1, the interconnecting parts 110 fill the space defined between the radially extending zones 108. In addition, the second zone 104 defines an outer part of the ring 112, which surrounds the first zone 102 and the parts of interconnection 110. It will be appreciated that in some embodiments, the outer ring part 112 is not provided so that the outer edge 114 of adhesive pad 100 is defined by the tip of the radially extending zones 108 and the outermost part of the interconnecting parts 110 .
    [055] In Fig. 2, the first zone 102 comprises six zones that extend radially 108. Each of these zones 108 are interconnected by circumferentially extending interconnecting parts, 110, which thus define the second zone 104.
    [056] In both embodiments (fig. 1 and 2) it will be appreciated that once the user peels off one of the radially extending zones 108, the interconnecting parts 110 will cause the remaining radially extending zones 108 to be peeled, since initially the two neighboring zones that extend radially 108 are peeled and later the following neighboring zones that extend radially 108.
    [057] It will be appreciated that due to the design, the central zone 106 and the radially extending zones 108 can be made relatively thick having a high absorption capacity, for example with materials such as hydrocolloids. Since not all adhesive pad 100 is made of such a thick layer, adhesive pad 100 is more comfortable for the user to use. The purpose of the interconnecting parts 110 may be to cause the remaining radially extending zones 108 to be peeled when one of these zones 108 is peeled.
    [058] Fig. 3 describes a cross-sectional view of adhesive pad 100 comprising a collection bag 116, the section through adhesive pad 100 corresponds to that of line 118 in Fig. 1. Thus, it will be appreciated in Fig. 3 that in the upper part of the adhesive pad 100, only the central zone 106, the interconnecting pieces 110 and the part of the outer ring 112 are visible, while in the lower part of the adhesive pad 100 the central zone 106, the zone that extends radially 108 and outer ring part 112 are visible. Of course, aperture 120 is also visible in the figure.
    [059] In the embodiment of Fig. 3, the collection pouch 116 is attached to the adhesive pad 100. However, in other embodiments, the collection pouch 116 can be attached to the adhesive pad 100 by the user, whereby the insert adhesive 100 can be used for the next collection bag 116.
    [060] In the embodiment of Figure 3, the first zone 106, 108 is in the form of a layer of adhesive being chamfered on the end portion. The second zone comprises a thin layer of adhesive 122 coated on a support layer 121. In this embodiment the entire support layer 121, including the part covering the first zone 106, 108, is provided with adhesive 122.
    权利要求:
    Claims (10)
    [0001]
    1. Ostomy appliance for fixation to a stoma, the ostomy appliance comprising: an adhesive tablet (100) defining a passageway (120) for receiving a stoma from a user, the adhesive tablet (1) comprising a support layer and a adhesive layer facing the skin; and a collection bag that in use is attached to the adhesive pad; where the adhesive tablet in a first adhesive zone (102) has a first set of properties and in a second adhesive zone (104) has a second set of properties, the first zone (102) defines a central zone (106) from of which three or more radially extending zones (108) extend to the edge (114) of the insert, characterized by the fact that the second zone (104) defines one or more interconnecting parts (110), each of which interconnects at least two of the radially extending zones (108), wherein a part of the second zone (104) defines at least 30% of the total circumference of the outer edge (114) of the adhesive pad.
    [0002]
    An ostomy apparatus according to claim 1, characterized by the fact that the interconnecting part (110) is defined between any two neighboring zones extending radially (108).
    [0003]
    3. Ostomy apparatus according to claim 1 or 2, characterized by the fact that the flow limit of the first zone (102) and the flow limit of the second zone (104) are identical.
    [0004]
    An ostomy apparatus according to claim 1 or 2, characterized by the fact that the flow limit of the first zone (102) is greater than the flow limit of the second zone (104).
    [0005]
    Ostomy apparatus according to any one of claims 1 to 4, characterized in that the stiffness of the first zone (102) may be greater than the stiffness of the second zone (104).
    [0006]
    An ostomy apparatus according to any one of claims 1 to 5, characterized in that the second zone (104) is thicker than the first zone (102) in a direction transverse to the line extending radially from the passage of the adhesive pad.
    [0007]
    Ostomy apparatus according to any one of claims 1 to 5, characterized in that the first zone (102) is thicker than the second zone (104) in a direction transverse to the line extending radially from the passage of the adhesive pad.
    [0008]
    An ostomy apparatus according to any one of claims 1 to 7, characterized in that the absorption capacity of the first zone (102) is higher than an absorption capacity of the second zone (104).
    [0009]
    Ostomy apparatus according to any one of claims 1 to 8, characterized in that the shape of the adhesive tablet (100) is round, such as circular or oval.
    [0010]
    An ostomy apparatus according to any one of claims 1 to 9, characterized in that the radially extending zones (108) can be spaced equidistantly around the circumference of the central zone (106).
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    同族专利:
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    CN103561693B|2015-09-09|
    RU2595010C2|2016-08-20|
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    BR112013032050A2|2016-12-13|
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    引用文献:
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    EP2150216A2|2007-04-09|2010-02-10|Bristol-Myers Squibb Company|Adhesive body fitment for ostomy appliance|
    WO2009000273A1|2007-06-25|2008-12-31|Coloplast A/S|An ostomy appliance with multiple release liners|
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    CN103561694B|2011-06-30|2015-06-17|科洛普拉斯特公司|An ostomy appliance|RU2595010C2|2011-06-30|2016-08-20|Колопласт А/С|Device for ostomy application|
    WO2015180731A1|2014-05-28|2015-12-03|Coloplast A/S|An ostomy wafer|
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    EP3250246A1|2015-01-28|2017-12-06|Hollister Incorporated|Adhesive for moist tissue and peristomal device made using the same|
    WO2016124202A1|2015-02-02|2016-08-11|Coloplast A/S|Ostomy device|
    WO2016146135A1|2015-03-16|2016-09-22|Coloplast A/S|Ostomy device|
    CA2982012A1|2015-04-10|2016-10-13|Coloplast A/S|Ostomy device|
    JP6880002B2|2015-09-11|2021-06-02|コロプラスト アクティーゼルスカブ|Ostomy device|
    EP3352715B1|2015-09-24|2019-06-26|Coloplast A/S|An ostomy appliance with a release liner with an enclosure|
    RU2724410C2|2015-10-08|2020-06-23|Колопласт А/С|Body-facing stoma adapter element|
    US10945873B2|2016-05-12|2021-03-16|Marlen Manufacturing And Development Co.|Multi-petaled mounting members for ostomy pouches|
    EP3454797B1|2016-05-12|2022-02-09|Marlen Manufacturing And Development Co.|Mounting assemblies for ostomy appliances comprising an adhesive skin barrier member having a multi-petaled outer perimeter|
    GB2560497A|2017-02-24|2018-09-19|Welland Medical Ltd|Flange for ostomy bag|
    EP3937862A1|2019-03-11|2022-01-19|Furine ApS|An ostomy wafer construction|
    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-08| B09A| Decision: intention to grant|
    2020-10-27| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/06/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA201170346|2011-06-30|
    DKPA201170346|2011-06-30|
    PCT/DK2012/050237|WO2013000482A1|2011-06-30|2012-06-29|An ostomy appliance|
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