lateral body member of an ostomy device, and ostomy device

专利摘要:
it is a lateral body member of an ostomy device that has a distal surface with one or more compartments that holds a manipulable material and allows the manipulative material to be moved between a first position and a second position in the compartment in use of the body's lateral limb around a user's stoma.
公开号:BR112019020914A2
申请号:R112019020914
申请日:2018-04-09
公开日:2020-04-28
发明作者:Ravn Joergensen Anders；Vestbo Andersen Birthe；Friis Kasper；Stendevad Windeballe Lars；Holler Langhorn Philip；Morgan Hickmott Richard
申请人:Coloplast As；
IPC主号:

专利说明:

SIDE MEMBER OF THE BODY OF AN OSTOMY APPARATUS, AND, OSTOMY APPARATUS
Background [001] The reversal outlet, in general, contains body fluids and visceral content that are aggressive to a user's skin and ostomy devices in particular, have a detrimental effect on the effectiveness and integrity of the adhesive materials that are applied to fix the ostomy device to the user's skin surface. Some ostomized individuals may choose or have to wear their device close to their bodies for extended periods of time. For users in general, and particularly for these ostomized individuals, safe, reliable and effective ostomy devices are highly desirable. Several attempts have been made to provide ostomy devices to meet such demands, for example, the demand for time of use with the extended body, but the provision of sufficient efficacy to achieve a long time of use with the satisfactory body of ostomy devices continues to be an unmet need.
[002] The ostomized individuals and health care professionals, likewise, would appreciate improvements in ostomy devices to better achieve such demands.
Summary [003] The present disclosure provides aspects of a lateral body member of an ostomy apparatus according to the appended claims.
Brief Description of the Drawings [004] The attached drawings are included to provide a greater understanding of modalities and are incorporated into and are part of this specification. The drawings illustrate modalities and, together with the description, serve to explain the principles of the modalities. Other modalities and many of the intended advantages of modalities will be
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2/55 readily observed as they become better understood in reference to the detailed description below. The elements of the drawings are not necessarily to scale relative to each other. Similar numerical references designate corresponding similar parts.
[005] Figure 1 is a schematic top view of an embodiment of a lateral body member of an ostomy device.
[006] Figure 2 is a schematic cross-sectional view of a modality showing a lateral body member comprising manipulable material.
[007] Figure 3 is a detailed schematic cross-sectional view of a modality that illustrates a portion of a lateral body member.
[008] Figure 4 is a detailed schematic cross-sectional view of a modality that illustrates a portion of a lateral body member.
[009] Figure 5 is a schematic cross-sectional view of an embodiment showing a lateral body member comprising manipulable material.
[0010] Figure 6 is a schematic perspective view of an embodiment of a lateral body member.
[0011] Figure 7 is a schematic cross-sectional view illustrating an embodiment of a lateral body member.
[0012] Figure 8 is a schematic top view showing a distal surface with openings for one or more compartments of a modality of a lateral body member.
[0013] Figure 9 is a cross-sectional, schematic view of an embodiment of a lateral body member.
[0014] Figure 10 is a schematic cross-sectional view of an embodiment of a lateral body member.
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3/55 [0015] Figure 11 is a cross-sectional, schematic view of an embodiment of a lateral body member.
[0016] Figure 12 is a cross-sectional, schematic view of an embodiment of a lateral body member.
[0017] Figure 13 is a cross-sectional, schematic view of a modality of a lateral body member.
[0018] Figure 14 is a cross-sectional, schematic view of an embodiment of a lateral body member comprising a first half of a coupling interface.
[0019] Figure 15 is a cross-sectional, schematic view of an embodiment of a lateral body member comprising a first half of a coupling interface.
[0020] Figure 16 is a schematic side view of an embodiment of an ostomy device that comprises a lateral body member attached to a user's skin surface.
[0021] Figure 17 is a schematic top view of an embodiment of a lateral body member.
[0022] Figure 18 is a schematic perspective view of an embodiment of a lateral body member.
[0023] Figure 19 is a schematic cross-sectional view of a modality of an ostomy device that comprises a lateral body member fixed to a user's skin surface.
[0024] Figure 20 is a schematic cross-sectional view of an embodiment of a lateral body member.
Detailed Description [0025] In the Detailed Description below, reference is made to the attached drawings, which form a part of it, and specific modalities are shown as a form of illustration in which the invention can be practiced. In this sense, directional terminology, such as top, “bottom, frontal,
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4/55 rear, front, rear, etc., is used in reference to the orientation of the Figure (or Figures) that is described. Due to the fact that the components of the modalities can be positioned in different orientations, directional terminology is used for purposes of illustration and is by no means limiting. It should be understood that other modalities can be used and structural or logical changes can be made without departing from the scope of the present invention. The following detailed description, therefore, should not be considered in a limiting sense and the scope of the present invention is defined by the appended claims.
[0026] It should be understood that the resources of the various exemplary modalities described in this document may be combined with one another, unless specifically described otherwise.
[0027] Throughout this disclosure, the words stoma and ostomy are used to represent a surgically created opening bypassing an individual's intestines or urinary tract system. The words are used interchangeably, and no different meaning is envisaged. The same applies to any words or phrases derived from them, for example, starlings, ostomies, etc. In addition, the solid and liquid residues that emanate from the stoma can both be interchangeably called output, residue (or residues) and fluids. An individual who has undergone ostomy surgery can be called an ostomized individual or with an ostomy - in addition, also as a patient or user. However, in some cases, the user may also be related to or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse or others. In such cases, it will either be explicitly stated, or it will be implied from the context that the user is not the patient itself.
[0028] The following, whenever referring to the proximal side of a
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5/55 device, or part of a device, the reference is next to the skin, when the ostomy device is used by a user. Likewise, whenever reference is made to the distal side of a device, or part of a device, the reference is to the side facing the opposite side of the skin, when the ostomy device is used by a user. In other words, the proximal side is the side closest to the user, when the device is fitted to a user, and the distal side is the opposite side - the side furthest from the user in use.
[0029] The axial direction is defined as the direction of the stoma when the device is used by a user. Thus, the axial direction is usually perpendicular to the user's skin or abdominal surface.
[0030] The radial direction is defined as transversal to the axial direction that is transversal to the direction of the stoma. In some sentences, the words internal and external can be used. These qualifiers, generally, must be perceived in reference to the radial direction, so that a reference to an external element means that the element is more distant from a central part of the ostomy apparatus than an element referred to as internal. Furthermore, deeper should be interpreted as the portion of a component that forms a center of the component and / or that is adjacent to the center of the component. In analogy, peripheral should be interpreted as a portion of a component that forms an outer edge or outer contour of a component and / or that is adjacent to that outer edge or outer contour.
[0031] In the context of the present disclosure, a compartment should be considered a partition or cavity, that is, a structure that forms, or allows, the presence of a volume or space that is surrounded by something and has the capacity to hold temporarily or permanently , surrounding or surrounding something else, such as a mass or volume of a material or substance kept in volume or space.
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6/55 [0032] In addition, manipulable material should be interpreted as including moldable and compressible materials, as well as materials with shape memory and permanently deformable (that is, materials capable of recovering their original shape after deformation). In addition, in alternative deployments, the manipulable material may not be deformable per se (that is, no significant deformation of the dimensions of a mass or volume per unit volume of the material is possible). However, it is possible to manipulate the material in order to move it in relation to other components. In an additional or alternative way, manipulable should be interpreted as referring to materials that can be moved and / or manipulated by the hands or fingers of an ordinary person. In one embodiment, the manipulable material is a viscoelastic material.
[0033] The use of the term substantially as a qualifier for certain features or effects in this disclosure is intended simply to mean that any divergences are within tolerances that would normally be expected by the individual skilled in the relevant field.
[0034] In one aspect, the present disclosure relates to a lateral body member of an ostomy apparatus comprising a proximal surface and a distal surface. At least a portion of the proximal surface comprises an adhesive. The lateral body member comprises a central portion. At least the central portion is prepared for the provision of a stoma receiving opening which extends through the lateral body member. The distal surface of the body side member is configured to comprise one or more compartments, each of which is configured to hold a manipulable material and to allow the manipulable material to be moved between at least a first and a second position in the compartment, at least less in use of the body's side limb around a user's stool. “At least in use it should
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7/55 be interpreted in such a way that, as long as the lateral body member is not prepared for, or attached to a user's skin surface, the manipulable material is not intended to be moved between the first and second positions.
[0035] The proximal surface of the lateral body member comprises an adhesive. In embodiments, the adhesive comprises a plurality of different adhesive materials. In one embodiment, the adhesive materials other than the adhesive are supplied side by side. In one embodiment, adhesive materials other than adhesive are provided as a layered structure. In one embodiment, the adhesive materials other than the adhesive are supplied mainly side by side, but with some overlapping portions of the different adhesive materials. Examples of suitable adhesive materials are provided below.
[0036] The manipulable material is provided, inter alia, to provide a better sealing effect between the lateral member of the body and that part of the surface of a user's skin surrounding the stoma. When the seal or sealing effect is enhanced, the likelihood of starch fluids to bypass that seal and accumulate below the side member of the body, that is, between the user's skin surface and the device, is reduced. However, another important aspect of the disclosure is the finding that any reversal exit that accumulates below the lateral limb of the body, which is almost inevitable to occur during use close to the body of the ostomy device, can be interpreted as harmful by the amount shear of manipulable material in which it engages (and needs to attack) and / or by incorporating a neutralizing substance in the manipulable material. The disclosure provides options for providing the harmful starter outlet even before it can engage with the adhesive on the proximal surface of the lateral body member. In this way, bodily substances, in general, are very aggressive (for example, including certain
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8/55 enzymes produced in the body) from the stool outlet are prevented from reaching the polymeric matrix of the adhesive on the proximal surface of the device. This, in turn, helps to prevent both damage to the skin surface (caused by aggressive starch fluids), and disintegration and / or failure of the adhesive. This, therefore, provides a lateral body member that has improved leakage safety and longer usage time with the longer body (that is, the time between replacing a used product with a new product). Longer wear time with the product body can, by itself, help provide less skin complications, as the removal of the adhesive body side member from some devices currently available from the skin surface has a tendency to remove the skin cells of the epidermis. This way, when reaching a time of use next to the longer body of the product, less product substitutions are necessary, resulting in fewer occurrences of potential removal of skin cells. In addition, there is an economic benefit for the user and / or the insurance provider / health care system, when fewer replacements and thus less products are needed.
[0037] The present disclosure allows an improved sealing effect of the lateral body member to be obtained either directly, in the event that an external surface of a compartment actually engages the surface of the stoma itself to create a seal between the stoma and the surface external of the compartment, and indirectly, in the case of externalization of the manipulable material out of a compartment and in contact with the stool outlet (and, optionally, also with the surface of the stool itself) provides the improved sealing effect. In the last case mentioned, the improved sealing effect is at least partially provided by an increase in the amount of material that aggressive steroidal fluids have to break in order to reach the adhesive on the side member of the body. The distal surface of the lateral body member is configured to comprise one or more
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9/55 compartments. This means that the distal surface of the lateral body member can be provided with one or more compartments during manufacture so that, when the user receives the lateral body member, one or more forms of compartments are present on or on the distal surface . However, it is also envisaged that the one or more compartments can be provided separately from the other elements that form the lateral body member, so that the user (or the HCP) can provide the one or more compartments for the distal surface of the member side of the body immediately before applying the product to the user's skin surface. This additionally allows for individual customization of the lateral body member. As an example, the user may have the ability to control both the quantity and the ideal location of one or more compartments on the side member of the body, that is, having the option of applying more manipulable material to certain locations where it is most needed.
[0038] In one embodiment, the one or more compartments are formed as one or more cavities in an adhesive layer provided both on the adhesive side of the proximal surface and on at least a portion of the distal surface of the lateral body member. The one or more cavities contain the manipulable material. Each cavity can be completely or only partially filled with the manipulable material. Thus, it should be understood that configuring the one or more compartments of the distal surface of the body side member to hold the manipulable material can also include forming the compartments without additional materials or components in addition to the adhesive of the body side member and the manipulable material. Thus, in the modalities, the one or more compartments are defined as incorporated into the adhesive of the side member of the body, and will be visible as one or more protuberances protruding from the distal surface of the side member of the body. The manipulable material can
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10/55 be released simply by pressing on the visible protuberances. This can help to press or compress the proximal surface of the lateral body member at the locations of one or more compartments (protuberances) in relation to the skin surface, which can be advantageous in locations where more material is needed to fill a crease or folding of skin surrounding the stoma, or in particularly vulnerable locations where the lateral limb is prone to leakage. In addition or alternatively, the user can refrain from applying pressure to one or more protrusions and, instead, the manipulable material contained in one or more cavities will then, eventually, only be released when the level of adhesive breakage of the lateral body member reaching one or more cavities. This can help to provide additional control over when and how much manipulable material can and will be released. In addition, these modalities can help to provide a simpler construction and still achieve the beneficial effects of the seal between the body's lateral limb and the skin.
[0039] The one or more compartments are configured to hold a manipulable material. In a deployment, this means that a compartment is suitable for holding, wrapping or trapping in a mass or volume of manipulative material or substance. In some embodiments, the one or more compartments form closed, lockable or locked elements. In other embodiments, the one or more compartments form open or openable elements.
[0040] In some modalities, a total volume or space for holding a compartment is greater than the volume of manipulable material provided in the compartment. In other embodiments, a total volume or holding space of a compartment is substantially filled with manipulable material so that none, or only an insignificant portion of the volume or space of the compartment is not
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11/55 filled with manipulable material.
[0041] In the modalities, in which a compartment is formed as a blocked element, the manipulable material can be configured to be moved around within the boundaries of the compartment. Thus, in one embodiment, the manipulable material is supplied within one or more compartments in the first and second positions. In other words, in these modalities, the one or more compartments are configured so that the manipulable material does not leave a compartment (including any unintended exit).
[0042] In the modalities, the improved sealing effect of the lateral body member can be achieved after applying the lateral body member to the user's skin surface (adhering the proximal side of adhesive to the skin) by providing pressure with the finger to the outside of one or more compartments on the distal surface, to manipulate effectively and thereby move the manipulable material trapped within the compartment (or compartments) in relation to the stoma. The manipulable material can thus be moved between at least a first and a second position (inside) in the compartment. In the embodiments, a portion of the distal surface of the lateral body member that forms an exterior of the one or more compartments is configured to be engaged or in contact with all or a portion of the external surface, that is, the mucous membrane, of the stoma, without manipulative material leaving or leaving the compartment. In this way, the manipulable material can be moved between at least a first and a second position in the compartment. In the embodiments, the outer surface of the compartment is configured to be plastic or elastically deformed, but, however, not limited to using an anisotropic material.
[0043] In the modalities, in which a compartment is formed as an open or openable element or component, the manipulable material is configured to be moved between at least one first
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12/55 position and a second position inside the compartment. However, in some deployments, the compartment (or compartments) comprises one or more openings, so that the manipulation of the manipulative material, providing pressure with a finger to the outside of the one or more compartments causes the manipulative material that is kept effectively inside the compartment (or compartments) exit through one or more openings. Consequently, the manipulable material can thus be moved between at least a first and a second position in the compartment. Thus, in one embodiment, the manipulable material is supplied within the one or more compartments in the first position, and at least part of the manipulable material is supplied outside the one or more compartments in the second position. As an example: in the case of an open or openable compartment, the manipulable material may, in the first position, be located in the compartment in a position opposite to one or more openings and then be moved to a second position (inside de) in the pressure compartment with finger. In addition, in the second position, a first portion or part of the manipulable material may be located inside the compartment and a second portion or part of the manipulable material may be located outside the compartment. In another implantation, the lateral body member is configured so that substantially all of the manipulable material is located outside the one or more compartments in the second position.
[0044] In one embodiment, the manipulable material is configured to expand in response to moisture absorption. In the modalities, the manipulable material is configured to be subjected to a swelling action by absorbing moisture from the stool outlet and / or mucus emanating from the stool's mucous membrane. In the modalities, the expansion of the manipulable material helps to create an improved seal between the stoma and the body's side member, thereby reducing the likelihood of leakage caused
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13/55 by starch fluids that attack the adhesive on the proximal surface of the lateral limb of the body. In the embodiments, the manipulable material includes a moisture-absorbing component or substance. In embodiments, the moisture absorption component has a high absorption capacity or potential, and in other embodiments, the moisture absorption component has a low absorption capacity. Suitable materials for the moisture-absorbing component include, without limitation, superabsorbent polymers commonly manufactured from polyacrylic acid salts.
[0045] In one embodiment, the lateral body member further comprises a reinforcing element. The reinforcement element may particularly, but not exclusively, include a sheet or layer of a polymeric film material, such as polyethylene (PE) or polypropylene (PP). Other film materials that have additional characteristics, for example, gas or vapor impermeability, upper / lower liquid or odor control and others, can be additionally and / or alternatively used. Other reinforcement element options include fabric and / or mesh or mesh-shaped materials. In one embodiment, the reinforcement element may be located (“sandwiched”) between the adhesive on the proximal surface and on the distal surface of the lateral body member. In one embodiment, the reinforcement element can be incorporated (completely contained) in the adhesive on the proximal surface of the lateral body member. In one embodiment, the reinforcement element includes reinforcement fibers provided on a surface of the body's lateral member. Reinforcement fibers can also be mixed into the adhesive on the proximal surface of the lateral body member. [0046] An advantageous effect of the reinforcement element is that it helps to provide a lateral body member that is more resistant to the forces acting on it. In general, a stoma is located in the user's lower abdomen (which corresponds to the location of the intestines). Thus, some examples of forces acting on the lateral limb of the body
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14/55 include forces generated by the user's clothes, as in the lining at the waist of a pair of pants or jeans, such forces, in general, are still amplified by the presence of a belt. The forces can be both pressure and shear forces, in general, in combination.
[0047] In one embodiment, the distal surface of the lateral body member comprises a layer of a laminated material. In the embodiments, the layer of a laminated material (layer of laminated material) is configured to form the distal surface of the lateral body member. The laminated material layer may, particularly, but not exclusively, include a polymeric film material, such as PE or PP. Other film materials that have additional characteristics, for example, gas or vapor impermeability, upper / lower liquid or odor control and others, can be additionally and / or alternatively used. In the embodiments, the layer of laminated material is dissolvable. In one embodiment, the laminated material layer is dissolvable when subjected to water or an aqueous liquid, such as aggressive starch fluids or mucus that emanates or secretes from the stoma's mucous membrane. In one embodiment, the dissolvable material comprises a polyvinyl alcohol (PVA). In one embodiment, the laminated material layer comprises a plurality (i.e., two or more) perforations.
[0048] In the embodiments, the laminated material layer comprises a woven or non-woven material. In one embodiment, the laminated material layer is a thermoplastic polymer film. In one embodiment, the laminated material layer comprises an elastic material. In one embodiment, the laminated material layer is suitably capable of transmitting moisture and can, for example, be produced from polymers, such as polyolefin types, for example, PE, PP or polybutylene, polyamide, such as nylon, polyurethane, acetate polyvinyl chloride, polyvinyl chloride, fluorinated polyvinyl compound, polyvinylidene chloride, alcohol
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15/55 polyvinyl, ethylene vinyl acetate, cellulose acetate or other thermoplastic polysaccharides, polyether block amides, such as PEBAX® available from Arkema, France, block copolymers such as styrene-isoprene-styrene block copolymers or block copolymers ethylene acrylate, polyesters, such as polyethylene terephthalate (PET) or derivatives thereof and any laminates of such polymers. In other embodiments, the laminated material layer comprises a thin foam layer produced from, for example, polyurethane, polyethylene or polyvinyl acetate.
[0049] In the modalities, a wall of each one of the one or more compartments comprises a flexible sheet. In the embodiments, the flexible sheet of a wall compartment is produced from the same material as the laminated material layer of the body side member. In other embodiments, the flexible sheet is produced from a material that is different from the laminated material layer of the body side member. In the embodiments, the flexible sheet that forms the wall of the one or more compartments comprises a different thickness when seen over a total extension of the compartment. In one embodiment, a wall thickness reduces from a greater thickness in an outer periphery portion of the compartment to be radially thinner closer to the central portion of the lateral body member. The differentiated wall thickness is believed to be useful in providing a smooth extermalization of the manipulative material from one or more compartments, and also to guide the manipulable material radially in relation to the stoma.
[0050] In the modalities, a wall of the one or more compartments comprises a thermoformable material. In the embodiments, the thermoformable material can be a thermostable material. In the embodiment, one or more walls of a compartment form a "blister-type packaging" compartment, as is particularly known from packaging of medicinal tablets and / or gum packs.
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16/55 chew. Suitable thermoformable materials include, but are not limited to, rigid PVC materials (polyvinyl chloride materials).
[0051] In the modalities, the wall of the one or more compartments is formed by a resilient material. In some deployments, such a wall formation in a resilient material facilitates the externalization of the manipulative material from one or more compartments, particularly due to the fact that the resilience of the material causes the wall to return to its original / initial shape after an outer surface of the compartment formed by the wall has been manipulated by finger pressure. Resilient materials suitable for the wall include, but are not limited to, thermoplastic elastomers (TPEs) and / or mixtures thereof. In the embodiments, a wall of one or more compartments is produced by injection molding. Alternatively or additionally, the wall is produced in a two-component casting process, advantageously in combination with the provision of a first half of an ostomy apparatus coupling interface.
[0052] In the modalities, any one or both of the flexible sheet that forms a wall of the one or more compartments, and the layer of laminated material, are supplied as one or more separate components and are configured to be fixable to other components of the member body side. In this way, either or both of them can be “loose components that are supplied with the side body member, but are not initially attached to the side body member (that is, not attached during the manufacturing process).
[0053] In another embodiment, the layer of laminated material can only be attached locally, that is, the layer of laminated material is not attached to the side member of the body on a whole of a surface of the layer of laminated material. In one embodiment, the layer of laminated material is attached to the side member of the body by joints or
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17/55 joint, including active joints. In such embodiments, the layer of laminated material can be movably attached to the side member of the body in some locations while it is not attached to the side member of the body in other locations.
[0054] In one embodiment, the layer of laminated material is formed as an integral component of the structure of the lateral body member. This means that the layer of laminated material is connected to or attached to the side member of the body during the manufacturing process. In such embodiments, it is therefore not a separate component to be subsequently connected to the lateral body member. The layer of laminated material can be connected or attached to a whole surface of the layer of laminated material which faces the distal surface of the lateral body member. Alternatively, it can be connected to or fixed to the surface of the layer of laminated material that faces the distal surface of the lateral body member in two or more locations or localized points. Attachment or connection to the distal surface of the side member of the body may be provided by welding, such as hot welding or ultrasonic welding, or by adhesion of the components to each other. The adhesion can, in such a case, be provided by the adhesive effect of a distal surface of the adhesive of the side member of the body or by additional adhesive material which is arranged either on the distal surface of the side member of the body, or on the surface of the layer of material laminate that faces the distal surface of the lateral body member. In one embodiment, also at least a portion of the distal surface of the lateral body member comprises an adhesive. In one embodiment, an adhesive on the proximal surface of the lateral body member and an adhesive on the distal surface of the lateral body member are identical adhesives. In one embodiment, an adhesive material forms both the proximal surface and the distal surface of the lateral body member. Other means or ways of securing or connecting
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18/55 components of the body side member to each other can be applied. [0055] In one embodiment, the manipulable material is supplied in one or more smaller entities placed inside one or more compartments in the manufacture. "Minor" must be interpreted to mean that each entity alone does not absorb 100% of the volume of each compartment, preferably it absorbs not more than 95%, not more than 90%, not more than 85% of the total volume of a compartment. In one embodiment, each smaller entity absorbs approximately 50% of the total volume of a compartment. In one embodiment, each smaller entity absorbs approximately 33% of the total volume of a compartment. In one embodiment, each smaller entity absorbs approximately 25% of the total volume of a compartment. In one embodiment, each smaller entity absorbs approximately 20% of the total volume of a compartment. In one embodiment, each smaller entity absorbs approximately 10% of the total volume of a compartment. In one embodiment, each smaller entity absorbs approximately 5% of the total volume of a compartment.
[0056] In the modalities, smaller entities may comprise one or more individual spheres or balls of manipulable material supplied in the compartment, in which each of the spheres or balls of manipulable material is surrounded by a material that is configured to break, tear, open ”Or similar, when the entity is subjected to pressure with a user's finger. It should be understood that finger pressure can be applied to an external surface of a compartment, so that an internal surface of the compartment contacts or acts on the entity or entities within the compartment, resulting in the tear or rupture of one or more entities. In the modalities, in which a plurality of smaller entities are provided in one or more compartments, the compartment and the entities are configured so that the force applied by finger pressure, and that acts initially on a first entity within the compartment, not only
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19/55 serves to tear or break the first entity, but still be passed as a translational force to nearby entities, as well as to tear or break them. In the modalities, the entities can have cylindrical, stem or sausage shape. The entities also assume other relevant formats and / or any format combined by two or more of the formats mentioned.
[0057] In the modalities, the layer of laminated material forms the distal surface of the lateral body member. In the embodiments, the proximal surface of the laminated material layer comprises an adhesive that forms the proximal surface of the lateral body member. Pressure sensitive adhesives, particularly those containing hydrocolloids, are a particularly suitable group of adhesives that are characterized by having a hydrocolloid particulate phase dispersed in the adhesive or matrix phase. An adhesive containing hydrocolloids can absorb moisture from the skin to prevent skin occlusion, while maintaining its skin adhesive properties. Furthermore, the adhesive body containing hydrocolloids can be of any thickness and still have non-occlusive properties. A hydrocolloid adhesive can be processed as a hot melt and is easily shaped into specific shapes.
[0058] A typical pressure sensitive adhesive composition comprises a substantially homogeneous mixture of 10 to 60 weight percent of one or more rubberized elastomeric components, 5 to 60% of one or more absorbent particles, 0 to 50% of rubber resin stickiness enhancer, 0 to 10% of a plasticizer and 0 to 60% of a non-polar oil extender, based on the total weight of the composition. The rubberized elastomeric base could be selected from the group consisting of physically crosslinked elastomers (suitable block copolymers containing polystyrene blocks), a chemically crosslinked synthetic or natural rubberized elastomer, or a rubberized homopolymer. a
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20/55 physically cross-linked elastomer selected from styrene block copolymers, and one or more butadiene may be a styrene-butadiene-styrene block copolymer, a styrene-isoprene copolymer and is preferably a mixture of copolymers block of styrene-isoprene styrene and styrene-isoprene. A chemically crosslinked rubberized elastomer can be, for example, butyl rubber or natural rubber. A rubberized homopolymer can be a lower alkene polymer such as low density polyethylene or propylene, preferably polypropylene or atactic polyisobutylene. A tackiness-enhancing resin optionally used according to the invention is preferably a hydrogenation-enhancing tackiness resin and is most preferably selected from a group comprising polymers and copolymers of cyclopentadiene, dicyclopentadiene, alpha-pinene or beta- pinene. When the physically cross-linked elastomer is a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer, the adhesive suitably comprises 0-10% of the plasticizer (eg CITROFOL® BII, Jungbunzlauer, Switzerland) . The hydrocolloid particles preferably consist of one or more water-swelling or water-soluble hydrocolloid polymers or gums. In other embodiments, the adhesive of the proximal surface of the lateral body member comprises one or more adhesives of the types disclosed in applications W02007 / 082538 and W02009 / 006901.
[0059] In the modalities, each one of the one or more compartments comprises at least one opening that provides a passage between an interior and an exterior of each one of the one or more compartments. The at least one opening provides a passage for manipulable material to exit through, and / or for liquid or moisture, as generated by a stool outlet, to enter through the compartment. At least in the last case mentioned, a capillarity action between the incoming humidity, the interior of the compartment
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21/55 and the manipulable material can result in the manipulable material being extermalized from the compartment. In addition, the manipulative material can be configured to expand in response to moisture absorption which can also cause the manipulative material to externalize and be dispensed from the compartment. Depending, among other factors, on the nature of the manipulative material, in some modalities, the absorption of moisture and a resulting expansion of the manipulative material initiate the exit of the manipulative material in relation to the stoma without any manipulation of the one or more compartments that the user needs. In other words, the extermalization of the manipulable material from one or more compartments can start automatically as soon as the manipulable material begins to absorb moisture. It has been found that the rate of extermalization of the manipulable material can be surprisingly high, thus causing a rapid release of the manipulable material. This is useful in guiding the manipulative material in relation to the stoma as quickly as possible, thereby providing a means of achieving safety faster and thus better against leakage. This is still advantageous due to the fact that no active participation of the user when externalizing the manipulable material from one or more compartments is necessary.
[0060] In one embodiment, each of the one or more compartments comprises at least two reservoir portions connected to each other by a transfer portion. In this way, the manipulable material can be moved between at least a first and a second position in the compartment, for example, between a first position in the first reservoir and a second position in the second reservoir. In one embodiment, when the manipulable material is in the second position, it is in a second reservoir portion of the compartment, in which it was moved (moved or relocated by finger pressure / manipulation) from a first portion of the reservoir of the compartment.
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22/55 compartment. In one embodiment, the one or more compartments comprise a single (one and only one) reservoir portion and a transfer portion, wherein the transfer portion is connected to the single reservoir portion in a first portion of the transfer portion and to the outside of the compartment in a second part of the transfer portion. In one embodiment, the first and second parts are provided at opposite ends of the transfer portion. In one embodiment, the manipulable material is located within the single reservoir of the compartment in the first portion, and at least a portion of the manipulable material is located outside the compartment when it has been moved to the second position. In the modalities, either the first and the second reservoir portions can contain a greater part of the manipulable material contained in a respective compartment. In the embodiments, most of the manipulable material is initially contained in one of the reservoir portions, while a small or smaller portion of manipulable material is at least initially contained in the transfer portion. [0061] In one embodiment, each of the one or more openings in the one or more compartments faces towards the central portion of the lateral body member. In one embodiment, at least one opening of the one or more compartments is in direct communication with a stoma receiving opening of the body lateral member. In such deployments, at least one opening is particularly suitable for allowing manipulable material to be dispensed outside the compartment through the opening in or near the stoma receiving opening. Thus, the manipulable material can be used to help adapt the lateral body member to fit the small creases and folds of the skin peristoma surface and still help to create an improved seal between the skin and the body side member. Additionally, the extermalization of the manipulable material outside a compartment puts the material in contact with the
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23/55 aggressive steal fluids and / or with the surface of the stoma itself, also helping to provide the enhanced sealing effect.
[0062] In such embodiments, each opening faces radially inward with respect to the chargeback at least when the lateral body member is in use on a user's skin surface. In this way, any manipulable material that leaves a compartment is directed immediately towards any stool or moisture that emanates from the stoma or the stoma surface. In the modalities, each opening is configured so that it directs manipulable material submitted to expansion in response to moisture absorption, in a radial direction in relation to a geometric axis that is perpendicular to the proximal and distal surfaces of the lateral body member and extending through the central portion. Thus, in use, the opening effectively guides the manipulative material in relation to the stoma to mitigate one or more of the problems discussed in this disclosure.
[0063] In the modalities, each opening is located in a portion of a compartment that is radially closer to the central portion of the lateral body member and axially closer to the distal surface of the lateral body member.
[0064] In another embodiment, each of one or more openings in the one or more compartments faces a radially peripheral portion of the lateral body member. This is particularly suitable for helping to provide a distribution of the manipulable material over a large portion, or even a whole distal surface of the side member of the body in use, where the entire surface is radially within or a first half of an interface coupling the ostomy apparatus or a permanent connection between the lateral body member and a reversal outlet collection bag (for example, radially inside an annular weld).
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24/55 [0065] In the modalities, the manipulable material comprises a neutralizing substance. The neutralizing substance is very useful to mitigate the harmful effects of the aggressive starter outlet. The suitable materials and characteristics of the neutralizing substance are described in more detail below.
[0066] In the modalities, each one of the one or more compartments are configured to allow the manipulative material exiting the compartment to be supplied to the compartment on the distal surface of the lateral body member, so that the manipulable material is available for coupling with the exit reversal.
[0067] In the embodiments, the configuration of the one or more compartments allows the manipulable material to be supplied extremly to the one or more compartments, over substantially a whole portion of the distal surface of the lateral body member. However, the totality is to be understood as being a totality of a portion of the distal surface located radially within connection means for connecting the lateral body member to a stool outlet collection pouch.
[0068] In this way, the configuration of the disclosure body side member is predominantly directed towards achieving protection of the adhesive interface between the skin and the body side member, and to a lesser extent to help fill the small creases and folds of the peristoma surface of skin.
[0069] Some previous solutions focused on addressing these issues in an area with a lateral limb immediately adjacent to the stoma. Contrary to this, the present disclosure provides different and inventive solutions to these and other problems due to the fact that, in some approaches, it is believed that the problems should be mitigated at least partially due to the best options for distributing the manipulable material kept in the one or more compartments, like, but not
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25/55 exclusively, when distributing or spreading the manipulable material over a larger surface or even the entire distal surface and / or proximal surface of the lateral body member. When having the options of distributing the manipulable material, provided by the modalities described above, an area of contact between the aggressive stool outlet and a component of the lateral body member suitable to cooperate with or mitigate the damaging effects of the stool outlet (that is, the material), is effective and significantly increased. This is considered particularly advantageous due to the fact that studies conducted by the inventors have shown that, while it is at least initially the central portion of the lateral body member immediately adjacent to the stoma that is engaged (attacked) by aggressive steroidal fluids, in reality, a portion very large, or even the entire distal surface of the body's lateral limb (radially within the collection bag connection means), it quickly becomes subjected to (“stained with) stool outlet. According to the invention, the provision of the options of distributing the manipulable material over a large portion of the distal surface of the lateral body member, which is stained with the aggressive stool outlet, means that the manipulable material can engage with the stool outlet on a Much greater effective “surface area”. This is particularly, but not exclusively, advantageous in the modalities in which the manipulable material comprises a neutralizing substance. The larger surface or area of engagement / interaction between the starter outlet and the neutralizing substance means that most aggressive content of the starter outlet present on the distal surface of the lateral body member, is neutralized (provided as non-harmful) even before it can contacting the adhesive on the proximal surface of the lateral body member. In this way, the adhesive on the proximal surface and the adhesive material immediately around the stoma and in the peristomal gap, will not be prone to a quick break, providing, in turn, an increased usage time with the body, as well as a
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26/55 safer fixation of the ostomy device to the user's skin.
[0070] In other embodiments, each of one or more openings in the one or more compartments is provided on the distal surface of the lateral body member. In embodiments, one or more openings are provided on an outer surface of a compartment. One or more openings may be provided as being substantially parallel to the distal surface of the lateral body member. However, one or more openings can also be provided at an angle to the distal surface of the lateral body member. In addition, one or more openings can be distributed in a pattern on the outer surface of the compartment. The pattern can be a symmetrical pattern or a random pattern.
[0071] In one embodiment, the one or more compartments are provided in a layer of laminated material that forms the distal surface of the side member of the body, and one or more openings in each of the compartments are then provided on the surface of the layer of laminated material. In one embodiment, each of the one or more compartments is configured to have an opening over an entire area of a portion of the compartment that is parallel to the distal surface of the lateral body member (i.e., parallel to the radial direction). In other words, the compartment does not have a surface that is parallel (that extends radially) to the distal surface of the lateral body member. These deployments can help provide a prolonged / extended and / or continuous release of the manipulative material, as it can be guaranteed that the manipulable material is not subjected to immediate attack by the aggressive stool exit. Particularly, the degree of protection of the material manipulable in compartments according to this modality, can be varied by changing the length of a compartment wall between the stove receiving opening of the lateral body member and the opening of the respective compartment that is parallel (extending radially) to the distal surface.
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27/55 [0072] In the modalities, each one of the one or more compartments includes a plurality of openings. In the modalities, the manipulable material is configured to be dispensed from one or more compartments through one or more openings. In this way, the manipulable material can be dispensed from a compartment and be directed out of one or more openings (or even several, such as 5 to 20 openings) in a particular direction in the opposite direction of the compartment. In the modalities, one or more openings can be additionally configured to open in relation to different directions. In this way, the provision of one or more openings in the compartments allows a versatile distribution of the manipulable material. This, in turn, provides an option for uniform distribution of material handled out of a compartment and over the distal surface of the lateral body member. Furthermore, this provides a lateral body member that offers many uses, while having a relatively simple structure. In addition or alternatively, a compartment having a plurality of openings can provide an option to differentiate the amount of manipulable material at any location on the distal surface of the lateral body member. This is particularly advantageous since more manipulable material can be guided or directed to a location where it may be more needed than elsewhere on the distal surface of the lateral body member. This can be, but is not limited to, a location where the user has an uneven skin surface and, therefore, can benefit from having an increased amount of available manipulative material to be applied at that particular location (to fill any crease) or skin fold). In particular, the manipulable material can be guided both towards and against the stoma. This configuration allows multiple options to address the beneficial effects of the manipulable material to the right locations, where a leak problem may be occurring or where the
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28/55 user warns at the same time that leakage, in general, occurs. Additionally or alternatively, one or more of the plurality of openings may be axially facing away from the distal surface of the lateral body member and thus help to direct the manipulable material to one or more locations where it is available for an extended period of time. time compared to when it is immediately subjected to starter output.
[0073] In modalities, the manipulable material is configured to be dispensed from one or more compartments. In modalities, the manipulable material is configured to be actively dispensed. In other embodiments, the manipulable material is configured to be passively dispensed. By “waived activation” is meant that, in some deployments, in order for the manipulable material to leave a compartment, the compartment must be manipulated by the fingers of a user. In other words, “actively dispensed” must be interpreted in such a way as to mean that the externalization of manipulable material constitutes an action or step that requires precipitation or active contribution by the user. In embodiments, an outer surface of the one or more compartments includes a texture to facilitate easier tactile recognition of where to manipulate the compartment. The texture is additionally useful to prevent the user's fingers from slipping off the outer surface of the compartment during such manipulation. Passively dispensed means that, in deployments, the manipulative material leaves a compartment because it is washed, dissolved, eroded, broken, etc. due to the content and humidity of the reversal outlet, that is, the material is extermalized without requiring the user's action.
[0074] In modalities, each one of the one or more openings of the one or more compartments is provided on the proximal surface of the lateral member of the body. In these deployments, the one or more compartments can be configured so that one or more compartments containing the manipulable material are located on or on the distal surface of the
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29/55 lateral body member, while one or more openings in each compartment are provided on or on the proximal surface of the lateral body member. In one embodiment, the opening (or openings) is provided in the adhesive of the proximal surface of the lateral body member. In one embodiment, each compartment comprises a first reservoir portion, which holds the manipulable material in the first position, and a transfer portion that extends between the first reservoir portion and the opening on or over the proximal surface of the lateral body member , so that, in the second position, the manipulable material can be pressed through the transfer portion and dispensed from one or more openings in or on the proximal surface. Thus, the distribution of the manipulable material can be controlled, particularly, but exclusively by hand, so that additional manipulable material can be directed to a problematic area or location. Such a problem area may be a location where the user has become aware that the leak has started, or is beginning to occur. By fostering the opportunity to guide additional manipulative material to the leak area, the user can gain, for himself, the extra time needed to be able to find a bathroom or other private space, where he can move to a new one. device. Of course, this is particularly beneficial in supporting the user's trust to participate and socialize in the public space. It is well known in the ostomy field that the risk of sudden product leakage is a stigma for many users, effectively limiting its presence in the public space.
[0075] In one embodiment, one or more compartments are connected and in communication with a channel that extends from the compartment towards the stoma receiving opening of the lateral body member. In one embodiment, the channel extends in a generally radial direction of the lateral body member from the compartment in
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30/55 towards a central longitudinal geometric axis that extends through the stoma receiving opening. Modalities of the body side member that includes a channel between a compartment and the stoma receiving opening provide that the manipulable material is stored at a distance from the stoma receiving opening. This, in turn, allows the user to personalize, such as cutting with scissors, the opening of the stoma to its specific size of stoma before manipulating the manipulative material without having to make the cut in the manipulative material, which, in some deployments, it can be relatively soft and sticky in nature and thus difficult to cut properly. After the lateral body member has been applied to the skin surface around the stoma, the manipulative material can subsequently be dispensed from the compartment out of the stoma receiving opening and adapt to the small folds and creases on the stoma surface, thereby further assisting in the creation of an improved seal between the skin and the lateral body member.
[0076] In an exemplary implementation of such a modality, a user initially customizes, as by cut, a starter receiving opening to an approximate size or circumference of the user's individual stool. By cutting the stoma receiving opening, which may, in some cases, be located in the first zone of the laminated layer material, the user can simultaneously cut or otherwise open one or more of the individual compartments to allow for passage between the manipulable material inside the compartment and the outside of the compartment. Then, the user can remove any protective coating (protective coatings) provided on the lateral body member, as in the adhesive on the proximal surface of the lateral body member, and apply the lateral body member to the skin surface around the stoma. The user can then apply finger pressure to each of the one or more
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31/55 individual compartments to dispense the manipulable material out of the one or more compartments.
[0077] In modalities, the one or more compartments are configured to be fixed to the distal surface of the lateral body member. Thus, each compartment forms a component that is initially separated from the lateral body member and is thus fixed to the distal surface or to the proximal surface, or both, of the lateral body member. In some deployments, such a structure separate from the one or more compartments facilitates the fabrication of the body side member, since the manipulable material and the compartment can be produced and prepared in a process independently of the production of the other components of the body side member and / or the charger. This is advantageous because process parameters relevant to handling the manipulable material (eg temperature and pressure) and the adhesive on the proximal surface of the lateral body member can be significantly different from each other.
[0078] From the above, it is understood that in the conception of the invention of the present disclosure, the inventors realized that the manipulable material does not, by itself, need to be supplied close or in direct contact with the surface of the stoma, or in the peristomal surface of skin, so that the manipulable material provides its beneficial effect on the sealing between the skin surface and the lateral body member. In fact, it was realized that the effect is attainable, to a certain extent, by releasing the manipulable material on the distal surface of the body's lateral limb, that is, on the surface of the body's lateral limb facing away from the user's skin , when the body side member is used.
[0079] Other useful effects are predicted by the lateral body member according to the disclosure, some effects which are believed to be at least partially controllable by the applied number of compartments and by the composition of the manipulable material. In
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32/55 modalities, the compartment (or compartments) comprises more than one type of manipulable material. In different modalities, different compartments contain different manipulable materials. Thus, it is believed that more than one useful effect can be achieved by the lateral member of the body. In addition, as an example, in modalities in which more than one type of manipulable material is provided in one or more compartments of the lateral body member, the useful effect (or useful effects) presented by a manipulative material can be amplified by the presence of another type of material that can be manipulated to provide even better results in terms of reducing or eliminating incidents and spills.
[0080] In embodiments, the distal surface of the lateral body member comprises a first half of a coupling interface for coupling the lateral body member to a stool outlet collection pouch. In one embodiment, the coupling half is a flange adapted to provide a surface for attaching another coupling half in the form of an adhesive flange provided in a starter outlet collection bag. In embodiments, the first half of the coupling interface is configured as a flat annular flexible flange which optionally comprises an adhesive. The first coupling half is adapted to mate with a second coupling half provided around an inlet opening of a reversible outlet collection pouch by means of an adhesive. The adhesive coupling can provide a release or permanent adhesive coupling between the components.
[0081] In embodiments, the coupling half is an annular ring that comprises a vertical flange that protrudes from the distal surface perpendicularly to it to fix another coupling half in the form of a coupling ring provided in a collection bag starter exit. In one embodiment, a first coupling half is attached to the distal surface of the lateral body member. In modalities, the first
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33/55 coupling half is fixed to the distal surface by an adhesive or by welding, but other forms of attachment are acceptable. In embodiments, a first coupling half is attached to the distal surface of the lateral body member at a location radially closer to the stoma receiving opening than where the one or more compartments are located. In embodiments, a channel extending from one or more compartments under (below) the location of attachment of a first coupling half to the distal surface of the lateral body member. In embodiments, one or more compartments are provided distally from the distal surface of the lateral body member and proximally to a first half of a coupling interface for connecting the lateral body member to a stool outlet collection pouch. In embodiments, the first half of the coupling interface is attached to a more distal portion of one or more compartments.
[0082] In embodiments, the vertical flange of the annular ring of the first coupling half comprises one or more hollow sections. One or more hollow sections form one or more divisions, each configured to contain a mass or volume of manipulable material. In embodiments, a radially innermost wall of the vertical flange comprises at least one opening that provides a communication passage between the manipulable material in one or more hollow sections or partitions and the distal surface portion of the body side member radially within the annular ring. of the first coupling half.
[0083] In embodiments, the first half of the coupling interface comprises an inner ring and an outer ring, the outer ring also comprising alternating hollow and solid sections in an inner portion of the outer ring, which is configured to receive the inner ring in it. The inner annular ring is fixed to the distal surface of the lateral body member and is provided with one or more sections of
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34/55 loading that are configured to form one or more compartments, which are adapted to retain a mass or volume of manipulable material. The hollow sections of the outer annular ring are configured to initially match the loading sections or compartments of the inner annular ring. In embodiments, the inner ring and the outer ring are configured to rotate in relation to each other. A radially innermost wall (with respect to the central portion of the lateral body member) of the outer annular ring comprises at least one opening that coincides with a hollow section of the outer annular ring. When the outer ring and the inner ring are rotated with respect to each other, the solid sections of the outer ring move to the manipulable material contained in the loading section or inner ring ring compartment and thus act to dispense the material manipulable out of an opening, to the portion of the distal surface of the lateral body member radially within the outer annular ring.
[0084] These modalities can be particularly advantageous since any pressure applied to the first and second coupling halves and, in particular, the pressure applied when connecting an outlet collection pouch to the lateral body member, can result in forces of pressure that are transferred by the first coupling half in one or more compartments to the manipulable material within each compartment, thereby causing the manipulable material to be dispensed from the compartment or loading section. In this way, both the coupling procedure and the dispensing of the manipulable material can be achieved in just one single action by the user.
[0085] In modalities, the distal surface of the lateral body member comprises a single compartment. A single compartment must be interpreted to mean one and only one compartment. In between
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35/55 other advantages, this provides that a lateral body member is produced that involves less complicated production steps.
[0086] In modalities, the single compartment is configured to extend annularly around the central portion of the lateral body member. Among other advantages, these modalities are particularly suitable for a relatively simple production process.
[0087] In embodiments, the first coupling half is configured as an annular ring that includes a vertical flange that extends axially in the opposite direction from the distal surface of the lateral body member. In one embodiment, the vertical flange is configured to be perpendicular to the distal surface of the lateral body member. In one embodiment, the first half of the coupling interface is attached to a more distal portion of the single compartment. In one embodiment, the single compartment has an outer perimeter that defines a first outer diameter D1 that is greater than a second maximum outer diameter D2 of the annular ring, forming the first half of the coupling interface.
[0088] In modalities, one or more openings of a compartment are located immediately above (over) or adjacent to the distal surface of the lateral body member. In embodiments, the single compartment includes a reservoir portion that contains a major portion of the manipulable material. In embodiments, the single compartment that includes the reservoir portion is defined by a compartment wall that generally extends in an S-shaped configuration, including a main flange, a connecting flange and a distal flange. In embodiments, the reservoir portion is connected to an opening through a slot. In modalities, the manipulable material is configured to be in fluid communication between the reservoir portion and the opening through the slot. Thus, the size of the reservoir portion and / or the characteristics of extemalization (such as, but not limited to, material outlet speed
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36/55 manipulable, required finger pressure, ejection direction, etc.) can be configured according to needs.
[0089] In modalities, a single compartment comprises a plurality of openings or doors. In modalities, the doors do not need to have identical magnitudes / sizes, such as providing an additional option to differentiate the distribution of the manipulable material in the lateral body member.
[0090] In modalities, a protuberance extends distally from the distal flange. In embodiments, the protrusion provides at least one radial contiguity of the compartment against which an annular ring of the first half of the coupling interface can adjoin.
[0091] In modalities, only a smaller portion of the surface of the manipulable material is exposed at each opening. In this way, a relatively small amount of manipulative material is not confined by the wall / flanges of the single compartment present in the opening gap. This is advantageous in that it allows you to control where and how quickly moisture and exudates from the stool outlet can attack the manipulable material. In other words, the structure of the single compartment protects the manipulable material from being exposed to the stool outlet on more than one side. These modalities are additionally advantageous in that the manipulable material will not be immediately visible to the user, thus providing a visually simpler impression of the ostomy device. In addition, since the manipulative material is generally protected in the single compartment, the distal surface of the lateral body member can be sterilized (by cleaning the starter outlet and the already eroded / used manipulative material) during an exchange of the starter outlet collection bag without also inadvertently remove still workable material.
[0092] In one embodiment, the lateral body member comprises
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37/55 a first half of a coupling interface for connecting the lateral body member to a reversible outlet collection bag, in which the one or more compartments are adapted to be attached to the first half of the coupling interface. Thus, the one or more compartments can be attached to the first half of the coupling interface during the manufacture of the body side member, or the one or more compartments can be attached to the first half of the coupling interface by a separate user action, i.e. that is, the one or more compartments are attached to the coupling part immediately before use, that is, just before the body side member is connected to the stamped out collection bag. In embodiments, the one or more compartments can be adapted to be attached to the second half of the coupling interface, that is, the one or more compartments can be attached to the coupling part of the outlet collection pouch immediately before the side member body to be connected to the starter outlet collection bag.
[0093] In one embodiment, the first half of the coupling interface comprises a vertical flange that extends axially in the direction opposite to the distal surface of the lateral body member. In one embodiment, the vertical flange is configured to be perpendicular to the distal surface of the lateral body member. In one embodiment, the vertical flange forms an annular ring.
[0094] In one embodiment, the one or more compartments are configured to be attached to the first half of the coupling interface by a gripping or fitting mechanism. Each of the one or more compartments can be supplied as one or more individual components. In embodiments, a component of the compartment comprises a reservoir portion that holds the manipulable material and further comprises one or more fixing flanges. In modalities, one or more fixing flanges project from a
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38/55 outer surface of the reservoir portion. The one or more clamping flanges are adapted to be clamped to the first half of the coupling interface, so as to secure or engage the clamping with the first coupling half. From its position fixed to the first half of the coupling interface, each of the compartments is available to externalize the retained manipulative material. In embodiments, the reservoir portion is formed from a material that is adapted to break or break when subjected to finger pressure, as discussed above in relation to other embodiments.
[0095] In embodiments, the one or more compartments are adapted to be fixed to a radially more internal portion of the first half of the coupling interface. In other embodiments, the one or more compartments are configured to allow the reservoir portion to be located on the side member of the body radially outside the coupling interface, when using the side member of the body. In such embodiments, the one or more compartments may further comprise a transfer portion, a channel or a slot which is adapted to deflect the coupling interface to allow the user to dispense manipulable material to the distal or proximal surface of the lateral member. body. Particularly, but not exclusively, this can be advantageous to allow the manipulable material to be dispensed after some time has elapsed, since the user has changed devices. This can help to increase the total time of use with the body of the lateral limb, thus resulting in less product changes and less skin irritation.
[0096] In embodiments, the one or more compartments are provided along an internal periphery of an annular insert, the annular insert being configured to engage with an annular ring of the first half of the coupling interface by fitting or securing it in the annular ring, so that the annular insert is located radially closer to the
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39/55 central portion of the lateral body member that the annular ring. In other words, the annular insert is located on and along an inner peripheral portion of the annular ring of the first half of the coupling interface. This provides a simple and intuitive option for the user to fix the annular insert with one or more compartments that contain the manipulable material to the lateral body member. However, the annular insert can instead be adapted to be attached to the second half of the coupling interface provided in the starter outlet collection bag, while providing the same or similar beneficial effects. An advantage of the modalities of the lateral body member revealed in this document is that a user who adapts the stoma receiving opening of the ostomy device before application to the skin, such as by cutting with a pair of stoma scissors, need not worry with cutting in the opposite direction or removing viable manipulative material. The application of one or more compartments to a side member of the body ensures that the manipulative material of manufacture is supplied sufficiently remote from the central portion prepared for personalization of the individual user of the stoma receiving opening.
The neutralizing substance [0097] By neutralizing substance in this document is meant a substance capable of neutralizing or at least minimizing the level of aggression to the skin or the excretion adhesive. In the embodiments, the neutralizer comprises a clay, such as organophilic clay, for example, bentonite, or synthetic clay, such as laponite. In embodiments, the neutralizing substance can be potato-derived inhibitors or protease inhibitors. Examples of inhibitors derived from potatoes such as potato protein, are disclosed in document EP ² No 1,736,136.
[0098] In modalities, the manipulable material is in the form of a matrix composition with a neutralizing substance incorporated. The neutralizing substance can be dissolved in the matrix composition or can
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40/55 be dispersed as particles in the matrix. In embodiments, the matrix may be in the form of coated particles of neutralizing substance.
[0099] In modalities, the matrix is designed to release neutralizing substance into the environment when the matrix is exposed to certain conditions. Such conditions may, for example, be in the presence of excretion from the stoma or in the presence of moisture as well.
[00101] In modalities, the matrix is in the form of a gel, foam, film layer, or paper or a coating.
[00102] In embodiments, a suitable example of a matrix composition could be an adhesive comprising 50% w / w polyisobutylene (PIB) and 25% w / w CMC and 25% w / w pectin.
[00103] In embodiments, a matrix composition in the form of a water-soluble film could be a PVOH-based thermoplastic film, such as a Monosol® 7031 film from kurakay WS Film Division ™, Portage, Indiana, United States.
[00104] In the modalities, the matrix is soluble in water or a component of excretion. It can be slowly soluble, as it is understood in the present document that the matrix layer will not be washed instantly, but will slowly dissolve during the time of use next to the wafer body.
[00105] In modalities, the matrix can absorb moisture and turn into a gel-like material when wet. The gel can be delivered in dry form, but swell into a gel when placed in contact with moisture. The gel may be slowly soluble in water or in a component of the excretion, or it may be insoluble, but be able to release the neutralizing substance when exposed to excretion or moisture.
[00106] In modalities, the matrix comprises polysaccharides and / or hydrocolloids. Polysaccharides or hydrocolloids can dissolve or hydrate when exposed to the outlet, thereby releasing substance
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41/55 neutralizing.
[00107] In the modalities, the matrix comprises protein. In the embodiments, the matrix comprises gelatin.
[00108] In modalities, the matrix is a material with the capacity to form a gel when wet. Examples of suitable materials for the matrix composition can be polyethylene glycol (PEG), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), ethylene-based matrix and vinyl acetate (EVA) and hydrocolloids, such as CMC or gelatin. In the embodiments, the matrix is substantially non-adhesive. By non-adhesive it is understood that it is not adhesive, although it can, under certain circumstances, become slightly sticky.
[00109] In another aspect, the disclosure refers to an ostomy apparatus that includes a lateral body member as described in this document and a stamped outlet collection pouch configured to be attached to the distal surface of the lateral body member .
[00110] In one embodiment, the ostomy appliance is a one-piece ostomy appliance, that is, without a coupling interface between the lateral body member and the stool outlet collection bag. In another embodiment, the ostomy appliance is a two-piece appliance that includes a coupling interface for connecting a starter outlet collection pouch to the side member of the body by connecting or coupling the first and second coupling halves each other.
[00111] In one embodiment, the reversible outlet collection pouch comprises a second half of a coupling interface that is configured to attach to a first half of the coupling interface on the side member of the body to secure the return pouch to the lateral body member.
[00112] In one embodiment, at least the distal surface of the lateral body member is defined by a first zone and a second zone that
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42/55 surrounds the first zone, the first zone being radially within an annular connection between a first half of a coupling interface and the body side member and the second zone is radially outside the annular connection between the first half of the coupling interface and the body side member.
[00113] In one embodiment, each of the one or more compartments is located in the second zone of the distal surface of the lateral body member. In the modality, one or more slits or openings are provided and create a passage between each compartment and the distal surface of the lateral body member to extermalize the manipulable material and deliver it in preferential locations on the distal surface 22. [00114] In modalities, the manipulable material comprises an adhesive. In other embodiments, the manipulable material comprises a powder. In other embodiments, the manipulable material comprises a liquid. In other embodiments, the manipulable material comprises a gel. In other embodiments, the manipulable material comprises a plurality of pellets. In still other embodiments, the manipulable material comprises a combination of any one or more of an adhesive, a powder, a liquid, a gel and / or a plurality of pellets. These options each provide one or more different advantages, including, but not limited to, manipulability, service life, suitability for different types of stool outlet (colostomy outlet tends to be much more solid than ileum and urostomy outlet) , processing and other characteristics. By selectively applying these options, individually or in combination, to meet the specific requirements of an ostomy target group, the suitability of the device and the improvement in the sealing effect that reduces or eliminates the risk of leakage can be significantly enhanced.
[00115] Particularly, in modalities in which the manipulable material comprises an adhesive, suitable materials include adhesives, as, however
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43/55 without limitation, adhesive pastes. Suitable materials for a paste-like adhesive comprise adhesives of the types disclosed in document nWO2010 / 069334. Other types of adhesive pastes are also acceptable.
[00116] In modalities, the displacement between the first and second positions of the manipulable material inside the compartment does not cause the extermalization of manipulable material in the compartment.
Detailed description of the drawings [00117] Figure 1 is a top view of an embodiment of a lateral member of body 20 of an ostomy apparatus according to the present disclosure. The body side member 20 includes a distal surface 22 (outside in Figure 1) and a proximal surface 24 (inside in Figure 1). The distal surface 22 comprises a first zone 28 and a second zone 30 surrounding the first zone 28. At least a portion of the proximal surface 24 of the side member of body 20 comprises an adhesive 31 (Figure 2). Figure 1 shows a central portion 28 of the body side member 20 that was provided with a stoma receiving opening 32. The stoma receiving opening 32 can be provided during manufacture of the body side member 20 or can be provided by user in the preparation of the body 20 lateral member for fixation to the skin surface around his stoma.
[00118] Furthermore, Figure 1 shows how the distal surface 22 of the lateral member of body 20 comprises one or more compartments 34 (Figure 1 illustrates six compartments). Each individual compartment 34 can take any suitable shape, such as having a slightly rounded or bean shaped outline shown in Figure 1, or a more circular, cylindrical, linear or square outline or any combination thereof.
[00119] Each one of the one or more compartments 34 is configured to retain a manipulable material 36 (Figure 2). In this way, each
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44/55 compartment 34 is suitable for retaining, enveloping or circulating a mass or volume of the manipulable material 36. Each of the one or more compartments 34 is configured to allow the manipulable material 36 to be moved between at least one first position and one second position in compartment 34. The manipulable material is displaceable between the first and second positions in the compartment at least in use of the body side member 20. In Figure 1 and Figure 2, the one or more compartments 34 each form a closed, lockable or locked element or component.
[00120] Figure 2 is a schematic cross-sectional view of an embodiment of the body side member 20 comprising closed compartments 34 that contain a manipulable material, in this case, a manipulable material 36 that is moldable. By applying finger pressure to an outer or outer surface of each of the closed compartments 34, the manipulable material 36 can be moved between a first position and a second position in a respective compartment 34. This principle is further illustrated in Figures 3 and 4.
[00121] Figures 3 and 4 are schematic cross-sectional views illustrating a portion of the lateral body member 20 in place on the skin surface S around a stool O of a user and, particularly, showing a modality of an open or openable compartment 34 that contains a mass or volume of manipulable material 36. The body side member 20 is adhered to a peristomal area of the skin surface S by adhesive 31. Figure 3 illustrates the manipulable material 36 in the first position in compartment 34. As indicated by the arrow R in Figure 3, the manipulable material 36 in compartment 34 can be subjected to pressure with a user's finger. This causes the manipulable material 36 to be moved to the second position in compartment 34 as shown in Figure 4, where it is
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45/55 shown the finger F of a user who provides pressure to compartment 34 to actively dispense the manipulable material 36 from compartment 34.
[00122] The manipulation of the material manipulable by pressure with a finger on an outer surface 37 of compartment 34 effectively causes the manipulable material 36 retained within compartment 34 to exit or be dispensed from compartment 34 through one or more openings 35 ( in Figures 3 and 4, only one opening 35 is shown). Consequently, the manipulable material 36 can thus be moved between at least a first and a second position in the compartment 34, in which case the manipulable material 36 is supplied within the compartment 34 in the first position, and at least part of the manipulable material 36 it is provided outside compartment 34 in the second position. This is illustrated in Figure 4. Figure 4 further illustrates the compartment 34 which has a reduced axial protuberance after some dispensing of manipulable material 36.
[00123] In Figures 3 and 4, only one opening 35 is shown. The opening 35 is provided in a wall of the compartment 34 so that the opening 35 faces towards the central portion 28 (Figure 1) of the lateral body member 20.
[00124] Figure 5 is a schematic cross-sectional view of an embodiment of an open compartment 34 of a body side member 20 that contains manipulable material 36, which faces a radially peripheral portion 39 of the body side member. When finger pressure is exerted on the outer surface of compartment 34, the manipulable material 36 leaves compartment 34 through opening 35. Manipulable material 36 is thus directed or oriented from compartment 34 and out of the distal surface 22 of the lateral body member 20. This helps the user to distribute the manipulable material 36 over a larger, or even a total, distal surface 22. Additionally, it is a visible
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46/55 a cross-sectional contour of a first half 40 of a coupling interface for connecting the body side member 20 to a starlet outlet collection bag (not shown) provided on the distal surface 22.
[00125] Figure 6 is a schematic perspective view of an embodiment in which a compartment 34 is illustrated as a single annular compartment 34 having a single annular opening 35. The manipulable material 36 is dispensable from one or more openings 35 which face a radially peripheral portion 39 of the body lateral member 20.
[00126] Figure 7 is a schematic cross-sectional view illustrating an embodiment comprising an open compartment 34 that has at least two openings 35 provided in a portion 41 of compartment 34 on the distal surface 22 of the lateral body member 20. When finger pressure is exerted on the outer surface of compartment 34, the manipulable material 36 exits, at least initially, from compartment 34 through the openings 35 in a direction axially facing away from the distal surface 22. The manipulable material 36 it can be directed or oriented out of the openings 35 of the compartment 34 and both towards the distal surface 22 of the body side member 20 when in contact with the surface of the stoma O. This can help the user to distribute the manipulable material 36 over a portion different and / or larger, or even over a total of the distal surface 22, while it is also possible to provide a better sealing effect between the chargeback O and the body side member 20, simultaneously directing the manipulable material 36 towards the chargeback surface O.
[00127] Figure 8 is a schematic perspective view of an embodiment of a side member of body 20, in which one or more openings 35 of one or more compartments 34 containing manipulable material 36 are provided on the distal surface 22 of the side member of body 20. In
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47/55 embodiments, each opening 35 and / or each compartment 34 has a hexagonal shape. In modalities, each compartment 34 is formed as an individual compartment containing the manipulable material 36.
[00128] Figure 9 is a schematic cross-sectional view taken along line IX-IX of Figure 8 and illustrating how the manipulable material 36 is retained in a plurality of compartments 34 that form different partitions 44 separated by walls 46. Each of the compartments 34 is opened with an opening 35 that faces the distal direction. Therefore, the manipulable material 36 can, in this way, be released or dispensed in a distal direction, that is, in the direction opposite to a user's skin surface when the body side member 20 is in use, as indicated by the arrow P in Figure 9. This allows the dispensable manipulative material to spread over a large area of the distal surface 22 of the lateral body member 20.
[00129] Figure 10 is a schematic cross-sectional view of an embodiment of a side member of body 20 comprising an open compartment 34 that contains a mass of manipulable material 36. The manipulable material 36 of Figure 10 is configured to comprise a moisture-absorbing material. An opening 35 faces towards the central portion of the lateral body member and thus towards the stoma O. This allows both the manipulable material 36 to be dispensed and oriented towards the stoma O and allows the moisture-absorbing material of the manipulable material 36 in the compartment absorb moisture M from the mucous membrane of the stoma. Thus, the open compartment 34 of Figure 10 can be considered to comprise or form a moisture or mucus collector 48, which absorbs excessive amounts of these fluids. Depending on the amount and content of moisture-absorbing material in the total manipulable material 36, the rate of moisture absorption can be varied. Since the humidity collector 48 is configured to absorb the
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48/55 excess fluids before they reach the proximal surface 24 comprising the adhesive 31 of the body side member 20, the time of use close to the body of the body side member can be effectively extended. [00130] Figure 11 is a schematic cross-sectional view of an embodiment of a lateral member of body 20 comprising an open compartment 34 containing a mass of manipulable material 36. The open compartment 34 of Figure 11 is configured to be fixable to distal surface 22 of body side member 20. Thus, housing 34 forms a component that is initially separated from body side member 20 and which is configured to subsequently be attached to distal surface 22 of body side member 20. Housing 34 has an opening 35 shown in Figure 11 facing stool O. Figure 11 further illustrates how finger pressure extermalizes and dispenses manipulable material 36 from compartment 34 through opening 35. The compartment 34 in Figure 11 is shown attached to the surface distal 22 in a fixation zone 50 in a more internal portion of the distal surface 22 of the lateral body member 20. The fixation can be provided by an alloy adhesive fastening of a mechanical fastener, such as, but not limited to, hook and loop fasteners. The embodiment of the modality of Figure 11 allows the manipulable material 36 to absorb moisture M from the mucous membrane of the stoma and is configured to absorb excess fluids from stoma O before it reaches the proximal surface 24 comprising the adhesive 31 of the lateral member of body 20, thus providing that the time of use close to the body of the body side member is effectively extended. The user can also choose to place the compartment 34 in other locations on the distal surface 22 of the lateral body member 20. For this purpose, the distal surface 22 may be sticky or comprise a top layer of mechanical fastener, as, without limitation, hook and loop fastener.
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49/55 [00131] Figures 12 and 13 are schematic cross-sectional views of an embodiment of a lateral member of body 20 comprising a closed compartment 34 containing a mass of manipulable material 36. Figure 12 shows the closed compartment 34 containing the manipulable material 36 in a first position in the compartment in use of the side member of body 20 around a stool O of a user. Figure 13 shows the closed compartment 34 containing the manipulable material 36 in a second position in the compartment in use of the body side member 20 around a user's stool O. In the first position in Figure 12, at least most of the manipulable material 36 is retained in a first portion of reservoir 52 of compartment 34. In the second position in Figure 13, most of the manipulable material 36 has been moved to a second portion of reservoir 54 of compartment 34 by applying pressure with a finger to an outer surface of compartment 34. In the second position shown in Figure 13, an outer surface 56 in the second portion of reservoir 54 of compartment 34 engages the mucous membrane of stoma O. This allows a better sealing effect of the body side member 20 obtained “directly”, since the outer surface 56 of the compartment 34 actually engages the surface of the stool O itself and creates a seal between the stool and the outer surface 56 of the compartment 34, preventing , thus, that fluids from stoma O reach the proximal surface 24 of the lateral member of body 20. This, in turn, allows for greater safety against leaking and prolonging the time of use close to the body of the lateral body member 20.
[00132] Figures 14 and 15 are schematic cross-sectional views of body side member 20 modalities, wherein the distal surface 22 includes a first half 40 of a coupling interface for coupling the body side member 20 to a pouch return collection method (see Figure 19).
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50/55 [00133] In the embodiment of Figure 14, the first coupling half 40 is an annular ring comprising a vertical flange 58 projecting from the distal surface 22 of the lateral body member 20 and perpendicularly thereto. The flange 58 is configured to secure a second coupling half 74 in the form of a coupling ring provided in a starter outlet collection bag 15 (Figure 19). The first coupling half 40 is shown to be attached to the distal surface 22 of the body side member 20. In embodiments, the first coupling half 40 is attached to the distal surface 22 by an adhesive or by welding, but other forms of attachment are acceptable. As illustrated by way of example in Figure 14, the first coupling half 40 is attached to distal surface 22 at a location radially closer to the stoma receiving opening 32 than where compartment 34 is located. The lateral body member 20 of Figure 14 further includes a channel 38 that extends between a compartment 34 and the stoma receiving opening 32. In Figure 14, the compartment 34 is located radially outside the first annular half of the interface. coupling. This provides for the manipulable material 36 to be stored in a location different from the body side member 20 from where it may be needed and / or applied. In Figure 14, compartment 34 and thus manipulable material 36 is located at a distance from the stoma receiving opening 32. Manipulable material 36 is configured to exit compartment 34 through opening 35.
[00134] In the embodiment of Figure 15, the first half 40 of the coupling interface is attached to a more distal portion 60 of compartment 34. Thus, the pressure applied to the first half 40 and the second half 62 (Figure 19) and, in In particular, the pressure applied when connecting a return collection bag 15 to the side member of body 20, results in pressure forces that are transferred by the first coupling half 40 to compartment 34 and to the manipulable material 36 within the
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51/55 compartment, thus causing the manipulable material 36 to be dispensed from compartment 34 through opening 35. In this way, the act of coupling the side member of body 20 and the exit collection bag reverses 15 between itself is advantageously combined with the act of dispensing the manipulable material 36 from compartment 34.
[00135] Figure 16 is a schematic cross-sectional view of an embodiment of an ostomy device 10 attached to the skin surface S around a user's stool O. In the embodiment of Figure 16, one or more compartments 34 are provided under the first half 40 of the coupling interface, so that the first half 40 of the coupling interface is fixed to a more distal portion 60 of the compartment 34. The mass of material manipulable 36 is provided asymmetrically around the central portion of the lateral body member 20. In Figure 16, this is illustrated by the fact that most of the manipulable material 36 is located in one or more compartments 34, so that, when using the apparatus 10 , most of the manipulable material 36 is available to be dispensed from the one or more compartments below the protrusion of the stoma O from the skin surface S. This and other asymmetric configurations of the one or more compartments 34 and / or the manipulable material provide improved versatility in the distribution of manipulable material 36 on the side member of body 20 and thus provides additional options for individual customization according to m the user's personal needs.
[00136] Figure 17 is a schematic top view of an embodiment of a lateral member of body 20, in which one or more compartments 34 are attached to the first half 40 of the coupling interface. In Figure 17, compartments 34 are attached to the first half 40 on or along a portion of an outer periphery 62 of the first half 40. Each compartment 34 contains a mass or volume of manipulable material 36. Instead of openings, the compartments
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52/55 of the embodiment of Figure 17 comprise a material that configures the compartments 34 to break or break when subjected to pressure with a finger, thus allowing the manipulable material 36 to be dispensed from the compartments 34. Particularly, the compartments 34 of the 17 are formed as blister packs that allow compartments 34 to remain closed until the manipulable material 36 is needed and are individually activated by breaking the blister packs, one at a time. One or more slots or openings (not shown) provide a passage for the manipulable material 36 between each of the compartments 34 and the distal surface 22 of the body side member 20, so that the manipulable material 36 can be extermalized to preferred locations on the distal surface 22.
[00137] Figure 18 is a schematic perspective view of an embodiment of a side member of body 20 comprising a first half 40 of a coupling interface, the first half 40 being fixed to the distal surface 22 of the side member of body 20. In the embodiment shown in Figure 18, the first half 40 is integrally formed with a fixing flange 64 that extends substantially perpendicular to a vertical flange 58 (Figure 14) of the first half 40 of the coupling interface. The fixing flange 64 is shown, comprising four protruding flanges that form sub-portions 66 of the fixing flange 64 and which generally extend in the same plane as the fixing flange 64. A surface of the fixing flange 64 facing the distal surface 22 of the body side member 20 is suitable for fixing the fixing flange 64, and thus from the first half 40 of the coupling interface, to the body side member 20. Each of the sub-portions 66 comprising a connection opening 68 is illustrated. Connection opening 68 can be used to connect the side member of body 20 to other components, such as, but not limited to, a strap (not shown) to assist the user
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53/55 to keep the device securely attached to the body.
[00138] The embodiment of Figure 18 further comprises one or more compartments 34 that hold a manipulable material 36. The one or more compartments 34 are attached to an annular insert 70. The annular insert 70 is configured to fit in a hitch by gripping or engaging with an inner periphery or portion of an annular ring of the first half 40 of the coupling interface. It should be understood that the annular insert 70 can also be rotated within the annular ring of the first half 40 of the coupling interface after it has been attached or engaged in engagement with it. This allows for additional control options in distributing the manipulable material 36 from a compartment 34 to the location where it is needed. In Figure 18, three individual compartments 34 are shown, provided symmetrically around the central portion of the lateral body member 20. Each of the compartments 34 can be open or closed compartments, as described above. In Figure 18, the compartments 34 each have an opening facing the central portion and the stoma receiving opening 32 of the lateral body member 20. However, the opening is not visible, since each opening is covered by a protective skirt 72. When manipulative material 36 is needed, the user breaks into one or more of the skirts 72 that cover the opening of a respective compartment 34. This configuration allows dispensing in stages and thus exposing the manipulable material 36 to moisture and reversal exit, and the annular insert also allows compartments 34 to be rotated and located in a desired or preferred location on the distal surface 22 of the lateral body member 20.
[00139] Figure 19 illustrates an embodiment of an ostomy apparatus 10 that includes a lateral body member 20 as described in this document and a starter outlet collection bag 15 configured to be fixed to the distal surface 22 of the body side member. 20. In Figure 19, the
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54/55 distal surface 22 of the side member of body 20 comprises a single compartment 34. A single compartment should be interpreted to mean one and only one compartment 34. Single compartment 34 is configured to extend annularly around the central portion 33 of the body side member 20. The single compartment 34 is attached to a first half 40 of a coupling interface for connection of the body side member 20 to a reversible outlet collection bag 15. Figure 19 shows an exemplary implantation of a connection between the single compartment 34 and the first half 40 of the coupling interface. [00140] As shown in Figure 19, the ostomy appliance 10 is a two-piece appliance that includes a coupling interface comprising a first half 40 and a second half 70 for connecting a reversible outlet collection bag 15 to the side member of body 20. It should be understood that the ostomy device 10 can also be a one-piece ostomy device, that is, without a coupling interface between the body side member 20 and the stool outlet collection bag 15.
[00141] In the embodiment of Figure 20, a first half 40 of the coupling interface comprises an inner ring (not shown) and an outer ring 70. An inner (not visible) portion of the outer ring 70 comprises hollow and solid sections alternating. The outer ring 70 receives the inner ring in the inner portion. The hollow sections of the outer annular ring 70 coincide with loading sections of the inner annular ring containing manipulable material. A radially innermost wall 72 of the outer annular ring 70 comprises openings 36 that coincide with a hollow section of the outer annular ring 70. If the outer annular ring 70 and the inner annular ring are rotated with respect to each other, that is, by rotating if the outer annular ring 70, the internal solid sections of the outer annular ring force the manipulable material out of one or more openings 36 to that portion of the distal surface 22 of the lateral body member, which is
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55/55 radially within the outer annular ring. The outer annular ring 70 includes one or more clamping portions 74 that extend radially towards the stoma receiving opening 32 from the innermost wall 72. The clamping portions 74 are suitable for providing a firm grip on the outer annular ring 70 to rotate it in relation to the inner annular ring and thus dispense the manipulable material out of the openings 36.
[00142] In another aspect of the disclosure, the use of the body 20 side member for an ostomy apparatus as disclosed in this document to reduce the frequency of stool leakage incidents is contemplated. The advantageous effects provided by the body 20 lateral limb modalities help to alleviate the discomfort of leakage frequently encountered by users of ostomy devices. This is achieved, at least partially, by the extermalization of the manipulative material that provides better security against disintegration of the skin adhesive on the proximal surface of the supporting film of the lateral limb. The use of the lateral body member according to the present disclosure allows an increase in the time of use close to the body of an ostomy device.
[00143] Although specific modalities have been illustrated and described in this document, it will be noted by those of ordinary skill in the art that a variety of alternative and / or equivalent deployments can be replaced by the specific modalities shown and described without departing from the scope of this document. invention. This application is intended to cover all adaptations or variations of lateral body members for ostomy devices as discussed in this document. Thus, it is intended that this invention is limited only by the claims and the equivalents thereof.

权利要求:
Claims (31)
[1]
1. Lateral body member of an ostomy device, characterized by the fact that it comprises:
a proximal surface and a distal surface, wherein at least a portion of the proximal surface comprises an adhesive;
wherein at least a central portion of the lateral body member is prepared to provide a stoma receiving opening extending through the lateral body member;
wherein the distal surface of the lateral body member is configured to comprise one or more compartments, where each of the one or more compartments is configured to contain a manipulable material and to allow the manipulable material to be displaced between at least one first position and a second position within the compartment, at least in use of the lateral body member around a user's stool.
[2]
2. Lateral body member according to claim 1, characterized by the fact that it also comprises at least one opening in each one of the one or more compartments, in which the opening provides a passage between an interior and an exterior of each one or more compartments.
[3]
Body side member according to claim 2, characterized by the fact that the manipulable material comprises a neutralizing substance.
[4]
4. Lateral body member according to claim 2 or 3, characterized by the fact that each one of the one or more compartments is configured to allow the manipulable material that exits the compartment to be supplied extremly in relation to the compartment on the distal surface of the body side member, so that the manipulable material is available for coupling with starter outlet.
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2/5
[5]
Body side member according to claim 2 or 3, characterized in that the configuration of the one or more compartments allows the manipulable material to be supplied extremly in relation to the one or more compartments, over substantially a whole portion from the distal surface of the lateral body member located radially within connection means for connecting the lateral body member with a reversal outlet collection bag.
[6]
Body side member according to any one of claims 1 to 5, characterized in that the distal surface of the body side member comprises a layer of a laminated material.
[7]
Body side member according to claim 6, characterized in that the layer of laminated material is formed as an integral component of the body side member.
[8]
Body side member according to claim 6, characterized in that the layer of laminated material is formed as a separate component and is configured to be fixable to other components of the body side member.
[9]
Body side member according to any one of claims 6 to 8, characterized in that the layer of laminated material comprises a dissolvable material.
[10]
Body side member according to any one of claims 6 to 9, characterized in that the one or more compartments are formed in the laminated material layer of the body side member.
[11]
Body side member according to any one of claims 1 to 10, characterized in that the manipulable material is supplied in one or more compartments at least in the first position.
[12]
12. Lateral body member according to any of the
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3/5 claims 1 to 11, characterized by the fact that at least a portion of the manipulable material is provided outside one or more compartments in the second position.
[13]
Body side member according to any of claims 2 to 12, characterized in that each opening faces toward the central portion of the body side member.
[14]
Body side member according to any of claims 2 to 12, characterized in that each opening faces towards a radially peripheral portion of the body side member.
[15]
Body side member according to any one of claims 2 to 12, characterized in that each opening is provided on the distal surface of the body side member.
[16]
Body side member according to any one of claims 2 to 15, characterized in that each compartment comprises a plurality of openings.
[17]
17. Lateral body member according to claim 16, characterized by the fact that two or more of the plurality of openings are configured to open in different directions.
[18]
Body side member according to any one of claims 2 to 17, characterized in that the manipulable material is adapted to be dispensed from one or more compartments through one or more openings.
[19]
19. Lateral body member according to claim 1, characterized by the fact that the manipulable material is supplied within one or more compartments in the first position and in the second position.
[20]
20. Body side member according to any one of claims 1 to 19, characterized in that each of the one or more compartments comprises at least two reservoir portions
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4/5 connected to each other by a transfer portion.
[21]
21. Lateral body member according to claim 1, characterized by the fact that the manipulable material comprises at least one of an adhesive, a powder, a liquid, a gel, a paste, a plurality of pellets or any combination thereof .
[22]
22. Lateral body member according to claim 1, characterized by the fact that the manipulable material is viscoelastic.
[23]
23. Lateral body member according to any one of claims 1 to 22, characterized in that the manipulable material is configured to expand in response to moisture absorption.
[24]
24. Lateral body member according to any one of claims 1 to 23, characterized in that the one or more compartments are fixable to the distal surface of the lateral body member.
[25]
25. Lateral body member according to claim 1, characterized by the fact that a wall of the one or more compartments comprises a thermoformable material.
[26]
26. Body side member according to any one of claims 1 to 25, characterized in that it further comprises a first half of a coupling interface for connecting the body side member to a stamping outlet collection pouch, wherein o one or more compartments are adapted to be attached to the first half of the coupling interface.
[27]
27. Lateral body member according to claim 26, characterized by the fact that the one or more compartments are configured to be fixed to the first half of the coupling interface by a gripping or fitting mechanism.
[28]
28. Lateral body member according to claim 26 or 27, characterized in that the first half of the coupling interface comprises a vertical flange that extends axially in the
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5/5 opposite direction of the distal surface of the lateral body member.
[29]
29. Lateral body member according to claim 28, characterized in that the one or more compartments are provided along an internal periphery of an annular insert, in which the annular insert is configured to engage with the annular ring of the first half of the coupling interface by fitting or attaching to the annular ring and thereby placing the annular insert radially closer to the central portion of the lateral body member than the annular ring.
[30]
30. Lateral body member according to claim 1, characterized by the fact that the displacement between the first and the second positions of the manipulable material inside the compartment does not cause the extermalization of manipulative material in the compartment.
[31]
31. Ostomy device, characterized by the fact that it comprises:
a body side member as defined in any one of claims 1 to 30; and a reversal collection bag.

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JP7008105B2|2022-02-10|How to seal the damaged or holed part of the body

同族专利:

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公开号 | 公开日

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WO2018188706A1|2018-10-18|

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EP3609446A1|2020-02-19|

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RU2019135073A|2021-05-11|

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CN110494105A|2019-11-22|

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US20210085510A1|2021-03-25|

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EP3609446B1|2021-03-17|

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RU2019135073A3|2021-07-15|

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EP3912602A4|2021-11-24|

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EP3912602A1|2021-11-24|

引用文献:

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NZ547991A|2005-06-22|2008-08-29|Squibb Bristol Myers Co|Enzyme inhibiting sprayable skin barrier compositions comprising enzyme inhibitors derived from potatoes|

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DK1981554T3|2006-01-18|2011-01-24|Coloplast As|Layered adhesive construction with adhesive layer with different hydrocolloid composition|

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HUE042651T2|2007-07-06|2019-09-30|Coloplast As|Permeable pressure sensitive adhesive|

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BRPI0923169B1|2008-12-19|2019-03-06|Coloplast A/S|"PRESSURE SENSITIVE FOLDER COMPOSITION AND MEDICAL DEVICE"|

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RU2724410C2|2015-10-08|2020-06-23|Колопласт А/С|Body-facing stoma adapter element|CA2689582C|2007-06-12|2016-08-09|Convatec Technologies Inc.|Ostomy appliance|

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KR101925739B1|2009-09-11|2018-12-05|컨바텍 테크놀러지스 인크|Controlled discharge ostomy appliance and shield therefor|

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GB201115160D0|2011-09-02|2011-10-19|Trio Healthcare Ltd|Discharge solidifier and malodour control|

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US10285847B2|2011-09-29|2019-05-14|Convatec Technologies Inc.|Ostomy pouch with filtering system|

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BR112018007554A2|2015-10-14|2018-10-23|Convatec Technologies Inc|medical device with opening system|

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CN111315326A|2017-11-08|2020-06-19|科洛普拉斯特公司|Adhesive sheet with neutralizer matrix|

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WO2019091527A1|2017-11-08|2019-05-16|Coloplast A/S|Complementary-material element for an ostomy appliance|

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EP3706673A1|2017-11-08|2020-09-16|Coloplast A/S|An adhesive wafer with a neutralizer matrix|

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EP3706619A1|2017-11-09|2020-09-16|11 Health and Technologies Limited|Ostomy monitoring system and method|

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法律状态:
2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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DKPA201770258|2017-04-10|

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PCT/DK2018/050068|WO2018188706A1|2017-04-10|2018-04-09|Body side member of an ostomy appliance|

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