巴西专利BR112019020890A2 lateral body member of an ostomy device, and ostomy device.

专利PDF首页>>巴西专利

专利附录

专利说明

权利要求

类似技术

同族专利

引用文献

法律状态

优先权

专利摘要:
it is a lateral member of the body of an ostomy apparatus comprising a non-woven element comprising a removable material. the contact of the non-woven element with liquid allows the release of the removable material from the non-woven element. the removable material can act to neutralize enzyme activity or stomatal exudate ph.
公开号:BR112019020890A2
申请号:R112019020890
申请日:2018-04-09
公开日:2020-04-28
发明作者:Grove Sund Anders；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] Stool excretion, 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 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 for these ostomized individuals in particular - safe, reliable and effective ostomy devices are highly desirable. Several attempts have been made to provide ostomy devices to meet such requirements, for example, the requirement 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] Ostomates and health care professionals alike would appreciate improvements in ostomy devices to better meet these requirements.
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
Petition 870190099435, of 10/04/2019, p. 10/37
2/20 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 IA is a cross-sectional side view, schematic of a modality of a lateral body member of an ostomy device.
[006] Figure 1B is a cross-sectional side view, schematic of the modality of Figure 1, which illustrates the lateral body member attached to a user's skin surface.
[007] Figure 1C is a lateral cross-sectional view, schematic of the modality of Figure IA, which illustrates removal of removable material in contact with liquid.
[008] Figure 2 is a cross-sectional side view, schematic of another modality of a lateral body member of an ostomy device.
[009] Figure 3 is a lateral cross-sectional view, schematic of another modality of a lateral body member of an ostomy device.
[0010] [0010] Figure 4 is a cross-sectional side view, schematic of another modality of a lateral body member of an ostomy device.
Detailed Description [0011] In the following detailed description, reference is made to the attached drawings, which form a part of it, and in which, by way of illustration, specific modalities in which the invention can be practiced are shown. In this sense, directional terminology, such as top, “bottom, front, rear, anterior, posterior, etc., is used in reference to the orientation of the Figure (or Figures) that is described. Due to the fact
Petition 870190099435, of 10/04/2019, p. 11/37
3/20 of the components of the modalities can be positioned in different orientations, the directional terminology is used for purposes of illustration and is in no way 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.
[0012] It should be understood that the resources of the various exemplary modalities described can be combined with each other, unless specifically described otherwise.
[0013] 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 excretion, residue (or waste) 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.
[0014] Next, whenever referring to the proximal side of a device, or part of a device, the reference is to the side facing the
Petition 870190099435, of 10/04/2019, p. 12/37
4/20 skin, when the ostomy device is used by a user. Similarly, 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.
[0015] 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.
[0016] 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. In addition, 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.
[0017] Furthermore, removable material must be interpreted to include a sacrificial component of the lateral body member, that is, a material suitable to be sacrificed to prevent or delay the breaking of the adhesive of the lateral body member and / or any of the others components of the body's lateral limb.
[0018] The use of the term substantially as a qualifier for certain features or effects in this disclosure is simply intended to
Petition 870190099435, of 10/04/2019, p. 13/37
5/20 means that any divergences are within tolerances that would normally be expected by the individual skilled in the relevant field.
[0019] 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 lateral body member includes a non-woven element that forms at least a portion of the distal surface.
[0020] The non-woven element of the body side member comprises a removable material. The non-woven element is configured so that - upon contact of the non-woven element with liquid - the removable material is removed from the non-woven element. Typically, such functionality is achieved by one or more components of the nonwoven element that are at least partially soluble in water. The liquid that comes into contact with the non-woven element is stool excretion, which contains water as a major component.
[0021] The removal of the removable material may occur on the distal surface of the lateral limb of the body, at least in use of the lateral limb of the body around a user's stoma. At least in use it should be interpreted in such a way that, as long as the side body member is not prepared for, or attached to a user's skin surface, the removable material is not intended to be removed on the distal surface of the side body member .
[0022] 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 a
Petition 870190099435, of 10/04/2019, p. 14/37
6/20 mode, the adhesive materials other than the 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.
[0023] Removable material is provided, inter alia, to provide a better neutralizing effect on starch fluids. In this way, stomach fluids, which generally contain very aggressive bodily substances (for example, including certain enzymes produced in the body), are neutralized before they can reach the polymeric matrix of the adhesive on the proximal surface of the device or the peristomal skin. . Neutralization includes pH neutralization, for example, to a pH between 5 and 8, and / or neutralization of enzyme activity. This, in turn, helps to prevent damage to the skin surface (caused by aggressive starch fluids), and disintegration and / or failure of the adhesive.
[0024] One way in which the body side member of the present disclosure allows for an enhanced neutralizing effect, is by allowing the removable material to be removed from the non-woven element and to come in contact with the stool excretion.
[0025] The non-woven element forms at least a portion of the distal surface of the lateral body member. In the embodiments, the nonwoven element is configured to provide or define a totality of the distal surface of the lateral body member, including the central portion. In other embodiments, the nonwoven element may be configured to extend over and carry only a portion of the distal surface, that is, configured so that it extends only over a portion of a radial distance between the central portion and / or the stoma receiving opening and a peripheral edge or peripheral edge portion of the body lateral member. In one aspect, the nonwoven element can be in two separate parts
Petition 870190099435, of 10/04/2019, p. 15/37
7/20 (that is, with no fluid connectivity between the two parts); a part which is arranged so that it is below the reversal opening when the user is standing, and another part which is arranged on the opposite side of the reversal opening.
[0026] The non-woven element comprises a removable material. A removable material is one that is removed from the non-woven element by contacting said non-woven element with the liquid, such as stool exudate.
[0027] In one aspect, one or more components of the nonwoven element are configured to be at least partially soluble in water. In this way, on contact of the nonwoven element with liquid, the nonwoven element of structure at least partially degrades, and the removable material is removed from the nonwoven element. In one aspect, the non-woven element itself degrades, releasing fibers in addition to the removable material. Alternatively, the removable material can be removed from the non-woven element through contact with liquid, without significant degradation of the non-woven element.
[0028] In the modalities, the non-woven element comprises one or more fibrous layers. By varying the layering, a variation in the removal profile of the removable material can be achieved, and a non-woven element can be customized to suit the particular chemistry of a particular stool exudate.
[0029] In the modalities, the non-woven element comprises hydrophilic fibers and, optionally, hydrophobic fibers. Suitably, the nonwoven element comprises both hydrophilic fibers and hydrophobic fibers. The correct balance of hydrophilic fibers and hydrophobic fibers can lead to the correct removal profile of the removable material. Fibers that are hydrophilic in nature can be coated to make them hydrophobic, and vice versa.
Petition 870190099435, of 10/04/2019, p. 16/37
8/20 [0030] In one embodiment, the non-woven element comprises a water-soluble binder. The water-soluble binder acts to maintain the structure of the non-woven element prior to contact with liquid, but dissolves in water so that the non-woven element degrades. The water-soluble binder itself may comprise fibers. In one aspect, the fibers of the nonwoven element are water soluble; in this way, the effects of a binder are complemented by the fibers, and a binder can still be avoided. [0031] In one embodiment, the removable material is integrated into the structure of the non-woven element. In an additional embodiment, the removable material is integrated into the structure of the non-woven element so that removal of the removable material before contact with liquid is minimal, or even absent. In this way, the removable material is only removed when necessary.
[0032] In one embodiment, the content of removable material in the non-woven element is at least 20% w / w, at least 30% w / w, at least 40% w / w or at least 45% w / w. Such a content of removable material is relatively high, which means that a high concentration of removable material can be achieved adjacent to the stoma.
[0033] In the modalities, the removable material is in the form of a powder or fibers. These options each provide one or more different advantages including, but not limited to, manipulability, service life, suitability for different types of stool excretion (colostomy excretion tends to be more solid than ileum and urostomy excretion), processing features and others. By selectively applying these options, individually or in combination, to meet the particular requirements of a target ostomy group, the suitability of the device and the improvement in neutralizing effect can be significantly improved.
[0034] In aspects, the removable material is a substance
Petition 870190099435, of 10/04/2019, p. 17/37
Neutralizing substance, for example, an enzyme neutralizing substance or a pH neutralizing substance, preferably an enzyme neutralizing substance.
[0035] In this document, neutralizing substance means a substance with the capacity to neutralize or at least minimize the level of aggression in the skin - or adhesive - of excretion. In some embodiments, the removable material is a mineral material. The removable material can comprise a plurality of different materials, so that the properties with respect to, for example, neutralization can be customized.
[0036] In the modalities, the neutralizer comprises a clay, like organophilic clay, for example, bentonite or synthetic clay like laponite. In the embodiments, the neutralizing substance can be potato-derived inhibitors or protease inhibitors. Examples of potato-derived inhibitors such as potato protein are disclosed in EP 1 736 136.
[0037] The non-woven element typically takes the form of a layer or layers of non-woven material comprising removable material. The removable material can be present in a certain non-woven layer of the non-woven element. Alternatively or additionally, the removable material may be present between non-woven layers. The non-woven element is formed using non-woven placement techniques, such as air placement, wet placement or centrifugation. Removable material can be incorporated into such techniques as needed. The non-woven element and / or the individual non-woven layers can be processed by, for example, interlacing, tangling, heat treatment or engraving, etc.
[0038] In aspects, the non-woven element is formed as an integral component of the lateral body member. Alternatively, the
Petition 870190099435, of 10/04/2019, p. 18/37
10/20 nonwoven element is formed as a separate component and is configured to be fixable to other components of the body side member. This allows a non-woven element - once used - to be replaced without replacing the entire body side element. The non-woven element typically has a thickness of between 1 and 5 mm, a diameter between 3 and 10 cm and a substantially oval, square or circular shape in the plane of the body side plate. Edges or the non-woven element can be rounded as needed.
[0039] In the modalities, at least a central portion of the non-woven element comprises a stoma receiving opening, or is prepared for the provision of a stoma receiving opening that extends through the non-woven element. In this way, the user can select the size and shape of the opening in the non-woven element that provides the best functionality (for example, the best fit). In a particular embodiment, regions of the non-woven element can comprise any removable material, and be designed to be cut or perforated by a user, thereby activating the non-woven element. In one aspect of this modality, the central region of the non-woven element, in which this region that must receive a stoma, does not comprise removable material. This region can be cut by a user. Alternatively, the central region of the non-woven element can disintegrate in water, forming an opening in the non-woven element. In this way, the removable material is not wasted when the central region is removed. One way to achieve this functionality is to weld or otherwise connect the upper and lower layers of the nonwoven element to each other in the regions of interest.
[0040] In the modalities, an additional layer comprising removable material is located between the non-woven element and the lateral body member. Upon contact of the non-woven element with liquid, the material
Petition 870190099435, of 10/04/2019, p. 19/37
Removable 11/20 is removed from the additional layer. The additional layer, therefore, acts as a reservoir that can provide a removable material removal profile that is different from that of the nonwoven element. For example, the non-woven element can provide an initial pulse of removable material, while the additional layer can provide a “steady state” removal of removable material. Alternatively, the non-woven element can provide steady-state removal of removable material, and the additional layer provides a pulse of removable material. Such an additional layer may be in the form of a gel or paste comprising removable material.
[0041] Experience shows that when a portion of the innermost edge of the lateral body member, or the central portion of the lateral body member immediately adjacent to, or that involves the stoma receiving opening, is engaged (“attacked) by aggressive steroidal fluids, this can, in general, cause a surprisingly (rapid) breakdown of the adhesive on the proximal surface of the lateral limb of the body that begins at the innermost edge and progresses radially from it. This can, in turn, lead to failure of the adhesive, thereby making the side member of the body and / or the entire ostomy apparatus unusable. Previous solutions have focused on addressing such problems in the area of a lateral body member immediately adjacent to the stoma, that is, attempted to resolve the issues in the innermost portion of the lateral body member.
[0042] In contrast, the present disclosure provides different and inventive solutions to overcome these and other problems, due to the fact that at least in some approaches, the problems are believed to be alleviated or reduced completely or partially, due to the best options for how to distribute and where the removable material leaves the non-woven element. As an example, but not exclusively, this is achieved by distributing or spreading removable material over a distal surface
Petition 870190099435, of 10/04/2019, p. 20/37
12/20 greater or even across the distal surface of the lateral body member.
[0043] The removable material can be removed in an axial direction (so that the removable material enters the distal surface of the lateral body member) or in a radial direction (that is, towards the stoma surface) immediately adjacent to the stoma . In this regard, one or more folds (for example, plastic films) may be located on the distal surface of the nonwoven element, to direct removal of removable material. One or more folds (for example, plastic films) can also be located on the proximal surface of the nonwoven element, to direct removal of removable material.
[0044] In one embodiment, the lateral body member further comprises a reinforcing element. The reinforcing element can 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 can be located between the adhesive on the proximal surface and the covering layer. 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.
[0045] 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). In this way, some examples of forces that act on the
Petition 870190099435, of 10/04/2019, p. 21/37
13/20 lateral body members 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.
[0046] In the modalities, the non-woven element comprises a different thickness when observed over a total extension of the non-woven element. In one embodiment, a thickness of the nonwoven element decreases from a greater thickness in a peripheral edge portion of the nonwoven element to be thinner radially closer to the central portion of the lateral body member. The differentiated thickness of the nonwoven element is believed to be useful in providing a smooth return of the removable material from the nonwoven element.
[0047] In the modalities, the non-woven element forms the distal surface of the lateral body member. In embodiments, a proximal surface of the non-woven element comprises an adhesive that provides the adhesive to the proximal surface of the lateral body member.
[0048] 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. The 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.
[0049] 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 resin accentor
Petition 870190099435, of 10/04/2019, p. 22/37
14/20 tackiness, 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 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 block copolymers 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.
[0050] In an exemplary implantation and member request
Petition 870190099435, of 10/04/2019, p. 23/37
15/20 body side according to the present disclosure, a user initially customizes, as by cut, a stoma receiving opening to an approximate size or circumference of the user's individual stoma. Then, the user can remove any protective liner (or liners) provided on the body's lateral limb, such as the adhesive on the proximal surface of the body's lateral limb and apply the body's lateral limb to the skin surface around the stoma. The user can then include the non-woven element as needed in the lateral body member.
[0051] Other useful effects are predicted by the lateral body member according to the disclosure, in which it is believed that some of these effects must be at least partially controllable by the composition of the removable material. In the embodiments, more than one type of removable material can be supplied, thus allowing different removable materials to be removed with different removal profiles. In this way, it is believed that more than one useful effect can be achieved by the claimed lateral body member. In addition, as an example, in modalities where more than one type of removable material is provided in one or more openings of the lateral body member, the useful effect (or effects) presented by a removable material can be amplified by the presence of another type removable material to provide even better results in terms of reducing or eliminating leak incidents.
[0052] In the modalities, the non-woven element is in the form of an annular disc that extends in the plane of the lateral member of the body. In aspects, the distal surface of the body side member comprises a first half of a coupling interface for coupling the body side member to a stool excretion collection bag. 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 sterling excretion collection bag. In
Petition 870190099435, of 10/04/2019, p. 24/37
16/20 embodiments, the first half of the coupling interface is configured as a flat, flexible ring flange that optionally comprises an adhesive. The first coupling half is adapted to mate with a second coupling half provided around an inlet opening of a sterling excretion collection bag by means of an adhesive. The adhesive coupling can provide a permanent or removable adhesive coupling between the components. In aspects, the non-woven element is disposed within said annular ring of the lateral body member.
[0053] In the embodiments, the coupling half is an annular ring that comprises a vertical flange that protrudes from the distal surface perpendicular thereto to fix another coupling half in the form of a coupling ring provided in a sterling excretion collection bag . In one embodiment, a first coupling half is attached to the distal surface of the lateral body member. In the embodiments, the first coupling half is fixed to the distal surface by an adhesive or by welding, but other ways of attachment are acceptable. In the 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 one or more openings are located.
[0054] In the modalities, the distal surface of the lateral body member comprises a single opening. A single opening should be interpreted as one and only one opening. Among other advantages, this allows a produced lateral body member to involve fewer complicated production steps.
[0055] In the modalities, the only opening is configured to extend in an annular way around the central portion of the lateral body member. Among other advantages, these modalities are particularly suitable for a relatively simple production process.
Petition 870190099435, of 10/04/2019, p. 25/37
17/20 [0056] In the embodiments, the first coupling half is configured as an annular ring, including a vertical flange that extends axially in the opposite direction of 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 single opening defines an outer perimeter that defines a first outer diameter D1 that is larger than a second maximum outer diameter D2 of the annular ring that forms the first half of the coupling interface.
[0057] In one embodiment, the first half of the coupling interface comprises 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 vertical flange forms an annular ring.
[0058] In another aspect, the disclosure refers to an ostomy device that includes a lateral body member as described in this document and a stool excretion collection bag. The collection bag can be configured to be attached to the distal surface of the lateral body member. [0059] 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 excretion collection bag. In another embodiment, the ostomy apparatus is a two-piece apparatus that includes a coupling interface for connecting a reversal collection bag to the lateral body member when connecting or coupling the first and second coupling halves to each other.
[0060] In one embodiment, the sterling excretion collection bag comprises a second half of a coupling interface that is configured to couple with a first half of the coupling interface
Petition 870190099435, of 10/04/2019, p. 26/37
18/20 coupling on the lateral body member to fix the reversible collection bag to the lateral body member.
[0061] In another aspect of the disclosure, the use of the lateral body member for an ostomy device, as disclosed in this document, to reduce the frequency of incidents of leaking excretory stools is further contemplated. The advantageous effects provided by the modalities of the lateral limb of the body, help to mitigate the annoyances of leakage of excretion, in general, found by users of ostomy devices. This is at least partially achieved by the neutralizing effects of the removable material on enzyme activity or pH of stool exudate. At a minimum, use of the lateral body member in accordance with the present disclosure allows increased use of the ostomy apparatus and / or reduced irritation of the peristomal skin by stool exudate.
Detailed description of the drawings [0062] Figure IA is a cross-sectional side view of an embodiment of a lateral body member 20 of an ostomy apparatus according to the present disclosure. The lateral body member 20 includes a distal surface 22 ("upper side in Figure IA) and a proximal surface 24 (lower side in Figure IA). At least a portion of the proximal surface 24 of the body 20 side member comprises an adhesive 31. Figure 1A shows a central portion 28 of the body 20 side member which has been provided with a stoma receiving opening 32. The receiving tray opening stool 32 can be provided during the manufacture of the body 20 side member, or it can be provided by the user when preparing the body 20 side member for attachment to the skin surface around his stoma.
[0063] Furthermore, Figure 1A shows how the distal surface 22 of the lateral member of body 20 comprises a non-woven element 34.
[0064] In the illustrated embodiment, the non-woven element 34 has
Petition 870190099435, of 10/04/2019, p. 27/37
19/20 essentially ring-shaped. The illustrated non-woven element 34, therefore, also comprises a stoma receiving opening.
[0065] Figure 1B is a schematic cross-sectional view illustrating a portion of the body side member 20 of Figure IA in place of the skin surface S around a stool O of a user. The lateral body member 20 is adhered to a peristomal area of the skin surface S by the adhesive 31.
[0066] Figure 1C illustrates the modality of Figure IA, in which the removable material 35 is removed from the non-woven element 34 by contacting the non-woven element with the liquid.
[0067] Figure 2 is a schematic cross-sectional view of another embodiment of the central region of the body's lateral member 20. In this embodiment, an additional layer 36 is present between the non-woven element 34 and the body's lateral member 20.
[0068] Figure 3 is a schematic cross-sectional view of another embodiment of the central region of the lateral member of body 20. In this embodiment, the non-woven element occupies the entire distal surface 22 of the lateral member of body 20 between the opening 32 and a first half 40 of a coupling interface (flange). The illustrated non-woven element 34, therefore, also comprises a stoma receiving opening.
[0069] Figure 4 is a schematic cross-sectional view of another modality of the central region of the lateral member of body 20. In this modality, the central region of the non-woven element 34, which is the region that must receive a stoma, does not include removable material. The central region is designed to be removed by a user before using the body lateral member 20.
[0070] 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 implantations
Petition 870190099435, of 10/04/2019, p. 28/37 / 20 equivalents can be replaced by the specific modality shown and described without departing from the scope of the present invention. This application is intended to cover all adaptations or variations of lateral body members for ostomy devices as discussed in this document. In particular, the illustrated modalities show two-part ostomy devices, but the present modalities can also be used in combination with one-part ostomy devices. Thus, it is intended that this invention is limited only by the claims and their equivalents.

权利要求:
Claims (19)
[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;
a non-woven element that forms at least a portion of the distal surface of the lateral body member;
wherein at least a central portion of the body-side member comprises a stoma-receiving opening, or is arranged to provide a stoma-receiving opening, which extends through the body-side member;
wherein the non-woven element comprises a removable material;
whereby the non-woven element is configured so that - upon contact of the non-woven element with liquid - the removable material is removed from the non-woven element.
[2]
2. Lateral body member according to claim 1, characterized in that one or more components of the non-woven element are at least partially soluble in water so that - upon contact of the non-woven element with liquid - the removable material is removed from the non-woven element.
[3]
Body side member according to any one of the preceding claims, characterized in that the non-woven element comprises one or more fibrous layers.
[4]
4. Body side member according to any one of the preceding claims, characterized in that the non-woven element comprises one or more layers of removable material.
[5]
5. Lateral body member according to any of the previous claims, characterized by the fact that the material content
Petition 870190099435, of 10/04/2019, p. 30/37
Ί / Α removable on the non-woven element is at least 20% w / w, at least 30% w / w, at least 40% w / w or at least 45% w / w.
[6]
Body side member according to any one of the preceding claims, characterized in that the non-woven element comprises hydrophilic fibers and, optionally, hydrophobic fibers.
[7]
Body side member according to any one of the preceding claims, characterized in that the non-woven element comprises a water-soluble binder.
[8]
8. Lateral body member according to any one of the preceding claims, characterized in that the fibers of the non-woven element are soluble in water.
[9]
Body side member according to any one of the preceding claims, characterized in that the non-woven element is formed as an integral component of the body side member.
[10]
Body side member according to any one of claims 1 to 7, characterized in that the non-woven element is formed as a separate component and is configured to be fixable to other components of the body side member.
[11]
11. Lateral body member according to any one of the preceding claims, characterized in that at least a central portion of the non-woven element comprises a stoma receiving opening, or is prepared to provide a stoma receiving opening. that extends through the nonwoven element.
[12]
Body side member according to any one of the preceding claims, characterized in that it additionally comprises an additional layer located between the non-woven element and the body side member, wherein said additional layer comprises removable material so that - on contact of the non-woven element with liquid - the removable material is removed from the additional layer.
Petition 870190099435, of 10/04/2019, p. 31/37
3 / Á
[13]
13. Lateral body member according to any of the preceding claims, characterized in that the removable material is removed from the non-woven element or from the additional layer on the distal surface of the lateral body member.
[14]
14. Body side member according to any one of the preceding claims, characterized in that the removable material is a neutralizing substance, for example, an enzyme neutralizing substance or a pH neutralizing substance.
[15]
15. Lateral body member according to any of the preceding claims, characterized in that the removable material is in the form of a powder or fibers.
[16]
16. Lateral body member according to any of the preceding claims, characterized by the fact that the removable material is a mineral material.
[17]
17. Lateral body member according to any one of the preceding claims, characterized in that the removable material comprises a plurality of different materials.
[18]
18. Lateral body member according to any one of the preceding claims, characterized in that the non-woven element is in the form of an annular disk that extends in the plane of the lateral body member, and in which the lateral body member comprises an annular ring which forms a first half of a coupling interface on the side member of the body configured to mate with a second half of the coupling interface provided in a sterling excretion collection bag, and wherein said non-woven element is disposed within said annular ring of the lateral body member.
[19]
19. Ostomy appliance, characterized by the fact that it comprises:
a lateral body member according to any of the
Petition 870190099435, of 10/04/2019, p. 32/37
4/4 previous claims; and a reversal collection bag.

类似技术:

公开号 | 公开日 | 专利标题

BR112019020890A2|2020-04-28|lateral body member of an ostomy device, and ostomy device.

US10470918B2|2019-11-12|Ostomy wafer

US20200046541A1|2020-02-13|Body side member of an ostomy appliance

DK176790B1|2009-09-07|Sticky patch

BR112019020928A2|2020-04-28|lateral body member of an ostomy device, and ostomy device.

BR112019020914A2|2020-04-28|lateral body member of an ostomy device, and ostomy device

EP3706674B1|2022-01-05|Complementary-material element for an ostomy appliance

EP3099276B1|2018-01-24|Ostomy faceplate including invertible stoma collar

JP6251283B2|2017-12-20|Applicable ostomy faceplate

BR112013013278B1|2020-07-07|ostomy device

WO2018054442A1|2018-03-29|Ostomy device

WO1999060959A1|1999-12-02|Ostomy skin barrier assembly, stoma seal assembly and materials for use in stoma seals

WO2006038025A1|2006-04-13|Ostomy bags

BR112020008443A2|2020-10-20|complementary material element and parts kit

JP6899175B2|2021-07-07|Flange expander

BR112012010285B1|2020-01-21|sealing disc, base plate, and ostomy utensil

BR112020014059A2|2020-12-01|system to apply a stoma cover, stoma cover, and parts kit.

GB2437059A|2007-10-17|Insert for the aperture of an adhesive flange for an ostomy device

同族专利:

公开号 | 公开日

CN110494103A|2019-11-22|

EP3609443A1|2020-02-19|

RU2019135072A3|2021-06-30|

WO2018188705A1|2018-10-18|

US20200060863A1|2020-02-27|

RU2019135072A|2021-05-11|

引用文献:

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

GB1256866A|1967-12-30|1971-12-15|

US4710182A|1986-12-04|1987-12-01|Hollister Incorporated|Ostomy appliance and method of making|

DK157899C|1987-12-15|1990-09-03|Coloplast As|A dressing|

US5074852A|1989-08-16|1991-12-24|E. R. Squibb & Sons, Inc.|Occlusive attaching device for ostomy appliance|

DK169711B1|1993-01-15|1995-01-23|Coloplast As|A dressing|

DE20207356U1|2002-05-08|2003-06-12|Riesinger Birgit|Absorbent body for connection to skin and mucous membrane surfaces|

AU2005259729B2|2004-06-30|2010-12-16|Coloplast A/S|Skin plate adhesive product and method for its manufacture|

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

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

SE534705C2|2010-03-02|2011-11-22|Moelnlycke Health Care Ab|ostomy device|

CN104244879B|2012-04-20|2017-09-26|科洛普拉斯特公司|Adhesive sheet|

AU2017259776B2|2016-05-04|2021-05-13|Coloplast A/S|An adhesive wafer with a neutralizer matrix|CA2689582C|2007-06-12|2016-08-09|Convatec Technologies Inc.|Ostomy appliance|

WO2010060115A1|2008-11-19|2010-05-27|Convatec Technologies Inc.|Ostomy pouch appliance|

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

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

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

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

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

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

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

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

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

优先权:

申请号 | 申请日 | 专利标题

DKPA201770255|2017-04-10|

PCT/DK2018/050067|WO2018188705A1|2017-04-10|2018-04-09|Body side member of an ostomy appliance|

[返回顶部]