lateral body member of an ostomy device, and ostomy device.

专利摘要:
it is a lateral member of the body of an ostomy apparatus that comprises a cover layer that forms a distal surface that has one or more openings to allow the return of a removable material to be displaced between a first position below the layer of cover and a second position above the cover layer in use of the lateral body member around a user's stoma.
公开号:BR112019020928A2
申请号:R112019020928
申请日:2018-04-09
公开日:2020-04-28
发明作者:Stendevad Windeballe Lars；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 often contains body fluids and visceral content that are aggressive to both the user's skin and ostomy devices, in particular, these have a detrimental effect on the efficiency and integrity of the adhesive materials that are used. 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 efficient ostomy devices are highly desirable. Numerous attempts have been made to provide ostomy devices in order to meet these needs, for example, the need for prolonged use of the body, but the provision of sufficient efficiency to obtain a satisfactorily long use time with the body. ostomy remains an unmet need.
[002] Ostomized individuals and similar health care professionals are open to improvements in ostomy devices in order to better meet these needs.
Summary [003] The present disclosure provides aspects of a lateral body member of an ostomy apparatus according to the appended claims. The disclosure additionally provides an ostomy apparatus that includes a lateral body member as disclosed herein.
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
Petition 870190099583, of 10/04/2019, p. 10/66
2/45 the description, serve to explain the principles of the modalities. Other modalities and several of the desired advantages of the modalities will be readily verified as they become better understood in reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Similar reference numerals designate similar corresponding parts.
[005] Figure 1 is a schematic cross-sectional view of an embodiment of a lateral body member of an ostomy apparatus comprising a removable material.
[006] Figure 2 is a schematic cross-sectional view of an embodiment showing a lateral body member comprising a removable material.
[007] Figure 3 is a schematic top view of an embodiment that illustrates an embodiment of a covering layer of a lateral body member.
[008] Figure 4 is a schematic top view of an embodiment that illustrates an embodiment of a covering layer of a lateral body member.
[009] Figure 5 is a schematic cross-sectional view of an embodiment of a cover layer of a lateral body member comprising an opening that allows the removable material to come out.
[0010] Figure 6 is a schematic top view of an embodiment that illustrates an embodiment of a covering layer of a lateral body member.
[0011] Figure 7 is a schematic top view of an embodiment that illustrates an embodiment of a covering layer of a lateral body member.
[0012] Figure 8 is a schematic top view of a modality that illustrates a modality of a covering layer of a
Petition 870190099583, of 10/04/2019, p. 11/66
3/45 lateral body member.
[0013] Figure 9 is a schematic cross-sectional view of an embodiment of a covering layer of a lateral body member. [0014] Figure 10 is a schematic cross-sectional view of an embodiment of a lateral body member comprising a cover layer comprising one or more openings.
[0015] Figure 11 is a schematic cross-sectional view of an embodiment of an ostomy device comprising a lateral body member, according to the present disclosure, attached to the surface of a user's skin.
DETAILED DESCRIPTION [0016] 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 regard, directional terminology, such as top, bottom, front, back, front, “rear, etc., is used in reference to the orientation of the Figure (or Figures) that is described. Because the components of the modalities may be positioned in different orientations, directional terminology is used for illustrative purposes and not in a limiting sense. 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.
[0017] It should be understood that the resources of the various exemplary modalities described can be combined with each other, unless specifically described otherwise.
[0018] Throughout this revelation, the words “stoma and ostomy are used to denote a surgically created opening bypassing the
Petition 870190099583, of 10/04/2019, p. 12/66
4/45 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 these, for example, ostomal, ostomies, etc. In addition, the solid and liquid residues that emanate from the stoma can be called both ostomal waste (or residues) and fluids interchangeably. An individual who has undergone ostomy surgery can be called an ostomized or ostomated individual - in addition, also called a “patient” or user. However, in some cases the user may also refer to a healthcare professional (HCP), such as a surgeon or an ostomal care nurse or others. In such cases, it will be explicitly stated, or implied from the context, that the user is not the patient.
[0019] Next, whenever referring to the proximal side of a device, or part of a device, the reference is on the side facing the 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.
[0020] 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.
[0021] 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 should generally be perceived with reference to the radial direction, so that a
Petition 870190099583, of 10/04/2019, p. 13/66
5/45 reference to an external element means that the element is more distant from a central portion of the ostomy apparatus than an element called internal. Additionally, the innermost term must 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. Similarly, the outermost term 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.
[0022] In addition, the term removable material should be interpreted to include moldable and squeezable materials, as well as permanently deformable materials and with format memory (that is, materials that are able to return to their original shape after deformation) ). In addition, in some deployments, the removable material may be properly non-deformable (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 in relation to other components. In addition or alternatively, the term releasable should be interpreted to refer to any materials that can be moved and / or manipulated by the hands or fingers of an ordinary person without the use of significant force. In embodiments, the removable material is a sacrificial component of the side member of the body, that is, a material suitable to be sacrificed to prevent or delay the decomposition of the adhesive of the side member of the body and / or any of the other components of the side member body.
[0023] The use of the term substantially as a qualifier for certain features or effects in this disclosure, is intended to simplify that various deviations are within the tolerances that would normally be expected by the skilled person in the relevant field.
[0024] In one aspect, the present revelation refers to a member
Petition 870190099583, of 10/04/2019, p. 14/66
6/45 body side 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 covering layer that forms at least a portion of the distal surface. The side body member additionally includes a removable material provided close to the cover layer. The cover layer of the body side member is configured to comprise one or more openings, each of which is configured to allow return of the removable material to the distal surface of the body side member (through the removable material that passes through one or more openings in the cover layer), at least in the use of the lateral body member around a user's stoma. “At least in use” should be interpreted in such a way that, while the lateral body member is not prepared or fixed to the surface of a user's skin, the removable material is not intended to return (release through the cover layer) to the distal surface of the lateral body member.
[0025] 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 different adhesive materials of the adhesive are supplied side by side. In one embodiment, the different adhesive materials of the adhesive are provided as a layered structure. In one embodiment, the different adhesive materials of the adhesive are supplied mainly side by side, but with some overlapping portions of the different adhesive materials. Examples of suitable adhesive materials are given below.
[0026] Removable material is provided inter alia to provide a better sealing effect between the lateral body member and that part of the body.
Petition 870190099583, of 10/04/2019, p. 15/66
7/45 surface of a user's skin surrounding the stoma. When the seal or the sealing effect is improved, the likelihood of starch fluids bypassing that seal and accumulating below the lateral body member, that is, between the user's skin surface and the device, is reduced. In this way, it prevents the fluids, which often contain very aggressive bodily substances (for example, which include certain enzymes produced in the body), 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 additionally provides a lateral body member that has improved leakage safety and longer usage time with the body (that is, the time between replacing a used product with a new one). A longer use-of-the-body product can help to provide fewer complications for the skin, as the removal of the adhesive body limb from some devices currently available from the skin surface tends to remove the skin cells. epidermis skin. Thus, obtaining a longer use time with the body of the product, less product substitutions are necessary, which results in fewer occurrences of potential skin cell removal. Additionally, there is an economic benefit to the user and / or the health care system / insurance operator, when fewer substitutions and thus less products are needed.
[0027] One way in which the body side member of the present disclosure allows for an improved sealing effect, is to allow the removable material to return through one or more openings in the cover layer and in contact with the stool excretion. In this way, the improved sealing effect is at least partially provided by an increase in the amount of material that aggressive starch fluids must decompose to reach the adhesive on the side member of the body. In this way, the material
Petition 870190099583, of 10/04/2019, p. 16/66
Removable 8/45 is provided as a sacrificial component of the body side member, i.e., a material that is suitable to be sacrificed in order to prevent or delay the decomposition of the adhesive of the body side member.
[0028] The cover layer forms at least a portion of the distal surface of the lateral body member and is configured to comprise one or more openings. In embodiments, the cover layer is configured to provide or define a totality of the distal surface of the lateral body member, which includes the central portion. In other embodiments, the cover layer can be configured to extend over and cover 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 opening of a stoma, and an outermost edge or outermost portion of the lateral body member.
[0029] With respect to one or more openings, the cover layer can be provided with one or more openings during manufacture so that, when the user receives the product from the body side member, each one of the one or more openings is present in the cover layer. However, it is also envisaged that one or more openings may be provided by the user (or by the HCP) in the covering layer immediately before the application of the lateral body member to the user's skin surface. In addition, one or more openings that are provided in the manufacture can be complemented by one or more additional openings provided by the user prior to application. These options allow for additional 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 (or locations) of one or more openings in the side member of the body, that is, the user has the option of allowing more removable material to return in certain locations from the distal surface of the lateral body member where the material is mostly needed.
Petition 870190099583, of 10/04/2019, p. 17/66
9/45 [0030] Each of one or more openings is configured to allow the removable material to return to the distal surface of the lateral body member when the lateral body member is used. “Regression must be interpreted as the act of leaving or being apparent. Thus, return should mean that the removable material may come out of one or more openings, or become apparent, that is, if it becomes present, visible and / or available on the distal surface of the lateral body member. In addition, returnable removable material is intended to cover situations where the removable material is deliberately or intentionally manipulated (such as through pressure with the user's finger) out of one or more openings, and situations where the removable material leaves or passes through an opening (return) without any force or interaction provided by the user. In modalities, the latter type of situations may be a result of the expansion of the removable material, for example, caused by the absorption of humidification of the mucous membrane of the stoma, humidification of the user's skin surface, humidification in the stool excretion and / or a combination of these factors.
[0031] The cover layer is configured to include one or more openings and allow the return of removable material to the distal surface of the lateral body member. Thus, one or more openings can be considered provided on the distal surface of the lateral body member, or at least on a portion of the distal surface formed by the cover layer. In embodiments, in which the cover layer forms only a portion of the distal surface of the lateral body member, one or more openings can be considered as comprised by the cover layer in one or more portions of the distal surface not covered by the cover layer. . In embodiments, a portion of the outermost edge of the distal surface is not covered by the covering layer (radial dimension of the covering layer smaller than the radial dimension of the lateral body member
Petition 870190099583, of 10/04/2019, p. 18/66
10/45 in that portion); thus, an opening in the cover layer is formed in that portion of the outermost edge. In one embodiment, the cover layer includes an opening at an outer edge of the cover layer and is configured by at least a portion of the cover layer to have a first radial extension dimension less than a second average radial extension dimension of the member. body side. In particular, however, without exclusivity, this is advantageous if the configuration of the body side member needs to be customized to return the removable material to a more outer edge portion of the body side member. Examples of the need for such a configuration are in cases of temporary or cycle reversals, or if the lateral body member is applied close to two or more reversals or fistulas. Surface areas of the skin that suffer from one or more fistulas in them, or in combination with one or more starlings, can be extremely difficult to treat or cover efficiently and without causing pain to the user / patient with standard-type ostomy devices . Thus, the present disclosure provides options to expand HCP options to provide the necessary care in such cases. By analogy, an opening may also be, or instead, be provided in an innermost edge portion (for example, but without limitation, in the central portion) adjacent and / or around the stoma receiving opening .
[0032] In embodiments, the cover layer includes one or more radial protuberances that extend radially in the opposite direction from an outer edge of the cover layer. In embodiments, the cover layer includes one or more radial protrusions that extend radially in the opposite direction from an outer edge of the lateral body member. In one embodiment, one or more protrusions of radial extension form attachment means for securing the cover layer to the lateral body member. In one embodiment, one or more protrusions of
Petition 870190099583, of 10/04/2019, p. 19/66
11/45 radial extension are configured to form joints that facilitate easy fixing and / or manipulation of the covering layer to the lateral body member.
[0033] One or more openings are configured to allow return of the removable material to the distal surface of the lateral body member. Releasable material that returns from one or more openings functions as a component of sacrificial material of the side member of the body, that is, a material that is suitable to be sacrificed to prevent or delay the decomposition of the adhesive on the proximal surface of the side member of the body . This is advantageous in that the harmful effects of aggressive starch fluids on the main adhesive, which carries the weight and creates the seal on the user's skin, of the ostomy device, are mitigated by sacrificing the release material. This, in turn, helps to mitigate or at least prolong the time required for such starch fluids to break the adhesive on the proximal surface of the lateral limb. In this way, an advantageous extension of the time of use close to the body of the ostomy device is achieved. Studies conducted by the inventors show that ensuring an unobstructed and efficient release of sacrificial material to engage with aggressive starch excretion provides promising results in terms of significantly reducing the rate or speed of breaking the adhesive and, thus, allowing time of use close to the body (useful life) of the body's lateral limb. Furthermore, studies have further suggested that for some implementations of the invention of the present disclosure, such an efficient and unobstructed release is a factor that has more weight than specifically controlling the direction of the release material to be sacrificed towards the stoma surface and / or an area of the lateral body member adjacent to the stoma, and / or the stoma receiving opening.
[0034] Additionally, the experience obtained by interviewing
Petition 870190099583, of 10/04/2019, p. 20/66
12/45 users show 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 surrounds the stoma receiving opening, is engaged (“attacked”) by fluids aggressive starlings, it can often cause a (surprisingly) rapid decomposition of the adhesive from the proximal surface of the body's lateral limb that begins from that innermost edge portion and returns radially from it. This can, in turn, result in failure of the adhesive, so the side body member and / or the entire ostomy device becomes useless. Previous solutions have focused on solving such problems in the area of a lateral body member immediately adjacent to the stoma, that is, they have tried to resolve the issues in the innermost portion of the lateral body member.
[0035] On the contrary, the present disclosure provides different and inventive solutions to overcome these and other problems, since, at least in some approaches, problems are believed to be mitigated or reduced completely or partially, due to the best options to distribute as and where the removable material returns out of one or more openings. By way of example, however, not exclusively, this is achieved by distributing or spreading the release material over a larger or even complete distal surface of the lateral body member. In this regard, the inventors have found that if the lateral body member is configured so that the releasable material enters the distal surface of the lateral body member, instead of being directed primarily towards the stoma surface (the membrane mucosa), and / or in relation to an area or location of the lateral limb of the body immediately adjacent to the stoma, the beneficial effects of the release material can be achieved to the same extent or even in a better measure than just targeting the release material. in relation to the stoma. In others
Petition 870190099583, of 10/04/2019, p. 21/66
13/45 words, providing one or more openings in the cover layer allows a release (return) of the removable material predominantly in a distal direction of the lateral body member, instead of just releasing the material in a radial direction towards the stoma .
[0036] In modalities, the removable material returns out of one or more openings providing finger pressure on the distal surface of the lateral body member adjacent to the respective one or more openings. If more sacrificial material is needed in one or more locations, in particular, vulnerable locations where the lateral body member is known to be susceptible to leakage, the user can cause more removable material to return outward in such localized areas focusing particularly in one or more openings in that specific area. In embodiments, the removable material is adapted to return through each of one or more openings in response to finger pressure being applied to a portion of the distal surface of the lateral body member adjacent to a respective opening. In addition or alternatively, the user does not provide pressure on the distal surface adjacent to one or more openings, and instead, the removable material may return outside one or more openings when the level of decay of the body side member adhesive reaches a or more openings, the position (or positions) of one or more openings are then configured to correspond to a certain lower limit value for acceptable adhesive decomposition levels. This can help provide additional control over when and how much removable material can and will be released. In addition, these modalities can help to provide a simpler construction and still obtain the beneficial effects on the sealing between the lateral body member and the skin and, thus, increased use time with the body.
[0037] In modalities, the improved sealing effect of the lateral body member can be achieved after applying the lateral body member in the
Petition 870190099583, of 10/04/2019, p. 22/66
14/45 surface of the user's skin (adhering the proximal side of adhesive to the skin) by applying pressure with a finger in an area around one or more openings in the distal surface, to manipulate effectively and thus move the removable material out to the distal surface of the lateral body member. In embodiments, the removable material can thus be moved between at least a first and a second position in relation to the cover layer. In embodiments, the covering layer is configured to be plastic or elastically deformable, as, however, without limitation, the covering layer is formed from an anisotropic material.
[0038] In one embodiment, the removable material is provided under or below one or more openings in the first position, and at least some of the removable material is provided outside one or more openings in the second position. Furthermore, in the second position, a first portion or some part of the removable material may be located below an opening and a second portion or some part of the removable material may be located outside (having returned out of) the opening. In embodiments, some or all of the removable material is located below the cover layer in the first position, and some or all of the removable material is located above or over the cover layer in the second position.
[0039] In one embodiment, the release material is configured to expand in response to the absorption of humidification. In embodiments, the releasable material is configured to undergo a swelling action through the absorption of humidification from the stool excretion and / or from mucus emanating from the stoma's mucous membrane. In embodiments, the expansion of the removable material helps to create an improved seal between the stoma and the body's lateral limb, thereby reducing the likelihood of leakage caused by steal fluids that attack the adhesive on the proximal surface of the body's lateral limb. In embodiments, the release material includes a
Petition 870190099583, of 10/04/2019, p. 23/66
15/45 humidifying absorption component or substance. In embodiments, the humidification-absorbing component has a high absorption capacity or potential, and in other embodiments, the humidification-absorbing component has a small absorption capacity. Suitable materials for the humidification-absorbing component include, but are not limited to, superabsorbent polymers normally produced from polyacrylic acid salts. In additional embodiments, the adhesive on the proximal surface of the body's side member is configured to undergo a swelling action through humidification absorption and thus helps to create an improved seal between the stoma and the body's side member. In modalities, both the adhesive on the proximal surface of the lateral body member and the removable material are configured to undergo a dilating action through the absorption of humidification. In one embodiment, the releasable material is a viscoelastic material.
[0040] In one embodiment, the lateral body member additionally comprises a reinforcing element. The reinforcement element may include particularly, but not exclusively, 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, upper / lower liquid, steam or gas impermeability or odor control and others, can additionally and / or alternatively be used. Other reinforcement element options include mesh or mesh-shaped materials and / or fabrics. 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.
[0041] An advantageous effect of the reinforcement element is that it
Petition 870190099583, of 10/04/2019, p. 24/66
16/45 helps to provide a lateral body member that is more resistant to the forces acting on it. Often 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 include forces generated by the wearer's clothes, such as in the waist lining of a trouser or jeans, such forces are often further amplified by the presence of a belt. The forces can be both pressure and shear forces, often in combination.
[0042] In one embodiment, the cover layer of the body side member comprises a sheet material. The laminated material may include, but is not limited to, a sheet or layer of a polymeric film material, such as PE or PP. The laminated material may include, but is not limited to, a sheet or layer of a polymeric film material, such as PE or PP. In one embodiment, the sheet material layer is dissolvable.
[0043] In one embodiment, the cover layer is formed as a separate component and is configured to be fixable on other components of the body side member. In this way, the cover layer can be a loose component that is supplied together with the side body member, however, which is not initially attached to the side body member (i.e., not attached during the manufacturing process). In embodiments, the cover layer is formed as a separate component and is configured to be fixable to other components of the body side member and to be fixed distally to the removable material.
[0044] In modalities, the covering layer is attached only in a localized manner, that is, the covering layer is fixed only to the lateral body member in a certain number of individual locations, where each one forms only a small portion of the lateral body member. In one embodiment, the cover layer is attached to the side member of
Petition 870190099583, of 10/04/2019, p. 25/66
17/45 body through joints or means of articulation, which includes living joints. In such embodiments, the cover layer can be movably attached to the body side member in some locations while it is not attached to the body side member in other locations.
[0045] In one embodiment, the covering layer is formed as an integral component of the structure of the lateral body member. This means that the cover layer is attached or attached to the side member of the body during the manufacturing process. In such embodiments, it is thus not a separate component to be subsequently connected to the lateral body member. The cover layer can be connected or fixed over a whole portion of the distal surface covered by the cover layer facing the distal surface of the lateral body member. Alternatively, it can be connected or attached to two or more places or points located. Fixation or connection to the other components of the side member of the body can be provided by welding, such as thermal welding or ultrasonic welding, or by adhesion of the components to each other. 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 through additional adhesive material that is disposed on the distal surface of the side member of the body, or on the surface of the covering layer facing the distal surface of the lateral body member. In one embodiment, at least a portion of a distal surface of the lateral body member also 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, a coherent adhesive material forms both the proximal and distal surfaces of the lateral body member. Other means or ways of securing or connecting the components of the body side member to each other can be applied.
Petition 870190099583, of 10/04/2019, p. 26/66
18/45 [0046] In one embodiment, the cover layer is dissolvable when subjected to water or an aqueous liquid, such as aggressive starch fluids or mucus that emanates or secretes from the mucous membrane of the stoma. In one embodiment, the dissolvable cover layer comprises one or more polymers of polyvinyl alcohol.
[0047] In one embodiment, the cover layer comprises a thermoformable material. In one embodiment, the cover layer is formed of a thermoplastic polymer. In one embodiment, the cover layer comprises an elastic material.
[0048] In one embodiment, the covering layer additionally has the capacity to transmit humidification and can, for example, be produced from polymers, such as types of polyolefin, for example, PE, PP or polybutylene, polyurethane, polyvinyl alcohol, ethylene vinyl acetate or other thermoplastic polysaccharides, polyether block amides, such as PEBAX® from Arkema, France, block copolymers such as styrene-isoprene-styrene block copolymers or ethylene acrylate block copolymers, polyesters, such as terephthalate polyethylene (PET) or derivatives thereof and any laminates produced from such polymers. In embodiments, the cover layer comprises a thin foam layer produced from, for example, polyurethane, polyethylene or polyvinyl acetate.
[0049] In modalities, the covering layer comprises a differentiated thickness when seen over a total extension of the covering layer. In one embodiment, a thickness of the cover layer decreases from a greater thickness in a more outer edge portion of the cover layer to be radially thinner closer to the central portion of the lateral body member. The differentiated thickness of the cover layer is believed to be useful to provide a smooth return of the removable material from one or more openings.
Petition 870190099583, of 10/04/2019, p. 27/66
19/45 [0050] In modalities, the covering layer is formed by a resilient material. In some deployments, such a resilient material facilitates the return of the removable material from one or more openings, particularly due to the resilience of the material causing the portion of the cover layer adjacent to an opening to return to its original / initial shape after the layer cover around the opening has been manipulated by finger pressure. Resilient materials suitable for the cover layer include, without limitation, thermoplastic elastomers (TPEs) and / or mixtures thereof. In embodiments, the cover layer is produced by injection molding. Alternatively or additionally, the cover layer is produced in a two-component casting process, advantageously in combination with the provision of a first half of an ostomy apparatus coupling interface.
[0051] In embodiments, one or more openings comprise one or more circular perforations in the cover layer. In embodiments, one or more circular perforations allows a relatively uniform return of the removable material through the cover layer and to the distal surface of the lateral body member. In addition, this provides particularly advantageous modalities for the lateral body member to be configured for automatic return of removable material, that is, for modalities in which the user must not provide pressure on the covering layer or otherwise interact with the member body side to make the removable material return through one or more openings in the cover layer.
[0052] In modalities, the cover layer comprises a plurality (that is, more than two) of circular perforations, each of which has a wider diameter in a range of 2 to 10 mm. This wider diameter range provides openings that display a good balance between
Petition 870190099583, of 10/04/2019, p. 28/66
20/45 ease of return of the removable material through the openings, and the user's choice and chance to control the release rate of the removable material. In embodiments, a preferential wider diameter of an opening may be at the higher end of the strip for low viscosity release materials (more similar to solid), and at the lower end of the strip for high viscosity release materials (more similar to fluid) . In some deployments, the deciding factor for choosing the widest diameter of one or more openings is chosen based on how much humidification should be allowed to come into contact with the removable material through an opening. In additional embodiments, the cover layer comprises differently sized openings (different diameters).
[0053] In modalities, the plurality of openings is located in one or more zones of the distal surface of the lateral body member. This provides another option for the user to control which particular locations more removable material can return from outside the openings and which locations less removable material can return to.
[0054] In modalities, one or more openings comprise one or more perforations with slits in the covering layer. In modalities, a slotted hole is provided in a straight line that extends between two points of the cover layer. In one embodiment, each perforation with slits completely penetrates the covering layer. In another embodiment, each perforation with slits only partially penetrates the covering layer. In modalities, each perforation with slits is provided in a straight line that extended in the radial direction of the covering layer. In modalities, the straight line of each slit perforation extends from a point located radially outward from the central portion of the lateral body member to a point located approximately 1/5 to 1/4 of the radial distance between a portion of the innermost edge body side member around the stoma receiving opening and a wider edge
Petition 870190099583, of 10/04/2019, p. 29/66
21/45 external of the body lateral member. In other embodiments, each slotted hole is provided in a curved line.
[0055] In one embodiment, the cover layer comprises a slotted hole provided in a spiral shape in the cover layer. The spiral shape of the single perforation provides another option for the user to personalize the side body member in terms of how much removable material it wants to return initially through the spiral shaped opening. Although radially slotted perforations provide options for returning removable material to one or more arched segments of the body's lateral limb, spiral-shaped perforations provide options for gradually returning material, starting from a radially outer edge portion of the lateral limb of body or a radially innermost edge portion of the lateral body member.
[0056] In modalities, each one of the one or more openings comprises an articulated door formed in the covering layer. In embodiments, the hinged door is provided by drilling a c-shaped or u-shaped perforation in the cover layer, so that a smaller portion of each door hinges to the cover layer. In other words, each hinged door takes the form of a flap of the cover layer. The releasable material that returns from or from one or more openings comprising a hinged door or flap acts to open or move the flap apart, and thereby allows sacrificial material to enter the distal surface of the lateral body member. In addition, the hinged door or flap additionally serves to protect the underlying layers and / or the material by slowing or even preventing the ingress of humidification or excretion through the openings. In modalities, this feature additionally provides additional options to differentiate return of removable material and / or ingress of humidification of the lateral body member. This provides additional control over the distribution of removable material on the surface
Petition 870190099583, of 10/04/2019, p. 30/66
22/45 distal of the lateral body member, that is, control of where, how and how much removable material to be sacrificed is regressed from one or more openings.
[0057] In modalities, the removable material is a fluid or a liquid. In modalities, the removable material is a paste or paste. In embodiments, the removable material is a gel or a substance or material suitable for gelation when exposed to certain conditions, such as exposed to humidification. In embodiments, the plurality of materials other than the removable material is provided as a composition. In embodiments, the plurality of materials other than the removable material is provided as a compound. In embodiments, the composition or compound comprises two or more substances.
[0058] In modalities, the removable material comprises a matrix. In embodiments, the removable material matrix additionally comprises a neutralizing substance incorporated therein. In embodiments, the matrix of removable material is in the form of a gel, a foam, a layer of film, paper or a coating, such as a solid coating or a powder coating. In embodiments, the matrix of removable material and the neutralizing substance combine to form a colloidal solution, such as a sun. In embodiments, the removable material or the removable material matrix comprises one or more medicaments. In embodiments, one or more medications are suitable for relieving problematic skin surface pain and / or peristomal skin disorders.
[0059] In embodiments, the body side member is configured to allow the respective individual materials from the plurality of materials other than the removable material to return to the distal surface of the body side member through two or more individual and different openings. In this way, the lateral body member can be configured so that an opening or a first group of openings is configured
Petition 870190099583, of 10/04/2019, p. 31/66
23/45 to return one type of removable material, and another opening or second group of openings is configured to return a different type of removable material. Alternatively or additionally, in modalities, the size and configuration of the individual openings can be differentiated. By providing differentiated openings in combination with the possibility of different releasable materials returning from different openings, the beneficial effects of improved sealing ability of the body side member can be achieved to a different degree or in ways among a plurality of configuration combinations, as well. provides a versatile product that provides the user with several options for customizing the lateral body member according to individual requirements. In embodiments, more than two different types of release materials and / or more than two openings, or more than two groups of openings, can therefore be configured.
[0060] In modalities, the removable material is supplied in one layer. This provides a relatively simple frame body member, which is advantageous for mass production. In embodiments, the layer of removable material is provided between the adhesive of the proximal surface of the side member of the body and the cover layer that forms at least a portion of the distal surface of the side member of the body. In embodiments, the layer of removable material is formed as two or more concentric and annular zones or rings, each separated from the other by an area in which no removable material is present. In embodiments, each concentric ring containing removable material is configured to coincide, in an axial direction of the lateral body member, with an opening or a group of openings that is at a predetermined radial distance from the stoma receiving opening. In embodiments, each of the concentric rings is configured with different releasable materials, or with different amounts of removable material, such as, however, without limitation to provide each ring with different (layer) thicknesses.
Petition 870190099583, of 10/04/2019, p. 32/66
24/45 [0061] In modalities, the covering layer forms the distal surface of the lateral body member. In embodiments, the sheet material comprised by the cover layer forms the distal surface of the lateral body member. In embodiments, a proximal surface of the cover layer, or of the sheet material of the cover layer, comprises an adhesive that provides the adhesive of the proximal surface of the lateral body member.
[0062] In embodiments, the body side member includes a cover layer formed of erodible material and additionally includes a relatively thin protective layer or coating provided on the distal surface of the provided erodible cover layer to prevent or delay erosion or decomposition thereof. through aggressive grouping of excretion, stool on the distal surface of the lateral body member. The protective layer or coating includes a unidirectional material (unidirectionally permeable) that allows humidification to penetrate through the protective layer or coating into the erodible cover layer. In such embodiments, the erosion rate of the erodible cover layer can be controlled, for example, by controlling the permeability parameters of the protective layer. In this way, the lateral body member can be configured so that a whole of the cover layer is displaced when a certain predeterminable amount of humidification has penetrated the protective layer. This is advantageous for reaching a lateral body member in which the release or engagement between the stool excretion and the removable material of the lateral body member can be delayed or postponed and / or to control where the exposure of the adhesive to the proximal surface of the limb side of the body to the stool excretion occurs.
[0063] Pressure sensitive adhesives, particularly those containing hydrocolloids, are a particularly suitable group of adhesives, characterized by having a particulate hydrocolloid phase dispersed in the phase
Petition 870190099583, of 10/04/2019, p. 33/66
25/45 or adhesive matrix. The hydrocolloid-containing adhesive can absorb skin moisturization to prevent skin occlusion, while maintaining its adhesive properties on the skin. In addition, an 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.
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 (suitably block copolymers containing polystyrene blocks), a chemically crosslinked natural or synthetic 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-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 preferably selected from a group comprising polymers and copolymers of cyclopentadiene, dicyclopentadiene, alpha-pinene
Petition 870190099583, of 10/04/2019, p. 34/66
26/45 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 to 10% of a plasticizer (eg CITROFOL® BII, Jungbunzlauer, Switzerland ). The hydrocolloid particles preferably consist of one or more water-soluble or water-swelling hydrocolloid polymers or gums. In other embodiments, the adhesive on the proximal surface of the lateral body member comprises one or more adhesives of the types disclosed in publications n-W02007 / 082538 and ² W02009 / 006901.
[0065] In modalities, each one of the one or more openings provides a passage between a lower side and an upper side of the covering layer. Each opening provides a passageway for the removable material to exit or return and / or for the liquid or humidification, as generated by the stool excretion, to enter the opening and the underside of the cover layer. At least in the latter case, a capillary action between the incoming humidification and the removable material can result in the removable material leaving the opening.
[0066] The removable material can be configured to expand in response to the absorption of humidification, which can also cause the removable material to extermalize and cause it to be dispensed through the openings. Depending, among other factors, on the nature of the removable material, in some embodiments, the absorption of humidification and the resulting expansion of the removable material initiates the return of the removable material without any manipulation of the cover layer adjacent to one or more openings through the opening. user. In other words, the return of the removable material through one or more openings can start "automatically" as soon as the removable material starts to absorb the humidification. It has been found that the rate of return of removable material can be surprisingly high, thereby causing a rapid
Petition 870190099583, of 10/04/2019, p. 35/66
27/45 release of the removable material through one or more openings in the distal surface of the lateral body member. This can also be useful in orienting the removable material quickly towards the stoma, where it is "sacrificed" for stool excretion, thereby providing faster and therefore better security against leakage caused by aggressive stool excretion. This is additionally advantageous because no active participation by the user is necessary for the return of the removable material through one or more openings.
[0067] In modalities, one or more openings of the covering layer are located radially close to the central portion of the lateral body member. In another embodiment, each of the one or more openings is located in a radially outermost portion of the lateral body member. This is particularly suited to assist in providing a distribution of the removable material over a large portion, or even an entire distal surface of the body side member in use.
[0068] In embodiments, one or more openings of the cover layer can be distributed in a pattern on the surface of the cover layer. The pattern can be a symmetric or random pattern.
[0069] In modalities, the adhesive of the proximal surface of the lateral body member is provided in a support layer, the support layer being distal to the adhesive of the proximal surface and proximal to the removable material. In embodiments, the support layer includes a film. In embodiments, the film includes a polyolefin material. In embodiments, the film material includes polyethylene. In embodiments, the support layer carries the adhesive from the proximal surface of the lateral body member. In embodiments, the removable material is provided on a surface distal from the backing layer. In embodiments, the removable material includes a layer that is located on the distal surface of the support layer. In
Petition 870190099583, of 10/04/2019, p. 36/66
28/45 modalities, the layer of removable material is fixed to the distal surface of the support film by one or more welds or welding zones, or by adhesion. In embodiments, the cover layer is provided distally to the layer of removable material. Thus, these modalities provide an advantageous simple construction of the lateral body member, which can be processed in a fast and reliable production process, maintaining low manufacturing costs, while providing a new and versatile lateral body member for an ostomy device with several options to create a customized and improved seal for the skin surface.
[0070] In modalities, the removable material is configured to be dispensed through one or more openings. In this way, the removable material can exit through one or more openings to enter a substantial portion of the distal surface of the lateral body member. In addition, one or more openings can be configured so that this return takes place relatively quickly, such as in a short time to provide a large surface area of sacrificial material to mitigate the harmful effects of stool excretion. In embodiments, one or more openings can be additionally configured to open in different directions. This allows for a versatile distribution of the removable material and, in turn, provides an option for uniform distribution of the removable material over the entire distal surface of the lateral body member. Furthermore, this provides a lateral body member that offers many uses as a relatively simple structure. Additionally or alternatively, a cover layer that has a plurality of openings can provide an option to differentiate the amount of removable material at any location on the distal surface of the lateral body member. This is particularly advantageous because more removable material can be oriented or directed to a location where it may be needed more than elsewhere on the distal surface of the lateral body member.
Petition 870190099583, of 10/04/2019, p. 37/66
29/45
In particular, the removable material can be oriented both towards the stoma and in the opposite direction. Such deployments allow for multiple options to address the beneficial effects of removable material in the correct locations, where a leak problem may be occurring or where user experience tells you that the leak occurs frequently. In embodiments, the cover layer includes a plurality of openings. One or more of the plurality of openings can be configured to face axially in the opposite direction to the distal surface of the lateral body member and thus help direct the removable material to one or more locations where it is available for an extended period in comparison with when it is immediately subjected to stool excretion.
[0071] In modalities, the removable material is configured to be dispensed through one or more openings. By "dispensed" it must be understood that, in some deployments, for the removable material to return or exit through an opening, the cover layer adjacent to the opening and surrounding it must be manipulated by the fingers of a user. In other words, “dispensed” must be interpreted as meaning that the return of the removable material constitutes an action or step that requires precipitation or active contribution by the user. In embodiments, a surface distal from the cover layer includes texture to facilitate easier tactile recognition from where to manipulate the cover layer to cause removable material to come out of the opening. The texture is even more useful to prevent the user's fingers from slipping off the surface of the covering layer during such manipulation.
[0072] In an exemplary implantation and application of the lateral body member in accordance with the present disclosure, a user initially customizes, such as by cutting, a stoma receiving opening to an approximate size or circumference of the user's stoma.
Petition 870190099583, of 10/04/2019, p. 38/66
30/45
Then, the user can remove any protective liner (or protective liners) provided on the side member of the body, such as the adhesive on the proximal surface of the side member of the body, and apply the side member of the body to the skin surface around the stoma. . The user can then apply finger pressure to the portions of the cover layer around each one of one or more openings to return the removable material out of one or more openings.
[0073] From the above, it is understood that, in the conception of the invention of the present disclosure, the inventors realized that the removable material does not, by itself, need to be supplied near or in direct contact with the surface of the stoma or on peristomal skin surface so that the removable 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 removable material on the distal surface of the lateral body member, that is, on the surface of the lateral body member that faces away from the skin of the body. user, when the body side member is used. This is believed to occur, at least partially, due to the provision of the removable material as a sacrificial material and / or the creation of additional surface area of that sacrificial material, distributing it over a large area of the lateral body member.
[0074] Other useful effects are predicted by the lateral body member according to the disclosure, and it is believed that some of these effects are at least partially controllable by the number of openings applied and the composition of the removable material. In embodiments, more than one type of removable material can be provided below the cover layer, thereby allowing different removable materials to be released through different openings. Thus, it is believed that more than one useful effect can be achieved by the claimed lateral body member.
Petition 870190099583, of 10/04/2019, p. 39/66
31/45
In addition, with an example, in modalities in which more than one type of removable material is provided in one or more openings of the lateral body member, the useful effect (or useful effects) presented by a removable material can be amplified by the presence of another type of removable material to provide even better results in terms of reducing or eliminating leak incidents.
[0075] 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 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 embodiments, the first half of the coupling interface is configured as a flexible flat ring 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 sterling excretion collection bag by means of an adhesive. The adhesive coupling can provide a removable or permanent adhesive coupling between the components.
[0076] In embodiments, the coupling half is an annular ring that comprises a vertical flange that protrudes from the distal surface perpendicularly to it to affix another coupling half in the form of a coupling ring supplied in a bag. reversal collection of excretion. In one embodiment, a first coupling half is attached to the distal surface of the lateral body member. In embodiments, the first coupling half is attached to the distal surface by means of an adhesive or by welding, but other forms of attachment are acceptable. In embodiments, a first coupling half is fixed to the distal surface of the lateral body member in a radially located location.
Petition 870190099583, of 10/04/2019, p. 40/66
32/45 closer to the stoma receiving opening than where one or more openings are located.
[0077] In modalities, the first coupling half is configured as an annular ring that includes a vertical flange that extends axially in the opposite direction 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.
[0078] In modalities, a first dimension of radial extension is less than an inner diameter of the annular ring that forms the first half of the coupling interface in the lateral body member. The annular ring of the first half of the coupling interface is configured to mate with a second half of the coupling interface provided in a sterling excretion collection bag.
[0079] In modalities, the stool excretion collection bag includes a front wall that forms a distal side and a rear wall that forms a proximal side. Each wall can be produced from sheet material impermeable to gas and liquid (for example, polyethylene (PE), polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA)) which is welded around the edges or the rim, to form a bag that defines a waste collection chamber. The bag can only be partially welded around the rim so that a discharge opening to empty the bag is provided at the bottom of the bag. In that case, the bag may be provided with means to close that opening. An entrance opening is provided on the rear wall and placed on the top of the collection bag, so that when a user stands, the entrance opening is located above a midline of the collection bag. This provides an important portion of the collection volume below the bag entry opening. Thus, a top of the collection bag is defined as the portion of the bag closest to the entrance opening, and the bottom is defined as an opposite portion of the bag.
Petition 870190099583, of 10/04/2019, p. 41/66
33/45 [0080] In modalities, only a smaller portion of the removable material surface is exposed to each one of one or more openings. Thus, only a relatively small amount of removable material is not initially covered by the cover layer. This is advantageous because it allows control of where and how quickly humidification and exudates from stool excretion can attack removable material. In other words, the structure of the cover layer can assist in directing the exposure of the removable material to stool excretion to only certain controlled locations. These modalities are additionally advantageous because the removable material will not be immediately visible to the user, thus providing, in some implantations, a visually simpler impression of the ostomy device. In embodiments, an important portion of the removable material is, at least initially, generally protected by the covering layer, thus allowing the distal surface of the lateral body member, formed by the covering layer, to be carefully cleaned ( cleaning the waste excretion and the removable material already eroded / used) during a change of the waste excretion collection bag without also inadvertently removing removable material still viable.
[0081] In modalities, the removable material comprises an adhesive. In other embodiments, the removable material comprises a powder. In other embodiments, the removable material comprises a liquid. In other embodiments, the removable material comprises a gel. In other embodiments, the removable material comprises a paste or putty. In other embodiments, the removable material comprises a plurality of dissolvable pellets. In still other embodiments, the removable material comprises a combination of any one or more of an adhesive, a powder, a liquid, a gel, a paste and / or a plurality of pellets. In modalities, the removable material can be supplied from the manufacture
Petition 870190099583, of 10/04/2019, p. 42/66
34/45 in one of the ways mentioned in this document and be configured for transition in one or more of the other ways. As an example, a paste that can start to gel and / or take a gel in response to the humidification sip. 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 and other characteristics. By selectively applying these options, individually or in combination, to meet specific requirements of a target type of ostomy, the suitability of the device and the improvement in the sealing effect that reduces or eliminates the risk of leakage can be significantly enhanced.
[0082] Particularly, in modalities in which the removable material comprises an adhesive, suitable materials include adhesives, such as, but not limited to, 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.
[0083] In another aspect of the disclosure, the use of the body 20 side member for an ostomy apparatus as disclosed herein to further reduce the frequency of stool leakage incidents is additionally contemplated. The advantageous effects provided by the body lateral limb 20 modalities help to alleviate the discomfort of excretion leaks 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. At least the use of the lateral body member in accordance with the present disclosure allows increased use of time with the body of an ostomy device.
Petition 870190099583, of 10/04/2019, p. 43/66
35/45
The neutralizing substance [0084] 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.
[0085] In modalities, the removable 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 it can be dispersed as particles in the matrix. In embodiments, the matrix may be in the form of coated particles of neutralizing substance.
[0086] In modalities, the matrix is designed to release neutralizing substance into the environment when the matrix is exposed to certain conditions. Such conditions can, for example, be in the presence of excretion from the stoma or in the presence of humidification as well.
[0087] In modalities, the matrix is in the form of a gel, foam, film or paper layer or a coating.
[0088] 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.
[0089] 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 the kurakay WS Film Division ™, Portage, Indiana, United States.
[0090] In the modalities, the matrix is soluble in water or a component of excretion. It can be slowly soluble, for example
Petition 870190099583, of 10/04/2019, p. 44/66
36/45 slowly it is understood in the present document that the matrix layer will not be washed instantly, but will dissolve slowly during the time of use next to the wafer body.
[0091] In modalities, the matrix can absorb humidification and becomes a gel-like material when wet. The gel can be delivered in dry form, but swell into a gel when placed in contact with humidification. The gel may be slowly soluble in water or in a component of the excretion or it may be insoluble, but have the capacity to release the neutralizing substance when exposed to excretion or humidification. [0092] In modalities, the matrix comprises polysaccharides and / or hydrocolloids. Polysaccharides or hydrocolloids can dissolve or hydrate when exposed to excretion, thereby releasing a neutralizing substance.
[0093] In the modalities, the matrix comprises protein. In the embodiments, the matrix comprises gelatin.
[0094] 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.
[0095] In another aspect, the disclosure refers to an ostomy apparatus that includes a lateral body member as described in this document and a stool excretion collection bag configured to be attached to the distal surface of the lateral body member .
[0096] In one embodiment, the ostomy appliance is a one-piece ostomy appliance, that is, without a coupling interface between the
Petition 870190099583, of 10/04/2019, p. 45/66
37/45 lateral body member and the reversal excretion collection bag. In another embodiment, the ostomy appliance is a two-piece appliance that includes a coupling interface for connecting a stool excretion collection bag to the lateral body member by connecting or coupling the first and second coupling halves. each other.
[0097] In one embodiment, the reversed excretion collection bag comprises a second half of a coupling interface that is configured to mate with a first half of the coupling interface on the side body member to secure the return collection bag to the lateral body member.
[0098] In one embodiment, at least the distal surface of the lateral body member formed by the covering layer is defined by a first zone and a second zone that surrounds the first zone, the first zone being radially within an annular connection between a first half of a coupling interface and the side body member and the second zone is radially out of the annular connection between the first half of the coupling interface and the side body member.
[0099] In one embodiment, each of the one or more openings is in the second zone of the covering layer.
Detailed description of the drawings [00100] Figure 1 is a cross-sectional view of an embodiment of a lateral body member 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). At least a portion of the proximal surface 24 of the side member of body 20 comprises an adhesive 31. At least a portion of the distal surface 22 is formed by a covering layer 36. Figure 1 shows a stool O of the user that extends through a stoma receiving opening 32 of the body 20 side member.
Petition 870190099583, of 10/04/2019, p. 46/66
38/45 stoma receiving opening 32 can be provided during the fabrication of the body 20 side member or can be provided by the user in preparing the body 20 side member for attachment to the skin surface around the stoma O. The side member body part 20 includes a cover layer 36 comprising one or more openings 34. A removable material 33 is provided next to cover layer 36. Figure 1 illustrates a situation immediately after the body side member 20 has been attached to the surface of skin S around the stool O of a user.
[00101] Each of the one or more openings 34 is configured to allow the return of a removable material 33. Thus, each opening 34 is suitable to let a mass or volume of the removable material 33 escape or escape through one or more openings 34. This is illustrated in Figure 2, which shows (by means of the plurality of arrows P) how the removable material returns through the openings 34 and is released on the distal surface 22 of the lateral body member 20. The removable material 33 can, thereby, being displaced between at least a first position and a second position in relation to an opening 34. The removable material 33 is displaceable between the first and second positions at least in use of the body side member 20.
[00102] Figure 2, which is a cross-sectional view of a modality of the side member of body 20, further illustrates how part of the removable material 33 started to engage with the U-star excretion, illustrated as an example in the position 38. In addition to engaging with the stool U excretion, the removable material also engages with the humidification (or mucin) that emanates from the mucous membrane M of stoma O and, in some situations, also with the humidification (sweat) that emerges from the surface of user's skin. By applying pressure with a finger to the distal surface 22 in each of the openings 34 or adjacent to them, the removable material 33 exits through the openings. Depending, among others, on the volume of excretion reverses U and / or
Petition 870190099583, of 10/04/2019, p. 47/66
39/45 of humidification, a mass of removable material 33 can come out through the opening 34 and act as a material that is sacrificed in the aggressive ugly excretion U. In some deployments, the removable material 33 comprises one or more neutralizing substances that release or engage with the reversal excretion U and thereby neutralize the harmful content of the excretion reverses so that the aggressive elements of the excretion do not decompose the adhesive 31 of the proximal surface 24 of the lateral body member 20. In the modalities shown in Figures 1 and 2, the removable material 33 can additionally engage with the stoma surface next to it, indicated by the arrows R and thereby assist in improving the seal between the body side member 20 and the skin surface S, and / or delay or eliminate the possibility of the reversal excretion U reaching the adhesive 31. However, it is not necessarily necessary that the lateral member of body 20 is in contiguity or very close to the s the stool surface, as shown in Figures 1 and 2. In any case, the important portion of the removable material 33 that engages with the stool excretion U exits through the openings 34. The removable material 33 that left the openings 34 can be configured, for example, sipping the humidification and / or mixing with the stool excretion, for collection (or collection) on the distal surface 22 of the side member of body 20, that is, in one or more openings 34 and in the portions of the layer coverings 36 that do not form the openings 34, as shown in position 40 in Figure 2. This can additionally assist in protecting the removable material 34 from rapid decomposition and additionally assist in providing extended availability of the removable material 34 for use as a sacrificial material.
[00103] Figure 3 is a schematic top view illustrating an embodiment of a cover layer 36 of the body side member 20. Cover layer 36 comprises a plurality of openings 34. As indicated by the arrows X in Figure 3, the removable material 33 can
Petition 870190099583, of 10/04/2019, p. 48/66
40/45 come out of the openings 34, such as by pressure with a user's finger.
[00104] By applying pressure with a finger on a distal surface 22 formed by the covering layer 36, the removable material 33 returns or leaves through the openings 34 in the covering layer. Consequently, the removable material 33 can thus be moved between at least a first and a second position. In the first position, the removable material 33 is supplied close to the cover layer 36 (below or below the cover layer 36 in Figure 3) and, in the second position, at least part of the removable material 33 returns through the openings 34 to the distal surface 22 of body side member 20.
[00105] In the embodiment of Figure 3, the removable material 33 can return or be 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. This allows the dispensable removable material to spread over a large area of the distal surface 22 of the body side member 20.
[00106] Figure 4 is a schematic top view illustrating an embodiment of a cover layer 36 of the side member of body 20. Cover layer 36 comprises a plurality of openings 34. Each of the openings 34 of Figure 4 comprises a hinged door 42 formed in the cover layer. In Figure 4, the openings 34 are illustrated as substantially circular, however, other shapes are also possible. A hinge 44 is formed in an arc portion of the periphery of the opening 34. The hinge 44 shown in Figure 4 provides an option to allow the door 42 to open to let the removable material 33 return through the opening 34 to the distal surface 22 of the lateral body member 20, as indicated by the dotted arrows Q. By applying pressure with a finger on the distal surface 22, the removable material 33 returns through the openings 34 in the cover layer 36. Consequently, the removable material 33 can be displaced between at least one first and one
Petition 870190099583, of 10/04/2019, p. 49/66
41/45 second positions. In the first position, the removable material 33 is supplied close to the cover layer 36 (below or below the cover layer 36 in Figure 4), and in the second position, at least part of the removable material 33 returns through the openings 34 to the distal surface 22 of the body side member 20. Since the hinged door 42 of the embodiment of Figure 4 can either “open” to allow the return of the removable material 33 or “close”, when the removable material does not come out of a respective opening 34 , the hinged door 42 can further assist in protecting the removable material 33 from being subjected to stool excretion, collecting on the distal surface 22 of the body side member 20.
[00107] Figure 5 is a schematic cross-sectional view of an embodiment of a cover layer 36 of a lateral member of body 20 formed with an opening 34, which is located radially closer to a coupling ring 46 that forms a first half of a coupling interface of the body side member 20 than to an inner edge portion 48 of the body side member 20. In the embodiment of Figure 5, it should be understood that the opening 34 is provided annularly or at least in a plurality of arc segments along the coupling ring 46. When finger pressure is exerted on the distal surface 22 of the cover layer 36 radially within the coupling ring 46, the removable material 33 leaves the opening 34 and stops the distal surface 22. The removable material 33 can also be directed or oriented towards the stoma O in the innermost portion 48. This configuration of the opening 34 can assist the user in distributing the removable material 33 goes over a whole of the distal surface 22 radially within the coupling ring 46.
[00108] Figure 6 is a schematic top view of an embodiment of a cover layer 36, with an opening 34 being a single annular opening 34. Removable material 33 is dispensable through
Petition 870190099583, of 10/04/2019, p. 50/66
42/45 of the single annular opening 34 which, in the embodiment of Figure 6, is located in a radially outermost edge portion 39 of the body side member 20. In the embodiment of the covering layer 36 illustrated in Figure 6, the covering layer 36 further comprises three radial protrusions 50 extending from the outermost edge portion 39. The radial protrusions 50 are suitable for securing the cover layer 36 to one or more of the other components of the body side member 20. The removable material 33 can return from a first position proximal to the cover layer 36 through the single annular opening 34 to a second position on the distal surface 22 of the body side member 20.
[00109] Figure 7 is a schematic top view illustrating an embodiment comprising a single annular opening 34 located on a radially outermost edge portion 39 of the body side member 20. In the embodiment illustrated in Figure 7, the cover layer 36 is a “loose” cover layer in the sense that it does not comprise means for attaching it to the other components of the body side member 20. However, some degree of attachment of the cover layer 36 is provided by the removable material 33. In some deployments, the removable material 33 is adhesive and therefore has the ability to attach to the cover layer 36 by adhesion. Other fixation options are possible.
[00110] Figure 8 is a schematic top view of an embodiment of a cover layer 36 of a side member of body 20, one or more openings 34 being provided as a plurality of perforations with slits in the cover layer 36 forms the distal surface 22 of the lateral body member 20. In the embodiment shown in Figure 8, each of the slotted holes 34 is linear. In addition, each of the slotted holes 34 is provided in a straight line extending between two points 52, 54 in the radial direction of the cover layer 36. In modalities, the straight line of each slotted hole 34 extends from one
Petition 870190099583, of 10/04/2019, p. 51/66
43/45 point 54 located radially outwardly from a central portion 55 of the side member of body 20 to a point 52 located approximately 1/5 to 1/4 of a radial distance L1 between a portion of the innermost edge 48 of the side member of body 20 around the stoma receiving opening 56 and a more outer edge portion 39 of the body 20 side member.
[00111] Figure 9 is a schematic cross-sectional view illustrating modalities in which the removable material 33 is located next to a cover layer 36 formed from an erodible material. The cover layer 36 comprises openings 34. In the embodiment of Figure 9, a relatively thin protective layer or coating 58 is provided on the distal surface of the erodible cover layer 36 to prevent or delay erosion or decomposition of the removable material 33 by means of the grouping. aggressive excretion reverses to the distal surface 22 of the body side member 20. The protective layer or coating 58 includes a unidirectional material (unidirectionally permeable) that allows humidification 60 to penetrate through the protective layer or coating 58 into the erodible cover layer 36, but it does not allow the removable material 33 to penetrate or escape in the opposite direction. When a certain predeterminable amount of humidification 60 has penetrated the protective layer 58, the covering layer 36 completely deteriorates, thereby displacing a totality of the covering layer 36, and taking the protective layer 58 together, that is, causing that the protective layer 58 disappears, since it is no longer attached to any other component of the body side member 20. This allows to leave a total of the surface area of the removable material 33 exposed to the stool excretion. In this way, the release of most of the removable material can be delayed or delayed, and / or caused suddenly and / or massively, for example, if an important or potentially incorrect leak event arises.
[00112] Figure 10 is a schematic cross-sectional view of
Petition 870190099583, of 10/04/2019, p. 52/66
44/45 is a embodiment of a side member of body 20 comprising a cover layer 36 comprising one or more openings 34. A mass of removable material 33 is located next to cover layer 36. The adhesive 31 of the proximal surface 24 of the body side member 20 is provided in a support layer. In the embodiment of Figure 10, the removable material 33 is provided on a distal surface of the support layer 62 and close to the cover layer 36. The removable material 36 can return through the openings 34 and to the distal surface 22 of the body side member. 20. The removable material 33 can thus absorb excess stool excretion before reaching the proximal surface 24 comprising the adhesive 31 of the side member of the body 20. Thus, the time of use close to the body of the side member of the body can be effectively extended. In the embodiment of Figure 10, the cover layer 36 is attached to the support layer 62 by welding, as in location 64.
[00113] Figure 11 is a schematic cross-sectional view of an embodiment of a lateral body member 20 of an ostomy apparatus 10 in use, that is, attached to the skin surface S around the stool O of a user. The lateral body member comprises a cover layer 36 comprising openings 34, which allows a mass of removable material 33 to return to the distal surface 22. Applying finger pressure through the distal sheet layer 64 of the collection bag reversal excretion 15, a user can externalize and return the removable material 33 through the openings 34 to the distal surface 22.
[00114] Figure 11 further illustrates that the distal surface 22 of the body side member includes a first half 46 of a coupling interface for coupling the body side member 20 to a second half 47 of the coupling interface provided in the collection bag. reversal of excretion 15.
[00115] In the form of Figure 11, the first half of
Petition 870190099583, of 10/04/2019, p. 53/66
45/45 coupling 46 is an annular ring comprising a vertical flange that projects from the distal surface 22, and perpendicularly thereto, of the body side member 20. The flange is configured to fix the second coupling half 47 in the form of a coupling ring provided in the sterling excretion collection bag 15. In embodiments, the first coupling half 46 is attached to the distal surface 22 by an adhesive or by welding, but other forms of attachment are acceptable.
[00116] Figure 11 illustrates an embodiment of an ostomy apparatus 10 that includes a lateral body member 20 as described herein and a sterling excretion collection bag 15 configured to be attached to the distal surface 22 of the body side member. 20. In Figure 11, the distal surface 22 of the body side member 20 comprises a plurality of openings 34. As shown in Figure 11, the ostomy apparatus 10 is a two-piece apparatus that includes a coupling interface comprising a first half 46 and a second half 47 to connect a reversal collection bag 15 to the lateral body member 20. It should be understood that the ostomy apparatus 10 can also be a one-piece ostomy apparatus, that is, without a coupling interface between the body lateral member 20 and the reversal excretion collection bag 15.
[00117] Although specific modalities have been illustrated and described in this document, it will be observed by those of ordinary skill in the art that a variety of alternative and / or equivalent deployments can be replaced by the specific modality shown and described without departing from the scope of this 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 (24)
[1]
1. Lateral body member of an ostomy device, characterized by the fact that it comprises:
a proximal surface and a distal surface, with at least a portion of the proximal surface comprising an adhesive;
a covering layer that forms at least a portion of the distal surface of the lateral body member;
a removable material provided close to the cover layer;
wherein at least a central portion of the lateral body member is prepared for the provision of a stoma receiving opening which extends through the lateral body member;
the cover layer being configured to comprise one or more openings, each of which within one or more openings is configured to allow the return of the removable material to the distal surface of the lateral body member, at least in the use of the member body side around a user's chargeback.
[2]
Body side member according to claim 1, characterized in that the cover layer comprises a sheet material.
[3]
Body side member according to claim 2, characterized in that the cover layer is formed as an integral component of the body side member.
[4]
Body side member according to claim 2, characterized in that the cover layer is formed as a separate component and is configured to be fixable to other components of the body side member and to be fixed distally to the removable material.
[5]
Body side member according to any one of claims 1 to 4, characterized by the fact that one or more openings
Petition 870190099583, of 10/04/2019, p. 55/66
2/4 comprise one or more circular perforations in the cover layer.
[6]
Body side member according to any one of claims 1 to 5, characterized in that it comprises a plurality of circular perforations in the covering layer, each circular perforation having a wider diameter in a range of 2 to 10 mm.
[7]
Body side member according to any one of claims 1 to 6, characterized in that the plurality of openings is located in one or more zones of the distal surface of the body side member.
[8]
Body side member according to any one of claims 1 to 4, characterized in that the one or more openings comprise one or more perforations with slits in the cover layer.
[9]
Body side member according to claim 8, characterized in that a slotted hole is provided in a spiral shape in the cover layer.
[10]
10. Lateral body member according to claim 1, characterized by the fact that each one of the one or more openings comprises a hinged door formed in the covering layer.
[11]
Body side member according to claim 1, characterized by the fact that it comprises an opening at an outer edge of the covering layer, and being configured by at least a portion of the covering layer having a first dimension of radial extension less than a second average radial extension dimension of the lateral body member.
[12]
Body side member according to claim 11, characterized in that the first dimension of radial extension is less than an inner diameter of an annular ring that forms a first half of a coupling interface on the configured body side member to couple with a second half of the interface
Petition 870190099583, of 10/04/2019, p. 56/66
3/4 coupling provided in a sterling excretion collection bag.
[13]
13. Lateral body member according to any one of claims 1 to 12, characterized in that the removable material is adapted to return through each one of the one or more openings in response to the finger pressure being applied to a portion from the distal surface of the lateral body member adjacent to a respective opening.
[14]
14. Body side member according to claim 1, characterized by the fact that the removable material comprises at least one of an adhesive, a powder, a paste, a liquid, a gel, a plurality of pellets or any combination thereof .
[15]
15. Lateral body member according to claim 1, characterized by the fact that the removable material is viscoelastic.
[16]
Body side member according to any one of claims 1 to 15, characterized in that the removable material is configured to expand in response to the absorption of humidification.
[17]
17. Body side member according to claim 1, characterized in that the cover layer comprises a thermoformable material.
[18]
Body side member according to any one of claims 1 to 17, characterized in that the cover layer comprises a dissolvable material.
[19]
19. Lateral body member according to any one of claims 1 to 18, characterized in that the removable material is provided in one layer.
[20]
20. Lateral body member according to claim 1, characterized by the fact that the adhesive of the proximal surface is provided in a support layer, the support layer being distal to the adhesive of the proximal surface and proximal to the removable material.
[21]
21. Lateral body member according to any of the
Petition 870190099583, of 10/04/2019, p. 57/66
4/4 claims 1 to 20, characterized in that the removable material comprises a plurality of different materials.
[22]
22. Lateral body member according to claim 21, characterized in that the plurality of different materials is provided as a composition.
[23]
23. Lateral body member according to claim 21, characterized in that it is additionally configured to allow the respective individual materials of the plurality of materials other than the removable material to return to the distal surface of the lateral body member through two or more individual and different openings.
[24]
24. Ostomy device, characterized by the fact that it comprises:
a lateral body member according to any one of the preceding claims; and a reversal collection bag.

类似技术:

---

公开号 | 公开日 | 专利标题

---

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

---

BR112019020921A2|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

---

US20200060863A1|2020-02-27|Body side member of an ostomy appliance

---

EP0686381B2|2004-12-29|Ostomy appliance with extrudable gasket

---

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

---

JP4780636B2|2011-09-28|Multi-layer adhesive medical device

---

EP3706672B1|2022-01-05|Kit of parts and a complementary-material element for an ostomy appliance

---

EP3515380A1|2019-07-31|Ostomy device

---

WO2006038025A1|2006-04-13|Ostomy bags

---

US6206864B1|2001-03-27|Ostomy appliance with inverted triangular faceplate and non-protruding pull tabs

---

EP3582726B1|2021-04-14|An adhesive wafer with an integrated release layer

---

US20200337879A1|2020-10-29|Perforated chamber ostomy wafers, ostomy devices including the same, and methods of applying ostomy wafers and ostomy devices

---

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

---

EP3609445A1|2020-02-19|

---

WO2018188707A1|2018-10-18|

---

CN110494104A|2019-11-22|

---

US20210113362A1|2021-04-22|

---

EP3609445B1|2021-06-09|

---

RU2019135069A3|2021-07-07|

---

RU2019135069A|2021-05-11|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

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

---

US5496296A|1994-06-06|1996-03-05|Dansac A/S|Ostomy appliance with extrudable gasket|

---

US5769831A|1996-05-25|1998-06-23|Louisville Laboratories, Inc.|Conveniently disposable ostomy appliance|

---

BR9809692A|1997-05-26|2000-07-11|Coloplast As|Ostomy utensil|

---

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|

---

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

---

ES2632718T3|2008-11-19|2017-09-15|Convatec Technologies Inc.|Ostomy device with moldable adhesive|

---

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

---

EP2421488B1|2009-04-21|2015-03-18|Coloplast A/S|Adhesive wafer for use in a collecting device|

---

US8211073B2|2009-06-17|2012-07-03|Hollister Incorporated|Ostomy faceplate having moldable adhesive wafer with diminishing surface undulations|

---

EP2846746B1|2012-05-10|2022-03-09|B.Braun Medical SAS|Ostomy appliance|

---

HUE043066T2|2012-12-06|2019-08-28|Coloplast As|An adaptable ostomy base plate|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|

---

USD893514S1|2018-11-08|2020-08-18|11 Health And Technologies Limited|Display screen or portion thereof with graphical user interface|

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

---

DKPA201770256|2017-04-10|

---

PCT/DK2018/050069|WO2018188707A1|2017-04-10|2018-04-09|Body side member of an ostomy appliance|

---