• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    adaptable ostomy base plate. it is an adaptable ostomy base plate (10) comprising a flexible top film (8), at least one elastic adhesive (6) disposed on the top film and at least one release liner (9), wherein the base plate has at least one convex first section (1) which can be inverted to a concave section to be used especially for demanding skin surface conditions such as in ostomates suffering from hernia.
    公开号:BR112015012979B1
    申请号:R112015012979-0
    申请日:2013-12-05
    公开日:2021-08-31
    发明作者:René Ferm Nyberg
    申请人:Coloplast A/S；
    IPC主号:
    专利说明:

    [001] The invention relates to an adaptable ostomy base plate. In particular, the invention relates to an adaptable ostomy base plate for ostomies or stomas located in a bulge or hernia on a wearer's skin surface. BACKGROUND
    [002] In connection with surgery for various diseases in the gastrointestinal tract, one of the consequences in many cases is that the patient is left with an abdominal stoma, such as a colostomy, an ileostomy or a urostomy in the abdominal wall for disposal of visceral contents. Disposal of visceral content cannot be arbitrarily regulated. For this purpose, the user will have to rely on equipment to collect the material that emerges from such an opening in a bag, which is later emptied and/or discarded in a suitable time.
    [003] An ostomy apparatus may be in the form of a one-piece apparatus to which a collection bag for human body waste is permanently attached or attached to an adhesive base plate for attaching to human skin. Alternatively, the ostomy apparatus may be a two-piece apparatus comprising a base plate and a collection bag which can be coupled to and uncoupled from each other through coupling means. This has the effect that the baseplate does not need to be separated from the wearer's skin as often as changing the collection bag requires. The baseplate may only need to be changed every three or four days depending on the user, while the collection bag may be changed more than once a day. Typically, it is desirable to need as few baseplate changes as possible in order to reduce the risk of skin complications.
    [004] One of the main concerns of ostomatists who use ostomy equipment that has an adhesive base plate to attach to the skin surrounding a stoma, and in which a collection bag is attached to the base plate to collect stoma output, is that the Adhesive ostomy fixation may be compromised resulting in leakage or even complete unattachment of the ostomy equipment.
    [005] Several attempts have been made to solve this problem and even though some attempts have been partially successful, there are still no products that completely solve this problem.
    [006] One reason this is so difficult to resolve is the fact that people's stomas and anatomies are very different. Different considerations need to be made for thin people as well as for larger people, for different skin types, for stoma placement that can vary greatly from person to person, for scar tissue surrounding the stoma, for local irregular skin topography and combinations of all the ones described above.
    [007] Particularly in relation to people who suffer from hernia, that is, the phenomenon that a body structure (for example, the intestine) projects through a rupture in smooth muscle tissue that surrounds it, experience shows that it is often It is very difficult to attach an ostomy device to the surface of the skin where the hernia is located in a way that provides satisfactory protection against leakage of stomach fluids. It is not uncommon that the surgical procedure undertaken to make a stoma in a patient also results in a weakening of the muscle tissue of the stomach wall which can consequently lead to the formation of a hernia where the stoma is located on the skin surface (either near or adjacent to or adjacent to it). to the stoma).
    [008] In some cases where the stoma is located in a hernia, further complication may occur as gravity forces the protruding intestines downward and consequently also forces the involved skin surface downward. Thus, a stoma located pc jfitpkc rqfg eqog>ct c “crqpVct” rctc dckzq *ie towards the user's foot) depriving the user of direct visual contact with the stoma and/or the peristomal skin surface. This is, of course, a big disadvantage for users who apply their product to themselves (which is the vast majority of users) as the risk of misalignment or improper positioning of the product is vastly increased. As a result, in such cases, leakage problems can occur much more frequently.
    [009] Furthermore, a hernia is not a static phenomenon. It almost certainly never takes a perfect geometric shape, but instead it generally has a highly irregular topography. This can be caused by many factors such as conditions in the user's physical surroundings, user activity level and bowel content at any given time, just to mention a few.
    [0010] In addition to hernia formation, other physical conditions or pathologies can also signify or lead to irregular skin topography such as bumps or otherwise stomach skin surface “cekfgpVcfc”, cu ecwucu kpenwgo. rqt gzgornq. Vtcwoc glqw qdgukfcfgo DESCRIPTION OF RELATED TECHNIQUE
    [0011] EP1178766 discloses a deformable pad for releasably securing an ostomy bag to a patient's skin consisting essentially of a plastic film bonded to an adhesive material; the pillow having an opening for receiving stomach waste, wherein the opening is surrounded by (i) a pliable connected formation of substantially uniform thickness on a body side face of the pillow or (ii) a hollow frustoconical ring of substantially uniform thickness extends outward from one side of the cushion's body side.
    [0012] The document GB2311467 describes an ostomy equipment comprising a bag and an adhesive flange coupled to the bag for securing the equipment to a user's skin. The adhesive flange has a slit that communicates with an interior of the bag and comprises a plurality of fingers extending in the opposite direction of the slit. The document also describes an adhesive flange for an ostomy device. SUMMARY OF THE INVENTION
    [0013] The present invention provides a base plate to be used as part of or with an ostomy apparatus. In particular, the invention provides one or more sections that have a shape that can be adapted or physically changed from one shape to another in order to both help the user to apply the baseplate in an easier way and to achieve a better fit to the body. The baseplate is especially advantageous for use on users who suffer from and have their stoma located on a non-flat, non-regular skin surface. BRIEF DESCRIPTION OF THE DRAWINGS
    [0014] Figure 1a is a schematic sectional view of an ostomy baseplate according to embodiments of the invention, Figure 1b is a schematic sectional view of an ostomy baseplate according to other embodiments of the invention, Figure 2 is a schematic sectional view of an ostomy baseplate according to embodiments of the invention placed on the skin surface of a user, Figures 3 to 5 are schematic sectional views of an ostomy baseplate according to the introduced embodiments. in Figure 2 shown at different stages of the application procedure, Figure 6 is a simplified schematic sectional view of a baseplate configuration in accordance with embodiments of the invention, and Figure 7 is a schematic plan top view of a distal surface of a adaptable ostomy base plate according to embodiments of the invention. DETAILED DESCRIPTION OF THE INVENTION
    [0015] For interpretations in the context of the present application, some definitions in relation to the subject matter of the appended claims are set forth below.
    [0016] By reference to the proximal side of a device or part of a device, the indication is the side facing the skin when the ostomy equipment is worn by a user. Likewise, when referring to the distal side of a device or part of a device, the indication is for the side facing away from the skin when the ostomy equipment is put on by a user. In other words, the proximal side is the side closest to the user when the equipment is fitted to a user and the distal side is the opposite side - the side farthest from the user in use.
    [0017] The axial, or axially, direction is defined as the direction of the stoma when the equipment is worn by a user. In this way, the axial direction is substantially perpendicular to the user's abdominal surface.
    [0018] The radial direction, or radially, is defined as transverse to the axial direction which is transverse to the direction of the stoma.
    [0019] Woc "plcec dcug fg quVqokc cfcrVáxgn" ug fguVkpc c fghrnkt that at least a portion of the ostomy base plate can change its shape or shape by an anticipated interaction of a user or healthcare professional.
    [0020] Woc "rgníewnc fg vqrq flgzíxgn" ug fguVkpc c fghrnkt wo film material that carries or has disposed thereon, adhesive material to make the product adhere to a user's skin and that the top film material does not break or break weaken even at very high rates of enlargement or elongation. A flexible top film is further defined below.
    [0021] Wo "cfgukxq gnáuVkeq swg p"q citkfg c rgng" ug fguVkpc c define an adhesive material that has a low risk of irritating a user's skin and that the adhesive material is able to follow the stretching and relaxation of the skin. flexible top without breaking or substantially changing characteristics. An elastic adhesive that does not harm the skin is further defined below.
    [0022] Wo “fotocVq uwduVcpekcnogpVg eqpxgzq” ug fguVkpc c fgfmkt that an element or its corresponding surface has a shape or shape that provides a general convexity. In other words, although a smaller section or zone forms part of the overall element or its corresponding surface may have, for example, a linear shape or shape, the element or surface as a whole has a convex shape. Of course, it should be understood that if for a blade- or plate-like element a larger surface has a convex shape, the opposite larger surface may necessarily have a corresponding concave shape. However, for clarification purposes only, and in relation to the present application, “eqpxgzq” rqfg rtgfètgpekclogpVg ug tgfetkt cq ncfq rtqzkocn g “e»pecxq” cq distal side as defined above.
    [0023] Fg oqfq ukoklct. wo “hqtocvq uwduvcpekclogpvg e»pecxq” ug is intended to define that an element or its corresponding surface has a shape or shape that provides a general concavity.
    [0024] Q "gpicvg kpkekcl" ug fguvkpc c fghkpkt q rtkogktq eqpvcvq gpvtg the ostomy base plate and the user's skin surface in the process in which the product is applied; however, it does not mean that the ostomy base plate is fully and functionally fixed to the skin surface.
    [0025] Q “gPicVg rgtocpgpVg” ug fguVkpc a fgfmkt q gPicVg qw fizc>«q of the ostomy base plate when the application process is complete and the ostomy base plate is fully and functionally fixed to the skin surface. However, it should be understood that permanent engagement is only intended to mean the normal lifetime - or wear time of the ostomy baseplate.
    [0026] Q “fbttq fg nkdgtc>«q” ug fguVkpc c fgfmkt wo hqttq swg eqdtg the proximal side (in contact with the skin) of the adhesive that does not harm the skin which guarantees at least that the properties of the adhesive are preserved and that the adhesive surface is not left open until just before use.
    [0027] “GPicVct fg oqfq cfgswcfq” ug fguVkpc c fgfmkt swg c fizc>«q between the ostomy base plate and the skin surface is as good as possibly feasible and at least with no or only insignificant creases or folds on the proximal surface of the base plate.
    [0028] C "uwrgtfiekg fg rgng rgtkguVqocn" ug fguVkpc c fgfmkt wc area of the skin surface adjacent to and surrounding the stoma. The extent of the area can be considered to roughly correspond to an area of skin surface covered by at least a first section of the ostomy base plate - the first section, then, is closer to the stoma than a second section.
    [0029] "Kpxgrtíxgn" ug fguVkpc c fgfipkt swg c rgnq ogpqu rtkogktce/or second section provides little or no resistance to being shifted from a substantially convex shape to a substantially concave shape, or vice versa, by a movement that does not involve switching tgrgpVkpc qw “xktcfc” fc ug>«q *kuVq fi, eqpfotog fi ucdkfq fg woc eqpuVtw>«q bistable which can change shape when a certain threshold force is reached).
    [0030] In a first aspect, the invention relates to an adaptable ostomy base plate comprising a flexible top film and having at least a first and a second section, at least a first elastic non-skin adhesive in a proximal surface of said flexible top film, a stoma-receiving through hole in said first section, wherein said first section is adjacent to and extending radially from said through hole and said second section surrounding said first section , and one or more release liners, wherein at least said first section has a first substantially convex shape for initial engagement with a peristomal skin surface, wherein at least said first section is reversible to a first substantially concave shape for engagement. suitably said first section to a topography of the peristomal skin surface for permanent engagement therewith.
    [0031] By the invention, according to the first aspect, several advantageous effects are achieved. First, a user who has a stoma located on a bulge or hernia, or on an rgng surface fg Vqrqitchkc fg qwVtq oqfq “ceifgpVcfc”. cwogpVqw q eqpVtqng fq product application procedure.
    [0032] This effect is at least partially achieved as follows: subsequent to the removal of at least one release liner that at least partially covers the first section, the user engages a portion of the first section immediately adjacent to the through hole that receives stoma with the peristomal skin surface, therethrough only a small area of the adhesive on the proximal surface of the flexible top film is engaged to the peristomal skin surface.
    [0033] In this way, the user is provided with the opportunity to correct the positioning of the ostomy base plate to a more suitable position in the event of misalignment of the initial engagement without having engaged the entire proximal adhesive surface of the flexible top film with the surface of skin. This can be particularly advantageous in cases where the user does not have visual contact with the stoma, or where it is limited.
    [0034] In addition, since at least the first section has a substantially convex first shape, a user who descends to the stoma located in the bulge or hernia in order to apply the product will have improved visual and/or tactile contact with the stoma and /or the peristomal area. This is due to the fact that the first section part does not initially engage and the peristomal skin surfaces extend in the opposite direction from the skin surface, thus leaving some space between the base plate and the skin making room for one or more user's fingers and, therefore, the first section also does not block or prevent possible eye contact for correct positioning of the base plate in relation to the stoma.
    [0035] Once the initial engagement of the first section is effected, the first invertible section is inverted by the user to a first substantially concave shape so as to properly engage the first section with the peristomal skin surface on the protuberance or hernia.
    [0036] It is important to understand the way in which this is done. Due to the flexibility of the flexible top film and the elasticity of the skin-friendly adhesive, the adhesive proximal side of the first section will smoothly conform to the topography of the peristomal skin surface when the user applies gentle pressure to the distal surface of the first section.
    [0037] This can advantageously, but not exclusively, be done by the user letting their finger or fingers describe one or more radial movements by placing the finger(s) immediately adjacent to the stoma, providing pressure to the distal surface, and gently sliding the finger on the distal surface of the first section radially away from the stoma. Alternatively, adaptation can be accomplished by a movement that places a finger immediately adjacent to the stoma, providing pressure to the uwrgtfiekg fkuVcn. g fgunkzcpfq q fgfq igntüogntg go wo rcft«q “ugognjcntg cq gurktd” itcfwdogntg nc fktg>«q qrquVc fq guVqoc uqdtg Vqfc c uwrgtfie the distal first section.
    [0038] However, regardless of the manner of adaptation, at least the flexibility of the flexible top film and the elasticity of the skin-friendly adhesive along with the first substantially convex shape of the first section make proper engagement of the first section possible.
    [0039] As can be understood from the above, the flexible top film and the non-aggressive elastic adhesive facilitates the inversion of the first section for application to the peristomal skin surface by a continuous regular movement (or movements). This gives a user improved control of the application procedure. This should be seen in contrast to a sudden movement which might be the case, for example, in the case of a bistable construction, that is, a construction that has a predetermined position where it changes shape from one shape to another, for example, from convex to concave.
    [0040] The flexible top film according to the invention can be a blown film primarily based on one or more Ethyl Vinyl Acetate (EVA) materials, one or more materials based on elastomeric thermoplastic polyurethane (TPU) and one or more more polyethylene (PE) materials. Particularly, but not exclusively, EVA and TPU based materials can provide a good base for engaging the top film with other ostomy baseplate elements such as adhesive(s) and optional first coupling means, or in the case of the base plate which is used for a one-piece ostomy equipment, with the material from the collection bag for human body waste. The PE material(s) may particularly, but not exclusively, provide a suitable base for shaping the flexible top film into a convex or concave shape to be able to properly engage with a topography of a user skin surface.
    [0041] In embodiments, the flexible top film is a three-layer laminate.
    [0042] Particularly, but not exclusively, flexible top film can be produced as a laminate comprising three individual (blown) layers each of which is produced either from EVA, TPU or PE or a combination thereof. In the three-layer laminate, the most distal layer (in reference to the usage situation of the ostomy base plate) can be produced from a combination of Elvax® 3190, an EVA material from DuPont and Orevac® 18360, a PE material from Arkema; the intermediate layer can be produced from a combination of Elvax® 3190, Elastollan® 890, a TPU Polyester material from BASF and Elastollan® 978, another TPU Polyester material from BASF and; the proximal layer can also be produced from a combination of Elvax® 3190, Elastollan® 890 and Elastollan® 978. In addition to these components, each of the distal and proximal layer of the three-layer laminate may also comprise a smaller amount of agent (to assist when unrolling the top film material for producing the ostomy base plate). The slip agent can be a PE/EVA polymer carrier that contains silica, oleostarch (oleic acid, fatty acid) and erucamide (omega 9 monounsaturated fatty acid), such as Polystatic® 90200-2. The silica and ole-/erucamides in the slip agent provide the slip effect.
    [0043] The overall thickness of the flexible top film can be in a range of 30 to 70μ, such as 35 to 50μ, such as approximately 40μ. In three-layer laminate embodiments, each individual layer can have a thickness of at least 10µ to facilitate the production of the individual layers.
    [0044] The flexible top film can be stretched before being used in the production of the ostomy base plate. This will provide a pre-strain or skew in the flexible top film. The flexible top film can be stretched radially in all directions to obtain the same slope in all directions of the plane of the same. This pre-strain or skew in the flexible top film incurs additional flexibility to the flexible top film. In particular, it can enhance the film's ability to adapt to a certain format in a shaping process.
    [0045] The flexible top film may have a flexibility measured as a percentage of elongation of the flexible top material film before it fails (considered as the pointer at which plastic deformation of the flexible top film occurs). Flexible top film can be stretch from 250 to 700%, as stretch from 300 to 600%, as stretch from 350 to 450%, as stretch from 400% before failing.
    [0046] The first skin-friendly elastic adhesive according to the invention may be a pressure-sensitive adhesive composition suitable for medical purposes comprising a rubberized elastomeric base and one or more water-swellable or water-soluble hydrocolloids in that the adhesive composition comprises a substantially homogeneous mixture of 25 to 60% of one or more polyisobutylenes, 3-35% one or more styrene copolymers and 20 to 60% of one or more hydrocolloids, wherein the percentage is by weight of one or more polyisobutylenes and one or more copolymers of styrene and one or more hydrocolloids add up to 100% by weight of the adhesive composition. For further information on such compositions reference is made to the applicant's granted European patent EP1541180B1.
    [0047] The thickness of the first layer of elastic adhesive that does not attack the skin can be in a range of 1 to 2 mm, which corresponds to 1000μ to 2000μ, such as 1200μ to 1800μ, such as 1400μ to 1600μ.
    [0048] For the production of the ostomy base plate, the following is a fabrication example: first, the adhesive(s) is/are provided on the proximal surface of the flexible top film and, consequently, the at least one release liner is provided on the adhesive surface. At least the first section of the flat rolled blank block is then subsequently placed in a vacuum forming machine, the forming tool having the relevant convex shape. Heating means such as a radiant heat source are placed in connection with the vacuum forming machine in order to soften the rolled raw block, and the laminated raw block is subjected to vacuum and heat formation for a suitable holding time . Alternatively, the laminated raw block can also be manufactured using a pressure and heat mold or indeed any other suitable procedure.
    [0049] In modalities where the second section of the ostomy base plate also has a convex shape (or concave shape), the modeling tool used in the process described above can be configured to provide both convex shapes (or convex shape of the first section and concave shape of a second section). Alternatively, the forming process can be divided into more steps, for example, first forming the first section and separately forming a second section. The through hole that receives the stoma can be cut in the ostomy base plate before or after the forming process.
    [0050] Due to its elasticity, the first adhesive that does not attack the skin can easily adapt to the convex shape of the at least first section along with the flexible top film and the at least one release liner in the forming process. In fact, subjected to the forming process described above, at least the first section of the ostomy base plate according to the invention initially always has a convex shape despite its high degree of adaptability. As mentioned, this can be seen in contrast to, for example, known bistable convex ostomy products that are relatively rigid and crgpcu cfcrVáxgku go wo ugpVkfq “VcpVq kpxgrtkfqlswcpVq p«q kpxgrtkfq”
    [0051] The at least one release liner used in connection with the ostomy base plate according to the invention may suitably be a silicone or fluorinated liner, such as a siliconized or fluorinated brown paper, polyethylene terephthalate film, polypropylene or polyethylene.
    [0052] In embodiments, a second section has a second substantially convex shape that is reversible to a second substantially concave shape.
    [0053] This can be particularly advantageous to further improve eye and/or tactile contact with the stoma and/or the peristomal area. In such embodiments, where then both the first and second sections initially extend away from the skin surface, there will be additional space between the baseplate and the skin giving plenty of room for the user's manual handling of the baseplate during application. . Furthermore, through this, a second section does not block or impede the user's visual tale with the stoma.
    [0054] The second section may be inverted and permanently engaged to the user's skin surface in the same or substantially similar manner as the first section and as described above. Engaging a second section to the skin surface is generally performed after the first section is permanently engaged with the peristomal skin surface. However, in the case of a two-piece ostomy apparatus, it may be advantageous to engage a second section to the user's skin surface only after the collection bag is attached to correctly engage with the ostomy base plate.
    [0055] The second section involves the first section of the adaptive ostomy base plate. In modalities, a transition between a first and a second section can be defined by a zone where the two convex sections meet each other at an angle.
    [0056] This can be particularly, but not exclusively advantageous if easy distinction of sections by the user is required, for example facilitating the user to follow instructions for use.
    [0057] In other modalities, the transition can be straight or smooth (ie, no angle between sections) thereby discarding at least any visual difference between sections. If the first and second sections are arranged according to such modalities there can be no difference between the convexity of the first and second sections, thus the first and second sections can be perceived or actually fabricated as a single ug>« q “eqgtgpVg” qw kptgitcL Kuuq rqfg ugt rcttkewnctogpVg tgngxcpVg go to minimize production costs.
    [0058] Additionally, however, the first and second sections may have different convexities. This may, by way of example, be relevant in relation to different dimensions and/or sizes of the ostomy base plate.
    [0059] In embodiments, the second section has a second substantially concave shape. This should be seen in contrast to the modalities described above where a second section is invertible to a second substantially concave shape. Therefore, in these modalities, a second section has a predefined substantially concave shape. A transition between the first and second sections is defined by a zone where the two sections meet each other at an angle. Consequently, the initial substantially convex shape of the first section causes the first section to extend away from the skin surface, while the substantially concave shape of a second section causes a second section to extend towards the skin surface from the position of the transition between. the sections.
    [0060] This may be particularly but not exclusively advantageous in that the adaptable ostomy base plate according to the invention is used in a two-piece ostomy apparatus with adhesive-type coupling means. In such two-piece equipment, a flat coupling flange is typically attached to the distal side of the baseplate and receives snap-on coupling means (pressure sensitive adhesive) attached around the opening of a collection bag for human bodily waste. Optimizing the coupling effect of this adhesive-type coupling means requires the user to be able to apply the necessary pressure to properly engage the adhesive. In this regard, it is particularly advantageous if the user can apply pressure to a distal side of the coupling (eg, with their index finger), while simultaneously clamping against the proximal side of the coupling (eg, with their thumb). Therefore, as the concave shape of a second section in accordance with these embodiments of the invention allows more space between the proximal side of the flat mating flange and the distal side of a second section, the user can more easily apply, for example, his thumb. in that space that effectively improves the coupling procedure.
    [0061] In embodiments, the ostomy base plate according to the invention further comprises a substantially flat surface zone between said first and second sections.
    [0062] “flat UwduVciekclogpVg” ug fguVkpc c fgfmkt swg woc zqpc fg ostomy base plate surface has a linear or flat shape close to parallel with a straight horizontal line; at least it is not slanted relative to such a horizontal line by more than +/- 10 degrees. At least this definition is intended to clearly identify that the surface zone does not have any kind of convex or concave shape in contrast to the first and second sections.
    [0063] The substantially flat surface zone between the sections can provide extra control over the user's handling of the product in the application procedure and can additionally make it difficult for the first and/or second sections to become obstructive in, for example, the distal or proximal direction to, for example, the wearer's clothing or to other objects or other physical contact areas on the wearer's body. This can be particularly, but not exclusively, effective if a relatively large adhesive area of the ostomy base plate is required (eg for high-volume outlet collection bags).
    [0064] The substantially flat surface zone may form at least part of a first transition between the first section and the zone and/or form at least part of a second transition between a second section and the zone.
    [0065] In embodiments, the substantially flat surface zone distally accommodates first coupling means for engaging engagement with corresponding coupling means in a collection pouch for human body waste.
    [0066] The first coupling means may comprise an annular ring having a flange or similar member extending axially in the opposite direction from the flat surface area to engage with second engagement coupling means in a collection pocket such as a corresponding annular ring with a channel to receive the flange. Alternatively, the first coupling means may comprise a radially extending annular flange that provides a receiving surface for receiving the second coupling means in a collection pocket as an annular flange adhesive. However, these are merely examples of a typical coupling medium for ostomy equipment; other types of hitch coupling means are not to be considered excluded.
    [0067] The first coupling means may be attached to the substantially flat surface by welding, heat lamination, bonding or other commonly known suitable joining procedures. In some cases, the first coupling means need not be directly joined to the surface, but may instead be joined by means of an additional intermediate element, such as an element of film material connected to the substantially flat surface at one end. and to the first coupling means at the other end.
    [0068] Accommodating the first coupling means in the first area of substantially flat surface, a user facing the same applies the collection bag to the base plate engaging the first and second coupling means that can be provided with the possibility of holding your thumb against the substantially flat surface zone closely while applying pressure with your index finger on the distal side of the coupling means. This is advantageous to achieve a more complete and safer engagement of the coupling means thus leading to a reduced risk of leakage. Furthermore, by accommodating the first coupling means in the region of substantially flat surface, the joining of the first coupling means to the zone is easier and, thereby, production costs are reduced.
    [0069] In other embodiments, the first or second section distally comprises first coupling means for engagement with corresponding coupling means in a collection pouch for human body waste.
    [0070] In these embodiments, the first coupling means can be provided both in the first and in the second section. However, this does not rule out the presence of a possible substantially flat surface zone between the first and second section. Positioning the first coupling means in the first section can be particularly advantageous if the proximal adhesive surface of the ostomy base plate is relatively small, for example in the absence of a suitable adhesive skin receiving surface due to additional physical conditions on the skin surface of user. A position of the first coupling means in the second section may, for example, be advantageous in the case of a large diameter stoma situated on a relatively small bulge or hernia.
    [0071] In embodiments, the adaptable ostomy base plate comprises a second skin-friendly adhesive on the proximal surface of the flexible top film.
    [0072] The second non-skin adhesive can be provided to provide the proximal surface of the baseplate with different characteristics or effects. As an example, the second non-skin adhesive may comprise a greater or lesser amount of a moisture absorbing component such as hydrocolloids and/or be more or less adaptable than the first non-skin adhesive. The second skin-friendly patch can be delivered in a single or multiple zones or areas. The zones or areas may have particular suitable shapes or shapes depending on the function or effect of the second non-aggressive adhesive.
    [0073] In embodiments, the first elastic non-skin adhesive is provided in the first section and the second non-skin adhesive is provided in the second section.
    [0074] This arrangement of the first and second non-skin adhesive effectively provides an ostomy baseplate in which the first non-skin adhesive has a set of characteristics that covers the peristomal area and the second non-skin adhesive the skin that has another set of characteristics that cover the skin surface around (radially beyond) the peristomal skin surface.
    [0075] In modalities, the second adhesive that does not attack the skin is elastic. This means that in addition to the first elastic adhesive that does not harm the skin, the second adhesive that does not harm the skin also has elastic properties. The second non-skin adhesive can be more or less elastic than the first non-skin elastic adhesive, or the two adhesives can even have identical elasticities if desired.
    [0076] In places where the elasticity of a construction is typically measured by the Modulus of Elasticity of Stress (E) (also known as the Young's Modulus) the elasticity of an adhesive is typically measured by the Modulus of Shear (G).
    [0077] The Shear Modulus of a visco-elastic adhesive-like material can be divided into a viscous part called Modwnq fg Rgtfc *G''+ g woc rcrtg fg gnáuVkeq ejcocfc fg q O„fwnq fg CtoczgpcogpVq *ff+ o C tgurquVc gnáuVkec fqu cfgukxqu rqfg, rqrtcpVq, ugt measure by measuring-ug G' rqt cpánkug ogeâpkec fkpâokec *FMC+, swg fi wo Established and well-known procedure for a knowledgeable person working in the field of adhesives.
    [0078] Body movements, in accordance with normal daily living routines, typically occur at a frequency of about 1 to 10Hz. Pguucu htgswepekcu, q G’ fq rtkogktq cfgukxq gnáuVkeq swg p«q citkfg c rgng podg guvct go wc hckzc fg :72 and 3422 ORc. gpswcpvq swg I’ fq ugiwpfq skin-friendly, elastic adhesive may be in a range of 40 to 80 MPa.
    [0079] In embodiments, the second non-skin elastic adhesive comprises a polar plasticity oil or a combination of polar plasticity oils in content of above 10% (w/w) of the second final adhesive, and at least one polar polyethylene copolymer, where the polyethylene copolymer content is 10 to 50% (w/w) of the second final adhesive, the polyethylene copolymer has a melt flow index below 2 g/10min (190°C /21.1N).
    [0080] The polymers that can be used for the second non-skin adhesive would generally be copolymers of ethylene and a polar monomer. Copolymers typically comprise less than about 70% ethylene, have water vapor transmission of more than 50 g/m2/day and a melt flow index of less than 2 g/10min (190°C/21.1N ). The melt flow index can be measured by the methods given in ISO 1133 and ASTM D1238. Examples of such polymers are copolymers of ethylene and vinyl acetate and copolymers of ethylene and butyl acrylate. Particularly preferred are copolymers of ethylene and vinyl acetate with greater than about 40% (w/w) vinyl acetate, a melt flow index of less than 2 g/10min (190°C/21.1N) and a water vapor transmission of more than 50 g/nf/day for a 150 µm slide when measured according to the MVTR Test Method (inverted cup method).
    [0081] Polar oils, which can be used in the invention, will generally be those that have good solubility in the polar domains of the polymer, that is, they provide softness without sacrificing too much tensile strength of the polymer. Oils that can sustain good water vapor permeability are preferred. Examples of such oils are vegetable and animal oils and derivatives thereof. Preferred polar oils are esters, ethers and glycols and particularly preferred is Polypropylene Oxide, for example alpha-butoxy-polyoxypropylene.
    [0082] Additional information on the types of adhesives suitable for the second non-skin adhesive disclosed in these embodiments is available in applicant's published application no. WO 2009/006901 A1.
    [0083] In modalities, the thickness of the second elastic adhesive that does not harm the skin is 300 to 700μ, such as 550 to 650μ, such as 600μ.
    [0084] Particularly, when the polyethylene copolymer defined above based on adhesive is used as the second elastic adhesive in the thickness of 300 to 700μ, a flexible and soft adhesive baseplate that can be handled without a rigid or stabilized layer is achieved. For further information on thickness range combination and the defined polyethylene copolymer, reference is made to applicant's published application in WO 2012/022352A1.
    [0085] In embodiments, at least the second section further comprises a reinforcing element. Thus, the second section may be easier to handle due to the fact that it is at least partially stiffened or stabilized by the reinforcing element. Particularly, in the case of a relatively large (diameter) ostomy base plate according to the invention this can help the user to control the product. By way of example, the reinforcing element may be a perforated or permeable film layer such as a blown film, but also includes foamed or non-woven film layers. The reinforcing element may be incorporated into the second non-skin adhesive or located between the distal surface of the adhesive and the proximal surface of the flexible top film. DETAILED DESCRIPTION OF THE DRAWINGS
    [0086] Initially, it should be noted that the Figures are schematic illustrations that are intended only to address the principles and functions of the base plate according to the invention and should not be considered limiting the scope of the appended claims. Furthermore, the Figures and particularly the individually illustrated elements are not necessarily to scale, neither individually nor in relation to each other.
    [0087] Figure 1a shows a schematic sectional view of an adaptable ostomy base plate 10 according to embodiments of the invention. The baseplate has a first section 1 and a second section 2a and is additionally shown with an optional substantially flat surface zone 3 between the first 1 and second 2nd sections. The first 1 and second 2nd sections are substantially convex in shape. Firstly, transition 5 between the first 1 and the second 2nd sections is also indicated. The ostomy base plate 10 comprises a flexible top film 8 having disposed thereon at least one first elastic, non-skin adhesive 6. Until use, the ostomy base plate 10 additionally comprises at least one release liner 9 (Figure 6) on at least the first sticker. The ostomy base plate 10 may optionally further comprise at least one second non-skin adhesive 7 (Figure 1b) disposed on the flexible top film 8. A stoma-receiving through hole 4 is also illustrated. Finally, the first coupling means 20 for engagement with the second coupling means in a collection pouch for human body waste.
    [0088] Figure 1b also shows a schematic sectional view of an adaptable ostomy base plate 10 in accordance with alternative embodiments of the invention. The base plate 10 has a first section 1 of convex shape and a second section 2b of concave shape. The configuration of the base plate 10 in accordance with these embodiments is particularly useful when the first coupling means for engagement with second coupling means in a collection bag for human body waste is a flat flange 30, as shown in the Figure. This provides space for a user to place a finger between the distal surface 11 (Figure 2) of the ostomy base plate 10 and the proximal side 13 of the flat flange 30 so as to press the second coupling means into the collection bag (like a adhesive flange) attached to the flat flange 30.
    [0089] Figure 2 is another schematic sectional view showing an ostomy base plate 10 in an initial position in the procedure in which you apply the base plate 10 to a user's skin surface 16. After removing one or more liners that cover at least the first section 1, the first section 1 is brought into initial engagement with the peristomal skin surface 17 surrounding a stoma S. As can be understood from Figure 2, the convex shape of the first 1 and the second 2nd sections of these embodiments keep a major portion of the proximal surface 12 of the base plate 10 out of contact with the skin surface 16,17 which aids the user in the application procedure as the focus need only be on the first section. Additionally, as it is initially only the innermost part of the first section 1 immediately adjacent to the stoma S that is in adhesive contact with the peristomal skin surface 17, the user is provided with a possibility to adjust or correct the position of the base plate 10 before to apply on a larger adhesive area. Furthermore, the ostomy base plate 10 is shown in position on a bulge or hernia 15 on the wearer's skin surface 16. Due to the convex shape of at least the first section 1, the ostomy base plate 10 according to the invention it is particularly suitable for users suffering from hernia.
    [0090] Figure 3 is another schematic sectional view showing the ostomy base plate 10 in a next step of the application procedure. Part of the first section 1 was permanently engaged with the peristomal skin surface 17 (Figure 2) by a user applying pressure to the distal surface 11 with one or more fingers F. A remaining part of the first section 1 and a second section 2a, both substantially convex in shape, they have not yet been engaged with the skin surface 16. As indicated, at least a second section 2a may have disposed a second skin-friendly adhesive 7 thereon. In addition, although not shown in Figure 3, a second section 2a may have at least one release liner (separate from the release liner(s) in the first section 1) that covers at least part of a second section 2a. As can be understood from Figure 3 at least, in the application procedure it can be an advantage to keep the release liner(s) in the second section 2a in place until the first section 1 has been completely and permanently engaged with the peristomal skin surface 17.
    [0091] Figure 4 is another schematic sectional view showing the ostomy base plate 10 in a next step of the application procedure. In this Figure, only a last part of a second section 2a remains not engaged with the skin surface 16.
    [0092] In Figure 5 which, again, is another schematic cross-sectional view showing the ostomy base plate 10 that is completely and correctly applied to the skin surface 16 of a user. Thereby, the first section 1 is permanently engaged with the peristomal skin surface 17 and the second section 2 is permanently engaged with the skin enveloping surface 16. As can be seen from Figure 5, the adaptive ostomy base plate 10 according to the invention thereby suitably engages the skin surface on the protuberance or hernia 15. The shown first coupling means (optional) 20 is ready for engagement with the corresponding second coupling means in a collection pocket in the case of a two-piece deployment of the invention.
    [0093] Figure 6 is a simple schematic sectional view of a cutout of the adaptive ostomy base plate 10. The cutout is not shown with a convex shape, but it should be understood that this may even be the case depending on the width of the cutout considered. The base plate 10 has a flexible top film 8, a non-skin adhesive layer 6 and a release liner 9. The relative thicknesses between the different layers are only shown to differentiate the layers from each other and should not be considered an actual display of any related thicknesses.
    [0094] Figure 7 is a schematic top plan view of the distal surface 11 of the adaptive ostomy base plate 10. The base plate 10 is shown with a circular configuration, but can also be applied with an elliptical or oval configuration. A second section 2 and a first section 1 are illustrated. The first section 1 is shown housing the first coupling means 20 in the form of an annular ring for engagement with corresponding coupling means in a collection pocket (not shown). A transition 5 between the first 1 and the second section 2 is shown highlighted by circular line 14, however the transition 5 is not necessarily visible not actually, at least not on the distal surface 11 of the base plate 10. EXAMPLE
    [0095] In a particular example of the adaptable ostomy base plate according to the invention, which can be further understood by referring to the drawing, particularly Figures 6 and 7, the following materials, dimensions and process parameters are applied:
    [0096] Flexible top film is an unstretched three-layer laminate in which the most distal layer is a combination of Elvax® 3190 and Orevac® 18360; the intermediate layer is a combination of Elvax® 3190, Elastollan® 890 and Elastollan® 978; the proximal layer is a combination of Elvax® 3190, Elastollan® 890 and Elastollan® 978. The distal and proximal layers additionally comprise a smaller amount of slip agent according to the invention. The thickness of the flexible top film is 40μ.
    [0097] A first skin-friendly, elastic adhesive in accordance with the invention is provided on the proximal surface of the flexible top film in an area or zone that corresponds to the first section of the base plate (number 1 in Figure 7). The thickness of the first skin-friendly elastic adhesive is approximately 1600μ (subject to negligible production variations).
    [0098] A second non-skin adhesive is chosen as an elastic non-skin adhesive in accordance with embodiments of the invention, and is provided on the proximal surface of the flexible top film in an area or zone corresponding to a second baseplate section (key 2 in Figure 7). The second section voids the first section of the base plate. The thickness of the second skin-friendly elastic adhesive is approximately 600μ (subject to negligible production variations).
    [0099] A single release liner according to the invention is provided on the proximal adhesive surface of the base plate. The release liner has a thickness of 80μ.
    [00100] In the example, both the first and second sections have a substantially convex shape. To obtain the substantially convex shapes, a raw ostomy baseplate block (flexible top film + adhesives + release liner) as defined in this example is preheated to 150 °C for 28 seconds and then formed in a forming machine vacuum with a modeling tool provided with two respectively convex sections. The depth of the convexities in the forming tool is 12 mm. A predefined stoma that receives a through hole (size, for example, 025 mm) is drilled into the raw ostomy base plate block after vacuum forming.
    [00101] In the example, the ostomy base plate has a circular configuration with an overall diameter of 0100 mm. The base plate allows the user the opportunity to adapt the predefined stoma that receives a through hole to adjust the size and shape of their individual stoma up to a maximum diameter of 053 mm (in Figure 7 this can be considered illustrated by number 4).
    [00102] The second section 2 of the baseplate 10, which voids the first section (see Figure 7), is at least 10mm wide. Furthermore, in the example (and as schematically illustrated in Figure 7), the first section 1 extends at least 10 mm radially beyond a radially outer periphery of the first coupling means in the form of an annular ring 20. The portion of the first section 1 extends radially into the first coupling means 20 depending on the hole receiving stoma 4 user-adapted as described above.
    权利要求:
    Claims (15)
    [0001]
    1. Adaptable ostomy base plate (10) comprising a flexible top film (8) and having at least a first (1) and a second section (2a), at least one first elastic adhesive (6) that does not attack the skin on a proximal surface of said flexible top film (8), a through hole (4) receiving stoma in said first section (1), said first section (1) adjacent to and extending radially from the said through hole (4) and said second section (2a) surrounding said first section (1), and one or more release liners (9), wherein at least said first section (1) may be reversed to a first substantially concave shape, and characterized in that said second section (2a) has a second substantially convex shape which can be inverted to a second substantially concave shape.
    [0002]
    2. Adaptable ostomy base plate according to claim 1, characterized in that it further comprises a substantially flat surface zone (3) between said first (1) and second sections (2a).
    [0003]
    3. Adaptable ostomy base plate according to claim 2, characterized in that said substantially flat surface area (3) distally accommodates first coupling means (20) for coupling by coupling corresponding coupling means in a collection bag for human body waste.
    [0004]
    4. Adaptable ostomy base plate according to any one of claims 1 to 3, characterized in that said first (1) or second section (2a) comprises, distally, first coupling means (20) for engagement with corresponding coupling means in a collection bag for human body waste.
    [0005]
    5. Adaptable ostomy base plate according to any one of claims 1 to 4, characterized in that it comprises a second skin-friendly adhesive (7) on said proximal surface of said flexible top film (8).
    [0006]
    6. Adaptable ostomy base plate according to claim 5, characterized in that the first elastic adhesive (6) that does not harm the skin is provided in the first section (1), and the second adhesive that does not harm the skin ( 7) is given in the second section (2a).
    [0007]
    7. Adaptable ostomy base plate according to claim 5 or 6, characterized in that the second adhesive that does not harm the skin (7) is elastic.
    [0008]
    8. Adaptable ostomy base plate according to any one of claims 5 to 7, characterized in that said second elastic adhesive that does not attack the skin (7) comprises a polar plasticizer oil or a combination of polar plasticizer oils in the content greater than 10% (w/w) of the second final adhesive (7), and at least one polar polyethylene copolymer, wherein the polyethylene copolymer content is 10 to 50% (w/w) of the second final adhesive ( 7), the polyethylene copolymer having a melt flow index of less than 2 g/10 min (190°C/21.1 N).
    [0009]
    9. Adaptable ostomy base plate according to any one of claims 5 to 8, characterized in that a thickness of the second elastic adhesive that does not attack the skin (7) is from 300 to 700 μ.
    [0010]
    10. Adaptable ostomy base plate according to any one of claims 1 to 9, characterized in that at least said second section (2a) additionally comprises a reinforcement element.
    [0011]
    11. Adaptable ostomy base plate according to any one of claims 1 to 10, characterized in that the flexible top film (8) is a three-layer laminate.
    [0012]
    12. Adaptive ostomy base plate according to claim 11, characterized in that the flexible top film (8) is extensible before failing to a measure between 400 and 700%.
    [0013]
    13. Adaptive ostomy base plate according to any one of claims 1 to 12, characterized in that a transition between the first (1) and the second section (2a) is defined by a zone in which the two sections are convex (1, 2a) are at an angle to each other.
    [0014]
    14. Adaptable ostomy baseplate according to any one of claims 1 to 12, characterized in that the first (1) and second section (2a) are manufactured as a single integral convex section with a smooth transition and without difference between a convexity of the first section (1) and a convexity of the second section (2a).
    [0015]
    15. Adaptive ostomy base plate according to claim 1, characterized in that a convexity of the first section (1) is different from a convexity of the second section (2a).
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    同族专利:
    公开号 | 公开日
    ES2636623T3|2017-10-06|
    EP3238671B1|2020-09-02|
    WO2014086369A1|2014-06-12|
    JP2016500281A|2016-01-12|
    DK2928421T3|2017-09-18|
    BR112015012979A2|2017-07-11|
    AU2013354536B2|2017-11-02|
    EP2928421A1|2015-10-14|
    CN104837442B|2017-03-29|
    JP6251283B2|2017-12-20|
    RU2015125683A|2017-01-12|
    ES2709364T3|2019-04-16|
    CN104837442A|2015-08-12|
    EP3238671A1|2017-11-01|
    CA2892770C|2020-10-06|
    CA2892770A1|2014-06-12|
    EP3199131A1|2017-08-02|
    US10893974B2|2021-01-19|
    AU2013354536A1|2015-07-02|
    US20180228641A1|2018-08-16|
    US20150297389A1|2015-10-22|
    HUE035835T2|2018-05-28|
    DK3199131T3|2019-03-18|
    RU2642729C2|2018-01-25|
    EP3199131B1|2018-11-28|
    HUE043066T2|2019-08-28|
    EP2928421B1|2017-05-31|
    US9968480B2|2018-05-15|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-06-15| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-08-31| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/12/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA201270765|2012-12-06|
    DKPA201270765|2012-12-06|
    PCT/DK2013/050412|WO2014086369A1|2012-12-06|2013-12-05|An adaptable ostomy base plate|
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