• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    OSTOMY APPARATUS This is an ostomy device comprising an adhesive wafer for attachment to the body, the wafer comprising a surface facing the skin and a surface not facing the skin, where the surface not facing the skin it is provided with a reinforcement layer, the surface facing the skin of the wafer comprising a central area comprising a substantially non-absorbent protective adhesive, an intermediate area surrounding the central area, wherein said area comprises a substantially soft adhesive non-absorbent and a border area surrounding the intermediate area, said border area comprising a substantially non-absorbent protective adhesive.
    公开号:BR112013013278B1
    申请号:R112013013278-7
    申请日:2011-12-20
    公开日:2020-07-07
    发明作者:Peter Kwok Hing Lam
    申请人:Coloplast A/S；
    IPC主号:
    专利说明:

    1. FIELD OF THE INVENTION
    [001] The invention relates to an ostomy device for attachment to the body and to collect body waste.
    [002] The ostomy devices are usually in the form of a bag to receive the residue, and the bag is connected to an adhesive wafer that can be attached to the patient's skin. The wafer is typically in the form of a reinforcement layer coated on the surface facing the skin with an adhesive layer and in which the wafer is provided with an opening to accommodate the entrance to the body. The size and shape of said opening can often be individually adapted to fit the patient's anatomy.
    [003] One of the crucial parts of such devices is the adhesive wafer. The wafer must have the ability to fit, leak proof, around the entrance to the body, have good adhesion to the skin without involuntary detachment of the skin, but at the same time it must be easy to remove again without damaging the skin. In addition, the wafer must have the ability to follow body movements and be comfortable to use.
    [004] Pressure sensitive adhesives have been used for a long time to connect medical devices, such as ostomy devices (including wound dressings), wound drainage bands, fistula drainage devices, urine collection devices, orthoses and prostheses for skin. Hydrocolloid adhesives are in particular used for ostomy devices.
    [005] Hydrocolloid adhesives contain hydrophilic or absorbent particles, which absorb moisture inside the adhesive volume and transmit moisture when conditions are saturated. However, moisture retention in hydrocolloid adhesives can cause changes in the adhesive, such as swelling, loss of cohesion and disintegration.
    [006] Due to the delicate nature of the skin, there is a narrow band where a pressure sensitive adhesive can work as a good skin-friendly adhesive: On the one hand, the adhesive must have the ability to provide a strong and secure fixation of the device thus avoiding leakage and unintentional detachment of the device, but on the other hand, removing the medical device from the skin must be painless and not cause damage to the skin.
    [007] Conventional pressure sensitive adhesives for collecting devices are usually based on adhesives that flow into the skin. This makes the patch too thick for the skin, but it also means that when the patch is removed; the part of the top layer of the skin or epidermis is peeling, a phenomenon known as skin extraction. 2. DESCRIPTION OF RELATED TECHNIQUE
    [008] Documents No. WO 94 / 15,562 and U.S. 5,051,259 disclose adhesive wafers in which the skin-facing surface comprises at least two different adhesives. The adhesives are preferably hydrocolloid adhesives with different cohesion.
    [009] Thus, there is still a need for an ostomy device with reduced skin extraction, but still with the ability to secure fixation to the skin. SUMMARY OF THE INVENTION
    [0010] The present invention aims to provide an ostomy device, which improves patient comfort by reducing skin extraction and eliminates or reduces, at least in large part, the risk of leakage and unintentional detachment of the device.
    [0011] An object of the invention is to provide an ostomy device with a skin-friendly adhesive that is easy and less painful to be removed from the skin.
    [0012] Another objective of the present invention is to provide an ostomy device that is less sensitive when exposed to moisture. BRIEF DESCRIPTION OF THE DRAWINGS
    [0013] The invention is disclosed in more detail with reference to the drawings in which Figure 1 shows a preferred embodiment of the invention seen from the side facing the skin, Figure 2 shows a embodiment of the invention in cross-section. DETAILED DESCRIPTION OF THE PRESENT INVENTION
    [0014] The invention relates to an ostomy apparatus that comprises an adhesive wafer for attachment to the body, the wafer comprising a central opening to accommodate a surface facing the stoma and one facing the skin and a non-facing surface for the skin, the non-skin surface being provided with a reinforcement layer, where the surface facing the wafer skin comprises a central area comprising a substantially non-absorbent protective adhesive, an intermediate area surrounding the central area, wherein said area comprises a substantially non-absorbent soft adhesive and an edge area surrounding the intermediate area, wherein said edge area comprises a substantially non-absorbent protector.
    [0015] The combination of a resistant protective adhesive on the edge portions and a soft non-damaging skin adhesive in the middle portion of the wafer unites the advantages of both adhesives providing good adhesion and leakage control along the edges together with a minimal amount of skin extraction on the rest of the wafer's adhesive surface.
    [0016] The central area and the border area may be in the form of separate areas or the protective adhesive may overlap the non-skin surface of the soft adhesive. The protective adhesive can thus cover the entire skin-facing surface of the reinforcement layer and the soft adhesive forms a layer that overlaps a portion of the skin-facing surface of the protective adhesive.
    [0017] The use of soft adhesive alone will generally not be sufficient to provide the degree of protection required against aggressive exits, for example, from starlings. The combined use of protector and soft adhesive will reduce the cell extraction effect compared to the use of resistant adhesive alone, but at the same time having the ability to maintain the advantages of the resistant adhesive by providing protection against leakage and effective and safe fixation to the skin.
    [0018] The device of the present invention is soft and comfortable to use, has good adhesive tackiness, but is still easy and smooth to remove and is permeable to moisture, thus overcoming the drawbacks of hydrocolloid adhesive devices. The soft adhesive is resistant to erosion and does not lose its adhesion when exposed to moisture.
    [0019] The device can be removed with minimal pain due to extreme flexibility and less skin cells extracted and thus less trauma to the skin. The soft adhesive has a wide peeling front and good toughness during use. The soft adhesive is resistant to erosion and has a good ability to deal with moisture due to the high permeability of moisture vapor.
    [0020] Through the use of a substantially non-absorbent adhesive, the traditional problems that occur when exposed to moisture such as erosion, the weakening of properties in use due to swelling and disintegration are reduced. The intermediate area facilitates reduced extraction and provides smoothness to the skin. The protective adhesive on the outer edge allows the user time to react if the leak penetrates through the central area and the middle area.
    [0021] The construction of the apparatus according to the invention facilitates delayed leakage along the wafer, leaving time for the user to change the wafer before the leak reaches the outside of the wafer.
    [0022] Because it has a layer of non-absorbent adhesive facing the skin combined with an absorbent layer facing the reinforcement layer it provides a non-harmful fixation to the skin to the skin that has the ability to carry moisture away from the skin and into the absorbent layer.
    [0023] The protective adhesive can be any skin adhesive known by itself, for example, an acrylic adhesive or a hydrogel adhesive. The adhesive material can, for example, comprise synthetic homo, co or block copolymers, polyacrylates and copolymers thereof, polyurethane, silicone, polyisobutylene, polyvinyl ether and natural or synthetic resins or mixtures thereof which optionally contain zinc oxide. The adhesive matrix may additionally contain various additives, such as plasticizers, thickeners and the like, and / or various medications, such as antiseptics, hormones, etc.
    [0024] Particularly preferred would be pressure sensitive adhesives with high peel strength. High detachment force means a detachment force above 2 N / 25 mm in steel, more preferably 3 to 20 N / 25 mm. Detachment force is measured by the approved standard ASTM D6862-04.
    [0025] The soft adhesive in the middle area is a soft adhesive that does not remove the skin.
    [0026] Such a soft adhesive may comprise a cross-linked adhesive, such as silicone, acrylic or polyurethane adhesives. As used herein, a crosslink means a small region in a macromolecule (polymer chain structure) from which more than 2 chains emanate.
    [0027] In a preferred embodiment, the soft adhesive is based on silicone, such as an adhesive composed of chemically cross-linked silicone gel (polydimethylsiloxane gel), for example, a hardening RTV silicone with the addition of 2 components catalyzed by platinum. Examples of gels that can be used are SilGel 612 from Wacker-Chemie GmbH, Burghausen, Germany, MED-6340 from NuSil Technology, DOW CORNING (R) MG 7-9900 SOFT SKIN ADHESIVE.
    [0028] The soft adhesive may comprise a polyalkylene oxide polymer and crosslinked adhesive system based on organosiloxane. The polyalkylene oxide polymer can be polypropylene oxide.
    [0029] The soft adhesive may comprise ethylene vinyl acetate. Examples of such an adhesive are disclosed in WO 2009 / 006.901.
    [0030] A soft adhesive layer means an adhesive with a complex G * module, as defined in this document, of less than 100 kPa measured at 32 ° C and 1 Hz.
    [0031] In a preferred embodiment, the soft adhesive has a G * complex modulus of less than 1 to 30 kPa measured at 32 ° C and 1 Hz.
    [0032] Particularly preferred would be pressure sensitive hydrophobic adhesives with low peel strength. Low detachment force means a detachment force above 0.5 N / 25 mm in steel, more preferably a detachment force of 1 to 10 N / 25 mm.
    [0033] The nature of the soft adhesive used in the present invention differs from the nature of the adhesives that are typically used, for example, hydrocolloid adhesives that are used for ostomy wafers. The significant difference between these adhesives and the soft adhesive used according to the invention is that the soft adhesive is much softer and has a better "wettability", which means more surface contact. This makes it possible for the soft adhesive to have a much lower specific adhesion, that is, lower adhesion per unit of contact surface area.
    [0034] This is the reason why the patient will feel very little pain when the soft patch is removed and removal can be achieved without extracting the cells from the skin's surface layer, in contrast to the effect of more aggressive patches typically used. The adhesive force between the soft adhesive and the skin is optimized according to the following principle: adhesion should be as strong as possible without the risk that the surface layer of the epidermis will be removed by the adhesive layer when the adhesive is removed.
    [0035] The adhesive compositions of the apparatus according to the invention may contain other conventional ingredients for adhesive compositions, such as stickiness enhancers, extenders, non-reactive polymers, oils (e.g., polypropylene oxide copolymers, ethylene oxide propylene oxide, oil mineral), plasticizers, fillers and surfactants. The adhesive can also comprise pharmaceutically active ingredients. These optional ingredients may be present in the reaction mixture during the crosslinking reaction.
    [0036] The reinforcement layer may, for example, be a water-impermeable layer or film, it may be any suitable material known per se for use in the preparation of ostomy adhesive wafers or wound dressings, for example, a foam , a layer of nonwoven or a film of polyurethane, polyethylene, polyester or polyamide.
    [0037] The water-impermeable layer or film is preferably a flexible, low-friction polymer film that reduces the risk of unwanted stress in an exposed area. A material suitable for use as a water-impermeable layer is a film conventionally used as a reinforcement layer in the preparation of wound dressings, which is suitably about 30 microns thick.
    [0038] A material especially suitable for use as a water-impermeable film is a polyurethane film. A preferred film material is disclosed in U.S. Patent No. 5,643,187.
    [0039] Preferably, the reinforcement layer has thermoplastic elements that make it possible to weld, for example, a bag or a coupling ring to the adhesive wafer. The preferred thickness of the reinforcement layer is between 10 and 60 pm in order to maintain the smoothness of the adhesive wafer.
    [0040] The absorbent layer can be any suitable absorbent material or mixtures thereof, such as CMC (carboxymethyl cellulose), SAP / SAF (super absorbent particles or fibers), salt, sandwiched layers that include nonwovens, within the polymer matrix permeable.
    [0041] The absorbent layer can be 10 to 2,000 pm thick.
    [0042] The absorbent layer must be at least 5 mm from both sides of the soft adhesive.
    [0043] The absorbent layer can be sandwiched between the protector and the soft adhesive and the edge portions of the soft adhesive can preferably overlap the edge portions of the absorbent layer. The edge portions of the absorbent layer are thus not exposed on the surface facing the wafer's skin.
    [0044] In order to improve the permeability of the soft adhesive, the intermediate layer can be provided with a plurality of perforations such as holes. The holes in the soft adhesive will also facilitate rapid absorption within the absorbent layer if such a layer is present and thereby reduce exposure to moisture for the soft adhesive. In this way, moisture will not affect the performance of the soft adhesive since the adhesive alone has no absorption.
    [0045] Perforations may be in the form of a pattern of holes or the soft adhesive may have a configuration similar to a mesh, for example, coated by pattern.
    [0046] The protective adhesive can be provided with a plurality of holes. Such holes may be in the central portion or they may be in the entire protective adhesive. An absorbent layer can be provided between the reinforcement layer and the protective adhesive with holes.
    [0047] With a construction in which the protective adhesive extends along the non-skin surface of the soft adhesive, production can be simple, as the soft adhesive is placed on top of the protective adhesive without the need for additional lamination. The wafer of the invention can, for example, be manufactured by molding or laminating.
    [0048] The wafer can have any suitable configuration for ostomy adhesive plates, but is preferably substantially circular or oval / elliptical.
    [0049] The intermediate area can constitute at least 50% of the surface facing the skin.
    [0050] In order to ensure good adhesion to the skin and prevent leakage, it is preferred that the central area comprising the protective adhesive has a minimum width of 15 mm, after cutting a central opening to accommodate the stoma (the width measured from the edge of the opening).
    [0051] Preferably, the border area is at least 5 mm wide.
    [0052] The intermediate area can preferably constitute at least 50% of the total adhesive area.
    [0053] The thickness of the protective adhesive can be from 50 to 1000 pm in exposed areas such as the central and edge areas and from 10 to 200 in the construction area, where the part overlaps the intermediate area.
    [0054] The soft adhesive layer can have a thickness of 10 to 20,000 pm, more preferably from 10 to 300 pm.
    [0055] Yet another advantage of the device according to the described mode is that it maintains its integrity through contact with fluid. In this context, it should be noted that if the entry of the device is very small, it must be enlarged by drilling or cutting in order to adapt its size to the stoma. Conventional fixing arrangements for stoma bags are generally provided with cut marks, for example, in the form of helical lines, to make this type of adaptation easier. Such size adaptation is important to ensure that the smallest possible area of skin around the stoma comes in contact with the intestinal contents collected in the stoma pouch. The formatting capability of the device means that it is easy to fine-tune the shape of the entry in a way that it matches the shape of the stoma, which can deviate from a circular shape.
    [0056] Substantially non-absorbent means, in this document, an absorption of less than 10%, preferably less than 5% by weight in 24 hours.
    [0057] The collection collection bag can be detachable from the adhesive wafer through a coupling system, or the bag and wafer can be integrated into the wafer, for example, through welding. Both versions are known as one-piece or two-piece ostomy devices.
    [0058] In order to avoid curling the edge portion during use, it may be advantageous to chamfer the edge portion of the wafer.
    [0059] A protective cover or release liner can be, for example, silicone paper. The protective cover is not present when using the adhesive plate of the invention and is therefore not an essential part of the invention. DESCRIPTION OF PREFERENTIAL MODALITIES
    [0060] The invention is now explained in greater detail with reference to the drawings showing the preferred embodiments of the invention.
    [0061] Figure 1 shows a preferred embodiment of the invention seen from the side facing the wafer skin. An adhesive wafer 1 comprises a central opening 2 to accommodate a stoma, a central area 3 and an edge area 4 and an intermediate area 5 therebetween. The edge area 4 and the central area 3 comprise a protective adhesive while the intermediate area 5 comprises a soft adhesive. An absorbent layer 6 is placed on the non-skin surface of the soft adhesive 5, but has a smaller width than the soft adhesive 5 which facilitates that the absorbent layer 6 is not directly exposed to the skin-facing surface. The absorbent layer as a whole 6 is covered by the soft adhesive 5 and the soft adhesive 5 overlaps the edges of the absorbent layer 6.
    [0062] Figure 2 shows the wafer 1 of the invention in cross section. The wafer comprises a reinforcement layer 7 covered over the skin-facing surface with a protective adhesive 8. An intermediate area 5 is surrounding the central area 2 and the central opening 2 and comprises a soft adhesive and optionally an absorbent layer 6. A location of the soft adhesive 5 provides a surface facing the skin of the wafer 1 which consists of a central portion 3 with protective adhesive and an intermediate portion 5 with soft adhesive and an edge portion 4 with protective adhesive. The absorbent layer 6 is sandwiched between the protector 8 and the soft adhesive 5 and the edge portions of the soft adhesive 5 overlap the edge portions of the absorbent layer 6 and the absorbent layer 6, thus, it is not exposed on the surface facing the skin of the wafer 1. The protective adhesive 8 extends along the non-skin surface of the soft adhesive 5 and the absorbent layer 6. The soft adhesive 5 can be provided with a plurality of holes 9. MATERIALS AND METHODS Determination of G *
    [0063] The parameter G * or complex module as defined in “Dynamics of polymeric liquids”, Vol. 1, second edition 1987, Bird, Armstrong and Hassager, John Wiley and Sons inc., Was used as a measure of the hardness of a adhesive. G * at 32 ° C and 0.01 Hz was measured as follows: A plate of non-foamed adhesive material was pressed into a 1 mm thick plate. A round sample of 25 mm in diameter was cut and placed in a RheoStress RS600 rheometer from Thermo Electron. The applied geometry was of 25 mm parallel plates and the deformation was fixed at 1% to ensure that the measurements were in a linear regime. The measurement was performed at 32 ° C.
    权利要求:
    Claims (11)
    [0001]
    1. Ostomy appliance characterized by the fact that it comprises an adhesive wafer for attachment to the body, the wafer comprising a central opening to accommodate a surface facing the stoma and a surface facing the skin and a surface not facing the skin , in which the non-skin surface is provided with a reinforcement layer, the surface facing the wafer skin comprising 1) a central area comprising a substantially non-absorbent protective adhesive, the protective adhesive having a strength of detachment of 3 to 20 N / 25 mm in steel, measured by the approved standard ASTM D6862-04, 2) an intermediate area that surrounds the central area, said area comprising a substantially non-absorbent soft adhesive, the soft adhesive having a detachment force from 1 to 10 N / 25 mm on steel, measured by the approved standard ASTM D6862-04, 3) an edge area that surrounds the intermediate area, and said edge area comprises an adhesive substantially non-absorbent protector, the protective adhesive having a detachment force of 3 to 20 N / 25 mm in steel, measured by the approved standard ASTM D6862-04.
    [0002]
    2. Apparatus, according to claim 1, characterized by the fact that the protective adhesive of the central area and the edge area is the same.
    [0003]
    3. Apparatus according to claim 2, characterized by the fact that the protective adhesive overlaps the non-skin surface of the soft adhesive.
    [0004]
    Apparatus according to any one of the preceding claims, characterized in that the soft adhesive comprises a cross-linked adhesive.
    [0005]
    5. Apparatus according to any of the preceding claims, characterized by the fact that the soft adhesive is based on silicone.
    [0006]
    6. Apparatus, according to any of the preceding claims, characterized by the fact that the protective adhesive is selected from the group of synthetic copolymers homo, co or in block, polyacrylate and copolymerized thereof, polyurethane, silicone, polyisobutylene, polyvinyl ether and natural or synthetic resins or mixtures.
    [0007]
    7. Apparatus according to any of the preceding claims, characterized by the fact that an absorbent layer is located between the reinforcement layer and the soft adhesive.
    [0008]
    8. Apparatus according to any of the preceding claims, characterized by the fact that the soft adhesive is provided with a plurality of holes.
    [0009]
    9. Apparatus according to any of the preceding claims, characterized by the fact that the intermediate area constitutes at least 50% of the surface facing the skin.
    [0010]
    10. Apparatus according to any of the preceding claims, characterized by the fact that the coupling ring is welded to the adhesive wafer.
    [0011]
    11. Apparatus according to any one of claims 1 to 9, characterized by the fact that a bag is welded to the adhesive wafer.
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-09-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-06-09| B09A| Decision: intention to grant|
    2020-07-07| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA201070575|2010-12-22|
    DKPA201070575|2010-12-22|
    PCT/DK2011/050503|WO2012083964A1|2010-12-22|2011-12-20|An ostomy appliance|
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