PT691113E - Pensos para feridas - Google Patents

Pensos para feridas Download PDF

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Publication number
PT691113E
PT691113E PT95303725T PT95303725T PT691113E PT 691113 E PT691113 E PT 691113E PT 95303725 T PT95303725 T PT 95303725T PT 95303725 T PT95303725 T PT 95303725T PT 691113 E PT691113 E PT 691113E
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PT
Portugal
Prior art keywords
layer
wound
dressing according
body layer
dressing
Prior art date
Application number
PT95303725T
Other languages
English (en)
Inventor
Graham Collyer
Paul Alan Gray
Original Assignee
Seton Healthcare Group Plc
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Publication date
Application filed by Seton Healthcare Group Plc filed Critical Seton Healthcare Group Plc
Publication of PT691113E publication Critical patent/PT691113E/pt

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/40Layered products comprising a layer of synthetic resin comprising polyurethanes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/01Non-adhesive bandages or dressings
    • A61F13/01034Non-adhesive bandages or dressings characterised by a property
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/06Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/22Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • B32B5/32Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed at least two layers being foamed and next to each other
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    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0203Adhesive bandages or dressings with fluid retention members
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    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/023Adhesive bandages or dressings wound covering film layers without a fluid retention layer
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    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0259Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer
    • A61F13/0263Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer especially adapted for island dressings
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    • A61F13/06Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
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    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00246Wound bandages in a special way pervious to air or vapours
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00314Wound bandages with surface treatments
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00412Plasters use for use with needles, tubes or catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
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    • A61F2013/00727Plasters means for wound humidity control
    • A61F2013/00731Plasters means for wound humidity control with absorbing pads
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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)

Description

85 736 ΕΡ Ο 691 113/ΡΤ DESCRICÃO “Pensos para feridas”
Este invento refere a um penso para feridas. É conhecida a utilização de materiais de plástico de espuma compressíveis de modo resiliente para pensos para feridas. Este material pode permitir a aplicação confortável da pressão mesmo em superfícies do corpo curvas ou outras não planas. O material pode ter também boas propriedades de absorção adequadas para utilização com pensos húmidos. É importante ou desejável ter propriedades de superfície, as quais para a superfície interior virada para a ferida permita o fluxo fácil da humidade para o penso, enquanto evita a colagem à ferida e para a outra superfície proporciona, pelo menos, numa certa medida, uma barreira respirável à prova de água. No entanto, aparecem problemas em ligação com o fornecimento de propriedades de superfície satisfatórias no contexto do material de espuma. Em particular, a modificação das superfícies do material de espuma, pelo tratamento do mesmo, ou pela aplicação camadas superficiais ao mesmo, tende a dar origem a distorção do material de espuma à medida que a espuma absorve a humidade e incha. A distorção é desvantajosa devido à mesma interromper a aplicação regular da pressão e poder perturbar a cura da ferida. Podem ser também formadas bolsas de ar que dão origem a locais de crescimento bacteriano. A patente britânica GB-A-1417962 descreve a utilização de uma espuma de poliuretano não reticulado, a qual é modificada na superfície interior virada para a ferida, pela aplicação de calor e de pressão, para proporcionar uma camada de células colapsadas, camada que é macia, dobrável e facilita o fluxo da humidade da ferida para dentro do corpo de material de espuma.
Um desenvolvimento desta estrutura conhecida, envolvendo a utilização de um corpo de espuma hidrofílica de células abertas está descrito em WO-A-92/13576. Esta construção facilita o fluxo de humidade a uma velocidade relativamente elevada para utilização com feridas muito húmidas. No entanto, pode aparecer inchaço considerável e consequente distorção.
85 736 ΕΡ Ο 691 113/ΡΤ 2 Ο pedido de patente europeia EP-A-0 230 387 descreve uma ligadura descartável, preparada a partir de uma única folha de espuma com uma superfície virada para a ferida, que compreende um material libertação enrolado não absorvente tipo rede para permitir a livre passagem dos fluidos através de si. O pedido de patente europeia EP-A-0 099 748 descreve um penso com uma superfície virada para a ferida que compreende uma rede elastomérica conformável. O pedido de patente europeia EP-A-0 457 977 e o pedido de patente britânica GB-A-2 228 682 descrevem um penso para feridas que compreende uma almofada de espuma, sendo uma superfície da mesma hidrofílica, para formar uma superfície virada para a ferida.
Um objecto do presente invento é proporcionar um penso para feridas, o qual inclui uma camada de espuma absorvente e tem boas propriedades superficiais, o qual tem ainda boa estabilidade dimensional e uma reduzida tendência para a distorção, quando de uma absorção da humidade.
De acordo com o invento é, por conseguinte, proporcionado um penso para feridas que compreende uma camada de corpo de um material de espuma absorvente da humidade e compressível de modo resiliente, tendo a dita camada de corpo uma superfície externa com uma camada, que proporciona uma barreira ao líquido, aplicado à mesma e uma superfície interna virada para a ferida com uma camada de contacto com a ferida aplicada à mesma, compreendendo a dita camada de barreia uma camada fixa de um material permeável a gases, o qual tem, pelo menos, uma permeabilidade reduzida à humidade em relação à camada de corpo, em que a espessura das camadas de contacto com a ferida e de suporte são uma proporção menor da espessura da camada de corpo, caracterizado por a dita camada de contacto com a ferida compreender uma camada fixa, formada separadamente de um material de espuma permeável à humidade e dimensionalmente estável, para controlar o fluxo do líquido exsudado da ferida através do dito material de espuma permeável à humidade para o dito material de espuma absorvente da humidade da dita camada de corpo.
Com esta disposição, o corpo de espuma pode permitir a aplicação confortável de pressão a uma ferida, enquanto absorve quantidades significativas da humidade
85 736 ΕΡ Ο 691 113/ΡΤ 3 da ferida, a superfície interna pode proporcionar contacto sem colagem, com o fluxo controlado da humidade para a camada de corpo, e a camada superficial externa pode proporcionar resistência à introdução de líquido através da superfície externa. Ao mesmo tempo, as camadas superficiais interna e externa fixas podem manter a estabilidade dimensional e evitar ou limitar a distorção após a absorção da humidade.
Em relação ao material de espuma da camada de corpo, pode ser utilizado qualquer material adequado. De preferência, é utilizada uma espuma de poliuretano de poiiéter, que tem características hidrofílicas. Este género de espuma pode ser facilmente absorvente e fisiologicamente compatível e pode demonstrar boa resiliência e compressibilidade adequada à aplicação confortável de pressão regular e sustentada. As espumas adequadas são descritas em WO-A-92/13576. A camada de corpo pode ter uma espessura na gama, digamos, de 3 a 20 mm, em particular de 8 a 12 mm antes da compressão. Uma espessura útil típica é 11 mm. Uma gama de espessuras preferida após a compressão é de 3 a 12 mm. Em particular 7 a 10 mm. A camada de corpo é a parte funcional de absorção de líquido funcional do penso. O líquido exsudado a partir da ferida é absorvido na parte de corpo. O líquido absorvido é retido contra o livre fluxo para fora do penso, mas é mantido fora da ferida, para facilitar a cura, e evapora-se com uma velocidade controlada, como uma consequência das propriedades da camada de corpo e também da camada superficial de contacto com a ferida.
Em relação à camada de barreira, esta pode ser também formada a partir de qualquer material adequado. A função da camada de barreira é evitar ou restringir o fluxo de líquido através de si, ao mesmo tempo que permite a passagem de gás ou de vapor, de modo que o líquido na camada de corpo possa gradualmente evaporar-se do penso. É preferido que a camada de barreira deva também ter a capacidade de evitar ou, pelo menos, restringir apreciavelmente o ingresso de bactérias. A elevada densidade da espuma de poliuretano de células fechadas é, em particular, adequada para a camada de suporte de barreia. Qualquer outro material
85 736 ΕΡ Ο 691 113/ΡΤ 4 adequado pode ser também utilizado, o qual proporcione propriedades semelhantes a esta espuma de poliuretano de células fechadas, por exemplo, películas de poliéster, películas de amido bloqueado com poliéter e as combinações das mesmas, as quais podem ser tornadas barreiras bacterianas respiráveis por processos mecânicos ou químicos. A gama de espessuras preferida é de 0,2 a 0,8 mm. Se a camada é demasiado fina, não será possível reter as bactérias. Se é demasiado espessa existirá pouca ou nenhuma evaporação através da camada. É particularmente útil a espessura de 0,4 mm. A camada de suporte pode ser fixa à camada de corpo de qualquer maneira adequada. Numa disposição preferida a camada de suporte é unida por calor à camada de corpo, pela aplicação de calor e pressão com uma placa aquecida ou semelhante, ou um rolo. A camada de suporte pode ser também unida utilizando um adesivo adequado (como, por exemplo, é utilizado no caso de pensos de ilha), embora isto possa interferir em certa medida com a permeabilidade ao vapor de humidade. Os adesivos adequados são o acrilato de isooctilo, o acrilato de etilenooctilo, o terpolímero de ácido acrílico e os compósitos dos mesmos. O adesivo pode conter também aditivos tais como a iodeto povidona, a cloroexidina ou indicadores químicos. A camada de suporte proporciona o fluxo restrito e controlado do líquido, gás, vapor e bactérias, como mencionado acima. A mesma actua também para manter estabilidade dimensional da camada de corpo. Quando a camada de corpo tende a expandir-se e inchar durante a absorção do líquido, a camada de suporte ajuda a evitar ou a restringir a distorção do penso.
Em relação à camada de contacto com a ferida, esta pode ser também formada a partir de qualquer material adequado, que tenha as propriedades requeridas de permeabilidade à humidade e compatibilidade com feridas. A camada é, de preferência, hidrofílica. É adequada uma espuma de poliuretano flexível com poliéter ou poliéster. Pode ser utilizada uma espuma hidrofóbica homogénea, a qual é tornada hidrofílica por tratamento por calor, por exemplo, durante a união por calor da mesma à camada de corpo.
85 736 ΕΡ Ο 691 113/ΡΤ 5 A camada de contacto com a ferida facilita o fluxo controlado do líquido exsudado da ferida para dentro da camada de corpo absorvente do penso. As propriedades da camada de contacto com a ferida, minimizam ou evitam, de preferência, o inchaço e evitam a retenção excessiva de humidade. A camada permite, de preferência, a retenção ligeira de humidade, de modo que tem uma tendência reduzida para colar ou interferir de outro modo com a ferida e a camada pode reter também a sua estrutura e dimensões e ajudar a manter a estabilidade dimensional do penso. O fluxo controlado do líquido da ferida para a camada de corpo pode ter também importância em relação à cura da ferida e no evitar da distorção do penso. O fluxo do líquido deve ter uma velocidade suficientemente elevada para evitar o desenvolvimento de líquido em excesso na superfície da ferida, mas não deve ser tão elevada que a ferida se torne demasiadamente seca e a estrutura de corpo excessivamente húmida. A camada de contacto com a ferida deve, de preferência, manter uma quantidade muito pequena de humidade na superfície da ferida para proporcionar à ferida um ambiente de cura com humidade.
Adequadamente a camada de contacto com a ferida pode ser formada a partir de espuma de poliuretano colapsada ou comprimida, com uma espessura de digamos 1 a 12 mm antes da compressão. Se a camada de contacto com a ferida é demasiado espessa existe uma maior possibilidade de invasão lateral indesejável através do exsudado. A camada de contacto com a ferida pode ser fixa à camada de corpo por união por calor, pela aplicação de calor e pressão, por exemplo, com uma placa aquecida ou semelhante, ou um rolo. A camada de contacto com a ferida pode também ser fixa pela utilização de adesivos, soldadura ultra-sónica, soldadura por infravermelhos ou de outro modo. A camada de barreira e a camada de contacto com a ferida podem ser fixa à camada de corpo em operações separadas ou, alternativamente, simultaneamente, por exemplo, passando as camadas entre rolos. 85 736 ΕΡ Ο 691 113/ΡΤ
6 Ο penso pode ser formado com a forma de tira ou folha e pode ser então cortado para dar originar aos pensos individuais de uma dimensão e forma desejadas.
Se desejado qualquer uma ou todas as camadas, em particular, a camada de corpo pode ser impregnada com qualquer substância adequada tal como um anti-séptico, por exemplo, iodeto povidona ou cloroexidina ou outro medicamento ou indicadores químicos.
Os pensos individuais podem ser esterilizados por irradiação ou de outro modo, por exemplo, após a embalagem. O penso para feridas pode ser conformado e fornecido com estruturas ou materiais adicionais tais como porções de adesivo, como desejado e de acordo com a utilização pretendida. Assim, por exemplo, o penso pode ser oblongo com cantos rectos ou redondos, em forma de lágrima, circular ou oval. Os bordos do penso podem ser de corte quadrado, arredondados, chanfrados ou frisados, etc, utilizando um certo número de processos, por exemplo, uma placa aquecida com pressão, soldadura/corte de alta frequência ou soldadura/corte ultra-sónico. O invento será agora descrito adicionalmente no exemplo seguinte.
Um exemplo de penso para feridas de acordo com o invento é feito a partir de uma camada de corpo absorvente com películas aplicadas às suas faces opostas. A camada de corpo compreende uma camada de “toque macio” compressível de modo resiliente de espuma de poliuretano de poliéter que tem uma espessura de 11 mm no seu estado não comprimido e relaxado. A espuma é um material hidrofílico de células abertas feito a partir dos seguintes ingredientes por partes em peso:
Poliol de poliéter rico em óxido de etileno (poliol 1) 75
Poliol de poliéter ramificado modificado com óxido de etileno (poliol) 25 Diisocianato de tolileno (T 80/20) 36,5
Dimetiletanolamina (DMEA) 0,05
Trietilenodiamina (TEDA) 0,20
Copolímero em blocos com polisiloxanopolioxietileno (estabilizador 1,20 de células Água 3,00
85 736 ΕΡ Ο 691 113/ΡΤ 7 Ο poliol 1 e 2 podem ser Voranol CP 1421 e Voranoi CP 4800 (ou CP 4810) vendidos com estas marcas por The Dow Chemical Company. Altemativamente, o poliol 1 e 2 podem ser Desmophen 7040 e Desmophen 3900 (ou 7160 ou 7116) vendidos com estas marcas pela Bayer AG.
As propriedades hidrofílicas podem ser ajustadas pelo ajustamento do conteúdo de óxido de etileno do poliol 1, ou pela alteração das proporções relativas dos poliois 1 e 2. A densidade da espuma pode variar pelo ajustamento do nível de água, tipicamente para proporcionar uma massa volúmica de 27 a 31 kg/m3 (tipicamente 30), uma dureza de 45 a 75 Newton, uma resistência nominal à tracção mínima de 70 KPa, uma elongação nominal na ruptura mínima de 150%, uma compressão nominal ajustada ao máximo de 20%. A camada de corpo de espuma pode absorver líquido, pelo menos, dez vezes o seu peso inicial. A espuma pode ser produzida como material em placas por maquinaria convencional de fabrico de espuma e pode ser cortada para a dimensão como requerido para a camada de corpo do penso. A camada de suporte com a forma de uma película, para aplicação a uma superfície da camada de corpo acima, compreende uma camada de espuma de poliuretano de poliéter de alta densidade de células predominantemente fechadas diisocianato de tolileno de natureza em blocos, que tem a espessura de 0,4 mm. Adequadamente, esta pode ser o material vendido com a marca registada Medifix 4003 por Medifix Adhesive Products Ltd. Este material tem uma dimensão de poro de 0,1 mm a 0,3 mm, uma massa volúmica de 325 a 435 kg/m3 e uma resistência à tracção de 1,276 kg/25mm. A permeabilidade ao vapor da humidade pode variar de 500 a 4000 g/m2/24 horas, os valores típicos são da ordem de 1200 g/m2/24 horas. De preferência, os valores são maiores do que 1000 g/m2/24 horas. A camada de contacto com a ferida com a forma de uma película, para aplicação à superfície oposta da camada de corpo, compreende uma camada de espuma de poliuretano (poliéter ou poliéster), tendo uma massa volúmica dentro da 8 85 736 ΕΡ Ο 691 113/ΡΤ gama de 12 a 75 kg/m3 (poliéter) ou 14 a 75 kg/m3 (poliéster). Isto é utilizado numa espessura de digamos 3 a 7 mm.
Em geral uma espuma de poliéter é feita pela selecção dos seguintes ingredientes por partes em peso:
Triol de poliéter e óxido de propileno/óxido de etileno 10 a 100
Triol de polioxipropileno 10 a 100
Diisocianato de tolileno (T 80) 25 a 65
Dimetiletanolamina 0,05 a 1,2
Trietilenodiamina 0 a 0,8
Tensioactivo de silicone 0,3 a 2,0
Octanoato estanoso 0,04 a 1,0 Água 1 a 5,5
Agente de sopragem de hidrocarboneto 0 a 20
Uma espuma de poliéster típica é feita a partir dos seguintes ingredientes:
Poliol de poliéster (glicoladipato ramificado) 100
Diisocianato de tolileno (T 65) 20 a 70
Amina terciária 0,1 a 1,0
Tensioactivo 0,5 a 2,0 Água 1 a 5,5
Agente de sopragem de hidrocarboneto 0 a 15
Uma formulação específica para uma espuma de poliéter seria: 100 partes em peso 63,0 partes em peso 11,2° 0,25 partes em peso 0,04 partes em peso 1,30 partes em peso 5,5 partes em peso 0,32 partes em peso 10 partes em peso
Poliol (A)
Isocianato (B) índice
Amina catalítica (C)
Amina catalítica (D) Tensioactivo de silicone (E) Água
Estanho catalítico (F) Agente de sopragem 85 736 ΕΡ Ο 691 113/ΡΤ 9
Em que:
A é um poliéter tal como o ARCOL 1131 vendido por ARCO B é um diisocianato de tolileno tal como o SYRANATE T80 vendido por Rhone Poulenc. C é dimetiloetanolamina tal como o DABCO DMEA vendida por Air Products. D é um catalisador de amina tal como o DABCO BL-11 vendido por Air Products. E é um tensioactivo de silicone tal como ο B8234 vendido por Goldschemidt. F é um catalisador de estanho tal como o DABCO T9 vendido por Air Products G é um agente de sopragem de hidrocarboneto tal como o cloreto de metileno. As propriedades físicas típicas são: 15 a 19 kg/m3 25 a 45 Newton 60 KPa mínima 150% mínimo 30% máximo gama de massas volúmicas nominais gama de durezas nominais resistência à tracção nominal elongação nominal na ruptura ajustamento de compressão nominal A camada de corpo está unida à camada de contacto com a ferida e à camada de barreira em faces opostas e a combinação é passada através de uma prensa aquecida. Isto provoca que as camadas sejam laminadas em conjunto devido à fusão nas interfaces entre as camadas. Ao mesmo tempo a camada de contacto com a ferida é esmagada ou colapsa, de modo que a sua espessura se reduz digamos a 1 mm. A espessura da camada de corpo pode ser reduzida digamos a 10 mm. O processo de laminação confere as propriedades hidrofílicas requeridas à camada de contacto com a ferida.
85 736 ΕΡ Ο 691 113/ΡΤ 10 Ο laminado resultante é cortado para proporcionar pensos individuais, os quais podem ser impregnados com medicamentos, embalados em invólucros selados e esterilizados por irradiação.
Em utilização o penso tem boa absorção controlada e elevada estabilidade dimensional.
Os desenhos anexos mostram uma gama das aplicações do penso exemplificativo acima.
Nos desenhos: a Fig. 1 é uma vista em perspectiva esquemática de uma forma de construção do penso exemplificativo; a Fig. 2 é um pormenor em corte de um bordo do penso da Fig. 1; as Figs. 3 a 8 mostram pormenores em corte de bordos com formas alternativas do penso; as Figs. 9 e 10 são vistas em perspectiva esquemáticas de uma modificação do penso que inclui cortes transversais; a Fig. 11 é uma vista em corte esquemática de um penso com uma camada de carvão activo; e a Fig. 12 é uma vista em corte esquemática de um penso de ilha. A Fig. 1 mostra um penso construído de acordo com o exemplo descrito acima, que tem uma camada de corpo 1, uma camada de suporte 2 e uma camada 3 de contacto com a ferida. O bordo por de direito como mostrado na Fig. 2, ou pode ser conformado como mostrado nas Figs. 3 a 8. A camada de suporte 2 e a camada 3 de contacto com a ferida podem terminar independentemente no bordo ou podem ser fixas em conjunto (termicamente ou de outro modo), como mostrado nas Figs. 6 a 8. 11 85 736 ΕΡ Ο 691 113/ΡΤ A Fig. 9 mostra um corte transversal normalizado e a Fig. 10 mostra um corte transversal com orifício, formado num penso do tipo mostrado na Fig. 1. A Fig. 11 mostra um penso do género mostrado na Fig. 8 com uma camada adicional 4, mantida na posição sobre a camada de suporte 2 por meio de uma camada de retenção 5. A camada adicional 4 pode ser uma camada de carvão activado, que compreende um material não tecido com uma composição de base de fibra de viscose/poliéster (80 partes em peso) ligante de acrilato (20 partes em peso) impregnada em ambos os lados com pó de carvão activo. Tipicamente, a composição de base pode ter um peso nominal de 36 g/m2 e o carvão de impregnação 40 g/m2. A permeabilidade ao ar pode ser de 30 cm3/cm2/s. A camada de retenção 5 pode ser um material de espuma de células abertas, o qual é uma espuma de poliéster ou de poliéter flexível e macia, por exemplo, de um dos géneros descritos acima com referência às camadas 1 a 3, embora possam ser também utilizados outros materiais. A construção da espuma não é critica, a sua finalidade é manter a camada de carvão em posição sem afectar inconvenientemente a permeabilidade à humidade do penso. Tipicamente a camada 5 pode ter 3 mm de espessura com uma densidade de 24 a 27 kg/m3. A camada 5 pode ser mantida por selagem com frisagem ou de outro modo no bordo do penso. A Fig. 12 mostra uma versão de ilha típica do penso da Fig. 1, na qual a camada de corpo 1 está unida à camada de suporte 2 por meio de uma camada de adesivo de pele, o qual cobre toda a superfície da camada de suporte. A camada de suporte 2 é muito mais larga do que a camada de corpo 1, de modo que a camada de corpo 1 define uma ilha central. A camada 3 de contacto com a ferida é unida por calor à camada de corpo e tem os seus bordos selados por frisagem (como na Fig. 8) e está unida por adesivo à camada de suporte. Os papéis de libertação de puxar são feitos aderir sobre o adesivo exposto e cobrem a camada de corpo. A utilização das várias formas dos pensos mostrados é como se segue.
85 736 ΕΡ 0 691 113/ΡΤ 12 Ο penso de base da Fig. 1 é utilizado principalmente no tratamento de feridas que exsudam de moderada a grandemente, tais como úlceras das pernas, inflamações de pressão, sítios de ferida de operação ou traumática, queimaduras e enxertos de pele. O penso mantém um micro-ambiente de ferida com humidade, remove o excesso de exsudado, permite a troca gasosa, proporciona isolamento térmico, evita traumas na mudança dos pensos, é impermeável a microorganismos e está livre de contaminantes particulares e tóxicos, a camada de suporte evita a invasão do exsudado e reduz o risco de infecção secundária. O penso de traqueostomia e cânula das Figs. 9 e 10 são utilizados como um penso para traqueostomia e proporciona protecção e amortecimento através do sítio da intubação e dos procedimentos de inserção de cânula e de fixadores de ossos externos. A configuração de corte transversal ou de corte de buraco de fechadura ajusta-se perfeitamente em torno dos tubos, cânulas ou pinos utilizados em procedimentos médicos invasivos. O penso com carvão activado da Fig. 11 é utilizado no tratamento de feridas com exsudado de moderado a grande e é, em particular, útil para absorver e neutralizar os odores ofensivos e é, em particular, útil para o tratamento de feridas infectadas malcheirosas. A camada de suporte assegura que a camada de carvão activado permaneça seca e eficaz ao longo do período de utilização. O penso de ilha da Fig. 12 é resistente à água, tendo um perímetro com cobertura de adesivo para reter a almofada do penso seguramente no lugar sem a necessidade de fitas adicionais ou ligaduras de retenção. O mesmo resiste à contaminação fecal ou urinária e é, em particular, útil para inflamações do sacro em pacientes incontinentes e em feridas cutâneas.
Os pensos podem ser utilizados como um penso impregnado de anti-séptico para evitar a infecção em feridas que incluem úlceras, queimaduras e cortes. O mesmo é altamente eficaz contra todo o espectro de microorganismos potencialmente patogénicos, incluindo as bactérias gram positivas e gram negativas, vírus, fungos, protozoários e esporos. O ingrediente anti-séptico é colocado na superfície de contacto com a ferida do penso com a forma de uma solução, creme ou pasta, ou pode ser contido dentro das camadas do penso, por exemplo, na forma de um pó.
85 736 ΕΡ Ο 691 113/ΡΤ 13
As variações do anti-séptico podem ser a iodeto povidona, a sulfadiazina de prata, material à base de zinco, a cloroexidina, a cetramida ou as suas combinações indicadas acima, etc.
Um produto particularmente útil pode ser produzido pela utilização de uma solução alcoólica que contém a iodeto povidona aplicada finamente através da superfície de contacto com a ferida e seca antes da embalagem. Quando da aplicação a uma ferida que exsuda, a iodeto povidona será liberta e mantidas as propriedades desejadas.
Pode ser aplicado um hidrogel à superfície de contacto com a ferida e mantida húmida em virtude da embalagem selada. O penso descrito acima no exemplo é altamente absorvente com boa estabilidade dimensional e resistência à invasão de bactérias através do mesmo. O desempenho do penso foi comparado com a espuma do tipo descrito na patente britânica GB-A-1417962 (marca registada Lyofoam). Verificou-se que o penso absorve quase duas vezes mais líquido para a mesma dimensão de corpo do material. É possível a utilização de materiais mais espessos para o penso, para absorver mais líquido. No entanto, a união por calor das camadas pode então tornar-se difícil e pode ser então necessária ou preferida a união de adesivo.
Um corpo espesso de material de espuma, digamos 20 mm, pode ser utilizado para elevados volumes de líquido, ao passo que um corpo fino, digamos de 5 mm, pode ser utilizado para feridas que exsudam de modo moderado a ligeiro. A formulação da espuma para o corpo de espuma no exemplo contém grandes quantidades de grupos de óxido de etileno para aumentar a absorção de líquidos. A absorção melhorada de líquidos pode ser também conseguida pela utilização de tensioactivos, embora a utilização de grandes quantidades de tensioactivos seja 14 85 736 ΕΡ Ο 691 113/ΡΤ indesejada uma vez que o tensioactivo pode ser transmitido ou absorvido pela ferida de modo a interferir com a cura da ferida.
Lisboa, 11. OUT. 2000
Por Seton Healthcare Group pic -O AGENTE OFICIAL-
EMG.· ÂMTÓ^IO JOÃO DA CUMHÁ FERREIRA Ag. Of. Pr. Ind. Sue das Flores, 74 - 4/ _ieoo LISBOA

Claims (14)

  1. 85 736 ΕΡ Ο 691 113/ΡΤ 1/3 REIVINDICAÇÕES 1 - Penso para feridas que compreende uma camada de corpo (1) de um material de espuma absorvente da humidade e compressível de modo resiliente, tendo a dita camada de corpo uma superfície externa com uma camada (2), que proporciona uma barreira ao líquido, aplicada à mesma e uma superfície interna virada para a ferida com uma camada (3) de contacto com a ferida aplicada à mesma, compreendendo a dita camada de barreia (2) uma camada fixa de um material permeável a gases, o qual tem, pelo menos, uma permeabilidade reduzida à humidade em relação à camada de corpo, em que a espessura da camada de suporte (2) e da camada de contacto com a ferida (3) são uma proporção menor da espessura da camada de corpo (1), caracterizado por a dita camada (3) de contacto com a ferida.compreender uma camada fixa, formada separadamente de um material de espuma permeável à humidade e dimensionalmente estável, para controlar o fluxo do líquido exsudado da ferida através do dito material de espuma permeável à humidade para o dito material de espuma absorvente da humidade da dita camada de corpo (1).
  2. 2 - Penso de acordo com a reivindicação 1, caracterizado por a camada de corpo (1) ser formada a partir de uma espuma de poliuretano de poliéter hidrofílica.
  3. 3 - Penso de acordo com a reivindicação 1 ou 2, caracterizado por a espessura da camada de corpo (1) estar na gama de 2 a 20 mm antes da compressão.
  4. 4 - Penso de acordo com qualquer uma das reivindicações 1 a 3, caracterizado por a camada de suporte e de barreira (2) ser uma espuma de poliuretano de células fechas de alta densidade.
  5. 5 - Penso de acordo com qualquer uma das reivindicações 1 a 4, caracterizado por a espessura da camada de suporte e de barreira (2) estar na gama de 0,2 mm a 0,8 mm.
  6. 6 - Penso de acordo com qualquer uma das reivindicações 1 a 5, caracterizado por a camada de suporte e de barreira (2) ser unida por calor à camada de corpo (1).
  7. 7 - Penso de acordo com qualquer uma das reivindicações 1 a 5, caracterizado por a camada de suporte e de barreira (2) estar unida com adesivo à camada de corpo (1).
  8. 8 - Penso de acordo com qualquer uma das reivindicações 1 a 7, caracterizado por a camada de contacto com a ferida ser uma espuma de poliuretano colapsada ou comprimida.
  9. 9 - Penso de acordo com qualquer uma das reivindicações 1 a 8, caracterizado por a camada (3) de contacto com a ferida ter uma espessura de 1 a 12 mm antes da compressão.
  10. 10 - Penso de acordo com qualquer uma das reivindicações 1 a 9, caracterizado por a camada (3) de contacto com a ferida ser unida por calor à camada de corpo.
  11. 11 - Penso de acordo com qualquer uma das reivindicações 1 a 10, caracterizado por, pelo menos, uma camada (1,2, 3) estar impregnada com um anti-séptico.
  12. 12 - Penso de acordo com qualquer uma das reivindicações 1 a 11, o qual é um penso de ilha, caracterizado por a camada de suporte e de barreira (2) ter uma superfície revestida com adesivo e a camada de corpo (1) e a camada (3) de contacto com a ferida estarem unidas em posição numa ilha centralmente na dita superfície.
  13. 13 - Penso de acordo com qualquer uma das reivindicações 1 a 12, caracterizado por estar prevista uma camada de carvão activado (4), retida na superfície externa da camada de suporte e de barreira (2) por uma camada de retenção sobreposta (5). 85 736 ΕΡ Ο 691 113/ΡΤ 3/3
  14. 14 - Penso de acordo com a reivindicação 13, caracterizado por a camada de retenção (5) ser formada a partir de um material de espuma permeável.
    Por Seton Healthcare Group pic -O AGENTE OFICIAL-
    |EMG.e ANTÓMIO l®Ã0 BA QJNHA FERRESRÁ Ag. Of. Pr. Ind. Ras das Flores, 74 - 4.® 1200 LISBOA
PT95303725T 1994-06-08 1995-05-31 Pensos para feridas PT691113E (pt)

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GB9411429A GB9411429D0 (en) 1994-06-08 1994-06-08 Wound dressings

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EP0691113B1 (en) 2000-07-12
DE69517876T2 (de) 2001-02-22
AU2054295A (en) 1995-12-14
GB9411429D0 (en) 1994-07-27
DE69517876D1 (de) 2000-08-17
JPH08154964A (ja) 1996-06-18
US5973221A (en) 1999-10-26
AU706006B2 (en) 1999-06-03
ZA954703B (en) 1996-01-29
ES2151025T3 (es) 2000-12-16
EP0691113A1 (en) 1996-01-10
ATE194480T1 (de) 2000-07-15
DK0691113T3 (da) 2000-11-13
GR3034614T3 (en) 2001-01-31

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