ES2606402T3 - Apósito y procedimiento para su fabricación - Google Patents

Apósito y procedimiento para su fabricación Download PDF

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ES2606402T3
ES2606402T3 ES09772151.8T ES09772151T ES2606402T3 ES 2606402 T3 ES2606402 T3 ES 2606402T3 ES 09772151 T ES09772151 T ES 09772151T ES 2606402 T3 ES2606402 T3 ES 2606402T3
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water
polyurethane foam
dressing
layer
weight
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Martin Junginger
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Paul Hartmann AG
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Paul Hartmann AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
    • A61F13/0209—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings comprising superabsorbent material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00987—Apparatus or processes for manufacturing non-adhesive dressings or bandages
    • A61F13/00991—Apparatus or processes for manufacturing non-adhesive dressings or bandages for treating webs, e.g. for moisturising, coating, impregnating or applying powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0213—Adhesive bandages or dressings with fluid retention members the fluid retention member being a layer of hydrocolloid, gel forming material
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0223—Adhesive bandages or dressings with fluid retention members characterized by parametric properties of the fluid retention layer, e.g. absorbency, wicking capacity, liquid distribution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/025—Adhesive bandages or dressings characterised by the skin-adhering layer having a special distribution arrangement of the adhesive
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F13/0289—Apparatus or processes for manufacturing adhesive dressings or bandages manufacturing of adhesive dressings
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
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    • A61F2013/00663—Plasters adhesive polymeric base acrylic
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
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    • A61F2013/00697—Plasters adhesive elastomer-, e.g. rubber- based
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00727—Plasters means for wound humidity control
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00731—Plasters means for wound humidity control with absorbing pads
    • A61F2013/0074—Plasters means for wound humidity control with absorbing pads containing foams
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F2013/00761—Plasters means for wound humidity control with permeable adhesive layers
    • A61F2013/00774—Plasters means for wound humidity control with permeable adhesive layers arranged in discrete dots
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00855—Plasters pervious to air or vapours
    • A61F2013/00868—Plasters pervious to air or vapours thin film
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10—Methods of surface bonding and/or assembly therefor

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  • Heart & Thoracic Surgery (AREA)
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Abstract

Apósito de varias capas que comprende a) una primera capa como capa de contacto con la herida con un primer lado y un segundo lado y b) al menos una segunda capa como capa absorbente con un primer lado y un segundo lado, que comprende una espuma de poliuretano hidrófila, conteniendo la espuma de poliuretano una parte de agua de al menos un 10 % en peso, caracterizado por que la espuma de poliuretano contiene, como máximo, un 80 % en peso de agua y presenta una libre absorción A2 de al menos 10 g/g, determinándose la libre absorción según DIN-EN 13726-1 (2002).

Description

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la capa de contacto con la herida (25) agujeros circulares (26) para mejorar el paso del exudado de la herida. La espuma de poliuretano comprende un primer lado con una superficie de 25 cm2, ocupando los agujeros (26) en total una superficie de 5 cm2.
La figura 3 muestra una tercera variante de realización de un apósito según la invención. El apósito (30) comprende una capa de soporte (31) de una película de poliuretano impermeable al agua y permeable al vapor de agua, una capa absorbente (33) de una espuma de poliuretano hidrófila de poros abiertos con una parte de agua del 52,8 % en peso (referida a la espuma de poliuretano) y una capa de contacto con la herida (35) de una matriz de hidrogel con una parte de agua de aprox. 63,5 % en peso (referida al hidrogel). La capa de soporte (31) se lamina por completo sobre la espuma de poliuretano hidrófila por medio de un adhesivo de acrilato (32) aplicado sobre la película de polímero. Por el primer lado de la capa absorbente, que en el caso de aplicación está orientado hacia la herida, se aplica una matriz de hidrogel (35) que contiene agua y que comprende un copolímero de poliuretano-poliurea. La matriz de hidrogel está dotada de canales cónicos (36) de sección transversal (paralela a la herida) circular, con lo que el exudado de la herida puede fluir mejor de la herida a la espuma hidrófila absorbente (compárese figura 3a). Durante la fabricación del apósito, la matriz de hidrogel aún viscosa penetra ligeramente en la espuma de poliuretano, formándose entre la matriz de hidrogel y la espuma de poliuretano hidrófila una capa de transición (34) compuesta por la matriz de hidrogel y la espuma de poliuretano hidrófila. La capa de transición presenta, por su parte, canales (37) que se llenan únicamente de espuma de poliuretano y que se disponen en concordancia con los canales de la matriz de hidrogel.
Ejemplo de realización
El apósito presenta la estructura descrita en la figura 3.
A) Fabricación del hidrogel
Para la fabricación del hidrogel se emplean las siguientes soluciones acuosas y componentes (componente A, B, C):
Componente A
Propilenglicol USP30 (99,8 %)
Cía. Hedinger Auq. GmbH; Stuttgart, Alemania 23,24 % en peso
Aqua purificata
Instalación de depuración de agua 75,41 % en peso
NaCl, muy puro, USP
Cía. HedingerAuq. GmbH; Stuttgart, Alemania 1,35 % en peso
Para la fabricación del componente A, los ingredientes se mezclan y agitan hasta que la sal se disuelva por completo. El componente A se enfría a 2 ºC.
Componente B
Jeffamin ED-2003
Cía. Huntsman; Everberg, Bélgica 52,5 % en peso
Aqua purificata
Instalación de depuración de agua 47,5 % en peso
Para la fabricación del componente acuoso B, el Jeffamin sólido se funde a 50 ºC y se añade al agua sin dejar de mover. El componente B se enfría a temperatura ambiente.
Componente C
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Los componentes preparados A, B y C se mezclan homogéneamente en la proporción de 75,4:14,0:10,6 por homogeneización mediante un sistema de mezcla rotatorio y se introducen, a ser posible sin burbujas, en moldes previamente preparados.
B1) Espuma de poliuretano empleada
Se emplea una espuma de poliuretano hidrófila (espuma de poliuretano MCF.03R; Cía. Corpura, Etten Leur, Países Bajos). La espuma de poliuretano hidrófila seca presenta las siguientes características: a) Densidad: 77,9 – 83,7 kg/m3 (EN-ISO 845) b) Tamaño medio de poros: Ø 208 μm (determinado por medio de microscopio)
c) Grosor de capa: 2,7 mm (medidor de espesores con plato de 25 cm2, carga de 2 g/cm2, medida según EN ISO 9073-2) d) Permeabilidad al vapor de agua: MVTR (upright) = 3593 g/ m2/ 24 h (medida según DIN EN 13726-2) e) Absorción: libre absorción A1 = 20,5 g/g (medida según DIN 13726-1)
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Claims (12)

  1. REIVINDICACIONES

    1. Apósito de varias capas que comprende
    a) una primera capa como capa de contacto con la herida con un primer lado y un segundo lado y
    b) al menos una segunda capa como capa absorbente con un primer lado y un segundo lado, que comprende una espuma de poliuretano hidrófila, conteniendo la espuma de poliuretano una parte de agua de al menos un 10 % en peso, caracterizado por que la espuma de poliuretano contiene, como máximo, un 80 % en peso de agua y presenta una libre absorción A2 de al menos 10 g/g, determinándose la libre absorción según DIN-EN 13726-1 (2002).
  2. 2.
    Apósito según la reivindicación 1, caracterizado por que el agua se reparte de forma homogénea en la espuma de poliuretano.
  3. 3.
    Apósito según al menos una de las reivindicaciones anteriores, caracterizado por que la espuma de poliuretano presenta un tamaño de poros de 100 a 500 μm.
  4. 4.
    Apósito según al menos una de las reivindicaciones anteriores, caracterizado por que la espuma de poliuretano presenta un grado de hinchamiento ΔV1 máximo del 80 %.
  5. 5.
    Apósito según al menos una de las reivindicaciones anteriores, caracterizado por que la capa de contacto con la herida presenta una pluralidaad de agujeros, canales u orificios.
  6. 6.
    Apósito según al menos una de las reivindicaciones anteriores, caracterizado por que la capa de contacto con la herida comprende una matriz de hidrogel, una película de polímero, una matriz de hidrocoloide, una red de polímeros, un material no tejido o un adhesivo.
  7. 7.
    Apósito según la reivindicación 6, caracterizado por que la matriz de hidrogel es una matriz de hidrogel que contiene agua con un contenido de aguja de al menos un 20 % en peso.
  8. 8.
    Apósito según la reivindicación 6 ó 7, caracterizado por que la matriz de hidrogel comprende uun copolímero de poliuretano-poliurea.
  9. 9.
    Apósito según la reivindicación 6, 7 u 8, caracterizado por que la matriz de hidrogel presenta canales del primer al segundo lado para el paso de líquidos.
  10. 10.
    Apósito según al menos una de las reivindicaciones anteriores, caracterizado por que el apósito comprende además, como capa de soporte, una película de polímero impermeable al agua y permeable al vapor de agua o una espuma de poímero impermeable al agua y permeable al vapro de agua.
  11. 11.
    Procedimiento para la fabricación de un apósito de varias capas, que como capa absorbente comprende una espuma de poliuretano, especialmente una según las reivindicaciones anteriores, comprendiendo el preocedimiento los siguientes pasos:
    a) puesta a disposición de una espuma de poliuretano,
    b) aplicación de a la espuma de poliuretano de al menos un 10 % en peso de agua y
    c) laminado de la espuma de poliuretano que contiene agua fabricado según b) para obtener una capa de contacto con la herida.
  12. 12. Procedimiento para la fabricación de un apósito de varias capas según la reivindicación 11, impregnándose la espuma de poliuretano con agua en al menos un 10 % en peso y, como máximo, un 80 % en peso y aplicándose el agua por pulverización o inmersión.
    12
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EP3115033A1 (de) 2017-01-11
EP2309956B1 (de) 2016-09-07
PL3115033T3 (pl) 2018-10-31
AU2009265996B9 (en) 2015-03-26
PL2309956T3 (pl) 2017-07-31
AU2009265996A1 (en) 2010-01-07
RU2519683C2 (ru) 2014-06-20
BRPI0915593A2 (pt) 2016-02-02
CN102076291B (zh) 2014-10-22
CN102076291A (zh) 2011-05-25
DE102008031183A1 (de) 2010-01-07
EP3115033B1 (de) 2018-05-09
JP5514816B2 (ja) 2014-06-04
JP2011526176A (ja) 2011-10-06
AU2009265996B2 (en) 2014-10-16
BRPI0915593B8 (pt) 2021-06-22
US20110280926A1 (en) 2011-11-17
ES2683649T3 (es) 2018-09-27
BRPI0915593B1 (pt) 2019-09-10
EP2309956A1 (de) 2011-04-20
WO2010000451A1 (de) 2010-01-07
RU2011102839A (ru) 2012-08-10
US10130521B2 (en) 2018-11-20

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