EP1082148A1 - Pansement ou adhesif destine a etre applique sur la peau - Google Patents

Pansement ou adhesif destine a etre applique sur la peau

Info

Publication number
EP1082148A1
EP1082148A1 EP99930030A EP99930030A EP1082148A1 EP 1082148 A1 EP1082148 A1 EP 1082148A1 EP 99930030 A EP99930030 A EP 99930030A EP 99930030 A EP99930030 A EP 99930030A EP 1082148 A1 EP1082148 A1 EP 1082148A1
Authority
EP
European Patent Office
Prior art keywords
adhesive
skin
dressing
plastic film
elastomer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP99930030A
Other languages
German (de)
English (en)
Inventor
Stefan Areskoug
Tomas Fabo
Marie-Ange Nyssen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Molnycke Health Care AB
Original Assignee
Molnycke Health Care AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Molnycke Health Care AB filed Critical Molnycke Health Care AB
Publication of EP1082148A1 publication Critical patent/EP1082148A1/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/58—Adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties

Definitions

  • the present invention relates to a plastic film dressing or an affixing tape for skin applications, comprising a plastic film layer coated with adhesive on one side thereof.
  • Thin adhesive wound dressings made from a plastic film that is permeable to water vapor for instance OpSite® (Smith & Nephew, England) or Tegaderm® (3M, USA), include an acrylate-type adhesive or an adhesive that has similar properties. When repeatedly applied and removed, such adhesives are apt to remove with them parts of the upper skin layer (the stratum corneum) and consequently dressings of this nature are liable to result in skin damage. These adhesives also fasten strongly to skin hairs, therewith causing pain and discomfort as the dressing is removed.
  • a gauze dressing designated Mepitel®, which is affixed to the skin by means of a very soft adhesive silicone elastomer.
  • a silicone elastomer has skin-friendly adhesive properties and is much more gentle to the skin than the aforesaid adhesives. Neither does it tend to strip away parts of the stratum corneum as it is removed. A person wearing such a dressing will not experience discomfort or pain as the dressing is removed. The adhesiveness of the silicone elastomer is not impaired by removal of the dressing, and the dressing can therefore be removed and replaced several times.
  • the adhesives used with plastic film dressings could be replaced with an adhesive elastomer that has adhesive characteristics similar to those of the silicone elastomers used with Mepitel®, particularly when the dressing is to be applied to sensitive skin.
  • an adhesive elastomer that has adhesive characteristics similar to those of the silicone elastomers used with Mepitel®, particularly when the dressing is to be applied to sensitive skin.
  • One serious problem in this regard is that such elastomers have been found to adhere to the skin with the same strength as that to which they adhere to the plastic film, and consequently there is a serious risk of the elastomer layer, or large parts thereof, remaining on the skin when attempting to remove the dressing.
  • One object of the present invention is to solve this problem and to provide a functional film dressing which includes a layer of soft, adhesive elastomer.
  • a dressing or affixing tape for skin applications which includes a plastic film layer that is coated with adhesive on one side thereof and which is characterized in that anchoring elements in particle form are fastened to the plastic film layer over the whole of that side thereof which is coated with a fully or partially covering layer of adhesive; and in that the adhesive is comprised of a soft, adhesive elastomer which surrounds the anchoring elements and which has a smooth, unbroken surface on the side thereof distal from the plastic film.
  • the adhesive elastomer is affixed to the plastic film via the anchoring elements, the elastomer will be anchored more strongly to the film than would otherwise be the case, so as to avoid the risk of the elastomer remaining on the skin when the dressing is removed therefrom.
  • the anchoring elements affixed to the plastic film do not reduce the flexibility and stretchability of the plastic film to any appreciable extent, these properties being important in some types of dressing.
  • the anchoring elements are comprised of short fibres and the adhesive elastomer is a silicone elastomer.
  • the anchoring elements are comprised of particles.
  • Figure 1 is a schematic cross-sectional view of a plastic film dressing or affixing tape for skin applications, according to one preferred embodiment of the invention.
  • Figure 2 illustrates a softnesss measuring instrument.
  • the wound dressing illustrated in the figure is comprised of a plastic film layer 1 whose underside is coated with a layer of adhesive elastomer 2.
  • Anchoring elements 3 in the form of short, loose fibres are affixed to the plastic film over the whole of its undersurface. The anchoring elements 3 have been affixed to the underside of the layer 1 prior to applying the elastomer layer 2 and function to increase the surface area with which the elastomer comes into contact.
  • the elastomer will adhere to the film layer 1 carrying the anchoring elements 3 with a greater force than that with which it adheres to the skin, therewith enabling a skin dressing of this kind to be removed safely from the skin without risk of the elastomer releasing its attachment with the film layer and remaining on the skin.
  • said anchoring elements will preferably be affixed to the plastic film in a discrete fashion, i.e. mutually unconnected.
  • the anchoring elements will also preferably be distributed relatively uniformly over the underside of the plastic film, so as to avoid local variations in the adhesion of the elastomer to the plastic film.
  • the anchoring elements 3 may comprise cellulose fibres measuring from 0.1-3 mm in length. Such fibres can be fastened to the film layer 1, by first providing the layer with a glue coating and then scattering or strewing the loose fibres over said glue layer, e.g. by air laying. Fibres other than cellulose fibres may, of course, be used, for instance viscose fibres, cotton fibres, polyester fibres, polyamide fibres and like fibres.
  • the anchoring elements may be affixed to the film by flocculation or extrusion for instance.
  • fibres are preferred as anchoring elements, there may be used, in principle, all types of particle material that can be fastened to plastic film.
  • particle material is meant in this document in addition to the aforesaid fibre material all material that consists of individual bodies having a size smaller than 10 " mm regardless of the shape of said bodies.
  • the particle material may comprise plastic granulate, silicone dioxide, silicone or the like.
  • the elastomer layer shall have a thickness that exceeds the largest dimension of the particles, so as to ensure that all particles will be enclosed regardless of the position in which said particles have been affixed to the film layer.
  • the elastomer layer is preferably formed by an adhesive silicone elastomer retailed under the designation Silgel 612 by Wacker Chemie GmbH, Germany. It will be understood, however, that other soft, adhesive silicone elastomers, hydrogels or soft adhesive hot melt glue can be used.
  • the wound dressing may, of course, be perforated, especially if it includes an overlaying absorbent pad.
  • sterilise the dressing by means of some conventional sterilisation method, e.g. b-sterilisation, steam sterilisation or sterilisation with ethylene oxide.
  • some conventional sterilisation method e.g. b-sterilisation, steam sterilisation or sterilisation with ethylene oxide.
  • skin-friendly adhesion is used in this document to characterise a particular form of adhesion exhibited by the soft, adhesive elastomers suited for use with the invention.
  • glues having relatively similar properties are used normally on adhesive dressings and surgical plasters of different kinds.
  • a common feature of the glues normally used is that they adhere to the outermost layer of dead skin cells (stratum corneum) so firmly that a number of layers of these cells will be stripped from the skin by the glue as the adhesive dressing is removed.
  • the glues used at present are most often acrylate-type glues, although hot melt glues and polyisobuthylene glues are also often used.
  • the penetration - which constitutes a measurement of softness - shall lie within the range of 7-20 mm, whereas corresponding values for those glues that are normally used with adhesive dressing are less than 3 mm. Penetration is measured by means of a method based on ASTM D 937 and D 51580.
  • the equipment used is a penetrometer PNR 10, Sommer & Runge KG, Germany.
  • a test body weighing 62.5 g and comprising a cone weighing 15 g and bearing article number 18-0122 and a rod weighing 47.5 g and bearing the article number 18-0042 was placed in the penetrometer vertically above a cylindrical cup containing the material to be tested, with the apex of the cone touching the surface of the test material.
  • the test body was then allowed to fall freely down into the cylindrical cup.
  • the extent to which the test body had penetrated the test material was measured after a time lapse of 5 seconds.
  • the cylindrical cup had a diameter of 50 mm and a height of 30 mm.
  • the cup was filled with test material to a level of 25 mm.
  • the soft elastomers having skin-friendly adhesive properties and used in accordance with the present invention had considerably weaker adhesive bonds to the skin than the glues normally used with adhesive dressings. Consequently, elastomers that have skin-friendly adhesive properties leave the stratum corneum essentially intact when dressings containing such elastomers are peeled or pulled away.
  • the elastomers nevertheless create secure and positive adhesion, i.e. there is small risk of the dressing loosening by itself, by virtue of the fact that the softness of the elastomer causes it to pass down into the skin and therewith provide a large effective contact surface.
  • the softness of the elastomer also results in a large energy build-up in the elastomer and its carrier when removing the dressing, which also results in more positive adhesion to the skin.
  • an adhesive dressing shall have a stripping effect of maximum 10% in the case of normal skin.
  • a dressing that includes a skin-friendly adhesive elastomer will only carry with it a very limited number of stratum corneum cells when the dressing is removed, the surface of the elastomer layer will be relatively unchanged after removal of the dressing. This enables a dressing of this nature to be re-applied, since it adhesiveness has not been impaired to any appreciable extent.
  • the adhesive surface of a dressing which pulls stratum corneum cells from the skin will be substantially covered with the cells subsequent to its removal. This means that dressings of this nature will fail to stick to the skin when attempting to re- apply the dressings.
  • Duoderm®, OpSite® and Leukoporev® lose from 70 to 100% of their adhesiveness, whereas skin-friendly adhesive dressings lose less than 10%.
  • the adhesive force of Duoderm®, OpSite® and Leukopore® was measured at 1.2, 2.2 and 0.8 N/25 mm respectively with tape applied to the backs of healthy test persons and left in place for 24 hours.
  • the silicone tape used in the stripping test above had a skin adhesion strength of 1.5 N/25 mm.
  • the plastic film will suitably comprise polyurethane, although other plastics, such as silicone plastic, may be used.

Abstract

L'invention concerne un pansement film plastique ou un adhésif destiné à être appliqué sur la peau et comprenant une couche film plastique (1) recouverte de colle (2) sur une face. Selon l'invention, des éléments d'ancrage (3) en forme de particules sont fixés à la couche film plastique (1) sur toute la face enduite de colle (2). La colle, constituée d'un élastomère collant aux propriétés d'adhésion eudermique, enveloppe les éléments d'ancrage et a une surface uniforme continue sur la face opposée au film plastique.
EP99930030A 1998-05-28 1999-05-27 Pansement ou adhesif destine a etre applique sur la peau Ceased EP1082148A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9801898 1998-05-28
SE9801898A SE510908C2 (sv) 1998-05-28 1998-05-28 Sårförband eller fixeringstejp för hud innefattande ett plastfilmsskikt belagt med en klibbig elastomer innehållande partikelformiga förankringselement
PCT/SE1999/000904 WO1999061078A1 (fr) 1998-05-28 1999-05-27 Pansement ou adhesif destine a etre applique sur la peau

Publications (1)

Publication Number Publication Date
EP1082148A1 true EP1082148A1 (fr) 2001-03-14

Family

ID=20411501

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99930030A Ceased EP1082148A1 (fr) 1998-05-28 1999-05-27 Pansement ou adhesif destine a etre applique sur la peau

Country Status (7)

Country Link
EP (1) EP1082148A1 (fr)
JP (1) JP2002516152A (fr)
CN (1) CN1303304A (fr)
CA (1) CA2332795A1 (fr)
PL (1) PL344443A1 (fr)
SE (1) SE510908C2 (fr)
WO (1) WO1999061078A1 (fr)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060002949A1 (en) 1996-11-14 2006-01-05 Army Govt. Of The Usa, As Rep. By Secretary Of The Office Of The Command Judge Advocate, Hq Usamrmc. Transcutaneous immunization without heterologous adjuvant
JP2004525921A (ja) * 2001-03-19 2004-08-26 イオマイ コーポレイシヨン 経皮免疫用パッチ
SE0500061L (sv) 2005-01-11 2006-07-12 Moelnlycke Health Care Ab Tätande filmförband
SE0500063L (sv) 2005-01-11 2006-07-12 Moelnlycke Health Care Ab Komponent för att täta runt en öppning i huden
SE0500062L (sv) 2005-01-11 2006-07-12 Moelnlycke Health Care Ab Komponent för att underlätta infästning av ett stomibandage mot hud
GB0606661D0 (en) 2006-04-03 2006-05-10 Brightwake Ltd Improvements relating to dressings
US20120029455A1 (en) * 2009-02-02 2012-02-02 Bsn Medical Gmbh Wound dressing, method for the production thereof, and use thereof for dressing wounds
EP2453858B2 (fr) 2009-07-16 2017-09-13 Brightwake Limited Procédé
GB2493960B (en) 2011-08-25 2013-09-18 Brightwake Ltd Non-adherent wound dressing

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE455466C (sv) * 1986-03-10 1993-06-17 Moelnlycke Ab Foerband foer vaetskande saar
GB8911151D0 (en) * 1989-05-16 1989-07-05 Smith & Nephew Dressings
SE503384C2 (sv) * 1994-09-20 1996-06-03 Moelnlycke Ab Förband innefattande en silikongel i vilken ett bärarmaterial är inneslutet
SE505000C2 (sv) * 1996-05-14 1997-06-09 Moelnlycke Ab Sårförband samt tillverkningsförfarande därför

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9961078A1 *

Also Published As

Publication number Publication date
JP2002516152A (ja) 2002-06-04
CN1303304A (zh) 2001-07-11
WO1999061078A1 (fr) 1999-12-02
SE9801898L (sv) 1999-07-05
CA2332795A1 (fr) 1999-12-02
SE510908C2 (sv) 1999-07-05
PL344443A1 (en) 2001-11-05
SE9801898D0 (sv) 1998-05-28

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