EP1176992A1 - Adhesifs hydrogels autocollants utilises comme pansements - Google Patents

Adhesifs hydrogels autocollants utilises comme pansements

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Publication number
EP1176992A1
EP1176992A1 EP00935894A EP00935894A EP1176992A1 EP 1176992 A1 EP1176992 A1 EP 1176992A1 EP 00935894 A EP00935894 A EP 00935894A EP 00935894 A EP00935894 A EP 00935894A EP 1176992 A1 EP1176992 A1 EP 1176992A1
Authority
EP
European Patent Office
Prior art keywords
wound dressing
adhesive
wound
hydrogel
rad
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.)
Withdrawn
Application number
EP00935894A
Other languages
German (de)
English (en)
Inventor
Gianfranco Palumbo
Judith Preuschen
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.)
Procter and Gamble Co
Original Assignee
Procter and Gamble Co
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
Priority claimed from EP99109155A external-priority patent/EP1051982A1/fr
Application filed by Procter and Gamble Co filed Critical Procter and Gamble Co
Priority to EP00935894A priority Critical patent/EP1176992A1/fr
Publication of EP1176992A1 publication Critical patent/EP1176992A1/fr
Withdrawn legal-status Critical Current

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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
    • A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
    • 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

Definitions

  • the present invention relates to pressure sensitive hydrogel adhesives for use alone or in combination with medical devices such as wound dressings for the treatment of wounds, cuts, burns, ulcers, blisters and the like, on the human body.
  • Bandages, plasters, band aids and the like are well known articles of manufacture that are designed to assist in wound care management.
  • such devices comprise an absorbent dressing material which is placed in direct contact with the area to be treated and absorbs the wound exudates, in addition to providing protection against bacteria and dirt thereby minimising the risk of infection.
  • the absorbent dressing material is then typically secured to the wearer.
  • the method used to secure the dressing to the body is to a large extent dependent upon the nature and size of the wound itself.
  • the absorbent dressing material is held in place by the use of additional material such as gauze which is wrapped around the absorbent dressing material and the wearer.
  • the dressing material is typically provided on a support material which is supplied with adhesive for attachment to the wearers' skin adjacent to the area to be treated to form what is commonly known as a plaster.
  • US 5 369 155 describes a dispersed gel adhesive composites comprising a gel of swollen hydrocoiloid dispersed in a pressure sensitive adhesive matrix for use as a tape or dressing on the skin.
  • such composites have poor absorption capacity and are painful to remove from the skin.
  • hydrogel materials As a replacement for and in addition to the use of traditional absorbent dressing materials. These materials are typically water based three dimensional matrix gels formed by crosslinking polymers, preferably in the presence of a plastizicer. In contrast to the absorbent dressing materials these hydrogel materials are able to absorb some of the wound exudate whilst not drying out and becoming attached to the wound itself. This is of particular benefit as the hydrogel can then be removed from the wound and if necessary replaced without interfering in the wound healing process or causing any pain.
  • hydrogel materials are disclosed for example in the following publications; US 4 391 278, US 4 593 053, US 4 699 146, US 4 768 523,
  • hydrogels are typically at least partially transparent thereby allowing the healing process to be observed without having to disturb the wound healing process.
  • the hydrogels also allow a degree of moisture vapour transport so that the normal transport of moisture from the skin is not substantially hindered despite the presence of the hydrogel.
  • a number of these hydrogel materials also provide a cooling effect which is particularly beneficial in the treatment of bums and blisters but also finds application in minor skin conditions or ailments whereby the itching associated with the later steps of the healing process is reduced.
  • the amount of moisture absorbency is not typically controlled such that the wound may still easily become dried out and cause scarring.
  • hydrogel materials of the prior art may exhibit a minimal degree of adhesiveness or tackiness this is not sufficient in order to ensure that the hydrogel remains attached to the wound site during normal activities.
  • the wearing conditions of such materials will naturally depend on the nature of the wearer. In any case when the wearer is active, the wearing conditions become much more stressed and the risk of detachment of the hydrogel materials will increase substantially, due to the movement of the wearer and the pressure from the wearer's body and garments. Consequently these hydrogel materials are infact typically supplied or as an extrudable jelly like paste or in a sheet form and have in use little if any resilience and are easily deformed or rubbed off the skin of the wearer.
  • the hydrogel materials are typically supplied with an adhesive supportive substrate to maintain the hydrogel material in place.
  • the adhesive substrates which are utilised whilst typically having a skin compatible composition are usually strongly adhesive and may cause skin irritation or inflammation. Hence the removal from the skin cannot be achieved without the wearer experiencing pain. This is particularly undesirable under circumstances, where the plaster is misplaced, and removal and reapplication of the plaster once or even a number of times is required.
  • hydrogel adhesive which will adhere to moist or wet skin. It is yet a further objective to provide a hydrogel adhesive which is provided in an easy and simple form and can be readily utilised by the consumer and which can be provided in pre-cut sizes, as perforated strips, or as single strips which can then be cut to size, if necessary, in order to treat a variety of wound types and sizes.
  • a wound dressing comprising a hydrogel adhesive as defined hereinafter.
  • the hydrogel adhesive provides secure attachment to the skin surrounding the wound but not to the wound site itself, is pleasing to the skin upon application, and yet causes no discomfort upon removal. This is achieved by selecting the characteristics of the hydrogel adhesive, particularly in terms of the elastic modulus G' and the viscous modulus G" of the hydrogel adhesive and the thickness C of the layer of hydrogel adhesive applied and the water absorption capability, moisture vapour transport and elasticity of the wound dressing.
  • the present invention hence relates to a wound dressing comprising a hydrogel adhesive, said dressing being defined by specific functional parameters.
  • the wound dressing further comprises a supportive substrate upon which a layer of the hydrogel adhesive according to the invention is applied.
  • the characteristics which have been considered in this context are the elastic modulus describing the elastic behaviour of the material and the viscous modulus which describes the viscous behaviour of the hydrogel adhesive material.
  • the viscous behaviour of the hydrogel adhesive can be interpreted to represent an indication of the ability of the adhesive to quickly attach and securely adhere to a particular surface.
  • the elastic behaviour can be interpreted as an indication of the "hardness" behaviour of the hydrogel adhesive. Its value is also critical for good initial attachment. Their combination is believed to be an indicator of the required force upon removal.
  • the relation between elastic and viscous modulus is considered to be an indication on which fraction of the removal energy will be dissipated within the hydrogel adhesive and which fraction is available to trigger the actual removal.
  • the hydrogel adhesive has an elastic modulus at a temperature of 37°C
  • G' 37 a viscous modulus at a temperature of 37°C (100° Fahrenheit) of G" 37 , and a viscous modulus at a temperature of 25°C (77° Fahrenheit) of G" 25 .
  • the relation between the thickness or calliper C, measured in millimetres (mm), of the layer in which the hydrogel adhesive is provided, typically onto at least a portion of the supportive substrate or the skin itself, and the viscous modulus G" 25 at about 100 rad/sec of the hydrogel adhesive is relevant to the scope of providing an easy and painless removal from the wearer's skin of such a wound dressing.
  • the hydrogel adhesive of the present invention is provided as a layer having a thickness C such that the viscous modulus G" 25 (100 rad/sec) and the thickness C satisfy the following empirical equation:
  • the hydrogel adhesive provide an adhesiviness such that the peel force as determined herein is from 0.5N/inch (0.2N/cm) to 6N/inch (2.4N/cm), preferably from 1.0N/inch (0.4N/cm) to 3.5N/inch (1.4N(cm), more preferably from 1. ON/inch (0.4N/cm) to 2.5N/inch (1.0N/cm).
  • the peel strength should remain constant under normal conditions on normal healthy skin over the time period of wear.
  • the hydrogel adhesive according to the present invention preferably also satisfies the following conditions;
  • G' 37 (1 rad/sec) is in the range 500 Pa to 20000 Pa, preferably 700 Pa to 15000 Pa, most preferably 1000 Pa to 10000 Pa.
  • G" 37 (1 rad/sec) is in the range 100 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, most preferably 300 Pa to 5000 Pa.
  • G' 37 (1 rad/sec) / G" 37 (1 rad/sec) is in the range of 1 to 30.
  • the rheological behaviour can also be related to the values of the Glass Transition Temperature Tg.
  • Tg should preferably be less than -15°C, more preferably less than - 20°C and most preferably less than -25°C. Provided the above Theological conditions are satisfied the hydrogel adhesives will also satisfy conditions such as sufficient cohesiveness (to prevent residue of hydrogel adhesive on the skin) which are critical for commercial use of such hydrogel adhesives and apparent to those skilled in the art.
  • the wound dressing has a vapour permeability of from 100g/m /24hrs. to 2000g/m 2 /24hrs., preferably from 200g/m724hrs. to 1500g/m 2 /24hrs., more preferably from 200g/m 2 /24hrs. to 1000g/m 2 /24hrs..
  • the wound dressing of the present invention further exhibits a water absorption capacity as defined hereinafter of at least 100% by weight preferably at least 300%, more preferably at least 500% most preferably at 1000% by weight after 48hrs, and a
  • the wound dressing is reversibly elastic at 25% elongation as defined by the test method hereinafter of 5N or less, preferably 3N or less, most preferably 2N or less.
  • Hydrogel adhesive compositions which satisfy the above criteria can be used as adhesives for wound dressings provided they also satisfy the common requirements of being safe for use on human or animal skin during use and disposal. Often the criteria of hygienic appearance such that adhesive compositions which are transparent or white upon application are preferred.
  • the wound dressing comprises as an essential component a hydrogel adhesive as defined herein.
  • the adhesive is preferably provided on the wearer facing surface of a supportive substrate, as a layer having a thickness or calliper C that is preferably constant.
  • the layer is preferably continuous but may alternatively be provided in a discontinuous manner, e.g. in form of dots, spirals, or stripes.
  • this can be interpreted as meaning that a high fraction of the energy applied for the debonding is dissipated within the adhesive (so it is not effective in causing the debonding) and through the interface of the adhesive and the skin, while this fact causes macroscopically the recording of a very high level of adhesive force.
  • materials useful as hydrogel adhesives according to the present invention have rheological characteristics which are measured at a reference temperature of 37°C (as usual body temperature of humans) and in a range of frequencies. It has been found that upon application of a wound dressing with a hydrogel adhesive, the adhesive contact is formed at a low frequency, while debonding happens at the speed of removing the dressing. This speed is expressed as a frequency of 100 rad/s, while the low frequency of forming the adhesive bond has been found to be on the order of 1 rad/s. Therefore, the frequency range for use according to the present invention is between 1 and 100 rad/s.
  • the absolute values of the elastic modulus should not be too high, otherwise the adhesive is too hard and it is not able to intimately join or mold to the surface to which it is expected to adhere. It is also important to have a low absolute value of G" in order to have good cohesion while the material remains soft and capable of gently adhering to skin.
  • the ratio of G' 37 (1 rad/sec) over G" 37 (1 rad/sec) is important to ensure that these two values are balanced upon adhesion to the skin.
  • the Glass Transition Temperature Tg of the adhesive composition is a parameter which is useful to more fully define the group of useful adhesives.
  • the hydrogel adhesive of the present invention is provided as a layer having a thickness C such that the viscous modulus G" 25 (100 rad/sec) and the thickness C satisfy the following empirical equation:
  • G' 37 (1 rad/sec) is in the range 500 Pa to 20000 Pa, preferably 700 Pa to 15000 Pa, most preferably 1000 Pa to 10000 Pa.
  • G" 37 (1 rad/sec) is in the range 100 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, most preferably 300 Pa to 5000 Pa.
  • the ratio of G' 37 (1 rad/sec) / G" 37 (1 rad/sec) is in the range of 1 to 30.
  • 1 rad/s up to 100 rad/s should preferably be 3.3 or above, more preferably 5 or above, most preferably 10 or above, while not exceeding about 30, preferably 20, anywhere in the frequency interval.
  • the rheological behaviour can also be related to the values of the Glass
  • Tg Transition Temperature
  • Tg should preferably be less than -15°C, more preferably less than -20°C and most preferably less than -25°C.
  • the wound dressing of the present invention has an adhesivity such that it has a peel force of from 0.5N/inch (0.2N/cm) to 6N/inch (2.4N/cm), preferably from 1 N/inch (0.4N/cm) to 3.5N/inch (1.4N/cm), more preferably from 1. ON/inch (0.4N/cm) to 2.5N/inch (1.ON/cm).
  • wound dressings which are compliant with the skin, ensure secure attachment, painless removal from the skin and effective multiple reapplication must not only meet the above rheology requirements but also a reversible elasticity parameter as defined hereinafter.
  • the wound dressing not only provide secure and painless attachment, and removal from the skin, but also that the wound dressing allows the skin bound to the hydrogel adhesive to move unhindered.
  • the wound dressing exhibit sufficient flexibility to enable the dressing to be applied to the skin at the site of the wound and adapt to the contours of the body.
  • the wound dressing is selected such that it allows the skin to stretch as required by certain bodily movements or functions without the wearer experiencing any pain but again still ensuring secure attachment during the entire period of wear. This is particularly important for wounds on sites such as elbows or knees. It is also important that if the wound dressing is applied to stretched skin for example or if the skin becomes stretched during wear, the skin bonded to the adhesive should be able to contract once the wearer resumes a relaxed position without the wearer experiencing any pain.
  • a wound dressing having a reversible elasticity at 25% elongation as defined by the test method hereinafter of 5N or less, preferably of 3N or less, most preferably of 2N or less provides such a benefit.
  • the ability of the wound dressing to stretch with the skin can be quantified by this test. Whilst not being bound by theory it is further believed that the ability of the wound dressing to be reversibly elastic is dependent upon the combination of the properties of the substrate material if present and in particular the elastic modulus (G ) of the hydrogel adhesive.
  • the wound healing process can be divided into three key phases; I Inflammatory Phase, II Proliferation Phase and III Remodelling Phase.
  • the inflammatory phase occurs immediately and up to about 5 days during which the blood clot is formed.
  • the proliferation phase which typically lasts up to 3 weeks, involves granulation, whereby fibroblasts lay a bed of collagen, contraction of the wound edges and epithelialization.
  • the final remodelling phase occurs from 3 weeks to 2 years during which period new collagen is formed.
  • the wound dressing has a vapour permeability of from 100g/m 2 /24hrs. to 2000 g/m 2 /24hrs., preferably from 200g/m 2 /24hrs. to 1500g/m 2 /24hrs., more preferably from 200g/m 2 /24hrs. to 1000g/m /24hrs.
  • this level of moisture permeability also ensures that the hydrogel adhesive material itself retains sufficient water and does not dry out.
  • another essential feature of the present invention is the ability of the wound dressing to absorb moisture. This is important so that the fluids which are dissipated from the wound particularly immediately after the formation of the wound are absorbed by the dressing so as to avoid inflammation or skin maceration.
  • the maintenance of the wound in a moist environment is beneficial to the wound healing process and stimulates healing and reduces infection rates. Thus it is also important to prevent the wound becoming dry.
  • the ability of the hydrogel adhesive to absorb fluid also plays an important role in the generation of a seal around the periphery of the wound site.
  • a wound dressing having a moisture absorption capacity of at least 100% by weight, preferably at least 300%, more preferably at least 500% most preferably at least 1000% in 48 hrs. and, which has a water absorption transport rate of at least 0.0001 g/cm 2 /s 1 2 , preferably from 0.0005g/cm 2 /s 1/2 to 0.1g/cm 2 /s 1/2 , more
  • hydrogel adhesive refers to a material comprising a polymer which forms a crosslinked 3-dimensional matrix and comprises at least 5% preferably at least 10% most preferably at least 15% by weight of the hydrogel adhesive of water.
  • the hydrogel adhesive comprises less than 10%, preferably less than 5% and is most preferably free of hydrocoiloid particles.
  • hydrocoiloid particles refers to materials mixtures of materials selected from starch, modified starches such as dextrin, cellulose ester such as carboxymethycellulose, and natural gums such as pectin karaya, gelatin, guar gum, gum arabic, locust bean gum, and carboxypolymethylene.
  • the 3 dimensional matrix also referred to herein as a gel, comprises as an essential component a polymer which can be physically or chemically cross linked.
  • the polymer may be naturally or synthetically derived.
  • the uncrosslinked polymer includes repeating units or monomers derived from vinyl alcohols, vinyl ethers and their comonomers, carboxy vinyl monomer, vinyl ester monomers, esters of carboxy vinyl monomers, vinyl amide monomers, anionic vinyl monomers, hydroxy vinyl monomers, cationic vinyl monomers containing amines or quaternary groups, N-vinyl lactam monomers, polyethylene oxides, polyvinylpyrrolidone (PVP), polyurethanes, acrylics such as methyl acrylate, 2-hydroxyethyl methacrylate, methoxydiethoxyethyl methacrylate and hydroxydiethoxyethyl methacrylate, acrylamides.and sulphonated monomers for example 2 acrylamido methylpropane sulph
  • the uncrosslinked polymer may be a homopolymer or copolymer of a polyvinyl ether, or a copolymer derived from a half ester of maleic ester.
  • any other compatible monomer units may be used as comonomers such as for example vinyl alcohol and acrylic acid or ethylene and vinyl acetate.
  • Particularly preferred polymers are acrylics, sulphonated polymers such as acrylamide sulphonated polymers, vinyl alcohols, vinyl pyrrolidone, polyethylene oxide and mixtures thereof. Most preferred are nitrogen containing polymers.
  • the 3-dimensional adhesive matrix also essentially comprises a plasticiser, which is preferably a liquid at room temperature.
  • a plasticiser which is preferably a liquid at room temperature.
  • This material is selected such that the polymer may be solubilized or dispersed within the plasticiser.
  • the plasticiser must also be irradiation cross linking compatible such that it does not inhibit the irradiation cross linking process of the polymer.
  • the plasticiser may be hydrophilic or hydrophobic.
  • Suitable plasticisers include water, alcohols, polyhydric alcohols such as glycerol and sorbitol, and glycols and ether glycols such as mono- or diethers of polyalkylene gylcol, mono- or diester polyalkylene glycols, polyethylene glycols (typically up to a molecular weight of about 600), glycolates, glycerol, sorbitan esters, esters of citric and tartaric acid, citric acid, (which may also function as an antimicrobial agent), imidazoline derived amphoteric surfactants, lactams, amides, polyamides, quaternary ammonium compounds, esters such phthalates, adipates, stearates, palmitates, sebacates, or myhstates, and combinations thereof. Particularly preferred are polyhydric alcohols, polyethylene glycol (with a molecular weight up to about 600), glycerol, sorbitol, water and mixtures thereof.
  • the adhesive comprises a ratio of polymer to plasticiser by weight of from 1 :100 to 100:1 , more preferably from 50:1 to 1 :50.
  • the exact amounts and ratios of the polymer and plasticiser will depend to a large extent on the exact nature of polymer and plasticisers utilised and can be readily selected by the skilled person in the art. For example a high molecular weight polymer material will require a greater amount of plasticiser than a low molecular weight polymer.
  • Other common additives known in the art such as preservatives, antioxidants, pigments, mineral fillers, antimicrobial agents such as citric acid or chitosan and mixtures thereof may also be comprised within the adhesive composition in quantities up to 10% by weight each respectively. Such additional additives, if present, should be permanently incorporated within the hydrogel adhesive matrix structure to prevent migration to and interaction at the wound site.
  • the polymer component of the adhesive can be physically or chemically cross linked in order to form the 3-dimensional matrix.
  • Physical cross linking refers to polymers having cross links which are not chemical covalent bonds but are of a physical nature such that there are areas in the 3-dimensional matrix having high crystallinity or areas having a high glass transition temperature.
  • Chemical cross linking refers to polymers which are linked by chemical bonds.
  • the polymer is chemically cross linked by radiation techniques such as thermal-, E beam-, UV-, gamma or micro-wave radiation, UV being preferred.
  • a particular advantage of the present invention is that the wound dressings may if necessary be provided in a sterile form. This can typically be achieved during the manufacture of the hydrogel adhesive by the use of the appropriate radiation techniques as known in the art such as such as UV irradiation.
  • a polyfunctional cross linker and/or a free radical initiator may be present in the premix to initiate the crosslinking upon irradiation.
  • Such an initiator can be present in quantities up to 5% by weight, preferably from 0.02% to 2%, more preferably from 0.02% to 0.2%.
  • Suitable photoinitiators include the Irgacure series available from Ciba Speciality Chemicals. In addition from 0.02% to 2% of thermal initiators may also be used.
  • the resulting adhesive composition is mainly hydrophilic. Hydrophobic and mixed phase compositions are dependant upon the nature of the components of the adhesive.
  • the adhesives of the present invention may be mixed phase hydrophilic hydrophobic, or single phase.
  • Mixed phase adhesives are compositions in which both hydrophobic and hydrophilic components, preferably in both plasticisers and polymers, form two or more separate phases. In such cases an emulsifier is preferably present at a suitable level to form stable emulsions between the incompatible phases.
  • the hydrogel adhesive is one phase, most preferably a one phase hydrophilic adhesive.
  • the adhesive is provided, typically on at least a portion of the wearer facing surface of a supportive substrate, as a layer having a thickness or calliper C that is preferably constant, or that alternatively can vary over the surface of application of the adhesive.
  • the relationship between the thickness or calliper C measured in millimetres (mm) of the layer of the adhesive typically onto at least part of the wearer's facing surface of the substrate, and the viscous modulus G" 25 at 25°C at about 100 rad/sec of the topical adhesive gives an indication of painless and easy removal of the adhesive from the skin.
  • the adhesive is preferably provided as a layer having a thickness C such that the viscous modulus G" 25 (100 rad/sec) and the thickness C of the adhesive layer satisfy the following empirical equation:
  • the thickness C of the adhesive layer is constant, such an adhesive layer can also have different thicknesses in different portions, provided that the above mentioned relationship between C and G" 25 is in any case satisfied in each portion.
  • hydrogel adhesive In order to protect the hydrogel adhesive, prior to use it typically covered with a release paper such as siliconized paper.
  • the hydrogel adhesive can cover the entire wearer facing surface of the supportive substrate but may also be provided with at least one, or preferably two non-adhesive portions. These portions can thereby serve to facilitate the placement and removal of the wound dressing whilst avoiding contact with the hydrogel adhesive and thereby preventing any contamination. These portions are however preferably also covered by the release means. Before application to the skin of the wearer, the release means if present is removed.
  • the hydrogel is provided as a layer at a thickness of from 0.02 mm to 5 mm, preferably from 0.5 mm to 4.0 mm, more preferably from 1 mm to 3 mm.
  • the hydrogel adhesive is applied at a basis weight of from 20g/m 2 to 5000g/m 2 , more preferably from 100g/m 2 to 3000g/m 2 most preferably from 500g/m 2 to 2000g/m 2 depending on the end use envisioned. For example, for large surfaces the amount of adhesive may be more than for wound dressings designed for small applications.
  • the wound dressing in addition to the hydrogel adhesive preferably further comprises a supportive substrate to render one surface of the hydrogel adhesive that may come into contact with garments of the wearer, non adhesive and to provide strength and resiliency.
  • the substrate material must be selected so as to ensure that the required parameters discussed hereinabove are obtained.
  • the hydrogel adhesive composition is typically treated so as to render the garment facing surface of the hydrogel adhesive substantially non adhesive.
  • the supportive substrate may be selected from any suitable material and should preferably be selected such that it is made of soft, flexible and malleable material to allow easy placement of the wound dressing to the skin. Any materials which meet the parameter requirements of the wound dressing may be usefully employed herein. Typical materials include nonwoven materials, wovens, open celled thermoplastic foams, composites of open celled foams and stretch nonwoven, and or breathable films and any combination thereof. Preferably, suitable substrates have an overall thickness within the general range of 0.1 to 5 millimetres and a basis weight of 5 to 250 g/m 2 , more preferably 50 g/m 2 .
  • thermoplastic foam materials or other suitable plastics sheet materials having the described properties of such foams (i.e., softness, pliability, stretchability, and contractability) might also be used.
  • the substrate comprises an open celled foam, a nonwoven or a combination thereof. Open celled foams and nonwovens have been found particularly advantageous as the hydrogel adhesive can effectively embed itself into these materials and thereby prevent delamination. It is also of advantage to utilise supportive substrate materials which are transparent. This is particularly useful for wound dressing utilised by medical professionals, as the combination of a transparent hydrogel adhesive and a transparent supportive substrate allows the medical practitioner to inspect the wound without removal of the dressing and/or disturbance of the wound.
  • the substrate may comprise a number of layers, such as non-wovens or films.
  • a laminate may be formed from a foam or non-woven layer and a film.
  • the laminate can be formed by means known to the man skilled in the art.
  • Any non-woven layer can comprise felt fabrics, spunlaced fabrics, fluid jet entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laid fabrics, melt-blown fabrics, staple fibre carding fabrics, spunbonded fabrics, stitch-bonded fabrics, apertured fabrics, combinations of the above or the like.
  • thermoplastic material can be selected from among all types of hot-melt adhesives, polyolefins especially polyethylene, polypropylene, amorphous polyolefins, and the like; material containing meltable components comprising fibres or polymeric binders including natural fibres such as cellulose wood pulp, cotton, jute, hemp; synthetic fibres such as fibreglass, rayon, polyester, polyolefin, acrylic, polyamid, aramid, polytetrafluroethylene polyimide; binders such as bicomponent high melt/low melt polymer, copolymer polyester, polyvinyl chloride, polyvinyl acetate/chloride copolymer, copolymer polyamide, materials comprising blends wherein some of the constituent materials are not meltable; air and vapour permeable materials including microporous films such as those supplied by EXXON Chemical Co., Ill, US under the designation EXXAIRE or those supplied by Mitoplastic adhesives, polyolefins especially polyethylene, polypropy
  • a particularly preferred substrate is a laminate of PebaxTM (MV3000 at 300 ⁇ imm)) aanndd aa nnoonnwwoovveenn ((FFiibbrreellllaa 22000000,, aatt 3300gg//mm 22 )),, wwhhiicchh pprovides the required moisture vapour transport rate and which is also transparent.
  • the supportive substrate can also be treated with agents to improve its tactile perceivable softness.
  • agents include but are not limited to vegetable, animal or synthetic oils, silicone oils and the like. The presence of these agents are known to impart a silky or flannel-like feel to the substrate without rendering it greasy or oily to the tactile sense of the wearer.
  • surfactant material including anionic, non-ionic, cationic and amphoteric surfactants, may be added to further enhance softness and surface smoothness.
  • the hydrogel adhesive can be applied to the supportive substrate by any means known in the art such as slot coating, spiral, or bead application or printing, typically prior to the curing step.
  • the entire wearer facing surface of the supportive substrate is covered with the hydrogel adhesive of the present invention.
  • the wound dressing can be supplied in large strips or rolls which can be readily cut to size by the consumer to meet the particular needs of the wound.
  • the wound dressing can be provided with perforations or in pre cut sizes.
  • the wound dressing should be packaged in an air and moisture vapour impermeable packaging material to ensure that the hydrogel adhesive material maintains the desired performance characteristics upon storage.
  • a particularly suitable material is aluminium foil. Test methods
  • the Vapour permeability test is utilised to quantify the vapour transmission properties of the wound dressing.
  • the basic principle of the test is to quantify the extent of water vapour transmission through the wound dressing.
  • the test method that is applied is based on a standardised textile industry applied test method and commonly referred to as the "cup test method".
  • the test is performed in a stable temperature/humidity laboratory maintained at a temperature of 23° C at 50% RH for a period of 24 hours.
  • a representative wound dressing is selected and a sample is cut to size using the punch.
  • the sample cut is sufficiently large to adequately overlap the sample holder and to ensure material that may have been damaged or undesirably stretched due to the cutting operation lies outside of the measurement centre when the measurement is performed.
  • the sample is so arranged onto of the sample cup so as to fully overlap the cup.
  • the sample is oriented so as to ensure that the surface exposed to the laboratory environment is the same that would be found while wearing the dressing.
  • the closure ring of the sample cup is then placed onto the sample and pushed down. This ensures that the excess material is held firmly in place and does not interfere with the measurement.
  • a wax is then applied to the entire surface of the closure ring to ensure the whole upper part of the apparatus is closed to the environment. Distilled water (5 ⁇ 0.25 ml) is introduced with the syringe into the sealed sample cup via the minute perforation. Finally this perforation is sealed with silicone grease.
  • the entire cup (containing sample and water) is weighed and the weight recorded to 4 decimal places.
  • the cup is then placed in a ventilation stream generated by a fan.
  • the air flowing over the top of the sample cup is 3 ⁇ 0.3 m/sec and confirmed via a wind velocity meter ("Anemo", supplied by Deuta SpA., Italy).
  • the sample cup remains in the ventilated test field for a period of 24 hrs and is then re-weighted. During this period if the test sample is sufficiently breathable the liquid in the sample holder is able to diffuse out of the sample holder and into the laboratory environment. This results in a reduction in the weight of water in the sample holder that can be quantified on re-weighing the complete sample cup following the 24 hr period.
  • the following test method is utilised to determine the elongation of samples of the wound dressing when the sample is stretched in the machine direction (MD) or the cross direction (CD).
  • test method measures the average maximum force required to stretch the sample in MD or CD by 25%.
  • Test samples are prepared by cutting using scissors 3 samples of dimensions (6x2 cm in the MDxCD direction).
  • Polyester Film PET 23 ⁇ available from EFFEGIDI S.p.A.,43052 Colorno, Italy.
  • Dry The forearm is untreated and not wiped prior to test or between repetitions.
  • test specimen should be prepared individually and tested immediately.
  • Test Environment 1 Conditioned Room as described in C1.
  • Step C6 Execution 1 minute after Step C6, take the free end of the specimen (approx.
  • the single values are the base to calculate the standard deviation between the samples.
  • the test fluid for the test is water. This fluid is absorbed by the hydrogel adhesive under demand absorption conditions at atmosphere pressure.
  • the hydrogel adhesive is tested at a specified relatively-high basis weight.
  • a piston/cylinder apparatus is used to laterally confine the hydrogel adhesive and impose a specified static confining pressure.
  • the bottom of the cylinder is faced with a No. 400 mesh screen to retain the hydrogel adhesive and permit absorption and z-direction transport of water.
  • a computer-interfaced sorption apparatus is used to measure the water absorption versus time.
  • Sorption Apparatus with computer - See Figure 1 a) 500 ml Separator/ Funnel - filling reservoir b) Glass tubing, 2 mm ID, 8 mm OD c) Glass, 3-way Stopcock, 2 mm ID minimum d) Tygon Tubing, 1/4" ID, 3/8" OD e) 150 mm x 15 mm Petri Dish - reservoir f) Teflon Inserts with o-rings, 2 mm - glass tubing connectors g) Course Fritted Buchner Funnel, 8 cm Diameter, 8 cm Depth i) Drain
  • the quantity of fluid that drains from the frit in this procedure (called the frit correction weight) is measured by conducting the experiment (see below) for a time period of 15 minutes without the piston/cylinder apparatus. Essentially all of the fluid drained from the frit via this procedure is very quickly reabsorbed by the frit when the experiment is initiated. Thus, it is necessary to substract this frit- correction weight from weights of fluid removed from the reservoir during the test (see below). The frit correction is stable so this procedure only needs to be performed every 10 - 15 measurements.
  • a single measurement is normally sufficient as long as a smooth curve is obtained.
  • Capacity is reported in units of g water/g hydrogel adhesive. Capacity at any time is determined as follows:
  • W r (t) is the weight in grams of the reservoir at elapsed time t
  • W fC is the frit correction weight in grams (measured separately)
  • W hydrog el adhes ive: wet basis is the weight in grams of the hydrogel adhesive. Capacity is typically reported for times of 5, 10, 30, and 60 minutes after initiation.
  • the Absorption/Transport Rate is reported in units of g/cm 2 /sec 0'5 .
  • the Rate at any time is determined as follows:
  • the Uptake Rate is the tangent to the smoothed uptake curve where the y-axis is fluid uptake in units of g/cm 2 and the x-axis is the square root of time, where time is in units of seconds.
  • the following example is an example of the preparation of a wound dressing according to the present invention.
  • the tray is carried on a conveyer belt at 5m/min and passes 12 times under a mercury (Hg) UV lamp (voltage induced 6.5 V, resulting intensity of lamps 900mW/cm 2 ).
  • Hg mercury
  • the hydrogel surface is covered after the polymerisation process by a standard release paper.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un pansement comprenant un adhésif hydrogel aux propriétés d'adhérence sur la peau améliorées, qui est néanmoins facile à appliquer sur la peau de l'utilisateur et à enlever, et qui améliore le processus de cicatrisation.
EP00935894A 1999-05-10 2000-05-09 Adhesifs hydrogels autocollants utilises comme pansements Withdrawn EP1176992A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP00935894A EP1176992A1 (fr) 1999-05-10 2000-05-09 Adhesifs hydrogels autocollants utilises comme pansements

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
EP99109155 1999-05-10
EP99109155A EP1051982A1 (fr) 1999-05-10 1999-05-10 Adhésifs autocollants aux hydrogels et son utilisation comme pansement pour blessure
EP99122204 1999-11-06
EP99122204A EP1051983A1 (fr) 1999-05-10 1999-11-06 Adhésifs autocollants aux hydrogels et son utilisation comme pansement pour blessure
EP00935894A EP1176992A1 (fr) 1999-05-10 2000-05-09 Adhesifs hydrogels autocollants utilises comme pansements
PCT/US2000/012692 WO2000067810A1 (fr) 1999-05-10 2000-05-09 Adhesifs hydrogels autocollants utilises comme pansements

Publications (1)

Publication Number Publication Date
EP1176992A1 true EP1176992A1 (fr) 2002-02-06

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ID=26152998

Family Applications (2)

Application Number Title Priority Date Filing Date
EP99122204A Withdrawn EP1051983A1 (fr) 1999-05-10 1999-11-06 Adhésifs autocollants aux hydrogels et son utilisation comme pansement pour blessure
EP00935894A Withdrawn EP1176992A1 (fr) 1999-05-10 2000-05-09 Adhesifs hydrogels autocollants utilises comme pansements

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP99122204A Withdrawn EP1051983A1 (fr) 1999-05-10 1999-11-06 Adhésifs autocollants aux hydrogels et son utilisation comme pansement pour blessure

Country Status (3)

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EP (2) EP1051983A1 (fr)
AU (1) AU5128900A (fr)
WO (1) WO2000067810A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100360605B1 (ko) * 2000-08-17 2002-11-18 주식회사 지인텍 의료기기
GB201019161D0 (en) 2010-11-12 2010-12-29 Reckitt Benckiser Nv Multi-dosing device
JP7155579B2 (ja) * 2018-03-30 2022-10-19 株式会社リコー ハイドロゲル構造体、その製造方法、及び臓器モデル

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5270358A (en) * 1989-12-28 1993-12-14 Minnesota Mining And Manufacturing Company Composite of a disperesed gel in an adhesive matrix
US5674275A (en) * 1994-04-06 1997-10-07 Graphic Controls Corporation Polyacrylate and polymethacrylate ester based hydrogel adhesives
US5846214A (en) * 1996-03-29 1998-12-08 Nichiban Company Limited PVA hydrogel, hydrogel laminate using the same and hydrogel wound-dressing material using the same
EP0852149A1 (fr) * 1996-12-23 1998-07-08 The Procter & Gamble Company Adhésif topical pour la peau et enlèvement confortable

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0067810A1 *

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EP1051983A1 (fr) 2000-11-15
WO2000067810A1 (fr) 2000-11-16
AU5128900A (en) 2000-11-21

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