US20160121013A1 - Fibres, a process for producing such fibres and a wound dressing incorporating them - Google Patents

Fibres, a process for producing such fibres and a wound dressing incorporating them Download PDF

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US20160121013A1
US20160121013A1 US13/811,483 US201113811483A US2016121013A1 US 20160121013 A1 US20160121013 A1 US 20160121013A1 US 201113811483 A US201113811483 A US 201113811483A US 2016121013 A1 US2016121013 A1 US 2016121013A1
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Prior art keywords
fibres
pectin
weight
proteinaceous material
multi component
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English (en)
Inventor
Lucy Louisa BALLAMY
Sharon Lam Po Tang
Marion Herbe
Alan Rogers
Sean Kelly
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Convatec Technologies Inc
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Convatec Technologies Inc
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Assigned to WILMINGTON TRUST (LONDON) LIMITED, AS COLLATERAL AGENT reassignment WILMINGTON TRUST (LONDON) LIMITED, AS COLLATERAL AGENT SECURITY AGREEMENT Assignors: 180 MEDICAL, INC., CONVATEC INC., CONVATEC TECHNOLOGIES INC., PRN MEDICAL SERVICES, LLC
Assigned to CONVATEC TECHNOLOGIES INC. reassignment CONVATEC TECHNOLOGIES INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: WILMINGTON TRUST (LONDON) LIMITED
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    • 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
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/225—Mixtures of macromolecular compounds
    • 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
    • A61L15/44—Medicaments
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0052—Mixtures of macromolecular compounds
    • B29C47/0014—
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/05—Filamentary, e.g. strands
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/919—Thermal treatment of the stream of extruded material, e.g. cooling using a bath, e.g. extruding into an open bath to coagulate or cool the material
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/06—Wet spinning methods
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
    • D01F4/00—Monocomponent artificial filaments or the like of proteins; Manufacture thereof
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
    • D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
    • D01F8/02—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from cellulose, cellulose derivatives, or proteins
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/23—Carbohydrates
    • A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/432—Inhibitors, antagonists
    • A61L2300/434—Inhibitors, antagonists of enzymes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2005/00—Use of polysaccharides or derivatives as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/731—Filamentary material, i.e. comprised of a single element, e.g. filaments, strands, threads, fibres

Definitions

  • the present invention is directed at fibres and in particular the use thereof in wound dressings for the reduction of the damaging activity of wound exudate components such as protein degrading enzymes and inflammatory mediators in wounds and a method of preparing the fibres.
  • the fibres are used particularly for the binding, sequestering or inhibiting of damaging components present in a chronic wound environment.
  • the fibres are preferably multi component fibres comprising pectin and more preferably pectin and gelatin.
  • inflammation-derived components such as protein degrading enzymes (proteases), lipid mediators, and the like
  • proteases There are two main classes of proteases, the matrix metalloproteinases (MMPs) and the elastases, which act in concert in order to be effective in breaking down body tissue.
  • MMPs matrix metalloproteinases
  • elastases which act in concert in order to be effective in breaking down body tissue.
  • the synthesis of new granulation tissue may be inhibited by elevated levels of enzymes which could impede the healing process. It has therefore been seen as desirable to reduce these elevated or excess levels of inflammation-derived components from the wound environment to enhance wound healing.
  • Wound healing may be observed by visual improvement of the wound bed (new granulation tissue formation) and a reduction in wound size.
  • a number of wound dressings were proposed with the aim of modulating protease in a wound.
  • These dressings include PromogranTM (Systagenix Wound Management), a lyophilized collagen-oxidised regenerated cellulose composition in the form of a matrix sheet that gels on contact with wound exudate. It is however targeted only at MMPs.
  • BiostepTM (Smith & Nephew)
  • EDTA ethylenediaminetetraacetic acid
  • TegadermTM Matrix which has as its active ingredients a mixture of metal salts which are claimed to modulate MMPs is in the form of a matrix sheet. Besides specificity to MMPs, all these dressings have limited fluid handling capability in comparison to fibre based dressings and particularly those based on Hydrofiber® such as AQUACEL® (ConvaTec Inc).
  • dressings are known that are either specific to one of the two major classes of proteinases known to be in chronic wounds and therefore are of limited effectiveness, or have limited fluid handling capability, or are dressing components in a form that presents practical difficulties, for example they are in powder form. Powders, if loose in the dressing, can fall out and need to be removed by irrigation of the wound. If contained in some kind of pocket in the dressing or used a separate pocketed component cannot be cut to fit the wound without encountering the problems of loose powder.
  • US2002012693A discloses a dressing said to have protease-lowering activity which is composed of a support matrix onto which peptide elastase inhibitors are incorporated by covalent bonding. The composition is targeted at elastase only.
  • US2006142242A discloses a phosphate starch composition said to have both elastase and MMP sequestering capability but typically used in the form of a powder.
  • Fibres based on pectin have now been made that are suitable for use in the treatment of wounds to alleviate the above problems.
  • multi component fibres for the reduction of the damaging activity of wound exudate components such as protein degrading enzymes and inflammatory mediators in wounds, the fibres comprising:
  • the fibres may comprise a sacrificial proteinaceous material such as gelatin, collagen, globular protein such as whey, soy and milk protein, albumin or casein.
  • a sacrificial proteinaceous material such as gelatin, collagen, globular protein such as whey, soy and milk protein, albumin or casein.
  • the function of sacrificial proteinaceous material when present is to maximally occupy the catalytic activities of the proteinases thereby reducing the proteinase activity against body proteins.
  • the sacrificial proteinaceous material is gelatin.
  • the fibres may comprise another polysaccharide such as alginate, chitosan or its derivatives or derivatives of cellulose, guar gum, xanthan gum, locust bean gum, dextrin, agar-agar, cellulose gum or other starch based material and to improve the fluid handling capabilities the fibres may comprise a water soluble polymer such as polyacrylate, polyester or polyamide.
  • a water soluble polymer such as polyacrylate, polyester or polyamide.
  • the fibres may comprise silver, gold and platinum or salts thereof and/or chelating agents such as EDTA or citric acid.
  • the fibres may also comprise divalent ions such as calcium or zinc, magnesium, copper or iron and buffering agents or a humectant or surfactant to improve textiling such as polysorbate.
  • the fibres comprise from 75% to 100% by weight of the fibres or more preferably 90% to 100% of pectin and a sacrificial proteinaceous material in a weight ratio of 100:0 to 10:90 pectin to sacrificial proteinaceous material.
  • the weight ratio of pectin to sacrificial proteinaceous material in the fibres is from 90:10 to 10:90, more preferably 90:10 to 30:70, or 80:20 to 50:50 and more preferably 70:30.
  • a wound dressing comprising multi component pectin fibres for use in the reduction of the damaging activity of wound exudate components such as protein degrading enzymes and inflammatory mediators in wounds.
  • the wound dressings of the present invention may comprise other fibres in addition to the multi component pectin fibres such as cellulose or cellulose derivative fibres.
  • the fibres may be present as a homogenous blend of multi component fibres with textile or gel forming fibres or may be present as a discrete layer in a wound dressing construct.
  • the dressing may comprise from 10% to 100% by weight of multi component pectin fibres with 0% to 90% by weight of another gel forming fibre such as CMC fibre.
  • the dressing may comprise from 25% to 75% by weight of multi component pectin fibres with 25% to 75% by weight of another gel forming fibre, more preferably the dressing comprises a 50% to 50% blend.
  • Multi component pectin fibres suitable for use according to the present invention can be prepared by the following steps:
  • the dope solution is prepared at a concentration from 2 to 11% (w/v) by dissolving pectin in hot water (40-80° C.) until a homogenous opaque mixture is obtained followed by cooling to room temperature and resting to stabilise the viscosity and remove air bubbles.
  • Spinning to form the fibres may be done by conventional wet spinning which includes passing the dope through a spinneret into a coagulation bath which can be composed of divalent metal ions such as calcium chloride or zinc chloride at a concentration from 0.5 to 35% (w/v). Next, the obtained pectin fibres may be washed and stretched in a water bath.
  • the fibres may be rinsed in a water miscible non-aqueous solvent such as acetone, IDA, isopropyl alcohol or propan-2-ol to remove any residual water from the fibre core and facilitate drying, followed by a drying step at a temperature generally below 120° C.
  • a water miscible non-aqueous solvent such as acetone, IDA, isopropyl alcohol or propan-2-ol
  • electrospinning may be used to produce nanofibres for example fibres having a diameter of a few hundred namometers.
  • Pectin suitable for use in the fibres or the preparation of fibres according to the invention is preferably either low methoxy pectins with methoxyl content lower than 15%, or amidated pectin with a degree of esterification in a range from 10 to 30% and a degree of amidation comprised between 10 and 30%.
  • the molecular weight of these pectins is preferably in a range of 30,000 and 85,000 daltons so as to optimise the required viscosity of the dope solution and the tensile strength properties of the fibres.
  • Suitable pectin is that available commercially as GENU Pectin Type LM-104 AS-FS ex CP Kelco which is a pectin stabilised with sugar.
  • Gelatin for use in the fibres or the preparation of fibres according to the invention is preferably of Type A gelatin. Suitable gelatin is that available commercially as porcine
  • fibre means both relatively short, discrete, randomly oriented material (sometimes known as staple fibre) and yarns made therefrom (sometimes known as staple yarn) and relatively long, structured, continuous filament yarn or continuous filament fibre.
  • the fibres may have a staple length of 5 mm to 70 mm, usually 20 mm to 50 mm.
  • the fibres may have a diameter in the nanometre to millimetre range.
  • FIG. 1 shows the MMP activity of various fibres and their components.
  • Multi component fibres according to the invention were prepared as follows.
  • the dope solution was transferred in a 3 litre kier pressurized at 5 Psi.
  • the spinning was carried out at room temperature. Directly after the kier, the dope solution was pushed through a candle filter composed of viscose cloth. Then, the dope solution was pushed through a flexible hose to a mesh filter mounted in the spinneret before going through the spinneret.
  • the spinneret had 500 holes of 75 ⁇ m diameter and the pump flow rate was set to 70 L/hour over three spinnerets of 40,000 holes each with a hole diameter of 75 ⁇ m.
  • the spin bath was a 10 litre bath of 5% (w/v) calcium chloride dehydrate in deionised water for the first run and a 10 litres bath of 5% (w/v) zinc chloride in deionised water for the second run.
  • the first wash bath was a water bath where a draw ratio of 1:6 was applied, followed by a 25% (v/v) aqueous IDA (Industrial Denatured Alcohol) bath.
  • the third wash bath was filled by a 50% (v/v) IDA aqueous solution and the fourth bath was a 75% (v/v) IDA aqueous bath.
  • the final bath was 100% IDA in which the fibres were left for about 1 hour before being removed, squeezed by hand and dried in a fan oven at 40 C.
  • the baths were separated by godets which lead the filaments through the following baths and applied a stretch to the filaments.
  • a draw ratio of 1.6 was targeted between the first godet (exit of the coagulation bath) and the second bath.
  • This example shows the proteinase uptake of the fibres.
  • Fibres manufactured with the method of Example 1 were observed under environmental scanning electron microscopy to investigate their gelling properties.
  • the fibres were found to demonstrate moderate swelling and gelling, with some areas blending in during the hydration phase.
  • the swelling ratio for the fibres spun into CaCl2 is higher, at 2.3, than that of fibres spun into ZnCl2 (1.54).
  • Fibres manufactured with the method of Example 1 were processed into a textile form.
  • the fibres were cut into staple lengths of 55 mm, opened manually using hand cards and carded using a pilot scale card of 500 mm working width. They were then needle punched into a textile web, with the characteristics given in Table 5.
  • the weight per unit area was measured gravimetrically by weighing a know size of sample.
  • the moisture regain was measured gravimetrically, after a minimum of 24 hours conditioning at 20 ⁇ 2° C. ⁇ and 65 ⁇ 4% RH, and after drying for 4 hours at 105° C. in a fan oven.
  • the absorbency and retention of the textile samples manufactured using the fibres spun into zinc chloride were measured using a BP recommended physiological solution as a hydrating medium.
  • Absorbency is measured by weighing a known size of sample (typically 5 cm ⁇ 5 cm), hydrating with 20 times its weight in the hydrating medium, incubating at 37° C. for 30 minutes, draining off excessive fluid by holding the sample with forceps for 30 seconds, and weighing the hydrated and drained sample.
  • Retention is measured by applying the weight equivalent to 40 mmHg to the hydrated and drained sample after it has been weighed, leaving for 1 minute and re-weighing. To assess further the fluid management capabilities, the ability of the material to prevent lateral spread was also evaluated.
  • Fibres manufactured with the method of Example 1 were processed into a textile form in a 50% blend with Hydrofibre tow material, using a similar route as described in Example 4.
  • the physical characteristics, and fluid handling characteristics, measured as per Example 4, are given in Table 7.
  • Multi component fibres according to the invention were manufactured in a wet spinning process similar to that described in Example 1 but on a smaller scale.
  • the fibres had a range of ratios of components as shown below.
  • the dope solution was pumped using a peristaltic pump at low flow rate (2.25 ml/min) to a spinneret which spun fibres into a 5% calcium chloride coagulation bath.
  • the fibres were collected in a bath of 50:50 IDA:water. They were then washed in 100% IDA before being air dried in a fume hood.
  • the capability of multicomponent fibres according to the invention to be formed into wound dressing was assessed along with the physical properties of the resulting dressing.
  • a medium scale spinning rig was used to produce 80 g of each type of fibre tow. The fibres were spun into either a calcium chloride bath or a zinc chloride bath. The resulting tow was opened, carded and needled in order to produce a non-woven fabric. From each tow, two non woven pads were produced, one with 100% fibres according to the invention and one with 50% fibre according to the invention and 50% of Hydrofibre® a carboxymethyl cellulose fibre produced from Lyocell and available in the product Aquacel (ex ConvaTec). The resulting pads were irradiated to evaluate any change in key physical properties.
  • wet Spinning The wet spinning process was the same as that used in Example 1. Once the fibres had been washed they were cut, tied at one end and placed in a bath containing 100% IDA for 1 hour. The fibres were then squeezed and placed in an oven at 40 C for an hour until dry.
  • the dried fibres were cut to 55 mm and opened manually using hand cards. They were carded using a pilot scale Automatex Model CA500 card with a 500 mm working width, single swift, 3 pairs of workers and strippers and a single fancy roller. Four carded webs were produced.
  • Needling was conducted on a pilot scale Garnett/Bywater Needleloom. The webs were folded either two or four fold to provide more bulk during needling.
  • HF-2010/078-2 100% Biointeractive fibres spun into CaCl2 2 nd trial (folded 4 times)
  • HF-2010/079 100% Biointeractive fibres spun into ZnCl2 (folded 4 times)
  • HF-2010/080 50% Biointeractive fibres spun into CaCl2 with 50% Hydrofiber® (folded twice only)
  • HF-2010/081 50% Biointeractive fibres spun into ZnCl2 with 50% Hydrofiber® (folded twice only)
  • Irradiation The samples were gamma irradiated with a dose between 25-42 kGy.
  • the absorbency of the non woven (CaCl2) material, in its unblended and blended form, is comparable (on a weight per weight basis), to AQUACEL
  • the absorbency of the samples spun into ZnCl2 is slightly lower in general. There is little difference between irradiated and non-irradiated samples.
  • the table below provides the absorbency results expressed in g/g.
  • N/A 11.5 (0.5) 17.7 (3.7) 14.5 (0.5) Irradiated 17.2 (1.2) 11.7 (0.7) 18.0 (0.9) 15.0 (0.2)
  • the blended fibres have slightly better retention than the pure multicomponent fibres, and overall, retention appears to be lower than AQUACEL®.
  • the results also indicate that irradiation results in a small drop in retention.
  • the table below provides the retention results expressed as g/g.
  • N/A 6.0 0.03 (0.3) 7.9 (0.2) Irradiated 5.8 (0.4) 4.9 (0.6) 7.6 (0.3) 7.0 (0.2)
  • the fibres that were spun into a bath containing calcium ions were more easily textiled than fibres spun into zinc ions.
  • Example 7 The dressings produced in Example 7 were sprayed with silver and irradiated using the following method.
  • Each dressing was passed through an ultrasonic spray of silver nitrate (5%) aqueous solution followed by an ultrasonic spray of sodium chloride (3%) aqueous solution.
  • the dressing was exposed first to the silver solution for approximately 10 seconds then to the salt solution for approximately 10 seconds.
  • the resulting dressing was dried using a forced air dryer for approximately 1 minute.
  • the dressings were each irradiated using gamma irradiation at a dose of 31.4 kGy. All samples were visually equivalent once irradiated to those prior to irradiation.
  • Example 7 To assess the ability of the dressings of Example 7 to modulate elastase a fluorescence assay was performed and data reported as activity of elastase remaining in the supernatant as a percentage of the positive control.
  • dressings according to the invention perform well both initially and over two hours with the highest elastase level returning to 40% when testing HF2010/079.
  • Dressing HF2010/078 performs best overall with approximately 90% reduction at T 0 and T 120 .
  • Overall calcium containing materials perform better over the course of the assay.
  • nanoscale fibres were prepared from solutions of gelatin and pectin.
  • the optimum conditions centre on a solids concentration of 25 w/w % with gelatin to pectin ratios between 90/10 and 70/30 with a needle to collector distance of 10 cm and a voltage of 20 kV.
  • Solutions for electrospinning were prepared in the following manner: A volume of 10 ml of distilled water was measured out by weight and heated to a temperature of 45° C. ( ⁇ 3° C.) using a hot plate. The temperature of the water was periodically measured. The appropriate amount of gelatin and pectin were measured out by weight. Gelatin was dissolved in the water by adding small amounts of gelatin into the water at a time. The solution was agitated using a laboratory mixer with a rotation speed of 550 rpm ( ⁇ 50 rpm) until each amount dissolved. When the entire amount of gelatin was fully dissolved the pectin was added in the same manner. After dissolving the components, the solution was weighed and water added if evaporation had occurred. This ensured the final solution was at the specified concentration. When all the material was fully dissolved and mixed the solution was allowed to cool to room temperature before electrospinning. Solutions not in use were stored in a laboratory refrigerator at ⁇ 5° C.
  • the electrospinning equipment consisted of a high voltage power supply, syringe pump and a grounded collector. Solutions were loaded into a 5 ml Luer lock glass syringe fitted with a 22G needle which has an internal diameter of 0.41 mm and a needle length of 12 mm. The syringe was mounted in a syringe pump, with flow rates from 0.1 ml/min-1 ml/min. The syringe pump was used in a standard room temperature environment, or housed inside a temperature controlled enclosure box The high voltage was provided by a Glassman High Voltage Unit (0-30 kV) with respect to ground. The voltage was measured on the needle using a high voltage probe and multi-meter. Samples are collected onto a flat electrode formed from aluminium foil.
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