AU719419B2 - Wound dressing - Google Patents

Wound dressing Download PDF

Info

Publication number
AU719419B2
AU719419B2 AU31128/97A AU3112897A AU719419B2 AU 719419 B2 AU719419 B2 AU 719419B2 AU 31128/97 A AU31128/97 A AU 31128/97A AU 3112897 A AU3112897 A AU 3112897A AU 719419 B2 AU719419 B2 AU 719419B2
Authority
AU
Australia
Prior art keywords
wound dressing
wound
dressing according
layer
section
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
AU31128/97A
Other versions
AU719419C (en
AU3112897A (en
Inventor
Staffan Bowald
Gudmund Dvarsater
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.)
AstraZeneca AB
Original Assignee
AstraZeneca 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 AstraZeneca AB filed Critical AstraZeneca AB
Publication of AU3112897A publication Critical patent/AU3112897A/en
Assigned to ASTRAZENECA AB reassignment ASTRAZENECA AB Amend patent request/document other than specification (104) Assignors: ASTRA AKTIEBOLAG
Publication of AU719419B2 publication Critical patent/AU719419B2/en
Application granted granted Critical
Publication of AU719419C publication Critical patent/AU719419C/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0203Adhesive bandages or dressings with fluid retention members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/023Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28Polysaccharides or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/64Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00902Plasters containing means
    • A61F2013/0091Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00902Plasters containing means
    • A61F2013/00927Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00902Plasters containing means
    • A61F2013/00927Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
    • A61F2013/00931Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors chitin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Description

WO 97/46265 PCT/SE97/00946 1 WOUND DRESSING The present invention relates to wound dressings for dressing of wounds on internal or external tissue structures of living human or animal bodies.
Existing wound dressings have a number of disadvantages. Conventionally, gauze dressings have been used for the treatment of wounds such as burns, cuts, abrasions and other tissue disorders. Such dressings, however, require to be changed frequently and the application and subsequent removal of a dressing for replacement with a fresh one can be painful for the patient. In fact, some dressings are so inconvenient that they may immobilise the patient In EP-A-0349505 (Astra Meditec AB) it is taught that the healing of soft tissue in mammals including man can be improved by the use of a porous flexible sheet of a protein-free bioresorbable polymer having a pore size which permits passage of water and salts therethrough but which locks out cells and other tissue particles. The sheet is disclosed as causing a specific stimulating effect on the formation of macrophages in soft tissue, the macrophages releasing a growth factor which stimulates tissue healing. Suitable polymer materials mentioned in EP-A-0349505 for the sheet are those based on polyglycolic acid, copolymers of glycolic acid and lactic acid, copolymers of lactic acid and E-aminocapronic acid, lactide polymers, polydesoxazon, poly(3-hydroxybutyrate), copolymers of poly(3hydroxybutyrate) and 3-hydroxyvalerate, polyesters of succinic acid and cross-linked hyaluronic acid. EP-A-0349505 makes known forming a non-woven sheet of poly(3hydroxybutyrate) having the requisite properties by pressing together solution-spun fibres of poly(3-hydroxybutyrate) manufactured in accordance with US-A-4603070 (Steel et al).
As the size of the pores in the sheet of EP-A-0349505 are sufficient to allow the passage of water therethrough there is the possibility of bacteria passing through the sheet to the wound. While this might not be so problematic for the case where the sheet is for internal use, that is to say, to be disposed inside a human or animal body to cover an internal wound, it might be problematical in the case of external wounds such as skin wounds.
PCT/SE97/00946 The Swedish Patent Office PCT International Application 1 4 -09- GB-A-2166354 (Imperial Chemical Industries Plc) discloses a wound dressing comprising a poly(3-hydroxybutyrate) polymer dissolved or swollen with a volatile solvent such as chloroform, preferably co-polymerised with 3-hydroxyvalerate units. The material is painted onto the wound as a solution or gel to give a thin film of polymer in intimate contact with the treated area. The poly(3-hydroxybutyrate) is stated to be hydrophilic, obviating the need for an outer hydrophilic layer. The dressing is stated to be particularly suitable for rapid protection of a wound site with a temporary covering.
0o The thin layer of hydrophilic poly(3-hydroxybutyrate) disclosed in GB-A-2166354 has a number of disadvantages as a wound dressing. To start with, there is no provision for removal of excess fluid since the layer of poly(3-hydroxybutyrate) is not particularly absorbent and exudate from the wound will not pass through it. Furthermore, it could be difficult to remove the dressing from an open wound and the volatile solvent in it tends to be cell-toxic and could cause irritation of the wound site. Moreover, the pore size distribution created in the poly(3-hydroxybutyrate) layer would be such that the size of the pores closest the wound would be less than the size of the pores remote from the wound.
The possibility of infection of the wound through ingress of bacteria to the dressing therefore exists.
In summary, the prior art has not addressed the problem of providing a convenient wound dressing for use during the gradual healing of wounds that may be conveniently applied and, where needed, removed, which provides thermal insulation to maintain body temperature in the vicinity of the wound surface and keeps the wound moist yet permits removal of excessive fluid from the wound.
The present invention proposes to improve this situation.
According to the present invention there is provided a wound dressing for dressing a wound on a tissue structure of a living human or animal body which when the wound dressing dresses the wound has a lower outer surface disposed adjacent the wound, an upper outer surface spaced from the lower outer surface, a fluid permeable lower section AMENDED SHEET 3 which presents the lower outer surface and comprises a bioresorbable material which promotes the healing process of the wound and which comprises poly(3-hydroxybutyrate) or a copolymer ofpoly(3-hydroxybutyrate) and 3-hydroxyvalerat, or both poly(3-hydroxybutyrate) and said copolymer, and a porous upper section overlying the lower section which presents the upper outer surface, the pore size of the pores in the porous upper section is less than about 0.25pm whereby the upper section is permeable to vapour and impermeable to bacteria.
Such a dressing is relatively simple to manufacture. Moreover, the dressing is easy to apply and can be adapted to facilitate easy removal. The dressing furthermore provides thermal insulation to maintain the body temperature in the vicinity of the wound surface and keeps the wound moist while removing excessive fluid from the wound. Ensuring that the upper section is essentially impermeable to bacteria also means that a barrier is presented to prevent infection from occurring.
Transport of exudate away from the wound could be hindered if the exudate has no means 5 of escape after it has accumulated on the upper surface of the lower section remote from the wound. The provision of an upper section which is permeable to vapour alleviates this problem by allowing the exudate to be slowly dispersed by evaporation. In addition, vapour from the tissue surrounding the wound will also be able to pass through the upper section.
The drawing of exudate from the wound into the lower section and subsequent evaporation of excess moisture creates a flux of material in the sense going away from the wound into the atmosphere. This flux further hinders the passing of bacteria in the opposite sense and thus infection from occurring.
The wound dressing of the invention may be left in place for a relatively long period. This means that fewer changes of dressing are needed than were hitherto, thus avoiding Sdisturbing the healing process with less pain for the patient.
WO 97/46265 PCT/SE97/00946 4 The use of an upper section which is vapour permeable ensures that the wound is kept moist, irrespective of how effective the removal of excessive fluid from the wound may be.
Preventing the wound from drying out results in pain being controlled.
In a first form of the invention the wound dressing is an integral structure.
In a second form of the invention the wound dressing is formed as an integrated structure.
For example, the upper and lower sections may respectively be presented by upper and lower wound dressing layers which are coupled to one another prior to dressing of the wound.
In a third form of the invention the wound dressing is formed once the wound is dressed, for example the upper and lower sections are respectively presented by upper and lower wound dressing layers which are applied to the wound separately.
is Having the lower section of the wound dressing as a lower wound dressing layer, for instance a sheet, means that it can be easily put.in position and used as a barrier facilitating the transport of exudate from the wound and retaining it away from the wound.
In an embodiment of the invention according to its various forms the wound dressing further comprises an intermediate section between the upper and lower sections which is adapted to absorb liquid. This is particularly advantageous where a large amount of exudate is encountered. For the second and third forms the intermediate section may be of any suitable material, for example treated cellulose fibres or polyacrylic acids. However, a hydrocolloid is particularly suitable. A hydrocolloid is normally able to absorb four to six times its own volume of fluid, and new hydrocolloids have been reported that absorb twenty times their own volume. Hydrocolloids also are adhesive to the skin, so the hydrocolloid can perform the dual function of intermediate absorbent layer and adhesive edge for the dressing. The intermediate section of the second and third forms of the invention may be in WO 97/46265 PCTISE97/00946 the form of an intermediate wound dressing layer or instead be part of the upper or lower wound dressing layer of the wound dressing.
In an embodiment of the first form of the invention the wound dressing consists of the upper and lower sections with the lower and upper sections comprising the bioresorbable material.
The bioresorbable material may be in particulate or fibre form. For example, the wound dressing may comprise particles or fibres of the bioresorbable material in a matrix material such as a gel matrix of hyaluronic acid or the like. On the other hand, the wound dressing may be a fibre sheet of the bioresorbable material, for instance a non-woven fibre sheet.
In an embodiment of the invention according to the second and third forms one or more of the wound dressing layers are in the form of one or more wound dressing sheets.
In an embodiment of the second form of the invention the wound dressing consists of the upper and lower wound dressing layers with the lower dressing layer being adhered to a lower surface of the upper wound dressing layer. Alternatively, where the wound dressing comprises the intermediate wound dressing layer the upper and lower wound dressing layers are respectively adhered to upper and lower surfaces of the intermediate wound dressing layer.
In an embodiment of the second form of the invention the lower wound dressing layer is releasably secured to the balance of the wound dressing. For example, the lower wound dressing layer may be releasably secured to the lower surface of the upper wound dressing layer or the lower surface of the intermediate wound dressing layer.
In a preferred embodiment of the invention according to its various forms the lower section of the wound dressing is substantially free of volatile solvent 6 In an embodiment of the second and third forms of the invention the lower wound dressing layer is presented by a layer of particles of the bioresorbable material. The particles may be supported in a matrix material, for example a gel matrix comprising hyaluronic acid.
In an embodiment of the second form of the invention the bioresorbable particulate material of the lower wound dressing layer is adhered to the lower surface of the upper or intermediate wound dressing layer by mixing the particles in a solvent, coating the mixture to the lower surface and then evaporating the solvent. Chloroform may be mentioned as a suitable solvent In an embodiment of the invention according to its third form, when the wound dressing dresses the wound the lower section is presented by a layer of loose particles or fibres of the bioresorbable material positioned on the wound. Alternatively, the lower wound dressing layer may be a gel comprising the bioresorbable material coated onto the wound or one or more lower wound dressing sheets laid over the wound.
S
In an embodiment of the second and third forms of the invention the bioresorbable material of the lower wound dressing layer is in fibre form, for example supported in a matrix such S as a gel matrix formed from hyaluronic acid. Alternately, the lower wound dressing layer {2 may take the form of one or more lower wound dressing fibre sheets, for example formed from non-woven- fibres in which case the lower surface of the lower wound dressing layer may to advantage be roughened to expose ends of the fibres.
As indicated above, the bioresorbable material of the lower section comprises poly(3hydroxybutyrate) or a copolymer of poly(3-hydroxybutyrate) and 3-hydroxyvalerat, or both poly(3-hydroxybutyrate) and said copolymer. Thus, protein-free polymers iirelude poly(3-hydroxybutyrate) (PHB), polylactic acids, polyglycolic acid, copolymers of glycolic acid and lactic acid, copolymers of lactic acid and E-aminocapronic acid, lactide polymers, polydesoxazon, copolymers of poly(3-hydroxybutyrate) and 3-hydroxyvalerate, 4 ''RyA esters of succinic acid and cross-linked hyaluronic acid.
WO 97/46265 PCT/SE97/00946 7 Use of a protein-free bioresorbable polymer in the lower section appears to stimulate healing during degradation by stimulating macrophages, by forming a barrier against the surrounding and working as a scaffold for cell growth. The macrophage invasion caused by protein-free polymers covers the wound with tissue and controls the wound pain effectively s in the first day or two. Vascularization and microcirculation occur, again stimulated by the polymer. Moreover, degradation of certain protein-free polymers such as PHB has a bacteriostatic and fungistatic effect and facilitates the wound healing of skin. The invading macrophages also have a bactericidal effect. The wound dressing can be left in place for a longer period owing to the bacteriostatic and fungistatic properties and the wound healing to environment created beneath the dressing. Fewer changes of dressing means less disturbance of the healing process and less pain for the patient.
Poly(3-hydroxybutyrate) is the preferred material for the lower section because Applicant has found that PHB has the ability to attract macrophages to the wound site at a greater rate is than other polymers tested. The PHB also appears to lead to an increased vascularization, perhaps through a macrophage effect promoted by the PHB. In addition, the dressing period is further enhanced when PHB is used due to the fact that the bacteriostatic and fungistatic properties increase over time with the degradation of the PHB.
Furthermore, in the case where the lower section is formed as a fibrous PHB sheet, for instance a non-woven sheet, having hydrophobic fibres the nature of the PHB fibres is such that the sheet has a capillary capacity which aids in the exudate being drawn away from the wound and retained in the region between the sheet and the upper section. Moreover, a non-woven PHB fibre sheet will swell during the first ten days or so by adding blood components and cells from the surrounding tissue owing to its construction despite the fibres being hydrophobic. In conclusion, a PHB fibre sheet as the lower section of the wound dressing will allow the wound to "breath" and enable vapour transport thereby leaving the wound surface with an adequate humidity.
PCT/SE97 /00946 '1 4 -09- 1998 8 Where poly(3-hydroxybutyrate) is selected oligo(3-hydroxybutyrate), e.g. having 3 to monomer units, may also be included in the lower section or may constitute the lower section.
A wide range of other materials may be suited for the function of the lower section which would easily be apparent to a skilled reader in the art, non-limiting examples being polysaccharides such as chitosan, collagen and proteins.
In an embodiment of the various forms of the invention the wound dressing is flexible thereby enabling the dressing to follow the contour of the wound, for example a recessed wound.
In an embodiment of the second and third forms of the invention the lower wound dressing layer is adapted to follow the contour of the wound, for example by being flexible.
To assist in the wound healing process the lower section of the various forms of wound dressing according to the invention may support one or more growth factors.
In an embodiment of the second and third forms of the invention the upper wound dressing layer of the wound dressing comprises a polymeric material. The polymeric material may be bioresorbable and may further be protein-free. As an example, the upper section may comprise poly(3-hydroxybutyrate). Alternately, the upper section may comprise a nonbioresorbable non-biodegradable material, non-limiting polymeric examples being polyurethane and polytetrafluoroethylene.
Where the upper and lower sections are both porous the pore size of the pores of the upper section will be less than the pore size of the pores of the lower section.
In an embodiment of the invention according to its various forms the wound dressing presents an adhesive edge for releasably adhering to a surface of the tissue structure AMENDED SHEET PCT SE97 /009 4 6 1 4-09- 1998 9 adjacent the wound. This facilitates application and removal of the dressing or the upper part thereof.
In an embodiment of the second and third forms of the invention the upper wound dressing layer presents the adhesive edge in which case the upper wound dressing layer may completely surround the lower wound dressing layer. An ideal overlap margin is approximately 10 to 15 mm. Where the upper wound dressing layer includes the intermediate section, the adhesive edge may be presented by the intermediate section of the upper wound dressing layer.
In an embodiment of the second and third forms of the invention the intermediate wound dressing layer presents the adhesive edge.
According to the invention there is also provided a method of treatment of a wound on a is tissue structure of a living human or animal body comprising the steps of applying to the wound a wound dressing according to the invention.
AMENDED SHEET WO 97/46265 PCT/SE97/00946 Embodiments of the invention will now be described by way of example with reference to the accompanying Figures of drawings in which:- Fig. 1 is a cross-sectional side view of a first wound dressing in accordance with the present invention; Fig. 2 is a cross-sectional side view of a second wound dressing in accordance with the present invention; and Fig. 3 is a cross-sectional side view of a third wound dressing in accordance with the present invention.
As can be seen from Fig. 1, a wound dressing 10 in accordance with the present invention comprises a layer 1 of a bioresorbable material which promotes wound healing processes, in this case poly(3-hydroxybutyrate) (hereinafter applied to a skin wound 2 in the form of a fibrous non-woven sheet substantially free of volatile solvent, and an exterior microporous layer 3 of a polyurethane polymer. The pores of the exterior polymer layer 3 have a pore size of less than 0.22 tm. This renders the layer 3 permeable to vapour and gases whilst maintaining the layer 3 essentially impermeable to bacteria.
The dressing 10-may be conveniently applied and removed and further provides thermal insulation to maintain the body temperature in the vicinity of the wound surface by virtue of the exterior polymer layer 3. The dressing 10 also keeps the wound 2 moist yet, by being permeable to moisture vapour, enables removal of excessive fluid from the wound 2. This prevents the nerve endings in the wound from drying out and concomitantly a cause of pain to the patient.
To facilitate application and removal of the dressing 10 the exterior polymer layer 3 has an adhesive edge 4.
WO 97/46265 PCT/SE9700946 11 The PHB fibres in the dressing 10 exhibit hydrophobic properties. The nature of the PHB fibres is such that exudate is drawn away from the wound 2 and retained in the PHB layer 1 and space between the PHB layer 1 and the exterior polymer layer 3.
The wound dressing 10 may be left in place for a relatively long period. This means that fewer changes of dressing are needed than with hitherto proposed dressings. This avoids disturbing the healing process with less pain for the patient. One possibility when changing the dressing 10 would be to remove the exterior layer of polymer 3 and excess exudate only, then put a fresh exterior layer 3 in place without disturbing the PHB layer 1.
Alternatively, most of the PHB layer 1 may be removed as well and replaced by a fresh piece of PHB, with fibres of PHB that are adhering to the wound 2 being left.
In Fig. 2 there is shown a second wound dressing 110 in accordance with the present invention which comprises a layer 101 of PHB applied to a skin wound 102 in the form of a fibrous non-woven sheet substantially free of volatile solvent and an exterior microporous layer 103 of a polyurethane polymer. The PHB layer 101 is in the form of a patch completely surrounded by the exterior polymer layer 103 with a 10 to 15 mm margin of the exterior polymer layer 103 around the PHB patch 101 being left. The size of the PHB patch 101 itself may vary according to the size of the wound 102.
Furthermore, an-rrintermediate absorbent layer 105 of a hydrocolloid material is provided.
This absorbs exudate that is transported away from the wound 102 by the PHB patch 101 and promotes the transport away of further exudate. The microporosity of the polyurethane exterior layer 103 means that the exudate can be slowly dispersed while still keeping the wound 102 moist and at the same time excluding bacteria. Vapour from the skin surrounding the wound 102 will also be able to pass through the exterior polymer layer 103.
The exterior polymer layer 103 has an adhesive edge 104 to facilitate application and removal of the dressing 110.
WO 97/46265 PCT/SE97/00946 12 Turning now to Fig. 3, a third wound dressing 210 in accordance with the present invention comprises a layer 201 of PHB applied to a skin wound 202 in the form of a fibrous nonwoven sheet substantially free of volatile solvent and an exterior microporous layer 203 of a polyurethane polymer. The PHB is again in the form of a patch completely surrounded by the exterior polymer layer 203 with a 10 to 15 mm margin of the polymer left around the PHB patch. An intermediate absorbent layer 205 of a hydrocolloid material is again provided, but in this case the hydrocolloid layer 205 is made integral with the exterior polymer layer 203. As the hydrocolloid material is adhesive to the skin, it may be stuck to the skin by its edge 204. Thus the hydrocolloid performs the dual function of intermediate absorbent layer and adhesive edge to the exterior layer 203.
A skilled reader in the art will readily appreciate that the invention is not restricted to the specific wound dressing examples described hereinabove with reference to the accompanying drawings but that the invention may take many forms or guises within the scope of the claims.
Applicant has observed that wound dressings ought to meet the following objectives:- Thermal insulation should maintain body temperature of the wound surface.
The wound should be kept moist but excess fluid should be removed.
The dressing should be permeable to vapour but impermeable to bacteria.
The dressing should be absorbent and breathable.
Pain should be controlled.
The dressing should be easy to apply and, where needed, to remove.
13 The dressing should stimulate healing.
The dressing should comply with other treatments, for example allowing an outer compressing bandage to be provided and for effective debridement of dead skin to occur.
The dressing should be biocompatible and non-toxic.
The dressing should not immobilise the patient The wound dressings hereinabove described with reference to the accompanying Figures of S drawings satisfy these objectives in a simple and inexpensive manner.
o.
o In a comparative test a wound dressing in accordance with the invention and a wound
TM
dressing comprising a sheet of polyurethane (Tagerderm were used to dress a skin 0 wound of a mammalian body. The dressing in accordance with the invention consisted of a lower section in the form of a non-woven fibre sheet of PHB and an upper section of a polyurethane sheet The wound dressing of the invention produced an improved healed wound compared to the polyurethane sheet wound dressing. This was characterised by the healed wound covered by the wound dressing of the invention having a thicker and better S quality layer of epithelial cells in the regenerated tissue than in the healed wound covered by the polyurethane sheet wound dressing.
With reference to the use of the word(s) "comprise" or "comprises" or "comprising" in the foregoing description and/or in the following claims, we note that unless the context requires otherwise, those words are used on the basis and clear understanding that they are to be interpreted inclusively, rather than exclusively, and that we intend each of those words to be so interpreted in construing the foregoing description and/or the following claims.

Claims (42)

1. A wound dressing for dressing a wound on a tissue structure of a living human or animal body which when the wound dressing dresses the wound has a S lower outer surface disposed adjacent the wound, an upper outer surface spaced from the lower outer surface, a fluid permeable lower section which presents the lower outer surface and comprises a bioresorbable material which promotes the healing process of the wound and which comprises poly(3-hydroxybutyrate) or a copolymer ofpoly(3-hydroxybutyrate) and 3-hydroxyvalerat, or both poly(3-hydroxybutyrate) and said copolymer, and a porous upper section overlying the lower section which presents the upper outer surface wherein the pore size of the pores in the porous upper section is less than about 0.25g±m whereby the upper section is permeable to vapour and impermeable to bacteria. g. 15
2. A wound dressing according to claim 1, wherein said bioresorbable material is constituted of essentially only poly(3-hydroxybutyrate). S*
3. A wound dressing according to claim 1 or 2, characterised in that the lower section is liquid permeable.
4. A wound dressing according to any one of claims 1 to 3, characterised in that the lower section of the wound dressing is substantially free of volatile solvent. 9
5. A wound dressing according to any one of claims 1 to 4, characterised in that 25 the bioresorbable material is in particulate or fibre form. f
6. A wound dressing according to claim 5, characterised in that the particles or fibres of the bioresorbable material are in a matrix material.
7. A wound dressing according to claim 6, characterised in that the matrix is a gel matrix.
8. A wound dressing according to claim 7, characterised in that the gel matrix is ofhyaluronic acid.
9. A wound dressing according to any one of claims 1 to 8, characterised in that the bioresorbable material is protein-free.
A wound dressing according to any one of claims 1 to 9, characterised in that the bioresorbable material of the lower section is a copolymer of poly(3- hydroxybutyrate) and 3-hydroxyvalerate.
11. A wound dressing according to claim 1, characterised in that the lower section comprises poly(3-hydroxybutyrate) and oligo(3-hydroxybutyrate).
12. A wound dressing according to any one of claims 1 to 11, characterised in that the lower section is porous.
13. A wound dressing according to claim 12, characterised in that the pore size :15 of the pores of the upper section is less than the pore size of the pores of the. lower section. "i
14. A wound dressing according to any one of claims 1 to 11, characterised in I that the lower section is perforate.
15. A wound dressing according to any one of the preceding claims, characterised in that the lower section supports one or more growth factors. o
16. A wound dressing according to any one of claims 1 to 15, characterised in 25 that the upper section comprises a non-bioresorbable material.
17. A wound dressing according to claim 16, characterised in that the upper section comprises a non-bioresorbable polymeric material.
18. A wound dressing according to claim 17, characterised in that the polymeric material is polyurethane or polytetrafluoroethylene.
19. A wound dressing according to any one of claims 1 to 18, characterised in that the wound dressing further comprises an intermediate section between the upper and lower sections which is adapted to absorb liquid.
A wound dressing according to claim 19, characterised in that the intermedi. ate section comprises a hydrocolloid.
21. A wound dressing according to any one of claims 1 to 20, characterised in that the wound dressing is an integral structure.
22. A wound dressing according to claim 21 when appendant to any one of claims 1 to 19, characterised in that the wound dressing consists of the upper and lower sections with the lower and upper sections comprising the bioresorbable material.
23 A wound dressing according to claim 21 or claim 22, characterised in that the wound dressing is in the form of a sheet.
24. A wound dressing according to claim 22, characterised in that the wound S* dressing is a fibre sheet of the bioresorbable material
25. A wound dressing according to claim 24, characterised in that the wound dressing is a non-woven fibre sheet.
26. A wound dressing according to claim 24 or 25, characterised in that the lower surface of the wound dressing is roughened to expose ends of the fibres.
27. A wound dressing according to any one of claims 21 to 26, characterised in So: 25 that the wound dressing is flexible thereby enabling the dressing to follow the contour of the wound such as a recessed wound.
28. A wound dressing according to any one of claims 1 to 20, characterised in that the wound dressing is formed as an integrated structure.
29. A wound dressing according to claim 28, characterised in that the upper and lower sections are respectively presented by upper and lower wound dressing layers which are coupled to one another prior to dressing of the wound.
30. A wound dressing according to any one of claims 1 to 20, characterised in that the wound dressing is formed once the wound is dressed.
31. A wound dressing according to claim 30, characterised in that the upper and lower sections are respectively presented by upper and lower wound dressing layers which are applied to the wound separately.
32. A wound dressing according to claim 30, characterised in that when the wound dressing dresses the wound the lower section is presented by a layer of loose particles or fibres of the bioresorbable material positioned on the wound.
33. A wound dressing according to claim 31, characterised in that when the wound dressing dresses the wound the lower wound dressing layer is a gel comprising the bioresorbable material coated onto the wound.
34. A wound dressing according to one of claims 29 or 31 when appendant to one of claims 20 or 21, characterised in that the intermediate section is in the form of 15 an intermediate wound dressing layer,
35. A wound dressing according to claim 29, 31 or 34, characterised in that one or more of the wound dressing layers are in the form of one or more wound dressing sheets.
36. A wound dressing according to claim 29, 31, 34 or 35, characterised in that the lower wound dressing layer is adapted to follow the contour of the wound.
37. A wound dressing according to claim 36, characterised in that the lower wound dressing layer is flexible.
38. A wound dressing according to any one of claims 29, 31 or 33 to 37, characterised in that the upper wound dressing layer of the wound dressing comprises a polymeric material.
39. A wound dressing according to claim 38, characterised in that the polymeric material is bioresorbable.
A wound dressing according to claim 39, characterised in that the polymeric material is protein-free. 18
41. A wound dressing according to claima 40, characterised in that the upper section comprises poly(3-hydroxybutyrate).
42, A method of treatment of a wound on a tissue structure of a living human or animal body comprising the steps of applying to the wound a wound dressing according to any one of the preceding claims. DATED this 6 day of M"arch 2000 ASTRAZENECA AB, EF. CO)., (Bruce Wellington to's
AU31128/97A 1996-06-03 1997-05-30 Wound dressing Ceased AU719419C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9602200A SE9602200D0 (en) 1996-06-03 1996-06-03 Wound dressing
SE9602200 1996-06-03
PCT/SE1997/000946 WO1997046265A1 (en) 1996-06-03 1997-05-30 Wound dressing

Publications (3)

Publication Number Publication Date
AU3112897A AU3112897A (en) 1998-01-05
AU719419B2 true AU719419B2 (en) 2000-05-11
AU719419C AU719419C (en) 2000-10-26

Family

ID=

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0599589A1 (en) * 1992-11-23 1994-06-01 JOHNSON & JOHNSON MEDICAL, INC. Wound dressing

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0599589A1 (en) * 1992-11-23 1994-06-01 JOHNSON & JOHNSON MEDICAL, INC. Wound dressing

Also Published As

Publication number Publication date
HUP0003151A2 (en) 2001-02-28
NZ332950A (en) 2000-05-26
CN1226178A (en) 1999-08-18
IS4898A (en) 1998-11-19
PL330307A1 (en) 1999-05-10
ZA974846B (en) 1998-12-02
KR20000016251A (en) 2000-03-25
HUP0003151A3 (en) 2002-05-28
TR199802501T2 (en) 1999-02-22
AR007386A1 (en) 1999-10-27
IL127107A0 (en) 1999-09-22
CA2255627A1 (en) 1997-12-11
AU3112897A (en) 1998-01-05
SE9602200D0 (en) 1996-06-03
NO985628D0 (en) 1998-12-02
NO985628L (en) 1999-02-03
WO1997046265A1 (en) 1997-12-11
EP0906126A1 (en) 1999-04-07
JP2000511446A (en) 2000-09-05
ID17733A (en) 1998-01-22
TW347318B (en) 1998-12-11
BR9709639A (en) 1999-08-10
CZ388398A3 (en) 1999-04-14

Similar Documents

Publication Publication Date Title
US8303551B2 (en) Wound dressings
KR100860896B1 (en) Bioabsorbable Wound Dressing
WO1997046265A1 (en) Wound dressing
JP7429996B2 (en) Tissue treatment devices containing microstructures
EP0682534A1 (en) Pharmaceutical compositions comprising a spongy material consisting of ester derivatives of hyaluronic acid combined with other pharmacologically active substances
JPS62246370A (en) Wound covering material
KR102090576B1 (en) Multi-layer dressing material for wound treatment
Mao et al. Nonwoven wound dressings
AU719419C (en) Wound dressing
RU2240140C2 (en) Medicinal multilayer bandage and articles based on such bandage
JP2645098B2 (en) Antibacterial agent-containing artificial skin and method for producing the same
MXPA98010047A (en) Aposito for heri
DE20122661U1 (en) Wound dressing for chronic wounds, comprises porous bioabsorbable layer as scaffold for cell attachment and proliferation, and absorbent gel forming layer as barrier for cell adhesion and penetration
JPH03206032A (en) Wound-covering material
JP2002200110A (en) Wound cover material
JP2001017532A (en) Wound dressing
RU2189210C1 (en) Multilayer medicinal bandage
JP2001017531A (en) Wound dressing
JPH05337174A (en) Cut covering material

Legal Events

Date Code Title Description
TC Change of applicant's name (sec. 104)

Owner name: ASTRAZENECA AB

Free format text: FORMER NAME: ASTRA AKTIEBOLAG (PUBL)

DA2 Applications for amendment section 104

Free format text: THE NATURE OF THE PROPOSED AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 20000323

FGA Letters patent sealed or granted (standard patent)
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS WAS NOTIFIED IN THE OFFICIAL JOURNAL DATED 20000511

MK14 Patent ceased section 143(a) (annual fees not paid) or expired