EP2900287A1 - Polymère gonflant destiné à être utilisé dans le traitement thérapeutique - Google Patents

Polymère gonflant destiné à être utilisé dans le traitement thérapeutique

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Publication number
EP2900287A1
EP2900287A1 EP13725914.9A EP13725914A EP2900287A1 EP 2900287 A1 EP2900287 A1 EP 2900287A1 EP 13725914 A EP13725914 A EP 13725914A EP 2900287 A1 EP2900287 A1 EP 2900287A1
Authority
EP
European Patent Office
Prior art keywords
swellable polymer
wound
negative pressure
phase
therapy
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Withdrawn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
EP13725914.9A
Other languages
German (de)
English (en)
Inventor
Hans Smola
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.)
Paul Hartmann AG
Original Assignee
Paul Hartmann AG
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 Paul Hartmann AG filed Critical Paul Hartmann AG
Priority to EP13725914.9A priority Critical patent/EP2900287A1/fr
Publication of EP2900287A1 publication Critical patent/EP2900287A1/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Withdrawn legal-status Critical Current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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0203—Adhesive plasters or dressings having a fluid handling member
    • A61F13/0206—Adhesive plasters or dressings having a fluid handling member the fluid handling member being absorbent fibrous layer, e.g. woven or nonwoven absorbent pad, island dressings
    • A61F13/0209—Adhesive plasters or dressings having a fluid handling member the fluid handling member being absorbent fibrous layer, e.g. woven or nonwoven absorbent pad, island dressings comprising superabsorbent material
    • A61F13/05—
    • 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
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/0054—Plasters use for deep wounds

Definitions

  • the invention generally relates to wound therapy and in particular to wound dressings and to special application forms of wound dressings for wound therapy.
  • Negative wound therapy also known as topical negative pressure (TNP), negative pressure wound therapy (NPWT) or vacuum assisted closure (VAC), has long been recognized, but has been particularly prevalent since the mid-term / Late 1990s increasingly used.
  • TNP topical negative pressure
  • NPWT negative pressure wound therapy
  • VAC vacuum assisted closure
  • a wound filling material is usually inserted into the wound, the wound area is covered with a foil and a negative pressure is generated in the wound space by means of a drainage tube and a vacuum pump.
  • the negative pressure causes effective wound cleansing by removing wound exudate.
  • Further advantages include promotion of granulation tissue formation and reduction of wound edema formation.
  • VAC As the name VAC already suggests, the negative pressure therapy is usually carried out until the wound is closed. Wound closure is generally considered to be achieved when there is a layer of epidermis over the former wound site. Wound closure can be achieved through healing processes or through surgical procedures.
  • Low pressure therapy is particularly useful in acute or chronic wounds such as ulcers (e.g., pressure ulcers, diabetic, neuropathic or venous ulcers), traumatic wounds, refractory wounds, infected wounds, postoperative wounds, probed fistulas, and skin flaps and skin grafts.
  • Chronic wounds are characterized by slow or absent wound healing.
  • WO 1993/009727 A1 describes a device for promoting wound healing by the application of negative pressure on the area of the skin having the wound and surrounding the wound.
  • the device according to WO 1993/009727 AI comprises a vacuum device for generating the negative pressure, an airtight covering of the wound, which with the vacuum device in a functional connection and a wound dressing for positioning on the wound within the airtight cover.
  • the wound dressing is preferably an open-cell polymer foam, for example polyester foam. In addition to the use of open cell polymer foam, other materials have been described for the preparation of wound dressings for wound wound therapy.
  • Wound wound therapy devices are also commercially available and include small, portable devices that allow patients some mobility to stationary devices, such as in long-term care facilities.
  • the increased expenditure on equipment and associated increased costs are primarily brought into the field and an impairment of the patient, in particular an impairment of the mobility of the patient.
  • the negative pressure therapy of patients is often perceived as more painful.
  • some wounds can not be treated satisfactorily.
  • a wound therapy should be provided, which affects the patient as little as possible.
  • the object of the present invention relates to a swellable polymer for use in the therapeutic treatment of wounds on the human or animal body, characterized in that the swellable polymer is used in a therapy scheme, which at least one treatment phase using negative pressure and at least one other preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the swellable polymer is used in at least one treatment phase without the use of negative pressure.
  • the swellable polymer according to the invention is used for the treatment of wounds in the context of the abovementioned therapy scheme.
  • the present invention relates to a swellable polymer for wound treatment in the above-mentioned therapy scheme.
  • the swellable polymer is preferably contained in an absorbent body and the absorbent body is contained in a wound dressing.
  • the subject of the present invention is a swellable polymer for the manufacture of a medicament or medical device for use in the therapeutic treatment of wounds on the human or animal body, characterized in that the swellable polymer is used in the context of a therapeutic regimen, which uses at least one treatment phase Underpressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure comprises, wherein the swellable polymer is used in at least one treatment phase without the use of negative pressure.
  • the subject of the present invention is the use of a swellable polymer for the manufacture of a medicament or medical device for use in the therapeutic treatment of wounds on the human or animal body, characterized in that the swellable polymer is used in the context of a treatment regimen which comprises at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the swellable Polymer is used in at least one treatment phase without the use of negative pressure.
  • swellable polymer and / or wound dressing herein are expressly claimed in the context of their particular medical application or indication, namely, the treatment of wounds based on the particular new therapeutic application or therapy regimen. which comprises at least two consecutive treatment phases.
  • the invention relates to a wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent body which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing in the context of a therapy scheme is used or is usable, which comprises at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the wound dressing is used or usable in at least one treatment phase without the use of negative pressure ,
  • the invention relates to the use of a wound dressing in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent body which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing is part of a therapy scheme is used or is usable, which comprises at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the wound dressing is used or usable in at least one treatment phase without the use of negative pressure , Furthermore, the invention relates to a wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent body comprising a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing in the context of Therapeutic regimen is used or usable, which is at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment
  • the invention relates to a wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent body comprising a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing in the context of Therapeutic regimen is used or usable, which comprises at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the wound dressing is used in at least one treatment phase without the use of negative pressure or usable wherein the wound dressing and / or the swellable polymer is used or can be used in at least one treatment phase without the use of negative pressure to stimulate the neovascularization in the wound area.
  • the advantageous stimulation of neovascularization is illustrated by FIG.
  • the invention relates to a wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent body comprising a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing in the context of Therapeutic regimen is used or usable, which comprises at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the wound dressing is used in at least one treatment phase without the use of negative pressure or usable and wherein the wound dressing and / or the swellable polymer is used in at least one treatment phase without the use of negative pressure to increase the fibroblast density in the superficial granulation tissue of a wound is or can be used.
  • the advantageous increase in fibroblast density is illustrated by FIG.
  • the device for performing wound therapy by means of negative pressure will also be referred to below as a negative pressure therapy device.
  • the treatment comprises a treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure.
  • the treatment phase without the use of negative pressure subsequent to the treatment phase using negative pressure.
  • the invention thus relates to a wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing in a second Therapy phase is used or can be used, which follows a first therapy phase, wherein the first therapy phase comprises a negative pressure therapy by means of a device for negative pressure therapy of wounds and wherein the second therapy phase using the wound dressing and / or the swellable polymer is carried out without generating a negative pressure, or is feasible.
  • the wound dressing preferably comprises an absorbent which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing in a second Therapy phase is used or can be used, which follows a first therapy phase, wherein the first therapy phase comprises a negative pressure therapy by means of a device for negative pressure therapy of wounds and wherein the second therapy phase using the wound dressing and / or the
  • the wound dressing and / or the swellable polymer are used during or after the decay of the inflammatory phase after a previous negative-pressure therapy.
  • the invention therefore furthermore relates to a wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing preferably comprises an absorbent which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing and or the swellable polymer is used in a second therapy phase after a first therapy phase aimed at combating inflammation and / or edema, wherein the first therapy phase comprises a negative pressure therapy by means of a device for negative pressure therapy of wounds and wherein the second therapy phase using the wound dressing without generating a negative pressure is carried out.
  • the invention further provides a method for the therapeutic treatment of wounds on the human or animal body, comprising i) a first therapy section, in which negative pressure therapy is carried out by means of a device for negative pressure therapy of wounds,
  • the second wound dressing preferably comprises an absorbent which comprises a swellable polymer, in particular a superabsorbent polymer.
  • the invention relates to a method for the therapeutic treatment of wounds on the human or animal body, comprising
  • a first therapy section in which negative pressure therapy by means of a device for negative pressure therapy of wounds - preferably for inflammation control and / or edema mobilization in the wound area -
  • the device is preferred for performing wound therapy by means of negative pressure
  • (a) comprises an air-impermeable cover material for airtight sealing of wound and wound environment, whereby a wound space is formed
  • (B) comprises a means for providing fluid communication between the wound space and a vacuum source located outside of the cover material, so that a negative pressure in the wound space can be produced and liquids are sucked from the wound space,
  • a first wound dressing which enables a substantially even distribution of the negative pressure in the wound space, comprises
  • a subsequent second treatment section in which using a second wound dressing and / or the swellable polymer increased stimulation of the formation of granulation tissue in the wound area and / or increased stimulation of neovascularization in the wound area and / or an increase in fibroblast density in superficial granulation tissue a wound is in each case carried out without generating a negative pressure
  • the second wound dressing preferably comprises an absorbent which comprises a swellable polymer, in particular a superabsorbent polymer.
  • the literature describes three major healing phases of a wound, especially in wounds with tissue loss. These include the inflammatory (inflammatory) or exudative phase for haemostasis and wound cleansing (phase 1, cleaning phase), the proliferative phase for the formation of granulation tissue (phase 2, granulation phase) and the differentiation phase for epithelization and scarring (phase 3, epithelization phase).
  • the inflammatory phase usually occurs immediately after wound formation. It is characterized by vascular constriction, activation of the coagulation cascade and complex immunological processes. The release of chemoattractive substances (eg chemokines) can cause a local inflammatory reaction. There are four main signs of inflammation: edema, exudation, redness and pain. The surrounding vessels can expand and inflammatory cells migrate into the site of inflammation. These can eliminate microorganisms and tissue necroses. This can be done a cleaning of the wound. In the subsequent proliferation or granulation phase, new tissue is created with vascular grafting and defect filling by granulation tissue. This is the basic requirement for later epithelization.
  • chemoattractive substances eg chemokines
  • Fibroblasts from the surrounding tissue can migrate into the fibrin net and use it as a temporary matrix. It begins the construction of collagen fibers.
  • the provisional fibrin scaffold is replaced by the granulation tissue.
  • Simultaneous angiogenesis supplies the granulation tissue with clogging capillaries and vessels.
  • the wound contracts by transforming fibroblasts into fibrocytes as well as myofibroblasts. As a result, the scar tissue shrinks and it leads to a reduction of the wound. Epithelialization from the edge of the wound completes wound healing.
  • the first therapy phase preferably comprises only the inflammatory phase or part of the inflammatory phase.
  • the first therapy phase preferably extends to the decay or completion of the inflammatory phase.
  • the decay of the inflammatory phase is recognizable to the physician as the disappearance of one or more of the inflammatory symptoms: edema, exudation, redness and pain.
  • the first therapy phase is preferably ended before a visible granulation can be detected.
  • the duration of the first therapy phase depends on the individual circumstances. However, successes have already been achieved if, for example, the first phase of therapy extends over a period of only 1, 2, 3, 4, 5, 6, 7 or 8 days, e.g. between 3 and 7 or 4 and 6 days, especially 4 days. This period of time is shorter than the typical duration of a negative pressure therapy. In particular, the negative pressure therapy no longer needs to be performed until the wound is closed.
  • the second phase of therapy should also be adapted to individual circumstances, but may, for example, be advantageously maintained over a period of from 1 to 1000 days, preferably from two to one hundred days, e.g. three to twenty days, especially four to ten days.
  • the second therapy phase immediately follows the first therapy phase.
  • the device to be used according to the invention for carrying out wound therapy by means of negative pressure may be a device known from the prior art.
  • the device for carrying out the negative pressure therapy may be a device known from the prior art.
  • a wound dressing which preferably comprises an open-celled foam.
  • the vacuum therapy device which can be used according to the invention comprises a covering material (a) for the airtight sealing of the wound.
  • a covering material for the airtight sealing of the wound.
  • airtight sealing is not to be understood here that no gas exchange takes place between the wound space and its surroundings. Rather, “airtight closing” in this context means that the vacuum necessary for the negative pressure therapy can be maintained. It can therefore also be used covering materials which have a slight gas permeability, as long as necessary for the negative pressure vacuum can be maintained.
  • the airtight cover material may be in the form of, for example, a shell made of a solid material or in the form of a flexible film. Also conceivable are combinations of these.
  • the covering material for airtight sealing of the wound comprises a water-insoluble polymer or a metal foil.
  • the cover material preferably has a thickness of 10 ⁇ m to 10,000 ⁇ m, in particular from 25 ⁇ m to 100 ⁇ m.
  • the covering material (a) is a water-insoluble polymer.
  • the water-insoluble polymer has a solubility of 10 mg / 1 or less, more preferably 1 mg / ml or less, especially 0.0001 to 1 mg / ml (determined by column elution method according to EU Directive RL67-548-EEC . Annex V Chap. A6).
  • Examples are polyurethane, polyester, polypropylene, polyethylene, polyamide or polyvinyl chloride, polyorganosiloxane (silicone), or a mixture thereof.
  • the polymers mentioned are preferably present in non-cellular form.
  • the cover material has a water vapor permeability of 100 to 2500 g / m 2 x 24 h, more preferably 500 to 2000 g / m 2 x 24 h, even more preferably 800 to 1600 g / m 2 x 24 h, especially 1050 to 1450 g / m 2 x 24 h, determined according to DIN EN 13726-2 at 23 ° C and 85% relative humidity, on.
  • cover material and finished products can be used which have the aforementioned properties.
  • the polyurethane film brand Hydrofilm ® (Paul Hartmann AG, Germany) or Visulin ® (Paul Hartmann AG, Germany) has been found.
  • the cover material is usually attached in the wound environment or at the wound edge so that an airtight wound closure is ensured. It may be expedient if the cover material is fully self-adhesive or has a self-adhesive edge. Alternatively, attachment and sealing can be done, for example, with an adhesive film, with a liquid adhesive or with a sealing compound. However, it is also possible that the covering material is held only by the negative pressure generated during the vacuum treatment at the wound.
  • the device according to the invention for negative pressure therapy comprises a means (b) for providing fluid communication between the wound space and a vacuum source located outside the covering material, so that a negative pressure can be produced in the wound space and liquid can be sucked out of the wound space.
  • negative pressure in the wound space in the context of the invention means a reduced air pressure within the wound dressing compared to the ambient air pressure (atmospheric air pressure).
  • ambient air pressure atmospheric air pressure
  • Negative pressure is often referred to as “negative pressure”.
  • the fluid communication can be made for example with a connection line and / or with a vacuum fitting.
  • Vacuum fittings are known in the art as "port".
  • the means for the functional connection of the wound space with a vacuum source located outside the covering material is at least one connecting line.
  • the at least one connecting line can be felt through the covering material.
  • the at least one connecting line can be carried out under the edge of the covering material. In both cases, the passage point must be hermetically sealed, so that the desired negative pressure in the dressing can be maintained.
  • a sealant for example, an adhesive film, an adhesive, or an adhesive strip is suitable.
  • connection line can be, for example, a hose, a pipe or another body with a cavity.
  • a suitable tube is, for example, a silicone drainage tube.
  • the means for operatively connecting the wound space to a source of negative pressure external to the cover material is a vacuum connector (port) which can be secured to one of the inner or outer sides of the cover material, the cover material being suitable openings having.
  • a vacuum connector port
  • the seal can be made for example with an adhesive film, with an adhesive, or with an adhesive strip. It is also conceivable that the port itself has corresponding fastening devices, such as adhesive surfaces.
  • cover material (a) and the means for providing fluid communication between the wound space and a vacuum source (b) located outside the cover material are already provided ready for use interconnected.
  • the inventive device for negative pressure therapy nor component (c), the wound dressing, the open-cell foam comprises or consists of this.
  • open-celled means that in foam (c) at least 60% open cells, preferably at least 90% open cells, more preferably at least 98% open cells, in particular in Substantially 100% open cells, based on the total number of cells, are present.
  • the wound dressing (c) of the vacuum device for example, also allows a substantially even distribution of the negative pressure in the wound space.
  • the open-cell foam is a polyurethane foam obtainable by reacting a mixture comprising the components (i) polyisocyanate, (ii) polyol, preferably polyester polyol, (iii) blowing agent, and (iv) catalyst.
  • polyisocyanates As polyisocyanates (i-PUR) it is possible to use generally known aliphatic, cycloaliphatic and / or especially aromatic polyisocyanates.
  • MDI diphenylmethane diisocyanate
  • 4,4'-MDI 4,4'-diphenylmethane diisocyanate
  • PMDI diphenylmethane diisocyanate
  • TMDI tetramethylene diisocyanate
  • HPI Hexamethylene diisocyanate
  • TDI tolylene diisocyanate
  • polyesterols As isocyanate-reactive compounds (ii-PUR), polyols such as polyetherols and / or polyesterols are usually used. Polyester polyols are preferably used in the component (ii-PUR).
  • the polyesterols (II-PUR) used are generally prepared by condensation of polyfunctional alcohols, preferably diols, having 2 to 12 carbon atoms, preferably 2 to 6 carbon atoms, with polyfunctional carboxylic acids having 2 to 12 carbon atoms, preferably 4 to 8 carbon atoms. Examples of suitable acids are succinic acid, glutaric acid, adipic acid, phthalic acid, isophthalic acid, and / or terephthalic acid and mixtures thereof. Adipic acid is particularly preferred.
  • dihydric and polyhydric alcohols examples include ethanediol, diethylene glycol, 1, 4-butanediol, 1, 5-pentanediol, and / or 1, 6-hexanediol and mixtures thereof. 1,4-butanediol is particularly preferred.
  • the compounds (ii-PUR) may be used in admixture with chain extenders and / or crosslinkers.
  • catalysts (iv-PUR) it is possible to use compounds which accelerate the reaction of component (i-PUR) with component (ii-PUR).
  • tertiary amines and / or organic metal compounds in particular tin compounds.
  • tin compounds for example, as Catalysts the following compounds are used: triethylenediamine, aminoalkyl and / or Aminophenylimidazole and / or tin (II) salts of organic carboxylic acids.
  • Catalysts are generally used in an amount of 0.1 to 5 wt .-% based on the weight of component (ii-PUR).
  • blowing agent iii-PUR
  • blowing agent iii-PUR
  • a physically acting propellant water may preferably be used, which forms by reaction with the isocyanate groups carbon dioxide.
  • physical blowing agents are (cyclo) aliphatic hydrocarbons, preferably those having 4 to 8, more preferably 4 to 6 and especially 5 carbon atoms, partially halogenated hydrocarbons or ethers, ketones or acetates. The amount of blowing agent used depends on the desired density of the foams. The different blowing agents can be used individually or in any mixtures with each other.
  • blowing agent generally in an amount of 0, 1 to 5 wt .-%, in particular from 2.5 to 4 wt .-%, based on the weight of component (ii-PUR).
  • Physical blowing agents are preferably used in an amount of ⁇ 0.5% by weight, based on the weight of component (II-PUR).
  • the reaction is optionally carried out in the presence of (v-PUR) auxiliaries and / or additives, such as.
  • auxiliaries such as.
  • the open-cell polyurethane foam is obtainable by reacting a mixture comprising or consisting of the following components: (i) polyisocyanate selected from MDI, PMDI, TDI and / or HDI,
  • polyesterpolyol the polyesterpolyol preferably being obtainable by reacting a dicarboxylic acid having 4 to 8 carbon atoms with a dialcohol having 2 to 6 carbon atoms and / or preferably having a weight-average molecular weight of 500 to 4000 g / mol,
  • the open-cell foam, in particular polyurethane foam after three days of storage in bovine serum has a tensile strength between 80 kPa and 300 kPa, measured according to DIN 53571.
  • the open-cell foam, in particular polyurethane foam preferably has an air permeability of 1000 to 8000 l / (m 2 sec), measured in accordance with DIN EN ISO 9237.
  • the wound dressing (c) of the vacuum device may contain silver in the form of silver ions or in the form of atomic silver.
  • silver is applied in the form of a silver coating on the wound dressing.
  • the silver may be distributed within the wound dressing.
  • the foam (c) contains 0.000001 to 0.1 wt%, more preferably 0.0001 to 0.01 wt% of silver, based on the total weight of the foam (c).
  • the wound dressing (c), in particular the open-cell foam has a thickness of 1 to 50 mm, in particular 15 mm to 30 mm.
  • the device for negative pressure therapy of wounds comprises at least one wound contact layer for introduction between wound dressing (c) and wound surface.
  • the additional wound contact layer may be adhesively or non-adhesively bonded to the wound dressing (c).
  • any wound contact layer known from the prior art may be considered wound contact layer as long as, on the one hand, passage of wound exudate is ensured and, on the other hand, the material has no tendency to coalesce or adhere to the wound tissue.
  • Especially suitable wound contact layers are ointment of Hydrotul ® brand Atrauman ® and Atrauman Ag ® (Paul Hartmann AG, Germany).
  • devices for negative pressure therapy of wounds can be used which contains as wound dressing (c) an open-cell foam based on a crosslinked polyorganosiloxane.
  • wound dressing c
  • an open-cell foam based on a crosslinked polyorganosiloxane contains as wound dressing (c) an open-cell foam based on a crosslinked polyorganosiloxane.
  • An advantage of the open-celled foam based on a crosslinked polyorganosiloxane is that it provides a soft wound dressing for the negative pressure therapy of wounds and ensures a uniform pressure distribution on the wound base. By providing a soft wound dressing and even pressure distribution, the vacuum treatment can be carried out gently and effectively.
  • the device for negative pressure therapy of wounds comprises at least one additional pressure distribution layer between the wound dressing (c) and the covering material (a).
  • an additional pressure distribution layer may be that the pressure exerted by the dressing on the wound base is more evenly distributed by the use of the pressure distribution layer. Furthermore, the pressure distribution layer can store and / or forward additional wound exudate.
  • the additional pressure distribution layer may be an open cell or semi-open cell foam, a spacer fabric, a textile layer, a structured gel, or a permeable nonwoven layer. Suitable textile layers include ES compresses or lattice garb.
  • the additional pressure distribution layer may be configured such that fluid, such as wound exudate, is passed therethrough.
  • the pressure distribution layer may contain suitable channels or openings, or consist of a material permeable to liquids.
  • first wound dressing is basically not to be confused with the swellable polymer or wound dressing according to the invention for wound therapy, which is used in the second therapy phase and is described in more detail below ("second wound dressing "). It is noted, however, that the wound dressings described below are in principle also suitable as wound dressings (c) and are correspondingly included in the present invention.
  • the second therapy phase is generally performed "without negative pressure". It is not to be understood that a wound treatment with vacuum device, however, is carried out without applied negative pressure. Rather, this is to be understood as meaning that the use of a vacuum device is completely dispensed with in the second therapy phase.
  • the swellable polymer and / or wound dressing (“second wound dressing”) is generally a wound dressing that is moist wound or moisturizing moist wet environment allowed.
  • Wet or moist wet means here that the wound under the wound dressing has a moist or wet-wet surface, ie the wound does not dry (at least not completely) under the surface.
  • the wound dressing (“second wound dressing”) preferably comprises an absorbent which comprises a swellable polymer, in particular a superabsorbent polymer.
  • the wound dressing comprises an absorbent which comprises an at least partially liquid-permeable cover and, arranged therein, a swellable polymer, in particular a superabsorbent polymer.
  • the swellable polymer is preferably surrounded by the shell. This polymer surrounded by the shell is preferably part of the absorbent body or forms the absorbent body.
  • the absorbent body is preferably part of the wound dressing.
  • the at least partially liquid-permeable casing allows the passage of liquids over its entire surface or at least in certain areas of the shell.
  • the shell may consist of a single material or comprise multiple materials.
  • the sheath may advantageously comprise a textile (surface) material, such as e.g. a knitted fabric, a knitted fabric or a woven fabric, in particular of polyolefin, in particular of polypropylene.
  • the sheath can advantageously at least partially consist of a textile surface which is non-elastically extensible in the longitudinal, transverse and diagonal directions, as disclosed in EP 0 594 034.
  • the swellable polymer is or preferably comprises a superabsorbent polymer.
  • a superabsorbent polymer (SAP) is generally understood to mean a water-insoluble, swellable polymer which can take up many times its own weight of liquid, for example water. The fluid intake leads to the formation of a hydrogel.
  • the term superabsorbent polymer is understood in particular to mean a polymer which is prepared according to the standard test method WSP 240.2 (05) has a w value ("free swell capacity") of at least 10 g / g, preferably at least 20 g / g.
  • WSP 240.2 (05) for determining the w-value is described in "Standard Test Methods for the Non-Wovens and Related Industries", Edition 2008 (edited by "EDANA, International Association Serving the Nonwoven and Related Industries", Cary, NC, USA and “INDA, Association of the Nonwovens Fabrics Industry", Brussels, Belgium).
  • WSP 240.2 (05) according to EDANA is a standard test method for determining the w value ("free swell capacity") of superabsorbent polyacrylate powder. According to WSP 240.2 (05), the free uptake capacity for a 0.9 weight percent saline solution is determined.
  • the superabsorbent polymer may be in the form of fibers or preferably particles.
  • the mean particle size of the particles of superabsorbent polymer is preferably from 150 to 850 ⁇ .
  • swellingable polymer preferably refers to polymers which are in principle capable of swelling, regardless of whether the polymer is in an unswollen or swollen state, that is, if a swellable polymer has come into contact with water is present as an already swollen polymer, it is still considered as a "swellable polymer" within the meaning of the invention.
  • the superabsorbent polymer is or comprises polyacrylate.
  • the monomer content is in particular more than 70, for example more than 80 or 95 percent by weight of acrylic acid and / or a salt thereof (based on the total weight of the polyacrylate).
  • the polyacrylate may be present as a homopolymer, copolymer or block polymer.
  • the superabsorbent polymer is a graft copolymer of polyacrylic acid and / or a salt thereof and polyvinyl alcohol, more preferably crosslinked polyacrylic acid and / or a salt thereof and polyvinyl alcohol.
  • the polyacrylate is preferably as a partially neutralized polymer
  • the degree of neutralization should be between 20% and 90%, more preferably between 45% and 80%.
  • the absorbent body comprises a mixture of polyacrylate particles, wherein the particle mixture contains polyacrylate particles of different sizes, characterized in that the particle mixture a) contains 5 to 100% by weight, preferably 5 to 98 wt .-%, particles having a particle size x with x ⁇ 300 ⁇ , and
  • the particle size is determined in the context of the present invention analogously to EDANA 420.2-02, wherein the sieves (diameter 200 mm) have the information corresponding hole sizes.
  • screens with other hole sizes such as e.g. 125 ⁇ , 160 ⁇ , 630 ⁇ , 900 ⁇ , and 1500 ⁇ be used.
  • dry polyacrylate particles having a moisture content of less than 10% by weight of water, based on the total weight of the particles, are used, the moisture content being determined according to EDANA 450.2-02.
  • the absorbent body may further comprise a nonwoven fabric.
  • the nonwoven can serve as a carrier material for the swellable polymer.
  • the swellable polymer according to the invention may preferably be applied or incorporated on a nonwoven as carrier material.
  • This arrangement is preferably part of the absorbent body or forms the absorbent body.
  • the absorbent is preferably part of the wound dressing. Reference is made to the following explanations, where the absorbent is identified as part (ii) of the wound dressing.
  • the nonwoven is preferably a hydrophilic fiber material.
  • the fibers of the hydrophilic fiber material for example, water-insoluble fibers of cellulose, for example, largely delignified technical pulp fibers, eg wood pulp fibers, preferably with a fiber length of ⁇ 5 mm or include.
  • the nonwoven may also contain or consist of hydrophilic fiber material of regenerated cellulose, carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose or hydroxyethylcellulose.
  • It may also be based on or consist of a mixture of fibers of cellulose, regenerated cellulose, carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose or hydroxyethylcellulose and thermoplastic fibers, for example of polyethylene, polypropylene or polyester.
  • the swellable or superabsorbent polymer is preferably distributed in the form of particles in the web.
  • the absorbent body comprises at least one superabsorbent polyacrylate and a nonwoven which comprises a mixture of cellulose fibers and polypropylene fibers or is based on such a mixture.
  • the fleece can serve as a carrier material.
  • the fibers can be processed into a layer together with particles or fibers of the superabsorbent polymer in a so-called airlaid process.
  • the absorbent body is a wrapped airlaid comprising a superabsorbent polyacrylate, cellulosic and polypropylene fibers.
  • the absorbent body and / or the swellable polymer is subjected to a solution.
  • the application is preferably carried out to saturation and preferably with an aqueous solution which swells the swellable or superabsorbent material and turns it into a gelatinous state.
  • the aqueous solution is preferably saline.
  • the absorbent body and / or the swellable polymer may for example be charged with at least 600 weight percent, at least 800 weight percent or at least 1000 weight percent of an aqueous solution, based on the weight of the dry absorbent body.
  • the absorbent is preferably less than 5000 weight percent, e.g. less than 3500 weight percent, e.g. less than 2500 weight percent of an aqueous solution applied.
  • the absorbent body contains that amount of an aqueous activation solution which corresponds to its maximum absorption capacity for Ringer's solution.
  • the maximum uptake capacity for Ringer's solution can be determined according to the aforementioned test method WSP 240.2 (05), except that a) Ringer's solution is used in place of the saline solution used in WSP 240.2 (05); and b) instead of the bag-sealed test substance ("Bag" according to paragraph 6.1 of WSP 240.2 (05)) Suction body according to the invention is used.
  • the maximum absorption capacity corresponds to the gravimetrically determined weight difference between the dry absorbent body and the activated absorbent body, whereby a deviation of the weight difference by 15% is included upwards or downwards.
  • the aqueous solution is a synthetic solution and does not contain body fluids or body-separated fluids.
  • the aqueous solution contains more than 50, eg more than 70, more than 80, more than 90 or 100 volume percent water. It can contain at least 5 mmol / l sodium ions, at least 0.1 mmol / l potassium ions, at least 0.1 mmol / l calcium ions and / or at least 5 mmol / l chloride ions.
  • the aqueous solution contains further inorganic cations and / or anions, optionally organic anions, and optionally additions of bioorganic compounds.
  • the pH is preferably 4 to 9.
  • the aqueous solution is a Ringer's solution.
  • a Ringer's solution is meant an approximately to the blood iso-osmotic synthetic solution comprising sodium chloride, potassium chloride and calcium chloride dissolved in distilled water.
  • the Ringer solution preferably contains 147 mmol / l sodium ions, 4.0 mmol / l potassium ions, 3.0 mmol / l calcium ions and 157 mmol / l chloride ions, whereby a deviation of the respective ion concentration from the stated value by 5% is possible ,
  • An advantage of the applied absorbent solution is that immediately after the start of therapy, the wound is kept in a moist environment and does not dry out, which promotes the healing of wounds.
  • the absorbent body and / or the swellable polymer may comprise an antimicrobial substance.
  • the antimicrobial substance is or comprises a substance having antimicrobial activity at pH values of 4 to 7.5 in cationic form, For example, substances with amino or imino groups.
  • the cationic antimicrobial substance can be antimicrobially active metal cations, in particular silver cations, for example a complex of l-vinyl-2-pyrrolidone with silver cations.
  • Particularly suitable cationic substances with antimicrobial action are biguanide derivatives such as chlorhexidine or polybiguanides, such as polyethylene biguanide (PEB), polytetramethylene biguanide (PTMB) or polyethylene hexamethylene biguanide (PEHMB).
  • biguanide derivatives such as chlorhexidine or polybiguanides, such as polyethylene biguanide (PEB), polytetramethylene biguanide (PTMB) or polyethylene hexamethylene biguanide (PEHMB).
  • PEB polyethylene biguanide
  • PTMB polytetramethylene biguanide
  • PEHMB polyethylene hexamethylene biguanide
  • a particularly preferred polybiguanide is polyhexamethylene biguanide (PHMB or polyhexanide).
  • polyguanidines such as polyhexamethyleneguanidines (PHMG), N-octyl-l - [10- (4-octyliminopyridin-1-yl) decyl] pyridin-4-imine (octenedin), quaternary ammonium compounds such as benzalkonium chloride or cetylpyridinium chloride, triazines such as 1- (3-chloroallyl) -3,5,7-triaza-1-azoniaadamantane chloride or the ammonium compound taurolidine.
  • PHMG polyhexamethyleneguanidines
  • quaternary ammonium compounds such as benzalkonium chloride or cetylpyridinium chloride
  • triazines such as 1- (3-chloroally
  • the wound dressing according to the invention can also contain a wound contact layer and an evaporation-inhibiting backing layer.
  • the wound dressing therefore comprises i) atraumatic wound contact layer,
  • the wound contact layer (i) is preferably a partially and / or structured applied, atraumatic coating.
  • the coating can be applied directly to the absorbent body. Preferably, it is applied to a suction body, which is surrounded by the textile cover described above.
  • the coating is preferably a silicone coating, which coating may be, for example, porous and formed by a plurality of relatively thin strips or lines or island-shaped areas which may be separated from each other by uncoated areas. In these uncoated areas, the wound-facing side of the absorbent body may be exposed to the wound.
  • the atraumatically acting coating can thus form a supernatant, whereby on the one hand adhesion of the absorbent body with wound tissue can be prevented and on the other hand a certain small distance between the wound-facing side of the absorbent body and the wound tissue can be maintained.
  • the porous shell layer material stay open three-dimensionally and provide or maintain less resistance to fluid passage in both directions over the life of the dressing.
  • the wound-facing side of the absorbent body can be covered by a film, preferably a plastic film.
  • the film is preferably substantially germ and waterproof and thus provides improved protection against evaporation.
  • the wound dressing can be applied to a wound or used to stamp out deep wounds.
  • the present invention is particularly advantageous when the wounds are burn wounds, wounds resulting from mechanical trauma, a wound resulting from the action of chemicals, a wound caused by a metabolic disorder, a wound caused by a circulatory disturbance, or a wound caused by a pressure ulcer wound acts.
  • treatment 1 included 8 days of negative pressure therapy
  • treatment 2 included a first phase of therapy with 4 days of negative pressure therapy, followed immediately by a second phase of therapy with 4 days of therapy in wet or damp Milieu.
  • treatment 3 included a first therapy phase with 6 days of negative pressure therapy, followed immediately by a second therapy phase with 2 days of therapy in a damp or damp wet environment.
  • a swellable polymer is used, the ® in the wound dressing TenderWet Plus (Paul Hartmann AG) was included for the negative pressure therapy polyurethane film were (hydro film ®, Paul Hartmann AG) as coating material (a) and open-cell foam (as a wound dressing c ) (Vivanomed ®, Paul Hartmann AG) (together with commercially available adapters, hose means for fluid communication b) and vacuum device used.
  • FIG. 1 shows that in the treatments B2 according to the invention (4 days underpressure + 4 days moist medium) and B3 (6 days underpressure + 2 days moist medium) the formation of granulation tissue is considerable compared to a negative pressure Bl of the same duration (8 days) has improved.
  • FIG. 2 shows that in the treatments B2 according to the invention (4 days underpressure + 4 days moist medium) and B3 (6 days underpressure + 2 days moist medium), the neo-vascularization improves compared to a negative-pressure therapy B1 of the same duration (8 days) Has. A significant improvement in the stimulation of neovascularization could be achieved.
  • FIG. 3 shows that in the treatments B2 according to the invention (4 days underpressure + 4 days moist medium) and B3 (6 days underpressure + 2 days moist medium) the formation of fibroblasts improves compared to a negative pressure Bl of the same duration (8 days) Has. A significant increase in fibroblast density could be achieved.
  • Example 2 Scavenging of inflammatory mediators by polyacrylate-containing wound dressings
  • Wound dressing for use in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing comprises a absorbent body, which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing is used in the context of a therapy scheme, which at least one treatment phase using negative pressure and at least one further preceding and / or interposed and / or subsequent Treatment phase without the use of negative pressure comprises, wherein the wound dressing is used in at least one treatment phase without the use of negative pressure.
  • a therapy scheme which at least one treatment phase using negative pressure and at least one further preceding and / or interposed and / or subsequent Treatment phase without the use of negative pressure comprises, wherein the wound dressing is used in at least one treatment phase without the use of negative pressure.
  • Vascular formation is used in the wound area.
  • Wound dressing according to item 1 wherein the wound dressing is used in at least one treatment phase without the use of negative pressure to increase the fibroblast density in the superficial granulation tissue of a wound.
  • the wound dressing according to item 6 wherein the wound dressing is used in a second therapy phase after a first therapy phase aimed at controlling inflammation and / or edema mobilization,
  • wound dressing according to one of the preceding points, wherein the wound dressing is used for intensified stimulation of the formation of granulation tissue in the wound area immediately after a previous negative pressure therapy and / or wherein the wound dressing is used for increased stimulation of the neovascularization in the wound area immediately after a previous negative pressure therapy and / or where the wound dressing is to increase the fibroblast density is used in the superficial granulation tissue of a wound immediately after a previous negative pressure therapy.
  • wound dressing according to one of the preceding points, wherein the wound dressing comprises:
  • the absorbent body comprises a non-woven, which preferably contains cellulose fibers.
  • a wound dressing in the therapeutic treatment of wounds on the human or animal body, wherein the wound dressing comprises an absorbent body which comprises a swellable polymer, in particular a superabsorbent polymer, characterized in that the wound dressing is used in the context of a therapy scheme which at least one treatment phase using negative pressure and at least one further preceding and / or intermediate and / or subsequent treatment phase without the use of negative pressure, wherein the wound dressing is used in at least one treatment phase without the use of negative pressure.

Abstract

L'invention concerne de manière générale le traitement des plaies et en particulier des pansements ainsi que des modalités particulières d'utilisation de ces pansements pour le traitement de plaies.
EP13725914.9A 2012-09-25 2013-05-14 Polymère gonflant destiné à être utilisé dans le traitement thérapeutique Withdrawn EP2900287A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP13725914.9A EP2900287A1 (fr) 2012-09-25 2013-05-14 Polymère gonflant destiné à être utilisé dans le traitement thérapeutique

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12006688.1A EP2711029A1 (fr) 2012-09-25 2012-09-25 Pansement
PCT/EP2013/001416 WO2014048513A1 (fr) 2012-09-25 2013-05-14 Polymère gonflant destiné à être utilisé dans le traitement thérapeutique
EP13725914.9A EP2900287A1 (fr) 2012-09-25 2013-05-14 Polymère gonflant destiné à être utilisé dans le traitement thérapeutique

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EP2900287A1 true EP2900287A1 (fr) 2015-08-05

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EP12006688.1A Withdrawn EP2711029A1 (fr) 2012-09-25 2012-09-25 Pansement
EP13725914.9A Withdrawn EP2900287A1 (fr) 2012-09-25 2013-05-14 Polymère gonflant destiné à être utilisé dans le traitement thérapeutique

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DE102012025124A1 (de) 2012-12-21 2014-06-26 Paul Hartmann Ag Saugkörper zur therapeutischen Behandlung einer Wunde mittels Unterdruck
DE102012025125A1 (de) 2012-12-21 2014-06-26 Paul Hartmann Ag Saugkörper zur therapeutischen Behandlung einer Wunde mittels Unterdruck

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US5645081A (en) 1991-11-14 1997-07-08 Wake Forest University Method of treating tissue damage and apparatus for same
ATE147253T1 (de) 1992-10-22 1997-01-15 Ivf Internationale Verbandstof Plastisch verformbare kompresse
DE202004017052U1 (de) * 2004-11-02 2005-06-09 Riesinger, Birgit Vorrichtung zur Wundbehandlung unter Einsatz von Unterdruck
US20110054375A1 (en) 2007-11-27 2011-03-03 Hans Smola Dressing comprising polyacrylate particles and use thereof
DE102009031992A1 (de) * 2009-07-06 2011-01-13 Paul Hartmann Ag Vorrichtung zur Unterdrucktherapie von Wunden

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EP2711029A1 (fr) 2014-03-26

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