FOAM IN WOUND TREATMENT

Abstract

The present invention relates to a hydrophilic foam material, which is of particular use in wound treatment, and to a method for producing said hydrophilic foam material. The hydrophilic foam material comprises nucleating particles, wherein at least 85% of all foam cells in said foam material have an average cell size of 0.01 mm 2 or less.

Claims

1.-14. (canceled)

15. A method for producing a hydrophilic polyurethane foam material, comprising the steps of: (i) preparing an aqueous mixture, (ii) mixing said aqueous mixture with a prepolymer composition to form an emulsion, and (iii) allowing the emulsion to cure, thereby producing said hydrophilic polyurethane foam material, wherein nucleating particles, at a concentration of least 5% by weight of said prepolymer composition, are added to said aqueous mixture in step (i) and/or are present in said prepolymer composition of step (ii).

16. (canceled)

17. The method of claim 15, wherein aqueous mixture of step (i) comprises a surfactant.

18. The method of claim 15, wherein nucleating particles, at a concentration of least 5% by weight of said prepolymer composition, are added to said aqueous mixture in step (i).

19. The method of claim 15, wherein nucleating particles, at a concentration of least 5% by weight of said prepolymer composition, are present in said prepolymer composition of step (ii).

20. The method of claim 15, wherein the method produces a hydrophilic polyurethane foam material comprising nucleating particles, which are present at a concentration of at least 5% by weight of said foam material, relative to the overall weight of the foam material, wherein at least 85% of all foam cells in said foam material have an average cell size of 0.01 mm.sup.2 or less, as measured by image analysis based on ISO 13322-1:2014.

21. The method of claim 15, wherein said nucleating particles are present at a concentration of from 5 to 25% by weight of said prepolymer composition.

22. The method of claim 15, wherein said nucleating particles have a particle size in the range of from 1 to 30 μm.

23. The method of claim 15, wherein said nucleating particles are selected from the group consisting of alumina trihydrate, calcium carbonate, carbon black, magnesium oxide, lime, clay, and diatomaceous earth, or a combination thereof.

24. The method of claim 15, wherein said nucleating particles comprise alumina trihydrate.

25. The method of claim 15, wherein said prepolymer composition comprises an isocyanate-capped polyol or isocyanate-capped polyurethane or a combination thereof.

26. The method of claim 15, wherein said prepolymer composition comprises an isocyanate-capped polyol.

27. The method of claim 15, wherein said prepolymer composition comprises an isocyanate-capped polyol selected from the group consisting of a polyester polyol, polyacrylate polyol, polyurethane polyol, polycarbonate polyol, polyether polyol, polyester-polyacrylate polyol, polyurethane polyacrylate polyol, polyurethane polyester polyol, polyurethane polyether polyol, polyurethane polycarbonate polyol, and polyester polycarbonate polyol.

28. The method of claim 15, wherein said prepolymer composition derives from a reaction between a polyol, and a diisocyanate compound selected from the group consisting of hexamethylene diisocyanate (HDI), toluene diisocyanate (TDI), methylene diphenyl diisocyanate (MDI), and isophorone diisocyanate (IPDI), or any mixture thereof.

29. The method of claim 15, wherein said aqueous mixture or said prepolymer composition comprises an antimicrobial agent.

30. The method of claim 29, wherein said antimicrobial agent comprises silver.

31. The method of claim 30, wherein said silver is a silver salt.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0066] These and other aspects of the invention will now be shown in more detail, with reference to the Figures showing exemplary embodiments of the invention, wherein:

[0067] FIG. 1 is a cross-sectional view of an embodiment of a layer of a hydrophilic polyurethane foam material according to the invention;

[0068] FIGS. 2a-d are cross-sectional views of embodiments of a medical dressing according to the invention;

[0069] FIG. 3 is a histogram representing a cell size analysis of the hydrophilic polyurethane foam produced according to Example 1; and

[0070] FIG. 4 is a histogram of cell size analysis of the hydrophilic polyurethane foam produced according to Example 2.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0071] In the following, detailed embodiments of the present invention are described, with reference to the accompanying Figures, which are exemplary illustrations of embodiments of the invention.

[0072] FIG. 1 illustrates a foam layer 1 comprising a hydrophilic polyurethane foam material 7 according to an embodiment of the invention.

[0073] The foam layer has a top side 31 and bottom side 35, opposite to the top side 31.

[0074] The hydrophilic polyurethane foam material 7 in accordance with the present invention comprises nucleating particles at a concentration of at least 5% by weight of the foam material (relative to the overall weight of the foam), wherein at least 85% of all foam cells in said foam material has an average cell size of 0.01 mm.sup.2 or less, as measured by image analysis based on ISO 13322-1:2014.

[0075] Accordingly, a hydrophilic polyurethane foam material 7 is provided with substantially homogenous small cell sizes (at least 85% of all foam cells have an average cell size of 0.01 mm.sup.2 or less), thereby improving at least one of the following foam properties associated with the liquid handling capacity of the foam material 7: liquid absorption (speed and maximum), and liquid spreading and transport within the foam material 7.

[0076] FIGS. 2a-d illustrate exemplary embodiments of medical dressings 20, 50, 80, 90 comprising the hydrophilic polyurethane foam material 7, as realized in the form of a layer 1. In embodiments of the invention, as shown in FIGS. 2a-d, the medical dressings 20, 50, 80, 90 further comprise a backing layer 21, 23 overlaying the top side 31 of the foam layer 1, wherein bottom side 35 is adapted to function as the skin or wound facing side which can thus function as a direct or indirect wound contact side through which side wound exudate can be absorbed and transported into the core of the foam layer 1.

[0077] The inventors have surprisingly realized that if the cell size of a hydrophilic polyurethane foam material is reduced, the speed of absorption of liquid (e.g. wound exudate) is increased. For example, in embodiments of the invention, the foam layer 1 according to the present invention has a speed of absorption of at least 10 μL/sec, preferably at least 20 μL/sec, more preferably at least 30 μL/sec.

[0078] In embodiments of the invention, as shown in FIGS. 2a-b, the backing layer 21 extends outside the peripheral portion of the foam layer 1, to define a border portion 40 of the backing layer 21 thus surrounding the peripheral portion the foam layer 1, thereby providing a so-called island dressing.

[0079] Suitable backing layers 21, 23 are, for example, films, foils, foams, or membranes. Furthermore, it is advantageous if the backing layer has a thickness in the area of from ≥5 μm up to 80 μm, particularly preferred of from ≥5 μm up to ≤60 μm, and particularly preferred of from ≥10 μm up to ≤30 μm and/or that the backing layer has an elongation at break of more than 450%.

[0080] The backing layer 21, 23 may be realized to be pervious to water vapor in accordance to DIN 53333 or DIN 54101.

[0081] Preferably, the backing layer 21, 23 may comprise a thermoplastic polymer, for example as a coating, or may consist thereof. A thermoplastic polymer, at first, is to be understood as a polymer that remains thermoplastic if the same is repeatedly heated and cooled within a temperature that is typical for the respective processing or application conditions. Being thermoplastic is understood to be the property of a polymer material to repeatedly soften upon application of heat and to repeatedly harden when cooled down, within a temperature range that is typical for the respective material, wherein the material remains capable of being formed, in the softened stage, and repeatedly, by way of flowing, for example as a shaped article, extruded or otherwise.

[0082] Preferred thermoplastic polymers are polyurethane, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyether, polyester, polyamide, polycarbonate, polyether polyamide copolymers, polyacrylate, polymethacrylate, and/or polymaleate. Preferably, the thermoplastic polymers are elastomeric. It is particularly preferred that the carrier foil comprises thermoplastic polyurethanes (TPU), or consists thereof. Thermoplastic polyurethanes selected from the group comprising aliphatic polyester polyurethanes, aromatic polyester polyurethanes, aliphatic polyether polyurethanes and/or aromatic polyether polyurethanes are particularly suitable. By using these polymers, it is possible to obtain backing layers as breathable elastic membrane films. These are characterized by high flexibility and elasticity over a broad range of temperatures, also having advantageous sealing properties for (liquid) water while having a high water vapor permeability. These materials are further characterized by low noise, advantageous textile feel, resistance against washing and cleaning, very good chemical and mechanical resistance and the fact they are free of plasticizers.

[0083] Particular preferred is also a backing layer that acts as a barrier for germs and has a high sealing capability against exudate emanating from the wound while, at the same time, being permeable for water vapor. In order to achieve the same, the backing layer may, for example, be realized as a semipermeable membrane.

[0084] In embodiments of the invention, the backing layer 21, 23 is preferably vapor permeable. The backing layer 21, 23 may be a plastic film, for example, comprising or consisting of polyurethane, polyethylene, or polypropylene. In embodiments of the invention, the backing layer 21, 23 is a polyurethane film having a thickness in the range of 10 to 100 μm, for example, 10 to 80 μm such as 10 to 50 μm, preferably from 10 μm to 30 μm.

[0085] As schematically illustrated in FIGS. 2a-d, the medical dressings 20, 50, 80, 90 may include an adhesive layer or coating 41, 42, 43 to adhere the medical dressing to a wound site (wound surface and/or the surrounding skin surface). In embodiments of the invention, the adhesive layer or coating 41, 42, 43 may be a silicone based adhesive or an acrylic based adhesive, preferably the adhesive layer or coating is a silicone based adhesive. The term “coating” should, in accordance with the present invention, be understood as essentially one continuous layer on a surface, or a discontinuous cover on a surface.

[0086] The medical dressings 20, 50, 80, 90 may furthermore comprise a release layer (not shown) that is releasably connected to the adhesive layer or coating 41, 42, 43 and can be removed prior to application. Suitable release layers comprise or consist of materials that have limited adhesion to the adhesive of the adhesive layer, if brought in contact with the same. Examples for such release layers are release papers that comprise a non-adhesive silicone or polyolefin layer.

[0087] As shown in FIG. 2b and FIG. 2d, the medical dressings 50, 90 preferably include a perforated layer 44, for example made of a polyurethane film, wherein an adhesive layer or coating 42 is provided on the non-perforated portions of the perforated layer 44. The perforated layer 44 includes a plurality of openings 45 (or through holes) of any desirable size and shape. The shape and size of the openings 45 may be adapted to achieve a desirable liquid transport from the wound to the above first foam layer 1.

[0088] In embodiments of the invention, as illustrated in FIG. 2b, the perforated layer 44 with the adhesive layer or coating 42 may be provided on the bottom side 35 of the foam layer 1, wherein the perforated layer 44 extends outside the peripheral portion of the foam layer 1 and is attached (e.g. by means of a second adhesive, not shown) to the border portion 40 of the backing layer 21.

[0089] In alternative embodiments, as shown in FIG. 2d, the extension in x-y direction of the perforated layer 44 corresponds to the extension in x-y direction of the foam layer 1. In embodiments of the invention, as shown in FIG. 2c the adhesive layer or coating 43 is provided directly on the bottom side 35 of the foam layer 1. In embodiments of the invention, as shown in FIG. 2a, an adhesive layer or coating 41 is provided on a continuous plastic film 46, for example a polyurethane film as discussed above, which continuous plastic film 46 is arranged adjacent to a peripheral portion of the foam layer 1, wherein the continuous film 46 extends away from said peripheral portion and is attached (e.g. by means of a second adhesive, not shown) to the border portion 40 of the backing layer 21. In further embodiments (not shown) an adhesive layer or coating may be provided directly on a skin facing surface of the border portion 40 of the backing layer 21.

[0090] The person skilled in the art realizes that the present invention by no means is limited to the exemplary embodiments described herein. For example, the medical dressing according to invention may comprise additional structural layer(s) in fluid communication with the hydrophilic polyurethane foam material to further optimize desirable properties and/or to achieve additional functionalities. For example, the medical dressing may comprise a second hydrophilic foam layer and/or a non-woven layer with absorption capacity, to thereby further optimize the liquid handling capacity of the medical dressing.

[0091] The invention is further illustrated in the following Examples. Unless otherwise specified, all experiments and tests described herein were performed at standard laboratory conditions, in particular at room temperature (20° C.) and standard pressure (1 atm.). Unless indicated otherwise, all indications regarding percentages are meant to refer to percentage by weight.

Example 1

[0092] Method of Preparing a Hydrophilic Polyurethane Foam

[0093] A foam layer was prepared using the following steps (1) (3): (1) An aqueous mixture comprising surfactant Pluronic® L62 0.125% w/w was prepared; (2) the aqueous mixture was mixed with the prepolymer Trepol® B1, at a 1.6:1 ratio by weight (aqueous mix./prepolymer) to give an emulsion mixture; (3) the emulsion mixture was poured onto and spread out on a casting paper (20×30 cm) and was allowed to cure at standard condition (at room temperature) to give a foam with a thickness of about 3 mm (foam thickness is controlled by adapting the thickness of spread of the emulsion mixture in step (3)). Chemicals used are commercially available and are, in particular: Trepol® B1 (TDI based prepolymer) from Rynel Inc., and Pluronic® L62, commercially available from BASF.

Example 2

[0094] Method of Preparing a Hydrophilic Polyurethane Foam with Added Nucleating Particles

[0095] A foam layer was prepared using the following steps (1) (3): (1) An aqueous mixture comprising surfactant Pluronic® L62 0.125% w/w and alumina trihydrate 7% w/w (SB-432 commercially available from Akrochem Corporation; 7% w/w of aqueous mix. corresponds to ca. 10% w/w of the final dried foam product, given prepolymer mixture ratio in step (2)) was prepared; (2) the aqueous mixture was mixed with the prepolymer Trepol® B1 at 1.6:1 ratio by weight (Aqueous mix./prepolymer) to give an emulsion mixture; (3) the emulsion mixture was poured onto and spread out on a casting paper (20×30 cm) and was allowed to cure at standard condition (at room temperature) to give a foam having a thickness of about 3 mm (foam thickness is controlled by adapting the thickness of spread of the emulsion mixture in step (3)).

Example 3

[0096] Foam Pore Cell Size Analysis

[0097] Images of cross-sections of the foam layers produced in Example 1 and Example 2 were analyzed according ISO 13322-1 using an Olympus SZX16 microscope and Olympus Stream Image Analysis Software Version 510 (software is based on ISO 13322-1) from Olympus Soft Imaging Solution GmbH, Johann-Krane-Weg 39, D48149 Munster, Germany. FIG. 3 and FIG. 4 are histograms of cell size analysis of the foam material according to Example 1 (without nucleating particles) and Example 2 (with ca. 10% nucleating particles (alumina trihydrate) by weight of the foam material), respectively.

[0098] As can be seen in FIG. 4, 87.6% of all foam cells of the hydrophilic polyurethane foam prepared according to Example 2, which foam includes nucleating particles according to an embodiment of the invention, have an average cell size in class 1 (corresponding to 0.01 mm.sup.2 or less). In contrast, as can be seen in FIG. 3, 69.6% of all foam cells in the corresponding foam material without added nucleating particles (Example 1) have an average cell size in class 1 (corresponding to 0.01 mm.sup.2 or less).

[0099] In FIG. 3 and FIG. 4, the classes 1 to 10 correspond to the following average cell sizes: class 1: 0-0.01 mm.sup.2, class 2: 0.01-0.02 mm.sup.2, class 3: 0.02-0.03 mm.sup.2, class 4: 0.03-0.04 mm.sup.2, class 5: 0.04-0.05 mm.sup.2, class 6: 0.05-0.06 mm.sup.2, class 7: 0.06-0.07 mm.sup.2, class 8: 0.07-0.08 mm.sup.2, class 9: 0.08-0.09 mm.sup.2, class 10: 0.09-0.3 mm.sup.2.

Example 4

[0100] Determination of Free Swell Absorptive (Fluid Absorption) Capacity

[0101] The free swell absorptive (or maximum absorption) capacity was determined according to EN 13726-1:2002 with the following minor modifications: a test piece with the size 10×10 cm (thickness ca. 3 mm) was used and the free swell absorptive capacity per volume unit of test piece was calculated, i.e. mass (kg) of retained Solution A per volume (m.sup.3). Weight per volume provides a more relevant measure (as compared with e.g. weight by weight as suggested in EN 13726-1:2002) when comparing hydrophilic foams with different densities, in particular as the nucleating particles typically increase the foam density. The “weight per volume” values can readily be converted to “weight per weight” by dividing the weight per volume value with the respective density value of the sample. The free swell absorptive capacity values of the foam material of Example 1 and 2 are presented in Table 1 below.

Example 5

[0102] Determination of Speed of Absorption

[0103] In accordance with the invention, speed of absorption is determined according to TAPPI standard T558 OM-97 (which method inter alia evaluates the absorptive properties of a surface, as the remaining liquid volume on top of the specimen surface is measured as a function of time), wherein the test solution used herein is the Solution A from EN 13726-1, and droplet volume is 30 μl. The speed of absorption of the foam layers of Example 1 and 2 are presented in Table 1 below. As can be seen in Table 1, the foam material of Example 2 (with alumina trihydrate) has approximately 50% greater speed of absorption compared to the foam material of Example 1 (without alumina trihydrate).

TABLE-US-00001 TABLE 1 Speed of Free-swell Test Density absorption absorptive capacity sample (g/cm.sup.3) (μl/sec.) (kg/m.sup.3 foam) Foam 0.0947 8.1 975 Example 1 Foam 0.1028 12.3 985 Example 2