Compositions Comprising Powder-Coated Biomaterial-Based Porous Materials - Patent application

Abstract

The present invention relates to a composition comprising a powder-coated biomaterial-based porous material, and a method for making such a composition. The present invention further relates to a method for controlling bleeding and / or leakage of other body fluids in surgery or in the treatment of injuries selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue, and for the treatment of skin, comprising administering such a composition.

Description

[Technical field]

[0001] The present invention relates to compositions comprising powder coated biomaterial-based porous materials and methods of making such compositions. The present invention further relates to methods of controlling bleeding and / or other fluid leakage in surgery or the treatment of injuries selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue, and for the treatment of skin, comprising administering such compositions. [Background technology]

[0002] Various coating techniques are used to deposit materials on substrates, including chemical or physical vapor deposition, electrochemical techniques, spraying, slot-die coating, etc. In particular, the use of electrostatic powder coating techniques to coat conductive substrates such as metals is well known. In this method, the powder coating material is electrostatically charged and then sprayed or sprayed onto the surface of the conductive material to which it is to be attached. The electrostatic attraction between the positively charged or ionized powder and the negatively charged surface of the conductive material, or vice versa, causes the material to be impregnated with the powder. This method is particularly used to paint metal articles.

[0003] However, in recent years, there has been an increase in the use of polymeric materials in the manufacture of articles, especially in applications requiring reduced weight and improved corrosion resistance, and at the same time, such polymers generally have insufficient electrical conductivity to be effectively coated by the above methods, since they cannot be efficiently electrostatically charged to attract charged powder particles.

[0004] One way to improve the conductivity of a polymer is to use a conductive primer composition for the polymer. WO2004 / 069942 discloses an example of such a primer composition. However, depending on the specific primer used, the prepared polymer may have less favorable physical and chemical properties, such as surface smoothness, physicochemical stability, etc., making the prepared material less suitable for certain applications. In addition, such primer compositions may contain volatile organic solvents, the release of which during the priming process is undesirable and may not be environmentally friendly.

[0005] Another approach is based on exposing a poorly conductive article and a coating powder to an electric field generated by an external source. International application WO 99 / 22920 describes a method for impregnating a network of fibers or filaments with a powder, in particular for producing a composite material. In this method, the powder and the network of fibers or filaments are subjected to an alternating electric field generated between them by two electrodes connected to the same voltage generator. Each electrode has the shape of a metal plate. In patent application EP 1 526 214 the electric field is generated by several electrode tubes. Further arrangements of electrodes are described in WO 2007 / 110524 and EP 2 231 209 B1.

[0006] The advantage of applying electrostatic powder coatings to porous biomaterials such as collagen is that the density of the biomaterial matrix is ​​not altered. As a result, the ability of the biomaterial matrix to take up water and / or release drug substances remains intact. In contrast, the application of solution coating techniques such as slot-die coating to a porous biomaterial matrix essentially increases the density of the material.

[0007] Collagen-based pads, tissues or sponges have been used for many years, especially to improve wound healing or to stop bleeding (see US4600574 A, WO 2004 / 028404, US5614587 A, EP2939697 B1). Their mechanism of action in hemostasis is based on the aggregation and activation of platelets, the formation of thrombin on the surface of activated platelets and the formation of a hemostatic fibrin clot by the catalytic action of thrombin on fibrinogen.

[0008] Certain functionalities of polymers, such as diffusion properties, water uptake, and electrical conductivity, are often pH sensitive. For example, the presence of functional groups in polymers, such as OH, COOH, or NH2, can affect the water diffusion in polymer films, which can result in a clear pH dependency of the release rate of drug from coated pellets. Therefore, adjustment of the pH properties of polymer substrates is often necessary to improve the effectiveness of active substances released from coated dosage forms. Summary of the Invention

[0009] [Detailed Description of the Invention] In one aspect, the present invention relates to a composition comprising a porous material, the porous material comprising a biomaterial, the porous material comprising a plurality of open and interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm 3 and has a density in the range The pores have an average diameter in the range of 15 to 70 μm, and the porous material is coated with an electrostatic powder containing particles, The particles have an average size in the range of 50-100 μm and the total amount of the coating is 2-100 g / m 2 The range is.

[0010] In one embodiment, a composition of the invention comprises a porous material, the porous material comprising collagen and comprising a plurality of open and interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm3 and has a density in the range The pores have an average diameter in the range of 15-70 μm, and the porous material is characterized in that it is coated with an electrostatic powder containing particles, the powder containing at least 95% by weight of sodium bicarbonate (NaHCO3); The particles have an average size in the range of 50 to 100 μm, The total amount of the coating is 2-100g / m2 on the outer surface of the porous material. 2 is in the range The coating adjusts the pH of the composition on the surface to within the range of 3.0 to 9.0, preferably within the range of 6.0 to 8.0, and more preferably within the range of 6.5 to 7.5.

[0011] In the composition of the present invention, the surface of the porous material is covered with an essentially uniform layer of powder particles, with the powder remaining mainly on the surface of the porous material, and only a small portion of the particles entering the pores. This is achieved by the size classification of the powder particles, which has an average size that is overwhelmingly larger than the average diameter of the pore size. As a result, the pores of the biomaterial remain unblocked, and the coated and conditioned biomaterial retains its ability to take up water and / or release drug substances. This is particularly illustrated by Example 2. As can be seen from Example 2, the essential technical parameters of the coated material, such as residual moisture, tensile strength and water absorption, remain essentially intact compared to uncoated collagen.

[0012] Powder coatings are two in one: they allow the functionalization of surfaces with practically any specific property attributable to the powder, such as pH adjustment, adhesive application, etc., but at the same time, by virtue of the electrostatic adhesion of the powder and the selection of the particle size distribution, they allow the preservation of the original properties, such as tensile strength, pore size, pore openness (and therefore stable water absorption compared to uncoated materials), wicking behavior, etc.

[0013] In another aspect, the present invention relates to a method of making a composition comprising a porous material, the method comprising: a) providing a porous material, the porous material comprising a biomaterial and including a plurality of open and interconnected pores having a pore surface, the porous material having a density of 0.01 to 1 g / cm 3 and has a density in the range the pores having an average diameter in the range of 15 to 70 μm; b) providing an electrostatic powder comprising particles, the particles having an average size in the range of 50 to 100 μm; c) positioning the porous material and the powder between opposing electrodes in a coating apparatus; the coating apparatus is capable of generating an electric field through the porous medium; the apparatus having an area for storing the powder; d) electrostatically depositing the powder onto a surface of the porous material by exposing the powder and the porous material to an electric field generated by opposing electrodes, the electric field causing the particles to migrate towards the porous material.

[0014] In one embodiment, the method of making a composition comprising the porous material of the present invention comprises the following steps: a) providing a porous material, the porous material comprising collagen and including a plurality of open interconnected pores having a pore surface, the porous material having a density of 0.01 to 1 g / cm 3 and has a density in the range the pores having an average diameter in the range of 15 to 70 μm; b) providing an electrostatic powder comprising particles, the powder comprising at least 95% by weight of sodium bicarbonate (NaHCO3), the particles having an average size in the range of 50-100 μm; c) positioning the porous material and the powder between opposing electrodes in a coating apparatus; the coating apparatus is capable of generating an electric field through the porous medium; the apparatus having an area for storing the powder; d) electrostatically depositing the powder onto a surface of the porous material by exposing the powder and the porous material to an electric field generated by opposing electrodes, the electric field causing the particles to migrate towards the porous material. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] In one aspect, the present invention relates to a composition comprising a porous material, the porous material comprising a biomaterial, the porous material comprising a plurality of open and interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm 3 and has a density in the range The pores have an average diameter in the range of 15 to 70 μm, The porous material is coated with an electrostatic powder containing particles, The particles have an average size in the range of 50 to 100 μm, Total coating weight is 2~100g / m 2 The range is.

[0016] In one embodiment, a composition of the invention comprises a porous material, the porous material comprising a biomaterial and comprising a plurality of open and interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm 3 and has a density in the range The pores have an average diameter in the range of 15 to 70 μm, The porous material is coated with an electrostatic powder containing particles, The particles have an average size in the range of 50 to 100 μm, Total coating weight is 2~100g / m 2 The range is.

[0017] In one embodiment the porous material comprises at least 90% by weight of biomaterial, preferably the porous material comprises at least 95% by weight of biomaterial, more preferably the porous material comprises at least 96% by weight of biomaterial, more preferably the porous material comprises at least 97% by weight of biomaterial, more preferably the porous material comprises at least 98% by weight of biomaterial and most preferably the porous material comprises at least 99% by weight of biomaterial, In one embodiment the biomaterial is collagen.

[0018] In one embodiment, the density of the porous material is between 0.01 and 1 g / cm 3 , preferably 0.02 to 0.05 g / cm 3 More preferably, in the range of 0.02 to 0.04 g / cm 3 in the range of 0.022 to 0.03 g / cm 3 The range is.

[0019] In one embodiment, the pores in the porous material have an average diameter in the range of 15 to 70 μm, preferably in the range of 25 to 65 μm.

[0020] In one embodiment, the porous material has a density of 0.01 to 1 g / cm 3 and the pores have an average diameter in the range of 15-70 μm. In a preferred embodiment the porous material has a density in the range of 0.02-0.05 g / cm 3 and the pores have an average diameter in the range of 25 to 65 μm. In a more preferred embodiment the porous material has a density in the range of 0.02 to 0.04 g / cm 3 and the pores have an average diameter in the range of 25 to 65 μm.

[0021] In one embodiment, the composition comprising a porous material is characterized by a water absorption of 20-40 grams of water per gram of porous material. In one embodiment, the composition comprising a porous material is characterized by a water absorption of at least 80%, preferably at least 90%, more preferably at least 95%, even more preferably at least 98%, and even more preferably at least 99% of the water absorption of the uncoated porous material.

[0022] In one embodiment, the particles of the electrostatic powder have an average size in the range of 50 to 100 μm, preferably in the range of 55 to 85 μm.

[0023] In one embodiment, the total amount of coating in the composition is from 2 to 100 g / m 2 in the range of 2 to 20 g / m 2 More preferably, in the range of 3.5 to 9 g / m 2 The range is.

[0024] In one embodiment, the total amount of coating in the composition is from 10 to 100 g / m 2 The range is.

[0025] In one embodiment, the total amount of coating in the composition is between 2 and 100 g / m2 on the outer surface of the porous material. 2 in the range of 2 to 20 g / m on the outer surface of the porous material. 2 and more preferably 3.5 to 9 g / m on the outer surface of the porous material. 2 The range is.

[0026] In one embodiment, the total amount of coating in the composition is between 10 and 100 g / m2 on the outer surface of the porous material. 2 The range is.

[0027] In one embodiment, the average size of at least 70% of the particles of the electrostatic powder exceeds the average diameter of the pores in the porous material of the composition. In one embodiment, the average size of at least 80% of the particles of the electrostatic powder exceeds the average diameter of the pores in the porous material of the composition. In one embodiment, the average size of at least 90% of the particles of the electrostatic powder exceeds the average diameter of the pores in the porous material of the composition. Thus, the particles of the powder remain mainly on the surface of the porous material, and only a small portion of the particles penetrate into the porous material through the pores.

[0028] In one embodiment, the pH at the surface of the composition is adjusted to a range of 3.0 to 9.0, preferably 6.0 to 8.0, more preferably 6.5 to 7.5 by the coating in the composition.

[0029] In one embodiment, the pH at the surface of the composition is adjusted to a range of 3.5 to 4.5 by a coating in the composition.

[0030] By choosing a suitable powder source, the pH can be adjusted to a suitable range. For example, sodium bicarbonate has been found to be particularly suitable for adjusting the pH at the surface of the composition to a range of 3.0 to 9.0, in particular to a range of 6.0 to 8.0.

[0031] The pH on the surface of the material can be measured by any suitable surface pH electrode. In particular, the pH on the surface of the composition can be measured by a pH electrode with a flat membrane and a polymer electrolyte, such as WTW SenTix® Sur, which is suitable for measurements on smooth surfaces.

[0032] In one embodiment, the porous material is a biomaterial.

[0033] In one embodiment the porous material is selected from the group comprising natural and / or synthetic polymers or mixtures thereof, in particular polysaccharides, glycosaminoglycans, proteins or mixtures thereof.

[0034] In one embodiment, the porous material is selected from the group consisting of collagen, alginate, such as calcium alginate, or mixtures thereof.

[0035] In one embodiment, the porous material is collagen.

[0036] In one embodiment, the porous material is an alginate, in particular calcium alginate.

[0037] In one embodiment, the porous material is a mixture of collagen and calcium alginate. In one embodiment, the porous material comprises collagen in the range of 80-98% by weight and calcium alginate in the range of 2-20% by weight. In a preferred embodiment, the porous material comprises collagen in the range of 85-95% by weight and calcium alginate in the range of 5-15% by weight. In particular, the porous material comprises about 90% by weight of collagen and about 10% by weight of calcium alginate.

[0038] In one embodiment, the collagen in the porous material of the composition is a natural collagen of animal origin having a triple helical structure.

[0039] In one embodiment, the collagen in the porous material of the composition is selected from the group comprising type I collagen, type III collagen, type V collagen or mixtures thereof.

[0040] In one embodiment, the composition of the present invention is in the form of a sheet or a 3D form. In one embodiment, the composition of the present invention is in the form of a sheet. In one embodiment, the composition of the present invention is in the form of a 3D form.

[0041] In one embodiment, the porous material is essentially flat, i.e. the thickness of the porous material does not deviate from the average thickness of the porous material over its length and width by more than ±20%, preferably ±10%. For example, for an average thickness of 1 mm, the thickness of the essentially flat material remains in the range of 0.8 to 1.2 mm, preferably in the range of 0.9 to 1.1 mm, over its length and width. For an average thickness of 2 mm, the thickness of the essentially flat material remains in the range of 1.6 to 2.4 mm, preferably in the range of 1.8 to 2.2 mm, over its length and width.

[0042] In one embodiment, the electrically charged powder comprises a compound selected from the group consisting of a salt, glucose polysaccharide, glucose, modified glucose, an enzyme, collagen, hyaluronic acid, a metal or a metal oxide.

[0043] In one embodiment, the electrically charged powder comprises a salt selected from the group including sodium bicarbonate (NaHCO3), magnesium carbonate (MgCO3), calcium carbonate (CaCO3), sodium lactate, sodium citrate, and sodium iodide (NaI), or mixtures thereof. In one embodiment, the electrically charged powder comprises a salt selected from the group including magnesium carbonate (MgCO3), calcium carbonate (CaCO3), sodium lactate, sodium citrate, and sodium iodide (NaI), or mixtures thereof.

[0044] In one embodiment, the electrically charged powder comprises a salt that is not sodium bicarbonate (NaHCO3).

[0045] In one embodiment, the salt has a monovalent cation and a monovalent anion, such as sodium bicarbonate (NaHCO3). In one embodiment, the salt has a divalent cation and a monovalent anion, such as calcium carbonate (CaCO3).

[0046] In one embodiment, the salt is sodium bicarbonate (NaHCO3). Preferably, the salt comprises at least 95% by weight, more preferably at least 96% by weight, even more preferably at least 97% by weight, even more preferably at least 98% by weight, even more preferably at least 99% by weight, in particular at least 99.5% by weight, of sodium bicarbonate (NaHCO3) based on the dry compound. The salt comprising sodium bicarbonate may also contain small amounts of sodium iodide (NaI) and / or magnesium carbonate (MgCO3). In one embodiment, the salt comprising sodium bicarbonate comprises up to 5% by weight, of sodium iodide (NaI) based on the dry compound. In one embodiment, the salt comprising sodium bicarbonate comprises up to 5% by weight, of magnesium carbonate (MgCO3) based on the dry compound. In one embodiment, the salt consists of sodium bicarbonate (NaHCO3).

[0047] In one embodiment, the sodium bicarbonate contains less than 40% moisture by weight, preferably less than 35% moisture by weight, more preferably less than 30% moisture by weight.

[0048] In one embodiment, the electrically charged powder comprises a glucose polysaccharide selected from the group including cellulose and starch.

[0049] In one embodiment, the electrically charged powder comprises a modified glucose, hi one embodiment, the modified glucose is glucose (FDG) having the radionuclide fluorine-18 (18F) in place of the hydroxyl group on the 2-carbon.

[0050] In one embodiment, the electrically charged powder comprises an enzyme.

[0051] In one embodiment, the electrically charged powder comprises collagen, hi one embodiment, the collagen in the porous material of the composition is selected from the group comprising collagen type I, collagen type III, collagen type V or mixtures thereof.

[0052] In one embodiment, the electrically charged powder comprises hyaluronic acid.

[0053] In one embodiment, the electrostatic powder comprises a metal such as titanium.

[0054] In one embodiment, the electrostatic powder comprises a metal oxide, such as titanium dioxide (TiO2).

[0055] In one embodiment, the thickness of the porous material in the composition is in the range of 0.5 to 10 mm, preferably in the range of 1 to 5 mm.

[0056] In one embodiment, the composition is in the form of a sheet or a 3D form and one side of the sheet or the 3D form is coated with a powder coating.In one embodiment, the composition is in the form of a sheet and two sides of the sheet are coated with a powder coating.

[0057] The composition of the present invention may be further coated with an additional layer of polymer or wax. Non-limiting examples of polymers include polyurethane and polyalkylene oxide polymers. In one embodiment, the polymer is a polyalkylene oxide polymer, preferably a PEG-containing polymer, such as a multi-electrophilic polyalkylene oxide polymer, such as a multi-electrophilic PEG, such as pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate (COH 102). In one embodiment, the composition is prepared in the form of a dressing. In one embodiment, the composition according to any of the previous embodiments further coated with an additional layer of polymer is suitable for use in controlling bleeding and / or leakage of other body fluids in surgery, or for treating injuries selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue. In one embodiment, the additional layer of polymer or wax in the composition of the present invention, such as a polyalkylene oxide polymer, is on top of the powder coating.

[0058] In another aspect, the present invention relates to a method of making a composition comprising a porous material, the method comprising: a) providing a porous material, the porous material comprising a biomaterial and including a plurality of open and interconnected pores having a pore surface, the porous material having a density of 0.01 to 1 g / cm 3 and has a density in the range the pores having an average diameter in the range of 15 to 70 μm; b) providing an electrostatic powder comprising particles, the particles having an average size in the range of 50 to 100 μm; c) positioning the porous material and the powder between opposing electrodes in a coating apparatus; the coating apparatus is capable of generating an electric field through the porous medium; the apparatus having an area for storing the powder; d) electrostatically depositing the powder onto a surface of the porous material by exposing the powder and the porous material to an electric field generated by opposing electrodes, the electric field causing the particles to migrate towards the porous material.

[0059] In another embodiment, a method of making a composition comprising a porous material comprises the steps of: a) providing a porous material, the porous material comprising collagen and including a plurality of open interconnected pores having a pore surface, the porous material having a density of 0.01 to 1 g / cm 3 and has a density in the range the pores having an average diameter in the range of 15 to 70 μm; b) providing an electrostatic powder comprising particles, the powder comprising at least 95% by weight of sodium bicarbonate (NaHCO3), the particles having an average size in the range of 50-100 μm; c) positioning the porous material and the powder between opposing electrodes in a coating apparatus; the coating apparatus is capable of generating an electric field through the porous medium; the apparatus having an area for storing the powder; d) electrostatically depositing the powder onto a surface of the porous material by exposing the powder and the porous material to an electric field generated by opposing electrodes, the electric field causing the particles to migrate towards the porous material.

[0060] In one embodiment, the powder of step d) in the method of making a composition comprising a porous material is fluidized by supplying a flow of fluidizing gas to an area for storing the powder in the coating device. Fluidization helps the particles to separate from each other, making it easier to charge and discharge to a flat film. In particular, the fluidizing gas can be air, nitrogen, helium, noble gas such as neon, argon, krypton or xenon, or a mixture thereof. In one embodiment, the fluidizing gas is air. In one embodiment, the fluidizing gas is nitrogen. In one embodiment, the fluidizing gas is argon.

[0061] In one embodiment, in the method for preparing a composition comprising a porous material, the voltage applied to the opposing electrodes is in the range of 20 to 250 kV. In a preferred embodiment, in the method for preparing a composition comprising a porous material, the voltage applied to the opposing electrodes is in the range of 30 to 60 kV. In a more preferred embodiment, in the method for preparing a composition comprising a porous material, the voltage applied to the opposing electrodes is in the range of 45 to 55 kV. Most preferably, in the method for preparing a composition comprising a porous material, the voltage applied to the opposing electrodes is about 50 kV.

[0062] In one embodiment, in a method of making a composition comprising a porous material, opposing electrodes in a coating apparatus are positioned such that at least a first electrode is positioned in close proximity to the porous material and at least a second electrode is in direct or indirect contact (e.g., separated by a polymer membrane) with an area for storing powder in the coating apparatus. In one embodiment, at least the first electrode is a cathode and at least the second electrode is an anode. In one embodiment, at least the first electrode is an anode and at least the second electrode is a cathode.

[0063] In one embodiment, at least a first electrode is positioned behind the porous material relative to the area for storing powder, and the area for storing powder is positioned behind the at least a second electrode. In one embodiment, at least a first electrode is positioned above the porous material relative to the area for storing powder, and the area for storing powder is positioned above the at least a second electrode. In one embodiment, the at least a first electrode and the at least a second electrode are positioned essentially parallel to each other.

[0064] In one embodiment, at least the first electrode is a metal plate.

[0065] In one embodiment, the at least second electrode is a plurality of electrode wires. The number of electrodes required, their size, spacing, and further arrangement in the coating apparatus are determined by several parameters. These parameters include diameter, conductivity, powder type, and applied voltage.

[0066] In one embodiment, the particles of the powder are negatively charged at at least the second electrode, which is a cathode, and are electrostatically attracted by at least the first electrode, which is an anode.In one embodiment, the particles of the powder are positively charged at at least the second electrode, which is an anode, and are electrostatically attracted by at least the first electrode, which is a cathode.

[0067] In one embodiment, the coating device is connected to a voltage generator.

[0068] In one embodiment, in the method of making a composition comprising a porous material, the coating apparatus includes a means for moving the porous material horizontally across the powder to at least partially move a portion of the powder across the porous material. This embodiment ensures a continuous mode of operation in which the powder is evenly distributed throughout the porous material, thus providing a coating of uniform thickness. In one embodiment, the moving means is at least one roll, e.g. a rotating drum, in which the porous material is cylindrically wound around a central axis, and the material can be removed from the center or inner circumference of the roll. In one embodiment, the residence time on the fluidized bed is in the range of 1 to 10 seconds, preferably in the range of 2 to 9 seconds, more preferably in the range of 3 to 6 seconds.

[0069] In one embodiment, the volumetric flow rate of the fluidizing gas in the method for producing a composition comprising a porous material is in the range of 40-120 l / min, preferably in the range of 60-100 l / min, in particular about 80 l / min.

[0070] In one embodiment, the density of the powder in the method for producing a composition comprising a porous material is between 2.0 and 2.5 g / cm 3 in the range of 2.1 to 2.3 g / cm 3 in the range of about 2.2 g / cm 3 It is.

[0071] In one embodiment the distance between the area for storing powder in the coating device and the porous material is in the range of 80-200 mm, preferably in the range of 100-180 mm, in particular about 160 mm.

[0072] In one embodiment, the coating apparatus is a modified fluidized bed, as shown in Figure 1. The fluidized bed comprises a container 1 of non-conductive material having a bottom 2 and end walls 3. Optionally, a porous membrane 4 is positioned above the bottom 2 of the fluidized bed container 1 to allow the passage of a fluidizing gas, such as air under pressure, and to prevent powder from falling. Alternatively, an electrostatic grid with appropriately positioned electrode wires may be used instead of the porous membrane.

[0073] The powder 5 in the vessel is fluidized by passing a fluidizing gas through an inlet 6 of the fluidizing vessel 1. The fluidizing gas may be provided by a conventional air compressor connected to the inlet 6. Preferably, the inlet 6 of the vessel 1 is positioned between the bottom 1 and the porous membrane 4.

[0074] The coating apparatus comprises at least two opposing electrodes, at least a first electrode 7 positioned above the porous material 8 and at least a second electrode 9 positioned below the surface of the fluidized powder. Preferably, the electrodes are arranged to be essentially parallel to each other and to the porous material 8. The at least second electrode may be in the form of a plurality of electrode wires or an electrostatic grid.

[0075] In one embodiment, the porous material in the method of making the composition is in the form of a sheet or rolled sheet, which is an advantageous form for a continuous operation mode of coating the porous material with a powder.

[0076] In one embodiment, the porous material in the method of making the composition is essentially flat, i.e. the thickness of the porous material does not deviate from the average thickness of the porous material by more than ±20%, preferably ±10%, over the entire length and width of the material. For example, for an average thickness of 1 mm, the thickness of the material remains in the range of 0.8 to 1.2 mm, preferably in the range of 0.9 to 1.1 mm, over its entire length and width. For an average thickness of 2 mm, the thickness of the essentially flat material remains in the range of 1.6 to 2.4 mm, preferably in the range of 1.8 to 2.2 mm, over its entire length and width.

[0077] In one embodiment, the porous material in the method of making the composition comprises at least 90% by weight of a biomaterial, preferably the porous material comprises at least 95% by weight of a biomaterial, more preferably the porous material comprises at least 96% by weight of a biomaterial, more preferably the porous material comprises at least 97% by weight of a biomaterial, more preferably the porous material comprises at least 98% by weight of a biomaterial, and most preferably the porous material comprises at least 99% by weight of a biomaterial. In one embodiment, the biomaterial is collagen.

[0078] In one embodiment, the density of the porous material in the method of making the composition is between 0.01 and 1 g / cm 3 in the range of 0.02 to 0.05 g / cm 3 More preferably, in the range of 0.02 to 0.04 g / cm 3 in the range of 0.022 to 0.03 g / cm 3 The range is.

[0079] In one embodiment, the pores in the porous material in the method of making the composition have an average diameter in the range of 15 to 70 μm, preferably in the range of 25 to 65 μm.

[0080] In one embodiment, the porous material in the method of making the composition has a density of 0.01 to 1 g / cm 3 In a preferred embodiment, the porous material in the method for making the composition has a density in the range of 0.02 to 0.05 g / cm and the pores have an average diameter in the range of 15 to 70 μm. 3 In a more preferred embodiment, the porous material in the method for making the composition has a density in the range of 0.02 to 0.04 g / cm and the pores have an average diameter in the range of 25 to 65 μm. 3 and the pores have an average diameter in the range of 25 to 65 μm.

[0081] In one embodiment, the particles of the electrostatic powder in the method for making a composition comprising a porous material have an average size in the range of 50 to 100 μm, preferably in the range of 55 to 85 μm.

[0082] In one embodiment, the porous material in the method of making the composition is a biomaterial.

[0083] In one embodiment, the porous material in the method of making the composition is selected from the group comprising natural and / or synthetic polymers or mixtures thereof, in particular polysaccharides, glycosaminoglycans, proteins or mixtures thereof.

[0084] In one embodiment, the porous material in the method of making the composition is selected from the group consisting of collagen, alginate, such as calcium alginate, or mixtures thereof.

[0085] In one embodiment, the porous material in the method of making the composition is collagen.

[0086] In one embodiment, the porous material in the method of making the composition is an alginate, particularly calcium alginate.

[0087] In one embodiment, the porous material in the method of making the composition is a mixture of collagen and calcium alginate. In one embodiment, the porous material comprises collagen in the range of 80-98% by weight and calcium alginate in the range of 2-20% by weight. In a preferred embodiment, the porous material comprises collagen in the range of 85-95% by weight and calcium alginate in the range of 5-15% by weight. In particular, the porous material comprises about 90% by weight of collagen and about 10% by weight of calcium alginate.

[0088] In one embodiment, the collagen in the porous material in the method of making a composition comprising a porous material is a natural collagen of animal origin having a triple helical structure.

[0089] In one embodiment, the collagen in the porous material in the method of making the composition is selected from the group comprising type I collagen, type III collagen, type V collagen or mixtures thereof.

[0090] In one embodiment, the electrically charged powder in the method of making a composition comprising a porous material comprises a compound selected from the group consisting of a salt, a glucose polysaccharide, glucose, a modified glucose, an enzyme, collagen, hyaluronic acid, a metal or a metal oxide.

[0091] In one embodiment, the electrically charged powder in the method of making the composition comprises a salt selected from the group including sodium bicarbonate (NaHCO3), magnesium carbonate (MgCO3), calcium carbonate (CaCO3), sodium lactate, sodium citrate, and sodium iodide (NaI), or mixtures thereof. In one embodiment, the electrically charged powder comprises a salt selected from the group including magnesium carbonate (MgCO3), calcium carbonate (CaCO3), sodium lactate, sodium citrate, and sodium iodide (NaI), or mixtures thereof.

[0092] In one embodiment, the electrostatic powder in the method of making the composition comprises a salt that is not sodium bicarbonate (NaHCO3).

[0093] In one embodiment, the salt in the method of making a composition comprising a porous material has a monovalent cation and a monovalent anion, such as sodium bicarbonate (NaHCO3). In one embodiment, the salt has a divalent cation and a monovalent anion, such as calcium carbonate (CaCO3).

[0094] In one embodiment, the salt in the method of making a composition comprising a porous material is sodium bicarbonate (NaHCO3). Preferably, the salt comprises at least 95% by weight, more preferably at least 96% by weight, even more preferably at least 97% by weight, even more preferably at least 98% by weight, even more preferably at least 99% by weight, in particular at least 99.5% by weight, of sodium bicarbonate (NaHCO3) based on the dry compound. The salt comprising sodium bicarbonate may contain small amounts of sodium iodide (NaI) and / or magnesium carbonate (MgCO3). In one embodiment, the salt comprising sodium bicarbonate comprises up to 5% by weight of sodium iodide (NaI) based on the dry compound. In one embodiment, the salt comprising sodium bicarbonate comprises up to 5% by weight of magnesium carbonate (MgCO3) based on the dry compound. In one embodiment, the salt consists of sodium bicarbonate (NaHCO3).

[0095] In one embodiment, the sodium bicarbonate contains less than 40% moisture by weight, preferably less than 35% moisture by weight, more preferably less than 30% moisture by weight.

[0096] In one embodiment, the electrically charged powder in the method of making a composition comprising a porous material comprises a glucose polysaccharide selected from the group comprising cellulose and starch.

[0097] In one embodiment, the electrically charged powder in the method of making a composition comprising a porous material comprises modified glucose. In one embodiment, the modified glucose is glucose (FDG) having the radionuclide fluorine-18 (18F) instead of the hydroxyl group on the 2-carbon.

[0098] In one embodiment, the electrically charged powder in the method of making a composition comprising a porous material comprises an enzyme.

[0099] In one embodiment, the electrically charged powder in the method of making a composition comprising a porous material comprises collagen, in one embodiment, the collagen in the porous material of the composition is selected from the group comprising collagen type I, collagen type III, collagen type V, or mixtures thereof.

[0100] In one embodiment, the electrically charged powder comprises hyaluronic acid.

[0101] In one embodiment, the electrostatic powder in the method of making a composition comprising a porous material comprises a metal such as titanium.

[0102] In one embodiment, the electrostatic powder in the method of making a composition comprising a porous material comprises a metal oxide, for example, titanium dioxide (TiO2).

[0103] In one embodiment, the method according to any of the previous embodiments further comprises coating the composition of step d) with a layer of polymer or wax. Examples of polymers include polyurethane and polyalkylene oxide polymers. In one embodiment, the polymer is a polyalkylene oxide polymer, preferably a PEG-containing polymer, such as a polyelectrophilic polyalkylene oxide polymer, i.e. a polyelectrophilic PEG, such as pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate (COH 102). A suitable method is described in EP 2939697 B1. For example, the polymer can be melted and sprayed or printed onto the biomaterial matrix. Alternatively, it is also possible to sprinkle the polymer in dry form (e.g. powder) onto the matrix. If necessary, the temperature can be increased to make the sponge into a permanent coating. Alternatively, the polymer can be dissolved in an inert organic solvent and applied onto the biomaterial matrix.

[0104] In a third aspect, the present invention relates to a method for the control of bleeding and / or leakage of other body fluids in surgery or for the treatment of an injury selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue, the method comprising administering to a subject in need thereof a composition according to any of the previous embodiments, in particular a composition coated with an additional layer of polymer such as a polyalkylene oxide polymer.

[0105] In a fourth aspect, the present invention relates to a method for the treatment or prevention of wrinkles, skin inflammation and other applications in the field of cosmetics and skin care, the method comprising administering to a subject in need thereof a composition according to any of the previous embodiments.

[0106] In a fifth aspect, the present invention relates to a composition comprising the porous material according to any of the previous embodiments, in particular coated with an additional layer of polymer such as a polyalkylene oxide polymer, for use in controlling bleeding and / or leakage of other body fluids in surgery or for the treatment of an injury selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue.

[0107] In a sixth aspect, the present invention relates to the use of a composition according to any of the previous embodiments for the treatment or prevention of wrinkles, skin inflammation and other types of cosmetic skin treatment.

[0108] With the above context in mind, the following consecutively numbered embodiments provide further specific aspects of the present invention. Embodiment 1. A composition comprising a porous material, the porous material comprising a biomaterial and comprising a plurality of open and interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm 3 in the range of 0.02 to 0.05 g / cm 3 In particular, in the range of 0.02 to 0.04 g / cm 3 and has a density in the range the pores have an average diameter in the range of 15 to 70 μm, preferably in the range of 25 to 65 μm, The porous material is coated with an electrostatic powder containing particles, The particles have an average size in the range of 50 to 100 μm, The total amount of coating is 2~100g / m 2 in the range of 3.5 to 9 g / m 2 A composition comprising a porous material, the porous material having a molecular weight in the range of 0.1 to 0.5.

[0109] Embodiment 2. A composition comprising a porous material according to embodiment 1, wherein the average size of at least 70%, preferably at least 80%, in particular at least 90% of said particles exceeds the average diameter of said pores.

[0110] Embodiment 3. A composition comprising a porous material according to embodiment 1 or 2, wherein the porous material is a biomaterial.

[0111] Embodiment 4. A composition comprising a porous material according to any of embodiments 1 to 3, wherein the porous material is selected from the group comprising natural and / or synthetic polymers or mixtures thereof, in particular polysaccharides, glycosaminoglycans, proteins and / or synthetic polymers or mixtures thereof.

[0112] Embodiment 5. A composition comprising a porous material according to any one of embodiments 1 to 4, wherein the porous material is selected from the group consisting of collagen, alginate or a mixture thereof.

[0113] Embodiment 6. A composition comprising the porous material of embodiment 5, wherein the biomaterial is collagen.

[0114] Embodiment 7. A composition comprising the porous material according to embodiment 6, wherein the porous material is a natural collagen of animal origin having a triple helix structure.

[0115] Embodiment 8. A composition comprising the porous material of any one of embodiments 1 to 7, wherein the composition is in the form of a sheet or in a 3D form.

[0116] Embodiment 9. A composition comprising a porous material according to any one of embodiments 1 to 8, wherein the coating adjusts the pH at the surface of the composition and the surfaces of the pores to a range of 3.0 to 9.0, preferably 6.0 to 8.0.

[0117] Embodiment 10. A composition comprising a porous material according to embodiment 9, wherein the pH at the surface is measured by a surface pH electrode, in particular a pH electrode having a flat membrane and a polymer electrolyte.

[0118] Embodiment 11. A composition comprising a porous material according to any one of embodiments 1 to 10, wherein the powder comprises a compound selected from the group consisting of salts, glucose-based polysaccharides, glucose, modified glucose, enzymes, collagen, hyaluronic acid, metals or metal oxides.

[0119] Embodiment 12. A composition comprising a porous material according to any one of embodiments 1 to 11, wherein the powder comprises a compound that is sodium bicarbonate (NaHCO3).

[0120] Embodiment 13. A composition comprising the porous material of embodiment 12, wherein the powder contains at least 95% by weight of sodium bicarbonate NaHCO3.

[0121] Embodiment 14. A composition comprising a porous material according to any one of embodiments 1 to 13, coated with a layer of polymer or wax.

[0122] Embodiment 15. A method for making a composition comprising a porous material as defined in any one of embodiments 1 to 13, comprising: a) providing a porous material as defined in embodiment 1; b) providing an electrostatic powder comprising particles, the particles being having an average size in the range of 50 to 100 μm; c) positioning the porous material and the powder between opposing electrodes in a coating apparatus; the coating apparatus is capable of generating an electric field through the porous medium; the apparatus having an area for storing the powder; d) electrostatically depositing the powder onto a surface of the porous material by exposing the powder and the porous material to an electric field generated by opposing electrodes, wherein the electric field causes the particles to migrate toward the porous material.

[0123] Embodiment 16. A method for making a composition comprising a porous material as described in embodiment 15, wherein the powder in step d) is in a fluidized state by providing a flow of fluidizing gas in the area of ​​the device for storing the powder.

[0124] Embodiment 17. A method for preparing a composition comprising the porous material according to embodiment 15 or 16, wherein the voltage applied to the opposing electrodes is in the range of 20 to 250 kV, preferably in the range of 30 to 60 kV, more preferably in the range of 45 to 55 kV, particularly about 50 kV.

[0125] Embodiment 18. A method of making a composition comprising a porous material according to any of embodiments 15 to 17, wherein opposing electrodes in the coating apparatus are arranged such that at least a first electrode, which is an anode, is positioned adjacent to the porous material and at least a second electrode, which is a cathode, is positioned adjacent to the area for storing powder in the apparatus.

[0126] Embodiment 19. A method of making a composition comprising a porous material according to embodiment 18, wherein at least the second electrode, which is a cathode, is an electrostatic grid.

[0127] Embodiment 20. A method of making a composition comprising the porous material of embodiment 18 or 19, wherein the particles are cathodically charged and electrostatically attracted by the anode.

[0128] Embodiment 21. A method for producing a composition comprising the porous material according to any one of embodiments 15 to 20, wherein the coating device is connected to a voltage generator.

[0129] Embodiment 22. A method of making a composition comprising a porous material according to any of embodiments 15-21, wherein the coating apparatus comprises means for moving the porous material horizontally across the powder and for at least partially moving a portion of the powder across the porous material.

[0130] Embodiment 23. A method of making a composition comprising a porous material according to embodiment 22, wherein said means for moving said porous material is at least one roll.

[0131] Embodiment 24. A method for producing a composition comprising a porous material according to any one of embodiments 16 to 23, wherein the volumetric flow rate of the fluidizing gas is in the range of 40 to 120 l / min, preferably in the range of 60 to 100 l / min, in particular about 80 l / min.

[0132] Embodiment 25. The density of the powder is 2.0 to 2.5 g / cm 3 in the range of 2.1 to 2.3 g / cm 3 in the range of about 2.2 g / cm 3 A method for producing a composition comprising the porous material according to any one of embodiments 15 to 24,

[0133] Embodiment 26. A method for producing a composition comprising a porous material according to any one of embodiments 15 to 25, wherein the distance between the area for storing the powder in the coating device and the porous material is in the range of 80 to 200 mm, preferably in the range of 100 to 180 mm, in particular about 160 mm.

[0134] Embodiment 27. A method for making a composition comprising the porous material of any one of embodiments 15 to 26, wherein the porous material is in the form of a sheet or rolled sheet.

[0135] Embodiment 28. A method for producing a composition comprising a porous material according to any one of embodiments 15 to 27, wherein the porous material is a biomaterial.

[0136] Embodiment 29. A method for producing a composition comprising a porous material according to any of embodiments 15 to 28, wherein the porous material is selected from the group comprising natural and / or synthetic polymers or mixtures thereof, in particular polysaccharides, glycosaminoglycans, proteins or mixtures thereof.

[0137] Embodiment 30. A method for producing a composition comprising a porous material according to any one of embodiments 15 to 29, wherein the porous material is selected from the group consisting of collagen, alginate or a mixture thereof.

[0138] Embodiment 31 A method of making a composition comprising the porous material of embodiment 30, wherein the porous material is collagen.

[0139] Embodiment 32. A method for making a composition comprising the porous material of embodiment 31, wherein the porous material is a natural collagen derived from an animal having a triple helix structure.

[0140] Embodiment 33. A method of making a composition comprising a porous material according to any of embodiments 15 to 32, wherein the powder comprises a compound selected from the group consisting of salt, glucose-based polysaccharide, glucose, modified glucose, enzyme, collagen, metal or metal oxide.

[0141] Embodiment 34. A method for making a composition comprising a porous material according to any one of embodiments 15 to 33, wherein the powder comprises a compound that is sodium bicarbonate (NaHCO3).

[0142] Embodiment 35. A method for making a composition comprising a porous material according to any one of embodiments 15 to 34, wherein the powder contains at least 95% by weight of sodium bicarbonate (NaHCO3).

[0143] Embodiment 36. A method for making a composition comprising a porous material according to any one of embodiments 15 to 35, further comprising the step of coating the composition of step d) with a layer of polymer or wax.

[0144] Embodiment 37. A method for controlling bleeding and / or other fluid leakage in surgery or treating an injury selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue, comprising administering to a subject in need thereof a composition comprising a porous material as defined in any of embodiments 1-14.

[0145] Embodiment 38. A method for the treatment or prevention of wrinkles, skin inflammation and other applications in the field of cosmetics and skin care, comprising administering to a subject in need thereof a composition comprising a porous material as defined in any of embodiments 1 to 14.

[0146] Embodiment 39. A composition comprising a porous material as defined in any of embodiments 1-14 for use in controlling bleeding and / or leakage of other bodily fluids in surgical procedures or for treating an injury selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue.

[0147] Embodiment 40. A composition comprising a porous material as defined in any of embodiments 1 to 14 for use in the treatment or prevention of wrinkles, skin inflammation, and for other applications in the field of cosmetics and skin care.

[0148] Embodiment 41. Use of a composition comprising a porous material as defined in any of embodiments 1 to 14 for the treatment or prevention of wrinkles, skin inflammation, and other applications in the field of cosmetics and skin care.

[0149] Embodiment 42. A composition comprising a porous material, the porous material comprising collagen and comprising a plurality of open and interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm 3 In the range of 0.02~0.05g / cm 3 In particular, in the range of 0.02 to 0.04 g / cm 3 and has a density in the range The pores are in the range of 15 to 70 μm, preferably having an average diameter in the range of 25 to 65 μm; The porous material is coated with an electrostatic powder containing particles, The powder contains at least 95% by weight of sodium bicarbonate (NaHCO3), The particles have an average size in the range of 50 to 100 μm, The total amount of coating is 2-100g / m2 on the outer surface of the porous material. 2 in the range of 3.5 to 9 g / m on the outer surface of the porous material. 2 is in the range The coating keeps the pH of the composition on the surface at 3.0 to A composition comprising a porous material, the porous material being adjusted to a viscosity in the range of 9.0, preferably in the range of 6.0 to 8.0.

[0150] Embodiment 43. A composition comprising a porous material according to embodiment 42, wherein the average size of at least 70% of the particles, preferably at least 80% of the particles, in particular at least 90% of the particles, exceeds the average diameter of the pores.

[0151] Embodiment 44. A composition comprising a porous material according to embodiment 42 or 43, wherein the pH at the surface is measured by a surface pH electrode, in particular a pH electrode having a flat membrane and a polymer electrolyte.

[0152] Embodiment 45. A composition comprising a porous material according to any one of embodiments 42 to 44, wherein the porous material is a natural animal-derived collagen having a triple helix structure.

[0153] Embodiment 46. A composition comprising the porous material of any one of embodiments 42 to 45, wherein the composition is in the form of a sheet or in a 3D form.

[0154] Embodiment 47. A composition comprising the porous material of any of embodiments 42-46 further coated with a layer of polyalkylene oxide polymer for use in controlling bleeding and / or leakage of other body fluids during surgical procedures.

[0155] Embodiment 48. A method for making a composition comprising the porous material defined in any one of embodiments 42 to 46, comprising: a) providing a porous material as defined in embodiment 1; b) providing a powder containing particles that are electrically charged, containing at least 95% by weight sodium bicarbonate (NaHCO3), the particles having an average size in the range of 50-100 μm; c) positioning the porous material and the powder between opposing electrodes of a coating apparatus; The process comprises: the coating apparatus is capable of generating an electric field through the porous medium; the apparatus having an area for storing the powder; d) exposing the powder and the porous material to an electric field generated by the opposing electrodes; electrostatically depositing the powder onto a surface of the porous material, wherein the electric field causes the particles to migrate toward the porous material.

[0156] Embodiment 49. A method for making a composition comprising a porous material as described in embodiment 48, wherein the powder in step d) is in a fluidized state by providing a flow of fluidizing gas within the area for storing the powder within the device.

[0157] Embodiment 50. A method for preparing a composition comprising a porous material according to embodiment 48 or 49, wherein the voltage applied to the opposing electrodes is in the range of 20 to 250 kV, preferably in the range of 30 to 60 kV, more preferably in the range of 45 to 55 kV, particularly about 50 kV.

[0158] Embodiment 51. A method for making a composition comprising a porous material according to any of embodiments 48 to 50, wherein opposing electrodes in the coating apparatus are arranged such that at least a first electrode, which is an anode, is positioned adjacent to the porous material and at least a second electrode, which is a cathode, is positioned adjacent to the area for storing powder in the apparatus.

[0159] Embodiment 52 A method of making a composition comprising a porous material according to embodiment 51, wherein at least the second electrode, which is a cathode, is an electrostatic grid.

[0160] Embodiment 53. A method of making a composition comprising the porous material of embodiment 51 or 52, wherein the particles are cathodically charged and electrostatically attracted by the anode.

[0161] Embodiment 54. A method for preparing a composition comprising a porous material according to any one of embodiments 48 to 53, wherein the coating device is connected to a voltage generator.

[0162] Embodiment 55. A method of making a composition comprising a porous material according to any of embodiments 48-54, wherein the coating apparatus comprises means for moving the porous material horizontally across the powder and for at least partially moving a portion of the powder across the porous material.

[0163] Embodiment 56. A method of making a composition comprising a porous material according to embodiment 55, wherein said means for moving said porous material is at least one roll.

[0164] Embodiment 57. A method for producing a composition comprising a porous material according to any one of embodiments 49 to 56, wherein the volumetric flow rate of the fluidizing gas is in the range of 40 to 120 l / min, preferably in the range of 60 to 100 l / min, in particular about 80 l / min.

[0165] Embodiment 58. The density of the powder is 2.0 to 2.5 g / cm 3in the range of 2.1 to 2.3 g / cm 3 in the range of about 2.2 g / cm 3 A method for producing a composition comprising the porous material according to any one of embodiments 48 to 57,

[0166] Embodiment 59. A method for producing a composition comprising a porous material according to any one of embodiments 48 to 58, wherein the distance between the area for storing the powder in the coating apparatus and the porous material is in the range of 80 to 200 mm, preferably in the range of 100 to 180 mm, in particular about 160 mm.

[0167] Embodiment 60. A method for making a composition comprising the porous material of any one of embodiments 48 to 59, wherein the porous material is in the form of a sheet or rolled sheet.

[0168] Embodiment 61. A method for producing a composition comprising a porous material according to any one of embodiments 48 to 60, wherein the porous material is natural animal-derived collagen having a triple helix structure.

[0169] Embodiment 62. A method for making a composition comprising a porous material according to any one of embodiments 48 to 61, further comprising the step of coating the composition of step d) with a layer of a polyalkylene oxide polymer.

[0170] Embodiment 63. A method for controlling bleeding and / or leakage of other bodily fluids in a surgical procedure, comprising administering to a subject in need thereof a composition comprising a porous material as defined in embodiment 47.

[0171] definition Listed below are definitions of various terms used to describe the present invention. These definitions apply to the terms used throughout this specification and claims, unless otherwise limited in certain instances, either individually or as part of a larger group. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs.

[0172] As used herein, the articles "a" and "an" refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one or more than one element, i.e., one element or more than one element.

[0173] As used herein, the term "porous material" refers to a material having pores, i.e. cavities, channels or crevices, the depth of the pores exceeding their average diameter.

[0174] Unless otherwise defined, the term "thickness" in reference to a porous material refers to the average thickness of the porous material.

[0175] As used herein, the term "electrostatically charged powder" means a powder that can be ionically charged by means of electrostatic induction.

[0176] As used herein, the term "essentially flat" refers to a material whose thickness throughout its length and width does not deviate more than ±20%, preferably ±10%, from the average thickness.

[0177] As used herein, the term "sheet" refers to an essentially flat material having a thickness in the range of 1-8 mm.

[0178] As used herein, the terms "rolled material" and "rolled sheet" are used interchangeably and refer to a sheet of porous material that is wound cylindrically around a central axis of a roll and allows for removal of the material from the center or inner circumference of the roll.

[0179] As used herein, the term "3D form" refers to any form of porous material that is not a sheet or rolled sheet.

[0180] As used herein, the term "dressing" refers to a composition comprising a porous material coated with a powder, which is further coated with an additional layer of polymer, for example over the powder coating, and which is in the form of a sheet.

[0181] As used herein, the term "coating" refers to a thin deposition of material that substantially covers the surface of a substrate.

[0182] As used herein, the term "wax" refers to hydrogenated forms of naturally occurring vegetable oils and / or animal fats.

[0183] As used herein, the term "anode" refers to the negative electrode through which electrons flow during the discharge phase of a battery. The anode is the electrode that undergoes chemical oxidation during the discharge phase and chemical reduction during the charge phase.

[0184] As used herein, the term "cathode" refers to the positive electrode into which electrons flow during the discharge phase of a battery. The cathode is the electrode that undergoes chemical reduction during the discharge phase and chemical oxidation during the charge phase.

[0185] As used herein, the term "salt" refers to an ionic compound consisting of an ionic assembly of positively charged cations and negatively charged anions. Non-limiting examples of salts include sodium bicarbonate (NaHCO3), magnesium carbonate (MgCO3), calcium carbonate (CaCO3), sodium lactate, sodium citrate, and sodium iodide (NaI).

[0186] As used herein, the term "biomaterial" refers to a natural or synthetic biocompatible material suitable for use in medical devices that are intended to interact with biological systems. Non-limiting examples include collagen, gelatin, alginates, and polysaccharides such as glycosaminoglycans.

[0187] As used herein, the term "polysaccharide" refers to a polymer containing a backbone composed primarily (at least 90%) of repeating monosaccharide units and / or repeating derivatized monosaccharide units.

[0188] As used herein, the term "glucose polysaccharide" refers to a polymer that contains a backbone composed primarily (at least 90%) of repeating glucose units and / or repeating derivatized glucose units. Non-limiting examples include starch, modified starch, cellulose, and modified cellulose.

[0189] As used herein, the term "modified glucose" refers to glucose in which at least one OH group has been replaced with a group that is not an OH group, or in which a hydrogen atom in at least one OH group has been replaced with an atom that is not hydrogen.

[0190] As used herein, the term "protein" or "polypeptide" refers to a polymer of two or more natural or non-natural amino acids.

[0191] As used herein, the term "enzyme" refers to any protein that catalyzes a chemical reaction. Enzymes are generally classified according to the type of catalytic function they perform, e.g., bond hydrolysis ("hydrolases"), isomerization "isomerases", etc.

[0192] As used herein, the term "glycosaminoglycan" refers to a group of acidic polysaccharides having repeating disaccharide units, each consisting of an amino sugar and either a uronic acid or galactose.

[0193] As used herein, the term "alginate" refers to the anion of alginic acid. Thus, the terms "alginate" and "alginate salt" are used interchangeably in the context of the present invention. The alginate salt may be, for example, calcium alginate. Alginate is a linear polymer formed by the anions of β-D-mannuronic acid (M, β-D-mannuronate) and α-L-guluronic acid (G, α-L-guluronate) linked by 1-4 glycosidic bonds.

[0194] As used herein, the term "collagen" refers to an extracellular family of fibrous proteins characterized by their rigid triple-stranded helical structure. Three collagen polypeptide chains ("alpha chains") wind around each other to form this helical molecule.

[0195] As used herein, the terms "parallel" and "essentially parallel" have a tolerance of ±10°.

[0196] As used herein, the term "subject" refers to a human or non-human mammal. Preferably, the subject is a human. [Brief description of the drawings]

[0197] [Figure 1] 1 shows a modified fluidized bed coating apparatus. EXAMPLES

[0198] The invention will now be described with reference to the following non-limiting examples.

[0199] Example 1. 0.3-0.4 g of NaHCO3 with a particle size in the range of 10-200 μm was sieved with a sieving diameter in the range of 50-100 μm. The sieved powder was filled into the perforated plate of the fluidized bed in a layer up to 30 mm thick. The thickness was 2 mm and the density was 0.02-0.04 g / cm. 3A collagen sheet with an average pore size of 15-70 μm was fixed on the coating plate at a distance of 160 mm from the powder level. Clean pressurized air was applied at a volumetric rate of 79 l / min to fluidize the powder. A voltage of -50 kV was applied to the fluidized bed for 3 seconds to coat the powder onto the collagen.

[0200] Example 2. Comparison of the properties of the collagen sheet coated with NaHCO3 obtained by the method of Example 1 with uncoated collagen material [Table 1] As can be seen from Table 1, the overall properties of the coated and uncoated materials are essentially the same. Deviations from each other are also seen within different batches of uncoated collagen only.

Claims

1. 1. A composition comprising a porous material, the porous material comprising a biomaterial and comprising a plurality of open, interconnected pores having a pore surface; The porous material has a density of 0.01 to 1 g / cm ３ in the range of 0.02 to 0.05 g / cm ３ in the range of 0.02 to 0.04 g / cm ３ and having a density in the range of the pores have an average diameter in the range of 15 to 70 μm, preferably in the range of 25 to 65 μm; The porous material is coated with an electrostatic powder containing particles, the particles have an average size in the range of 50 to 100 μm; The total amount of the coating is 2 to 100 g / m ２ in the range of 3.5 to 9 g / m ２ A composition comprising a porous material, the porous material being in the range of

2. 2. A composition comprising a porous material according to claim 1, wherein the average size of at least 70%, preferably at least 80%, in particular at least 90% of the particles exceeds the average diameter of the pores.

3. 2. A composition comprising a porous material according to claim 1, wherein the porous material is selected from the group comprising natural and / or synthetic polymers or mixtures thereof, in particular polysaccharides, glycosaminoglycans, proteins and / or synthetic polymers or mixtures thereof.

4. The composition comprising the porous material of claim 1 , wherein the porous material is selected from the group consisting of collagen, alginate, or a mixture thereof.

5. 2. The composition comprising the porous material according to claim 1, wherein the coating adjusts the pH at the surface of the composition and at the surfaces of the pores to a range of 3.0 to 9.0, preferably a range of 6.0 to 8.

0.

6. 2. The composition comprising the porous material of claim 1, wherein the powder comprises a compound selected from the group consisting of salt, glucose-based polysaccharide, glucose, modified glucose, enzyme, collagen, hyaluronic acid, metal or metal oxide.

7. The powder is sodium bicarbonate (NaHCO ３ ) A composition comprising the porous material of claim 1.

8. A composition comprising the porous material of claim 1 coated with a layer of polymer or wax.

9. A method for making a composition comprising a porous material as defined in any one of claims 1 to 8, comprising the steps of: a) providing a porous material as defined in claim 1; b) providing an electrostatic powder comprising particles, said particles having an average size in the range of 50 to 100 μm; c) positioning the porous material and the powder between opposing electrodes in a coating apparatus; the coating device is capable of generating an electric field through the porous medium; the device having an area for storing the powder; d) electrostatically depositing the powder onto a surface of the porous material by exposing the powder and the porous material to an electric field generated by opposing electrodes, wherein the electric field causes the particles to migrate toward the porous material.

10. 10. The method for making a composition comprising a porous material according to claim 9, wherein the powder in step d) is in a fluidized state by supplying a flow of fluidizing gas into the area for storing the powder in the device.

11. 10. A method for making a composition comprising a porous material according to claim 9, wherein the voltage applied to the opposing electrodes is in the range of 20 to 250 kV, preferably in the range of 30 to 60 kV, more preferably in the range of 45 to 55 kV, especially about 50 kV.

12. 10. The method of making a composition comprising a porous material of claim 9, wherein the opposing electrodes in the coating apparatus are arranged such that at least a first electrode, which is an anode, is positioned adjacent to the porous material and at least a second electrode, which is a cathode, is positioned adjacent to the area for storing powder in the apparatus.

13. The density of the powder is 2.0 to 2.5 g / cm ３ in the range of 2.1 to 2.3 g / cm ３ in the range of about 2.2 g / cm ３ A method for producing a composition comprising the porous material according to claim 9,

14. 10. A method for producing a composition comprising a porous material according to claim 9, further comprising the step of coating the composition of step d) with a layer of polymer or wax.

15. 10. A pharmaceutical composition for use in a method for controlling bleeding and / or leakage of other body fluids in surgery or for treating an injury selected from the group consisting of wounds, bleeding, damaged tissue and / or bleeding tissue, the pharmaceutical composition comprising a composition comprising a porous material as defined in any one of claims 1 to 8.

Images