![]() THERMOPLASTIC PLATE MATERIAL AND ITS USE
专利摘要:
The present invention provides a thermoplastic sheet material for cosmetic skin treatment and / or medical skin treatment, comprising a thermoplastic composite layer having a top surface and a bottom surface, and a backing layer bonded to at least one surface of the thermoplastic composition layer, the backing layer comprising silicone. 公开号:BE1022498B1 申请号:E2014/0243 申请日:2014-04-11 公开日:2016-05-12 发明作者:Jean-Michel Anthony 申请人:Tomtec N.V.;Anthony Medical & Marine Technologies Bvba; IPC主号:
专利说明:
THERMOPLASTIC PLATE MATERIAL AND ITS TECHNICAL FIELD USE The present invention relates to a thermoplastic sheet material. More specifically, it relates to a thermoplastic sheet material suitable for directly forming a mask on at least a portion of a person's body. BACKGROUND Thermoplastic materials are known in their medical application as shaped articles for the purpose of immobilizing an anatomical region of the body. These materials are also used in the medical field to control dermal scars from traumatic injuries such as burns, mainly of the face. The contours of the shape can be formed and the thermoplastic can be reformed at different times to guide the soft tissue of the patient into forming the desired contours. WO2013 / 001083 provides a thermoplastic sheet material comprising a thermoplastic composition layer and a bonded support layer comprising an elastic fabric. The backing layer is continuously bonded to the thermoplastic sheet material by heat bonding or by the use of a suitable binder. The thermoplastic sheet material is suitable for use in a method of forming anatomically shaped medical articles, in particular face masks and braces. The bonding of a support layer to a thermoplastic composition layer by a heat-bonding technique has some disadvantages. Indeed, in order to obtain a high-performance composition, the thermoplastic composition layer must meet specific requirements. For example, excessive cleaning and pretreatment of the surface of the thermoplastic composition layer should be performed. Furthermore, the temperature range is limited for the thermal bonding. If the temperature is too low, there is insufficient binding force. If the temperature is too high, the thermoplastic composition layer will melt excessively and the properties of the thermoplastic composition layer will change. Consequently, the resulting thermoplastic plate will have few formable properties and the resulting mask will not fit well on the patient's body part to be treated. In addition, heat bonding usually requires the use of quenching under pressure to consolidate the bonding layer and cause the rapid cure of the heated thermoplastic composition. This slows down the production process and increases production costs. Another problem arises when wearing a thermoplastic material, especially with sensitive skin such as the skin of the face. The direct contact of the thermoplastic material with the skin causes complaints or even skin irritation. For example, face masks to support the administration of medicines must be worn for a long time and must therefore offer optimum comfort. The present invention has for its object to solve at least some of the above problems. To this end, the invention has for its object to provide a thermoplastic sheet material suitable for being formed directly on the body of a patient. The thermoplastic sheet material is as described in claim 1. SUMMARY OF THE INVENTION In a first aspect, the present invention provides a thermoplastic sheet material for cosmetic skin treatment and / or medical skin treatment, comprising a thermoplastic composition layer with an upper surface and a lower surface; and a support layer bonded to at least one surface of the thermoplastic composition layer, the support layer comprising silicone. Preferably, the backing layer comprises a silicone layer that is directly bonded to at least one surface of the thermoplastic composition layer. The silicone layer is in direct communication with the surface of the thermoplastic composition layer and therefore with the thermoplastic composition layer. " In a preferred embodiment, the backing layer further comprises a compound selected from the group consisting of silver ions, silver bromide, silver carbonate, silver chloride, silver nitrate, silver sulfadiazine, a biocide, an antibacterial, or a combination thereof. In a preferred embodiment, the support layer is bonded by spraying the support layer on at least one surface of the thermoplastic composition layer. In a preferred embodiment, the backing layer further comprises a coating on the surface that is not bonded to the thermoplastic composition layer. In a preferred embodiment, the coating comprises a synthetic polymer. In a preferred embodiment, the plate material is moldable at a low temperature that is between 40 ° C and 90 ° C, preferably between 50 ° C and 70 ° C and remains in a plastic state until it is cooled below 30 ° C. In a preferred embodiment, the plate material is stiff when hardened. In another aspect, the present invention provides a method for cosmetic skin treatment and / or medical skin treatment comprising the step of directly forming a mask on at least a portion of a person's body through the use of a thermoplastic sheet material as described above. The present invention provides for the use of a thermoplastic sheet material as described above for direct forming on a person and / or for forming a mask, wherein the support layer is the skin-facing layer. This feature is advantageous as direct shaping on the person provides a customized mask. In use, the customized mask and in particular the thermoplastic composition layer of the mask exerts a pressure on the skin and / or scar of the person. More specifically, the stiffness of the mask exerts a pressure on the skin and / or the scar of the person. The latter optimizes treatment, which leads to a reduction in treatment time. The working method of the mask formed is then comparable with the working method of pressure bandages. The present invention provides for the use of a thermoplastic sheet material as described above for cosmetic skin treatment and / or medical skin treatment of burns or dermatological scars. In another aspect, the present invention provides a method for the production of a thermoplastic sheet material as described above, comprising the step of spraying a backing layer on at least one surface of the thermoplastic composition layer. In a preferred embodiment, the backing layer comprises silicone. Preferably, the backing layer comprises a silicone layer that is directly bonded to at least one surface of the thermoplastic composition layer. The present invention further provides a method for the production of a thermoplastic sheet material as described above, comprising the step of bonding the support layer to at least one surface of the thermoplastic composition layer by using UV curing (UV curing). In a preferred embodiment, the support layer comprises silicone. Preferably, the backing layer comprises a silicone layer that is directly bonded to at least one surface of the thermoplastic composition layer. The present invention offers several advantages. The thermoplastic plate can be covered with a very thin layer of silicone thanks to the use of the spraying technique. Thin layers of silicone are usually difficult and the bonding of a thin silicone layer to a thermoplastic layer often leads to a non-uniform bonding. In addition, the silicone layer creates a microclimate that promotes the penetration of a compound into the skin of the person, reducing the treatment period and leading to optimum results. DESCRIPTION OF THE FIGURES Figure 1 shows a top view of a preferred embodiment of a thermoplastic sheet material according to the invention. Figure 2 illustrates a section A-A of a preferred embodiment of a thermoplastic sheet material bonded with a coated backing according to the invention. Figure 3 shows a section A-A, a preferred embodiment of a thermoplastic sheet material bonded with an uncoated support layer according to the invention. Figure 4 shows a preferred embodiment of the method of softening a thermoplastic sheet material according to the invention. DETAILED DESCRIPTION OF THE INVENTION Unless defined otherwise, all terms used to describe the invention, including technical and scientific terms, have the meaning commonly understood by one skilled in the art to which this invention belongs. For further guidance, term definitions are included to better value the teachings of the present invention. "A" and "de", "het" as used herein refers to both singular and plural unless the context clearly dictates otherwise. By way of example, "a compartment" refers to both one or more compartments. "Approximately" as used herein referring to a measurable value, such as a parameter, an amount, a duration, and the like, is intended to include variations of +/- 20% or less, preferably +/- 10% or less, more preferably +/- 5% or less, even more preferably +/- 1% or less, and even more preferably +/- 0.1% or less of the declared value, insofar as such variations are suitable for implement the described invention. However, it is to be understood that the value to which the "approximately" determination refers itself is also specifically described. "Include", "comprising" and "includes" and "including" as used herein is synonymous with "included", "including", "includes" or "contain", "containing", "contains" and are included or extensible terms specifying the presence of what follows eg component and do not exclude the presence of additional, non-listed component, properties, elements, parts, steps, known from and described in the prior art. The indication of numerical ranges by end points includes all numbers and fractional numbers that are included within that range, as well as the stated end points. The term "% by weight" (weight percent), throughout and throughout the description, unless otherwise defined, refers to the relative weight of the component in question based on the total weight of the formulation. The terms "thermoplastic sheet material" and "thermoplastic sheet" used herein are synonymous. The terms "bracket" and "splint" or "preform" used herein are used as synonyms. In a first aspect, the present invention provides a thermoplastic sheet material 1 for cosmetic skin treatment and / or medical skin treatment, comprising a thermoplastic composition layer 3 with an upper surface 4 and a lower surface 5; and a support layer 6 bonded to at least one surface of the thermoplastic composition layer 3, wherein the support layer 6 comprises silicone. In a preferred embodiment, the present invention provides a face mask for skin treatment wherein the mask is produced by forming the thermoplastic sheet material 1 directly on the patient's face. Thermoplastic composition layer The term "thermoplastic composition layer" 1 as used herein is understood to mean a layer comprising a thermoplastic composition 3 with two surfaces: an upper surface 4 and a lower surface 5. The thermoplastic composition 3 can be selected from the group of polycaprolactone and polyurethane or a combination thereof. The polyurethane can be present in an amount of 0%, 10%, 20%, 30%, 40% or 50% (weight%), preferably 20% to 40% or any value in between, most preferably 30% . The polycaprolactone can be present in an amount of 60%, 70%, 80%, or 90% (weight%) or any value in between, preferably 60% to 80%, and most preferably 70%. Usually there will be more polycaprolactone than polyurethane, which polycaprolactone lowers the temperature at which the plate deforms. The ratio of polycaprolactone: polyurethane (weight: weight) can be 5: 1, 4: 1, 3: 2, 3: 1, 2.3: 1, 2: 1, preferably 2.3: 1. The molecular weight of the polyurethane can be equal to or less than 10000, 20000, 30000, 40000, 50000, 60000, 70000, 80000, 90000, 100000, 120000, 140000, 150000 or one or any value in between, preferably between 10000 and 100,000. Polyester polyurethane is the polyurethane preferably. The molecular weight of the polycaprolactone can be 10000, 20000, 30000, 40000, 50000, 60000, 70000, 80000, 100000, 200000, 300000, 400000, 500000 or any value in-between, preferably between 10000 and 60000, more preferably between 37000 and 500000. Caprolactone polyester polyurethane is particularly suitable, which polyurethane can be obtained by a reaction of isocyanate and polycaprolactone-based polyester. Such caprolactone polyester polyurethane is commercially available as a granulate. The melting point of the polycaprolactone polyester polyurethane is between 190 ° C and 210 ° C. By adding polycaprolactone, also preferably in granulate form, a thermoplastic composition is obtained which is deformable and moldable at a temperature of approximately 69 ° C and which remains deformable by cooling at approximately 30 ° C. At this temperature, the thermoplastic composition layer 3 can be stretched to at least twenty times its original length. In the cured state, the thermoplastic material is rigid and has a memory effect which, after heating, returns this material to its original shape, i.e. to its shape prior to forming. It is non-elastic in the cured state. The thermoplastic composition layer of the present invention is used to be formed directly on a human body part, thereby obtaining anatomically shaped medical articles (corresponding to the hardened thermoplastic composition layer). The thermoplastic composition layer 3 can have a thickness of 0.8 mm, 1.0 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2 , 1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3 , 1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4 , 1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, 5.0 mm, 5 , 1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm or 6.0 mm or any value in between. In one embodiment, the thermoplastic composition layer 3 comprises between 1% and 40% (weight%) of microspheres of non-metallic, heat-accumulating material that is especially suitable for heating in a microwave oven. Glass microspheres with a diameter between 20 and 800 pm are preferred. A dye can be added to the composition. The thermoplastic composition layer 3 is preferably perforated to increase the breathability. The perforations 2 can have a diameter of 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0, 9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm , 2.0 mm or any value in between. A non-limiting example of a thermoplastic composition that can be used in the present invention is Turbocast® (TTape Company BV). Support layer By the term "backing layer" 6 is meant a layer that comprises a different composition than the thermoplastic composition layer 3 and which supports the thermoplastic composition layer 3. In a preferred embodiment of the invention, the thermoplastic composition layer 3 comprises a support layer 6 only on one of its surfaces 4 and 5. In another embodiment of the invention, the thermoplastic composition layer 3 comprises support layers 6 on both (of its) surfaces 4 and 5. In in a preferred embodiment the support layer comprises silicone. Preferably, the backing layer is a silicone layer that is directly bonded to at least one surface of the thermoplastic composition layer. By direct bonding is meant that the silicone layer is in direct contact with the surface of the thermoplastic composition layer. In a further preferred embodiment the support layer consists of silicone. The advantage of using silicone as a backing layer is that the silicone will act as a material that prevents friction and will provide comfort to the wearer if the silicone side is the skin-facing side of the plate. Silicone reduces the friction between the plate and the skin. Another advantage of silicone is its heat-resistant property; this will buffer the heat from the thermoplastic sheet material 1 when it is formed directly on the skin. Another advantage of silicone is that it is vapor-permeable. In addition, an important advantage of using silicone is that it creates a microclimate where it is used. So if the mask is used for the face, a microclimate is created between the facial skin and the silicone of the mask. Such a microclimate improves penetration into the skin of the patient of compounds and / or active molecules in the silicone. In addition, the microclimate will accelerate the healing of burns and / or dermatological scars and will reduce permanent scars on the skin. This increases the efficiency of the treatment and shortens the treatment time. The microclimate created by the silicone improves the treatment by 10 to 20 times, preferably by 15 times compared to a treatment in which such microclimate is not created. Another advantage of the microclimate created by the silicone is to provide a reproducible treatment, thus providing constant conditions for a treatment involving repeated use of the mask. With treatment we refer to cosmetic treatments, medical treatments or other treatments known to those skilled in the art that require the immobilization of at least a portion of the patient's body. The silicone further improves the memory effect of the thermoplastic plate. As mentioned earlier, in the cured state or after molding on the body part of a patient, the thermoplastic material returns to its original shape, i.e., to its shape prior to forming, after heating. Silicone applied in a relatively thin layer on the thermoplastic plate provides more elasticity to the plate, which enhances the memory effect. Preferably, the thickness of the silicone is 10 to 60 microns, preferably 20 to 50 microns, more preferably about 40 microns. The silicone is preferably non-adhesive. The silicone can also be adhesive on at least one of its sides. The adhesive side can then be used to bond the silicone to the thermoplastic composition layer. The silicone can also be partially adhesive, including adhesive and non-adhesive surfaces. The silicone is preferably washable, which reduces contamination when the treatment requires repeated use of the mask. Preferably the silicone is translucent. In a preferred embodiment, the silicone is provided with a high tear resistance. Preferably, the mass of the silicone, determined according to ASTM D792, is 0.5 to 2 g / cm 3, more preferably 0.8 to 1.5 g / cm 3, most preferably about 1 g / cm 3. In a preferred embodiment, the shore A of the silicone, determined according to ASTM D2240, is 40 to 100, preferably 45 to 85, more preferably 50 to 70 and most preferably about 60. In a preferred embodiment, the tensile strength of the silicone, determined according to ASTM D412, is 5 to 12 MPa, preferably 6 to 10 MPa, more preferably 7 to 9 MPa, most preferably about 8 MPa. In a preferred embodiment, the tear resistance of the silicone, determined according to ASTM D624 method A, is 10 to 25 KN / m, preferably 12 to 20 KN / m, more preferably 14 to 17 KN / m, most preferably about 15 KN / m. In a preferred embodiment, the stretch of the silicone, determined according to ASTM D412, is 400-900%, preferably 500-800%, more preferably 600-700%. In a preferred embodiment, the cure time determined according to ASTM C679 / NT-TM005 is 2 to 20 minutes, preferably 5 to 18 minutes, more preferably 8 to 16 minutes, most preferably 10 to 12 minutes. In a preferred embodiment, the temperature of fragility of the silicone is 100 to 400 ° C, preferably 150-350 ° C, more preferably 180-250 ° C, most preferably 200-220 ° C. In another preferred embodiment, the backing layer comprises a layer of non-adhesive material such as polyurethane or any other material known to a person skilled in the art. This layer is obtained by spraying a water-based polyurethane suspension onto the thermoplastic composition layer. In a preferred embodiment, the backing layer 6 further comprises a compound selected from the group comprising silver ions, silver bromide, silver carbonate, silver chloride, silver nitrate, silver sulfadiazine, a biocide, an antibacterial, or a combination thereof. In a preferred embodiment, the thermoplastic plate comprises approximately 3% of the connection. In a preferred embodiment, the support layer consists of silicone and each compound represented in the above-mentioned group. In a preferred embodiment of the invention, the thermoplastic composition layer and / or the backing layer comprises a compound selected from the group comprising silver ions, silver bromide, silver carbonate, silver chloride, silver nitrate, silver sulfadiazine, a biocide, an antibacterial or any combination thereof. In a preferred embodiment, the thermoplastic plate comprises approximately 3% of the connection. In a preferred embodiment, the backing layer may contain other metals such as gold (in the form of glitters or filaments), platinum, zirconium, copper, or any combination thereof. The use of the above compounds is advantageous compared to the use of nanotechnologies and / or nanoparticles for cosmetic treatments and / or for medical treatment. It is true that secondary and / or side effects of nanotechnologies and / or nanoparticles are unknown, while it has been proven that the use of the above compounds and in particular the silver compounds has no side effects and / or secondary effects. Silver in its elemental form, in particular, has a very low solubility product, which means that, compared to other active antimicrobial components, a very low concentration of active components is released in the presence of wound exudate. However, this concentration is sufficient to provide an antimicrobial effect within a wound dressing. Without wishing to be bound by theory, it is believed that silver compound within a wound dressing develops its effect in elemental form at the level of the support layer and in the form of silver complex ions or silver ions separates from the support layer by the wound exudate. Consequently, the silver can only have an effect within the wound dressing with the exception of a very low concentration, thereby preventing any contamination with excessive amounts of silver on the wound. In addition, the backing layer improves the hygiene of the mask. For example, when the mask is used for cosmetic purposes or for any other purpose, it is often the case that the skin of the user covered by the mask sweats. As mentioned above, the silver of the backing layer provides an antimicrobial effect, thereby improving the hygiene of the mask. In a preferred embodiment, the support layer releases less than 25 pg of silver per 1 cm 2 of the support layer surface per 24 hours at 25 ° C in 100 ml of water or a physiological saline solution, more particularly less than 15 pg of silver per 1 cm 2 of the support layer surface per 24 hours at 25 ° C in 100 ml of water or a physiological saline solution and more particularly less than 5 µg of silver per 1 cm 2 of the backing layer surface per 24 hours at 25 ° C in 100 ml of water or a physiological saline solution. By the term "breathable" is meant that air can pass through the fabric and / or the material. " As used herein, the term "breathable" also refers to a material that is permeable to water vapor. Breathable fabrics of the present invention have a water vapor diffusion density WVTRs between 1 and 2000 g / m2 / 24 hours, preferably between 2 and 1800 g / m2 / 24 hours, more preferably between 3 and 1600 g / m2 / 24 hours, the most preferably between 3 and 1400 g / m2 / 24 hours. In a preferred embodiment of the invention, the support layer is adapted to freely follow the deformations of the thermoplastic composition layer 3 during and after forming the thermoplastic sheet material. The support layer will provide support to the thermoplastic sheet material 1 when it is in the formable phase, but during the curing and forming of the thermoplastic composition, the support layer freely follows the expansion and contraction of the thermoplastic composition. When the thermoplastic composition is stiff, the support layer is fully adapted to the shape of the thermoplastic sheet material 1. In one embodiment of the invention, the support layer 6 is uncoated. Such an embodiment is shown in Figure 3. In a second aspect, the invention relates to a thermoplastic sheet material 1, comprising a thermoplastic composition layer 3 bonded to a support layer 6 that is coated. In one embodiment of the invention, the backing layer 6 is coated with a polymer as in Figure 2. Preferably, the polymer is selected from the group comprising but not limited to elastomers such as ethylene-vinyl acetate, ethylene propylene rubber, polyester, breathable polyurethane, and synthetic silicone. The support layer 6 can be coated on one side or on both sides. The advantage of using polymer coating 7 is that it will freely follow the expansion and contraction of the thermoplastic sheet material. In a preferred embodiment of the invention, the support layer 6 optionally comprises a bottom layer which is removed prior to application to the subject. The bottom layer binds inversely to the support layer intended for contact with the subject's skin. The bottom layer can be made of any suitable material such as, for example, polyethylene, polyethylene or other polymeric substances. According to an aspect of the invention, the bottom layer is smooth, or with a uniform pattern of pits or grooves. In another preferred embodiment of the invention, the coating 7 optionally comprises a bottom layer. The bottom layer of the coating is similar to that described for the backing layer. In another embodiment of the invention, the backing layer can be impregnated. The support layer is preferably impregnated with a polymer. More preferably, the polymer is selected from the group comprising but not limited to elastomers such as ethylene vinyl acetate, ethylene propylene rubber, polyester. In a preferred embodiment, the present invention provides a breathable thermoplastic plate comprising a thermoplastic composition layer 3, a support layer 6 bonded to a surface of the thermoplastic composition layer 3. The thermoplastic composition layer 3 is preferably provided with perforations. The backing layer 6 is preferably open cell polyurethane foam that is coated and / or impregnated with a breathable silicone elastomer. Consequently, the thermoplastic plate exhibits good breathability and and an improved wearing comfort, which is advantageous for the user. It is to be understood that the thermoplastic composition layer can also be without perforations. The thickness of the backing layer 6 is equal to or less than 0.025 mm, 0.05 mm, 0.06 mm, 0.08 mm, 0.1 mm, 0.5 mm, 0.8 mm, 1 mm, 1.2 mm , 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm or any value in between. Binding of support layer on thermoplastic composition layer In another aspect, the present invention provides a method for producing a thermoplastic sheet material as described above, comprising the step of spraying a support layer 6 on at least one surface of the thermoplastic composition layer. In a preferred embodiment, the support layer comprises silicone. Preferably, the backing layer comprises a silicone layer that is directly bonded to at least one surface of the thermoplastic composition layer. The backing layer is in direct contact with the surface of the thermoplastic composition layer. In a preferred embodiment, the support layer 6 is sprayed onto the thermoplastic composition layer 3, wherein at least one surface of the thermoplastic composition layer is coated. This spraying can be carried out at room temperature. Spraying can be carried out using any method known to those skilled in the art. Preferably, the support layer is sprayed on the thermoplastic composition layer by use of a spray gun. By using the spray method, a thin support layer can easily be made on the thermoplastic composition layer. This is not offered with other binding processes where working with thin supporting layers is delicate and leads to irregularities in the material finally produced. In a preferred embodiment, silicone is sprayed onto the thermoplastic composition layer and is allowed to cool and dry, thereby forming a first layer of silicone that covers at least one surface of the thermoplastic composition layer. A second layer of silicone can be made on the silicone layer that has already been obtained. The second layer is also created by spraying silicone with the help of a spray gun. The second layer together with the first layer determine the thickness of the support layer that is applied to the thermoplastic composition layer. This provides control over the total thickness of the thermoplastic sheet material. In a preferred embodiment, the support layer 6 is deposited on the thermoplastic composition layer 3. After deposition, the support layer is scraped with the aid of a scraping means, whereby at least one surface of the thermoplastic composition layer is coated with an evenly distributed support layer. The backing layer could be deposited by spraying it on the thermoplastic composition layer. Here too, a thin support layer can be easily made on the thermoplastic composition layer. In a preferred embodiment, the thermoplastic composition layer 3 is treated with a binding primer for applying and / or making the backing layer 6. The primers improve the binding of the backing layer to the thermoplastic composition layer. The primers may be of a chemical and / or mechanical nature or of any other type known to those skilled in the art. In a preferred embodiment of the invention, 70%, preferably 80%, more preferably 90% and most preferably 100% of the surface of at least one side of the thermoplastic composition layer 3 is coated by the backing layer 6. Both sides of the thermoplastic composition layer 3 can be coated by the support layer 6. In the method according to the present invention, the silicone support layer 6 can be applied to the thermoplastic composition layer by various techniques. The support layer can be applied by screen printing or by roll coating. The present invention further provides a method for the production of a thermoplastic sheet material as described above, comprising the step of bonding the support layer to at least one surface of the thermoplastic composition layer by using ultraviolet (UV) curing. In a preferred embodiment, the support layer comprises silicone. Preferably, the backing layer comprises a silicone layer that is directly bonded to at least one surface of the thermoplastic composition layer. The backing layer is in direct contact with the surface of the thermoplastic composition layer. A silicone layer is placed on at least one surface of the thermoplastic composition layer. The laminated structure is placed under UV lamps to cure. Preferably the curing time is 10 to 120 seconds, more preferably 20 to 100 seconds, most preferably 30 seconds to 80 seconds, most preferably 40 to 60 seconds. The advantages of UV curing include the ease of application and treatment and the short working time, which increases the production speed. In addition, due to the use of UV curing, the laminate does not have to be heated, so that the thermoplastic composition layer is protected from any deformation. The thermoplastic composition layer is moldable at low temperatures as mentioned above. Thermoplastic sheet material By the term "thermoplastic sheet material" 1 as used herein is meant a sheet material that is deformable under the use of heat and after cooling it retains the deformed shape and becomes stiff. The total thickness of the sheet material 1 can be 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.2 mm, 2.4 mm, 2 , 5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.2 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3 7 mm, 3.8 mm, 3, 9 mm or 4.0 mm or any value in between. In one embodiment of the invention, the thickness of the thermoplastic sheet material 1 is more than 4.0 mm, for example 4.1 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 7.0 mm, 8.0 mm or any value in between. The thermoplastic sheet material 1 according to the invention is preferably moldable at temperatures between 40 ° C and 90 ° C, more preferably between 50 ° C and 70 ° C. This temperature depends on the polycaprolactone content of the plate material. The plate material remains in a plastic state until it is cooled below 30 ° C. Usually the plate is brought into the moldable state by heating in a water bath 8 set at about 5 ° C above the melting temperature, most preferably at 65 ° C. Such a method is shown in Figure 4. Alternatively, the plate material 1 can be heated by using a convection or convection oven, a microwave oven or a hair dryer, or another heat-producing device or method. The perforations 2 with a diameter of at least 0.5 mm and preferably between 1.0 and 2.0 mm, or any value between them, can be provided in the thermoplastic plate material, so that skin respiration is not impeded after the application of the plate. When working with an unsupported thermoplastic plate while in a castable state, initial deformations occur in the thermoplastic composition 3, such as fingerprint or glove-contacting contact with the plate. An unsupported thermoplastic plate also deforms under its own weight when it is reheated prior to molding. A preferred embodiment of the support layer according to the invention will prevent these deformations due to the presence of a support layer consisting of silicone. Therefore, a thermoplastic plate according to the invention will retain its original shape until it is formed during its plastic phase. The properties of the support layer will provide the desired deformation of the thermoplastic material in the application of external forces, such as during molding. The thermoplastic plate 1 preferably remains in the moldable state for 1-10 minutes, more preferably between 2-5 minutes. The sturgeon layer 6 is able to freely follow the expansion and contraction of the thermoplastic composition 3 while the thermoplastic composition hardens during and after forming. Such a plate 1 can be formed directly on a person and is suitable for use as a mask, bracket, splint or preform for immobilizing a part of a person. The backing layer is preferably the skin-facing side while the non-skin-facing side is comprised of the thermoplastic sheet material. In an embodiment of the invention, the thermoplastic sheet material 1 comprises a Turbocast® thermoplastic composition on which a silicone layer is applied. The plate, according to the present invention, can be formed directly on a person and is suitable for use as a mask wherein the backing layer will be the skin-facing layer. The resulting face mask is suitable for use in skin treatment. The face mask offers a comfortable wearing experience and the support layer 6 prevents binding to the skin and / or the hair by the thermoplastic composition 3. The plate 1 exhibits excellent formability properties, corresponding to the shape of the face without exerting excessive pressure. The silicone layer offers a comfortable wearing experience against the skin. In a preferred embodiment, the face mask further comprises at least one opening for the nose and / or at least one opening for the mouth and / or at least one opening for the eyes. The mask may comprise at least one device for attachment to a cord. For forming, the mask is supplied as a pre-cut thermoplastic sheet material. The plate, according to the present invention, can be formed directly on a part of a person's body, the backing layer being the skin-facing layer. The resulting mask can therefore be a face mask, a mask that covers only a part of the face, a mask that covers the face, the neck and at least a part of the shoulders, a mask that covers any other part of a person's body covered. In a preferred embodiment, a preformed preform is used during the molding of the plate of the present invention to the body part of a person. Preferably, the thermoplastic material formed and the preform cover the entire body part. The preformed preform is designed to cover the anatomical contours of a first surface of the body part. The anatomical contours of a second surface of the body part are then covered by the shaped plate. This second surface is not covered by the preform. The second part of the body part is the part to be treated and will be covered by the formed thermoplastic sheet material. The use of a preformed preform during shaping of the plate immobilizes the desired body part, thereby preventing movement of the body part during forming. This increases the shape accuracy, which leads to a mask that is perfectly adequate and that covers the body part to be treated. The preform is used to form the thermoplastic plate on the body part to be treated. After forming the thermoplastic plate, the resulting mask can be used and attached to the body part of the patient without the use of the preformed preform. The preform is used to assist the specialist in forming the thermoplastic plate on the body part to be treated. Preferably the thermoplastic plate to be molded is suitable for being attached to the preform at at least 2, 4, 6 or 8 different fixing points. The attachment can be carried out using a hook and loop fastener, a snap button or a snap button closure. To form the thermoplastic plate on the desired body part, the specialist can attach the plate to the preform at one or two different points. The plate can then be formed on the body part and attached to any of the remaining attachment points of the preform. If necessary, a slight pressure can be applied to the plate during forming, whereby a mask is obtained which perfectly complies with the contours of the body part to be treated. The presence of attachment points on the preform allows one specialist to form the thermoplastic plate. There is no longer a need for more than one person to hold the plate while forming. The use of the preform therefore significantly reduces the number of personnel required to form the thermoplastic plate on a body part to be treated. In a preferred embodiment, the preformed preform is suitable for spanning and supporting a body part of a human. The preform consists of a preformed sheet of material comprising cork and a thermoplastic binder. This preform is preferably flexible. A special feature of the preform that, while flexible, nevertheless provides sufficient rigidity to the body part to be treated. The preform can be made from a thermoplastic material. Preferably, the preform is made of a material comprising a combination of cork and a thermoplastic binder; such as preferably ethylene vinyl acetate (EVA). Cork is a moisture-absorbing material, while the thermoplastic binder used is a moisture-repellent material. Combining two materials with different and conflicting properties leads to a preform with optimum properties of hardness and flexibility. The preform is made of flexible material such that it is deformable in a suitable manner to conform to the contours of the body part to be treated. The preform can be perforated. Preferably, the perforations cover approximately 75% to 95% of the surface of the preform. The material of the preform, in particular the cork, is breathable, making this preform comfortable to wear. The preform allows perspiration / exhalation. Problems of skin irritation or skin maceration can be avoided. In a preferred embodiment, the preform is made of a flexible material comprising cellulose, preferably cork and a binder, preferably a thermoplastic binder. The use of cork in the preform has the advantage that cork has an initial strength. The cork thus contributes to the stability and strength of the preform. Cork is a naturally flexible and strong component, which makes the material - in combination with a thermoplastic binder, such as EVA - very suitable for functional support or splinting. Moreover, cork is a natural and environmentally friendly component. The binder is preferably a thermoplastic binder. Suitable thermoplastic polymers include polyurethanes (especially polyurethanes based on semi-crystalline polyester polyols), polyethylene, ethylene vinyl acetate (EVA), cis and trans polyisoprene, polyesters such as polycaprolactone and the like. The presently preferred binder is a rubber, such as a synthetic rubber, preferably an acetate polymer, and most preferably EVA (ethyl vinyl acetate). EVA is a durable plastic foam material made from ethylene vinyl acetate resin. Material that contains EVA is sufficiently deformable, but still offers sufficient rigidity to the preform. In practice, the preform containing EVA material will easily adapt to the contours of the body part to which it is attached. EVA feels soft on the skin, causes no allergic reactions to the skin and allows X-rays through. The material can be made inexpensively at low production costs and it has a natural appearance. In a particularly preferred embodiment, the preform is made from a preformed sheet of material comprising cork and EVA. Preferably the material used contains at least 20% by weight of cork and at least 40% by weight of EVA. In one example, the present material comprises 1 kg of cork for 4; 4.5; 5.5; 6; 6.5; 7; 7.5; or 8 kg of EVA. The combination of cork and EVA gives the material unique properties that cannot be obtained with a combination with other materials such as cotton or cellulose with EVA. The combination of cork with EVA makes it possible to control both strength and flexibility. In addition, the combination makes the preform water-repellent, which makes the bracket reusable. In another preferred embodiment, the material of the preform may further contain additives and / or dyes. In a preferred embodiment, the additives may comprise metal oxides. In one example, the present preform consists of cork material that has been pulverized and mixed with acetate polymers and ethyl vinyl in the presence of the metal oxide additives such as silicon oxide (preferably 15-20% w / v), alumina (preferably 5-10%) w / v), zinc oxide (preferably 1-2% w / v), iron oxide (preferably 0.5-1% w / v), sodium, potassium and calcium oxide (preferably 0.1-0.5% w / v) / vol) and titanium dioxide (preferably 0.01-1% w / v). The material can be supplied as a foamed and crosslinked (cross-linked) microcellular solid with or without dyes. This material can be extruded and / or injected, e.g. into a preformed preform or the like. In a preferred embodiment, the softening temperature of the preform is preferably 75 to 130 ° C and more preferably about 80 to 110 ° C. In a preferred embodiment, the mask obtained after forming the thermoplastic plate is provided with at least one device for a cord. It is to be understood that the holders are provided for attaching the mask to the body part to be treated. Attaching the mask to a body part to be treated exerts a slight pressure on this body part. The position and number of these holders depend on the body part to be treated. The holders for the cord can be one slot, or two or more slots, but it is not necessarily limited thereto. The holders may comprise a part of a hook-and-loop closure, or a part of a snap button or a snap button closure, which is tied to a reciprocating element on the cord. The holder is adapted to attach a cord that wraps around the back of the head, and attaches the mask to the subject's face. The cord is preferably made of an elastic material, such as a band of elastic material, and may include a length regulator to adjust the length of the cord and therefore the pressure exerted by the mask on the face. In a preferred embodiment, the cords are attached to the mask in a configuration in which at least a portion of the cord at least partially surrounds the mask sheet, for example when both parts are provided with a hook and loop closure, a snap button or a snap button closure on the string self. The cord is inserted into the holder and both parts of the hook and loop closure, the snap button or the snap button closure are attached to each other. This is advantageous since the pressure exerted on the wearer's face is smaller compared to the pressure exerted by a mask in which the cords are attached at the top and / or at the side of the mask that does not come into contact with the face of the carrier. In the latter case, the cords will push the mask onto the wearer's face, which will be uncomfortable for the wearer. In the configuration described in the context of the present invention, the cords do not push the mask on the wearer's face but they will only attach the mask to the wearer's face. In a preferred embodiment, the thermoplastic plate material and / or the mask obtained after forming the thermoplastic plate can be connected to at least one electrode that provides electro-stimulation to the body part. This electrode can be banned from a generator and can be attached to the thermoplastic plate material and / or the mask by any suitable means known to those skilled in the art. The plate and / or the mask can preferably be connected to 2, 3, 4 or 5 electrodes. The generator produces electrical impulses and the electrodes offer electrostimulation treatment by stimulating the skin and subcutaneous muscles. Where the thermoplastic sheet material comprises perforations, the electrode can be attached so as to be in contact with the sheet surface covering the treated body part. The electrode can be placed between the thermoplastic composition layer and the support layer. The electrode can also be attached to the skin-facing surface of the backing layer. The size of the electrode is preferably larger than the size of the perforations. The electrode is connected to a generator via at least one electrical wire that enters via at least one perforation of the plate or mask. The difference in size prevents the electrode from passing through the perforation and thereby it is attached to the body part by the mask or plate. The size of the electrode is preferably at least 1.1 to 4 times larger than the size of the perforation, more preferably between 1.5 and 2 times larger than the size of the perforation. The plate and / or the mask can preferably be connected to a number of electrodes that lie between 1 and 30, preferably between 5 and 25 electrodes. The generator produces electrical impulses and the electrodes offer electrostimulation treatment by stimulating the skin and subcutaneous muscles. In a preferred embodiment, the number of electrodes and / or the position of each electrode can be changed within the mask according to the area of the face to be treated. This is possible thanks to the perforations of the mask that make it possible to connect electrodes to the mask as described above. This gives the user the freedom to choose the area of the face to be treated. The user can treat the same zone or different zones during consecutive use of the mask. In a preferred embodiment, the mask of the present invention is reusable 2 to 30 times, preferably 5 to 25 times, most preferably 10 to 20 times. In a preferred embodiment, the thermoplastic sheet material or the mask obtained after forming the thermoplastic sheet comprises a pulsed electromagnetic field (PEMF) for pulsed electromagnetic fields. This transducer comprises at least one transducer coil for generating a PEMF stimulation signal in response to bi-directional current through the coil. The transducer coil can be attached to any side of the thermoplastic plate that is coated or non-coated with a backing. This winding can also be incorporated, during the production process, into the thermoplastic sheet material. The pulsed electromagnetic field (PEMF) transducer delivers pulsed magnetic fields to the body part to be treated that is covered by the mask, thereby treating injuries and / or stimulating cellular repair and / or regeneration. In another aspect, the present invention provides a method for cosmetic skin treatment and / or medical skin treatment comprising the step of directly forming a mask on at least a portion of a person's body using a thermoplastic sheet material 1 as described above. The mask is formed by heating the thermoplastic sheet material in a water bath 8 as described above. The heated plate is applied to the body part of the person, for example the face, so that the silicone layer is in contact with the skin. The plate will deform according to the person's face. The plate can cool and cure. This method offers each person a made-up mask that can be kept for future use. Preferably, a preformed preform is used during the molding of the plate of the present invention on a person's body part. The preformed preform is as described above. In a preferred embodiment, the method comprises the step of providing electro-stimulation to the body part to be treated. In a preferred embodiment, during heating of the thermoplastic plate, a signal is supplied to the user or specialist when the temperature of the plate is suitable for formation. This signal is preferably a visual signal such as a change in the color of the plate. In a preferred embodiment, the silicone comprises a compound intended to be applied to the person's skin. The silicone creates a microclimate that increases the penetration of the compound into the skin of the person. The penetration can take place during the curing of the thermoplastic plate and therefore during the production of the customized mask. In another scenario, the custom-made mask is produced, the silicone is then impregnated with the compound and the mask is placed on the person's face. Still in another scenario, the connection is applied directly to the person's face and the mask is then placed on the face to improve penetration of the connection into the person's skin. A thermoplastic sheet material 1 according to the invention is suitable for use in cosmetic treatments and / or in the treatment of burns and / or dermatological scars. In addition, the backing layer may contain antibacterial products and / or any compound as described above. In another embodiment of the invention, a thermoplastic sheet material 1 according to the invention can be used for cosmetic skin care. In addition, the backing layer 6 can be treated with cosmetic products suitable for use in cosmetic treatment. In another embodiment of the invention, a thermoplastic sheet material 1 according to the invention can be used for the treatment of dermatological scars after breast surgery. A thermoplastic plate material 1 can be added in a bra with the silicone layer facing the skin of the patient. The addition of a thermoplastic sheet material according to the invention to a bra will accelerate the healing process of the skin after such treatment and reduce the amount and gradation of the scars. In an embodiment of the invention, the thermoplastic material can be preformed prior to molding. In another embodiment of the invention, the thermoplastic sheet material 1 is available in sheets with standard dimensions. In an embodiment of the invention, the thermoplastic material can be sealed before use. This seal is preferably sterile, vacuum and water-repellent. Such an embodiment is suitable for use in the treatment of burns and dermatological scars. Such an embodiment of a thermoplastic sheet material 1 is preferably heated while it is hermetically sealed and opened in a sterile environment just prior to application to the skin to be treated. The seal is preferably watertight. " The invention is further described by the following non-limiting examples, which further illustrate the invention, and are not intended, nor should be construed, to limit the scope of the invention. It is believed that the present invention is not limited to any form of realization previously described and that some modifications may be added to the present example of production without reviewing the appended claims. EXAMPLES Example 1: Thermoplastic sheet material A preferred embodiment of the invention is shown in Figure 1 and has a thermoplastic composition layer 3 with the following properties: - material: 30% polyester polyurethane, 70% polycaprolactone - melting point: 200 ° C - thickness: 2 mm - perforations: 0.7 mm diameter This composition is sprayed on the bottom surface 5 of silicone with the following properties: - material: synthetic silicone - coating weight: 12 g / m2 - application: sprayed on one side of the thermoplastic composition layer 3. Example 2: facial skin treatment with the use of mask The mask of the present invention was used to treat the facial skin with an active ingredient that reduces wrinkles. Two masks of the invention were used, the first mask comprising a support layer consisting of silicone and the support layer of the second mask consisting of silicone and silver ions. In parallel and under the same conditions, the same active ingredient was applied to a facial skin using a mask of the same composition as the mask of the present invention but without silicone. The treatment involved 4 repetitions, with each repetition of the active ingredient applied to the skin for 15 minutes before being washed. The amount of the active ingredient applied to the skin was 0.5 g / cm 2 or 1 g / cm 2 skin. The results were expressed as a percentage of treated wrinkles including reduction in size, depth of wrinkles and reduction in the number of wrinkles. The results obtained are shown in Table 1. Table 1 clearly shows that the use of the mask comprising silicone as provided in the present invention leads to a more efficient treatment. For example, the percentage of treated wrinkles after using the silicone mask was indeed always higher compared to the treatment using a silicone-free mask. In addition, the results obtained show that better results are achieved when using the silicone-coated mask even when a small amount of active ingredient is used. The results obtained when using a mask provided with silicone and 0.5 g / cm 3 of active ingredient were approximately similar to the results obtained when using a mask without silicone and 1 g / cm 3 of active ingredient.
权利要求:
Claims (14) [1] Adapted conclusions without indication of changes A thermoplastic sheet material (1) for cosmetic skin treatment and / or medical skin treatment, comprising a thermoplastic composition layer (3) with an upper surface (4) and a lower surface (5), and a backing layer (6) bonded to at least one surface of the thermoplastic composition layer (3), wherein the support layer (6) comprises a silicone layer that is in direct contact with the surface of the thermoplastic composition layer (3) and wherein the thermoplastic composition layer (3) further comprises a compound selected from the group comprising silver ions, silver bromide, silver carbonate, silver chloride, silver nitrate, silver sulphadiazine, a biocide, an antibacterial or a combination thereof. [2] A thermoplastic sheet material (1) according to claim 1, wherein the backing layer (6) further comprises a compound selected from the group comprising silver ions, silver bromide, silver carbonate, silver chloride, silver nitrate, silver sulfadiazine, a biocide, an antibacterial or a combination thereof . [3] A thermoplastic sheet material (1) according to any one of claims 1-2, wherein the support layer (6) is bonded to the thermoplastic composition layer (3) by UV curing. [4] A thermoplastic sheet material (1) according to any of claims 1-2, wherein the support layer (6) is bonded by spraying the support layer (6) onto at least one surface of the thermoplastic composition layer (3). [5] A thermoplastic sheet material (1) according to any of the preceding claims 1-4, wherein the support layer (6) further comprises a coating (7) on the surface that is not bonded to the thermoplastic composition layer (3). [6] A thermoplastic sheet material (1) according to any of the preceding claims 1-5, wherein the sheet material can be connected to at least one electrode, which provides electrostimulation to the skin. [7] A thermoplastic sheet material (1) according to any of the preceding claims 1-6, wherein the sheet material (1) is moldable at a temperature lying between 40 ° C and 90 ° C, preferably between 50 ° C and 70 ° C and remains in plastic condition until cooled below 30 ° C. [8] A thermoplastic sheet material (1) according to any of the preceding claims 1-7, wherein the sheet material (1) is rigid in the cured state. [9] A method for cosmetic skin treatment and / or medical skin treatment comprising the step of directly forming a mask on at least a portion of a person's body using a thermoplastic sheet material (1) as described in any of claims 1- 8. [10] Use of a thermoplastic sheet material (1) according to any of the preceding claims 1-8, for direct molding on a person. [11] Use of a thermoplastic sheet material (1) according to one of claims 18, for forming a mask, wherein the support layer (6) is the skin-facing layer. [12] Use of a thermoplastic sheet material (1) according to one of the claims 18, for cosmetic skin treatment and / or medical skin treatment of burns or dermatological scars. [13] A method for the production of a thermoplastic sheet material (1) as described in any one of claims 1-8, comprising the step of spraying a support layer (6) on at least one surface of the thermoplastic composition layer (3). [14] A method for the production of a thermoplastic sheet material (1) as described in any one of claims 1-8, comprising the step of UV curing the backing layer (6) on at least one surface of the thermoplastic composition layer (3).
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同族专利:
公开号 | 公开日 WO2014170220A3|2014-12-31| US20160067103A1|2016-03-10| WO2014170220A2|2014-10-23| EP2986660A2|2016-02-24|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 US20040243042A1|2003-05-20|2004-12-02|Lipman Roger D. A.|Facial masks for managing skin wounds| US20050136266A1|2003-12-22|2005-06-23|3M Innovative Properties Company|Silicone pressure sensitive adhesive and articles| US20070212314A1|2004-09-07|2007-09-13|Dow Corning Corporation|Silicone Adhesive Formulation Containing An Antiperspirant| WO2013001083A1|2011-06-30|2013-01-03|Tomtec Nv|Thermoplastic sheet material provided with a support layer and use thereof| KR101414493B1|2013-09-24|2014-07-14|주식회사 우리소재|Thermoplastic Cast and Its Manufacturing Method| EP3078702B1|2015-04-08|2020-09-16|T Tape Company BV|Silicone covered sheet for radiotherapy applications| WO2017037352A1|2015-09-04|2017-03-09|Wb Technologies|System for analysis and activation and/or localised release for the human face| WO2018089795A1|2016-11-10|2018-05-17|Qoravita LLC|System and method for applying a low frequency magnetic field to biological tissues| WO2018118450A1|2016-12-19|2018-06-28|Medtec, Inc.|Hydrophilic coating on thermoplastic masks| WO2019055551A1|2017-09-12|2019-03-21|University Of Maryland, Baltimore|Dural repair device and method of use|
法律状态:
2019-12-19| MM| Lapsed because of non-payment of the annual fee|Effective date: 20190430 |
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申请号 | 申请日 | 专利标题 EP13164006|2013-04-16| EP131640062|2013-04-16| 相关专利
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