DEVICE FOR MAPPING THE SHAPE OF A SPATIAL FORM

Abstract

The apparatus for mapping the shape of the spatial form according to the invention comprises a thermoplastic sheet provided with a system adapted to generate heat capable of plasticizing said sheet under the influence of the current flowing through said system. The subject of the invention is also a device for immobilizing human or animal body parts, in particular limbs or joints, the immobilizing device comprising said device for mapping the shape of the spatial form. The subject of the invention is also a system comprising an apparatus for mapping the shape of a spatial form.

Claims

1. A device for mapping the shape of a spatial form comprising a thermoplastic sheet, the thermoplastic sheet is provided with a flexible system for generating heat to plasticize said sheet due to the flow of current, characterized in that said system for generating heat is provided in the form of a system or systems of conductor arranged in a thermoplastic sheet to form the shape of a mesh and in that perforation is provided in the areas of the sheet defined between the conductors forming the system for generating heat.

2. The device according to claim 1, characterized in that the system for generating heat is equipped with current connecting means.

3. The device according to claim 1, characterized in that the thermoplastic sheet consists of a top layer and a base layer, wherein on the surface of the base layer facing the top layer grooves are provided for receiving conductor laid in the layer.

4. The device according to claim 3, characterized in that on the surface of the top layer facing the base layer there are provided projections in a size and shape substantially corresponding to the size and shape of the groves in the base layer, wherein the height of said projections is smaller than the depth of the groves, and the difference between the groove depth and the projection height substantially corresponds to the height of the conductor or conductors laid in the base layer.

5. The device according to claim 4, characterized in that said layers are joint with a flexible and heat conducting binder.

6. The device according to claim 5, characterized in that the binder is a universal silicone.

7. The device according to claim 3, characterized in that said layers are made by injection molding or by use a 3D printer or by use of stamped molds.

8. The device according to claim 1, characterized in that the thermoplastic sheet is made of a material selected from thermoplastic polymers, in particular thermoplastic elastomers such as thermoplastic polyurethanes, thermoplastic polyisoprenes, thermoplastic polyesters, thermoplastic polyolefins, polyvinylchloride, polystyrene, blends of two or more of these materials.

9. The device according to claim 1, characterized in that the thermoplastic sheet is made of thermoplastic polyolefins selected from the group consisting of isotactic polypropylene, ethylene 1-butene copolymers, ethylene 1-ethene copolymer; poly-&-caprolactone; polycaprolactone-containing thermoplastic polyurethane or blend of two or more of these materials.

10. The device according to claim 1, characterized in that the thermoplastic sheet is made of a blend based on polycaprolactone with the addition of plasticizers.

11. The device according to claim 1, characterized in that the thermoplastic sheet is made of a material having a softening point in the range of 38 to 100 degrees Celsius.

12. The device according to claim 1, characterized in that it comprises means for connecting, preferably detachable connecting, the opposite edges of the thermoplastic sheet.

13. The device according to claim 1, characterized in that it comprises a heat-insulating layer on the surface of a thermoplastic sheet.

14. The device according to claim 1, wherein the thermoplastic sheet under current flow immobilize a human or animal body part, in particular a limb or a joint.

15. The device according to claim 1, further comprises a controller for controlling the parameters of the system for generating heat.

Description

[0053] Device for mapping the shape of a spatial form according to the invention is shown in the embodiments on the drawing, in which:

[0054] FIG. 1 schematically illustrates a top view a device for mapping the shape of a spatial form in an embodiment comprising two layers of a thermoplastic sheet and a system for generating heat, with the topsheet removed in part.

[0055] FIG. 2 schematically shows, in an exploded view, device for mapping the shape of a spatial form in an embodiment comprising two layers of thermoplastic sheet and a system for generating heat.

[0056] FIG. 3 is a cross-sectional view of a top layer and a base layer equipped with projections and grooves, respectively.

[0057] FIG. 4 shows in an embodiment a device for mapping the shape of a spatial form used as a device for immobilizing a human upper limb.

[0058] FIG. 5 shows a device for device for mapping the shape of a spatial form according to FIG. 4 in a folded-out form.

[0059] The same reference numbers in the various figures refer to the same parts of the device.

[0060] The embodiment shown in FIG. 1 illustrates a device for mapping the shape of a spatial form 1 comprising a base layer 2 and a top layer 3 together forming a thermoplastic sheet, wherein under the top layer 3 and on the base layer 2 there is provided a system for generating heat 4, equipped with means for connecting a current 5. The top layer and base layer together with the arranged system for generating heat can be combined with the heat conducting adhesive (not shown in the figure). Universal silicone may be such a binder. The top and base layers together with the arranged system for generating heat can also be placed in the area of the alternating electromagnetic field. The induced eddy currents will heat up the conductor and weld the system, providing a functional blank that can be used in the example below.

[0061] The coupling of the top and base layers can also be achieved by welding the system under pressure through connecting the system to generate heat to the source of electric current.

[0062] The conductor wires in the embodiment shown in FIG. 1 are arranged in the shape of a broken strip (zigzag). As described above, it is possible to arrange the conductor in other configurations, e.g. in the shape of a spiral, a sinusoid or a mesh.

[0063] In the embodiment shown in FIG. 1, an opening 6 is also provided. The opening 6 can be provided for an embodiment of a device for mapping the shape of a spatial form 1 used as a device for immobilizing the anterior limb of the human and is provided for receiving the thumb of a forelimb of the patient.

[0064] In FIG. 2, in an exploded view, the internal structure of the device is schematically shown in an embodiment of the invention including the base layer 2 and the top layer 3 of the thermoplastic sheet and conductor systems 7 and 8 disposed between the layers, wherein said conductor systems together form a system for generating heat in the thermoplastic sheet composed of layers 2 and 3. In the embodiment shown in FIG. 2, an opening 6 is provided in both sheet layers and the conductor systems 7 and 8. All elements of the device are placed on each as shown by the dashed line and joined together with a conductive adhesive in the form of a universal silicone, and then welded under load. In the embodiment shown in FIG. 2, the device according to the invention, after being assembled, presents itself in the form of a mesh constituted by a system for generating heat placed between layers of a thermoplastic material forming together a sheet of thermoplastic material. As can be seen in the drawing, after assembling the device elements shown in FIG. 2, no thermoplastic material is provided in the areas of the sheet defined between the conductors forming the heat generating system in the sheet. Such an embodiment is particularly advantageous both because of the very good ability of the device to reproduce the shape of the patient's body parts, but also its lightness and excellent ventilation. FIG. 4 schematically shows the use of such a device as a device for immobilizing a human front limb.

[0065] FIG. 3 schematically shows an embodiment of the base layer 2 and the top layer 3, wherein the base layer 2 has been provided with grooves 8, provided for receiving a conductor of the system for generating heat (not shown in the figure), while the top layer is provided with projections 7, which during assembly of the device are intended to fit into the grooves 8. The height A of the said projections 7 is smaller than the depth B of the grooves 8. Such configuration makes it possible to provide free space in the grooves for guiding the conductor. Typically, the height A is provided to be about 0.5 mm, while the height B is about 2 mm. In this way, a free space is provided, allowing for example for laying a conductor with a diameter of up to 1.5 mm, or in the case of a system for generating heat in the form of a mesh, it is possible to arrange a conductor with a diameter of 0.7 mm, where at the points where the wires are laid one above the other do not exceed the height of the free space defined by the difference between the depth of the grooves and the height of the projections, which in the described example is 1.5 mm.

[0066] The width C of the projections 7 is slightly smaller than the width D of the grooves 8, so that the projections 7 after applying the top layer 3 to the base layer 2 fit and fasten in the grooves 8. C may for example be 0.7 mm, D respectively may be 0.8 mm.

[0067] As indicated above, the difference between the depth B of the grooves and the height A of the projections essentially corresponds to the size of the conductor laid in the grooves of the base layer, which after joining the two layers 2 and 3 with the conductor laid in the grooves ensures tight adhesion of the layers.

[0068] FIG. 5 shows an exploded device for mapping the shape of a spatial form shown on the patient's limb in FIG. 4. In the examples, the figures do not show means for connecting the current and the controller for controlling the operating parameters of the device.

[0069] As mentioned above, a preferred embodiment of the solution can be provided, in which ferromagnetic particles are provided in the thermoplastic material. It is also possible to emboss a sheet of thermoplastic material enriched with superparamagnetic magnetite nanoparticles (Fe3O4, d=11 nm) produced in a manner known to one skilled in the art. The sheet can then be combined with a layer of thermal insulation material that protects the patient's skin surface, for example in the form of a 1 mm thick polyurethane foam layer. Due to the external source of the changing magnetic field, induced by induction coils in the form of a spiral controlled by a system dedicated for induction heaters, eddy currents are induced in the device, as a result of which heat is generated which leads to the plastification of the sheet. The external induction source may additionally include a system that optically measures the temperature of the thermoplastic sheet and a control module that regulates the operation of the system based on pyrometer readings.

[0070] After obtaining the plasticity of the sheet by generating heat plasticizing the sheet due to the current flowing in it, the device goes into the shape mapping mode. The power supply is then disconnected (or moved away from the magnetic field), and the device is formed to correspond to the shape of the spatial form. At the disappearance of the plasticity again the heat generating system is activated (or the device is placed again within the variable electromagnetic field) until the re-plasticizing of the dressing.

[0071] The layers of the thermoplastic sheet of the device according to the invention can be made using polycaprolactone, available under the trade name PCI 99 FILAMENT, and the conductor systems can be provided in the form of a 0.7 mm Teflon™ heating cable. In the embodiment where thermoplastic sheet is made by 3D printing using for example PCL filament 1.75 mm (PCL 99 FILAMENT 750 GRAM 1.75 MM from 3D4MAKERS™, the thermoplastic material has a softening temperature of about 60 degrees Celsius, while the temperature on the outer surface measured using a pyrometer is 42-43 degrees C., which is the temperature within the range of values well-tolerated by human skin.

[0072] The resulting sheet may in a preferred embodiment have a thickness of 3 mm and form a net with nodal points spaced about 1 cm apart. In a preferred embodiment of the device according to the invention, the perforation between the filaments of the net is provided in the form of a square with a side of 5 mm. The joint top and base layers can be fixed by welding the layers caused by connecting the device to the electrical circuit and pressing. In described embodiment of the invention, for the purpose of rapid plasticizing of the device according to the invention, measuring 35 cm×25 cm, it is placed on a thermal insulator in the form of a textile fabric and then a direct current of 24 V and a current of approximately 4 A is connected The person skilled in the art as part of their routine operation is able to adjust the parameters of the current parameters depending on the size and properties of the sheet. After about 1 minute, the sheet according to the example described becomes plasticized. The device thus prepared matches the shape of the immobilized hand (as shown in FIG. 4). The material typically stiffens after about 1 minute and reaches full stiffness after about 5 minutes. This parameter depends on many variables, including ambient temperature. In order to correct the mapped shape of the device, the device can be reconnected to electrical circuit, for example to a current of 5V and about 2 A, which results in a slow heating of the sheet. It is also possible to heat up the system faster by using a higher voltage, e.g. 24V, but slower heating results in less discomfort. After obtaining sufficient plasticizing of the plastic, the mapped shape of the device is corrected. In the embodiment according to FIG. 4, the opposite ends of the sheet were wrapped around the forearm and joined together by arranging them in a shape of the linen seam. This joint is particularly advantageous because it allows for a perfect fit to the spatial form while maintaining very strong fastening and high aesthetic qualities.

[0073] A particular example of a solution according to the invention is a sheet in the form of a mesh formed by the filaments of conductors coated with an insulator in the form of a thermoplastic polymer or a suitable thermoplastic blend based on a flexible polymer, where the mesh elements can optionally be joined together at nodal points. The connection of these elements can be caused by the use of a flexible and conductive heat binder. Alternatively, the filaments may be joined together in the form of knots of welded polymer layers or a polymer-based blend. The eyehole in the mesh can have in any shape, especially can be a square, a rectangle or a hexagon. The ends of the mesh can be connected with a conductor that is not part of the system, and then the system can be connected to a power source in the form of a dedicated device driver.

[0074] A conductor for use in a system adapted to generate heat can be, among others, properly insulated: resistance wire, copper wire as well as carbon fiber. It is particularly advantageous to use carbon fiber because it is not visible in image methods using X-rays. This is particularly advantageous when using the device for medical purposes, such as immobilizing a broken limb or in the field of teleradiotherapy, as it allows for performing control tests without disturbing the image caused by the use of the immobilizing dressing such as the scales.

[0075] It is also possible to provide a device consisting of areas that can be heated and, consequently, plasticized, independently from one another, which can be used when repositioning parts of the device without need to plasticize the entire device.

[0076] The heating process takes place much faster when the device is placed on a thermo-insulator, thanks to which heat losses to the environment are minimized.

[0077] The use of sheets with thermoplastic materials and a system adapted to generate plasticizing heat for the sheet, makes it possible to precisely adjust the shape according to the user's intentions without the time constraints due to the hardening of the sheet. The possibility of reheating the system allows for plasticizing the material and possible corrections in order to set it properly also in the case where hardening of the plastic occurs before the end of forming the target shape, for example to ensure adequate comfort for the user (patient), or in case of later correction of immobilized object. The solution according to the invention allows multiple shape adjustments if the mold without any time constraints associated with the time of material stiffening, as well as reuse of the device due to the possibility of regenerating its shape to a sufficient extent for its subsequent use. Thanks to the possibility of matching the sheet to the size and shape of the expected spatial form, it is possible to use it conveniently for many applications of mapping the shape of the spatial forms, objects such as, for example, anatomical parts of the body or sculptures. In contrast to the solutions available on the market and based on sheets made using thermoplastic materials, in use of the solution according to the invention there is no need to place the device in the area of elevated temperature every time, and therefore there is no need to employ additional large-size devices. In medical applications, the solution allows, for example, to adjust fractures with a stiffening bandage already installed or a reposition of improperly set bone fragments.