Integrated pressure protection element for diabetic foot ulcer wound dressing

Abstract

The invention relates to a method for adapting a composite medical shoe to a human foot (1). A pressure protection element (2) serves to relieve pressure from the human foot or parts thereof.

Description

[0001] Integrated pressure protection for wound dressings for diabetic foot ulcers

[0002] The invention relates to a method for adapting a medical wound dressing to a human foot, in particular for the indication of diabetic foot ulcer.

[0003] Furthermore, the invention relates to a medical wound dressing for a human foot, in particular for the indication of diabetic foot ulcer, wherein the wound dressing is fixed to the pressure protection by one or more straps and thus has a pressure protection serving to relieve pressure on the foot.

[0004] Diabetes has become an enormous health problem. Approximately 10% of the German population is affected. Every year, 2.2-6.4% of people with diabetes develop a diabetic foot wound. 15-25% of people develop a diabetes-related foot lesion during their lifetime. This is the most common cause of non-traumatic amputations of the lower extremities. An ulceration in a diabetes-related foot lesion on the sole or edge of the foot can only heal with consistent pressure relief and wound rest. The currently recognized medical standard for local pressure relief for diabetic foot syndrome (DFS) is based on the felting technique. The basic principle of the felting technique is the most precise possible relief using several layers of felt applied on top of one another in order to achieve the best possible redistribution of the pressure acting on the wound. The contact surface is enlarged, i.e. the foot ulcer is exposed.The applied felt becomes part of the bandage. The felting technique has proven to be an unsatisfactory solution for these conditions. The felt compresses very quickly and is not dimensionally stable. Precise adaptations to the human foot are not optimal in some areas of the foot. The use of adhesives applied with the felt can cause skin irritation. If the foot has to be applied in many layers to create optimal pressure relief, the individual layers occasionally shift and thus do not provide optimal pressure relief. In addition, patients often walk short distances without protective shoes, e.g., in their own home. This leads to a significant deterioration of the healing process. Finally, the felt is not recyclable. After all, wound secretions can run into the felt and cause hygiene problems if it is not changed immediately.

[0005] The object of the present invention is therefore to provide a method for adapting a medical wound dressing to a human foot, as well as a medical wound dressing which is characterized by a precise adaptation to all regions of the foot in the present medical indication.

[0006] This task is solved with regard to the method in that the wound dressing is equipped with one or more frames fixed in the area of ​​the sole and includes a pressure protection device that serves to relieve pressure on the foot.

[0007] With regard to the wound dressing, the task is solved by the fact that it is equipped with one or more straps fixed in the area of ​​the sole and includes a pressure protection device that serves to relieve pressure on the human foot.

[0008] Three-dimensional printing technology makes an additional contribution to the realization of this pressure protection. The fact that the pressure protection is produced in a device for producing a three-dimensional structure by heating a material to a working temperature, creating a molten material, and then applying a layer of the molten material layer by layer to the workpiece to be produced corresponds to this solution using 3D technology. The material is reusable and can be reattached to the dressing after each dressing. It is also easy to clean and disinfect. This prevents the repetition of traumatic pressure and shear forces on the wound, which is essential for wound closure.

[0009] A key component of the invention is also the pressure protection and its integration into the dressing shoe. This integrated pressure protection for a wound dressing for diabetic ulcers (IDW) serves to relieve pressure in this syndrome. The IDW is a dressing component printed using 3D technology. The IDW is part of a wound dressing. The latter consists of a wound pad, a wound pad fixation, an IDW, and a fixation of the IDW.

[0010] Integrating pressure protection into the wound dressing during production leads to advantageous solutions with homogeneous materials. Instead of felt or fleece, 3D technology is used for production with significantly higher precision.

[0011] The foot scan is also particularly important in clinical planning. The technology involves a full-flow 3D scan with corresponding applications. The CAD design for the pressure protection according to the invention is determined using software based on the currently established standards (e.g., material thickness, rolling techniques, standard relief, etc.) and the properties determined during the measurement process. The software is automatically generated from the measurements and drawings recorded during the measurement process, as well as the 3D scan of the foot. The shape of the foot is imported, and further information regarding shape and color is extracted from the drawings implemented in the scan and incorporated into the 3D creation process. The 3D creation process is automated based on previously defined rules.Further information from the medical history can be used for automated design via a digital interface. The shape of the previously selected foot protection is automatically adopted, and the product is digitally created to suit the patient. Based on the scan and the provided information or drawings, different areas of the product are assigned metadata about the hardness in that area. This so-called point cloud data is transferred to a 3D printer along with the product shape.

[0012] In this sense, the proposal is intended to manufacture the pressure protection based on the data obtained from the scan regarding hardness levels, lowering, and / or corrective measures. This could, for example, involve an arrangement divided into a number of grids, each with individual parameters assigned, particularly with regard to physical properties, i.e., hardness in particular.

[0013] Shore hardness is of utmost importance. According to clinical planning, the wound is first treated and the wound dressing is secured. The wound dressing, of which the IDW is a component, is then applied.

[0014] By manufacturing the pressure protection taking into account zones of different hardness levels, it is ensured that work can be carried out with high tolerances.

[0015] In the most efficient and simple way possible, it is recommended that the zones of different degrees of hardness are visualized on the wound dressing, for example by colors according to the specifications or the measured values ​​achieved.

[0016] As part of the clinical process planning, the properties of the pressure protection such as hardness, lowering, pressure protection from the side, interruption of the shell shape, filling technique, stiffening, attachment and / or correction are determined.

[0017] Furthermore, it is proposed that the pressure protection be manufactured as a bandage component in combination with a bandage shoe, a cast, etc. In addition, various rolling techniques known in orthopedic shoe technology (ball roll, metatarsal roll, etc.) can be used and designed into the CAD.

[0018] According to a further particular embodiment of the invention, it is provided that pressure sensors are incorporated into the dressing during its manufacture in order to implement an even more targeted and helpful variant with pressure sensors.

[0019] A further interesting embodiment of the invention is that in which the pressure protection is produced as a dressing component in combination with a dressing shoe, a cast, etc. With regard to the dressing shoe, the object of the invention is achieved in that the dressing shoe is to be worn over the wound dressings and is equipped with a sole and one or more straps fixed in the area of ​​the sole and with a pressure protection serving to relieve pressure on the human foot or parts thereof.

[0020] The resulting wound dressing component is then directly bandaged with a wound dressing, then joined to a wound dressing, ensuring a precise fit to the foot or bandage. This offers several advantages, including the highly dimensionally stable material, the fiberglass bond, and the precise, optimal adaptation to all areas of the foot. Adhesives are unnecessary, and associated skin irritations are a thing of the past. Strong and high pressure redistribution is possible, providing optimal pressure relief.

[0021] Further proposals include the use of a plastic milled bandage component and / or its fiber reinforcement as an alternative to the 3D process.

[0022] Finally, the invention also relates to a medical wound dressing.

[0023] The invention is particularly characterized by the fact that the 3D printing process according to claim 2 will replace previously known solutions using felt, fleece, etc. Instead, the compact solution replaces these multi-part designs. The material used is very dimensionally stable and durable. Precise foot adaptation to all foot regions is possible. Strong and high pressure redistributions are possible to create optimal pressure relief. No materials shift, thus enabling optimal pressure relief and wound rest. The integrated pressure protection is used to relieve pressure in diabetic foot syndrome (DFS). A dressing component manufactured using the 3D printing process is used, either milled or handcrafted from plastic, which is used on diabetic patients. The IDW is a dressing component printed using 3D technology. The IDW is part of a wound dressing.The latter consists of wound dressing, fixation of the wound dressing, IDW and fixation of the IDW.

[0024] Further details and advantages of the subject matter of the invention will become apparent from the following description of the accompanying drawings, which illustrate a preferred embodiment with the necessary details and individual parts. They show:

[0025] Figure 1 a foot in a shoe

[0026] Figure 2 a variant of Figure 1

[0027] Figure 3 Pressure protection hardness pattern with marking

[0028] Figure 4 a table

[0029] Figure 5 a CAD design

[0030] Figure 6 a variant of Figure 5

[0031] Figure 7 Wound dressing before scanning with markings of the hardness levels

[0032] Figure 8 a marked area

[0033] Figure 9 a supply example without shoe

[0034] Figure 10 a supply example without bandage shoe

[0035] Figure 11 shows an example of a control measurement using foot pressure measurement with bandage protection

[0036] Figures 1 and 2 show a human foot 1 on the sole 15 in a bandage shoe 4. The bandage fastening strips 9, 10, also referred to as straps, are shown in Figure 1, along with the dust absorber 3. Figure 2 additionally shows a rolling body 17.

[0037] Figure 3 shows a plurality of soles, one of which bears the reference number 15 as an example, together with a table 14 in Figure 4 for recording the determined degrees of hardness.

[0038] Figures 5 and 6 show CAD designs with the respective pressure protection 2 and the table with the various relevant Shore values. One of these is marked with the reference number 14 and the value 40 as an example.

[0039] A CAD design then shows Figure 5 and Figure 6 with the relevant reference number 2.

[0040] Figure 7 reveals a pre-scan bandage for pressure protection 2 and various markings 11 to 13.

[0041] Figure 8 illustrates the print file to be created with the color markings 15 and 16.

[0042] Figures 9-11 show an exemplary case report on control using foot pressure measurement with corresponding colored fields 20-25 without shoe in Figure 9, without bandage shoe according to Figure 10 and with bandage shoe according to Figure 11.

Claims

Claims 1. A method for adapting a medical wound dressing to a human foot, in particular in the case of diabetic foot ulcers, wherein the wound dressing is fixed to the pressure protection by one or more straps and thus comprises a pressure protection serving to relieve pressure on the foot.

2. Method according to claim 1, characterized in that the pressure protection is produced in a device for producing a three-dimensional structure by heating a material to a working temperature to form a molten material and applying a layer of the molten material layer by layer to the workpiece to be produced (3D printing).

3. Method according to claim 1, characterized in that the pressure protection is integrated into the wound dressing during manufacture.

4. Method according to claim 1, characterized in that the pressure protection is manufactured on the basis of the data determined from a three-dimensional foot scan.

5. Method according to claim 1, characterized in that the pressure protection is manufactured on the basis of the data on hardness levels, lowering and / or corrective measures determined in the foot scan.

6. Method according to claim 1, characterized in that the pressure protection is produced taking into account zones of different degrees of hardness.

7. Method according to claim 6, characterized in that the zones of different degrees of hardness are visualized on the wound dressing.

8. Method according to claim 7, characterized in that properties of the pressure protection such as hardness, lowering, pressure protection from the side, interruption of the shell shape, rolling technology, stiffening, attachment and / or correction are determined.

9. Method according to claim 1, characterized in that the pressure protection is produced as a bandage component in combination with a bandage shoe, a cast, etc.

10. Method according to claim 1, characterized in that pressure sensors are incorporated into the wound dressing during its manufacture.

11. Medical wound dressing for a human foot (1), in particular for the indication of diabetic foot ulcer, wherein the wound dressing is fixed to the pressure protection with one or more straps and thus comprises a pressure protection serving to relieve pressure on the foot.

12. A wound dressing according to claim 11, characterized in that the pressure protection is integrated into the composite shoe.

13. Wound dressing according to claim 1, characterized in that the pressure protection is formed substantially homogeneously.

14. Wound dressing according to claim 13, characterized in that the integrated dressing component is a dressing component manufactured using the 3D printing process.

15. Wound dressing according to claim 1, characterized in that a dressing component milled from plastics is used.

16. Wound dressing according to claim 1, characterized in that the plastic is fiber-reinforced.

17. A wound dressing manufactured according to at least one of claims 1 to 16.

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