CH713992A1 - Multilayer support element for direct or indirect support to a perfused skin area. - Google Patents

Abstract

Multilayer support element (1) for direct or indirect support to a perfused skin area, in particular for stimulating microcirculation. The support element is characterized in that it comprises at least two self-supporting plastic layers (3, 6), between which at least one metal foil (4) is arranged, and that between the plastic layers (3, 6) a powder mixture (2) is arranged, wherein these Powder mixture (2) has at least the following components: (A) at least one sulfate mineral; (B) at least one silicate mineral; (C) at least one clay mineral; (D) at least one boron mineral; (E) at least one calcite mineral; (F) at least one zeolite mineral; (G) at least one noble metal in elemental form; (H) at least one organic natural product, wherein the components having a particle size (d50) in the range of 10-150 microns are present.

Description

description

TECHNICAL FIELD The present invention relates to a support element for direct or indirect support on a perfused skin area. It is designed in such a way that it can stimulate and improve the microcirculation at least in the adjacent perfused skin area.

PRIOR ART Increasing health awareness and the ever increasing demands on people in today's industrial societies have given well-being and health-promoting measures (protection and prophylaxis) a high priority. All measures to promote and support age-appropriate physical activity in leisure time and in sport are of paramount importance. In addition, physical exercise as an additional measure to proven treatment measures is indispensable. This affects not only patients with type II diabetes mellitus as part of exercise therapy, but also all other younger and older people. In this context, measures to increase the blood flow to the organs and to expand the regulation range of the blood circulation play a very important role. For broad application, the focus is on non-drug measures.

DISCLOSURE OF THE INVENTION It is an object of the present invention to provide a product which does justice to these aspects, and consequently can improve well-being and, if appropriate, even improve the state of health, and particularly preferably demonstrably, biologically relevant blood circulation to increase the physical (and intellectual) performance and the promotion of regeneration processes and restoration of health (restitutive processes).

This object is achieved by the proposed support element according to claim 1. In the course of several series of investigations with the help of high-resolution validated measurement methods based on representative characteristics on suitable samples it was checked whether and to what extent the proposed support element meets these requirements. The results are summarized in the detailed description and show that, surprisingly, the proposed support element can sustainably and significantly increase the microcirculation.

The present invention relates accordingly to a multi-layer support element for direct or indirect support on a perfused skin area, in particular for stimulating microcirculation, wound healing, and / or immune defense. The proposed support element is characterized in that it has at least two self-supporting plastic layers, between which at least one metal foil is arranged.

Furthermore, a powder mixture (typically a total mass of 20-250 micrograms / cm ² , preferably 80-120 micrograms / cm ² ) is arranged between the plastic layers, either on one side of the metal foil or on both sides. This powder mixture has at least the following components:

(A) at least one sulfate mineral in a proportion of 20-150 parts;

(B) at least one silicate mineral in a proportion of 300-550 parts;

(C) at least one clay mineral in a proportion of 50-120 parts;

(D) at least one boron mineral in a proportion of 0-120 parts, preferably 50-120 parts;

(E) at least one calcite mineral in a proportion of 0-40 parts;

(F) at least one zeolite mineral in a proportion of 150-350 parts;

(G) at least one precious metal in elemental form in a proportion of 2-20 parts;

(H) at least one organic natural product in a proportion of 50-150 parts, the components (A) - (H) adding up to 1000 parts.

The components are present with a particle size (d50) in the range of 10-150 microns. The microcirculation of the human blood circulation affects all transport processes between blood and tissue cells, which are realized in the area of blood vessels with diameters smaller than 100 μm. It is the functionally most important part of the human blood circulation, since this is where the exchange of substances between the blood and the body cells takes place. At the same time, this is where the first steps in immunological reactions take place. Disorders of the microcirculation always mean restrictions or even disorders of cell functions and organ functions - right up to cell death. A large number of diseases are caused by disorders of the microcirculation or occur as accompanying processes in the case of disease states, whereby these accompanying disorders have the tendency to develop with their own pathological dynamics and to gradually influence the rest of the disease. Without adequate participation in the microcirculation, no recovery process, no restitutive process and no complete regeneration are possible. This results in the great prophylactic and protective importance of therapy-relevant influencing with limited or disturbed microcirculation, but also to promote performance e.g. during sporting activities.

As the measurements and analyzes shown in the detailed description show, the proposed support element is effective in the context of protection and prophylaxis and is recommended as an additive option. The

CH 713 992 A1

Support element shows effects not only for the exchange of substances between blood and tissue cells and thus for the performance of the organ to be supplied, but can also have an (indirect) influence on the mechanisms of temperature regulation (heat balance).

According to a first preferred embodiment, the support element is characterized in that the proportion of (A) is in the range of 35-65 parts, preferably in the range of 45-55 parts.

[0010] Preferably (A) is formed by celestin.

The proportion of (B) is preferably in the range of 350-550 parts, preferably in the range of 400-500 parts.

Preferably, (B) contains constituents selected from the following list, or consists of these, the stated proportions being based in each case on the entire powder mixture:

Hornstein, preferably in a proportion of 0-60 parts, particularly preferably in a proportion of 20-60 or 30-45 parts;

Tiger eye, preferably in a proportion of 2-20 parts, particularly preferably in a proportion of 5-10 parts; Rock crystal, preferably in a proportion in the range of 10-50 parts, particularly preferably in a proportion in the range of 20-35 parts;

Silica, preferably in a proportion in the range of 200-300 parts, particularly preferably in a proportion in the range of 220-270 parts;

Stilbit, preferably in a proportion in the range of 20-50 parts, particularly preferably in a proportion in the range of 30-40 parts;

Chrysocoll, preferably in a proportion in the range of 50-100 parts, particularly preferably in a proportion in the range of 65-80 parts;

Garnet, preferably in a proportion of 5-30 parts, particularly preferably in a proportion of 10-20 parts; Tourmaline, preferably black tourmaline, preferably in a proportion in the range of 5-30 parts, particularly preferably in a proportion of 7-18 parts, or a mixture of these components.

The proportion of (C) is preferably in the range of 60-85 parts, preferably in the range of 65-80 parts.

[0014] Preferably, (C) has components selected from the following list or consists of the following components: kaolin, hectorite, montmorillonite, smectite, or a mixture thereof.

The proportion of (D) is preferably in the range of 60-85 parts, preferably in the range of 65-80 parts.

[0016] Preferably, (D) contains borax or is formed from borax. The proportion of (E) is preferably in the range of 5-25 parts, preferably in the range of 10-20 parts.

(E) preferably contains chalk or is formed from chalk.

The proportion of (F) is preferably in the range of 180-280 parts, preferably in the range of 200-250 parts.

(F) may contain clinoptilolite or be formed from clinoptilolite.

The proportion of (G) is preferably in the range of 4-15 parts, preferably in the range of 5-12 parts.

(G) is preferably gold, silver or platinum or a mixture thereof or is formed from gold.

According to a further preferred embodiment, the support element is characterized in that the proportion of (H) is in the range from 70-130 parts, preferably in the range from 90-115 parts.

(H) is preferably a plant extract or dry meal, an algae extract or dry meal, or a mixture thereof. Ginseng is preferred, preferably in a proportion of 40-70 parts based on the total powder mixture, or chlorella, preferably in a range of 30-50 parts based on the total powder mixture or a mixture thereof.

The powder mixture preferably consists exclusively of components (A) - (H). According to a further preferred embodiment, the support element is characterized in that the metal foil is a foil made of aluminum or an aluminum alloy, preferably with a thickness in the range of 10-500 μm, particularly preferably in the range of 20-100 μm, or in the range of 40 -60 μm. At least one, preferably both plastic layers are preferably designed as a flexible plastic layer and contain a thermoplastic or consist of a thermoplastic, preferably selected from the following group: polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polycarbonate, or a blend thereof, the plastic layers in addition to the thermoplastic plastic fillers, in particular mineral fillers, for example Calcium carbonate, in a proportion of 0-10 percent by mass based on the thermoplastic, and any other additives, such as in particular light stabilizers, stabilizers, plasticizers, antioxidants, lubricants, processing aids, impact modifiers, dyes and pigments, or mixtures thereof, in one proportion of at most 10 mass percent, preferably at most 5 mass percent.

The plastic foils and the metal foil are preferably essentially congruent in their shape.

The plastic films and the metal foil can be glued to one another, for example in a heat sealing process, preferably with an acrylate-based adhesive, the powder mixture preferably being on an or

CH 713 992 A1 is arranged on both sides of the metal foil, preferably in a substantially uniformly distributed form, optionally leaving a bonded edge area with a width of at least 0.2 mm without powder mixture, and is present in a form bound by the adhesive. The plastic foils and / or the metal foils can have an angular, preferably polygonal, particularly preferably triangular, rectangular, square, pentagonal or hexagonal shape, or a rounded shape, in particular an oval shape or a circular shape, preferably the maximum diameter or the maximum length in the range of 300 mm, and the minimum diameter or the minimum length in the range of 5 mm, the plastic foils and the single metal foil being particularly preferably circular with a diameter in the range of 10-30 mm.

According to a very particularly preferred embodiment, the powder mixture has the following composition:

40-60 parts of sulfate mineral, preferably in the form of celestine;

430-470 parts of silicate mineral, made up of 30-45 parts of chert, 5-10 parts

Tiger eye, 20-35 parts rock crystal, 230-260 parts silica, 30-40 parts stilbit, 60-80 parts chrysocolla, 10-20 parts garnet, 5-20 parts black tourmaline;

60-80 parts of clay minerals made up of kaolin, hectorite, montmorillonite and / or smectite;

60-80 parts of boron mineral in the form of borax;

10-20 parts of calcite mineral in the form of calcite;

200-250 parts of zeolite mineral;

5-15 parts of precious metal in the form of gold;

90-120 parts of organic natural substance in the form of ginseng as an extract or dry regrind in a mixture with chlorella (algae) as an extract or dry regrind. The components of the powder mixture can be present with a particle size (d50) in the range of 20-60, preferably in the range of 30-50 μm.

Furthermore, the present invention relates to the use of a support element according to one of the preceding claims in a single or multi-layer element for fixation in direct or indirect support on the human body, for example in a shoe sole insert, preferably in the arch area, in a patch , a mattress, seating, clothing or jewelry.

Further embodiments are specified in the dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are described below with reference to the drawings, which are used only for explanation and are not to be interpreted as restrictive. The drawings show:

Fig. 1 support element in an exploded view;

Fig. 2 support element in a sectional view;

3 oxygen depletion in the microcirculation (microvascular networks in the skin and subcutis of the ankle region), changes on the x-axis being indicated in percent compared to the initial values which were set to zero;

4 oxygen depletion in the microcirculation (microvascular networks in the skeletal muscles and ankle region), x-axis as in FIG. 3;

5 oxygen depletion in the microcirculation (microvascular networks in the skin and subcutis of the calf), x-axis as in FIG. 3;

6 oxygen depletion in the microcirculation (microvascular networks in the skeletal muscles of the calf), x-axis as in FIG. 3;

FIG. 7 flow flow of the red blood cells in the microcirculation (microvascular networks in the skin and subcutis of the ankle region), x-axis as in FIG. 3;

8 flow flow of the red blood cells in the microcirculation (microvascular networks in the skeletal muscles of the ankle region), x-axis as in FIG. 3;

FIG. 9 flow flow of the red blood cells in the microcirculation (microvascular networks in the skin and subcutis of the calf), x-axis as in FIG. 3;

10 flow flow of the red blood cells in the microcirculation (microvascular networks in the skeletal muscles of the calf), x-axis as in FIG. 3;

CH 713 992 A1

11 oxygen depletion in the microcirculation (microvascular networks in the skin and subcutis of the ankle region), x-axis as in FIG. 3;

FIG. 12 flow flow of the red blood cells in the microcirculation (microvascular networks in the skin and subcutis of the ankle region), x-axis as in FIG. 3;

FIG. 13 flow flow of the red blood cells in the microcirculation (microvascular networks in the skeletal muscles of the ankle region), x-axis as in FIG. 3;

14 oxygen depletion in the microcirculation (microvascular networks in the skin and subcutis of the ankle region), x-axis as in FIG. 3;

15 maximum roughness depth as a percentage difference in comparison of the scar tissue on the 60th day after the operation with the surrounding skin tissue;

Fig. 16 superficial skin temperature as the difference between the temperature of the scar tissue and the temperature of the surrounding skin tissue (in degrees Celsius) on the 60th day after the operation.

DESCRIPTION OF PREFERRED EMBODIMENTS An overlay element 1 is shown in an exploded view in FIG. 1. A central aluminum layer 4, which carries the powder mixture 2 shown above and detailed below on one or both sides on one or both sides, is delimited on each side by a plastic film 3 or 6. There may also be further plastic films on one or both sides, as indicated by the protective film 3 'on the right in FIG. 1. Symbols, lettering or the like can also be printed, punched out and / or painted on this protective film or else on these or additional plastic films.

In the embodiment shown in Fig. 1, the aluminum foil 4 has essentially the same area and shape (here circular or oval) as the plastic foils, i.e. all components are congruent in their shape. However, it is also possible, for example, to design the aluminum foil 4 with a slightly smaller diameter, so that the aluminum foil 4 is not exposed at the edge.

2 is a sectional view through such a support element. Here you can see how the different layers are connected. In particular, there is an adhesive layer 7, typically based on an acrylate adhesive, between the plastic layer 6 shown below in this illustration and the aluminum layer 4. In this exemplary embodiment, the powder mixture 2 is arranged only on one side of the aluminum foil 4, but the powder mixture 2 can also be arranged on both sides of the aluminum foil 4. As can be seen in this section, the distribution of the powder mixture can be evenly distributed over the surface of the aluminum foil 4, but without reaching all the way to the edge. But it is also possible that the powder mixture is evenly distributed over the surface of the aluminum foil 4 and extends to the edge. Furthermore, as can also be seen in this figure, the powder mixture 2 is preferably embedded to a certain extent in the adhesive layer 5. Specifically, in the present case in the adhesive layer 5, which connects the aluminum foil to the plastic film 3 arranged on the upper side in this figure. In this embodiment there is another protective layer 3 'at the very top, i.e. a further plastic film, which can also be connected to the underlying plastic film 3 via an adhesive layer (not shown further here), but the films 3 and 3 'can also be connected to one another, for example, in a thermal process.

As already stated above, the plastic layers are preferably 3.6 μm layers made of a thermoplastic polymer, for example polyethylene, polypropylene, polyamide, or polyvinyl chloride. Polyvinyl chloride (PVC-P) is preferably used, for example colored white. The thickness of the plastic layers is typically in the range of 0.07-0.12, preferably in the range of 0.1 mm.

The aluminum layer 4 is usually somewhat thinner, namely in the range of 0.05 mm, and consists of 99.1 aluminum (pure aluminum).

The support element can either be integrated in another structural element, for example in an insole for the shoes, but it can also be provided, for example, on one or both sides with an adhesive layer which is covered with a cover layer. Before use, the cover layer can be removed and then the support element can be glued, for example, to the surface of an insole facing the foot, or in another place to the inside of the clothing, which rests on an area of the body whose microcirculation is to be stimulated. It is also possible to embed the support element in a plaster, a mattress, seating furniture, clothing or jewelry.

A preferred composition of the powder mixture is set out below, namely that which was also used in the subsequent experimental test of the effectiveness:

CH 713 992 A1 A mixture consisting of the following materials was used as the powder mixture, the parts add up to 1000 parts, and it was ground material with an average particle size of approximately 40 μm (d50): as a sulfate mineral 51 parts of Celestine (Sr (S04)) were used.

The following minerals were used as the silicate mineral (448 parts in total):

Parts of Hornstein (Chert), i.e. SiO2-rich sedimentary rocks;

Parts tiger's eye (i.e. essentially mineral of the following chemical structure SiO2 (+ FeOOH + (AI, Mg, Na));

Parts rock crystal, i.e. essentially pure SiO2;

242 parts of silicon in the form of silica (SiO2);

Share Stilbit, i.e. Mineral from the group of silicates / germanates, collective term for:

Stilbit Ca: NaCa4 (Si27A19) 072 28 H2O

Stilbit Na: Na9 (Si27A19) 072 28 H2O

Parts of chrysocolla, i.e. also a mineral from the group of

Silicates / Germanates, with the chemical structural formula Cu4H4 [(OH) 8ISi4O10] η H2O

Parts of garnet, i.e. an island silicate with the general structure:

[8] X3 [6] Y2 [[4] Z04] 3 or also A32 + B23 + [R04] 3, [3] [4] where 'X', Ύ 'and Z' or A ',' B 'and R 'do not represent chemical elements, but represent defined places in the crystal lattice. The respective grid positions can be occupied by different ions:

X and A: predominantly divalent cations, dodecahedral surrounded by eight oxygen anions, mostly Mg2 +, Fe2 +, Mn2 + and Ca2 + but also Y3 + or Na +

Y and B: predominantly trivalent cations, octahedrally surrounded by six oxygen anions, mostly AI3 +, Fe3 +, Cr3 + and V3 +, but also TÌ4 +, Zr4 +, Sn4 +, Sb5 + or Mg2 +, Mn2 +

Z or R: predominantly tetravalent cations surrounded by four oxygen anions, mostly Si4 +, but also AI3 +, Fe3 +, TÌ4 +, P5 +, As5 +, V5 +

Anion: mostly 02, rarely also (OH) or F12 parts of black tourmaline, i.e. a ring silicate with the following structure: XY3Z6 (T6018) (B03) 3V3W, where the black color means that the mineral Fe2 + is rich, and where

X = (Na, Ca, K); Y = (Fe2 +, Mg, Mn2 +, AI, Li, Fe3 +, Cr3 +);

Z = (Al, Fe3 +, Mg, Cr3 +); T = (Si, Al, B3 +); B = (B3 +); V = ((0H), 0); W = ((0H), F, 0) 72 parts of lava earth (also known under the names Ghassoul or Rhassoul) were used as clay minerals, i.e. Clay minerals based on SiAl, especially Kaolin (AI2O3 2SÌO2 2H2O), hectorite (Na0.3 (Mg, Li) 3Si4O10 (OH) 2), montmorillonite ((Na, Ca) 0.3 (AI, Mg) 2Si4O10 (OH) 2 nH2O) or smectite (smectites consist mainly of montmorillonite, but also contain quartz and calcite dust) - individually or combined;

72 parts of borax (Na2 [B4O5 (OH) 4] -8H2O) were used as boron mineral;

14 parts of Rügen healing chalk were used as calcite mineral, chemical calcite or calcium carbonate, typically made from 98.2% pure calcium carbonate (CaC03) and small parts of silicon, magnesium, aluminum, iron, iodine and phosphorus compounds;

230 parts of clinoptilolite (collective term for

Clinoptilolite Ca: Ca3 (Si30AI6) 072-20H20 [3]

Clinoptilolite-K: K6 (Si30AI6) 072-20H20 [3]

Clinoptilolite Na: Na6 (Si30AI6) 072-20H20 [3j);

8 parts of gold were used as the precious metal;

A total of 105 parts were used as an organic natural product, made up of:

Parts of ginseng (ginseng radix pulvis, for example available from Hänseler, Herisau, Switzerland) 43 parts of chlorella (Chlorella vulgaris, for example available from Roquette Klötze GmbH & Co KG, DE under the name Algomed).

Checking the effectiveness:

The microcirculation of the human blood circulation relates to all transport processes between blood and tissue cells, which are realized in the area of blood vessels with diameters smaller than 100 μm. It is the functionally most important part of the human blood circulation, since this is where the exchange of substances between the blood and the body cells takes place.

CH 713 992 A1 At the same time here is the place where the first steps of immunological reactions take place. Disorders of the microcirculation always mean restrictions or even disorders of cell functions and organ functions - right up to cell death. A large number of diseases are caused by disorders of the microcirculation or occur as accompanying processes in the case of disease states, whereby these accompanying disorders have the tendency to develop with their own pathological dynamics and to gradually influence the rest of the disease. Without adequate participation in the microcirculation, no recovery process, no restitutive process and no complete regeneration are possible.

This results in the great prophylactic and protective importance of therapy-relevant influencing with limited or disturbed microcirculation, but also to promote performance e.g. during sporting activities. In addition to the fact that the drug options for treating a disturbed microcirculation are currently very limited, it should also be noted that drugs can only work in the area of large-caliber arterioles, but not in the downstream small-caliber arteriolar branches, which are upstream of the capillary networks. Their regulations are implemented (largely locally) as part of the shear stress-dependent endothelium-mediated tone regulation through certain biorhythmic physical influences. In the area of the small-caliber arteriolar sections, where the local blood flow regulation is not done by hormonal and / or nervous control, but autoregulatory by physical means, there is the Achilles heel of the local blood flow regulation. And here at this point, appropriate non-medicinal measures can be used to take effective preventive measures. In the past two decades, the use of certain physical treatment measures has therefore become an increasing subject of research. The aim of this research is to optimize the treatment of established (medicinal) treatment measures in the disease state and to increase the therapeutic success of prophylactic, regenerative and restorative measures. The target groups are patients with type II diabetes mellitus, patients with chronic wound healing disorders, delayed or inadequate regeneration and restitution in rehabilitation patients - but also prophylaxis for sports injuries, prophylaxis for work-related stress, increasing success in training for physical conditioning, etc.

It is generally recognized today that in the case of local regulatory deficits in organ perfusion, a certain physical stimulation is possible (demonstrated using the example of certain biorhythmically defined electromagnetic fields).

At the center of all medical considerations is the question of the state of distribution of the plasma-blood cell mixture in the capillary networks. How many capillaries, through which red blood cells flow, can be switched on if necessary and, if necessary, switched off when an organ is at rest? This affects the resulting changes in the diffusion path.

The design of the investigations:

Material and methods: The investigations were carried out on biometrically defined, largely homogeneous samples in a placebo-controlled manner in the following groups:

[0047] Approx. 40-year-old stress-exposed, untrained female and male volunteers (general practitioner without pathological findings). Total sample N tot = 32 (16 controls and 16 tests). BMI in the norm. Single use of the test product. Approximately 55-year-old female and male people with type II diabetes mellitus (diet and exercise therapy prescribed, little or no insulin medication, slightly overweight). Total sample N tot = 32 (16 controls and 16 tests). Single use of the test product.

[0048] Approx. 50-year-old female and male subjects with mild type II diabetes mellitus (diet, discontinued)). Total sample N tot = 24 (12 control and 12 test). 7-day application of the test product.

Supplementary examination: approx. 48-year-old stress-exposed, untrained female and male volunteers (general practitioner without pathological findings). Total sample N tot = 16 (control and test as an intra-individual comparison). Single use of the test product.

[0050] The experimental procedure:

[0051] Collection of the initial values under defined rest conditions. Then 60 minutes of treadmill exercise (corresponding to a walk). The measuring times were determined before treadmill loading and after treadmill loading.

High-resolution, non-invasive examination methods (validated) based on the latest state of the art and research were used: white light spectroscopy and laser DOPPLER microflow measurement (collection of the measurement data in 2 tissue depths: - 2mm (micro vessels of the subcutis) and - 6 mm ( Microvessels in the skeletal muscles).

The target tissues were: ankle region (preferred region for the development of circulatory disorders) and calf (treadmill load).

The following were used as representative features of the functional state of the microcirculation:

Oxygen depletion, the mean flow of the red blood cells in the microvessels, the mean flow velocity of the red blood cells in the microvessels and the relative saturation of the hemoglobin in the red blood cells.

CH 713 992 A1 The internationally recognized WILCOXON rank sum test was used for the statistical evaluation of the measurement data obtained.

[0056] Completed investigations on wound healing.

[0057] Approx. 45-year-old female and male patients in whom a nevus removal was performed, as medically indicated. Total sample N tot = 28 (14 controls with placebo and 14 with test product). Length of the O.P. -Cut approx. 3 to 4 cm, wound dressing customary in clinics. The oxygen depletion was determined as the difference in the characteristic amounts between the wound edge and the uninjured skin tissue over the course of 10 days.

Female and male patients in whom a nevus removal was carried out medically indicated. Age - 50-60 years. Total sample N tot = 24 (12 control with placebo and 12 with test product). Length of the O.P. incision approx. 3 to 4 cm, wound dressing customary in clinical practice. The characteristics maximum roughness depth and superficial skin temperature were determined as the difference in the characteristic amounts between the wound edge and the uninjured skin tissue on the 60th day after O.P.

Results of the investigations on younger people exposed to stress: FIGS. 3 to 10 illustrate the measured data determined as mean value representations. Oxygen depletion is the most important feature of the functional state of the microcirculation. 3 shows a slight decrease in this characteristic in the microvascular region of the skin and subcutaneous tissue in the control group and a clear increase in physical activity with a decrease in this characteristic change in a period of more than 30 minutes after exercise in the test group. This is physiologically advantageous, especially when you consider that the subjects examined are untrained people. FIG. 4 shows a similar feature behavior in the skeletal muscles of the ankle region, but with smaller amounts of the feature changes in the test group compared to the skin and subcutaneous tissue. 7 and 6, the characteristic changes for oxygen depletion in the calf are shown. The deficits in the oxygen supply in the control group during physical exertion can again be seen. In the test group, however, in comparison to the measured data of the ankle region in the area of the calf, higher feature amounts were found in the skeletal muscles than in the skin and subcutaneous tissue of the calf. This indicates a higher performance with the treadmill load in the test group. We found that the subjects in the control group tired more quickly when using the treadmill and needed longer regeneration times than the subjects in the test group.

The results for determining the mean flow of the red blood cells in the microvascular networks of skin and subcutaneous tissue and skeletal muscles in the area of the ankles and calves in the control group and the test group are in agreement with the measurement data for oxygen depletion. 7 to 10). Here too, the characteristic behavior in the control group differs significantly from the test group. In the case of the characteristics relative hemoglobin saturation and flow velocity of the red blood cells, changes in characteristics which were in the same direction were determined.

Results of the investigations in elderly people with type II diabetes mellitus:

11 provides information about the measurement data (mean values) of this series of tests. 11, this time only the microcirculation in the skin and subcutis of the ankle region, the values for the skeletal muscles of the ankle region, for the skin and subcutis of the calf, for the skeletal muscles of the calf are essentially analog.

12 shows the flow of the red blood cells in the microcirculation (microvascular network in the skin and subcutaneous tissue of the ankle region), and in FIG. 18 the flow of the red blood cells in the microcirculation (microvascular network in the skeletal muscles of the ankle region). The flow in the skin and subcutis of the calf and in the skeletal muscles of the calf behaves analogously to FIG. 13.

Untrained people and especially patients with a restricted range of control of the microcirculation (patients with type II diabetes mellitus) are affected by deficits in the regulation of the blood flow during physical exercise or exercise, which restrict performance and prolong regeneration times. In this context, the results of this series of studies deserve special attention. The measurement data from the control group and test group differ significantly from one another. In contrast to the patients in the control group, there are no deficits in the blood flow regulation in the test group during physical exertion. The measured data on oxygen depletion in the examined tissue regions of the calf (in particular skeletal muscles) show that the patients in the test group had a higher physical performance (less fatigue and shorter regeneration times compared to the patients in the control group).

The test product used (test group) can thus be said to have a biologically relevant influence on important functional features of the microcirculation, as a result of which physiologically beneficial effects on the tissue supply and thus the. Functionality of the organ areas to be supplied and on the temperature regulation occur.

Results of the tests after 7 days of use of the test product, including:

The results of the measurements were confirmed in an intra-individual comparison of control versus test. This summary does not present the measurement results. Of particular interest is the question of whether the change in characteristics occurs after the test product has been used for several days. 14 illustrates the measured data determined after 7 days of use of the test product. The corresponding values

CH 713 992 A1 for the oxygen depletion of the skeletal muscles of the ankle region, the skin and subcutis of the calf, and the skeletal muscles of the calf behave analogously. The same applies to the flow of red blood cells in these microvessel networks. The test product and the placebo were worn by the test subjects with a special holding device day and night. The subjects were exposed to a daily treadmill load during the study period. The measuring times were:

Day 0 collection of the initial values, day 1 to 7 of measured value surveys 1 hour after the daily treadmill load.

Both the investigated characteristic oxygen depletion and the characteristic flow flow of the red blood cells in the microcirculation in the ankle region and in the calf in the test group a cumulative effect of the characteristic changes occurred in the 7-day measurement period.

Results of the investigations on wound healing: The influence of the test product on wound healing was examined in a sample of male and female patients with indication for surgical nevus removal. The total sample N tot = 28 was randomly divided into two equal sized partial samples each n = 14):

Control placebo on the clinically customary wound dressing, test-test product on the clinically customary wound dressing.

In an observation period of 10 days, measured value surveys were carried out at equidistant measurement times at an interval of 1 day. The investigated feature was the oxygen depletion in the microvascular networks of the skin and subcutaneous tissue of the wound edge (3-4mm from the cut edge) and at a distance of approx. 5 cm from the wound edge in the uninjured skin tissue. The difference in the characteristic amounts between the wound edge and the uninjured skin tissue was determined. This difference was set equal to 100% immediately after the surgical intervention. The test group showed a significantly smaller difference compared to the control group. The cause of this characteristic behavior is the more pronounced new formation of microvessels in the test group and thus a physiologically better wound healing. In a further sample of male patients with indications for surgical nevus removal, the influence of the test product on features of the surface quality of the later scar tissue was examined. The total sample N tot = 24 was randomly divided into two equal sized partial samples each n = 12):

Control - placebo on the customary wound dressing during the previous wound healing.

Test - test product on the clinically customary wound dressing during the previous wound healing.

On the 60th day after surgery, the following features of the surface quality of the scar were determined (red scar): maximum roughness (difference in comparison with the surrounding skin tissue / normal skin tissue set to 100%), superficial skin temperature (difference to the surrounding skin tissue in ° C).

The determined measurement data can be seen in FIGS. 15 and 16. In the test group, there were significantly smaller differences to the surrounding skin tissue compared to the control group, i.e. scarring in the test group was carried out with a higher surface quality.

Discussion: For the consideration of the effects of the test object, the laws of the interaction of waves and matter are in the foreground - the interaction of the body's own radiation and the test object.

The sources of the body's own radiation, which are released from the skin surface to the environment are: activities of the nervous system (b), certain activities of the body cells (a), activities of the smooth muscle cells that surround the vessel walls (here the smaller) blood vessels (c) et al These are various electromagnetic waves (transverse waves) that are emitted from the skin surface mainly as so-called heat radiation.

At each interface or boundary layer of the test object, these interactions relate to the following physical laws, which determine the energy reflected back into the tissue by the test object: reflection, scattering, diffraction, refraction, absorption of energy (energy conversions), and interference (extinction, amplification) ) of the different wavelength components of the electromagnetic wave.

The wave retroreflected into the tissue is thus somewhat different in terms of the frequencies, wavelengths and phase shifts of its components from those wave components which were emitted by the body tissue. The electromagnetic wave emitted by the body, like the retroreflected wave, is a mixture of different spectral components.

If one considers the individual layers of the test object, the aluminum / powder layer is of outstanding importance with regard to the absorption properties of its material constituents. This is supported by measurement results from an orientation study of the material properties of this layer. Taking into account the proven effects of the test object (see previous sections), the conclusion is permitted that the test object self-stimulates the most important local regulatory mechanism of organ blood flow, the spontaneous autorhythmic vasomotion of arteriolar microvessels, to an adjuvant-therapeutic extent. The wave reflected back into the tissue by the test object is obviously configured to exert a physiological stimulus on this regulatory mechanism.

CH 713 992 A1 It is currently not possible to assess whether other (intracellular) phenomena are also involved, since suitable measurement methods are not available for this. The studies on the health-promoting or prophylactic effects of the test object were carried out in the ankle region of the lower extremities, which is a preferred tissue region for the development and manifestation of circulatory disorders (especially in patients with type II diabetes - but also in people who have special physical characteristics Are exposed). The determined effects of the test object (test results vergi, previous sections) allow a recommendation for the following areas of application:

For prophylaxis, in particular for occupationally exposed persons (wetness, cold, etc.), in sports and in particular for older people with limited regulation of the blood circulation, etc. To increase performance under physical stress. Adjuvant-therapeutic to optimize the therapeutic success of established medical treatment methods (e.g. to support exercise therapy in people with type II diabetes mellitus).

It is proposed to use the test object e.g. as a shoe insert, in (protective gloves, in (protective) vests, jackets etc.

The test object is also suitable for increasing the therapeutic success as a supplement to established wound healing treatments in the case of delayed or impaired wound healing. For this purpose, the test object is attached to a commercially available wound dressing. For example, a demanding influence on the new formation of microvessels at the wound edge in the inflammatory phase of wound healing on the state of the subsequent scarring.

In the case of serious illnesses, the test product can be said to have less causal-therapeutic effectiveness, but the test product is suitable as a supplementary measure to recognized treatment measures (increase in therapeutic success).

In the context of protection and prophylaxis, the test product is effective and can be recommended as an additive option. It should be noted that the effects of the test product are not only important for the exchange of substances between blood and tissue cells and thus for the performance of the organ to be supplied, but also exert an (indirect) influence on the mechanisms of temperature regulation (heat balance).

REFERENCE SIGN LIST [0086]

support element

powder mixture

Plastic film

3 'more plastic film than

protective layer

aluminum foil

adhesive layer

Plastic film

adhesive layer

Claims (15)

claims 1. multilayer support element (1) for direct or indirect application to a perfused area of skin, in particular for stimulating the microcirculation, characterized in that the support element (1) has at least two self-supporting plastic layers (3, 6), between which at least one metal foil (4 ) and that a powder mixture (2) is arranged between the plastic layers (3, 6), this powder mixture (2) having at least the following components: (A) at least one sulfate mineral in a proportion of 20-150 parts; (B) at least one silicate mineral in a proportion of 300-550 parts; (C) at least one clay mineral in a proportion of 50-120 parts; (D) at least one boron mineral in a proportion of 0-120 parts; (E) at least one calcite mineral in a proportion of 0-40 parts; (F) at least one zeolite mineral in a proportion of 150-350 parts; (G) at least one precious metal in elemental form in a proportion of 2-20 parts; (H) at least one organic natural product in a proportion of 50-150 parts, CH 713 992 A1 where the components (A) - (H) add up to 10000 parts, and where the components are present with a particle size (d50) in the range from 10-150 μm. 2. support element (1) according to claim 1, characterized in that the proportion of (A) is in the range of 35-65 parts, preferably in the range of 45-55 parts, and / or that (A) is formed by celestin. 3. support element (1) according to any one of the preceding claims, characterized in that the proportion of (B) in the range of 350-550 parts, preferably in the range of 400-500 parts, and / or that (B) components selected from of the following list, the proportions given being based in each case on the entire powder mixture (2): Chert, preferably in a proportion of 20-60 parts, particularly preferably in a proportion of 30-45 parts; Tiger eye, preferably in a proportion of 2-20 parts, particularly preferably in a proportion of 5-10 parts; Rock crystal, preferably in a proportion in the range of 10-50 parts, particularly preferably in a proportion in the range of 20-35 parts; Silica, preferably in a proportion in the range of 200-300 parts, particularly preferably in a proportion in the range of 220-270 parts; Stilbit, preferably in a proportion in the range of 20-50 parts, particularly preferably in a proportion in the range of 30-40 parts; Chrysocoll, preferably in a proportion in the range of 50-100 parts, particularly preferably in a proportion in the range of 65-80 parts; Garnet, preferably in a proportion of 5-30 parts, particularly preferably in a proportion of 10-20 parts; Tourmaline, preferably black tourmaline, preferably in a proportion in the range of 5-30 parts, particularly preferably in a proportion of 7-18 parts, or a mixture of these components. 4. support element (1) according to any one of the preceding claims, characterized in that the proportion of (C) in the range of 60-85 parts, preferably in the range of 65-80 parts, and / or that (C) components selected from or consists of the following list: kaolin, hectorite, montmorillonite, smectite, or a mixture thereof. 5. support element (1) according to any one of the preceding claims, characterized in that the proportion of (D) in the range of 50-120 parts or 60-85 parts, preferably in the range of 65-80 parts, and / or that ( D) contains borax or is formed from borax. 6. support element (1) according to any one of the preceding claims, characterized in that the proportion of (E) is in the range of 5-25 parts, preferably in the range of 10-20 parts, and / or that (E) contains chalk or is made of chalk; and / or characterized in that the proportion of (F) is in the range of 180-280 parts, preferably in the range of 200-250 parts, and / or in that (F) contains clinoptilolite or is formed from clinoptilolite. 7. support element (1) according to any one of the preceding claims, characterized in that the proportion of (G) in the range of 4-15 parts, preferably in the range of 5-12 parts, and / or that (G) gold, silver or contains platinum or a mixture thereof or is formed from gold. 8. support element (1) according to any one of the preceding claims, characterized in that the proportion of (Ff) in the range of 70-130 parts, preferably in the range of 90-115 parts, and / or that (Ff) is a plant extract or dry ground material, an algae extract or dry ground material, or a mixture thereof, preferably ginseng, preferably in a proportion of 40-70 parts based on the total powder mixture (2), or chlorella, preferably in a proportion in the range of 30-50 parts based on the entire powder mixture (2) or a mixture thereof, contains or is formed therefrom. 9. support element (1) according to any one of the preceding claims, characterized in that the powder mixture (2) consists of the components (A) - (H). 10. support element (1) according to any one of the preceding claims, characterized in that the metal foil (4) is a foil made of aluminum or an aluminum alloy, preferably with a thickness in the range of 10-500 microns, particularly preferably in the range of 20-100 μm, or in the range of 40-60 μm, and / or that at least one, preferably both, plastic layers (3, 6) is preferably designed as a flexible plastic layer and contains a thermoplastic or consists of a thermoplastic, preferably selected from the following Group: polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polycarbonate, or a blend thereof, the plastic layers (3, 6) in addition to the thermoplastic plastic, fillers, in particular mineral fillers, preferably calcium carbonate, in a proportion of 0-10 percent by mass based on the thermoplastic Plastic, may contain, and possibly wide re additives, such as in particular light stabilizers, stabilizers, plasticizers, antioxidants, lubricants, processors CH 713 992 A1 processing aids, impact modifiers, dyes and pigments, or mixtures thereof, in a proportion of at most 10 mass percent, preferably at most 5 mass percent. 11. support element (1) according to any one of the preceding claims, characterized in that the plastic foils (3, 6) and the metal foil (4) are substantially congruent in their shape, and / or that the plastic foils (3, 6) and Metal foil (4) are glued to one another via an adhesive layer (5, 7), preferably with an acrylate-based adhesive, the powder mixture (2) preferably being optional on one or both sides of the metal foil (4), preferably in a substantially uniformly distributed form while leaving a bonded edge area with a width of at least 0.2 mm without powder mixture (2), and is present in a form bound by the adhesive. 12. Support element (1) according to one of the preceding claims, characterized in that the plastic foils (3, 6) and / or the metal foils (4) have an angular, preferably polygonal, in particular preferably triangular, rectangular, square, pentagonal or 6- angular shape, or a rounded shape, in particular an oval shape or a circular shape, preferably the maximum diameter or the maximum length in the range of 300 mm, and the minimum diameter or the minimum length in the range of 5 mm, wherein in particular the plastic foils (3, 6) and the single metal foil (4) are preferably circular with a diameter in the range of 10-30 mm. 13. support element (1) according to one of the preceding claims, characterized in that the powder mixture (2) has the following composition: 40-60 parts of sulfate mineral, preferably in the form of celestine; 430-470 parts of silicate mineral, made up of 30-45 parts of chert, 5-10 parts of tiger's eye, 20-35 parts of rock crystal, 230-260 parts of silica, 30-40 parts of stilbit, 60-80 parts of chrysocolla, 10 -20 parts of garnet, 5-20 parts of black tourmaline; 60-80 parts of clay minerals made up of kaolin, hectorite, montmorillonite and / or smectite; 60-80 parts of boron mineral in the form of borax; 10-20 parts of calcite mineral in the form of calcite; 200-250 parts of zeolite mineral; 5-15 parts of precious metal in the form of gold; 90-120 Organic natural substance in the form of ginseng as an extract or dry regrind in a mixture with chlorella (algae) as an extract or dry regrind. 14. support element (1) according to any one of the preceding claims, characterized in that components of the powder mixture with a particle size (d50) in the range of 20-60, preferably in the range of 30-50 microns. 15. Use of a support element (1) according to one of the preceding claims in a single- or multi-layer element for fixation in direct or indirect support on the human body, particularly preferably in a shoe sole insert, preferably in the area of the arch of the foot, in a plaster, a mattress Seating, clothing or jewelry. CH 713 992 A1 RG. 2 output values Immediately after 30 minutes after the run 60 minutes Treadmill exercise 15 minutes after treadmill load ~~ 'Ί El test □ control RG. 3 CH 713 992 A1 output values 30 minutes after Treadmill exercise 15 minutes after Treadmill load immediately after 60 minute treadmill load | Ο