Therapeutic insole with associated real-time-capable control and evaluation electronics

Abstract

The invention relates to a system comprising a therapeutic insole (1) adapted to the human foot and real-time-capable control and evaluation electronics (2). The aim of the invention is to provide a soft footbed constructed from a plurality of air cushions, which soft footbed has a smaller number of energy-consuming and electrically controllable components than in the prior art. For this purpose, the therapeutic insole (1) comprises a soft footbed which has a plurality of air cushions (5, 5a, 5b, 5c, 5', 5") which are filled with air at variable filling levels, and which has a plurality of electrically controllable and switchable valves (6), wherein: each air cushion (5, 5a, 5b, 5c, 5', 5") is connected to at least one associated electrically controllable and switchable valve (6) via a line so as to conduct air; at least one barometric pressure sensor (8) is located within each air cushion (5, 5a, 5b, 5c, 5', 5"); all air cushions (5, 5a, 5b, 5c, 5', 5") are connected to one another via a line so as to conduct air, via the electrically controllable and switchable valves (6) and / or one or more air-conducting connecting lines (7, 7a, 7b, 7c); and both the controllable and switchable valves (6) and the barometric pressure sensors (8) are each operatively connected for signal transmission to the real-time-capable control and evaluation electronics (2), which are equipped and configured to continuously detect the plantar pressure distribution occurring under the sole of the foot of a person standing up and during a physiological rolling-off process of a foot in the gait cycle, and to create promptly and control by way of a selective temporal opening of individual valves (6), a pressure distribution-induced and surface pressure-induced air and pressure redistribution between individual or a plurality of air cushions (5, 5a, 5b, 5c, 5', 5") caused solely by the respective contact pressure of the foot, by selectively changing the air filling level of one or more of the plurality of air cushions (5, 5a, 5b, 5c, 5', 5").

Description

[0001] Supply sole with associated real-time capable control and evaluation electronics

[0002] The invention relates to a system comprising a supply sole adapted to the human foot, in particular for the treatment of diabetic foot syndrome, and real-time capable control and evaluation electronics as well as a method for controlling the system.

[0003] Diabetic foot ulcers (DFS) are the most common complication in diabetics. It is a syndrome that encompasses various clinical pictures with different causes. Diabetic foot ulcers (DFUs) are tissue defects of the skin that, in the late stages, extend to the bone and may be necrotic, and occur in the context of DFS. They arise, on the one hand, from the pathological deformity of the feet and, on the other hand, from a loss of sensation due to diabetes-related nerve damage and the subsequent lack of pressure relief during (local) pressure overload. As a serious consequence of diabetes, they are one of the leading causes of preventable morbidity in adults with diabetes.

[0004] In the Federal Republic of Germany, care for diabetic foot syndrome is regulated in product group 31 (PG31 for short), specifically in PG 31.03.07 of the medical aid directory of the Federal Association of Statutory Health Insurance Funds (G KV-Spitzenverband). In addition to wound care, it includes the manufacture and application of so-called diabetes-adapted footbeds (DAF). DAF are soft-bed insoles that relieve pressure on ulcerated foot regions and redistribute pressure to the adjacent healthy regions of the foot. Medical supply stores or orthopedic shoemakers manufacture and verify functionality through occasional plantar pressure distribution measurements. Functionality according to PG31 is defined as 30% pressure relief of the affected area compared to the original shoe.The PG31 does not specify a treatment period for DAFs, so in practice, it has been shown that the majority of patients use the same DAF for several years. However, a 2017 study highlights the problem that approximately 40% of patients with DAFs experience re-ulceration within the first 12 months. The problem with the current care situation lies in the long treatment cycle and the resulting time intervals between individual, non-time-defined checkups of the care at the medical supply store. Currently, monitoring is only carried out via inpatient plantar pressure distribution measurements at the medical supply store at unspecified intervals.However, since studies have shown that 40% of patients develop re-ulceration within the first 12 months, there is a need for a solution that eliminates this disadvantage of the currently large time interval between pressure distribution measurements.

[0005] CN 115251527 A discloses a diabetic foot orthosis comprising a plurality of air cushions. This insole creates a uniform pressure distribution based on the plantar pressure distribution occurring during a gait cycle. For this purpose, the air cushions of the insole are connected to each other and, with the integration of an air-releasing storage element, are in free, air-conducting communication. During the course of a gait cycle, the air is freely distributed between the air cushions and the storage element of the insole, solely by the current foot pressure.

[0006] A system comprising a sole equipped with a plurality of air cushions, adapted to the human foot and featuring valves, as well as control and evaluation electronics, is known from US 20160174657 A1 and US 2019000183 A1, respectively. These systems are also equipped with one or more pumps that redistribute air and pressure or, by changing the air filling level in individual air cushions, increase or decrease the pressure in the individual air cushions.

[0007] Further systems comprising a soft footbed adapted to the human foot and equipped with a plurality of air cushions are known from the publications WO 2011067758 A1, JP 2001238702 A, CN 106072977 A, EP 1872763 A1, CN 208274198 U, and WO 2017190495 A1. All embodiments known therefrom each comprise at least one pump, compressor, or inflation device as a separate component, which must be activated to achieve a pressure increase.

[0008] A disadvantage of these state-of-the-art systems, which comprise a sole equipped with a plurality of air cushions, adapted to the human foot and equipped with valves, as well as control and evaluation electronics, is that at least one pump is used as the driving force for generating the air movement required for air redistribution, making it a necessary component of the respective system. Each pump requires an installation space in the supply sole and must also be supplied with electrical power, which must also be provided in the area of ​​the supply sole. Furthermore, the required pumps are small in design and prone to failure, so that long-term, continuously functional use of these state-of-the-art supply soles is not always guaranteed.

[0009] There is therefore a need for a system that can be implemented with a smaller number of critical components and can also be operated reliably and continuously.

[0010] Cushioning systems that do not require a pump and in which a user can adjust the cushioning properties of a shoe sole are known from US 5 813 142 A and US 2005 / 0 132 617 A1.

[0011] US 5,813,142 A discloses a shoe with an adjustable cushioned sole containing air cushions, each air cushion having an associated pressure measuring device that measures the pressure exerted by a user's foot on the respective air cushion. When the pressure rises above a threshold, a control system opens a valve to allow air to escape from the air cushion. Each air cushion has a restoring force and returns to its original position when the user's foot no longer exerts pressure. Since the air cushions are connected to an air reservoir, air is drawn back into the respective air cushion upon return to the original position. A cushioning control allows the user to decrease or increase the cushioning provided by the shoe.

[0012] US 2005 / 0 132 617 A1 discloses a shoe sole comprising a plurality of interconnected air cushions. This cushioning system comprises a sealed air reservoir, a plurality of air cushions configured as separate cushioning chambers, and a control system. The control system, which includes a CPU, pressure sensors, and valves, controls the air connection between the air cushions to dynamically adjust the pressure in the cushioning chambers to various conditions, such as the intended activity, the user's weight, and their running style. The chambers are fluidly connected to one another, and a control device dynamically distributes and regulates the pressure within the chambers based on sensed criteria entered or specified by the user.The invention is therefore based on the object of creating a solution that provides a soft footbed constructed from a plurality of air cushions, which can be realized with a smaller number of energy-consuming and electrically controllable components than the prior art.

[0013] In particular, the driving force for a redistribution of air and pressure in the soft footbed should come from a load applied to the soft footbed with a mechanical load size or force by a limb or extremity, in particular a foot, of a biological system, in particular a human being.

[0014] The soft footbed should also be able to continuously measure the current pressure distributions over the surface of the soft footbed at short intervals and to automatically adjust the filling level and pressure resistance of the individual air cushions to the pressure distribution values.

[0015] Furthermore, a solution is to be provided that provides a diabetes-adaptive footbed for the treatment of diabetic foot syndrome, which enables short-term pressure distribution measurements and automated adaptive treatment of diabetic foot syndrome.

[0016] This object is achieved by a system according to claim 1. Expedient embodiments and advantageous further developments of the invention are the subject of the dependent subclaims.

[0017] The object is also achieved by a method according to claim 16.

[0018] According to the invention, a system comprising a supply sole adapted to the human foot, in particular for treating diabetic foot syndrome, and real-time capable control and evaluation electronics is proposed, wherein the supply sole comprises a soft footbed, in particular one adapted to diabetes, which has a plurality of air cushions that are filled with air at variable heights and a plurality of electrically controllable and switchable valves, wherein each air cushion is in air-conducting line connection with at least one associated electrically controllable and switchable valve and at least one barometric pressure sensor is arranged within each air cushion, and wherein all air cushions are in air-conducting line connection with one another via the electrically controllable and switchable valves and / or one or more air-conducting connecting lines,and wherein both the electrically controllable and switchable valves and the barometric pressure sensors are each in signal-conducting connection with the real-time capable control and evaluation electronics, which are equipped and configured to continuously record the plantar pressure distribution arising under the foot surface during stance and a physiological rolling process of a foot in the gait cycle, and to generate and control, via a targeted temporal opening of individual valves, a pressure distribution and surface pressure-induced air and pressure redistribution between individual or multiple air cushions by means of a targeted change in the air filling level of one or more of the plurality of air cushions.

[0019] Likewise, the invention proposes a method for controlling a system, in particular for controlling air and pressure diversion within air cushions of a care sole equipped with a plurality of air cushions by means of the system, wherein the system comprises a care sole adapted to the human foot, in particular for treating diabetic foot syndrome, and real-time capable control and evaluation electronics, wherein the care sole comprises a soft footbed, in particular one adapted to diabetes, which has a plurality of air cushions that are filled with air at variable heights, and a plurality of electrically controllable and switchable valves, wherein each air cushion is in air-conducting line connection with at least one associated electrically controllable and switchable valve and at least one barometric pressure sensor is arranged within each air cushion,and wherein all air cushions are connected to one another via the electrically controllable and switchable valves and / or one or more air-conducting connecting lines, and wherein both the controllable and switchable valves and the barometric pressure sensors are each in signal-conducting connection with the real-time capable control and evaluation electronics, which continuously records the plantar pressure distribution occurring under the foot surface during standing and a physiological rolling process of a foot in the gait cycle, and which, through a targeted temporal opening of individual valves, promptly generates and controls a pressure distribution and surface pressure-induced redistribution of air and pressure between individual or multiple air cushions by means of a targeted change in the air filling level of one or more of the plurality of air cushions.

[0020] To achieve the stated object, the invention proposes a system and a control of the system, wherein the system comprises a supply sole and associated control and evaluation electronics and is equipped and configured to carry out pressure measurements by means of a plurality of small-sized air cushions, which are distributed over a surface adapted to the human foot shape and are provided with a barometric pressure sensor and at least one associated electrically controllable and switchable valve and are filled with air at variable heights, after its activation in a standing position and during a physiological rolling process of a foot, permanently and continuously distributed over the entire surface adapted to the human foot shape - in relation to a respective air cushion in a small area and / or at specific points - and to determine the respective current plantar pressure distribution over this surface and in response thereto autonomously and automatically by targetedControlling one or more valves to bring about a change in the air filling level in one or more of the air cushions through a pressure distribution and surface pressure induced air and pressure redirection between one or more air cushions - and thus across the majority of the air cushions. The air and compressed air redirection is triggered and brought about solely by the interaction of the controlled valves and the surface pressure exerted on the air cushions by a human foot when standing and / or during a gait cycle. The total air volume initially present in all of the air cushions is not changed, but merely redistributed. This means that when the system is in use, there is no further air supply from the outside or any other type of air exchange with the outside environment.

[0021] A support sole or pressure relief sole equipped with air cushions, which, when applied to the human foot, enables the measurement of plantar pressure distribution and autonomously effects and / or controls pressure redistribution between individual air cushions solely through the rolling motion of the foot resting on them—i.e., without the use of a pump, compressor, or inflation device—is not disclosed in the prior art. Using the support sole of the system according to the invention, it is possible, on the one hand, to detect a current localized pressure overload and, on the other hand, to respond immediately and appropriately to a detected overstress by means of pressure redistribution, for example, to prevent ulceration.The implemented sensors, particularly the barometric pressure sensors, ensure continuous measurement of plantar pressure distribution during use of the insole, thus enabling the detection of overloads and pressure peaks. The insole of the system according to the invention also makes it possible to produce insoles with a standard air filling of the air cushions and to adjust the ultimately required individual air filling level for each user during a one-time fitting, allowing for rapid production for the user.

[0022] The invention thus achieves the above-mentioned object by implementing a suitable sensor system in the form of barometric pressure sensors in the insole, which ensures continuous measurement of the plantar pressure distribution during use, i.e., during one or more consecutive physiological rolling movements of a foot, and enables continuous detection of overloads and pressure peaks independent of measurements in medical supply stores. The insole of the system according to the invention is thus designed to permanently and continuously ensure automated, adaptive care for diabetic foot syndrome.The system according to the invention thus enables the detection of the point in time and the foot regions at which the current treatment no longer ensures optimal protection of the patient against DFU by means of the treatment sole and the control and evaluation electronics. The system also enables the detection of pressure redirection at the required points on the sole of the foot, providing the necessary support or soft positioning. Continuous measurement is advantageous because pressure overloads are detected as soon as they occur and not only at the next check-up appointment. In the current treatment situation, once pressure overloads are identified, a new DAF is created for the patient, which can take days or weeks.The system according to the invention, with the inventive orthosis and the associated control and evaluation electronics, goes beyond the mere measurement of plantar pressure distribution and enables a permanent, timely, self-sufficient, and autonomous adjustment of the pressure distribution and air filling levels in the individual air cushions based on the targeted air and pressure redistribution between individual, controllably selectable air cushions of the orthosis, induced and initiated by current measurement data. Using the system according to the invention, the orthosis, i.e., the air filling level of the individual air cushions, adapts independently, self-sufficiently, and autonomously to the current plantar pressure distribution while the patient is wearing the orthosis. This significantly minimizes the risk of a DFU.A further advantage achieved with the system according to the invention is that the adjustment of the insole is achieved within seconds to minutes, rather than days or weeks as was previously the case. Overall, the time between the point at which the insole no longer functions and its restoration is reduced from months in the worst case (since DFS patients themselves are not aware of pressure overload) to seconds to minutes. The patient does not need to intervene. The system automatically restores or prepares the fully functional insole.

[0023] This is achieved via the individual air cushions. The advantage of using air as a medium is that, according to Boyle's law, there is a direct relationship between the barometric pressure within an air cushion and the plantar pressure (surface pressure) exerted on it by a foot. Using this relationship, the system according to the invention uses the barometric pressure in each air cushion to determine a plantar pressure distribution across all air cushions in the area equipped with air cushions, thus detecting localized pressure overloads. For this purpose, a barometric pressure sensor is arranged within each air cushion and is operatively connected to the real-time capable control and evaluation electronics via a signal-conducting active connection.

[0024] A further advantage of the system according to the invention is that pressure redistribution occurs by changing the filling level of the individual air cushions, so that an autonomous reaction of the supply sole to detected excessive load peaks can occur in the form of targeted pressure redistribution. This pressure redistribution, caused by a change in the filling level, is achieved by means of the valves, to which the air cushions are connected via an air-conducting line. The valves allow each air cushion to have a different internal pressure and air filling level, thus allowing the air cushions to be variable in height and, in particular, inflated to a variable height.

[0025] Valves represent passive elements within a pneumatic system, allowing the dynamics of the physiological rolling motion of a foot during the gait cycle to be exploited as an active element. Since the individual foot regions are not loaded simultaneously during walking, pressure redistribution, i.e. a change in the air fill level, can be achieved from over-stressed areas to any area of ​​the air cushion arrangement by opening or closing individual electrically switchable valves at specific times. This can be used both by controlling the valves for defined pressure relief of defined foot regions and by using an algorithm in the state space for automated pressure relief in any foot region. For this purpose, the electrically switchable valves are in a signal-conducting connection with the real-time capable control and evaluation electronics.Overall, the system according to the invention enables continuous detection of the plantar pressure distribution across the foot contact surface of the insole and immediate reaction to a detected inadmissible pressure peak through targeted pressure redistribution from the foot regions with pressure overload.

[0026] Although the invention is explained above specifically in connection with diabetic foot syndrome, its application is not limited to this. It can be used for all medical conditions or foot care cases in which pressure redistribution in the sole is necessary, as is the case, for example, with a heel spur or flat foot. The system according to the invention can be used for ulcer prevention, for the treatment of ulcers, or to prevent re-ulceration in patients with sensory and / or motor neuropathy of the feet, as well as in patients with foot deformities.

[0027] For a rapid redistribution of pressure and air in the supply sole, it is advantageous if the plurality of air cushions as a whole form a closed air cushion system, which is what the invention provides in its embodiment.

[0028] The air cushions are expediently of small design and preferably have a maximum height between 2 mm and 25 mm, in particular between 5 mm and 20 mm, particularly preferably between 8 mm and 16 mm.

[0029] Likewise, in a further embodiment of the invention, the valves are of small design.

[0030] In an embodiment of the system according to the invention, it is further provided that the degree of air filling of the individual air cushions is adjusted in such a way that an increase in the barometric air pressure within an air cushion caused by an externally acting force upon opening of at least one valve assigned to the respective air cushion causes an air flow out of the respective air cushion.

[0031] It is also advantageous if each valve can be electrically controlled by the control and evaluation electronics separately or in groups, particularly in a matrix-like configuration, which is what the invention provides for in a further development. In particular, when valves are connected to form a matrix, each of these air cushions can have connections to the directly adjacent cushions.

[0032] In order to achieve a targeted pressure and air redistribution, the invention is advantageously further characterized in that the control and evaluation electronics specifically activates valves to initiate an opening or closing process or specifically leaves them unactuated.

[0033] A particularly advantageous realization of a supply sole can be achieved according to the invention in that the supply sole is designed as a shoe insole and the plurality of air cushions and associated valves are arranged between an upper cover layer and a lower cover layer.

[0034] However, it is also possible for the supply sole to be a component, in particular of the sole, of a shoe, which the invention also advantageously provides.

[0035] For the realization of the desired mechanism of action of the system according to the invention, it is particularly expedient and advantageous that the control and evaluation electronics comprise a microcontroller which converts the measurement signals of the barometric pressure sensors, which are processed by a measurement electronics, into control signals for the valves, whereby the invention is also characterized in its embodiment

[0036] A particularly preferred embodiment of the invention provides that the microcontroller comprises a conversion unit, a state space control and a pressure redistribution unit.

[0037] In this case, it may be advantageous for the microcontroller's conversion unit to convert the measurement signals from the barometric pressure sensors supplied by the measurement electronics into pressure data representing the surface pressure values ​​of the respective air cushions, based on a mathematical model stored therein, which further enhances the invention. The mathematical model responsible for calculating the plantar pressure applied from the barometric measurement data is advantageously part of the software stored on the microcontroller for measuring and controlling the insole.

[0038] Furthermore, according to a further embodiment of the invention, it may be expedient if the state space control of the microcontroller converts the surface pressure values ​​of the pressure data representing the respective air cushions into a pressure distribution, preferably a plantar pressure distribution, of the values ​​representing the supply sole surface subjected to a foot pressure.

[0039] The state space can be used advantageously because it makes it possible to model a system with multiple inputs and outputs and to observe the internal states. The multiple inputs to the system could then be, for example, the pressure data from each individual air cushion, and the outputs the discrete-time control of the valves. Mathematically speaking, the state space is a set of differential equations, with the coefficients for the system summarized in matrices and vectors. The advantage lies primarily in the overall mathematical description of the system, since the pressure change of one air cushion also affects at least the neighboring air cushions, and this behavior can be described and predicted.This makes it possible to detect and counteract any pressure overload that the patient is unable to perceive or compensate for due to existing neuropathy while wearing the device, in order to minimize the risk of ulceration.

[0040] More expediently and advantageously, software is stored on the microcontroller. This software creates a closed-loop control of the supply sole or its components based on the internal pressure measurement of the air cushions, the valve position, and the mathematical model. For this purpose, the control takes place in the state space, which is responsible for pressure redistribution based on the current measurement data. The state space is necessary to describe the entirety of all individual air cushions, since changes in the internal pressure of an air cushion inevitably influence the pressure exerted by the foot on the surrounding air cushions. With the state space, with its unlimited number of inputs and outputs, a closed-loop control system can be created that determines these influences and regulates them accordingly.Finally, according to a further embodiment of the invention, it may be expedient if the pressure redistribution unit of the microcontroller analyses the values ​​representing a pressure distribution, preferably a plantar pressure distribution, and activates valve control electronics on the basis of a pressure redistribution model, which promptly controls selected valves to initiate an opening process or a closing process.

[0041] In order to realize signal-conducting or electrically conductive active connections, the invention finally provides in an embodiment that the respective signal-conducting active connection between the real-time capable control and evaluation electronics and the valves as well as the barometric pressure sensors is designed as a connecting line conducting an electrical or optical signal.

[0042] The invention is explained in more detail below with reference to a drawing. This shows

[0043] Fig. 1a is a schematic exploded side view of a first embodiment of a supply sole,

[0044] Fig. 1b is a schematic plan view of the supply sole according to Figure 1a,

[0045] Fig. 2a is a schematic exploded side view of a second embodiment of a supply sole,

[0046] Fig. 2b is a schematic plan view of the supply sole according to Figure 2a,

[0047] Fig. 3 shows a schematic plan view of an embodiment of a matrix-shaped

[0048] Connection of four air cushions using four valves,

[0049] Fig. 4 shows a schematic plan view of an embodiment of an interconnection of eight air cushions, each with an associated valve, by means of air-conducting connecting lines,

[0050] Fig. 5a shows a schematic side view of a first embodiment of an air-conducting line connection between several air cushions with at least one associated electrically switchable valve,

[0051] Fig. 5b shows a schematic side view of a second embodiment of an air-conducting line connection between several air cushions with at least one associated electrically switchable valve, Fig. 5c shows a schematic side view of a third embodiment of an air-conducting line connection between several air cushions with at least one associated electrically switchable valve,

[0052] Fig. 5d is a schematic plan view of a supply sole with a fourth embodiment of an air-conducting line connection between several air cushions with at least one associated electrically switchable valve,

[0053] Fig. 6a shows a schematic side view of a first embodiment of an air cushion with a pressure sensor arranged therein,

[0054] Fig. 6b in schematic side view a second embodiment of a

[0055] Air cushion with pressure sensor arranged inside,

[0056] Fig. 6c in schematic side view a third embodiment of a

[0057] Air cushion with pressure sensor arranged inside,

[0058] Fig. 7 shows a schematic representation of an embodiment of the topology of the system according to the invention and in

[0059] Fig. 8 shows an example of a plantar pressure distribution during a step in different phases of the gait cycle.

[0060] Figures 1a and 1b show a first exemplary embodiment of a supply sole, designated overall by 1, for the automated, adaptive treatment of, in particular, a diabetic foot syndrome by means of an associated control and evaluation electronics system, designated overall by 2 (see Figure 7). A plurality of small-sized air cushions 5, 5a and a plurality of small-sized, electrically controllable and switchable valves 6 are arranged between an upper cover layer 3 and a lower cover layer 4, each of which has a surface shape adapted to a human foot. In the exemplary embodiment, all air cushions 5, 5a have the same height, although the air cushions 5a are larger than the air cushions 5 in terms of their longitudinal and cross-sectional area. The air cushions 5, 5a have a perspective side view, as shown in Figure 6b.Adjacent air cushions 5, 5a are connected to one another by means of at least one associated valve 6 and an air-conducting connecting line 7, as is shown by way of example in a schematic side view in Figure 5a. In this case, the respective air-conducting connecting line 7 can also be at least partially a component of a valve 6. The valves 6 can seal the respectively connected air-conducting connecting line 7 in an airtight manner, so that each individual air cushion 5, 5a can be sealed airtight. Overall, all air cushions 5, 5a are connected to one another via one or more air-conducting connecting lines 7, so that an exchange of air from each air cushion 5, 5a to each other, if necessary with the interposition of one or more intermediate air cushions 5, 5a.The plurality of air cushions 5, 5a together form a preferably closed air cushion system, in which the entire plurality of air cushions 5, 5a is filled with air at variable heights. The degree of air filling is such that the insole 1 forms a soft footbed.

[0061] In the assembled state, the upper cover layer 3 preferably rests on the upper side of the air cushions 5, 5a, and the lower cover layer 4 preferably rests on the underside of the air cushions 5, 5a. The air cushions 5, 5a are then arranged between the upper and lower cover layers 3, 4 such that a foot resting on the upper cover layer 3 is well supported by the air cushions 5, 5a. The insole 1 then forms a soft footbed, particularly one adapted for diabetes. It also represents a shoe insole. However, it can also be a component of a shoe, particularly a shoe sole.

[0062] Within each air cushion 5, 5a, a barometric pressure sensor 8 is arranged, as can be seen schematically in Figure 6b.

[0063] The air cushions 5, 5a are particularly compact in that they have a maximum height of between 2 mm and 25 mm, preferably between 5 mm and 20 mm, in particular between 8 mm and 16 mm. These height specifications also apply analogously to the height of the valves 6.

[0064] The degree of air filling of the individual air cushions 5 is set such that an increase in the barometric air pressure within an air cushion 5, 5a caused by an externally acting force upon opening of at least one valve 6 assigned to the respective air cushion 5, 5a causes an air flow out of the respective air cushion 5, 5a.

[0065] In addition, each valve 6 can be electrically controlled by the control and evaluation electronics 2 either separately or in groups, particularly in a matrix-like manner. In the exemplary embodiment according to Figures 1a and 1b, the air cushions 5, 5a are partially interconnected with each adjacent air cushion 5, 5a to form a matrix 9 (see Figure 3), allowing air exchange between adjacent air cushions 5, 5a.

[0066] The embodiment according to Figures 2a and 2b differs from the embodiment according to Figures 1a and 1b only in that air cushions 5b, 5c of a different size—but still in the same height range—are formed and arranged there. Due to the different sizes, the supply base 1 in this embodiment comprises fewer air cushions 5b, 5c and thus a correspondingly smaller number of valves 6.

[0067] In principle, the design, size, and number of air cushions 5, 5a, 5b, and 5c are variable, as illustrated by the exemplary embodiments shown in Figures 1a - 2b. The geometry and number of air cushions 5, 5a, 5b, 5c, as well as 5' and 5" (see Figures 6a and 6b) can be freely selected and arranged as desired.

[0068] Possible geometries of the air cushions 5, 5', 5" are shown in Figures 6a - 6c. All of the air cushions 5, 5' and 5" shown have a flat, circular lower support surface and differ essentially in their respective upper support surface. This is flat in the case of the air cushion 5' shown in Figure 6a, whereby the air cushion 5' is cylindrical overall. The upper support surface of the air cushion 5" shown in Figure 6c is part of a hemispherical design of the air cushion 5". In the case of the air cushion 5 shown in Figure 6b, the upper support surface is flat with adjacent rounded surface areas that transition into a cylindrical shape towards the lower support surface of the air cushion 5. Further shapes can be seen in Figures 1a - 2b, where air cushions 5 and 5c are shown with a circular base surface and air cushions 5a and 5b with elliptical base surfaces.However, cuboid, cube-shaped or pyramid-shaped air cushion bodies are also possible.

[0069] Likewise, the interconnection of the valves 6 and thus the interconnection of the air-conducting connecting lines 7 can be designed variably. A schematic representation of the structure with only four air cushions 5 is shown schematically in Figure 3, showing the barometric pressure sensors 8 within the air cushions 5 as well as the air-conducting connecting lines 7 and the electrically controllable and switchable valves 6 arranged therein.

[0070] In addition to the interconnection of the air cushions 5 as a matrix 9 shown in Figure 3, a central connection of the air cushions 5 by means of a preferably additional central air-conducting connecting line 7a, 7b is also possible, as shown in Figure 4. Each air cushion 5 is in turn assigned a valve 6, which enables the inflow and outflow of air to and from the respective air cushion 5. For this purpose, such a valve 6 is connected on the one hand to an air cushion 5 and on the other hand, at a second outlet and inlet, to the central air-conducting connecting line 7a, 7b. Thus, each valve 6 is interconnected with all other valves 6, so that air exchange is not limited to immediately adjacent air cushions 5. Consequently, all air cushions 5 of a supply base 1 are in air-conducting connection with one another, and not just immediately adjacent air cushions 5.

[0071] As with the air cushions 5, 5a, 5b, and 5c, the design and shape of the valves 6 are also variable. The valves 6 are shut-off valves that can be used in any configuration, particularly in the form of solenoid valves or pinch valves. The only requirements for the valves 6 are a small design and that they must be electrically controllable, i.e., electrical control must be possible.

[0072] Figures 5a - 5c show various embodiments of the arrangement of the valves 6 in relation to the respectively assigned air cushions 5. A comparison of Figure 5a with Figures 5b and 5c shows that with valves 6 arranged between the air cushions 5, the overall height is lower than in the embodiments according to Figures 5b and 5c, in which an air-conducting connecting line 7 or 7a, 7b is arranged below the air cushions 5 and the valves 6 are arranged in this. In the embodiments according to Figures 5b and 5c, the lower cover layer 4 of the supply sole 1 would then not rest on the underside of the air cushions 5. The difference between the embodiments according to Figures 5b and 5c is that according to Fig. 5b, the air cushions are each connected from air cushion 5 to air cushion 5 with a separate air-conducting connecting line 7, whereas in the embodiment according to Fig.In FIG. 5c, all air cushions 5 are connected to one another via a central air-conducting connecting line 7a, 7b. Such an embodiment is also shown in FIG. 5d, where all air cushions 5b and 5c are also connected to one another via a central air-conducting connecting line 7c, with the possibility of forming an air-conducting connection. However, here the central air-conducting connecting line 7c is arranged between the air cushions 5b, 5c, resulting in an overall height analogous to the embodiment according to FIG. 5a.

[0073] A covering material can be arranged on the upper and lower cover layers 3, 4 to protect the air cushions 5 and the valves 6.

[0074] The maximum height of the supply sole 1 should preferably not exceed the maximum height specified in Germany according to the information from the list of medical aids on the height of the current DAF supply, whereby the possible height can currently be between 8 mm and 16 mm.

[0075] A barometric pressure sensor 8 is arranged in each air cushion 5, 5a, 5b, 5c, 5', 5". As shown schematically in Figures 6a - 6c for the air cushions 5, 5', and 5", the pressure sensor 8 is located at the bottom of the respective air cushion 5, 5', 5". However, it is also possible to arrange the barometric pressure sensor 8 freely within the respective air cushion 5, 5', 5". The respective barometric pressure sensor 8 can be freely selected in terms of design and embodiment. It only needs to be dimensioned such that it fits into the air cushion interior of the respective air cushion 5, 5', 5". In addition, the respective barometric pressure sensor 8 is in a signal-conducting operative connection with the real-time capable control and evaluation electronics 2, wherein the signal-conducting operative connection is designed in the form of a connecting line 11a conducting an electrical or optical signal.The connecting line 11a carrying an electrical or optical signal can be made of enamelled wires, particularly in the interior of a respective air cushion 5, 5', 5".

[0076] The air cushions 5, 5a, 5b, 5c, 5', and 5" are hollow inside and filled with air. To enable initial filling, refilling, or readjustment of the air cushion arrangement, which otherwise operates as a closed system and is formed from the respective combination of air cushions 5, 5a, 5b, 5c, 5', or 5", with a desired initial or starting air filling level, this respective combination of air cushions 5, 5a, 5b, 5c, 5', or 5" or the respective combination of connecting lines 7, 7a, 7b, or 7c has at least one closable inlet or outlet 19 through which air can be supplied to the respective air cushion arrangement from the outside or air can be discharged to the outside. This inlet or outlet can preferably be opened and closed by means of a valve, in particular an electrically actuated valve. However, during use and application of the supply sole, this valve is continuously closed.

[0077] Figure 7 shows a schematic representation of the control and evaluation electronics, designated overall by 2, as well as the supply sole 1.

[0078] The control and evaluation electronics 2 comprises a microcontroller 12, which converts the measurement signals of the barometric pressure sensors 8, which are processed by a measuring electronics 13, into control signals for the valves 6. For this purpose, the microcontroller 12 comprises a conversion unit 14, a state space controller 15, and a pressure redistribution unit 16. The conversion unit 14 of the microcontroller 12 converts the measurement signals of the barometric pressure sensors 8 supplied by the measuring electronics 13 into pressure data representing surface pressure values ​​of the respective air cushions 5, 5a, 5b, 5c, 5', 5", on the basis of a mathematical model stored there. The state space controller 15 of the microcontroller 12 converts the pressure data representing the surface pressure values ​​of the respective air cushions 5, 5a, 5b, 5c, 5', 5", into values ​​representing a pressure distribution, preferably a plantar pressure distribution, of the supply sole surface subjected to foot pressure.The pressure redistribution unit 16 of the microcontroller 12 analyzes the values ​​representing a pressure distribution, preferably a plantar pressure distribution, and activates a valve control electronics based on a pressure redistribution model, which promptly controls desired valves 6 to initiate an opening process or a closing process.

[0079] The system topology shown in Figure 7 comprises the microcontroller 12 as its central element, which is externally connected to the measuring electronics 13 via a connecting line 11a carrying an electrical or optical signal for measuring the barometric pressure sensors 8 and via a connecting line 11b carrying an electrical or optical signal to the control electronics 17 for controlling the valves 6. This is shown as a block diagram in the graphic in Figure 7.

[0080] The source required for the energy supply is an accumulator 18 or a battery. Both the entire electronics and parts thereof, as well as the accumulator 18 or the battery, can be components of the supply sole 1 or can be arranged outside of it.

[0081] The measured values ​​of the pressure sensors 8, preprocessed by the electronics, are recorded by the microcontroller 12 and converted into pressure data (surface pressure) using the mathematical model. The pressure data of the individual air cushions 5, 5a, 5b, 5c, 5', 5" are then passed on to the state-space control 15, where they are essentially combined to form a plantar pressure distribution. The underlying model then independently decides whether pressure redistribution is necessary. Should pressure redistribution be necessary, another software module of the microcontroller 12 controls the electronics of the valves 6 to open the valves 6 at precisely the right time. For this redistribution, the system must be capable of real-time operation, as the gait cycle is utilized.The gait cycle is depicted in the prior art illustration shown in Figure 8 using a plantar pressure distribution that occurs in different phases during a gait cycle or step. The gait cycle is depicted here over a period of 20 ms - 750 ms in a sequence of 20 chronologically consecutive partial images beginning in the top left of Figure 8, each of which represents a point in time of the gait cycle following the first partial image in a consecutive sequence, in the form of detected pressure loads or pressure measurements in the respectively displayed foot regions.

[0082] Figure 8 shows that during a step, the different regions of the foot are subjected to different loads over time. This fact is exploited for pressure redistribution. If, for example, excessive pressure is detected in the heel, there are several points in time at which this pressure can be redistributed, i.e., the corresponding valves 6 can be opened. The first ten partial images of Figure 8 show that pressure redistribution from the heel to surrounding areas would be possible, since heel pressure is highest during this time period.

[0083] Overall, it can therefore be stated that both the controllable and switchable valves 6 and the barometric pressure sensors 8 are each in signal-conducting connection with the real-time capable control and evaluation electronics 2, which is equipped and configured to continuously record the plantar pressure distribution occurring under the foot surface during standing and a physiological rolling process of a foot in the gait cycle and to promptly control a pressure distribution and surface pressure-induced air and pressure redistribution by changing the air filling level of one or more of the plurality of air cushions 6 via a targeted temporal opening of individual valves 6.

[0084] To initiate an opening or closing process, the control and evaluation electronics 2 specifically activates valves 6 or leaves them specifically unactuated.

[0085] Since the individual foot regions are not loaded simultaneously during a gait cycle, pressure can be redistributed from overstressed areas / air cushions to other, non-overstressed areas / air cushions by selectively opening individual valves 6. This can be used both by controlling the valves 6 for the defined pressure relief of specific foot regions and by using an algorithm in the state space for the automated pressure relief of all foot regions.

Claims

Patent claims 1. System comprising a supply sole (1) adapted to the human foot, in particular for treating a diabetic foot syndrome, and real-time capable control and evaluation electronics (2), wherein the supply sole (1) comprises a soft footbed, in particular one adapted to diabetes, which has a plurality of air cushions (5, 5a, 5b, 5c, 5', 5"), which are filled with air at variable heights, and a plurality of electrically controllable and switchable valves (6), wherein each air cushion (5, 5a, 5b, 5c, 5', 5") is in air-conducting line connection with at least one associated electrically controllable and switchable valve (6) and at least one barometric pressure sensor (8) is arranged within each air cushion (5, 5a, 5b, 5c, 5', 5"), and wherein all air cushions (5, 5a, 5b, 5c, 5', 5") to each other via the electrically controllable and switchable valves (6) and / or one or more air-conducting connecting lines (7, 7a, 7b,7c) are in air-conducting connection with one another, and wherein both the controllable and switchable valves (6) and the barometric pressure sensors (8) are each in signal-conducting connection with the real-time capable control and evaluation electronics (2), which is equipped and configured to continuously record the plantar pressure distribution arising under the foot surface during standing and a physiological rolling process of a foot in the gait cycle, and to generate and control, via a targeted temporal opening of individual valves (6), a pressure distribution and surface pressure-induced air and pressure redistribution between individual or multiple air cushions (5, 5a, 5b, 5c, 5', 5") by means of a targeted change in the air filling level of one or more of the plurality of air cushions (5, 5a, 5b, 5c, 5', 5").

2. System according to claim 1, characterized in that the plurality of air cushions (5, 5a, 5b, 5c, 5', 5") as a whole form a closed air cushion system.

3. System according to claim 1 or 2, characterized in that the air cushions (5, 5a, 5b, 5c, 5', 5") are of small design and preferably have a maximum height between 2 mm and 25 mm, in particular between 5 mm and 20 mm, particularly preferably between 8 mm and 16 mm.

4. System according to one or more of claims 1 - 3, characterized in that the valves (6) are of small design.

5. System according to one or more of the preceding claims, characterized in that the degree of air filling of the individual air cushions (5, 5a, 5b, 5c, 5', 5") is set such that an increase in the barometric air pressure within an air cushion (5, 5a, 5b, 5c, 5', 5") caused by an externally acting force upon opening of at least one valve (6) assigned to the respective air cushion (5, 5a, 5b, 5c, 5', 5") causes an air flow out of the respective air cushion (5, 5a, 5b, 5c, 5', 5").

6. System according to one or more of the preceding claims, characterized in that each valve (6) can be electrically controlled by the control and evaluation electronics (2) separately or in groups, in particular in a matrix-like manner.

7. System according to one or more of the preceding claims, characterized in that the control and evaluation electronics (2) specifically controls valves (6) to initiate an opening or closing process or specifically leaves them unactuated.

8. System according to one or more of the preceding claims, characterized in that the supply sole (1) is designed as a shoe insole and the plurality of air cushions (5, 5a, 5b, 5c, 5', 5") and associated valves (6) are arranged between an upper cover layer (3) and a lower cover layer (4).

9. System according to one or more of claims 1 - 7, characterized in that the supply sole (1) is a component, in particular the sole, of a shoe.

10. System according to one or more of the preceding claims, characterized in that the control and evaluation electronics (2) comprise a microcontroller (12) which converts the measurement signals of the barometric pressure sensors (8) processed by a measurement electronics (13) into control signals for the valves (6).

11. System according to one or more of the preceding claims, characterized in that the microcontroller (12) comprises a conversion unit (14), a state space control unit (15) and a pressure redistribution unit (16).

12. System according to claim 11, characterized in that the conversion unit (14) of the microcontroller (12) converts the measurement signals of the barometric pressure sensors (8) supplied by the measurement electronics (13) into pressure data representing surface pressure values ​​of the respective air cushions (5, 5a, 5b, 5c, 5', 5") on the basis of a mathematical model stored therein.

13. System according to claim 11 or 12, characterized in that the state space control (15) of the microcontroller (12) converts the pressure data representing the surface pressure values ​​of the respective air cushions (5, 5a, 5b, 5c, 5', 5") into a pressure distribution, preferably a plantar pressure distribution, of the supply sole surface subjected to a foot pressure.

14. System according to one or more of claims 11 - 13, characterized in that the pressure redistribution unit (16) of the microcontroller (12) analyses the values ​​representing a pressure distribution, preferably a plantar pressure distribution, and, based on a pressure redistribution model, activates valve control electronics (17) which promptly controls selected valves (6) to initiate an opening process or a closing process.

15. System according to one or more of the preceding claims, characterized in that the signal-conducting active connection between the real-time capable control and evaluation electronics (2) and the valves (6) as well as the barometric pressure sensors (8) is designed as a connecting line (10) conducting an electrical or optical signal.

16. Method for controlling a system, in particular for controlling air and pressure diversion within air cushions (5, 5a, 5b, 5c, 5', 5") of a supply sole (1) equipped with a plurality of air cushions (5, 5a, 5b, 5c, 5', 5") by means of the system, wherein the system comprises a supply sole (1) adapted to the human foot, in particular for treating a diabetic foot syndrome, and real-time capable control and evaluation electronics (2), wherein the supply sole (1) comprises a soft bed footbed, in particular adapted to diabetes, which has a plurality of air cushions (5, 5a, 5b, 5c, 5', 5"), which are filled with air at variable heights, and a plurality of electrically controllable and switchable valves (6), wherein each air cushion (5, 5a, 5b, 5c, 5', 5") is provided with at least an associated electrically controllable and switchable valve (6) is in air-conducting line connection and within each air cushion (5, 5a, 5b, 5c, 5',5") at least one barometric pressure sensor (8) is arranged, and wherein all air cushions (5, 5a, 5b, 5c, 5', 5") are in air-conducting line connection with one another via the electrically controllable and switchable valves (6) and / or one or more air-conducting connecting lines (7, 7a, 7b, 7c), and wherein both the controllable and switchable valves (6) and the barometric pressure sensors (8) are each in signal-conducting operative connection with the real-time capable control and evaluation electronics (2), by which the plantar pressure distribution arising under the foot surface during standing and a physiological rolling process of a foot in the gait cycle is continuously recorded and which, by means of a targeted temporal opening of individual valves (6), promptly carries out a pressure distribution and surface pressure-induced air and pressure redistribution between individual or several air cushions (5, 5a, 5b,5c, 5', 5") is generated and controlled by means of a targeted change in the degree of air filling of one or more of the plurality of air cushions (5, 5a, 5b, 5c, 5', 5").

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