Device for the treatment of chronic wounds, in particular diabetic foot syndrome

Abstract

The invention relates to a device for the treatment of chronic wounds, in particular diabetic foot syndrome, in which an electronic circuit (5) is arranged in a material layer or between at least two material layers, said electronic circuit (5) being connected via a wire to ultrasonic transducers (3). The ultrasonic transducers (3) are applied to at least one matrix (2) forming the structural material, wherein the ultrasonic transducers (3) are controlled and arranged at such a distance from one another that they induce wave interference during operation.

Description

[0001] Device for the treatment of chronic wounds, especially diabetic foot syndrome

[0002] The invention relates to a device for treating chronic wounds, including diabetic foot syndrome, using ultrasound transducers. The invention serves to further support the treatment process of foot ulcers and / or chronic wounds, such as pressure ulcers. The device emits ultrasound waves with precisely selected parameters that disrupt the bacterial biofilm on the wound and penetrate the skin tissue, thereby stimulating regenerative processes at the cellular level. The device can be used by the patient at home.

[0003] Diabetic foot syndrome is a serious condition that occurs in people with diabetes. It is characterized by infection, ulceration, or destruction of the deep tissues of the foot, sometimes affecting the bones. Patients with diabetic foot syndrome also experience neurological disorders and peripheral vascular disease in the lower extremities to varying degrees.

[0004] The pathomechanism of the syndrome includes motor neuropathy, which leads to muscle atrophy in the foot, potentially resulting in foot deformities and contractures. The sensory neuropathy exposes the foot to trauma due to the lack of pain, temperature, and touch sensation, promoting ulcer formation.

[0005] Changes resulting from autonomic neuropathy can lead to arteriovenous fistulas and trophic abnormalities. Ischemia of the foot due to atherosclerosis of the lower extremity arteries is another important factor contributing to the development of local osteoporosis and other complications such as osteomyelitis and sterile necrosis.

[0006] There are three main types of diabetic foot syndrome: neuropathic, ischemic, and neuropathic / ischemic. Accurate diagnosis is crucial, as treatment varies depending on the type of syndrome.

[0007] Ultrasound treatment is applicable in the treatment of chronic wounds, particularly diabetic foot syndrome, as demonstrated by Chen H, Yu Z, Liu N, et al. The efficacy of low-frequency ultrasound as an added treatment for chronic wounds: A meta-analysis. Int Wound J. 2023;20(2):448-457. doi: 10.1111 / iwj.13893. In Zhou, Shaoxia, et al. "Molecular mechanisms of low intensity pulsed ultrasound in human skin fibroblasts". Journal of Biological Chemistry 279.52 (2004): 54463-54469, it was shown that low-intensity pulsed ultrasound (US) promotes wound healing by influencing fibroblast proliferation and activating various signaling mechanisms (Zhou et al., 2004).

[0008] The use of low-frequency ultrasound in the 20-40 kHz range as adjunctive therapy for chronic wound healing has also been investigated, and its efficacy in cleansing and supporting the healing process has been demonstrated – Voigt J, Wendelken M, Driver V, Alvarez OM. Low-frequency ultrasound (20-40 kHz) as adjunctive therapy for chronic wound healing: A systematic review of the literature and meta-analysis of eight randomized controlled trials. The International Journal of Lower Extremity Wounds. 2011; 10(4): 190-199

[0009] Ultrasound transducers are also known in the prior art, with publication W02016061410A1 showing piezoelectric ultrasound transducers with three connections.

[0010] Also known from the description of invention US2003050674A1 is a wound treatment device comprising a housing, a corona and / or ultraviolet light generating element, an ultrasonic wave generator, and / or a photoactive material. The housing has a cavity and at least one opening. The corona discharge and / or ultraviolet light generating element in the housing cavity comprises a surface corona discharge device and an associated power supply. The photoactivatable material is located in the housing cavity. The device further comprises an ultrasonic wave generator and / or an oxygen generator in the housing cavity.

[0011] Publication US2017209717A1 discloses a device for treating infections, which includes an ultrasound transducer for applying ultrasound to a patient treatment site. This device comprises a handheld applicator configured to interact acoustically with the patient's treatment site. The ultrasound transducer itself is housed within the applicator and coupled to it to deliver the generated ultrasound energy to the treatment site. Additionally, the applicator includes a vibrator configured to generate vibration energy, coupled to the applicator to deliver this energy to the user's hand, providing haptic feedback.The ultrasound transducer and the vibrator are electrically coupled to a control circuit that is configured to selectively supply electrical energy to the ultrasound transducer to generate ultrasound energy, and selectively supply electrical energy to the vibrator to give haptic feedback to the user.

[0012] From the description of invention WO2014210065 Al, a portable ultrasound device – of the "wearable" type – is also known, comprising a power control unit with a power source and at least one integrated circuit that supplies the applicator with electrical energy. The applicator is electrically connected to the power control unit, and the surface of the applicator transmits ultrasound to the user for a predetermined period of time.The applicator comprises high-frequency (HF) driver electronics, an ultrasonic transducer coupled to the driver electronics, a monitoring device comprising a thermal shutdown coupled to the driver electronics, wherein the monitoring device monitors the temperature of the applicator surface and the thermal shutdown shuts off the applicator when the temperature exceeds a predefined threshold, and a coupling bandage coupled to the applicator, wherein the bandage positions the applicator surface near the user at a point on the user's body.

[0013] Another similar portable solution is presented in the description of invention EP3542740A1. In this case, the portable ultrasound device comprises a power controller with a power source and at least one integrated circuit that supplies the applicator with electrical energy. The applicator is electrically connected to the power controller, and the surface of the applicator transmits ultrasound to the user for a predetermined period of time.The applicator comprises high-frequency (HF) driver electronics, an ultrasonic transducer coupled to the driver electronics, a monitoring device comprising a thermal shutdown coupled to the driver electronics, wherein the monitoring device monitors the temperature of the applicator surface and the thermal shutdown shuts off the applicator when the temperature exceeds a predefined threshold, and a coupling bandage coupled to the applicator, wherein the bandage positions the applicator surface near the user at a point on the user's body.

[0014] Integration of electronic systems into shoe insoles is also known in the prior art. Such insoles are described, for example, in publications CN214209183U or CN216293191U, which show insoles heated by ultra-low-frequency infrared pulses.

[0015] Similar to the invention is the solution presented in publication W02023012830A1. This solution presents a shoe insole for the treatment of diabetic foot ulcers. In this case, the shoe insole for the treatment of diabetic foot ulcers consists of a first layer of polydimethylsiloxane, a second layer of bamboo, and a third layer of coconut fibers. The first layer contains selectively laser-treated areas that come into contact with the ulcer and form a channel for oxygen supply. The aforementioned second layer serves to increase the oxygen supply to the ulcer area through the channel, and the third layer serves to provide the insole with structural support, stability, and strength. The insole's design is sustainable and a self-generating device that does not require an external power supply, such as a battery.

[0016] Another solution for monitoring physiological parameters of the diabetic foot is presented in publication CNII3967006A. The system described in this solution consists of a clog-shaped shoe body, a toe guide, a fastening strap, a pressure sensor module, a near-infrared module, a power supply module, an analog-to-digital converter module, a microcontroller, a signal processing and data analysis module, a speech recognition module, and a wireless communication module. The toe guide separates the toes and guides the sole so that it is oriented with the monitoring system from front to back, preventing the sensor from deviating from the detection point during the measurement process.The pressure measurement module, in turn, serves to detect the pressure in the ulcer-prone area of ​​the foot; the near-infrared module is placed in the vascularized area of ​​the foot and serves to detect the foot's temperature and blood flow velocity; and the microcontroller is the main control unit of the monitoring system and controls the signal processing and data analysis module to assess whether the toe alignment is functioning normally and whether the standing posture is correct. According to the invention, the accuracy of the monitoring is improved, and several parameters such as foot pressure, temperature, and blood flow velocity can be monitored simultaneously.

[0017] The invention relates to a device for treating chronic wounds, in particular diabetic foot syndrome, in which an electronic circuit, connected via a wire to ultrasound transducers, is embedded in a material layer or between at least two material layers. Crucially, the ultrasound transducers are embedded in at least one matrix that forms the structural material for the embedded transducers, and furthermore, the ultrasound transducers are arranged at such a distance from one another and controlled in such a way that they induce wave interference during operation.

[0018] With only two ultrasound transducers, the distance between the centers of the transducers arranged on the die can be twice their diameter. In the case of three or more ultrasound transducers, they are arranged according to the shape of an equilateral geometric figure and at the vertices of such a figure, with the side of the figure forming the outline of the arrangement of the ultrasound transducers corresponding to twice the diameter of the ultrasound transducers.

[0019] Advantageously, the matrix has the shape of an equilateral geometric figure, where the number of vertices is equal to the number of ultrasound transducers.

[0020] With two ultrasound transducers, the matrix can have a rectangular shape with two transducers, wherein the longer side of the matrix has a length of at least three ultrasound transducer diameters and the shorter side has a width of at least one ultrasound transducer diameter.

[0021] The device according to the invention consists of four layers permanently bonded together by means of an adhesive: a base layer made of a hard / semi-hard polymer, a cushioning layer made of a shape-memory material, a layer to facilitate the transmission of ultrasound waves, advantageously medical-grade silicone, and a skin contact layer covering it. An electronic circuit is located on the base layer and beneath the cushioning layer, and is connected via cables to the ultrasound transducers arranged on at least one matrix.

[0022] Advantageously, the skin contact layer can have an opening / cavity for a dressing, preferably a hydrocolloid dressing or an antiseptic gel to ensure the facilitation of the ultrasound wave, i.e., an antiseptic gel that is permeable to ultrasound.

[0023] The electronic circuit can include a wireless communication module, a microcontroller, an actuator module, as well as a Uade and a wired control module.

[0024] Advantageously, the device according to the invention can have four layers with a shape resembling the foot, forming the shoe insole, with the electronic circuitry located in the heel part of the insole and the matrix with ultrasound transducers in the midfoot and toe parts. It is obvious to those skilled in the art that, due to the possibility of different wound locations on the foot, the transducers can also be arranged in a different area.

[0025] The invention stimulates blood circulation, which promotes the healing process. Thanks to the therapeutic emission of ultrasound waves into the patient's wound, the bacterial biofilm that has formed due to bacterial growth is broken down. This consequently contributes to increased drug penetration into the wound and stimulates regeneration at the cellular level. Furthermore, the aforementioned ultrasound emission increases blood flow to the wound area. Both of these factors combined accelerate wound bed closure and thus the healing process of the ulceration (wound).

[0026] How the device works:

[0027] • Solution utilizes wave beam generation with a matrix of ultrasound transducer to treat chronic wounds, infected or difficult-to-heal areas;

[0028] • The solution features software that controls the intensity, frequency, and phase of the ultrasound wave. The software adapts the effect of the ultrasound transducers to the wound site (specific modules are programmed to change the wave's concentration points).

[0029] By positioning the transmitters and modifying the emitted wave through interference, the concentration point of the emitted wave can be altered. The software makes it possible to precisely direct the ultrasound waves to a specific part of the wound, thus ensuring effective treatment without damaging healthy tissue.

[0030] This solution can take the form of a shoe / shoe insert / weight-bearing orthosis for patients with diabetic foot syndrome, or an active dressing for patients with chronic, slow-healing pressure ulcers on parts of the body other than the foot. In patients with diabetic foot syndrome, both solutions can also be used interchangeably if the ulceration is located outside the most affected area (most wounds in diabetic foot syndrome develop under the metatarsal heads, but the wounds can also spread to other areas; in this case, an "active dressing" can be helpful because the electrical system is external and the lack of padding and base layers gives the dressing more flexibility).

[0031] A shoe insert / device for the treatment of diabetic ulcerations, which contains inventive ultrasound transducers, is shown in the figures in exemplary embodiments:

[0032] Fig. 1 shows an insole for a shoe / ankle / weight-bearing orthosis - top view:

[0033] Fig. 2 shows a schematic representation of the cross-section of the shoe insole / shoe cap / relief orthosis - cross-section:

[0034] Fig. 3 shows a matrix made of a flat structural material of rectangular shape, in which two ultrasound transducers are arranged;

[0035] Fig. 4 shows a matrix made of a flat, circular material with three ultrasonic transducers arranged in the form of an equilateral triangle;

[0036] Fig. 5 shows a cross-section of a matrix made of a flat structural material:

[0037] Fig. 6 shows a schematic representation of the working unit of the device in the form of an active bandage - top view;

[0038] Fig. 7 shows a schematic representation of the working unit of the device in the form of an active assembly - cross-section;

[0039] Fig. 8: Schematic representation of the principle of the device for the treatment of chronic wounds, in particular diabetic foot syndrome; and Fig. 9 shows a schematic representation of the insert, divided into areas for the assembly arrangement.

[0040] Insole for shoes. In this case, the device according to the invention consists of three layers: a base layer 8 made of a semi-rigid or rigid material, preferably a polymer; a cushioning layer 7 made of a shape-memory material; and a layer to facilitate the transmission of the ultrasound wave 1, preferably medical-grade silicone, which in this case also forms a skin contact layer 9. The layers are bonded together with an adhesive and shaped to represent the foot and together form an insole for footwear / an orthosis.

[0041] On the base layer 8 – in the heel area of ​​the insole A (Fig. 9) – and beneath the cushioning layer 7, there is an electronic circuit 5, which is connected via a wire to ultrasonic transducers 3 with a resonant frequency of 20 kHz to 1 MHz, distributed across at least one matrix 2. The matrix 2 is a flat construction material and can have various shapes – for example, in Figs. 4 and 6, matrices 2 are shown in a circular shape, at the apex of which three ultrasonic transducers 3 are arranged in the form of an equilateral triangle, and Fig. 3 shows a rectangular matrix 2 with two ultrasonic transducers 3. In each case, the ultrasonic transducers 3 are arranged at such a distance from each other that they induce wave interference during operation.

[0042] If only two ultrasound transducers 3 are present, the distance between the centers of the ultrasound transducers 3 can be twice their diameter (as in Fig. 3) - for example, if ultrasound transducers 3 with a diameter of 20 mm are used, the distance between the ultrasound transducers 3 is 40 mm.

[0043] Due to the specific nature of ulcers 10 on the diabetic foot (most wounds are located under the heads of the metatarsal bones), it is assumed that the most common distribution of the ultrasound transducer arrangement in the insole for patients with diabetic foot syndrome is the midfoot and toe area labeled "A" in Fig. 9. However, due to the possibility of a different distribution of wounds on the foot, it is permissible to arrange the matrix 2 of the ultrasound transducers 3 in a different area as well.

[0044] The sales area B houses the electronics 5 with the wireless communication module, the microcontroller, the execution module and the charging and wired control module 6.

[0045] Power module - embedded in an electronic circuit as a printed circuit board or part of a printed circuit board, in a charging and cable control module.

[0046] Wireless communication module - can be integrated into the microcontroller or be a separate module.

[0047] The microcontroller receives physical signals and forwards them to the microcontroller program. The microcontroller program then passes data to the knowledge module (which can be a subroutine or a separate program) in the form of a structured data frame. Data transmission can occur via dedicated memory, shared memory, external memory, or serial or parallel communication interfaces such as UART, SPI, I2C, or Ethernet.

[0048] The microcontroller can have a knowledge module (program – knowledge base) that is placed as a subroutine on the microcontroller. The knowledge module can also run on a separate coprocessor, microprocessor, or microcontroller. The microcontroller's program passes data to the knowledge module (which is either a subroutine or a separate program) in the form of a framework of structured data.

[0049] Executive module - The executive module is embedded in an electronic circuit (PCB or a collection of PCBs).

[0050] Charging and wired control module 6.

[0051] Optionally, the skin contact layer is provided to have an opening / indentation for a dressing 11, which could be a hydrocolloid dressing or an antiseptic gel to ensure the facilitation of the ultrasound wave.

[0052] Active training

[0053] Figures 6 and 7 show an example of a device in the form of an active dressing. In this case, the device according to the invention consists of a layer for facilitating the ultrasound wave 1, advantageously made of medical-grade silicone, which in this case also constitutes a skin contact layer 1. A matrix 2 for the ultrasound transducers 3, a flat structural material, is concealed in the center of the layer for facilitating the ultrasound wave 1. The distribution of the matrix on the body depends on the wound location, with the distribution and size principle being the same as for an insole.

[0054] The electronic circuit 5 exposed here has a wireless communication module, a microcontroller, an execution module and a charging and wired control module 6.

[0055] The circuit diagram for electronic circuit 5 is analogous to that of the cartridge.

[0056] Power module - embedded in an electronic circuit as a printed circuit board or part of a printed circuit board, in a charging and cable control module.

[0057] Wireless communication module - can be integrated into the microcontroller or be a separate module.

[0058] The microcontroller receives physical signals and forwards them to the microcontroller program. The microcontroller program then passes data to the knowledge module (which can be a subroutine or a separate program) in the form of a structured data frame. Data transmission can occur via dedicated memory, shared memory, external memory, or serial or parallel communication interfaces such as UART, SPI, I2C, or Ethernet.

[0059] The microcontroller can have a knowledge module (program – knowledge base) that is placed as a subroutine on the microcontroller. The knowledge module can also run on a separate device coprocessor, microprocessor, or microcontroller. The microcontroller's program passes data to the knowledge module (which is either a subroutine or a separate program) in the form of a framework of structured data.

[0060] Executive module - The executive module is embedded in an electronic circuit (PCB or a collection of PCBs).

[0061] Charging and wired control module 6.

[0062] Optionally, the skin contact layer 1 is provided to have an opening / cavity for a dressing 11, advantageously a hydrocolloid or an antiseptic gel, to ensure the facilitation of the ultrasound wave.

[0063] The device according to the invention enables the application of the following method:

[0064] Data collection is an option:

[0065] • by taking an image of the wound and using the computer vision algorithm,

[0066] • by scanning the wound and creating a 3D file,

[0067] • by marking the areas where the wound is located with your hand.

[0068] In order to offer the invention to the broadest possible patient base, the possibilities for data acquisition are not limited to a specific option due to the unequal availability of the technology for patients and medical centers.

[0069] The software on the personal device processes—with or without the aid of a cloud knowledge base—the input data about the location and shape of the wound. The result of this processing is a set of instructions that is transmitted to the device via a wired or wireless connection. This instruction set is a grid of squares with a defined resolution (squared area, power, and pulse duration at the specified grid point).

[0070] The microcontroller using the knowledge module processes the instructions:

[0071] 1. Pulse duration

[0072] 2. Amplitude

[0073] 3. Phase for each of the measuring transducers.

[0074] The process of using the device for specific therapeutic cycles to disrupt bacterial biofilm and stimulate tissue at the cellular level may involve the periodic / sequential acquisition of data about the patient's wound(s). The aim of this process is to process information about the location, shape, and characteristics of the wound in order to generate an updated set of instructions for the specific treatment area. In this way, the delivery of ultrasound waves can be tailored to the individual therapeutic needs of the patient, resulting in improved treatment efficiency and a reduction in the workload of medical staff.

[0075] The software employs a predictive model based on machine learning algorithms. This model, which relies on cyclically collected data, will analyze the course of therapy, assess its progress, and suggest a further treatment plan. Thanks to its ability to recognize patterns in the patient's data, the system will enable a personalized evaluation of therapy effectiveness and optimal adaptation of the treatment plan to the individual user. Key advantages of the device include the ability to actively perform the therapy at home, monitor therapy progress without the involvement of medical personnel, cyclically update the therapy—focusing the treatment wave where the therapeutic process is needed after cyclically acquiring data about the patient's wound—and the device's small size.Furthermore, the use of the invention enables a better therapeutic effect to be achieved through the use of interference and phase control capabilities.

[0076] This device is the only ultrasound solution that offers remote at-home care, monitoring with self-examination of the feet, and individualized design and therapy tailored to the patient's needs, bringing clinical treatment directly into the patient's home. The patient requires no additional effort, and the doctor can offer more effective therapy because treatment takes place between visits. This is particularly important in rural areas where specialized wound care centers are lacking.

Claims

Patent claims 1. Device for the treatment of chronic wounds, in particular diabetic foot syndrome, in which an electronic circuit with an ultrasonic transducer is wire-connected in a material layer or between at least two material layers, characterized in that the ultrasonic transducers (3) are applied to at least one matrix (2) forming the structural material for the applied transducers, wherein the ultrasonic transducers (3) are controlled and arranged at such a distance from each other that they induce wave interference during operation.

2. Device for treatment according to claim 1, characterized in that, in the case of only two ultrasound transducers (3), the distance between the centers of the ultrasound transducers (3) on the matrix (2) is twice their diameter, and in the case of three or more ultrasound transducers (3), these are arranged according to the shape of an equilateral geometric figure and on the vertices of such a figure, wherein the side of the figure that forms the outline of the arrangement of the ultrasound transducers (3) is equal to twice the diameter of the ultrasound transducers (3).

3. Device for treatment according to one of claims 1 or 2, characterized in that the matrix (2) has the shape of an equilateral geometric figure, preferably with the number of vertices equal to the number of ultrasound transducers (3).

4. Device for treatment according to Anspmch. 2, characterized in that the matrix (2) has a rectangular shape with two ultrasonic transducers (3), wherein the longer side of the matrix (2) has a span of at least three diameters of the ultrasonic transducer (3) and the shorter side has a width of the diameter of at least one ultrasonic transducer (3).

5. Device for treatment according to Annex 1, characterized in that it consists of four layers permanently bonded together by means of an adhesive: a base layer (8) made of a hard or semi-hard polymer, a damping layer (7) made of a shape-memory material, a layer to facilitate the ultrasound wave (1), preferably made of medical-grade silicone, and a skin contact layer covering it, wherein an electronic The circuit (5) is arranged on the base layer (8) and under the damping layer (7), which is connected via wires to the ultrasonic transducers (3) arranged on at least one matrix (2).

6. Device for treatment according to claim 5, characterized in that the skin contact layer (1) has an opening or recess for a dressing (11), preferably a hydrocolloid dressing or for or on an antiseptic gel.

7. Device for treatment according to claim 1, characterized in that the electronic circuit (5) comprises a wireless communication module, a microcontroller, an actuator module and a charging and wired control module (6).

8. Device for treatment according to claims 5, 6 or 7, characterized in that the four layers have the shape of a foot and together form an insole for footwear, wherein the electronic circuit (5) is located in the heel part of the insole (B) and the matrix (2) is connected with The ultrasound transducer (3) is located in the metatarsal and toe (A).

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