Device for the heat therapy treatment of a selected area of ​​the body of a human or animal.

Abstract

Device for use in the thermotherapeutic treatment of a selected area of ​​the body of a human or an animal, and in particular for use in the treatment of tissue damage after surgical procedures, injuries, inflammations and chronic diseases of the rheumatic group, and in particular to support chemotherapeutic treatments, comprising: a temperature control device (1) designed to control the temperature of a temperature control fluid; a heat transfer device (2) designed to transfer heat to the selected area of ​​the body, wherein the temperature control device (1) is fluidically connected to the heat transfer device (2), and is further arranged to temperature control the heat transfer device (2) with a heat-transferring temperature control fluid flowing through the heat transfer device (2), a control device (3) which is connected to the temperature control device (1) and the heat transfer device (2), wherein the control device (3) is configured to control the temperature control device (1), and to effect, that the heat transfer device (2), in the area of ​​a contact surface between the heat transfer device (2) and the selected area of ​​the body to be tempered, has at least partially a roughly uniform temperature.

Description

[0001] The present invention relates to a device for use in the heat-therapeutic treatment of a selected area of ​​the body of a human or animal, and in particular for use in the treatment of tissue damage following surgical procedures, injuries, inflammation, and chronic rheumatic diseases, and in particular for supporting chemotherapeutic treatments. A method for operating such a device is also disclosed.

[0002] In the context of the present invention, the term “heat therapeutic treatment” is understood to mean a treatment in which heat is added to or removed from the human or animal body.

[0003] This preferably does not involve the supply or removal of heat to or from the entire body, as happens, for example, in a sauna and subsequent immersion in a plunge pool filled with cold water, but rather it preferably involves supplying or removing heat from a selected area of ​​the human body, for example the limbs, areas of the back, abdomen, chest or head, in order to achieve therapeutic effects.

[0004] Known devices for thermotherapeutic treatment have temperature control devices, as described, for example, in European patents EP 2 194 940 B1 and EP 2 462 906 B1. These temperature control devices have a cooling unit and / or a heating unit with which a fluid, preferably water, is cooled and / or heated to the desired temperature. Preferably, one or more pumps are also provided, with which the temperature-controlled fluid is conveyed via connecting hoses to a heat transfer device.

[0005] DE 20 2018 107 423 U1 shows an example of a heat transfer device with which the heat generated by the temperature control device is transferred to the selected area of ​​the body. The device shown there, commonly referred to there as a cuff, as well as in practice, has a first and a second flexible material layer, between which flow spaces are provided through which the temperature-controlled fluid flows. These cuffs can be designed in many different shapes for a predetermined body area, for example as hand-knit cuffs, forearm cuffs, knee cuffs, calf cuffs, round cuffs, chest cuffs, or face cuffs. They can also be designed as trapezoidal cuffs or flat cuffs, which, depending on their size and shape, are suitable for application to any area of ​​the body.Fasteners, straps and the like are used to attach the cuffs to the body.

[0006] Although the aforementioned devices have proven themselves in practice, there is a desire for further improvement. The present invention is therefore based on the object of improving the known device.

[0007] This object is achieved according to the invention by a device according to claim 1. Preferred developments of the invention are the subject of the dependent claims.

[0008] The disclosure of the cited documents EP 2 194 940 B17-07-27, EP 2 462 906 B17-07-27, DE 20 2018 107 423 U1 and DE 10 2015 003 473 A1 are incorporated by reference into the disclosure of the present invention.

[0009] The device according to the invention comprises a temperature control device designed to control the temperature of a temperature control fluid. For this purpose, the temperature control device is fluidly connected to a heat transfer device designed to transfer heat to the selected region of the body, and is further designed to temperature control the heat transfer device using a heat-transferring temperature control fluid flowing through the heat transfer device. The device further comprises a control device connected to the temperature control device and the heat transfer device, wherein the control device is designed to actuate the temperature control device in order to ensure that the heat transfer device, in the region of a contact surface between the heat transfer device and the selected region of the body to be temperature controlled, has an approximately uniform temperature, at least partially.

[0010] The term "control device" refers to a device that either controls and / or regulates parts of a device based on data or values ​​supplied to it and / or data, values, or settings entered by a user. This control is preferably achieved via control devices. A control device is understood to be any electrical or mechanical component capable of influencing a technical system in a directed manner.

[0011] The selected area of ​​a person's body can be any region on the surface of the body. In particular, the selected area can be one of the limbs, such as an arm or a leg, preferably a hand or a foot. Furthermore, the selected area can also be an area of ​​the chest, abdomen, back, or head. The patient's skin in the selected area is also referred to below as the skin contact area.

[0012] A fluid connection, or fluidly connected connection, is a connection that enables the exchange of a liquid or gaseous fluid from one location to another. Typical fluid connections are preferably made via a hose or pipe. The fluid connections are preferably partially or completely thermally insulated to minimize heat or cold loss during fluid flow, ensuring both an energy-saving design and the most precise possible maintenance of the target temperature that the heat transfer device is intended to achieve in the area of ​​skin contact.

[0013] According to the invention, a heat-transferring temperature control fluid is used. A heat-transferring temperature control fluid is understood to be a fluid that is functionally configured to transport its inherent heat, in the form of thermal energy, to a target location. Advantageously, a heat-transferring temperature control fluid is therefore a liquid that is suitable for storing or absorbing a large amount of thermal energy. Water is preferably used as the temperature control fluid, but a water-salt mixture or a suitable mineral or synthetic oil is also preferred.

[0014] In the context of the invention, the term "connected" can mean "directly connected," preferably via a cable or hose, or "indirectly connected," preferably via light, infrared, or radio according to the Wi-Fi or Bluetooth standard. The temperature control device is connected to the heat transfer device directly, i.e., via at least one fluid line, while the temperature control device can also be connected to the control device indirectly, i.e., wirelessly via radio or the like.

[0015] The area of ​​a contact surface between the heat transfer device and the area of ​​the body to be tempered is the area where a contact surface of the heat transfer device has a small distance to the skin surface of the area of ​​the body to be tempered and preferably lies directly on the skin surface.

[0016] According to the invention, the heat transfer device is intended to generate a roughly uniform temperature on the selected area of ​​the body to be tempered. A roughly uniform temperature is understood here to mean that all points in this area of ​​the contact surface of the heat transfer device are within an interval of 10°C, preferably 5°C, particularly preferably 3°C, and furthermore particularly preferably 1°C.

[0017] In a preferred embodiment, the heat transfer device comprises at least one heat transfer unit, which is designed to be brought into contact with the selected area of ​​the body. The heat transfer unit consists of a substantially flexible material in which one or more temperature control fluid chambers through which the temperature control fluid can flow are arranged.

[0018] The area of ​​the body to be heated is generally not flat, but rather has concave and / or convex areas. Within the scope of the present invention, it was discovered that these unevennesses can lead to the formation of individual air pockets between the heat transfer unit and the skin surface of the body to be treated, which thermally insulate the affected local area of ​​the skin in the selected area from the heat transfer unit. As a result, the heating of the selected area is uneven, and the desired effects of the heating, in particular an increase or decrease in blood circulation, are not achieved evenly.

[0019] In order to reduce this effect of localized thermal insulation, the heat transfer device comprises a substantially flexible material in order to keep the distance between the heat transfer unit and the area to be tempered as small as possible over the entire three-dimensional surface, wherein the flexibility preferably enables direct contact over the selected area to be tempered.

[0020] The temperature control fluid chambers are arranged within the heat transfer unit in such a way that when the fluid flows through the temperature control chambers, the heat of the temperature control fluid is transferred as evenly as possible to the area of ​​the body to be temperature controlled.

[0021] In order to dissipate the heat as evenly as possible, the essentially flexible material of the heat transfer unit, in a preferred embodiment, has at least one first flexible material layer with at least one first skin contact surface, which at least partially faces a selected region of the body of a human or animal, and at least one first temperature control fluid contact surface facing away from the first skin contact surface. In addition, the heat transfer unit has at least one second flexible material layer with at least one second temperature control fluid contact surface, which, between itself and the first temperature control fluid contact surface of the first flexible material layer, at least partially delimits the one or more temperature control fluid chambers through which the heat-transferring temperature control fluid can flow.

[0022] The heat transfer unit further comprises at least one first supply line for supplying a heat-transferring temperature control fluid to the heat transfer unit and at least one second supply line for removing a heat-transferring temperature control fluid from the heat transfer unit. The first and second supply lines are connected to the temperature control device in order to heat or cool the temperature control fluid to the desired temperature in a circuit.

[0023] By using flexible materials, the heat transfer unit has at least one shape, or can take on such a shape, in which it covers and / or at least partially encloses the selected area of ​​the body of a human or an animal.

[0024] In a preferred embodiment, to reduce the above-described effect of local thermal insulation by air cushions, the heat transfer device further comprises a pressure device for generating or increasing the contact pressure of the heat transfer unit on the selected area of ​​the body, thereby at least partially or largely completely reducing the occurrence of thermally insulating air cushions between the heat transfer unit and the area to be tempered. The pressure device comprises at least one pressure unit and a support device, wherein the pressure device is prevented by the support device from moving in a direction opposite to the skin contact surface of the selected area.

[0025] The pressure unit is designed to at least partially apply pressure to the heat transfer unit, which is then absorbed as the contact pressure of the heat transfer device by the part of the body to be treated. For this purpose, the pressure unit has at least one pressure chamber with a predetermined or variable internal pressure.

[0026] The use of a fluid-filled pressure chamber offers particular advantages. In a fluid-filled pressure chamber, the pressure within the fluid is always constant. This means that the heat transfer unit is pressed onto the skin of the selected area with even pressure. This allows the flexible material of the heat transfer unit to adapt particularly well to convex and / or concave areas of the selected area, preventing the formation of air pockets and achieving particularly good heat transfer.

[0027] The contact pressure represents the portion of the surface force that is transferred from the pressure unit via the heat transfer unit to the selected area of ​​the body to be tempered.

[0028] A support device is provided to build up the contact pressure. A support device is defined as any type of device capable of absorbing surface forces that oppose the contact pressure.

[0029] In a preferred embodiment, the at least one pressure unit has a chamber filled with a pressure fluid, wherein the at least one chamber filled with a pressure fluid is enclosed by a flexible material. A pressure fluid is understood to be a fluid that can be compressible, preferably air or a gas, or incompressible, preferably water, a water-salt mixture, a water-oil mixture, or an oil. However, other fluids can also be used as pressure fluids.

[0030] In a preferred embodiment, the at least one chamber filled with a pressurized fluid is connected to a pressure line. The pressurized fluid in the at least one chamber filled with a pressurized fluid can be pressurized either manually by a user using muscle power and / or via a compressor via the pressure line connected to the at least one chamber filled with a pressurized fluid. This allows the internal pressure in the at least one pressure chamber filled with a pressurized fluid to be varied. The variable internal pressure also allows the pressure applied by the heat transfer device to the part of the body to be adjusted. Preferably, a device is provided that is actuated by human muscle power.

[0031] A compressor is a machine designed to apply mechanical power to a pressurized fluid, thereby increasing its internal pressure. If the fluid is a liquid, the compressor acts as a pump.

[0032] In one embodiment, the pressure device has a release valve for reducing the internal pressure of the pressure unit.

[0033] In a further preferred embodiment, the at least one pressure unit is not formed from a pressure chamber filled with a pressurized fluid, but is made of an elastic material and is also arranged between the support device and the heat transfer unit. The elastic material can be a foam, a rubber, or a combination of these or similar materials. The elasticity can be constant across the volume of the pressure unit; however, embodiments are also conceivable in which the elasticity of the pressure unit varies across the volume in order to avoid possible pressure peaks and / or to specifically apply increased pressure, preferably across small radii of the body part to be treated.

[0034] In a preferred embodiment, the support device of the printing device is made of a less flexible material.

[0035] A less flexible material is defined as one with a higher modulus of elasticity, preferably hard plastic. It is particularly important that the material used for the support device has a higher stiffness than the pressure unit in order to transfer the internal pressure of the pressure unit to the contact surface between the heat transfer unit and the selected area of ​​the body and the heat transfer unit.

[0036] In a preferred embodiment, the support device of the pressure device around the selected area of ​​the body of a human or animal further comprises a connecting device with at least one fixing element. The connecting device is designed such that it at least partially surrounds the pressure device and, in this surrounding position, exerts supporting forces on the pressure device, which at least partially contribute to fixing the pressure device to the selected area of ​​the body of a human or animal in a use state. The connecting device with at least one fixing element can be continuously adjustable, such as preferably by a strap, or can include dedicated fixing points, such as preferably snap fasteners, or can consist of a combination of both.

[0037] A usage state is understood to be the state in which the heat transfer device is in contact with the selected area of ​​the body.

[0038] In a preferred embodiment, at least one sensor device is further provided, which is connected to the control device. The sensor device is preferably configured to measure a sensor signal at specific positions of the device. The sensor device preferably measures the temperature and / or the contact pressure between the selected region of the body and the skin contact surface and / or in the heat transfer device and / or in an edge region of the heat transfer device facing the body.

[0039] A sensor device is any device that has a sensor for measuring a physical state and is configured to convert this state into a sensor signal. The sensor signal can be optical, acoustic, or digital.

[0040] In a preferred embodiment, the at least one sensor device is a plurality of sensor devices, which are preferably arranged at least partially in a grid, preferably in the edge region or on the surface of the first material layer facing the skin in the use position. The grid can be a grid with identical spacing, a grid with nearly identical spacing, a grid with different spacing, or a combination thereof.

[0041] In a preferred embodiment, the measured sensor signal is selected from the group consisting of pressure, current, and temperature. However, other physical quantities are also conceivable.

[0042] In a preferred embodiment, at least one display device is provided. The display device is connected to the control device and configured to output the sensor signal measured by the sensor device to a user via the display device.

[0043] The display device can comprise any form of display that allows a user to provide information about the status of the individual devices and / or the measured sensor signal. The display can be visual, preferably in the form of a screen, acoustic, preferably in the form of an audible tone, or even haptic, preferably in the form of a vibration. However, other forms of display are also conceivable.

[0044] A temperature control device is provided to supply or remove the energy required to temperature-control the selected area of ​​the body from the heat-transfer fluid. The temperature control device preferably comprises a housing, preferably a temperature control fluid supply device, through which a heat-transferring temperature control fluid is provided in the housing, and at least one temperature control unit, preferably arranged in the housing, through which the heat-transferring temperature control fluid is temperature-controlled. Furthermore, the temperature control device comprises at least one temperature control fluid discharge device, through which the heat-transferring temperature control fluid is led out of the housing at a substantially predetermined temperature, and preferably at least one pump device, preferably arranged in the housing, which pressurizes the heat-transferring temperature control fluid flowing through the housing.

[0045] The temperature control unit preferably comprises an electric heating unit. Further preferably, the temperature control unit comprises at least one conventional cooling unit in which a refrigerant is compressed, expanded via an expansion valve, and condensed via a condenser.

[0046] Particularly preferably, the temperature control unit additionally or exclusively comprises at least one temperature control element configured as a thermoelectric element, in particular a Peltier element. Furthermore, a heat exchanger element through which a temperature control fluid can flow is preferably provided for transferring heat to or from the temperature control fluid, and preferably at least one cooling unit.

[0047] Preferably, the device uses at least one of the three groups of sensors described below.

[0048] A first group of sensors is designed to detect the condition of the heat transfer device and, if applicable, also of the supply lines.

[0049] These include temperature sensors that measure the temperature at predetermined points on the heat transfer device and the supply lines, pressure sensors that measure the pressure forces of the pressure unit within the heat transfer device and flow measurement sensors that can measure the flow velocity and / or the quantity of the supplied and / or discharged temperature control fluid.

[0050] A second group of sensors is provided within the temperature control unit. Here, too, temperatures, pressure, and flow velocity or flow volume are primarily measured.

[0051] A third group of sensors is intended to take measurements of physiological data on the patient, which are preferably used by the control device to control and / or regulate the operation of the device and in particular the temperature of the heat transfer device.

[0052] Preferably, temperature sensors are used, which are preferably arranged as thin electrodes in the selected area of ​​the body to be tempered by the device. Furthermore, pressure sensors are preferably used, also preferably as thin electrodes, with which the contact pressure of the heat transfer device can be measured.

[0053] Furthermore, sensors that record the physiological state of the treated patient are preferably used. For this purpose, one or more sensors are selected from a subgroup that includes the following sensors: sensors that measure heart rate, sensors that record an ECG, sensors that measure blood pressure, and preferably sensors that measure blood flow.

[0054] In a preferred embodiment, the control device is configured to form one or more control loops based on the signal(s) measured by the sensor devices or sensors such that a region of a contact surface between the heat transfer device and the part of the body to be tempered has an approximately uniform, preselected temperature at least in one region.

[0055] The device preferably has one or more adjusting or regulating devices that allow parameters of the device, such as the temperature of the fluid, the flow rate, the amount of fluid delivered, and the like, to be changed. These adjusting or regulating devices can be electrical control devices that preferably influence a voltage, a frequency, and / or a current. More preferably, the control devices can be mechanical control devices that can preferably change the flow resistance and / or stop the flow, or they can be electromechanically designed.

[0056] The control device is equipped with at least one, but preferably two, or more preferably a plurality of control elements that allow the desired treatment parameters to be set. These preferably include the specification of operating and pause times, as well as the specification of temperatures or temperature intervals.

[0057] If the device is used for cooling, the following temperature ranges are particularly advantageous, depending on the application, and should be covered by the respective device. For use in hospitals, etc., a temperature range of 10–35 °C is recommended; for hospitals and outpatient treatments, a temperature range of 12–22 °C; and for treatment in private settings, a temperature range of 15–22 °C. However, it is also preferable to design the device to cover a wider temperature range of 10–35 °C, or even a temperature range of 10–43 °C.

[0058] The control device preferably comprises a processor device and a memory device. One or more program routines are preferably stored in the memory device, which, individually or jointly, serve to influence or control the operation of the control device and preferably also parts of the device by means of the processor device. The program routines are preferably predefined and permanently stored in the memory device. Furthermore, the program routines can be modified by the user and / or additional program routines can be entered into the memory device.

[0059] Particularly, but not exclusively, in the case of a device that is used only or also in the private sphere outside of a hospital or other medical facility, part or all of the control of the control device can be carried out by an external processor device. Preferably, a stationary or portable computer, such as a laptop, is used for this purpose. Further preferably, a mobile communications device, in particular a mobile phone or particularly preferably a smartphone, is used as the external processor device. Preferably, the mobile communications device, in particular a smartphone, is connected to external sensors that can record the patient's physiological data. Preferably, sensors that can be attached to the patient's body, such as wristbands with sensors or a smartwatch, are used for this purpose.The programs used on the mobile communication device to collect physiological data such as preferably heart rate and ECG functions can then be used to control the device.

[0060] The device preferably has an alarm mode. This alarm mode is preferably triggered when a temperature is within an undesirable range. This can preferably be the case when the fluid temperature rises above a predetermined value or, more preferably, when a housing temperature assumes an undesirable value. Furthermore, the alarm mode can also be triggered when the physiological values ​​recorded by the sensors connected to the patient are within an undesirable range.

[0061] In connection with the aforementioned examples according to the invention, a method for operating a device for the heat-therapeutic treatment of a selected area of ​​the body of a human or animal is also disclosed, the method comprising the following steps: Initially, a heat transfer device is brought into contact with a pressure device in a use state against the selected area of ​​the body. A contact pressure acting on the selected area of ​​the body is then applied via the pressure device.The selected area of ​​the body is tempered via a tempering device connected to the heat transfer device, in that a heat-transferring tempering fluid flows through a heat transfer unit of the heat transfer device, so that in the area of ​​a contact surface between the heat transfer device and the part of the body to be tempered, an approximately uniform temperature prevails at least in one area.

[0062] Bringing the heat transfer device into contact can preferably be understood as placing a cuff containing a heat transfer device around a patient's hand. Furthermore, bringing a body part into contact can also be understood as placing it on a heat transfer device resting on a cushion.

[0063] In a preferred embodiment, the method further comprises the following step: The internal pressure of a pressure unit of the pressure device is adjusted, wherein the pressure unit has at least one chamber filled with a pressurized fluid. The internal pressure of the at least one chamber filled with a pressurized fluid can be adjusted manually via the user's muscle power and / or via an external pressure source.

[0064] In a preferred embodiment, the method further comprises the following steps: A sensor signal is measured via a sensor device connected to the heat transfer device. Based on the measured sensor signal, a control device then controls a pressure device connected to the control device. This control can also be referred to as a control loop.

[0065] Therapeutic treatments for which the device according to the invention is particularly suitable are described below: Targeted heat treatments before a surgical procedure improve capillary blood flow and promote healing after the procedure. For this purpose, heat is applied several times using the device according to the invention approximately 18 hours before the procedure, with a temperature adjustment of the tissue to 41-43°C being particularly beneficial. This temperature adjustment is applied, for example, three times for half an hour each, interrupted by a cooling phase at room temperature of half an hour each time.

[0066] For this purpose, a sequence program is stored or entered into the device that controls the timing and the various components of the device. Physical (temperature, pressure, etc.) or physiological data measured by the sensors are particularly preferred for this purpose.

[0067] After a surgical procedure, but especially after injuries and in the case of chronic diseases and the resulting swelling, bleeding, hematomas, edema, and inflammation, cooling the affected tissue with the device according to the invention promotes healing and reduces pain intensity, which can result in a significantly reduced drug administration. This therapeutic effect can be explained by the fact that the affected tissue reacts to the procedure or injury with inflammation and thus overheating, which increases the oxygen requirement. Cooling the tissue reduces this oxygen requirement and prevents cell death. For this purpose, the device is controlled so that a specific target temperature is reached. The target temperature for achieving the tissue can be, for example, 14.5 °C.The sensors can monitor whether the target temperature has been reached, and furthermore, the patient's physiological condition can be monitored, and the control device can be switched off if the values ​​for heart rate, blood flow or the like are in an undesirable range.

[0068] Heat therapy is also particularly important in the treatment of cancer with chemotherapy. The chemotherapy drug used to reduce cancer cells penetrates the blood capillaries of the hands and feet and can lead to the dreaded chemotherapy-induced polyneuropathy (CIPN) or hand-foot syndrome (HFS), with permanent damage to the tissue and particularly to the nerve cells. In mild cases, this manifests as sensory disturbances, "tingling," and the like; in severe cases, it leads to widespread or complete numbness, which can make using the hands and even walking difficult. Pain, sometimes very intense, has also been reported. In severe cases, onycholysis, i.e., the detachment of one or more nails, frequently occurs.

[0069] The preferential involvement of the sensory nervous system is commonly understood to be due to the blood supply to these nerve cells via fenestrated capillaries. This means that the protein composition of the cell wall is different, making it more permeable to certain chemotherapeutic agents. This causes fundamental damage to the nerve cells. Damage to both cellular and mitochondrial DNA, impaired calcium balance, and oxidative stress promote the disintegration of ganglion cells. Since the longest nerve fibers are more sensitive to these damaging influences, CIPN usually presents as length-dependent, with a predominance in the lower extremities.

[0070] Cooling hands and feet or other areas of the body during chemotherapy with the device according to the invention leads to a reduction in blood flow in these areas, whereby less therapeutic agent reaches the blood capillaries and the development of polyneuropathy can be prevented. This, too, can be advantageously achieved with the device according to the invention and with the method for operating the device disclosed here.

[0071] Cooling is preferably carried out in a temperature range between 8°C and 30°C, but particularly preferably in a range between 10°C and 14°C. A cooling temperature in the range of 10-12°C is most preferred.

[0072] Preferably, the heat treatment explained above with regard to surgical interventions is also applied in the form of a cold treatment in connection with chemotherapy. For this purpose, cold is applied using the device according to the invention, preferably approximately 30 minutes before the administration of the chemotherapeutic agent, with a temperature of 10-12°C being particularly advantageous for the tissue or skin surface of the selected area. This temperature is preferably applied throughout the entire administration of the chemotherapeutic agent and preferably for 1 hour to 3 hours beyond the completion of the administration of the chemotherapeutic agent.

[0073] Cytostatic drugs such as carboplatin, capecitabine, 5-FU, cyclophosphamide, cytarabine, docetaxel, doxorubicin, oxaliplatin, paclitaxel, sorafinide, and sunitinib are preferred as chemotherapeutic agents. These names are trademarks protected by the respective manufacturers or distributors.

[0074] In order to be able to set the optimal cooling temperature for each patient, the temperature control device can adjust the temperature control fluid with an accuracy of 1 °C, but preferably with an accuracy between 0.5 and 0.2 °C. For the desired therapeutic effect, it can be essential that the desired temperature, also referred to as the target temperature in this description, is maintained as precisely as possible during the cooling process.

[0075] For this application in conjunction with chemotherapy, the device is particularly advantageously equipped with a pressure device. Since the goal is to reduce blood flow in the blood capillaries, it is particularly advantageous if the heat transfer unit is in uniform contact with the skin of the selected area of ​​the patient's body, i.e., ideally without thermally insulating air pockets. This is achieved by the pressure device.

[0076] For example, by timing the device, the time required to reach the target temperature before the chemotherapy drug is started can be specified.

[0077] Instead, temperature sensors can also be used on the heat transfer device to detect when the target temperature is reached and then output a corresponding signal.

[0078] Finally, a sensor for measuring blood flow can also be used here, particularly advantageously. The cooling process is then initiated and continued until blood flow has dropped to a predetermined level. At the same time, by monitoring the patient's physiological parameters, such as heart rate and blood pressure, the device can ensure that the cooling does not lead to an undesirable condition in the patient.

[0079] The aforementioned examples assume that the temperature control device heats or cools the selected area to a specific target temperature. Instead of a constant target temperature, the temperature can also be changed during the treatment. This can be achieved by modulating the temperature / time curve. This modulation can preferably have a rectangular, sinusoidal, sawtooth, or trapezoidal shape in the temperature / time curve.

[0080] Further advantageous embodiments of the invention are explained in the following description in conjunction with the accompanying drawings. They show: Fig. 1: a device according to the invention for use in heat therapy treatment; Fig. 2: a glove-shaped heat transfer unit according to the invention in the unfolded state; Fig. 3: a printing device according to the invention in the unfolded state; Fig. 4: a heat transfer unit according to the invention according to Fig. 1 in combination with a printing device according to the invention according to Fig. 3; and Fig. 5: a flowchart of a method for operating the device disclosed herein.

[0081] Fig. 1 shows a device for use in the heat-therapeutic treatment of a selected area of ​​the body of a human or animal, and in particular for use in the treatment of tissue damage after surgical interventions, injuries, inflammations, and chronic rheumatic diseases, and in particular to support chemotherapeutic treatments, comprising a temperature control device 1 designed to control the temperature of a temperature control fluid. The temperature control device 1 is fluidly connected to a heat transfer device 2 designed to transfer heat to the selected area of ​​the body and is further designed to control the temperature of the heat transfer device 2 with a heat-transferring temperature control fluid flowing through the heat transfer device 2.Furthermore, a control device 3 is connected to the temperature control device 1 and the heat transfer device 2, wherein the control device 3 is configured to control the temperature control device 1 in order to ensure that the heat transfer device 2, in the region of a contact surface between the heat transfer device 2, and the selected region of the body to be temperature controlled, has at least partially an approximately uniform temperature.

[0082] The heat transfer device 2 has at least one heat transfer unit 4, which is intended to be brought into contact with the selected region of the body, wherein the heat transfer unit 4 consists of a substantially flexible material in which one or more tempering fluid chambers 5 are arranged, through which the tempering fluid can flow.

[0083] The heat transfer device further comprises a pressure device 10 adjacent to the heat transfer unit 4, wherein the pressure device 10 comprises at least one pressure unit 11 and a support device 12.

[0084] The pressure unit 11 is connected to the support device 12, and the pressure unit 11 is designed to at least partially apply pressure to the heat transfer unit 4, which is then absorbed as the contact pressure of the heat transfer device 2 by the part of the body to be treated. For this purpose, the pressure unit 11 has at least one pressure chamber 13 with a predetermined or variable internal pressure and is configured to at least partially increase the contact pressure of the heat transfer device 2 on the selected area. The at least one pressure chamber 13 comprises a chamber filled with a pressurized fluid, wherein the at least one chamber filled with a pressurized fluid is formed by a flexible material.The pressure fluid in the at least one pressure chamber filled with a pressure fluid can be pressurized via a pressure line connected to the at least one chamber filled with a pressure fluid, either manually by muscle power and / or by using a compressor 17, in order to change an internal pressure in the at least one chamber filled with a pressure fluid.

[0085] The support device 12 of the pressure device 10 further comprises a connecting device 14 with at least one fixing element, and the connecting device 14 is designed such that it at least partially surrounds the pressure device 10 and, in this surrounding position, exerts supporting forces on the pressure device 10, which at least partially contribute to fixing the pressure device 10 in a use state to the selected region of the body of a human or an animal.

[0086] Furthermore, at least one sensor device 15 is provided, which is connected to the control device 3. The sensor device 15 is configured to measure a sensor signal between the selected area of ​​the body and the skin contact surface. The sensor signal can be optical, acoustic, or digital. Fig. In the embodiment shown in Figure 1, the sensor device 15 is mounted between the heat transfer unit 4 and the part of the body to be treated, but other positions are also possible.

[0087] Furthermore, at least one display device 16 is provided, wherein the display device 16 is connected to the control device 3 and configured to output the sensor signal measured by the sensor device 15 to a user via the display device 16. The sensor signal can also be used for control, so that a region of a contact surface between the heat transfer device 2 and the part of the body to be tempered has an approximately uniform, preselected temperature, at least in one region.

[0088] Fig. 2 shows a heat transfer unit 4 which is intended to be brought into contact with the selected region of the body, wherein the heat transfer unit 4 consists of a substantially flexible material in which one or more tempering fluid chambers 5 (not shown) are arranged, through which the tempering fluid can flow.

[0089] The heat transfer unit 4 comprises: - at least one first flexible material layer 6 with at least one first skin contact surface, which is at least partially facing a selected area of ​​the body of a human or an animal, and with at least one first temperature control fluid contact surface facing away from the first skin contact surface, - at least one second flexible material layer 7 with at least one second temperature control fluid contact surface, which at least partially defines one or more temperature control fluid chambers through which a heat-transferring temperature control fluid can flow, between itself and the first temperature control fluid contact surface of the first flexible material layer 6, wherein the heat transfer unit 4 further comprises: - at least one first supply line 8 for supplying a heat-transferring tempering fluid to the heat transfer unit 4, - at least one second supply line 9 for discharging a heat-transferring tempering fluid from the heat transfer unit 4.

[0090] The use of flexible material layers 6, 7 is necessary because the area of ​​the body to be tempered is not flat, but has concave and / or convex areas, and the flexibility of the material layers 6, 7 makes it possible to keep the distance between the heat transfer unit 4 and the area to be tempered as small as possible over the entire three-dimensional area, wherein the heat transfer unit 4 preferably lies directly on the skin surface.

[0091] The heat transfer unit 4 has at least one first shape or can assume such a first shape in which it at least partially encloses the selected area of ​​the body of a human or an animal.

[0092] In a preferred variant, the heat transfer unit 4 has one of the following forms, or can take one of these forms: - the shape of a hand-enclosing shell without any subdivision of the interior; - the shape of a glove with partially separated coverings for at least one finger, in particular the shape of a mitten with a partially separated covering for the thumb, as in Fig. 2 shown; - the shape of a finger glove with partially separated coverings for each finger; - the shape of an at least partially fingerless glove in which at least one finger is not enclosed.

[0093] However, the body part to be treated can also be a foot or another body part, wherein the heat transfer unit 2 then has or can take on a shoe or stocking shape or another shape adapted to the respective body part.

[0094] Fig. 3 shows the pressure device 10, wherein the pressure device 10 has at least one pressure unit 11 and a support device 12, which is intended to build up an application pressure. The pressure unit 11 is attached to the support device 12 and is intended to at least partially apply pressure to the heat transfer unit 4. For this purpose, the pressure unit 11 has at least one pressure chamber 13, which has a predetermined or variable internal pressure and is designed to at least partially increase the application pressure of the heat transfer device 2 on the selected area via the internal pressure. According to one embodiment, the pressure unit 11 can have a pressure chamber 13 in the form of a chamber filled with a pressurized fluid, wherein the at least one chamber filled with a pressurized fluid is delimited by a flexible material.In a further preferred embodiment, the at least one pressure unit 11 is made of an elastic material, such as preferably a foam, a rubber, or a combination of these or similar materials, wherein the pressure unit 11 and the pressure chamber 13 are to be regarded as the same component in this embodiment.

[0095] Fig. 4 again shows the heat transfer device 2 from Fig. 1 and the printing device 10 from Fig. 3 in slightly different dimensions. The right figure shows a section AA through the section plane from the drawing plane along the dashed straight line AA in the left figure. In the left figure, the heat transfer unit 4 is made of Fig. 2 is also indicated by dashed lines. The heat transfer device 2 comprises at least one heat transfer unit 4, in which one or more temperature control fluid chambers 5 are arranged. A pressure device 10 is located on the heat transfer unit 4, wherein the pressure device 10 has at least one pressure unit 11 and a support device 12. The support device 12 is attached to the pressure unit 11 and is intended to at least partially build up a contact pressure of the heat transfer device 2 on the part of the body to be treated via the heat transfer unit 4. For this purpose, the pressure unit 11 has at least one pressure chamber 13. The pressure chamber 13 is designed to at least partially increase the contact pressure of the heat transfer device 2 on the selected area via an internal pressure.The pressure device 10 further comprises a support device 12, wherein the pressure device 10 is attached to the support device 12, and the pressure unit 11 is provided to at least partially apply pressure to the heat transfer unit 4. In this embodiment, the pressure device has three connecting devices 14, although more or fewer connecting devices are also conceivable. The connecting devices 14 shown are each designed as a single piece in this embodiment; in a preferred embodiment, the connecting device is designed to be circumferential, for example in the form of a zipper or a similar mechanism. In the embodiment shown in . Fig. 4, the pressure unit 11 is larger in plan view than the heat transfer unit 4, and is designed in one piece, but smaller dimensions and multi-part pressure units are also conceivable in relation to the heat transfer unit, which can be filled individually or jointly via a common fluid connection, or controlled using a control device 3.

[0096] Fig. 5 shows a flowchart of a method disclosed herein for operating a device for heat-therapeutic treatment of a selected area of ​​the body of a human or animal, the method comprising the following steps: - Bringing into contact 101 a heat transfer device 2 with a pressure device 10 to the selected area of ​​the body in a use state; - applying 102 a pressure acting on the selected area of ​​the body via the pressure device 10, - Tempering 103, via a tempering device 1 connected to the heat transfer device 2 of the selected region of the body in which a heat transfer unit 4 of the heat transfer device 2 is flowed through by a heat-transferring tempering fluid; so that in the region of a contact surface between the heat transfer device 2 and the part of the body to be tempered, at least in one region, an approximately uniform temperature is present.

[0097] In a preferred embodiment, the method for operating a device for heat therapy treatment further comprises the following step: - Adjusting 104 an internal pressure of a pressure unit 11 of the pressure device 10, wherein the pressure unit 11 has at least one chamber filled with a pressure fluid, wherein the internal pressure of the at least one chamber filled with a pressure fluid can be adjusted manually via muscle power of a user and / or via an external pressure source.

[0098] In a further preferred embodiment, the method for operating a device for heat therapy treatment further comprises the following steps: - measuring 105 a sensor signal via a sensor device 15 connected to the heat transfer device 2; - Controlling 106, via a control device 3, the printing device 10 connected to the control device 3, based on the measured sensor signal.

[0099] The control device 3 is preferably configured to form a control loop with the heat transfer device 2 and the temperature control device 1 using the sensor signal measured by the sensor device 15, so that an approximately uniform, preselected temperature is regulated in at least one area of ​​a contact surface between the heat transfer device and the part of the body to be temperature-controlled. Heat transfer is significantly improved by avoiding thermally insulating air cushions between the heat transfer unit and the area of ​​the body to be temperature-controlled. List of reference symbols 1 temperature control device 2 Heat transfer device 3 Control device 4 Heat transfer unit 5 Tempering fluid chamber 6 first flexible material layer 7 second flexible material layer 8 first supply line 9 second supply line 10 Printing device 11 printing unit 12 Support device 13 Pressure chamber 14 Connecting device 15 Sensor device 16 Display device 17 compressors 101 Getting in touch 102 Investment 103 Tempering 104 Setting 105 trade fairs 106 Taxes QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] EP 2 194 940 B1 [0004, 0008] EP 2 462 906 B1 [0004, 0008] OF 20 2018 107 423 U1 [0005, 0008] DE 10 2015 003 473 A1

[0008]

Claims

[1] A device for use in the heat-therapeutic treatment of a selected area of the body of a human or animal, and in particular for use in the treatment of tissue damage following surgical interventions, injuries, inflammations and chronic rheumatic diseases, and in particular for supporting chemotherapeutic treatments, comprising: a tempering device (1) which is intended to temper a tempering fluid; a heat transfer device (2) designed to transfer heat to the selected area of the body, wherein the temperature control device (1) is fluidically connected to the heat transfer device (2) and is further configured to temperature control the heat transfer device (2) with a heat-transferring temperature control fluid flowing through the heat transfer device (2), a control device (3) connected to the temperature control device (1) and the heat transfer device (2), wherein the control device (3) is arranged to control the tempering device (1) and to cause that the heat transfer device (2) has, at least partially, an approximately uniform temperature in the region of a contact surface between the heat transfer device (2) and the selected region of the body to be tempered. [2] Device according to claim 1, characterized by in that the heat transfer device (2) has at least one heat transfer unit (4) which is intended to be brought into contact with the selected region, wherein the heat transfer unit (4) consists of a substantially flexible material in which one or more tempering fluid chambers (5) are arranged, through which the tempering fluid can flow. [3] Device according to claim 2, characterized by that the heat transfer unit (4) comprises: at least one first flexible material layer (6) with at least one first skin contact surface, which is at least partially facing a selected area of the body of a human or an animal, and with at least one first temperature control fluid contact surface facing away from the first skin contact surface, at least one second flexible material layer (7) with at least one second temperature control fluid contact surface, which at least partially defines one or more temperature control fluid chambers through which a heat-transferring temperature control fluid can flow, between itself and the first temperature control fluid contact surface of the first flexible material layer (6), wherein the heat transfer unit (4) further comprises: at least one first supply line (8) for supplying a heat-transferring tempering fluid to the heat transfer unit (4), at least one second supply line (8) for discharging a heat-transferring tempering fluid from the heat transfer unit (4), wherein the heat transfer unit (4) has at least one first shape or can assume such a first shape in which it at least partially encloses the selected region of the body of a human or an animal. [4] Device according to at least one of the preceding claims, characterized by that the heat transfer device further comprises a pressure device (10), wherein the pressure device (10) comprises: at least one printing unit (11), and a support device (12), wherein the pressure device (10) is attached to the support device (12) and the pressure unit (11) is provided to at least partially apply a pressure to the heat transfer unit (4), wherein the pressure unit (11) has at least one pressure chamber (13) which has a predetermined or a variable internal pressure and is designed to at least partially increase an applied pressure of the heat transfer device (2) on the selected area. [5] Device according to claim 4, characterized by that the at least one pressure chamber (13) comprises a chamber filled with a pressure fluid, wherein the at least one chamber filled with a pressure fluid is formed by a flexible material. [6] Device according to claim 5, characterized by that the at least one chamber filled with a pressure fluid is a plurality of chambers filled with a pressure fluid. [7] Device according to at least one of claims 5 or 6, characterized by that the pressure fluid is selected from the group of air, water, oil or a combination thereof. [8] Device according to at least one of claims 5 to 7, characterized by that the pressure fluid in the at least one chamber filled with a pressure fluid is either: manually via muscle power, and / or via a compressor (17) can be pressurized via a pressure line which is connected to the at least one chamber filled with a pressure fluid in order to change an internal pressure in the at least one chamber filled with a pressure fluid. [9] Device according to claim 4, characterized by that the at least one pressure chamber (13) is made of an elastic material and is arranged between the support device (12) and the heat transfer unit (4). [10] Device according to at least one of claims 4 to 9, characterized by that the support device (12) of the pressure device (10) is made of a material with little flexibility. [11] Device according to at least one of claims 4 to 10, characterized by in that the support device (12) of the pressure device (10) around the selected region of the body of a human or animal further comprises a connecting device (14) with at least one fixing element, and the connecting device (14) is designed such that it at least partially surrounds the pressure device (10) and, in this surrounding position, exerts supporting forces on the pressure device (10), which at least partially contribute to fixing the pressure device (10) to the selected region of the body of a human or animal in a state of use. [12] Device according to at least one of the preceding claims, characterized bythat at least one sensor device (15) is provided which is connected to the control device (3), wherein the sensor device (15) is designed to measure a sensor signal between the selected region of the body and the skin contact surface. [13] Device according to claim 12, characterized by that the at least one sensor device (15) is a plurality of sensor devices which are at least partially arranged in a grid on the skin contact surface of the first material layer. [14] Device according to at least one of claims 12 or 13, characterized by that the measured sensor signal is selected from the group pressure, current, temperature. [15] Device according to at least one of the preceding claims, characterized by that at least one display device (16) is provided, wherein the display device (16) is connected to the control device (3) and is configured to output the sensor signal measured by the sensor device (15) to a user via the display device (16). [16] Device according to at least one of the preceding claims, characterized by that the tempering device (1) has: at least one housing, at least one tempering fluid supply device, by which a heat-transferring tempering fluid is provided in the housing, at least one temperature control unit arranged in the housing, which controls the temperature of the heat-transferring temperature control fluid flowing through the housing, at least one tempering fluid outflow device through which the heat-transferring tempering fluid is led out of the housing at a substantially predetermined temperature, at least one pump device arranged in the housing, which pressurizes the heat-transferring tempering fluid flowing through the housing, wherein said at least one temperature control unit comprises at least one first temperature control element and at least one second temperature control element, each of which comprises at least one thermoelectric element, in particular at least one Peltier element, at least one heat exchanger element through which a temperature control fluid can flow for transferring heat to or from the temperature control fluid, and at least one heat sink. [17] Device according to at least one of claims 12 to 16, characterized bythat the control device (3) is designed to form a control circuit via the sensor signal measured by the sensor device (15) and the temperature control device (1) such that an area of a contact surface between the heat transfer device (2) and the part of the body to be temperature-controlled has an approximately uniform temperature at least in one area [18] Device according to at least one of the preceding claims, characterized by that the cooling device enables a temperature control of the temperature control fluid in a temperature range from 10°C to 35°C, preferably from 12°C to 22°C, more preferably from 15°C to 22°C, more preferably 10°C to 35°C, or also preferably from 10°C to 43°C. [19] Device according to at least one of claims 1 to 17, characterized bythat the heating device enables a temperature control of the temperature control fluid in a temperature range from 35°C to 45°C, preferably from 38°C to 44°C, more preferably from 41°C to 43°C.

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