Cryotherapy Skin Growth Removal Device

Abstract

A medical device comprises a cooling system; a heating system; and an applicator, the applicator comprising a cold base operably connected to the cooling system and a heating element operably connected to the heating system, and an applicator head for use with the cold base and the heating element, the applicator head being suitable for applying a combination of heat and cold to a target area.

Description

Technical Field

[0001] This disclosure generally relates to medical devices, and more specifically, to a device for treating skin growth by removing tissue using a combination of cryotherapy and thermotherapy. Background Technology

[0002] Conventional devices used for cryotherapy to remove tissue can cause tissue necrosis, including unhealthy tissue as well as surrounding healthy tissue, leading to pain and unnecessary damage. Another drawback of conventional devices and methods is that conventional treatments do not always result in necrosis of unhealthy tissue.

[0003] Because tissue necrosis cannot be successfully achieved every time, such treatments usually need to be repeated. Another drawback is that routine treatments are time-consuming, user-unfriendly, and inconvenient to use. Another disadvantage is that routine treatments are expensive, and the equipment is heavy and often difficult to transport. Summary of the Invention

[0004] This disclosure discloses a unique treatment method that combines rapid cold and heat transfer gradients. Controlling the cooling and heating gradients induces a more effective treatment that causes tissue necrosis. Furthermore, this method shortens treatment time. The device is constructed and configured to control the effects of treatment on the surrounding area, ensuring that surrounding tissue is not adversely affected by the extremely low / high temperatures experienced at the center of the treatment area.

[0005] Another important feature of this device is the ability to selectively combine needles inserted into the target / infected tissue, thereby achieving more effective treatment of necrosis. Furthermore, heat transfer is more efficient through needle insertion. Therefore, the overall treatment is more effective, efficient, and less time-consuming.

[0006] According to this disclosure, a medical device is provided, comprising: a cooling system; a heating system; and an applicator including a cold base operatively connected to the cooling system and a heating element operatively connected to the heating system, and an applicator head used in conjunction with the cold base and the heating element, the applicator head being adapted to apply a combination of heat and cold to a target region. According to a further feature of a preferred embodiment of this disclosure described below, the target region is target tissue.

[0007] According to a further feature of the preferred embodiment, the cooling system is a vapor compression refrigeration system, and may be a cascaded vapor compression refrigeration system. According to a further feature, the cooling system includes one or more thermoelectric coolers (TECs).

[0008] According to a further feature, the cold base and the heating element are in thermal contact with the applicator head, and the cold base is in thermal contact with and cooled by a conduit adapted to receive cold, low-pressure fluid, such that the target area is cryogenically cooled when the applicator head contacts the target area; and wherein the heating element is actuated to provide location-specific heat to the target area while the target area is cooled.

[0009] According to a further feature, a disposable component is removably attached to the applicator head, such that the disposable component is adapted to contact the target area. According to a further feature, the disposable component is filled with one or more sharp elements adapted to transfer heat and cold to the target area. Exemplarily, the sharp element is a needle.

[0010] According to a further feature, ethanol is applied to the surface of the disposable component suitable for contacting the target area. According to a further feature, thermal conductive paste is applied between the applicator head and the disposable component. According to a further feature, the thermal conductive paste is applied between the heating element and the disposable component.

[0011] According to a further feature, the heating element is fixed to the applicator head via a slider device having a first position and a second position, wherein the heating element is in contact with the applicator head at the first position and the heating element is separated from the applicator head at the second position.

[0012] According to a further feature, the heating element is configured with a specific geometry. According to a further feature, the heating element includes more than one heating component. The applicator head is an interchangeable applicator head, which is removably connected to the applicator.

[0013] According to a further feature, the heating system and the cooling system are disposed in the main unit, and the applicator is operatively connected to the main unit via a connector.

[0014] According to a further feature, the device also includes a controller configured to provide instructions for controlling the temperature profile of the cooling and heating system. According to a further feature, the instructions include the number of times the temperature profile is applied.

[0015] According to a further feature, the device also includes a communication module adapted to connect to a network to retrieve data regarding the method of applying the combination of heat and cold to the target area.

[0016] According to a further feature, the device also includes a communication module adapted to connect to a network to update a database of instances of applying the combination of heat and cold to the target area.

[0017] According to another embodiment, a medical device is provided in which the heating system, the cooling system and the applicator are disposed in a single unit. Attached Figure Description

[0018] This document describes various implementation methods by way of example only, with reference to the accompanying drawings, in which:

[0019] Figure 1 This is a schematic diagram of the medical device 10 according to the present disclosure;

[0020] Figure 2 This is a schematic diagram of an exemplary cooling system known as a cascaded mechanical compression refrigeration system;

[0021] Figure 3A This is an isometric view of the applicator 200;

[0022] Figure 3B This is a cross-sectional view of the applicator 200;

[0023] Figure 3C With Figure 3B Cross-sectional views of the applicator 200 with different configurations shown;

[0024] Figure 4 This is a three-dimensional view of the microchannel 206 of the device;

[0025] Figure 5 This is an axonometric view of an exemplary disposable sterilization component 214 having a needle 215;

[0026] Figure 6A This is an exemplary square-circular contact surface of the heating element 220;

[0027] Figure 6B This is an exemplary configuration in which the heating element 220 is formed in a circular shape around a central region. Detailed Implementation

[0028] The principles and operation of the combined cryotherapy device and heating according to this disclosure can be better understood by referring to the accompanying drawings and description.

[0029] Figure 1This is a schematic diagram of a medical device 10 according to the present disclosure. The device comprises a main unit 100 and a handheld applicator 200. In the exemplary embodiment depicted in the drawings, the handheld applicator 200 is connected to the main unit 100 via a connector 300. The connector 300 includes power and signal cables, as well as conduits for supplying and discharging refrigerant to and from the applicator.

[0030] The main unit 100 includes a power module 110, a controller 120, a heating system 130, an optional communication module 140, a user interface 150, and a (vapor compression cascade) cooling system 160.

[0031] Power module 110 supplies power to the device. The power module may be connected to a power supply line. Additionally or alternatively, the power module may include a rechargeable battery. Alternatively, the power module may include electrical components known in the art for supplying power to a medical device.

[0032] Controller 120 controls all processes of the device. Controller 120 may be a microcontroller (MCU for a microcontroller unit), which is a small computer on a single metal-oxide-semiconductor (MOS) integrated circuit (IC) chip. Exemplarily, the microcontroller may include one or more CPUs (processor cores), as well as memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory, or OTP ROM, and a small amount of RAM may also be included on the chip.

[0033] In some implementations, the controller receives and interprets input from input peripherals (e.g., buttons, levers, knobs, dial pads, keyboards, mice, and / or touchscreen consoles) of the user interface 150 and sends relevant instructions to the applicator. Conversely, signals received from the applicator (e.g., temperature sensor values) and other components of the main unit are relayed to the controller, and relevant information is presented to the user via user interface devices (e.g., console displays, LEDs, etc.).

[0034] Heating system 130 provides heat to the end of the applicator, thus providing both heating and cooling to the applicator simultaneously. Any type of related heating device can be used herein. Therefore, a main unit with a heating system is optional, or it may simply refer to a heating control system that controls the heating element disposed in the handheld applicator. Heating system 140 can control various parameters such as temperature, heating configuration (see below for more details), power supply, safety parameters, etc. Alternatively, the heating system may actually generate heat and transfer it to the heating element in the applicator via connector 300.

[0035] Communication module 140 facilitates communication between the device and external entities. For example, communication module 140 may facilitate wired or wireless connections to the Internet. In another example, the communication component may communicate with an external computer (wired or wirelessly), for example, to receive software updates, instructions, protocols, and / or send reports. Any other communication device may be connected to and docked with device 10 via communication module 140. For this purpose, the communication module includes components and ports for receiving wired connections from external devices. Additionally or alternatively, the module includes wireless communication components for wirelessly connecting and docking with external devices. Wired and wireless communication components are well known in the art. Because medical device 10 may be a self-contained, stand-alone device that does not communicate with external devices, the communication module is optional.

[0036] User interface 150 includes all components that a user can use to provide input to and receive output from the device. As is known in the art, the user interface can be embodied on a console in the form of buttons, levers, knobs, dials, keyboards, mice / trackballs, and / or touchscreens. One or more integrated or separate screens can display output information for the user. Other indicators, such as flashing and various colored solid lights, can also provide information. These lights can be embodied in light-emitting diodes (LEDs) of different colors.

[0037] The user interface 150 may also include controls that allow activation, deactivation, and modification of various system parameters, such as refrigerant gas flow rate, pressure, and temperature. The console display can provide the operator with monitoring capabilities, in some implementations, to adjust the system to ensure its proper operation, and can provide real-time display of system parameters as well as recorded and historical displays.

[0038] The cooling system 160 is responsible for cooling the end of the handheld applicator. Figure 2 An exemplary cooling system, referred to as a cascaded mechanical compression refrigeration system 160 (also known as a vapor compression refrigeration system), is shown. The exemplary cascaded refrigeration system consists of two compression loops, each with an independent cycle. The exemplary refrigeration system is a freezing system using two refrigerants with different boiling points. Each refrigerant undergoes an independent freezing cycle, but these cycles intersect at a common heat exchanger.

[0039] The first cycle / loop is a high-temperature (HT) cycle, and the second cycle is a low-temperature (LT) cycle. The first cycle has a higher temperature than the second cycle. The components of the refrigeration system include: a high-temperature condenser 162, a high-temperature compressor 164, a high-temperature thermal expansion valve 166, and a low-temperature condenser 170, a low-temperature compressor 172, a low-temperature thermal expansion valve 174, and a low-temperature evaporator 176 during the low-temperature cycle.

[0040] After the cooled high-pressure liquid passes through expansion valve 166, an exemplary first cycle / loop (shown at the top) outputs a cold low-pressure liquid / vapor 168. During heat exchange, the cold liquid / vapor cools the hot high-pressure vapor 178 of the second cycle (shown below the first cycle) as it passes through heat exchanger 190, effectively cooling the high-pressure vapor 180 of the second cycle to a temperature lower than the high-pressure vapor 163 that is cooled in parallel (through condenser 164) in the first cycle. As a result, the cold low-pressure liquid 182 of the second cycle is even colder than the parallel cold low-pressure liquid 168 of the first cycle after passing through expansion valve 174. Essentially, by making the starting temperature of the cooled high-pressure liquid lower than that when cooled at ambient temperature or using a standard fan / condenser such as condenser 164, the cold refrigerant of the first cycle makes the cold refrigerant of the second cycle even colder. Evaporator 176 is disposed within applicator 200, and refrigerant fluid enters and exits the cooling system from the applicator via pipe 204 disposed within connector 300.

[0041] Although the above system uses two different refrigerants with two different boiling points, it is clear that using the same refrigerant in both cycles can achieve similar results.

[0042] Furthermore, while the above configuration is both efficient and relatively cost-effective, other configurations can also be used. For example, a standard single-compression cycle refrigeration system can be used instead of the aforementioned dual-cycle cascade system. Alternatively, three or more cycles can be used in similar cascade configurations to provide even lower temperatures. Regardless of the configuration, the coldest refrigerant is used to cool the applicator tip for cryotherapy applications.

[0043] Figure 3A and 3B An exemplary applicator 200 is shown in more detail. Figure 3A An isometric view of the applicator 200 is depicted. Figure 3B This is a cross-sectional view of the applicator 200. The applicator 200 is typically a handheld applicator. The applicator consists of a housing 202, an application tube 204, and a microchannel 206. A liquid flow (e.g., cold, low-pressure refrigerant) entering through the application tube 204 enters the microchannel 206, causing the fluid to evaporate and absorb heat from the surrounding area. For clarity, microchannels are preferred to further increase the cooling potential.

[0044] Reference Figure 4 Further discussion on microchannels. Figure 4 A three-dimensional view of the microchannel 206 of the device is shown. The microchannel, which has a large surface area to volume ratio, is cooled by a gaseous or liquid coolant. Cooling performance can be improved by modifying the walls of the microchannel with fins, pins, or grooves. One possible fin material for increasing the surface area of ​​the microchannel is carbon nanotubes, which possess excellent thermal and mechanical properties.

[0045] Refer to Figure 3A and 3B The evaporation process is carried out via a cold base 210 and an interchangeable applicator head 212. Although the exemplary embodiments depicted in the drawings and described herein include interchangeable applicator heads that can be removably placed with different applicator heads, it is clear that non-removable integrated applicator heads are also considered to be within the scope of this disclosure.

[0046] In a preferred embodiment, disposable sterilization component 214 ( Figure 3B (Not shown) It is detachably connected to the applicator head 212 (see Figure 3C and Figure 5 When the disposable component 214 (which is in thermal contact with the applicator head 212, which in turn is in thermal contact with the cold base 210) comes into contact with the skin (target tissue), a heat transfer process (evaporation) occurs, causing the temperature of the target tissue to drop to as low as 10°C, or even below -70°C. Heat is transferred to the cold base and conducted to the gas pipe, heating the refrigerant in the pipe, which is then circulated back into the cooling system for recooling.

[0047] In embodiments without disposable parts, interchangeable applicator heads come into contact with the target tissue. In such embodiments, the heating element 220 either shares a common contact surface with the applicator head or is disposed behind the applicator head contact surface 218 (i.e., inside the applicator head).

[0048] The interchangeable applicator head 212 can be of various sizes and shapes. Figure 5 The most visible part of the applicator head is tapered (actually a truncated tapered shape). The contact surface can be square, rectangular, or virtually any shape, depending on the requirements. Interchangeable applicator heads are attached to the applicator body by sliding the notch 216 into the groove 208 on the applicator housing. The applicator head is preferably made of a material that conducts heat efficiently and effectively.

[0049] The applicator 200 also includes a heating element 220. As described above, the heating element can be positioned in different locations depending on the implementation of the device. Figure 3C A cross-sectional view of the applicator 200 is disclosed, which has the same characteristics as... Figure 3B The different configurations of the applicator are shown. Except for the location of the heating element 220 (behind the contact surface 218 and inside the interchangeable applicator head 212), Figure 3C Applicator 200 and Figure 3B The applicator is the same.

[0050] Figure 3C It also depicts Figure 3B The disposable (i.e., single-use) component 214 is not shown. The disposable sterile component 214 can be manufactured in different sizes and adjusted according to the required area and size. The disposable component is the interface element between the target tissue and the applicator. Once used on the target tissue (e.g., a wart), the component is preferably discarded to increase hygiene.

[0051] Optionally, the disposable sterilization component 214 may be supplemented with an ethanol-infused gauze (or other impregnable material) cover, which serves as an intermediate fluid layer to improve heat transfer (from the heating element discussed below). Tangentially, ethanol also serves as a disinfectant to prevent infection of the treatment area.

[0052] Figure 5 An axonometric view of an exemplary disposable sterilization component 214 with needle 215 is shown. In a preferred embodiment, component 214 is augmented with one or more sharp elements 215 (e.g., needles). The one or more sharp elements penetrate the treatment area to improve heat / cold conduction to the target tissue. Heat and / or cold can be conducted to the treatment area through the sharp elements.

[0053] exist Figure 5 In the illustrated embodiment, a heating element 220 is disposed between the conical applicator head 212 and the disposable component 214. A wire 230 connects the heating element 220 to a heating control system 130 in the main unit 100. Exemplarily, the heating element 220 is secured to the applicator head via a slider (or similar) device. The slider (not shown) is in a first position where the heating element is in contact with the applicator head and a second position where the heating element is separated from the applicator head.

[0054] Disposable sterile components 214 can be pre-packaged in a sealed package. In a preferred embodiment, the package can be a foil-lined package filled with ethanol, such that the disposable component is immersed in ethanol to improve heat / cryogenic conductivity. For optimal results, the sharp elements 215 must be close enough to each other to hold the ethanol droplets between the elements. Even if the sharp elements are non-porous, the liquid will not succumb to gravity due to intermolecular forces (capillary action) between the liquid and the surrounding solid surface. The combination of surface tension (caused by cohesive forces within the liquid) and adhesive forces between the liquid and the non-porous elements holds the liquid in place.

[0055] The heating element 220 may include one or more heating components 222, which may be activated to heat the entire surface or only a portion of the surface. Figure 6A and 6B An exemplary embodiment of the heating element 220 is shown. Typically, the heating element is positioned between the cold base 210 and the disposable component. In a preferred embodiment, thermal paste may be applied between the applicator head and the disposable component. Exemplarily, the disposable component may have thermal paste pre-applied to the device-facing surface of the component. Preferably, the thermal paste is covered with a non-stick layer that is peeled off before attaching the disposable component to the applicator tip. Thermal paste is a thermally conductive compound commonly used as an interface between heat sinks and heat sources (e.g., high-power semiconductor devices). The primary function of thermal paste is to eliminate air gaps or spaces in the interface region to maximize heat transfer and dissipation.

[0056] In a preferred embodiment, the single-use disposable component includes a leg with a protrusion (not shown) for locking the component into a corresponding groove (not shown) on the applicator head. In some embodiments, the heating element can be mechanically detached from the cold base, for example by manipulating a sliding device through which the heating element is connected to the applicator end / head.

[0057] As described above, the heating element can be configured to heat the entire surface (e.g., as...). Figure 5 (As shown) or only the selected area can be heated. For example, the contact surface can include areas of different shapes for both cooling and heating.

[0058] Various alternative configurations can be implemented in the heating element. Figure 6AAn exemplary grid-like circular contact surface of the heating element 220 is depicted. The heating element has a grid configuration, where “black” squares are connected to a first heating element / circuit 222, and “white” squares are connected to a second heating element / circuit 224. The heating system 130 controls the “pattern” of the heated heating element 220. The pattern refers to the geometric pattern formed by one or more elements 222, 224 and the intervals / cycles (if any) at which the geometry of the heating element 220 is heated. The medical device 10 can use the heating element to repeatedly cryogenically freeze and thaw a target area within a short period of time to accelerate the thawing process.

[0059] There are many ways to implement the heating element 220. An exemplary configuration may include one or more heating elements 222 connected to the inner surface 230 of the applicator head 212. The heating element 222 may include leads 230 for operative connection to a current source. The heating element may consist of one or more resistors. Alternatively or additionally, the heating element may be implemented as or include radio frequency (RF) contacts. In fact, any heating mechanism, alone or in combination with other heating mechanisms, is within the scope of this disclosure.

[0060] In some currently preferred embodiments, the current source may be integrated with and located within the heating system 130. The heating element 222 may also be connected to a thermal cutoff (not shown), which may also be fixed to the inner surface of the applicator head 212. If the temperature in the system rises to an abnormal or unsafe level, the thermal cutoff will sense the change and disconnect the circuit. A thermocouple (not shown) may also be included to transmit temperature measurements from the applicator heads 212 to 230 to the main unit 100. The thermocouple may be encased in the heating elements 222, 224, or it may be attached to the inner surface of the applicator head 212 and "float" within the applicator head 212.

[0061] Special features

[0062] Device 10 is specially designed to maintain a low temperature while continuously absorbing heat in the treatment area. The temperature gradient between the hot and cold areas further enhances the efficacy of the treatment, as the gradient between heat and cold is highly effective in inducing tissue necrosis.

[0063] This disclosure is described herein as a medical device for treating skin diseases using unique temperature-controlled specifications. However, the device disclosed herein may also be used in electrical equipment / plastics / other manufacturing processes and / or other applications.

[0064] According to a preferred embodiment, a combination of heating and cooling is provided simultaneously during application. Alternatively or additionally, the treatment method employs a process of switching between cooling and heating zones.

[0065] According to the implementation, the temperature distribution of the cooling and heating system is automatically controlled. For example, the device can be set to cool to -70°C within 3 minutes and then quickly rise to 50°C. Such a process can be repeated rapidly. Cooling and heating cycles like this can be programmed into the device, for example, via a user interface or external device (e.g., running a software application [app] for controlling device 10). For this purpose, the controller 120 can be configured to provide instructions (programs) for controlling the temperature distribution of the cooling and heating system. The temperature distribution refers to desired hot and cold parameters, possibly the desired time limits for reaching these temperatures, and the desired time during which these temperatures are applied to the target area. Furthermore, the instructions include the number of times such a temperature distribution is applied.

[0066] Another treatment method involves acupuncture during heating and / or cooling.

[0067] The communication module 140 may be adapted to connect to a network (such as the Internet or a private medical network) to retrieve data on methods of performing cryotherapy, which will be used as an immediate device to apply a combination of heat and cold to a target area.

[0068] Similarly, the communication module 140 may be adapted to connect to a network to update a database of application examples of cryotherapy. This database may be a medical insurance database used for billing insurance companies and / or reimbursing patients.

[0069] The instantaneous device 10 is designed to continuously absorb heat from the treatment area while maintaining a low temperature, unlike other devices where the treatment area can affect the device's temperature.

[0070] Instantaneous devices can be used for hair removal. For this purpose, the process involves a combination of simultaneous heating and cooling. Figure 6B An exemplary configuration is depicted, in which the heating element 220 is formed in a circular shape around a central region. Thus, the center of the disposable part 214 is cooled to an extremely cold temperature (low temperature), while the surrounding area is heated by the heating element 220. The low temperature destroys the hair follicles, while the warm area protects the skin from damage. In a preferred embodiment, each hair follicle is identified using image processing methods employing a camera or 3D camera. After identifying the hair follicles, an automated mechanism moves the applicator head from one follicle to another. In this embodiment, the applicator is not handheld but mounted on a robotic arm or other robotic hand. The hair removal method can also be used for light-colored hair.

[0071] In other embodiments, the handheld applicator and main unit can be integrated into a single housing. A single handheld device comprising both the main unit and the applicator can use alternative technologies to cool the applicator tip, which requires less space than the vapor compression refrigeration described below as part of device 10. One such technology is the Peltier cooler, a small and flexible solid-state refrigerator. For a given cooling capacity (typically less than vapor compression refrigeration), such coolers suffer from high cost and low power efficiency. However, the field of thermoelectric cooling continues to develop and improve, enabling similar handheld (i.e., single-unit) devices. Currently, the single handheld device according to the above configuration is not as efficient or effective as the vapor compression-based embodiments described above.

[0072] Peltier coolers can also be cascaded into multi-stage systems to achieve even lower temperatures. In this arrangement, the hot side of a first Peltier cooler is cooled by the cold side of a larger second Peltier cooler, which in turn is cooled by the cold side of an even larger Peltier cooler, and so on. Efficiency decreases very rapidly with increasing number of stages, but for very small heat loads, down to near-low temperatures, this is often an effective solution due to its compactness and low cost. All the above features, explanations, and details are modified as necessary for implementations of a single unit.

[0073] It is clear that any component, mechanism, combination of features, method, and process disclosed with respect to one embodiment can be applied, equivalently or similarly, with necessary modifications, to any other embodiment of the combination of embodiments.

[0074] Although this disclosure has been described with reference to a limited number of embodiments, it should be understood that many variations, modifications, and other applications can be made to this disclosure. Therefore, the disclosure as set forth in the appended claims is not limited to the embodiments described herein.

Claims

1. A medical device comprising: Cooling system; Heating system; as well as An applicator comprising a cold base operably connected to the cooling system and a heating element operably connected to the heating system, wherein the cold base is adapted to cool the tip of the applicator and the heating element is adapted to provide heat to the tip of the applicator, and an applicator head for use with the cold base and the heating element, the applicator head having a contact surface including differently shaped areas for cooling and heating, the applicator head being adapted to apply a simultaneous combination of heat and cold to a target area, thereby affecting a temperature gradient between the hot and cold areas.

2. The medical device according to claim 1, wherein: The target area is a target tissue.

3. The medical device according to claim 1, wherein: The cooling system is a vapor compression refrigeration system.

4. The medical device according to claim 1, wherein: The cooling system is a cascade vapor compression refrigeration system.

5. The medical device according to claim 1, wherein: The cooling system includes one or more thermoelectric coolers.

6. The medical device according to claim 3, wherein: The cold base and the heating element are in thermal contact with the applicator head, and the cold base is in thermal contact with and cooled by a conduit adapted to receive a cold low pressure fluid such that when the applicator head is in contact with the target area, the target area is cryogenically cooled; and Wherein the heating element is actuated to provide location-specific heat to the target area while the target area is cooled.

7. The medical device according to claim 1, wherein: A disposable component is removably connected to the applicator head such that the disposable component is adapted to contact the target area.

8. The medical device according to claim 7, wherein: Ethanol is applied to a surface of the disposable component adapted to contact the target area.

9. The medical device according to claim 7, wherein: The disposable component is filled with one or more sharp elements adapted to transfer heat and cold to the target area.

10. The medical device according to claim 9, wherein: The sharp element is a needle.

11. The medical device according to claim 7, wherein: Thermally conductive paste is applied between the applicator head and the disposable component.

12. The medical device according to claim 11, wherein: The thermally conductive paste is applied between the heating element and the disposable component.

13. The medical device according to claim 1, wherein: The heating element is secured to the applicator head via a slide arrangement having a first position in which the heating element is in contact with the applicator head and a second position in which the heating element is separated from the applicator head.

14. The medical device according to claim 1, wherein: The heating elements are arranged in a geometric shape.

15. The medical device according to claim 1, wherein: The heating element comprises more than one heating component.

16. The medical device according to claim 1, wherein: The applicator head is an interchangeable applicator head that is removably connectable to the applicator.

17. The medical device according to claim 1, wherein: The heating system and the cooling system are provided in a main unit, and the applicator is operably connected to the main unit via a connector.

18. The medical device according to claim 1, wherein: The heating system, the cooling system and the applicator are provided in a single unit.

19. The medical device according to claim 9, wherein: A plurality of the sharp elements are disposed sufficiently close to each other to support capillary action therebetween.

20. The medical device of claim 1, further comprising a controller configured to provide instructions for controlling a temperature profile of the cooling system and the heating system.

21. The medical device according to claim 20, wherein: The instructions include a number of times to apply the temperature profile.

22. The medical device of claim 1, further comprising a communication module adapted to connect to a network to retrieve data regarding a method of applying the simultaneous combination of heat and cold to the target area.

23. The medical device of claim 1, further comprising a communication module adapted to connect to a network to update a database of instances of applying the simultaneous combination of heat and cold to the target area.

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