Device and method for treating part of human body

Abstract

A system for treating at least a part of a human body, comprising: one or more generators configured to generate a radio frequency signal and a pulsed electric field (PEF) signal; one or more applicators electrically coupled to the one or more generators and configured to transmit a radio frequency field and a PEF to at least a part of the human body based on the radio frequency signal and the PEF signal from the one or more generators; and at least one control unit in communication with the one or more generators and / or the one or more applicators and configured to control transmission of at least one of the radio frequency field and the PEF to at least a part of the human body. An applicator for treating at least a part of a human body and a method of treating at least a part of a human body are also disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 345,469, filed on May 25, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to apparatus and methods for treating at least a region of the human body by applying a combination of radiofrequency energy and electric fields to tissue of at least the region of the human body. Background Art

[0004] The human or animal body is covered by skin. The skin tissue on the surface of the human or animal body includes the epidermis, dermis and subcutaneous tissue. The epidermis is the outermost layer of the skin and the thinnest layer. The second layer is called the dermis, which includes connective tissue, reticular fibers, hair follicle roots, lymphatic vessels, collagen tissue and nerves. The third layer of the skin is sometimes called the subcutaneous tissue, which is the lowest layer of the skin and may contain fat that forms subcutaneous white adipose tissue. The body cavity includes more or less differentiated layers and may include, for example, mucosal tissue. For example, the tissue layers in the vaginal cavity include epithelium, lamina propria (with similar components to the dermis), muscle and adventitia.

[0005] Recently, so-called staged treatment of tissues (e.g., skin, adipose tissue or mucosal tissue) has been introduced. This treatment uses the effect of point-like spatially defined tissue damage to induce the natural healing process in the tissue. The spatially defined area of ​​damaged tissue is usually surrounded by undamaged tissue. This tissue damage is usually achieved by using electromagnetic energy (e.g., laser) or, for example, radio frequency (RF) energy (e.g., RF field), which can be transmitted by surface or invasive surface energy transmission elements, for example, by flat or needle-shaped energy transmission elements placed on an applicator. The RF field can be transmitted in a monopolar or bipolar manner, and the distance between the specific energy transmission elements of the applicator can ensure spatially defined (partial) skin damage. In such a process, the RF field causes the temperature in the tissue area adjacent to the energy transmission element to rise to a certain limit (e.g., the coagulation limit) above, thereby killing tissue cells (e.g., by necrosis, e.g., coagulative necrosis) and damaging or damaging (e.g., by coagulation) the non-cellular structures in the area. Then, this damaged tissue is repaired by the natural healing process, especially driven from the cells of the undamaged area outside the damaged area.

[0006] RF stage treatment has some disadvantages. The undamaged cells outside the damaged area, or at least some of the undamaged cells therein, may already be relatively old or may be senescent. Such old or senescent cells may not be able to effectively drive the healing process compared to young cells. It would then be advantageous to replace the old or senescent cells with new cells in the undamaged area. However, replacing the old or senescent cells by killing them with heat caused by the RF field is clearly not optimal, as the heat may cause cell necrosis and may damage non-cellular structures in undesirable areas, which may result in an even longer healing process. Therefore, current methods and devices need to be improved to provide new or better treatment results. Summary of the invention

[0007] Disclosed herein are therapeutic devices and methods, particularly devices and methods for treating at least a portion of a human body by radiofrequency (RF) energy (e.g., by RF fields) and electric fields (e.g., by pulsed electric fields (PEF)). The combined application of RF fields and pulsed electric fields (PEF) has a surprisingly positive synergistic effect that can provide advantages over current methods that use only RF energy by addressing and resolving the above-mentioned problems and by improving the quality, efficacy, and reliability of the methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Exemplary aspects of the present disclosure are illustrated by way of example in the accompanying drawings, in which like reference numerals designate the same or similar elements, and in which:

[0009] Figure 1 is a block diagram of an exemplary system.

[0010] Figure 2 An overview of an exemplary applicator is provided.

[0011] Figure 3 An example of a distal end of an applicator having a surface energy delivery element is shown.

[0012] Figure 4 Another example of a distal end of an applicator is shown, this time with an invasive energy delivery element.

[0013] Figure 5 Examples of applicators with invasive and surface energy delivery elements are shown.

[0014] Figure 6 Details of exemplary invasive energy delivery elements are shown.

[0015] Figure 7 A portion of an exemplary RF treatment protocol is shown.

[0016] Figure 8 A portion of an exemplary PEF treatment regimen is shown.

[0017] Fig. 9 is an example of a combination of RF pulses and PEF pulses in one approach.

[0018] Fig.10 An example of an exemplary PEF generator is shown. DETAILED DESCRIPTION

[0019] Combining the application of RF energy (e.g., RF field and PEF) can bring advantages to the process of treating at least a part of the human body, for example, the treatment of skin, mucosal tissue or fat tissue. As described above, RF treatment (e.g., so-called staged RF treatment) includes transmitting an RF field (e.g., at least one AC current pulse (RF pulse)) into the tissue, damaging the tissue by heating to a high temperature, for example, by heating to 43-120° C. or 50-95° C. or 60-85° C. The high temperature can cause blood coagulation of, for example, cells and non-cellular structures (e.g., collagen and / or elastin). Treatment using an electric field (e.g., a pulsed electric field (PEF)) includes transmitting, for example, at least one direct current (DC) electric pulse (PEF pulse), which can mainly affect cells while avoiding damage to non-cellular structures. Cells may not be mainly damaged by high temperatures (in this treatment process, the tissue temperature may not exceed 42° C.), but by a process called electroporation of the cell membrane. Tissue damage caused by RF treatment can be spatially defined (staged) because the application of RF fields can heat and thereby damage cells and non-cellular structures in a tissue region (zone) immediately adjacent to the energy delivery element, while tissue damage caused by PEF treatment can be more continuous because the electric field can be more uniform compared to the RF field. The combined application of these two treatments (RF and PEF fields) can produce at least one first region in the treated tissue where cells and non-cellular tissue are damaged by high temperatures (cells may die, for example, by necrosis) and a second region where cells may be damaged by electroporation of the cell membrane and may die, for example, by apoptosis. The first region may extend near and / or around at least one energy delivery element. The second region may intersect with the first region, or may be separate from the first region and may extend beyond the region (zone) of tissue damaged by RF.

[0020] Cells (e.g., cells in the second region of the treated tissue) that are damaged by electroporation of the cell membrane (particularly, for example, old or senescent cells) can be rapidly replaced by new cells, which can then drive the healing process in the treated tissue including the first region, for example, by generating new non-cellular structures in the treated tissue including the first region.

[0021] Although electroporation of the cell membrane has been described as the main trigger of cell death after application of PEF, actual cell death may also be caused by, for example, electrical breakdown of the mitochondrial or nuclear membrane; direct tearing of individual cells (or groups of cells) of the tissue by the electric field or mechanical damage; by cell myolysis; by wrinkling of the cells directly under the influence of the electric field or by mechanical damage; irreversible damage to the calcium cycle; for example, calcium overload caused by non-physiological function of one or more calcium channels; or by the formation of reactive oxygen species (ROS) and subsequent oxidation of membrane phospholipids by the electric field. In addition, cells can be killed by a combination of elevated temperature and PEF, where temperature alone is not sufficient to kill the cells.

[0022] like Figure 1 As shown, the system (100) according to the present invention may include one or more generators (120) suitable for providing a radio frequency (RF) signal suitable for generating an RF field (RF signal) - an RF generator (122), and / or suitable for providing an electric signal suitable for generating a pulsed electric field (PEF signal) - a PEF generator (124). The system (100) may also include at least one control unit (101), at least one applicator (102), at least one power supply unit (103), a data storage unit (104), at least one switch unit (110) and at least one user interface unit (105). Other parts may also be included, for example, a cooling unit (106) suitable for cooling a part of the system (100) or at least a part of the human body, or a fluid transfer unit (107) suitable for transferring a fluid near at least a part of the human body.

[0023] At least one control unit (101) can be communicatively coupled to one or more generators (120), a switch unit (110) and / or at least one applicator (102), for example, to control the provision of at least one of an RF signal and a PEF signal from the one or more generators to at least one energy delivery element, and thereby control the delivery of at least one of an RF field and a PEF to at least a part of the human body according to a treatment regimen. The at least one control unit can further be communicatively coupled to a user interface unit (105), from which the control unit can receive instructions. The at least one control unit can also be communicatively coupled to other parts of the system (100), for example, to at least one power supply unit (103), a cooling unit (106) and / or a fluid delivery unit (107), or, for example, to at least one sensor included in the system (100). The control unit (101) can include, for example, a microprocessor and / or a memory.

[0024] The user interface device (105) may be configured to communicate with a person, for example, an operator of the system (100), and may be used as a communication interface for the system (100). The user interface device may be configured to receive instructions from an operator and / or present information to an operator. The communication may, for example, include graphical communication via, for example, at least one display unit, audio communication via, for example, at least one microphone and / or at least one speaker, or tactile communication via, for example, at least one touch display, keyboard, mouse, knob, joystick or other similar device suitable for tactile communication.

[0025] The at least one power supply unit (103) may include, for example, an energy source, for example, a connection to an electrical grid or to at least one battery (108). The at least one power supply unit may also include an AC / DC adapter and / or may be electrically coupled to one or more generators (120) and other parts of the system (100), in particular to parts requiring electrical energy, for example, to the control unit (101), the user interface unit (105), the switch unit (110) and / or to at least one applicator (102), and may provide electrical energy thereto.

[0026] The entire system (100) may be contained in a single device, or may be divided into several separate devices. The system may also be connected to a network, such as the Internet or a data server, via a network connection (109) (e.g., via Ethernet or Wi-Fi). The system may include a data storage, for example, the data storage includes a database, however, the database may be stored externally, for example, in a data server, and may be reached via a connection to the network. The database may, for example, include a treatment plan, a treatment database, a parameter (e.g., treatment parameter) database, and / or a patient database.

[0027] The system (100) may include one or more generators (120) adapted to provide a radio frequency (RF) signal suitable for generating an RF field (RF signal) - an RF generator (122), and / or adapted to provide an electrical signal suitable for generating a pulsed electric field (PEF signal) - a PEF generator (124). The system (100) may include a single generator (120) configured to provide RF and PEF signals, or the system may include more than one generator (120), for example, at least one RF generator (122) and at least one PEF generator (124). The one or more generators (120) may be electrically coupled to at least one applicator (102), for example, to at least one energy delivery element and a power supply unit (103). The generator may be communicatively coupled to other parts of the system (100), for example, to a control unit (101), a user interface unit (105), an applicator (102), etc. One or more generators (120) may also be coupled to the cooling unit (106) (eg, via a fluid connection).

[0028] The RF generator provides an RF AC signal to at least one energy delivery element, which generates an RF field based on the RF signal from the RF generator and applies (delivers) it to at least a part of the human body to induce heating in the target tissue. The RF generator may have the following exemplary characteristics—the acceptable load may be 10Ω-15000Ω, the rated load may be 50Ω-5000Ω, and the rated RF power may be from 1W to 500W.

[0029] The PEF generator provides a direct current (DC) electrical signal to at least one energy transfer element. At least one transfer element generates an electric field, such as a PEF, and applies (transmits) it to at least a part of the human body to cause electroporation of cell membranes in the treated tissue. The PEF generator may have a power input of 0.01 W to 600 W and a power output of 0.01 W to 500 W. The PEF generator may include a Marx-type generator and / or at least one transformer. The pulse generator may allow for setting, for example, the pulse width, amplitude, shape of the PEF pulse and / or the number of pulses during activation. The pulse generator or other parts of the device may be capable of measuring electrical waveform quality, power, impedance, current, voltage, temperature and / or other variables.

[0030] The PEF generator may be, for example, a Marx-type generator, for example, with semiconductor switches. The generator may include a plurality of capacitors and a plurality of switches. The capacitors are charged in a parallel configuration and discharged in a series configuration. The generator may have a single-phase configuration for generating only positive or negative pulses, or a two-phase configuration for generating alternately positive and negative pulses. Fig.10An example of an exemplary PEF generator (124) is shown. The PEF generator (124) is based on a Marx-type generator with semiconductor switches. The exemplary design includes a plurality of common integrated pulse voltage multiplier stages (1001) (generator stages), wherein each voltage multiplier stage (1001) includes a single storage element (1003) (e.g., a capacitor) and a plurality of semiconductor switches (S 1x -S 8x ). Compared to two unipolar generators, the exemplary PEF generator (124) can have a more compact design. The PEF generator (124) can have one input (V i1 ) and an output (V o1 ), in one input, V i1 is the DC voltage input to the generator, at one output, V o1 is the high voltage output from the generator. The PEF generator (124) may also have two ground terminals (V i2 , V o2 ). The number of voltage multiplier stages (1001) included in the PEF generator (124) depends on the desired pulse voltage (amplitude), for example, from 2 to 30 or from 3 to 10. The exemplary PEF generator (124) uses all storage elements (1003), and therefore all voltage multiplier stages (1001) included in the PEF generator (124), to generate monophasic (positive and negative) and biphasic pulses.

[0031] In order to charge the positive pulse PEF generator (124), the switch S 5x and S 8x is non-conductive, while all other switches in all voltage multiplier stages (1001) are conductive. During the positive charging phase, the output (V o1 ) is disconnected (e.g., the applicator or energy transfer element is disconnected from the PEF generator (124)). This configuration allows the storage element (1003) to be charged in parallel mode from the positive side (in this case, the B side of the storage element (1003)) to the negative side (in this case, the A side of the storage element (1003)). In order to send a positive pulse from the PEF generator (124) to the output (V o1 ) discharge, switch S 7x and S 8x The A side (1001) is conductive, while all other switches in all voltage multiplier stages (1001) of the PEF generator (124) are non-conductive. In this configuration, the storage element (1003) is serially discharged in the opposite direction compared to the positive charging phase from the A side (positive at this time) to the B side (negative at this time).

[0032] In order to charge the negative pulse PEF generator (124), the switch S 6x and S 7x During the negative charging phase, the output (V o1 ) is disconnected again (possibly disconnecting the applicator or energy transfer element from the PEF generator (124)). All other switches in all voltage multiplier stages (1001) are conductive. The storage element (1003) is charged again in parallel mode, but in the direction from side A (positive this time) to side B (negative). To discharge the negative pulse from the generator in series, switch S 7x and S 8x The storage elements (1003) are again discharged in series in the opposite direction compared to the negative charging phase from the B side (positive at this time) to the A side (negative at this time).

[0033] The switches in the generator may be semiconductor switches such as MOSFETs (Metal Oxide Semiconductor Field Effect Transistors). This type of switch is very fast, which allows the PEF generator (124) to generate very short DC pulses with a pulse width of nanosecond length, for example, starting from 2 ns. However, the semiconductor switch may be replaced by another type of switch, for example, a relay. In the switch S 1x , S 2x and S 3x , S 4x In the case where the switches are replaced by another type of switch (e.g., a type that does not include a diode, such as a relay), the number of switches can be reduced in such a way that S 1x , S 2x can be replaced by only one switch in a voltage multiplier stage (1001), S 3x , S 4x The pair can be replaced by another switch within a voltage multiplier stage (1001).

[0034] The switch unit may be coupled to the at least one generator and the at least one applicator. The switch unit may be configured to switch between transmission of an RF signal and a PEF signal provided by the at least one generator to the at least one energy delivery element. The switch unit may include at least one switch or a relay.

[0035] The system may also include at least one applicator (102). The applicator may be adapted to engage at least a part of the human body. The system may also be adapted to transmit the RF field and / or PEF to at least a part of the human body. The applicator may also be adapted to be manually operated (manipulated) by a person (e.g., by an operator), or may be adapted to be operated without manual manipulation, for example, may be automatically operated. The system may also be fixed. The system may also include at least one device for attaching to at least a part of the human body, for example, a strap, a clip, a cuff, a button, a pin, an adhesive surface, a suction device, etc. The applicator may be electrically coupled to or include one or more generators and / or one or more switch units. The applicator may further be electrically coupled to a power supply unit, or may include its own energy source, for example, at least one battery. The applicator may be communicatively coupled to or include other parts of the system, for example, a control unit, a user interface unit, a data storage device, a network connection, a sensor, etc. Other couplings of the applicator to the system are also possible, for example, coupling to a cooling unit, a fluid transfer unit or a fluid of the cooling unit, and / or the fluid transfer unit may be part of the applicator. The applicator may also include, for example, one or more handles. The applicator may also include at least one portion adapted to engage at least a part of the human body, e.g., skin, subcutaneous tissue, dermal tissue, adipose tissue, or mucosal tissue. The at least one portion adapted to engage at least a part of the human body may be completely non-invasive (e.g., adapted to engage at least a part of the human body by contacting only a surface), or may include an invasive portion or element (e.g., adapted to be inserted into tissue of at least a part of the human body, e.g., skin, subcutaneous tissue, dermal tissue, adipose tissue, or mucosal tissue). The system may include one applicator, e.g., adapted to transmit an RF field and / or PEF, or may include multiple applicators adapted to transmit an RF field and / or PEF.

[0036] The applicator may include at least one energy transmission element, which is included in a portion suitable for engaging with at least a part of the human body. The energy transmission element may be, for example, at least one electrode, may include at least one electrode, may be a part of at least one electrode, or may be coupled to at least one electrode. The energy transmission element may be configured to receive signals from an RF generator or a PEF generator, and generate RF fields and / or electric fields, particularly PEFs, based on these signals, and apply (transmit) the RF fields and / or PEFs to at least a part of the human body to cause heating in the case of RF fields and electroporation of cell membranes in the case of PEFs. The energy transmission element may be configured to transmit the AC RF field continuously or in a pulsed manner to at least a part of the human body, and to transmit the DC electric field continuously or in a pulsed manner to at least a part of the human body in the form of PEFs. The energy transmission element may be surface, for example, suitable for engaging at least a part of the human body by only touching the surface. For example, the energy transmission element may take the form of a surface electrode or a surface pin. Before applying at least one of the RF field and the PEF, the surface energy transmission element does not penetrate the tissue. On the other hand, the energy delivery element can be invasive, for example, suitable for insertion into tissue of at least a human body part, such as skin, subcutaneous tissue, dermal tissue, adipose tissue or mucosal tissue. For example, the energy delivery element can take the form of a needle or a blade or any type of sharp protrusion suitable for penetrating tissue. The invasive energy delivery element is suitable for penetrating tissue prior to applying at least one of the RF field and the PEF.

[0037] In some cases, the surface energy delivery element can be used for invasive application of at least one of the RF field and the PEF. For example, the surface pins can first contact the tissue without any penetration during treatment or application of at least one applicator, but during or after delivery of at least one of the RF field and the PEF, the surface pins can at least partially penetrate the tissue.

[0038] At least one applicator may include one type of energy delivery element or may include multiple types of energy delivery elements. For example, one or more energy delivery elements included on an applicator may be invasive. In another example, one or more energy delivery elements included on an applicator may be surface. It is also possible to combine at least one surface energy delivery element and at least one invasive energy delivery element on one applicator.

[0039] On the other hand, one or more energy delivery elements included on the applicator may be suitable for delivering RF fields and PEF, or the applicator may include more than one energy delivery element, each energy delivery element being suitable for delivering at least one of RF fields and PEF. For example, the applicator may include one or more energy delivery elements suitable for delivering RF fields and another one or more energy delivery elements suitable for delivering PEF. The applicator may also include at least one energy delivery element configured to deliver RF fields and PEF and at least one other energy delivery element configured to deliver RF fields or PEF, or the applicator may include a combination of all described energy delivery elements. For example, the applicator may include at least one invasive energy delivery element suitable for delivering RF fields and at least one surface energy delivery element suitable for delivering PEF, or vice versa.

[0040] exist Figure 2 An example of an applicator (102) adapted to engage at least a part of a human body (e.g., skin) can be seen in . The exemplary applicator may include a proximal portion (201), which may, for example, be adapted to engage with an operator's hand. The proximal portion (201) may be a handle, or may include a handle, and may include at least one connection (202), for example, an electrical connection to at least one generator, for example, a communication connection to a control unit, a user interface unit, or a data storage device. The applicator may also be coupled to a cooling unit, for example via a fluid connection, and / or may be fluidly coupled to a fluid transfer unit. The distal portion (204) of the applicator may include a portion adapted to engage at least a part of a human body (e.g., skin), and may include at least one energy transfer element (203).

[0041] The entire applicator or at least a portion of the applicator may be replaceable or disposable. For example, the distal portion (204) of the applicator or at least a portion thereof may be replaceable or disposable, for example, a portion adapted to engage at least a portion of a human body comprising an energy transfer element. A replaceable portion is any portion of the distal portion that is removable from the applicator and replaceable. The replaceable portion may, for example, be adapted to be sterilized and reused, or the portion may be disposable, meaning that, for example, the portion may be adapted only for a single use. The replaceable portion may be coupled to other portions of the applicator, wherein the coupling may include a mechanical device, for example, a locking mechanism, a snap mechanism (e.g., a pin and hole, a snap fit, a hook and hole), a threaded mechanism (e.g., a thread or screw), a bayonet, etc. The coupling may also include a magnet. The electrical leads between the replaceable portion (and therefore, at least one energy transfer element) and the other portions of the applicator should be adapted to replace the replaceable portion. The electrical leads may include, for example, at least one connector adapted to connect and disconnect during coupling and separation of the replaceable portion. The connector can be, for example, a deflectable connector, such as a spring-loaded connector, or can be another connector that allows safe and easy disconnection and connection during coupling and separation of the replaceable part, such as a magnetic connector. There can be a common connector between the replaceable part and other parts of the applicator, or there can be multiple connectors. For example, there can be a common connector suitable for connecting the RF signal lead and the PEF signal lead, or one or more (e.g., 1 to 50 or 2 to 40 or 3 to 20 or 4 to 15) RF signal leads and one or more (e.g., 1 to 20 or 2 to 16 or 3 to 14 or 4 to 12) PEF signal leads can have different connectors.

[0042] In some cases, the applicator may include some other parts of the system, for example, it may include at least one generator, at least one control unit, at least one user interface unit, a memory, at least one cooling unit and / or at least one fluid transfer unit. The applicator may also include, for example, a mechanism for extension / retraction of at least one energy transfer element, for example, a mechanism for manual extension / retraction or for electric extension / retraction, for example, a motor. The applicator may also include at least one sensor, for example, a temperature sensor, a position sensor, or an impedance sensor.

[0043] Figure 3An example of a distal portion (204) of an applicator (102) suitable for engaging at least a part of a human body (e.g., the skin) is shown. The distal portion includes a plurality of energy transfer elements, in this particular example, surface energy transfer elements (303) in the form of, for example, flat energy transfer elements or surface pins. The energy transfer elements can be all of one type, for example, configured to transfer RF fields and PEF, or there can be multiple types of energy transfer elements, some of which are suitable for transferring RF fields and other of which are suitable for transferring PEF. On the other hand, some of the energy transfer elements may be suitable for transferring RF fields and PEF, while some other of the energy transfer elements may be suitable for transferring only one of the RF field or the PEF. The number of energy transfer elements may be from 4 to 200, or from 6 to 120, or from 10 to 80. The maximum cross-sectional area of ​​the energy transfer elements may be, for example, from 0.05 mm 2 Up to 5mm 2 The surface of the energy transfer element can be, for example, from 0.05 mm 2 Up to 10mm 2 . In the example where the energy delivery elements are surface pins, the maximum diameter of the pins can be, for example, from 0.05 mm to 3 mm. The distance between specific energy delivery elements can be from 0.5 mm to 10 mm. All of the above dimensions can be consistent within an applicator or can be different. The surface (301) of the distal portion of the applicator including the energy delivery elements can be flat, or can be a shape that conforms to a specific part of the human anatomy (e.g., curved), for example.

[0044] exist Figure 4 , another example of a distal portion (204) of an applicator (102) adapted to engage at least a part of a human body (e.g., skin) is shown. The depicted example includes a plurality of energy delivery elements, in this particular example, invasive energy delivery elements (403) in the form of needles, for example. The energy delivery elements may be of one type, for example, adapted to deliver both RF fields and PEF, or there may be multiple types of energy delivery elements, some adapted to deliver RF fields and others adapted to deliver PEF. On the other hand, some energy delivery elements may be adapted to deliver both RF fields and PEF, while some other energy delivery elements may be adapted to deliver only RF fields or PEF. The number of energy delivery elements may be from 4 to 200, or from 6 to 120, or from 10 to 80.

[0045] The length of at least one energy delivery element may be fixed or adjustable (e.g., the energy delivery element may extend from at least one surface of the applicator), and thus, the depth to which the energy delivery element penetrates the tissue may be fixed or adjustable. In aspects having multiple energy delivery elements, wherein the length of the energy delivery element is fixed, all of the energy delivery elements may have the same length, or the energy delivery elements may vary in length. The length may vary, for example, from 0.1 mm to 20 mm, or from 0.2 mm to 15 mm, or from 0.3 mm to 10 mm. In examples where the length of at least one energy delivery element is adjustable, the possible range of lengths of the extended energy delivery element (the extended length measured from the tip of the energy delivery element to the surface of the applicator from which the energy delivery element extends) may be adjusted, for example, from 0.1 mm to 20 mm, or from 0.2 mm to 15 mm, or from 0.3 mm to 10 mm. The length or extension of the energy delivery element may be selected based on the intended use of the device and / or the intended area of ​​the human body in which the device should be used, for example, by the following non-limiting examples. For example, an energy delivery element extended to a certain length or having a length from 0.1 mm to 0.8 mm can be used for skin regeneration, senescent cell apoptosis, melasma treatment, hyperpigmentation treatment, PIH treatment, and / or rosacea treatment in a patient's facial area. An extension or length of an energy delivery element from 0.4 mm to 3 mm can be used for skin regeneration, senescent cell apoptosis, wrinkle reduction, skin tightening, stretch mark reduction, melasma treatment, rosacea treatment, and / or hyperhidrosis treatment in a patient's facial and / or body area. A retracted energy delivery element or an energy delivery element having a length of 3 mm to 10 mm can be used, for example, in a patient's body for wrinkle reduction, senescent cell apoptosis, skin tightening, stretch mark reduction, scar treatment, fat reduction, and / or cellulite reduction.

[0046] In examples with an extendable energy delivery element, it may be desirable to be able to limit the maximum possible extension length of the energy delivery element. This may be desirable, for example, for safety reasons. An example of such a situation may be the use of the device in a particular part of the human body where the extension of the needle beyond a certain distance may be uncomfortable for the patient or may cause injury or undesirable side effects. For example, when treating a patient in the facial area, the operator may want to limit the maximum length of the extended energy delivery element. The length (extension) and / or the maximum length (extension) may be set, for example, by the operator via a user interface unit. The setting may be performed and controlled, for example, by a control unit. However, for further safety, the device may, for example, include an adjustable mechanical barrier, for example, in the applicator, preventing the energy delivery element from extending beyond a certain predetermined maximum extension length. For example, for facial treatment, the barrier may be set to prevent the energy delivery element from extending beyond a length of 1 mm to 5 mm (e.g., to 2 mm). For treating the human body, the barrier may be set to prevent the energy delivery from extending beyond a length of 2 mm to 8 mm (e.g., to 4 mm). The barrier may, for example, be set by a setting device placed on the applicator, such as a knob, a dial, a lever or the like. The setting means may be continuously adjustable, or may be adjustable in steps, and / or may comprise several predetermined positions and markings identifying at least one predetermined maximum extension length.The barrier may comprise, for example, a mechanical stop.

[0047] In examples with multiple energy delivery elements, the distance between specific energy delivery elements can be 0.5 mm to 10 mm, which can be consistent or different within the applicator. Invasive energy delivery elements in the form of needles can have a diameter of, for example, from 0.05 mm to 2 mm, or from 0.1 mm to 1 mm, or from 0.15 mm to 0.5 mm, and can also be uniform or can vary within the applicator. The surface (301) of the distal portion of the applicator including the energy delivery elements can be flat or can be curved, for example, to conform to a specific part of the human anatomy.

[0048] As described above, in some examples, at least one energy delivery element may be adapted to deliver both an RF field and a PEF, or may be specifically adapted to deliver one of an RF field or a PEF. In various examples, multiple energy delivery elements may be physically identical (may have the same shape, configuration, size, chemical composition), or the physical form of the energy delivery elements may be different (at least one of the shape, configuration, size, or chemical composition may be different). In aspects having different energy delivery elements, the energy delivery elements may be included in one applicator and / or different applicators, for example, Figure 5An applicator (102) is shown, the distal portion (204) of the applicator comprising an invasive energy delivery element (403) and a surface energy delivery element (303).

[0049] All energy delivery elements may have the same electrical coupling to at least one generator, e.g., at least one control unit may ensure that the correct signal is distributed to the correct energy delivery element at the correct time. However, different energy delivery elements may have separate different couplings to at least one generator. For example, at least one energy delivery element suitable for delivering RF fields may have a separate coupling to at least one generator suitable for generating RF signals, and / or an energy delivery element suitable for delivering PEF may have a separate coupling to at least one generator suitable for generating PEF signals. In some aspects, at least one energy delivery element suitable for delivering PEF may have a different physical form than at least one energy delivery element suitable for delivering RF fields.

[0050] In aspects where at least one energy delivery element is invasive and extendable and / or has an adjustable length, the extension and / or retraction of the energy delivery element may be manually driven or may be electrically powered. A mechanism capable of extension and / or retraction may be included in the applicator, for example, in the proximal portion of the applicator. The extension and / or retraction may be controlled by a control unit and may be set, for example, via a user interface unit. An applicator may include at least one fixed energy delivery element and at least one extendable and / or adjustable energy delivery element, or may include only at least one fixed or at least one extendable and / or adjustable energy delivery element. In aspects where the applicator includes more than one extendable and / or adjustable energy delivery element, the control of extension and / or retraction may be common to all of these energy delivery elements, or may be controlled individually (extension and / or retraction), or, for example, the energy delivery elements may be organized into groups, and the extension and / or retraction may be controlled by several groups of energy delivery elements. For example, at least one energy delivery element adapted to deliver an RF field may be independently controlled on at least one energy delivery element adapted to deliver a PEF.

[0051] At least one energy delivery element (203) may be made of various materials suitable for delivering RF fields and / or PEF to at least a portion of a human body or in the vicinity thereof. Examples of such materials may be copper, gold, steel, titanium, platinum, platinum-iridium, silver, etc. Figure 6As shown, at least one energy delivery element (203) may be insulated (601), non-insulated (602), or partially insulated (603). In examples where more than one energy delivery element is included on the applicator, any combination of insulated, non-insulated, or partially insulated energy delivery elements is possible. For example, at least one energy delivery element suitable for delivering RF energy may be non-insulated or partially insulated, and at least one energy delivery element suitable for delivering PEF may be insulated, partially insulated, or non-insulated. In aspects where at least one energy delivery element (203) is an invasive energy delivery element (403) and has a needle form, partial insulation may mean that the tip of the needle is not insulated, while the rest of the needle is insulated. The non-insulated portion of the tip may account for several percent of the total length of the needle, for example, from 0.1% to 20% or from 0.5% to 15% or from 1% to 10%. However, partial insulation may also mean that the rest of the needle except the tip may be non-insulated. For example, along the length of the needle, the needle may have several insulated portions and several non-insulated portions. The insulation of the energy transfer element can be achieved by any suitable material, for example, by polyimide, polyurethane, polyester, polyvinyl chloride (PVC), rubber, rubber-like polymers, nylon, polyethylene, polypropylene, silicone, fiberglass, ceramic, ethylene propylene diene monomer (EPDM), different fluoropolymers (e.g., polytetrafluoroethylene (PTFE)), etc. In some examples, a combination of different insulating materials is possible. For example, in an example with an invasive energy transfer element, the tip portion can be coated with a hard material, such as a ceramic that can withstand damage due to wear and tear, while the rest of the energy transfer element can be coated with a different material, such as polyimide, polyurethane, polyester, polyvinyl chloride (PVC), rubber, rubber-like polymers, nylon, polyethylene, polypropylene, silicone, fiberglass, ethylene propylene diene monomer (EPDM) or different fluoropolymers, such as polytetrafluoroethylene (PTFE).

[0052] In examples where multiple energy transfer elements are included in the applicator, the energy transfer elements may be arranged in rows or circles, or appear to be random. The energy transfer elements may form an array together. An exemplary array of energy transfer elements may include from 2 to 100 rows, with 2 to 100 energy transfer elements in a row. An example of an array of transfer elements may include, for example, two rows of energy transfer elements, wherein each row includes 2 to 4 energy transfer elements. The distance between rows may be from 2 mm to 8 mm, and the distance between energy transfer elements in a row may be from 1.5 mm to 7 mm. In another example, an array of energy transfer elements may include 3 to 8 rows of 3 to 8 energy transfer elements. The distance between energy transfer elements in a row may be, for example, from 1 mm to 4 mm.

[0053] An example of a layout with energy delivery elements organized in circles may include one to 20 circles of energy delivery elements. Each circle may, for example, include 3 to 100 energy delivery elements. For example, one or more energy delivery elements may be placed in the center of at least one circle. At least one energy delivery element placed in the center may have, for example, a different polarity than an energy delivery element placed in at least one circle.

[0054] A method of treating a human body according to the present disclosure comprises delivering (applying) RF energy and PEF to at least a part of a human body, for example, by the above-mentioned system. The part of a human body can be, for example, the skin, in particular, for example, skin tissue, for example, at least one of subcutaneous tissue, dermal tissue, adipose tissue, and mucosal tissue. The method can be used, for example, to treat fine lines and wrinkles, acne and acne scars, scars, stretch marks, fat reduction, hyperhidrosis, age spots / hyperpigmentation, post-inflammatory hyperpigmentation (PI H), melasma, rosacea, warts, skin tags, or tumors.

[0055] RF energy can be transmitted in monopolar, bipolar and / or multipolar modes to produce thermal damage in the treated tissue. The frequency of the RF field transmitted to the tissue can be in the range of 80kHz to 5GHz, or in the range of 0.1MHz to 500MHz, or in the range of 0.2MHz to 50MHz, or in the range of 0.3MHz to 30MHz. The transmission of the RF field can be provided by at least one RF pulse (701) having a specific time (t1), which is called the RF pulse duration, which can be in the range of 0.1ms to 2500ms, or in the range of 0.5ms to 2000ms, or in the range of 0.1ms to 1500ms. The current density of the RF field transmitted by an energy transmission element can be in the range of 1A / cm 2 Up to 300A / cm 2 In the range of 5A / cm 2 Up to 200A / cm 2 In the range of 10A / cm 2 Up to 150A / cm 2 The RF pulse voltage (amplitude) may be from 1 V to 1000 V. The maximum energy may depend on the type of energy delivery element and may be, for example, between 10 mJ and 500 mJ per needle-type energy delivery element or pin-type energy delivery element.

[0056] In a monopolar mode, RF energy may be transmitted between one or more energy transfer elements placed on an applicator and one or more neutral electrodes placed at a distance, for example, on the patient's skin and / or on the applicator. In some aspects, one or more indifferent electrodes may have a surface area much larger than the sum of the surface areas of the active energy transfer elements. In a bipolar mode, RF energy is applied between two or more adjacent energy transfer elements, for example, of different polarities. In this example, the sum of the surfaces of the active energy transfer elements of a first polarity is similar to the sum of the surfaces of the active electrodes of a second polarity. In a multipolar mode, there is at least one first energy transfer element operating in a mode having a first polarity and at least one second energy transfer element operating in a mode having a polarity different from the operating mode of the at least one first energy transfer element (which may be an opposite polarity). The surface or the sum of the surfaces of the at least one first energy transfer element is much smaller than the surface or the sum of the surfaces of the at least one second energy transfer element.

[0057] Figure 7 An example of an RF treatment regimen is shown. The signal of the RF pulse can be generated by a PEF generator (a generator suitable for generating RF signals) in the form of an RF signal and can be transmitted to the target tissue in the form of an RF field by at least one energy transmission element, which can be included on the applicator and can be electrically coupled to the RF generator. The RF pulse (701) can be transmitted as a single RF pulse (701) with an amplitude Um and a pulse width of duration t1, or can be repeated in at least one pulse train (TR) of duration t5, wherein the parameters of the pulse can vary or can remain constant. The pulse train can also be repeated and a pulse train (B) can be generated. A specific pulse train (TR) can be separated by an inter-pulse train pause (702) of duration t2. The pulse train (B) can have a duration t3, and in an example with multiple pulse trains (B), can be separated by an inter-pulse train pause (703) defined by a time period t4. The RF pulses can be transmitted continuously, for example, in a pulse train during application by an applicator, without a pause between specific pulses, or can be transmitted sequentially. In sequential transmission, single RF pulses (701) may be separated from each other by non-transmission pauses of a certain duration.Another option for sequential transmission may include the transmission of several pulse trains (TRs) separated by inter-pulse train pauses (702).

[0058] PEF can be transmitted (applied) by unipolar, bipolar or multipolar mode. PEF can be transmitted in the form of electrical pulses, including monophasic (monopolar) pulses, symmetrical and / or asymmetrical biphasic pulses. The pulse can be repeated 1 to 100,000 times during treatment, or 1 to 1000 times, 1 to 100 times, or 1 to 50 times during one application of the applicator. The frequency of the high-frequency pulse can vary from 1 Hz to 500 Hz, or from 5 Hz to 250 Hz, or from 10 Hz to 100 Hz. The amplitude (Um) of the monophasic pulse can vary from 10 V to 15 kV, and the peak-to-peak amplitude of the biphasic pulse can vary from 20 V to 30 kV.

[0059] In monopolar mode, an electric field, e.g., a PEF, can be generated between one or more energy delivery elements included on the applicator and one or more indifferent electrodes placed elsewhere (e.g., on the patient's skin and / or on the applicator). In some aspects, the one or more indifferent electrodes can have a surface area that is much larger than the sum of the surface areas of the active energy delivery elements.

[0060] In bipolar mode, an electric field is generated between two or more adjacent energy transfer elements, for example, having different polarities. In this example, the surface area or the sum of the surface areas of one or more energy transfer elements having a first polarity is similar to the surface area or the sum of the surface areas of one or more energy transfer elements having a second polarity. The energy transfer elements having different polarities in bipolar mode can be all surface energy transfer elements, all invasive energy transfer elements, or in some examples, at least one energy transfer element having a first polarity can be a surface energy transfer element, and at least one other energy transfer element having a polarity different from the first polarity can be an invasive energy transfer element.

[0061] In a multipolar mode, at least one first energy transfer element operates in a first polarity mode and at least one second energy transfer element operates in a polarity mode different from the operating mode of the at least one first energy transfer element (which may be an opposite polarity). The surface area or the sum of the surface areas of at least one first energy transfer element may be much smaller than the surface area or the sum of the surface areas of at least one second energy transfer element. The ratio between the surfaces may be from 2:3 to 1:100, or 3:5 to 1:70, or 1:2 to 1:40. The energy transfer elements with different polarities in the multipolar mode may be all surface energy transfer elements, all invasive energy transfer elements, or at least one energy transfer element with a first polarity may be a surface energy transfer element and at least one other energy transfer element with a polarity different from the first polarity may be an invasive energy transfer element.

[0062] Figure 8is an example of a PEF treatment regimen. The signal of the PEF pulse can be generated in the form of a PEF signal by a PEF generator (a generator suitable for generating a PEF signal) and can be transmitted to the target tissue in the form of a PEF by at least one energy transmission element, which can be included on the applicator and can be electrically coupled to the PEF generator. The PEF treatment regimen may include at least one or a series of PEF pulses (801) and pauses (702, 703, 802). The PEF pulses (801) can be further organized into units with a certain hierarchy, such as a pulse train (TR) and a pulse train (B). The PEF pulse (801) can be defined, for example, by a shape, an amplitude (Um) with a specific voltage, and a pulse width with a duration t1. In the case of a monophasic pulse, the pulse amplitude (Um) can be negative or positive (the pulse can have a negative voltage or a positive voltage). The PEF pulses can be separated from each other by an inter-pulse pause (802), which can be defined by a duration (t6) and a voltage. The voltage during the inter-pulse pause can drop to 0V, or can have a positive or negative voltage value. The absolute voltage value of the pause between pulses is less than the absolute voltage (amplitude (Um)) of the adjacent electrical pulses, in particular up to 50% of the amplitude (Um) of the adjacent electrical pulses. In the case of electrical pulses with positive amplitude (Um), the voltage value of the pause between pulses may remain positive between 0V and the electrical pulse amplitude (Um), and in the case of electrical pulses with negative amplitude (Um), the voltage value of the pause between pulses may remain negative between 0V and the electrical pulse amplitude (Um). The biphasic pulses may be symmetrical or asymmetrical in at least one of time, amplitude or energy.

[0063] The pulse train (TR) of the PEF pulses (801) is characterized by a duration t5. The pulse parameters contained in the pulse train may vary or remain unchanged. The pulse train (TR) may include monophasic pulses, biphasic pulses, or both. The pulse train (TR) may be repeated and may generate pulse trains (B). A particular pulse train (TR) may be separated by an inter-pulse train pause (702) of duration t2. The pulse trains (B) may have a duration t3 and, in an example with multiple pulse trains (B), may be separated by an inter-pulse train pause (703) defined by a time period t4.

[0064] The PEF pulse may be combined with an additional pre-pulse, for example, for tissue modulation. The pulse may be delivered as a single pulse, or may be repeated in at least one pulse sequence, wherein the parameters of the pulse may vary or may remain constant. The pulse sequence may also be repeated, and one or more pulse trains may be generated.

[0065] The maximum amplitude of the pulse can depend on the target tissue, electrode size and / or electrode distance so as to generate an electric field in the target tissue with a maximum electric field amplitude of, for example, between 0.1 kV and 30 kV per centimeter, or between 0.2 kV and 5 kV, or between 0.3 kV and 2 kV. The duration of the pulse can vary from the nanosecond range to the millisecond range, for example, from 2 ns to 10 ms, or from 10 ns to 1 ms, or from 100 ns to 100 μs. The shape of the pulse can be, for example, a square, a curve similar to an exponential discharge, a rectangle, a sawtooth, a triangle, a trapezoid, or a sine. The maximum power output can be 0.01 W to 500 W. The energy of the pulse can be from 0.01 J to 1 J, or from 0.05 J to 0.7 J, or from 0.1 J to 0.45 J. The energy transmitted per unit area can be from 0.01 J / mm 2 Change to 1J / mm 2 , or from 0.05J / mm 2 Change to 0.7J / mm 2 , or change from 0.1J / mm2 to 0.45J / mm 2 The energy transmitted per unit volume can be 0.01J / mm 3 Up to 1J / mm 3 , or 0.05J / mm 3 Up to 0.6J / mm 3 , or 0.1J / mm 3 Up to 0.3J / mm 3 .

[0066] The parameters of the PEF pulse may not be fixed (fixedly set) to one value, but may be changed depending on the treatment, for example, before the start of treatment or during the treatment. In some examples, the parameters of the PEF pulse need to be changed, or set, for example, in the case where the device is suitable for using multiple applicators and / or multiple distal portions of the applicator, which can be exchanged (replaced) before, during or after treatment. The replaceable applicators or distal portions of the applicators can be of several types, including different energy transfer elements, for example, some applicators or distal portions can include only surface energy transfer elements, some applicators or distal portions can include surface and invasive energy transfer elements, and some applicators or distal portions can include only invasive energy transfer elements. Other types of applicators or distal portions of applicators may include insulated energy transfer elements, some of which may include non-insulated energy transfer elements or partially insulated energy transfer elements, and some applicators or distal portions of applicators may use more than one type of insulated / partially insulated / non-insulated energy transfer elements. In another example, the applicator or the distal portion of the applicator may include a different number of energy delivery elements, or energy delivery elements with different sizes, or energy delivery elements with different distances between them, or a combination of different numbers of elements with different sizes or different distances between them.

[0067] In examples where the device comprises a plurality of replaceable applicators or distal portions of applicators having the above-mentioned differences, it may be necessary to adapt the PEF pulse parameters and / or the pulse scheme to each applicator or distal portion of the applicator, for example, to prevent the possibility of sparks during the application of the PEF pulse. The PEF pulse parameters and / or the pulse scheme parameters may need to be set manually by an operator, for example, via a user interface unit, or may be set automatically, for example, after coupling a particular applicator or applicator distal tip to the device. In examples where the PEF pulse parameters are set automatically, the particular applicator or applicator distal tip may include information about its configuration (type of applicator), and the device may be adapted to receive this information and set the parameters accordingly. The information may, for example, be stored in a memory included in the applicator or the distal end of the applicator and transmitted to the control unit, for example, via an electrical coupling.

[0068] Adjustable parameters of the PEF pulse and / or pulse scheme may include, for example, amplitude, pulse width, number of pulses, pause length between pulses, pause length between pulse trains, etc. The parameters may be set, for example, based on the distance between specific energy delivery elements, for example, energy delivery elements that create a bipolar pair. In a specific example of an applicator or the distal end of an applicator that includes an invasive energy delivery element (e.g., in the form of a needle), it may be necessary to limit the maximum amplitude. For example, depending on the distance between the needles in the bipolar pair, the maximum absolute maximum amplitude of the PEF pulse may be limited in the following manner: for a needle distance of 3mm to 6mm, the maximum amplitude may be set to 3000V to 6000V, for a distance of 2mm to 3mm, the maximum amplitude may be set to 2000V to 3000V, for a distance of 1.5mm to 2mm, the maximum amplitude may be set to 1300V to 2200V, and for a distance of 1mm to 1.5mm, the maximum amplitude may be set to 1000V to 1700V.

[0069] Although the description refers to the term "electric field" or "pulsed electric field", the electric field contemplated herein may also include a magnetic element.

[0070] The method of treating at least a part of a human body according to the present invention comprises applying an RF field and a PEF in one treatment. The RF field and the PEF can be applied to tissue of at least a part of a human body by the above-mentioned system or device. The RF field and the PEF can be applied during one or more applications of at least one applicator, or during treatment via at least one energy transmission element, which can be included on at least one applicator.

[0071] The treatment scheme for transmitting RF field and PEF can include at least one RF pulse and at least one PEF pulse. In the case of multiple pulses, these pulses can also be applied to pulse sequences and pulse trains. Pulses, pulse sequences and pulse trains can be combined. RF pulses can be transmitted together with PEF pulses, for example, in an alternating manner. The same applies to pulse sequences and / or pulse trains. Pulse sequences and / or pulse trains with RF pulses can change with pulse sequences and / or pulse trains with PEF pulses. In other aspects, a pulse, pulse sequence or pulse train of one energy (RF or PEF) can be transmitted in a first time period, and a pulse, pulse sequence or pulse train of a second energy can be transmitted in a second time period during application of the applicator or during treatment. These time periods can be separate, can be established with each other, or can overlap. A single pulse of one energy (RF or PEF) can be combined not only with a single pulse of another energy, but also with a pulse sequence or pulse train of another energy. For example, a single RF pulse can be combined with a pulse sequence of PEF pulses, or a single PEF pulse can be combined with a pulse sequence of RF pulses.

[0072] The treatment regimen may include an additional pre-pulse applied before applying the treatment RF pulse or PEF pulse. The pre-pulse may be used, for example, for tissue conditioning or measurement purposes. The conditioning pre-pulse may, for example, cause the target tissue to be preheated to a non-coagulation temperature. The measurement pre-pulse may, for example, be used for current measurement or for impedance measurement of the target tissue. The pre-pulse may include an RF pulse and / or a PEF pulse.

[0073] In one treatment scenario, an example of a combination of a pulse sequence (TR(RF)) of RF pulses (701) and a pulse sequence (TR(RF)) of PEF pulses (801) can be seen in Fig. 9 . This exemplary treatment regimen may begin with delivering an RF pulse (701), for example, delivering at least one pulse train (TR(RF)) of RF pulses during a first time period (t5), which first time period may last, for example, from 0.01 s to 10 s or from 0.05 s to 5 s or from 0.1 s to 1 s. The RF pulses (701) within the pulse train (TR(RF)) may be delivered continuously. After delivering the RF pulse (701), a PEF pulse (801) is then delivered, for example, a specific number (e.g., 1 to 100) of PEF pulses (801). Specific PEF pulses (801) may be separated from each other by inter-pulse pauses (802), which may be defined by a duration (16). The RF pulses (701) may be delivered as described above during one applicator application, followed by the delivery of the PEF pulse (801). The treatment regimen delivered during one applicator application may also include delivering a pre-pulse prior to applying the therapeutic RF pulses (701) and / or PEF pulses.

[0074] In another example of a combination of a pulse train (TR(RF)) of RF pulses (701) and a pulse train (TR(PEF)) of PEF pulses (801) in a treatment regimen, the RF pulses may be delivered in more than one pulse train (TR(RF)) of RF pulses. In this example, each pulse train may include at least one RF pulse (701), and the pulse trains of RF pulses (TR(RF)) may be separated by inter-pulse train pauses (702).

[0075] "Application of at least one applicator" or "applicator application" is to be understood as a specific term compared to the general term "application". Specifically means that before removing the at least one applicator or before repositioning the at least one applicator to a different position, the applicator is transferred to the vicinity of at least the part of the human body and at least one energy transfer action is performed near the tissue of the part of the human body. Treatment means one or more applications of at least one applicator at the same or different locations in space of at least the part of the human body. Treatment can be started, for example, by turning on the device and can include at least one application of at least one applicator, and can be ended, for example, by turning off the device.

[0076] Both energies can be applied invasively or non-invasively, for example, surface application (e.g., by a surface energy delivery element), or one energy can be applied non-invasively, for example, surface application (e.g., PEF), and the other energy can be applied invasively (e.g., RF field) during treatment or during a single application of at least one applicator. Invasive application can be performed by an invasive energy delivery element. Non-invasive (e.g., surface) application of RF field and invasive application of PEF during a single application of at least one applicator or during a single treatment is also possible. The option of applying at least one energy non-invasively and invasively during a single application of at least one applicator or during a single treatment is also contemplated.

[0077] The application or treatment of at least one applicator may include non-invasive application of RF fields and / or PEF. In this example, the RF fields and / or PEF may be delivered via at least one surface energy delivery element placed near the tissue. In this example, the energy delivery element does not penetrate the tissue before, during, or after the application or treatment of at least one applicator.

[0078] In another example, an RF field may be applied during application or invasive treatment of at least one applicator. In one aspect, one or more RF pulses may be applied, for example, via an invasive energy delivery element. The energy delivery element may be included on the applicator and may have one or more fixed lengths. In this example, the applicator may be brought near the tissue, and a pressure sufficient to cause at least one energy delivery element included on the applicator to at least partially penetrate the tissue may be applied to the applicator, or applied to the applicator. One or more RF pulses may be transmitted into the tissue during or after at least one energy delivery element is at least partially inserted into the tissue. In one example, one or more RF pulses may be transmitted after at least one energy delivery element is inserted to a specified depth. One or more other RF pulses may be applied after one or more RF pulses. One or more first RF pulses may have a different RF pulse duration and / or amplitude from one or more other RF pulses. In another example, the applicator may be brought near the tissue, one or more RF pulses may be transmitted into the tissue, and one or more other RF pulses may be subsequently applied. During or after transmitting any RF pulses, at least one energy delivery element may be at least partially inserted into the tissue. One or more first RF pulses may have a different RF pulse duration and / or amplitude from one or more other RF pulses.

[0079] In some examples, the energy delivery element may also extend from at least one surface of the applicator. In this application example, the applicator can be applied near the tissue, and the energy delivery element can extend a predetermined length from at least one surface of the applicator so that at least a portion of the one or more energy delivery elements at least partially penetrates the tissue or is inserted into the tissue. After at least one energy delivery element is at least partially inserted to a specified depth, one or more RF pulses can be delivered to the tissue. One or more other RF pulses can be applied after the one or more RF pulses. The one or more first RF pulses may have a different RF pulse duration and / or amplitude than the one or more other RF pulses.

[0080] Application or treatment by at least one applicator may include sequential application of RF fields. More than one RF pulse may be applied to tissue in one application by at least one applicator. In one example of invasive treatment, one or more RF pulses may be applied to a first penetration depth of one or more invasive energy delivery elements, then one or more energy delivery elements may be repositioned deeper and / or shallower within the tissue (e.g., the length of the energy delivery element may be reconfigured), and another one or more RF pulses may be applied by the one or more repositioned invasive energy delivery elements to a second penetration depth.

[0081] In another example, PEF can be applied during the application of at least one applicator or during an invasive treatment process. In one aspect, one or more PEF pulses can be applied, for example, via an invasive energy delivery element. The energy delivery element can be included on the applicator and can have one or more fixed lengths. In this example, the applicator can be brought near the tissue, and a pressure sufficient to cause at least one energy delivery element included on the applicator to at least partially penetrate the tissue can be applied to the applicator, or applied to the applicator. One or more PEF pulses can be transmitted into the tissue during or after at least one energy delivery element is at least partially inserted into the tissue. In one example, one or more PEF pulses can be transmitted after at least one energy delivery element is inserted to a specified depth. One or more other PEF pulses can be applied after one or more PEF pulses. One or more first RF pulses can have a PEF pulse duration and / or amplitude different from one or more other PEF pulses. In another example, the applicator can be brought near the tissue, one or more PEF pulses can be transmitted into the tissue, and one or more other PEF pulses can be applied subsequently. During or after transmitting any PEF pulses, at least one energy delivery element can be at least partially inserted into the tissue. The one or more first RF pulses may have a different PEF pulse duration and / or amplitude than one or more other PEF pulses.

[0082] In some examples, the energy delivery element may also extend from at least one surface of the applicator. In this application example, the applicator may be applied near the tissue, and the energy delivery element may extend a predetermined length from at least one surface of the applicator so that at least a portion of the one or more energy delivery elements at least partially penetrates the tissue or is inserted into the tissue. After at least one energy delivery element is at least partially inserted to a specified depth, one or more PEF pulses may be delivered to the tissue. One or more other PEF pulses may be applied after the one or more PEF pulses. The one or more first RF pulses may have a different PEF pulse duration and / or amplitude than the one or more other PEF pulses.

[0083] Application or treatment by at least one applicator may include sequential application of PEF. More than one PEF pulse may be applied to tissue in one application by at least one applicator. In one example of invasive treatment, one or more PEF pulses may be applied to a first penetration depth of one or more invasive energy delivery elements, then one or more energy delivery elements may be repositioned deeper and / or shallower within the tissue (e.g., the length of the energy delivery element may be reconfigured), and another one or more PEF pulses may be applied to a second penetration depth by the one or more repositioned invasive energy delivery elements.

[0084] Advantageously, during at least one application of at least one applicator or during at least one treatment, both the RF field and the PEF can be applied to tissue of at least one part of the human body. During at least one application of at least one applicator or during at least one treatment, the RF field and the PEF can be applied simultaneously or partially simultaneously or at different time periods.

[0085] In one example, for example, an RF field may be applied during one application of at least one applicator, and a PEF may be applied during another application of at least one applicator, with the two applications occurring during different time periods that may be separated in time.

[0086] In examples where the PEF field and the RF field are applied by different applicators, the PEF can be transmitted in a first application by at least one applicator, and the RF field can be transmitted in a second application by at least one applicator, wherein the first and second applications can be performed within the same time period, the time periods of application can at least partially overlap with each other, or can be separated in time.

[0087] In another example, for example, the RF field may be applied in one time period and the PEF may be applied in another time period, both of which occur during one application of at least one applicator. The time periods occurring during one application of at least one applicator may be completely separated in time, or may at least partially overlap with each other.

[0088] On the other hand, the RF field and the PEF may be applied sequentially. The delivery sequence of the RF field and the PEF may occur during one application of at least one applicator and / or during the treatment. The delivery sequence means that the delivery time periods of the RF field and / or the PEF may be repeated more than once during the application of at least one applicator or during the treatment. In this example, the delivery time periods of the RF field and the PEF may be separated in time or may at least partially overlap each other.

[0089] The RF field and PEF can be applied to the same depth of the tissue, or can be applied to different depths. RF and PEF can also be applied by energy delivery elements placed at the same depth of the tissue, for example, both RF and PEF can be applied topically, non-invasively, by surface energy delivery elements, or invasively by invasive energy delivery elements of the same length, or the RF field can be applied by at least one energy delivery element having a first length, and the PEF can be applied by at least one energy delivery element having a second length, wherein the first length is different from the second length. The PEF and RF field can be delivered to different tissue depths. For example, the PEF can be applied to a first tissue depth by at least one surface energy delivery element or an invasive energy delivery element, and the RF field can be applied to a second depth by at least one surface or invasive energy delivery element, wherein the first depth and the second depth can be different.

[0090] In one example, an RF field may be delivered by at least one invasive energy delivery element and a PEF may be delivered by at least one different invasive energy delivery element while at least one invasive energy delivery element may be extended. The RF field and PEF may be applied by at least one energy delivery element that at least partially extends to a delivery length (the length over which energy is delivered by the energy delivery element) or by at least one fixed energy delivery element (implicitly in the delivery length). RF or PEF may be applied (simultaneously or in a time-separated manner) when all energy delivery elements are at least partially extended over their delivery lengths.

[0091] On the other hand, the RF field and the PEF can be applied in a time-separated manner at different time periods. The first field (one of the RF field and the PEF) can be applied by at least one first extendable energy delivery element, and the second field can be applied by at least one second extendable energy delivery element different from the first energy delivery element. The energy delivery element that delivers the field (one of the RF field and the PEF) in a specific time period can be referred to as an active energy delivery element, and the energy delivery element that does not deliver the field (one of the RF field and the PEF) in a specific time period can be referred to as an inactive energy delivery element. In this regard, when at least one active energy delivery element adapted to deliver the first field (RF field or PEF) is extended to its delivery length, the first energy is delivered, and at least one inactive energy delivery element adapted to deliver the second field (RF field or PEF) different from the first field can be fully or at least partially extended to a length different from its delivery length. When at least one energy delivery element adapted to deliver the second field can become an active energy delivery element and can be extended to its delivery length, and at least one energy delivery element adapted to deliver the first field can be extended to a length different from its delivery length, the second field (RF field or PEF field) is delivered in another time period. Where more than one energy delivery element is adapted to deliver an RF field or PEF, only a portion of the inactive energy delivery elements may extend to a length different from their delivery length.

[0092] On the other hand, the RF field and the PEF may be applied again in a time-separated manner at different time periods. The first field (one of the RF field and the PEF) may be applied by at least one first fixed or extendable energy delivery element, and the second field (one of the RF field and the PEF) may be applied by at least one second fixed or extendable energy delivery element different from the first energy delivery element. In this regard, the first field (one of the RF field and the PEF) may be applied when all energy delivery elements are at their delivery length, and the second field (different from the first field) may be applied when at least one active energy delivery element suitable for delivering the second field is at its delivery length, and when at least one inactive energy delivery element is extended to a length different from its delivery length. In examples where more than one energy delivery element is suitable for delivering an RF field or a PEF, only a portion of the inactive energy delivery elements may be extended to a length different from its delivery length.

[0093] On the other hand, during a time period of transmitting a field (one of the RF field and the PEF), when all energy transmission elements are in their transmission length, all energy transmission elements may be active and may transmit a specific field during this time period, or only a portion of the energy transmission elements may be active, transmitting the field, while another portion may be inactive.

[0094] The order of the time periods of field transmission when all energy delivery elements are at their delivery lengths and the time periods of applying the field (one of an RF field and a PEF) can be varied when at least one active energy delivery element is at its delivery length, and when at least one inactive energy delivery element is extended to a length different from its delivery length. For example, in some examples, a first field can be applied first with all energy delivery elements at their delivery lengths, then at least one energy delivery element is at least partially extended, and then the application of a second energy can be performed. In some examples, a first field (one of an RF field and a PEF) can be applied when at least one inactive energy delivery element is extended, then at least one energy delivery element can be extended to the delivery length, and the second field can be applied, for example, when all energy delivery elements are extended.

[0095] In another example, the RF field and the PEF can be applied by the same energy delivery element. In this example, all energy delivery elements can be included on an applicator suitable for delivering the RF field and the PEF. Both the RF field and the PEF can be applied, for example, during one applicator application, for example, at separate times. In this particular example, during treatment or during application of the applicator, all energy delivery elements included on the applicator can apply the RF field as well as the PEF. The RF field can be applied simultaneously by all delivery elements in one time period, and the PEF can be applied simultaneously by all delivery elements in another time period. The time period for RF field transmission can be separated from the time period for PEF transmission, for example, the RF field transmission time period can be followed by a PEF transmission time period. Both transmission time periods can occur in one applicator application.

Claims

1. A system for treating at least a part of a human body, the system comprising: one or more generators configured to generate a radio frequency signal and a pulsed electric field (PEF) signal; one or more applicators electrically coupled to the one or more generators and configured to deliver an RF field and a PEF to at least a portion of a human body based on the RF signal and the PEF signal from the one or more generators; as well as At least one control unit in communication with the one or more generators and / or the one or more applicators and configured to control delivery of at least one of the RF field and the PEF to at least a portion of a human body.

2. The system according to claim 1, wherein: At least the part of the human body includes skin.

3. The system according to claim 2, wherein: The one or more applicators include at least one energy delivery element configured to deliver the RF field and / or the PEF to at least a portion of a human body.

4. The system according to claim 3, wherein: The at least one energy delivery element is configured to deliver the RF field and the PEF to at least a portion of a human body.

5. The system according to claim 3, wherein: The at least one energy delivery element is configured to penetrate the skin.

6. The system according to claim 5, wherein: The penetration depth is adjustable.

7. The system according to claim 3, wherein: More than one energy delivery element is placed on a single applicator.

8. An applicator for treating at least a part of a human body, the applicator comprising: At least one energy delivery element configured to deliver a radio frequency field and / or a pulsed electric field (PEF) to at least a portion of a human body, wherein the at least one energy delivery element is electrically coupled to one or more generators, wherein the one or more generators are configured to provide radio frequency signals and PEF signals to the energy delivery element.

9. The applicator of claim 8, wherein: At least the part of the human body includes skin.

10. The applicator of claim 9, comprising more than one energy delivery element.

11. The applicator of claim 9, wherein: The more than one energy delivery elements include at least one energy delivery element configured to deliver the radio frequency field and at least one energy delivery element configured to deliver the PEF to at least a region of the human body.

12. The applicator of claim 9, wherein: The at least one energy delivery element is configured to penetrate the skin.

13. The applicator of claim 12, wherein: The penetration depth is adjustable.

14. A method of treating at least a part of a human body, the method comprising: providing one or more generators configured to generate a radio frequency signal and a pulsed electric field (PEF) signal; providing at least one applicator including at least one energy delivery element electrically coupled to the one or more generators; as well as The RF field and PEF from the one or more energy delivery elements are delivered to at least a portion of a human body based on the RF signal and the PEF signal from the one or more generators.

15. The method according to claim 14, wherein: At least the part of the human body includes skin.

16. The method according to claim 15, wherein: Transmitting the RF field and the PEF from the one or more energy delivery elements to at least a portion of the human body includes contacting at least the portion of the human body with the at least one energy delivery element.

17. The method according to claim 16, wherein: During a single application of the applicator, the RF field and the PEF are delivered while the energy delivery element is in contact with at least a portion of the human body.

18. The method according to claim 17, wherein: The RF field and the PEF are delivered sequentially during application of the applicator.

19. The method according to claim 15, wherein: The radio frequency field is invasively delivered to at least a portion of a human body at a first depth in at least a portion of a human body, and wherein the PEF is invasively delivered to at least a portion of a human body at a second depth in at least a portion of a human body.

20. The method according to claim 19, wherein: The first depth and the second depth are the same.

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