Cosmetic device for enhancing mucosal tissue restoration

Abstract

The present invention provides a cosmetic device for restoring at least one site of mucosal tissue, comprising: a cylindrical shell, the cylindrical shell including a plurality of annular electrodes surrounding the exterior of the shell and communicating with an RF tissue diathermy device, the plurality of annular electrodes being configured to be placed on at least one site of mucosal tissue; a control system; and at least one temperature sensor in communication with the control system, wherein the RF tissue diathermy device heats at least one site of mucosal tissue via the plurality of annular electrodes; wherein the at least one site of mucosal tissue is located within the vagina; further wherein the control system is adapted to: create at least one temperature profile of the mucosal tissue based on feedback by comparing a temperature measured by the at least one temperature sensor with at least one predetermined temperature profile of the at least one site of the mucosal tissue; and adjust the RF power applied to each of the plurality of annular electrodes according to the predetermined temperature profile.

Description

[0001] This application is a divisional application of the invention patent application with the application date of July 7, 2017, application number "201710552696.2", and invention name "Beauty device for enhancing mucosal tissue restoration". Technical Field

[0002] The present invention generally relates to cosmetic devices for improving the viability and rejuvenation of mucosal tissue. Background Art

[0003] As women age, mucosal tissue, such as that in the vagina, ages in a similar manner to external skin tissue, experiencing a decrease in collagen production and a loss of elasticity. This decrease in elasticity may result in the vagina not being able to respond appropriately to hormonal changes. This may result in painful intercourse if the tissue does not expand properly, or a decrease in sensation during intercourse if the tissue does not contract properly.

[0004] There are several major methods in common use today to tighten tissue. Surgical methods carry disadvantages associated with anesthesia, surgical complications, and a healing process that can cause scarring. Chemical peel regimens typically involve injury to the outermost layer of the skin (i.e., the epidermis), which can cause discoloration. Because collagen fibers are found in the dermis (the subcutaneous layer of the skin), and because heat has been shown to shrink these fibers and produce collagen production [Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9], different methods of heating the dermis (deep tissue diathermy) have recently emerged.

[0005] A unique approach to treating the dermis is called pulsed electromagnetic field (PEMF) therapy. This approach typically employs electromagnetic radiation of varying frequencies—from static magnetic fields, through very low frequencies to higher radio frequencies (RF)—applied in a pulsed fashion.

[0006] PEMF works in a variety of ways. Depending on the power applied, the frequency transmitted, and more importantly, the characteristics of the tissue, the radiation absorbed by the tissue can heat the tissue to a desired temperature. For example, the tissue can be heated to a denaturation temperature, which can cause tissue damage and coagulative necrosis. The tissue can also be heated to a lower temperature, which can cause the aforementioned contraction of collagen fibers.

[0007] Another approach involves non-thermal effects, which rely on the response of specific tissue components to the characteristics of the applied radiation. These effects may be due to charged macromolecules and their response to various frequencies and their harmonics, small charged ions in cell membranes that affect cell function and response to hormones and chemical signals, small charged ions in the extracellular space, and other less well-known mechanisms.

[0008] In addition, it has been found that applying radiation in a pulsed manner also has non-thermal effects. Moreover, specific combinations of frequency, duty cycle, and delivered power achieve specific tissue responses. Recent scientific research has determined that PEMF characteristics can induce desired biophysical responses.

[0009] It is now generally accepted that weak electromagnetic fields (EMFs) applied in pulses can start various healing processes in fractures, multiple sclerosis, and Parkinson's disease, and can even relieve pain; however, for the most part, the conditions most likely to respond to PEMFs are musculoskeletal. Twenty years ago, the FDA approved the use of pulsed radiofrequency electromagnetic fields for the treatment of pain and edema in superficial soft tissues [Rosch, PJ, Markov, MS, eds. Bioelectromagnetic Medicine, 2004; Marcel Dekker, NY, 251-264].

[0010] PEMF can also be used for tissue restoration or regeneration as described above. Several studies have addressed the effects of PEMF on dermal components. For example, in vivo experiments have shown that pulsed electromagnetic fields of certain field strengths and frequencies enhance epidermal collagen synthesis [Ahmadian S, Zarchi SR, Bolouri B. Effects of extremely-low-frequency pulse delectromagnetic fields on collagen synthesis in rat skin. Biotechnol Appl Biochem. 2006 February; 43 (Pt 2): 71-75]. This newly formed collagen increases skin elasticity and restores skin appearance.

[0011] In vitro studies have shown that PEMF increases the extent of endothelial cell tubulization and proliferation, and increases angiogenesis primarily by stimulating endothelial release of FGF-2, inducing paracrine and autocrine changes in surrounding tissues [Tepper OM et al., Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. FASEB J. 2004 Aug; 18(11): 1231-3. Epub 2004 Jun 18]. Angiogenesis, the formation of new blood vessels, increases blood flow to tissues, which in turn increases the delivery of oxygen and nutrients to the tissues. This effect is most beneficial for damaged tissues, rapidly promoting and improving healing. The released growth factors further enhance the healing process, both in terms of quality and speed.

[0012] Scientific evidence of PEMF's effects on tissue is used in a variety of applications. For example, US20050182462A1 discloses the use of PEMF to heat healthy deep tissue in order to produce contraction and tightening of the skin.

[0013] PEMF has also been used to improve skin wound healing. For example, WO08064272 discloses a method of using PEMF to treat severe diabetic ulcers. The patent also discloses the addition of intermittent compression therapy (ICT) and the use of low-intensity ultrasound (up to 50 W / cm 2 ), the latter of which is intended to inhibit the growth of microorganisms.

[0014] Other methods of heating the dermis use non-pulsed RF radiation applied by an antenna or electrodes. For example, WO98005380 discloses a method of tightening the skin using an RF electromagnetic energy delivery device.

[0015] Improving skin tightening results not based on dermal diathermy remains a long-felt need for both aesthetic and therapeutic purposes. Summary of the invention

[0016] The object of the present invention is to provide a device for restoring at least one portion of mucosal tissue, comprising:

[0017] a pulsed electromagnetic frequency generator that applies pulsed electromagnetic field therapy to the site of mucosal tissue; and

[0018] a plurality of electrodes in communication with an RF tissue diathermy device;

[0019] Wherein, the RF tissue diathermy device heats at least one portion of the mucosal tissue via the electrode.

[0020] It is another object of the present invention to provide the apparatus as described above, wherein at least one of the following applies:

[0021] a. at least a portion of at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 is equal to or not equal to T2;

[0022] b. The device further comprises at least one

[0023] Temperature sensor;

[0024] c. at least one portion of the mucosal tissue is in the vagina; and

[0025] d. The device further comprises a processor in communication with the at least one temperature sensor and with the database, the at least one temperature sensor being selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0026] It is another object of the present invention to provide the apparatus as described above, wherein at least one of the following applies:

[0027] a. The processor is configured to feedback control the RF output of the pulsed electromagnetic frequency generator and the RF tissue diathermy device so that at least one

[0028] The temperature distribution can be maintained in the predetermined portion; and

[0029] b. Each of said at least one temperature is measurable in said at least a portion of the site of said mucosal tissue.

[0030] It is another object of the present invention to provide the apparatus as described above, wherein at least one of the following applies:

[0031] a. The duration of the pulses from the pulsed electromagnetic frequency generator is between about 3 ms and

[0032] The range is about 1000ms;

[0033] b. the frequency F of the pulses from the pulsed electromagnetic frequency generator is in the range of about 1 Hz to about 50 Hz; and

[0034] c. The pulsed electromagnetic power from the pulsed electromagnetic frequency generator is configured to stimulate collagen production.

[0035] It is another object of the present invention to provide the apparatus as described above, wherein at least one of the following applies:

[0036] a. the pulsed electromagnetic power is configured to induce angiogenesis; and

[0037] b. The pulsed electromagnetic power comprises pulses at a frequency F of about 15 Hz and a magnetic field strength B of about 12 Gauss.

[0038] Another object of the present invention is to provide an apparatus as described above, wherein a member selected from the group consisting of at least one temperature in the temperature distribution, the predetermined temperature range T1, the predetermined temperature range T2, and any combination thereof, is in a range selected from the group consisting of: from about 30 degrees Celsius to about 80 degrees Celsius, and from about 40 degrees Celsius to about 50 degrees Celsius.

[0039] Another object of the present invention is to provide an integrated system for enhancing the healing of at least one site of mucosal tissue of a patient, the system comprising:

[0040] at least two electrodes configured to be placed on at least one of the sites of mucosal tissue of the patient;

[0041] an electromagnetic field generator configured to generate electromagnetic field pulses, and

[0042] applying the electromagnetic field pulses to at least one location of mucosal tissue of the patient; and

[0043] Control systems;

[0044] in,

[0045] None of the electrodes are configured to be inserted into at least one site of mucosal tissue of the patient;

[0046] Each of the electrodes is configured to conduct RF pulses to at least one of the locations of mucosal tissue of the patient; the electrodes are configured to heat the mucosal tissue to a temperature T in the range of 30 degrees Celsius to 80 degrees Celsius; and

[0047] The control system is configured to control the electromagnetic field generator and the RF pulses applied by the electrodes.

[0048] It is another object of the present invention to provide an integrated system as described above, wherein at least one of the following applies:

[0049] a. at least a portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 is not equal to or

[0050] Equal to T2;

[0051] b. said at least one mucosal tissue site is within the vagina; and

[0052] c. The system further comprises a database configured to store at least one temperature distribution comprising at least one temperature and at least one predetermined portion of at least one site of the mucosal tissue.

[0053] It is another object of the present invention to provide an integrated system as described above, wherein at least one of the following applies:

[0054] a. The system further comprises a

[0055] processor;

[0056] b. The control system monitors body tissue parameters and accordingly changes the applied

[0057] A member of the group consisting of heat, said electromagnetic pulse, and any combination thereof;

[0058] c. The duration of each pulse applied by the system ranges from about 3 ms to about 1000 ms;

[0059] d. The frequency F applied by the electromagnetic pulse of the system ranges from about 1 Hz to about 50 Hz;

[0060] e. The frequency range of the RF pulses applied by the system is between about 200 kHz and about 10 MHz; and

[0061] f. The power P applied by the RF of the system ranges between about 1 W to about 100 W RMS average power.

[0062] It is another object of the present invention to provide an integrated system as described above, wherein at least one of the following applies:

[0063] a. Each of the at least one temperature sensors is configured to measure the patient's

[0064] at least one temperature in the predetermined portion of at least one mucosal site; and

[0065] b. The at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0066] Another object of the present invention is to provide a system configured to enhance healing of at least one site of mucosal tissue of a patient by synergistically applying heat and a pulsed electromagnetic field (PEMF) to at least one site of mucosal tissue of the patient, the system comprising:

[0067] a pulsed electromagnetic field generator for generating a pulsed electromagnetic field (PEMF) frequency for delivering a pulsed electromagnetic field (PEMF) to at least one of the mucosal tissues of the patient according to a predetermined protocol;

[0068] providing electromagnetic pulses to the site; and

[0069] an RF generator configured to operate a plurality of electrodes, said operation of said electrodes being configured to induce tissue diathermy;

[0070] wherein said system is configured to provide rejuvenation of at least one said site of mucosal tissue by a synergistic combination of said PEMF and said tissue diathermy;

[0071] Further wherein the plurality of electrodes are configured to be placed on the at least one location of the patient's mucosal tissue.

[0072] It is another object of the present invention to provide the system as described above, wherein at least one of the following applies:

[0073] a. at least one of the sites of mucosal tissue is in the vagina;

[0074] b. The system further comprises at least one temperature sensor, wherein the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0075] c. at least a portion of the at least one portion of the mucosal tissue can be maintained at least temporarily in a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue can be maintained at least temporarily in a predetermined temperature range T2, wherein T1 is not equal to or

[0076] Equal to T2;

[0077] d. The system further comprises a database configured to store at least one temperature distribution, the temperature distribution comprising at least one temperature and at least one of the mucosal tissue sites.

[0078] part;

[0079] e. A control system comprising a portion for cooling the mucosal tissue

[0080] cooling mechanism; and

[0081] f. The system is enclosed in at least one platform.

[0082] It is another object of the present invention to provide the system as described above, wherein at least one of the following applies:

[0083] a. The system further comprises a communication with the at least one temperature sensor and with the database

[0084] The processor of the letter;

[0085] b. A member of the group consisting of said temperature, said temperature range T1, said temperature range T2, and any combination thereof is above about 30 degrees Celsius and below about 80 degrees Celsius.

[0086] It is another object of the present invention to provide the system as described above, wherein at least one of the following applies:

[0087] a. the processor is configured to feedback control the pulse electromagnetic frequency generator and the RF generator so that at least one predetermined location outside the device can be maintained.

[0088] maintaining the temperature distribution;

[0089] b. Each of said at least one temperature is measurable in said at least a portion of the site of said mucosal tissue.

[0090] It is another object of the present invention to provide the system as described above, wherein all of said electrodes are configured to synchronously apply said RF power to said mucosal tissue site.

[0091] Another object of the present invention is to provide an integrated system for enhancing the healing of at least one region of a patient, the at least one region being selected from the group consisting of the skin of the patient, the mucosal tissue of the patient, and any combination thereof, the system comprising:

[0092] at least two electrodes configured to be placed on at least one of the sites on the patient;

[0093] an electromagnetic field generator configured to generate electromagnetic field pulses;

[0094] a generator configured to generate RF power; and

[0095] Control systems;

[0096] in,

[0097] The at least two electrodes are not configured to penetrate the at least one site;

[0098] Each of the at least two electrodes is configured to provide RF pulses to at least one of the sites, the RF power being configured to apply heat up to a temperature T in the range of about 30 degrees Celsius to about 80 degrees Celsius;

[0099] The control system is configured to control a member of the group consisting of: the electromagnetic field generator, the heat applied by the electrodes, and any combination thereof; and the electromagnetic pulses can be applied to the at least one part, and the heat can be applied to the at least one part in a manner selected from the group consisting of simultaneously, continuously, separately, and any combination thereof.

[0100] It is another object of the present invention to provide an integrated system as described above, wherein at least one of the following applies:

[0101] a. at least a portion of the at least one portion can be maintained at least temporarily in a predetermined temperature range T1, while at least another portion of the at least one portion can be maintained at least temporarily in

[0102] a predetermined temperature range T2, wherein T1 is not equal to or equal to T2;

[0103] b. said at least one part of said patient is in the vagina;

[0104] c. The system further comprises a database configured to store at least one temperature distribution, the temperature distribution comprising at least one temperature and at least one predetermined part of the patient;

[0105] d. The heat applied to the area of ​​the patient is applied by emitting RF radiation or

[0106] It is obtainable via the generation of an electric current which is absorbed by the tissue;

[0107] e. The system is configured to provide a dynamic electromagnetic field so that the amplitude of the electromagnetic pulse

[0108] Ability to change over time;

[0109] f. body tissue parameters can be monitored by said control system, and thus a member of the group consisting of said applied heat, said electromagnetic pulses, and any combination thereof is variable;

[0110] g. The duration of each pulse applied by the system ranges from about 3 ms to about 1000 ms;

[0111] h. A frequency F applied by the pulses of the system ranges from about 200 kHz to about 1 MHz; and

[0112] i. The power P applied by the pulses of the system ranges from about 1 W to about 100 W of RMS average power.

[0113] Another object of the present invention is to provide an integrated system as described above, further comprising a processor communicating with the database and with at least one temperature sensor, wherein the at least one temperature sensor is configured to measure at least one temperature in at least a portion of the at least one part of the patient; the at least one temperature sensor is selected from the group consisting of thermistors, thermocouples and any combination thereof.

[0114] Another object of the present invention is to provide a device for restoring at least one portion of mucosal tissue, comprising:

[0115] Pulsed electromagnetic frequency generator;

[0116] RF tissue diathermy devices; and

[0117] a plurality of electrodes in communication with the pulsed electromagnetic frequency generator and the RF tissue diathermy device;

[0118] wherein the pulsed electromagnetic pulse frequency generator and the RF tissue diathermy device heat at least one portion of the mucosal tissue via the electrodes;

[0119] Further wherein at least a portion of at least one portion of the mucosal tissue is at least temporarily maintainable within a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue is at least temporarily maintainable within a predetermined temperature range T2, wherein T1 is equal to or not equal to T2;

[0120] It is another object of the present invention to provide an apparatus further comprising at least one temperature sensor adjacent to at least one of the plurality of electrodes.

[0121] It is another object of the present invention to provide an apparatus, wherein said at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0122] It is another object of the present invention to provide a device wherein at least one portion of said mucosal tissue is in the vagina.

[0123] Another object of the present invention is to provide an apparatus further comprising a database configured to store at least one temperature distribution comprising at least one temperature and at least a portion of at least one portion of the mucosal tissue.

[0124] Another object of the present invention is to provide an apparatus further comprising a processor in communication with said at least one temperature sensor and with said database.

[0125] Another object of the present invention is to provide a device, wherein the processor is configured to feedback control outputs of the pulsed electromagnetic frequency generator and the RF tissue diathermy device so that the temperature distribution can be maintained at at least one predetermined location outside the device.

[0126] It is another object of the present invention to provide an apparatus wherein each of said at least one temperature is measurable in at least a portion of at least one location of said mucosal tissue.

[0127] Another object of the present invention is to provide an apparatus, wherein the pulse shape of the pulse electromagnetic power is selected from the group consisting of square wave, triangle wave, sawtooth wave, ramp wave, spike wave and any combination thereof.

[0128] It is another object of the present invention to provide an apparatus wherein the duration of the pulses of the pulsed electromagnetic power ranges from about 3 ms to about 1000 ms.

[0129] It is another object of the present invention to provide an apparatus, wherein a frequency F of said pulses of said pulsed electromagnetic power is in a range between about 1 Hz and about 1 MHz.

[0130] It is another object of the present invention to provide an apparatus wherein the pulsed electromagnetic power is configured to induce angiogenesis.

[0131] It is another object of the present invention to provide an apparatus, wherein the pulsed electromagnetic power comprises pulses at a frequency F of about 15 Hz, a pulse duration of about 5 ms and a magnetic field strength B of about 12 Gauss.

[0132] It is another object of the present invention to provide an apparatus wherein the pulsed magnetic field power is configured to stimulate collagen production.

[0133] It is another object of the present invention to provide an apparatus wherein the pulsed electromagnetic power comprises pulses having a frequency F between about 10 Hz and about 25 Hz and an intensity I of about 20 Gauss.

[0134] It is another object of the present invention to provide an apparatus, wherein said at least one temperature in said temperature profile is in a range from about 30 degrees Celsius to about 80 degrees Celsius.

[0135] It is another object of the present invention to provide an apparatus, wherein said at least one temperature in said temperature profile is in a range from about 40 degrees Celsius to about 50 degrees Celsius.

[0136] It is another object of the present invention to provide a device wherein the pulsed electromagnetic power from the pulsed electromagnetic frequency generator and the heat from the RF tissue diathermy device synergistically rejuvenate at least one site of the mucosal tissue such that the rejuvenating effect by the pulsed electromagnetic power and the heat is greater than the sum of the rejuvenating effect by the pulsed electromagnetic power alone and the rejuvenating effect by the heat alone.

[0137] Another object of the present invention is to provide an apparatus further comprising at least one suction unit, wherein the at least one suction unit is in fluid communication with at least one port in the apparatus, the port being configured to allow air to pass therethrough.

[0138] It is another object of the present invention to provide a device wherein said port is configured to draw said tissue into contact with said device.

[0139] Another object of the present invention is to provide an apparatus, wherein the suction unit is configured to operate continuously or in pulses.

[0140] Another object of the present invention is to provide an integrated system for enhancing the healing of at least one site of mucosal tissue of a patient, the system comprising:

[0141] at least two electrodes configured to be placed on the at least one site;

[0142] an electromagnetic field generator configured to generate electromagnetic field pulses, and a control system;

[0143] in,

[0144] The at least two electrodes are not configured to penetrate the at least one site;

[0145] Each of the at least two electrodes is configured to provide an electromagnetic pulse to the at least one site;

[0146] Each of the at least two electrodes is configured to apply heat up to a temperature T in a range of about 30 degrees Celsius to about 80 degrees Celsius;

[0147] The control system is configured to control the electromagnetic field generator and the heat applied by the at least two electrodes; and

[0148] Each of the at least two electrodes is configured to provide the electromagnetic pulse to the at least one site and apply the heat to the at least one site, wherein the providing of the electromagnetic pulse and the applying of the heat occur in a manner selected from the group consisting of simultaneously, continuously, separately, and any combination thereof.

[0149] Another object of the present invention is to provide a system, wherein at least a portion of the at least one part can be at least temporarily maintained in a predetermined temperature range T1, and at least another portion of the at least one part can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 is not equal to or equal to T2.

[0150] It is another object of the present invention to provide a system wherein said at least one site is in the vagina.

[0151] Another object of the present invention is to provide a system further comprising a database configured to store at least one temperature distribution including at least one temperature and at least one predetermined portion of the at least one location.

[0152] It is another object of the present invention to provide a system further comprising at least one temperature sensor adjacent to at least one of the plurality of electrodes.

[0153] It is another object of the present invention to provide a system, wherein the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0154] Another object of the present invention is to provide a system further comprising a processor in communication with said at least one temperature sensor and with said database.

[0155] Another object of the present invention is to provide a system, wherein the processor is configured to feedback control outputs of the pulsed electromagnetic frequency generator and the RF tissue diathermy device so that the temperature distribution can be maintained at at least one predetermined location outside the device.

[0156] It is another object of the present invention to provide a system wherein each of said at least one temperature is measurable in said at least one predetermined portion of at least one site of said mucosal tissue.

[0157] It is another object of the present invention to provide a system, wherein the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0158] It is another object of the present invention to provide a system wherein said heat applied to at least one portion of said patient's mucosal tissue is obtained by emitting RF radiation or by generating an electric current absorbed by subcutaneous tissue.

[0159] Another object of the present invention is to provide a system wherein the electromagnetic pulse is selected from a waveform having a frequency between about 10 Hz and about 25 Hz and an intensity of about 20 Gauss, or a waveform having a frequency of about 15 Hz, a duration of about 5 microseconds, and an intensity of about 12 Gauss.

[0160] Another object of the present invention is to provide a system, wherein the system is configured to provide a dynamic magnetic field so that the electromagnetic pulses vary over time.

[0161] Another object of the present invention is to provide a system, wherein each of the electromagnetic pulses has a shape selected from the group consisting of a square wave, a sine wave, a triangle wave, a sawtooth wave, a ramp wave, a spike wave, and any combination thereof.

[0162] It is another object of the present invention to provide a system wherein said control system monitors body tissue parameters and varies said applied heat and said electromagnetic pulses accordingly.

[0163] It is another object of the present invention to provide a system wherein the duration of each pulse applied by the system ranges from about 3 to about 1000 microseconds.

[0164] It is another object of the present invention to provide a system wherein the frequency F applied by the pulses of the system ranges from about 1 Hz to about 1 MHz.

[0165] It is another object of the present invention to provide a system wherein the power P applied by the pulses of said system ranges from about 1 W to about 100 W of power per pulse.

[0166] Another object of the present invention is to provide a system, further comprising at least one suction unit, wherein the at least one suction unit is fluidically connected to at least one port in the system, the port being configured to allow air to pass therethrough.

[0167] It is another object of the present invention to provide a system wherein said port is configured to draw said tissue into contact with said system.

[0168] Another object of the present invention is to provide a system wherein the suction unit is configured to operate continuously or in pulses.

[0169] Another object of the present invention is to provide a system configured to enhance healing of at least one portion of mucosal tissue of a patient by synergistically applying heat and a pulsed electromagnetic field (PEMF) to at least one portion of mucosal tissue of the patient, the system comprising:

[0170] a. a pulsed electromagnetic field generator for generating a pulsed electromagnetic field (PEMF) frequency for providing electromagnetic pulses to at least one site according to a predetermined protocol; and

[0171] b. an RF generator configured to operate a plurality of electrodes;

[0172] wherein the system is configured to provide restoration of the site via a synergistic combination of PEMF and RF tissue diathermy;

[0173] Wherein, the plurality of electrodes are configured to be placed on the site.

[0174] Another object of the present invention is to provide a system further comprising at least one temperature sensor.

[0175] It is another object of the present invention to provide a system, wherein the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0176] Another object of the present invention is to provide a system, wherein at least a portion of at least one of the parts can be at least temporarily maintained within a predetermined time interval T1, and at least another portion of the at least one part can be at least temporarily maintained within a predetermined time range T2, wherein T1 is not equal to or equal to T2.

[0177] It is another object of the present invention to provide a system wherein each of said at least one temperature is measurable in said at least a portion of said at least one location.

[0178] It is another object of the present invention to provide a system wherein said at least one site is in the vagina.

[0179] Another object of the present invention is to provide a system, wherein the predetermined protocol is selected from the group consisting of: a series of pulses having a frequency between about 10 Hz and about 25 Hz and an intensity of about 20 Gauss; a series of pulses having a duration of about 5 ms and an intensity of about 12 Gauss and repeated at a frequency of about 15 Hz; and any combination thereof.

[0180] Another object of the present invention is to provide a system wherein each of the plurality of electrodes is configured to (i) provide electromagnetic pulses to the at least one site; and (ii) apply heat to the at least one site up to a temperature of about 80 degrees Celsius.

[0181] Another object of the present invention is to provide a system, wherein each of the plurality of electrodes is configured to provide the electromagnetic pulse to the at least one site and apply heat to the at least one site simultaneously, continuously, individually, and any combination thereof.

[0182] Another object of the present invention is to provide a system further comprising a database configured to store at least one temperature distribution including at least one temperature and at least one predetermined portion of the at least one location.

[0183] Another object of the present invention is to provide a system further comprising a processor in communication with said at least one temperature sensor and with said database.

[0184] Another object of the present invention is to provide a system, wherein the processor is configured to feedback control the output of the pulsed electromagnetic frequency generator and the RF generator so that the temperature distribution can be maintained at at least one predetermined location outside the device.

[0185] Another object of the present invention is to provide a system wherein the RF generator is an RF tissue diathermy device.

[0186] It is another object of the present invention to provide a system, wherein the RF tissue diathermy device is selected from the group consisting of a current generating device, electromagnetic induction, and direct heat application instrument, the current generating device being configured to generate an electric current absorbed by subcutaneous tissue.

[0187] Another object of the present invention is to provide a system, wherein the RF generator further comprises:

[0188] a. at least one electrical output device configured to generate RF electromagnetic power or current; and

[0189] b. Electrical coupling between said at least one electrical output device and said plurality of electrodes such that said plurality of electrodes are configured to simultaneously apply a member of the group consisting of said RF power, said current, and any combination thereof to said site.

[0190] Another object of the present invention is to provide a system wherein the pulsed electromagnetic frequency generator is configured to provide a dynamic magnetic field such that the electromagnetic pulses vary over time.

[0191] Another object of the present invention is to provide a system, wherein at least one of the following is applicable: (a) the shape of the electromagnetic pulse is selected from the group consisting of square wave, sine wave, triangle wave, sawtooth wave, ramp wave, spike wave and any combination thereof; (b) the duration of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 3 ms to about 1000 ms; (c) the frequency range of the pulse applied by the pulsed electromagnetic frequency generator ranges from about 1 Hz to about 1 MHz; (d) the power range of the pulse applied by the pulsed electromagnetic frequency generator ranges from about 1 W to about 100 W per pulse; and any combination thereof.

[0192] It is another object of the present invention to provide a system, wherein the temperature is above about 30 degrees Celsius and below about 80 degrees Celsius.

[0193] Another object of the present invention is to provide a system wherein the power supply and control system comprises a cooling device for cooling the at least one portion.

[0194] Another object of the present invention is to provide a system, wherein the system is enclosed in at least one platform.

[0195] Another object of the present invention is to provide a system wherein the pulsed electromagnetic frequency generator and the RF tissue diathermy device have more than one applicator for treating more than one area simultaneously; further wherein the pulsed electromagnetic frequency generator has electrostatic shielding.

[0196] Another object of the present invention is to provide a system, wherein the system is configured to operate according to an IEC protocol selected from the group consisting of IEC 60601-2-33, IEC 60601-2-3, IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601-1-2, IEC 60601-1-1, and any combination thereof.

[0197] Another object of the present invention is to provide a system, further comprising at least one suction unit, wherein the at least one suction unit is fluidically connected to at least one port in the system, the port being configured to allow air to pass therethrough.

[0198] It is another object of the present invention to provide a system wherein said port is configured to draw said tissue into contact with said system.

[0199] Another object of the present invention is to provide a system wherein the suction unit is configured to operate continuously or in pulses.

[0200] Another object of the present invention is to provide an integrated system for enhancing the healing of at least one region of a patient, the at least one region being selected from the group consisting of the skin of the patient, the mucosal tissue of the patient, and any combination thereof, the system comprising:

[0201] at least two electrodes configured to be placed on the at least one site;

[0202] an electromagnetic field generator configured to generate electromagnetic field pulses; and a control system, wherein

[0203] The at least two electrodes are not configured to penetrate the at least one site;

[0204] Each of the at least two electrodes is configured to provide an electromagnetic pulse to the at least one site;

[0205] Each of the at least two electrodes is configured to apply heat up to a temperature T in a range of about 30 degrees Celsius to about 80 degrees Celsius;

[0206] The control system is configured to control the electromagnetic field generator and the heat applied by the at least two electrodes; and

[0207] The electrodes are configured to provide the electromagnetic pulses to the at least one site and apply the heat to the at least one site in a manner selected from the group consisting of simultaneously, sequentially, separately, and any combination thereof.

[0208] Another object of the present invention is to provide a system, wherein at least a portion of the at least one part can be at least temporarily maintained in a predetermined temperature range T1, and at least another portion of the at least one part can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 is not equal to or equal to T2.

[0209] It is another object of the present invention to provide a system wherein said at least one site is in the vagina.

[0210] Another object of the present invention is to provide a system, wherein at least a portion of the at least one part can be at least temporarily maintained in a predetermined temperature range T1, and at least another portion of the at least one part can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 is not equal to or equal to T2.

[0211] Another object of the present invention is to provide a system further comprising at least one temperature sensor.

[0212] It is another object of the present invention to provide a system, wherein the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0213] Another object of the present invention is to provide a system further comprising a processor in communication with said at least one temperature sensor and with said database.

[0214] Another object of the present invention is to provide a system, wherein the processor is configured to feedback control outputs to the pulsed electromagnetic frequency generator and the RF tissue diathermy device so that the temperature distribution can be maintained in at least one predetermined location outside the device.

[0215] Another object of the present invention is to provide a system further comprising a database configured to store at least one temperature distribution including at least one temperature and at least one predetermined portion of the site.

[0216] It is another object of the present invention to provide a system wherein each of said at least one temperature is measurable in said at least one portion of said site.

[0217] It is another object of the present invention to provide a system wherein said heat applied to said at least one site is obtained by emitting RF radiation or via generating an electric current absorbed by subcutaneous tissue.

[0218] Another object of the present invention is to provide a system wherein the electromagnetic pulse is selected from the group consisting of: a waveform having a frequency greater than about 10 Hz and less than about 25 Hz and an intensity of about 20 Gauss; and a waveform having a frequency of about 15 Hz, a duration of about 5 ms and an intensity of about 12 Gauss.

[0219] Another object of the present invention is to provide a system, wherein the system is configured to provide a dynamic magnetic field so that the average intensity of the electromagnetic pulses is variable over time.

[0220] Another object of the present invention is to provide a system, wherein each of the electromagnetic pulses has a shape selected from the group consisting of a square wave, a sine wave, a triangle wave, a sawtooth wave, a ramp wave, a spike wave, and any combination thereof.

[0221] It is another object of the present invention to provide a system wherein said control system is configured to monitor body tissue parameters and vary said applied heat and said electromagnetic pulses accordingly.

[0222] It is another object of the present invention to provide a system wherein the duration of each pulse applied by the system ranges from about 3 ms to about 1000 ms.

[0223] It is another object of the present invention to provide a system wherein the frequency F of the pulses applied by the system is in a range between about 1 Hz and about 1 MHz.

[0224] It is another object of the present invention to provide a system wherein the RMS average power P applied by the pulses of the system ranges between about 1 W and about 100 W per pulse.

[0225] Another object of the present invention is to provide a system, further comprising at least one suction unit, wherein the at least one suction unit is fluidically connected to at least one port in the system, the port being configured to allow air to pass therethrough.

[0226] It is another object of the present invention to provide a system wherein said port is configured to draw said tissue into contact with said system.

[0227] Another object of the present invention is to provide a system, wherein the suction unit is configured to operate continuously or in a pulsed manner.

[0228] Another object of the present invention is to provide a cosmetic device for restoring at least one site of mucosal tissue, comprising: a pulsed electromagnetic frequency generator, the pulsed electromagnetic frequency generator applying pulsed electromagnetic field therapy to the at least one site of mucosal tissue; a cylindrical housing, the cylindrical housing including a plurality of ring electrodes surrounding the exterior of the housing and in communication with an RF tissue diathermy device, the plurality of ring electrodes being configured to be placed on the at least one site of the mucosal tissue; a control system; and at least one temperature sensor in communication with the control system, wherein the RF tissue diathermy device heats the at least one site of mucosal tissue via the plurality of ring electrodes; wherein the at least one site of the mucosal tissue is located within the vagina; further wherein the control system is adapted to: create at least one temperature profile of the mucosal tissue based on feedback by comparing a temperature measured by the at least one temperature sensor with at least one predetermined temperature profile of the at least one site of the mucosal tissue; and adjust the RF power applied to each of the plurality of ring electrodes according to the predetermined temperature profile; wherein the at least one temperature sensor is disposed adjacent to at least one of the plurality of ring electrodes, and wherein the temperature of at least a portion of each of the plurality of ring electrodes is individually and separately controlled.

[0229] Another object of the present invention is to provide an integrated system for enhancing the recovery of at least one portion of a patient's mucosal tissue, the system comprising: a cylindrical shell, the cylindrical shell comprising at least two annular electrodes surrounding the outside of the shell, the at least two annular electrodes being configured to be placed on the at least one portion of the patient's mucosal tissue; a pulsed electromagnetic frequency generator, the pulsed electromagnetic frequency generator applying pulsed electromagnetic field therapy to the at least one portion of the mucosal tissue; a control system; and at least one temperature sensor communicating with the control system; wherein the at least two annular electrodes are not configured to penetrate the at least one portion of the patient's mucosal tissue; each of the at least two annular electrodes is configured to conduct RF to the at least one portion of the patient's mucosal tissue; the at least two annular electrodes are configured to heat the mucosal tissue to a temperature T in the range of 30 degrees Celsius to 80 degrees Celsius; and the control system is configured to control the application of heat by the at least two annular electrodes; wherein the at least one portion of the patient's mucosal tissue is located within the vagina; further wherein the control system is suitable for: creating at least one temperature distribution of the patient based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature distribution of the at least one portion of the patient's mucosal tissue; and adjusting the RF power applied to each of the at least two annular electrodes according to the predetermined temperature distribution; wherein the at least one temperature sensor is disposed adjacent to at least one of the at least two annular electrodes, and wherein the temperature of at least a portion of each of the at least two annular electrodes is individually and separately controlled.

[0230] Another object of the present invention is to provide a system configured to enhance the restoration of at least one portion of a patient's mucosal tissue by applying heat to at least one portion of the patient's mucosal tissue, the system comprising: a pulsed electromagnetic frequency generator, the pulsed electromagnetic frequency generator applying pulsed electromagnetic field therapy to the at least one portion of the mucosal tissue; a cylindrical shell, the cylindrical shell comprising a plurality of annular electrodes surrounding the exterior of the shell; and an RF generator, the RF generator being configured to operate the plurality of annular electrodes, the operation of the plurality of annular electrodes being configured to induce tissue diathermy; wherein the system is configured to provide restoration of at least one portion of the mucosal tissue by the tissue diathermy; and further wherein the plurality of annular electrodes are configured to be placed on the patient's mucosal tissue. on at least one portion of the mucosal tissue of the patient; wherein the system further comprises a control system and at least one temperature sensor in communication with the control system; wherein the at least one portion of the mucosal tissue of the patient is located within the vagina; further wherein the control system is suitable for: creating at least one temperature distribution of the patient based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature distribution of the portion of the patient; and adjusting the RF power applied to each of the plurality of annular electrodes according to the predetermined temperature distribution; wherein the at least one temperature sensor is disposed adjacent to at least one of the plurality of annular electrodes, and wherein the temperature of at least a portion of each of the plurality of annular electrodes is individually and separately controlled.

[0231] Another object of the present invention is to provide an integrated system for enhancing the recovery of at least one part of a patient, the system comprising: a pulsed electromagnetic frequency generator, the pulsed electromagnetic frequency generator applies pulsed electromagnetic field therapy to the at least one part of the patient; a cylindrical shell, the cylindrical shell comprising at least two annular electrodes surrounding the outside of the shell, the at least two annular electrodes being configured to be placed on at least one part of the patient; a generator configured to generate RF power; a control system; and at least one temperature sensor communicating with the control system; wherein none of the at least two annular electrodes is configured to penetrate the at least one part; each of the at least two annular electrodes is configured to provide RF pulses to at least one part, the RF power being configured to apply heat until a temperature T of from 30 degrees Celsius to 80 degrees Celsius; The control system is configured to control the application of the heat performed by the at least two annular electrodes; and the heat can be applied to the at least one part in a manner selected from the group consisting of simultaneously, sequentially, separately and any combination thereof; wherein the at least one part of the patient is located within the vagina; further wherein the control system is suitable for: creating at least one temperature distribution of the patient based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature distribution of the part of the patient; and adjusting the RF power applied to each of the at least two annular electrodes according to the predetermined temperature distribution; wherein the at least one temperature sensor is disposed adjacent to the at least two annular electrodes, and wherein the temperature of at least a portion of each of the at least two annular electrodes is individually and separately controlled. BRIEF DESCRIPTION OF THE DRAWINGS

[0232] In order to understand the invention and to see how it may be carried out in practice, some preferred embodiments will now be described, by way of non-limiting examples only, and with reference to the accompanying drawings, in which:

[0233] Figures 1A to 1D A skin or mucosal tissue viability enhancement system is schematically shown, the system comprising a pulsed electromagnetic frequency generator and a tissue diathermy device;

[0234] Figure 2 Schematically illustrates a skin viability enhancement system comprising a pulsed electromagnetic frequency generator, a tissue diathermy device, and a power supply and control system;

[0235] Figures 3 to 8 A method of improving the viability of skin or mucosal tissue is schematically shown;

[0236] Fig. 9 schematically illustrates a cross-sectional view of an embodiment of a device for treating mucosal tissue in the vagina;

[0237] Fig.10 schematically illustrates a temperature profile of an embodiment of an apparatus for treating mucosal tissue in a vagina; and

[0238] FIG. 11A to FIG. 11F Schematically illustrated are embodiments of a port configured to allow suction to draw tissue into contact with the device. DETAILED DESCRIPTION

[0239] The following description and all sections of the present invention are provided to enable any person skilled in the art to utilize the invention and set forth the best mode contemplated by the inventors for carrying out the invention. However, variations will be apparent to those skilled in the art since the general principles of the invention have been specifically defined to provide a device for at least temporarily restoring mucosal tissue and treating tissue damage. In addition, the present invention provides devices and systems for vaginal tightening and restoration.

[0240] One object of the present invention is to disclose a device for at least temporarily restoring mucosal tissue, such as vaginal tissue, by a synergistic method of tissue diathermy, in particular RF tissue diathermy, in combination with the application of PEMF, wherein at least two tissue restoration mechanisms are included, one of which is based on PEMF therapy. The latter improves the restoration process initiated by the at least one tissue diathermy device.

[0241] Hereinafter, the term "pulsed electromagnetic field (PEMF)" refers in a non-limiting manner to electromagnetic radiation of different frequencies - ranging from static magnetic fields through very low frequencies to radio frequencies - applied in pulses.

[0242] In the following, the term "radio frequency (RF)" refers in a non-limiting manner to the part of the electromagnetic spectrum with a frequency range of about 3 Hz to 300 GHz.

[0243] Hereinafter, the term "collagen" refers in a non-limiting manner to a long fibrous structural protein that is a major component of the extracellular matrix that supports most tissues and provides cellular structure. It is responsible for the strength and elasticity of skin and mucosal tissues, and its degradation leads to wrinkles and sagging that accompany aging.

[0244] In the following, the term "epidermis" refers in a non-limiting manner to the outermost layer of the skin.

[0245] Hereinafter, the term "dermis" refers in a non-limiting manner to a layer of tissue beneath the epidermis or mucosal surface, which includes connective tissue and relieves the body of stress and tension.

[0246] Hereinafter, the term "deep tissue diathermy" or "tissue diathermy" refers in a non-limiting manner to a device that heats tissue beneath the surface of the dermis or mucosal tissue.

[0247] Hereinafter, the term "electrodiathermy" refers in a non-limiting manner to a device that uses a high frequency alternating electric or magnetic field, sometimes without electrodes or device contact with skin or mucosal tissue, to induce gentle tissue heating by induction. For collagen fiber stimulation, typical electrical parameters may include, in a non-limiting manner, a frequency of about 1 MHz applied for about 6 seconds.

[0248] Hereinafter, the term "about" refers to a range of 25% below or above the indicated value.

[0249] In the following, the term "physical tissue parameters" refers to parameters such as tissue temperature, electrical current, tissue impedance, specific absorption rate (SAR), treatment depth, and superficial muscle contraction.

[0250] Hereinafter, the term "angiogenesis" refers to the formation of new blood vessels.

[0251] In the following, the term "square wave" refers to a non-sinusoidal waveform named for its square shape.

[0252] Hereinafter, the term "triangle wave" refers to a non-sinusoidal waveform named for its triangular shape.

[0253] Hereinafter, the term "International Electrotechnical Commission Standard (IEC) 60601-1" refers to the medical electrical equipment standard. More specifically, it refers to the general requirements for basic safety and essential performance.

[0254] In the following, the term "IEC 60601-1-1" refers to the medical electrical equipment standard. More specifically, it refers to the General Requirements for Safety-Parallel Standard: Safety Requirements for Medical Electrical Systems. The IEC 60601-1 series of standards is divided into three different areas. The first area is the basic standard IEC 60601-1, which is a common requirement for all electrical medical basic products. The second area is the parallel standard, which covers plug-in board issues, such as combining with other equipment, EMC, radiation protection and programmable electronic medical systems (software, firmware, etc.) into a system. The standard numbers are IEC 60601-1-1, -1-2, -1-3 and -1-4 respectively. The third area is a specific standard for a specific type of medical device. The specific standard is represented as IEC 60601-2-XX, where XX represents the specific standard number of a specific type of medical device. An example is IEC 60601-2-3, which is a specific standard for shortwave therapy equipment.

[0255] In the following, the term "IEC 60601-1-2" refers to the medical electrical equipment standard. More specifically, it refers to General requirements for basic safety and essential performance - collateral standard: Electromagnetic compatibility - Requirements and tests.

[0256] In the following, the term "IEC 60601-1-3" refers to the standard for medical electrical equipment. More specifically, it refers to General requirements for basic safety and essential performance - collateral standard: Radiation protection in diagnostic X-ray machines.

[0257] In the following, the term "IEC 60601-1-4" refers to the standard for medical electrical equipment. More specifically, it refers to General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems.

[0258] In the following, the term "IEC 60601-1-6" refers to the medical electrical equipment standard. More specifically, it refers to the General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.

[0259] In the following, the term "IEC 60601-1-8" refers to the medical electrical equipment standard. More specifically, it refers to General requirements for basic safety and essential performance - collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

[0260] In the following, the term "IEC 60601-2-3" refers to the medical electrical equipment standard. More specifically, it refers to the special requirements for the safety of shortwave therapy equipment.

[0261] In the following, the term "IEC 60601-2-9" refers to the medical electrical equipment standard. More specifically, it refers to the particular requirements for the safety of patient contact dosimeters used in radiotherapy using electrically connected radiation detectors.

[0262] In the following, the term "IEC 60601-2-29" refers to the standard for medical electrical equipment. More specifically, it refers to the special requirements for basic safety and essential performance of radiation therapy simulators.

[0263] In the following, the term "IEC 60601-2-33" refers to the medical electrical equipment standard. More specifically, it refers to the special requirements for the safety of magnetic resonance equipment used for medical diagnosis.

[0264] In the following, the term "IEC 60601-2-35" refers to the medical electrical equipment standard. More specifically, it refers to the special requirements for the safety of blankets, pads and mattresses used for heating in medical applications.

[0265] The present invention relates to physical therapy methods and systems in which dynamic electromagnetic pulses and electromagnetic heating systems are combined to achieve physical therapy, particularly tightening and rejuvenation of vaginal tissue.

[0266] The present invention provides a system configured to enhance the restoration of a vaginal tissue region of a patient. The system includes, but is not limited to, the following:

[0267] a. a pulsed electromagnetic field (PEMF) frequency generator 2 for constantly providing electromagnetic pulses to the vaginal tissue portion of the patient; and

[0268] b. A tissue diathermy device 4, preferably an RF tissue diathermy device, applies heat to the patient's vaginal tissue region, thereby heating the patient's vaginal tissue to a temperature T.

[0269] The system 10 is configured to simultaneously apply heat and PEMF to the patient's vaginal tissue region. In addition, the system enhances tissue healing such that the enhancement is greater than the sum of the electromagnetic pulse enhancement and the tissue diathermy enhancement.

[0270] Furthermore, the system reduces the electromagnetic pulse and / or the tissue diathermy side effect and / or Adverse effects , such that the reduction in side effects and / or adverse effects is greater than the sum of the reduction in the effects of the electromagnetic pulse and / or the reduction in the effects of tissue diathermy.

[0271] Another object of the present invention is to provide an integrated system 20 configured to enhance the healing of a vaginal tissue site of a patient. The system includes at least two electrodes configured to be placed in the vagina, near the vaginal tissue site of the patient. It is emphasized that each electrode is configured to both (i) provide electromagnetic pulses to the vaginal tissue site of the patient; and (ii) apply heat to the vaginal tissue site of the patient until a temperature T. Embodiments include: at least one electrode is configured to simultaneously provide electromagnetic pulses to the vaginal tissue site of the patient and apply heat to the vaginal tissue site of the patient until a temperature T; at least one electrode is configured to sequentially provide electromagnetic pulses to the vaginal tissue site of the patient and apply heat to the vaginal tissue site of the patient until a temperature T, so that the pattern of applying electromagnetic pulses and applying heat is repeated at least once; and at least one electrode is configured to independently provide electromagnetic pulses to the vaginal tissue site of the patient, and apply heat to the vaginal tissue site of the patient until a temperature T, so that all electromagnetic pulses are provided in one time period, and all applied heat is provided in another time period; wherein, in some variations, the electromagnetic pulses are provided first, and in other variations, the heat is applied first.

[0272] In some embodiments, during some time periods, no electrodes are active.

[0273] During time periods in which multiple electrodes are active, the following application patterns can be used: all active electrodes provide the same treatment, whether providing electromagnetic pulses and applying heat simultaneously, providing electromagnetic pulses only, or applying heat only; or at least one electrode provides a treatment that is different from the treatment provided by at least one other electrode.

[0274] The reduced side effects of tissue diathermy are due to the restorative effect of pulsed electromagnetic frequency therapy.

[0275] Reference now Figures 1A to 1D , which illustrate a system 10 for enhancing dermal tissue restoration. As described above, and as Figure 1A As shown, the system comprises: a pulsed electromagnetic frequency generator 2 for providing electromagnetic pulses to a site of dermal tissue of a patient; and a tissue diathermy device 4, preferably an RF tissue diathermy device, which is configured to apply heat to the site of dermal tissue of the patient to heat the temperature of the tissue to a temperature T. It is emphasized that the system enhances the healing of vaginal tissue such that the enhancement is greater than the sum of the healing enhancement due to the electromagnetic pulse enhancement and the healing enhancement due to the tissue diathermy.

[0276] By exposing the vaginal tissue to a combination of controlled heat and pulsed electromagnetic fields, an enhanced effect of increasing the healing of the vaginal tissue is obtained.

[0277] The present invention relies on two effects, thermal effect and electromagnetic pulse effect:

[0278] Thermal effects include heating the tissue to temperatures high enough to produce tissue damage. In addition, when heat is generated within the dermis, it generally causes shrinkage and thickening of collagen fibers. Each of these will cause an overall tightening and remodeling of the vaginal tissue.

[0279] Heat within the dermis causes limited thermal damage. The body's natural response to this damage is to produce collagen at the site of the injury. This makes the vaginal tissue stronger, thicker, and more elastic. Typically, the vaginal tissue is heated to a temperature below about 60 degrees Celsius for a short period of time. The thermal effect can be produced by:

[0280] 1.RF tissue diathermy;

[0281] 2. Electrical - by passing an electric current through the tissue;

[0282] 3. Electromagnetic means - by delivering an electromagnetic field to the tissue, by inducing (by electromagnetic induction) an electromagnetic field on the surface of the tissue, or a combination of these mechanisms;

[0283] and any combination thereof.

[0284] Electromagnetic pulses (either dynamic, with varying RMS average pulse intensity, or static, with constant RMS average pulse intensity) can initiate the natural healing processes that occur in response to injury (particularly angiogenesis and production of new collagen fibers through the release of tissue growth factors).

[0285] The electromagnetic field causes the charged molecules (ions) in the intercellular fluid to move. This movement generates heat, which can enhance the thermal effects discussed above.

[0286] As is known, healing is the process by which cells in the body regenerate and repair to reduce the size of the damaged area. Healing involves removing dead tissue (destruction) and replacing that tissue.

[0287] Substitution can occur in two ways:

[0288] 1. By regeneration: the dead cells are replaced by tissues identical to the original tissues at that location.

[0289] 2. Through repair: damaged tissue is replaced by scar tissue.

[0290] As described above, the pulsed electromagnetic fields (PEMF) applied by the system 10 have no direct thermal effects and rely on tissue composition and its response to the applied radiation. These responses to the applied radiation may be due to the response of charged macromolecules to specific frequencies and harmonics of those frequencies, small charged ions in cell membranes that affect cell function and affect cell response to hormones and chemical signals, small charged ions in the extracellular space, and other poorly understood mechanisms.

[0291] Furthermore, it has been found that applying radiation in pulses has non-thermal effects. Furthermore, only specific combinations of frequency, duty cycle, and delivered power achieve specific tissue responses.

[0292] It is now generally accepted that electromagnetic fields (EMF) or PEMF can initiate various healing processes and treat pain and edema in superficial soft tissues; twenty years ago, the FDA approved the use of pulsed radiofrequency electromagnetic fields to treat pain and edema in [Rosch, PJ, Markov, MS, eds. Bioelectromagnetic Medicine, Marcel Dekker, 2004; NY, 251-264].

[0293] The present invention utilizes PEMF in combination with heating from a heat source, which may be separate or may be integrated with a device for restoration and healing purposes as described above. When used at a specific field strength, duty cycle, and frequency, PEMF as described above will enhance dermal collagen synthesis. The newly formed collagen will enhance tissue elasticity and restore skin appearance for skin treatment. In addition, PEMF enhances the extent of endothelial cell cannulation and proliferation and promotes angiogenesis, primarily by stimulating the endothelium to release FGF-2, inducing paracrine and autocrine changes in surrounding tissues. Angiogenesis, the formation of new blood vessels, enhances the flow of blood to the tissue, which in turn enhances the delivery of oxygen and nutrients to the tissue. This effect is most beneficial for damaged tissue, promoting rapid and improved healing. The released growth factors further enhance the healing process in terms of both quality and speed.

[0294] A more detailed description of the two combined effects is provided below.

[0295] As disclosed above, the present invention discloses a system 10 including both a controlled heating device and electromagnetic pulses.

[0296] Typically, heat can be generated by:

[0297] 1.RF power supply

[0298] 2. Electrical means - by passing an electric current.

[0299] 3. Electromagnetic method - by transmitting electromagnetic field or inducing electromagnetic field (electromagnetic induction) on the treatment tissue. Now refer to Figures 1B to 1D , shows a system 10 according to some embodiments of the present invention.

[0300] According to these embodiments, the tissue diathermy device 4 comprises:

[0301] a. at least one electrical output device configured to generate an electrical current; and

[0302] b. At least two electrodes 41, electrically coupled to the electrical output device and placed on a site on the patient's skin or mucosal tissue.

[0303] According to some embodiments, all electrodes are configured to apply current to the skin site simultaneously. According to other embodiments, only a portion of the electrodes are active at any given time.

[0304] Figure 1B A system 10 for treating external skin tissue is shown, wherein a tissue diathermy device 4 comprises four electrodes 41 .

[0305] refer to Figure 1C, shows an embodiment of a disposable portion 2300 of a device for vaginal use. The disposable portion is the portion for insertion into the vagina; not shown is a reusable portion that includes a handle mechanism for holding the device during insertion and removal (and possibly during use), a control mechanism for controlling the delivery of power to the disposable portion, and a mechanism for delivering a heating or cooling fluid in some embodiments.

[0306] The cooling device can be selected from the group consisting of: a Peltier effect cooling device, an irrigation device with cold water and a device for blowing air onto the tissue.

[0307] It should be noted that in some embodiments, the disposable portion is sterilizable and reusable.

[0308] The device 2300 includes a distal segment 2310 for insertion into the vagina, a ring 2320 for limiting the insertion depth, an intermediate portion 2330, and a proximal portion 2340 configured to provide a connection between the disposable portion 2300 and the reusable portion. The connection provided by the proximal portion 2340 includes mechanical connection and electrical communication; it may also include a fluid connection.

[0309] Figure 1C An embodiment has a longitudinal electrode 2315.

[0310] Figure 1C The embodiment has four longitudinal electrodes 2315; the number of longitudinal electrodes can be between 1 and about 20, preferably between about 4 and about 10.

[0311] In a preferred variant, the device comprises a sensor to monitor temperature. This may be the temperature of at least a portion of the electrode, the temperature of tissue proximate a portion of the electrode, or any combination thereof.

[0312] In preferred variations of these embodiments, the temperature of the tissue is measured.

[0313] In embodiments having at least one temperature sensor, preferably the sensor is proximate to or within the electrode so that the temperature measured by the temperature sensor can be associated with at least a portion of the electrode that is primarily responsible for sensing the temperature. In a preferred variation of an embodiment having a temperature sensor, at least one temperature sensor is proximate to each electrode, and the temperature is controlled individually and separately for at least a portion of each electrode. The temperatures of any selected portions of a given pair of electrodes may be the same, or they may be different. In a preferred variation, the temperatures may be different, with the temperature of the distal portion of the electrode being higher and the temperature of the proximal portion of the electrode being lower. The difference between a device for treating external skin tissue and a device for treating vaginal tissue is that labial tissue and vulvar tissue are far more sensitive to heat than vaginal tissue. Therefore, it is preferred that the proximal end of the distal segment 2410 of the device be heated less than the remainder of the distal segment 2410.

[0314] Figure 1D An embodiment of a vaginal treatment device 2400 is shown in which the electrode 2415 is annular and surrounds the distal segment 2410 of the device. Figure 1D The device has a ring 2420 for preventing the device from being over-inserted into the vagina, a middle portion 2430, and a proximal portion 2440, wherein the proximal portion 2440 is configured to provide a connection between the disposable portion 2400 and the reusable portion (not shown). The connection provided by the proximal portion 2440 includes mechanical connection and electrical communication; it may also include a fluid connection.

[0315] Figure 1D The embodiment has four annular electrodes 2415; the number of annular electrodes can be between 1 and about 20, preferably between about 4 and about 10.

[0316] In embodiments having at least one temperature sensor, preferably the sensor is proximate to or within the electrode such that the temperature measured by the temperature sensor can be correlated to at least the portion of the electrode that is primarily responsible for sensing the temperature.

[0317] Preferably, the temperature sensor is configured to measure tissue temperature rather than electrode temperature.

[0318] In a preferred variation of the embodiment with temperature sensors, there is at least one temperature sensor near each electrode, and the temperature is controlled individually and separately for at least a portion of each electrode. The temperatures of any selected portion of a given pair of electrodes can be the same, or they can be different. In a preferred variation, the temperatures are different, with the center electrode having a higher temperature and the edge electrodes having a lower temperature.

[0319] In a typical embodiment of the present invention, a pulsed electromagnetic frequency is generated by a pulsed electromagnetic frequency generator in communication with a power unit, which may be located in the handle or in a separate unit. The pulsed electromagnetic frequency generator 2 is located near the treatment tissue and provides electromagnetic pulses to the patient's tissue. In some embodiments, the pulsed electromagnetic frequency generator 2 provides an electromagnetic field in which the frequency, RMS average amplitude, pulse width, and duty cycle are constant over time. In some embodiments, the pulsed electromagnetic frequency generator 2 provides a dynamic electromagnetic field in which at least one of the frequency, RMS average amplitude, pulse width, and duty cycle varies over time.

[0320] As a non-limiting example, the pulsed electromagnetic frequency generator may be an electromagnetic field generator or an acoustic transducer.

[0321] The specific terms that are varied in the dynamic magnetic field are selected according to the specific treatment to be applied. As a non-limiting example, to stimulate angiogenesis, pulses with a frequency of about 15 Hz, an intensity of about 12 Gauss, and a duration of about 5 ms are generated. In another non-limiting example, to stimulate collagen production, pulses with a frequency between about 10 Hz and about 25 Hz and an intensity of about 20 Gauss are generated.

[0322] The tissue diathermy device 4 is configured to apply heat to a dermal region of a patient, heating it to a predetermined temperature T. According to some embodiments of the present invention, the heat is applied by passing an electric current through the tissue.

[0323] The current may be applied in any combination of the following ways:

[0324] 1. Through at least one electrode in direct physical contact with the tissue;

[0325] 2. Passing current through at least one electrode that is not in physical contact with the tissue and by induction.

[0326] 3. Through at least one antenna that delivers electrical current to the tissue via electromagnetic induction.

[0327] Reference now Figure 2 , which shows an embodiment of the present invention, comprising a pulsed electromagnetic frequency generator 2 and a tissue diathermy device 4, and additionally comprising a control system 6 configured to regulate a member of the group consisting of: electromagnetic pulses, tissue diathermy, and any combination thereof.

[0328] In some embodiments of the invention, treatment is provided only within safe treatment parameters (Table 1). Unsafe treatment parameters are avoided (Table 2).

[0329] Safe treatment parameters are defined by the parameters in Table 1:

[0330] Table 1: Safe treatment parameters

[0331]

[0332]

[0333] Unsafe treatment parameters are defined by the parameters in Table 2:

[0334] Table 2: Unsafe treatment parameters

[0335]

[0336] In some embodiments, the control system 6 further comprises:

[0337] (a) a processor configured to store predetermined parameters in a communicable database, the predetermined parameters defining (i) safe treatment parameters and (i) unsafe treatment parameters, wherein the parameters are selected from the group consisting of: total treatment duration t t , the time t during which PEMF is applied p , the temperature T to which the treated tissue is heated, the duty cycle t p / t t , frequency F, power P applied by pulses from a pulsed electromagnetic frequency generator, intensity I of RF diathermy, depth D of treated tissue, magnetic field strength B, tissue impedance, specific absorption rate (SAR), superficial muscle contraction, and any combination thereof;

[0338] (b) a sensing mechanism configured to sense electromagnetic radiation and a heating parameter selected from the group consisting of: treatment time (duration) t t , the time t during which electromagnetic radiation and / or heating is applied p , the temperature T to which the treated tissue is heated, the duty cycle t p / t t , frequency F of applied electromagnetic or thermal radiation, power P applied by pulses from a pulsed electromagnetic frequency generator, intensity I of RF diathermy, depth D of treated tissue, magnetic field strength B, tissue impedance, specific absorption rate (SAR), superficial muscle contraction, and any combination thereof; and

[0339] (c) a regulating mechanism configured to allow pulsed electromagnetic radiation and thermal radiation if the parameters fall within the range of safe treatment parameters, and to stop pulsed electromagnetic radiation if the radiation parameters are outside the range of safe treatment parameters and therefore fall within the range of unsafe treatment parameters.

[0340] In some embodiments, the system further comprises at least one sensor for monitoring at least one physical parameter selected from the group consisting of: total treatment duration t t , the time t during which PEMF is appliedp , the temperature T to which the treated tissue is heated, the duty cycle t p / t t , frequency F of the PEMF, power P applied by the pulses from the pulsed electromagnetic frequency generator, depth D of the treated tissue, magnetic field strength B, tissue impedance, specific absorption rate (SAR), superficial muscle contraction, and any combination thereof.

[0341] The at least one sensor receives at least one parameter from the treated tissue. Based on the received parameter, at least one change can be made to at least one operating parameter of the pulsed electromagnetic frequency generator 2, at least one operating parameter of the tissue diathermy device 4, or both. The at least one operating parameter can be changed to optimize the effect of the pulsed electromagnetic field, optimize the effect of tissue diathermy, enhance the synergistic effect of the two components, and any combination thereof, while avoiding damage to the tissue.

[0342] In some embodiments of the present invention, the shape of the electromagnetic pulse is selected from the group consisting of, but not limited to, a square wave, a sine wave, a triangle wave, a sawtooth wave, a ramp wave, a spike wave, and any combination thereof.

[0343] In some embodiments, the system defined above is configured to provide electromagnetic pulses with a frequency of about 15-16 Hz, wherein the pulse RMS average intensity varies over time between about 0 and about 12 Gauss. In some variations of these embodiments, the pulse RMS average intensity increases over time from about 0 Gauss to about 12 Gauss, then decreases to about 0, and the cycle repeats. In some variations of these embodiments, the RMS average intensity decreases gradually, as a non-limiting example, in approximately the same time as it takes to increase. In other embodiments, the intensity decreases rapidly to zero in no more than a few pulses, preferably in less than one pulse.

[0344] In some embodiments, the system defined above is configured to provide square wave pulses having a frequency of about 15-16 Hz, wherein the RMS average amplitude of the pulses repeatedly increases from about 0 to about 12 Gauss.

[0345] In some embodiments intended to stimulate collagen production, the system defined above is configured to provide wave pulses with a frequency between about 10 Hz and about 25 Hz and a constant RMS average intensity of about 20 Gauss. In some embodiments intended to stimulate collagen production, the wave pulses are triangular. In other embodiments, other waveforms as disclosed herein are used.

[0346] In some embodiments, the system defined above is configured to provide alternating current (AC) having a frequency of about 1 MHz.

[0347] In some embodiments, the system defined above is configured to provide about 80 J / cm 2 The strength of sec.

[0348] In some embodiments of the invention, the duration of each pulse applied by the pulsed electromagnetic frequency generator is in the range of between about 3 ms to about 1000 ms.

[0349] In some embodiments of the invention, the frequency F of the pulses of the pulsed electromagnetic frequency generator is in the range of between about 1 Hz and about 1 MHz.

[0350] In some embodiments of the invention, the power P applied by the pulses of the pulsed electromagnetic frequency generator is in the range of between about 1 W / pulse to about 100 W / pulse.

[0351] In some embodiments of the present invention, the tissue diathermy device 4 is selected from the group consisting of, without limitation, an electric diathermy device, an RF diathermy device, and any combination thereof. In some embodiments of the present invention, the tissue diathermy device 4 is selected from the group consisting of, without limitation, an electromagnetic induction device, a short-wave RF diathermy device, or any other device that controllably heats subcutaneous tissue to a temperature T.

[0352] In some embodiments of the invention, the temperature T to which the tissue is heated is in the range of about 30 degrees Celsius to about 80 degrees Celsius.

[0353] In some embodiments of the invention, the system includes a mechanism for cooling tissue.

[0354] In some embodiments of the invention, the pulsed electromagnetic frequency generator 2 and tissue diathermy device 4 have more than one applicator in order to treat more than one body part simultaneously.

[0355] In some embodiments of the invention, the pulsed electromagnetic frequency generator 2 has an electrostatic shield.

[0356] It should be emphasized that the system defined in any of the embodiments produces synergistic results in each of the following time scales: short term (less than about a week), medium term (about two to three weeks), and long term (about a month or longer).

[0357] In the short term, there is contraction and thickening of the collagen fibers, which in turn results in an overall tightening of the vaginal tissue.

[0358] In the mid-stage condition, new epidermal cells and new collagen fibers are produced.

[0359] In the long term, cellulite is dispersed.

[0360] In other embodiments of the invention disclosed herein, at least one of the electrodes further comprises a hypodermic syringe for piercing subcutaneous tissue. Through such a syringe, a substance containing an appropriate active agent can be injected into the tissue during treatment. Non-limiting examples of such substances include muscle relaxants, local anesthetics, etc.

[0361] Also within the scope of the present invention is disclosed a method for providing healing to tissue, the method comprising (a) generating N independent signals of predetermined waveform, frequency, amplitude, and relative phase, wherein N is the number of electrodes or the number of electrode pairs, to control at least one of pulsed electromagnetic frequency generation or tissue diathermy; (b) transmitting each of the N independent signals to at least one electrode; (c) placing at least one of the electrodes at least in the vicinity of the tissue to be treated; and (d) transmitting power carried by the signal to the tissue. In a preferred embodiment, the N independent signals are phase-shifted relative to each other. The method may be performed using an apparatus according to any of the embodiments described herein or any variation of an apparatus described herein.

[0362] It is also within the scope of the present invention that the step of generating N independent signals further comprises generating N independent pulsed electromagnetic fields such that the time-dependent amplitude A of the mth of the N independent signals is t,m By the relation Given, where A 0,m is a predetermined constant greater than or equal to 1, F m is a predetermined time period function, ω m is the angular frequency of the mth signal, and is the predetermined phase shift of the mth signal. Meanwhile, in a preferred embodiment of the method, the step of generating N independent signals comprises the following steps, wherein A of all N signals 0,m 、F m and ω m are basically the same, and any two pairs of signals m and m+1 substantially the same, such limitation is not required, and it is also within the scope of the present invention to disclose a method in which any or all of them are different for all N signals. In a preferred embodiment of the substantially same method, the method further comprises: And provide a phase shift for each of the N independent signals , where 0≤k≤1, m=1,2,3...N, and j=1,2,3...; where N is the number of electrodes. For example, for one electrode in a group of four (N=4), k=1 and the phase is 135 degrees, while for another electrode in the group of four, the phase is 45 degrees, and so on.

[0363] In some embodiments of the method, the method further comprises selecting F from the group consisting of m The step of, the group includes: sine, cosine, tangent, cotangent (cot), sawtooth wave, triangle wave, square wave, rectangular wave, trapezoidal wave, spike wave, and any combination thereof.

[0364] In other embodiments of the invention disclosed herein, at least one of the electrodes further comprises a hypodermic syringe for piercing subcutaneous tissue. Through such a syringe, a substance containing an appropriate active agent can be injected into the tissue during treatment. Non-limiting examples of such substances include muscle relaxants, local anesthetics, etc.

[0365] Also within the scope of the present invention is disclosed a method for providing healing to treated tissue, the method comprising (a) generating N independent signals of predetermined waveform, frequency, amplitude, and relative phase, wherein N is the number of electrodes or the number of electrode pairs, to control at least one of pulsed electromagnetic frequency generation or tissue diathermy; (b) transmitting each of the N independent signals to at least one electrode; (c) placing at least one of the electrodes at least in the vicinity of the tissue to be treated; and (d) transmitting power carried by the signal to the tissue. In a preferred embodiment, the N independent signals are phase-shifted relative to each other. The method may be performed using an apparatus according to any of the embodiments described herein or any variation of an apparatus described herein.

[0366] It is also within the scope of the present invention that the step of generating N independent signals further comprises generating N independent pulsed electromagnetic fields such that the time-dependent amplitude A of the mth of the N independent signals is t,m By the relation Given, where A 0,m is a predetermined constant greater than or equal to 1, F m is a predetermined time period function, ω m is the angular frequency of the mth signal, and is the predetermined phase shift of the mth signal. Meanwhile, in a preferred embodiment of the method, the step of generating N independent signals comprises the following steps: 0,m 、F m and ω m are basically the same, and any two pairs of signals m and m+1 substantially the same, such limitation is not required, and it is also within the scope of the present invention to disclose a method in which any or all of them are different for all N signals. In substantially the same preferred embodiment, the method further comprises the following steps: And provide a phase shift for each of the N independent signals , where 0≤k≤1, m=1,2,3...N, and j=1,2,3...; where N is the number of electrodes. For example, for one electrode in a group of four (N=4), k=1 and the phase is 135 degrees, while for another electrode in the group of four, the phase is 45 degrees, and so on.

[0367] In a preferred embodiment of the method, the method further includes selecting F from sine, cosine, tangent, cotangent (cot), sawtooth wave, triangle wave, square wave m steps.

[0368] Heat may be provided to the treated tissue by applying an electric current through the electrodes, which is absorbed by the subcutaneous tissue or by RF power applied to the tissue.

[0369] Now refer to Figure 3 , which schematically illustrates an embodiment of a method 400 for enhancing the healing of a site of skin or mucosal tissue of a patient. The method includes steps selected, inter alia, from: obtaining (i) a pulsed electromagnetic frequency generator and (ii) a tissue diathermy device 401; applying heat to subcutaneous tissue within the site, heating the site up to a predetermined temperature T 402; the temperature T being optimized to produce new collagen and induce dermal hyperplasia and to contract existing collagen. While collagen contraction causes an immediate tightening of the vaginal tissue, the effects of dermal hyperplasia and new collagen production will be apparent at a later stage. The next step is to apply an additional pulsed electromagnetic field 403, which produces a healing mechanism in the heated tissue including growth factor production and cytokine release and ultimately angiogenesis.

[0370] Now refer to Figure 4 , which shows an embodiment of a preferred method of the present invention. According to this embodiment, method 400 further includes step 404, which includes at least one of the following steps: monitoring the application of heat to the subcutaneous tissue in the region, controlling the application of heat to the subcutaneous tissue in the region, monitoring the application of pulsed electromagnetic therapy to the region, and controlling the application of pulsed electromagnetic therapy to the region.

[0371] Now refer to Figure 5 , schematically illustrates an embodiment of a method 410 for enhancing tissue rejuvenation in a patient's vaginal tissue region. The method includes steps selected, inter alia, from: obtaining (i) a pulsed electromagnetic frequency generator and (ii) a tissue diathermy device 411; applying a pulsed electromagnetic field 412 that produces a repair mechanism in the tissue, including the release of growth factors and cytokines and eventual angiogenesis; and finally, applying heat to the subcutaneous tissue within the region, thereby heating the subcutaneous tissue to a temperature T 413; the temperature T is optimized to produce new collagen and cause dermal hyperplasia and contraction of collagen. While collagen contraction tightens the tissue, the effects of dermal hyperplasia and new collagen production will subsequently be apparent.

[0372] Now refer to Figure 6 , which shows another embodiment of the method of the present invention. According to this embodiment, method 410 further includes step 414, which includes at least one of the following steps: monitoring the application of heat to the subcutaneous tissue in the site, controlling the application of heat to the subcutaneous tissue in the site, monitoring the application of pulsed electromagnetic therapy to the site, and controlling the application of pulsed electromagnetic therapy to the site.

[0373] Now refer to Figure 7 , schematically illustrating an embodiment of a method 420 for increasing the healing of a site of skin or mucosal tissue. The method includes steps selected, inter alia, from: obtaining (i) a pulsed electromagnetic frequency generator and (ii) a tissue diathermy device 421; and applying a pulsed electromagnetic field 422 while simultaneously applying heat to subcutaneous tissue within the site, heating the tissue to a temperature T. The electromagnetic pulses produce repair mechanisms in the heated tissue, including growth factor and cytokine release and eventual angiogenesis. The temperature T is optimized to produce new collagen and cause dermal hyperplasia and contraction of collagen. Although collagen contraction causes an immediate tightening of the affected tissue, the effects of dermal hyperplasia and new collagen synthesis will be revealed later.

[0374] Now refer to Figure 8 , which shows a preferred embodiment of the method of the present invention. According to this embodiment, method 420 further includes step 424, which includes at least one of the following steps: monitoring the application of heat to the subcutaneous tissue in the site, controlling the application of heat to the subcutaneous tissue in the site, monitoring the application of pulsed electromagnetic therapy to the site, and controlling the application of pulsed electromagnetic therapy to the site.

[0375] In some embodiments of the invention, each of the methods defined above further comprises the step of selecting the temperature T in the range of about 30 degrees Celsius to about 80 degrees Celsius.

[0376] In some embodiments of the invention, each of the methods as defined above further comprises the step of applying a dynamic electromagnetic field in said region, wherein the peak intensity of the electromagnetic field varies with time.

[0377] In some embodiments of the invention, each of the methods defined above further comprises the following steps:

[0378] a. storing predetermined parameters in a communicable database, the predetermined parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; the parameters are selected from the group consisting of: the total duration of treatment t t , the time t during which the PEMF is applied p , the temperature of the treated tissue T, the duty cycle tp / t t , frequency F, power P applied by pulses from a pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field strength B, tissue impedance, specific absorption rate (SAR), superficial contraction, and any combination thereof;

[0379] b. Sensing electromagnetic radiation and a heating parameter selected from the group consisting of: total duration of treatment t t , the time t during which the PEMF is applied p , the temperature of the treated tissue T, the duty cycle t p / t t , frequency F of the applied radiation, power P applied by the pulses from the pulsed electromagnetic frequency generator, heating intensity I, depth D of the treated tissue, magnetic field strength B, tissue impedance, specific absorption rate (SAR), superficial contraction, and any combination thereof;

[0380] c. Allowing electromagnetic radiation and heating if the parameters fall within the safe processing parameters and stopping electromagnetic radiation and heating if the parameters fall within unsafe processing parameters.

[0381] In some embodiments of the invention, the step of applying heat is performed by a device selected from the group consisting of: an electromagnetic induction device, a device configured to apply direct heat or any other means of heating the subcutaneous tissue to temperature T.

[0382] In some embodiments of the invention, each of the methods as defined above further comprises the step of selecting a frequency F of the pulses applied during the step of applying pulsed electromagnetic therapy to the site within the range of about 1 Hz to about 1 MHz.

[0383] In some embodiments of the invention, each of the methods defined above further comprises the step of selecting the power P applied during the step of applying pulsed electromagnetic therapy to the site to be in the range of about 1 W / pulse to about 100 W / pulse.

[0384] In some embodiments of the present invention, in each of the methods defined above, the duration of the step of applying heat is in the range of about 0.01 minutes to about 100 minutes.

[0385] In some embodiments of the invention, in each of the methods defined above, the pulsed electromagnetic field application time is in the range of about 0.01 minutes to about 100 minutes.

[0386] In some embodiments of the present invention, in each of the methods defined above, the steps of applying heat and applying pulsed electromagnetic therapy are performed in a manner selected from the group consisting of: simultaneously, sequentially (alternating application of heat and application of pulsed electromagnetic therapy) or independently (applying heat in one phase of treatment and applying pulsed electromagnetic therapy in a separate phase of treatment).

[0387] In some embodiments of the invention, in each of the methods defined above, the method is repeated 1 to 100 times per treatment.

[0388] In some embodiments of the present invention, as a non-limiting example, a typical protocol for the pulsed electromagnetic frequency generator 4 includes a preset number of pulses of about 1 μs with a duty cycle of about 50% and a pause of up to 250 μs. In this type of protocol, power is provided to the tissue during a period of applying a preset number of pulses.

[0389] In some embodiments of the present invention, as a non-limiting example, a typical protocol for the pulsed electromagnetic frequency generator 4 includes 10 pulses of about 1 μs period with about 50% duty cycle and a preset pause of about 512 μs in length. In this type of protocol, power is provided to the tissue during a period of applying a preset number of pulses.

[0390] In some embodiments of the invention, by way of non-limiting example, a typical protocol for pulsed electromagnetic frequency generator 4 comprises a variation of the previous protocol wherein the number of pulses applied is a multiple of approximately ten.

[0391] In some embodiments of the invention, in each of the methods defined above, the treatment is repeated more than once.

[0392] In some embodiments of the invention, each of the methods as defined above further comprises the step of selecting the shape of the electromagnetic pulse from the group consisting of: square wave, sine wave, triangle wave, sawtooth wave, ramp wave, spike wave and combinations thereof.

[0393] It should also be understood that in order to enable ordinary technicians to practice the present invention, the description of the above method and apparatus will be interpreted as including apparatus for performing the method, as well as methods using any type of apparatus known to ordinary technicians in the field, and this does not need to be described in detail herein.

[0394] For the main embodiments of the present invention, the specific selection of type and mode is not critical, although it may be relevant in the case of specific identification. The present invention has been described by a detailed description of its embodiments provided as examples and not intended to limit the scope of the present invention. Generally, restrictive or with words such as "may", "should", "preferably", "must" or other terms to indicate the degree of importance or motivation should not be regarded as a limitation on the scope of the claims or their equivalents, unless there is a literal limitation on its scope in such claims. It should be understood that the features and steps described with respect to one embodiment can be used in other embodiments, and not all embodiments of the present invention have all the features and / or steps shown in a particular figure or described with respect to one of the embodiments. That is, from the perspective of combination, the disclosure should be considered complete, wherein each embodiment of each element is regarded as being disclosed in conjunction with each other embodiment of each element (and in fact in various combinations of compatible implementations of variations of the same element). Variations of the described embodiments will occur to those skilled in the art. In addition, the terms "comprise", "include", "have" and their variations should mean "including but not necessarily limited to" when used in the claims. Each element in the claims presented in the singular should refer to one or more of the elements claimed, and when one or more groups of options are provided, it should be interpreted to mean that the claim requires only one of the various options to be selected, and does not require one of each option. The abstract should not be interpreted as limiting the scope of the application or the claims.

[0395] It should be noted that some of the above embodiments describe the best mode expected by the inventor, and therefore may include details of structures, actions, or structures and actions that may be unnecessary for the present invention and described as examples. As known in the art, the structures and actions described herein may also be replaced by equivalents that perform the same functions, even if the structures or actions are different. Therefore, the scope of the present invention is limited only by the elements and limiting factors used in the claims.

[0396] Fig. 9 A cross section of a device is shown having six ring electrodes 2415 surrounding the distal portion of the device 2410 ; a ring 2420 is also shown to prevent over-insertion of the device into the vagina; a temperature sensor 2417 is shown adjacent to each ring electrode 2415 .

[0397] In a preferred embodiment of the device having the ring electrodes, a predetermined temperature profile can be generated within the vagina. Typically, at least one predefined temperature profile can be stored in a database in communication with a processor, wherein the processor is in communication with at least one temperature sensor and at least one power source; the power source provides power to the electrodes.

[0398] In a preferred embodiment, both PEMF and heating are supplied to the electrodes, wherein the heating mechanism is selected from the group consisting of tissue diathermy, electric current, induced electromagnetic field, and any combination thereof. In a preferred embodiment, the heating mechanism is RF tissue diathermy.

[0399] The temperature can vary longitudinally along the distal portion 2410 of the device, radially around the distal portion 2410 of the device, and any combination thereof. Typically, the temperature profile is generated via feedback, where a comparison between the temperature measured by each sensor and a predetermined stored temperature profile is used to adjust the power applied to each electrode.

[0400] Fig.10 An exemplary temperature profile is shown, where the temperature varies longitudinally along the distal portion 2410 of the device. Numbers 1 to 6 refer to Fig. 9 6 electrodes are shown in FIG. 1 , where 1 is the most proximal electrode and 6 is the most distal electrode. The temperature is lowest at electrode 1, which is closest to the vulva and labia that are sensitive to heat. In this embodiment, the temperature of the most distal electrode 6 is also lower than that of the central electrode.

[0401] Under feedback control, more RF power will be provided to electrodes 3, 4 and 5, and less power will be provided to electrodes 1, 2 and 6, so as to maintain a desired temperature distribution in the vagina.

[0402] In some embodiments, the temperature within the vagina during treatment will be between about 30 degrees Celsius and about 80 degrees Celsius, preferably between about 40 degrees Celsius and about 50 degrees Celsius.

[0403] from Figure 1B , Figure 1C , Figure 1D as well as Fig. 9 As can be seen in the Figure 1 , electrodes and sensors can be enclosed in a platform to keep them in a desired position. Similarly, a processor and a conditioning device can be encapsulated in a platform. The processor / conditioning mechanism platform can be the same as the electrode / sensor platform that is reversibly connected to the platform or permanently connected to the platform. Either platform can additionally include a power source.

[0404] In some embodiments, the device can provide at least one of fractional PEMF and fractional tissue diathermy, wherein only a portion of the electrodes are active at any one time. This can reduce patient discomfort during treatment.

[0405] In some embodiments, the device may additionally include a mechanism to induce suction so as to induce at least a portion of the tissue to be in close contact with the device. In some embodiments, the device will include at least one port. When the device is in use, suction is applied to at least one of the ports, causing the tissue to be drawn into close contact with the device, and if the port leads to a recess in the device, causing the tissue to be drawn into the recess in the device. In a preferred embodiment, the tissue is drawn to a sufficient length so that it is in physical contact with the port and any electrodes or transducers disposed around it.

[0406] The suction unit is configured to operate continuously or in a pulsed manner, delivering constant suction or pulsed suction to the tissue.

[0407] FIG. 11A to FIG. 11F Schematic cross-sectional views of five exemplary embodiments of the device are provided, which provide non-limiting illustrations of possible geometries of the device. Although these illustrations only show the arrangement of the elements in the cross-sectional plane and the hidden view of a limited number of elements hidden by tissue 500 drawn into the housing, it is emphasized that the only limitations on the number of tissue diathermy devices and pulsed electromagnetic frequency generators that can be used are the physical size of the housing and the minimum distance required to prevent short circuits. In the embodiments shown, the tissue diathermy device and the pulsed electromagnetic frequency generator are shown separately; in some embodiments, the same electrodes generate the tissue diathermy device and the pulsed electromagnetic field.

[0408] Fig.11A An embodiment is shown in which a single port 400 is provided; arrows indicate the direction of air flow when the device is fluidly connected to a vacuum source. The tissue diathermy device 200 is disposed on the lip and interior surface of the housing, while the pulsed electromagnetic frequency generator 300 is disposed on the interior surface of the housing. Fig. 11B FIG. 1 shows a tissue diathermy device and a transducer as shown in FIG. Fig.11A The arrangement shown, however, is an embodiment in which multiple ports 400 are provided. The arrows indicate the direction of air flow when the device is fluidly connected to a vacuum source and when air is being returned after treatment is complete.

[0409] Fig. 11C An embodiment is shown in which at least one transducer is disposed about a substantially closed end of the housing. Fig.11D An embodiment is shown in which both the pulsed electromagnetic frequency generator and the tissue diathermy device are disposed around a lip of the housing and both the pulsed electromagnetic frequency generator and the tissue diathermy device are disposed around an inner surface of the housing. In this embodiment, at least one tissue diathermy device is disposed around a substantially closed end of the housing. Fig. 11C and Fig.11D In the embodiment shown, the ports are displaced from the central axis of the housing and are therefore not shown in the figures.

[0410] Fig.11E A schematic illustration of an embodiment of the invention is shown. In this embodiment, the housing has a generally cylindrical, rather than cup-shaped, housing, and the pulsed electromagnetic frequency generator is disposed around the inner surface of the side of the housing, as shown in the figure.

[0411] Fig.11F A schematic illustration of the distal end of an embodiment of the invention having a cylindrical housing, longitudinal electrodes on the exterior of the housing, and a port 400 between electrodes 2315 is shown. The airflow causing suction is schematically shown by arrows 420.

[0412] In some embodiments, the device further comprises a recess configured to be placed against or proximate to a surface of the skin or mucosal tissue.

[0413] In some embodiments, tissue is drawn into the recess to a sufficient depth to bring it into physical contact with any tissue diathermy applicators or pulsed electromagnetic frequency electrodes disposed about the interior surface of the recess, as well as the port itself.

[0414] In some embodiments, tissue is drawn into the recess without physical contact with any tissue diathermy applicators or pulsed electromagnetic frequency electrodes disposed about the interior surface of the housing.

[0415] The technical solution of the present invention can also be configured as follows:

[0416] Item 1. A device for restoring at least one portion of mucosal tissue, comprising:

[0417] A pulsed electromagnetic frequency generator is provided to generate pulsed electromagnetic frequency signals to the mucosal tissue.

[0418] applying pulsed electromagnetic field therapy to the above mentioned areas; and

[0419] a plurality of electrodes in communication with an RF tissue diathermy device;

[0420] Wherein, the RF tissue diathermy device heats the at least one portion of mucosal tissue via the electrode.

[0421] Item 2. The apparatus of item 1, wherein at least one of the following applies:

[0422] a. at least a portion of at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T1, while at least another portion of at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 and T2 are

[0423] Same or different;

[0424] b. The device further comprises at least one adjacent to at least one of the plurality of electrodes

[0425] Temperature sensor;

[0426] c. said at least one portion of said mucosal tissue is within the vagina; and

[0427] d. The device further comprises a processor in communication with the at least one temperature sensor and with the database, the at least one temperature sensor being selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0428] Item 3. The apparatus of item 2, wherein at least one of the following applies:

[0429] a. The processor is configured to feedback control the RF output of the pulsed electromagnetic frequency generator and the RF tissue diathermy device so that at least one

[0430] The temperature distribution can be maintained in a predetermined portion; and

[0431] b. Each of said at least one temperature is measurable in said at least a portion of said site of said mucosal tissue.

[0432] Item 4. The apparatus of item 1, wherein at least one of the following applies:

[0433] a. The duration of the pulses from the pulsed electromagnetic frequency generator is between about 3 ms and

[0434] In the range of about 1000ms;

[0435] b. The frequency F of the pulses from the pulsed electromagnetic frequency generator is about 1 Hz.

[0436] in the range of about 50 Hz; and

[0437] c. The pulsed electromagnetic power from the pulsed electromagnetic frequency generator is configured to stimulate collagen production.

[0438] Item 5. The apparatus of item 1, wherein at least one of the following applies:

[0439] a. the pulsed electromagnetic power is configured to induce angiogenesis; and

[0440] b. The pulsed electromagnetic power comprises pulses at a frequency F of about 15 Hz and a magnetic field strength B of about 12 Gauss.

[0441] Item 6. The apparatus according to Item 1, wherein at least one of the temperature distributions is selected from

[0442] The member of the group of temperature, the predetermined temperature range T1, the predetermined temperature range T2 and any combination thereof is within a range selected from the group consisting of: from about 30 degrees Celsius to about 80 degrees Celsius; and from about 40 degrees Celsius to about 50 degrees Celsius.

[0443] Item 7. An integrated system for enhancing the restoration of at least one portion of mucosal tissue of a patient,

[0444] The system includes:

[0445] At least two electrodes, the at least two electrodes are configured to be placed on the patient's mucosa

[0446] at least one of the parts of the tissue;

[0447] an electromagnetic field generator configured to generate electromagnetic field pulses and apply the electromagnetic field pulses to the at least one site of mucosal tissue of the patient; and

[0448] Control systems;

[0449] in,

[0450] None of the electrodes are configured to penetrate the at least one site of mucosal tissue of the patient;

[0451] Each of the electrodes is configured to conduct RF to at least one of the locations of the patient's mucosal tissue; the electrodes are configured to heat the mucosal tissue to a temperature T in the range of 30 degrees Celsius to 80 degrees Celsius; and

[0452] The control system is configured to control the electromagnetic field generator and the application of the heat by the electrodes.

[0453] Item 8. The system of Item 7, wherein at least one of the following applies:

[0454] a. at least a portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 and T2 are not

[0455] Same or identical;

[0456] b. said at least one mucosal tissue site is located in the vagina; and

[0457] c. The system further comprises a database configured to store: at least one temperature distribution, the temperature distribution comprising at least one temperature, and at least one predetermined portion of the at least one site of the mucosal tissue.

[0458] Item 9. The system of Item 8, wherein at least one of the following applies:

[0459] a. The system further comprises communicating with the database and with at least one temperature sensor

[0460] Processor;

[0461] b. The control system monitors body tissue parameters and changes the applied

[0462] A member of the group consisting of heat, said electromagnetic pulse, and any combination thereof;

[0463] c. The duration of each pulse applied by the system ranges from about 3 ms to about 1000 ms;

[0464] d. The frequency F applied by the electromagnetic pulse of the system ranges from about 1 Hz to about 50 Hz

[0465] between;

[0466] e. The frequency range of the RF pulses applied by the system is about 200 kHz to about 10

[0467] MHz; and

[0468] f. The power P applied by the RF of the system ranges from about 1W to about 100W

[0469] The RMS average power is between

[0470] Item 10. The system of Item 9, wherein at least one of the following applies:

[0471] a. Each of the at least one temperature sensor is configured to measure at least one temperature in the predetermined portion of the at least one mucosal site of the patient; and

[0472] b. The at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0473] Item 11. A method configured to synergistically apply heat and

[0474] A system for enhancing the healing of at least one of said sites of mucosal tissue of a patient using a pulsed electromagnetic field (PEMF), the system comprising:

[0475] a pulsed electromagnetic field generator for generating a pulsed electromagnetic field (PEMF) frequency for applying a pulsed electromagnetic field (PEMF) to at least one of the mucosal tissues of the patient according to a predetermined protocol;

[0476] providing an electromagnetic pulse to said site; and

[0477] an RF generator configured to operate a plurality of electrodes, said operation of said electrodes being configured to induce tissue diathermy;

[0478] wherein said system is configured to provide rejuvenation of at least one said site of mucosal tissue by a synergistic combination of said PEMF and said tissue diathermy;

[0479] Furthermore, the plurality of electrodes are configured to be placed on the at least one location of the patient's mucosal tissue.

[0480] Item 12. The system of Item 11, wherein at least one of the following applies:

[0481] a. at least one of the portions of mucosal tissue is located in the vagina;

[0482] b. The system further comprises at least one temperature sensor, wherein the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

[0483] c. at least a portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 and T2 are not

[0484] Same or identical;

[0485] d. The system further comprises a database configured to store: at least one temperature distribution, the temperature distribution comprising at least one temperature, and the mucosal tissue site

[0486] at least in part;

[0487] e. A control system comprising a control system for cooling the area of ​​mucosal tissue

[0488] cooling mechanism; and

[0489] f. The system is housed in at least one platform.

[0490] Item 13. The system of Item 12, wherein at least one of the following applies:

[0491] a. The system further comprises at least one temperature sensor and a database

[0492] a processor for communications;

[0493] b. A member of the group consisting of said temperature, said temperature range T1, said temperature range T2, and any combination thereof is above about 30 degrees Celsius and below about 80 degrees Celsius.

[0494] Item 14. The system of Item 13, wherein at least one of the following applies:

[0495] a. The processor is configured to feedback control the pulse electromagnetic frequency generator and the RF generator so that at least one predetermined location outside the device can be maintained.

[0496] said temperature distribution;

[0497] b. Each of said at least one temperature is measurable in said at least a portion of said site of mucosal tissue.

[0498] Item 15. A system according to Item 14, wherein all of the electrodes are configured to direct the mucosal

[0499] The RF power is applied simultaneously to the portion of the tissue.

[0500] Item 16. An integrated system for enhancing the recovery of at least one part of a patient, the at least one

[0501] A site is selected from the group consisting of the skin of the patient, the mucosal tissue of the patient, and any combination thereof, the system comprising:

[0502] At least two electrodes, the at least two electrodes are configured to be placed on the patient's

[0503] At least one of the above mentioned parts;

[0504] an electromagnetic field generator configured to generate electromagnetic field pulses;

[0505] a generator configured to generate RF power; and

[0506] Control systems;

[0507] in,

[0508] The at least two electrodes are not configured to penetrate the at least one site;

[0509] Each of the at least two electrodes is configured to provide RF pulses to at least one of the sites, the RF power being configured to apply heat up to a temperature T in the range of about 30 degrees Celsius to about 80 degrees Celsius;

[0510] The control system is configured to control a member of the group consisting of: the electromagnetic field generator, the application of the heat by the electrodes, and any combination thereof; and

[0511] The electromagnetic pulses can be applied to the at least one location, and the heat can be applied to the at least one location in a manner selected from the group consisting of simultaneously, sequentially, separately, and any combination thereof.

[0512] Item 17. The system of Item 16, wherein at least one of the following applies:

[0513] a. at least a portion of the at least one portion can at least temporarily be maintained in a predetermined temperature range T1, while at least another portion of the at least one portion can at least temporarily be maintained

[0514] In a predetermined temperature range T2, wherein T1 is different from or the same as T2;

[0515] b. said at least one part of the patient is located in the vagina;

[0516] c. The system further comprises a database configured to store: at least one temperature distribution, the temperature distribution comprising at least one temperature, and at least one

[0517] Predetermined part;

[0518] d. The application can be obtained by emitting RF radiation or by generating an electric current absorbed by the tissue.

[0519] said heat applied to said part of said patient;

[0520] e. The system is configured to provide a dynamic magnetic field so that the amplitude of the electromagnetic pulse varies with

[0521] Time can change;

[0522] f. The control system can monitor body tissue parameters and accordingly can change the members of the group consisting of the applied heat, the electromagnetic pulses and any combination thereof;

[0523] g. The duration of each pulse applied by the system ranges from about 3 ms to about 1000 ms;

[0524] h. The frequency F applied by the pulses of the system ranges from about 200 kHz to about 1 MHz

[0525] between; and

[0526] i. The power P applied by the pulses of the system ranges from about 1 W to about 100 W of RMS average power.

[0527] Item 18. The system according to Item 17 further comprises a temperature sensor connected to the database and to at least one temperature sensor.

[0528] a processor communicating with a device, the at least one temperature sensor being configured to measure at least one temperature of at least a portion of the at least one part of the patient; the at least one temperature sensor being selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

Claims

1. A cosmetic device for restoring at least one portion of mucosal tissue, comprising: a pulsed electromagnetic frequency generator that applies pulsed electromagnetic field therapy to the at least one site of mucosal tissue; a cylindrical housing including a plurality of ring electrodes surrounding an exterior of the housing in communication with an RF tissue diathermy device, the plurality of ring electrodes being configured to be placed on at least one of the sites of the mucosal tissue; Control systems; as well as at least one temperature sensor in communication with the control system, wherein the RF tissue diathermy device heats the at least one portion of mucosal tissue via the plurality of annular electrodes; wherein said at least one portion of said mucosal tissue is located in the vagina; wherein the control system is adapted to: create at least one temperature distribution of the mucosal tissue based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature distribution of the at least one portion of the mucosal tissue; and adjust the RF power applied to each of the plurality of annular electrodes according to the predetermined temperature distribution; and Wherein the at least one temperature sensor is disposed adjacent to at least one of the plurality of annular electrodes, and wherein at least a portion of each of the plurality of annular electrodes is individually and separately temperature controlled.

2. The cosmetic device for restoring at least one part of mucosal tissue according to claim 1, wherein: At least one of the following applies: At least a portion of the at least one portion of the mucosal tissue is at least temporarily maintainable within a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue is at least temporarily maintainable within a predetermined temperature range T2, wherein T1 is the same as or different from T2; and The cosmetic device further includes a processor in communication with the at least one temperature sensor and with a database, the at least one temperature sensor being selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

3. The cosmetic device for restoring at least one part of mucosal tissue according to claim 2, in, At least one of the following applies: The processor is configured to feedback-control RF output of the pulsed electromagnetic frequency generator and the RF tissue diathermy device so that the at least one temperature profile created based on the feedback can be maintained in at least one predetermined location outside the cosmetic device; as well as At least one temperature is measurable by the at least one temperature sensor in the at least a portion of the site of the mucosal tissue.

4. The cosmetic device for restoring at least one part of mucosal tissue according to claim 1, in, At least one of the following applies: The duration of the pulses from the pulsed electromagnetic frequency generator is between 3 ms and 1000 ms; The frequency F of the pulses from the pulsed electromagnetic frequency generator is between 1 Hz and 50 Hz; and The pulsed electromagnetic power from the pulsed electromagnetic frequency generator is configured to stimulate collagen production.

5. The cosmetic device for restoring at least one part of mucosal tissue according to claim 1, wherein: At least one of the following applies: The pulsed electromagnetic power from the pulsed electromagnetic frequency generator is configured to induce angiogenesis; or The pulsed electromagnetic power from the pulsed electromagnetic frequency generator comprises pulses at a frequency F of 15 Hz and a magnetic field strength B of 12 Gauss.

6. The cosmetic device for restoring at least one part of a mucosal tissue according to claim 1, wherein: At least one temperature in the at least one temperature profile created based on feedback, one or more of the predetermined temperature range T1 or the predetermined temperature range T2 is: between 30 degrees Celsius and 80 degrees Celsius; or between 40 degrees Celsius and 50 degrees Celsius.

7. An integrated system for enhancing the healing of at least one site of mucosal tissue in a patient, the system comprising: a pulsed electromagnetic frequency generator that applies pulsed electromagnetic field therapy to the at least one site of mucosal tissue; a cylindrical housing comprising at least two annular electrodes surrounding an exterior of the housing, the at least two annular electrodes being configured to be placed on the at least one site of mucosal tissue of the patient; Control systems; as well as at least one temperature sensor in communication with the control system; in, The at least two annular electrodes are not configured to penetrate the at least one site of mucosal tissue of the patient; Each of the at least two annular electrodes is configured to conduct RF to the at least one location of the patient's mucosal tissue; the at least two annular electrodes are configured to heat the mucosal tissue to a temperature T in the range of 30 degrees Celsius to 80 degrees Celsius; and The control system is configured to control the application of heat by the at least two annular electrodes; wherein the at least one portion of the patient's mucosal tissue is located in the vagina; In addition, the control system is adapted to: create at least one temperature profile of the patient based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature profile of the at least one portion of the patient's mucosal tissue; and adjust the RF power applied to each of the at least two annular electrodes according to the predetermined temperature profile; and Wherein, the at least one temperature sensor is disposed adjacent to at least one of the at least two annular electrodes, and wherein at least a portion of each of the at least two annular electrodes is temperature controlled individually and separately.

8. An integrated system for enhancing the healing of at least one site of mucosal tissue in a patient according to claim 7, wherein: At least one of the following applies: At least a portion of the at least one portion of the mucosal tissue is at least temporarily maintainable within a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue is at least temporarily maintainable within a predetermined temperature range T2, wherein T1 is different from or the same as T2; and The system also includes a database configured to store the at least one temperature profile created based on the feedback, the at least one temperature profile including at least one temperature and at least one predetermined portion of the at least one site of the mucosal tissue.

9. An integrated system for enhancing the healing of at least one site of mucosal tissue of a patient according to claim 8, wherein: At least one of the following applies: The system also includes a processor in communication with the database and with the at least one temperature sensor; The control system further comprises an electromagnetic field generator, and the control system monitors body tissue parameters and accordingly varies a member of the group consisting of the applied heat, electromagnetic field pulses from the electromagnetic field generator, and any combination thereof; The control system further comprises an electromagnetic field generator, and the duration of each electromagnetic field pulse applied by the electromagnetic field generator is between 3 ms and 1000 ms; The control system further comprises an electromagnetic field generator, and the frequency F of the electromagnetic field pulses applied by the electromagnetic field generator is between 1 Hz and 50 Hz; The frequency of the RF pulses applied by the system is between 200 kHz and 10 MHz; and The power P applied by the RF pulses of the system is between 1 W and 100 W of RMS average power.

10. An integrated system for enhancing the healing of at least one site of mucosal tissue of a patient according to claim 9, wherein: At least one of the following applies: Each of the at least one temperature sensor is configured to measure at least one temperature in the predetermined portion of the at least one part of the patient; and The at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

11. A system configured to enhance healing of at least one site of mucosal tissue of a patient by applying heat to at least one site of mucosal tissue of the patient, the system comprising: a pulsed electromagnetic frequency generator that applies pulsed electromagnetic field therapy to the at least one site of mucosal tissue; a cylindrical housing including a plurality of annular electrodes surrounding an exterior of the housing; an RF generator configured to operate the plurality of annular electrodes, the operation of the plurality of annular electrodes being configured to induce tissue diathermy; wherein the system is configured to provide restoration of the at least one site of mucosal tissue by the tissue diathermy; Furthermore, wherein the plurality of annular electrodes are configured to be placed on the at least one site of the patient's mucosal tissue; Wherein, the system further comprises a control system and at least one temperature sensor in communication with the control system; wherein the at least one portion of the patient's mucosal tissue is located within the vagina; In addition, the control system is adapted to: create at least one temperature profile of the patient based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature profile of the part of the patient; and adjust the RF power applied to each of the plurality of annular electrodes according to the predetermined temperature profile; and Wherein the at least one temperature sensor is disposed adjacent to at least one of the plurality of annular electrodes, and wherein at least a portion of each of the plurality of annular electrodes is individually and separately temperature controlled.

12. The system of claim 11 configured to enhance healing of at least one portion of mucosal tissue of a patient by applying heat to the at least one portion of mucosal tissue of the patient, wherein: At least one of the following applies: The at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof; At least a portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T1, while at least another portion of the at least one portion of the mucosal tissue can be at least temporarily maintained in a predetermined temperature range T2, wherein T1 is different from or the same as T2; The system further comprises a database configured to store: at least one temperature profile, the temperature profile comprising at least one temperature, and at least a portion of the at least one site of the mucosal tissue; a control system including a cooling mechanism for cooling the region of mucosal tissue; and The system is housed in at least one platform.

13. The system of claim 12 configured to enhance healing of at least one portion of mucosal tissue of a patient by applying heat to the at least one portion of mucosal tissue of the patient, wherein: At least one of the following applies: The system also includes a processor in communication with the at least one temperature sensor and with the database; The temperature, the predetermined temperature range T1, the predetermined temperature range T2, and any combination thereof are higher than 30 degrees Celsius and lower than 80 degrees Celsius.

14. The system of claim 13 configured to enhance healing of at least one portion of mucosal tissue of a patient by applying heat to the at least one portion of mucosal tissue of the patient, the system further comprising a pulsed electromagnetic field generator, wherein: At least one of the following applies: The processor is configured to feedback-control the pulsed electromagnetic field generator and the RF generator so that the at least one temperature distribution created based on the feedback is maintained in at least one predetermined location outside the system; Each of the at least one temperature is measurable in the at least a portion of the site of mucosal tissue.

15. The system of claim 14 configured to enhance healing of at least one portion of mucosal tissue of a patient by applying heat to the at least one portion of mucosal tissue of the patient, wherein: All of the plurality of ring electrodes are configured to simultaneously apply the RF power to the site of mucosal tissue.

16. An integrated system for enhancing healing of at least one part of a patient, the system comprising: a pulsed electromagnetic frequency generator that applies pulsed electromagnetic field therapy to the at least one site of the patient; a cylindrical housing comprising at least two ring electrodes surrounding an exterior of the housing, the at least two ring electrodes being configured to be placed on the at least one site of the patient; a generator configured to generate RF power; Control systems; as well as at least one temperature sensor in communication with the control system; in, The at least two annular electrodes are not configured to penetrate the at least one site; Each of the at least two annular electrodes is configured to provide RF pulses to the at least one site, the RF power being configured to apply heat up to a temperature T from 30 degrees Celsius to 80 degrees Celsius; The control system is configured to control the application of the heat by the at least two annular electrodes; and The heat can be applied to the at least one location in a manner selected from the group consisting of simultaneously, sequentially, separately, and any combination thereof; wherein the at least one part of the patient is located in the vagina; In addition, the control system is adapted to: create at least one temperature profile of the patient based on feedback by comparing the temperature measured by the at least one temperature sensor with at least one predetermined temperature profile of the part of the patient; and adjust the RF power applied to each of the at least two annular electrodes according to the predetermined temperature profile; and Wherein, the at least one temperature sensor is disposed adjacent to the at least two annular electrodes, and wherein the temperature of at least a portion of each of the at least two annular electrodes is individually and separately controlled.

17. An integrated system for enhancing healing of at least one part of a patient according to claim 16, wherein: At least one of the following applies: At least a portion of the at least one portion can be maintained at least temporarily in a predetermined temperature range T1, while at least another portion of the at least one portion can be maintained at least temporarily in a predetermined temperature range T2, wherein T1 is different from or the same as T2; The system further includes a database configured to store: at least one temperature profile, the temperature profile including at least one temperature, and at least one predetermined location of the patient; said heat applied to said region of said patient can be obtained by emitting RF radiation or by generating an electric current absorbed by tissue; The system further comprises a pulsed electromagnetic field generator configured to generate electromagnetic field pulses, the system being configured to provide a dynamic magnetic field such that the amplitude of the electromagnetic field pulses can vary over time; Body tissue parameters can be monitored by said control system and members of the group consisting of said applied heat, said electromagnetic field pulses, and any combination thereof can be varied accordingly; The duration of each pulse applied by the system is between 3 ms and 1000 ms; The frequency F of the electromagnetic field pulses applied by the system is between 200 kHz and 1 MHz; as well as The power P applied by the electromagnetic field pulses of the system is between 1 W and 100 W RMS average power.

18. An integrated system for enhancing the recovery of at least one part of a patient according to claim 17, further comprising a processor in communication with the database and with at least one temperature sensor, wherein the at least one temperature sensor is configured to measure at least one temperature in at least a portion of the at least one part of the patient; the at least one temperature sensor is selected from the group consisting of a thermistor, a thermocouple, and any combination thereof.

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